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Are you at legal risk for speaking at conferences?
When Jerry Gardner, MD, and a junior colleague received the acceptance notification for their abstract to be presented at Digestive Diseases Week® (DDW) 2021, a clause in the mandatory participation agreement gave Dr. Gardner pause. It required his colleague, as the submitting author, to completely accept any and all legal responsibility for any claims that might arise out of their presentation.
The clause was a red flag to Dr. Gardner, president of Science for Organizations, a Mill Valley, Calif.–based consulting firm. The gastroenterologist and former head of the digestive diseases branch at the National Institute of Diabetes and Digestive and Kidney Diseases – who has made hundreds of presentations and had participated in DDW for 40 years – had never encountered such a broad indemnity clause.
This news organization investigated just how risky it is to make a presentation at a conference – more than a dozen professional societies were contacted. Although DDW declined to discuss its agreement, Houston health care attorney Rachel V. Rose said that Dr. Gardner was smart to be cautious. “I would not sign that agreement. I have never seen anything that broad and all encompassing,” she said.
The DDW requirement “means that participants must put themselves at great potential financial risk in order to present their work,” Dr. Gardner said. He added that he and his colleague would not have submitted an abstract had they known about the indemnification clause up front.
Dr. Gardner advised his colleague not to sign the DDW agreement. She did not, and both missed the meeting.
Speakers ‘have to be careful’
Dr. Gardner may be an exception. How many doctors are willing to forgo a presentation because of a concern about something in an agreement?
John Mandrola, MD, said he operates under the assumption that if he does not sign the agreement, then he won’t be able to give his presentation. He admits that he generally just signs them and is careful with his presentations. “I’ve never really paid much attention to them,” said Dr. Mandrola, a cardiac electrophysiologist in Louisville, Ky., and chief cardiology correspondent for Medscape.
Not everyone takes that approach. “I do think that people read them, but they also take them with a grain of salt,” said E. Magnus Ohman, MBBS, professor of medicine at Duke University, Durham, N.C. He said he’s pragmatic and regards the agreements as a necessary evil in a litigious nation. Speakers “have to be careful, obviously,” Dr. Ohman said in an interview.
Some argue that the requirements are not only fair but also understandable. David Johnson, MD, a former president of the American College of Gastroenterology, said he has never had questions about agreements for meetings he has been involved with. “To me, this is not anything other than standard operating procedure,” he said.
Presenters participate by invitation, noted Dr. Johnson, a professor of medicine and chief of gastroenterology at the Eastern Virginia Medical School, Norfolk, who is a contributor to this news organization. “If they stand up and do something egregious, I would concur that the society should not be liable,” he said.
Big asks, big secrecy
Even for those who generally agree with Dr. Johnson’s position, it may be hard to completely understand what’s at stake without an attorney.
Although many declined to discuss their policies, a handful of professional societies provided their agreements for review. In general, the agreements appear to offer broad protection and rights to the organizers and large liability exposure for the participants. Participants are charged with a wide range of responsibilities, such as ensuring against copyright violations and intellectual property infringement, and that they also agree to unlimited use of their presentations and their name and likeness.
The American Academy of Neurology, which held its meeting virtually in 2021, required participants to indemnify the organization against all “losses, expenses, damages, or liabilities,” including “reasonable attorneys’ fees.” Federal employees, however, could opt out of indemnification.
The American Society of Clinical Oncology said that it does not usually require indemnification from its meeting participants. However, a spokesperson noted that ASCO did require participants at its 2021 virtual meeting to abide by the terms of use for content posted to the ASCO website. Those terms specify that users agree to indemnify ASCO from damages related to posts.
The American Psychiatric Association said it does not require any indemnification but did not make its agreement available. The American Academy of Pediatrics also said it did not require indemnification but would not share its agreement.
An American Diabetes Association spokesperson said that “every association is different in what they ask or require from speakers,” but would not share its requirements.
The American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the Endocrine Society all declined to participate.
The organizations that withheld agreements “probably don’t want anybody picking apart their documents,” said Kyle Claussen, CEO of the Resolve Physician Agency, which reviews employment contracts and other contracts for physicians. “The more fair a document, the more likely they would be willing to disclose that, because they have nothing to hide,” he said.
‘It’s all on you’
Requiring indemnification for any and all aspects of a presentation appears to be increasingly common, said the attorneys interviewed for this article. As organizations repackage meeting presentations for sale, they put the content further out into the world and for a longer period, which increases liability exposure.
“If I’m the attorney for DDW, I certainly think I’d want to have this in place,” said Mr. Claussen.
“It’s good business sense for them because it reduces their risk,” said Courtney H. A. Thompson, an attorney with Fredrikson & Byron in Minneapolis, who advises regional and national corporations and ad agencies on advertising, marketing, and trademark law. She also works with clients who speak at meetings and who thus encounter meeting agreements.
Ms. Thompson said indemnity clauses have become fairly common over the past decade, especially as more companies and organizations have sought to protect trademarks, copyrights, and intellectual property and to minimize litigation costs.
A conference organizer “doesn’t want a third party to come after them for intellectual property, privacy, or publicity right infringement based on the participation of the customer or, in this case, the speaker,” said Ms. Thompson.
The agreements also reflect America’s litigation-prone culture.
Dean Fanelli, a patent attorney in the Washington, D.C., office of Cooley LLP, said the agreements he’s been asked to sign as a speaker increasingly seem “overly lawyerly.”
Two decades ago, a speaker might have been asked to sign a paragraph or a one-page form. Now “they often look more like formalized legal agreements,” Mr. Fanelli told this news organization.
The DDW agreement, for instance, ran four pages and contained 21 detailed clauses.
The increasingly complicated agreements “are a little over the top,” said Mr. Fanelli. But as an attorney who works with clients in the pharmaceutical industry, he said he understands that meeting organizers want to protect their rights.
DDW’s main indemnification clause requires the participant to indemnify DDW and its agents, directors, and employees “against any and all claims, demands, causes of action, losses, damages, liabilities, costs, and expenses,” including attorneys’ fees “arising out of a claim, action or proceeding” based on a breach or “alleged breach” by the participant.
“You’re releasing this information to them and then you’re also giving them blanket indemnity back, saying if there’s any type of intellectual property violation on your end – if you’ve included any type of work that’s protected, if this causes any problems – it’s all on you,” said Mr. Claussen.
Other potential pitfalls
Aside from indemnification, participation agreements can contain other potentially worrisome clauses, including onerous terms for cancellation and reuse of content without remuneration.
DDW requires royalty-free licensing of a speaker’s content; the organization can reproduce it in perpetuity without royalties. Many organizations have such a clause in their agreements, including the AAN and the American College of Cardiology.
ASCO’s general authorization form for meeting participants requires that they assign to ASCO rights to their content “perpetually, irrevocably, worldwide and royalty free.” Participants can contact the organization if they seek to opt out, but it’s not clear whether ASCO grants such requests.
Participants in the upcoming American Heart Association annual meeting can deny permission to record their presentation. But if they allow recording and do not agree to assign all rights and copyright ownership to the AHA, the work will be excluded from publication in the meeting program, e-posters, and the meeting supplement in Circulation.
Mr. Claussen said granting royalty-free rights presents a conundrum. Having content reproduced in various formats “might be better for your personal brand,” but it’s not likely to result in any direct compensation and could increase liability exposure, he said.
How presenters must prepare
Mr. Claussen and Ms. Rose said speakers should be vigilant about their own rights and responsibilities, including ensuring that they do not violate copyrights or infringe on intellectual property rights.
“I would recommend that folks be meticulous about what is in their slide deck and materials,” said Ms. Thompson. He said that presenters should be sure they have the right to share material. Technologies crawl the internet seeking out infringement, which often leads to cease and desist letters from attorneys, she said.
It’s better to head off such a letter, Ms. Thompson said. “You need to defend it whether or not it’s a viable claim,” and that can be costly, she said.
Both Ms. Thompson and Mr. Fanelli also warn about disclosing anything that might be considered a trade secret. Many agreements prohibit presenters from engaging in commercial promotion, but if a talk includes information about a drug or device, the manufacturer will want to review the presentation before it’s made public, said Mr. Fanelli.
Many organizations prohibit attendees from photographing, recording, or tweeting at meetings and often require speakers to warn the audience about doing so. DDW goes further by holding presenters liable if someone violates the rule.
“That’s a huge problem,” said Dr. Mandrola. He noted that although it might be easy to police journalists attending a meeting, “it seems hard to enforce that rule amongst just regular attendees.”
Accept or negotiate?
Individuals who submit work to an organization might feel they must sign an agreement as is, especially if they are looking to advance their career or expand knowledge by presenting work at a meeting. But some attorneys said it might be possible to negotiate with meeting organizers.
“My personal opinion is that it never hurts to ask,” said Ms. Thompson. If she were speaking at a legal conference, she would mark up a contract and “see what happens.” The more times pushback is accepted – say, if it works with three out of five speaking engagements – the more it reduces overall liability exposure.
Mr. Fanelli, however, said that although he always reads over an agreement, he typically signs without negotiating. “I don’t usually worry about it because I’m just trying to talk at a particular seminar,” he said.
Prospective presenters “have to weigh that balance – do you want to talk at a seminar, or are you concerned about the legal issues?” said Mr. Fanelli.
If in doubt, talk with a lawyer.
“If you ever have a question on whether or not you should consult an attorney, the answer is always yes,” said Mr. Claussen. It would be “an ounce of prevention,” especially if it’s just a short agreement, he said.
Dr. Ohman, however, said that he believed “it would be fairly costly” and potentially unwieldy. “You can’t litigate everything in life,” he added.
As for Dr. Gardner, he said he would not be as likely to attend DDW in the future if he has to agree to cover any and all liability. “I can’t conceive of ever agreeing to personally indemnify DDW in order to make a presentation at the annual meeting,” he said.
A version of this article first appeared on Medscape.com.
When Jerry Gardner, MD, and a junior colleague received the acceptance notification for their abstract to be presented at Digestive Diseases Week® (DDW) 2021, a clause in the mandatory participation agreement gave Dr. Gardner pause. It required his colleague, as the submitting author, to completely accept any and all legal responsibility for any claims that might arise out of their presentation.
The clause was a red flag to Dr. Gardner, president of Science for Organizations, a Mill Valley, Calif.–based consulting firm. The gastroenterologist and former head of the digestive diseases branch at the National Institute of Diabetes and Digestive and Kidney Diseases – who has made hundreds of presentations and had participated in DDW for 40 years – had never encountered such a broad indemnity clause.
This news organization investigated just how risky it is to make a presentation at a conference – more than a dozen professional societies were contacted. Although DDW declined to discuss its agreement, Houston health care attorney Rachel V. Rose said that Dr. Gardner was smart to be cautious. “I would not sign that agreement. I have never seen anything that broad and all encompassing,” she said.
The DDW requirement “means that participants must put themselves at great potential financial risk in order to present their work,” Dr. Gardner said. He added that he and his colleague would not have submitted an abstract had they known about the indemnification clause up front.
Dr. Gardner advised his colleague not to sign the DDW agreement. She did not, and both missed the meeting.
Speakers ‘have to be careful’
Dr. Gardner may be an exception. How many doctors are willing to forgo a presentation because of a concern about something in an agreement?
John Mandrola, MD, said he operates under the assumption that if he does not sign the agreement, then he won’t be able to give his presentation. He admits that he generally just signs them and is careful with his presentations. “I’ve never really paid much attention to them,” said Dr. Mandrola, a cardiac electrophysiologist in Louisville, Ky., and chief cardiology correspondent for Medscape.
Not everyone takes that approach. “I do think that people read them, but they also take them with a grain of salt,” said E. Magnus Ohman, MBBS, professor of medicine at Duke University, Durham, N.C. He said he’s pragmatic and regards the agreements as a necessary evil in a litigious nation. Speakers “have to be careful, obviously,” Dr. Ohman said in an interview.
Some argue that the requirements are not only fair but also understandable. David Johnson, MD, a former president of the American College of Gastroenterology, said he has never had questions about agreements for meetings he has been involved with. “To me, this is not anything other than standard operating procedure,” he said.
Presenters participate by invitation, noted Dr. Johnson, a professor of medicine and chief of gastroenterology at the Eastern Virginia Medical School, Norfolk, who is a contributor to this news organization. “If they stand up and do something egregious, I would concur that the society should not be liable,” he said.
Big asks, big secrecy
Even for those who generally agree with Dr. Johnson’s position, it may be hard to completely understand what’s at stake without an attorney.
Although many declined to discuss their policies, a handful of professional societies provided their agreements for review. In general, the agreements appear to offer broad protection and rights to the organizers and large liability exposure for the participants. Participants are charged with a wide range of responsibilities, such as ensuring against copyright violations and intellectual property infringement, and that they also agree to unlimited use of their presentations and their name and likeness.
The American Academy of Neurology, which held its meeting virtually in 2021, required participants to indemnify the organization against all “losses, expenses, damages, or liabilities,” including “reasonable attorneys’ fees.” Federal employees, however, could opt out of indemnification.
The American Society of Clinical Oncology said that it does not usually require indemnification from its meeting participants. However, a spokesperson noted that ASCO did require participants at its 2021 virtual meeting to abide by the terms of use for content posted to the ASCO website. Those terms specify that users agree to indemnify ASCO from damages related to posts.
The American Psychiatric Association said it does not require any indemnification but did not make its agreement available. The American Academy of Pediatrics also said it did not require indemnification but would not share its agreement.
An American Diabetes Association spokesperson said that “every association is different in what they ask or require from speakers,” but would not share its requirements.
The American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the Endocrine Society all declined to participate.
The organizations that withheld agreements “probably don’t want anybody picking apart their documents,” said Kyle Claussen, CEO of the Resolve Physician Agency, which reviews employment contracts and other contracts for physicians. “The more fair a document, the more likely they would be willing to disclose that, because they have nothing to hide,” he said.
‘It’s all on you’
Requiring indemnification for any and all aspects of a presentation appears to be increasingly common, said the attorneys interviewed for this article. As organizations repackage meeting presentations for sale, they put the content further out into the world and for a longer period, which increases liability exposure.
“If I’m the attorney for DDW, I certainly think I’d want to have this in place,” said Mr. Claussen.
“It’s good business sense for them because it reduces their risk,” said Courtney H. A. Thompson, an attorney with Fredrikson & Byron in Minneapolis, who advises regional and national corporations and ad agencies on advertising, marketing, and trademark law. She also works with clients who speak at meetings and who thus encounter meeting agreements.
Ms. Thompson said indemnity clauses have become fairly common over the past decade, especially as more companies and organizations have sought to protect trademarks, copyrights, and intellectual property and to minimize litigation costs.
A conference organizer “doesn’t want a third party to come after them for intellectual property, privacy, or publicity right infringement based on the participation of the customer or, in this case, the speaker,” said Ms. Thompson.
The agreements also reflect America’s litigation-prone culture.
Dean Fanelli, a patent attorney in the Washington, D.C., office of Cooley LLP, said the agreements he’s been asked to sign as a speaker increasingly seem “overly lawyerly.”
Two decades ago, a speaker might have been asked to sign a paragraph or a one-page form. Now “they often look more like formalized legal agreements,” Mr. Fanelli told this news organization.
The DDW agreement, for instance, ran four pages and contained 21 detailed clauses.
The increasingly complicated agreements “are a little over the top,” said Mr. Fanelli. But as an attorney who works with clients in the pharmaceutical industry, he said he understands that meeting organizers want to protect their rights.
DDW’s main indemnification clause requires the participant to indemnify DDW and its agents, directors, and employees “against any and all claims, demands, causes of action, losses, damages, liabilities, costs, and expenses,” including attorneys’ fees “arising out of a claim, action or proceeding” based on a breach or “alleged breach” by the participant.
“You’re releasing this information to them and then you’re also giving them blanket indemnity back, saying if there’s any type of intellectual property violation on your end – if you’ve included any type of work that’s protected, if this causes any problems – it’s all on you,” said Mr. Claussen.
