Business of Medicine

Making medications more accessible to those who need them is the focus of attention in the media and in all levels of government. For a drug to be accessible, it must be affordable and available. Something may be affordable, but if it isn’t available, no one will have access to it. Think of toilet paper in the first year of the COVID pandemic. The opposite is also true. An item may be available, but if it isn’t affordable, access is lost. While medication affordability is viewed as the major problem for patients, lack of availability has begun to creep into our drug supply chain. We are now experiencing drug shortages for medications that are very affordable. The perverse incentives, inherent in formulary construction, favor higher-priced medications, which decreases the availability of lower-priced – yet still expensive – drugs, thus increasing patient cost share. Formulary placement and patient cost share, important determinants of accessibility, are controlled by health plans and differ considerably even from the same payer. And yet, the price of drugs remains the target of most approaches to increasing patients’ access. And now price negotiations and drug affordability boards enter into the picture.

What are prescription drug affordability boards?

Both state and federal legislatures have placed the affordability of medications front and center on their agendas. However, neither are considering how formulary construction affects patient’s access to medications. The Inflation Reduction Act is Congress’s foray into price setting/negotiation of expensive drugs. Over the last few years, states are also attempting to make drugs more affordable by creating prescription drug affordability boards (PDABs). Governors (or other state leaders) appoint PDAB members who are charged with the task of evaluating the affordability of certain drugs for both the state and its residents. How to do it, and what the limitations are, vary from state to state. In 2019, Maryland was first state to establish a PDAB, charging its members to study commercial insurance and drug pricing and make recommendations on how to make drugs more affordable for Maryland residents. Other states that have passed PDAB legislation are Colorado, Maine, Minnesota, New Hampshire, Ohio, Oregon, and Washington.

Colorado, Minnesota, and Washington – and soon Maryland and Oregon – hope to make drugs more affordable for patients by allowing their PDABs to set an upper payment limit (UPL). A UPL serves as a cap on the sales price and reimbursement for a drug. The Michigan legislature is actively debating legislation that would establish a PDAB and allow it to set UPLs. On the surface, this may appear to be a potential solution to the affordability issue. However, as always, there are many questions as to how this will work and what are the unintended consequences of price setting and establishing UPLs for medications. UPLs have the potential to harm access to provider-administered drugs. With the help of advocacy from the Coalition of State Rheumatology Organizations (CSRO), Washington’s PDAB statute potentially has a carve-out for provider-administered drugs.
 

Possible unintended consequences for provider-administered drugs

CSRO asked for a meeting with the Colorado PDAB after they announced their list of drugs for which UPLs would be set. We spoke with the PDAB in October, hoping to point out some of the unintended consequences that needed to be considered. One of the big questions we have revolves around the “buy and bill” provider-administered drugs. According to the language of the Colorado statute, providers would not be paid any more than the UPL for a drug administered in their office. CSRO is concerned that this would leave providers uncompensated for the service of administering the drug and associated overhead. This is not to mention that providers may not be able to find a group purchasing organization that would even sell the drug at the UPL, much less a lower price than the UPL. And even if a provider could buy it at the UPL, that would mean there would be no margin to cover the overhead for their infusion suite. Interestingly, while Colorado’s rules for the UPL state that pharmacies can be paid an additional reasonable dispensing fee beyond the UPL, no such allowance is made for providers administering one of these medications. In fact, the Colorado PDAB specifically indicated that the goal of the state’s UPL methodology was to ensure that there was no “delta” between what is paid for the drug by the provider and what is reimbursed to a provider for the drug by the payer. This may cause some providers to be unable to “afford” to administer those drugs with UPLs, which ultimately reduces access for residents of Colorado to that particular medication. This is the exact opposite of what the PDAB is supposed to accomplish.

There are still many questions. What impact will UPLs have on a medication’s placement on a formulary? As we know, preferred formulary placement is often given to drugs with the highest price concession from the manufacturers. Will setting a UPL on payment for specialty pharmacy drugs to pharmacy benefit manager-owned specialty pharmacies affect that drug’s ability to be on the formulary? And again, how will the PDAB resolve the issue of compensating the provider for overhead costs associated with administering the medication?

Even more confusing questions remain. How will the UPL be enforced when a “purchase” or “sale” of the drug is made by an out-of-state entity somewhere along the supply chain? When ultimately the drug is purchased and delivered to a Colorado consumer by a Colorado provider/pharmacy, there are multiple points of the supply chain that may be outside of the jurisdiction of Colorado to enforce the UPL. This would create a misalignment in pricing among various supply chain entities.

While the sentiment behind creating PDABs is noble, it may end up having the unintended consequence of patients losing access to these drugs because of the perverse incentives involved in formulary construction or providers’ inability to afford to offer provider-administered drugs with UPLs.

Remember, expensive specialty pharmacy medications are already discounted greatly by manufacturers, often more than 50% to pharmacy benefit managers; and yet those cost savings are not passed on to the patients. Also, there is no oversight of 340B hospital contracted pharmacies to make sure that they pass those savings on to needy patients. Perhaps PDABs should address those issues, as well, if patient access to expensive medications is the goal.

Clearly, there are no easy answers. But with so many variables in the drug supply chain affecting patient access, concentrating only on one aspect may end up causing more harm than good. If your state is thinking of passing a PDAB, please let your legislators know that there are issues with this type of legislation that perhaps should be worked out before the bill is passed.
 

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s Vice President of Advocacy and Government Affairs and its immediate Past President, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].

Making medications more accessible to those who need them is the focus of attention in the media and in all levels of government. For a drug to be accessible, it must be affordable and available. Something may be affordable, but if it isn’t available, no one will have access to it. Think of toilet paper in the first year of the COVID pandemic. The opposite is also true. An item may be available, but if it isn’t affordable, access is lost. While medication affordability is viewed as the major problem for patients, lack of availability has begun to creep into our drug supply chain. We are now experiencing drug shortages for medications that are very affordable. The perverse incentives, inherent in formulary construction, favor higher-priced medications, which decreases the availability of lower-priced – yet still expensive – drugs, thus increasing patient cost share. Formulary placement and patient cost share, important determinants of accessibility, are controlled by health plans and differ considerably even from the same payer. And yet, the price of drugs remains the target of most approaches to increasing patients’ access. And now price negotiations and drug affordability boards enter into the picture.

What are prescription drug affordability boards?

Both state and federal legislatures have placed the affordability of medications front and center on their agendas. However, neither are considering how formulary construction affects patient’s access to medications. The Inflation Reduction Act is Congress’s foray into price setting/negotiation of expensive drugs. Over the last few years, states are also attempting to make drugs more affordable by creating prescription drug affordability boards (PDABs). Governors (or other state leaders) appoint PDAB members who are charged with the task of evaluating the affordability of certain drugs for both the state and its residents. How to do it, and what the limitations are, vary from state to state. In 2019, Maryland was first state to establish a PDAB, charging its members to study commercial insurance and drug pricing and make recommendations on how to make drugs more affordable for Maryland residents. Other states that have passed PDAB legislation are Colorado, Maine, Minnesota, New Hampshire, Ohio, Oregon, and Washington.

Colorado, Minnesota, and Washington – and soon Maryland and Oregon – hope to make drugs more affordable for patients by allowing their PDABs to set an upper payment limit (UPL). A UPL serves as a cap on the sales price and reimbursement for a drug. The Michigan legislature is actively debating legislation that would establish a PDAB and allow it to set UPLs. On the surface, this may appear to be a potential solution to the affordability issue. However, as always, there are many questions as to how this will work and what are the unintended consequences of price setting and establishing UPLs for medications. UPLs have the potential to harm access to provider-administered drugs. With the help of advocacy from the Coalition of State Rheumatology Organizations (CSRO), Washington’s PDAB statute potentially has a carve-out for provider-administered drugs.
 

Possible unintended consequences for provider-administered drugs

CSRO asked for a meeting with the Colorado PDAB after they announced their list of drugs for which UPLs would be set. We spoke with the PDAB in October, hoping to point out some of the unintended consequences that needed to be considered. One of the big questions we have revolves around the “buy and bill” provider-administered drugs. According to the language of the Colorado statute, providers would not be paid any more than the UPL for a drug administered in their office. CSRO is concerned that this would leave providers uncompensated for the service of administering the drug and associated overhead. This is not to mention that providers may not be able to find a group purchasing organization that would even sell the drug at the UPL, much less a lower price than the UPL. And even if a provider could buy it at the UPL, that would mean there would be no margin to cover the overhead for their infusion suite. Interestingly, while Colorado’s rules for the UPL state that pharmacies can be paid an additional reasonable dispensing fee beyond the UPL, no such allowance is made for providers administering one of these medications. In fact, the Colorado PDAB specifically indicated that the goal of the state’s UPL methodology was to ensure that there was no “delta” between what is paid for the drug by the provider and what is reimbursed to a provider for the drug by the payer. This may cause some providers to be unable to “afford” to administer those drugs with UPLs, which ultimately reduces access for residents of Colorado to that particular medication. This is the exact opposite of what the PDAB is supposed to accomplish.

There are still many questions. What impact will UPLs have on a medication’s placement on a formulary? As we know, preferred formulary placement is often given to drugs with the highest price concession from the manufacturers. Will setting a UPL on payment for specialty pharmacy drugs to pharmacy benefit manager-owned specialty pharmacies affect that drug’s ability to be on the formulary? And again, how will the PDAB resolve the issue of compensating the provider for overhead costs associated with administering the medication?

Even more confusing questions remain. How will the UPL be enforced when a “purchase” or “sale” of the drug is made by an out-of-state entity somewhere along the supply chain? When ultimately the drug is purchased and delivered to a Colorado consumer by a Colorado provider/pharmacy, there are multiple points of the supply chain that may be outside of the jurisdiction of Colorado to enforce the UPL. This would create a misalignment in pricing among various supply chain entities.

While the sentiment behind creating PDABs is noble, it may end up having the unintended consequence of patients losing access to these drugs because of the perverse incentives involved in formulary construction or providers’ inability to afford to offer provider-administered drugs with UPLs.

Remember, expensive specialty pharmacy medications are already discounted greatly by manufacturers, often more than 50% to pharmacy benefit managers; and yet those cost savings are not passed on to the patients. Also, there is no oversight of 340B hospital contracted pharmacies to make sure that they pass those savings on to needy patients. Perhaps PDABs should address those issues, as well, if patient access to expensive medications is the goal.

Clearly, there are no easy answers. But with so many variables in the drug supply chain affecting patient access, concentrating only on one aspect may end up causing more harm than good. If your state is thinking of passing a PDAB, please let your legislators know that there are issues with this type of legislation that perhaps should be worked out before the bill is passed.
 

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s Vice President of Advocacy and Government Affairs and its immediate Past President, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].

Making medications more accessible to those who need them is the focus of attention in the media and in all levels of government. For a drug to be accessible, it must be affordable and available. Something may be affordable, but if it isn’t available, no one will have access to it. Think of toilet paper in the first year of the COVID pandemic. The opposite is also true. An item may be available, but if it isn’t affordable, access is lost. While medication affordability is viewed as the major problem for patients, lack of availability has begun to creep into our drug supply chain. We are now experiencing drug shortages for medications that are very affordable. The perverse incentives, inherent in formulary construction, favor higher-priced medications, which decreases the availability of lower-priced – yet still expensive – drugs, thus increasing patient cost share. Formulary placement and patient cost share, important determinants of accessibility, are controlled by health plans and differ considerably even from the same payer. And yet, the price of drugs remains the target of most approaches to increasing patients’ access. And now price negotiations and drug affordability boards enter into the picture.

What are prescription drug affordability boards?

Both state and federal legislatures have placed the affordability of medications front and center on their agendas. However, neither are considering how formulary construction affects patient’s access to medications. The Inflation Reduction Act is Congress’s foray into price setting/negotiation of expensive drugs. Over the last few years, states are also attempting to make drugs more affordable by creating prescription drug affordability boards (PDABs). Governors (or other state leaders) appoint PDAB members who are charged with the task of evaluating the affordability of certain drugs for both the state and its residents. How to do it, and what the limitations are, vary from state to state. In 2019, Maryland was first state to establish a PDAB, charging its members to study commercial insurance and drug pricing and make recommendations on how to make drugs more affordable for Maryland residents. Other states that have passed PDAB legislation are Colorado, Maine, Minnesota, New Hampshire, Ohio, Oregon, and Washington.

Colorado, Minnesota, and Washington – and soon Maryland and Oregon – hope to make drugs more affordable for patients by allowing their PDABs to set an upper payment limit (UPL). A UPL serves as a cap on the sales price and reimbursement for a drug. The Michigan legislature is actively debating legislation that would establish a PDAB and allow it to set UPLs. On the surface, this may appear to be a potential solution to the affordability issue. However, as always, there are many questions as to how this will work and what are the unintended consequences of price setting and establishing UPLs for medications. UPLs have the potential to harm access to provider-administered drugs. With the help of advocacy from the Coalition of State Rheumatology Organizations (CSRO), Washington’s PDAB statute potentially has a carve-out for provider-administered drugs.
 

Possible unintended consequences for provider-administered drugs

CSRO asked for a meeting with the Colorado PDAB after they announced their list of drugs for which UPLs would be set. We spoke with the PDAB in October, hoping to point out some of the unintended consequences that needed to be considered. One of the big questions we have revolves around the “buy and bill” provider-administered drugs. According to the language of the Colorado statute, providers would not be paid any more than the UPL for a drug administered in their office. CSRO is concerned that this would leave providers uncompensated for the service of administering the drug and associated overhead. This is not to mention that providers may not be able to find a group purchasing organization that would even sell the drug at the UPL, much less a lower price than the UPL. And even if a provider could buy it at the UPL, that would mean there would be no margin to cover the overhead for their infusion suite. Interestingly, while Colorado’s rules for the UPL state that pharmacies can be paid an additional reasonable dispensing fee beyond the UPL, no such allowance is made for providers administering one of these medications. In fact, the Colorado PDAB specifically indicated that the goal of the state’s UPL methodology was to ensure that there was no “delta” between what is paid for the drug by the provider and what is reimbursed to a provider for the drug by the payer. This may cause some providers to be unable to “afford” to administer those drugs with UPLs, which ultimately reduces access for residents of Colorado to that particular medication. This is the exact opposite of what the PDAB is supposed to accomplish.

There are still many questions. What impact will UPLs have on a medication’s placement on a formulary? As we know, preferred formulary placement is often given to drugs with the highest price concession from the manufacturers. Will setting a UPL on payment for specialty pharmacy drugs to pharmacy benefit manager-owned specialty pharmacies affect that drug’s ability to be on the formulary? And again, how will the PDAB resolve the issue of compensating the provider for overhead costs associated with administering the medication?

