Alicia Gallegos

Physician groups are praising a new option by the American Board of Internal Medicine (ABIM) that will offer doctors a self-paced pathway for maintenance of certification (MOC) in place of the traditional long-form assessment route.

The new longitudinal assessment option, announced in late August, would enable physicians to acquire and demonstrate ongoing knowledge through shorter evaluations of specific content. The option, currently under development, also would provide doctors with immediate feedback about their answers and share links to educational material to address knowledge gaps, according to an announcement. While details are still being flushed out, a summary of the longitudinal assessment concept by the American Board of Medical Specialties explains that the approach draws on the principles of adult learning and modern technology “to promote learning, retention, and transfer of information.”

Developing a longitudinal assessment option is part of ABIM’s ongoing evolution, Marianne M. Green, MD, chair for ABIM’s board of directors and ABIM President Richard J. Baron, MD, wrote in a joint letter to internists posted on ABIM’s blog.

“We recognize that some physicians may prefer a more continuous process that easily integrates into their lives and allows them to engage seamlessly at their preferred pace, while being able to access the resources they use in practice,” the doctors wrote.

Douglas DeLong, MD, chair of the American College of Physician’s (ACP) board of regents said the option is a positive, first step that will support lifelong learning. He noted the new option is in line with recommendations by the American Board of Medical Specialties’ Continuing Board Certification: Vision for the Future Commission, which included ACP concerns.

“It’s pretty clear that some of the principles of adult learning – frequent information with quick feedback, repetition of material, and identifying gaps in knowledge – is really how people most effectively learn,” Dr. DeLong said in an interview. “Just cramming for an examination every decade hasn’t ever really been shown to affect long-term retention of knowledge or even patient care outcomes.”

agallegos@mdedge.com

Physician groups are praising a new option by the American Board of Internal Medicine (ABIM) that will offer doctors a self-paced pathway for maintenance of certification (MOC) in place of the traditional long-form assessment route.

The new longitudinal assessment option, announced in late August, would enable physicians to acquire and demonstrate ongoing knowledge through shorter evaluations of specific content. The option, currently under development, also would provide doctors with immediate feedback about their answers and share links to educational material to address knowledge gaps, according to an announcement. While details are still being flushed out, a summary of the longitudinal assessment concept by the American Board of Medical Specialties explains that the approach draws on the principles of adult learning and modern technology “to promote learning, retention, and transfer of information.”

Developing a longitudinal assessment option is part of ABIM’s ongoing evolution, Marianne M. Green, MD, chair for ABIM’s board of directors and ABIM President Richard J. Baron, MD, wrote in a joint letter to internists posted on ABIM’s blog.

“We recognize that some physicians may prefer a more continuous process that easily integrates into their lives and allows them to engage seamlessly at their preferred pace, while being able to access the resources they use in practice,” the doctors wrote.

Douglas DeLong, MD, chair of the American College of Physician’s (ACP) board of regents said the option is a positive, first step that will support lifelong learning. He noted the new option is in line with recommendations by the American Board of Medical Specialties’ Continuing Board Certification: Vision for the Future Commission, which included ACP concerns.

“It’s pretty clear that some of the principles of adult learning – frequent information with quick feedback, repetition of material, and identifying gaps in knowledge – is really how people most effectively learn,” Dr. DeLong said in an interview. “Just cramming for an examination every decade hasn’t ever really been shown to affect long-term retention of knowledge or even patient care outcomes.”

agallegos@mdedge.com

Physician groups are praising a new option by the American Board of Internal Medicine (ABIM) that will offer doctors a self-paced pathway for maintenance of certification (MOC) in place of the traditional long-form assessment route.

The new longitudinal assessment option, announced in late August, would enable physicians to acquire and demonstrate ongoing knowledge through shorter evaluations of specific content. The option, currently under development, also would provide doctors with immediate feedback about their answers and share links to educational material to address knowledge gaps, according to an announcement. While details are still being flushed out, a summary of the longitudinal assessment concept by the American Board of Medical Specialties explains that the approach draws on the principles of adult learning and modern technology “to promote learning, retention, and transfer of information.”

Developing a longitudinal assessment option is part of ABIM’s ongoing evolution, Marianne M. Green, MD, chair for ABIM’s board of directors and ABIM President Richard J. Baron, MD, wrote in a joint letter to internists posted on ABIM’s blog.

“We recognize that some physicians may prefer a more continuous process that easily integrates into their lives and allows them to engage seamlessly at their preferred pace, while being able to access the resources they use in practice,” the doctors wrote.

Douglas DeLong, MD, chair of the American College of Physician’s (ACP) board of regents said the option is a positive, first step that will support lifelong learning. He noted the new option is in line with recommendations by the American Board of Medical Specialties’ Continuing Board Certification: Vision for the Future Commission, which included ACP concerns.

“It’s pretty clear that some of the principles of adult learning – frequent information with quick feedback, repetition of material, and identifying gaps in knowledge – is really how people most effectively learn,” Dr. DeLong said in an interview. “Just cramming for an examination every decade hasn’t ever really been shown to affect long-term retention of knowledge or even patient care outcomes.”

agallegos@mdedge.com

When the summons arrived, Nataly Minkina, MD, took one look at the lawsuit and fainted.

Leonid Weinstein

The Boston-area internist had treated the plaintiff just once while covering for the patient’s primary care physician. During a visit for an upper respiratory infection, the patient mentioned a lump in her breast, and Dr. Minkina confirmed a small thickening in the woman’s right breast. She sent the patient for a mammogram and ultrasound, the results of which the radiologist reported were normal, according to court documents.