Other potential pitfalls
Aside from indemnification, participation agreements can contain other potentially worrisome clauses, including onerous terms for cancellation and reuse of content without remuneration.
DDW requires royalty-free licensing of a speaker’s content; the organization can reproduce it in perpetuity without royalties. Many organizations have such a clause in their agreements, including the AAN and the American College of Cardiology.
ASCO’s general authorization form for meeting participants requires that they assign to ASCO rights to their content “perpetually, irrevocably, worldwide and royalty free.” Participants can contact the organization if they seek to opt out, but it’s not clear whether ASCO grants such requests.
Participants in the upcoming American Heart Association annual meeting can deny permission to record their presentation. But if they allow recording and do not agree to assign all rights and copyright ownership to the AHA, the work will be excluded from publication in the meeting program, e-posters, and the meeting supplement in Circulation.
Mr. Claussen said granting royalty-free rights presents a conundrum. Having content reproduced in various formats “might be better for your personal brand,” but it’s not likely to result in any direct compensation and could increase liability exposure, he said.
How presenters must prepare
Mr. Claussen and Ms. Rose said speakers should be vigilant about their own rights and responsibilities, including ensuring that they do not violate copyrights or infringe on intellectual property rights.
“I would recommend that folks be meticulous about what is in their slide deck and materials,” said Ms. Thompson. He said that presenters should be sure they have the right to share material. Technologies crawl the internet seeking out infringement, which often leads to cease and desist letters from attorneys, she said.
It’s better to head off such a letter, Ms. Thompson said. “You need to defend it whether or not it’s a viable claim,” and that can be costly, she said.
Both Ms. Thompson and Mr. Fanelli also warn about disclosing anything that might be considered a trade secret. Many agreements prohibit presenters from engaging in commercial promotion, but if a talk includes information about a drug or device, the manufacturer will want to review the presentation before it’s made public, said Mr. Fanelli.
Many organizations prohibit attendees from photographing, recording, or tweeting at meetings and often require speakers to warn the audience about doing so. DDW goes further by holding presenters liable if someone violates the rule.
“That’s a huge problem,” said Dr. Mandrola. He noted that although it might be easy to police journalists attending a meeting, “it seems hard to enforce that rule amongst just regular attendees.”
Accept or negotiate?
Individuals who submit work to an organization might feel they must sign an agreement as is, especially if they are looking to advance their career or expand knowledge by presenting work at a meeting. But some attorneys said it might be possible to negotiate with meeting organizers.
“My personal opinion is that it never hurts to ask,” said Ms. Thompson. If she were speaking at a legal conference, she would mark up a contract and “see what happens.” The more times pushback is accepted – say, if it works with three out of five speaking engagements – the more it reduces overall liability exposure.
Mr. Fanelli, however, said that although he always reads over an agreement, he typically signs without negotiating. “I don’t usually worry about it because I’m just trying to talk at a particular seminar,” he said.
Prospective presenters “have to weigh that balance – do you want to talk at a seminar, or are you concerned about the legal issues?” said Mr. Fanelli.
If in doubt, talk with a lawyer.
“If you ever have a question on whether or not you should consult an attorney, the answer is always yes,” said Mr. Claussen. It would be “an ounce of prevention,” especially if it’s just a short agreement, he said.
Dr. Ohman, however, said that he believed “it would be fairly costly” and potentially unwieldy. “You can’t litigate everything in life,” he added.
As for Dr. Gardner, he said he would not be as likely to attend DDW in the future if he has to agree to cover any and all liability. “I can’t conceive of ever agreeing to personally indemnify DDW in order to make a presentation at the annual meeting,” he said.
A version of this article first appeared on Medscape.com.
When Jerry Gardner, MD, and a junior colleague received the acceptance notification for their abstract to be presented at Digestive Diseases Week® (DDW) 2021, a clause in the mandatory participation agreement gave Dr. Gardner pause. It required his colleague, as the submitting author, to completely accept any and all legal responsibility for any claims that might arise out of their presentation.
The clause was a red flag to Dr. Gardner, president of Science for Organizations, a Mill Valley, Calif.–based consulting firm. The gastroenterologist and former head of the digestive diseases branch at the National Institute of Diabetes and Digestive and Kidney Diseases – who has made hundreds of presentations and had participated in DDW for 40 years – had never encountered such a broad indemnity clause.
This news organization investigated just how risky it is to make a presentation at a conference – more than a dozen professional societies were contacted. Although DDW declined to discuss its agreement, Houston health care attorney Rachel V. Rose said that Dr. Gardner was smart to be cautious. “I would not sign that agreement. I have never seen anything that broad and all encompassing,” she said.
The DDW requirement “means that participants must put themselves at great potential financial risk in order to present their work,” Dr. Gardner said. He added that he and his colleague would not have submitted an abstract had they known about the indemnification clause up front.
Dr. Gardner advised his colleague not to sign the DDW agreement. She did not, and both missed the meeting.
Speakers ‘have to be careful’
Dr. Gardner may be an exception. How many doctors are willing to forgo a presentation because of a concern about something in an agreement?
John Mandrola, MD, said he operates under the assumption that if he does not sign the agreement, then he won’t be able to give his presentation. He admits that he generally just signs them and is careful with his presentations. “I’ve never really paid much attention to them,” said Dr. Mandrola, a cardiac electrophysiologist in Louisville, Ky., and chief cardiology correspondent for Medscape.
Not everyone takes that approach. “I do think that people read them, but they also take them with a grain of salt,” said E. Magnus Ohman, MBBS, professor of medicine at Duke University, Durham, N.C. He said he’s pragmatic and regards the agreements as a necessary evil in a litigious nation. Speakers “have to be careful, obviously,” Dr. Ohman said in an interview.
Some argue that the requirements are not only fair but also understandable. David Johnson, MD, a former president of the American College of Gastroenterology, said he has never had questions about agreements for meetings he has been involved with. “To me, this is not anything other than standard operating procedure,” he said.
Presenters participate by invitation, noted Dr. Johnson, a professor of medicine and chief of gastroenterology at the Eastern Virginia Medical School, Norfolk, who is a contributor to this news organization. “If they stand up and do something egregious, I would concur that the society should not be liable,” he said.
Big asks, big secrecy
Even for those who generally agree with Dr. Johnson’s position, it may be hard to completely understand what’s at stake without an attorney.
Although many declined to discuss their policies, a handful of professional societies provided their agreements for review. In general, the agreements appear to offer broad protection and rights to the organizers and large liability exposure for the participants. Participants are charged with a wide range of responsibilities, such as ensuring against copyright violations and intellectual property infringement, and that they also agree to unlimited use of their presentations and their name and likeness.
The American Academy of Neurology, which held its meeting virtually in 2021, required participants to indemnify the organization against all “losses, expenses, damages, or liabilities,” including “reasonable attorneys’ fees.” Federal employees, however, could opt out of indemnification.
The American Society of Clinical Oncology said that it does not usually require indemnification from its meeting participants. However, a spokesperson noted that ASCO did require participants at its 2021 virtual meeting to abide by the terms of use for content posted to the ASCO website. Those terms specify that users agree to indemnify ASCO from damages related to posts.
The American Psychiatric Association said it does not require any indemnification but did not make its agreement available. The American Academy of Pediatrics also said it did not require indemnification but would not share its agreement.
An American Diabetes Association spokesperson said that “every association is different in what they ask or require from speakers,” but would not share its requirements.
The American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the American College of Physicians, and the Endocrine Society all declined to participate.
The organizations that withheld agreements “probably don’t want anybody picking apart their documents,” said Kyle Claussen, CEO of the Resolve Physician Agency, which reviews employment contracts and other contracts for physicians. “The more fair a document, the more likely they would be willing to disclose that, because they have nothing to hide,” he said.
‘It’s all on you’
Requiring indemnification for any and all aspects of a presentation appears to be increasingly common, said the attorneys interviewed for this article. As organizations repackage meeting presentations for sale, they put the content further out into the world and for a longer period, which increases liability exposure.
“If I’m the attorney for DDW, I certainly think I’d want to have this in place,” said Mr. Claussen.
“It’s good business sense for them because it reduces their risk,” said Courtney H. A. Thompson, an attorney with Fredrikson & Byron in Minneapolis, who advises regional and national corporations and ad agencies on advertising, marketing, and trademark law. She also works with clients who speak at meetings and who thus encounter meeting agreements.
Ms. Thompson said indemnity clauses have become fairly common over the past decade, especially as more companies and organizations have sought to protect trademarks, copyrights, and intellectual property and to minimize litigation costs.
A conference organizer “doesn’t want a third party to come after them for intellectual property, privacy, or publicity right infringement based on the participation of the customer or, in this case, the speaker,” said Ms. Thompson.
The agreements also reflect America’s litigation-prone culture.
Dean Fanelli, a patent attorney in the Washington, D.C., office of Cooley LLP, said the agreements he’s been asked to sign as a speaker increasingly seem “overly lawyerly.”
Two decades ago, a speaker might have been asked to sign a paragraph or a one-page form. Now “they often look more like formalized legal agreements,” Mr. Fanelli told this news organization.
The DDW agreement, for instance, ran four pages and contained 21 detailed clauses.
The increasingly complicated agreements “are a little over the top,” said Mr. Fanelli. But as an attorney who works with clients in the pharmaceutical industry, he said he understands that meeting organizers want to protect their rights.
DDW’s main indemnification clause requires the participant to indemnify DDW and its agents, directors, and employees “against any and all claims, demands, causes of action, losses, damages, liabilities, costs, and expenses,” including attorneys’ fees “arising out of a claim, action or proceeding” based on a breach or “alleged breach” by the participant.
“You’re releasing this information to them and then you’re also giving them blanket indemnity back, saying if there’s any type of intellectual property violation on your end – if you’ve included any type of work that’s protected, if this causes any problems – it’s all on you,” said Mr. Claussen.
Other potential pitfalls
Aside from indemnification, participation agreements can contain other potentially worrisome clauses, including onerous terms for cancellation and reuse of content without remuneration.
DDW requires royalty-free licensing of a speaker’s content; the organization can reproduce it in perpetuity without royalties. Many organizations have such a clause in their agreements, including the AAN and the American College of Cardiology.
ASCO’s general authorization form for meeting participants requires that they assign to ASCO rights to their content “perpetually, irrevocably, worldwide and royalty free.” Participants can contact the organization if they seek to opt out, but it’s not clear whether ASCO grants such requests.
Participants in the upcoming American Heart Association annual meeting can deny permission to record their presentation. But if they allow recording and do not agree to assign all rights and copyright ownership to the AHA, the work will be excluded from publication in the meeting program, e-posters, and the meeting supplement in Circulation.
Mr. Claussen said granting royalty-free rights presents a conundrum. Having content reproduced in various formats “might be better for your personal brand,” but it’s not likely to result in any direct compensation and could increase liability exposure, he said.
How presenters must prepare
Mr. Claussen and Ms. Rose said speakers should be vigilant about their own rights and responsibilities, including ensuring that they do not violate copyrights or infringe on intellectual property rights.
“I would recommend that folks be meticulous about what is in their slide deck and materials,” said Ms. Thompson. He said that presenters should be sure they have the right to share material. Technologies crawl the internet seeking out infringement, which often leads to cease and desist letters from attorneys, she said.
It’s better to head off such a letter, Ms. Thompson said. “You need to defend it whether or not it’s a viable claim,” and that can be costly, she said.
Both Ms. Thompson and Mr. Fanelli also warn about disclosing anything that might be considered a trade secret. Many agreements prohibit presenters from engaging in commercial promotion, but if a talk includes information about a drug or device, the manufacturer will want to review the presentation before it’s made public, said Mr. Fanelli.
Many organizations prohibit attendees from photographing, recording, or tweeting at meetings and often require speakers to warn the audience about doing so. DDW goes further by holding presenters liable if someone violates the rule.
“That’s a huge problem,” said Dr. Mandrola. He noted that although it might be easy to police journalists attending a meeting, “it seems hard to enforce that rule amongst just regular attendees.”
Accept or negotiate?
Individuals who submit work to an organization might feel they must sign an agreement as is, especially if they are looking to advance their career or expand knowledge by presenting work at a meeting. But some attorneys said it might be possible to negotiate with meeting organizers.
“My personal opinion is that it never hurts to ask,” said Ms. Thompson. If she were speaking at a legal conference, she would mark up a contract and “see what happens.” The more times pushback is accepted – say, if it works with three out of five speaking engagements – the more it reduces overall liability exposure.
Mr. Fanelli, however, said that although he always reads over an agreement, he typically signs without negotiating. “I don’t usually worry about it because I’m just trying to talk at a particular seminar,” he said.
Prospective presenters “have to weigh that balance – do you want to talk at a seminar, or are you concerned about the legal issues?” said Mr. Fanelli.
If in doubt, talk with a lawyer.
“If you ever have a question on whether or not you should consult an attorney, the answer is always yes,” said Mr. Claussen. It would be “an ounce of prevention,” especially if it’s just a short agreement, he said.
Dr. Ohman, however, said that he believed “it would be fairly costly” and potentially unwieldy. “You can’t litigate everything in life,” he added.
As for Dr. Gardner, he said he would not be as likely to attend DDW in the future if he has to agree to cover any and all liability. “I can’t conceive of ever agreeing to personally indemnify DDW in order to make a presentation at the annual meeting,” he said.
A version of this article first appeared on Medscape.com.
Watchdog group demands removal of FDA leaders after aducanumab approval
In a letter to the U.S. Department of Health and Human Services Secretary Xavier Becerra, Michael A. Carome, MD, director of Public Citizen’s Health Research Group, said: “The FDA’s decision to approve aducanumab for anyone with Alzheimer’s disease, regardless of severity, showed a stunning disregard for science, eviscerated the agency’s standards for approving new drugs, and ranks as one of the most irresponsible and egregious decisions in the history of the agency.”
Public Citizen urged Mr. Becerra to seek the resignations or the removal of the three FDA officials it said were most responsible for the approval – Acting FDA Commissioner Janet Woodcock, MD; Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni, MD; and CDER’s Office of Neuroscience Director Billy Dunn, MD.
“This decision is a disastrous blow to the agency’s credibility, public health, and the financial sustainability of the Medicare program,” writes Dr. Carome, noting that Biogen said it would charge $56,000 annually for the infusion.
Aaron Kesselheim, MD, one of three FDA Peripheral and Central Nervous System Drugs advisory committee members who resigned in the wake of the approval, agreed with Public Citizen that the agency’s credibility is suffering.
“The aducanumab decision is the worst example yet of the FDA’s movement away from its high standards,” Dr. Kesselheim, a professor of medicine at Harvard Medical School, Boston, and Harvard colleague Jerry Avorn, MD, wrote in the New York Times on June 15.
“As physicians, we know well that Alzheimer’s disease is a terrible condition,” they wrote. However, they added, “approving a drug that has such poor evidence that it works and causes such worrisome side effects is not the solution.”
In his resignation letter, Dr. Kesselheim said he had also been dismayed by the agency’s 2016 approval of eteplirsen (Exondys 51, Sarepta Therapeutics) for Duchenne muscular dystrophy. In both the eteplirsen and aducanumab approvals, the agency went against its advisers’ recommendations, Dr. Kesselheim said.
Advocates who backed approval decry cost
Aducanumab had a rocky road to approval but had unwavering backing from the Alzheimer’s Association and at least one other organization, UsAgainstAlzheimer’s.
The Alzheimer’s Association was particularly outspoken in its support and, in March, was accused of potential conflict of interest by Public Citizen and several neurologists because the association accepted at least $1.4 million from Biogen and its partner Eisai since fiscal year 2018.
The association applauded the FDA approval but, a few days later, expressed outrage over the $56,000-a-year price tag.
“This price is simply unacceptable,” the Alzheimer’s Association said in the statement. “For many, this price will pose an insurmountable barrier to access, it complicates and jeopardizes sustainable access to this treatment, and may further deepen issues of health equity,” the association said, adding, “We call on Biogen to change this price.”
UsAgainstAlzheimer’s also expressed concerns about access, even before it knew aducanumab’s price.