Even more confusing questions remain. How will the UPL be enforced when a “purchase” or “sale” of the drug is made by an out-of-state entity somewhere along the supply chain? When ultimately the drug is purchased and delivered to a Colorado consumer by a Colorado provider/pharmacy, there are multiple points of the supply chain that may be outside of the jurisdiction of Colorado to enforce the UPL. This would create a misalignment in pricing among various supply chain entities.

While the sentiment behind creating PDABs is noble, it may end up having the unintended consequence of patients losing access to these drugs because of the perverse incentives involved in formulary construction or providers’ inability to afford to offer provider-administered drugs with UPLs.

Remember, expensive specialty pharmacy medications are already discounted greatly by manufacturers, often more than 50% to pharmacy benefit managers; and yet those cost savings are not passed on to the patients. Also, there is no oversight of 340B hospital contracted pharmacies to make sure that they pass those savings on to needy patients. Perhaps PDABs should address those issues, as well, if patient access to expensive medications is the goal.

Clearly, there are no easy answers. But with so many variables in the drug supply chain affecting patient access, concentrating only on one aspect may end up causing more harm than good. If your state is thinking of passing a PDAB, please let your legislators know that there are issues with this type of legislation that perhaps should be worked out before the bill is passed.
 

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s Vice President of Advocacy and Government Affairs and its immediate Past President, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].

An anesthesiologist is suing the Mayo Clinic after it allegedly ordered him to stick to “prescribed messaging” after his outspoken comments about transgender athletes and a federal agency’s sluggishness regarding a COVID-19 treatment.

Michael J. Joyner, MD, claims that the Mayo Clinic violated its own policies by muzzling him, slapping him with an unpaid 1-week suspension, and labeling his comments to the media “unprofessional.”

In his Nov. 13 lawsuit, filed in Minnesota state court, Dr. Joyner asks that a judge order Mayo Clinic to stop its “retaliation and interference” with his “communications about his research.” He that claims the retaliation stems from his 2020 report about a Mayo Clinic business partner’s “attempt to unlawfully access and use protected patient data.”

Medical institutions often refuse to comment on pending litigation. But in a pair of unusual statements, the Mayo Clinic forcefully rebutted Joyner’s claims in some detail: “Dr. Joyner’s lawsuit is yet another manifestation of his refusal to recognize or accept responsibility for his inappropriate behaviors,” it told Becker’s Hospital Review.

In a June letter to colleagues, the institution’s communications head said Dr. Joyner was not punished over his transgender athlete comments but instead because he mistreated coworkers and made “unprofessional” comments to The New York Times.

Dr. Joyner, a prominent physiologist and anesthesiologist who has worked for Mayo Clinic for 36 years, has become a cause célèbre in academic and free-speech circles over the past several months.

Two conversations with journalists appear to be at the heart of the Mayo Clinic’s complaints.

First, a 2022 New York Times article about transgender athletes quoted him about how testosterone dramatically affects performance in males: “There are social aspects to sport, but physiology and biology underpin it. Testosterone is the 800-pound gorilla.”

“The language was at best, insensitive. At worst, transphobic,” an LGBTQ advocate told a TV news station in Rochester, Minn., where the Mayo Clinic is based. The article didn’t elaborate on why the advocate believed the language could be transphobic.

Then, a CNN story in 2023 noted that Dr. Joyner has studied convalescent plasma as a treatment for COVID-19 and quoted him about how the National Institutes of Health declined to take a stand on the use of the therapy: “Joyner said he’s ‘frustrated’ with the NIH’s ‘bureaucratic rope-a-dope,’ calling the agency’s guidelines ‘a wet blanket.’ ”

It is not unusual for medical researchers to comment bluntly to the media about federal agencies.

For example, a 2020 New York Times story that unraveled the Trump Administration’s apparent mischaracterization of Dr. Joyner’s research into convalescent plasma quoted a University of Pittsburgh physician as saying, “For the first time ever, I feel like official people in communications and people at the FDA grossly misrepresented data about a therapy.”

In a March 5 letter, a Mayo Clinic administrator wrote to Dr. Joyner to complain that his comments regarding the NIH were an example of his “problematic” use of “idiomatic language” that “reflects poorly on Mayo Clinic’s brand and reputation.” A paragraph in the letter is redacted in the version posted by the Foundation for Individual Rights and Expression, which supports Dr. Joyner.

The letter adds that Dr. Joyner’s comments to The New York Times “were problematic in the media and the LGBTQI+ community at Mayo Clinic.” The letter, which didn’t elaborate about the blowback, also says that “concerns remain with disrespectful communications with colleagues who describe your tone as unpleasant and having a ‘bullying’ quality to it.”

Kellie Miller, one of Dr. Joyner’s attorneys, noted in a statement that “Dr. Joyner’s personnel file is free of any documentation of Mayo’s ongoing and vague allegations of bullying and unprofessionalism with colleagues.”

The letter also ordered Dr. Joyner to not be rude or criticize the work of others and repair his relationship with Mayo Clinic’s public affairs staff: “This will take individual effort on your part.” It also ordered him to “discuss approved topics only” with reporters, “stick to prescribed messaging,” and not resist if the public affairs department doesn’t let him be interviewed: “Accept ‘no’ for an answer and move forward.”

Medical institutions often monitor how their employees interact with the media in order to control “messaging.” But firm rules at academic medical institutions like the Mayo Clinic may run the risk of running afoul of the tenets of academic freedom.

The institution and its CEO then retaliated by calling his claims “unprofessional,” according to the lawsuit, which provided no further details about the situation.

In a statement, the Mayo Clinic said it “hired an outside attorney to investigate these concerns. The attorney, who is now a federal judge, found there was no retaliation and that Dr. Joyner had engaged in a pattern of asserting inflammatory allegations grounded almost entirely in speculation.”

A petition signed by dozens of professors demands that Mayo Clinic “revoke the penalties and constraints it has imposed on him.”

“Dr. Joyner, a faculty member at a medical school that avows a commitment to academic freedom and to free expression, did not exceed the limits of his expertise in any of his statements to the press that led to these sanctions,” they wrote. “At no time did he claim to be speaking for the Mayo Clinic, and his remarks were well within the mainstream of the range of scientific opinion on topics in which he is expert.”

A version of this article first appeared on Medscape.com.

An anesthesiologist is suing the Mayo Clinic after it allegedly ordered him to stick to “prescribed messaging” after his outspoken comments about transgender athletes and a federal agency’s sluggishness regarding a COVID-19 treatment.

Michael J. Joyner, MD, claims that the Mayo Clinic violated its own policies by muzzling him, slapping him with an unpaid 1-week suspension, and labeling his comments to the media “unprofessional.”

In his Nov. 13 lawsuit, filed in Minnesota state court, Dr. Joyner asks that a judge order Mayo Clinic to stop its “retaliation and interference” with his “communications about his research.” He that claims the retaliation stems from his 2020 report about a Mayo Clinic business partner’s “attempt to unlawfully access and use protected patient data.”

Medical institutions often refuse to comment on pending litigation. But in a pair of unusual statements, the Mayo Clinic forcefully rebutted Joyner’s claims in some detail: “Dr. Joyner’s lawsuit is yet another manifestation of his refusal to recognize or accept responsibility for his inappropriate behaviors,” it told Becker’s Hospital Review.

In a June letter to colleagues, the institution’s communications head said Dr. Joyner was not punished over his transgender athlete comments but instead because he mistreated coworkers and made “unprofessional” comments to The New York Times.

Dr. Joyner, a prominent physiologist and anesthesiologist who has worked for Mayo Clinic for 36 years, has become a cause célèbre in academic and free-speech circles over the past several months.

Two conversations with journalists appear to be at the heart of the Mayo Clinic’s complaints.

First, a 2022 New York Times article about transgender athletes quoted him about how testosterone dramatically affects performance in males: “There are social aspects to sport, but physiology and biology underpin it. Testosterone is the 800-pound gorilla.”

“The language was at best, insensitive. At worst, transphobic,” an LGBTQ advocate told a TV news station in Rochester, Minn., where the Mayo Clinic is based. The article didn’t elaborate on why the advocate believed the language could be transphobic.

Then, a CNN story in 2023 noted that Dr. Joyner has studied convalescent plasma as a treatment for COVID-19 and quoted him about how the National Institutes of Health declined to take a stand on the use of the therapy: “Joyner said he’s ‘frustrated’ with the NIH’s ‘bureaucratic rope-a-dope,’ calling the agency’s guidelines ‘a wet blanket.’ ”

It is not unusual for medical researchers to comment bluntly to the media about federal agencies.

For example, a 2020 New York Times story that unraveled the Trump Administration’s apparent mischaracterization of Dr. Joyner’s research into convalescent plasma quoted a University of Pittsburgh physician as saying, “For the first time ever, I feel like official people in communications and people at the FDA grossly misrepresented data about a therapy.”

In a March 5 letter, a Mayo Clinic administrator wrote to Dr. Joyner to complain that his comments regarding the NIH were an example of his “problematic” use of “idiomatic language” that “reflects poorly on Mayo Clinic’s brand and reputation.” A paragraph in the letter is redacted in the version posted by the Foundation for Individual Rights and Expression, which supports Dr. Joyner.

The letter adds that Dr. Joyner’s comments to The New York Times “were problematic in the media and the LGBTQI+ community at Mayo Clinic.” The letter, which didn’t elaborate about the blowback, also says that “concerns remain with disrespectful communications with colleagues who describe your tone as unpleasant and having a ‘bullying’ quality to it.”

Kellie Miller, one of Dr. Joyner’s attorneys, noted in a statement that “Dr. Joyner’s personnel file is free of any documentation of Mayo’s ongoing and vague allegations of bullying and unprofessionalism with colleagues.”

The letter also ordered Dr. Joyner to not be rude or criticize the work of others and repair his relationship with Mayo Clinic’s public affairs staff: “This will take individual effort on your part.” It also ordered him to “discuss approved topics only” with reporters, “stick to prescribed messaging,” and not resist if the public affairs department doesn’t let him be interviewed: “Accept ‘no’ for an answer and move forward.”

Medical institutions often monitor how their employees interact with the media in order to control “messaging.” But firm rules at academic medical institutions like the Mayo Clinic may run the risk of running afoul of the tenets of academic freedom.

The institution and its CEO then retaliated by calling his claims “unprofessional,” according to the lawsuit, which provided no further details about the situation.

In a statement, the Mayo Clinic said it “hired an outside attorney to investigate these concerns. The attorney, who is now a federal judge, found there was no retaliation and that Dr. Joyner had engaged in a pattern of asserting inflammatory allegations grounded almost entirely in speculation.”

A petition signed by dozens of professors demands that Mayo Clinic “revoke the penalties and constraints it has imposed on him.”

“Dr. Joyner, a faculty member at a medical school that avows a commitment to academic freedom and to free expression, did not exceed the limits of his expertise in any of his statements to the press that led to these sanctions,” they wrote. “At no time did he claim to be speaking for the Mayo Clinic, and his remarks were well within the mainstream of the range of scientific opinion on topics in which he is expert.”

A version of this article first appeared on Medscape.com.

An anesthesiologist is suing the Mayo Clinic after it allegedly ordered him to stick to “prescribed messaging” after his outspoken comments about transgender athletes and a federal agency’s sluggishness regarding a COVID-19 treatment.

Michael J. Joyner, MD, claims that the Mayo Clinic violated its own policies by muzzling him, slapping him with an unpaid 1-week suspension, and labeling his comments to the media “unprofessional.”

In his Nov. 13 lawsuit, filed in Minnesota state court, Dr. Joyner asks that a judge order Mayo Clinic to stop its “retaliation and interference” with his “communications about his research.” He that claims the retaliation stems from his 2020 report about a Mayo Clinic business partner’s “attempt to unlawfully access and use protected patient data.”

Medical institutions often refuse to comment on pending litigation. But in a pair of unusual statements, the Mayo Clinic forcefully rebutted Joyner’s claims in some detail: “Dr. Joyner’s lawsuit is yet another manifestation of his refusal to recognize or accept responsibility for his inappropriate behaviors,” it told Becker’s Hospital Review.

In a June letter to colleagues, the institution’s communications head said Dr. Joyner was not punished over his transgender athlete comments but instead because he mistreated coworkers and made “unprofessional” comments to The New York Times.

Dr. Joyner, a prominent physiologist and anesthesiologist who has worked for Mayo Clinic for 36 years, has become a cause célèbre in academic and free-speech circles over the past several months.

Two conversations with journalists appear to be at the heart of the Mayo Clinic’s complaints.

First, a 2022 New York Times article about transgender athletes quoted him about how testosterone dramatically affects performance in males: “There are social aspects to sport, but physiology and biology underpin it. Testosterone is the 800-pound gorilla.”

“The language was at best, insensitive. At worst, transphobic,” an LGBTQ advocate told a TV news station in Rochester, Minn., where the Mayo Clinic is based. The article didn’t elaborate on why the advocate believed the language could be transphobic.

Then, a CNN story in 2023 noted that Dr. Joyner has studied convalescent plasma as a treatment for COVID-19 and quoted him about how the National Institutes of Health declined to take a stand on the use of the therapy: “Joyner said he’s ‘frustrated’ with the NIH’s ‘bureaucratic rope-a-dope,’ calling the agency’s guidelines ‘a wet blanket.’ ”

It is not unusual for medical researchers to comment bluntly to the media about federal agencies.

For example, a 2020 New York Times story that unraveled the Trump Administration’s apparent mischaracterization of Dr. Joyner’s research into convalescent plasma quoted a University of Pittsburgh physician as saying, “For the first time ever, I feel like official people in communications and people at the FDA grossly misrepresented data about a therapy.”

In a March 5 letter, a Mayo Clinic administrator wrote to Dr. Joyner to complain that his comments regarding the NIH were an example of his “problematic” use of “idiomatic language” that “reflects poorly on Mayo Clinic’s brand and reputation.” A paragraph in the letter is redacted in the version posted by the Foundation for Individual Rights and Expression, which supports Dr. Joyner.

The letter adds that Dr. Joyner’s comments to The New York Times “were problematic in the media and the LGBTQI+ community at Mayo Clinic.” The letter, which didn’t elaborate about the blowback, also says that “concerns remain with disrespectful communications with colleagues who describe your tone as unpleasant and having a ‘bullying’ quality to it.”

Kellie Miller, one of Dr. Joyner’s attorneys, noted in a statement that “Dr. Joyner’s personnel file is free of any documentation of Mayo’s ongoing and vague allegations of bullying and unprofessionalism with colleagues.”

The letter also ordered Dr. Joyner to not be rude or criticize the work of others and repair his relationship with Mayo Clinic’s public affairs staff: “This will take individual effort on your part.” It also ordered him to “discuss approved topics only” with reporters, “stick to prescribed messaging,” and not resist if the public affairs department doesn’t let him be interviewed: “Accept ‘no’ for an answer and move forward.”

