SAN FRANCISCO—New research indicates that extending anticoagulant therapy to 2 years can reduce the risk of recurrent venous thromboembolism (VTE) without increasing major bleeding, but this benefit only lasts while patients are receiving the therapy.

In the PADIS-PE study, patients with a first episode of symptomatic, unprovoked pulmonary embolism (PE) received 6 months of treatment with a vitamin K antagonist (VKA), followed by 18 months of warfarin or placebo.

Patients who received warfarin had a 77% reduction in the relative risk of recurrent VTE or major bleeding while they received treatment. But an additional 2 years of follow-up showed that this benefit was lost once patients stopped anticoagulation.

Francis Couturaud, MD, PhD, of the Brest University Hospital Center in Brest, France, presented these data at the 2014 ASH Annual Meeting as LBA-3.*

He and his colleagues randomized patients to receive warfarin (n=184) or placebo (n=187) for 18 months after their intial VKA treatment. Patients were followed for an additional 24 months after treatment ended.

Most baseline characteristics were similar between the treatment arms, although there was a significantly higher percentage of females in the warfarin arm.

“[Overall,] the mean age was below 60, [and] the mean BMI [body mass index] was below 30,” Dr Couturaud noted. “About 4% of patients had previous cancer [that had been] resolved for more than 2 years, 8% had previous distal DVT [deep vein thrombosis] or superficial venous thrombosis, a quarter of women were on estrogen-containing pills, and about one-third had an associated proximal DVT at the time of PE diagnosis.”

“Before the randomization, the mean duration of VKA [therapy] was 6 months, and the mean percentage of time within the therapeutic range was 70. At inclusion, about one-third of patients had residual perfusion defect, about 15% had residual DVT, the mean D-dimer level was below 500 μg/L, and about 27% had thrombophilia.”

Results

The study’s primary outcome was the composite of recurrent VTE or major bleeding during the 18-month treatment period. Significantly fewer patients met this endpoint in the warfarin arm than in the placebo arm—6 (3.3%) and 25 (13.5%), respectively (hazard ratio [HR]=0.23, P=0.0004).

Likewise, the number of patients with recurrent VTE at 18 months was significantly lower in the warfarin arm than in the placebo arm—3 (1.7%) and 25 (13.5%), respectively (HR=0.11, P<0.0001).

On the other hand, there was no significant difference in the rate of major bleeding between the treatment arms at 18 months. Four patients (2.2%) had major bleeding in the warfarin arm, as did 1 (0.5%) in the placebo arm (HR=4.07, P=0.18).

At 42 months, there was no significant difference between the treatment arms with regard to the composite outcome, the rate of recurrent VTE, or the rate of major bleeding.

The composite outcome occurred in 33 (20.8%) patients in the warfarin arm and 42 (24%) in the placebo arm (HR=0.74, P=0.19). Recurrent VTE occurred in 28 (17.9%) and 39 patients (22.1%), respectively (HR=0.67, P=0.10). And major bleeding occurred in 6 (3.5%) and 5 patients (3%), respectively (HR=1.12, P=0.71).

“[E]xtending anticoagulation for 18 additional months was associated with a major relative risk reduction of 77% of recurrent VTE or major bleeding during the treatment period,” Dr Couturaud said in summary. “However, this benefit was lost during a long-term follow-up of 2 years after stopping anticoagulation.”

“In addition, recurrent VTE occurred in 80% of cases as recurrent PE and in 90% of cases as unprovoked VTE. So additional investigations are needed to identify subgroups of patients at lower risk who may not need indefinite anticoagulation.”

This study was sponsored by Brest University Hospital. Investigators received research funding from Actelion Pharmaceuticals, GlaxoSmithKline, Bristol-Myers Squibb, Boehringer Ingelheim, Sanofi, LEO Pharma, and Bayer.

*Information in the abstract differs from that presented at the meeting.

SAN FRANCISCO—New research indicates that extending anticoagulant therapy to 2 years can reduce the risk of recurrent venous thromboembolism (VTE) without increasing major bleeding, but this benefit only lasts while patients are receiving the therapy.

In the PADIS-PE study, patients with a first episode of symptomatic, unprovoked pulmonary embolism (PE) received 6 months of treatment with a vitamin K antagonist (VKA), followed by 18 months of warfarin or placebo.

Patients who received warfarin had a 77% reduction in the relative risk of recurrent VTE or major bleeding while they received treatment. But an additional 2 years of follow-up showed that this benefit was lost once patients stopped anticoagulation.

Francis Couturaud, MD, PhD, of the Brest University Hospital Center in Brest, France, presented these data at the 2014 ASH Annual Meeting as LBA-3.*

He and his colleagues randomized patients to receive warfarin (n=184) or placebo (n=187) for 18 months after their intial VKA treatment. Patients were followed for an additional 24 months after treatment ended.

Most baseline characteristics were similar between the treatment arms, although there was a significantly higher percentage of females in the warfarin arm.

“[Overall,] the mean age was below 60, [and] the mean BMI [body mass index] was below 30,” Dr Couturaud noted. “About 4% of patients had previous cancer [that had been] resolved for more than 2 years, 8% had previous distal DVT [deep vein thrombosis] or superficial venous thrombosis, a quarter of women were on estrogen-containing pills, and about one-third had an associated proximal DVT at the time of PE diagnosis.”

“Before the randomization, the mean duration of VKA [therapy] was 6 months, and the mean percentage of time within the therapeutic range was 70. At inclusion, about one-third of patients had residual perfusion defect, about 15% had residual DVT, the mean D-dimer level was below 500 μg/L, and about 27% had thrombophilia.”

Results

The study’s primary outcome was the composite of recurrent VTE or major bleeding during the 18-month treatment period. Significantly fewer patients met this endpoint in the warfarin arm than in the placebo arm—6 (3.3%) and 25 (13.5%), respectively (hazard ratio [HR]=0.23, P=0.0004).

Likewise, the number of patients with recurrent VTE at 18 months was significantly lower in the warfarin arm than in the placebo arm—3 (1.7%) and 25 (13.5%), respectively (HR=0.11, P<0.0001).

On the other hand, there was no significant difference in the rate of major bleeding between the treatment arms at 18 months. Four patients (2.2%) had major bleeding in the warfarin arm, as did 1 (0.5%) in the placebo arm (HR=4.07, P=0.18).

At 42 months, there was no significant difference between the treatment arms with regard to the composite outcome, the rate of recurrent VTE, or the rate of major bleeding.

The composite outcome occurred in 33 (20.8%) patients in the warfarin arm and 42 (24%) in the placebo arm (HR=0.74, P=0.19). Recurrent VTE occurred in 28 (17.9%) and 39 patients (22.1%), respectively (HR=0.67, P=0.10). And major bleeding occurred in 6 (3.5%) and 5 patients (3%), respectively (HR=1.12, P=0.71).

“[E]xtending anticoagulation for 18 additional months was associated with a major relative risk reduction of 77% of recurrent VTE or major bleeding during the treatment period,” Dr Couturaud said in summary. “However, this benefit was lost during a long-term follow-up of 2 years after stopping anticoagulation.”

“In addition, recurrent VTE occurred in 80% of cases as recurrent PE and in 90% of cases as unprovoked VTE. So additional investigations are needed to identify subgroups of patients at lower risk who may not need indefinite anticoagulation.”

This study was sponsored by Brest University Hospital. Investigators received research funding from Actelion Pharmaceuticals, GlaxoSmithKline, Bristol-Myers Squibb, Boehringer Ingelheim, Sanofi, LEO Pharma, and Bayer.

*Information in the abstract differs from that presented at the meeting.

SAN FRANCISCO—New research indicates that extending anticoagulant therapy to 2 years can reduce the risk of recurrent venous thromboembolism (VTE) without increasing major bleeding, but this benefit only lasts while patients are receiving the therapy.

In the PADIS-PE study, patients with a first episode of symptomatic, unprovoked pulmonary embolism (PE) received 6 months of treatment with a vitamin K antagonist (VKA), followed by 18 months of warfarin or placebo.

Patients who received warfarin had a 77% reduction in the relative risk of recurrent VTE or major bleeding while they received treatment. But an additional 2 years of follow-up showed that this benefit was lost once patients stopped anticoagulation.

Francis Couturaud, MD, PhD, of the Brest University Hospital Center in Brest, France, presented these data at the 2014 ASH Annual Meeting as LBA-3.*

He and his colleagues randomized patients to receive warfarin (n=184) or placebo (n=187) for 18 months after their intial VKA treatment. Patients were followed for an additional 24 months after treatment ended.

Most baseline characteristics were similar between the treatment arms, although there was a significantly higher percentage of females in the warfarin arm.

“[Overall,] the mean age was below 60, [and] the mean BMI [body mass index] was below 30,” Dr Couturaud noted. “About 4% of patients had previous cancer [that had been] resolved for more than 2 years, 8% had previous distal DVT [deep vein thrombosis] or superficial venous thrombosis, a quarter of women were on estrogen-containing pills, and about one-third had an associated proximal DVT at the time of PE diagnosis.”

“Before the randomization, the mean duration of VKA [therapy] was 6 months, and the mean percentage of time within the therapeutic range was 70. At inclusion, about one-third of patients had residual perfusion defect, about 15% had residual DVT, the mean D-dimer level was below 500 μg/L, and about 27% had thrombophilia.”

Results

The study’s primary outcome was the composite of recurrent VTE or major bleeding during the 18-month treatment period. Significantly fewer patients met this endpoint in the warfarin arm than in the placebo arm—6 (3.3%) and 25 (13.5%), respectively (hazard ratio [HR]=0.23, P=0.0004).

Likewise, the number of patients with recurrent VTE at 18 months was significantly lower in the warfarin arm than in the placebo arm—3 (1.7%) and 25 (13.5%), respectively (HR=0.11, P<0.0001).

On the other hand, there was no significant difference in the rate of major bleeding between the treatment arms at 18 months. Four patients (2.2%) had major bleeding in the warfarin arm, as did 1 (0.5%) in the placebo arm (HR=4.07, P=0.18).

At 42 months, there was no significant difference between the treatment arms with regard to the composite outcome, the rate of recurrent VTE, or the rate of major bleeding.

The composite outcome occurred in 33 (20.8%) patients in the warfarin arm and 42 (24%) in the placebo arm (HR=0.74, P=0.19). Recurrent VTE occurred in 28 (17.9%) and 39 patients (22.1%), respectively (HR=0.67, P=0.10). And major bleeding occurred in 6 (3.5%) and 5 patients (3%), respectively (HR=1.12, P=0.71).

“[E]xtending anticoagulation for 18 additional months was associated with a major relative risk reduction of 77% of recurrent VTE or major bleeding during the treatment period,” Dr Couturaud said in summary. “However, this benefit was lost during a long-term follow-up of 2 years after stopping anticoagulation.”

“In addition, recurrent VTE occurred in 80% of cases as recurrent PE and in 90% of cases as unprovoked VTE. So additional investigations are needed to identify subgroups of patients at lower risk who may not need indefinite anticoagulation.”

This study was sponsored by Brest University Hospital. Investigators received research funding from Actelion Pharmaceuticals, GlaxoSmithKline, Bristol-Myers Squibb, Boehringer Ingelheim, Sanofi, LEO Pharma, and Bayer.

*Information in the abstract differs from that presented at the meeting.

Credit: FDA

The US Food and Drug Administration (FDA) is alerting healthcare professionals not to use Wallcur, LLC, simulated intravenous (IV) products in human or animal patients, as the products are for training purposes only.

The FDA has become aware that some Wallcur training IV products have been distributed to healthcare facilities and administered to patients.

There have been reports of serious adverse events associated with some of these products, such as Practi IV Solution Bags.

Before administering IV solutions to patients, healthcare providers should carefully check the labels to ensure that products are not training products.

Wallcur’s training products, which may bear the words “for clinical simulation,” are not to be administered to patients.

If you suspect that any Wallcur training IV products may have been administered to a patient, whether or not the incident has resulted in an adverse event, please report the incident to the FDA’s MedWatch Adverse Event Reporting Program.