“Shockingly, Medicare does not reimburse patients for the expensive PET scans important to determine whether someone is appropriate for this drug,” noted George Vradenburg, chairman and cofounder of the group, in a June 7 statement. “We intend to work with Biogen and Medicare to make access to this drug affordable for every American who needs it,” Mr. Vradenburg said.
Dr. Carome said the advocates’ complaints were hard to fathom.
“This should not have come as a surprise to anyone,” Dr. Carome said, adding that “it’s essentially the ballpark figure the company threw out weeks ago.”
“Fifty-six-thousand-dollars is particularly egregiously overpriced for a drug that doesn’t work,” Dr. Carome said. “If the [Alzheimer’s Association] truly finds this objectionable, hopefully they’ll stop accepting money from Biogen and its partner Eisai,” he added.
“The Alzheimer’s Association is recognizing that the genie is out of the bottle and that they are going to have trouble reining in the inevitable run-away costs,” said Mike Greicius, MD, MPH, associate professor of neurology at Stanford University’s Wu Tsai Neurosciences Institute, Stanford, California.
“In addition to the eye-popping annual cost that Biogen has invented, I hope the Alzheimer’s Association is also concerned about the dangerously loose and broad FDA labeling which does not require screening for amyloid-positivity and does not restrict use to the milder forms of disease studied in the Phase 3 trials,” Dr. Greicius said.
Another advocacy group, Patients For Affordable Drugs, commended the Alzheimer’s Association. Its statement “was nothing short of courageous, especially in light of the Alzheimer’s Association’s reliance on funding from drug corporations, including Biogen,” said David Mitchell, a cancer patient and founder of Patients For Affordable Drugs, in a statement.
Mr. Mitchell said his members “stand with the Alzheimer’s Association in its denunciation of the price set by Biogen” and called for a new law that would allow Medicare to negotiate drug prices.
A version of this article first appeared on Medscape.com.
In a letter to the U.S. Department of Health and Human Services Secretary Xavier Becerra, Michael A. Carome, MD, director of Public Citizen’s Health Research Group, said: “The FDA’s decision to approve aducanumab for anyone with Alzheimer’s disease, regardless of severity, showed a stunning disregard for science, eviscerated the agency’s standards for approving new drugs, and ranks as one of the most irresponsible and egregious decisions in the history of the agency.”
Public Citizen urged Mr. Becerra to seek the resignations or the removal of the three FDA officials it said were most responsible for the approval – Acting FDA Commissioner Janet Woodcock, MD; Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni, MD; and CDER’s Office of Neuroscience Director Billy Dunn, MD.
“This decision is a disastrous blow to the agency’s credibility, public health, and the financial sustainability of the Medicare program,” writes Dr. Carome, noting that Biogen said it would charge $56,000 annually for the infusion.
Aaron Kesselheim, MD, one of three FDA Peripheral and Central Nervous System Drugs advisory committee members who resigned in the wake of the approval, agreed with Public Citizen that the agency’s credibility is suffering.
“The aducanumab decision is the worst example yet of the FDA’s movement away from its high standards,” Dr. Kesselheim, a professor of medicine at Harvard Medical School, Boston, and Harvard colleague Jerry Avorn, MD, wrote in the New York Times on June 15.
“As physicians, we know well that Alzheimer’s disease is a terrible condition,” they wrote. However, they added, “approving a drug that has such poor evidence that it works and causes such worrisome side effects is not the solution.”
In his resignation letter, Dr. Kesselheim said he had also been dismayed by the agency’s 2016 approval of eteplirsen (Exondys 51, Sarepta Therapeutics) for Duchenne muscular dystrophy. In both the eteplirsen and aducanumab approvals, the agency went against its advisers’ recommendations, Dr. Kesselheim said.
Advocates who backed approval decry cost
Aducanumab had a rocky road to approval but had unwavering backing from the Alzheimer’s Association and at least one other organization, UsAgainstAlzheimer’s.
The Alzheimer’s Association was particularly outspoken in its support and, in March, was accused of potential conflict of interest by Public Citizen and several neurologists because the association accepted at least $1.4 million from Biogen and its partner Eisai since fiscal year 2018.
The association applauded the FDA approval but, a few days later, expressed outrage over the $56,000-a-year price tag.
“This price is simply unacceptable,” the Alzheimer’s Association said in the statement. “For many, this price will pose an insurmountable barrier to access, it complicates and jeopardizes sustainable access to this treatment, and may further deepen issues of health equity,” the association said, adding, “We call on Biogen to change this price.”
UsAgainstAlzheimer’s also expressed concerns about access, even before it knew aducanumab’s price.
“Shockingly, Medicare does not reimburse patients for the expensive PET scans important to determine whether someone is appropriate for this drug,” noted George Vradenburg, chairman and cofounder of the group, in a June 7 statement. “We intend to work with Biogen and Medicare to make access to this drug affordable for every American who needs it,” Mr. Vradenburg said.
Dr. Carome said the advocates’ complaints were hard to fathom.
“This should not have come as a surprise to anyone,” Dr. Carome said, adding that “it’s essentially the ballpark figure the company threw out weeks ago.”
“Fifty-six-thousand-dollars is particularly egregiously overpriced for a drug that doesn’t work,” Dr. Carome said. “If the [Alzheimer’s Association] truly finds this objectionable, hopefully they’ll stop accepting money from Biogen and its partner Eisai,” he added.
“The Alzheimer’s Association is recognizing that the genie is out of the bottle and that they are going to have trouble reining in the inevitable run-away costs,” said Mike Greicius, MD, MPH, associate professor of neurology at Stanford University’s Wu Tsai Neurosciences Institute, Stanford, California.
“In addition to the eye-popping annual cost that Biogen has invented, I hope the Alzheimer’s Association is also concerned about the dangerously loose and broad FDA labeling which does not require screening for amyloid-positivity and does not restrict use to the milder forms of disease studied in the Phase 3 trials,” Dr. Greicius said.
Another advocacy group, Patients For Affordable Drugs, commended the Alzheimer’s Association. Its statement “was nothing short of courageous, especially in light of the Alzheimer’s Association’s reliance on funding from drug corporations, including Biogen,” said David Mitchell, a cancer patient and founder of Patients For Affordable Drugs, in a statement.
Mr. Mitchell said his members “stand with the Alzheimer’s Association in its denunciation of the price set by Biogen” and called for a new law that would allow Medicare to negotiate drug prices.
A version of this article first appeared on Medscape.com.
In a letter to the U.S. Department of Health and Human Services Secretary Xavier Becerra, Michael A. Carome, MD, director of Public Citizen’s Health Research Group, said: “The FDA’s decision to approve aducanumab for anyone with Alzheimer’s disease, regardless of severity, showed a stunning disregard for science, eviscerated the agency’s standards for approving new drugs, and ranks as one of the most irresponsible and egregious decisions in the history of the agency.”
Public Citizen urged Mr. Becerra to seek the resignations or the removal of the three FDA officials it said were most responsible for the approval – Acting FDA Commissioner Janet Woodcock, MD; Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni, MD; and CDER’s Office of Neuroscience Director Billy Dunn, MD.
“This decision is a disastrous blow to the agency’s credibility, public health, and the financial sustainability of the Medicare program,” writes Dr. Carome, noting that Biogen said it would charge $56,000 annually for the infusion.
Aaron Kesselheim, MD, one of three FDA Peripheral and Central Nervous System Drugs advisory committee members who resigned in the wake of the approval, agreed with Public Citizen that the agency’s credibility is suffering.
“The aducanumab decision is the worst example yet of the FDA’s movement away from its high standards,” Dr. Kesselheim, a professor of medicine at Harvard Medical School, Boston, and Harvard colleague Jerry Avorn, MD, wrote in the New York Times on June 15.
“As physicians, we know well that Alzheimer’s disease is a terrible condition,” they wrote. However, they added, “approving a drug that has such poor evidence that it works and causes such worrisome side effects is not the solution.”
In his resignation letter, Dr. Kesselheim said he had also been dismayed by the agency’s 2016 approval of eteplirsen (Exondys 51, Sarepta Therapeutics) for Duchenne muscular dystrophy. In both the eteplirsen and aducanumab approvals, the agency went against its advisers’ recommendations, Dr. Kesselheim said.
Advocates who backed approval decry cost
Aducanumab had a rocky road to approval but had unwavering backing from the Alzheimer’s Association and at least one other organization, UsAgainstAlzheimer’s.
The Alzheimer’s Association was particularly outspoken in its support and, in March, was accused of potential conflict of interest by Public Citizen and several neurologists because the association accepted at least $1.4 million from Biogen and its partner Eisai since fiscal year 2018.
The association applauded the FDA approval but, a few days later, expressed outrage over the $56,000-a-year price tag.
“This price is simply unacceptable,” the Alzheimer’s Association said in the statement. “For many, this price will pose an insurmountable barrier to access, it complicates and jeopardizes sustainable access to this treatment, and may further deepen issues of health equity,” the association said, adding, “We call on Biogen to change this price.”
UsAgainstAlzheimer’s also expressed concerns about access, even before it knew aducanumab’s price.
“Shockingly, Medicare does not reimburse patients for the expensive PET scans important to determine whether someone is appropriate for this drug,” noted George Vradenburg, chairman and cofounder of the group, in a June 7 statement. “We intend to work with Biogen and Medicare to make access to this drug affordable for every American who needs it,” Mr. Vradenburg said.
Dr. Carome said the advocates’ complaints were hard to fathom.
“This should not have come as a surprise to anyone,” Dr. Carome said, adding that “it’s essentially the ballpark figure the company threw out weeks ago.”
“Fifty-six-thousand-dollars is particularly egregiously overpriced for a drug that doesn’t work,” Dr. Carome said. “If the [Alzheimer’s Association] truly finds this objectionable, hopefully they’ll stop accepting money from Biogen and its partner Eisai,” he added.
“The Alzheimer’s Association is recognizing that the genie is out of the bottle and that they are going to have trouble reining in the inevitable run-away costs,” said Mike Greicius, MD, MPH, associate professor of neurology at Stanford University’s Wu Tsai Neurosciences Institute, Stanford, California.
“In addition to the eye-popping annual cost that Biogen has invented, I hope the Alzheimer’s Association is also concerned about the dangerously loose and broad FDA labeling which does not require screening for amyloid-positivity and does not restrict use to the milder forms of disease studied in the Phase 3 trials,” Dr. Greicius said.
Another advocacy group, Patients For Affordable Drugs, commended the Alzheimer’s Association. Its statement “was nothing short of courageous, especially in light of the Alzheimer’s Association’s reliance on funding from drug corporations, including Biogen,” said David Mitchell, a cancer patient and founder of Patients For Affordable Drugs, in a statement.
Mr. Mitchell said his members “stand with the Alzheimer’s Association in its denunciation of the price set by Biogen” and called for a new law that would allow Medicare to negotiate drug prices.
A version of this article first appeared on Medscape.com.
Physician convicted in buprenorphine scheme faces up to 20 years in prison
A West Virginia physician faces up to 20 years in prison in the wake of his conviction by a federal jury for illegally distributing buprenorphine.
The jury convicted Sriramloo Kesari, MD, 78, of Charleston, for distributing buprenorphine outside the scope of medical practice, according to a U.S. Department of Justice statement.
Investigators from the Drug Enforcement Administration presented evidence at the trial that Dr. Kesari, a general practitioner, operated a cash-only business selling buprenorphine prescriptions.
Federal prosecutors said that the physician signed prescriptions, which were then distributed by an employee in exchange for cash. Dr. Kesari was often absent, at times physically located in California, according to the federal government.
Prosecutors indicted the West Virginia physician in September 2019 as part of an “opioid strikeforce takedown” in Ohio, Virginia, and West Virginia that resulted in charges against 13 individuals, including 11 physicians.
Dr. Kesari’s attorneys filed motions during the course of the lengthy case showing that psychiatric and neurological exams indicated that the physician was cognitively impaired.
Based on that evidence and the federal indictment, the West Virginia Board of Medicine suspended Dr. Kesari’s license in February 2020, stating that he is not “mentally and/or physically fit to practice medicine and surgery with reasonable skill and safety.”
Dr. Kesari was first licensed in West Virginia in 1979. In 1987, the Board of Medicine placed Dr. Kesari on a 3-year probation because of his failure to keep records for patients for whom he was prescribing controlled substances.
However, within a few months, the Board changed the probation order to allow Dr. Kesari to write prescriptions for schedule II and III substances in the Boone Hospital emergency room where he continued to work.
The physician had no other disciplinary actions until his license suspension, but the Board lists settlement of four malpractice cases and the dismissal of a fifth between 1986 and 2001.
A version of this article first appeared on Medscape.com.
A West Virginia physician faces up to 20 years in prison in the wake of his conviction by a federal jury for illegally distributing buprenorphine.
The jury convicted Sriramloo Kesari, MD, 78, of Charleston, for distributing buprenorphine outside the scope of medical practice, according to a U.S. Department of Justice statement.
Investigators from the Drug Enforcement Administration presented evidence at the trial that Dr. Kesari, a general practitioner, operated a cash-only business selling buprenorphine prescriptions.
Federal prosecutors said that the physician signed prescriptions, which were then distributed by an employee in exchange for cash. Dr. Kesari was often absent, at times physically located in California, according to the federal government.
Prosecutors indicted the West Virginia physician in September 2019 as part of an “opioid strikeforce takedown” in Ohio, Virginia, and West Virginia that resulted in charges against 13 individuals, including 11 physicians.
Dr. Kesari’s attorneys filed motions during the course of the lengthy case showing that psychiatric and neurological exams indicated that the physician was cognitively impaired.
Based on that evidence and the federal indictment, the West Virginia Board of Medicine suspended Dr. Kesari’s license in February 2020, stating that he is not “mentally and/or physically fit to practice medicine and surgery with reasonable skill and safety.”
Dr. Kesari was first licensed in West Virginia in 1979. In 1987, the Board of Medicine placed Dr. Kesari on a 3-year probation because of his failure to keep records for patients for whom he was prescribing controlled substances.
However, within a few months, the Board changed the probation order to allow Dr. Kesari to write prescriptions for schedule II and III substances in the Boone Hospital emergency room where he continued to work.
The physician had no other disciplinary actions until his license suspension, but the Board lists settlement of four malpractice cases and the dismissal of a fifth between 1986 and 2001.
A version of this article first appeared on Medscape.com.
A West Virginia physician faces up to 20 years in prison in the wake of his conviction by a federal jury for illegally distributing buprenorphine.
The jury convicted Sriramloo Kesari, MD, 78, of Charleston, for distributing buprenorphine outside the scope of medical practice, according to a U.S. Department of Justice statement.
Investigators from the Drug Enforcement Administration presented evidence at the trial that Dr. Kesari, a general practitioner, operated a cash-only business selling buprenorphine prescriptions.
Federal prosecutors said that the physician signed prescriptions, which were then distributed by an employee in exchange for cash. Dr. Kesari was often absent, at times physically located in California, according to the federal government.
Prosecutors indicted the West Virginia physician in September 2019 as part of an “opioid strikeforce takedown” in Ohio, Virginia, and West Virginia that resulted in charges against 13 individuals, including 11 physicians.
Dr. Kesari’s attorneys filed motions during the course of the lengthy case showing that psychiatric and neurological exams indicated that the physician was cognitively impaired.
Based on that evidence and the federal indictment, the West Virginia Board of Medicine suspended Dr. Kesari’s license in February 2020, stating that he is not “mentally and/or physically fit to practice medicine and surgery with reasonable skill and safety.”
Dr. Kesari was first licensed in West Virginia in 1979. In 1987, the Board of Medicine placed Dr. Kesari on a 3-year probation because of his failure to keep records for patients for whom he was prescribing controlled substances.
However, within a few months, the Board changed the probation order to allow Dr. Kesari to write prescriptions for schedule II and III substances in the Boone Hospital emergency room where he continued to work.
The physician had no other disciplinary actions until his license suspension, but the Board lists settlement of four malpractice cases and the dismissal of a fifth between 1986 and 2001.
A version of this article first appeared on Medscape.com.