Medical institutions often monitor how their employees interact with the media in order to control “messaging.” But firm rules at academic medical institutions like the Mayo Clinic may run the risk of running afoul of the tenets of academic freedom.

The institution and its CEO then retaliated by calling his claims “unprofessional,” according to the lawsuit, which provided no further details about the situation.

In a statement, the Mayo Clinic said it “hired an outside attorney to investigate these concerns. The attorney, who is now a federal judge, found there was no retaliation and that Dr. Joyner had engaged in a pattern of asserting inflammatory allegations grounded almost entirely in speculation.”

A petition signed by dozens of professors demands that Mayo Clinic “revoke the penalties and constraints it has imposed on him.”

“Dr. Joyner, a faculty member at a medical school that avows a commitment to academic freedom and to free expression, did not exceed the limits of his expertise in any of his statements to the press that led to these sanctions,” they wrote. “At no time did he claim to be speaking for the Mayo Clinic, and his remarks were well within the mainstream of the range of scientific opinion on topics in which he is expert.”

A version of this article first appeared on Medscape.com.

“I went to the woods because I wished to live deliberately, to front only the essential facts of life, and see if I could not learn what it had to teach.” – Henry David Thoreau

I have many patients like Maxine. Tall, with a shock of white hair. Old, but still in charge. When you try to make eye contact, she looks right through you. First with her left eye. Then her right. Her face is inscrutable. What’s she thinking? Unlike many of my patients, however, this Maxine was a llama. Every morning my daughter and I tried to coax her into moving as we leaned on the cold steel gate that kept her in her pasture. We were visiting family in October and chose to stay on a working New England farm. The kids will love the animals, we thought, and we’ll appreciate the extra bedrooms.

Jeffrey Benabio, MD, MBA

Airbnb helped us find this charming fiber-farm in Rhode Island where they raise Leicester Longwool sheep, a historic breed that once roamed George Washington’s pastures, along with a few goats, ducks, chickens, and Maxine. It’s situated deep in the woods, which were yellow, orange, and red that week. As it happens, we were just a short drive due south of Walden Pond where Henry David Thoreau spent 2 years, 2 months and 2 days escaping “overcivilization” nearly 175 years ago. Hoisting our overweight bags over the uneven granite stone steps when we arrived, I realized this was going to be more like the Thoreau experiment than I intended. The farmhouse dated to the 1790s. There were wide, creaky floorboards, low ceilings, one staircase to the bedrooms (which could have aptly been called a ladder) and loads of book-laden shelves. Instructions posted in the kitchen warned that the heat is tricky to regulate – a redundant admonition as we watched our 3-year-old putting on her socks and shoes as she got into bed.

Now, if you’ve ever been on vacation with little kids, you know that it’s basically just childcare in a novel location. After barricading the staircase with luggage and unplugging lamps from their dicey outlets we set out to feed the chickens and try to pet a sheep. Walking the perimeter of the farm we saw stone walls that needed mending and stumbled across two ancient cemeteries, one had been for family, the other for slaves. I wondered how many farmers and weavers and menders had walked this trail with their kids over the generations.

The next morning, we learned that roosters do not in fact crow at dawn, they crow before dawn (which could also aptly be called nighttime). There were no commutes or late patients here. But there was work to be done. Chickens don’t care that it’s Sunday. It downpoured. Watching the sheep from the kitchen as I sipped my coffee, they didn’t seem to mind. Nor did our farmer hosts who trudged past them in tall boots, just as they had every other day of their farmer lives.

Kaiser Permanente

By the fifth day, we had fallen into the rhythms of the homestead. We cracked the blue, green, and brown eggs that our hosts placed outside our door in the early hours and made omelets that were as orange as the foliage. We finally learned to adjust the heat so we neither got chilblains nor had to open the windows and strip naked to cool down. The sky was a brilliant blue that last morning and Sloan ran around trying to catch leaves as they blew off the trees. She had no objective. No counting. No contest. Just chasing leaves as they fell. It was the ultimate atelic activity, done just for doing it. I joined her and found I was no better at this than a 3-year-old.

We came to see family and a few animals and we left with a new appreciation for the goodness of people and nature. Perhaps it’s time to bring back Transcendentalism again? We might all benefit from a little time in the woods.
 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

“I went to the woods because I wished to live deliberately, to front only the essential facts of life, and see if I could not learn what it had to teach.” – Henry David Thoreau

I have many patients like Maxine. Tall, with a shock of white hair. Old, but still in charge. When you try to make eye contact, she looks right through you. First with her left eye. Then her right. Her face is inscrutable. What’s she thinking? Unlike many of my patients, however, this Maxine was a llama. Every morning my daughter and I tried to coax her into moving as we leaned on the cold steel gate that kept her in her pasture. We were visiting family in October and chose to stay on a working New England farm. The kids will love the animals, we thought, and we’ll appreciate the extra bedrooms.

Jeffrey Benabio, MD, MBA

Airbnb helped us find this charming fiber-farm in Rhode Island where they raise Leicester Longwool sheep, a historic breed that once roamed George Washington’s pastures, along with a few goats, ducks, chickens, and Maxine. It’s situated deep in the woods, which were yellow, orange, and red that week. As it happens, we were just a short drive due south of Walden Pond where Henry David Thoreau spent 2 years, 2 months and 2 days escaping “overcivilization” nearly 175 years ago. Hoisting our overweight bags over the uneven granite stone steps when we arrived, I realized this was going to be more like the Thoreau experiment than I intended. The farmhouse dated to the 1790s. There were wide, creaky floorboards, low ceilings, one staircase to the bedrooms (which could have aptly been called a ladder) and loads of book-laden shelves. Instructions posted in the kitchen warned that the heat is tricky to regulate – a redundant admonition as we watched our 3-year-old putting on her socks and shoes as she got into bed.

Now, if you’ve ever been on vacation with little kids, you know that it’s basically just childcare in a novel location. After barricading the staircase with luggage and unplugging lamps from their dicey outlets we set out to feed the chickens and try to pet a sheep. Walking the perimeter of the farm we saw stone walls that needed mending and stumbled across two ancient cemeteries, one had been for family, the other for slaves. I wondered how many farmers and weavers and menders had walked this trail with their kids over the generations.

The next morning, we learned that roosters do not in fact crow at dawn, they crow before dawn (which could also aptly be called nighttime). There were no commutes or late patients here. But there was work to be done. Chickens don’t care that it’s Sunday. It downpoured. Watching the sheep from the kitchen as I sipped my coffee, they didn’t seem to mind. Nor did our farmer hosts who trudged past them in tall boots, just as they had every other day of their farmer lives.

Kaiser Permanente

By the fifth day, we had fallen into the rhythms of the homestead. We cracked the blue, green, and brown eggs that our hosts placed outside our door in the early hours and made omelets that were as orange as the foliage. We finally learned to adjust the heat so we neither got chilblains nor had to open the windows and strip naked to cool down. The sky was a brilliant blue that last morning and Sloan ran around trying to catch leaves as they blew off the trees. She had no objective. No counting. No contest. Just chasing leaves as they fell. It was the ultimate atelic activity, done just for doing it. I joined her and found I was no better at this than a 3-year-old.

We came to see family and a few animals and we left with a new appreciation for the goodness of people and nature. Perhaps it’s time to bring back Transcendentalism again? We might all benefit from a little time in the woods.
 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

“I went to the woods because I wished to live deliberately, to front only the essential facts of life, and see if I could not learn what it had to teach.” – Henry David Thoreau

I have many patients like Maxine. Tall, with a shock of white hair. Old, but still in charge. When you try to make eye contact, she looks right through you. First with her left eye. Then her right. Her face is inscrutable. What’s she thinking? Unlike many of my patients, however, this Maxine was a llama. Every morning my daughter and I tried to coax her into moving as we leaned on the cold steel gate that kept her in her pasture. We were visiting family in October and chose to stay on a working New England farm. The kids will love the animals, we thought, and we’ll appreciate the extra bedrooms.

Jeffrey Benabio, MD, MBA

Airbnb helped us find this charming fiber-farm in Rhode Island where they raise Leicester Longwool sheep, a historic breed that once roamed George Washington’s pastures, along with a few goats, ducks, chickens, and Maxine. It’s situated deep in the woods, which were yellow, orange, and red that week. As it happens, we were just a short drive due south of Walden Pond where Henry David Thoreau spent 2 years, 2 months and 2 days escaping “overcivilization” nearly 175 years ago. Hoisting our overweight bags over the uneven granite stone steps when we arrived, I realized this was going to be more like the Thoreau experiment than I intended. The farmhouse dated to the 1790s. There were wide, creaky floorboards, low ceilings, one staircase to the bedrooms (which could have aptly been called a ladder) and loads of book-laden shelves. Instructions posted in the kitchen warned that the heat is tricky to regulate – a redundant admonition as we watched our 3-year-old putting on her socks and shoes as she got into bed.

Now, if you’ve ever been on vacation with little kids, you know that it’s basically just childcare in a novel location. After barricading the staircase with luggage and unplugging lamps from their dicey outlets we set out to feed the chickens and try to pet a sheep. Walking the perimeter of the farm we saw stone walls that needed mending and stumbled across two ancient cemeteries, one had been for family, the other for slaves. I wondered how many farmers and weavers and menders had walked this trail with their kids over the generations.

The next morning, we learned that roosters do not in fact crow at dawn, they crow before dawn (which could also aptly be called nighttime). There were no commutes or late patients here. But there was work to be done. Chickens don’t care that it’s Sunday. It downpoured. Watching the sheep from the kitchen as I sipped my coffee, they didn’t seem to mind. Nor did our farmer hosts who trudged past them in tall boots, just as they had every other day of their farmer lives.

Kaiser Permanente

By the fifth day, we had fallen into the rhythms of the homestead. We cracked the blue, green, and brown eggs that our hosts placed outside our door in the early hours and made omelets that were as orange as the foliage. We finally learned to adjust the heat so we neither got chilblains nor had to open the windows and strip naked to cool down. The sky was a brilliant blue that last morning and Sloan ran around trying to catch leaves as they blew off the trees. She had no objective. No counting. No contest. Just chasing leaves as they fell. It was the ultimate atelic activity, done just for doing it. I joined her and found I was no better at this than a 3-year-old.

We came to see family and a few animals and we left with a new appreciation for the goodness of people and nature. Perhaps it’s time to bring back Transcendentalism again? We might all benefit from a little time in the woods.
 

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

Changes may be in store for how physicians do business based on pending proposals from the Federal Trade Commission to ban noncompete clauses and monitor potential merger monopolies.

In January 2023, the FTC announced a rule that would ban noncompete clauses, stating that such clauses reduce workers’ wages and stifle new businesses. Simply put, the rule would ban employers from entering into noncompete clauses with workers, including independent contractors.

Aspects of the rule include whether it should pertain to franchisees, whether senior executives should be exempted, and whether low-wage and high-wage workers should be treated differently.

According to the FTC, banning noncompete clauses would increase workers’ earnings by approximately $300 billion per year, save consumers as much as $148 billion in health care costs, and double the number of companies founded by former workers in the same field.

In June 2023, the FTC and the Department of Justice proposed changes to rules governing mergers, including changes to prenotification forms that would promote more efficient screening of potential mergers. According to a press release from the FTC, the proposed changes include provision of details about investments or corporate relationships, product and services, projected revenue streams, and previous acquisitions.

The proposal also includes a waiting period during which agencies would assess the risk that a merger would lessen competition or tend to create a monopoly.
 

What the FTC proposals mean for physicians

FTC Chair Lina M. Khan addressed attendees at the American College of Physicians at their annual meeting in October.

In March 2023, ACEP wrote to Ms. Khan in support of the banning of noncompete clauses. The ACEP also stated that the FTC should monitor the effect of a ban on the ability to recruit and maintain a stable physician workforce in rural and underserved areas “and should examine the potential impacts should nonprofit health systems be exempt from a ban.”

However, the American Medical Group Association, a nonprofit trade organization that supports multispecialty medical groups, opposes the ban. In a press release issued in March 2023, AMGA noted that, “As employers, AMGA members rely in part on noncompete agreements to build strong, sustainable care teams that work together to coordinate care for their patients. These care teams emphasize the importance of the doctor-patient relationship, which reasonable noncompete agreements help support.”

The American Medical Association supports the ban on noncompete clauses, detailed in an official AMA policy statement as, “support[ing] policies, regulations, and legislation that prohibits covenants not-to-compete for all physicians in clinical practice who hold employment contracts with for-profit or nonprofit hospital, hospital system, or staffing company employers.”

In regard to the merger guidelines, ACEP wrote a separate letter to Ms. Khan identifying some of the unique aspects of emergency medicine practice. The ACEP stressed the need for caution as the consolidation of medical practices continues, many under the umbrella of private equity investment companies.

“Unchecked mergers that substantially lessen competition in the labor market for emergency physicians, in which the employer is the buyer and the physician is the seller, can impact physicians directly by lowering wages or slowing wage growth, worsening benefits or working conditions, or contributing to other degradations in workplace quality,” according to ACEP.

The AMA also supports the FTC’s draft merger guidelines as protective of physicians and their working environments.

In September 2023, the AMA sent a letter to the FTC commending the agency on the proposed guidelines: “It is our strong contention that the agencies must have merger guidelines that protect physicians against health insurer mergers that may substantially lessen competition for the purchase of physician services and that degrade physician working conditions,” according to the AMA letter.

According the FTC, the proposed changes represent an expansion and reorganization of information along with the addition of new document requirements and represents the first comprehensive review of the Hart-Scott-Rodino Antitrust Improvements Act since 1978.

After soliciting public comments, the FTC is reviewing the proposals, and no specific date for a final vote has been announced.

More specifics on the potential changes to premerger notification, reporting, and waiting period requirements are available on the FTC website.

A version of this article appeared on Medscape.com.

Changes may be in store for how physicians do business based on pending proposals from the Federal Trade Commission to ban noncompete clauses and monitor potential merger monopolies.

In January 2023, the FTC announced a rule that would ban noncompete clauses, stating that such clauses reduce workers’ wages and stifle new businesses. Simply put, the rule would ban employers from entering into noncompete clauses with workers, including independent contractors.

Aspects of the rule include whether it should pertain to franchisees, whether senior executives should be exempted, and whether low-wage and high-wage workers should be treated differently.

According to the FTC, banning noncompete clauses would increase workers’ earnings by approximately $300 billion per year, save consumers as much as $148 billion in health care costs, and double the number of companies founded by former workers in the same field.