The FDA said it will continue to investigate and monitor this issue. The agency is also working with the Centers for Disease Control and Prevention to inform healthcare professionals and state health departments.

Credit: FDA

The US Food and Drug Administration (FDA) is alerting healthcare professionals not to use Wallcur, LLC, simulated intravenous (IV) products in human or animal patients, as the products are for training purposes only.

The FDA has become aware that some Wallcur training IV products have been distributed to healthcare facilities and administered to patients.

There have been reports of serious adverse events associated with some of these products, such as Practi IV Solution Bags.

Before administering IV solutions to patients, healthcare providers should carefully check the labels to ensure that products are not training products.

Wallcur’s training products, which may bear the words “for clinical simulation,” are not to be administered to patients.

If you suspect that any Wallcur training IV products may have been administered to a patient, whether or not the incident has resulted in an adverse event, please report the incident to the FDA’s MedWatch Adverse Event Reporting Program.

The FDA said it will continue to investigate and monitor this issue. The agency is also working with the Centers for Disease Control and Prevention to inform healthcare professionals and state health departments.

Credit: FDA

The US Food and Drug Administration (FDA) is alerting healthcare professionals not to use Wallcur, LLC, simulated intravenous (IV) products in human or animal patients, as the products are for training purposes only.

The FDA has become aware that some Wallcur training IV products have been distributed to healthcare facilities and administered to patients.

There have been reports of serious adverse events associated with some of these products, such as Practi IV Solution Bags.

Before administering IV solutions to patients, healthcare providers should carefully check the labels to ensure that products are not training products.

Wallcur’s training products, which may bear the words “for clinical simulation,” are not to be administered to patients.

If you suspect that any Wallcur training IV products may have been administered to a patient, whether or not the incident has resulted in an adverse event, please report the incident to the FDA’s MedWatch Adverse Event Reporting Program.

The FDA said it will continue to investigate and monitor this issue. The agency is also working with the Centers for Disease Control and Prevention to inform healthcare professionals and state health departments.

Besides caring for these patients, many of us also have a parent, spouse, or a close relative with dementia. My 90-year-old mother has multi-infarct dementia from her diabetes and vascular disease, but is still able to live in an apartment with my 91-year-old father, with assistance from wonderful home aides. Despite her profound dementia, she can still play the piano and read music.

Menchola and Weiss are to be congratulated for their excellent, evidence-based review of the diagnosis, treatment, and prevention of Alzheimer’s disease (AD). (See "Addressing Alzheimer’s: A pragmatic approach.") They do not get caught up in unjustified enthusiasm for screening and drug treatment. Some of their important recommendations bear repeating here:

A look at the evidence on Alzheimer's disease should prompt us to use drugs sparingly and avoid treatments that do more harm than good. Do not routinely screen for AD. This may seem like heresy in these days of early detection and prevention. But for screening to be useful, there must be effective early interventions, and so far, early treatments for AD have been disappointing. Cholinesterase inhibitors and N-methyl-D-aspartate glutamate receptor blockers provide very small improvements in cognitive function and have significant adverse effects. Some behavioral interventions to delay onset of cognitive decline show promise—but are unproven.

Although routine screening is not recommended, “case finding” remains important. We need to be alert to signs and symptoms that suggest early dementia in our patients, and we need to evaluate these patients carefully or refer them for neurologic testing if the diagnosis is in doubt.

Use drugs sparingly, especially when treating behavioral problems. They have serious adverse effects, and behavioral interventions should always be used first. Encourage caregivers to seek out social support. My father attends an Alzheimer’s support group each month, and this has lifted some of the burden.

Address prognosis and end-of-life care, and avoid unnecessary and aggressive treatments that are likely to cause more harm than benefit. Hospice care is suitable and beneficial for those with late-stage Alzheimer’s, but feeding tubes are not.

With many new advances in research techniques, it is likely that investigators will develop better methods of diagnosis and treatment of AD. In the meantime, there is already much we can do to alleviate the suffering of these patients and support their caregivers. This knowledge will likely serve us at home, as well.

Besides caring for these patients, many of us also have a parent, spouse, or a close relative with dementia. My 90-year-old mother has multi-infarct dementia from her diabetes and vascular disease, but is still able to live in an apartment with my 91-year-old father, with assistance from wonderful home aides. Despite her profound dementia, she can still play the piano and read music.

Menchola and Weiss are to be congratulated for their excellent, evidence-based review of the diagnosis, treatment, and prevention of Alzheimer’s disease (AD). (See "Addressing Alzheimer’s: A pragmatic approach.") They do not get caught up in unjustified enthusiasm for screening and drug treatment. Some of their important recommendations bear repeating here:

A look at the evidence on Alzheimer's disease should prompt us to use drugs sparingly and avoid treatments that do more harm than good. Do not routinely screen for AD. This may seem like heresy in these days of early detection and prevention. But for screening to be useful, there must be effective early interventions, and so far, early treatments for AD have been disappointing. Cholinesterase inhibitors and N-methyl-D-aspartate glutamate receptor blockers provide very small improvements in cognitive function and have significant adverse effects. Some behavioral interventions to delay onset of cognitive decline show promise—but are unproven.

Although routine screening is not recommended, “case finding” remains important. We need to be alert to signs and symptoms that suggest early dementia in our patients, and we need to evaluate these patients carefully or refer them for neurologic testing if the diagnosis is in doubt.

Use drugs sparingly, especially when treating behavioral problems. They have serious adverse effects, and behavioral interventions should always be used first. Encourage caregivers to seek out social support. My father attends an Alzheimer’s support group each month, and this has lifted some of the burden.

Address prognosis and end-of-life care, and avoid unnecessary and aggressive treatments that are likely to cause more harm than benefit. Hospice care is suitable and beneficial for those with late-stage Alzheimer’s, but feeding tubes are not.

With many new advances in research techniques, it is likely that investigators will develop better methods of diagnosis and treatment of AD. In the meantime, there is already much we can do to alleviate the suffering of these patients and support their caregivers. This knowledge will likely serve us at home, as well.

Besides caring for these patients, many of us also have a parent, spouse, or a close relative with dementia. My 90-year-old mother has multi-infarct dementia from her diabetes and vascular disease, but is still able to live in an apartment with my 91-year-old father, with assistance from wonderful home aides. Despite her profound dementia, she can still play the piano and read music.

Menchola and Weiss are to be congratulated for their excellent, evidence-based review of the diagnosis, treatment, and prevention of Alzheimer’s disease (AD). (See "Addressing Alzheimer’s: A pragmatic approach.") They do not get caught up in unjustified enthusiasm for screening and drug treatment. Some of their important recommendations bear repeating here:

A look at the evidence on Alzheimer's disease should prompt us to use drugs sparingly and avoid treatments that do more harm than good. Do not routinely screen for AD. This may seem like heresy in these days of early detection and prevention. But for screening to be useful, there must be effective early interventions, and so far, early treatments for AD have been disappointing. Cholinesterase inhibitors and N-methyl-D-aspartate glutamate receptor blockers provide very small improvements in cognitive function and have significant adverse effects. Some behavioral interventions to delay onset of cognitive decline show promise—but are unproven.

Although routine screening is not recommended, “case finding” remains important. We need to be alert to signs and symptoms that suggest early dementia in our patients, and we need to evaluate these patients carefully or refer them for neurologic testing if the diagnosis is in doubt.

Use drugs sparingly, especially when treating behavioral problems. They have serious adverse effects, and behavioral interventions should always be used first. Encourage caregivers to seek out social support. My father attends an Alzheimer’s support group each month, and this has lifted some of the burden.

Address prognosis and end-of-life care, and avoid unnecessary and aggressive treatments that are likely to cause more harm than benefit. Hospice care is suitable and beneficial for those with late-stage Alzheimer’s, but feeding tubes are not.

With many new advances in research techniques, it is likely that investigators will develop better methods of diagnosis and treatment of AD. In the meantime, there is already much we can do to alleviate the suffering of these patients and support their caregivers. This knowledge will likely serve us at home, as well.

At least one, if not many, of the coding changes highlighted below is likely to modify the incomes of ObGyns in the upcoming year. Here, I outline the 2015 changes that are most likely to affect your practice to some degree.

Medicare changes kick off a melancholy 2015
Surgical global periods: A move to eliminate them is underway
I begin this article not with a new or revised code, but with an active proposal, which, if implemented, could adversely affect your surgical income in a few short years.

Starting in 2017, the Centers for Medicare and Medicaid Services (CMS) has indicated that it will change all surgical codes to 0-day global periods. They plan on starting by converting 10-day global codes to 0-day codes in 2017, and then move on to the conversion of 90-day global codes in 2018. This is being proposed because of an Office of Inspector General (OIG) finding that many surgeons are not providing the evaluation and management (E/M) services included in the surgical code; therefore, Medicare is reimbursing for surgical procedures at a higher rate than warranted. In addition, the number of assigned visits may no longer reflect current care protocols, which again may mean that Medicare is not paying appropriately.

The immediate effect of this proposal—which has been adopted in the final rule published in the November 13, 2014, Federal Register—would be a reduction in payment for the converted codes due to a decrease in the assigned relative value units (RVUs). In addition, surgeons would need to document and provide the level of service for all preoperative and postoperative care, which may lead some payers to begin scrutinizing both levels of service billed and frequency of visits before and after surgical procedures.

CMS is still looking for any additional comments from physicians on this conversion process and such comments can be submitted electronically through a link at www.regulations.gov. Reference the final rule as CMS-1612-FC in your reply.

Medicare reimbursements poised to decrease in April
The calendar year 2015 conversion factor will remain at $35.80 from January 1 through March 31, 2015, as mandated by section 101 of the Protecting Access to Medicare Act of 2014. This represents the amount that will be multiplied by the geographically adjusted RVU for a code to determine the final Medicare allowable per procedure or service billed. Effective April 1, 2015, the conversion factor based on the sustainable growth rate (SGR) formula will be only $28.22—representing a 21.2% decrease—unless Congress acts to override this mandate.

Code bundling leads to lost Medicare compensation
Hysterectomy bundling. Effective October 1, 2014, CMS began permanently bundling anterior/posterior colporrhaphy and colpopexy procedures into all vaginal and laparoscopic-assisted hysterectomy codes. By permanently, CMS means that no modifier can be used to report Current Procedural Terminology (CPT) code 57260 (anterior and posterior [A&P] repair) or codes 57280, 57282, 57283 (abdominal, and vaginal approach colpopexy procedures) separately when performed with a vaginal or laparoscopic-­assisted hysterectomy.

The American Congress of Obstetricians and Gynecologists (ACOG) and the American Urogynecologic Society (AUGS) wrote to CMS in May with regard to these edits and objected to them strongly. These organizations will continue to work with CMS to get them removed. Until then, physicians who perform anterior/posterior colporrhaphy and colpopexy procedures with a vaginal or laparoscopic-assisted hysterectomy will need to clearly make a case in the operative report for the need to perform the additional procedures in order to add a modifier -22 (Increased procedural services) to the hysterectomy code for consideration of additional payment. If an A&P repair is performed, it would not be appropriate to bill only an anterior repair (CPT code 57240) or a posterior repair (CPT code 57250) to obtain some separate reimbursement as this would represent inaccurate coding.

Hysteroscopy bundling. Another edit that will affect ObGyns is the bundling of CPT code 58558 (Hysteroscopy, surgical; with sampling [biopsy] of endometrium and/or poly-pectomy, with or without D&C) into codes for hysteroscopic removal of a fibroid (58561) and the removal of an impacted foreign body (58562).

Previously, these codes could have been billed together, but now only the addition of a modifier -22 to the primary procedure (myomectomy or foreign body removal) presents any chance for additional reimbursement. In order to report the modifier, Medicare has indicated that the documentation must clearly support the additional work in accomplishing the primary procedure, including a statement of how much time it added to the normal procedure.

Awareness of new or revised CPT codes could benefit your earnings
The 2015 CPT code set includes several changes, including laboratory and vaccination codes, which may be of interest to your practice. Because of Health Insurance Portability and Accountability Act (HIPAA) requirements, insurers were required to accept new codes on January 1, 2015.