Study finds little impact of private equity on dermatology practices
A new 
The authors reported that – with an average of five quarters postacquisition – there was no statistically significant differential between investor-owned and non–investor-owned practices “in total spending, overall use of dermatology procedures per patient, or specific high-volume and profitable procedures.”
Essentially, the study findings were equivocal, reported Robert Tyler Braun, PhD and his colleagues at Weill Cornell Medicine, New York. “The results provide mixed support for both proponents and opponents of private equity acquisitions,” they wrote in the study, which was published in Health Affairs.
But two dermatologists not involved with the study said the analysis has significant limitations, including a lack of pathology data, a lack of Medicare data, and a lack of insight into how advanced practice clinicians, such as nurse practitioners and physician assistants, were used by the private equity (PE)–owned practices. The study was not able to track “incident to billing.”
Leaving out Medicare data is a “huge oversight,” Joseph K. Francis, MD, a Mohs surgeon at the University of Florida, Gainesville, said in an interview. “The study is fundamentally flawed.”
“With all of these limitations, it’s difficult to draw meaningful conclusions,” agreed Clifford Perlis, MD, Mbe, of Keystone Dermatology in King of Prussia, Pa.
Both Dr. Francis and Dr. Perlis also questioned the influence of one of the study’s primary sponsors, the Physicians Foundation, formed out of the settlement of a class action lawsuit against third-party payers.
In addition, Dr. Francis and Dr. Perlis said they thought the study did not follow the PE-owned practices for a long enough period of time after acquisition to detect any differences, and that the dataset – looking at practice acquisitions from 2012 to 2017 – was too old to paint a reliable picture of the current state of PE-owned practices. Acquisitions have accelerated since 2017.
In March 2021, Harvard researchers reported in JAMA Health Forum that PE purchases in health care peaked in the first quarter of 2018 and surged to almost as high a level in the fourth quarter of 2020, with 153 deals announced in the second half of the year. Of the 153 acquisitions, 98, or 64%, were for physician practices or other health care services.
Dr. Braun said his study focused on 2012-2017 because it was an available data set. And, he defended the snapshot, saying that he and his colleagues had as much as 4 years of postacquisition data for the practices that were purchased in 2013. He acknowledged there were less data on practices purchased from 2014 to 2016.
“It is possible that our results would change with a longer postacquisition period,” Dr. Braun said in an interview. But, he said there was no way to predict whether that change “would look better or worse for private equity.”
Modest price increases
The authors analyzed data from the Health Care Cost Institute, which aggregates claims for some 50 million individuals insured by Aetna, Humana, and United Healthcare. The data do not include Medicare claims.
They examined dermatologists in practices bought between 2013 and 2016 and compared them to dermatologists who were in practices not owned by private equity. Each dermatologist had to have at least 2 years of data, and the authors compared preacquisition with postacquisition data for those in PE-owned practices.
They identified 64 practices – with 246 dermatologists – bought by private investors. Preacquisition, PE practices were larger than non-PE practices, with 4.2 clinicians (including advanced practitioners) per practice, compared with 1.7 in non–investor-owned practices.
The authors looked at volume and prices for routine office visits (CPT code 99213), biopsies (11101), excisions (11602), destruction of first lesion (cryotherapy; 17000), and Mohs micrographic surgery (17311).
Prices for a routine office visit rose nominally in the first quarter after acquisition (under $1), stayed at 0 in the second quarter, decreased in the third quarter, and was 0 again in the fourth quarter. It was not until the fifth quarter post acquisition that prices rose, increasing by 3% ($2.26), and then rising 5% ($3.20) in the ninth quarter.
Dr. Braun said the price increases make sense because practices get “rolled up” into larger platforms, theoretically giving them more negotiating leverage with insurers. And he said the paper’s results “are consistent with physician practice consolidation research – mainly hospitals acquiring practices – that prices increase after acquisition.” He acknowledged that the dermatology paper found “more modest effects,” than other studies.
Dr. Francis, however, said the increases are basically “pocket change,” and that they reflect a failed promise from private investors that clinicians in PE-owned practices will be paid more. The small differences in pay may also mean that insurers are likely not acquiescing to the theoretical leverage of larger dermatology entities.
PE-owned dermatologists saw about 5% more patients per quarter initially, rising to 17% more per quarter by eight quarters after purchase, according to the study.
The study reported a significant increase in Mohs surgery and cryotherapy in the first quarter post purchase, and a significant increase in biopsies after eight quarters. But Dr. Braun and colleagues concluded that total spending per patient did not change significantly after acquisition. “That says that maybe physicians aren’t changing their behaviors that much,” Dr. Braun said in an interview.
Dr. Perlis disagreed, noting that practices rarely change quickly. “Anecdotally, most groups that are taken over, nothing changes initially,” while the new owners are getting a feel for the practice.
He also said the paper erred in not addressing quality of and access to care. “Quality and patient satisfaction and access are also other important factors that need to be examined.”
Not benign players
Both Dr. Perlis and Dr. Francis said the study may have been improved by having a dermatologist as a coauthor. Dr. Braun countered that he and his colleagues consulted several dermatologists during the course of the study, and that they also conducted 30 interviews with proponents and opponents of PE ownership.
The authors warned of what they viewed as some disturbing trends in PE-owned practices, including what Dr. Braun called “stealth” consolidation – investors making small purchases that fall outside of federal regulation, and then amassing them into large entities.
He also commented that it was “alarming” that PE-owned practices were hiring a larger number of advanced practitioners. The authors also expressed concern about leveraged buyouts, in which investors require a practice to carry high debt loads that can eventually drive it into bankruptcy.
“These are not benign players,” said Dr. Francis. He noted that it took “an act of Congress to stop surprise billing,” a tactic employed by PE-owned health care entities. “Policy makers should be looking at what’s best for patients, especially Medicare and vulnerable patients.”
Dr. Perlis also has qualms about PE-owned practices. “The money to support returns to investors has to come from somewhere and that creates an inherent tension between patient care and optimizing revenue for investors,” he said. “It’s a pretty head-on conflict.”
A new
The authors reported that – with an average of five quarters postacquisition – there was no statistically significant differential between investor-owned and non–investor-owned practices “in total spending, overall use of dermatology procedures per patient, or specific high-volume and profitable procedures.”
Essentially, the study findings were equivocal, reported Robert Tyler Braun, PhD and his colleagues at Weill Cornell Medicine, New York. “The results provide mixed support for both proponents and opponents of private equity acquisitions,” they wrote in the study, which was published in Health Affairs.
But two dermatologists not involved with the study said the analysis has significant limitations, including a lack of pathology data, a lack of Medicare data, and a lack of insight into how advanced practice clinicians, such as nurse practitioners and physician assistants, were used by the private equity (PE)–owned practices. The study was not able to track “incident to billing.”
Leaving out Medicare data is a “huge oversight,” Joseph K. Francis, MD, a Mohs surgeon at the University of Florida, Gainesville, said in an interview. “The study is fundamentally flawed.”
“With all of these limitations, it’s difficult to draw meaningful conclusions,” agreed Clifford Perlis, MD, Mbe, of Keystone Dermatology in King of Prussia, Pa.
Both Dr. Francis and Dr. Perlis also questioned the influence of one of the study’s primary sponsors, the Physicians Foundation, formed out of the settlement of a class action lawsuit against third-party payers.
In addition, Dr. Francis and Dr. Perlis said they thought the study did not follow the PE-owned practices for a long enough period of time after acquisition to detect any differences, and that the dataset – looking at practice acquisitions from 2012 to 2017 – was too old to paint a reliable picture of the current state of PE-owned practices. Acquisitions have accelerated since 2017.
In March 2021, Harvard researchers reported in JAMA Health Forum that PE purchases in health care peaked in the first quarter of 2018 and surged to almost as high a level in the fourth quarter of 2020, with 153 deals announced in the second half of the year. Of the 153 acquisitions, 98, or 64%, were for physician practices or other health care services.
Dr. Braun said his study focused on 2012-2017 because it was an available data set. And, he defended the snapshot, saying that he and his colleagues had as much as 4 years of postacquisition data for the practices that were purchased in 2013. He acknowledged there were less data on practices purchased from 2014 to 2016.
“It is possible that our results would change with a longer postacquisition period,” Dr. Braun said in an interview. But, he said there was no way to predict whether that change “would look better or worse for private equity.”
Modest price increases
The authors analyzed data from the Health Care Cost Institute, which aggregates claims for some 50 million individuals insured by Aetna, Humana, and United Healthcare. The data do not include Medicare claims.
They examined dermatologists in practices bought between 2013 and 2016 and compared them to dermatologists who were in practices not owned by private equity. Each dermatologist had to have at least 2 years of data, and the authors compared preacquisition with postacquisition data for those in PE-owned practices.
They identified 64 practices – with 246 dermatologists – bought by private investors. Preacquisition, PE practices were larger than non-PE practices, with 4.2 clinicians (including advanced practitioners) per practice, compared with 1.7 in non–investor-owned practices.
The authors looked at volume and prices for routine office visits (CPT code 99213), biopsies (11101), excisions (11602), destruction of first lesion (cryotherapy; 17000), and Mohs micrographic surgery (17311).
Prices for a routine office visit rose nominally in the first quarter after acquisition (under $1), stayed at 0 in the second quarter, decreased in the third quarter, and was 0 again in the fourth quarter. It was not until the fifth quarter post acquisition that prices rose, increasing by 3% ($2.26), and then rising 5% ($3.20) in the ninth quarter.
Dr. Braun said the price increases make sense because practices get “rolled up” into larger platforms, theoretically giving them more negotiating leverage with insurers. And he said the paper’s results “are consistent with physician practice consolidation research – mainly hospitals acquiring practices – that prices increase after acquisition.” He acknowledged that the dermatology paper found “more modest effects,” than other studies.
Dr. Francis, however, said the increases are basically “pocket change,” and that they reflect a failed promise from private investors that clinicians in PE-owned practices will be paid more. The small differences in pay may also mean that insurers are likely not acquiescing to the theoretical leverage of larger dermatology entities.
PE-owned dermatologists saw about 5% more patients per quarter initially, rising to 17% more per quarter by eight quarters after purchase, according to the study.
The study reported a significant increase in Mohs surgery and cryotherapy in the first quarter post purchase, and a significant increase in biopsies after eight quarters. But Dr. Braun and colleagues concluded that total spending per patient did not change significantly after acquisition. “That says that maybe physicians aren’t changing their behaviors that much,” Dr. Braun said in an interview.
Dr. Perlis disagreed, noting that practices rarely change quickly. “Anecdotally, most groups that are taken over, nothing changes initially,” while the new owners are getting a feel for the practice.
He also said the paper erred in not addressing quality of and access to care. “Quality and patient satisfaction and access are also other important factors that need to be examined.”
Not benign players
Both Dr. Perlis and Dr. Francis said the study may have been improved by having a dermatologist as a coauthor. Dr. Braun countered that he and his colleagues consulted several dermatologists during the course of the study, and that they also conducted 30 interviews with proponents and opponents of PE ownership.
The authors warned of what they viewed as some disturbing trends in PE-owned practices, including what Dr. Braun called “stealth” consolidation – investors making small purchases that fall outside of federal regulation, and then amassing them into large entities.
He also commented that it was “alarming” that PE-owned practices were hiring a larger number of advanced practitioners. The authors also expressed concern about leveraged buyouts, in which investors require a practice to carry high debt loads that can eventually drive it into bankruptcy.
“These are not benign players,” said Dr. Francis. He noted that it took “an act of Congress to stop surprise billing,” a tactic employed by PE-owned health care entities. “Policy makers should be looking at what’s best for patients, especially Medicare and vulnerable patients.”
Dr. Perlis also has qualms about PE-owned practices. “The money to support returns to investors has to come from somewhere and that creates an inherent tension between patient care and optimizing revenue for investors,” he said. “It’s a pretty head-on conflict.”
A new
The authors reported that – with an average of five quarters postacquisition – there was no statistically significant differential between investor-owned and non–investor-owned practices “in total spending, overall use of dermatology procedures per patient, or specific high-volume and profitable procedures.”
Essentially, the study findings were equivocal, reported Robert Tyler Braun, PhD and his colleagues at Weill Cornell Medicine, New York. “The results provide mixed support for both proponents and opponents of private equity acquisitions,” they wrote in the study, which was published in Health Affairs.
But two dermatologists not involved with the study said the analysis has significant limitations, including a lack of pathology data, a lack of Medicare data, and a lack of insight into how advanced practice clinicians, such as nurse practitioners and physician assistants, were used by the private equity (PE)–owned practices. The study was not able to track “incident to billing.”
Leaving out Medicare data is a “huge oversight,” Joseph K. Francis, MD, a Mohs surgeon at the University of Florida, Gainesville, said in an interview. “The study is fundamentally flawed.”
“With all of these limitations, it’s difficult to draw meaningful conclusions,” agreed Clifford Perlis, MD, Mbe, of Keystone Dermatology in King of Prussia, Pa.
Both Dr. Francis and Dr. Perlis also questioned the influence of one of the study’s primary sponsors, the Physicians Foundation, formed out of the settlement of a class action lawsuit against third-party payers.
In addition, Dr. Francis and Dr. Perlis said they thought the study did not follow the PE-owned practices for a long enough period of time after acquisition to detect any differences, and that the dataset – looking at practice acquisitions from 2012 to 2017 – was too old to paint a reliable picture of the current state of PE-owned practices. Acquisitions have accelerated since 2017.
In March 2021, Harvard researchers reported in JAMA Health Forum that PE purchases in health care peaked in the first quarter of 2018 and surged to almost as high a level in the fourth quarter of 2020, with 153 deals announced in the second half of the year. Of the 153 acquisitions, 98, or 64%, were for physician practices or other health care services.
Dr. Braun said his study focused on 2012-2017 because it was an available data set. And, he defended the snapshot, saying that he and his colleagues had as much as 4 years of postacquisition data for the practices that were purchased in 2013. He acknowledged there were less data on practices purchased from 2014 to 2016.
“It is possible that our results would change with a longer postacquisition period,” Dr. Braun said in an interview. But, he said there was no way to predict whether that change “would look better or worse for private equity.”
Modest price increases
The authors analyzed data from the Health Care Cost Institute, which aggregates claims for some 50 million individuals insured by Aetna, Humana, and United Healthcare. The data do not include Medicare claims.
They examined dermatologists in practices bought between 2013 and 2016 and compared them to dermatologists who were in practices not owned by private equity. Each dermatologist had to have at least 2 years of data, and the authors compared preacquisition with postacquisition data for those in PE-owned practices.
They identified 64 practices – with 246 dermatologists – bought by private investors. Preacquisition, PE practices were larger than non-PE practices, with 4.2 clinicians (including advanced practitioners) per practice, compared with 1.7 in non–investor-owned practices.
The authors looked at volume and prices for routine office visits (CPT code 99213), biopsies (11101), excisions (11602), destruction of first lesion (cryotherapy; 17000), and Mohs micrographic surgery (17311).
Prices for a routine office visit rose nominally in the first quarter after acquisition (under $1), stayed at 0 in the second quarter, decreased in the third quarter, and was 0 again in the fourth quarter. It was not until the fifth quarter post acquisition that prices rose, increasing by 3% ($2.26), and then rising 5% ($3.20) in the ninth quarter.
Dr. Braun said the price increases make sense because practices get “rolled up” into larger platforms, theoretically giving them more negotiating leverage with insurers. And he said the paper’s results “are consistent with physician practice consolidation research – mainly hospitals acquiring practices – that prices increase after acquisition.” He acknowledged that the dermatology paper found “more modest effects,” than other studies.
Dr. Francis, however, said the increases are basically “pocket change,” and that they reflect a failed promise from private investors that clinicians in PE-owned practices will be paid more. The small differences in pay may also mean that insurers are likely not acquiescing to the theoretical leverage of larger dermatology entities.
PE-owned dermatologists saw about 5% more patients per quarter initially, rising to 17% more per quarter by eight quarters after purchase, according to the study.
