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OBG Management is a leading publication in the ObGyn specialty addressing patient care and practice management under one cover.
gambling
compulsive behaviors
ammunition
assault rifle
black jack
Boko Haram
bondage
child abuse
cocaine
Daech
drug paraphernalia
explosion
gun
human trafficking
ISIL
ISIS
Islamic caliphate
Islamic state
mixed martial arts
MMA
molestation
national rifle association
NRA
nsfw
pedophile
pedophilia
poker
porn
pornography
psychedelic drug
recreational drug
sex slave rings
slot machine
terrorism
terrorist
Texas hold 'em
UFC
substance abuse
abuseed
abuseer
abusees
abuseing
abusely
abuses
aeolus
aeolused
aeoluser
aeoluses
aeolusing
aeolusly
aeoluss
ahole
aholeed
aholeer
aholees
aholeing
aholely
aholes
alcohol
alcoholed
alcoholer
alcoholes
alcoholing
alcoholly
alcohols
allman
allmaned
allmaner
allmanes
allmaning
allmanly
allmans
alted
altes
alting
altly
alts
analed
analer
anales
analing
anally
analprobe
analprobeed
analprobeer
analprobees
analprobeing
analprobely
analprobes
anals
anilingus
anilingused
anilinguser
anilinguses
anilingusing
anilingusly
anilinguss
anus
anused
anuser
anuses
anusing
anusly
anuss
areola
areolaed
areolaer
areolaes
areolaing
areolaly
areolas
areole
areoleed
areoleer
areolees
areoleing
areolely
areoles
arian
arianed
arianer
arianes
arianing
arianly
arians
aryan
aryaned
aryaner
aryanes
aryaning
aryanly
aryans
asiaed
asiaer
asiaes
asiaing
asialy
asias
ass
ass hole
ass lick
ass licked
ass licker
ass lickes
ass licking
ass lickly
ass licks
assbang
assbanged
assbangeded
assbangeder
assbangedes
assbangeding
assbangedly
assbangeds
assbanger
assbanges
assbanging
assbangly
assbangs
assbangsed
assbangser
assbangses
assbangsing
assbangsly
assbangss
assed
asser
asses
assesed
asseser
asseses
assesing
assesly
assess
assfuck
assfucked
assfucker
assfuckered
assfuckerer
assfuckeres
assfuckering
assfuckerly
assfuckers
assfuckes
assfucking
assfuckly
assfucks
asshat
asshated
asshater
asshates
asshating
asshatly
asshats
assholeed
assholeer
assholees
assholeing
assholely
assholes
assholesed
assholeser
assholeses
assholesing
assholesly
assholess
assing
assly
assmaster
assmastered
assmasterer
assmasteres
assmastering
assmasterly
assmasters
assmunch
assmunched
assmuncher
assmunches
assmunching
assmunchly
assmunchs
asss
asswipe
asswipeed
asswipeer
asswipees
asswipeing
asswipely
asswipes
asswipesed
asswipeser
asswipeses
asswipesing
asswipesly
asswipess
azz
azzed
azzer
azzes
azzing
azzly
azzs
babeed
babeer
babees
babeing
babely
babes
babesed
babeser
babeses
babesing
babesly
babess
ballsac
ballsaced
ballsacer
ballsaces
ballsacing
ballsack
ballsacked
ballsacker
ballsackes
ballsacking
ballsackly
ballsacks
ballsacly
ballsacs
ballsed
ballser
ballses
ballsing
ballsly
ballss
barf
barfed
barfer
barfes
barfing
barfly
barfs
bastard
bastarded
bastarder
bastardes
bastarding
bastardly
bastards
bastardsed
bastardser
bastardses
bastardsing
bastardsly
bastardss
bawdy
bawdyed
bawdyer
bawdyes
bawdying
bawdyly
bawdys
beaner
beanered
beanerer
beaneres
beanering
beanerly
beaners
beardedclam
beardedclamed
beardedclamer
beardedclames
beardedclaming
beardedclamly
beardedclams
beastiality
beastialityed
beastialityer
beastialityes
beastialitying
beastialityly
beastialitys
beatch
beatched
beatcher
beatches
beatching
beatchly
beatchs
beater
beatered
beaterer
beateres
beatering
beaterly
beaters
beered
beerer
beeres
beering
beerly
beeyotch
beeyotched
beeyotcher
beeyotches
beeyotching
beeyotchly
beeyotchs
beotch
beotched
beotcher
beotches
beotching
beotchly
beotchs
biatch
biatched
biatcher
biatches
biatching
biatchly
biatchs
big tits
big titsed
big titser
big titses
big titsing
big titsly
big titss
bigtits
bigtitsed
bigtitser
bigtitses
bigtitsing
bigtitsly
bigtitss
bimbo
bimboed
bimboer
bimboes
bimboing
bimboly
bimbos
bisexualed
bisexualer
bisexuales
bisexualing
bisexually
bisexuals
bitch
bitched
bitcheded
bitcheder
bitchedes
bitcheding
bitchedly
bitcheds
bitcher
bitches
bitchesed
bitcheser
bitcheses
bitchesing
bitchesly
bitchess
bitching
bitchly
bitchs
bitchy
bitchyed
bitchyer
bitchyes
bitchying
bitchyly
bitchys
bleached
bleacher
bleaches
bleaching
bleachly
bleachs
blow job
blow jobed
blow jober
blow jobes
blow jobing
blow jobly
blow jobs
blowed
blower
blowes
blowing
blowjob
blowjobed
blowjober
blowjobes
blowjobing
blowjobly
blowjobs
blowjobsed
blowjobser
blowjobses
blowjobsing
blowjobsly
blowjobss
blowly
blows
boink
boinked
boinker
boinkes
boinking
boinkly
boinks
bollock
bollocked
bollocker
bollockes
bollocking
bollockly
bollocks
bollocksed
bollockser
bollockses
bollocksing
bollocksly
bollockss
bollok
bolloked
bolloker
bollokes
bolloking
bollokly
bolloks
boner
bonered
bonerer
boneres
bonering
bonerly
boners
bonersed
bonerser
bonerses
bonersing
bonersly
bonerss
bong
bonged
bonger
bonges
bonging
bongly
bongs
boob
boobed
boober
boobes
boobies
boobiesed
boobieser
boobieses
boobiesing
boobiesly
boobiess
boobing
boobly
boobs
boobsed
boobser
boobses
boobsing
boobsly
boobss
booby
boobyed
boobyer
boobyes
boobying
boobyly
boobys
booger
boogered
boogerer
boogeres
boogering
boogerly
boogers
bookie
bookieed
bookieer
bookiees
bookieing
bookiely
bookies
bootee
booteeed
booteeer
booteees
booteeing
booteely
bootees
bootie
bootieed
bootieer
bootiees
bootieing
bootiely
booties
booty
bootyed
bootyer
bootyes
bootying
bootyly
bootys
boozeed
boozeer
boozees
boozeing
boozely
boozer
boozered
boozerer
boozeres
boozering
boozerly
boozers
boozes
boozy
boozyed
boozyer
boozyes
boozying
boozyly
boozys
bosomed
bosomer
bosomes
bosoming
bosomly
bosoms
bosomy
bosomyed
bosomyer
bosomyes
bosomying
bosomyly
bosomys
bugger
buggered
buggerer
buggeres
buggering
buggerly
buggers
bukkake
bukkakeed
bukkakeer
bukkakees
bukkakeing
bukkakely
bukkakes
bull shit
bull shited
bull shiter
bull shites
bull shiting
bull shitly
bull shits
bullshit
bullshited
bullshiter
bullshites
bullshiting
bullshitly
bullshits
bullshitsed
bullshitser
bullshitses
bullshitsing
bullshitsly
bullshitss
bullshitted
bullshitteded
bullshitteder
bullshittedes
bullshitteding
bullshittedly
bullshitteds
bullturds
bullturdsed
bullturdser
bullturdses
bullturdsing
bullturdsly
bullturdss
bung
bunged
bunger
bunges
bunging
bungly
bungs
busty
bustyed
bustyer
bustyes
bustying
bustyly
bustys
butt
butt fuck
butt fucked
butt fucker
butt fuckes
butt fucking
butt fuckly
butt fucks
butted
buttes
buttfuck
buttfucked
buttfucker
buttfuckered
buttfuckerer
buttfuckeres
buttfuckering
buttfuckerly
buttfuckers
buttfuckes
buttfucking
buttfuckly
buttfucks
butting
buttly
buttplug
buttpluged
buttpluger
buttpluges
buttpluging
buttplugly
buttplugs
butts
caca
cacaed
cacaer
cacaes
cacaing
cacaly
cacas
cahone
cahoneed
cahoneer
cahonees
cahoneing
cahonely
cahones
cameltoe
cameltoeed
cameltoeer
cameltoees
cameltoeing
cameltoely
cameltoes
carpetmuncher
carpetmunchered
carpetmuncherer
carpetmuncheres
carpetmunchering
carpetmuncherly
carpetmunchers
cawk
cawked
cawker
cawkes
cawking
cawkly
cawks
chinc
chinced
chincer
chinces
chincing
chincly
chincs
chincsed
chincser
chincses
chincsing
chincsly
chincss
chink
chinked
chinker
chinkes
chinking
chinkly
chinks
chode
chodeed
chodeer
chodees
chodeing
chodely
chodes
chodesed
chodeser
chodeses
chodesing
chodesly
chodess
clit
clited
cliter
clites
cliting
clitly
clitoris
clitorised
clitoriser
clitorises
clitorising
clitorisly
clitoriss
clitorus
clitorused
clitoruser
clitoruses
clitorusing
clitorusly
clitoruss
clits
clitsed
clitser
clitses
clitsing
clitsly
clitss
clitty
clittyed
clittyer
clittyes
clittying
clittyly
clittys
cocain
cocaine
cocained
cocaineed
cocaineer
cocainees
cocaineing
cocainely
cocainer
cocaines
cocaining
cocainly
cocains
cock
cock sucker
cock suckered
cock suckerer
cock suckeres
cock suckering
cock suckerly
cock suckers
cockblock
cockblocked
cockblocker
cockblockes
cockblocking
cockblockly
cockblocks
cocked
cocker
cockes
cockholster
cockholstered
cockholsterer
cockholsteres
cockholstering
cockholsterly
cockholsters
cocking
cockknocker
cockknockered
cockknockerer
cockknockeres
cockknockering
cockknockerly
cockknockers
cockly
cocks
cocksed
cockser
cockses
cocksing
cocksly
cocksmoker
cocksmokered
cocksmokerer
cocksmokeres
cocksmokering
cocksmokerly
cocksmokers
cockss
cocksucker
cocksuckered
cocksuckerer
cocksuckeres
cocksuckering
cocksuckerly
cocksuckers
coital
coitaled
coitaler
coitales
coitaling
coitally
coitals
commie
commieed
commieer
commiees
commieing
commiely
commies
condomed
condomer
condomes
condoming
condomly
condoms
coon
cooned
cooner
coones
cooning
coonly
coons
coonsed
coonser
coonses
coonsing
coonsly
coonss
corksucker
corksuckered
corksuckerer
corksuckeres
corksuckering
corksuckerly
corksuckers
cracked
crackwhore
crackwhoreed
crackwhoreer
crackwhorees
crackwhoreing
crackwhorely
crackwhores
crap
craped
craper
crapes
craping
craply
crappy
crappyed
crappyer
crappyes
crappying
crappyly
crappys
cum
cumed
cumer
cumes
cuming
cumly
cummin
cummined
cumminer
cummines
cumming
cumminged
cumminger
cumminges
cumminging
cummingly
cummings
cummining
cumminly
cummins
cums
cumshot
cumshoted
cumshoter
cumshotes
cumshoting
cumshotly
cumshots
cumshotsed
cumshotser
cumshotses
cumshotsing
cumshotsly
cumshotss
cumslut
cumsluted
cumsluter
cumslutes
cumsluting
cumslutly
cumsluts
cumstain
cumstained
cumstainer
cumstaines
cumstaining
cumstainly
cumstains
cunilingus
cunilingused
cunilinguser
cunilinguses
cunilingusing
cunilingusly
cunilinguss
cunnilingus
cunnilingused
cunnilinguser
cunnilinguses
cunnilingusing
cunnilingusly
cunnilinguss
cunny
cunnyed
cunnyer
cunnyes
cunnying
cunnyly
cunnys
cunt
cunted
cunter
cuntes
cuntface
cuntfaceed
cuntfaceer
cuntfacees
cuntfaceing
cuntfacely
cuntfaces
cunthunter
cunthuntered
cunthunterer
cunthunteres
cunthuntering
cunthunterly
cunthunters
cunting
cuntlick
cuntlicked
cuntlicker
cuntlickered
cuntlickerer
cuntlickeres
cuntlickering
cuntlickerly
cuntlickers
cuntlickes
cuntlicking
cuntlickly
cuntlicks
cuntly
cunts
cuntsed
cuntser
cuntses
cuntsing
cuntsly
cuntss
dago
dagoed
dagoer
dagoes
dagoing
dagoly
dagos
dagosed
dagoser
dagoses
dagosing
dagosly
dagoss
dammit
dammited
dammiter
dammites
dammiting
dammitly
dammits
damn
damned
damneded
damneder
damnedes
damneding
damnedly
damneds
damner
damnes
damning
damnit
damnited
damniter
damnites
damniting
damnitly
damnits
damnly
damns
dick
dickbag
dickbaged
dickbager
dickbages
dickbaging
dickbagly
dickbags
dickdipper
dickdippered
dickdipperer
dickdipperes
dickdippering
dickdipperly
dickdippers
dicked
dicker
dickes
dickface
dickfaceed
dickfaceer
dickfacees
dickfaceing
dickfacely
dickfaces
dickflipper
dickflippered
dickflipperer
dickflipperes
dickflippering
dickflipperly
dickflippers
dickhead
dickheaded
dickheader
dickheades
dickheading
dickheadly
dickheads
dickheadsed
dickheadser
dickheadses
dickheadsing
dickheadsly
dickheadss
dicking
dickish
dickished
dickisher
dickishes
dickishing
dickishly
dickishs
dickly
dickripper
dickrippered
dickripperer
dickripperes
dickrippering
dickripperly
dickrippers
dicks
dicksipper
dicksippered
dicksipperer
dicksipperes
dicksippering
dicksipperly
dicksippers
dickweed
dickweeded
dickweeder
dickweedes
dickweeding
dickweedly
dickweeds
dickwhipper
dickwhippered
dickwhipperer
dickwhipperes
dickwhippering
dickwhipperly
dickwhippers
dickzipper
dickzippered
dickzipperer
dickzipperes
dickzippering
dickzipperly
dickzippers
diddle
diddleed
diddleer
diddlees
diddleing
diddlely
diddles
dike
dikeed
dikeer
dikees
dikeing
dikely
dikes
dildo
dildoed
dildoer
dildoes
dildoing
dildoly
dildos
dildosed
dildoser
dildoses
dildosing
dildosly
dildoss
diligaf
diligafed
diligafer
diligafes
diligafing
diligafly
diligafs
dillweed
dillweeded
dillweeder
dillweedes
dillweeding
dillweedly
dillweeds
dimwit
dimwited
dimwiter
dimwites
dimwiting
dimwitly
dimwits
dingle
dingleed
dingleer
dinglees
dingleing
dinglely
dingles
dipship
dipshiped
dipshiper
dipshipes
dipshiping
dipshiply
dipships
dizzyed
dizzyer
dizzyes
dizzying
dizzyly
dizzys
doggiestyleed
doggiestyleer
doggiestylees
doggiestyleing
doggiestylely
doggiestyles
doggystyleed
doggystyleer
doggystylees
doggystyleing
doggystylely
doggystyles
dong
donged
donger
donges
donging
dongly
dongs
doofus
doofused
doofuser
doofuses
doofusing
doofusly
doofuss
doosh
dooshed
doosher
dooshes
dooshing
dooshly
dooshs
dopeyed
dopeyer
dopeyes
dopeying
dopeyly
dopeys
douchebag
douchebaged
douchebager
douchebages
douchebaging
douchebagly
douchebags
douchebagsed
douchebagser
douchebagses
douchebagsing
douchebagsly
douchebagss
doucheed
doucheer
douchees
doucheing
douchely
douches
douchey
doucheyed
doucheyer
doucheyes
doucheying
doucheyly
doucheys
drunk
drunked
drunker
drunkes
drunking
drunkly
drunks
dumass
dumassed
dumasser
dumasses
dumassing
dumassly
dumasss
dumbass
dumbassed
dumbasser
dumbasses
dumbassesed
dumbasseser
dumbasseses
dumbassesing
dumbassesly
dumbassess
dumbassing
dumbassly
dumbasss
dummy
dummyed
dummyer
dummyes
dummying
dummyly
dummys
dyke
dykeed
dykeer
dykees
dykeing
dykely
dykes
dykesed
dykeser
dykeses
dykesing
dykesly
dykess
erotic
eroticed
eroticer
erotices
eroticing
eroticly
erotics
extacy
extacyed
extacyer
extacyes
extacying
extacyly
extacys
extasy
extasyed
extasyer
extasyes
extasying
extasyly
extasys
fack
facked
facker
fackes
facking
fackly
facks
fag
faged
fager
fages
fagg
fagged
faggeded
faggeder
faggedes
faggeding
faggedly
faggeds
fagger
fagges
fagging
faggit
faggited
faggiter
faggites
faggiting
faggitly
faggits
faggly
faggot
faggoted
faggoter
faggotes
faggoting
faggotly
faggots
faggs
faging
fagly
fagot
fagoted
fagoter
fagotes
fagoting
fagotly
fagots
fags
fagsed
fagser
fagses
fagsing
fagsly
fagss
faig
faiged
faiger
faiges
faiging
faigly
faigs
faigt
faigted
faigter
faigtes
faigting
faigtly
faigts
fannybandit
fannybandited
fannybanditer
fannybandites
fannybanditing
fannybanditly
fannybandits
farted
farter
fartes
farting
fartknocker
fartknockered
fartknockerer
fartknockeres
fartknockering
fartknockerly
fartknockers
fartly
farts
felch
felched
felcher
felchered
felcherer
felcheres
felchering
felcherly
felchers
felches
felching
felchinged
felchinger
felchinges
felchinging
felchingly
felchings
felchly
felchs
fellate
fellateed
fellateer
fellatees
fellateing
fellately
fellates
fellatio
fellatioed
fellatioer
fellatioes
fellatioing
fellatioly
fellatios
feltch
feltched
feltcher
feltchered
feltcherer
feltcheres
feltchering
feltcherly
feltchers
feltches
feltching
feltchly
feltchs
feom
feomed
feomer
feomes
feoming
feomly
feoms
fisted
fisteded
fisteder
fistedes
fisteding
fistedly
fisteds
fisting
fistinged
fistinger
fistinges
fistinging
fistingly
fistings
fisty
fistyed
fistyer
fistyes
fistying
fistyly
fistys
floozy
floozyed
floozyer
floozyes
floozying
floozyly
floozys
foad
foaded
foader
foades
foading
foadly
foads
fondleed
fondleer
fondlees
fondleing
fondlely
fondles
foobar
foobared
foobarer
foobares
foobaring
foobarly
foobars
freex
freexed
freexer
freexes
freexing
freexly
freexs
frigg
frigga
friggaed
friggaer
friggaes
friggaing
friggaly
friggas
frigged
frigger
frigges
frigging
friggly
friggs
fubar
fubared
fubarer
fubares
fubaring
fubarly
fubars
fuck
fuckass
fuckassed
fuckasser
fuckasses
fuckassing
fuckassly
fuckasss
fucked
fuckeded
fuckeder
fuckedes
fuckeding
fuckedly
fuckeds
fucker
fuckered
fuckerer
fuckeres
fuckering
fuckerly
fuckers
fuckes
fuckface
fuckfaceed
fuckfaceer
fuckfacees
fuckfaceing
fuckfacely
fuckfaces
fuckin
fuckined
fuckiner
fuckines
fucking
fuckinged
fuckinger
fuckinges
fuckinging
fuckingly
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Even in a virtual environment, the Society of Gynecologic Surgeons delivers without a “glitch”
Earlier this year, I was honored to serve as the Scientific Program Chair for the 46th Annual Scientific Meeting of the Society of Gynecologic Surgeons (SGS). This year’s meeting was the first ever (and hopefully last) “virtual” scientific meeting, which consisted of a hybrid of prerecorded and live presentations. Although faculty and attendees were not able to be together physically, the essence of the lively SGS meetings came through loud and clear. We still had “discussants” comment on the oral presentations and ask questions of the presenters. These questions and answers were all done live—without a glitch! Many thanks to all who made this meeting possible.
In addition to the outstanding abstract and video presentations, there were 4 superb postgraduate courses:
- Mikio Nihira, MD, chaired “Enhanced recovery after surgery: Overcoming barriers to implementation.”
- Charles Hanes, MD, headed up “It’s all about the apex: The key to successful POP surgery.”
- Cara King, DO, MS, led “Total laparoscopic hysterectomy: Pushing the envelope.”
- Vincent Lucente, MD, chaired “Transvaginal reconstructive pelvic surgery using graft augmentation post-FDA.”
Many special thanks to Dr. Lucente who transformed his course into a wonderful article for this special section of
One of our exceptional keynote speakers was Marc Beer (a serial entrepreneur and cofounder, chairman, and CEO of Renovia, Inc.), whose talk was entitled “A primer on medical device innovation—How to avoid common pitfalls while realizing your vision.” Mr. Beer has turned this topic into a unique article for this special section (see next month’s issue for Part 2).
Our TeLinde Lecture, entitled “Artificial intelligence in surgery,” was delivered by the dynamic Vicente Gracias, MD, professor of surgery at Robert Wood Johnson University Hospital, New Brunswick, New Jersey. We also held 2 live panel discussions that were very popular. The first, “Work-life balance and gynecologic surgery,” featured various perspectives from Drs. Kristie Green, Sally Huber, Catherine Matthews, and Charles Rardin. The second panel discussion, entitled “Understanding, managing, and benefiting from your e-presence,” by experts Heather Schueppert; Chief Marketing Officer at Unified Physician Management, Brad Bowman, MD; and Peter Lotze, MD. Both of these panel discussions are included in this special section as well.
I hope you enjoy the content of this special section of
Earlier this year, I was honored to serve as the Scientific Program Chair for the 46th Annual Scientific Meeting of the Society of Gynecologic Surgeons (SGS). This year’s meeting was the first ever (and hopefully last) “virtual” scientific meeting, which consisted of a hybrid of prerecorded and live presentations. Although faculty and attendees were not able to be together physically, the essence of the lively SGS meetings came through loud and clear. We still had “discussants” comment on the oral presentations and ask questions of the presenters. These questions and answers were all done live—without a glitch! Many thanks to all who made this meeting possible.
In addition to the outstanding abstract and video presentations, there were 4 superb postgraduate courses:
- Mikio Nihira, MD, chaired “Enhanced recovery after surgery: Overcoming barriers to implementation.”
- Charles Hanes, MD, headed up “It’s all about the apex: The key to successful POP surgery.”
- Cara King, DO, MS, led “Total laparoscopic hysterectomy: Pushing the envelope.”
- Vincent Lucente, MD, chaired “Transvaginal reconstructive pelvic surgery using graft augmentation post-FDA.”
Many special thanks to Dr. Lucente who transformed his course into a wonderful article for this special section of
One of our exceptional keynote speakers was Marc Beer (a serial entrepreneur and cofounder, chairman, and CEO of Renovia, Inc.), whose talk was entitled “A primer on medical device innovation—How to avoid common pitfalls while realizing your vision.” Mr. Beer has turned this topic into a unique article for this special section (see next month’s issue for Part 2).
Our TeLinde Lecture, entitled “Artificial intelligence in surgery,” was delivered by the dynamic Vicente Gracias, MD, professor of surgery at Robert Wood Johnson University Hospital, New Brunswick, New Jersey. We also held 2 live panel discussions that were very popular. The first, “Work-life balance and gynecologic surgery,” featured various perspectives from Drs. Kristie Green, Sally Huber, Catherine Matthews, and Charles Rardin. The second panel discussion, entitled “Understanding, managing, and benefiting from your e-presence,” by experts Heather Schueppert; Chief Marketing Officer at Unified Physician Management, Brad Bowman, MD; and Peter Lotze, MD. Both of these panel discussions are included in this special section as well.
I hope you enjoy the content of this special section of
Earlier this year, I was honored to serve as the Scientific Program Chair for the 46th Annual Scientific Meeting of the Society of Gynecologic Surgeons (SGS). This year’s meeting was the first ever (and hopefully last) “virtual” scientific meeting, which consisted of a hybrid of prerecorded and live presentations. Although faculty and attendees were not able to be together physically, the essence of the lively SGS meetings came through loud and clear. We still had “discussants” comment on the oral presentations and ask questions of the presenters. These questions and answers were all done live—without a glitch! Many thanks to all who made this meeting possible.
In addition to the outstanding abstract and video presentations, there were 4 superb postgraduate courses:
- Mikio Nihira, MD, chaired “Enhanced recovery after surgery: Overcoming barriers to implementation.”
- Charles Hanes, MD, headed up “It’s all about the apex: The key to successful POP surgery.”
- Cara King, DO, MS, led “Total laparoscopic hysterectomy: Pushing the envelope.”
- Vincent Lucente, MD, chaired “Transvaginal reconstructive pelvic surgery using graft augmentation post-FDA.”
Many special thanks to Dr. Lucente who transformed his course into a wonderful article for this special section of
One of our exceptional keynote speakers was Marc Beer (a serial entrepreneur and cofounder, chairman, and CEO of Renovia, Inc.), whose talk was entitled “A primer on medical device innovation—How to avoid common pitfalls while realizing your vision.” Mr. Beer has turned this topic into a unique article for this special section (see next month’s issue for Part 2).
Our TeLinde Lecture, entitled “Artificial intelligence in surgery,” was delivered by the dynamic Vicente Gracias, MD, professor of surgery at Robert Wood Johnson University Hospital, New Brunswick, New Jersey. We also held 2 live panel discussions that were very popular. The first, “Work-life balance and gynecologic surgery,” featured various perspectives from Drs. Kristie Green, Sally Huber, Catherine Matthews, and Charles Rardin. The second panel discussion, entitled “Understanding, managing, and benefiting from your e-presence,” by experts Heather Schueppert; Chief Marketing Officer at Unified Physician Management, Brad Bowman, MD; and Peter Lotze, MD. Both of these panel discussions are included in this special section as well.
I hope you enjoy the content of this special section of
Is vertical transmission of SARS-CoV-2 possible? Is that the right question?
Pique-Regi R, Romero R, Tarca AL, et al. Does the human placenta express the canonical cell entry mediators for SARS CoV-2? eLife. 2020;9:e58716.
EXPERT COMMENTARY
Maternal infection with the novel SARS-CoV-2 virus has been associated with severe maternal morbidity and mortality causing adverse pregnancy outcomes, such as preterm birth and, potentially, stillbirth, with vertical transmission of the virus to the fetus possible.1,2
Uniquely, maternal physiology supports both pro- and anti-inflammatory states within pregnancy—a system that not only must protect the mother but also must tolerate a semi-allogenic fetus. Studies demonstrate that the first and third trimesters are pro-inflammatory, while the second trimester is thought to be anti-inflammatory.3 Since the discovery of the SARS-CoV-2 virus, the question surrounding vertical transmission (infectivity from mother to fetus via the placenta) has occupied the imagination of physicians, scientists, and pregnant women. Importantly, the virus is transmitted to human cells via the ACE2 (angiotensin-converting enzyme 2) receptor, which aids in viral cell attachment. ACE2 receptors are expressed in placental stromal cells, perivascular cells of decidua, cytotrophoblast and syncytiotrophoblast,4 as well as blood vessel endothelium and vascular smooth muscle from both primary and secondary villi.
Details of the study
In their recent study, Pique-Regi and colleagues used single-cell RNA sequencing data to investigate whether the receptors responsible for SARS-CoV-2 infection are expressed in the human placenta.5 Their findings suggest that TMPRSS2 is present in insufficient quantity in the placenta to make vertical transmission possible and/or clinically relevant. Thus, despite the presence of ACE2 receptors in placental tissue, without the enzymatic assistance of a helper protein like TMPRSS2 (transmembrane protease, serine 2), vertical transmission is highly unlikely. The researchers found that there was negligible co-transcription for ACE2 and TMPRSS2 in the placenta and that placental tissue lacks the mRNA necessary to produce the enzyme; they concluded that the likelihood of vertical transmission to the fetus was therefore unlikely.
As a caveat to their research, the authors noted that:
- transcription levels do not always correlate with protein expression
- it is possible that a noncanonical cell-entry mediator facilitates entry
- individuals with complications related to the renin-angiotensin-aldosterone system (such as hypertensive disease) may have alterations to the expression of ACE2.
Study strengths and limitations
Methods for this study reveal that the researchers examined 32 placentas, all taken in the third trimester (32.9-39.1 weeks), with a median gestational age of 36.9 weeks. Notably, 81.3% of placentas were from Black women, 6.2% from White women, and 12.5% from Other women. The median maternal age was 25 years, median body mass index was 27.8 kg/m2, and 84.4% of women were multiparous. While this sample was not representative of race, gestational age, or parity, it is difficult to know whether those selection biases would have changed the researchers' findings.
The question regarding vertical transmission is one not answered solely on the basis of RNA sequencing data. Clinically, we know that neonates of mothers infected with SARS-CoV-2 have been born with immunoglobulin M antibodies, indicating antenatal exposure to the virus.6,7 In addition, infants have tested positive immediately after birth for coronavirus disease 2019 (COVID-19) via nasopharyngeal swab and amniotic fluid, and there are ample cases of histologic and polymerase chain reaction evidence of placental infection.8,9 We also know that inflammatory damage to the placenta could possibly break down the placental barrier.10
The destruction that SARS-CoV-2 often leaves in its wake is devastating for the maternal-fetal dyad. The effects of maternal infection on the placenta—where additional research is needed—can be profound, causing profuse endothelial damage, vascular malperfusion, thrombi, and infarcts, all of which can be lethal to some developing fetuses.
While the study by Pique-Regi and colleagues is an important contribution to the literature, it does not satisfactorily answer the question regarding vertical transmission. More research is needed, especially regarding maternal infection in the first and second trimesters, on the effects on placental vasculature (and timing of infection in each trimester), the potential breakdown of the maternal-fetal barrier, and, most important, the clinical courses and outcomes in both mother and infant.
JANE VAN DIS, MD
- Khalil A, Kalafat E, Benlioglu C, et al. SARS-CoV-2 infection in pregnancy: a systematic review and meta-analysis of clinical features and pregnancy outcomes. EClinical Medicine. 2020;25:100446.
- Khalil A, von Dadelszen P, Draycott T, et al. Change in the incidence of stillbirth and preterm delivery during the COVID-19 pandemic. JAMA. 2020;324:705-706.
- Liu H, Wang LL, Zhao SJ, et al. Why are pregnant women susceptible to COVID-19? An immunological viewpoint. J Reprod Immunol. 2020;139;103122.
- Li M, Chen L, Zhang J, et al. The SARS-CoV-2 receptor ACE2 expression of maternal-fetal interface and fetal organs by single-cell transcriptome study. PLoS One. 2020;15:e0230295.
- Pique-Regi R, Romero R, Tarca AL, et al. Does the human placenta express the canonical cell entry mediators for SARS-CoV-2? eLife. 2020;9:e58716.
- Zeng H, Xu C, Fan J, et al. Antibodies in infants born to mothers with COVID-19 pneumonia. JAMA. 2020;323:1848-1849.
- Dong L, Tian J, He S, et al. Possible vertical transmission of SARS-CoV-2 from an infected mother to her newborn. JAMA. 2020;323:1846-1848.
- Kotlyar A, Grechukhina O, Chen A, et al. Vertical transmission of COVID-19: a systematic review and meta-analysis. Am J Obstet Gynecol. 2020;S0002-9378(20)30823-1.
- Richtmann R, Torloni MR, Oyamada Otani AR, et al. Fetal deaths in pregnancies with SARS-CoV-2 infection in Brazil: a case series. Case Rep Womens Health. 2020;e00243.
- Wang C, Zhou YH, Yang HX, et al. Intrauterine vertical transmission of SARS-CoV-2: what we know so far. Ultrasound Obstet Gynecol. 2020;55:724-725.
Pique-Regi R, Romero R, Tarca AL, et al. Does the human placenta express the canonical cell entry mediators for SARS CoV-2? eLife. 2020;9:e58716.
EXPERT COMMENTARY
Maternal infection with the novel SARS-CoV-2 virus has been associated with severe maternal morbidity and mortality causing adverse pregnancy outcomes, such as preterm birth and, potentially, stillbirth, with vertical transmission of the virus to the fetus possible.1,2
Uniquely, maternal physiology supports both pro- and anti-inflammatory states within pregnancy—a system that not only must protect the mother but also must tolerate a semi-allogenic fetus. Studies demonstrate that the first and third trimesters are pro-inflammatory, while the second trimester is thought to be anti-inflammatory.3 Since the discovery of the SARS-CoV-2 virus, the question surrounding vertical transmission (infectivity from mother to fetus via the placenta) has occupied the imagination of physicians, scientists, and pregnant women. Importantly, the virus is transmitted to human cells via the ACE2 (angiotensin-converting enzyme 2) receptor, which aids in viral cell attachment. ACE2 receptors are expressed in placental stromal cells, perivascular cells of decidua, cytotrophoblast and syncytiotrophoblast,4 as well as blood vessel endothelium and vascular smooth muscle from both primary and secondary villi.
Details of the study
In their recent study, Pique-Regi and colleagues used single-cell RNA sequencing data to investigate whether the receptors responsible for SARS-CoV-2 infection are expressed in the human placenta.5 Their findings suggest that TMPRSS2 is present in insufficient quantity in the placenta to make vertical transmission possible and/or clinically relevant. Thus, despite the presence of ACE2 receptors in placental tissue, without the enzymatic assistance of a helper protein like TMPRSS2 (transmembrane protease, serine 2), vertical transmission is highly unlikely. The researchers found that there was negligible co-transcription for ACE2 and TMPRSS2 in the placenta and that placental tissue lacks the mRNA necessary to produce the enzyme; they concluded that the likelihood of vertical transmission to the fetus was therefore unlikely.
As a caveat to their research, the authors noted that:
- transcription levels do not always correlate with protein expression
- it is possible that a noncanonical cell-entry mediator facilitates entry
- individuals with complications related to the renin-angiotensin-aldosterone system (such as hypertensive disease) may have alterations to the expression of ACE2.
Study strengths and limitations
Methods for this study reveal that the researchers examined 32 placentas, all taken in the third trimester (32.9-39.1 weeks), with a median gestational age of 36.9 weeks. Notably, 81.3% of placentas were from Black women, 6.2% from White women, and 12.5% from Other women. The median maternal age was 25 years, median body mass index was 27.8 kg/m2, and 84.4% of women were multiparous. While this sample was not representative of race, gestational age, or parity, it is difficult to know whether those selection biases would have changed the researchers' findings.
The question regarding vertical transmission is one not answered solely on the basis of RNA sequencing data. Clinically, we know that neonates of mothers infected with SARS-CoV-2 have been born with immunoglobulin M antibodies, indicating antenatal exposure to the virus.6,7 In addition, infants have tested positive immediately after birth for coronavirus disease 2019 (COVID-19) via nasopharyngeal swab and amniotic fluid, and there are ample cases of histologic and polymerase chain reaction evidence of placental infection.8,9 We also know that inflammatory damage to the placenta could possibly break down the placental barrier.10
The destruction that SARS-CoV-2 often leaves in its wake is devastating for the maternal-fetal dyad. The effects of maternal infection on the placenta—where additional research is needed—can be profound, causing profuse endothelial damage, vascular malperfusion, thrombi, and infarcts, all of which can be lethal to some developing fetuses.
While the study by Pique-Regi and colleagues is an important contribution to the literature, it does not satisfactorily answer the question regarding vertical transmission. More research is needed, especially regarding maternal infection in the first and second trimesters, on the effects on placental vasculature (and timing of infection in each trimester), the potential breakdown of the maternal-fetal barrier, and, most important, the clinical courses and outcomes in both mother and infant.
JANE VAN DIS, MD
Pique-Regi R, Romero R, Tarca AL, et al. Does the human placenta express the canonical cell entry mediators for SARS CoV-2? eLife. 2020;9:e58716.
EXPERT COMMENTARY
Maternal infection with the novel SARS-CoV-2 virus has been associated with severe maternal morbidity and mortality causing adverse pregnancy outcomes, such as preterm birth and, potentially, stillbirth, with vertical transmission of the virus to the fetus possible.1,2
Uniquely, maternal physiology supports both pro- and anti-inflammatory states within pregnancy—a system that not only must protect the mother but also must tolerate a semi-allogenic fetus. Studies demonstrate that the first and third trimesters are pro-inflammatory, while the second trimester is thought to be anti-inflammatory.3 Since the discovery of the SARS-CoV-2 virus, the question surrounding vertical transmission (infectivity from mother to fetus via the placenta) has occupied the imagination of physicians, scientists, and pregnant women. Importantly, the virus is transmitted to human cells via the ACE2 (angiotensin-converting enzyme 2) receptor, which aids in viral cell attachment. ACE2 receptors are expressed in placental stromal cells, perivascular cells of decidua, cytotrophoblast and syncytiotrophoblast,4 as well as blood vessel endothelium and vascular smooth muscle from both primary and secondary villi.
Details of the study
In their recent study, Pique-Regi and colleagues used single-cell RNA sequencing data to investigate whether the receptors responsible for SARS-CoV-2 infection are expressed in the human placenta.5 Their findings suggest that TMPRSS2 is present in insufficient quantity in the placenta to make vertical transmission possible and/or clinically relevant. Thus, despite the presence of ACE2 receptors in placental tissue, without the enzymatic assistance of a helper protein like TMPRSS2 (transmembrane protease, serine 2), vertical transmission is highly unlikely. The researchers found that there was negligible co-transcription for ACE2 and TMPRSS2 in the placenta and that placental tissue lacks the mRNA necessary to produce the enzyme; they concluded that the likelihood of vertical transmission to the fetus was therefore unlikely.
As a caveat to their research, the authors noted that:
- transcription levels do not always correlate with protein expression
- it is possible that a noncanonical cell-entry mediator facilitates entry
- individuals with complications related to the renin-angiotensin-aldosterone system (such as hypertensive disease) may have alterations to the expression of ACE2.
Study strengths and limitations
Methods for this study reveal that the researchers examined 32 placentas, all taken in the third trimester (32.9-39.1 weeks), with a median gestational age of 36.9 weeks. Notably, 81.3% of placentas were from Black women, 6.2% from White women, and 12.5% from Other women. The median maternal age was 25 years, median body mass index was 27.8 kg/m2, and 84.4% of women were multiparous. While this sample was not representative of race, gestational age, or parity, it is difficult to know whether those selection biases would have changed the researchers' findings.
The question regarding vertical transmission is one not answered solely on the basis of RNA sequencing data. Clinically, we know that neonates of mothers infected with SARS-CoV-2 have been born with immunoglobulin M antibodies, indicating antenatal exposure to the virus.6,7 In addition, infants have tested positive immediately after birth for coronavirus disease 2019 (COVID-19) via nasopharyngeal swab and amniotic fluid, and there are ample cases of histologic and polymerase chain reaction evidence of placental infection.8,9 We also know that inflammatory damage to the placenta could possibly break down the placental barrier.10
The destruction that SARS-CoV-2 often leaves in its wake is devastating for the maternal-fetal dyad. The effects of maternal infection on the placenta—where additional research is needed—can be profound, causing profuse endothelial damage, vascular malperfusion, thrombi, and infarcts, all of which can be lethal to some developing fetuses.
While the study by Pique-Regi and colleagues is an important contribution to the literature, it does not satisfactorily answer the question regarding vertical transmission. More research is needed, especially regarding maternal infection in the first and second trimesters, on the effects on placental vasculature (and timing of infection in each trimester), the potential breakdown of the maternal-fetal barrier, and, most important, the clinical courses and outcomes in both mother and infant.
JANE VAN DIS, MD
- Khalil A, Kalafat E, Benlioglu C, et al. SARS-CoV-2 infection in pregnancy: a systematic review and meta-analysis of clinical features and pregnancy outcomes. EClinical Medicine. 2020;25:100446.
- Khalil A, von Dadelszen P, Draycott T, et al. Change in the incidence of stillbirth and preterm delivery during the COVID-19 pandemic. JAMA. 2020;324:705-706.
- Liu H, Wang LL, Zhao SJ, et al. Why are pregnant women susceptible to COVID-19? An immunological viewpoint. J Reprod Immunol. 2020;139;103122.
- Li M, Chen L, Zhang J, et al. The SARS-CoV-2 receptor ACE2 expression of maternal-fetal interface and fetal organs by single-cell transcriptome study. PLoS One. 2020;15:e0230295.
- Pique-Regi R, Romero R, Tarca AL, et al. Does the human placenta express the canonical cell entry mediators for SARS-CoV-2? eLife. 2020;9:e58716.
- Zeng H, Xu C, Fan J, et al. Antibodies in infants born to mothers with COVID-19 pneumonia. JAMA. 2020;323:1848-1849.
- Dong L, Tian J, He S, et al. Possible vertical transmission of SARS-CoV-2 from an infected mother to her newborn. JAMA. 2020;323:1846-1848.
- Kotlyar A, Grechukhina O, Chen A, et al. Vertical transmission of COVID-19: a systematic review and meta-analysis. Am J Obstet Gynecol. 2020;S0002-9378(20)30823-1.
- Richtmann R, Torloni MR, Oyamada Otani AR, et al. Fetal deaths in pregnancies with SARS-CoV-2 infection in Brazil: a case series. Case Rep Womens Health. 2020;e00243.
- Wang C, Zhou YH, Yang HX, et al. Intrauterine vertical transmission of SARS-CoV-2: what we know so far. Ultrasound Obstet Gynecol. 2020;55:724-725.
- Khalil A, Kalafat E, Benlioglu C, et al. SARS-CoV-2 infection in pregnancy: a systematic review and meta-analysis of clinical features and pregnancy outcomes. EClinical Medicine. 2020;25:100446.
- Khalil A, von Dadelszen P, Draycott T, et al. Change in the incidence of stillbirth and preterm delivery during the COVID-19 pandemic. JAMA. 2020;324:705-706.
- Liu H, Wang LL, Zhao SJ, et al. Why are pregnant women susceptible to COVID-19? An immunological viewpoint. J Reprod Immunol. 2020;139;103122.
- Li M, Chen L, Zhang J, et al. The SARS-CoV-2 receptor ACE2 expression of maternal-fetal interface and fetal organs by single-cell transcriptome study. PLoS One. 2020;15:e0230295.
- Pique-Regi R, Romero R, Tarca AL, et al. Does the human placenta express the canonical cell entry mediators for SARS-CoV-2? eLife. 2020;9:e58716.
- Zeng H, Xu C, Fan J, et al. Antibodies in infants born to mothers with COVID-19 pneumonia. JAMA. 2020;323:1848-1849.
- Dong L, Tian J, He S, et al. Possible vertical transmission of SARS-CoV-2 from an infected mother to her newborn. JAMA. 2020;323:1846-1848.
- Kotlyar A, Grechukhina O, Chen A, et al. Vertical transmission of COVID-19: a systematic review and meta-analysis. Am J Obstet Gynecol. 2020;S0002-9378(20)30823-1.
- Richtmann R, Torloni MR, Oyamada Otani AR, et al. Fetal deaths in pregnancies with SARS-CoV-2 infection in Brazil: a case series. Case Rep Womens Health. 2020;e00243.
- Wang C, Zhou YH, Yang HX, et al. Intrauterine vertical transmission of SARS-CoV-2: what we know so far. Ultrasound Obstet Gynecol. 2020;55:724-725.
Facing systemic racism in health care: Inequities in medical education