In June 2023, the FTC and the Department of Justice proposed changes to rules governing mergers, including changes to prenotification forms that would promote more efficient screening of potential mergers. According to a press release from the FTC, the proposed changes include provision of details about investments or corporate relationships, product and services, projected revenue streams, and previous acquisitions.

The proposal also includes a waiting period during which agencies would assess the risk that a merger would lessen competition or tend to create a monopoly.
 

What the FTC proposals mean for physicians

FTC Chair Lina M. Khan addressed attendees at the American College of Physicians at their annual meeting in October.

In March 2023, ACEP wrote to Ms. Khan in support of the banning of noncompete clauses. The ACEP also stated that the FTC should monitor the effect of a ban on the ability to recruit and maintain a stable physician workforce in rural and underserved areas “and should examine the potential impacts should nonprofit health systems be exempt from a ban.”

However, the American Medical Group Association, a nonprofit trade organization that supports multispecialty medical groups, opposes the ban. In a press release issued in March 2023, AMGA noted that, “As employers, AMGA members rely in part on noncompete agreements to build strong, sustainable care teams that work together to coordinate care for their patients. These care teams emphasize the importance of the doctor-patient relationship, which reasonable noncompete agreements help support.”

The American Medical Association supports the ban on noncompete clauses, detailed in an official AMA policy statement as, “support[ing] policies, regulations, and legislation that prohibits covenants not-to-compete for all physicians in clinical practice who hold employment contracts with for-profit or nonprofit hospital, hospital system, or staffing company employers.”

In regard to the merger guidelines, ACEP wrote a separate letter to Ms. Khan identifying some of the unique aspects of emergency medicine practice. The ACEP stressed the need for caution as the consolidation of medical practices continues, many under the umbrella of private equity investment companies.

“Unchecked mergers that substantially lessen competition in the labor market for emergency physicians, in which the employer is the buyer and the physician is the seller, can impact physicians directly by lowering wages or slowing wage growth, worsening benefits or working conditions, or contributing to other degradations in workplace quality,” according to ACEP.

The AMA also supports the FTC’s draft merger guidelines as protective of physicians and their working environments.

In September 2023, the AMA sent a letter to the FTC commending the agency on the proposed guidelines: “It is our strong contention that the agencies must have merger guidelines that protect physicians against health insurer mergers that may substantially lessen competition for the purchase of physician services and that degrade physician working conditions,” according to the AMA letter.

According the FTC, the proposed changes represent an expansion and reorganization of information along with the addition of new document requirements and represents the first comprehensive review of the Hart-Scott-Rodino Antitrust Improvements Act since 1978.

After soliciting public comments, the FTC is reviewing the proposals, and no specific date for a final vote has been announced.

More specifics on the potential changes to premerger notification, reporting, and waiting period requirements are available on the FTC website.

A version of this article appeared on Medscape.com.

Changes may be in store for how physicians do business based on pending proposals from the Federal Trade Commission to ban noncompete clauses and monitor potential merger monopolies.

In January 2023, the FTC announced a rule that would ban noncompete clauses, stating that such clauses reduce workers’ wages and stifle new businesses. Simply put, the rule would ban employers from entering into noncompete clauses with workers, including independent contractors.

Aspects of the rule include whether it should pertain to franchisees, whether senior executives should be exempted, and whether low-wage and high-wage workers should be treated differently.

According to the FTC, banning noncompete clauses would increase workers’ earnings by approximately $300 billion per year, save consumers as much as $148 billion in health care costs, and double the number of companies founded by former workers in the same field.

In June 2023, the FTC and the Department of Justice proposed changes to rules governing mergers, including changes to prenotification forms that would promote more efficient screening of potential mergers. According to a press release from the FTC, the proposed changes include provision of details about investments or corporate relationships, product and services, projected revenue streams, and previous acquisitions.

The proposal also includes a waiting period during which agencies would assess the risk that a merger would lessen competition or tend to create a monopoly.
 

What the FTC proposals mean for physicians

FTC Chair Lina M. Khan addressed attendees at the American College of Physicians at their annual meeting in October.

In March 2023, ACEP wrote to Ms. Khan in support of the banning of noncompete clauses. The ACEP also stated that the FTC should monitor the effect of a ban on the ability to recruit and maintain a stable physician workforce in rural and underserved areas “and should examine the potential impacts should nonprofit health systems be exempt from a ban.”

However, the American Medical Group Association, a nonprofit trade organization that supports multispecialty medical groups, opposes the ban. In a press release issued in March 2023, AMGA noted that, “As employers, AMGA members rely in part on noncompete agreements to build strong, sustainable care teams that work together to coordinate care for their patients. These care teams emphasize the importance of the doctor-patient relationship, which reasonable noncompete agreements help support.”

The American Medical Association supports the ban on noncompete clauses, detailed in an official AMA policy statement as, “support[ing] policies, regulations, and legislation that prohibits covenants not-to-compete for all physicians in clinical practice who hold employment contracts with for-profit or nonprofit hospital, hospital system, or staffing company employers.”

In regard to the merger guidelines, ACEP wrote a separate letter to Ms. Khan identifying some of the unique aspects of emergency medicine practice. The ACEP stressed the need for caution as the consolidation of medical practices continues, many under the umbrella of private equity investment companies.

“Unchecked mergers that substantially lessen competition in the labor market for emergency physicians, in which the employer is the buyer and the physician is the seller, can impact physicians directly by lowering wages or slowing wage growth, worsening benefits or working conditions, or contributing to other degradations in workplace quality,” according to ACEP.

The AMA also supports the FTC’s draft merger guidelines as protective of physicians and their working environments.

In September 2023, the AMA sent a letter to the FTC commending the agency on the proposed guidelines: “It is our strong contention that the agencies must have merger guidelines that protect physicians against health insurer mergers that may substantially lessen competition for the purchase of physician services and that degrade physician working conditions,” according to the AMA letter.

According the FTC, the proposed changes represent an expansion and reorganization of information along with the addition of new document requirements and represents the first comprehensive review of the Hart-Scott-Rodino Antitrust Improvements Act since 1978.

After soliciting public comments, the FTC is reviewing the proposals, and no specific date for a final vote has been announced.

More specifics on the potential changes to premerger notification, reporting, and waiting period requirements are available on the FTC website.

A version of this article appeared on Medscape.com.

Here is how old I am: When I graduated from medical school in 1977, marketing was prohibited. It was the legal profession that challenged the ban on advertising by professionals, leading to a landmark Supreme Court decision (Bates v State Bar of Arizona, 1977), which opened the door to marketing in the legal and medical professions.

Since then, marketing has become a critical component of growing, sustaining, and supporting private medical practices. Strategies range from the basic Internet website through postings on the major social media sites, and occasionally to larger-budget campaigns involving local radio, television, or billboard advertising.

All these methods are effective, to varying degrees; but nothing provides as much benefit – relative to its comparatively low cost – as the original marketing tool, word-of-mouth patient referrals. According to one survey, a clear majority of Americans still consider word-of-mouth recommendations to be the most influential element driving purchase decisions. Of course, some of your new patients already come from such referrals; but you can get a lot more by actively encouraging your existing patients to sing your praises, rather than waiting for them to do it on their own.

Soliciting current patients for referrals does take a little planning, structure, and a basic understanding of exactly how patient referral programs work. When executed correctly, a patient referral program can add substantial growth to your practice at minimal cost.

Your first step, as with any new project, should be to identify your goals: Clearly define what kind of patients you are looking to attract. Do you want more patients for cosmetic procedures, medical treatment, skin cancer screenings, a specific diagnosis (such as psoriasis), or a general mix? Design your announcements, brochures, and other literature (more on that in a minute) with those goals in mind.

Next, identify any applicable federal or state laws that dictate what you can and cannot legally do to encourage such referrals. It might be tempting, for example, to offer discounts on future services for successful referrals; but some medical groups frown on it, some states prohibit it, and the Federal Anti-Kickback Statute makes it illegal to pay anyone to refer Medicare or Medicaid patients to you if you file a claim for your services. In my experience, most patients are happy to recommend someone whom they believe provides excellent care to a friend or relative without any sort of monetary incentive; but if you plan to offer a material reward of any kind, run it by your attorney first.

Once your legal ducks are in order, make patients aware that you are accepting new patients and would welcome referrals by posting notices to that effect around your office and on your website and social media pages. Outline exactly what sort of patients (based on your goals, above) you are looking for, how to refer someone, whom to contact, and what kind of information is needed. Make it clear why existing patients should refer someone to your practice. Remind them of your specialized training, advanced technology, and patient-focused approach to health care. Highlight the benefits of the program and encourage your patients to participate.

Before implementation, you will need to educate your employees about the referral program and its benefits. All staff members should understand the program and be able to answer basic questions about it from patients or referring professionals. Encourage staffers to actively promote the program during patient interactions.

Then, start making some decisions. How, specifically, will you be requesting referrals in the office? Many physicians are not comfortable asking patients themselves. If you are going to let your assistants or receptionists do it, you will need to write a script for them to follow. An example of a basic script might be, “If you are happy with the care you are receiving here, we would love for you to tell your friends and family about us.” Your staff can then hand out cards, brochures, or both to reinforce the message, and perhaps send a follow-up email to remind them.

A referral system isn’t worth the effort if you don’t know whether it is working. Establish a system to track and monitor referrals. This could be as simple as a spreadsheet or purchasing a more sophisticated software program. Ensure that you can accurately identify and credit the referring patients for their referrals.

Make sure to thank referring patients with a thank-you note or email. Expressing gratitude will encourage continued participation in the program.

A successful referral program does not happen overnight. It relies on providing exceptional patient care and building strong relationships with your existing patients. By implementing such a program, you can leverage the satisfaction and loyalty of your patients to attract new patients and grow your private practice.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Here is how old I am: When I graduated from medical school in 1977, marketing was prohibited. It was the legal profession that challenged the ban on advertising by professionals, leading to a landmark Supreme Court decision (Bates v State Bar of Arizona, 1977), which opened the door to marketing in the legal and medical professions.

Since then, marketing has become a critical component of growing, sustaining, and supporting private medical practices. Strategies range from the basic Internet website through postings on the major social media sites, and occasionally to larger-budget campaigns involving local radio, television, or billboard advertising.

All these methods are effective, to varying degrees; but nothing provides as much benefit – relative to its comparatively low cost – as the original marketing tool, word-of-mouth patient referrals. According to one survey, a clear majority of Americans still consider word-of-mouth recommendations to be the most influential element driving purchase decisions. Of course, some of your new patients already come from such referrals; but you can get a lot more by actively encouraging your existing patients to sing your praises, rather than waiting for them to do it on their own.

Soliciting current patients for referrals does take a little planning, structure, and a basic understanding of exactly how patient referral programs work. When executed correctly, a patient referral program can add substantial growth to your practice at minimal cost.

Your first step, as with any new project, should be to identify your goals: Clearly define what kind of patients you are looking to attract. Do you want more patients for cosmetic procedures, medical treatment, skin cancer screenings, a specific diagnosis (such as psoriasis), or a general mix? Design your announcements, brochures, and other literature (more on that in a minute) with those goals in mind.

Next, identify any applicable federal or state laws that dictate what you can and cannot legally do to encourage such referrals. It might be tempting, for example, to offer discounts on future services for successful referrals; but some medical groups frown on it, some states prohibit it, and the Federal Anti-Kickback Statute makes it illegal to pay anyone to refer Medicare or Medicaid patients to you if you file a claim for your services. In my experience, most patients are happy to recommend someone whom they believe provides excellent care to a friend or relative without any sort of monetary incentive; but if you plan to offer a material reward of any kind, run it by your attorney first.

Once your legal ducks are in order, make patients aware that you are accepting new patients and would welcome referrals by posting notices to that effect around your office and on your website and social media pages. Outline exactly what sort of patients (based on your goals, above) you are looking for, how to refer someone, whom to contact, and what kind of information is needed. Make it clear why existing patients should refer someone to your practice. Remind them of your specialized training, advanced technology, and patient-focused approach to health care. Highlight the benefits of the program and encourage your patients to participate.

Before implementation, you will need to educate your employees about the referral program and its benefits. All staff members should understand the program and be able to answer basic questions about it from patients or referring professionals. Encourage staffers to actively promote the program during patient interactions.

Then, start making some decisions. How, specifically, will you be requesting referrals in the office? Many physicians are not comfortable asking patients themselves. If you are going to let your assistants or receptionists do it, you will need to write a script for them to follow. An example of a basic script might be, “If you are happy with the care you are receiving here, we would love for you to tell your friends and family about us.” Your staff can then hand out cards, brochures, or both to reinforce the message, and perhaps send a follow-up email to remind them.

A referral system isn’t worth the effort if you don’t know whether it is working. Establish a system to track and monitor referrals. This could be as simple as a spreadsheet or purchasing a more sophisticated software program. Ensure that you can accurately identify and credit the referring patients for their referrals.

Make sure to thank referring patients with a thank-you note or email. Expressing gratitude will encourage continued participation in the program.

A successful referral program does not happen overnight. It relies on providing exceptional patient care and building strong relationships with your existing patients. By implementing such a program, you can leverage the satisfaction and loyalty of your patients to attract new patients and grow your private practice.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Here is how old I am: When I graduated from medical school in 1977, marketing was prohibited. It was the legal profession that challenged the ban on advertising by professionals, leading to a landmark Supreme Court decision (Bates v State Bar of Arizona, 1977), which opened the door to marketing in the legal and medical professions.

Since then, marketing has become a critical component of growing, sustaining, and supporting private medical practices. Strategies range from the basic Internet website through postings on the major social media sites, and occasionally to larger-budget campaigns involving local radio, television, or billboard advertising.

All these methods are effective, to varying degrees; but nothing provides as much benefit – relative to its comparatively low cost – as the original marketing tool, word-of-mouth patient referrals. According to one survey, a clear majority of Americans still consider word-of-mouth recommendations to be the most influential element driving purchase decisions. Of course, some of your new patients already come from such referrals; but you can get a lot more by actively encouraging your existing patients to sing your praises, rather than waiting for them to do it on their own.

Soliciting current patients for referrals does take a little planning, structure, and a basic understanding of exactly how patient referral programs work. When executed correctly, a patient referral program can add substantial growth to your practice at minimal cost.

Your first step, as with any new project, should be to identify your goals: Clearly define what kind of patients you are looking to attract. Do you want more patients for cosmetic procedures, medical treatment, skin cancer screenings, a specific diagnosis (such as psoriasis), or a general mix? Design your announcements, brochures, and other literature (more on that in a minute) with those goals in mind.