The study reported a significant increase in Mohs surgery and cryotherapy in the first quarter post purchase, and a significant increase in biopsies after eight quarters. But Dr. Braun and colleagues concluded that total spending per patient did not change significantly after acquisition. “That says that maybe physicians aren’t changing their behaviors that much,” Dr. Braun said in an interview.
Dr. Perlis disagreed, noting that practices rarely change quickly. “Anecdotally, most groups that are taken over, nothing changes initially,” while the new owners are getting a feel for the practice.
He also said the paper erred in not addressing quality of and access to care. “Quality and patient satisfaction and access are also other important factors that need to be examined.”
Not benign players
Both Dr. Perlis and Dr. Francis said the study may have been improved by having a dermatologist as a coauthor. Dr. Braun countered that he and his colleagues consulted several dermatologists during the course of the study, and that they also conducted 30 interviews with proponents and opponents of PE ownership.
The authors warned of what they viewed as some disturbing trends in PE-owned practices, including what Dr. Braun called “stealth” consolidation – investors making small purchases that fall outside of federal regulation, and then amassing them into large entities.
He also commented that it was “alarming” that PE-owned practices were hiring a larger number of advanced practitioners. The authors also expressed concern about leveraged buyouts, in which investors require a practice to carry high debt loads that can eventually drive it into bankruptcy.
“These are not benign players,” said Dr. Francis. He noted that it took “an act of Congress to stop surprise billing,” a tactic employed by PE-owned health care entities. “Policy makers should be looking at what’s best for patients, especially Medicare and vulnerable patients.”
Dr. Perlis also has qualms about PE-owned practices. “The money to support returns to investors has to come from somewhere and that creates an inherent tension between patient care and optimizing revenue for investors,” he said. “It’s a pretty head-on conflict.”
FROM HEALTH AFFAIRS
APA, AMA, others move to stop insurer from overturning mental health claims ruling
The American Psychiatric Association has joined with the American Medical Association and other medical societies to oppose United Behavioral Health’s (UBH) request that a court throw out a ruling that found the insurer unfairly denied tens of thousands of claims for mental health and substance use disorder services.
Wit v. United Behavioral Health, in litigation since 2014, is being closely watched by clinicians, patients, providers, and attorneys.
Reena Kapoor, MD, chair of the APA’s Committee on Judicial Action, said in an interview that the APA is hopeful that “whatever the court says about UBH should be applicable to all insurance companies that are providing employer-sponsored health benefits.”
In a friend of the court (amicus curiae) brief, the APA, AMA, the California Medical Association, Southern California Psychiatric Society, Northern California Psychiatric Society, Orange County Psychiatric Society, Central California Psychiatric Society, and San Diego Psychiatric Society argue that “despite the availability of professionally developed, evidence-based guidelines embodying generally accepted standards of care for mental health and substance use disorders, managed care organizations commonly base coverage decisions on internally developed ‘level of care guidelines’ that are inappropriately restrictive.”
The guidelines “may lead to denial of coverage for treatment that is recommended by a patient’s physician and even cut off coverage when treatment is already being delivered,” said the groups.
The U.S. Department of Labor also filed a brief in support of the plaintiffs who are suing UBH. Those individuals suffered injury when they were denied coverage, said the federal agency, which regulates employer-sponsored insurance plans.
California Attorney General Rob Bonta also made an amicus filing supporting the plaintiffs.
“When insurers limit access to this critical care, they leave Californians who need it feeling as if they have no other option than to try to cope alone,” said Mr. Bonta in a statement.
‘Discrimination must end’
Mr. Bonta said he agreed with a 2019 ruling by the U.S. District Court for the Northern District of California that UBH had violated its fiduciary duties by wrongfully using its internally developed coverage determination guidelines and level of care guidelines to deny care.
The court also found that UBH’s medically necessary criteria meant that only “acute” episodes would be covered. Instead, said the court last November, chronic and comorbid conditions should always be treated, according to Maureen Gammon and Kathleen Rosenow of Willis Towers Watson, a risk advisor.
In November, the same Northern California District Court ruled on the remedies it would require of United, including that the insurer reprocess more than 67,000 claims. UBH was also barred indefinitely from using any of its guidelines to make coverage determinations. Instead, it was ordered to make determinations “consistent with generally accepted standards of care,” and consistent with state laws.
The District Court denied a request by UBH to put a hold on the claims reprocessing until it appealed the overall case. But the Ninth Circuit Court of Appeals in February granted that request.
Then, in March, United appealed the District Court’s overall ruling, claiming that the plaintiffs had not proven harm.
The U.S. Chamber of Commerce has filed a brief in support of United, agreeing with its arguments.
However, the APA and other clinician groups said there is no question of harm.
“Failure to provide appropriate levels of care for treatment of mental illness and substance use disorders leads to relapse, overdose, transmission of infectious diseases, and death,” said APA CEO and Medical Director Saul Levin, MD, MPA, in a statement.
APA President Vivian Pender, MD, said guidelines that “are overly focused on stabilizing acute symptoms of mental health and substance use disorders” are not treating the underlying disease. “When the injury is physical, insurers treat the underlying disease and not just the symptoms. Discrimination against patients with mental illness must end,” she said.
No court has ever recognized the type of claims reprocessing ordered by the District Court judge, said attorneys Nathaniel Cohen and Joseph Laska of Manatt, Phelps & Phillips, in an analysis of the case.
Mr. Cohen and Mr. Laska write. “Practitioners, health plans, and health insurers would be wise to track UBH’s long-awaited appeal to the Ninth Circuit.”
This article first appeared on Medscape.com.
The American Psychiatric Association has joined with the American Medical Association and other medical societies to oppose United Behavioral Health’s (UBH) request that a court throw out a ruling that found the insurer unfairly denied tens of thousands of claims for mental health and substance use disorder services.
Wit v. United Behavioral Health, in litigation since 2014, is being closely watched by clinicians, patients, providers, and attorneys.
Reena Kapoor, MD, chair of the APA’s Committee on Judicial Action, said in an interview that the APA is hopeful that “whatever the court says about UBH should be applicable to all insurance companies that are providing employer-sponsored health benefits.”
In a friend of the court (amicus curiae) brief, the APA, AMA, the California Medical Association, Southern California Psychiatric Society, Northern California Psychiatric Society, Orange County Psychiatric Society, Central California Psychiatric Society, and San Diego Psychiatric Society argue that “despite the availability of professionally developed, evidence-based guidelines embodying generally accepted standards of care for mental health and substance use disorders, managed care organizations commonly base coverage decisions on internally developed ‘level of care guidelines’ that are inappropriately restrictive.”
The guidelines “may lead to denial of coverage for treatment that is recommended by a patient’s physician and even cut off coverage when treatment is already being delivered,” said the groups.
The U.S. Department of Labor also filed a brief in support of the plaintiffs who are suing UBH. Those individuals suffered injury when they were denied coverage, said the federal agency, which regulates employer-sponsored insurance plans.
California Attorney General Rob Bonta also made an amicus filing supporting the plaintiffs.
“When insurers limit access to this critical care, they leave Californians who need it feeling as if they have no other option than to try to cope alone,” said Mr. Bonta in a statement.
‘Discrimination must end’
Mr. Bonta said he agreed with a 2019 ruling by the U.S. District Court for the Northern District of California that UBH had violated its fiduciary duties by wrongfully using its internally developed coverage determination guidelines and level of care guidelines to deny care.
The court also found that UBH’s medically necessary criteria meant that only “acute” episodes would be covered. Instead, said the court last November, chronic and comorbid conditions should always be treated, according to Maureen Gammon and Kathleen Rosenow of Willis Towers Watson, a risk advisor.
In November, the same Northern California District Court ruled on the remedies it would require of United, including that the insurer reprocess more than 67,000 claims. UBH was also barred indefinitely from using any of its guidelines to make coverage determinations. Instead, it was ordered to make determinations “consistent with generally accepted standards of care,” and consistent with state laws.
The District Court denied a request by UBH to put a hold on the claims reprocessing until it appealed the overall case. But the Ninth Circuit Court of Appeals in February granted that request.
Then, in March, United appealed the District Court’s overall ruling, claiming that the plaintiffs had not proven harm.
The U.S. Chamber of Commerce has filed a brief in support of United, agreeing with its arguments.
However, the APA and other clinician groups said there is no question of harm.
“Failure to provide appropriate levels of care for treatment of mental illness and substance use disorders leads to relapse, overdose, transmission of infectious diseases, and death,” said APA CEO and Medical Director Saul Levin, MD, MPA, in a statement.
APA President Vivian Pender, MD, said guidelines that “are overly focused on stabilizing acute symptoms of mental health and substance use disorders” are not treating the underlying disease. “When the injury is physical, insurers treat the underlying disease and not just the symptoms. Discrimination against patients with mental illness must end,” she said.
No court has ever recognized the type of claims reprocessing ordered by the District Court judge, said attorneys Nathaniel Cohen and Joseph Laska of Manatt, Phelps & Phillips, in an analysis of the case.
Mr. Cohen and Mr. Laska write. “Practitioners, health plans, and health insurers would be wise to track UBH’s long-awaited appeal to the Ninth Circuit.”
This article first appeared on Medscape.com.
The American Psychiatric Association has joined with the American Medical Association and other medical societies to oppose United Behavioral Health’s (UBH) request that a court throw out a ruling that found the insurer unfairly denied tens of thousands of claims for mental health and substance use disorder services.
Wit v. United Behavioral Health, in litigation since 2014, is being closely watched by clinicians, patients, providers, and attorneys.
Reena Kapoor, MD, chair of the APA’s Committee on Judicial Action, said in an interview that the APA is hopeful that “whatever the court says about UBH should be applicable to all insurance companies that are providing employer-sponsored health benefits.”
In a friend of the court (amicus curiae) brief, the APA, AMA, the California Medical Association, Southern California Psychiatric Society, Northern California Psychiatric Society, Orange County Psychiatric Society, Central California Psychiatric Society, and San Diego Psychiatric Society argue that “despite the availability of professionally developed, evidence-based guidelines embodying generally accepted standards of care for mental health and substance use disorders, managed care organizations commonly base coverage decisions on internally developed ‘level of care guidelines’ that are inappropriately restrictive.”
The guidelines “may lead to denial of coverage for treatment that is recommended by a patient’s physician and even cut off coverage when treatment is already being delivered,” said the groups.
The U.S. Department of Labor also filed a brief in support of the plaintiffs who are suing UBH. Those individuals suffered injury when they were denied coverage, said the federal agency, which regulates employer-sponsored insurance plans.
California Attorney General Rob Bonta also made an amicus filing supporting the plaintiffs.
“When insurers limit access to this critical care, they leave Californians who need it feeling as if they have no other option than to try to cope alone,” said Mr. Bonta in a statement.
‘Discrimination must end’
Mr. Bonta said he agreed with a 2019 ruling by the U.S. District Court for the Northern District of California that UBH had violated its fiduciary duties by wrongfully using its internally developed coverage determination guidelines and level of care guidelines to deny care.
The court also found that UBH’s medically necessary criteria meant that only “acute” episodes would be covered. Instead, said the court last November, chronic and comorbid conditions should always be treated, according to Maureen Gammon and Kathleen Rosenow of Willis Towers Watson, a risk advisor.
In November, the same Northern California District Court ruled on the remedies it would require of United, including that the insurer reprocess more than 67,000 claims. UBH was also barred indefinitely from using any of its guidelines to make coverage determinations. Instead, it was ordered to make determinations “consistent with generally accepted standards of care,” and consistent with state laws.
The District Court denied a request by UBH to put a hold on the claims reprocessing until it appealed the overall case. But the Ninth Circuit Court of Appeals in February granted that request.
Then, in March, United appealed the District Court’s overall ruling, claiming that the plaintiffs had not proven harm.
The U.S. Chamber of Commerce has filed a brief in support of United, agreeing with its arguments.
However, the APA and other clinician groups said there is no question of harm.
“Failure to provide appropriate levels of care for treatment of mental illness and substance use disorders leads to relapse, overdose, transmission of infectious diseases, and death,” said APA CEO and Medical Director Saul Levin, MD, MPA, in a statement.
APA President Vivian Pender, MD, said guidelines that “are overly focused on stabilizing acute symptoms of mental health and substance use disorders” are not treating the underlying disease. “When the injury is physical, insurers treat the underlying disease and not just the symptoms. Discrimination against patients with mental illness must end,” she said.
No court has ever recognized the type of claims reprocessing ordered by the District Court judge, said attorneys Nathaniel Cohen and Joseph Laska of Manatt, Phelps & Phillips, in an analysis of the case.
Mr. Cohen and Mr. Laska write. “Practitioners, health plans, and health insurers would be wise to track UBH’s long-awaited appeal to the Ninth Circuit.”
This article first appeared on Medscape.com.
HHS to inject billions into mental health, substance use disorders
The U.S. Department of Health and Human Services will inject billions of dollars into programs designed to address mental health and substance use disorders, including $3 billion released to states as of May 18, said federal officials.
The American Rescue Plan, a COVID-relief package signed into law in March, contained the money, which will be divided equally between the Community Mental Health Services Block Grant Program and the Substance Abuse Prevention and Treatment Block Grant Program, said Tom Coderre, Acting Assistant Secretary for Mental Health and Substance Use, in a call with reporters.
The award amounts will vary by state.
The mental health program helps states and territories provide services for children with serious emotional issues and adults with serious mental illness.
The substance use program provides money to plan, implement, and evaluate prevention, intervention, treatment, and recovery services.
, which fueled an increase in anxiety, depression, and overdose, said Assistant Secretary for Health Rachel Levine, MD, on the call.
“We know multiple stressors during the pandemic – isolation, sickness, grief, job loss, food instability, and loss of routines – have devastated many Americans and presented the unprecedented behavioral health challenges across the nation,” said Dr. Levine.
The HHS also announced that it is re-establishing a Behavioral Health Coordinating Council (BHCC). Dr. Levine and Mr. Coderre will serve as cochairs of the Council, which will coordinate action-oriented approaches to addressing the HHS’s behavioral health efforts.
However, in 2014, the U.S. Government Accountability Office criticized the BHCC for only focusing on the HHS, and noted the lack of coordination across the federal government’s various efforts to address mental health.
‘A huge step forward’
The American Psychiatric Association welcomed the new money and the return of the council.
“In the wake of the pandemic an unprecedented, and as of yet untold, number of Americans are faced with mental health and substance use disorders, particularly in communities impacted by structural racism,” said APA President Vivian Pender, MD, in a statement. “With the creation of this Council and this investment in mental health, the administration is taking a huge step forward.”
APA CEO and Medical Director Saul Levin, MD, MPA, added: “This Council has great potential to ease the challenges we face as we begin to recover from the pandemic’s impact on our society, and [the] APA looks forward to assisting in their efforts.”
HHS Secretary Xavier Becerra noted in a statement that the COVID-19 pandemic “has made clear the need to invest resources in our nation’s mental health and address the inequities that still exist around behavioral health care.” He added, “This national problem calls for department-wide coordination to address the issue.”
Dr. Levine said the Council “will assure the right prioritization and guidelines are in place to provide pathways to prevention, intervention, treatment, and recovery services.”
A version of this article first appeared on Medscape.com.
The U.S. Department of Health and Human Services will inject billions of dollars into programs designed to address mental health and substance use disorders, including $3 billion released to states as of May 18, said federal officials.
The American Rescue Plan, a COVID-relief package signed into law in March, contained the money, which will be divided equally between the Community Mental Health Services Block Grant Program and the Substance Abuse Prevention and Treatment Block Grant Program, said Tom Coderre, Acting Assistant Secretary for Mental Health and Substance Use, in a call with reporters.
The award amounts will vary by state.
The mental health program helps states and territories provide services for children with serious emotional issues and adults with serious mental illness.
The substance use program provides money to plan, implement, and evaluate prevention, intervention, treatment, and recovery services.
, which fueled an increase in anxiety, depression, and overdose, said Assistant Secretary for Health Rachel Levine, MD, on the call.