Added: Fetal chromosomal aneuploidy code for genomic sequencing
On January 1, 2014, CPT added a new code to report cell-free DNA to screen for fetal aneuploidy. This new code is 81507 (Fetal aneuploidy [trisomy 21, 18, and 13] DNA sequence analysis of selected regions using maternal plasma, algorithm reported as a risk score for each trisomy), and it was added to report the Harmony™ Prenatal Test.

For 2015, another new code, 81420 (­Fetal chromosomal aneuploidy [eg, trisomy 21, monosomy X] genomic sequence analysis panel, circulating cell-free fetal DNA in maternal blood, must include analysis of chromosomes 13, 18, and 21), was added. This code represents a more comprehensive analysis and would therefore not be reported or ordered with code 81507. This new code requires a genomic sequence analysis panel.

HPV revisions extend beyond new codes
The codes for HPV testing have been redefined. These codes have been deleted: 87620-87622 (Infectious agent detection by nucleic acid [DNA or RNA]; papillomavirus, human, direct probe technique/amplified probe technique/quantification). In their place are three new codes to choose from:

This coding change may be significant for payment as some payers will cover testing for high-risk HPV types only, so be sure your practice management team is aware of the latest rules for ordering HPV testing for your patients. Otherwise, patients could be faced with unexpected out-of-pocket expenses.

Egg freezing recognized as mainstream

Vaccination codes for 2015
Almost every year new codes are added, and 2015 is no different. This year, you will see codes for:

There is also a revision to the flu virus vaccine code 90654 to indicate that it represents a trivalent preservative-free vaccine. See the TABLE below for a complete list of all the vaccines by trade name and CPT/Medicare Healthcare Common Procedure Coding System (HCPCS) codes for the 2014−2015 flu season.

Keep in mind that reporting administration of the flu vaccine is different for Medicare than for private payers. Administration code G0008 and diagnosis code V04.81 (Need for prophylactic vaccination and inoculation against influenza) would be reported in conjunction with the appropriate vaccine code for Medicare, while CPT instructs you to report 90471 instead for the administration. When we switch to ICD-10 diagnostic coding on October 1, 2015, the code V04.81 becomes Z23 (Encounter for immunization).

Three new codes for anoscopy
The first two codes were formerly Category III codes representing new technology, but now have proven to be more mainstream.

Replacement codes for vertebral fracture assessments
If your practice is performing or ordering vertebral assessments for patients, there are two new codes to report. The old code, 77082 (­Dual-energy X-ray absorptiometry [DXA], bone density study, 1 or more sites; vertebral fracture assessment) for vertebral fracture assessment has been deleted and replaced with:

Coding for breast ultrasound and tomosynthesis get more descriptive—at least for private insurance
The CPT Editorial Panel created three codes to describe digital breast tomosynthesis services and two new codes for a breast ultrasound.

Medicare, on the other hand, has decided to create a G code for tomosynthesis, which is the only code that will be accepted for payment if the patient meets her high-risk criteria for performance of this test.

Under Medicare rules you would report/order the following codes for mammographic services:

Modifier 59 becomes more specific
Another Medicare coding change that may affect ObGyns is the addition of new Medicare modifiers that are intended to eventually replace the modifier -59. This new list of modifiers will need to be appended to bundled procedures to more clearly explain why the secondary procedures should be paid separately. At the most recent American Medical Association (AMA) CPT symposium in Chicago, Illinois, CMS medical directors indicated that the new modifiers should be used only when the clinician is given instructions to do so by the carrier. Until then, the modifier -59 should continue to be used by most clinicians.

Here are the new modifiers, with an example of their use with currently bundled procedures that allow a modifier -59 to be used under certain circumstances:

For example, Dr. Bates is performing a laparoscopic paravaginal defect repair (57423) and calls Dr. Clark, a urogynecologist in his practice, to remove severe adhesions from the ureters. The claim should go in under the same tax ID number, with the code 50715 listed first (as it has greater RVUs) and code 57423 reported with the -XP modifier.

In this case, code 59400-52 (reduced services since the patient delivered at 20 weeks and there were reduced antepartum services), and 57720-XU because the repair of the cervix is not part of the usual services for a vaginal delivery.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

At least one, if not many, of the coding changes highlighted below is likely to modify the incomes of ObGyns in the upcoming year. Here, I outline the 2015 changes that are most likely to affect your practice to some degree.

Medicare changes kick off a melancholy 2015
Surgical global periods: A move to eliminate them is underway
I begin this article not with a new or revised code, but with an active proposal, which, if implemented, could adversely affect your surgical income in a few short years.

Starting in 2017, the Centers for Medicare and Medicaid Services (CMS) has indicated that it will change all surgical codes to 0-day global periods. They plan on starting by converting 10-day global codes to 0-day codes in 2017, and then move on to the conversion of 90-day global codes in 2018. This is being proposed because of an Office of Inspector General (OIG) finding that many surgeons are not providing the evaluation and management (E/M) services included in the surgical code; therefore, Medicare is reimbursing for surgical procedures at a higher rate than warranted. In addition, the number of assigned visits may no longer reflect current care protocols, which again may mean that Medicare is not paying appropriately.

The immediate effect of this proposal—which has been adopted in the final rule published in the November 13, 2014, Federal Register—would be a reduction in payment for the converted codes due to a decrease in the assigned relative value units (RVUs). In addition, surgeons would need to document and provide the level of service for all preoperative and postoperative care, which may lead some payers to begin scrutinizing both levels of service billed and frequency of visits before and after surgical procedures.

CMS is still looking for any additional comments from physicians on this conversion process and such comments can be submitted electronically through a link at www.regulations.gov. Reference the final rule as CMS-1612-FC in your reply.

Medicare reimbursements poised to decrease in April
The calendar year 2015 conversion factor will remain at $35.80 from January 1 through March 31, 2015, as mandated by section 101 of the Protecting Access to Medicare Act of 2014. This represents the amount that will be multiplied by the geographically adjusted RVU for a code to determine the final Medicare allowable per procedure or service billed. Effective April 1, 2015, the conversion factor based on the sustainable growth rate (SGR) formula will be only $28.22—representing a 21.2% decrease—unless Congress acts to override this mandate.

Code bundling leads to lost Medicare compensation
Hysterectomy bundling. Effective October 1, 2014, CMS began permanently bundling anterior/posterior colporrhaphy and colpopexy procedures into all vaginal and laparoscopic-assisted hysterectomy codes. By permanently, CMS means that no modifier can be used to report Current Procedural Terminology (CPT) code 57260 (anterior and posterior [A&P] repair) or codes 57280, 57282, 57283 (abdominal, and vaginal approach colpopexy procedures) separately when performed with a vaginal or laparoscopic-­assisted hysterectomy.

The American Congress of Obstetricians and Gynecologists (ACOG) and the American Urogynecologic Society (AUGS) wrote to CMS in May with regard to these edits and objected to them strongly. These organizations will continue to work with CMS to get them removed. Until then, physicians who perform anterior/posterior colporrhaphy and colpopexy procedures with a vaginal or laparoscopic-assisted hysterectomy will need to clearly make a case in the operative report for the need to perform the additional procedures in order to add a modifier -22 (Increased procedural services) to the hysterectomy code for consideration of additional payment. If an A&P repair is performed, it would not be appropriate to bill only an anterior repair (CPT code 57240) or a posterior repair (CPT code 57250) to obtain some separate reimbursement as this would represent inaccurate coding.

Hysteroscopy bundling. Another edit that will affect ObGyns is the bundling of CPT code 58558 (Hysteroscopy, surgical; with sampling [biopsy] of endometrium and/or poly-pectomy, with or without D&C) into codes for hysteroscopic removal of a fibroid (58561) and the removal of an impacted foreign body (58562).

Previously, these codes could have been billed together, but now only the addition of a modifier -22 to the primary procedure (myomectomy or foreign body removal) presents any chance for additional reimbursement. In order to report the modifier, Medicare has indicated that the documentation must clearly support the additional work in accomplishing the primary procedure, including a statement of how much time it added to the normal procedure.

Awareness of new or revised CPT codes could benefit your earnings
The 2015 CPT code set includes several changes, including laboratory and vaccination codes, which may be of interest to your practice. Because of Health Insurance Portability and Accountability Act (HIPAA) requirements, insurers were required to accept new codes on January 1, 2015.

Added: Fetal chromosomal aneuploidy code for genomic sequencing
On January 1, 2014, CPT added a new code to report cell-free DNA to screen for fetal aneuploidy. This new code is 81507 (Fetal aneuploidy [trisomy 21, 18, and 13] DNA sequence analysis of selected regions using maternal plasma, algorithm reported as a risk score for each trisomy), and it was added to report the Harmony™ Prenatal Test.

For 2015, another new code, 81420 (­Fetal chromosomal aneuploidy [eg, trisomy 21, monosomy X] genomic sequence analysis panel, circulating cell-free fetal DNA in maternal blood, must include analysis of chromosomes 13, 18, and 21), was added. This code represents a more comprehensive analysis and would therefore not be reported or ordered with code 81507. This new code requires a genomic sequence analysis panel.

HPV revisions extend beyond new codes
The codes for HPV testing have been redefined. These codes have been deleted: 87620-87622 (Infectious agent detection by nucleic acid [DNA or RNA]; papillomavirus, human, direct probe technique/amplified probe technique/quantification). In their place are three new codes to choose from:

This coding change may be significant for payment as some payers will cover testing for high-risk HPV types only, so be sure your practice management team is aware of the latest rules for ordering HPV testing for your patients. Otherwise, patients could be faced with unexpected out-of-pocket expenses.

Egg freezing recognized as mainstream

Vaccination codes for 2015
Almost every year new codes are added, and 2015 is no different. This year, you will see codes for:

There is also a revision to the flu virus vaccine code 90654 to indicate that it represents a trivalent preservative-free vaccine. See the TABLE below for a complete list of all the vaccines by trade name and CPT/Medicare Healthcare Common Procedure Coding System (HCPCS) codes for the 2014−2015 flu season.

Keep in mind that reporting administration of the flu vaccine is different for Medicare than for private payers. Administration code G0008 and diagnosis code V04.81 (Need for prophylactic vaccination and inoculation against influenza) would be reported in conjunction with the appropriate vaccine code for Medicare, while CPT instructs you to report 90471 instead for the administration. When we switch to ICD-10 diagnostic coding on October 1, 2015, the code V04.81 becomes Z23 (Encounter for immunization).

Three new codes for anoscopy
The first two codes were formerly Category III codes representing new technology, but now have proven to be more mainstream.

Replacement codes for vertebral fracture assessments
If your practice is performing or ordering vertebral assessments for patients, there are two new codes to report. The old code, 77082 (­Dual-energy X-ray absorptiometry [DXA], bone density study, 1 or more sites; vertebral fracture assessment) for vertebral fracture assessment has been deleted and replaced with:

Coding for breast ultrasound and tomosynthesis get more descriptive—at least for private insurance
The CPT Editorial Panel created three codes to describe digital breast tomosynthesis services and two new codes for a breast ultrasound.

Medicare, on the other hand, has decided to create a G code for tomosynthesis, which is the only code that will be accepted for payment if the patient meets her high-risk criteria for performance of this test.

Under Medicare rules you would report/order the following codes for mammographic services:

Modifier 59 becomes more specific
Another Medicare coding change that may affect ObGyns is the addition of new Medicare modifiers that are intended to eventually replace the modifier -59. This new list of modifiers will need to be appended to bundled procedures to more clearly explain why the secondary procedures should be paid separately. At the most recent American Medical Association (AMA) CPT symposium in Chicago, Illinois, CMS medical directors indicated that the new modifiers should be used only when the clinician is given instructions to do so by the carrier. Until then, the modifier -59 should continue to be used by most clinicians.

Here are the new modifiers, with an example of their use with currently bundled procedures that allow a modifier -59 to be used under certain circumstances:

For example, Dr. Bates is performing a laparoscopic paravaginal defect repair (57423) and calls Dr. Clark, a urogynecologist in his practice, to remove severe adhesions from the ureters. The claim should go in under the same tax ID number, with the code 50715 listed first (as it has greater RVUs) and code 57423 reported with the -XP modifier.