Resources:
- The Pulse of Perseverance: Three Black Doctors on Their Journey to Success
Pierre Johnson, MD; Maxime Madhere, MD, Joseph Semien Jr, MD - Mindset: The New Psychology of Success
Carol S. Dweck

Resources:
- The Pulse of Perseverance: Three Black Doctors on Their Journey to Success
Pierre Johnson, MD; Maxime Madhere, MD, Joseph Semien Jr, MD - Mindset: The New Psychology of Success
Carol S. Dweck

Resources:
- The Pulse of Perseverance: Three Black Doctors on Their Journey to Success
Pierre Johnson, MD; Maxime Madhere, MD, Joseph Semien Jr, MD - Mindset: The New Psychology of Success
Carol S. Dweck
Transvaginal reconstructive surgery for POP: Innovative approach to graft augmentation in the post-mesh era
Pelvic organ prolapse (POP) is a common occurrence over the course of a woman’s lifetime, especially in parous women (up to 50% of women who have given birth).1 The anterior vaginal wall is the most common site of POP and has the highest recurrence rate of up to 70%.2 The risk of developing POP increases with age, obesity, White race, family history, and prior pelvic surgery, such as hysterectomy. It affects more than 3 million women in the United States alone, often negatively impacting sexual function and overall quality of life.3,4
Because women are living longer than ever before and are more active in their senior years, a long-lasting, durable surgical repair is desirable, if not necessary. To be cost-effective and to avoid general anesthesia, the surgical approach ideally should be vaginal.
Biologic and synthetic grafts to augment transvaginal repair traditionally are used to improve on the well-recognized high failure rate of native-tissue repair that is often seen at both short-term and medium-term follow-up.5 The failure rate is commonly referenced as 30% to 40% at 2-year follow-up and 61% to 70% at 5-year follow-up, well-established by the results of the OPTIMAL randomized clinical trial.6 The more recent Descent trial likewise demonstrates a higher failure rate of native-tissue repair versus transvaginal mesh repair at a shorter term of 30 to 42 months.7 Furthermore, the use of permanent versus absorbable suture in suspension of the vaginal apex is associated with lower short-term failure rates.8
Despite this Level I evidence that demonstrates a clear advantage for obtaining a longer or more durable repair with permanent materials, native-tissue repairs with absorbable suture are still performed routinely. Since the US Food and Drug Administration (FDA) ordered that the use of transvaginal surgical mesh augmentation for pelvic reconstructive surgery be discontinued, it is more important than ever to explore evolving alternative native-tissue augmentation repair techniques that hopefully can preserve the advantages and merits of vaginal surgery and achieve longer durability.9
Biologic graft augmentation use in transvaginal reconstruction
All biologic grafts, including allografts derived from human tissue and xenografts derived from animal tissue, are acellular constructs composed of extracellular matrix (ECM) that acts as scaffolding for the host tissue. The ECM is predominantly composed of collagen (types I and III) and noncollagenous fibronectin, laminin, and glycosaminoglycans in various amounts depending on the source tissue. The 3D presentation of ECM’s complex molecules allows for rapid repopulation of host cells and revascularization with eventual regeneration.
Once a biologic graft is placed surgically, the body’s response to the scaffold ECM mimics the normal wound-healing process, beginning with fibrin-rich matrix hemostasis and the subsequent innate immune response of neutrophil and M1 macrophage infiltration. M1 macrophages are proinflammatory and clear cellular debris and begin the process of graft scaffold degradation. The host tissue then begins the process of remodeling through pro-remodeling M2 macrophages and stem cell recruitment, proliferation, and differentiation.10 As the biologic graft provides initial structure and strength for pelvic repairs, the ideal ECM scaffold would not degrade before the host is able to fully undergo regeneration and maintain its structure and strength.
Biologic grafts differ in source (allograft or xenograft), type (pericardium, dermis, or bladder), developmental stage (fetal or adult), decellularization processing, and sterilization techniques. These 5 aspects determine the distinct 3D ECM scaffold structure, strength, and longevity. If the ECM scaffold is damaged or retains noncollagenous proteins during the preparation process, an inflammatory response is triggered in which the graft is degraded, resorbed, and replaced with scar tissue. Furthermore, certain processing techniques aimed at extending the ECM’s durability—that is, cross-linking collagen—results in the foreign body response in which there is no vascular infiltration or cellular penetration of the graft and a collagen capsule is created around the empty matrix.11 To avoid resorption or encapsulation of the graft, the ECM scaffolds of biologic grafts must be optimized to induce regeneration.
Continue to: Choosing surgical POP repair...
Choosing surgical POP repair
The decision to undergo surgical treatment for prolapse is a shared decision-making process between the patient and surgeon and always should be individualized. The type of procedure and the surgical approach will depend on the patient’s goals, the degree of prolapse, clinical history, risk tolerance, the surgeon’s skill set, and whether or not there is an indication or relative contraindication for uterine removal at the time of prolapse repair.
While the FDA’s order does not apply to transabdominally placed surgical mesh, such as sacrocolpopexy, not all patients are ideal candidates for an abdominal sacrocolpopexy. Most notable are women with a history of multiple prior abdominal surgeries with higher rates of intraperitoneal adhesions. Ideally, to be cost-effective and to avoid general anesthesia, the surgical approach should be vaginal whenever possible.
Biologic versus native-tissue grafts
Currently, only low-quality evidence exists that compares the outcomes of biologic grafts with traditional native-tissue repairs in POP. Studies have been limited by poor reporting of methods, inconsistency in technique and materials used, and imprecise definitions. One Cochrane Review on the surgical management of POP concluded that biologic graft augmentation was associated with a lower failure rate (18%) within 1 to 2 years when compared with a traditional anterior colporrhaphy (28%).12
Based on consideration of all Cochrane Database Reviews and recent large systematic reviews, there clearly is a paucity of information on which to draw well-defined conclusions regarding the advantage of biomaterials in prolapse surgery.12-14 This is due in part to the variation in graft material used and the surgical technique employed.
Similarly, evidence is lacking regarding the superiority of one type of biologic graft over another. Furthermore, some of the grafts previously studied are no longer on the market.15 With the FDA’s removal of all transvaginal mesh, including xenografts, only allografts are available for pelvic floor reconstruction. Currently, only 3 commercial manufacturers market allografts for pelvic floor reconstruction. Each allograft is available in various sizes and all can be trimmed at the time of the surgical procedure to customize both the size and shape to fit the individual patient.
A novel technique using Axis Dermis and polypropylene suture
One of the commercially available allografts, Axis Dermis (Coloplast), is non–cross-linked and is derived from human cadaveric dermal tissue from the back and dorsum of the upper leg. It is sterilized by a proprietary Tutoplast️ sterilization process that uses gamma irradiation to inactivate and prevent the transmission of pathogens. This unique technique involving solvent dehydration means the graft is never freeze dried; thus, the natural tissue matrix is preserved.
Additionally, the allograft is antigen-free, which decreases the risk of tissue reaction (scarring/fibrosis) and aids in the process of host tissue remodeling; invasion by growth factors, blood cells, collagen, elastin, and neovascularization. This natural tissue remodeling facilitates the anticipated “reabsorption” of the graft by the host tissue, leaving the patient with a tissue scaffold, that is, a stronger layer of “fascia” beneath the muscularis.16 As a result of this “biocompatible” graft, the host tissue remodeling has been shown in the rat model to involve early cellular infiltration and angiogenesis (in the first week after implantation), that leads to an organized cellular architecture with greater tensile strength by week 4, and ultimately inability to distinguish host collagen from the implant by 8 to 12 weeks.17,18
Continue to: Steps in performing the technique...
Steps in performing the technique
To ensure that the graft is placed adjacent to the vaginal serosa, a full-thickness dissection is carried out to enter the true vesicovaginal space, which lies below all 4 histologic layers of the vagina (nonkeratinized stratified squamous epithelium, lamina propria, muscularis, and serosa). For the anterior dissection, a Tuohy epidural needle is used to achieve an accurate and consistent depth when injecting fluid (hydrodissection) to enter this true pelvic space (FIGURE 1). Correct entry into the vesicovaginal space can be confirmed visually by the presence of adipose tissue.

Many pelvic surgeons use the sacrospinous ligament (SSL) as a strong and reliable point of attachment for vaginal prolapse repair. It can be approached either anteriorly or posteriorly with careful dissection. Permanent suture (0-Prolene) is used to “bridge” the attachment between the SSL, the Axis Dermis graft, and the cervix (or vaginal apex). The suture is placed in the middle third and lower half of the ligament to avoid injury to nearby neurovascular structures.
While the surgeon may use any suture-capturing device, we prefer the Anchosure System (Neomedic). This device delivers a small anchor securely into the ligament through a single point of entry, minimizing the risk of postoperative pain for the patient. A 6 cm x 8 cm size Axis Dermis graft is then trimmed to meet the specifications of the patient’s anatomy.
Most commonly, we measure, mark, and trim the body of the graft to 5.5 cm in length with a width of 3 cm. The bilateral arms are approximately 1 cm in width and comprise the remaining length of the 8 cm graft (FIGURE 2). As shown in Figure 2, pre-made holes are marked and punched out using a large hollow needle. These serve as the points of attachment for the permanent suture to be “weaved” into the graft arms and delayed absorbable “tacking suture” to be attached from the pubocervical fascia at the bladder neck to the distal end of the graft. This facilitates fixation of the graft in the midline of the anterior vaginal wall, overlying any central distention-type defect.

Finally, following attachment of the SSL permanent suture to the distal graft arm, this suture is then attached to the proximal U-shaped end of the graft body (in the midline), followed by a deep and secure bite through the cervix (or vaginal vault apex) and back through the proximal graft. These SSL suspension sutures are then tied such that the distal arms of the graft advance down to the ligament. Care is taken not to tie down to the SSL itself, rather until the cervix (or apex) is reduced to its normal anatomical location.
After the graft is secured in place, the full-thickness vaginal wall is closed with delayed absorbable suture. Sterile 1-inch ribbon packing is placed in the vagina immediately to close any dead space between the vagina and the graft to decrease the risk of seroma or hematoma formation.
This newly developed technique, like many surgeries for POP, requires extensive knowledge of pelvic anatomy and skill in vaginal surgery, and we recommend referral to a subspecialist in Female Pelvic Medicine and Reconstructive Surgery.

Continue to: Upcoming plans to share outcomes data...
Upcoming plans to share outcomes data
We are in the process of performing a retrospective review of all of the cases we have performed at our institution using this technique of permanent suture bridging to the SSL within the arm of the biograft. Given the relatively recent FDA announcement, we have yet to establish any long-term outcomes data. However, the preliminary results at 6-month follow-up are promising and demonstrate a low (2.6%) failure rate, without significant safety concerns. We hope to publish these data as well as more data on longitudinal outcomes in the future.
In summary
Many women are at risk for native-tissue repair failure or are not well suited for an abdominal procedure to correct their pelvic support defect and restore their quality of life. As expert pelvic surgeons, we play an important role in the search for innovative solutions for these women. There is ample opportunity for future research and clinical trials to determine the best biologic materials and their optimal use in pelvic reconstructive surgery.
Originally, polypropylene mesh was designed for use in augmenting abdominal hernia repairs and later was adapted by manufacturers for use in POP repair. The FDA removal from the market of existing transvaginal synthetic mesh kits was a unique catalyst that challenged our community to develop transvaginal repairs using biologic grafts that are genuinely tailored to the unique needs of the female pelvic anatomy. ●
- Maher C, Feiner B, Baessler K. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2013:CD004014.
- Weber AM, Walters MD, Piedmonte MR, et al. Anterior colporrhaphy: a randomized trial of three surgical techniques. Am J Obstet Gynecol. 2001;185:1299-1304.
- Walters MD, Ridgeway BM. Surgical treatment of vaginal apex prolapse. Obstet Gynecol. 2013;121(2 pt 1):354-374.
- Meister MRL, Sutcliffe S, Lowder JL. Definitions of apical vaginal support loss: a systematic review. Am J Obstet Gynecol. 2017;216:232. e1-232.e14.
- Cox A, Herschorn S. Evaluation of current biologic meshes in pelvic organ prolapse repair. Curr Urol Rep. 2012;13:247-255.
- Jelovsek JE, Barber M, Brubaker K, et al. Effect of uterosacral ligament suspension vs sacrospinous ligament fixation with or without perioperative behavioral therapy for pelvic organ vaginal prolapse on surgical outcomes and prolapse symptoms at 5 years in the OPTIMAL randomized clinical trial. JAMA. 2018:319:1554-1565.
- Bowen ST, Moalli P, Abramowitch S, et al. Outcomes of the defining mechanisms of anterior vaginal wall descent trial [abstract 15]. Am J Obstet Gynecol. 2020;222:S770-S771.
- Chung CP, Miskimins R, Kuehl TJ, et al. Permanent suture used in uterosacral ligament suspension offers better anatomical support than delayed absorbable suture. Int Urogynecol J. 2012;23:223-227.
- US Food and Drug Administration. FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices. https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-womens-health-orders-manufacturers-surgical -mesh-intended-transvaginal. April 16, 2019. Accessed September 1, 2020.
- Londono R, Badylak SF. Biologic scaffolds for regenerative medicine: mechanisms of in vivo remodeling. Ann Biomed Eng. 2015;43:577-592.
- Cornwell KG, Landsman A, James KS. Extracellular matrix biomaterials for soft tissue repair. Clin Podiatr Med Surg. 2009;26: 507-523.
- Maher CM, Feiner B, Baessler K, et al. Surgical management of pelvic organ prolapse in women: the updated summary version Cochrane review. Int Urogynecol J. 2011;22:1445-1447.
- Maher C, Feiner B, Baessler K, et al. Surgery for women with anterior compartment prolapse. Cochrane Database Syst Rev. 2016;11:CD004014.
- Maher C, Feiner B, Baessler K, et al. Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse. Cochrane Database Syst Rev. 2016;2:CD012179.
- Rosenblatt P, Von Bargen E. Use of biologic grafts in pelvic organ prolapse surgery. Contemporary OB/GYN. 2017;62:14-19.
- Greenspan DC, Hernandez R, Faleris J. Histology of surgically implanted Tutoplast processed dermis. http://www.zimmerbiomet .co.il/images/lib_artHistologyDermis%2010.pdf. Accessed September 2, 2020.
- Williams D. Revisiting the definition of biocompatibility. Med Device Technol. 2003;14:10-13.
- Nosti PA, Carter CM, Sokol AI, et al. Transvaginal versus transabdominal placement of synthetic mesh at time of sacrocolpopexy. Female Pelvic Med Reconstr Surg. 2016;22:151-155.
Pelvic organ prolapse (POP) is a common occurrence over the course of a woman’s lifetime, especially in parous women (up to 50% of women who have given birth).1 The anterior vaginal wall is the most common site of POP and has the highest recurrence rate of up to 70%.2 The risk of developing POP increases with age, obesity, White race, family history, and prior pelvic surgery, such as hysterectomy. It affects more than 3 million women in the United States alone, often negatively impacting sexual function and overall quality of life.3,4
Because women are living longer than ever before and are more active in their senior years, a long-lasting, durable surgical repair is desirable, if not necessary. To be cost-effective and to avoid general anesthesia, the surgical approach ideally should be vaginal.
Biologic and synthetic grafts to augment transvaginal repair traditionally are used to improve on the well-recognized high failure rate of native-tissue repair that is often seen at both short-term and medium-term follow-up.5 The failure rate is commonly referenced as 30% to 40% at 2-year follow-up and 61% to 70% at 5-year follow-up, well-established by the results of the OPTIMAL randomized clinical trial.6 The more recent Descent trial likewise demonstrates a higher failure rate of native-tissue repair versus transvaginal mesh repair at a shorter term of 30 to 42 months.7 Furthermore, the use of permanent versus absorbable suture in suspension of the vaginal apex is associated with lower short-term failure rates.8
Despite this Level I evidence that demonstrates a clear advantage for obtaining a longer or more durable repair with permanent materials, native-tissue repairs with absorbable suture are still performed routinely. Since the US Food and Drug Administration (FDA) ordered that the use of transvaginal surgical mesh augmentation for pelvic reconstructive surgery be discontinued, it is more important than ever to explore evolving alternative native-tissue augmentation repair techniques that hopefully can preserve the advantages and merits of vaginal surgery and achieve longer durability.9
Biologic graft augmentation use in transvaginal reconstruction
All biologic grafts, including allografts derived from human tissue and xenografts derived from animal tissue, are acellular constructs composed of extracellular matrix (ECM) that acts as scaffolding for the host tissue. The ECM is predominantly composed of collagen (types I and III) and noncollagenous fibronectin, laminin, and glycosaminoglycans in various amounts depending on the source tissue. The 3D presentation of ECM’s complex molecules allows for rapid repopulation of host cells and revascularization with eventual regeneration.
Once a biologic graft is placed surgically, the body’s response to the scaffold ECM mimics the normal wound-healing process, beginning with fibrin-rich matrix hemostasis and the subsequent innate immune response of neutrophil and M1 macrophage infiltration. M1 macrophages are proinflammatory and clear cellular debris and begin the process of graft scaffold degradation. The host tissue then begins the process of remodeling through pro-remodeling M2 macrophages and stem cell recruitment, proliferation, and differentiation.10 As the biologic graft provides initial structure and strength for pelvic repairs, the ideal ECM scaffold would not degrade before the host is able to fully undergo regeneration and maintain its structure and strength.
Biologic grafts differ in source (allograft or xenograft), type (pericardium, dermis, or bladder), developmental stage (fetal or adult), decellularization processing, and sterilization techniques. These 5 aspects determine the distinct 3D ECM scaffold structure, strength, and longevity. If the ECM scaffold is damaged or retains noncollagenous proteins during the preparation process, an inflammatory response is triggered in which the graft is degraded, resorbed, and replaced with scar tissue. Furthermore, certain processing techniques aimed at extending the ECM’s durability—that is, cross-linking collagen—results in the foreign body response in which there is no vascular infiltration or cellular penetration of the graft and a collagen capsule is created around the empty matrix.11 To avoid resorption or encapsulation of the graft, the ECM scaffolds of biologic grafts must be optimized to induce regeneration.
Continue to: Choosing surgical POP repair...
Choosing surgical POP repair
The decision to undergo surgical treatment for prolapse is a shared decision-making process between the patient and surgeon and always should be individualized. The type of procedure and the surgical approach will depend on the patient’s goals, the degree of prolapse, clinical history, risk tolerance, the surgeon’s skill set, and whether or not there is an indication or relative contraindication for uterine removal at the time of prolapse repair.
While the FDA’s order does not apply to transabdominally placed surgical mesh, such as sacrocolpopexy, not all patients are ideal candidates for an abdominal sacrocolpopexy. Most notable are women with a history of multiple prior abdominal surgeries with higher rates of intraperitoneal adhesions. Ideally, to be cost-effective and to avoid general anesthesia, the surgical approach should be vaginal whenever possible.
Biologic versus native-tissue grafts
Currently, only low-quality evidence exists that compares the outcomes of biologic grafts with traditional native-tissue repairs in POP. Studies have been limited by poor reporting of methods, inconsistency in technique and materials used, and imprecise definitions. One Cochrane Review on the surgical management of POP concluded that biologic graft augmentation was associated with a lower failure rate (18%) within 1 to 2 years when compared with a traditional anterior colporrhaphy (28%).12
Based on consideration of all Cochrane Database Reviews and recent large systematic reviews, there clearly is a paucity of information on which to draw well-defined conclusions regarding the advantage of biomaterials in prolapse surgery.12-14 This is due in part to the variation in graft material used and the surgical technique employed.
Similarly, evidence is lacking regarding the superiority of one type of biologic graft over another. Furthermore, some of the grafts previously studied are no longer on the market.15 With the FDA’s removal of all transvaginal mesh, including xenografts, only allografts are available for pelvic floor reconstruction. Currently, only 3 commercial manufacturers market allografts for pelvic floor reconstruction. Each allograft is available in various sizes and all can be trimmed at the time of the surgical procedure to customize both the size and shape to fit the individual patient.
A novel technique using Axis Dermis and polypropylene suture
One of the commercially available allografts, Axis Dermis (Coloplast), is non–cross-linked and is derived from human cadaveric dermal tissue from the back and dorsum of the upper leg. It is sterilized by a proprietary Tutoplast️ sterilization process that uses gamma irradiation to inactivate and prevent the transmission of pathogens. This unique technique involving solvent dehydration means the graft is never freeze dried; thus, the natural tissue matrix is preserved.
Additionally, the allograft is antigen-free, which decreases the risk of tissue reaction (scarring/fibrosis) and aids in the process of host tissue remodeling; invasion by growth factors, blood cells, collagen, elastin, and neovascularization. This natural tissue remodeling facilitates the anticipated “reabsorption” of the graft by the host tissue, leaving the patient with a tissue scaffold, that is, a stronger layer of “fascia” beneath the muscularis.16 As a result of this “biocompatible” graft, the host tissue remodeling has been shown in the rat model to involve early cellular infiltration and angiogenesis (in the first week after implantation), that leads to an organized cellular architecture with greater tensile strength by week 4, and ultimately inability to distinguish host collagen from the implant by 8 to 12 weeks.17,18
Continue to: Steps in performing the technique...
Steps in performing the technique
To ensure that the graft is placed adjacent to the vaginal serosa, a full-thickness dissection is carried out to enter the true vesicovaginal space, which lies below all 4 histologic layers of the vagina (nonkeratinized stratified squamous epithelium, lamina propria, muscularis, and serosa). For the anterior dissection, a Tuohy epidural needle is used to achieve an accurate and consistent depth when injecting fluid (hydrodissection) to enter this true pelvic space (FIGURE 1). Correct entry into the vesicovaginal space can be confirmed visually by the presence of adipose tissue.