Next, identify any applicable federal or state laws that dictate what you can and cannot legally do to encourage such referrals. It might be tempting, for example, to offer discounts on future services for successful referrals; but some medical groups frown on it, some states prohibit it, and the Federal Anti-Kickback Statute makes it illegal to pay anyone to refer Medicare or Medicaid patients to you if you file a claim for your services. In my experience, most patients are happy to recommend someone whom they believe provides excellent care to a friend or relative without any sort of monetary incentive; but if you plan to offer a material reward of any kind, run it by your attorney first.

Once your legal ducks are in order, make patients aware that you are accepting new patients and would welcome referrals by posting notices to that effect around your office and on your website and social media pages. Outline exactly what sort of patients (based on your goals, above) you are looking for, how to refer someone, whom to contact, and what kind of information is needed. Make it clear why existing patients should refer someone to your practice. Remind them of your specialized training, advanced technology, and patient-focused approach to health care. Highlight the benefits of the program and encourage your patients to participate.

Before implementation, you will need to educate your employees about the referral program and its benefits. All staff members should understand the program and be able to answer basic questions about it from patients or referring professionals. Encourage staffers to actively promote the program during patient interactions.

Then, start making some decisions. How, specifically, will you be requesting referrals in the office? Many physicians are not comfortable asking patients themselves. If you are going to let your assistants or receptionists do it, you will need to write a script for them to follow. An example of a basic script might be, “If you are happy with the care you are receiving here, we would love for you to tell your friends and family about us.” Your staff can then hand out cards, brochures, or both to reinforce the message, and perhaps send a follow-up email to remind them.

A referral system isn’t worth the effort if you don’t know whether it is working. Establish a system to track and monitor referrals. This could be as simple as a spreadsheet or purchasing a more sophisticated software program. Ensure that you can accurately identify and credit the referring patients for their referrals.

Make sure to thank referring patients with a thank-you note or email. Expressing gratitude will encourage continued participation in the program.

A successful referral program does not happen overnight. It relies on providing exceptional patient care and building strong relationships with your existing patients. By implementing such a program, you can leverage the satisfaction and loyalty of your patients to attract new patients and grow your private practice.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

PHOENIX – Artificial intelligence (AI) is poised to dramatically alter health care, and it presents opportunities for increased production and automation of some tasks. However, it is prone to error and ‘hallucinations’ despite an authoritative tone, so its conclusions must be verified.

Those were some of the messages from a talk by John Morren, MD, an associate professor of neurology at Case Western Reserve University, Cleveland, who spoke about AI at the 2023 annual meeting of the American Association for Neuromuscular and Electrodiagnostic Medicine (AANEM).

He encouraged attendees to get involved in the conversation of AI, because it is here to stay and will have a big impact on health care. “If we’re not around the table making decisions, decisions will be made for us in our absence and won’t be in our favor,” said Dr. Morren.

He started out his talk by asking if anyone in the room had used AI. After about half raised their hands, he countered that nearly everyone likely had. Voice assistants like SIRI and Alexa, social media with curated feeds, online shopping tools that provide product suggestions, and content recommendations from streaming services like Netflix all rely on AI technology.

Within medicine, AI is already playing a role in various fields, including medical imaging, disease diagnosis, drug discovery and development, predictive analytics, personalized medicine, telemedicine, and health care management.

It also has potential to be used on the job. For example, ChatGPT can generate and refine conversations towards a specific length, format, style, and level of detail. Alternatives include Bing AI from Microsoft, Bard AI from Google, Writesonic, Copy.ai, SpinBot, HIX.AI, and Chatsonic.

Specific to medicine, Consensus is a search engine that uses AI to search for, summarize, and synthesize studies from peer-reviewed literature.
 

Trust, but verify

Dr. Morren presented some specific use cases, including patient education and responses to patient inquiries, as well as generating letters to insurance companies appealing denial of coverage claims. He also showed an example where he asked Bing AI to explain to a patient, at a sixth- to seventh-grade reading level, the red-flag symptoms of myasthenic crisis.

AI can generate summaries of clinical evidence of previous studies. Asked by this reporter how to trust the accuracies of the summaries if the user hasn’t thoroughly read the papers, he acknowledged the imperfection of AI. “I would say that if you’re going to make a decision that you would not have made normally based on the summary that it’s giving, if you can find the fact that you’re anchoring the decision on, go into the article yourself and make sure that it’s well vetted. The AI is just good to tap you on your shoulder and say, ‘hey, just consider this.’ That’s all it is. You should always trust, but verify. If the AI is forcing you to say something new that you would not say, maybe don’t do it – or at least research it to know that it’s the truth and then you elevate yourself and get yourself to the next level.”
 

Limitations

The need to verify can create its own burden, according to one attendee. “I often find I end up spending more time verifying [what ChatGPT has provided]. This seems to take more time than a traditional way of going to PubMed or UpToDate or any of the other human generated consensus way,” he said.

Dr. Morren replied that he wouldn’t recommend using ChatGPT to query medical literature. Instead he recommended Consensus, which only searches the peer-reviewed medical literature.

Another key limitation is that most AI programs are date limited: For example, ChatGPT doesn’t include information after September 2021, though this may change with paid subscriptions. He also starkly warned the audience to never enter sensitive information, including patient identifiers.

There are legal and ethical considerations to AI. Dr. Morren warned against overreliance on AI, as this could undermine compassion and lead to erosion of trust, which makes it important to disclose any use of AI-generated content.

Another attendee raised concerns that AI may be generating research content, including slides for presentations, abstracts, titles, or article text. Dr. Morren said that some organizations, such as the International Committee of Medical Journal Editors, have incorporated AI in their recommendations, stating that authors should disclose any contributions of AI to their publications. However, there is little that can be done to identify AI-generated content, leaving it up to the honor code.

Asked to make predictions about how AI will evolve in the clinic over the next 2-3 years, Dr. Morren suggested that it will likely be embedded in electronic medical records. He anticipated that it will save physicians time so that they can spend more time interacting directly with patients. He quoted Eric Topol, MD, professor of medicine at Scripps Research Translational Institute, La Jolla, Calif., as saying that AI could save 20% of a physician’s time, which could be spent with patients. Dr. Morren saw it differently. “I know where that 20% of time liberated is going to go. I’m going to see 20% more patients. I’m a realist,” he said, to audience laughter.

He also predicted that AI will be found in wearables and devices, allowing health care to expand into the patient’s home in real time. “A lot of what we’re wearing is going to be an extension of the doctor’s office,” he said.

For those hoping for more guidance, Dr. Morren noted that he is the chairman of the professional practice committee of AANEM, and the group will be putting out a position statement within the next couple of months. “It will be a little bit of a blueprint for the path going forward. There are specific things that need to be done. In research, for example, you have to ensure that datasets are diverse enough. To do that we need to have inter-institutional collaboration. We have to ensure patient privacy. Consent for this needs to be a little more explicit because this is a novel area. Those are things that need to be stipulated and ratified through a task force.”

Dr. Morren has no relevant financial disclosures.

PHOENIX – Artificial intelligence (AI) is poised to dramatically alter health care, and it presents opportunities for increased production and automation of some tasks. However, it is prone to error and ‘hallucinations’ despite an authoritative tone, so its conclusions must be verified.

Those were some of the messages from a talk by John Morren, MD, an associate professor of neurology at Case Western Reserve University, Cleveland, who spoke about AI at the 2023 annual meeting of the American Association for Neuromuscular and Electrodiagnostic Medicine (AANEM).

He encouraged attendees to get involved in the conversation of AI, because it is here to stay and will have a big impact on health care. “If we’re not around the table making decisions, decisions will be made for us in our absence and won’t be in our favor,” said Dr. Morren.

He started out his talk by asking if anyone in the room had used AI. After about half raised their hands, he countered that nearly everyone likely had. Voice assistants like SIRI and Alexa, social media with curated feeds, online shopping tools that provide product suggestions, and content recommendations from streaming services like Netflix all rely on AI technology.

Within medicine, AI is already playing a role in various fields, including medical imaging, disease diagnosis, drug discovery and development, predictive analytics, personalized medicine, telemedicine, and health care management.

It also has potential to be used on the job. For example, ChatGPT can generate and refine conversations towards a specific length, format, style, and level of detail. Alternatives include Bing AI from Microsoft, Bard AI from Google, Writesonic, Copy.ai, SpinBot, HIX.AI, and Chatsonic.

Specific to medicine, Consensus is a search engine that uses AI to search for, summarize, and synthesize studies from peer-reviewed literature.
 

Trust, but verify

Dr. Morren presented some specific use cases, including patient education and responses to patient inquiries, as well as generating letters to insurance companies appealing denial of coverage claims. He also showed an example where he asked Bing AI to explain to a patient, at a sixth- to seventh-grade reading level, the red-flag symptoms of myasthenic crisis.

AI can generate summaries of clinical evidence of previous studies. Asked by this reporter how to trust the accuracies of the summaries if the user hasn’t thoroughly read the papers, he acknowledged the imperfection of AI. “I would say that if you’re going to make a decision that you would not have made normally based on the summary that it’s giving, if you can find the fact that you’re anchoring the decision on, go into the article yourself and make sure that it’s well vetted. The AI is just good to tap you on your shoulder and say, ‘hey, just consider this.’ That’s all it is. You should always trust, but verify. If the AI is forcing you to say something new that you would not say, maybe don’t do it – or at least research it to know that it’s the truth and then you elevate yourself and get yourself to the next level.”
 

Limitations

The need to verify can create its own burden, according to one attendee. “I often find I end up spending more time verifying [what ChatGPT has provided]. This seems to take more time than a traditional way of going to PubMed or UpToDate or any of the other human generated consensus way,” he said.

Dr. Morren replied that he wouldn’t recommend using ChatGPT to query medical literature. Instead he recommended Consensus, which only searches the peer-reviewed medical literature.

Another key limitation is that most AI programs are date limited: For example, ChatGPT doesn’t include information after September 2021, though this may change with paid subscriptions. He also starkly warned the audience to never enter sensitive information, including patient identifiers.

There are legal and ethical considerations to AI. Dr. Morren warned against overreliance on AI, as this could undermine compassion and lead to erosion of trust, which makes it important to disclose any use of AI-generated content.

Another attendee raised concerns that AI may be generating research content, including slides for presentations, abstracts, titles, or article text. Dr. Morren said that some organizations, such as the International Committee of Medical Journal Editors, have incorporated AI in their recommendations, stating that authors should disclose any contributions of AI to their publications. However, there is little that can be done to identify AI-generated content, leaving it up to the honor code.

Asked to make predictions about how AI will evolve in the clinic over the next 2-3 years, Dr. Morren suggested that it will likely be embedded in electronic medical records. He anticipated that it will save physicians time so that they can spend more time interacting directly with patients. He quoted Eric Topol, MD, professor of medicine at Scripps Research Translational Institute, La Jolla, Calif., as saying that AI could save 20% of a physician’s time, which could be spent with patients. Dr. Morren saw it differently. “I know where that 20% of time liberated is going to go. I’m going to see 20% more patients. I’m a realist,” he said, to audience laughter.

He also predicted that AI will be found in wearables and devices, allowing health care to expand into the patient’s home in real time. “A lot of what we’re wearing is going to be an extension of the doctor’s office,” he said.

For those hoping for more guidance, Dr. Morren noted that he is the chairman of the professional practice committee of AANEM, and the group will be putting out a position statement within the next couple of months. “It will be a little bit of a blueprint for the path going forward. There are specific things that need to be done. In research, for example, you have to ensure that datasets are diverse enough. To do that we need to have inter-institutional collaboration. We have to ensure patient privacy. Consent for this needs to be a little more explicit because this is a novel area. Those are things that need to be stipulated and ratified through a task force.”

Dr. Morren has no relevant financial disclosures.

PHOENIX – Artificial intelligence (AI) is poised to dramatically alter health care, and it presents opportunities for increased production and automation of some tasks. However, it is prone to error and ‘hallucinations’ despite an authoritative tone, so its conclusions must be verified.

Those were some of the messages from a talk by John Morren, MD, an associate professor of neurology at Case Western Reserve University, Cleveland, who spoke about AI at the 2023 annual meeting of the American Association for Neuromuscular and Electrodiagnostic Medicine (AANEM).

He encouraged attendees to get involved in the conversation of AI, because it is here to stay and will have a big impact on health care. “If we’re not around the table making decisions, decisions will be made for us in our absence and won’t be in our favor,” said Dr. Morren.

He started out his talk by asking if anyone in the room had used AI. After about half raised their hands, he countered that nearly everyone likely had. Voice assistants like SIRI and Alexa, social media with curated feeds, online shopping tools that provide product suggestions, and content recommendations from streaming services like Netflix all rely on AI technology.

Within medicine, AI is already playing a role in various fields, including medical imaging, disease diagnosis, drug discovery and development, predictive analytics, personalized medicine, telemedicine, and health care management.

It also has potential to be used on the job. For example, ChatGPT can generate and refine conversations towards a specific length, format, style, and level of detail. Alternatives include Bing AI from Microsoft, Bard AI from Google, Writesonic, Copy.ai, SpinBot, HIX.AI, and Chatsonic.

Specific to medicine, Consensus is a search engine that uses AI to search for, summarize, and synthesize studies from peer-reviewed literature.
 

Trust, but verify

Dr. Morren presented some specific use cases, including patient education and responses to patient inquiries, as well as generating letters to insurance companies appealing denial of coverage claims. He also showed an example where he asked Bing AI to explain to a patient, at a sixth- to seventh-grade reading level, the red-flag symptoms of myasthenic crisis.

AI can generate summaries of clinical evidence of previous studies. Asked by this reporter how to trust the accuracies of the summaries if the user hasn’t thoroughly read the papers, he acknowledged the imperfection of AI. “I would say that if you’re going to make a decision that you would not have made normally based on the summary that it’s giving, if you can find the fact that you’re anchoring the decision on, go into the article yourself and make sure that it’s well vetted. The AI is just good to tap you on your shoulder and say, ‘hey, just consider this.’ That’s all it is. You should always trust, but verify. If the AI is forcing you to say something new that you would not say, maybe don’t do it – or at least research it to know that it’s the truth and then you elevate yourself and get yourself to the next level.”
 

Limitations

The need to verify can create its own burden, according to one attendee. “I often find I end up spending more time verifying [what ChatGPT has provided]. This seems to take more time than a traditional way of going to PubMed or UpToDate or any of the other human generated consensus way,” he said.

Dr. Morren replied that he wouldn’t recommend using ChatGPT to query medical literature. Instead he recommended Consensus, which only searches the peer-reviewed medical literature.

Another key limitation is that most AI programs are date limited: For example, ChatGPT doesn’t include information after September 2021, though this may change with paid subscriptions. He also starkly warned the audience to never enter sensitive information, including patient identifiers.

There are legal and ethical considerations to AI. Dr. Morren warned against overreliance on AI, as this could undermine compassion and lead to erosion of trust, which makes it important to disclose any use of AI-generated content.