In this case, code 59400-52 (reduced services since the patient delivered at 20 weeks and there were reduced antepartum services), and 57720-XU because the repair of the cervix is not part of the usual services for a vaginal delivery.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

At least one, if not many, of the coding changes highlighted below is likely to modify the incomes of ObGyns in the upcoming year. Here, I outline the 2015 changes that are most likely to affect your practice to some degree.

Medicare changes kick off a melancholy 2015
Surgical global periods: A move to eliminate them is underway
I begin this article not with a new or revised code, but with an active proposal, which, if implemented, could adversely affect your surgical income in a few short years.

Starting in 2017, the Centers for Medicare and Medicaid Services (CMS) has indicated that it will change all surgical codes to 0-day global periods. They plan on starting by converting 10-day global codes to 0-day codes in 2017, and then move on to the conversion of 90-day global codes in 2018. This is being proposed because of an Office of Inspector General (OIG) finding that many surgeons are not providing the evaluation and management (E/M) services included in the surgical code; therefore, Medicare is reimbursing for surgical procedures at a higher rate than warranted. In addition, the number of assigned visits may no longer reflect current care protocols, which again may mean that Medicare is not paying appropriately.

The immediate effect of this proposal—which has been adopted in the final rule published in the November 13, 2014, Federal Register—would be a reduction in payment for the converted codes due to a decrease in the assigned relative value units (RVUs). In addition, surgeons would need to document and provide the level of service for all preoperative and postoperative care, which may lead some payers to begin scrutinizing both levels of service billed and frequency of visits before and after surgical procedures.

CMS is still looking for any additional comments from physicians on this conversion process and such comments can be submitted electronically through a link at www.regulations.gov. Reference the final rule as CMS-1612-FC in your reply.

Medicare reimbursements poised to decrease in April
The calendar year 2015 conversion factor will remain at $35.80 from January 1 through March 31, 2015, as mandated by section 101 of the Protecting Access to Medicare Act of 2014. This represents the amount that will be multiplied by the geographically adjusted RVU for a code to determine the final Medicare allowable per procedure or service billed. Effective April 1, 2015, the conversion factor based on the sustainable growth rate (SGR) formula will be only $28.22—representing a 21.2% decrease—unless Congress acts to override this mandate.

Code bundling leads to lost Medicare compensation
Hysterectomy bundling. Effective October 1, 2014, CMS began permanently bundling anterior/posterior colporrhaphy and colpopexy procedures into all vaginal and laparoscopic-assisted hysterectomy codes. By permanently, CMS means that no modifier can be used to report Current Procedural Terminology (CPT) code 57260 (anterior and posterior [A&P] repair) or codes 57280, 57282, 57283 (abdominal, and vaginal approach colpopexy procedures) separately when performed with a vaginal or laparoscopic-­assisted hysterectomy.

The American Congress of Obstetricians and Gynecologists (ACOG) and the American Urogynecologic Society (AUGS) wrote to CMS in May with regard to these edits and objected to them strongly. These organizations will continue to work with CMS to get them removed. Until then, physicians who perform anterior/posterior colporrhaphy and colpopexy procedures with a vaginal or laparoscopic-assisted hysterectomy will need to clearly make a case in the operative report for the need to perform the additional procedures in order to add a modifier -22 (Increased procedural services) to the hysterectomy code for consideration of additional payment. If an A&P repair is performed, it would not be appropriate to bill only an anterior repair (CPT code 57240) or a posterior repair (CPT code 57250) to obtain some separate reimbursement as this would represent inaccurate coding.

Hysteroscopy bundling. Another edit that will affect ObGyns is the bundling of CPT code 58558 (Hysteroscopy, surgical; with sampling [biopsy] of endometrium and/or poly-pectomy, with or without D&C) into codes for hysteroscopic removal of a fibroid (58561) and the removal of an impacted foreign body (58562).

Previously, these codes could have been billed together, but now only the addition of a modifier -22 to the primary procedure (myomectomy or foreign body removal) presents any chance for additional reimbursement. In order to report the modifier, Medicare has indicated that the documentation must clearly support the additional work in accomplishing the primary procedure, including a statement of how much time it added to the normal procedure.

Awareness of new or revised CPT codes could benefit your earnings
The 2015 CPT code set includes several changes, including laboratory and vaccination codes, which may be of interest to your practice. Because of Health Insurance Portability and Accountability Act (HIPAA) requirements, insurers were required to accept new codes on January 1, 2015.

Added: Fetal chromosomal aneuploidy code for genomic sequencing
On January 1, 2014, CPT added a new code to report cell-free DNA to screen for fetal aneuploidy. This new code is 81507 (Fetal aneuploidy [trisomy 21, 18, and 13] DNA sequence analysis of selected regions using maternal plasma, algorithm reported as a risk score for each trisomy), and it was added to report the Harmony™ Prenatal Test.

For 2015, another new code, 81420 (­Fetal chromosomal aneuploidy [eg, trisomy 21, monosomy X] genomic sequence analysis panel, circulating cell-free fetal DNA in maternal blood, must include analysis of chromosomes 13, 18, and 21), was added. This code represents a more comprehensive analysis and would therefore not be reported or ordered with code 81507. This new code requires a genomic sequence analysis panel.

HPV revisions extend beyond new codes
The codes for HPV testing have been redefined. These codes have been deleted: 87620-87622 (Infectious agent detection by nucleic acid [DNA or RNA]; papillomavirus, human, direct probe technique/amplified probe technique/quantification). In their place are three new codes to choose from:

This coding change may be significant for payment as some payers will cover testing for high-risk HPV types only, so be sure your practice management team is aware of the latest rules for ordering HPV testing for your patients. Otherwise, patients could be faced with unexpected out-of-pocket expenses.

Egg freezing recognized as mainstream

Vaccination codes for 2015
Almost every year new codes are added, and 2015 is no different. This year, you will see codes for:

There is also a revision to the flu virus vaccine code 90654 to indicate that it represents a trivalent preservative-free vaccine. See the TABLE below for a complete list of all the vaccines by trade name and CPT/Medicare Healthcare Common Procedure Coding System (HCPCS) codes for the 2014−2015 flu season.

Keep in mind that reporting administration of the flu vaccine is different for Medicare than for private payers. Administration code G0008 and diagnosis code V04.81 (Need for prophylactic vaccination and inoculation against influenza) would be reported in conjunction with the appropriate vaccine code for Medicare, while CPT instructs you to report 90471 instead for the administration. When we switch to ICD-10 diagnostic coding on October 1, 2015, the code V04.81 becomes Z23 (Encounter for immunization).

Three new codes for anoscopy
The first two codes were formerly Category III codes representing new technology, but now have proven to be more mainstream.

Replacement codes for vertebral fracture assessments
If your practice is performing or ordering vertebral assessments for patients, there are two new codes to report. The old code, 77082 (­Dual-energy X-ray absorptiometry [DXA], bone density study, 1 or more sites; vertebral fracture assessment) for vertebral fracture assessment has been deleted and replaced with:

Coding for breast ultrasound and tomosynthesis get more descriptive—at least for private insurance
The CPT Editorial Panel created three codes to describe digital breast tomosynthesis services and two new codes for a breast ultrasound.

Medicare, on the other hand, has decided to create a G code for tomosynthesis, which is the only code that will be accepted for payment if the patient meets her high-risk criteria for performance of this test.

Under Medicare rules you would report/order the following codes for mammographic services:

Modifier 59 becomes more specific
Another Medicare coding change that may affect ObGyns is the addition of new Medicare modifiers that are intended to eventually replace the modifier -59. This new list of modifiers will need to be appended to bundled procedures to more clearly explain why the secondary procedures should be paid separately. At the most recent American Medical Association (AMA) CPT symposium in Chicago, Illinois, CMS medical directors indicated that the new modifiers should be used only when the clinician is given instructions to do so by the carrier. Until then, the modifier -59 should continue to be used by most clinicians.

Here are the new modifiers, with an example of their use with currently bundled procedures that allow a modifier -59 to be used under certain circumstances:

For example, Dr. Bates is performing a laparoscopic paravaginal defect repair (57423) and calls Dr. Clark, a urogynecologist in his practice, to remove severe adhesions from the ureters. The claim should go in under the same tax ID number, with the code 50715 listed first (as it has greater RVUs) and code 57423 reported with the -XP modifier.

In this case, code 59400-52 (reduced services since the patient delivered at 20 weeks and there were reduced antepartum services), and 57720-XU because the repair of the cervix is not part of the usual services for a vaginal delivery.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

PLASMA ELECTROSURGERY DEVICE
Bovie Medical Corporation's new J-Plasma^® hand piece has a retractable cutting feature for use in soft-tissue coagulation and cutting during surgery. The J-Plasma stream is formed by passing inert helium over the retractable blade. The blade can be extended and used with or without energy or plasma, similar to a scalpel, for incisions and other cutting procedures. The hand piece is available in open and a new laparoscopic Pistol Grip configuration, with an accompanying Bovie Ultimate generator.
FOR MORE INFORMATION, VISIT www.boviemedical.com

EMBRYO VIABILITY TEST FOR IVF
The Eeva Test™ from Auxogyn is an automated, noninvasive test that uses time-lapse imaging to determine which embryos will have the highest developmental potential during in vitro fertilization. The Eeva Test uses proprietary software to analyze embryo development against scientific and clinical cell-division timing parameters.
FOR MORE INFORMATION, VISIT www.eevaivf.com

NATURAL REMEDIES FOR POSTPARTUM PAIN
Fairhaven Health says its Sitting Pretty products offer pain relief and help to increase the healing process for perineal tears, vaginal swelling and bruising, and hemorrhoids following delivery. A 2-oz Soothing Spray bottle contains witch hazel, peppermint, lavender, and tea tree oils with grapefruit seed and other herbal extracts. A 4-oz jar of Soothing Balm has shea butter, coconut oil, and other organic ingredients.
FOR MORE INFORMATION, VISIT www.fairhavenhealth.com

TREATMENT FOR LARGE AND SMALL SCARS
ScarAway Daily Discs are small, round discs (1.375” in diameter) used to treat small scars that result from biopsies, mole removal, or acne blemishes. ScarAway Flex Long Sheets are for treating longer scars that may result from cesarean deliveries and other operations, injuries, and burns. The Flex Long Sheets measure 1.5”x7”. ScarAway Scar Gel is a colorless, odorless, self-drying silicon gel that forms a flexible, breathable, waterproof cover over the affected area. Once dry, makeup and sunscreen can be applied.
FOR MORE INFORMATION, VISIT www.MyScarAway.com

PORTABLE COLPOSCOPE
The Gynocular™ is a lightweight, portable colposcope with smart-phone adapter. Gynius says the battery-operated handheld device can be used with a tripod and allows physicians to capture, store, and send high-quality digital images and videos via phone or Skype. Gynius is collaborating with Woman Care Global, a nonprofit health-care company, to market and distri­bute The Gynocular worldwide.
FOR MORE INFORMATION, VISIT www.gynocular.com

SUTURING IN ROBOT-ASSISTED SURGERY
StitchKit^® Robotic-Assisted Surgery Suturing Technology, from Origami Surgical, is a sterile, single-use plastic canister preloaded with six ePTFE sutures (8” each), with a secure, see-through disposal compartment permitting needle counting during surgery. Origami Surgical says that each canister is intended to complete one sacrocolpopexy surgery.
FOR MORE INFORMATION, VISIT www.origamisurgical.com

COLLAGEN DRESSING FOR CHRONIC WOUNDS
Gentell has introduced four new collagen products designed to treat chronic nonhealing wounds. Gentell Collagen, derived from bovine collagen, is available in a powdery particle (1-g bottle), or as dressing sheets in 2”x2”, 4”x5.25”, and 8”x12” sizes. Gentell Collagen products can be used to treat aggressive wounds with minimal to heavy exudate, and partial- or full-thickness, granulating or necrotic, or second-degree burns.
FOR MORE INFORMATION, VISIT www.gentell.com