Many pelvic surgeons use the sacrospinous ligament (SSL) as a strong and reliable point of attachment for vaginal prolapse repair. It can be approached either anteriorly or posteriorly with careful dissection. Permanent suture (0-Prolene) is used to “bridge” the attachment between the SSL, the Axis Dermis graft, and the cervix (or vaginal apex). The suture is placed in the middle third and lower half of the ligament to avoid injury to nearby neurovascular structures.
While the surgeon may use any suture-capturing device, we prefer the Anchosure System (Neomedic). This device delivers a small anchor securely into the ligament through a single point of entry, minimizing the risk of postoperative pain for the patient. A 6 cm x 8 cm size Axis Dermis graft is then trimmed to meet the specifications of the patient’s anatomy.
Most commonly, we measure, mark, and trim the body of the graft to 5.5 cm in length with a width of 3 cm. The bilateral arms are approximately 1 cm in width and comprise the remaining length of the 8 cm graft (FIGURE 2). As shown in Figure 2, pre-made holes are marked and punched out using a large hollow needle. These serve as the points of attachment for the permanent suture to be “weaved” into the graft arms and delayed absorbable “tacking suture” to be attached from the pubocervical fascia at the bladder neck to the distal end of the graft. This facilitates fixation of the graft in the midline of the anterior vaginal wall, overlying any central distention-type defect.

Finally, following attachment of the SSL permanent suture to the distal graft arm, this suture is then attached to the proximal U-shaped end of the graft body (in the midline), followed by a deep and secure bite through the cervix (or vaginal vault apex) and back through the proximal graft. These SSL suspension sutures are then tied such that the distal arms of the graft advance down to the ligament. Care is taken not to tie down to the SSL itself, rather until the cervix (or apex) is reduced to its normal anatomical location.
After the graft is secured in place, the full-thickness vaginal wall is closed with delayed absorbable suture. Sterile 1-inch ribbon packing is placed in the vagina immediately to close any dead space between the vagina and the graft to decrease the risk of seroma or hematoma formation.
This newly developed technique, like many surgeries for POP, requires extensive knowledge of pelvic anatomy and skill in vaginal surgery, and we recommend referral to a subspecialist in Female Pelvic Medicine and Reconstructive Surgery.

Continue to: Upcoming plans to share outcomes data...
Upcoming plans to share outcomes data
We are in the process of performing a retrospective review of all of the cases we have performed at our institution using this technique of permanent suture bridging to the SSL within the arm of the biograft. Given the relatively recent FDA announcement, we have yet to establish any long-term outcomes data. However, the preliminary results at 6-month follow-up are promising and demonstrate a low (2.6%) failure rate, without significant safety concerns. We hope to publish these data as well as more data on longitudinal outcomes in the future.
In summary
Many women are at risk for native-tissue repair failure or are not well suited for an abdominal procedure to correct their pelvic support defect and restore their quality of life. As expert pelvic surgeons, we play an important role in the search for innovative solutions for these women. There is ample opportunity for future research and clinical trials to determine the best biologic materials and their optimal use in pelvic reconstructive surgery.
Originally, polypropylene mesh was designed for use in augmenting abdominal hernia repairs and later was adapted by manufacturers for use in POP repair. The FDA removal from the market of existing transvaginal synthetic mesh kits was a unique catalyst that challenged our community to develop transvaginal repairs using biologic grafts that are genuinely tailored to the unique needs of the female pelvic anatomy. ●
Pelvic organ prolapse (POP) is a common occurrence over the course of a woman’s lifetime, especially in parous women (up to 50% of women who have given birth).1 The anterior vaginal wall is the most common site of POP and has the highest recurrence rate of up to 70%.2 The risk of developing POP increases with age, obesity, White race, family history, and prior pelvic surgery, such as hysterectomy. It affects more than 3 million women in the United States alone, often negatively impacting sexual function and overall quality of life.3,4
Because women are living longer than ever before and are more active in their senior years, a long-lasting, durable surgical repair is desirable, if not necessary. To be cost-effective and to avoid general anesthesia, the surgical approach ideally should be vaginal.
Biologic and synthetic grafts to augment transvaginal repair traditionally are used to improve on the well-recognized high failure rate of native-tissue repair that is often seen at both short-term and medium-term follow-up.5 The failure rate is commonly referenced as 30% to 40% at 2-year follow-up and 61% to 70% at 5-year follow-up, well-established by the results of the OPTIMAL randomized clinical trial.6 The more recent Descent trial likewise demonstrates a higher failure rate of native-tissue repair versus transvaginal mesh repair at a shorter term of 30 to 42 months.7 Furthermore, the use of permanent versus absorbable suture in suspension of the vaginal apex is associated with lower short-term failure rates.8
Despite this Level I evidence that demonstrates a clear advantage for obtaining a longer or more durable repair with permanent materials, native-tissue repairs with absorbable suture are still performed routinely. Since the US Food and Drug Administration (FDA) ordered that the use of transvaginal surgical mesh augmentation for pelvic reconstructive surgery be discontinued, it is more important than ever to explore evolving alternative native-tissue augmentation repair techniques that hopefully can preserve the advantages and merits of vaginal surgery and achieve longer durability.9
Biologic graft augmentation use in transvaginal reconstruction
All biologic grafts, including allografts derived from human tissue and xenografts derived from animal tissue, are acellular constructs composed of extracellular matrix (ECM) that acts as scaffolding for the host tissue. The ECM is predominantly composed of collagen (types I and III) and noncollagenous fibronectin, laminin, and glycosaminoglycans in various amounts depending on the source tissue. The 3D presentation of ECM’s complex molecules allows for rapid repopulation of host cells and revascularization with eventual regeneration.
Once a biologic graft is placed surgically, the body’s response to the scaffold ECM mimics the normal wound-healing process, beginning with fibrin-rich matrix hemostasis and the subsequent innate immune response of neutrophil and M1 macrophage infiltration. M1 macrophages are proinflammatory and clear cellular debris and begin the process of graft scaffold degradation. The host tissue then begins the process of remodeling through pro-remodeling M2 macrophages and stem cell recruitment, proliferation, and differentiation.10 As the biologic graft provides initial structure and strength for pelvic repairs, the ideal ECM scaffold would not degrade before the host is able to fully undergo regeneration and maintain its structure and strength.
Biologic grafts differ in source (allograft or xenograft), type (pericardium, dermis, or bladder), developmental stage (fetal or adult), decellularization processing, and sterilization techniques. These 5 aspects determine the distinct 3D ECM scaffold structure, strength, and longevity. If the ECM scaffold is damaged or retains noncollagenous proteins during the preparation process, an inflammatory response is triggered in which the graft is degraded, resorbed, and replaced with scar tissue. Furthermore, certain processing techniques aimed at extending the ECM’s durability—that is, cross-linking collagen—results in the foreign body response in which there is no vascular infiltration or cellular penetration of the graft and a collagen capsule is created around the empty matrix.11 To avoid resorption or encapsulation of the graft, the ECM scaffolds of biologic grafts must be optimized to induce regeneration.
Continue to: Choosing surgical POP repair...
Choosing surgical POP repair
The decision to undergo surgical treatment for prolapse is a shared decision-making process between the patient and surgeon and always should be individualized. The type of procedure and the surgical approach will depend on the patient’s goals, the degree of prolapse, clinical history, risk tolerance, the surgeon’s skill set, and whether or not there is an indication or relative contraindication for uterine removal at the time of prolapse repair.
While the FDA’s order does not apply to transabdominally placed surgical mesh, such as sacrocolpopexy, not all patients are ideal candidates for an abdominal sacrocolpopexy. Most notable are women with a history of multiple prior abdominal surgeries with higher rates of intraperitoneal adhesions. Ideally, to be cost-effective and to avoid general anesthesia, the surgical approach should be vaginal whenever possible.
Biologic versus native-tissue grafts
Currently, only low-quality evidence exists that compares the outcomes of biologic grafts with traditional native-tissue repairs in POP. Studies have been limited by poor reporting of methods, inconsistency in technique and materials used, and imprecise definitions. One Cochrane Review on the surgical management of POP concluded that biologic graft augmentation was associated with a lower failure rate (18%) within 1 to 2 years when compared with a traditional anterior colporrhaphy (28%).12
Based on consideration of all Cochrane Database Reviews and recent large systematic reviews, there clearly is a paucity of information on which to draw well-defined conclusions regarding the advantage of biomaterials in prolapse surgery.12-14 This is due in part to the variation in graft material used and the surgical technique employed.
Similarly, evidence is lacking regarding the superiority of one type of biologic graft over another. Furthermore, some of the grafts previously studied are no longer on the market.15 With the FDA’s removal of all transvaginal mesh, including xenografts, only allografts are available for pelvic floor reconstruction. Currently, only 3 commercial manufacturers market allografts for pelvic floor reconstruction. Each allograft is available in various sizes and all can be trimmed at the time of the surgical procedure to customize both the size and shape to fit the individual patient.
A novel technique using Axis Dermis and polypropylene suture
One of the commercially available allografts, Axis Dermis (Coloplast), is non–cross-linked and is derived from human cadaveric dermal tissue from the back and dorsum of the upper leg. It is sterilized by a proprietary Tutoplast️ sterilization process that uses gamma irradiation to inactivate and prevent the transmission of pathogens. This unique technique involving solvent dehydration means the graft is never freeze dried; thus, the natural tissue matrix is preserved.
Additionally, the allograft is antigen-free, which decreases the risk of tissue reaction (scarring/fibrosis) and aids in the process of host tissue remodeling; invasion by growth factors, blood cells, collagen, elastin, and neovascularization. This natural tissue remodeling facilitates the anticipated “reabsorption” of the graft by the host tissue, leaving the patient with a tissue scaffold, that is, a stronger layer of “fascia” beneath the muscularis.16 As a result of this “biocompatible” graft, the host tissue remodeling has been shown in the rat model to involve early cellular infiltration and angiogenesis (in the first week after implantation), that leads to an organized cellular architecture with greater tensile strength by week 4, and ultimately inability to distinguish host collagen from the implant by 8 to 12 weeks.17,18
Continue to: Steps in performing the technique...
Steps in performing the technique
To ensure that the graft is placed adjacent to the vaginal serosa, a full-thickness dissection is carried out to enter the true vesicovaginal space, which lies below all 4 histologic layers of the vagina (nonkeratinized stratified squamous epithelium, lamina propria, muscularis, and serosa). For the anterior dissection, a Tuohy epidural needle is used to achieve an accurate and consistent depth when injecting fluid (hydrodissection) to enter this true pelvic space (FIGURE 1). Correct entry into the vesicovaginal space can be confirmed visually by the presence of adipose tissue.

Many pelvic surgeons use the sacrospinous ligament (SSL) as a strong and reliable point of attachment for vaginal prolapse repair. It can be approached either anteriorly or posteriorly with careful dissection. Permanent suture (0-Prolene) is used to “bridge” the attachment between the SSL, the Axis Dermis graft, and the cervix (or vaginal apex). The suture is placed in the middle third and lower half of the ligament to avoid injury to nearby neurovascular structures.
While the surgeon may use any suture-capturing device, we prefer the Anchosure System (Neomedic). This device delivers a small anchor securely into the ligament through a single point of entry, minimizing the risk of postoperative pain for the patient. A 6 cm x 8 cm size Axis Dermis graft is then trimmed to meet the specifications of the patient’s anatomy.
Most commonly, we measure, mark, and trim the body of the graft to 5.5 cm in length with a width of 3 cm. The bilateral arms are approximately 1 cm in width and comprise the remaining length of the 8 cm graft (FIGURE 2). As shown in Figure 2, pre-made holes are marked and punched out using a large hollow needle. These serve as the points of attachment for the permanent suture to be “weaved” into the graft arms and delayed absorbable “tacking suture” to be attached from the pubocervical fascia at the bladder neck to the distal end of the graft. This facilitates fixation of the graft in the midline of the anterior vaginal wall, overlying any central distention-type defect.

Finally, following attachment of the SSL permanent suture to the distal graft arm, this suture is then attached to the proximal U-shaped end of the graft body (in the midline), followed by a deep and secure bite through the cervix (or vaginal vault apex) and back through the proximal graft. These SSL suspension sutures are then tied such that the distal arms of the graft advance down to the ligament. Care is taken not to tie down to the SSL itself, rather until the cervix (or apex) is reduced to its normal anatomical location.
After the graft is secured in place, the full-thickness vaginal wall is closed with delayed absorbable suture. Sterile 1-inch ribbon packing is placed in the vagina immediately to close any dead space between the vagina and the graft to decrease the risk of seroma or hematoma formation.
This newly developed technique, like many surgeries for POP, requires extensive knowledge of pelvic anatomy and skill in vaginal surgery, and we recommend referral to a subspecialist in Female Pelvic Medicine and Reconstructive Surgery.

Continue to: Upcoming plans to share outcomes data...
Upcoming plans to share outcomes data
We are in the process of performing a retrospective review of all of the cases we have performed at our institution using this technique of permanent suture bridging to the SSL within the arm of the biograft. Given the relatively recent FDA announcement, we have yet to establish any long-term outcomes data. However, the preliminary results at 6-month follow-up are promising and demonstrate a low (2.6%) failure rate, without significant safety concerns. We hope to publish these data as well as more data on longitudinal outcomes in the future.
In summary
Many women are at risk for native-tissue repair failure or are not well suited for an abdominal procedure to correct their pelvic support defect and restore their quality of life. As expert pelvic surgeons, we play an important role in the search for innovative solutions for these women. There is ample opportunity for future research and clinical trials to determine the best biologic materials and their optimal use in pelvic reconstructive surgery.
Originally, polypropylene mesh was designed for use in augmenting abdominal hernia repairs and later was adapted by manufacturers for use in POP repair. The FDA removal from the market of existing transvaginal synthetic mesh kits was a unique catalyst that challenged our community to develop transvaginal repairs using biologic grafts that are genuinely tailored to the unique needs of the female pelvic anatomy. ●
- Maher C, Feiner B, Baessler K. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2013:CD004014.
- Weber AM, Walters MD, Piedmonte MR, et al. Anterior colporrhaphy: a randomized trial of three surgical techniques. Am J Obstet Gynecol. 2001;185:1299-1304.
- Walters MD, Ridgeway BM. Surgical treatment of vaginal apex prolapse. Obstet Gynecol. 2013;121(2 pt 1):354-374.
- Meister MRL, Sutcliffe S, Lowder JL. Definitions of apical vaginal support loss: a systematic review. Am J Obstet Gynecol. 2017;216:232. e1-232.e14.
- Cox A, Herschorn S. Evaluation of current biologic meshes in pelvic organ prolapse repair. Curr Urol Rep. 2012;13:247-255.
- Jelovsek JE, Barber M, Brubaker K, et al. Effect of uterosacral ligament suspension vs sacrospinous ligament fixation with or without perioperative behavioral therapy for pelvic organ vaginal prolapse on surgical outcomes and prolapse symptoms at 5 years in the OPTIMAL randomized clinical trial. JAMA. 2018:319:1554-1565.
- Bowen ST, Moalli P, Abramowitch S, et al. Outcomes of the defining mechanisms of anterior vaginal wall descent trial [abstract 15]. Am J Obstet Gynecol. 2020;222:S770-S771.
- Chung CP, Miskimins R, Kuehl TJ, et al. Permanent suture used in uterosacral ligament suspension offers better anatomical support than delayed absorbable suture. Int Urogynecol J. 2012;23:223-227.
- US Food and Drug Administration. FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices. https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-womens-health-orders-manufacturers-surgical -mesh-intended-transvaginal. April 16, 2019. Accessed September 1, 2020.
- Londono R, Badylak SF. Biologic scaffolds for regenerative medicine: mechanisms of in vivo remodeling. Ann Biomed Eng. 2015;43:577-592.
- Cornwell KG, Landsman A, James KS. Extracellular matrix biomaterials for soft tissue repair. Clin Podiatr Med Surg. 2009;26: 507-523.
- Maher CM, Feiner B, Baessler K, et al. Surgical management of pelvic organ prolapse in women: the updated summary version Cochrane review. Int Urogynecol J. 2011;22:1445-1447.
- Maher C, Feiner B, Baessler K, et al. Surgery for women with anterior compartment prolapse. Cochrane Database Syst Rev. 2016;11:CD004014.
- Maher C, Feiner B, Baessler K, et al. Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse. Cochrane Database Syst Rev. 2016;2:CD012179.
- Rosenblatt P, Von Bargen E. Use of biologic grafts in pelvic organ prolapse surgery. Contemporary OB/GYN. 2017;62:14-19.
- Greenspan DC, Hernandez R, Faleris J. Histology of surgically implanted Tutoplast processed dermis. http://www.zimmerbiomet .co.il/images/lib_artHistologyDermis%2010.pdf. Accessed September 2, 2020.
- Williams D. Revisiting the definition of biocompatibility. Med Device Technol. 2003;14:10-13.
- Nosti PA, Carter CM, Sokol AI, et al. Transvaginal versus transabdominal placement of synthetic mesh at time of sacrocolpopexy. Female Pelvic Med Reconstr Surg. 2016;22:151-155.
- Maher C, Feiner B, Baessler K. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2013:CD004014.
- Weber AM, Walters MD, Piedmonte MR, et al. Anterior colporrhaphy: a randomized trial of three surgical techniques. Am J Obstet Gynecol. 2001;185:1299-1304.
- Walters MD, Ridgeway BM. Surgical treatment of vaginal apex prolapse. Obstet Gynecol. 2013;121(2 pt 1):354-374.
- Meister MRL, Sutcliffe S, Lowder JL. Definitions of apical vaginal support loss: a systematic review. Am J Obstet Gynecol. 2017;216:232. e1-232.e14.
- Cox A, Herschorn S. Evaluation of current biologic meshes in pelvic organ prolapse repair. Curr Urol Rep. 2012;13:247-255.
- Jelovsek JE, Barber M, Brubaker K, et al. Effect of uterosacral ligament suspension vs sacrospinous ligament fixation with or without perioperative behavioral therapy for pelvic organ vaginal prolapse on surgical outcomes and prolapse symptoms at 5 years in the OPTIMAL randomized clinical trial. JAMA. 2018:319:1554-1565.
- Bowen ST, Moalli P, Abramowitch S, et al. Outcomes of the defining mechanisms of anterior vaginal wall descent trial [abstract 15]. Am J Obstet Gynecol. 2020;222:S770-S771.
- Chung CP, Miskimins R, Kuehl TJ, et al. Permanent suture used in uterosacral ligament suspension offers better anatomical support than delayed absorbable suture. Int Urogynecol J. 2012;23:223-227.
- US Food and Drug Administration. FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices. https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-womens-health-orders-manufacturers-surgical -mesh-intended-transvaginal. April 16, 2019. Accessed September 1, 2020.
- Londono R, Badylak SF. Biologic scaffolds for regenerative medicine: mechanisms of in vivo remodeling. Ann Biomed Eng. 2015;43:577-592.
- Cornwell KG, Landsman A, James KS. Extracellular matrix biomaterials for soft tissue repair. Clin Podiatr Med Surg. 2009;26: 507-523.
- Maher CM, Feiner B, Baessler K, et al. Surgical management of pelvic organ prolapse in women: the updated summary version Cochrane review. Int Urogynecol J. 2011;22:1445-1447.
- Maher C, Feiner B, Baessler K, et al. Surgery for women with anterior compartment prolapse. Cochrane Database Syst Rev. 2016;11:CD004014.
- Maher C, Feiner B, Baessler K, et al. Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse. Cochrane Database Syst Rev. 2016;2:CD012179.
- Rosenblatt P, Von Bargen E. Use of biologic grafts in pelvic organ prolapse surgery. Contemporary OB/GYN. 2017;62:14-19.
- Greenspan DC, Hernandez R, Faleris J. Histology of surgically implanted Tutoplast processed dermis. http://www.zimmerbiomet .co.il/images/lib_artHistologyDermis%2010.pdf. Accessed September 2, 2020.
- Williams D. Revisiting the definition of biocompatibility. Med Device Technol. 2003;14:10-13.
- Nosti PA, Carter CM, Sokol AI, et al. Transvaginal versus transabdominal placement of synthetic mesh at time of sacrocolpopexy. Female Pelvic Med Reconstr Surg. 2016;22:151-155.
How to build your identity as a physician online
To have a thriving business in today’s world, a functioning website is crucial to the overall business health. For a medical practice in general, and for its physicians specifically, it is one of the first steps for maintaining a practice. But to grow that practice, it is crucial to take the steps beyond just having a website. Growth requires website optimization for search engines, an expanding referral base, and the knowledge to use web tools and social media at your disposal to promote the practice and its physicians. In this roundtable, several marketing experts and web-savvy physicians discuss using available tools to best position and grow a practice.
Choosing a web upgrade
Patrick J. Culligan, MD: Peter, can you start us off by describing your relationship with Heather, and how your practice benefitted from her expertise?
Peter M. Lotze, MD: Sure. I am a urogynecologist in the competitive market of pelvic reconstructive surgery in Houston, Texas. Within that market, my main approach was to reach out to other physicians to refer patients to my practice. It generally would work, but took increasingly greater amounts of time to call these physicians up, write them letters, and maintain relationships. I felt that the large, national practice group that I am in did not have a significant web presence optimized to promote my practice, which makes it difficult for patients seeking your services to find you in their search for a doctor. It is helpful for patients to be able to understand from your website who you are, what you do, and what their experience may be like.
Glaring to me was that a web search specific for me or things that I do, would not produce our company’s results until page 2 or more on Google. This can be devastating for a practice because most people don’t go past the first page, and you can end up with fewer self-referrals, which should be a significant portion of new patients to your practice. I knew I needed guidance; I knew of Heather’s expertise given her exceptional past work building marketing strategies.
Digital go-tos for marketing
Heather Schueppert: Yes, I was pleased to work with Dr. Lotze, and at the time was a marketing consultant for practices such as his. But gone are the days of printed material—brochures, pamphlets, or even billboards—to effectively promote a business, or in this case, a practice. What still withstands the test of time, however, as the number 1 marketing referral source is word of mouth—from your trusted friend, family member, or coworker.
It is now proven that the number 2 most trusted form of advertising, the most persuasive and the most motivating, is online marketing.1 It is the “digital word of mouth”—the review. Patients are actively online, and a strong digital presence is critical to provide that direct value to retain and grow your patient base.
Continue to: Foundations of private practice reach out...
Foundations of private practice reach out
There are 3 important areas that I consider the foundation of any private practice marketing strategy (TABLE). First is an updated website that is search engine optimized (SEO). You can’t just set it and forget it, it needs to be an updated website. The algorithms for search engines are changing constantly to try to make it as fair and relevant as possible for patients or consumers to find the businesses they are searching for online.

The second area is review management, and for a physician, or even a care center, to do this on your own is a daunting task. It is a critical component, however, to making sure that your reputation out there, that online word of mouth, is as high a star rating as possible.
The third component is local search, which is basically a form of SEO that helps businesses show up in relevant local searches. We are all familiar with the search, “find a restaurant near me,” anything that pushes those search engines to find something local.
Those are what I call the effective triad: that updated website, the review management, and the local search, and all of these are tied together. I think Dr. Lotze and his practice did these effectively well, and I believe that he achieved his goals for the longer term.
Review/reputation management
Dr. Culligan: Brad, is there something that doctors may not know about Healthgrades, and are there opportunities to take full advantage of this physician-rating site?
Brad Bowman, MD: I agree with everything that Dr. Lotze and Heather have said. Start with yourself—what is it that you want to be, the one thing you want to stand for? Get your own marketing, your website right, then, the point is, once you do all that and you are number 1 in SEO, you are still only going to get about 25% of the people looking for you by name to come to your website. The other 75% are going to look at all the other different sites that are out there to provide information to consumers. So the question becomes what do you do with all these other third-party sites? Healthgrades is the most comprehensive and has the highest traffic of the third-party “find a doctor” sites. In 2020, half of all Americans who go to a doctor will use Healthgrades at some point to help select and connect with that doctor.
Physicians have their focus on the quality of the care they provide. Patients, however, focus on the quality of the entire health care experience. Did I get better? How long did I have to wait? Was the office staff helpful? Scarily enough, we still spend more time shopping for a refrigerator or mattress than we do shopping for a doctor. We still tend to think that all doctors are the same. It is the reality of how we have been trained by our insurance companies and by the health care system. That is why getting your marketing right and getting what is it that you want to be known for out there is important, so that you can get the types of patients you want.
Listings management is very important. Make sure that you are findable everywhere. There are services that will do this: Doctor.com, Reputation.com, and many others. They can help you make sure you get all your basic materials right: addresses, phone numbers, your picture. Because 75% of people are going to end up on third-party websites, if your phone number is wrong there, you could lose that patient.
Then the second piece of working with third-party sites is reputation management. Physician reviews are not a bad thing, they are the new word of mouth, as Heather pointed out. Most (80%) of the reviews are going to be positive. The others will be negative, and that is okay. It is important that you get at least 1 or 2 reviews on all the different sites. We know from Healthgrades.com that going from zero reviews to 1 review will increase your call volume by 60%. If you have the choice between 2 physicians and one practice looks like people have been there before, you will go to that one.
You can learn from reviews as well, consumers provide valid feedback. Best practice is to respond to every positive and negative review. Thank them, indicate that you have listened to them, and address any concerns as necessary.
Continue to: Dr. Lotze...
Dr. Lotze: As an example, one of the paramount things that Heather introduced me to was the third party I use to run my website. That company sends a HIPAA-compliant review out to each patient we have seen that day and gives them the opportunity to rate our services and leave comments. If a patient brings up a concern, we can respond immediately, which is important. Patients appreciate feeling that they have been heard. Typically, communicating with a patient will turn the 3-star review into a 5-star as she follows up with the practice.
Ms. Schueppert: Timeliness is important. And just to mention, there certainly is a time commitment to this (and it is a marathon versus a sprint) and there is some financial investment to get it going, but it could truly be detrimental to a practice if you decide not to do anything at all.
Dr. Bowman: Agencies can really help with the time commitment.
Handling bad reviews
Dr. Culligan: What about that person who seems to have it out for you, perhaps giving you multiple bad reviews?
Dr. Bowman: I have seen this before. At Healthgrades, we recently analyzed 8.4 million patient reviews to see what people wrote about.2 The first thing they will talk about is quality of care as they see it. Did I get better or not? You can’t “fix” every patient; there will be some that you cannot help. The next thing patients comment on is bedside manner. With negative reviews, you will see more comments about the office staff.2
A single negative review actually helps make the positive ones look more credible. But if you do believe someone is trolling you, we can flag it and will investigate to the best of our ability. (Different sites likely have different editorial policies.) For example, we look at the IP addresses of all reviews, and if multiple reviews are coming from the same location, we would only let one through, overwriting the previous review from that address.
Patients just want to be heard. We have seen people change their views, based on how their review is handled and responded to.
Dr. Lotze: Is there a response by the physician that you think tends to work better in terms of resolving the issue that can minimize a perceived caustic reaction to a patient’s criticism?
Dr. Bowman: First, just like with any stressful situation, take a deep breath and respond when you feel like you can be constructive. When you do respond, be gracious. Thank them for their feedback. Make sure you reference something about their concern: “I understand that you had to wait longer than you would have liked.” Acknowledge the problem they reference, and then just apologize: “I’m sorry we didn’t meet your expectations.” Then, if they waited too long for example, “We have a new system where no one should have to wait more than 30 minutes….” You can respond privately or publically. Generally, public responses are better as it shows other consumers that you are willing to listen and consider their point of view.
Continue to: The next phase at Healthgrades...
The next phase at Healthgrades
Dr. Culligan: Do you see changes to the way physician-rating sites are working now? Are we going to stay status quo over the next 10 years, or do you see frontiers in how your site is going to develop?
Dr. Bowman: For Healthgrades, we rely on quantitative and objective measures, not just the qualitative. We are investing heavily right now in trying to help consumers understand what are the relative volumes of different procedures or different patient types that each individual doctor sees. Orthopedics is an easy example—if you have a knee problem, you want to go to someone who specializes in knees. Our job is to help consumers easily identify, “This is a shoulder doctor, this is a knee doctor, and this is why that matters.”
In the meantime, as a physician, you can always go into our site and state your care philosophy, identifying what is the sort of patient that you like to treat. Transparency is good for everyone, and especially physicians. It helps the right patient show up for you, and it helps you do a better job providing referrals.
Social media: Avoid pitfalls, and use it to your benefit
Dr. Lotze: Branding was one of the things that I was confused about, and Heather really helped me out. As physicians, we put ourselves out there on our websites, which we try to make professional sources of information for patients. But patients often want to see what else they can find out about us, including Healthgrades and social media. I think the thing that is important to know with social media is that it is a place where people learn about you as a person. Your social media should be another avenue of promotion. Whether it is your personal or professional Facebook page, people are going to see those sites. You have an opportunity to promote yourself as a good physician and a good person with a wholesome practice that you want people to come to. If a physician is posting questionable things about themselves on any kind of social media, it could be perceived as inappropriate by the patient. That can impact how patients think of you as a person, and how they are going to grade you. If people lose sight of who you are due to a questionable social media posting, everything else (SEO, the website) can be for naught.
Dr. Culligan: What are the most important social media tools to invest your time in?
Ms. Schueppert: Before anybody jumps into social media, I firmly recommend that you make sure your local search and your Google 3-pack is set up—which is basically a method Google uses to display the top 3 results on its listings page. Then make sure you have a review management system in place. Make sure you have that updated website. Those are the foundational elements. Once you have that going, social media is the next added layer to that digital presence.
I usually recommend LinkedIn. It is huge because you are staying in contact with your colleagues, that business-to-business type of connection. It remains a way for physicians to set themselves up as experts in their level of specialty.
From there, it’s either Instagram or Facebook. If you are serving more of the younger generations, the millennials and younger, then Instagram is the way to go. If you are focusing on your 40+, 50+, they are going to be far more on Facebook.
Continue to: Dr. Lotze...
Dr. Lotze: For me, a Facebook page was a great place to start. The cost of those Google ads—the first things we see at the top of a Google search in their own separate box—is significant. If a practice has that kind of money to invest, great; it is an instant way to be first on the page during a search. But there are more cost-effective ways of doing that, especially as you are getting your name out. Facebook provides, at a smaller cost, promotion of whatever it is that you are seeking to promote. You can find people within a certain zip code, for instance, and use a Facebook ad campaign that can drive people to your Facebook page—which should have both routinely updated new posts and a link to your website. The posts should be interesting topics relevant to the patients you wish to treat (avoiding personal stories or controversial discussions). You can put a post together, or you can have a third-party service do this. People who follow your page will get reminders of you and your practice with each new post. As your page followers increase, your Facebook rank will improve, and your page will more likely be discovered by Facebook searches for your services. With an added link to your office practice website, those patients go straight to your site without getting lost in the noise of Google search results.
For Instagram, a short video or an interesting picture, along with a brief statement, are the essentials. You can add a single link. Marketing here is by direct messaging or having patients going to your website through a link. Instagram, like Facebook, offers analytics to help show you what your audience likes to read about, improving the quality of your posts and increasing number of followers.
YouTube is the number 2 search engine behind Google. A Google search for your field of medicine may be filled with pages of competitors. However, YouTube has a much lower volume of competing practices, making it easier for patients to find you. The only downside to YouTube is that it will list your video along with other competing videos, which can draw attention away from your practice.
If you want to promote your website or practice with video, using a company such as Vimeo is a better choice compared with YouTube, as YouTube gets credit for video views—which improves YouTube’s SEO and not your own website. Vimeo allows for your website to get credit each time the video is watched. Regardless of where you place your videos, make them short and to the point, with links to your website. Videos only need to be long enough to get your message across and stimulate interest in your practice.
If you can have a blog on your website, it also will help with SEO. What a search engine like Google wants to see is that a patient is on your web page and looking at something for at least 60 seconds. If so, the website is deemed to have information that is relevant, improving your SEO ranking.
Finally, Twitter also can be used for getting messaging out and for branding. The problem with it is that many people go to Twitter to follow a Hollywood celebrity, a sports star, or are looking for mass communication. There is less interest on Twitter for physician outreach.
Continue to: Measuring ROI...
Measuring ROI
Dr. Culligan: What’s the best way to track your return on investment?
Dr. Lotze: First for me was to find out what didn’t work in the office and fix that before really promoting my practice. It’s about the global experience for a patient, as Brad mentioned. As a marketing expert, Heather met with me to understand my goals. She then called my office as a patient to set up an appointment and went through that entire office experience. We identified issues needing improvement.
The next step was to develop a working relationship with my webmaster—someone who can help manage Internet image and SEO. Together, you will develop goals for what the SEO should promote specific to your practice. Once a good SEO program is in place, your website’s ranking will go up—although it can take a minimum of 6 months to see a significant increase. To help understand your website’s performance, your webmaster should provide you with reports on your site’s analytics.
As you go through this process, it is great to have a marketing expert to be the point person. You will work closely together for a while, but eventually you can back off over time. The time and expense you invest on the front end have huge rewards on the back end. Currently, I still spend a reasonable amount of money every month. I have a high self-referral base because of these efforts, however, which results in more patient surgeries and easily covers my expenses. It is money well invested. My website traffic increased by 268% over 2 years (FIGURE). I’ll propose that currently more than half of my patients are self-referrals due to online marketing.