Another attendee raised concerns that AI may be generating research content, including slides for presentations, abstracts, titles, or article text. Dr. Morren said that some organizations, such as the International Committee of Medical Journal Editors, have incorporated AI in their recommendations, stating that authors should disclose any contributions of AI to their publications. However, there is little that can be done to identify AI-generated content, leaving it up to the honor code.

Asked to make predictions about how AI will evolve in the clinic over the next 2-3 years, Dr. Morren suggested that it will likely be embedded in electronic medical records. He anticipated that it will save physicians time so that they can spend more time interacting directly with patients. He quoted Eric Topol, MD, professor of medicine at Scripps Research Translational Institute, La Jolla, Calif., as saying that AI could save 20% of a physician’s time, which could be spent with patients. Dr. Morren saw it differently. “I know where that 20% of time liberated is going to go. I’m going to see 20% more patients. I’m a realist,” he said, to audience laughter.

He also predicted that AI will be found in wearables and devices, allowing health care to expand into the patient’s home in real time. “A lot of what we’re wearing is going to be an extension of the doctor’s office,” he said.

For those hoping for more guidance, Dr. Morren noted that he is the chairman of the professional practice committee of AANEM, and the group will be putting out a position statement within the next couple of months. “It will be a little bit of a blueprint for the path going forward. There are specific things that need to be done. In research, for example, you have to ensure that datasets are diverse enough. To do that we need to have inter-institutional collaboration. We have to ensure patient privacy. Consent for this needs to be a little more explicit because this is a novel area. Those are things that need to be stipulated and ratified through a task force.”

Dr. Morren has no relevant financial disclosures.

I am not a marketing person. I never will be. I don’t think like one.

A current article on FiercePharma talked about Boehringer Ingelheim’s recent “rebranding,” which involved (among other things) changing the blues in its logo and ads to greens.

Maybe someone else out there would notice that change, but I wouldn’t have if I hadn’t read about it. Nor am I sure what affect it would have on me, if any. But I’m sure they paid psychologists and marketing teams quite a bit to make sure it was a good idea.

Likewise, when AbbVie repackaged Ubrelvy from 10 to a package to 16, the company felt the need to change the design of the sample boxes (which are also now green). I’m pretty sure none of my patients noticed. The only reason I did is because I’m the one who stocks my sample shelf here.

Abbvie and Boehringer aren’t alone in this, of course. Pharmaceutical marketing is big business. I understand the companies want doctors and patients to know about their products. In that respect they’re no different from General Motors or Kellogg’s.

But pharmaceuticals fall into a different area. Kellogg’s products don’t require a middleman handing you a script allowing you to buy corn flakes, so although the products are sold to the public, they also have to be sold to a person who isn’t buying them – the prescriber.

Not all these ads are bad, of course. At best they raise public awareness of different health conditions and the options to treat them. At worst ... well, currently there are several movies out there about the results of marketing done by the Sackler family and Purdue.

To me, most pharmaceutical ads look the same. They show happy people going about their lives, with the impression being that they couldn’t have done this without the benefit of the drug being marketed.

To a large extent I can’t knock that. Pharmaceuticals are amazing things. They’ve contributed dramatically to human health, life quality, and longevity.

But would I, or most people, notice if the lettering in the ads were blue, green, or yellow? Probably not. Someone with a background in the psychology of marketing would be able to show me data on how different colors affect our perceptions, but I still look at this and wonder if the money could have been better spent.

Maybe that’s why I’m not in marketing. I tend to be on the practical side. The idea of hiring a celebrity to endorse a migraine (or pretty much any) medication would never have occurred to me. I have no idea how much Pfizer paid Lady Gaga to sell Nurtec, but I’m pretty sure it’s a lot more than I’ll earn this year. Probably ever.

Like most neurologists I’m hopelessly left-brained. But I still wonder how much things like this really make a difference.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

I am not a marketing person. I never will be. I don’t think like one.

A current article on FiercePharma talked about Boehringer Ingelheim’s recent “rebranding,” which involved (among other things) changing the blues in its logo and ads to greens.

Maybe someone else out there would notice that change, but I wouldn’t have if I hadn’t read about it. Nor am I sure what affect it would have on me, if any. But I’m sure they paid psychologists and marketing teams quite a bit to make sure it was a good idea.

Likewise, when AbbVie repackaged Ubrelvy from 10 to a package to 16, the company felt the need to change the design of the sample boxes (which are also now green). I’m pretty sure none of my patients noticed. The only reason I did is because I’m the one who stocks my sample shelf here.

Abbvie and Boehringer aren’t alone in this, of course. Pharmaceutical marketing is big business. I understand the companies want doctors and patients to know about their products. In that respect they’re no different from General Motors or Kellogg’s.

But pharmaceuticals fall into a different area. Kellogg’s products don’t require a middleman handing you a script allowing you to buy corn flakes, so although the products are sold to the public, they also have to be sold to a person who isn’t buying them – the prescriber.

Not all these ads are bad, of course. At best they raise public awareness of different health conditions and the options to treat them. At worst ... well, currently there are several movies out there about the results of marketing done by the Sackler family and Purdue.

To me, most pharmaceutical ads look the same. They show happy people going about their lives, with the impression being that they couldn’t have done this without the benefit of the drug being marketed.

To a large extent I can’t knock that. Pharmaceuticals are amazing things. They’ve contributed dramatically to human health, life quality, and longevity.

But would I, or most people, notice if the lettering in the ads were blue, green, or yellow? Probably not. Someone with a background in the psychology of marketing would be able to show me data on how different colors affect our perceptions, but I still look at this and wonder if the money could have been better spent.

Maybe that’s why I’m not in marketing. I tend to be on the practical side. The idea of hiring a celebrity to endorse a migraine (or pretty much any) medication would never have occurred to me. I have no idea how much Pfizer paid Lady Gaga to sell Nurtec, but I’m pretty sure it’s a lot more than I’ll earn this year. Probably ever.

Like most neurologists I’m hopelessly left-brained. But I still wonder how much things like this really make a difference.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

I am not a marketing person. I never will be. I don’t think like one.

A current article on FiercePharma talked about Boehringer Ingelheim’s recent “rebranding,” which involved (among other things) changing the blues in its logo and ads to greens.

Maybe someone else out there would notice that change, but I wouldn’t have if I hadn’t read about it. Nor am I sure what affect it would have on me, if any. But I’m sure they paid psychologists and marketing teams quite a bit to make sure it was a good idea.

Likewise, when AbbVie repackaged Ubrelvy from 10 to a package to 16, the company felt the need to change the design of the sample boxes (which are also now green). I’m pretty sure none of my patients noticed. The only reason I did is because I’m the one who stocks my sample shelf here.

Abbvie and Boehringer aren’t alone in this, of course. Pharmaceutical marketing is big business. I understand the companies want doctors and patients to know about their products. In that respect they’re no different from General Motors or Kellogg’s.

But pharmaceuticals fall into a different area. Kellogg’s products don’t require a middleman handing you a script allowing you to buy corn flakes, so although the products are sold to the public, they also have to be sold to a person who isn’t buying them – the prescriber.

Not all these ads are bad, of course. At best they raise public awareness of different health conditions and the options to treat them. At worst ... well, currently there are several movies out there about the results of marketing done by the Sackler family and Purdue.

To me, most pharmaceutical ads look the same. They show happy people going about their lives, with the impression being that they couldn’t have done this without the benefit of the drug being marketed.

To a large extent I can’t knock that. Pharmaceuticals are amazing things. They’ve contributed dramatically to human health, life quality, and longevity.

But would I, or most people, notice if the lettering in the ads were blue, green, or yellow? Probably not. Someone with a background in the psychology of marketing would be able to show me data on how different colors affect our perceptions, but I still look at this and wonder if the money could have been better spent.

Maybe that’s why I’m not in marketing. I tend to be on the practical side. The idea of hiring a celebrity to endorse a migraine (or pretty much any) medication would never have occurred to me. I have no idea how much Pfizer paid Lady Gaga to sell Nurtec, but I’m pretty sure it’s a lot more than I’ll earn this year. Probably ever.

Like most neurologists I’m hopelessly left-brained. But I still wonder how much things like this really make a difference.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Emergency department (ED) boarding in the United States has escalated to crisis levels, sparking significant concerns among adults, according to a poll conducted on behalf of the American College of Emergency Physicians in September 2023. This issue not only affects patient care but also has far-reaching consequences for the efficiency of emergency medical services (EMS).

The survey interviewed 2,164 adults and showed that an overwhelming majority (80%) expressed serious concerns about the boarding crisis. Moreover, 43% of respondents either delayed seeking medical care at an ED or avoided it altogether if they anticipated prolonged wait times before being admitted to the hospital or transferred to another facility.

Nearly half of adults (44%) experienced long wait times following initial care in an ED, and 16% of these adults reported 13 or more hours of waiting after receiving initial care.

“The boarding crisis is a predictable result of an acute care hospital system with insufficient capacity – we lack enough space and staff in our acute care hospitals, as we have not created the bed capacity needed for an aging and higher acuity patient population, and staffing shortages for inpatient beds have resulted in a longer hospital length of stay that we observe as boarding patients in the ED,” Arjun Venkatesh, MD, chief of emergency services at Yale New Haven Hospital, told this news organization, commenting on the factors contributing to this crisis.

One concerning side effect of boarding in EDs is the delayed response of ambulance services. When a hospital is unprepared to receive patients arriving in an ambulance, ambulance crews often wait with the patients for extended periods until the hospital can admit them. This situation can have critical implications, as parked ambulances are unable to respond to other emergencies in the community.

Adults who have endured long wait times in EDs voiced concerns about the negative impact such delays can have on their medical care. The experiences of patients and their families have underscored the urgency of addressing the boarding crisis.

“There are no low-hanging fruit solutions or simple communication strategies to alleviate these concerns,” said Dr. Venkatesh, adding that “the only way to change that perception is to change the care by addressing the lack of inpatient capacity and community care capacity to avoid back-up in the ED.”

The poll revealed that 93% of adults across different demographic groups considered EMS, including paramedics, essential. Older adults were more likely to emphasize the significance of these services than were younger adults.

“We all need a place for people to go when there is an emergency, whether it be trauma, a heart attack, a stroke, or similar conditions,” said Scott Weiner, MD, associate professor of emergency medicine at Harvard Medical School and attending emergency physician at Brigham and Women’s Hospital, Boston.

“However, the modern ED is much more than that. It has become the center for coordination of care across the health system where diagnostic tests can be completed promptly, where follow-up care is arranged, and where behavioral health emergencies come,” he added.

A vast majority, 89%, believed that additional or supplemental government funding should be directed toward these essential services, highlighting the public’s concern for the accessibility of EMS.

Dr. Weiner stressed the need for a complete realignment of the payment system: “It’s unfair that public insurance like Medicaid reimburses sometimes less than a quarter of the rate that commercial insurance pays for the exact same service. This exacerbates and perpetuates disparities in health.” According to him, the solution may involve transitioning to a single-payer model, but it could face significant challenges owing to people’s apprehensions about changes in their health care and negative perceptions of “socialized” medicine in other countries. Furthermore, the poll found that the largest share of adults (42%) believed that hospitals should take the lead in improving boarding and shortening ED wait times. These findings indicated the need for hospitals to reevaluate their processes and capabilities to reduce boarding and enhance the overall patient experience in EDs.

“The top three entities that can fix the boarding crisis are hospitals, Congress, and insurance companies,” noted Dr. Wiener. “However, until there is parity at all levels, hospitals will continue to accept lucrative elective admissions but allow ED patients to linger without a bed,” he added.
 

A version of this article first appeared on Medscape.com.

Emergency department (ED) boarding in the United States has escalated to crisis levels, sparking significant concerns among adults, according to a poll conducted on behalf of the American College of Emergency Physicians in September 2023. This issue not only affects patient care but also has far-reaching consequences for the efficiency of emergency medical services (EMS).

The survey interviewed 2,164 adults and showed that an overwhelming majority (80%) expressed serious concerns about the boarding crisis. Moreover, 43% of respondents either delayed seeking medical care at an ED or avoided it altogether if they anticipated prolonged wait times before being admitted to the hospital or transferred to another facility.

Nearly half of adults (44%) experienced long wait times following initial care in an ED, and 16% of these adults reported 13 or more hours of waiting after receiving initial care.

“The boarding crisis is a predictable result of an acute care hospital system with insufficient capacity – we lack enough space and staff in our acute care hospitals, as we have not created the bed capacity needed for an aging and higher acuity patient population, and staffing shortages for inpatient beds have resulted in a longer hospital length of stay that we observe as boarding patients in the ED,” Arjun Venkatesh, MD, chief of emergency services at Yale New Haven Hospital, told this news organization, commenting on the factors contributing to this crisis.

One concerning side effect of boarding in EDs is the delayed response of ambulance services. When a hospital is unprepared to receive patients arriving in an ambulance, ambulance crews often wait with the patients for extended periods until the hospital can admit them. This situation can have critical implications, as parked ambulances are unable to respond to other emergencies in the community.

Adults who have endured long wait times in EDs voiced concerns about the negative impact such delays can have on their medical care. The experiences of patients and their families have underscored the urgency of addressing the boarding crisis.

“There are no low-hanging fruit solutions or simple communication strategies to alleviate these concerns,” said Dr. Venkatesh, adding that “the only way to change that perception is to change the care by addressing the lack of inpatient capacity and community care capacity to avoid back-up in the ED.”

The poll revealed that 93% of adults across different demographic groups considered EMS, including paramedics, essential. Older adults were more likely to emphasize the significance of these services than were younger adults.

“We all need a place for people to go when there is an emergency, whether it be trauma, a heart attack, a stroke, or similar conditions,” said Scott Weiner, MD, associate professor of emergency medicine at Harvard Medical School and attending emergency physician at Brigham and Women’s Hospital, Boston.

“However, the modern ED is much more than that. It has become the center for coordination of care across the health system where diagnostic tests can be completed promptly, where follow-up care is arranged, and where behavioral health emergencies come,” he added.

A vast majority, 89%, believed that additional or supplemental government funding should be directed toward these essential services, highlighting the public’s concern for the accessibility of EMS.

Dr. Weiner stressed the need for a complete realignment of the payment system: “It’s unfair that public insurance like Medicaid reimburses sometimes less than a quarter of the rate that commercial insurance pays for the exact same service. This exacerbates and perpetuates disparities in health.” According to him, the solution may involve transitioning to a single-payer model, but it could face significant challenges owing to people’s apprehensions about changes in their health care and negative perceptions of “socialized” medicine in other countries. Furthermore, the poll found that the largest share of adults (42%) believed that hospitals should take the lead in improving boarding and shortening ED wait times. These findings indicated the need for hospitals to reevaluate their processes and capabilities to reduce boarding and enhance the overall patient experience in EDs.