INTRAOPERATIVE RADIATION THERAPY
The Xoft^® Axxent^® Electronic Brachytherapy System (eBx^®) delivers intraoperative brachytherapy to treat breast cancer. Intraoperative radiation therapy is delivered as a single radiation dose using a balloon and a miniature x-ray source within the surgical cavity at the time of breast-conserving surgery (lumpectomy). Axxent eBx is designed to minimize radiation exposure to surrounding healthy tissue.
FOR MORE INFORMATION, VISIT www.xoftinc.com

KEGEL EXERCISE SYSTEM
Juve is a biofeedback Kegel exercise system that helps women develop pelvic-floor muscle strength. A device inserted into the vagina has sensors that work with a Bluetooth smartphone app to monitor pelvic-floor muscle strength and provide instant feedback to the user. Six training programs are offered.
FOR MORE INFORMATION, VISIT www.thejuve.com

WEARABLE BIOSENSOR FOR CORE METRICS
Vital Connect announced FDA clearance of its HealthPatch™ MD Biosensor. The device can capture clinical-grade biometric measurements of core-health metrics: single-lead ECG; heart rate; heart-rate variability; respiratory rate; skin temperature; posture including fall detection and severity; and steps.
FOR MORE INFORMATION, VISIT www.vitalconnect.com

HORMONE-FREE CONTRACEPTION
FemCap is a reusable, hormone-free, latex-free cervical cap for birth control. Made of surgical-grade silicone in three sizes, it covers the cervix, preventing sperm from moving into the uterus. Used in conjunction with spermicide, it is more than 92% effective in the prevention of pregnancy, says FemCap, Inc.
FOR MORE INFORMATION, VISIT www.femcap.com

PLASMA ELECTROSURGERY DEVICE
Bovie Medical Corporation's new J-Plasma^® hand piece has a retractable cutting feature for use in soft-tissue coagulation and cutting during surgery. The J-Plasma stream is formed by passing inert helium over the retractable blade. The blade can be extended and used with or without energy or plasma, similar to a scalpel, for incisions and other cutting procedures. The hand piece is available in open and a new laparoscopic Pistol Grip configuration, with an accompanying Bovie Ultimate generator.
FOR MORE INFORMATION, VISIT www.boviemedical.com

EMBRYO VIABILITY TEST FOR IVF
The Eeva Test™ from Auxogyn is an automated, noninvasive test that uses time-lapse imaging to determine which embryos will have the highest developmental potential during in vitro fertilization. The Eeva Test uses proprietary software to analyze embryo development against scientific and clinical cell-division timing parameters.
FOR MORE INFORMATION, VISIT www.eevaivf.com

NATURAL REMEDIES FOR POSTPARTUM PAIN
Fairhaven Health says its Sitting Pretty products offer pain relief and help to increase the healing process for perineal tears, vaginal swelling and bruising, and hemorrhoids following delivery. A 2-oz Soothing Spray bottle contains witch hazel, peppermint, lavender, and tea tree oils with grapefruit seed and other herbal extracts. A 4-oz jar of Soothing Balm has shea butter, coconut oil, and other organic ingredients.
FOR MORE INFORMATION, VISIT www.fairhavenhealth.com

TREATMENT FOR LARGE AND SMALL SCARS
ScarAway Daily Discs are small, round discs (1.375” in diameter) used to treat small scars that result from biopsies, mole removal, or acne blemishes. ScarAway Flex Long Sheets are for treating longer scars that may result from cesarean deliveries and other operations, injuries, and burns. The Flex Long Sheets measure 1.5”x7”. ScarAway Scar Gel is a colorless, odorless, self-drying silicon gel that forms a flexible, breathable, waterproof cover over the affected area. Once dry, makeup and sunscreen can be applied.
FOR MORE INFORMATION, VISIT www.MyScarAway.com

PORTABLE COLPOSCOPE
The Gynocular™ is a lightweight, portable colposcope with smart-phone adapter. Gynius says the battery-operated handheld device can be used with a tripod and allows physicians to capture, store, and send high-quality digital images and videos via phone or Skype. Gynius is collaborating with Woman Care Global, a nonprofit health-care company, to market and distri­bute The Gynocular worldwide.
FOR MORE INFORMATION, VISIT www.gynocular.com

SUTURING IN ROBOT-ASSISTED SURGERY
StitchKit^® Robotic-Assisted Surgery Suturing Technology, from Origami Surgical, is a sterile, single-use plastic canister preloaded with six ePTFE sutures (8” each), with a secure, see-through disposal compartment permitting needle counting during surgery. Origami Surgical says that each canister is intended to complete one sacrocolpopexy surgery.
FOR MORE INFORMATION, VISIT www.origamisurgical.com

COLLAGEN DRESSING FOR CHRONIC WOUNDS
Gentell has introduced four new collagen products designed to treat chronic nonhealing wounds. Gentell Collagen, derived from bovine collagen, is available in a powdery particle (1-g bottle), or as dressing sheets in 2”x2”, 4”x5.25”, and 8”x12” sizes. Gentell Collagen products can be used to treat aggressive wounds with minimal to heavy exudate, and partial- or full-thickness, granulating or necrotic, or second-degree burns.
FOR MORE INFORMATION, VISIT www.gentell.com

INTRAOPERATIVE RADIATION THERAPY
The Xoft^® Axxent^® Electronic Brachytherapy System (eBx^®) delivers intraoperative brachytherapy to treat breast cancer. Intraoperative radiation therapy is delivered as a single radiation dose using a balloon and a miniature x-ray source within the surgical cavity at the time of breast-conserving surgery (lumpectomy). Axxent eBx is designed to minimize radiation exposure to surrounding healthy tissue.
FOR MORE INFORMATION, VISIT www.xoftinc.com

KEGEL EXERCISE SYSTEM
Juve is a biofeedback Kegel exercise system that helps women develop pelvic-floor muscle strength. A device inserted into the vagina has sensors that work with a Bluetooth smartphone app to monitor pelvic-floor muscle strength and provide instant feedback to the user. Six training programs are offered.
FOR MORE INFORMATION, VISIT www.thejuve.com

WEARABLE BIOSENSOR FOR CORE METRICS
Vital Connect announced FDA clearance of its HealthPatch™ MD Biosensor. The device can capture clinical-grade biometric measurements of core-health metrics: single-lead ECG; heart rate; heart-rate variability; respiratory rate; skin temperature; posture including fall detection and severity; and steps.
FOR MORE INFORMATION, VISIT www.vitalconnect.com

HORMONE-FREE CONTRACEPTION
FemCap is a reusable, hormone-free, latex-free cervical cap for birth control. Made of surgical-grade silicone in three sizes, it covers the cervix, preventing sperm from moving into the uterus. Used in conjunction with spermicide, it is more than 92% effective in the prevention of pregnancy, says FemCap, Inc.
FOR MORE INFORMATION, VISIT www.femcap.com

PLASMA ELECTROSURGERY DEVICE
Bovie Medical Corporation's new J-Plasma^® hand piece has a retractable cutting feature for use in soft-tissue coagulation and cutting during surgery. The J-Plasma stream is formed by passing inert helium over the retractable blade. The blade can be extended and used with or without energy or plasma, similar to a scalpel, for incisions and other cutting procedures. The hand piece is available in open and a new laparoscopic Pistol Grip configuration, with an accompanying Bovie Ultimate generator.
FOR MORE INFORMATION, VISIT www.boviemedical.com

EMBRYO VIABILITY TEST FOR IVF
The Eeva Test™ from Auxogyn is an automated, noninvasive test that uses time-lapse imaging to determine which embryos will have the highest developmental potential during in vitro fertilization. The Eeva Test uses proprietary software to analyze embryo development against scientific and clinical cell-division timing parameters.
FOR MORE INFORMATION, VISIT www.eevaivf.com

NATURAL REMEDIES FOR POSTPARTUM PAIN
Fairhaven Health says its Sitting Pretty products offer pain relief and help to increase the healing process for perineal tears, vaginal swelling and bruising, and hemorrhoids following delivery. A 2-oz Soothing Spray bottle contains witch hazel, peppermint, lavender, and tea tree oils with grapefruit seed and other herbal extracts. A 4-oz jar of Soothing Balm has shea butter, coconut oil, and other organic ingredients.
FOR MORE INFORMATION, VISIT www.fairhavenhealth.com

TREATMENT FOR LARGE AND SMALL SCARS
ScarAway Daily Discs are small, round discs (1.375” in diameter) used to treat small scars that result from biopsies, mole removal, or acne blemishes. ScarAway Flex Long Sheets are for treating longer scars that may result from cesarean deliveries and other operations, injuries, and burns. The Flex Long Sheets measure 1.5”x7”. ScarAway Scar Gel is a colorless, odorless, self-drying silicon gel that forms a flexible, breathable, waterproof cover over the affected area. Once dry, makeup and sunscreen can be applied.
FOR MORE INFORMATION, VISIT www.MyScarAway.com

PORTABLE COLPOSCOPE
The Gynocular™ is a lightweight, portable colposcope with smart-phone adapter. Gynius says the battery-operated handheld device can be used with a tripod and allows physicians to capture, store, and send high-quality digital images and videos via phone or Skype. Gynius is collaborating with Woman Care Global, a nonprofit health-care company, to market and distri­bute The Gynocular worldwide.
FOR MORE INFORMATION, VISIT www.gynocular.com

SUTURING IN ROBOT-ASSISTED SURGERY
StitchKit^® Robotic-Assisted Surgery Suturing Technology, from Origami Surgical, is a sterile, single-use plastic canister preloaded with six ePTFE sutures (8” each), with a secure, see-through disposal compartment permitting needle counting during surgery. Origami Surgical says that each canister is intended to complete one sacrocolpopexy surgery.
FOR MORE INFORMATION, VISIT www.origamisurgical.com

COLLAGEN DRESSING FOR CHRONIC WOUNDS
Gentell has introduced four new collagen products designed to treat chronic nonhealing wounds. Gentell Collagen, derived from bovine collagen, is available in a powdery particle (1-g bottle), or as dressing sheets in 2”x2”, 4”x5.25”, and 8”x12” sizes. Gentell Collagen products can be used to treat aggressive wounds with minimal to heavy exudate, and partial- or full-thickness, granulating or necrotic, or second-degree burns.
FOR MORE INFORMATION, VISIT www.gentell.com

INTRAOPERATIVE RADIATION THERAPY
The Xoft^® Axxent^® Electronic Brachytherapy System (eBx^®) delivers intraoperative brachytherapy to treat breast cancer. Intraoperative radiation therapy is delivered as a single radiation dose using a balloon and a miniature x-ray source within the surgical cavity at the time of breast-conserving surgery (lumpectomy). Axxent eBx is designed to minimize radiation exposure to surrounding healthy tissue.
FOR MORE INFORMATION, VISIT www.xoftinc.com

KEGEL EXERCISE SYSTEM
Juve is a biofeedback Kegel exercise system that helps women develop pelvic-floor muscle strength. A device inserted into the vagina has sensors that work with a Bluetooth smartphone app to monitor pelvic-floor muscle strength and provide instant feedback to the user. Six training programs are offered.
FOR MORE INFORMATION, VISIT www.thejuve.com

WEARABLE BIOSENSOR FOR CORE METRICS
Vital Connect announced FDA clearance of its HealthPatch™ MD Biosensor. The device can capture clinical-grade biometric measurements of core-health metrics: single-lead ECG; heart rate; heart-rate variability; respiratory rate; skin temperature; posture including fall detection and severity; and steps.
FOR MORE INFORMATION, VISIT www.vitalconnect.com

HORMONE-FREE CONTRACEPTION
FemCap is a reusable, hormone-free, latex-free cervical cap for birth control. Made of surgical-grade silicone in three sizes, it covers the cervix, preventing sperm from moving into the uterus. Used in conjunction with spermicide, it is more than 92% effective in the prevention of pregnancy, says FemCap, Inc.
FOR MORE INFORMATION, VISIT www.femcap.com

There are many controversies in psychiatry, but the most controversial issue continues to be that of involuntary treatment. Over the past year, I have been working on a book on forced care, along with Dr. Annette Hanson, the forensic psychiatrist who also writes this Shrink Rap News column. The work I’ve been doing for the manuscript – identifying and interviewing the people with a stake in the issue – has placed me in a funny role of being more journalist than physician. It’s a role I mostly love, and if you’ve hit the midpoint of your career and have an opportunity to dedicate some of your time to doing something completely different, I highly recommend shifting gears for a little while.