Ms. Schueppert: The only thing I would add is training your front staff. They are checking people in, taking appointments, checking your patients out. Have them be mindful that there are campaigns going on, whether it is a social media push, or a new video that went on the website. They can ask, “How did you hear about us?” when a new patient calls.
Dr. Bowman: Unless you are a large university hospital, where the analytics get significantly more advanced in terms of measuring return on investment (ROI), I think you should just be looking at your schedule and looking at your monthly billings and seeing how they change over time. You can calculate how much a new patient is worth because you can figure out how many patients you have and how much you bill and what your profits are.
Dr. Culligan: For those of us who are hospital employees, you can try to convince the hospital that you can do a detailed ROI analysis, or you can just look at it like (say it’s $3,000 per month), how many surgeries does this project have to generate before the hospital makes that back? The answer is a fraction of 1 case.
Thank you to all of you for your expertise on this roundtable.
- Anderson A. Online reviews vs. word of mouth: Which one is more important. https://www.revlocal.com/blog/reviewandreputationmanagement/onlinereviewsvswordofmouthwhichoneismoreimportant. Accessed July 17, 2020.
- 2020 Patient sentiment report. Healthgrades; Medical Group Management Association. https://www.healthgrades.com/content /patientsentimentreport. Accessed July 17, 2020
To have a thriving business in today’s world, a functioning website is crucial to the overall business health. For a medical practice in general, and for its physicians specifically, it is one of the first steps for maintaining a practice. But to grow that practice, it is crucial to take the steps beyond just having a website. Growth requires website optimization for search engines, an expanding referral base, and the knowledge to use web tools and social media at your disposal to promote the practice and its physicians. In this roundtable, several marketing experts and web-savvy physicians discuss using available tools to best position and grow a practice.
Choosing a web upgrade
Patrick J. Culligan, MD: Peter, can you start us off by describing your relationship with Heather, and how your practice benefitted from her expertise?
Peter M. Lotze, MD: Sure. I am a urogynecologist in the competitive market of pelvic reconstructive surgery in Houston, Texas. Within that market, my main approach was to reach out to other physicians to refer patients to my practice. It generally would work, but took increasingly greater amounts of time to call these physicians up, write them letters, and maintain relationships. I felt that the large, national practice group that I am in did not have a significant web presence optimized to promote my practice, which makes it difficult for patients seeking your services to find you in their search for a doctor. It is helpful for patients to be able to understand from your website who you are, what you do, and what their experience may be like.
Glaring to me was that a web search specific for me or things that I do, would not produce our company’s results until page 2 or more on Google. This can be devastating for a practice because most people don’t go past the first page, and you can end up with fewer self-referrals, which should be a significant portion of new patients to your practice. I knew I needed guidance; I knew of Heather’s expertise given her exceptional past work building marketing strategies.
Digital go-tos for marketing
Heather Schueppert: Yes, I was pleased to work with Dr. Lotze, and at the time was a marketing consultant for practices such as his. But gone are the days of printed material—brochures, pamphlets, or even billboards—to effectively promote a business, or in this case, a practice. What still withstands the test of time, however, as the number 1 marketing referral source is word of mouth—from your trusted friend, family member, or coworker.
It is now proven that the number 2 most trusted form of advertising, the most persuasive and the most motivating, is online marketing.1 It is the “digital word of mouth”—the review. Patients are actively online, and a strong digital presence is critical to provide that direct value to retain and grow your patient base.
Continue to: Foundations of private practice reach out...
Foundations of private practice reach out
There are 3 important areas that I consider the foundation of any private practice marketing strategy (TABLE). First is an updated website that is search engine optimized (SEO). You can’t just set it and forget it, it needs to be an updated website. The algorithms for search engines are changing constantly to try to make it as fair and relevant as possible for patients or consumers to find the businesses they are searching for online.

The second area is review management, and for a physician, or even a care center, to do this on your own is a daunting task. It is a critical component, however, to making sure that your reputation out there, that online word of mouth, is as high a star rating as possible.
The third component is local search, which is basically a form of SEO that helps businesses show up in relevant local searches. We are all familiar with the search, “find a restaurant near me,” anything that pushes those search engines to find something local.
Those are what I call the effective triad: that updated website, the review management, and the local search, and all of these are tied together. I think Dr. Lotze and his practice did these effectively well, and I believe that he achieved his goals for the longer term.
Review/reputation management
Dr. Culligan: Brad, is there something that doctors may not know about Healthgrades, and are there opportunities to take full advantage of this physician-rating site?
Brad Bowman, MD: I agree with everything that Dr. Lotze and Heather have said. Start with yourself—what is it that you want to be, the one thing you want to stand for? Get your own marketing, your website right, then, the point is, once you do all that and you are number 1 in SEO, you are still only going to get about 25% of the people looking for you by name to come to your website. The other 75% are going to look at all the other different sites that are out there to provide information to consumers. So the question becomes what do you do with all these other third-party sites? Healthgrades is the most comprehensive and has the highest traffic of the third-party “find a doctor” sites. In 2020, half of all Americans who go to a doctor will use Healthgrades at some point to help select and connect with that doctor.
Physicians have their focus on the quality of the care they provide. Patients, however, focus on the quality of the entire health care experience. Did I get better? How long did I have to wait? Was the office staff helpful? Scarily enough, we still spend more time shopping for a refrigerator or mattress than we do shopping for a doctor. We still tend to think that all doctors are the same. It is the reality of how we have been trained by our insurance companies and by the health care system. That is why getting your marketing right and getting what is it that you want to be known for out there is important, so that you can get the types of patients you want.
Listings management is very important. Make sure that you are findable everywhere. There are services that will do this: Doctor.com, Reputation.com, and many others. They can help you make sure you get all your basic materials right: addresses, phone numbers, your picture. Because 75% of people are going to end up on third-party websites, if your phone number is wrong there, you could lose that patient.
Then the second piece of working with third-party sites is reputation management. Physician reviews are not a bad thing, they are the new word of mouth, as Heather pointed out. Most (80%) of the reviews are going to be positive. The others will be negative, and that is okay. It is important that you get at least 1 or 2 reviews on all the different sites. We know from Healthgrades.com that going from zero reviews to 1 review will increase your call volume by 60%. If you have the choice between 2 physicians and one practice looks like people have been there before, you will go to that one.
You can learn from reviews as well, consumers provide valid feedback. Best practice is to respond to every positive and negative review. Thank them, indicate that you have listened to them, and address any concerns as necessary.
Continue to: Dr. Lotze...
Dr. Lotze: As an example, one of the paramount things that Heather introduced me to was the third party I use to run my website. That company sends a HIPAA-compliant review out to each patient we have seen that day and gives them the opportunity to rate our services and leave comments. If a patient brings up a concern, we can respond immediately, which is important. Patients appreciate feeling that they have been heard. Typically, communicating with a patient will turn the 3-star review into a 5-star as she follows up with the practice.
Ms. Schueppert: Timeliness is important. And just to mention, there certainly is a time commitment to this (and it is a marathon versus a sprint) and there is some financial investment to get it going, but it could truly be detrimental to a practice if you decide not to do anything at all.
Dr. Bowman: Agencies can really help with the time commitment.
Handling bad reviews
Dr. Culligan: What about that person who seems to have it out for you, perhaps giving you multiple bad reviews?
Dr. Bowman: I have seen this before. At Healthgrades, we recently analyzed 8.4 million patient reviews to see what people wrote about.2 The first thing they will talk about is quality of care as they see it. Did I get better or not? You can’t “fix” every patient; there will be some that you cannot help. The next thing patients comment on is bedside manner. With negative reviews, you will see more comments about the office staff.2
A single negative review actually helps make the positive ones look more credible. But if you do believe someone is trolling you, we can flag it and will investigate to the best of our ability. (Different sites likely have different editorial policies.) For example, we look at the IP addresses of all reviews, and if multiple reviews are coming from the same location, we would only let one through, overwriting the previous review from that address.
Patients just want to be heard. We have seen people change their views, based on how their review is handled and responded to.
Dr. Lotze: Is there a response by the physician that you think tends to work better in terms of resolving the issue that can minimize a perceived caustic reaction to a patient’s criticism?
Dr. Bowman: First, just like with any stressful situation, take a deep breath and respond when you feel like you can be constructive. When you do respond, be gracious. Thank them for their feedback. Make sure you reference something about their concern: “I understand that you had to wait longer than you would have liked.” Acknowledge the problem they reference, and then just apologize: “I’m sorry we didn’t meet your expectations.” Then, if they waited too long for example, “We have a new system where no one should have to wait more than 30 minutes….” You can respond privately or publically. Generally, public responses are better as it shows other consumers that you are willing to listen and consider their point of view.
Continue to: The next phase at Healthgrades...
The next phase at Healthgrades
Dr. Culligan: Do you see changes to the way physician-rating sites are working now? Are we going to stay status quo over the next 10 years, or do you see frontiers in how your site is going to develop?
Dr. Bowman: For Healthgrades, we rely on quantitative and objective measures, not just the qualitative. We are investing heavily right now in trying to help consumers understand what are the relative volumes of different procedures or different patient types that each individual doctor sees. Orthopedics is an easy example—if you have a knee problem, you want to go to someone who specializes in knees. Our job is to help consumers easily identify, “This is a shoulder doctor, this is a knee doctor, and this is why that matters.”
In the meantime, as a physician, you can always go into our site and state your care philosophy, identifying what is the sort of patient that you like to treat. Transparency is good for everyone, and especially physicians. It helps the right patient show up for you, and it helps you do a better job providing referrals.
Social media: Avoid pitfalls, and use it to your benefit
Dr. Lotze: Branding was one of the things that I was confused about, and Heather really helped me out. As physicians, we put ourselves out there on our websites, which we try to make professional sources of information for patients. But patients often want to see what else they can find out about us, including Healthgrades and social media. I think the thing that is important to know with social media is that it is a place where people learn about you as a person. Your social media should be another avenue of promotion. Whether it is your personal or professional Facebook page, people are going to see those sites. You have an opportunity to promote yourself as a good physician and a good person with a wholesome practice that you want people to come to. If a physician is posting questionable things about themselves on any kind of social media, it could be perceived as inappropriate by the patient. That can impact how patients think of you as a person, and how they are going to grade you. If people lose sight of who you are due to a questionable social media posting, everything else (SEO, the website) can be for naught.
Dr. Culligan: What are the most important social media tools to invest your time in?
Ms. Schueppert: Before anybody jumps into social media, I firmly recommend that you make sure your local search and your Google 3-pack is set up—which is basically a method Google uses to display the top 3 results on its listings page. Then make sure you have a review management system in place. Make sure you have that updated website. Those are the foundational elements. Once you have that going, social media is the next added layer to that digital presence.
I usually recommend LinkedIn. It is huge because you are staying in contact with your colleagues, that business-to-business type of connection. It remains a way for physicians to set themselves up as experts in their level of specialty.
From there, it’s either Instagram or Facebook. If you are serving more of the younger generations, the millennials and younger, then Instagram is the way to go. If you are focusing on your 40+, 50+, they are going to be far more on Facebook.
Continue to: Dr. Lotze...
Dr. Lotze: For me, a Facebook page was a great place to start. The cost of those Google ads—the first things we see at the top of a Google search in their own separate box—is significant. If a practice has that kind of money to invest, great; it is an instant way to be first on the page during a search. But there are more cost-effective ways of doing that, especially as you are getting your name out. Facebook provides, at a smaller cost, promotion of whatever it is that you are seeking to promote. You can find people within a certain zip code, for instance, and use a Facebook ad campaign that can drive people to your Facebook page—which should have both routinely updated new posts and a link to your website. The posts should be interesting topics relevant to the patients you wish to treat (avoiding personal stories or controversial discussions). You can put a post together, or you can have a third-party service do this. People who follow your page will get reminders of you and your practice with each new post. As your page followers increase, your Facebook rank will improve, and your page will more likely be discovered by Facebook searches for your services. With an added link to your office practice website, those patients go straight to your site without getting lost in the noise of Google search results.
For Instagram, a short video or an interesting picture, along with a brief statement, are the essentials. You can add a single link. Marketing here is by direct messaging or having patients going to your website through a link. Instagram, like Facebook, offers analytics to help show you what your audience likes to read about, improving the quality of your posts and increasing number of followers.
YouTube is the number 2 search engine behind Google. A Google search for your field of medicine may be filled with pages of competitors. However, YouTube has a much lower volume of competing practices, making it easier for patients to find you. The only downside to YouTube is that it will list your video along with other competing videos, which can draw attention away from your practice.
If you want to promote your website or practice with video, using a company such as Vimeo is a better choice compared with YouTube, as YouTube gets credit for video views—which improves YouTube’s SEO and not your own website. Vimeo allows for your website to get credit each time the video is watched. Regardless of where you place your videos, make them short and to the point, with links to your website. Videos only need to be long enough to get your message across and stimulate interest in your practice.
If you can have a blog on your website, it also will help with SEO. What a search engine like Google wants to see is that a patient is on your web page and looking at something for at least 60 seconds. If so, the website is deemed to have information that is relevant, improving your SEO ranking.
Finally, Twitter also can be used for getting messaging out and for branding. The problem with it is that many people go to Twitter to follow a Hollywood celebrity, a sports star, or are looking for mass communication. There is less interest on Twitter for physician outreach.
Continue to: Measuring ROI...
Measuring ROI
Dr. Culligan: What’s the best way to track your return on investment?
Dr. Lotze: First for me was to find out what didn’t work in the office and fix that before really promoting my practice. It’s about the global experience for a patient, as Brad mentioned. As a marketing expert, Heather met with me to understand my goals. She then called my office as a patient to set up an appointment and went through that entire office experience. We identified issues needing improvement.
The next step was to develop a working relationship with my webmaster—someone who can help manage Internet image and SEO. Together, you will develop goals for what the SEO should promote specific to your practice. Once a good SEO program is in place, your website’s ranking will go up—although it can take a minimum of 6 months to see a significant increase. To help understand your website’s performance, your webmaster should provide you with reports on your site’s analytics.
As you go through this process, it is great to have a marketing expert to be the point person. You will work closely together for a while, but eventually you can back off over time. The time and expense you invest on the front end have huge rewards on the back end. Currently, I still spend a reasonable amount of money every month. I have a high self-referral base because of these efforts, however, which results in more patient surgeries and easily covers my expenses. It is money well invested. My website traffic increased by 268% over 2 years (FIGURE). I’ll propose that currently more than half of my patients are self-referrals due to online marketing.

Ms. Schueppert: The only thing I would add is training your front staff. They are checking people in, taking appointments, checking your patients out. Have them be mindful that there are campaigns going on, whether it is a social media push, or a new video that went on the website. They can ask, “How did you hear about us?” when a new patient calls.
Dr. Bowman: Unless you are a large university hospital, where the analytics get significantly more advanced in terms of measuring return on investment (ROI), I think you should just be looking at your schedule and looking at your monthly billings and seeing how they change over time. You can calculate how much a new patient is worth because you can figure out how many patients you have and how much you bill and what your profits are.
Dr. Culligan: For those of us who are hospital employees, you can try to convince the hospital that you can do a detailed ROI analysis, or you can just look at it like (say it’s $3,000 per month), how many surgeries does this project have to generate before the hospital makes that back? The answer is a fraction of 1 case.
Thank you to all of you for your expertise on this roundtable.
To have a thriving business in today’s world, a functioning website is crucial to the overall business health. For a medical practice in general, and for its physicians specifically, it is one of the first steps for maintaining a practice. But to grow that practice, it is crucial to take the steps beyond just having a website. Growth requires website optimization for search engines, an expanding referral base, and the knowledge to use web tools and social media at your disposal to promote the practice and its physicians. In this roundtable, several marketing experts and web-savvy physicians discuss using available tools to best position and grow a practice.
Choosing a web upgrade
Patrick J. Culligan, MD: Peter, can you start us off by describing your relationship with Heather, and how your practice benefitted from her expertise?
Peter M. Lotze, MD: Sure. I am a urogynecologist in the competitive market of pelvic reconstructive surgery in Houston, Texas. Within that market, my main approach was to reach out to other physicians to refer patients to my practice. It generally would work, but took increasingly greater amounts of time to call these physicians up, write them letters, and maintain relationships. I felt that the large, national practice group that I am in did not have a significant web presence optimized to promote my practice, which makes it difficult for patients seeking your services to find you in their search for a doctor. It is helpful for patients to be able to understand from your website who you are, what you do, and what their experience may be like.
Glaring to me was that a web search specific for me or things that I do, would not produce our company’s results until page 2 or more on Google. This can be devastating for a practice because most people don’t go past the first page, and you can end up with fewer self-referrals, which should be a significant portion of new patients to your practice. I knew I needed guidance; I knew of Heather’s expertise given her exceptional past work building marketing strategies.
Digital go-tos for marketing
Heather Schueppert: Yes, I was pleased to work with Dr. Lotze, and at the time was a marketing consultant for practices such as his. But gone are the days of printed material—brochures, pamphlets, or even billboards—to effectively promote a business, or in this case, a practice. What still withstands the test of time, however, as the number 1 marketing referral source is word of mouth—from your trusted friend, family member, or coworker.
It is now proven that the number 2 most trusted form of advertising, the most persuasive and the most motivating, is online marketing.1 It is the “digital word of mouth”—the review. Patients are actively online, and a strong digital presence is critical to provide that direct value to retain and grow your patient base.
Continue to: Foundations of private practice reach out...
Foundations of private practice reach out
There are 3 important areas that I consider the foundation of any private practice marketing strategy (TABLE). First is an updated website that is search engine optimized (SEO). You can’t just set it and forget it, it needs to be an updated website. The algorithms for search engines are changing constantly to try to make it as fair and relevant as possible for patients or consumers to find the businesses they are searching for online.

The second area is review management, and for a physician, or even a care center, to do this on your own is a daunting task. It is a critical component, however, to making sure that your reputation out there, that online word of mouth, is as high a star rating as possible.
The third component is local search, which is basically a form of SEO that helps businesses show up in relevant local searches. We are all familiar with the search, “find a restaurant near me,” anything that pushes those search engines to find something local.
Those are what I call the effective triad: that updated website, the review management, and the local search, and all of these are tied together. I think Dr. Lotze and his practice did these effectively well, and I believe that he achieved his goals for the longer term.
Review/reputation management
Dr. Culligan: Brad, is there something that doctors may not know about Healthgrades, and are there opportunities to take full advantage of this physician-rating site?
Brad Bowman, MD: I agree with everything that Dr. Lotze and Heather have said. Start with yourself—what is it that you want to be, the one thing you want to stand for? Get your own marketing, your website right, then, the point is, once you do all that and you are number 1 in SEO, you are still only going to get about 25% of the people looking for you by name to come to your website. The other 75% are going to look at all the other different sites that are out there to provide information to consumers. So the question becomes what do you do with all these other third-party sites? Healthgrades is the most comprehensive and has the highest traffic of the third-party “find a doctor” sites. In 2020, half of all Americans who go to a doctor will use Healthgrades at some point to help select and connect with that doctor.
Physicians have their focus on the quality of the care they provide. Patients, however, focus on the quality of the entire health care experience. Did I get better? How long did I have to wait? Was the office staff helpful? Scarily enough, we still spend more time shopping for a refrigerator or mattress than we do shopping for a doctor. We still tend to think that all doctors are the same. It is the reality of how we have been trained by our insurance companies and by the health care system. That is why getting your marketing right and getting what is it that you want to be known for out there is important, so that you can get the types of patients you want.
Listings management is very important. Make sure that you are findable everywhere. There are services that will do this: Doctor.com, Reputation.com, and many others. They can help you make sure you get all your basic materials right: addresses, phone numbers, your picture. Because 75% of people are going to end up on third-party websites, if your phone number is wrong there, you could lose that patient.
Then the second piece of working with third-party sites is reputation management. Physician reviews are not a bad thing, they are the new word of mouth, as Heather pointed out. Most (80%) of the reviews are going to be positive. The others will be negative, and that is okay. It is important that you get at least 1 or 2 reviews on all the different sites. We know from Healthgrades.com that going from zero reviews to 1 review will increase your call volume by 60%. If you have the choice between 2 physicians and one practice looks like people have been there before, you will go to that one.
You can learn from reviews as well, consumers provide valid feedback. Best practice is to respond to every positive and negative review. Thank them, indicate that you have listened to them, and address any concerns as necessary.
Continue to: Dr. Lotze...
Dr. Lotze: As an example, one of the paramount things that Heather introduced me to was the third party I use to run my website. That company sends a HIPAA-compliant review out to each patient we have seen that day and gives them the opportunity to rate our services and leave comments. If a patient brings up a concern, we can respond immediately, which is important. Patients appreciate feeling that they have been heard. Typically, communicating with a patient will turn the 3-star review into a 5-star as she follows up with the practice.
Ms. Schueppert: Timeliness is important. And just to mention, there certainly is a time commitment to this (and it is a marathon versus a sprint) and there is some financial investment to get it going, but it could truly be detrimental to a practice if you decide not to do anything at all.
Dr. Bowman: Agencies can really help with the time commitment.
Handling bad reviews
Dr. Culligan: What about that person who seems to have it out for you, perhaps giving you multiple bad reviews?
Dr. Bowman: I have seen this before. At Healthgrades, we recently analyzed 8.4 million patient reviews to see what people wrote about.2 The first thing they will talk about is quality of care as they see it. Did I get better or not? You can’t “fix” every patient; there will be some that you cannot help. The next thing patients comment on is bedside manner. With negative reviews, you will see more comments about the office staff.2
A single negative review actually helps make the positive ones look more credible. But if you do believe someone is trolling you, we can flag it and will investigate to the best of our ability. (Different sites likely have different editorial policies.) For example, we look at the IP addresses of all reviews, and if multiple reviews are coming from the same location, we would only let one through, overwriting the previous review from that address.
Patients just want to be heard. We have seen people change their views, based on how their review is handled and responded to.
Dr. Lotze: Is there a response by the physician that you think tends to work better in terms of resolving the issue that can minimize a perceived caustic reaction to a patient’s criticism?
Dr. Bowman: First, just like with any stressful situation, take a deep breath and respond when you feel like you can be constructive. When you do respond, be gracious. Thank them for their feedback. Make sure you reference something about their concern: “I understand that you had to wait longer than you would have liked.” Acknowledge the problem they reference, and then just apologize: “I’m sorry we didn’t meet your expectations.” Then, if they waited too long for example, “We have a new system where no one should have to wait more than 30 minutes….” You can respond privately or publically. Generally, public responses are better as it shows other consumers that you are willing to listen and consider their point of view.
Continue to: The next phase at Healthgrades...
The next phase at Healthgrades
Dr. Culligan: Do you see changes to the way physician-rating sites are working now? Are we going to stay status quo over the next 10 years, or do you see frontiers in how your site is going to develop?
Dr. Bowman: For Healthgrades, we rely on quantitative and objective measures, not just the qualitative. We are investing heavily right now in trying to help consumers understand what are the relative volumes of different procedures or different patient types that each individual doctor sees. Orthopedics is an easy example—if you have a knee problem, you want to go to someone who specializes in knees. Our job is to help consumers easily identify, “This is a shoulder doctor, this is a knee doctor, and this is why that matters.”
In the meantime, as a physician, you can always go into our site and state your care philosophy, identifying what is the sort of patient that you like to treat. Transparency is good for everyone, and especially physicians. It helps the right patient show up for you, and it helps you do a better job providing referrals.
Social media: Avoid pitfalls, and use it to your benefit
Dr. Lotze: Branding was one of the things that I was confused about, and Heather really helped me out. As physicians, we put ourselves out there on our websites, which we try to make professional sources of information for patients. But patients often want to see what else they can find out about us, including Healthgrades and social media. I think the thing that is important to know with social media is that it is a place where people learn about you as a person. Your social media should be another avenue of promotion. Whether it is your personal or professional Facebook page, people are going to see those sites. You have an opportunity to promote yourself as a good physician and a good person with a wholesome practice that you want people to come to. If a physician is posting questionable things about themselves on any kind of social media, it could be perceived as inappropriate by the patient. That can impact how patients think of you as a person, and how they are going to grade you. If people lose sight of who you are due to a questionable social media posting, everything else (SEO, the website) can be for naught.
Dr. Culligan: What are the most important social media tools to invest your time in?
Ms. Schueppert: Before anybody jumps into social media, I firmly recommend that you make sure your local search and your Google 3-pack is set up—which is basically a method Google uses to display the top 3 results on its listings page. Then make sure you have a review management system in place. Make sure you have that updated website. Those are the foundational elements. Once you have that going, social media is the next added layer to that digital presence.
I usually recommend LinkedIn. It is huge because you are staying in contact with your colleagues, that business-to-business type of connection. It remains a way for physicians to set themselves up as experts in their level of specialty.
From there, it’s either Instagram or Facebook. If you are serving more of the younger generations, the millennials and younger, then Instagram is the way to go. If you are focusing on your 40+, 50+, they are going to be far more on Facebook.
Continue to: Dr. Lotze...
Dr. Lotze: For me, a Facebook page was a great place to start. The cost of those Google ads—the first things we see at the top of a Google search in their own separate box—is significant. If a practice has that kind of money to invest, great; it is an instant way to be first on the page during a search. But there are more cost-effective ways of doing that, especially as you are getting your name out. Facebook provides, at a smaller cost, promotion of whatever it is that you are seeking to promote. You can find people within a certain zip code, for instance, and use a Facebook ad campaign that can drive people to your Facebook page—which should have both routinely updated new posts and a link to your website. The posts should be interesting topics relevant to the patients you wish to treat (avoiding personal stories or controversial discussions). You can put a post together, or you can have a third-party service do this. People who follow your page will get reminders of you and your practice with each new post. As your page followers increase, your Facebook rank will improve, and your page will more likely be discovered by Facebook searches for your services. With an added link to your office practice website, those patients go straight to your site without getting lost in the noise of Google search results.
For Instagram, a short video or an interesting picture, along with a brief statement, are the essentials. You can add a single link. Marketing here is by direct messaging or having patients going to your website through a link. Instagram, like Facebook, offers analytics to help show you what your audience likes to read about, improving the quality of your posts and increasing number of followers.
YouTube is the number 2 search engine behind Google. A Google search for your field of medicine may be filled with pages of competitors. However, YouTube has a much lower volume of competing practices, making it easier for patients to find you. The only downside to YouTube is that it will list your video along with other competing videos, which can draw attention away from your practice.
If you want to promote your website or practice with video, using a company such as Vimeo is a better choice compared with YouTube, as YouTube gets credit for video views—which improves YouTube’s SEO and not your own website. Vimeo allows for your website to get credit each time the video is watched. Regardless of where you place your videos, make them short and to the point, with links to your website. Videos only need to be long enough to get your message across and stimulate interest in your practice.
If you can have a blog on your website, it also will help with SEO. What a search engine like Google wants to see is that a patient is on your web page and looking at something for at least 60 seconds. If so, the website is deemed to have information that is relevant, improving your SEO ranking.
Finally, Twitter also can be used for getting messaging out and for branding. The problem with it is that many people go to Twitter to follow a Hollywood celebrity, a sports star, or are looking for mass communication. There is less interest on Twitter for physician outreach.
Continue to: Measuring ROI...
Measuring ROI
Dr. Culligan: What’s the best way to track your return on investment?
Dr. Lotze: First for me was to find out what didn’t work in the office and fix that before really promoting my practice. It’s about the global experience for a patient, as Brad mentioned. As a marketing expert, Heather met with me to understand my goals. She then called my office as a patient to set up an appointment and went through that entire office experience. We identified issues needing improvement.
The next step was to develop a working relationship with my webmaster—someone who can help manage Internet image and SEO. Together, you will develop goals for what the SEO should promote specific to your practice. Once a good SEO program is in place, your website’s ranking will go up—although it can take a minimum of 6 months to see a significant increase. To help understand your website’s performance, your webmaster should provide you with reports on your site’s analytics.
As you go through this process, it is great to have a marketing expert to be the point person. You will work closely together for a while, but eventually you can back off over time. The time and expense you invest on the front end have huge rewards on the back end. Currently, I still spend a reasonable amount of money every month. I have a high self-referral base because of these efforts, however, which results in more patient surgeries and easily covers my expenses. It is money well invested. My website traffic increased by 268% over 2 years (FIGURE). I’ll propose that currently more than half of my patients are self-referrals due to online marketing.