“The top three entities that can fix the boarding crisis are hospitals, Congress, and insurance companies,” noted Dr. Wiener. “However, until there is parity at all levels, hospitals will continue to accept lucrative elective admissions but allow ED patients to linger without a bed,” he added.
 

A version of this article first appeared on Medscape.com.

Emergency department (ED) boarding in the United States has escalated to crisis levels, sparking significant concerns among adults, according to a poll conducted on behalf of the American College of Emergency Physicians in September 2023. This issue not only affects patient care but also has far-reaching consequences for the efficiency of emergency medical services (EMS).

The survey interviewed 2,164 adults and showed that an overwhelming majority (80%) expressed serious concerns about the boarding crisis. Moreover, 43% of respondents either delayed seeking medical care at an ED or avoided it altogether if they anticipated prolonged wait times before being admitted to the hospital or transferred to another facility.

Nearly half of adults (44%) experienced long wait times following initial care in an ED, and 16% of these adults reported 13 or more hours of waiting after receiving initial care.

“The boarding crisis is a predictable result of an acute care hospital system with insufficient capacity – we lack enough space and staff in our acute care hospitals, as we have not created the bed capacity needed for an aging and higher acuity patient population, and staffing shortages for inpatient beds have resulted in a longer hospital length of stay that we observe as boarding patients in the ED,” Arjun Venkatesh, MD, chief of emergency services at Yale New Haven Hospital, told this news organization, commenting on the factors contributing to this crisis.

One concerning side effect of boarding in EDs is the delayed response of ambulance services. When a hospital is unprepared to receive patients arriving in an ambulance, ambulance crews often wait with the patients for extended periods until the hospital can admit them. This situation can have critical implications, as parked ambulances are unable to respond to other emergencies in the community.

Adults who have endured long wait times in EDs voiced concerns about the negative impact such delays can have on their medical care. The experiences of patients and their families have underscored the urgency of addressing the boarding crisis.

“There are no low-hanging fruit solutions or simple communication strategies to alleviate these concerns,” said Dr. Venkatesh, adding that “the only way to change that perception is to change the care by addressing the lack of inpatient capacity and community care capacity to avoid back-up in the ED.”

The poll revealed that 93% of adults across different demographic groups considered EMS, including paramedics, essential. Older adults were more likely to emphasize the significance of these services than were younger adults.

“We all need a place for people to go when there is an emergency, whether it be trauma, a heart attack, a stroke, or similar conditions,” said Scott Weiner, MD, associate professor of emergency medicine at Harvard Medical School and attending emergency physician at Brigham and Women’s Hospital, Boston.

“However, the modern ED is much more than that. It has become the center for coordination of care across the health system where diagnostic tests can be completed promptly, where follow-up care is arranged, and where behavioral health emergencies come,” he added.

A vast majority, 89%, believed that additional or supplemental government funding should be directed toward these essential services, highlighting the public’s concern for the accessibility of EMS.

Dr. Weiner stressed the need for a complete realignment of the payment system: “It’s unfair that public insurance like Medicaid reimburses sometimes less than a quarter of the rate that commercial insurance pays for the exact same service. This exacerbates and perpetuates disparities in health.” According to him, the solution may involve transitioning to a single-payer model, but it could face significant challenges owing to people’s apprehensions about changes in their health care and negative perceptions of “socialized” medicine in other countries. Furthermore, the poll found that the largest share of adults (42%) believed that hospitals should take the lead in improving boarding and shortening ED wait times. These findings indicated the need for hospitals to reevaluate their processes and capabilities to reduce boarding and enhance the overall patient experience in EDs.

“The top three entities that can fix the boarding crisis are hospitals, Congress, and insurance companies,” noted Dr. Wiener. “However, until there is parity at all levels, hospitals will continue to accept lucrative elective admissions but allow ED patients to linger without a bed,” he added.
 

A version of this article first appeared on Medscape.com.

PHILADELPHIA – A proprietary formula showed good performance stratifying the risk of adults with early-stage chronic kidney disease (CKD) advancing to more severe kidney dysfunction and increased health care needs. The analyses offer the possibility of focusing intensified medical management of early-stage CKD on those patients who could potentially receive the most benefit.

The Klinrisk model predicts the risk of an adult with early-stage CKD developing either a 40% or greater drop in estimated glomerular filtration rate or kidney failure. It calculates risk based on 20 lab-measured variables that include serum creatinine, urine albumin-to-creatinine ratio, and other values taken from routinely ordered tests such as complete blood cell counts, chemistry panels, comprehensive metabolic panels, and urinalysis.

Mitchel L. Zoler/MDedge News

In the most recent and largest external validation study using data from 4.6 million American adults enrolled in commercial and Medicare insurance plans, the results showed Klinrisk correctly predicted CKD progression in 80%-83% of individuals over 2 years and in 78%-83% of individuals over 5 years, depending on the insurance provider, Navdeep Tangri, MD, PhD, reported at the annual meeting of the American Society of Nephrology. When urinalysis data were available, the model correctly predicted CKD progression in 81%-87% of individuals over 2 years and in 80%-87% of individuals over 5 years. These results follow prior reports of several other successful validations of Klinrisk.
 

‘Ready to implement’

“The Klinrisk model is ready to implement by any payer, health system, or clinic where the needed lab data are available,” said Dr. Tangri, a nephrologist and professor at the University of Manitoba, Winnipeg, and founder of Klinrisk Inc., the company developing and commercializing the Klinrisk assessment tool.

For the time being, Dr. Tangri sees Klinrisk as a population health device that can allow insurers and health systems to track management quality and quality improvement and to target patients who stand to benefit most from relatively expensive resources. This includes prescriptions for finerenone (Kerendia, Bayer) for people who also have type 2 diabetes, and agents from the class of sodium-glucose cotransporter 2 (SGLT2) inhibitors such as dapagliflozin (Farxiga, AstraZeneca) and empagliflozin (Jardiance, Boehringer Ingelheim and Lilly).

He has also begun discussions with the Food and Drug Administration about the data the agency will need to consider Klinrisk for potential approval as a new medical device, perhaps in 2025. That’s how he envisions getting a Klinrisk assessment into the hands of caregivers that they could use with individual patients to create an appropriate treatment plan.

Results from his new analysis showed that “all the kidney disease action is in the 10%-20% of people with the highest risk on Klinrisk, while not much happens in those in the bottom half,” Dr. Tangri said during his presentation.

“We’re trying to find the patients who get the largest [absolute] benefit from intensified treatment,” he added in an interview. “Klinrisk finds people with high-risk kidney disease early on, when kidney function is still normal or near normal. High-risk patients are often completely unrecognized. Risk-based management” that identifies the early-stage CKD patients who would benefit most from treatment with an SGLT2 inhibitor, finerenone, and other foundational treatments to slow CKD progression “is better than the free-for-all that occurs today.”

Simplified data collection

“Klinrisk is very effective,” but requires follow-up by clinicians and health systems to implement its findings, commented Josef Coresh, MD, a professor of clinical epidemiology at Johns Hopkins Bloomberg, Baltimore. Dr. Coresh compared it with a free equation that estimates a person’s risk for a 40% drop in kidney function over the next 3 years developed by Dr. Tangri, Dr. Coresh, and many collaborators led by Morgan C. Grams, MD, PhD, of New York University that they published in 2022, and posted on a website of the CKD Prognosis Consortium.

Mitchel L. Zoler/MDedge News

The CKD Prognosis Consortium formula “takes a different approach” from Klinrisk. The commercial formula “is simpler, only using lab measures, and avoids inputs taken from physical examination such as systolic blood pressure and body mass index and health history data such as smoking, noted Dr. Coresh. He also speculated that “a commercial formula that must be paid for may counterintuitively result in better follow-up for making management changes if it uses some of the resources for education and system changes.”

Using data from multiple sources, like the CKD Prognosis Consortium equation, can create implementation challenges, said Dr. Tangri. “Lab results don’t vary much,” which makes Klinrisk “quite an improvement for implementation. It’s easier to implement.”

Other findings from the newest validation study that Dr. Tangri presented were that the people studied with Klinrisk scores in the top 10% had, over the next 2 years of follow-up and compared with people in the bottom half for Klinrisk staging, a 3- to 5-fold higher rate of all-cause medical costs, a 13-30-fold increase in CKD-related costs, and a 5- to 10-fold increase in hospitalizations and ED visits.

Early identification of CKD and early initiation of intensified treatment for high-risk patients can reduce the rate of progression to dialysis, reduce hospitalizations for heart failure, and lower the cost of care, Dr. Tangri said.

The validation study in 4.6 million Americans was sponsored by Boehringer Ingelheim. Dr. Tangri founded and has an ownership interest in Klinrisk. He has also received honoraria from, has ownership interests in, and has been a consultant to multiple pharmaceutical companies. Dr. Coresh had no disclosures.

PHILADELPHIA – A proprietary formula showed good performance stratifying the risk of adults with early-stage chronic kidney disease (CKD) advancing to more severe kidney dysfunction and increased health care needs. The analyses offer the possibility of focusing intensified medical management of early-stage CKD on those patients who could potentially receive the most benefit.

The Klinrisk model predicts the risk of an adult with early-stage CKD developing either a 40% or greater drop in estimated glomerular filtration rate or kidney failure. It calculates risk based on 20 lab-measured variables that include serum creatinine, urine albumin-to-creatinine ratio, and other values taken from routinely ordered tests such as complete blood cell counts, chemistry panels, comprehensive metabolic panels, and urinalysis.

Mitchel L. Zoler/MDedge News

In the most recent and largest external validation study using data from 4.6 million American adults enrolled in commercial and Medicare insurance plans, the results showed Klinrisk correctly predicted CKD progression in 80%-83% of individuals over 2 years and in 78%-83% of individuals over 5 years, depending on the insurance provider, Navdeep Tangri, MD, PhD, reported at the annual meeting of the American Society of Nephrology. When urinalysis data were available, the model correctly predicted CKD progression in 81%-87% of individuals over 2 years and in 80%-87% of individuals over 5 years. These results follow prior reports of several other successful validations of Klinrisk.
 

‘Ready to implement’

“The Klinrisk model is ready to implement by any payer, health system, or clinic where the needed lab data are available,” said Dr. Tangri, a nephrologist and professor at the University of Manitoba, Winnipeg, and founder of Klinrisk Inc., the company developing and commercializing the Klinrisk assessment tool.

For the time being, Dr. Tangri sees Klinrisk as a population health device that can allow insurers and health systems to track management quality and quality improvement and to target patients who stand to benefit most from relatively expensive resources. This includes prescriptions for finerenone (Kerendia, Bayer) for people who also have type 2 diabetes, and agents from the class of sodium-glucose cotransporter 2 (SGLT2) inhibitors such as dapagliflozin (Farxiga, AstraZeneca) and empagliflozin (Jardiance, Boehringer Ingelheim and Lilly).

He has also begun discussions with the Food and Drug Administration about the data the agency will need to consider Klinrisk for potential approval as a new medical device, perhaps in 2025. That’s how he envisions getting a Klinrisk assessment into the hands of caregivers that they could use with individual patients to create an appropriate treatment plan.

Results from his new analysis showed that “all the kidney disease action is in the 10%-20% of people with the highest risk on Klinrisk, while not much happens in those in the bottom half,” Dr. Tangri said during his presentation.

“We’re trying to find the patients who get the largest [absolute] benefit from intensified treatment,” he added in an interview. “Klinrisk finds people with high-risk kidney disease early on, when kidney function is still normal or near normal. High-risk patients are often completely unrecognized. Risk-based management” that identifies the early-stage CKD patients who would benefit most from treatment with an SGLT2 inhibitor, finerenone, and other foundational treatments to slow CKD progression “is better than the free-for-all that occurs today.”

Simplified data collection

“Klinrisk is very effective,” but requires follow-up by clinicians and health systems to implement its findings, commented Josef Coresh, MD, a professor of clinical epidemiology at Johns Hopkins Bloomberg, Baltimore. Dr. Coresh compared it with a free equation that estimates a person’s risk for a 40% drop in kidney function over the next 3 years developed by Dr. Tangri, Dr. Coresh, and many collaborators led by Morgan C. Grams, MD, PhD, of New York University that they published in 2022, and posted on a website of the CKD Prognosis Consortium.

Mitchel L. Zoler/MDedge News

The CKD Prognosis Consortium formula “takes a different approach” from Klinrisk. The commercial formula “is simpler, only using lab measures, and avoids inputs taken from physical examination such as systolic blood pressure and body mass index and health history data such as smoking, noted Dr. Coresh. He also speculated that “a commercial formula that must be paid for may counterintuitively result in better follow-up for making management changes if it uses some of the resources for education and system changes.”

Using data from multiple sources, like the CKD Prognosis Consortium equation, can create implementation challenges, said Dr. Tangri. “Lab results don’t vary much,” which makes Klinrisk “quite an improvement for implementation. It’s easier to implement.”

Other findings from the newest validation study that Dr. Tangri presented were that the people studied with Klinrisk scores in the top 10% had, over the next 2 years of follow-up and compared with people in the bottom half for Klinrisk staging, a 3- to 5-fold higher rate of all-cause medical costs, a 13-30-fold increase in CKD-related costs, and a 5- to 10-fold increase in hospitalizations and ED visits.

Early identification of CKD and early initiation of intensified treatment for high-risk patients can reduce the rate of progression to dialysis, reduce hospitalizations for heart failure, and lower the cost of care, Dr. Tangri said.

The validation study in 4.6 million Americans was sponsored by Boehringer Ingelheim. Dr. Tangri founded and has an ownership interest in Klinrisk. He has also received honoraria from, has ownership interests in, and has been a consultant to multiple pharmaceutical companies. Dr. Coresh had no disclosures.

PHILADELPHIA – A proprietary formula showed good performance stratifying the risk of adults with early-stage chronic kidney disease (CKD) advancing to more severe kidney dysfunction and increased health care needs. The analyses offer the possibility of focusing intensified medical management of early-stage CKD on those patients who could potentially receive the most benefit.

The Klinrisk model predicts the risk of an adult with early-stage CKD developing either a 40% or greater drop in estimated glomerular filtration rate or kidney failure. It calculates risk based on 20 lab-measured variables that include serum creatinine, urine albumin-to-creatinine ratio, and other values taken from routinely ordered tests such as complete blood cell counts, chemistry panels, comprehensive metabolic panels, and urinalysis.