One of the things I have found most surprising is the reactions of people when I ask to include them. While most people are willing, almost all hesitate a little. Some are quite eager to participate, and one group in Richmond who uses involuntary electroconvulsive therapy heard of my project and extended an invitation for me to come visit, interview them, watch the procedure, and speak with one of their patients. Many people are proud of the work they do and eager to showcase it; they want to have their viewpoint included. With others, I have needed to ask repeatedly, listen to their concerns, and offer reassurances. I’ve taken to telling people they can read a draft of what I write about them – I learned early in the process that without this offer, few people would be willing to speak to me.

I wish I could say that I’ve noticed a pattern to who is comfortable speaking and who is not. Many of the psychiatrists and researchers I’ve approached have given their time willingly without hesitation ( or at least without that much hesitation), including Dr. E. Fuller Torrey; Dr. Paul Appelbaum; Jeffrey Swanson, Ph.D.; Dr. Steven Sharfstein; Dr. Daniel Fisher; Vermont Psychiatric Society President Margaret Bolton; Dr. Bruce Hershfield; and American Psychiatric Association President Paul Summergrad, to name just a few of the many people who have shared their time, experiences, and wisdom with me. It was not as easy for me to find a psychiatrist I could observe working on an inpatient unit, and the project might have been halted in its tracks if not for the enthusiasm of Johns Hopkins psychiatry chair Raymond DePaulo, who allowed me to shadow his team while they tended to inpatients. It was surprisingly easy to find a Crisis Intervention Team police officer to ride with, a little more effort to engage a mental health court judge.

Those who oppose forced treatment initially were more difficult to engage, but with perseverance, I was able to persuade the leadership of MindFreedom International to speak with me, and well, I ambushed a barely willing Scientologist while I was in New York for APA last May. In terms of patient participation, this hesitation did not hold true – many people volunteered to speak with me about how involuntary treatment harmed them, and it was much more difficult to find patients who felt helped by the treatment that was thrust upon them. Two absolutely wonderful women gave generously of themselves so that this project would have real voices to it: both “Lily” and “Eleanor” relived difficult experiences for me and allowed me to obtain their medical records and to speak with their families and their doctors. None of this was easy for them, but it did provide me with an education I would have gotten no other way as they reflected back on the meaning it had to them to have been committed to psychiatric units.

The subject of involuntary outpatient commitment has been particularly difficult to research, in part because I live in Maryland, a state which has no provision for this. I spoke with one family member in Arizona who initially was eager to be interviewed, along with her adult child who has come to feel that involuntary care has been very helpful. When I called back, the mom had changed her mind about participating: “You’re writing a book with a balanced view. There no balance or controversy here for me; it’s a medical problem that needs treatment. ” Unless I could promise to support, unequivocally, the views she held without qualification, she was not interested in participating in our book, even if it would provide an avenue to express her beliefs about the value of outpatient commitment. For similar reasons, I had to approach Ron Honberg, J.D., at the national office of the National Alliance on Mental Illness (NAMI); the Maryland NAMI members did not want me to speak with me after two articles I wrote for this Clinical Psychiatry News column suggested that I was not wholeheartedly in favor of outpatient commitment. I was told the topic was “too sensitive” for their members to discuss with me. So while I’ve learned that the topic inspires a great deal of emotion, there are still surprises with every step.

With all that as a prelude, I am continuing to look for people to interview who are the subjects of mandated civil outpatient treatment orders, as well as their family members. I thought perhaps readers might be able to help me, and I am interested in hearing both the good and the bad. If you, your patients, or their families would like to participate, by all means contact me at [email protected].

Dr. Miller is a coauthor of Shrink Rap: Three Psychiatrists Explain Their Work (Baltimore: Johns Hopkins University Press, 2011).

There are many controversies in psychiatry, but the most controversial issue continues to be that of involuntary treatment. Over the past year, I have been working on a book on forced care, along with Dr. Annette Hanson, the forensic psychiatrist who also writes this Shrink Rap News column. The work I’ve been doing for the manuscript – identifying and interviewing the people with a stake in the issue – has placed me in a funny role of being more journalist than physician. It’s a role I mostly love, and if you’ve hit the midpoint of your career and have an opportunity to dedicate some of your time to doing something completely different, I highly recommend shifting gears for a little while.

One of the things I have found most surprising is the reactions of people when I ask to include them. While most people are willing, almost all hesitate a little. Some are quite eager to participate, and one group in Richmond who uses involuntary electroconvulsive therapy heard of my project and extended an invitation for me to come visit, interview them, watch the procedure, and speak with one of their patients. Many people are proud of the work they do and eager to showcase it; they want to have their viewpoint included. With others, I have needed to ask repeatedly, listen to their concerns, and offer reassurances. I’ve taken to telling people they can read a draft of what I write about them – I learned early in the process that without this offer, few people would be willing to speak to me.

I wish I could say that I’ve noticed a pattern to who is comfortable speaking and who is not. Many of the psychiatrists and researchers I’ve approached have given their time willingly without hesitation ( or at least without that much hesitation), including Dr. E. Fuller Torrey; Dr. Paul Appelbaum; Jeffrey Swanson, Ph.D.; Dr. Steven Sharfstein; Dr. Daniel Fisher; Vermont Psychiatric Society President Margaret Bolton; Dr. Bruce Hershfield; and American Psychiatric Association President Paul Summergrad, to name just a few of the many people who have shared their time, experiences, and wisdom with me. It was not as easy for me to find a psychiatrist I could observe working on an inpatient unit, and the project might have been halted in its tracks if not for the enthusiasm of Johns Hopkins psychiatry chair Raymond DePaulo, who allowed me to shadow his team while they tended to inpatients. It was surprisingly easy to find a Crisis Intervention Team police officer to ride with, a little more effort to engage a mental health court judge.

Those who oppose forced treatment initially were more difficult to engage, but with perseverance, I was able to persuade the leadership of MindFreedom International to speak with me, and well, I ambushed a barely willing Scientologist while I was in New York for APA last May. In terms of patient participation, this hesitation did not hold true – many people volunteered to speak with me about how involuntary treatment harmed them, and it was much more difficult to find patients who felt helped by the treatment that was thrust upon them. Two absolutely wonderful women gave generously of themselves so that this project would have real voices to it: both “Lily” and “Eleanor” relived difficult experiences for me and allowed me to obtain their medical records and to speak with their families and their doctors. None of this was easy for them, but it did provide me with an education I would have gotten no other way as they reflected back on the meaning it had to them to have been committed to psychiatric units.

The subject of involuntary outpatient commitment has been particularly difficult to research, in part because I live in Maryland, a state which has no provision for this. I spoke with one family member in Arizona who initially was eager to be interviewed, along with her adult child who has come to feel that involuntary care has been very helpful. When I called back, the mom had changed her mind about participating: “You’re writing a book with a balanced view. There no balance or controversy here for me; it’s a medical problem that needs treatment. ” Unless I could promise to support, unequivocally, the views she held without qualification, she was not interested in participating in our book, even if it would provide an avenue to express her beliefs about the value of outpatient commitment. For similar reasons, I had to approach Ron Honberg, J.D., at the national office of the National Alliance on Mental Illness (NAMI); the Maryland NAMI members did not want me to speak with me after two articles I wrote for this Clinical Psychiatry News column suggested that I was not wholeheartedly in favor of outpatient commitment. I was told the topic was “too sensitive” for their members to discuss with me. So while I’ve learned that the topic inspires a great deal of emotion, there are still surprises with every step.

With all that as a prelude, I am continuing to look for people to interview who are the subjects of mandated civil outpatient treatment orders, as well as their family members. I thought perhaps readers might be able to help me, and I am interested in hearing both the good and the bad. If you, your patients, or their families would like to participate, by all means contact me at [email protected].

Dr. Miller is a coauthor of Shrink Rap: Three Psychiatrists Explain Their Work (Baltimore: Johns Hopkins University Press, 2011).

There are many controversies in psychiatry, but the most controversial issue continues to be that of involuntary treatment. Over the past year, I have been working on a book on forced care, along with Dr. Annette Hanson, the forensic psychiatrist who also writes this Shrink Rap News column. The work I’ve been doing for the manuscript – identifying and interviewing the people with a stake in the issue – has placed me in a funny role of being more journalist than physician. It’s a role I mostly love, and if you’ve hit the midpoint of your career and have an opportunity to dedicate some of your time to doing something completely different, I highly recommend shifting gears for a little while.

One of the things I have found most surprising is the reactions of people when I ask to include them. While most people are willing, almost all hesitate a little. Some are quite eager to participate, and one group in Richmond who uses involuntary electroconvulsive therapy heard of my project and extended an invitation for me to come visit, interview them, watch the procedure, and speak with one of their patients. Many people are proud of the work they do and eager to showcase it; they want to have their viewpoint included. With others, I have needed to ask repeatedly, listen to their concerns, and offer reassurances. I’ve taken to telling people they can read a draft of what I write about them – I learned early in the process that without this offer, few people would be willing to speak to me.

I wish I could say that I’ve noticed a pattern to who is comfortable speaking and who is not. Many of the psychiatrists and researchers I’ve approached have given their time willingly without hesitation ( or at least without that much hesitation), including Dr. E. Fuller Torrey; Dr. Paul Appelbaum; Jeffrey Swanson, Ph.D.; Dr. Steven Sharfstein; Dr. Daniel Fisher; Vermont Psychiatric Society President Margaret Bolton; Dr. Bruce Hershfield; and American Psychiatric Association President Paul Summergrad, to name just a few of the many people who have shared their time, experiences, and wisdom with me. It was not as easy for me to find a psychiatrist I could observe working on an inpatient unit, and the project might have been halted in its tracks if not for the enthusiasm of Johns Hopkins psychiatry chair Raymond DePaulo, who allowed me to shadow his team while they tended to inpatients. It was surprisingly easy to find a Crisis Intervention Team police officer to ride with, a little more effort to engage a mental health court judge.

Those who oppose forced treatment initially were more difficult to engage, but with perseverance, I was able to persuade the leadership of MindFreedom International to speak with me, and well, I ambushed a barely willing Scientologist while I was in New York for APA last May. In terms of patient participation, this hesitation did not hold true – many people volunteered to speak with me about how involuntary treatment harmed them, and it was much more difficult to find patients who felt helped by the treatment that was thrust upon them. Two absolutely wonderful women gave generously of themselves so that this project would have real voices to it: both “Lily” and “Eleanor” relived difficult experiences for me and allowed me to obtain their medical records and to speak with their families and their doctors. None of this was easy for them, but it did provide me with an education I would have gotten no other way as they reflected back on the meaning it had to them to have been committed to psychiatric units.

The subject of involuntary outpatient commitment has been particularly difficult to research, in part because I live in Maryland, a state which has no provision for this. I spoke with one family member in Arizona who initially was eager to be interviewed, along with her adult child who has come to feel that involuntary care has been very helpful. When I called back, the mom had changed her mind about participating: “You’re writing a book with a balanced view. There no balance or controversy here for me; it’s a medical problem that needs treatment. ” Unless I could promise to support, unequivocally, the views she held without qualification, she was not interested in participating in our book, even if it would provide an avenue to express her beliefs about the value of outpatient commitment. For similar reasons, I had to approach Ron Honberg, J.D., at the national office of the National Alliance on Mental Illness (NAMI); the Maryland NAMI members did not want me to speak with me after two articles I wrote for this Clinical Psychiatry News column suggested that I was not wholeheartedly in favor of outpatient commitment. I was told the topic was “too sensitive” for their members to discuss with me. So while I’ve learned that the topic inspires a great deal of emotion, there are still surprises with every step.