Ms. Schueppert: The only thing I would add is training your front staff. They are checking people in, taking appointments, checking your patients out. Have them be mindful that there are campaigns going on, whether it is a social media push, or a new video that went on the website. They can ask, “How did you hear about us?” when a new patient calls.
Dr. Bowman: Unless you are a large university hospital, where the analytics get significantly more advanced in terms of measuring return on investment (ROI), I think you should just be looking at your schedule and looking at your monthly billings and seeing how they change over time. You can calculate how much a new patient is worth because you can figure out how many patients you have and how much you bill and what your profits are.
Dr. Culligan: For those of us who are hospital employees, you can try to convince the hospital that you can do a detailed ROI analysis, or you can just look at it like (say it’s $3,000 per month), how many surgeries does this project have to generate before the hospital makes that back? The answer is a fraction of 1 case.
Thank you to all of you for your expertise on this roundtable.
- Anderson A. Online reviews vs. word of mouth: Which one is more important. https://www.revlocal.com/blog/reviewandreputationmanagement/onlinereviewsvswordofmouthwhichoneismoreimportant. Accessed July 17, 2020.
- 2020 Patient sentiment report. Healthgrades; Medical Group Management Association. https://www.healthgrades.com/content /patientsentimentreport. Accessed July 17, 2020
- Anderson A. Online reviews vs. word of mouth: Which one is more important. https://www.revlocal.com/blog/reviewandreputationmanagement/onlinereviewsvswordofmouthwhichoneismoreimportant. Accessed July 17, 2020.
- 2020 Patient sentiment report. Healthgrades; Medical Group Management Association. https://www.healthgrades.com/content /patientsentimentreport. Accessed July 17, 2020
COVID-SAFE: Strategies for safeguarding your outpatient clinical practice against COVID-19
No question, the COVID-19 pandemic has been a challenging time for medical practices across the United States. Uncertainty remains regarding bringing patients and services back into our offices. One factor that distinguishes many ObGyn practices from other specialties is that our practices have remained open—in some form—since the beginning of the pandemic. In various parts of the country, gynecologic surgeries and routine office visits have been significantly reduced; however, deliveries and gynecologic emergencies have continued.
In this article, I suggest a framework of strategies and resources to provide insight for outpatient operations. Individual practices will vary across the nation depending on local conditions. Full practice capacity may take on a different look than it had prior to the pandemic, and there is opportunity to change the way we operate.
Strategy 1: Consult regulatory requirements frequently
As the local status of COVID-19 evolves quickly, it is essential to examine the frequently updated recommendations from regulatory agencies at the federal, state, and local levels. Clinical practices that function within health systems need to demonstrate alignment with hospital or university policies and procedures. The Centers for Disease Control and Prevention (CDC), Occupational Safety and Health Administration (OSHA), Centers for Medicare and Medicaid Services (CMS), and individual state departments of health provide dynamic resources that are easily accessible online.1-3
The American College of Obstetricians and Gynecologists (ACOG) continues to be an excellent medical society resource.4 Subspecialty organizations that provide up-to-date guidance include the Society for Maternal-Fetal Medicine (SMFM), Society of Gynecologic Surgeons (SGS), AAGL (American Association of Gynecologic Laparoscopists), American Society for Reproductive Medicine (ASRM), and Society of Gynecologic Oncology (SGO).5-9 These resources are updated as more information about COVID-19 emerges, and they may be modified to different local-regional conditions.
The professional liability insurance carrier is an important source of insight for a number of circumstances, including modifications to your office practice, such as returning to full-scope or part-time practice; operating outside normal clinical service arrangements (for example, assisting with emergency care); offering telehealth services; and adding extra hours or employees to accommodate the patient backlog. Business insurance coverage is a separate issue to consider. Reviewing the practice policy may protect your business from COVID-related liabilities.
Consulting with legal counselors can be helpful. They can assist with navigating various practice and personnel COVID-related changes, as well as developing a viable plan for patients who were previously insured pre–COVID-19 who are currently uninsured.
Continue to: Strategy 2: Reimagine schedule capacity...
Strategy 2: Reimagine schedule capacity
The waxing and waning of the COVID-19 crisis presents an opportunity to evaluate our office practices and make necessary and positive changes. The question becomes, do we operate our practices as usual or do we rethink our strategy for seeing patients and integrate lessons learned from the pandemic? Patients are deciding when they are comfortable to schedule elective surgeries and routine office encounters. This gives us the chance to break from the tradition of 100% in-person visits and change the way we care for women.
The coronavirus has accelerated the rise of telehealth/telemedicine and is, perhaps, a silver lining of the pandemic. Telehealth is a valuable tool for accessing health services when in-person visits are not possible. Evaluating and triaging patients for in-person versus telehealth visits is now a viable option for clinical practice and reduces exposure to COVID-19 infection.
Telemedicine is convenient, and clinicians can use it to counsel and screen for various health issues as well as to extend their reach to rural communities. Appropriate consent should be documented in the patient chart. As some areas continue to be without adequate access to WiFi, telephone contact also is currently acceptable. Telehealth does not replace the in-person visit but can be viewed as a complementary and supplementary service.
Consider a balance between telehealth and in-person visits by evaluating which visits can continue remotely and which can alternate with in-person visits. This offers tremendous flexibility and will expand delivery of essential health care to patients.10 Integrating telemedicine into clinical practice provides an additional benefit: It minimizes the exposure and transmission of COVID-19 to health care workers and patients and preserves supplies, including personal protective equipment (PPE).
Prioritize the backlog of patients who require follow-up testing, procedures, and surgeries. Communicate with patients that it is safe to be seen and important to not avoid routine and preventative visits that might reveal concerns or conditions that require treatment.
Strategy 3: Institute infection prevention and control measures
The importance of instituting and ensuring safety measures for office personnel and patients cannot be underestimated. Recently, a study from King’s College in London found that frontline health care workers with PPE still have 3 to 4 times the risk of contracting coronavirus compared with the general public.11 Health care systems should ensure adequate PPE availability and develop additional strategies to protect health care workers from COVID-19. We have to be fanatical about cleanliness and PPE. We have to be diligent about how we space ourselves and our patients. Consider adjusting workflows to ensure that visits can be conducted as quickly and safely as possible.
Communicating updated safety plans and processes are invaluable for both patients and health care workers. Patients want to be reassured that safety precautions are in place to keep the environment safe and clean. Additionally, privacy and confidentiality concerns should be addressed.
Consider a modified office schedule that can reduce the number of people in the office, person-to-person contact, and COVID-19 transmission. Social distancing is improved and PPE and other supplies are preserved.
Continue to: Employees can work on alternating days...
- Employees can work on alternating days or during different parts of the day.
- Administrative staff who do not need to be physically present in the office might work remotely.
- Expanding office hours (early morning, evening, and weekends) spreads patient visits throughout the day and minimizes high-volume in-person visits.
Institute a daily COVID-19 symptom attestation and temperature check for employees on arrival at work.
Health care personnel with symptoms of COVID-19 should be prioritized for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) RNA testing with an approved nucleic acid or antigen detection assay. A negative result indicates that the person most likely did not have an active SARS-CoV-2 infection at the time the sample was collected. A second test for SARS-CoV-2 RNA may be performed at the discretion of the evaluating health care provider, particularly when a higher level of clinical suspicion for infection exists.
The return to work decision should be determined by an agreed on symptom-based approach to clearance. If needed on a case-by-case basis, a review can be performed with the individual’s health care provider.12
Require universal masking and appropriate protective equipment.
- All staff members, patients, and visitors must wear masks correctly in the facilities (except children under age 2).
- All clinical staff members must wear masks correctly and eye protection during every patient encounter.
Reconfigure the waiting room and patient flow.
- Configure waiting room furniture to reinforce 6 feet of physical distancing.
- Remove all books, magazines, and toys from all waiting areas.
- Laminate signage for display.
- Install plexiglass at the check-in desk to minimize virus transmission.
- If possible, ask patients to wait in their car until their appointment time or to go directly to their exam room on arrival if it is available.
- Implement virtual check-in and check-out so that patients reduce unnecessary contact with surfaces and staff.
- Limit a high volume of patients to maintain social distancing etiquette, avoid delays, and allow adequate cleaning time between patients.
- Permit visitors to accompany adult patients to their ambulatory appointments only if special assistance is required.
- Limit the number of staff members in the exam and treatment rooms and maintain at least 6 feet between people except during medical care activities.
- Consider patient flow in a one-way traffic pattern.
Focus on keeping the clinical practice clean. (Follow the instructions and disinfect with a registered disinfectant product that meets the US Environmental Protection Agency criteria for use against COVID-19.13)
- Clean waiting rooms and restrooms frequently.
- Coordinate patient appointments to allow for infection control measures.
- Frequently clean high-touch surfaces, including tables, doorknobs, light switches, countertops, handles, desks, phones, keyboards, toilets, faucets, and sinks.
- Clinicians and all medical staff members should wash their hands before and after interacting with patients.
- Clean and disinfect the exam and treatment rooms before and after each patient.
- Use products that are effective against a range of organisms and viruses, including the coronavirus that causes COVID-19.
- Place signs indicating that rooms have been cleaned; this will assure and comfort patients. Take credit for your infection control processes.
Keep abreast of isolation and precaution guidelines. Based on data available at the time of this article’s publication, the CDC recommends ending isolation and transmission-based precautions for most people with COVID-19 using a symptom-based strategy.14 This limits unnecessary prolonged isolation and use of laboratory testing resources.
Generally, repeat SARS-CoV-2 polymerase chain reaction (PCR) testing is not recommended for “COVID-19 recovered” patients. Specifically, those patients with a prior positive SARS-CoV-2 PCR test result and who have met criteria for isolation discontinuation do not need a follow-up PCR test. A test-based strategy to discontinue isolation and transmission-based precautions is required only for severely immunocompromised patients.15
Prepare for a future COVID-19 surge and review your emergency plan and responses and revise as needed. Review handling of the current pandemic and best practices plus areas of improvement.
Symptom-based criteria for discontinuing transmission-based precautions include the following:
Patients with mild to moderate illness, not severely immunocompromised:
- at least 10 days have passed since symptoms first appeared and
- at least 24 hours have passed since last fever without fever-reducing medications and
- symptoms (cough, shortness of breath) have improved.
Note: For patients who are not severely immunocompromised and are asymptomatic throughout their infection, transmission-based precautions may be discontinued when at least 10 days have passed since the date of their first positive viral diagnostic test.
Patients with severe to critical illness, severely immunocompromised:
- at least 20 days have passed since symptoms first appeared and
- at least 24 hours have passed since last fever without fever-reducing medications and
- symptoms (cough, shortness of breath) have improved.
Note: For patients who are severely immunocompromised and are asymptomatic throughout their infection, transmission-based precautions may be discontinued when at least 20 days have passed since the date of their first positive viral diagnostic test.
Continue to: Strategy 4: Implement frequent employee communication and care...
Strategy 4: Implement frequent employee communication and care
The safety and well-being of our health care workers and patients in our clinical practices is paramount. Continuing to communicate this message and developing and sharing a plan may ameliorate the obvious toll on mental and emotional well-being. Frequent and effective communication with your clinical team is vital to reinforce policies and protocols, eliminate silos, and reduce errors.
Practice communication and care with these approaches:
- Offer regular employee COVID-19 testing.
- Re-educate staff about infection control protocols to ensure buy-in.
- Communicate with staff about the plan to address staffing shortages.
- Implement regular employee team huddles that can address accomplishments, challenges, areas for improvement, and top priorities.
- Perform regular celebrations for staff appreciation.
- Address mental health and chronic stress and offer empathy and coping resources and services to staff and clinicians. This will have a valuable, long-term benefit.
Patient communication. As the COVID-19 pandemic continues and stay-at-home policies are in place, patients should be encouraged to seek medical care if they are ill or have acute or chronic conditions. Communicate regularly with patients and let them know that their safety and well-being is the top priority. Prior to in-person visits, inform them of the safety processes that are in place to protect them.
Fostering an honest clinician-patient relationship enhances communication. Despite these efforts, some patients may not be forthcoming about their COVID-19 symptoms, illness, exposure, or travel. Health care staff can be encouraged to set a tone of tolerance and compassion and treat everyone with universal precautions.
Rising to the challenges
During the coronavirus pandemic, ObGyns continue to safely care for pregnant women and also triage and treat women who require timely office care as well as emergency and cancer-related surgeries.
The COVID-19 environment rapidly changes depending on the practice location. The strategies described represent a compilation of resources from key organizations that hopefully will prove useful and can be shaped to fit your practice. Local and regional recommendations vary, and no one can predict the course of the virus.
Consider reviewing your contingency plans regularly. As we have learned over the last several months, there is a science to maintaining a COVID-SAFE environment.
Practice operations likely will change to adapt to new conditions. The pandemic has challenged us to evolve, and we have responded with new capabilities and resilience while we continue to deliver superior and compassionate care for women.
For additional strategies on how to safeguard your practice against COVID-19, see the box below. ●
Continue to: Additional strategies on how to safeguard your practice against COVID-19...
Strategy 5: Develop a resource plan for practice operations
Assess financial solvency. Because of the mitigation measures taken during the pandemic, physician practices of all sizes are facing financial hardships and instability. As the pandemic progresses, physicians in private practice and those employed by health systems may benefit from existing resources and pandemic relief to help navigate COVID-related challenges.
Frequent revision of your financial plan may safeguard cash flow in the event of fewer patient visits and elective surgeries. Many medical organizations, including ACOG, are advocating for financial relief, fair reimbursement for telehealth and in-person visits, and access to adequate PPE. ACOG provides updated information on practice management.1
The American Medical Association (AMA) has created resources for physician practices to assist in staying focused on business and financial operations. The AMA has provided a summary of the Health, Economic Assistance, Liability Protection and Schools Act (HEALS Act).2 This is the next proposed coronavirus relief fund package, which includes provisions that benefit physicians and physician practices.
Create a plan. Review available resources and establish processes to optimize your practice capacity during the ongoing COVID-19 pandemic. Develop a game plan for patient care with a phased approach to identify and address challenges. This planning will allow your practice to pivot in response to changing local COVID-19 conditions to help you anticipate and prepare for a future surge. Maintain and revise plans as the pandemic shifts. Thinking ahead avoids the need to navigate issues in real time. Communicating clearly and often with all members of the office staff and patients lets everyone know that their safety is the main priority.
Assess staffing for flexible coverage. Frequent needs assessment helps to determine the number of staff needed to maintain a safe work environment for the patient volume.
Staff shortages may occur because of COVID-19 exposure, personal or family member illness, or childcare constraints due to daycare or school availability. Staff readiness includes evaluating individual availability and willingness.
Staff members with health issues, including comorbidities and chronic medical conditions, may not be comfortable working. Nonclinical staff members with health concerns could work remotely, although some may not be able to work from home due to technology-related issues such as WiFi deficiencies.
The CDC has interim guidelines to assist employers with providing a safe workplace and employees with making the best health decisions for themselves and their families.3,4 The US Office of Personnel Management provides guidance for COVID-19–related leave and benefits for federal employees.5
To mitigate staff shortages, approaches include adjusting schedules, cross-training to perform the tasks of other positions, and hiring additional personnel. A needs assessment can help determine if existing personnel could be cross-trained for other purposes or if additional staff should be hired. Understanding the minimum number of staff required for safe and effective patient care will assist in planning for shortages as the pandemic progresses. Understanding the availability of external resources could be a critical part of an office contingency plan.6
Proactively manage your supply chain. The pandemic has caused global supply shortages. Solid supply chain management is crucial for practice operations. Take inventory of your PPE and various supplies and place orders in advance. Analyze cash flow and connect with vendors as well as local and state health agencies to understand available resources. Given ongoing PPE shortages, practices should consider preserving PPE and employ appropriate strategies for optimizing supplies of face masks.7
Certain medications and vaccines administered in the office setting may be outdated and need to be replaced. Office equipment that has not been used for several months will need to be tested. For equipment used in office electrosurgery procedures, certain safety measures can be taken to reduce the transmission of aerosolized viral particles to the health care team. While currently the risk is theoretical and more research is needed, this potential risk should be mitigated.8 Assessing availability of hospital and ambulance or transport services also is recommended as these may change depending on the local COVID-19 status.
Strategy 6: Establish and refine the patient screening process
Patients want reassurance that the health care environment is safe and that their well-being is a priority. In advance of a patient’s visit, relieve any anxiety by explaining the COVID-SAFE measures that your practice has taken.
For employee use, consider telephone and in-person scripting to ensure consistent messaging for patients.
Prescreening. At the time of appointment scheduling and on the day prior to the scheduled appointment, all patients should be screened for symptoms of COVID-19,9 fever, exposure within 14 days to someone newly diagnosed with COVID-19, and travel within 14 days from a foreign country or from a US state with a quarantine requirement.
Patients who screen positive for symptoms, exposure, or travel should be referred to a clinician. If possible, asymptomatic patients who report exposure or travel should have their in-person visit deferred until after the required 14-day quarantine.
Consider restricting visitors from accompanying adult patients to their appointment unless they are required for special assistance.
Arrival screening. At the time of presentation for the appointment, all patients and any accompanying visitors should be rescreened. The optimal location for arrival screening should be determined by the local operations team and the infection prevention and control program.
At presentation, all patients and visitors should appropriately don a surgical mask or other face covering. Patients and visitors should have their temperature checked on arrival. Patients who screen positive for symptoms, exposure to COVID-19, and/or travel should be referred to a clinician or the visit deferred and a telehealth visit considered.
Visitors who screen positive for symptoms, fever, or exposure to COVID-19 are not permitted to accompany the patient. Asymptomatic parents or guardians of pediatric patients may serve as support persons.
References
- American College of Obstetricians and Gynecologists. Financial support for physicians and practices during the COVID-19 pandemic. https://www.acog.org/practice -management/coding/coding-library/financial-support-for-physicians-and-practices-during-the-covid-19-pandemic. Accessed July 23, 2020.
- American Medical Association. HEALS Act: What physicians and medical students need to know. https://www.ama-assn.org/delivering-care/public-health/heals-act -what-physicians-and-medical-students-need-know. Accessed July 29, 2020.
- Centers for Disease Control and Prevention. Interim guidance for businesses and employers responding to coronavirus disease 2019 (COVID-19). https://www.cdc.gov /coronavirus/2019-ncov/community/guidance-business-response.html. Accessed July 12, 2020.
- Centers for Disease Control and Prevention. Criteria for return to work for healthcare personnel with SARS-CoV-2 infection (interim guidance). https://www.cdc.gov /coronavirus/2019-ncov/hcp/return-to-work.html. Accessed July 20, 2020.
- US Office of Personnel Management. Questions and answers on human resources flexibilities and authorities for coronavirus disease 2019 (COVID-19). https://www .opm.gov/policy-data-oversight/covid-19/questions-and-answers-on-human-resources-flexibilities-and-authorities-for-coronavirus-disease-2019-covid-19.pdf. Accessed July 3, 2020.
- Centers for Disease Control and Prevention. Strategies to mitigate healthcare personnel staffing shortages. https://www.cdc.gov/coronavirus/2019-ncov/hcp /mitigating-staff-shortages.html. Accessed July 17, 2020.
- Centers for Disease Control and Prevention. Strategies for optimizing the supply of facemasks. https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/face -masks.html. Accessed July 3, 2020.
- Rahman S, Klebanoff J, Moawad G. Smoke evacuation in the age of COVID-19. Contemporary OB/GYN. July 2, 2020. https://www.contemporaryobgyn.net/view/smoke -evacuation-in-the-age-of-covid-19. Accessed July 3, 2020.
- Centers for Disease Control and Prevention. Symptoms of coronavirus. https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html. Accessed July 25, 2020.
- Centers for Disease Control and Prevention. Information for healthcare professionals about coronavirus (COVID-19). https://www.cdc.gov/coronavirus/2019-nCoV/hcp/index.html. Accessed July 22, 2020.
- US Department of Labor Occupational Safety and Health Administration. COVID-19 control and prevention: healthcare workers and employers. https://www.osha.gov/SLTC/covid-19/healthcare-workers.html. Accessed August 5, 2020.
- Centers for Medicare and Medicaid Services. COVID-19 resources for health care professionals and researchers. https://www.cms.gov/About-CMS/Agency-Information/OMH/resource-center/hcps-and-researchers. Accessed August 7, 2020.
- American College of Obstetricians and Gynecologists. COVID-19. https://www.acog.org/topics/covid-19. Accessed August 7, 2020.
- Society for Maternal-Fetal Medicine. Coronavirus (COVID-19). https://www.smfm.org/covid19. Accessed August 7, 2020.
- Society of Gynecologic Surgeons. Joint statement on re-introduction of hospital and office-based procedures in the COVID-19 climate for the practicing gynecologist. https://www.sgsonline.org/joint-statement-on-re-introduction-of-hospital-and-office-based-procedures-in-the-covid-19-climate. Accessed August 7, 2020.
- AAGL. COVID-19 articles, resources and webinars. https://www.aagl.org/covid-19/. Accessed August 7, 2020.
- American Society for Reproductive Medicine. COVID-19 updates and resources. https://www.asrm.org/news-and-publications/covid-19/. Accessed August 7, 2020.
- Society of Gynecologic Oncology. COVID-19 resources for health care practitioners. https://www.sgo.org/practice-management/covid-19/. Accessed August 7, 2020.
- Centers for Disease Control and Prevention. Using telehealth to expand access to essential health services during the COVID-19 pandemic. https://www.cdc.gov/coronavirus/2019-ncov/hcp/telehealth.html. Accessed July 3, 2020.
- Nguyen LH, Drew DA, Graham MS, et al; on behalf of the COronavirus Pandemic Epidemiology Consortium. Risk of COVID-19 among front-line health-care workers and the general community: a prospective cohort study. Lancet. July 31, 2020. http://www.thelancet-press.com/embargo/hcwcovid.pdf. Accessed August 25, 2020.
- Centers for Disease Control and Prevention. Criteria for return to work for healthcare personnel with SARS-CoV-2 infection (interim guidance). https://www.cdc.gov/coronavirus/2019-ncov/hcp/return-to-work.html. Accessed July 20, 2020.
- US Environmental Protection Agency. List N: Disinfectants for use against SARS-CoV-2 (COVID-19). https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2-covid-19. Accessed August 24, 2020.
- Centers for Disease Control and Prevention. Duration of isolation and precautions for adults with COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html. Accessed July 23, 2020.
- Centers for Disease Control and Prevention. Discontinuation of transmission-based precautions and disposition of patients with COVID-19 in healthcare settings (interim guidance). https://www.cdc.gov/coronavirus/2019-ncov/hcp/disposition-hospitalized-patients.html#fn1. Accessed July 23, 2020.
No question, the COVID-19 pandemic has been a challenging time for medical practices across the United States. Uncertainty remains regarding bringing patients and services back into our offices. One factor that distinguishes many ObGyn practices from other specialties is that our practices have remained open—in some form—since the beginning of the pandemic. In various parts of the country, gynecologic surgeries and routine office visits have been significantly reduced; however, deliveries and gynecologic emergencies have continued.
In this article, I suggest a framework of strategies and resources to provide insight for outpatient operations. Individual practices will vary across the nation depending on local conditions. Full practice capacity may take on a different look than it had prior to the pandemic, and there is opportunity to change the way we operate.
Strategy 1: Consult regulatory requirements frequently
As the local status of COVID-19 evolves quickly, it is essential to examine the frequently updated recommendations from regulatory agencies at the federal, state, and local levels. Clinical practices that function within health systems need to demonstrate alignment with hospital or university policies and procedures. The Centers for Disease Control and Prevention (CDC), Occupational Safety and Health Administration (OSHA), Centers for Medicare and Medicaid Services (CMS), and individual state departments of health provide dynamic resources that are easily accessible online.1-3
The American College of Obstetricians and Gynecologists (ACOG) continues to be an excellent medical society resource.4 Subspecialty organizations that provide up-to-date guidance include the Society for Maternal-Fetal Medicine (SMFM), Society of Gynecologic Surgeons (SGS), AAGL (American Association of Gynecologic Laparoscopists), American Society for Reproductive Medicine (ASRM), and Society of Gynecologic Oncology (SGO).5-9 These resources are updated as more information about COVID-19 emerges, and they may be modified to different local-regional conditions.
The professional liability insurance carrier is an important source of insight for a number of circumstances, including modifications to your office practice, such as returning to full-scope or part-time practice; operating outside normal clinical service arrangements (for example, assisting with emergency care); offering telehealth services; and adding extra hours or employees to accommodate the patient backlog. Business insurance coverage is a separate issue to consider. Reviewing the practice policy may protect your business from COVID-related liabilities.
Consulting with legal counselors can be helpful. They can assist with navigating various practice and personnel COVID-related changes, as well as developing a viable plan for patients who were previously insured pre–COVID-19 who are currently uninsured.
Continue to: Strategy 2: Reimagine schedule capacity...
Strategy 2: Reimagine schedule capacity
The waxing and waning of the COVID-19 crisis presents an opportunity to evaluate our office practices and make necessary and positive changes. The question becomes, do we operate our practices as usual or do we rethink our strategy for seeing patients and integrate lessons learned from the pandemic? Patients are deciding when they are comfortable to schedule elective surgeries and routine office encounters. This gives us the chance to break from the tradition of 100% in-person visits and change the way we care for women.
The coronavirus has accelerated the rise of telehealth/telemedicine and is, perhaps, a silver lining of the pandemic. Telehealth is a valuable tool for accessing health services when in-person visits are not possible. Evaluating and triaging patients for in-person versus telehealth visits is now a viable option for clinical practice and reduces exposure to COVID-19 infection.
Telemedicine is convenient, and clinicians can use it to counsel and screen for various health issues as well as to extend their reach to rural communities. Appropriate consent should be documented in the patient chart. As some areas continue to be without adequate access to WiFi, telephone contact also is currently acceptable. Telehealth does not replace the in-person visit but can be viewed as a complementary and supplementary service.
Consider a balance between telehealth and in-person visits by evaluating which visits can continue remotely and which can alternate with in-person visits. This offers tremendous flexibility and will expand delivery of essential health care to patients.10 Integrating telemedicine into clinical practice provides an additional benefit: It minimizes the exposure and transmission of COVID-19 to health care workers and patients and preserves supplies, including personal protective equipment (PPE).
Prioritize the backlog of patients who require follow-up testing, procedures, and surgeries. Communicate with patients that it is safe to be seen and important to not avoid routine and preventative visits that might reveal concerns or conditions that require treatment.
Strategy 3: Institute infection prevention and control measures
The importance of instituting and ensuring safety measures for office personnel and patients cannot be underestimated. Recently, a study from King’s College in London found that frontline health care workers with PPE still have 3 to 4 times the risk of contracting coronavirus compared with the general public.11 Health care systems should ensure adequate PPE availability and develop additional strategies to protect health care workers from COVID-19. We have to be fanatical about cleanliness and PPE. We have to be diligent about how we space ourselves and our patients. Consider adjusting workflows to ensure that visits can be conducted as quickly and safely as possible.
Communicating updated safety plans and processes are invaluable for both patients and health care workers. Patients want to be reassured that safety precautions are in place to keep the environment safe and clean. Additionally, privacy and confidentiality concerns should be addressed.
Consider a modified office schedule that can reduce the number of people in the office, person-to-person contact, and COVID-19 transmission. Social distancing is improved and PPE and other supplies are preserved.
Continue to: Employees can work on alternating days...
- Employees can work on alternating days or during different parts of the day.
- Administrative staff who do not need to be physically present in the office might work remotely.
- Expanding office hours (early morning, evening, and weekends) spreads patient visits throughout the day and minimizes high-volume in-person visits.
Institute a daily COVID-19 symptom attestation and temperature check for employees on arrival at work.
Health care personnel with symptoms of COVID-19 should be prioritized for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) RNA testing with an approved nucleic acid or antigen detection assay. A negative result indicates that the person most likely did not have an active SARS-CoV-2 infection at the time the sample was collected. A second test for SARS-CoV-2 RNA may be performed at the discretion of the evaluating health care provider, particularly when a higher level of clinical suspicion for infection exists.
The return to work decision should be determined by an agreed on symptom-based approach to clearance. If needed on a case-by-case basis, a review can be performed with the individual’s health care provider.12
Require universal masking and appropriate protective equipment.
- All staff members, patients, and visitors must wear masks correctly in the facilities (except children under age 2).
- All clinical staff members must wear masks correctly and eye protection during every patient encounter.
Reconfigure the waiting room and patient flow.
- Configure waiting room furniture to reinforce 6 feet of physical distancing.
- Remove all books, magazines, and toys from all waiting areas.
- Laminate signage for display.
- Install plexiglass at the check-in desk to minimize virus transmission.
- If possible, ask patients to wait in their car until their appointment time or to go directly to their exam room on arrival if it is available.
- Implement virtual check-in and check-out so that patients reduce unnecessary contact with surfaces and staff.
- Limit a high volume of patients to maintain social distancing etiquette, avoid delays, and allow adequate cleaning time between patients.
- Permit visitors to accompany adult patients to their ambulatory appointments only if special assistance is required.
- Limit the number of staff members in the exam and treatment rooms and maintain at least 6 feet between people except during medical care activities.
- Consider patient flow in a one-way traffic pattern.
Focus on keeping the clinical practice clean. (Follow the instructions and disinfect with a registered disinfectant product that meets the US Environmental Protection Agency criteria for use against COVID-19.13)
- Clean waiting rooms and restrooms frequently.
- Coordinate patient appointments to allow for infection control measures.
- Frequently clean high-touch surfaces, including tables, doorknobs, light switches, countertops, handles, desks, phones, keyboards, toilets, faucets, and sinks.
- Clinicians and all medical staff members should wash their hands before and after interacting with patients.
- Clean and disinfect the exam and treatment rooms before and after each patient.
- Use products that are effective against a range of organisms and viruses, including the coronavirus that causes COVID-19.
- Place signs indicating that rooms have been cleaned; this will assure and comfort patients. Take credit for your infection control processes.
Keep abreast of isolation and precaution guidelines. Based on data available at the time of this article’s publication, the CDC recommends ending isolation and transmission-based precautions for most people with COVID-19 using a symptom-based strategy.14 This limits unnecessary prolonged isolation and use of laboratory testing resources.
Generally, repeat SARS-CoV-2 polymerase chain reaction (PCR) testing is not recommended for “COVID-19 recovered” patients. Specifically, those patients with a prior positive SARS-CoV-2 PCR test result and who have met criteria for isolation discontinuation do not need a follow-up PCR test. A test-based strategy to discontinue isolation and transmission-based precautions is required only for severely immunocompromised patients.15
Prepare for a future COVID-19 surge and review your emergency plan and responses and revise as needed. Review handling of the current pandemic and best practices plus areas of improvement.
Symptom-based criteria for discontinuing transmission-based precautions include the following:
Patients with mild to moderate illness, not severely immunocompromised:
- at least 10 days have passed since symptoms first appeared and
- at least 24 hours have passed since last fever without fever-reducing medications and
- symptoms (cough, shortness of breath) have improved.
Note: For patients who are not severely immunocompromised and are asymptomatic throughout their infection, transmission-based precautions may be discontinued when at least 10 days have passed since the date of their first positive viral diagnostic test.
Patients with severe to critical illness, severely immunocompromised:
- at least 20 days have passed since symptoms first appeared and
- at least 24 hours have passed since last fever without fever-reducing medications and
- symptoms (cough, shortness of breath) have improved.
Note: For patients who are severely immunocompromised and are asymptomatic throughout their infection, transmission-based precautions may be discontinued when at least 20 days have passed since the date of their first positive viral diagnostic test.
Continue to: Strategy 4: Implement frequent employee communication and care...
Strategy 4: Implement frequent employee communication and care
The safety and well-being of our health care workers and patients in our clinical practices is paramount. Continuing to communicate this message and developing and sharing a plan may ameliorate the obvious toll on mental and emotional well-being. Frequent and effective communication with your clinical team is vital to reinforce policies and protocols, eliminate silos, and reduce errors.
Practice communication and care with these approaches:
- Offer regular employee COVID-19 testing.
- Re-educate staff about infection control protocols to ensure buy-in.
- Communicate with staff about the plan to address staffing shortages.
- Implement regular employee team huddles that can address accomplishments, challenges, areas for improvement, and top priorities.
- Perform regular celebrations for staff appreciation.
- Address mental health and chronic stress and offer empathy and coping resources and services to staff and clinicians. This will have a valuable, long-term benefit.
Patient communication. As the COVID-19 pandemic continues and stay-at-home policies are in place, patients should be encouraged to seek medical care if they are ill or have acute or chronic conditions. Communicate regularly with patients and let them know that their safety and well-being is the top priority. Prior to in-person visits, inform them of the safety processes that are in place to protect them.
Fostering an honest clinician-patient relationship enhances communication. Despite these efforts, some patients may not be forthcoming about their COVID-19 symptoms, illness, exposure, or travel. Health care staff can be encouraged to set a tone of tolerance and compassion and treat everyone with universal precautions.
Rising to the challenges
During the coronavirus pandemic, ObGyns continue to safely care for pregnant women and also triage and treat women who require timely office care as well as emergency and cancer-related surgeries.
The COVID-19 environment rapidly changes depending on the practice location. The strategies described represent a compilation of resources from key organizations that hopefully will prove useful and can be shaped to fit your practice. Local and regional recommendations vary, and no one can predict the course of the virus.
Consider reviewing your contingency plans regularly. As we have learned over the last several months, there is a science to maintaining a COVID-SAFE environment.
Practice operations likely will change to adapt to new conditions. The pandemic has challenged us to evolve, and we have responded with new capabilities and resilience while we continue to deliver superior and compassionate care for women.
For additional strategies on how to safeguard your practice against COVID-19, see the box below. ●
Continue to: Additional strategies on how to safeguard your practice against COVID-19...
Strategy 5: Develop a resource plan for practice operations
Assess financial solvency. Because of the mitigation measures taken during the pandemic, physician practices of all sizes are facing financial hardships and instability. As the pandemic progresses, physicians in private practice and those employed by health systems may benefit from existing resources and pandemic relief to help navigate COVID-related challenges.
Frequent revision of your financial plan may safeguard cash flow in the event of fewer patient visits and elective surgeries. Many medical organizations, including ACOG, are advocating for financial relief, fair reimbursement for telehealth and in-person visits, and access to adequate PPE. ACOG provides updated information on practice management.1
The American Medical Association (AMA) has created resources for physician practices to assist in staying focused on business and financial operations. The AMA has provided a summary of the Health, Economic Assistance, Liability Protection and Schools Act (HEALS Act).2 This is the next proposed coronavirus relief fund package, which includes provisions that benefit physicians and physician practices.
Create a plan. Review available resources and establish processes to optimize your practice capacity during the ongoing COVID-19 pandemic. Develop a game plan for patient care with a phased approach to identify and address challenges. This planning will allow your practice to pivot in response to changing local COVID-19 conditions to help you anticipate and prepare for a future surge. Maintain and revise plans as the pandemic shifts. Thinking ahead avoids the need to navigate issues in real time. Communicating clearly and often with all members of the office staff and patients lets everyone know that their safety is the main priority.
Assess staffing for flexible coverage. Frequent needs assessment helps to determine the number of staff needed to maintain a safe work environment for the patient volume.
Staff shortages may occur because of COVID-19 exposure, personal or family member illness, or childcare constraints due to daycare or school availability. Staff readiness includes evaluating individual availability and willingness.
Staff members with health issues, including comorbidities and chronic medical conditions, may not be comfortable working. Nonclinical staff members with health concerns could work remotely, although some may not be able to work from home due to technology-related issues such as WiFi deficiencies.
The CDC has interim guidelines to assist employers with providing a safe workplace and employees with making the best health decisions for themselves and their families.3,4 The US Office of Personnel Management provides guidance for COVID-19–related leave and benefits for federal employees.5
To mitigate staff shortages, approaches include adjusting schedules, cross-training to perform the tasks of other positions, and hiring additional personnel. A needs assessment can help determine if existing personnel could be cross-trained for other purposes or if additional staff should be hired. Understanding the minimum number of staff required for safe and effective patient care will assist in planning for shortages as the pandemic progresses. Understanding the availability of external resources could be a critical part of an office contingency plan.6
Proactively manage your supply chain. The pandemic has caused global supply shortages. Solid supply chain management is crucial for practice operations. Take inventory of your PPE and various supplies and place orders in advance. Analyze cash flow and connect with vendors as well as local and state health agencies to understand available resources. Given ongoing PPE shortages, practices should consider preserving PPE and employ appropriate strategies for optimizing supplies of face masks.7
Certain medications and vaccines administered in the office setting may be outdated and need to be replaced. Office equipment that has not been used for several months will need to be tested. For equipment used in office electrosurgery procedures, certain safety measures can be taken to reduce the transmission of aerosolized viral particles to the health care team. While currently the risk is theoretical and more research is needed, this potential risk should be mitigated.8 Assessing availability of hospital and ambulance or transport services also is recommended as these may change depending on the local COVID-19 status.
Strategy 6: Establish and refine the patient screening process
Patients want reassurance that the health care environment is safe and that their well-being is a priority. In advance of a patient’s visit, relieve any anxiety by explaining the COVID-SAFE measures that your practice has taken.
For employee use, consider telephone and in-person scripting to ensure consistent messaging for patients.
Prescreening. At the time of appointment scheduling and on the day prior to the scheduled appointment, all patients should be screened for symptoms of COVID-19,9 fever, exposure within 14 days to someone newly diagnosed with COVID-19, and travel within 14 days from a foreign country or from a US state with a quarantine requirement.
Patients who screen positive for symptoms, exposure, or travel should be referred to a clinician. If possible, asymptomatic patients who report exposure or travel should have their in-person visit deferred until after the required 14-day quarantine.
Consider restricting visitors from accompanying adult patients to their appointment unless they are required for special assistance.
Arrival screening. At the time of presentation for the appointment, all patients and any accompanying visitors should be rescreened. The optimal location for arrival screening should be determined by the local operations team and the infection prevention and control program.
At presentation, all patients and visitors should appropriately don a surgical mask or other face covering. Patients and visitors should have their temperature checked on arrival. Patients who screen positive for symptoms, exposure to COVID-19, and/or travel should be referred to a clinician or the visit deferred and a telehealth visit considered.
Visitors who screen positive for symptoms, fever, or exposure to COVID-19 are not permitted to accompany the patient. Asymptomatic parents or guardians of pediatric patients may serve as support persons.
References
- American College of Obstetricians and Gynecologists. Financial support for physicians and practices during the COVID-19 pandemic. https://www.acog.org/practice -management/coding/coding-library/financial-support-for-physicians-and-practices-during-the-covid-19-pandemic. Accessed July 23, 2020.
- American Medical Association. HEALS Act: What physicians and medical students need to know. https://www.ama-assn.org/delivering-care/public-health/heals-act -what-physicians-and-medical-students-need-know. Accessed July 29, 2020.
- Centers for Disease Control and Prevention. Interim guidance for businesses and employers responding to coronavirus disease 2019 (COVID-19). https://www.cdc.gov /coronavirus/2019-ncov/community/guidance-business-response.html. Accessed July 12, 2020.
- Centers for Disease Control and Prevention. Criteria for return to work for healthcare personnel with SARS-CoV-2 infection (interim guidance). https://www.cdc.gov /coronavirus/2019-ncov/hcp/return-to-work.html. Accessed July 20, 2020.
- US Office of Personnel Management. Questions and answers on human resources flexibilities and authorities for coronavirus disease 2019 (COVID-19). https://www .opm.gov/policy-data-oversight/covid-19/questions-and-answers-on-human-resources-flexibilities-and-authorities-for-coronavirus-disease-2019-covid-19.pdf. Accessed July 3, 2020.
- Centers for Disease Control and Prevention. Strategies to mitigate healthcare personnel staffing shortages. https://www.cdc.gov/coronavirus/2019-ncov/hcp /mitigating-staff-shortages.html. Accessed July 17, 2020.
- Centers for Disease Control and Prevention. Strategies for optimizing the supply of facemasks. https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/face -masks.html. Accessed July 3, 2020.
- Rahman S, Klebanoff J, Moawad G. Smoke evacuation in the age of COVID-19. Contemporary OB/GYN. July 2, 2020. https://www.contemporaryobgyn.net/view/smoke -evacuation-in-the-age-of-covid-19. Accessed July 3, 2020.
- Centers for Disease Control and Prevention. Symptoms of coronavirus. https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html. Accessed July 25, 2020.
No question, the COVID-19 pandemic has been a challenging time for medical practices across the United States. Uncertainty remains regarding bringing patients and services back into our offices. One factor that distinguishes many ObGyn practices from other specialties is that our practices have remained open—in some form—since the beginning of the pandemic. In various parts of the country, gynecologic surgeries and routine office visits have been significantly reduced; however, deliveries and gynecologic emergencies have continued.
In this article, I suggest a framework of strategies and resources to provide insight for outpatient operations. Individual practices will vary across the nation depending on local conditions. Full practice capacity may take on a different look than it had prior to the pandemic, and there is opportunity to change the way we operate.
Strategy 1: Consult regulatory requirements frequently
As the local status of COVID-19 evolves quickly, it is essential to examine the frequently updated recommendations from regulatory agencies at the federal, state, and local levels. Clinical practices that function within health systems need to demonstrate alignment with hospital or university policies and procedures. The Centers for Disease Control and Prevention (CDC), Occupational Safety and Health Administration (OSHA), Centers for Medicare and Medicaid Services (CMS), and individual state departments of health provide dynamic resources that are easily accessible online.1-3
The American College of Obstetricians and Gynecologists (ACOG) continues to be an excellent medical society resource.4 Subspecialty organizations that provide up-to-date guidance include the Society for Maternal-Fetal Medicine (SMFM), Society of Gynecologic Surgeons (SGS), AAGL (American Association of Gynecologic Laparoscopists), American Society for Reproductive Medicine (ASRM), and Society of Gynecologic Oncology (SGO).5-9 These resources are updated as more information about COVID-19 emerges, and they may be modified to different local-regional conditions.
The professional liability insurance carrier is an important source of insight for a number of circumstances, including modifications to your office practice, such as returning to full-scope or part-time practice; operating outside normal clinical service arrangements (for example, assisting with emergency care); offering telehealth services; and adding extra hours or employees to accommodate the patient backlog. Business insurance coverage is a separate issue to consider. Reviewing the practice policy may protect your business from COVID-related liabilities.
Consulting with legal counselors can be helpful. They can assist with navigating various practice and personnel COVID-related changes, as well as developing a viable plan for patients who were previously insured pre–COVID-19 who are currently uninsured.
Continue to: Strategy 2: Reimagine schedule capacity...
Strategy 2: Reimagine schedule capacity
The waxing and waning of the COVID-19 crisis presents an opportunity to evaluate our office practices and make necessary and positive changes. The question becomes, do we operate our practices as usual or do we rethink our strategy for seeing patients and integrate lessons learned from the pandemic? Patients are deciding when they are comfortable to schedule elective surgeries and routine office encounters. This gives us the chance to break from the tradition of 100% in-person visits and change the way we care for women.
The coronavirus has accelerated the rise of telehealth/telemedicine and is, perhaps, a silver lining of the pandemic. Telehealth is a valuable tool for accessing health services when in-person visits are not possible. Evaluating and triaging patients for in-person versus telehealth visits is now a viable option for clinical practice and reduces exposure to COVID-19 infection.
Telemedicine is convenient, and clinicians can use it to counsel and screen for various health issues as well as to extend their reach to rural communities. Appropriate consent should be documented in the patient chart. As some areas continue to be without adequate access to WiFi, telephone contact also is currently acceptable. Telehealth does not replace the in-person visit but can be viewed as a complementary and supplementary service.
Consider a balance between telehealth and in-person visits by evaluating which visits can continue remotely and which can alternate with in-person visits. This offers tremendous flexibility and will expand delivery of essential health care to patients.10 Integrating telemedicine into clinical practice provides an additional benefit: It minimizes the exposure and transmission of COVID-19 to health care workers and patients and preserves supplies, including personal protective equipment (PPE).
Prioritize the backlog of patients who require follow-up testing, procedures, and surgeries. Communicate with patients that it is safe to be seen and important to not avoid routine and preventative visits that might reveal concerns or conditions that require treatment.
Strategy 3: Institute infection prevention and control measures
The importance of instituting and ensuring safety measures for office personnel and patients cannot be underestimated. Recently, a study from King’s College in London found that frontline health care workers with PPE still have 3 to 4 times the risk of contracting coronavirus compared with the general public.11 Health care systems should ensure adequate PPE availability and develop additional strategies to protect health care workers from COVID-19. We have to be fanatical about cleanliness and PPE. We have to be diligent about how we space ourselves and our patients. Consider adjusting workflows to ensure that visits can be conducted as quickly and safely as possible.
Communicating updated safety plans and processes are invaluable for both patients and health care workers. Patients want to be reassured that safety precautions are in place to keep the environment safe and clean. Additionally, privacy and confidentiality concerns should be addressed.
Consider a modified office schedule that can reduce the number of people in the office, person-to-person contact, and COVID-19 transmission. Social distancing is improved and PPE and other supplies are preserved.
Continue to: Employees can work on alternating days...
- Employees can work on alternating days or during different parts of the day.
- Administrative staff who do not need to be physically present in the office might work remotely.
- Expanding office hours (early morning, evening, and weekends) spreads patient visits throughout the day and minimizes high-volume in-person visits.
Institute a daily COVID-19 symptom attestation and temperature check for employees on arrival at work.
Health care personnel with symptoms of COVID-19 should be prioritized for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) RNA testing with an approved nucleic acid or antigen detection assay. A negative result indicates that the person most likely did not have an active SARS-CoV-2 infection at the time the sample was collected. A second test for SARS-CoV-2 RNA may be performed at the discretion of the evaluating health care provider, particularly when a higher level of clinical suspicion for infection exists.
The return to work decision should be determined by an agreed on symptom-based approach to clearance. If needed on a case-by-case basis, a review can be performed with the individual’s health care provider.12
Require universal masking and appropriate protective equipment.
- All staff members, patients, and visitors must wear masks correctly in the facilities (except children under age 2).
- All clinical staff members must wear masks correctly and eye protection during every patient encounter.
Reconfigure the waiting room and patient flow.
- Configure waiting room furniture to reinforce 6 feet of physical distancing.
- Remove all books, magazines, and toys from all waiting areas.
- Laminate signage for display.
- Install plexiglass at the check-in desk to minimize virus transmission.
- If possible, ask patients to wait in their car until their appointment time or to go directly to their exam room on arrival if it is available.
- Implement virtual check-in and check-out so that patients reduce unnecessary contact with surfaces and staff.
- Limit a high volume of patients to maintain social distancing etiquette, avoid delays, and allow adequate cleaning time between patients.
- Permit visitors to accompany adult patients to their ambulatory appointments only if special assistance is required.
- Limit the number of staff members in the exam and treatment rooms and maintain at least 6 feet between people except during medical care activities.
- Consider patient flow in a one-way traffic pattern.
Focus on keeping the clinical practice clean. (Follow the instructions and disinfect with a registered disinfectant product that meets the US Environmental Protection Agency criteria for use against COVID-19.13)
- Clean waiting rooms and restrooms frequently.
- Coordinate patient appointments to allow for infection control measures.
- Frequently clean high-touch surfaces, including tables, doorknobs, light switches, countertops, handles, desks, phones, keyboards, toilets, faucets, and sinks.
- Clinicians and all medical staff members should wash their hands before and after interacting with patients.
- Clean and disinfect the exam and treatment rooms before and after each patient.
- Use products that are effective against a range of organisms and viruses, including the coronavirus that causes COVID-19.
- Place signs indicating that rooms have been cleaned; this will assure and comfort patients. Take credit for your infection control processes.
Keep abreast of isolation and precaution guidelines. Based on data available at the time of this article’s publication, the CDC recommends ending isolation and transmission-based precautions for most people with COVID-19 using a symptom-based strategy.14 This limits unnecessary prolonged isolation and use of laboratory testing resources.
Generally, repeat SARS-CoV-2 polymerase chain reaction (PCR) testing is not recommended for “COVID-19 recovered” patients. Specifically, those patients with a prior positive SARS-CoV-2 PCR test result and who have met criteria for isolation discontinuation do not need a follow-up PCR test. A test-based strategy to discontinue isolation and transmission-based precautions is required only for severely immunocompromised patients.15
Prepare for a future COVID-19 surge and review your emergency plan and responses and revise as needed. Review handling of the current pandemic and best practices plus areas of improvement.
Symptom-based criteria for discontinuing transmission-based precautions include the following:
Patients with mild to moderate illness, not severely immunocompromised:
- at least 10 days have passed since symptoms first appeared and
- at least 24 hours have passed since last fever without fever-reducing medications and
- symptoms (cough, shortness of breath) have improved.
Note: For patients who are not severely immunocompromised and are asymptomatic throughout their infection, transmission-based precautions may be discontinued when at least 10 days have passed since the date of their first positive viral diagnostic test.
Patients with severe to critical illness, severely immunocompromised:
- at least 20 days have passed since symptoms first appeared and
- at least 24 hours have passed since last fever without fever-reducing medications and
- symptoms (cough, shortness of breath) have improved.
Note: For patients who are severely immunocompromised and are asymptomatic throughout their infection, transmission-based precautions may be discontinued when at least 20 days have passed since the date of their first positive viral diagnostic test.
Continue to: Strategy 4: Implement frequent employee communication and care...
Strategy 4: Implement frequent employee communication and care
The safety and well-being of our health care workers and patients in our clinical practices is paramount. Continuing to communicate this message and developing and sharing a plan may ameliorate the obvious toll on mental and emotional well-being. Frequent and effective communication with your clinical team is vital to reinforce policies and protocols, eliminate silos, and reduce errors.
Practice communication and care with these approaches:
- Offer regular employee COVID-19 testing.
- Re-educate staff about infection control protocols to ensure buy-in.
- Communicate with staff about the plan to address staffing shortages.
- Implement regular employee team huddles that can address accomplishments, challenges, areas for improvement, and top priorities.
- Perform regular celebrations for staff appreciation.
- Address mental health and chronic stress and offer empathy and coping resources and services to staff and clinicians. This will have a valuable, long-term benefit.
Patient communication. As the COVID-19 pandemic continues and stay-at-home policies are in place, patients should be encouraged to seek medical care if they are ill or have acute or chronic conditions. Communicate regularly with patients and let them know that their safety and well-being is the top priority. Prior to in-person visits, inform them of the safety processes that are in place to protect them.
Fostering an honest clinician-patient relationship enhances communication. Despite these efforts, some patients may not be forthcoming about their COVID-19 symptoms, illness, exposure, or travel. Health care staff can be encouraged to set a tone of tolerance and compassion and treat everyone with universal precautions.
Rising to the challenges
During the coronavirus pandemic, ObGyns continue to safely care for pregnant women and also triage and treat women who require timely office care as well as emergency and cancer-related surgeries.
The COVID-19 environment rapidly changes depending on the practice location. The strategies described represent a compilation of resources from key organizations that hopefully will prove useful and can be shaped to fit your practice. Local and regional recommendations vary, and no one can predict the course of the virus.
Consider reviewing your contingency plans regularly. As we have learned over the last several months, there is a science to maintaining a COVID-SAFE environment.
Practice operations likely will change to adapt to new conditions. The pandemic has challenged us to evolve, and we have responded with new capabilities and resilience while we continue to deliver superior and compassionate care for women.
For additional strategies on how to safeguard your practice against COVID-19, see the box below. ●
Continue to: Additional strategies on how to safeguard your practice against COVID-19...
Strategy 5: Develop a resource plan for practice operations
Assess financial solvency. Because of the mitigation measures taken during the pandemic, physician practices of all sizes are facing financial hardships and instability. As the pandemic progresses, physicians in private practice and those employed by health systems may benefit from existing resources and pandemic relief to help navigate COVID-related challenges.
Frequent revision of your financial plan may safeguard cash flow in the event of fewer patient visits and elective surgeries. Many medical organizations, including ACOG, are advocating for financial relief, fair reimbursement for telehealth and in-person visits, and access to adequate PPE. ACOG provides updated information on practice management.1
The American Medical Association (AMA) has created resources for physician practices to assist in staying focused on business and financial operations. The AMA has provided a summary of the Health, Economic Assistance, Liability Protection and Schools Act (HEALS Act).2 This is the next proposed coronavirus relief fund package, which includes provisions that benefit physicians and physician practices.
Create a plan. Review available resources and establish processes to optimize your practice capacity during the ongoing COVID-19 pandemic. Develop a game plan for patient care with a phased approach to identify and address challenges. This planning will allow your practice to pivot in response to changing local COVID-19 conditions to help you anticipate and prepare for a future surge. Maintain and revise plans as the pandemic shifts. Thinking ahead avoids the need to navigate issues in real time. Communicating clearly and often with all members of the office staff and patients lets everyone know that their safety is the main priority.
Assess staffing for flexible coverage. Frequent needs assessment helps to determine the number of staff needed to maintain a safe work environment for the patient volume.
Staff shortages may occur because of COVID-19 exposure, personal or family member illness, or childcare constraints due to daycare or school availability. Staff readiness includes evaluating individual availability and willingness.
Staff members with health issues, including comorbidities and chronic medical conditions, may not be comfortable working. Nonclinical staff members with health concerns could work remotely, although some may not be able to work from home due to technology-related issues such as WiFi deficiencies.
The CDC has interim guidelines to assist employers with providing a safe workplace and employees with making the best health decisions for themselves and their families.3,4 The US Office of Personnel Management provides guidance for COVID-19–related leave and benefits for federal employees.5
To mitigate staff shortages, approaches include adjusting schedules, cross-training to perform the tasks of other positions, and hiring additional personnel. A needs assessment can help determine if existing personnel could be cross-trained for other purposes or if additional staff should be hired. Understanding the minimum number of staff required for safe and effective patient care will assist in planning for shortages as the pandemic progresses. Understanding the availability of external resources could be a critical part of an office contingency plan.6
Proactively manage your supply chain. The pandemic has caused global supply shortages. Solid supply chain management is crucial for practice operations. Take inventory of your PPE and various supplies and place orders in advance. Analyze cash flow and connect with vendors as well as local and state health agencies to understand available resources. Given ongoing PPE shortages, practices should consider preserving PPE and employ appropriate strategies for optimizing supplies of face masks.7
Certain medications and vaccines administered in the office setting may be outdated and need to be replaced. Office equipment that has not been used for several months will need to be tested. For equipment used in office electrosurgery procedures, certain safety measures can be taken to reduce the transmission of aerosolized viral particles to the health care team. While currently the risk is theoretical and more research is needed, this potential risk should be mitigated.8 Assessing availability of hospital and ambulance or transport services also is recommended as these may change depending on the local COVID-19 status.
Strategy 6: Establish and refine the patient screening process
Patients want reassurance that the health care environment is safe and that their well-being is a priority. In advance of a patient’s visit, relieve any anxiety by explaining the COVID-SAFE measures that your practice has taken.
For employee use, consider telephone and in-person scripting to ensure consistent messaging for patients.
Prescreening. At the time of appointment scheduling and on the day prior to the scheduled appointment, all patients should be screened for symptoms of COVID-19,9 fever, exposure within 14 days to someone newly diagnosed with COVID-19, and travel within 14 days from a foreign country or from a US state with a quarantine requirement.
Patients who screen positive for symptoms, exposure, or travel should be referred to a clinician. If possible, asymptomatic patients who report exposure or travel should have their in-person visit deferred until after the required 14-day quarantine.
Consider restricting visitors from accompanying adult patients to their appointment unless they are required for special assistance.
Arrival screening. At the time of presentation for the appointment, all patients and any accompanying visitors should be rescreened. The optimal location for arrival screening should be determined by the local operations team and the infection prevention and control program.
At presentation, all patients and visitors should appropriately don a surgical mask or other face covering. Patients and visitors should have their temperature checked on arrival. Patients who screen positive for symptoms, exposure to COVID-19, and/or travel should be referred to a clinician or the visit deferred and a telehealth visit considered.
Visitors who screen positive for symptoms, fever, or exposure to COVID-19 are not permitted to accompany the patient. Asymptomatic parents or guardians of pediatric patients may serve as support persons.
References
- American College of Obstetricians and Gynecologists. Financial support for physicians and practices during the COVID-19 pandemic. https://www.acog.org/practice -management/coding/coding-library/financial-support-for-physicians-and-practices-during-the-covid-19-pandemic. Accessed July 23, 2020.
- American Medical Association. HEALS Act: What physicians and medical students need to know. https://www.ama-assn.org/delivering-care/public-health/heals-act -what-physicians-and-medical-students-need-know. Accessed July 29, 2020.
- Centers for Disease Control and Prevention. Interim guidance for businesses and employers responding to coronavirus disease 2019 (COVID-19). https://www.cdc.gov /coronavirus/2019-ncov/community/guidance-business-response.html. Accessed July 12, 2020.
- Centers for Disease Control and Prevention. Criteria for return to work for healthcare personnel with SARS-CoV-2 infection (interim guidance). https://www.cdc.gov /coronavirus/2019-ncov/hcp/return-to-work.html. Accessed July 20, 2020.
- US Office of Personnel Management. Questions and answers on human resources flexibilities and authorities for coronavirus disease 2019 (COVID-19). https://www .opm.gov/policy-data-oversight/covid-19/questions-and-answers-on-human-resources-flexibilities-and-authorities-for-coronavirus-disease-2019-covid-19.pdf. Accessed July 3, 2020.
- Centers for Disease Control and Prevention. Strategies to mitigate healthcare personnel staffing shortages. https://www.cdc.gov/coronavirus/2019-ncov/hcp /mitigating-staff-shortages.html. Accessed July 17, 2020.
- Centers for Disease Control and Prevention. Strategies for optimizing the supply of facemasks. https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/face -masks.html. Accessed July 3, 2020.
- Rahman S, Klebanoff J, Moawad G. Smoke evacuation in the age of COVID-19. Contemporary OB/GYN. July 2, 2020. https://www.contemporaryobgyn.net/view/smoke -evacuation-in-the-age-of-covid-19. Accessed July 3, 2020.
- Centers for Disease Control and Prevention. Symptoms of coronavirus. https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html. Accessed July 25, 2020.
- Centers for Disease Control and Prevention. Information for healthcare professionals about coronavirus (COVID-19). https://www.cdc.gov/coronavirus/2019-nCoV/hcp/index.html. Accessed July 22, 2020.
- US Department of Labor Occupational Safety and Health Administration. COVID-19 control and prevention: healthcare workers and employers. https://www.osha.gov/SLTC/covid-19/healthcare-workers.html. Accessed August 5, 2020.
- Centers for Medicare and Medicaid Services. COVID-19 resources for health care professionals and researchers. https://www.cms.gov/About-CMS/Agency-Information/OMH/resource-center/hcps-and-researchers. Accessed August 7, 2020.
- American College of Obstetricians and Gynecologists. COVID-19. https://www.acog.org/topics/covid-19. Accessed August 7, 2020.
- Society for Maternal-Fetal Medicine. Coronavirus (COVID-19). https://www.smfm.org/covid19. Accessed August 7, 2020.
- Society of Gynecologic Surgeons. Joint statement on re-introduction of hospital and office-based procedures in the COVID-19 climate for the practicing gynecologist. https://www.sgsonline.org/joint-statement-on-re-introduction-of-hospital-and-office-based-procedures-in-the-covid-19-climate. Accessed August 7, 2020.
- AAGL. COVID-19 articles, resources and webinars. https://www.aagl.org/covid-19/. Accessed August 7, 2020.
- American Society for Reproductive Medicine. COVID-19 updates and resources. https://www.asrm.org/news-and-publications/covid-19/. Accessed August 7, 2020.
- Society of Gynecologic Oncology. COVID-19 resources for health care practitioners. https://www.sgo.org/practice-management/covid-19/. Accessed August 7, 2020.
- Centers for Disease Control and Prevention. Using telehealth to expand access to essential health services during the COVID-19 pandemic. https://www.cdc.gov/coronavirus/2019-ncov/hcp/telehealth.html. Accessed July 3, 2020.
- Nguyen LH, Drew DA, Graham MS, et al; on behalf of the COronavirus Pandemic Epidemiology Consortium. Risk of COVID-19 among front-line health-care workers and the general community: a prospective cohort study. Lancet. July 31, 2020. http://www.thelancet-press.com/embargo/hcwcovid.pdf. Accessed August 25, 2020.
- Centers for Disease Control and Prevention. Criteria for return to work for healthcare personnel with SARS-CoV-2 infection (interim guidance). https://www.cdc.gov/coronavirus/2019-ncov/hcp/return-to-work.html. Accessed July 20, 2020.
- US Environmental Protection Agency. List N: Disinfectants for use against SARS-CoV-2 (COVID-19). https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2-covid-19. Accessed August 24, 2020.
- Centers for Disease Control and Prevention. Duration of isolation and precautions for adults with COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html. Accessed July 23, 2020.
- Centers for Disease Control and Prevention. Discontinuation of transmission-based precautions and disposition of patients with COVID-19 in healthcare settings (interim guidance). https://www.cdc.gov/coronavirus/2019-ncov/hcp/disposition-hospitalized-patients.html#fn1. Accessed July 23, 2020.
- Centers for Disease Control and Prevention. Information for healthcare professionals about coronavirus (COVID-19). https://www.cdc.gov/coronavirus/2019-nCoV/hcp/index.html. Accessed July 22, 2020.
- US Department of Labor Occupational Safety and Health Administration. COVID-19 control and prevention: healthcare workers and employers. https://www.osha.gov/SLTC/covid-19/healthcare-workers.html. Accessed August 5, 2020.
- Centers for Medicare and Medicaid Services. COVID-19 resources for health care professionals and researchers. https://www.cms.gov/About-CMS/Agency-Information/OMH/resource-center/hcps-and-researchers. Accessed August 7, 2020.
- American College of Obstetricians and Gynecologists. COVID-19. https://www.acog.org/topics/covid-19. Accessed August 7, 2020.
- Society for Maternal-Fetal Medicine. Coronavirus (COVID-19). https://www.smfm.org/covid19. Accessed August 7, 2020.
- Society of Gynecologic Surgeons. Joint statement on re-introduction of hospital and office-based procedures in the COVID-19 climate for the practicing gynecologist. https://www.sgsonline.org/joint-statement-on-re-introduction-of-hospital-and-office-based-procedures-in-the-covid-19-climate. Accessed August 7, 2020.
- AAGL. COVID-19 articles, resources and webinars. https://www.aagl.org/covid-19/. Accessed August 7, 2020.
- American Society for Reproductive Medicine. COVID-19 updates and resources. https://www.asrm.org/news-and-publications/covid-19/. Accessed August 7, 2020.
- Society of Gynecologic Oncology. COVID-19 resources for health care practitioners. https://www.sgo.org/practice-management/covid-19/. Accessed August 7, 2020.
- Centers for Disease Control and Prevention. Using telehealth to expand access to essential health services during the COVID-19 pandemic. https://www.cdc.gov/coronavirus/2019-ncov/hcp/telehealth.html. Accessed July 3, 2020.
- Nguyen LH, Drew DA, Graham MS, et al; on behalf of the COronavirus Pandemic Epidemiology Consortium. Risk of COVID-19 among front-line health-care workers and the general community: a prospective cohort study. Lancet. July 31, 2020. http://www.thelancet-press.com/embargo/hcwcovid.pdf. Accessed August 25, 2020.
- Centers for Disease Control and Prevention. Criteria for return to work for healthcare personnel with SARS-CoV-2 infection (interim guidance). https://www.cdc.gov/coronavirus/2019-ncov/hcp/return-to-work.html. Accessed July 20, 2020.
- US Environmental Protection Agency. List N: Disinfectants for use against SARS-CoV-2 (COVID-19). https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2-covid-19. Accessed August 24, 2020.
- Centers for Disease Control and Prevention. Duration of isolation and precautions for adults with COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html. Accessed July 23, 2020.
- Centers for Disease Control and Prevention. Discontinuation of transmission-based precautions and disposition of patients with COVID-19 in healthcare settings (interim guidance). https://www.cdc.gov/coronavirus/2019-ncov/hcp/disposition-hospitalized-patients.html#fn1. Accessed July 23, 2020.
Major changes in Medicare billing are planned for January 2021: Some specialties fare better than others
The Centers for Medicare and Medicaid Services (CMS) finalized an increase in the relative value of evaluation and management (E/M) service codes effective January 1, 2021, which results in an overall decrease in the payment for procedural services in the Medicare program. (Due to the mandate for budget neutrality, an increase in relative value units [RVUs] for E/M resulted in a large decrease in the conversion factor—the number of dollars per RVU). This has increased payments for endocrinologists, rheumatologists, and family medicine clinicians and decreased payments for radiologists, pathologists, and surgeons.
In a major win for physicians, CMS proposes to simplify documentation requirements for billing and focus on the complexity of the medical decision making (MDM) or the total time needed to care for the patient on the date of the service as the foundation for determining the relative value of the service. Therefore, there is no more counting bullets—ie, we don’t have to perform a comprehensive physical exam or review of systems to achieve a high level code! Prior to this change, time was only available for coding purposes when counseling and coordination of care was the predominant service (>50%), and only face-to-face time with the patient was considered. Effective January 1, for office and other outpatient services, total time on the calendar date of the encounter will be used. This acknowledges the intensity and value of non–face-to-face work.
Acting through CMS, the federal government influences greatly the US health care system. CMS is an agency in the Department of Health and Human Services that administers the Medicare program and partners with state governments to administer the Health Insurance Exchanges, Medicaid, and the Children’s Health Insurance programs (CHIP).1 In addition, CMS is responsible for enforcing quality care standards in long-term care facilities and clinical laboratories and the implementation of the Health Insurance Portability and Accountability Act.1
In January, CMS plans the following major changes to coding and documentation2,3:
- Selection of the level of E/M service will no longer require documentation of bullet points in the history, physical exam, and MDM. The simplified system allows physicians and qualified health care professionals to code either by total time (both face-to-face and non–face-to-face) on the date of the encounter or by level of MDM.
- For established office patients, 5 levels of office-based evaluation and management services will be retained. CMS had initially proposed to reduce the number of office-based E/M codes from 5 to 3, combining code levels 2, 3, and 4 into 1 code.4 However, after receiving feedback from professional societies and the public, CMS abandoned the plan for radical simplification of coding levels.2,3 Implementation of their proposal would have resulted in the same payment for treatment of a hang nail as for a complex gyn patient with multiple medical problems. Both patient advocacy groups and professional societies argued that incentives originally were misaligned.
- For new office patients, since both 99201 and 99202 require straightforward MDM, the level 1 code (99201) has been eliminated, reducing the number of code levels from 5 to 4.
- History and physical exam will no longer be used to determine code level for office E/M codes. These elements will be required only as medically appropriate. This means that documentation review will no longer focus on “bean counting” the elements in the history and physical exam.
- Following a reassessment of the actual time required to provide E/M services in real-life practice, CMS plans to markedly increase the relative value of office visits for established patients and modestly increase the relative value of office visits for new patients. CMS operates under the principle of “neutral budgeting,” meaning that an increase of the relative value of E/M codes will result in a decrease in the payment for procedural codes. The actual RVUs for procedural services do not change; however, budget neutrality requires a decrease in the dollar conversion factor. The proposed changes will increase the payment for E/M services and decrease payments for procedural services.
Continue to: Refocusing practice on MDM complexity...
Refocusing practice on MDM complexity
The practice of medicine is a calling with great rewards. Prominent among those rewards are improving the health of women, children, and the community, developing deep and trusting relationships with patients, families, and clinical colleagues. The practice of medicine is also replete with a host of punishing administrative burdens, including prior authorizations, clunky electronic medical records, poorly designed quality metrics that are applied to clinicians, and billing compliance rules that emphasize the repetitive documentation of clinical information with minimal value.
Some of the most irritating aspects of medical practice are the CMS rules governing medical record documentation required for billing ambulatory office visits. Current coding compliance focuses on counting the number of systems reviewed in the review of systems; the documentation of past history, social history, and family history; the number of organs and organ elements examined during the physical examination; and the complexity of MDM.
In January 2021, CMS plans to adopt new Current Procedural Terminology (CPT) code descriptors for the office and other outpatient E/M services that sunset most of the “bean-counting” metrics and emphasize the importance of the complexity of MDM in guiding selection of a correct code.2 Beginning in January 2021, clinicians will have the option of selecting an E/M code level based on the total amount of time required to provide the office visit service or the complexity of MDM. When selecting a code level based on MDM the new guidance emphasizes the importance of reviewing notes from other clinicians, reviewing test results, ordering of tests, and discussing and coordinating the care of the patient with other treating physicians. These changes reflect a better understanding of what is most important in good medical practice, promoting better patient care. TABLES 1 and 2 provide the initial guidance from CMS concerning selection of E/M code level based on time and MDM, respectively.2 The guidance for using MDM to select an E/M code level is likely to evolve following implementation, so stay tuned. When using MDM to select a code, 2 of the 3 general categories are required to select that level of service.