“We know multiple stressors during the pandemic – isolation, sickness, grief, job loss, food instability, and loss of routines – have devastated many Americans and presented the unprecedented behavioral health challenges across the nation,” said Dr. Levine.
The HHS also announced that it is re-establishing a Behavioral Health Coordinating Council (BHCC). Dr. Levine and Mr. Coderre will serve as cochairs of the Council, which will coordinate action-oriented approaches to addressing the HHS’s behavioral health efforts.
However, in 2014, the U.S. Government Accountability Office criticized the BHCC for only focusing on the HHS, and noted the lack of coordination across the federal government’s various efforts to address mental health.
‘A huge step forward’
The American Psychiatric Association welcomed the new money and the return of the council.
“In the wake of the pandemic an unprecedented, and as of yet untold, number of Americans are faced with mental health and substance use disorders, particularly in communities impacted by structural racism,” said APA President Vivian Pender, MD, in a statement. “With the creation of this Council and this investment in mental health, the administration is taking a huge step forward.”
APA CEO and Medical Director Saul Levin, MD, MPA, added: “This Council has great potential to ease the challenges we face as we begin to recover from the pandemic’s impact on our society, and [the] APA looks forward to assisting in their efforts.”
HHS Secretary Xavier Becerra noted in a statement that the COVID-19 pandemic “has made clear the need to invest resources in our nation’s mental health and address the inequities that still exist around behavioral health care.” He added, “This national problem calls for department-wide coordination to address the issue.”
Dr. Levine said the Council “will assure the right prioritization and guidelines are in place to provide pathways to prevention, intervention, treatment, and recovery services.”
A version of this article first appeared on Medscape.com.
The U.S. Department of Health and Human Services will inject billions of dollars into programs designed to address mental health and substance use disorders, including $3 billion released to states as of May 18, said federal officials.
The American Rescue Plan, a COVID-relief package signed into law in March, contained the money, which will be divided equally between the Community Mental Health Services Block Grant Program and the Substance Abuse Prevention and Treatment Block Grant Program, said Tom Coderre, Acting Assistant Secretary for Mental Health and Substance Use, in a call with reporters.
The award amounts will vary by state.
The mental health program helps states and territories provide services for children with serious emotional issues and adults with serious mental illness.
The substance use program provides money to plan, implement, and evaluate prevention, intervention, treatment, and recovery services.
, which fueled an increase in anxiety, depression, and overdose, said Assistant Secretary for Health Rachel Levine, MD, on the call.
“We know multiple stressors during the pandemic – isolation, sickness, grief, job loss, food instability, and loss of routines – have devastated many Americans and presented the unprecedented behavioral health challenges across the nation,” said Dr. Levine.
The HHS also announced that it is re-establishing a Behavioral Health Coordinating Council (BHCC). Dr. Levine and Mr. Coderre will serve as cochairs of the Council, which will coordinate action-oriented approaches to addressing the HHS’s behavioral health efforts.
However, in 2014, the U.S. Government Accountability Office criticized the BHCC for only focusing on the HHS, and noted the lack of coordination across the federal government’s various efforts to address mental health.
‘A huge step forward’
The American Psychiatric Association welcomed the new money and the return of the council.
“In the wake of the pandemic an unprecedented, and as of yet untold, number of Americans are faced with mental health and substance use disorders, particularly in communities impacted by structural racism,” said APA President Vivian Pender, MD, in a statement. “With the creation of this Council and this investment in mental health, the administration is taking a huge step forward.”
APA CEO and Medical Director Saul Levin, MD, MPA, added: “This Council has great potential to ease the challenges we face as we begin to recover from the pandemic’s impact on our society, and [the] APA looks forward to assisting in their efforts.”
HHS Secretary Xavier Becerra noted in a statement that the COVID-19 pandemic “has made clear the need to invest resources in our nation’s mental health and address the inequities that still exist around behavioral health care.” He added, “This national problem calls for department-wide coordination to address the issue.”
Dr. Levine said the Council “will assure the right prioritization and guidelines are in place to provide pathways to prevention, intervention, treatment, and recovery services.”
A version of this article first appeared on Medscape.com.
HHS prohibits discrimination against LGBTQ patients: Action reverses Trump-era policy
The Biden administration is reversing a Trump-era policy that allowed health care providers to bar services to lesbian, gay, bisexual, transgender, or queer (LGBTQ) patients.
The U.S. Department of Health and Human Services gave notice on Monday that it would interpret the Affordable Care Act’s Section 1557 – which bars discrimination on the basis of sex – to include discrimination on the basis of sexual orientation or gender identity. The department said its position is consistent with a June 2020 U.S. Supreme Court ruling in Bostock v. Clayton County, GA. The ruling determined that the Civil Rights Act’s prohibition of employment discrimination on the basis of sex includes sexual orientation and gender identity.
“The mission of our Department is to enhance the health and well-being of all Americans, no matter their gender identity or sexual orientation,” said HHS Assistant Secretary for Health Rachel Levine, MD, in a statement released Monday.
“All people need access to health care services to fix a broken bone, protect their heart health, and screen for cancer risk,” she said. “No one should be discriminated against when seeking medical services because of who they are.”
Many physician organizations applauded the decision.
“The Biden administration did the right thing by terminating a short-lived effort to allow discrimination based on gender or sexual orientation when seeking health care,” said Susan R. Bailey, MD, president of the American Medical Association, in a statement.
When, in 2019, the Trump administration proposed to allow providers to deny care to LGBTQ people, the AMA said in a letter to the HHS that its interpretation “was contrary to the intent and the plain language of the law.”
Now, said Bailey, the AMA welcomes the Biden administration’s interpretation. It “is a victory for health equity and ends a dismal chapter in which a federal agency sought to remove civil rights protections,” she said.
An alliance of patient groups – including the American Cancer Society, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Epilepsy Foundation, the National Multiple Sclerosis Society, and the National Organization for Rare Disorders – also applauded the new policy. “This community already faces significant health disparities,” the groups noted in a statement. People with chronic illness such as HIV and cancer “need to be able to access care quickly and without fear of discrimination,” they said.
The groups had filed a friend of the court brief in a case against the Trump administration rule.
“We welcome this positive step to ensure access is preserved without hindrance, as intended by the health care law,” they said.
Twenty-two states and Washington, D.C. – led by former California Attorney General Xavier Becerra, who is now HHS secretary – sued the Trump administration in July 2020, aiming to overturn the rule.
Chase Strangio, deputy director for Trans Justice with the American Civil Liberties Union LGBTQ & HIV Project, noted that the HHS announcement was crucial in the face of efforts in multiple states to bar health care for transgender youth. “The Biden administration has affirmed what courts have said for decades: Discrimination against LGBTQ people is against the law. It also affirms what transgender people have long said: Gender-affirming care is life-saving care,” he said in a statement.
Lambda Legal, which led another lawsuit against the Trump administration rule, said it welcomed the HHS action but noted in a statement by the organization’s senior attorney, Omar Gonzalez-Pagan, that it “does not address significant aspects of the Trump-era rule that we and others have challenged in court.”
The Trump rule also “limited the remedies available to people who face health disparities, limited access to health care for people with Limited English Proficiency, unlawfully incorporated religious exemptions, and dramatically reduced the number of health care entities and insurance subject to the rule, all of which today’s action does not address,” said Gonzalez-Pagan.
“We encourage Secretary Xavier Becerra and the Biden administration to take additional steps to ensure that all LGBTQ people are completely covered wherever and whenever they may encounter discrimination during some of the most delicate and precarious moments of their lives: When seeking health care,” he said.
A version of this article first appeared on Medscape.com.
The Biden administration is reversing a Trump-era policy that allowed health care providers to bar services to lesbian, gay, bisexual, transgender, or queer (LGBTQ) patients.
The U.S. Department of Health and Human Services gave notice on Monday that it would interpret the Affordable Care Act’s Section 1557 – which bars discrimination on the basis of sex – to include discrimination on the basis of sexual orientation or gender identity. The department said its position is consistent with a June 2020 U.S. Supreme Court ruling in Bostock v. Clayton County, GA. The ruling determined that the Civil Rights Act’s prohibition of employment discrimination on the basis of sex includes sexual orientation and gender identity.
“The mission of our Department is to enhance the health and well-being of all Americans, no matter their gender identity or sexual orientation,” said HHS Assistant Secretary for Health Rachel Levine, MD, in a statement released Monday.
“All people need access to health care services to fix a broken bone, protect their heart health, and screen for cancer risk,” she said. “No one should be discriminated against when seeking medical services because of who they are.”
Many physician organizations applauded the decision.
“The Biden administration did the right thing by terminating a short-lived effort to allow discrimination based on gender or sexual orientation when seeking health care,” said Susan R. Bailey, MD, president of the American Medical Association, in a statement.
When, in 2019, the Trump administration proposed to allow providers to deny care to LGBTQ people, the AMA said in a letter to the HHS that its interpretation “was contrary to the intent and the plain language of the law.”
Now, said Bailey, the AMA welcomes the Biden administration’s interpretation. It “is a victory for health equity and ends a dismal chapter in which a federal agency sought to remove civil rights protections,” she said.
An alliance of patient groups – including the American Cancer Society, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Epilepsy Foundation, the National Multiple Sclerosis Society, and the National Organization for Rare Disorders – also applauded the new policy. “This community already faces significant health disparities,” the groups noted in a statement. People with chronic illness such as HIV and cancer “need to be able to access care quickly and without fear of discrimination,” they said.
The groups had filed a friend of the court brief in a case against the Trump administration rule.
“We welcome this positive step to ensure access is preserved without hindrance, as intended by the health care law,” they said.
Twenty-two states and Washington, D.C. – led by former California Attorney General Xavier Becerra, who is now HHS secretary – sued the Trump administration in July 2020, aiming to overturn the rule.
Chase Strangio, deputy director for Trans Justice with the American Civil Liberties Union LGBTQ & HIV Project, noted that the HHS announcement was crucial in the face of efforts in multiple states to bar health care for transgender youth. “The Biden administration has affirmed what courts have said for decades: Discrimination against LGBTQ people is against the law. It also affirms what transgender people have long said: Gender-affirming care is life-saving care,” he said in a statement.
Lambda Legal, which led another lawsuit against the Trump administration rule, said it welcomed the HHS action but noted in a statement by the organization’s senior attorney, Omar Gonzalez-Pagan, that it “does not address significant aspects of the Trump-era rule that we and others have challenged in court.”
The Trump rule also “limited the remedies available to people who face health disparities, limited access to health care for people with Limited English Proficiency, unlawfully incorporated religious exemptions, and dramatically reduced the number of health care entities and insurance subject to the rule, all of which today’s action does not address,” said Gonzalez-Pagan.
“We encourage Secretary Xavier Becerra and the Biden administration to take additional steps to ensure that all LGBTQ people are completely covered wherever and whenever they may encounter discrimination during some of the most delicate and precarious moments of their lives: When seeking health care,” he said.
A version of this article first appeared on Medscape.com.
The Biden administration is reversing a Trump-era policy that allowed health care providers to bar services to lesbian, gay, bisexual, transgender, or queer (LGBTQ) patients.
The U.S. Department of Health and Human Services gave notice on Monday that it would interpret the Affordable Care Act’s Section 1557 – which bars discrimination on the basis of sex – to include discrimination on the basis of sexual orientation or gender identity. The department said its position is consistent with a June 2020 U.S. Supreme Court ruling in Bostock v. Clayton County, GA. The ruling determined that the Civil Rights Act’s prohibition of employment discrimination on the basis of sex includes sexual orientation and gender identity.
“The mission of our Department is to enhance the health and well-being of all Americans, no matter their gender identity or sexual orientation,” said HHS Assistant Secretary for Health Rachel Levine, MD, in a statement released Monday.
“All people need access to health care services to fix a broken bone, protect their heart health, and screen for cancer risk,” she said. “No one should be discriminated against when seeking medical services because of who they are.”
Many physician organizations applauded the decision.
“The Biden administration did the right thing by terminating a short-lived effort to allow discrimination based on gender or sexual orientation when seeking health care,” said Susan R. Bailey, MD, president of the American Medical Association, in a statement.
When, in 2019, the Trump administration proposed to allow providers to deny care to LGBTQ people, the AMA said in a letter to the HHS that its interpretation “was contrary to the intent and the plain language of the law.”
Now, said Bailey, the AMA welcomes the Biden administration’s interpretation. It “is a victory for health equity and ends a dismal chapter in which a federal agency sought to remove civil rights protections,” she said.
An alliance of patient groups – including the American Cancer Society, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Epilepsy Foundation, the National Multiple Sclerosis Society, and the National Organization for Rare Disorders – also applauded the new policy. “This community already faces significant health disparities,” the groups noted in a statement. People with chronic illness such as HIV and cancer “need to be able to access care quickly and without fear of discrimination,” they said.
The groups had filed a friend of the court brief in a case against the Trump administration rule.
“We welcome this positive step to ensure access is preserved without hindrance, as intended by the health care law,” they said.
Twenty-two states and Washington, D.C. – led by former California Attorney General Xavier Becerra, who is now HHS secretary – sued the Trump administration in July 2020, aiming to overturn the rule.
Chase Strangio, deputy director for Trans Justice with the American Civil Liberties Union LGBTQ & HIV Project, noted that the HHS announcement was crucial in the face of efforts in multiple states to bar health care for transgender youth. “The Biden administration has affirmed what courts have said for decades: Discrimination against LGBTQ people is against the law. It also affirms what transgender people have long said: Gender-affirming care is life-saving care,” he said in a statement.
Lambda Legal, which led another lawsuit against the Trump administration rule, said it welcomed the HHS action but noted in a statement by the organization’s senior attorney, Omar Gonzalez-Pagan, that it “does not address significant aspects of the Trump-era rule that we and others have challenged in court.”
The Trump rule also “limited the remedies available to people who face health disparities, limited access to health care for people with Limited English Proficiency, unlawfully incorporated religious exemptions, and dramatically reduced the number of health care entities and insurance subject to the rule, all of which today’s action does not address,” said Gonzalez-Pagan.
“We encourage Secretary Xavier Becerra and the Biden administration to take additional steps to ensure that all LGBTQ people are completely covered wherever and whenever they may encounter discrimination during some of the most delicate and precarious moments of their lives: When seeking health care,” he said.
A version of this article first appeared on Medscape.com.
Small clinics, practices key to COVID-19 vaccine success: State officials
Primary care physicians and providers in small offices and clinics are going to be key to ensuring that the remaining half of the nation receives a COVID-19 vaccination, state health officials said Wednesday, and the federal government will soon start shipping smaller packages of the Pfizer/BioNTech vaccine that can be more readily used by individual doctors.
According to the Centers for Disease Control and Prevention, as of April 21, more than 215 million doses have been administered. About 40% – 134 million Americans – have had at least one dose of a vaccine.
Among those who still haven’t received a shot are people who don’t have the time, may be homebound, or who have questions about the vaccine, or might say they will never be vaccinated, said Nirav Shah, MD, JD, president of the Association of State and Territorial Health Officials and director of the Maine Center for Disease Control and Prevention, on a call with reporters.
Especially for those who fall into the “not-ever” category, state officials “are working to find trusted messengers like doctors” who can connect with these individuals and give them information, he said.
Primary care physicians’ offices and other small practice settings are “where we are most likely to reach many of the remaining 50%,” Steven Stack, MD, MBA, FACEP, commissioner of the Kentucky Department for Public Health, said on the briefing.
State officials also “need to support all people to consult their personal physicians in whom they have confidence and trust to be informed of the benefits of COVID vaccination and the safety of this vaccination,” he said, adding that “this is the way we put this pandemic in the rearview mirror and move on with our lives.”
Dr. Stack said the federal government is starting by working with Pfizer to slim down its packages from 1,170 doses to 450 doses. That should happen before June, said Dr. Stack, adding that state health officials will be able to distribute the smaller packages “more widely and to smaller settings.”
Ideally, packaging for all vaccines will get down to single-dose, pre-filled syringes, he said. But that is a “journey” that the federal government has just begun, said Dr. Stack.
The White House had not responded to a request from this news organization for comment by press time.