With all that as a prelude, I am continuing to look for people to interview who are the subjects of mandated civil outpatient treatment orders, as well as their family members. I thought perhaps readers might be able to help me, and I am interested in hearing both the good and the bad. If you, your patients, or their families would like to participate, by all means contact me at [email protected].

Dr. Miller is a coauthor of Shrink Rap: Three Psychiatrists Explain Their Work (Baltimore: Johns Hopkins University Press, 2011).

Hot flashes are associated with a significant increase in the risk of hip fracture, regardless of age, body mass index, and other confounders such as smoking, according to analysis of data from the Women’s Health Study.

The prospective, observational study among 4,867 women aged 50-79 years found a 78% increase in the risk of hip fracture among women with moderate to severe menopausal vasomotor symptoms at baseline, compared with women with no symptoms.

Vasomotor symptom severity was also inversely associated with bone mineral density (BMD) at both the femoral neck and the spine. Compared with women who had no vasomotor symptoms, those with moderate or severe symptoms had 0.015 g/cm² lower femoral neck BMD and 0.016 g/cm² lower lumbar spine BMD, according to an analysis published on Dec. 18 in the Journal of Clinical Endocrinology and Metabolism (2014 [doi:10.1210/jc.2014-3062]).

“Despite being younger and heavier than asymptomatic women, characteristics associated with higher BMD, women with moderate/severe [vasomotor symptoms] had a higher risk of hip fractures that was also independent of other established risk factors for fractures,” wrote Dr. Carolyn J. Crandall of the University of California, Los Angeles, and her colleagues.

The study was funded by the National Institutes of Health. Two of the study authors reported consulting and other financial relationships with drug and device companies.

Hot flashes are associated with a significant increase in the risk of hip fracture, regardless of age, body mass index, and other confounders such as smoking, according to analysis of data from the Women’s Health Study.

The prospective, observational study among 4,867 women aged 50-79 years found a 78% increase in the risk of hip fracture among women with moderate to severe menopausal vasomotor symptoms at baseline, compared with women with no symptoms.

Vasomotor symptom severity was also inversely associated with bone mineral density (BMD) at both the femoral neck and the spine. Compared with women who had no vasomotor symptoms, those with moderate or severe symptoms had 0.015 g/cm² lower femoral neck BMD and 0.016 g/cm² lower lumbar spine BMD, according to an analysis published on Dec. 18 in the Journal of Clinical Endocrinology and Metabolism (2014 [doi:10.1210/jc.2014-3062]).

“Despite being younger and heavier than asymptomatic women, characteristics associated with higher BMD, women with moderate/severe [vasomotor symptoms] had a higher risk of hip fractures that was also independent of other established risk factors for fractures,” wrote Dr. Carolyn J. Crandall of the University of California, Los Angeles, and her colleagues.

The study was funded by the National Institutes of Health. Two of the study authors reported consulting and other financial relationships with drug and device companies.

Hot flashes are associated with a significant increase in the risk of hip fracture, regardless of age, body mass index, and other confounders such as smoking, according to analysis of data from the Women’s Health Study.

The prospective, observational study among 4,867 women aged 50-79 years found a 78% increase in the risk of hip fracture among women with moderate to severe menopausal vasomotor symptoms at baseline, compared with women with no symptoms.

Vasomotor symptom severity was also inversely associated with bone mineral density (BMD) at both the femoral neck and the spine. Compared with women who had no vasomotor symptoms, those with moderate or severe symptoms had 0.015 g/cm² lower femoral neck BMD and 0.016 g/cm² lower lumbar spine BMD, according to an analysis published on Dec. 18 in the Journal of Clinical Endocrinology and Metabolism (2014 [doi:10.1210/jc.2014-3062]).

“Despite being younger and heavier than asymptomatic women, characteristics associated with higher BMD, women with moderate/severe [vasomotor symptoms] had a higher risk of hip fractures that was also independent of other established risk factors for fractures,” wrote Dr. Carolyn J. Crandall of the University of California, Los Angeles, and her colleagues.

The study was funded by the National Institutes of Health. Two of the study authors reported consulting and other financial relationships with drug and device companies.

Credit: Rhoda Baer

Researchers say they’ve discovered key events that prompt drug resistance in myeloproliferative neoplasms (MPNs) and certain solid tumor malignancies.

By mapping the steps that myelofibrosis, melanoma, and breast cancer cells use to become resistant to drugs, the investigators believe they have identified better targets for blocking those pathways to ensure current therapies are effective.

The groups reported these findings in two papers published in Science Signaling.

“In our studies, we developed a screening technology that allows us to quickly identify the routes cells can use to become resistant, and, using that information, we were able to show that these mechanisms seen in the laboratory are actually also occurring in patients’ tumors,” said Kris Wood, PhD, an assistant professor at Duke University in Durham, North Carolina, and senior author of both studies.

In the first study, Dr Wood and his colleagues conducted a broad survey of the known cell-signaling pathways that, when activated, have the potential to trigger drug resistance.

Using this screening technology, the researchers were able to corroborate the results of earlier drug-resistance studies, while also finding pathways that had not previously been described.

The team identified the MAPK and PI3K pathways, which are known to mediate drug resistance. But they also found that activation of the Notch1 pathway caused drug resistance, and inhibiting Notch1 signaling restored drug efficacy.

“Interestingly, the mechanisms are quite similar among all 3 of the cancer types,” Dr Wood noted. “In breast cancer and melanoma, our findings suggest the same Notch1 pathway as a potential driver of resistance to a wide array of targeted therapies—a role that has not been widely acknowledged previously.”

The investigators found that Notch signaling mediated drug resistance to an estrogen receptor-targeted therapy used in breast cancer and to a kinase-targeted therapy used in melanoma. And tumors from some patients with relapsed breast cancer or melanoma had increased markers of Notch1 signaling.

In the second study, the researchers used the aforementioned pathway-centric screen to track a pair of separate signaling pathways downstream of RAS, a protein frequently activated in MPNs.

The team found the pathway mediated by RAS promoted drug resistance in hematopoietic cell lines containing an activating mutation in JAK2. And RAS signaling led to the phosphorylation-mediated inactivation of the pro-apoptotic protein BAD, which enabled cell survival.

Combining JAK inhibitors with inhibitors of kinases downstream of RAS signaling prompted apoptosis in cell lines that were resistant to JAK inhibitors. This suggests such combinations may be effective for treating drug-resistant MPNs.

“Together, these findings improve our ability to stratify patients into groups more and less likely to respond to therapy and design drug combinations that work together to block or delay resistance,” Dr Wood concluded.

Credit: Rhoda Baer

Researchers say they’ve discovered key events that prompt drug resistance in myeloproliferative neoplasms (MPNs) and certain solid tumor malignancies.

By mapping the steps that myelofibrosis, melanoma, and breast cancer cells use to become resistant to drugs, the investigators believe they have identified better targets for blocking those pathways to ensure current therapies are effective.

The groups reported these findings in two papers published in Science Signaling.

“In our studies, we developed a screening technology that allows us to quickly identify the routes cells can use to become resistant, and, using that information, we were able to show that these mechanisms seen in the laboratory are actually also occurring in patients’ tumors,” said Kris Wood, PhD, an assistant professor at Duke University in Durham, North Carolina, and senior author of both studies.

In the first study, Dr Wood and his colleagues conducted a broad survey of the known cell-signaling pathways that, when activated, have the potential to trigger drug resistance.

Using this screening technology, the researchers were able to corroborate the results of earlier drug-resistance studies, while also finding pathways that had not previously been described.

The team identified the MAPK and PI3K pathways, which are known to mediate drug resistance. But they also found that activation of the Notch1 pathway caused drug resistance, and inhibiting Notch1 signaling restored drug efficacy.

“Interestingly, the mechanisms are quite similar among all 3 of the cancer types,” Dr Wood noted. “In breast cancer and melanoma, our findings suggest the same Notch1 pathway as a potential driver of resistance to a wide array of targeted therapies—a role that has not been widely acknowledged previously.”

The investigators found that Notch signaling mediated drug resistance to an estrogen receptor-targeted therapy used in breast cancer and to a kinase-targeted therapy used in melanoma. And tumors from some patients with relapsed breast cancer or melanoma had increased markers of Notch1 signaling.

In the second study, the researchers used the aforementioned pathway-centric screen to track a pair of separate signaling pathways downstream of RAS, a protein frequently activated in MPNs.

The team found the pathway mediated by RAS promoted drug resistance in hematopoietic cell lines containing an activating mutation in JAK2. And RAS signaling led to the phosphorylation-mediated inactivation of the pro-apoptotic protein BAD, which enabled cell survival.

Combining JAK inhibitors with inhibitors of kinases downstream of RAS signaling prompted apoptosis in cell lines that were resistant to JAK inhibitors. This suggests such combinations may be effective for treating drug-resistant MPNs.

“Together, these findings improve our ability to stratify patients into groups more and less likely to respond to therapy and design drug combinations that work together to block or delay resistance,” Dr Wood concluded.

Credit: Rhoda Baer

Researchers say they’ve discovered key events that prompt drug resistance in myeloproliferative neoplasms (MPNs) and certain solid tumor malignancies.

By mapping the steps that myelofibrosis, melanoma, and breast cancer cells use to become resistant to drugs, the investigators believe they have identified better targets for blocking those pathways to ensure current therapies are effective.

The groups reported these findings in two papers published in Science Signaling.

“In our studies, we developed a screening technology that allows us to quickly identify the routes cells can use to become resistant, and, using that information, we were able to show that these mechanisms seen in the laboratory are actually also occurring in patients’ tumors,” said Kris Wood, PhD, an assistant professor at Duke University in Durham, North Carolina, and senior author of both studies.

In the first study, Dr Wood and his colleagues conducted a broad survey of the known cell-signaling pathways that, when activated, have the potential to trigger drug resistance.

Using this screening technology, the researchers were able to corroborate the results of earlier drug-resistance studies, while also finding pathways that had not previously been described.

The team identified the MAPK and PI3K pathways, which are known to mediate drug resistance. But they also found that activation of the Notch1 pathway caused drug resistance, and inhibiting Notch1 signaling restored drug efficacy.

“Interestingly, the mechanisms are quite similar among all 3 of the cancer types,” Dr Wood noted. “In breast cancer and melanoma, our findings suggest the same Notch1 pathway as a potential driver of resistance to a wide array of targeted therapies—a role that has not been widely acknowledged previously.”

The investigators found that Notch signaling mediated drug resistance to an estrogen receptor-targeted therapy used in breast cancer and to a kinase-targeted therapy used in melanoma. And tumors from some patients with relapsed breast cancer or melanoma had increased markers of Notch1 signaling.

In the second study, the researchers used the aforementioned pathway-centric screen to track a pair of separate signaling pathways downstream of RAS, a protein frequently activated in MPNs.

The team found the pathway mediated by RAS promoted drug resistance in hematopoietic cell lines containing an activating mutation in JAK2. And RAS signaling led to the phosphorylation-mediated inactivation of the pro-apoptotic protein BAD, which enabled cell survival.

Combining JAK inhibitors with inhibitors of kinases downstream of RAS signaling prompted apoptosis in cell lines that were resistant to JAK inhibitors. This suggests such combinations may be effective for treating drug-resistant MPNs.

“Together, these findings improve our ability to stratify patients into groups more and less likely to respond to therapy and design drug combinations that work together to block or delay resistance,” Dr Wood concluded.

SAN FRANCISCO—Pharmaceutical-grade L-glutamine can reduce the risk of complications in patients with sickle cell disease (SCD), according to new research.

In a phase 3 study of more than 200 patients, those who received L-glutamine saw a reduction in sickle cell crises, hospitalizations, and the incidence of acute chest syndrome (ACS) when compared to patients who received placebo.

In addition, L-glutamine appeared to have a synergistic effect with hydroxyurea.

Yutaka Niihara, MD, of Emmaus Medical, Inc., in Torrance, California, presented these results at the 2014 ASH Annual Meeting (abstract 86*). Emmaus Medical produced the pharmaceutical-grade L-glutamine used in the study.