Mitchel L. Zoler/MDedge News

In the most recent and largest external validation study using data from 4.6 million American adults enrolled in commercial and Medicare insurance plans, the results showed Klinrisk correctly predicted CKD progression in 80%-83% of individuals over 2 years and in 78%-83% of individuals over 5 years, depending on the insurance provider, Navdeep Tangri, MD, PhD, reported at the annual meeting of the American Society of Nephrology. When urinalysis data were available, the model correctly predicted CKD progression in 81%-87% of individuals over 2 years and in 80%-87% of individuals over 5 years. These results follow prior reports of several other successful validations of Klinrisk.
 

‘Ready to implement’

“The Klinrisk model is ready to implement by any payer, health system, or clinic where the needed lab data are available,” said Dr. Tangri, a nephrologist and professor at the University of Manitoba, Winnipeg, and founder of Klinrisk Inc., the company developing and commercializing the Klinrisk assessment tool.

For the time being, Dr. Tangri sees Klinrisk as a population health device that can allow insurers and health systems to track management quality and quality improvement and to target patients who stand to benefit most from relatively expensive resources. This includes prescriptions for finerenone (Kerendia, Bayer) for people who also have type 2 diabetes, and agents from the class of sodium-glucose cotransporter 2 (SGLT2) inhibitors such as dapagliflozin (Farxiga, AstraZeneca) and empagliflozin (Jardiance, Boehringer Ingelheim and Lilly).

He has also begun discussions with the Food and Drug Administration about the data the agency will need to consider Klinrisk for potential approval as a new medical device, perhaps in 2025. That’s how he envisions getting a Klinrisk assessment into the hands of caregivers that they could use with individual patients to create an appropriate treatment plan.

Results from his new analysis showed that “all the kidney disease action is in the 10%-20% of people with the highest risk on Klinrisk, while not much happens in those in the bottom half,” Dr. Tangri said during his presentation.

“We’re trying to find the patients who get the largest [absolute] benefit from intensified treatment,” he added in an interview. “Klinrisk finds people with high-risk kidney disease early on, when kidney function is still normal or near normal. High-risk patients are often completely unrecognized. Risk-based management” that identifies the early-stage CKD patients who would benefit most from treatment with an SGLT2 inhibitor, finerenone, and other foundational treatments to slow CKD progression “is better than the free-for-all that occurs today.”

Simplified data collection

“Klinrisk is very effective,” but requires follow-up by clinicians and health systems to implement its findings, commented Josef Coresh, MD, a professor of clinical epidemiology at Johns Hopkins Bloomberg, Baltimore. Dr. Coresh compared it with a free equation that estimates a person’s risk for a 40% drop in kidney function over the next 3 years developed by Dr. Tangri, Dr. Coresh, and many collaborators led by Morgan C. Grams, MD, PhD, of New York University that they published in 2022, and posted on a website of the CKD Prognosis Consortium.

Mitchel L. Zoler/MDedge News

The CKD Prognosis Consortium formula “takes a different approach” from Klinrisk. The commercial formula “is simpler, only using lab measures, and avoids inputs taken from physical examination such as systolic blood pressure and body mass index and health history data such as smoking, noted Dr. Coresh. He also speculated that “a commercial formula that must be paid for may counterintuitively result in better follow-up for making management changes if it uses some of the resources for education and system changes.”

Using data from multiple sources, like the CKD Prognosis Consortium equation, can create implementation challenges, said Dr. Tangri. “Lab results don’t vary much,” which makes Klinrisk “quite an improvement for implementation. It’s easier to implement.”

Other findings from the newest validation study that Dr. Tangri presented were that the people studied with Klinrisk scores in the top 10% had, over the next 2 years of follow-up and compared with people in the bottom half for Klinrisk staging, a 3- to 5-fold higher rate of all-cause medical costs, a 13-30-fold increase in CKD-related costs, and a 5- to 10-fold increase in hospitalizations and ED visits.

Early identification of CKD and early initiation of intensified treatment for high-risk patients can reduce the rate of progression to dialysis, reduce hospitalizations for heart failure, and lower the cost of care, Dr. Tangri said.

The validation study in 4.6 million Americans was sponsored by Boehringer Ingelheim. Dr. Tangri founded and has an ownership interest in Klinrisk. He has also received honoraria from, has ownership interests in, and has been a consultant to multiple pharmaceutical companies. Dr. Coresh had no disclosures.

Routine screenings for signs of cavities and gum disease by primary care clinicians may not catch patients most at risk of these conditions, according to a statement by the U.S. Preventive Services Task Force (USPSTF) that was published in JAMA.

Suggesting ways to improve oral health also may fail to engage the patients who most need the message, the group said in its statement.

The task force is not suggesting that primary care providers stop all oral health screening of adults or that they never discuss ways to improve oral health. But the current evidence of the most effective oral health screenings or enhancement strategies in primary care settings received an “I” rating, for “Inconclusive.” The highest ranking a screening can receive is an “A” or “B,” which indicate that there is strong evidence for conducting a screening, while a “C” would indicate that clinicians could rarely provide a screening, and a “D” would indicate not to, given the current evidence.

Primary care clinicians should immediately refer any patients with apparent caries or gum disease to a dentist, the USPSTF noted. But what clinicians should do for patients who have no obvious oral health problems is up for debate.

“The ‘I’ is a note about where the evidence is at this point and then a call for more research to see if we can’t get some more clarity for next time,” said John Ruiz, PhD, professor of clinical psychology at the University of Arizona, Tucson, who is a member of the task force.

More than 90% of U.S. adults may have caries, including 26% with untreated caries that can cause serious infections or tooth loss. In addition, 42% of adults have some type of gum disease. More than two-thirds of Americans aged 65 or older have gum disease, and it is the leading cause of tooth loss in this population. People earning low incomes and those who do not have health insurance or who belong to a marginalized racial or ethnic group are at greater risk of the harms of caries and gum disease.

“Oral health care is important to overall health,” and any new research on oral health screening and enhancement efforts should be demographically representative of adults affected by these conditions, Dr. Ruiz said.

In an accompanying editorial, oral health researchers from the National Institutes of Health and the University of California, San Francisco, echoed the call for representative research and encouraged closer collaboration between primary care providers and dentists to promote oral health.

“Oral health screening and referral by medical primary care clinicians can help ensure that individuals get to the dental chair to receive needed interventions that can benefit both oral and potentially overall health,” the authors wrote. “Likewise, medical challenges and oral mucosal manifestations of chronic health conditions detected at a dental visit should result in medical referral, allowing prompt evaluation and treatment.”
 

Lack of data

The USPSTF defined oral health screenings for patients older than 18 who have no obvious signs of caries or gum disease as looking at a patient’s mouth during physical exams. Additionally, clinicians might use prediction models to identify patients at greater risk of facing these problems.

Strategies to improve oral health include providing encouragement to patients to reduce intake of refined sugar, to floss and brush effectively to reduce bacteria, and to use fluoride gels, fluoride varnishes, or other kinds of sealants to make caries harder to form.

A literature review found that there has been limited analysis of primary care clinicians performing these tasks. Perhaps unsurprisingly, more such studies about dentists existed, leaving an open field for dedicated studies about what primary care clinicians should do to optimize oral health with patients.

“Clinicians, in the absence of clear guidelines, should continue to use their best judgment,” Dr. Ruiz said.

One dentist interviewed said screening could be as simple as doctors asking patients how often they brush their teeth and giving patients a toothbrush as part of the office visit.

“It all comes down to, ‘Is the person brushing their teeth?’ ” said Jennifer Hartshorn, DDS, who specializes in community and preventive dentistry at the University of Iowa, Iowa City.

“By all means look in their mouth, ask how much they are brushing, and urge them to find a dental home if at all possible,” Dr. Hartshorn said, especially for patients who smoke or have conditions such as dry mouth, which can increase the risk of oral disease.

Dr. Ruiz and Dr. Hartshorn report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Routine screenings for signs of cavities and gum disease by primary care clinicians may not catch patients most at risk of these conditions, according to a statement by the U.S. Preventive Services Task Force (USPSTF) that was published in JAMA.

Suggesting ways to improve oral health also may fail to engage the patients who most need the message, the group said in its statement.

The task force is not suggesting that primary care providers stop all oral health screening of adults or that they never discuss ways to improve oral health. But the current evidence of the most effective oral health screenings or enhancement strategies in primary care settings received an “I” rating, for “Inconclusive.” The highest ranking a screening can receive is an “A” or “B,” which indicate that there is strong evidence for conducting a screening, while a “C” would indicate that clinicians could rarely provide a screening, and a “D” would indicate not to, given the current evidence.

Primary care clinicians should immediately refer any patients with apparent caries or gum disease to a dentist, the USPSTF noted. But what clinicians should do for patients who have no obvious oral health problems is up for debate.

“The ‘I’ is a note about where the evidence is at this point and then a call for more research to see if we can’t get some more clarity for next time,” said John Ruiz, PhD, professor of clinical psychology at the University of Arizona, Tucson, who is a member of the task force.

More than 90% of U.S. adults may have caries, including 26% with untreated caries that can cause serious infections or tooth loss. In addition, 42% of adults have some type of gum disease. More than two-thirds of Americans aged 65 or older have gum disease, and it is the leading cause of tooth loss in this population. People earning low incomes and those who do not have health insurance or who belong to a marginalized racial or ethnic group are at greater risk of the harms of caries and gum disease.

“Oral health care is important to overall health,” and any new research on oral health screening and enhancement efforts should be demographically representative of adults affected by these conditions, Dr. Ruiz said.

In an accompanying editorial, oral health researchers from the National Institutes of Health and the University of California, San Francisco, echoed the call for representative research and encouraged closer collaboration between primary care providers and dentists to promote oral health.

“Oral health screening and referral by medical primary care clinicians can help ensure that individuals get to the dental chair to receive needed interventions that can benefit both oral and potentially overall health,” the authors wrote. “Likewise, medical challenges and oral mucosal manifestations of chronic health conditions detected at a dental visit should result in medical referral, allowing prompt evaluation and treatment.”
 

Lack of data

The USPSTF defined oral health screenings for patients older than 18 who have no obvious signs of caries or gum disease as looking at a patient’s mouth during physical exams. Additionally, clinicians might use prediction models to identify patients at greater risk of facing these problems.

Strategies to improve oral health include providing encouragement to patients to reduce intake of refined sugar, to floss and brush effectively to reduce bacteria, and to use fluoride gels, fluoride varnishes, or other kinds of sealants to make caries harder to form.

A literature review found that there has been limited analysis of primary care clinicians performing these tasks. Perhaps unsurprisingly, more such studies about dentists existed, leaving an open field for dedicated studies about what primary care clinicians should do to optimize oral health with patients.

“Clinicians, in the absence of clear guidelines, should continue to use their best judgment,” Dr. Ruiz said.

One dentist interviewed said screening could be as simple as doctors asking patients how often they brush their teeth and giving patients a toothbrush as part of the office visit.

“It all comes down to, ‘Is the person brushing their teeth?’ ” said Jennifer Hartshorn, DDS, who specializes in community and preventive dentistry at the University of Iowa, Iowa City.

“By all means look in their mouth, ask how much they are brushing, and urge them to find a dental home if at all possible,” Dr. Hartshorn said, especially for patients who smoke or have conditions such as dry mouth, which can increase the risk of oral disease.

Dr. Ruiz and Dr. Hartshorn report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Routine screenings for signs of cavities and gum disease by primary care clinicians may not catch patients most at risk of these conditions, according to a statement by the U.S. Preventive Services Task Force (USPSTF) that was published in JAMA.

Suggesting ways to improve oral health also may fail to engage the patients who most need the message, the group said in its statement.

The task force is not suggesting that primary care providers stop all oral health screening of adults or that they never discuss ways to improve oral health. But the current evidence of the most effective oral health screenings or enhancement strategies in primary care settings received an “I” rating, for “Inconclusive.” The highest ranking a screening can receive is an “A” or “B,” which indicate that there is strong evidence for conducting a screening, while a “C” would indicate that clinicians could rarely provide a screening, and a “D” would indicate not to, given the current evidence.

Primary care clinicians should immediately refer any patients with apparent caries or gum disease to a dentist, the USPSTF noted. But what clinicians should do for patients who have no obvious oral health problems is up for debate.

“The ‘I’ is a note about where the evidence is at this point and then a call for more research to see if we can’t get some more clarity for next time,” said John Ruiz, PhD, professor of clinical psychology at the University of Arizona, Tucson, who is a member of the task force.

More than 90% of U.S. adults may have caries, including 26% with untreated caries that can cause serious infections or tooth loss. In addition, 42% of adults have some type of gum disease. More than two-thirds of Americans aged 65 or older have gum disease, and it is the leading cause of tooth loss in this population. People earning low incomes and those who do not have health insurance or who belong to a marginalized racial or ethnic group are at greater risk of the harms of caries and gum disease.

“Oral health care is important to overall health,” and any new research on oral health screening and enhancement efforts should be demographically representative of adults affected by these conditions, Dr. Ruiz said.

In an accompanying editorial, oral health researchers from the National Institutes of Health and the University of California, San Francisco, echoed the call for representative research and encouraged closer collaboration between primary care providers and dentists to promote oral health.

“Oral health screening and referral by medical primary care clinicians can help ensure that individuals get to the dental chair to receive needed interventions that can benefit both oral and potentially overall health,” the authors wrote. “Likewise, medical challenges and oral mucosal manifestations of chronic health conditions detected at a dental visit should result in medical referral, allowing prompt evaluation and treatment.”
 

Lack of data

The USPSTF defined oral health screenings for patients older than 18 who have no obvious signs of caries or gum disease as looking at a patient’s mouth during physical exams. Additionally, clinicians might use prediction models to identify patients at greater risk of facing these problems.

Strategies to improve oral health include providing encouragement to patients to reduce intake of refined sugar, to floss and brush effectively to reduce bacteria, and to use fluoride gels, fluoride varnishes, or other kinds of sealants to make caries harder to form.

A literature review found that there has been limited analysis of primary care clinicians performing these tasks. Perhaps unsurprisingly, more such studies about dentists existed, leaving an open field for dedicated studies about what primary care clinicians should do to optimize oral health with patients.

“Clinicians, in the absence of clear guidelines, should continue to use their best judgment,” Dr. Ruiz said.

One dentist interviewed said screening could be as simple as doctors asking patients how often they brush their teeth and giving patients a toothbrush as part of the office visit.

“It all comes down to, ‘Is the person brushing their teeth?’ ” said Jennifer Hartshorn, DDS, who specializes in community and preventive dentistry at the University of Iowa, Iowa City.

“By all means look in their mouth, ask how much they are brushing, and urge them to find a dental home if at all possible,” Dr. Hartshorn said, especially for patients who smoke or have conditions such as dry mouth, which can increase the risk of oral disease.

Dr. Ruiz and Dr. Hartshorn report no relevant financial relationships.

A version of this article first appeared on Medscape.com.