Increase in the valuation of office-based E/M services
The Medicare Physician Fee Schedule uses a resource-based relative value system to determine time and intensity of the work of clinical practice. This system recognizes 3 major factors that influence the resources required to provide a service:
- work of the clinician
- practice expense for technical components
- cost of professional liability insurance.
Many primary care professional associations have long contended that CMS has undervalued office-based E/M services relative to procedures, resulting in the devaluing of primary care practice. After the CPT code descriptors were updated by the CPT editorial panel, 52 specialty societies surveyed their members to provide inputs to CMS on the time and intensity of the office and other outpatient E/M codes as currently practiced. The American Medical Association’s Specialty Society Resource-Based Relative Value Scale Update Committee (RUC) reviewed the surveys and provided new inputs via open comment to CMS. CMS has responded to this feedback with a review of the intensity of clinical work required to provide an ambulatory visit service. In response to the review, CMS proposes to accept the recommendations of the RUC representing the house of medicine and increase the work and practice expense relative value assigned to new and established office visit codes. Overall, the combination of changes in relative values assigned for the work of the clinician and the expense of practice, increases the total value of office-based E/M codes for new patients by 7% to 14% and for established patients from 28% to 46% (see supplemental table in the sidebar at the end of this article).
Continue to: Decreased payments for procedural services...
Decreased payments for procedural services
Medicare is required to offset increased payment in one arena of health care delivery with decreased payment in other arenas of care, thereby achieving “budget-neutrality.” As detailed above, CMS plans to increase Medicare payments for office-based E/M services. Payment for services is calculated by multiplying the total RVUs for a particular service by a “conversion factor” (ie, number of dollars per RVU). To achieve budget-neutrality, CMS has proposed substantially reducing the conversion factor for 2021 (from $36.09 to $32.26), which will effectively decrease Medicare payments for procedural services since their RVUs have not changed. While the AMA RUC and many specialty societies continue to strongly advocate for the E/M work RVU increases to be included in the E/M components of 10- and 90-day global services, CMS has proposed to implement them only for “stand alone” E/M services.
Organizations are lobbying to delay or prevent the planned decrease in conversion factor, which results in substantial declines in payment for procedural services. (See "What do the Medicare billing changes mean for the Obstetrical Bundled services?" at the end of this article.) Due to the economic and clinical practice challenges caused by the coronavirus disease 2019 (COVID-19) pandemic it would be best if CMS did not reduce payments to physicians who are experts in procedural health care, thereby avoiding the risk of reduced access to these vital services.
If the current CMS changes in payment are implemented, endocrinologists, rheumatologists, and family physicians will have an increase in payment, and radiologists, pathologists, and surgeons will have a decrease in payment (TABLE 3).6 Obstetrics and gynecology is projected to have an 8% increase in Medicare payment. However, if an obstetrician-gynecologist derives most of their Medicare payments from surgical procedures, they are likely to have a decrease in payment from Medicare. Other payers will be incorporating the new coding structure for 2021; however, their payment structures and conversion factors are likely to vary. It is important to note that the RVUs for procedures have not changed. The budget neutrality adjustment resulted in a much lower conversion factor and therefore a decrease in payment for those specialties whose RVUs did not increase.