Dr Niihara noted that nicotinamide adenine dinucleotide (NAD) is an important physiological antioxidant in red blood cells. But in sickled red blood cells, NAD redox potential is significantly compromised.

So he and his colleagues hypothesized that glutamine, a precursor for NAD, can improve NAD redox potential and modify the destructive effect of increased oxidation and the pathophysiology of SCD. They also theorized that glutamine will decrease the frequency of vaso-occlusive crises.

To test their theories, the researchers enrolled 230 patients from 31 different sites on a phase 3 trial. Patients had sickle cell anemia (SS) or sickle B⁰ thalassemia. They were 5 years of age or older, and some were receiving hydroxyurea.

Patients were randomized 2:1 to receive L-glutamine at 0.3 g/kg twice daily (maximum 30 g/day) or placebo (maltodextrin) at 0.3 g/kg twice daily for 48 weeks. The researchers had discovered high variation in the quality of over-the-counter L-glutamine, so they used pharmaceutical-grade L-glutamine only.

In all, 152 patients received L-glutamine, and 78 received placebo. Demographics and baseline characteristics were similar between the two treatment arms.

The median age was 19 (range, 5-57) in the L-glutamine arm and 17 (range, 5-58) in the placebo arm. There were more females than males in both arms—52% and 57.7%, respectively. And most patients in both arms had sickle cell anemia—89.5% and 91%, respectively.

Safety and efficacy

Dr Niihara said there were no serious adverse events attributable to L-glutamine and no dose modifications due to toxicity.

There were more gastrointestinal events (such as constipation and flatulence) in the L-glutamine arm (8.6%) than in the placebo arm (5.2%). But there was no difference in other adverse events between the two arms.

The study’s primary endpoint was the frequency of painful sickle cell crises. Patients in the L-glutamine arm had 25% fewer crises than patients in the placebo arm (P=0.008).

In patients aged 18 and younger, the median number of sickle cell crises was 3 in the L-glutamine arm and 4 in the placebo arm (P<0.001). The numbers were the same in patients older than 18 (P<0.001) and among patients receiving hydroxyurea (P<0.001).

“Those patients, even though they were on hydroxyurea, they have shown improvements [with L-glutamine],” Dr Niihara said. “And it appears there is some synergistic effect . . ., certainly more than just an additive effect.”

Dr Niihara also noted that patients who received placebo took less than 2 months to experience a first sickle cell crisis, but, for patients on L-glutamine, it took almost 3 months before they had a first crisis. The time to a first crisis was a median of 87 days in the L-glutamine arm and 54 days in the placebo arm (P=0.010).

The study’s secondary endpoint was the frequency of hospitalizations. Compared to patients in the placebo arm, those in the L-glutamine arm had a 33% reduction in hospitalizations (P=0.005) and a 41% reduction in the length of hospital stay (P=0.022).

The researchers also looked at the incidence of ACS and found that L-glutamine was associated with a 58% reduction in ACS. The incidence was 26.9% in the placebo arm and 11.9% in the L-glutamine arm (P=0.006).

“We observed this cascade improvement [with L-glutamine],” Dr Niihara noted. “And what we mean [by that] is that, with glutamine, there is less chance of having painful crises, but if patients have to have crises, they have less chance of being hospitalized. And if they have to be hospitalized, their stays in the hospital are shorter. And, again, if they have to be hospitalized, there’s less chance of them going to the ICU with acute chest syndrome.”

Dr Niihara said the researchers’ next steps are to investigate L-glutamine in a clinical setting, in patients younger than 5 years old, in pregnant women, and as part of combination therapy.

*Information in the abstract differs from that presented at the meeting.

SAN FRANCISCO—Pharmaceutical-grade L-glutamine can reduce the risk of complications in patients with sickle cell disease (SCD), according to new research.

In a phase 3 study of more than 200 patients, those who received L-glutamine saw a reduction in sickle cell crises, hospitalizations, and the incidence of acute chest syndrome (ACS) when compared to patients who received placebo.

In addition, L-glutamine appeared to have a synergistic effect with hydroxyurea.

Yutaka Niihara, MD, of Emmaus Medical, Inc., in Torrance, California, presented these results at the 2014 ASH Annual Meeting (abstract 86*). Emmaus Medical produced the pharmaceutical-grade L-glutamine used in the study.

Dr Niihara noted that nicotinamide adenine dinucleotide (NAD) is an important physiological antioxidant in red blood cells. But in sickled red blood cells, NAD redox potential is significantly compromised.

So he and his colleagues hypothesized that glutamine, a precursor for NAD, can improve NAD redox potential and modify the destructive effect of increased oxidation and the pathophysiology of SCD. They also theorized that glutamine will decrease the frequency of vaso-occlusive crises.

To test their theories, the researchers enrolled 230 patients from 31 different sites on a phase 3 trial. Patients had sickle cell anemia (SS) or sickle B⁰ thalassemia. They were 5 years of age or older, and some were receiving hydroxyurea.

Patients were randomized 2:1 to receive L-glutamine at 0.3 g/kg twice daily (maximum 30 g/day) or placebo (maltodextrin) at 0.3 g/kg twice daily for 48 weeks. The researchers had discovered high variation in the quality of over-the-counter L-glutamine, so they used pharmaceutical-grade L-glutamine only.

In all, 152 patients received L-glutamine, and 78 received placebo. Demographics and baseline characteristics were similar between the two treatment arms.

The median age was 19 (range, 5-57) in the L-glutamine arm and 17 (range, 5-58) in the placebo arm. There were more females than males in both arms—52% and 57.7%, respectively. And most patients in both arms had sickle cell anemia—89.5% and 91%, respectively.

Safety and efficacy

Dr Niihara said there were no serious adverse events attributable to L-glutamine and no dose modifications due to toxicity.

There were more gastrointestinal events (such as constipation and flatulence) in the L-glutamine arm (8.6%) than in the placebo arm (5.2%). But there was no difference in other adverse events between the two arms.

The study’s primary endpoint was the frequency of painful sickle cell crises. Patients in the L-glutamine arm had 25% fewer crises than patients in the placebo arm (P=0.008).

In patients aged 18 and younger, the median number of sickle cell crises was 3 in the L-glutamine arm and 4 in the placebo arm (P<0.001). The numbers were the same in patients older than 18 (P<0.001) and among patients receiving hydroxyurea (P<0.001).

“Those patients, even though they were on hydroxyurea, they have shown improvements [with L-glutamine],” Dr Niihara said. “And it appears there is some synergistic effect . . ., certainly more than just an additive effect.”

Dr Niihara also noted that patients who received placebo took less than 2 months to experience a first sickle cell crisis, but, for patients on L-glutamine, it took almost 3 months before they had a first crisis. The time to a first crisis was a median of 87 days in the L-glutamine arm and 54 days in the placebo arm (P=0.010).

The study’s secondary endpoint was the frequency of hospitalizations. Compared to patients in the placebo arm, those in the L-glutamine arm had a 33% reduction in hospitalizations (P=0.005) and a 41% reduction in the length of hospital stay (P=0.022).

The researchers also looked at the incidence of ACS and found that L-glutamine was associated with a 58% reduction in ACS. The incidence was 26.9% in the placebo arm and 11.9% in the L-glutamine arm (P=0.006).

“We observed this cascade improvement [with L-glutamine],” Dr Niihara noted. “And what we mean [by that] is that, with glutamine, there is less chance of having painful crises, but if patients have to have crises, they have less chance of being hospitalized. And if they have to be hospitalized, their stays in the hospital are shorter. And, again, if they have to be hospitalized, there’s less chance of them going to the ICU with acute chest syndrome.”

Dr Niihara said the researchers’ next steps are to investigate L-glutamine in a clinical setting, in patients younger than 5 years old, in pregnant women, and as part of combination therapy.

*Information in the abstract differs from that presented at the meeting.

SAN FRANCISCO—Pharmaceutical-grade L-glutamine can reduce the risk of complications in patients with sickle cell disease (SCD), according to new research.

In a phase 3 study of more than 200 patients, those who received L-glutamine saw a reduction in sickle cell crises, hospitalizations, and the incidence of acute chest syndrome (ACS) when compared to patients who received placebo.

In addition, L-glutamine appeared to have a synergistic effect with hydroxyurea.

Yutaka Niihara, MD, of Emmaus Medical, Inc., in Torrance, California, presented these results at the 2014 ASH Annual Meeting (abstract 86*). Emmaus Medical produced the pharmaceutical-grade L-glutamine used in the study.

Dr Niihara noted that nicotinamide adenine dinucleotide (NAD) is an important physiological antioxidant in red blood cells. But in sickled red blood cells, NAD redox potential is significantly compromised.

So he and his colleagues hypothesized that glutamine, a precursor for NAD, can improve NAD redox potential and modify the destructive effect of increased oxidation and the pathophysiology of SCD. They also theorized that glutamine will decrease the frequency of vaso-occlusive crises.

To test their theories, the researchers enrolled 230 patients from 31 different sites on a phase 3 trial. Patients had sickle cell anemia (SS) or sickle B⁰ thalassemia. They were 5 years of age or older, and some were receiving hydroxyurea.

Patients were randomized 2:1 to receive L-glutamine at 0.3 g/kg twice daily (maximum 30 g/day) or placebo (maltodextrin) at 0.3 g/kg twice daily for 48 weeks. The researchers had discovered high variation in the quality of over-the-counter L-glutamine, so they used pharmaceutical-grade L-glutamine only.

In all, 152 patients received L-glutamine, and 78 received placebo. Demographics and baseline characteristics were similar between the two treatment arms.

The median age was 19 (range, 5-57) in the L-glutamine arm and 17 (range, 5-58) in the placebo arm. There were more females than males in both arms—52% and 57.7%, respectively. And most patients in both arms had sickle cell anemia—89.5% and 91%, respectively.

Safety and efficacy

Dr Niihara said there were no serious adverse events attributable to L-glutamine and no dose modifications due to toxicity.

There were more gastrointestinal events (such as constipation and flatulence) in the L-glutamine arm (8.6%) than in the placebo arm (5.2%). But there was no difference in other adverse events between the two arms.

The study’s primary endpoint was the frequency of painful sickle cell crises. Patients in the L-glutamine arm had 25% fewer crises than patients in the placebo arm (P=0.008).

In patients aged 18 and younger, the median number of sickle cell crises was 3 in the L-glutamine arm and 4 in the placebo arm (P<0.001). The numbers were the same in patients older than 18 (P<0.001) and among patients receiving hydroxyurea (P<0.001).

“Those patients, even though they were on hydroxyurea, they have shown improvements [with L-glutamine],” Dr Niihara said. “And it appears there is some synergistic effect . . ., certainly more than just an additive effect.”

Dr Niihara also noted that patients who received placebo took less than 2 months to experience a first sickle cell crisis, but, for patients on L-glutamine, it took almost 3 months before they had a first crisis. The time to a first crisis was a median of 87 days in the L-glutamine arm and 54 days in the placebo arm (P=0.010).

The study’s secondary endpoint was the frequency of hospitalizations. Compared to patients in the placebo arm, those in the L-glutamine arm had a 33% reduction in hospitalizations (P=0.005) and a 41% reduction in the length of hospital stay (P=0.022).

The researchers also looked at the incidence of ACS and found that L-glutamine was associated with a 58% reduction in ACS. The incidence was 26.9% in the placebo arm and 11.9% in the L-glutamine arm (P=0.006).

“We observed this cascade improvement [with L-glutamine],” Dr Niihara noted. “And what we mean [by that] is that, with glutamine, there is less chance of having painful crises, but if patients have to have crises, they have less chance of being hospitalized. And if they have to be hospitalized, their stays in the hospital are shorter. And, again, if they have to be hospitalized, there’s less chance of them going to the ICU with acute chest syndrome.”

Dr Niihara said the researchers’ next steps are to investigate L-glutamine in a clinical setting, in patients younger than 5 years old, in pregnant women, and as part of combination therapy.

*Information in the abstract differs from that presented at the meeting.