Having vaccines onsite in a physician’s office is important, Dr. Stack said, adding that doctors “need to reach people in their persuadable moment.”
Bringing pediatricians on board
Illinois state health officials have begun a process that will let pediatricians have weekly vaccination clinics and also have vaccine on hand to meet patients in the moment, said Ngozi Ezike, MD, director of the Illinois Department of Public Health, on the briefing.
She said the distribution can start even before the Pfizer vaccine is shipped in smaller packages – and as soon as the Food and Drug Administration authorizes the vaccine for adolescents. Pfizer applied for emergency use approval for children aged 12-15 on April 9.
Local health departments will store the vaccine in their ultra-cold freezers. Pediatricians will identify how many people they hope to vaccinate each week and receive the doses on Monday, with the understanding that they must use the vaccine within 5 days, said Dr. Ezike.
The aim is to support vaccination clinics but also to ensure doctors have “doses on hand,” so that a parent or adolescent could opt for vaccination during a visit.
Although estimating the number of doses required will be difficult and likely involve some waste, Dr. Ezike said it’s important to be able to offer a vaccine in the office instead of having to refer someone elsewhere.
A version of this article first appeared on Medscape.com.
Primary care physicians and providers in small offices and clinics are going to be key to ensuring that the remaining half of the nation receives a COVID-19 vaccination, state health officials said Wednesday, and the federal government will soon start shipping smaller packages of the Pfizer/BioNTech vaccine that can be more readily used by individual doctors.
According to the Centers for Disease Control and Prevention, as of April 21, more than 215 million doses have been administered. About 40% – 134 million Americans – have had at least one dose of a vaccine.
Among those who still haven’t received a shot are people who don’t have the time, may be homebound, or who have questions about the vaccine, or might say they will never be vaccinated, said Nirav Shah, MD, JD, president of the Association of State and Territorial Health Officials and director of the Maine Center for Disease Control and Prevention, on a call with reporters.
Especially for those who fall into the “not-ever” category, state officials “are working to find trusted messengers like doctors” who can connect with these individuals and give them information, he said.
Primary care physicians’ offices and other small practice settings are “where we are most likely to reach many of the remaining 50%,” Steven Stack, MD, MBA, FACEP, commissioner of the Kentucky Department for Public Health, said on the briefing.
State officials also “need to support all people to consult their personal physicians in whom they have confidence and trust to be informed of the benefits of COVID vaccination and the safety of this vaccination,” he said, adding that “this is the way we put this pandemic in the rearview mirror and move on with our lives.”
Dr. Stack said the federal government is starting by working with Pfizer to slim down its packages from 1,170 doses to 450 doses. That should happen before June, said Dr. Stack, adding that state health officials will be able to distribute the smaller packages “more widely and to smaller settings.”
Ideally, packaging for all vaccines will get down to single-dose, pre-filled syringes, he said. But that is a “journey” that the federal government has just begun, said Dr. Stack.
The White House had not responded to a request from this news organization for comment by press time.
Having vaccines onsite in a physician’s office is important, Dr. Stack said, adding that doctors “need to reach people in their persuadable moment.”
Bringing pediatricians on board
Illinois state health officials have begun a process that will let pediatricians have weekly vaccination clinics and also have vaccine on hand to meet patients in the moment, said Ngozi Ezike, MD, director of the Illinois Department of Public Health, on the briefing.
She said the distribution can start even before the Pfizer vaccine is shipped in smaller packages – and as soon as the Food and Drug Administration authorizes the vaccine for adolescents. Pfizer applied for emergency use approval for children aged 12-15 on April 9.
Local health departments will store the vaccine in their ultra-cold freezers. Pediatricians will identify how many people they hope to vaccinate each week and receive the doses on Monday, with the understanding that they must use the vaccine within 5 days, said Dr. Ezike.
The aim is to support vaccination clinics but also to ensure doctors have “doses on hand,” so that a parent or adolescent could opt for vaccination during a visit.
Although estimating the number of doses required will be difficult and likely involve some waste, Dr. Ezike said it’s important to be able to offer a vaccine in the office instead of having to refer someone elsewhere.
A version of this article first appeared on Medscape.com.
Primary care physicians and providers in small offices and clinics are going to be key to ensuring that the remaining half of the nation receives a COVID-19 vaccination, state health officials said Wednesday, and the federal government will soon start shipping smaller packages of the Pfizer/BioNTech vaccine that can be more readily used by individual doctors.
According to the Centers for Disease Control and Prevention, as of April 21, more than 215 million doses have been administered. About 40% – 134 million Americans – have had at least one dose of a vaccine.
Among those who still haven’t received a shot are people who don’t have the time, may be homebound, or who have questions about the vaccine, or might say they will never be vaccinated, said Nirav Shah, MD, JD, president of the Association of State and Territorial Health Officials and director of the Maine Center for Disease Control and Prevention, on a call with reporters.
Especially for those who fall into the “not-ever” category, state officials “are working to find trusted messengers like doctors” who can connect with these individuals and give them information, he said.
Primary care physicians’ offices and other small practice settings are “where we are most likely to reach many of the remaining 50%,” Steven Stack, MD, MBA, FACEP, commissioner of the Kentucky Department for Public Health, said on the briefing.
State officials also “need to support all people to consult their personal physicians in whom they have confidence and trust to be informed of the benefits of COVID vaccination and the safety of this vaccination,” he said, adding that “this is the way we put this pandemic in the rearview mirror and move on with our lives.”
Dr. Stack said the federal government is starting by working with Pfizer to slim down its packages from 1,170 doses to 450 doses. That should happen before June, said Dr. Stack, adding that state health officials will be able to distribute the smaller packages “more widely and to smaller settings.”
Ideally, packaging for all vaccines will get down to single-dose, pre-filled syringes, he said. But that is a “journey” that the federal government has just begun, said Dr. Stack.
The White House had not responded to a request from this news organization for comment by press time.
Having vaccines onsite in a physician’s office is important, Dr. Stack said, adding that doctors “need to reach people in their persuadable moment.”
Bringing pediatricians on board
Illinois state health officials have begun a process that will let pediatricians have weekly vaccination clinics and also have vaccine on hand to meet patients in the moment, said Ngozi Ezike, MD, director of the Illinois Department of Public Health, on the briefing.
She said the distribution can start even before the Pfizer vaccine is shipped in smaller packages – and as soon as the Food and Drug Administration authorizes the vaccine for adolescents. Pfizer applied for emergency use approval for children aged 12-15 on April 9.
Local health departments will store the vaccine in their ultra-cold freezers. Pediatricians will identify how many people they hope to vaccinate each week and receive the doses on Monday, with the understanding that they must use the vaccine within 5 days, said Dr. Ezike.
The aim is to support vaccination clinics but also to ensure doctors have “doses on hand,” so that a parent or adolescent could opt for vaccination during a visit.
Although estimating the number of doses required will be difficult and likely involve some waste, Dr. Ezike said it’s important to be able to offer a vaccine in the office instead of having to refer someone elsewhere.
A version of this article first appeared on Medscape.com.
Percentage of doctors who are Black barely changed in 120 years
according to a new study.
In 1900, 1.3% of physicians were Black. In 1940, 2.8% of physicians were Black, and by 2018 – when almost 13% of the population was Black – 5.4% of doctors were Black, reports Dan Ly, MD, PhD, MPP, an assistant professor of medicine at the University of California, Los Angeles, in a study published online April 19, 2021, in the Journal of General Internal Medicine.
The proportion of male Black physicians was 2.7% in 1940 and 2.6% in 2018.
Dr. Ly also found a significant wage gap. The median income earned by White doctors was $50,000 more than the median income of Black physicians in 2018. Dr. Ly based his findings on the U.S. Census Decennial Census long form, accessed via IPUMS, a free database funded by the National Institutes of Health and other organizations.
“If we care about the health of the population, particularly the health of Black patients, we should care about how small the proportion of our physicians who are Black is and the extremely slow progress we have made as a medical system in increasing that proportion,” Dr. Ly said in an interview.
Dr. Ly said he took on this research in part because previous studies have shown that Black patients are more likely to seek preventive care from Black doctors. Thus, increasing the numbers of Black physicians could narrow gaps in life expectancy between Whites and Blacks.
He also wanted to see whether progress had been made as a result of various medical organizations and the Association of American Medical Colleges undertaking initiatives to increase workforce diversity. There has been “very, very little” progress, he said.
Norma Poll-Hunter, PhD, the AAMC’s senior director of workforce diversity, said Dr. Ly’s report “was not surprising at all.”
The AAMC reported in 2014 that the number of Black men who apply to and matriculate into medical schools has been declining since 1978. That year, there were 1,410 Black male applicants and 542 Black enrollees. In 2014, there were 1,337 applicants and 515 enrollees.
Since 2014, Black male enrollment has increased slightly, rising from 2.4% in the 2014-2015 school year to 2.9% in the 2019-2020 year, the AAMC reported last year.
In addition, among other historically underrepresented minorities, “we really have seen very small progress” despite the increase in the number of medical schools, Dr. Poll-Hunter said in an interview.
The AAMC and the National Medical Association consider the lack of Black male applicants and matriculants to be a national crisis. The two groups started an alliance in 2020 aimed at finding ways to amplify and support Black men’s interest in medicine and the biomedical sciences and to “develop systems-based solutions to address exclusionary practices that create barriers for Black men and prevent them from having equitable opportunities to successfully enroll in medical school.”
Solutions include requiring medical school admissions committees and application screeners to undergo implicit bias awareness and mitigation training, adopting holistic admissions reviews, and incentivizing institutions of higher learning to partner with Black communities in urban and rural school systems to establish K-12 health sciences academies, said NMA President Leon McDougle, MD, MPH.
“There are the systems factors, and racism is a big one that we have to tackle,” said Dr. Poll-Hunter.
Diversity isn’t just about numbers, said Dr. McDougle, a professor of family medicine and associate dean for diversity and inclusion at Ohio State University, Columbus. “We know that medical school graduates who are African American or Black, Hispanic or Latinx, or American Indian or Alaskan Native are more likely to serve those communities as practicing physicians.
“The COVID-19 pandemic highlighted the urgent need for more African American or Black, Hispanic or Latinx, or American Indian or Alaskan Native physicians,” he said. “Inadequate access to culturally competent care has exacerbated existing health disparities, resulting in death and hospitalization rates up to three to four times the rates of European American or White people.”
Dr. Poll-Hunter also said that studies have shown that diversity in the classroom creates a more enriched learning environment and increases civic mindedness and cognitive complexity, “as well as helps us understand people who are different than ourselves.”
The diversity goal “is not about quotas, it’s about excellence,” she said. “We know that there’s talent that exists, and we want to make sure that everyone has an opportunity to be successful.”
Dr. Ly has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to a new study.
In 1900, 1.3% of physicians were Black. In 1940, 2.8% of physicians were Black, and by 2018 – when almost 13% of the population was Black – 5.4% of doctors were Black, reports Dan Ly, MD, PhD, MPP, an assistant professor of medicine at the University of California, Los Angeles, in a study published online April 19, 2021, in the Journal of General Internal Medicine.
The proportion of male Black physicians was 2.7% in 1940 and 2.6% in 2018.
Dr. Ly also found a significant wage gap. The median income earned by White doctors was $50,000 more than the median income of Black physicians in 2018. Dr. Ly based his findings on the U.S. Census Decennial Census long form, accessed via IPUMS, a free database funded by the National Institutes of Health and other organizations.
“If we care about the health of the population, particularly the health of Black patients, we should care about how small the proportion of our physicians who are Black is and the extremely slow progress we have made as a medical system in increasing that proportion,” Dr. Ly said in an interview.
Dr. Ly said he took on this research in part because previous studies have shown that Black patients are more likely to seek preventive care from Black doctors. Thus, increasing the numbers of Black physicians could narrow gaps in life expectancy between Whites and Blacks.
He also wanted to see whether progress had been made as a result of various medical organizations and the Association of American Medical Colleges undertaking initiatives to increase workforce diversity. There has been “very, very little” progress, he said.
Norma Poll-Hunter, PhD, the AAMC’s senior director of workforce diversity, said Dr. Ly’s report “was not surprising at all.”
The AAMC reported in 2014 that the number of Black men who apply to and matriculate into medical schools has been declining since 1978. That year, there were 1,410 Black male applicants and 542 Black enrollees. In 2014, there were 1,337 applicants and 515 enrollees.
Since 2014, Black male enrollment has increased slightly, rising from 2.4% in the 2014-2015 school year to 2.9% in the 2019-2020 year, the AAMC reported last year.
In addition, among other historically underrepresented minorities, “we really have seen very small progress” despite the increase in the number of medical schools, Dr. Poll-Hunter said in an interview.
The AAMC and the National Medical Association consider the lack of Black male applicants and matriculants to be a national crisis. The two groups started an alliance in 2020 aimed at finding ways to amplify and support Black men’s interest in medicine and the biomedical sciences and to “develop systems-based solutions to address exclusionary practices that create barriers for Black men and prevent them from having equitable opportunities to successfully enroll in medical school.”
Solutions include requiring medical school admissions committees and application screeners to undergo implicit bias awareness and mitigation training, adopting holistic admissions reviews, and incentivizing institutions of higher learning to partner with Black communities in urban and rural school systems to establish K-12 health sciences academies, said NMA President Leon McDougle, MD, MPH.
“There are the systems factors, and racism is a big one that we have to tackle,” said Dr. Poll-Hunter.
Diversity isn’t just about numbers, said Dr. McDougle, a professor of family medicine and associate dean for diversity and inclusion at Ohio State University, Columbus. “We know that medical school graduates who are African American or Black, Hispanic or Latinx, or American Indian or Alaskan Native are more likely to serve those communities as practicing physicians.
“The COVID-19 pandemic highlighted the urgent need for more African American or Black, Hispanic or Latinx, or American Indian or Alaskan Native physicians,” he said. “Inadequate access to culturally competent care has exacerbated existing health disparities, resulting in death and hospitalization rates up to three to four times the rates of European American or White people.”
Dr. Poll-Hunter also said that studies have shown that diversity in the classroom creates a more enriched learning environment and increases civic mindedness and cognitive complexity, “as well as helps us understand people who are different than ourselves.”
The diversity goal “is not about quotas, it’s about excellence,” she said. “We know that there’s talent that exists, and we want to make sure that everyone has an opportunity to be successful.”
Dr. Ly has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to a new study.
In 1900, 1.3% of physicians were Black. In 1940, 2.8% of physicians were Black, and by 2018 – when almost 13% of the population was Black – 5.4% of doctors were Black, reports Dan Ly, MD, PhD, MPP, an assistant professor of medicine at the University of California, Los Angeles, in a study published online April 19, 2021, in the Journal of General Internal Medicine.
The proportion of male Black physicians was 2.7% in 1940 and 2.6% in 2018.
Dr. Ly also found a significant wage gap. The median income earned by White doctors was $50,000 more than the median income of Black physicians in 2018. Dr. Ly based his findings on the U.S. Census Decennial Census long form, accessed via IPUMS, a free database funded by the National Institutes of Health and other organizations.
“If we care about the health of the population, particularly the health of Black patients, we should care about how small the proportion of our physicians who are Black is and the extremely slow progress we have made as a medical system in increasing that proportion,” Dr. Ly said in an interview.
Dr. Ly said he took on this research in part because previous studies have shown that Black patients are more likely to seek preventive care from Black doctors. Thus, increasing the numbers of Black physicians could narrow gaps in life expectancy between Whites and Blacks.
He also wanted to see whether progress had been made as a result of various medical organizations and the Association of American Medical Colleges undertaking initiatives to increase workforce diversity. There has been “very, very little” progress, he said.
Norma Poll-Hunter, PhD, the AAMC’s senior director of workforce diversity, said Dr. Ly’s report “was not surprising at all.”
The AAMC reported in 2014 that the number of Black men who apply to and matriculate into medical schools has been declining since 1978. That year, there were 1,410 Black male applicants and 542 Black enrollees. In 2014, there were 1,337 applicants and 515 enrollees.