Bottom line
Working through the Medicare, Medicaid, and CHIP programs, CMS can influence greatly the practice of medicine including medical record documentation practices and payment rates for every clinical service. CMS proposes to end the onerous “bean counting” approach to billing compliance and refocus on the complexity of MDM as the foundation for selecting a billing code level. This change is long overdue, valuing the effective management of complex patients in office practice. Hopefully, CMS will reverse the planned reduction in the payment for procedural services, preserving patient access to important health care services. ●
The CY 2020 Medicare Physician Fee Schedule Final Rule was published electronically in the Federal Register on November 1, 2019. This final rule aligns the evaluation and management (E/M) coding and payment with changes recommended by the Current Procedural Terminology (CPT) Editorial Panel and American Medical Association’s (AMA) Specialty Society Resource-Based Relative Value Scale Update Committee (RUC) for office/outpatient E/M visits. Unfortunately, the Centers for Medicare and Medicaid Services (CMS) did not agree with the RUC, AMA, and specialty societies that the E/M payment changes should be applicable across all global services that incorporate E/M visits—despite the fact that the values proposed by the RUC incorporated survey data from 52 specialties, representing most of medicine (including those specialties that predominantly perform procedures). Specifically, CMS expressed the view that the number of E/M visits within the 10- and 90-day global codes, as well as the maternity care bundle, were difficult to validate; therefore, the increased values would not be distributed to those procedural services.
Many professional societies expressed significant concerns about the resulting budget neutrality adjustments that would occur effective January 2021. The great news for ObGyns is that the American College of Obstetricians and Gynecologists (ACOG) was able to respond directly to CMS’s concerns with data to support the number of prenatal visits within the Obstetrical Bundle. Tapping into a de-identified, cloud-based data set of prenatal records—representing more than 1,100 obstetric providers with close to 30,000 recently completed pregnancies—ACOG was able to document both a mean and median number of prenatal visits across a broad geographic, payer, and patient demographic that supported the 13 prenatal visits in the Obstetrical Bundle.
With ACOG’s advocacy and ability to provide data to CMS, the proposed physician fee schedule rule for 2021 has proposed to incorporate the E/M increased reimbursement into the prenatal care codes. Now we urge the CMS to finalize this proposal. Although Medicare pays for a tiny number of pregnancies annually, we hope that all payers, including Medicaid and managed care plans, will agree with this acknowledgement of the increased work of evaluation and management that obstetricians provide during prenatal care. Join ACOG in telling CMS to finalize their proposal to increase the values of the global obstetric codes: https://acog.quorum.us/campaign/28579/.

- Centers for Medicare and Medicaid Services. https://www.cms.gov/. Accessed August 28, 2020.
- American Medical Association. CPT Evaluation and Management (E/M) Office or Other Outpatient (99202-99215) and Prolonged Services (99354, 99355, 99356, 99XXX) Code and Guideline Changes. 2019. https://www.ama-assn.org /system/files/2019-06/cpt-office-prolonged-svs -code-changes.pdf. Accessed August 28, 2020.
- The American Academy of Family Physicians. Family medicine updates. Ann Fam Med. 2020;18:84-85. doi: 10.1370/afm.2508.
- Centers for Medicare and Medicaid Services. Final policy, payment and quality provisions changes to the Medicare Physician Fee Schedule for calendar year 2019. November 1, 2018. https://www.cms.gov/newsroom/fact-sheets /final-policy-payment-and-quality-provisionschanges-medicare-physician-fee-schedulecalendar-year. Accessed August 28, 2020.
- Department of Health and Human Services; Centers for Medicare and Medicaid Services. 42 CFR Parts 410, 414, 415, 423, 424, and 425. Federal Register. 2020;85(159). https://www.govinfo.gov /content/pkg/FR-2020-08-17/pdf/2020-17127 .pdf. Accessed August 28, 2020.
The Centers for Medicare and Medicaid Services (CMS) finalized an increase in the relative value of evaluation and management (E/M) service codes effective January 1, 2021, which results in an overall decrease in the payment for procedural services in the Medicare program. (Due to the mandate for budget neutrality, an increase in relative value units [RVUs] for E/M resulted in a large decrease in the conversion factor—the number of dollars per RVU). This has increased payments for endocrinologists, rheumatologists, and family medicine clinicians and decreased payments for radiologists, pathologists, and surgeons.
In a major win for physicians, CMS proposes to simplify documentation requirements for billing and focus on the complexity of the medical decision making (MDM) or the total time needed to care for the patient on the date of the service as the foundation for determining the relative value of the service. Therefore, there is no more counting bullets—ie, we don’t have to perform a comprehensive physical exam or review of systems to achieve a high level code! Prior to this change, time was only available for coding purposes when counseling and coordination of care was the predominant service (>50%), and only face-to-face time with the patient was considered. Effective January 1, for office and other outpatient services, total time on the calendar date of the encounter will be used. This acknowledges the intensity and value of non–face-to-face work.
Acting through CMS, the federal government influences greatly the US health care system. CMS is an agency in the Department of Health and Human Services that administers the Medicare program and partners with state governments to administer the Health Insurance Exchanges, Medicaid, and the Children’s Health Insurance programs (CHIP).1 In addition, CMS is responsible for enforcing quality care standards in long-term care facilities and clinical laboratories and the implementation of the Health Insurance Portability and Accountability Act.1
In January, CMS plans the following major changes to coding and documentation2,3:
- Selection of the level of E/M service will no longer require documentation of bullet points in the history, physical exam, and MDM. The simplified system allows physicians and qualified health care professionals to code either by total time (both face-to-face and non–face-to-face) on the date of the encounter or by level of MDM.
- For established office patients, 5 levels of office-based evaluation and management services will be retained. CMS had initially proposed to reduce the number of office-based E/M codes from 5 to 3, combining code levels 2, 3, and 4 into 1 code.4 However, after receiving feedback from professional societies and the public, CMS abandoned the plan for radical simplification of coding levels.2,3 Implementation of their proposal would have resulted in the same payment for treatment of a hang nail as for a complex gyn patient with multiple medical problems. Both patient advocacy groups and professional societies argued that incentives originally were misaligned.
- For new office patients, since both 99201 and 99202 require straightforward MDM, the level 1 code (99201) has been eliminated, reducing the number of code levels from 5 to 4.
- History and physical exam will no longer be used to determine code level for office E/M codes. These elements will be required only as medically appropriate. This means that documentation review will no longer focus on “bean counting” the elements in the history and physical exam.
- Following a reassessment of the actual time required to provide E/M services in real-life practice, CMS plans to markedly increase the relative value of office visits for established patients and modestly increase the relative value of office visits for new patients. CMS operates under the principle of “neutral budgeting,” meaning that an increase of the relative value of E/M codes will result in a decrease in the payment for procedural codes. The actual RVUs for procedural services do not change; however, budget neutrality requires a decrease in the dollar conversion factor. The proposed changes will increase the payment for E/M services and decrease payments for procedural services.
Continue to: Refocusing practice on MDM complexity...
Refocusing practice on MDM complexity
The practice of medicine is a calling with great rewards. Prominent among those rewards are improving the health of women, children, and the community, developing deep and trusting relationships with patients, families, and clinical colleagues. The practice of medicine is also replete with a host of punishing administrative burdens, including prior authorizations, clunky electronic medical records, poorly designed quality metrics that are applied to clinicians, and billing compliance rules that emphasize the repetitive documentation of clinical information with minimal value.
Some of the most irritating aspects of medical practice are the CMS rules governing medical record documentation required for billing ambulatory office visits. Current coding compliance focuses on counting the number of systems reviewed in the review of systems; the documentation of past history, social history, and family history; the number of organs and organ elements examined during the physical examination; and the complexity of MDM.
In January 2021, CMS plans to adopt new Current Procedural Terminology (CPT) code descriptors for the office and other outpatient E/M services that sunset most of the “bean-counting” metrics and emphasize the importance of the complexity of MDM in guiding selection of a correct code.2 Beginning in January 2021, clinicians will have the option of selecting an E/M code level based on the total amount of time required to provide the office visit service or the complexity of MDM. When selecting a code level based on MDM the new guidance emphasizes the importance of reviewing notes from other clinicians, reviewing test results, ordering of tests, and discussing and coordinating the care of the patient with other treating physicians. These changes reflect a better understanding of what is most important in good medical practice, promoting better patient care. TABLES 1 and 2 provide the initial guidance from CMS concerning selection of E/M code level based on time and MDM, respectively.2 The guidance for using MDM to select an E/M code level is likely to evolve following implementation, so stay tuned. When using MDM to select a code, 2 of the 3 general categories are required to select that level of service.


Increase in the valuation of office-based E/M services
The Medicare Physician Fee Schedule uses a resource-based relative value system to determine time and intensity of the work of clinical practice. This system recognizes 3 major factors that influence the resources required to provide a service:
- work of the clinician
- practice expense for technical components
- cost of professional liability insurance.
Many primary care professional associations have long contended that CMS has undervalued office-based E/M services relative to procedures, resulting in the devaluing of primary care practice. After the CPT code descriptors were updated by the CPT editorial panel, 52 specialty societies surveyed their members to provide inputs to CMS on the time and intensity of the office and other outpatient E/M codes as currently practiced. The American Medical Association’s Specialty Society Resource-Based Relative Value Scale Update Committee (RUC) reviewed the surveys and provided new inputs via open comment to CMS. CMS has responded to this feedback with a review of the intensity of clinical work required to provide an ambulatory visit service. In response to the review, CMS proposes to accept the recommendations of the RUC representing the house of medicine and increase the work and practice expense relative value assigned to new and established office visit codes. Overall, the combination of changes in relative values assigned for the work of the clinician and the expense of practice, increases the total value of office-based E/M codes for new patients by 7% to 14% and for established patients from 28% to 46% (see supplemental table in the sidebar at the end of this article).
Continue to: Decreased payments for procedural services...
Decreased payments for procedural services
Medicare is required to offset increased payment in one arena of health care delivery with decreased payment in other arenas of care, thereby achieving “budget-neutrality.” As detailed above, CMS plans to increase Medicare payments for office-based E/M services. Payment for services is calculated by multiplying the total RVUs for a particular service by a “conversion factor” (ie, number of dollars per RVU). To achieve budget-neutrality, CMS has proposed substantially reducing the conversion factor for 2021 (from $36.09 to $32.26), which will effectively decrease Medicare payments for procedural services since their RVUs have not changed. While the AMA RUC and many specialty societies continue to strongly advocate for the E/M work RVU increases to be included in the E/M components of 10- and 90-day global services, CMS has proposed to implement them only for “stand alone” E/M services.
Organizations are lobbying to delay or prevent the planned decrease in conversion factor, which results in substantial declines in payment for procedural services. (See "What do the Medicare billing changes mean for the Obstetrical Bundled services?" at the end of this article.) Due to the economic and clinical practice challenges caused by the coronavirus disease 2019 (COVID-19) pandemic it would be best if CMS did not reduce payments to physicians who are experts in procedural health care, thereby avoiding the risk of reduced access to these vital services.
If the current CMS changes in payment are implemented, endocrinologists, rheumatologists, and family physicians will have an increase in payment, and radiologists, pathologists, and surgeons will have a decrease in payment (TABLE 3).6 Obstetrics and gynecology is projected to have an 8% increase in Medicare payment. However, if an obstetrician-gynecologist derives most of their Medicare payments from surgical procedures, they are likely to have a decrease in payment from Medicare. Other payers will be incorporating the new coding structure for 2021; however, their payment structures and conversion factors are likely to vary. It is important to note that the RVUs for procedures have not changed. The budget neutrality adjustment resulted in a much lower conversion factor and therefore a decrease in payment for those specialties whose RVUs did not increase.

Bottom line
Working through the Medicare, Medicaid, and CHIP programs, CMS can influence greatly the practice of medicine including medical record documentation practices and payment rates for every clinical service. CMS proposes to end the onerous “bean counting” approach to billing compliance and refocus on the complexity of MDM as the foundation for selecting a billing code level. This change is long overdue, valuing the effective management of complex patients in office practice. Hopefully, CMS will reverse the planned reduction in the payment for procedural services, preserving patient access to important health care services. ●
The CY 2020 Medicare Physician Fee Schedule Final Rule was published electronically in the Federal Register on November 1, 2019. This final rule aligns the evaluation and management (E/M) coding and payment with changes recommended by the Current Procedural Terminology (CPT) Editorial Panel and American Medical Association’s (AMA) Specialty Society Resource-Based Relative Value Scale Update Committee (RUC) for office/outpatient E/M visits. Unfortunately, the Centers for Medicare and Medicaid Services (CMS) did not agree with the RUC, AMA, and specialty societies that the E/M payment changes should be applicable across all global services that incorporate E/M visits—despite the fact that the values proposed by the RUC incorporated survey data from 52 specialties, representing most of medicine (including those specialties that predominantly perform procedures). Specifically, CMS expressed the view that the number of E/M visits within the 10- and 90-day global codes, as well as the maternity care bundle, were difficult to validate; therefore, the increased values would not be distributed to those procedural services.
Many professional societies expressed significant concerns about the resulting budget neutrality adjustments that would occur effective January 2021. The great news for ObGyns is that the American College of Obstetricians and Gynecologists (ACOG) was able to respond directly to CMS’s concerns with data to support the number of prenatal visits within the Obstetrical Bundle. Tapping into a de-identified, cloud-based data set of prenatal records—representing more than 1,100 obstetric providers with close to 30,000 recently completed pregnancies—ACOG was able to document both a mean and median number of prenatal visits across a broad geographic, payer, and patient demographic that supported the 13 prenatal visits in the Obstetrical Bundle.
With ACOG’s advocacy and ability to provide data to CMS, the proposed physician fee schedule rule for 2021 has proposed to incorporate the E/M increased reimbursement into the prenatal care codes. Now we urge the CMS to finalize this proposal. Although Medicare pays for a tiny number of pregnancies annually, we hope that all payers, including Medicaid and managed care plans, will agree with this acknowledgement of the increased work of evaluation and management that obstetricians provide during prenatal care. Join ACOG in telling CMS to finalize their proposal to increase the values of the global obstetric codes: https://acog.quorum.us/campaign/28579/.

The Centers for Medicare and Medicaid Services (CMS) finalized an increase in the relative value of evaluation and management (E/M) service codes effective January 1, 2021, which results in an overall decrease in the payment for procedural services in the Medicare program. (Due to the mandate for budget neutrality, an increase in relative value units [RVUs] for E/M resulted in a large decrease in the conversion factor—the number of dollars per RVU). This has increased payments for endocrinologists, rheumatologists, and family medicine clinicians and decreased payments for radiologists, pathologists, and surgeons.
In a major win for physicians, CMS proposes to simplify documentation requirements for billing and focus on the complexity of the medical decision making (MDM) or the total time needed to care for the patient on the date of the service as the foundation for determining the relative value of the service. Therefore, there is no more counting bullets—ie, we don’t have to perform a comprehensive physical exam or review of systems to achieve a high level code! Prior to this change, time was only available for coding purposes when counseling and coordination of care was the predominant service (>50%), and only face-to-face time with the patient was considered. Effective January 1, for office and other outpatient services, total time on the calendar date of the encounter will be used. This acknowledges the intensity and value of non–face-to-face work.
Acting through CMS, the federal government influences greatly the US health care system. CMS is an agency in the Department of Health and Human Services that administers the Medicare program and partners with state governments to administer the Health Insurance Exchanges, Medicaid, and the Children’s Health Insurance programs (CHIP).1 In addition, CMS is responsible for enforcing quality care standards in long-term care facilities and clinical laboratories and the implementation of the Health Insurance Portability and Accountability Act.1
In January, CMS plans the following major changes to coding and documentation2,3:
- Selection of the level of E/M service will no longer require documentation of bullet points in the history, physical exam, and MDM. The simplified system allows physicians and qualified health care professionals to code either by total time (both face-to-face and non–face-to-face) on the date of the encounter or by level of MDM.
- For established office patients, 5 levels of office-based evaluation and management services will be retained. CMS had initially proposed to reduce the number of office-based E/M codes from 5 to 3, combining code levels 2, 3, and 4 into 1 code.4 However, after receiving feedback from professional societies and the public, CMS abandoned the plan for radical simplification of coding levels.2,3 Implementation of their proposal would have resulted in the same payment for treatment of a hang nail as for a complex gyn patient with multiple medical problems. Both patient advocacy groups and professional societies argued that incentives originally were misaligned.
- For new office patients, since both 99201 and 99202 require straightforward MDM, the level 1 code (99201) has been eliminated, reducing the number of code levels from 5 to 4.
- History and physical exam will no longer be used to determine code level for office E/M codes. These elements will be required only as medically appropriate. This means that documentation review will no longer focus on “bean counting” the elements in the history and physical exam.
- Following a reassessment of the actual time required to provide E/M services in real-life practice, CMS plans to markedly increase the relative value of office visits for established patients and modestly increase the relative value of office visits for new patients. CMS operates under the principle of “neutral budgeting,” meaning that an increase of the relative value of E/M codes will result in a decrease in the payment for procedural codes. The actual RVUs for procedural services do not change; however, budget neutrality requires a decrease in the dollar conversion factor. The proposed changes will increase the payment for E/M services and decrease payments for procedural services.
Continue to: Refocusing practice on MDM complexity...
Refocusing practice on MDM complexity
The practice of medicine is a calling with great rewards. Prominent among those rewards are improving the health of women, children, and the community, developing deep and trusting relationships with patients, families, and clinical colleagues. The practice of medicine is also replete with a host of punishing administrative burdens, including prior authorizations, clunky electronic medical records, poorly designed quality metrics that are applied to clinicians, and billing compliance rules that emphasize the repetitive documentation of clinical information with minimal value.
Some of the most irritating aspects of medical practice are the CMS rules governing medical record documentation required for billing ambulatory office visits. Current coding compliance focuses on counting the number of systems reviewed in the review of systems; the documentation of past history, social history, and family history; the number of organs and organ elements examined during the physical examination; and the complexity of MDM.
In January 2021, CMS plans to adopt new Current Procedural Terminology (CPT) code descriptors for the office and other outpatient E/M services that sunset most of the “bean-counting” metrics and emphasize the importance of the complexity of MDM in guiding selection of a correct code.2 Beginning in January 2021, clinicians will have the option of selecting an E/M code level based on the total amount of time required to provide the office visit service or the complexity of MDM. When selecting a code level based on MDM the new guidance emphasizes the importance of reviewing notes from other clinicians, reviewing test results, ordering of tests, and discussing and coordinating the care of the patient with other treating physicians. These changes reflect a better understanding of what is most important in good medical practice, promoting better patient care. TABLES 1 and 2 provide the initial guidance from CMS concerning selection of E/M code level based on time and MDM, respectively.2 The guidance for using MDM to select an E/M code level is likely to evolve following implementation, so stay tuned. When using MDM to select a code, 2 of the 3 general categories are required to select that level of service.


Increase in the valuation of office-based E/M services
The Medicare Physician Fee Schedule uses a resource-based relative value system to determine time and intensity of the work of clinical practice. This system recognizes 3 major factors that influence the resources required to provide a service:
- work of the clinician
- practice expense for technical components
- cost of professional liability insurance.
Many primary care professional associations have long contended that CMS has undervalued office-based E/M services relative to procedures, resulting in the devaluing of primary care practice. After the CPT code descriptors were updated by the CPT editorial panel, 52 specialty societies surveyed their members to provide inputs to CMS on the time and intensity of the office and other outpatient E/M codes as currently practiced. The American Medical Association’s Specialty Society Resource-Based Relative Value Scale Update Committee (RUC) reviewed the surveys and provided new inputs via open comment to CMS. CMS has responded to this feedback with a review of the intensity of clinical work required to provide an ambulatory visit service. In response to the review, CMS proposes to accept the recommendations of the RUC representing the house of medicine and increase the work and practice expense relative value assigned to new and established office visit codes. Overall, the combination of changes in relative values assigned for the work of the clinician and the expense of practice, increases the total value of office-based E/M codes for new patients by 7% to 14% and for established patients from 28% to 46% (see supplemental table in the sidebar at the end of this article).
Continue to: Decreased payments for procedural services...
Decreased payments for procedural services
Medicare is required to offset increased payment in one arena of health care delivery with decreased payment in other arenas of care, thereby achieving “budget-neutrality.” As detailed above, CMS plans to increase Medicare payments for office-based E/M services. Payment for services is calculated by multiplying the total RVUs for a particular service by a “conversion factor” (ie, number of dollars per RVU). To achieve budget-neutrality, CMS has proposed substantially reducing the conversion factor for 2021 (from $36.09 to $32.26), which will effectively decrease Medicare payments for procedural services since their RVUs have not changed. While the AMA RUC and many specialty societies continue to strongly advocate for the E/M work RVU increases to be included in the E/M components of 10- and 90-day global services, CMS has proposed to implement them only for “stand alone” E/M services.
Organizations are lobbying to delay or prevent the planned decrease in conversion factor, which results in substantial declines in payment for procedural services. (See "What do the Medicare billing changes mean for the Obstetrical Bundled services?" at the end of this article.) Due to the economic and clinical practice challenges caused by the coronavirus disease 2019 (COVID-19) pandemic it would be best if CMS did not reduce payments to physicians who are experts in procedural health care, thereby avoiding the risk of reduced access to these vital services.
If the current CMS changes in payment are implemented, endocrinologists, rheumatologists, and family physicians will have an increase in payment, and radiologists, pathologists, and surgeons will have a decrease in payment (TABLE 3).6 Obstetrics and gynecology is projected to have an 8% increase in Medicare payment. However, if an obstetrician-gynecologist derives most of their Medicare payments from surgical procedures, they are likely to have a decrease in payment from Medicare. Other payers will be incorporating the new coding structure for 2021; however, their payment structures and conversion factors are likely to vary. It is important to note that the RVUs for procedures have not changed. The budget neutrality adjustment resulted in a much lower conversion factor and therefore a decrease in payment for those specialties whose RVUs did not increase.