Since 2014, Black male enrollment has increased slightly, rising from 2.4% in the 2014-2015 school year to 2.9% in the 2019-2020 year, the AAMC reported last year.
In addition, among other historically underrepresented minorities, “we really have seen very small progress” despite the increase in the number of medical schools, Dr. Poll-Hunter said in an interview.
The AAMC and the National Medical Association consider the lack of Black male applicants and matriculants to be a national crisis. The two groups started an alliance in 2020 aimed at finding ways to amplify and support Black men’s interest in medicine and the biomedical sciences and to “develop systems-based solutions to address exclusionary practices that create barriers for Black men and prevent them from having equitable opportunities to successfully enroll in medical school.”
Solutions include requiring medical school admissions committees and application screeners to undergo implicit bias awareness and mitigation training, adopting holistic admissions reviews, and incentivizing institutions of higher learning to partner with Black communities in urban and rural school systems to establish K-12 health sciences academies, said NMA President Leon McDougle, MD, MPH.
“There are the systems factors, and racism is a big one that we have to tackle,” said Dr. Poll-Hunter.
Diversity isn’t just about numbers, said Dr. McDougle, a professor of family medicine and associate dean for diversity and inclusion at Ohio State University, Columbus. “We know that medical school graduates who are African American or Black, Hispanic or Latinx, or American Indian or Alaskan Native are more likely to serve those communities as practicing physicians.
“The COVID-19 pandemic highlighted the urgent need for more African American or Black, Hispanic or Latinx, or American Indian or Alaskan Native physicians,” he said. “Inadequate access to culturally competent care has exacerbated existing health disparities, resulting in death and hospitalization rates up to three to four times the rates of European American or White people.”
Dr. Poll-Hunter also said that studies have shown that diversity in the classroom creates a more enriched learning environment and increases civic mindedness and cognitive complexity, “as well as helps us understand people who are different than ourselves.”
The diversity goal “is not about quotas, it’s about excellence,” she said. “We know that there’s talent that exists, and we want to make sure that everyone has an opportunity to be successful.”
Dr. Ly has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
HHS proposes overturning Title X ‘gag’ rule
The Department of Health & Human Services has proposed overturning rules issued during the Trump administration that effectively prohibit clinicians at Title X–funded health clinics from discussing abortion or referring patients for abortions.
HHS proposed the overhaul of the Title X regulations on April 14. The previous administration’s 2019 rules “have undermined the public health of the population the program is meant to serve,” HHS said in the introduction to its proposal.
Medical organizations and reproductive health specialists lauded the move.
“Clinicians providing care to patients must be empowered to share the full spectrum of accurate medical information necessary to ensure that their patients are able to make timely, fully informed medical decisions,” Maureen G. Phipps, MD, MPH, CEO of the American College of Obstetricians and Gynecologists, said in a statement. “This means transparent, respectful, evidence-based conversations about contraception and abortion care. The proposed rule will ensure that those conversations can once again happen without restrictions, interference, or threat of financial loss.”
“Providers of comprehensive reproductive health care, including abortion care, base their relationships with their patients on trust,” Physicians for Reproductive Health President and CEO Jamila Perritt, MD, said in a statement. “The Title X gag rule went against everything we knew as providers of ethical, evidence-based health care by forcing providers at Title X funded clinics to withhold information that their patients needed and requested.”
HHS said that, since 2019, more than 1,000 Title X–funded service sites (25% of the total) have withdrawn from the program. Currently, Title X services – which include family planning, STI testing, cancer screening, and HIV testing and treatment – are not available in six states and are only available on a limited basis in six additional states. Planned Parenthood fully withdrew from Title X.
HHS said that tens of thousands fewer birth control implant procedures have been performed and that hundreds of thousands fewer Pap tests and a half-million or more fewer tests for chlamydia and gonorrhea have been conducted. In addition, the reduction in services may have led to up to 181,477 unintended pregnancies, HHS said.
The closure of sites and decreased availability of services have also exacerbated health inequities, according to the department.
The loss of services “has been especially felt by those already facing disproportionate barriers to accessing care, including the Black, Latinx and Indigenous communities that have also suffered the most harm during the COVID-19 pandemic,” agreed Dr. Phipps.
The new regulation proposes to “ensure access to equitable, affordable, client-centered, quality family-planning services for all clients, especially for low-income clients,” HHS said.
The proposed change in the rules “brings us one step closer to restoring access to necessary care for millions of low-income and uninsured patients who depend on Title X for family planning services,” American Medical Association President Susan R. Bailey, MD, said in a statement. “We are pleased that the Biden administration shares our commitment to undoing this dangerous and discriminatory ‘gag rule,’ and look forward to its elimination through any means necessary to achieve the best outcome for patients and physicians – improving the health of our nation.”
Planned Parenthood also applauded the move, and the HIV Medicine Association thanked the Biden administration for its proposal, which it called “a major step to improve #HealthEquity for all people in this country,” in a tweet.
March for Life, an antiabortion group, however, said it strongly opposed the HHS proposal. The rules “appear specifically designed to bring America’s largest abortion provider, Planned Parenthood, back into the taxpayer-funded program and keep prolife organizations out,” said the group in a tweet.
“Abortion is neither health care nor family planning, and the Title X program should not be funding it,” said the group.
The Title X program does not pay for abortions, however.
The Trump administration rules prohibit abortion referrals and impose counseling standards for pregnant patients and what the Guttmacher Institute called “unnecessary and stringent requirements for the physical and financial separation of Title X–funded activities from a range of abortion-related activities.”
The new rules would reestablish regulations from 2000, with some new additions. For instance, the program will “formally integrate elements of quality family-planning services guidelines developed by [Centers for Disease Control and Prevention] and Office of Population Affairs,” tweeted Alina Salganicoff, director of women’s health policy at the Kaiser Family Foundation. “That means that higher standards for providing family planning will be required,” she tweeted. In addition, sites that offer natural family planning and abstinence “will only be able to participate if they offer referrals to other providers that offer clients access to the contraceptive of their choice.”
The proposed rules are open for public comment for 30 days. They could be made final by the fall. The Kaiser Family Foundation reports that many sites could be ready to return to the program by then, especially since the recently passed coronavirus relief package, the American Rescue Plan, included a $50 million supplemental appropriation for Title X.
The 2019 rules remain in effect in the meantime, although the U.S. Supreme Court agreed in February to hear a challenge mounted by 21 states, the city of Baltimore, and organizations that included the AMA and Planned Parenthood. Those plaintiffs have requested that the case be dismissed, but it currently remains on the docket.
Not all medical providers are likely to support the new rules if they go into effect. The American Association of Pro-Life Obstetricians and Gynecologists, the Christian Medical and Dental Associations, and the Catholic Medical Association filed motions in the Supreme Court case to defend the Trump regulations.
A version of this article first appeared on Medscape.com.
The Department of Health & Human Services has proposed overturning rules issued during the Trump administration that effectively prohibit clinicians at Title X–funded health clinics from discussing abortion or referring patients for abortions.
HHS proposed the overhaul of the Title X regulations on April 14. The previous administration’s 2019 rules “have undermined the public health of the population the program is meant to serve,” HHS said in the introduction to its proposal.
Medical organizations and reproductive health specialists lauded the move.
“Clinicians providing care to patients must be empowered to share the full spectrum of accurate medical information necessary to ensure that their patients are able to make timely, fully informed medical decisions,” Maureen G. Phipps, MD, MPH, CEO of the American College of Obstetricians and Gynecologists, said in a statement. “This means transparent, respectful, evidence-based conversations about contraception and abortion care. The proposed rule will ensure that those conversations can once again happen without restrictions, interference, or threat of financial loss.”
“Providers of comprehensive reproductive health care, including abortion care, base their relationships with their patients on trust,” Physicians for Reproductive Health President and CEO Jamila Perritt, MD, said in a statement. “The Title X gag rule went against everything we knew as providers of ethical, evidence-based health care by forcing providers at Title X funded clinics to withhold information that their patients needed and requested.”
HHS said that, since 2019, more than 1,000 Title X–funded service sites (25% of the total) have withdrawn from the program. Currently, Title X services – which include family planning, STI testing, cancer screening, and HIV testing and treatment – are not available in six states and are only available on a limited basis in six additional states. Planned Parenthood fully withdrew from Title X.
HHS said that tens of thousands fewer birth control implant procedures have been performed and that hundreds of thousands fewer Pap tests and a half-million or more fewer tests for chlamydia and gonorrhea have been conducted. In addition, the reduction in services may have led to up to 181,477 unintended pregnancies, HHS said.
The closure of sites and decreased availability of services have also exacerbated health inequities, according to the department.
The loss of services “has been especially felt by those already facing disproportionate barriers to accessing care, including the Black, Latinx and Indigenous communities that have also suffered the most harm during the COVID-19 pandemic,” agreed Dr. Phipps.
The new regulation proposes to “ensure access to equitable, affordable, client-centered, quality family-planning services for all clients, especially for low-income clients,” HHS said.
The proposed change in the rules “brings us one step closer to restoring access to necessary care for millions of low-income and uninsured patients who depend on Title X for family planning services,” American Medical Association President Susan R. Bailey, MD, said in a statement. “We are pleased that the Biden administration shares our commitment to undoing this dangerous and discriminatory ‘gag rule,’ and look forward to its elimination through any means necessary to achieve the best outcome for patients and physicians – improving the health of our nation.”
Planned Parenthood also applauded the move, and the HIV Medicine Association thanked the Biden administration for its proposal, which it called “a major step to improve #HealthEquity for all people in this country,” in a tweet.
March for Life, an antiabortion group, however, said it strongly opposed the HHS proposal. The rules “appear specifically designed to bring America’s largest abortion provider, Planned Parenthood, back into the taxpayer-funded program and keep prolife organizations out,” said the group in a tweet.
“Abortion is neither health care nor family planning, and the Title X program should not be funding it,” said the group.
The Title X program does not pay for abortions, however.
The Trump administration rules prohibit abortion referrals and impose counseling standards for pregnant patients and what the Guttmacher Institute called “unnecessary and stringent requirements for the physical and financial separation of Title X–funded activities from a range of abortion-related activities.”
The new rules would reestablish regulations from 2000, with some new additions. For instance, the program will “formally integrate elements of quality family-planning services guidelines developed by [Centers for Disease Control and Prevention] and Office of Population Affairs,” tweeted Alina Salganicoff, director of women’s health policy at the Kaiser Family Foundation. “That means that higher standards for providing family planning will be required,” she tweeted. In addition, sites that offer natural family planning and abstinence “will only be able to participate if they offer referrals to other providers that offer clients access to the contraceptive of their choice.”
The proposed rules are open for public comment for 30 days. They could be made final by the fall. The Kaiser Family Foundation reports that many sites could be ready to return to the program by then, especially since the recently passed coronavirus relief package, the American Rescue Plan, included a $50 million supplemental appropriation for Title X.
The 2019 rules remain in effect in the meantime, although the U.S. Supreme Court agreed in February to hear a challenge mounted by 21 states, the city of Baltimore, and organizations that included the AMA and Planned Parenthood. Those plaintiffs have requested that the case be dismissed, but it currently remains on the docket.
Not all medical providers are likely to support the new rules if they go into effect. The American Association of Pro-Life Obstetricians and Gynecologists, the Christian Medical and Dental Associations, and the Catholic Medical Association filed motions in the Supreme Court case to defend the Trump regulations.
A version of this article first appeared on Medscape.com.
The Department of Health & Human Services has proposed overturning rules issued during the Trump administration that effectively prohibit clinicians at Title X–funded health clinics from discussing abortion or referring patients for abortions.
HHS proposed the overhaul of the Title X regulations on April 14. The previous administration’s 2019 rules “have undermined the public health of the population the program is meant to serve,” HHS said in the introduction to its proposal.
Medical organizations and reproductive health specialists lauded the move.
“Clinicians providing care to patients must be empowered to share the full spectrum of accurate medical information necessary to ensure that their patients are able to make timely, fully informed medical decisions,” Maureen G. Phipps, MD, MPH, CEO of the American College of Obstetricians and Gynecologists, said in a statement. “This means transparent, respectful, evidence-based conversations about contraception and abortion care. The proposed rule will ensure that those conversations can once again happen without restrictions, interference, or threat of financial loss.”
“Providers of comprehensive reproductive health care, including abortion care, base their relationships with their patients on trust,” Physicians for Reproductive Health President and CEO Jamila Perritt, MD, said in a statement. “The Title X gag rule went against everything we knew as providers of ethical, evidence-based health care by forcing providers at Title X funded clinics to withhold information that their patients needed and requested.”
HHS said that, since 2019, more than 1,000 Title X–funded service sites (25% of the total) have withdrawn from the program. Currently, Title X services – which include family planning, STI testing, cancer screening, and HIV testing and treatment – are not available in six states and are only available on a limited basis in six additional states. Planned Parenthood fully withdrew from Title X.
HHS said that tens of thousands fewer birth control implant procedures have been performed and that hundreds of thousands fewer Pap tests and a half-million or more fewer tests for chlamydia and gonorrhea have been conducted. In addition, the reduction in services may have led to up to 181,477 unintended pregnancies, HHS said.
The closure of sites and decreased availability of services have also exacerbated health inequities, according to the department.
The loss of services “has been especially felt by those already facing disproportionate barriers to accessing care, including the Black, Latinx and Indigenous communities that have also suffered the most harm during the COVID-19 pandemic,” agreed Dr. Phipps.
The new regulation proposes to “ensure access to equitable, affordable, client-centered, quality family-planning services for all clients, especially for low-income clients,” HHS said.
The proposed change in the rules “brings us one step closer to restoring access to necessary care for millions of low-income and uninsured patients who depend on Title X for family planning services,” American Medical Association President Susan R. Bailey, MD, said in a statement. “We are pleased that the Biden administration shares our commitment to undoing this dangerous and discriminatory ‘gag rule,’ and look forward to its elimination through any means necessary to achieve the best outcome for patients and physicians – improving the health of our nation.”
Planned Parenthood also applauded the move, and the HIV Medicine Association thanked the Biden administration for its proposal, which it called “a major step to improve #HealthEquity for all people in this country,” in a tweet.
March for Life, an antiabortion group, however, said it strongly opposed the HHS proposal. The rules “appear specifically designed to bring America’s largest abortion provider, Planned Parenthood, back into the taxpayer-funded program and keep prolife organizations out,” said the group in a tweet.
“Abortion is neither health care nor family planning, and the Title X program should not be funding it,” said the group.
The Title X program does not pay for abortions, however.
The Trump administration rules prohibit abortion referrals and impose counseling standards for pregnant patients and what the Guttmacher Institute called “unnecessary and stringent requirements for the physical and financial separation of Title X–funded activities from a range of abortion-related activities.”
The new rules would reestablish regulations from 2000, with some new additions. For instance, the program will “formally integrate elements of quality family-planning services guidelines developed by [Centers for Disease Control and Prevention] and Office of Population Affairs,” tweeted Alina Salganicoff, director of women’s health policy at the Kaiser Family Foundation. “That means that higher standards for providing family planning will be required,” she tweeted. In addition, sites that offer natural family planning and abstinence “will only be able to participate if they offer referrals to other providers that offer clients access to the contraceptive of their choice.”
The proposed rules are open for public comment for 30 days. They could be made final by the fall. The Kaiser Family Foundation reports that many sites could be ready to return to the program by then, especially since the recently passed coronavirus relief package, the American Rescue Plan, included a $50 million supplemental appropriation for Title X.
The 2019 rules remain in effect in the meantime, although the U.S. Supreme Court agreed in February to hear a challenge mounted by 21 states, the city of Baltimore, and organizations that included the AMA and Planned Parenthood. Those plaintiffs have requested that the case be dismissed, but it currently remains on the docket.
Not all medical providers are likely to support the new rules if they go into effect. The American Association of Pro-Life Obstetricians and Gynecologists, the Christian Medical and Dental Associations, and the Catholic Medical Association filed motions in the Supreme Court case to defend the Trump regulations.
A version of this article first appeared on Medscape.com.