Bottom line
Working through the Medicare, Medicaid, and CHIP programs, CMS can influence greatly the practice of medicine including medical record documentation practices and payment rates for every clinical service. CMS proposes to end the onerous “bean counting” approach to billing compliance and refocus on the complexity of MDM as the foundation for selecting a billing code level. This change is long overdue, valuing the effective management of complex patients in office practice. Hopefully, CMS will reverse the planned reduction in the payment for procedural services, preserving patient access to important health care services. ●
The CY 2020 Medicare Physician Fee Schedule Final Rule was published electronically in the Federal Register on November 1, 2019. This final rule aligns the evaluation and management (E/M) coding and payment with changes recommended by the Current Procedural Terminology (CPT) Editorial Panel and American Medical Association’s (AMA) Specialty Society Resource-Based Relative Value Scale Update Committee (RUC) for office/outpatient E/M visits. Unfortunately, the Centers for Medicare and Medicaid Services (CMS) did not agree with the RUC, AMA, and specialty societies that the E/M payment changes should be applicable across all global services that incorporate E/M visits—despite the fact that the values proposed by the RUC incorporated survey data from 52 specialties, representing most of medicine (including those specialties that predominantly perform procedures). Specifically, CMS expressed the view that the number of E/M visits within the 10- and 90-day global codes, as well as the maternity care bundle, were difficult to validate; therefore, the increased values would not be distributed to those procedural services.
Many professional societies expressed significant concerns about the resulting budget neutrality adjustments that would occur effective January 2021. The great news for ObGyns is that the American College of Obstetricians and Gynecologists (ACOG) was able to respond directly to CMS’s concerns with data to support the number of prenatal visits within the Obstetrical Bundle. Tapping into a de-identified, cloud-based data set of prenatal records—representing more than 1,100 obstetric providers with close to 30,000 recently completed pregnancies—ACOG was able to document both a mean and median number of prenatal visits across a broad geographic, payer, and patient demographic that supported the 13 prenatal visits in the Obstetrical Bundle.
With ACOG’s advocacy and ability to provide data to CMS, the proposed physician fee schedule rule for 2021 has proposed to incorporate the E/M increased reimbursement into the prenatal care codes. Now we urge the CMS to finalize this proposal. Although Medicare pays for a tiny number of pregnancies annually, we hope that all payers, including Medicaid and managed care plans, will agree with this acknowledgement of the increased work of evaluation and management that obstetricians provide during prenatal care. Join ACOG in telling CMS to finalize their proposal to increase the values of the global obstetric codes: https://acog.quorum.us/campaign/28579/.

- Centers for Medicare and Medicaid Services. https://www.cms.gov/. Accessed August 28, 2020.
- American Medical Association. CPT Evaluation and Management (E/M) Office or Other Outpatient (99202-99215) and Prolonged Services (99354, 99355, 99356, 99XXX) Code and Guideline Changes. 2019. https://www.ama-assn.org /system/files/2019-06/cpt-office-prolonged-svs -code-changes.pdf. Accessed August 28, 2020.
- The American Academy of Family Physicians. Family medicine updates. Ann Fam Med. 2020;18:84-85. doi: 10.1370/afm.2508.
- Centers for Medicare and Medicaid Services. Final policy, payment and quality provisions changes to the Medicare Physician Fee Schedule for calendar year 2019. November 1, 2018. https://www.cms.gov/newsroom/fact-sheets /final-policy-payment-and-quality-provisionschanges-medicare-physician-fee-schedulecalendar-year. Accessed August 28, 2020.
- Department of Health and Human Services; Centers for Medicare and Medicaid Services. 42 CFR Parts 410, 414, 415, 423, 424, and 425. Federal Register. 2020;85(159). https://www.govinfo.gov /content/pkg/FR-2020-08-17/pdf/2020-17127 .pdf. Accessed August 28, 2020.
- Centers for Medicare and Medicaid Services. https://www.cms.gov/. Accessed August 28, 2020.
- American Medical Association. CPT Evaluation and Management (E/M) Office or Other Outpatient (99202-99215) and Prolonged Services (99354, 99355, 99356, 99XXX) Code and Guideline Changes. 2019. https://www.ama-assn.org /system/files/2019-06/cpt-office-prolonged-svs -code-changes.pdf. Accessed August 28, 2020.
- The American Academy of Family Physicians. Family medicine updates. Ann Fam Med. 2020;18:84-85. doi: 10.1370/afm.2508.
- Centers for Medicare and Medicaid Services. Final policy, payment and quality provisions changes to the Medicare Physician Fee Schedule for calendar year 2019. November 1, 2018. https://www.cms.gov/newsroom/fact-sheets /final-policy-payment-and-quality-provisionschanges-medicare-physician-fee-schedulecalendar-year. Accessed August 28, 2020.
- Department of Health and Human Services; Centers for Medicare and Medicaid Services. 42 CFR Parts 410, 414, 415, 423, 424, and 425. Federal Register. 2020;85(159). https://www.govinfo.gov /content/pkg/FR-2020-08-17/pdf/2020-17127 .pdf. Accessed August 28, 2020.
Lifting the restrictions on mifepristone during COVID-19: A step in the right direction
Mifepristone is a safe, effective, and well-tolerated medication for managing miscarriage and for medical abortion when combined with misoprostol.1,2 Since the US Food and Drug Administration (FDA) approved its use in 2000, more than 4 million women have used this medication.3 The combination of mifepristone with misoprostol was used for 39% of all US abortions in 2017.4 Approximately 10% of all clinically recognized pregnancies end in miscarriages, and many are safely managed with either misoprostol alone or with the combination of mifepristone and misoprostol.5
The issue
The prescription and distribution of mifepristone is highly regulated by the FDA via requirements outlined in the Risk Evaluation and Mitigation Strategies (REMS) drug safety program. The FDA may determine a REMS is necessary for a specific drug to ensure the benefits of a drug outweigh the potential risks. A REMS may include an informative package insert for patients, follow-up communication to prescribers—including letters, safety protocols or recommended laboratory tests, or Elements to Assure Safe Use (ETASU). ETASU are types of REMS that are placed on medications that have significant potential for serious adverse effects, and without such restrictions FDA approval would be rescinded.
Are mifepristone requirements fairly applied?
The 3 ETASU restrictions on the distribution of mifepristone are in-person dispensation, prescriber certification, and patient signatures on special forms.6 The in-person dispensing requirement is applied to only 16 other medications (one of which is Mifeprex, the brand version of mifepristone), and Mifeprex/mifepristone are the only ones deemed safe for self-administration—meaning that patients receive the drug from a clinic but then may take it at a site of their choosing. The prescriber certification requirement places expectations on providers to account for distribution of doses and keep records of serial numbers (in effect, having clinicians act as both physician and pharmacist, as most medications are distributed and recorded in pharmacies). The patient form was recommended for elimination in 2016 due to its duplicative information and burden on patients—a recommendation that was then overruled by the FDA commissioner.7
These 3 requirements placed on mifepristone specifically target dosages for use related to abortions and miscarriages. Mifepristone is used to treat other medical conditions, with much higher doses, without the same restrictions—in fact, the FDA has allowed much higher doses of mifepristone to be mailed directly to a patient when prescribed for different disorders. The American College of Obstetricians and Gynecologists (ACOG) has long opposed the burdensome REMS requirements on mifepristone for reproductive health indications.8
Arguments regarding the safety of mifepristone must be understood in the context of how the medication is taken, and the unique difference with other medications that must be administered by physicians or in health care facilities. Mifepristone is self-administered, and the desired effect—evacuation of uterine contents—typically occurs after a patient takes the accompanying medication misoprostol, which is some 24 to 72 hours later. This timeframe makes it highly unlikely that any patient would be in the presence of their provider at the time of medication effect, thus an in-person dispensing requirement has no medical bearing on the outcome of the health of the patient.
REMS changes during the COVID-19 pandemic
The coronavirus disease 2019 (COVID-19) pandemic has necessarily changed the structure of REMS and ETASU requirements for many medications, with changes made in order to mitigate viral transmission through the limitation of unnecessary visits to clinics or hospitals. The FDA announced in March of 2020 that it would not enforce pre-prescription requirements, such as laboratory or magnetic resonance imaging results, for many medications (including those more toxic than mifepristone), and that it would lift the requirement for in-person dispensation of several medications.9 Also in March 2020 the Department of Health and Human Services Secretary (HHS) and the Drug Enforcement Agency (DEA) activated a “telemedicine exception” to allow physicians to use telemedicine to satisfy mandatory requirements for prescribing controlled substances, including opioids.10
Despite repeated pleas from organizations, individuals, and physician groups, the FDA continued to enforce the REMS/ETASU for mifepristone as the pandemic decimated communities. Importantly, the pandemic has not had an equal effect on all communities, and the disparities highlighted in outcomes as related to COVID-19 are also reflected in disparities to access to reproductive choices.11 By enforcing REMS/ETASU for mifepristone during a global pandemic, the FDA has placed additional burden on women and people who menstruate. As offices and clinics have closed, and as many jobs have evaporated, additional barriers have emerged, such as lack of childcare, fewer transportation options, and decreased clinic appointments.
As the pandemic continues to affect communities in the United States, ACOG has issued guidance recommending assessment for eligibility for medical abortion remotely, and has encouraged the use of telemedicine and other remote interactions for its members and patients to limit transmission of the virus.
The lawsuit
On May 27, 2020, the American Civil Liberties Union (ACLU) (on behalf of ACOG, the Council of University Chairs of Obstetrics and Gynecology, New York State Academy of Family Physicians, SisterSong, and Honor MacNaughton, MD) filed a civil action against the FDA and HHS challenging the requirement for in-person dispensing of mifepristone and associated ETASU requirements during the COVID-19 pandemic. The plaintiffs sought this injunction based on the claim that these restrictions during the pandemic infringe on the constitutional rights to patients’ privacy and liberty and to equal protection of the law as protected by the Due Process Clause of the Fifth Amendment. Additionally, the ACLU and other organizations said these unnecessary restrictions place patients, providers, and staff at unnecessary risk of viral exposure amidst a global pandemic.
The verdict
On July 13, 2020, a federal court granted the preliminary injunction to suspend FDA’s enforcement of the in-person requirements of mifepristone for abortion during the COVID-19 pandemic. The court denied the motion for suspension of in-person restrictions as applied to miscarriage management. The preliminary injunction applies nationwide without geographic limitation. It will remain in effect until the end of the litigation or for 30 days following the expiration of the public health emergency.
What the outcome means
This injunction is a step in the right direction for patients and providers to allow for autonomy and clinical practice guided by clinician expertise. However, this ruling remains narrow. Patients must be counseled about mifepristone via telemedicine and sign a Patient Agreement Form, which must be returned electronically or by mail. Patients must receive a copy of the mifepristone medication guide, and dispensing of mifepristone must still be conducted by or under the supervision of a certified provider. The medication may not be dispensed by retail pharmacies, thus requiring providers to arrange for mailing of prescriptions to patients. Given state-based legal statutes regarding mailing of medications, this injunction may not lead to an immediate increase in access to care. In addition, patients seeking management for miscarriage must go to clinic to have mifepristone dispensed and thus risk exposure to viral transmission.
What now?
The regulation of mifepristone—in spite of excellent safety and specifically for the narrow purpose of administration in the setting of abortion and miscarriage care—is by definition a discriminatory practice against patients and providers. As clinicians, we are duty-bound to speak out against injustices to our practices and our patients. At a local level, we can work to implement safe practices in the setting of this injunction and continue to work on a national level to ensure this injunction becomes permanent and with more broad scope to eliminate all of the REMS requirements for mifepristone.
ACTION ITEMS
- Act locally! Are you an abortion provider? Contact your local ACLU (find them here) or lawyer in your area for assistance navigating the legal landscape to prescribe after this injunction.
- Act statewide! Press candidates in your state to stand up for science and data. Support legislative acts and bills that address combating discriminatory regulations.
- Act nationally! The President is responsible for appointing the Commissioner of the FDA and the Secretary of Health and Human Services (with Senate advice and consent). Who we elect matters. Seek out opportunities to become involved in increasing access to and awareness of voter registration and Election Day, and speak out against voter suppression. Make sure you are registered to vote here and check your area to review new recommendations amidst the pandemic.
- American College of Obstetricians and Gynecologists. Practice bulletin number 143: medical management of first trimester abortion. Obstet Gynecol. 2014;123:676-692.
- Schreiber CA, Crenin MD, Atrio J, et al. Mifepristone pretreatment for the medical management of early pregnancy loss. N Engl J Med. 2018;378:2161-2170.
- Danco Laboratories. Mifeprex effectiveness and advantages. https://www.earlyoptionpill.com/is-mifeprex-right-for-me/effectiveness-advantages/ Accessed August 2, 2020.
- Jones RK, Witwer E, Jerman J. Abortion incidence and service availability in the United States, 2017. September 2019. https://www.guttmacher.org/report/abortion-incidence-service-availability-us-2017. Accessed September 10, 2020.
- American College of Obstetricians and Gynecologists. Practice bulletin no. 150: early pregnancy loss. Obstet Gynecol. 2015;125:1258-1267.
- US Food and Drug Administration. Risk evaluation and mitigation strategy (REMS) single shared system for mifepristone 200 mg. April 2019. https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2019_04_11_REMS_Full.pdf. Accessed September 10, 2020.
- US Food and Drug Administration; Center for Drug Evaluation and Research. 2016 REMS Review, Summary Review 25. March 29, 2016. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020687Orig1s020SumR.pdf. Accessed September 10, 2020.
- American College of Obstetricians and Gynecologists. Improving access to mifepristone for reproductive health indications. June 2018. https://www.acog.org/clinical-information/policy-and-position-statements/position-statements/2018/improving-access-to-mifepristone-for-reproductive-health-indications. Accessed August 2, 2020.
- US Food and Drug Administration. Policy for certain REMS requirements during the COVID-19 public health emergency: guidance for industry and health care professionals. March 2020. https://www.fda.gov/media/136317/download. Accessed September 10, 2020.
- US Department of Justice. US Drug Enforcement Administration. COVID-19 Information Page, Telemedicine. https://www.deadiversion.usdoj.gov/coronavirus.html#TELE. Accessed May 25, 2020.
- Centers for Disease Control and Prevention. Coronavirus disease 2019: health equity considerations and racial and ethnic minority groups. https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/race-ethnicity.html. Updated July 24, 2020. Accessed September 10, 2020.
Mifepristone is a safe, effective, and well-tolerated medication for managing miscarriage and for medical abortion when combined with misoprostol.1,2 Since the US Food and Drug Administration (FDA) approved its use in 2000, more than 4 million women have used this medication.3 The combination of mifepristone with misoprostol was used for 39% of all US abortions in 2017.4 Approximately 10% of all clinically recognized pregnancies end in miscarriages, and many are safely managed with either misoprostol alone or with the combination of mifepristone and misoprostol.5
The issue
The prescription and distribution of mifepristone is highly regulated by the FDA via requirements outlined in the Risk Evaluation and Mitigation Strategies (REMS) drug safety program. The FDA may determine a REMS is necessary for a specific drug to ensure the benefits of a drug outweigh the potential risks. A REMS may include an informative package insert for patients, follow-up communication to prescribers—including letters, safety protocols or recommended laboratory tests, or Elements to Assure Safe Use (ETASU). ETASU are types of REMS that are placed on medications that have significant potential for serious adverse effects, and without such restrictions FDA approval would be rescinded.
Are mifepristone requirements fairly applied?
The 3 ETASU restrictions on the distribution of mifepristone are in-person dispensation, prescriber certification, and patient signatures on special forms.6 The in-person dispensing requirement is applied to only 16 other medications (one of which is Mifeprex, the brand version of mifepristone), and Mifeprex/mifepristone are the only ones deemed safe for self-administration—meaning that patients receive the drug from a clinic but then may take it at a site of their choosing. The prescriber certification requirement places expectations on providers to account for distribution of doses and keep records of serial numbers (in effect, having clinicians act as both physician and pharmacist, as most medications are distributed and recorded in pharmacies). The patient form was recommended for elimination in 2016 due to its duplicative information and burden on patients—a recommendation that was then overruled by the FDA commissioner.7
These 3 requirements placed on mifepristone specifically target dosages for use related to abortions and miscarriages. Mifepristone is used to treat other medical conditions, with much higher doses, without the same restrictions—in fact, the FDA has allowed much higher doses of mifepristone to be mailed directly to a patient when prescribed for different disorders. The American College of Obstetricians and Gynecologists (ACOG) has long opposed the burdensome REMS requirements on mifepristone for reproductive health indications.8
Arguments regarding the safety of mifepristone must be understood in the context of how the medication is taken, and the unique difference with other medications that must be administered by physicians or in health care facilities. Mifepristone is self-administered, and the desired effect—evacuation of uterine contents—typically occurs after a patient takes the accompanying medication misoprostol, which is some 24 to 72 hours later. This timeframe makes it highly unlikely that any patient would be in the presence of their provider at the time of medication effect, thus an in-person dispensing requirement has no medical bearing on the outcome of the health of the patient.
REMS changes during the COVID-19 pandemic
The coronavirus disease 2019 (COVID-19) pandemic has necessarily changed the structure of REMS and ETASU requirements for many medications, with changes made in order to mitigate viral transmission through the limitation of unnecessary visits to clinics or hospitals. The FDA announced in March of 2020 that it would not enforce pre-prescription requirements, such as laboratory or magnetic resonance imaging results, for many medications (including those more toxic than mifepristone), and that it would lift the requirement for in-person dispensation of several medications.9 Also in March 2020 the Department of Health and Human Services Secretary (HHS) and the Drug Enforcement Agency (DEA) activated a “telemedicine exception” to allow physicians to use telemedicine to satisfy mandatory requirements for prescribing controlled substances, including opioids.10
Despite repeated pleas from organizations, individuals, and physician groups, the FDA continued to enforce the REMS/ETASU for mifepristone as the pandemic decimated communities. Importantly, the pandemic has not had an equal effect on all communities, and the disparities highlighted in outcomes as related to COVID-19 are also reflected in disparities to access to reproductive choices.11 By enforcing REMS/ETASU for mifepristone during a global pandemic, the FDA has placed additional burden on women and people who menstruate. As offices and clinics have closed, and as many jobs have evaporated, additional barriers have emerged, such as lack of childcare, fewer transportation options, and decreased clinic appointments.
As the pandemic continues to affect communities in the United States, ACOG has issued guidance recommending assessment for eligibility for medical abortion remotely, and has encouraged the use of telemedicine and other remote interactions for its members and patients to limit transmission of the virus.
The lawsuit
On May 27, 2020, the American Civil Liberties Union (ACLU) (on behalf of ACOG, the Council of University Chairs of Obstetrics and Gynecology, New York State Academy of Family Physicians, SisterSong, and Honor MacNaughton, MD) filed a civil action against the FDA and HHS challenging the requirement for in-person dispensing of mifepristone and associated ETASU requirements during the COVID-19 pandemic. The plaintiffs sought this injunction based on the claim that these restrictions during the pandemic infringe on the constitutional rights to patients’ privacy and liberty and to equal protection of the law as protected by the Due Process Clause of the Fifth Amendment. Additionally, the ACLU and other organizations said these unnecessary restrictions place patients, providers, and staff at unnecessary risk of viral exposure amidst a global pandemic.
The verdict
On July 13, 2020, a federal court granted the preliminary injunction to suspend FDA’s enforcement of the in-person requirements of mifepristone for abortion during the COVID-19 pandemic. The court denied the motion for suspension of in-person restrictions as applied to miscarriage management. The preliminary injunction applies nationwide without geographic limitation. It will remain in effect until the end of the litigation or for 30 days following the expiration of the public health emergency.
What the outcome means
This injunction is a step in the right direction for patients and providers to allow for autonomy and clinical practice guided by clinician expertise. However, this ruling remains narrow. Patients must be counseled about mifepristone via telemedicine and sign a Patient Agreement Form, which must be returned electronically or by mail. Patients must receive a copy of the mifepristone medication guide, and dispensing of mifepristone must still be conducted by or under the supervision of a certified provider. The medication may not be dispensed by retail pharmacies, thus requiring providers to arrange for mailing of prescriptions to patients. Given state-based legal statutes regarding mailing of medications, this injunction may not lead to an immediate increase in access to care. In addition, patients seeking management for miscarriage must go to clinic to have mifepristone dispensed and thus risk exposure to viral transmission.
What now?
The regulation of mifepristone—in spite of excellent safety and specifically for the narrow purpose of administration in the setting of abortion and miscarriage care—is by definition a discriminatory practice against patients and providers. As clinicians, we are duty-bound to speak out against injustices to our practices and our patients. At a local level, we can work to implement safe practices in the setting of this injunction and continue to work on a national level to ensure this injunction becomes permanent and with more broad scope to eliminate all of the REMS requirements for mifepristone.
ACTION ITEMS
- Act locally! Are you an abortion provider? Contact your local ACLU (find them here) or lawyer in your area for assistance navigating the legal landscape to prescribe after this injunction.
- Act statewide! Press candidates in your state to stand up for science and data. Support legislative acts and bills that address combating discriminatory regulations.
- Act nationally! The President is responsible for appointing the Commissioner of the FDA and the Secretary of Health and Human Services (with Senate advice and consent). Who we elect matters. Seek out opportunities to become involved in increasing access to and awareness of voter registration and Election Day, and speak out against voter suppression. Make sure you are registered to vote here and check your area to review new recommendations amidst the pandemic.
Mifepristone is a safe, effective, and well-tolerated medication for managing miscarriage and for medical abortion when combined with misoprostol.1,2 Since the US Food and Drug Administration (FDA) approved its use in 2000, more than 4 million women have used this medication.3 The combination of mifepristone with misoprostol was used for 39% of all US abortions in 2017.4 Approximately 10% of all clinically recognized pregnancies end in miscarriages, and many are safely managed with either misoprostol alone or with the combination of mifepristone and misoprostol.5
The issue
The prescription and distribution of mifepristone is highly regulated by the FDA via requirements outlined in the Risk Evaluation and Mitigation Strategies (REMS) drug safety program. The FDA may determine a REMS is necessary for a specific drug to ensure the benefits of a drug outweigh the potential risks. A REMS may include an informative package insert for patients, follow-up communication to prescribers—including letters, safety protocols or recommended laboratory tests, or Elements to Assure Safe Use (ETASU). ETASU are types of REMS that are placed on medications that have significant potential for serious adverse effects, and without such restrictions FDA approval would be rescinded.
Are mifepristone requirements fairly applied?
The 3 ETASU restrictions on the distribution of mifepristone are in-person dispensation, prescriber certification, and patient signatures on special forms.6 The in-person dispensing requirement is applied to only 16 other medications (one of which is Mifeprex, the brand version of mifepristone), and Mifeprex/mifepristone are the only ones deemed safe for self-administration—meaning that patients receive the drug from a clinic but then may take it at a site of their choosing. The prescriber certification requirement places expectations on providers to account for distribution of doses and keep records of serial numbers (in effect, having clinicians act as both physician and pharmacist, as most medications are distributed and recorded in pharmacies). The patient form was recommended for elimination in 2016 due to its duplicative information and burden on patients—a recommendation that was then overruled by the FDA commissioner.7
These 3 requirements placed on mifepristone specifically target dosages for use related to abortions and miscarriages. Mifepristone is used to treat other medical conditions, with much higher doses, without the same restrictions—in fact, the FDA has allowed much higher doses of mifepristone to be mailed directly to a patient when prescribed for different disorders. The American College of Obstetricians and Gynecologists (ACOG) has long opposed the burdensome REMS requirements on mifepristone for reproductive health indications.8
Arguments regarding the safety of mifepristone must be understood in the context of how the medication is taken, and the unique difference with other medications that must be administered by physicians or in health care facilities. Mifepristone is self-administered, and the desired effect—evacuation of uterine contents—typically occurs after a patient takes the accompanying medication misoprostol, which is some 24 to 72 hours later. This timeframe makes it highly unlikely that any patient would be in the presence of their provider at the time of medication effect, thus an in-person dispensing requirement has no medical bearing on the outcome of the health of the patient.
REMS changes during the COVID-19 pandemic
The coronavirus disease 2019 (COVID-19) pandemic has necessarily changed the structure of REMS and ETASU requirements for many medications, with changes made in order to mitigate viral transmission through the limitation of unnecessary visits to clinics or hospitals. The FDA announced in March of 2020 that it would not enforce pre-prescription requirements, such as laboratory or magnetic resonance imaging results, for many medications (including those more toxic than mifepristone), and that it would lift the requirement for in-person dispensation of several medications.9 Also in March 2020 the Department of Health and Human Services Secretary (HHS) and the Drug Enforcement Agency (DEA) activated a “telemedicine exception” to allow physicians to use telemedicine to satisfy mandatory requirements for prescribing controlled substances, including opioids.10
Despite repeated pleas from organizations, individuals, and physician groups, the FDA continued to enforce the REMS/ETASU for mifepristone as the pandemic decimated communities. Importantly, the pandemic has not had an equal effect on all communities, and the disparities highlighted in outcomes as related to COVID-19 are also reflected in disparities to access to reproductive choices.11 By enforcing REMS/ETASU for mifepristone during a global pandemic, the FDA has placed additional burden on women and people who menstruate. As offices and clinics have closed, and as many jobs have evaporated, additional barriers have emerged, such as lack of childcare, fewer transportation options, and decreased clinic appointments.
As the pandemic continues to affect communities in the United States, ACOG has issued guidance recommending assessment for eligibility for medical abortion remotely, and has encouraged the use of telemedicine and other remote interactions for its members and patients to limit transmission of the virus.
The lawsuit
On May 27, 2020, the American Civil Liberties Union (ACLU) (on behalf of ACOG, the Council of University Chairs of Obstetrics and Gynecology, New York State Academy of Family Physicians, SisterSong, and Honor MacNaughton, MD) filed a civil action against the FDA and HHS challenging the requirement for in-person dispensing of mifepristone and associated ETASU requirements during the COVID-19 pandemic. The plaintiffs sought this injunction based on the claim that these restrictions during the pandemic infringe on the constitutional rights to patients’ privacy and liberty and to equal protection of the law as protected by the Due Process Clause of the Fifth Amendment. Additionally, the ACLU and other organizations said these unnecessary restrictions place patients, providers, and staff at unnecessary risk of viral exposure amidst a global pandemic.
The verdict
On July 13, 2020, a federal court granted the preliminary injunction to suspend FDA’s enforcement of the in-person requirements of mifepristone for abortion during the COVID-19 pandemic. The court denied the motion for suspension of in-person restrictions as applied to miscarriage management. The preliminary injunction applies nationwide without geographic limitation. It will remain in effect until the end of the litigation or for 30 days following the expiration of the public health emergency.
What the outcome means
This injunction is a step in the right direction for patients and providers to allow for autonomy and clinical practice guided by clinician expertise. However, this ruling remains narrow. Patients must be counseled about mifepristone via telemedicine and sign a Patient Agreement Form, which must be returned electronically or by mail. Patients must receive a copy of the mifepristone medication guide, and dispensing of mifepristone must still be conducted by or under the supervision of a certified provider. The medication may not be dispensed by retail pharmacies, thus requiring providers to arrange for mailing of prescriptions to patients. Given state-based legal statutes regarding mailing of medications, this injunction may not lead to an immediate increase in access to care. In addition, patients seeking management for miscarriage must go to clinic to have mifepristone dispensed and thus risk exposure to viral transmission.
What now?
The regulation of mifepristone—in spite of excellent safety and specifically for the narrow purpose of administration in the setting of abortion and miscarriage care—is by definition a discriminatory practice against patients and providers. As clinicians, we are duty-bound to speak out against injustices to our practices and our patients. At a local level, we can work to implement safe practices in the setting of this injunction and continue to work on a national level to ensure this injunction becomes permanent and with more broad scope to eliminate all of the REMS requirements for mifepristone.
ACTION ITEMS
- Act locally! Are you an abortion provider? Contact your local ACLU (find them here) or lawyer in your area for assistance navigating the legal landscape to prescribe after this injunction.
- Act statewide! Press candidates in your state to stand up for science and data. Support legislative acts and bills that address combating discriminatory regulations.
- Act nationally! The President is responsible for appointing the Commissioner of the FDA and the Secretary of Health and Human Services (with Senate advice and consent). Who we elect matters. Seek out opportunities to become involved in increasing access to and awareness of voter registration and Election Day, and speak out against voter suppression. Make sure you are registered to vote here and check your area to review new recommendations amidst the pandemic.
- American College of Obstetricians and Gynecologists. Practice bulletin number 143: medical management of first trimester abortion. Obstet Gynecol. 2014;123:676-692.
- Schreiber CA, Crenin MD, Atrio J, et al. Mifepristone pretreatment for the medical management of early pregnancy loss. N Engl J Med. 2018;378:2161-2170.
- Danco Laboratories. Mifeprex effectiveness and advantages. https://www.earlyoptionpill.com/is-mifeprex-right-for-me/effectiveness-advantages/ Accessed August 2, 2020.
- Jones RK, Witwer E, Jerman J. Abortion incidence and service availability in the United States, 2017. September 2019. https://www.guttmacher.org/report/abortion-incidence-service-availability-us-2017. Accessed September 10, 2020.
- American College of Obstetricians and Gynecologists. Practice bulletin no. 150: early pregnancy loss. Obstet Gynecol. 2015;125:1258-1267.
- US Food and Drug Administration. Risk evaluation and mitigation strategy (REMS) single shared system for mifepristone 200 mg. April 2019. https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2019_04_11_REMS_Full.pdf. Accessed September 10, 2020.
- US Food and Drug Administration; Center for Drug Evaluation and Research. 2016 REMS Review, Summary Review 25. March 29, 2016. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020687Orig1s020SumR.pdf. Accessed September 10, 2020.
- American College of Obstetricians and Gynecologists. Improving access to mifepristone for reproductive health indications. June 2018. https://www.acog.org/clinical-information/policy-and-position-statements/position-statements/2018/improving-access-to-mifepristone-for-reproductive-health-indications. Accessed August 2, 2020.
- US Food and Drug Administration. Policy for certain REMS requirements during the COVID-19 public health emergency: guidance for industry and health care professionals. March 2020. https://www.fda.gov/media/136317/download. Accessed September 10, 2020.
- US Department of Justice. US Drug Enforcement Administration. COVID-19 Information Page, Telemedicine. https://www.deadiversion.usdoj.gov/coronavirus.html#TELE. Accessed May 25, 2020.
- Centers for Disease Control and Prevention. Coronavirus disease 2019: health equity considerations and racial and ethnic minority groups. https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/race-ethnicity.html. Updated July 24, 2020. Accessed September 10, 2020.
- American College of Obstetricians and Gynecologists. Practice bulletin number 143: medical management of first trimester abortion. Obstet Gynecol. 2014;123:676-692.
- Schreiber CA, Crenin MD, Atrio J, et al. Mifepristone pretreatment for the medical management of early pregnancy loss. N Engl J Med. 2018;378:2161-2170.
- Danco Laboratories. Mifeprex effectiveness and advantages. https://www.earlyoptionpill.com/is-mifeprex-right-for-me/effectiveness-advantages/ Accessed August 2, 2020.
- Jones RK, Witwer E, Jerman J. Abortion incidence and service availability in the United States, 2017. September 2019. https://www.guttmacher.org/report/abortion-incidence-service-availability-us-2017. Accessed September 10, 2020.
- American College of Obstetricians and Gynecologists. Practice bulletin no. 150: early pregnancy loss. Obstet Gynecol. 2015;125:1258-1267.
- US Food and Drug Administration. Risk evaluation and mitigation strategy (REMS) single shared system for mifepristone 200 mg. April 2019. https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2019_04_11_REMS_Full.pdf. Accessed September 10, 2020.
- US Food and Drug Administration; Center for Drug Evaluation and Research. 2016 REMS Review, Summary Review 25. March 29, 2016. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020687Orig1s020SumR.pdf. Accessed September 10, 2020.
- American College of Obstetricians and Gynecologists. Improving access to mifepristone for reproductive health indications. June 2018. https://www.acog.org/clinical-information/policy-and-position-statements/position-statements/2018/improving-access-to-mifepristone-for-reproductive-health-indications. Accessed August 2, 2020.
- US Food and Drug Administration. Policy for certain REMS requirements during the COVID-19 public health emergency: guidance for industry and health care professionals. March 2020. https://www.fda.gov/media/136317/download. Accessed September 10, 2020.
- US Department of Justice. US Drug Enforcement Administration. COVID-19 Information Page, Telemedicine. https://www.deadiversion.usdoj.gov/coronavirus.html#TELE. Accessed May 25, 2020.
- Centers for Disease Control and Prevention. Coronavirus disease 2019: health equity considerations and racial and ethnic minority groups. https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/race-ethnicity.html. Updated July 24, 2020. Accessed September 10, 2020.