Five years later, the patient claimed Dr. Minkina was one of several providers responsible for a missed breast cancer diagnosis.

Even worse than the lawsuit, however, was how her former insurer resolved the case, said Dr. Minkina, now an internist at Brigham and Women’s Hospital in Chestnut Hill, Mass. The claim was settled against the defendants for $500,000, and Dr. Minkina was alloted 30% of the liability. No fault was assigned to the other physicians named, while a nurse practitioner was alloted 10%, and the medical practice was alloted 60% liability, according to court documents.

“I was very upset,” Dr. Minkina said. “First of all, I was kept in the dark. Nobody ever talked to me. I did not get a single report or any document from my attorney in 12 months. When I asked why was I assigned the [30%] liability, they said the experts gave me bad evaluations, but they would not show reports to me. I was literally scapegoated.”

When the insurer refused to reconsider the allocation, Dr. Minkina took her complaint to court. The internist now has been embroiled in a legal challenge against Medical Professional Mutual Insurance Company (ProMutual) for 7 years. Dr. Minkina’s lawsuit alleges the insurer engaged in a bad faith allocation to serve its own economic interests by shifting fault for the claim from its insureds to its former client, Dr. Minkina. The insurance company contends the allocation was a careful and rational decision based on case evidence. In late July, the case went to trial in Dedham, Mass.

ProMutual declined comment on the case; the insurer also would not address general questions about its allocation policies.

“I started this fight because I felt violated and betrayed, not to make money,” Dr. Minkina said. “I am not rich by a long shot, and I wanted to clear my name because [a] good name is all I have. Additionally, having [a] record about malpractice payment in my physician profile makes me vulnerable.”

Liability experts say the case highlights the conflicts that can arise between physicians and insurers during malpractice lawsuits. The legal challenge also raises questions about allocations of liability by insurers, how the determinations are made, and what impact they have on doctors going forward.

The proportion of liability assigned after a settlement matters, said Jeffrey Segal, MD, JD, a neurosurgeon and founder of Medical Justice, a medicolegal consulting firm for physicians.

Vidyard Video

“There’s a subtext that your piece of the pie – the part that is allocated to you – is your liability, your culpability, your guilt,” Dr. Segal said in an interview. “This has impact going down the road in terms of reputation, in terms of credibility, and potentially of your premiums going forward. There are some real-world economic consequences.”

 

 

Bad care or bad faith?

In Dr. Minkina’s case, some facts are undisputed. In 2002, Dr. Minkina, then a physician at Blue Hills Medical Associates in Braintree, Mass., referred a 55-year-old patient for a mammogram and an ultrasound after confirming some nodularity in the women’s breast. A radiologist twice reported no abnormalities which Dr. Minkina relayed to the patient, advising her to follow-up with her primary care physician and to schedule yearly mammograms. The patient did neither, according to court records. Dr. Minkina left the practice shortly after the visit.

In early 2006, the patient visited the practice, and a nurse practitioner sent her for another mammogram and an ultrasound. The mammogram report included some signs of malignancy, but the nurse misread, misunderstood, or overlooked the signs and recorded that “the benign breast condition had no changes,” according to court transcripts. Later that year, the patient visited the practice complaining of headaches and a droopy eye at which time her primary care physician diagnosed sinusitis and prescribed antibiotics. In 2007, the patient underwent a brain MRI and a breast MRI, which revealed widespread metastatic carcinoma. She and her family sued Dr. Minkina and several others in June 2007. The patient died in 2008.

The agreement between parties ends there. Dr. Minkina believes she followed the standard of care and was not responsible for the delayed breast cancer diagnosis. Given the radiologist’s negative report and the patient’s lack of visual abnormalities, she contends she adequately referred the patient to her primary care physician for further consultation and evaluation. Dr. Minkina argues the insurer allocated an unjustifiably high percentage of liability to her because she was no longer an insured and because the company had an economic incentive to allocate a disproportionate percentage of responsibility and damages.

ProMutual contends Dr. Minkina bore more responsibility than the other health care professionals named for the delayed diagnosis because of violations of standards of care and because of causation factors. The insurer’s experts asserted that when treating an older woman with a palpable lump, the standard of care is to obtain a biopsy, according to opening arguments by ProMutual defense counsel Tamara Wolfson.

The experts also concluded that, when the nurse practitioner and primary care physician saw the patient in 2006, the patient would have already had metastatic disease, and a cancer diagnosis at that time would not have saved her, according to court transcripts. Had the cancer been diagnosed in 2002 when Dr. Minkina saw the patient, the disease would have been “very treatable,” the experts further concluded.

“So, faced with negative opinions on both the standard of care and causation, [the claim representative] was very concerned that Dr. Minkina not only faced a very substantial risk of an adverse verdict in the ... suit, but a verdict that would exceed Dr. Minkina’s policy limits,” Ms. Wolfson said during opening arguments.

The evidence led to the settlement and the allocation decision, Ms. Wolfson said, adding that the majority – 60% – fell on Blue Hills Medical Associates because it lacked a good system to track and follow up with patients. There was zero benefit to ProMutual as to how the $500,000 settlement was parsed, she said during trial.

A lower court initially dismissed Dr. Minkina’s suit, but the Commonwealth of Massachusetts Appeals Court in 2015 overturned that decision, ruling the case could move forward. In 2018, the superior court agreed Dr. Minkina had a valid bad faith claim, stating that she had provided information about ProMutual’s conduct from which “a reasonable juror could infer the defendant’s bad faith in connection with its settling the underlying malpractice suit, including the allocation of liability.”

Dr. Minkina had been a plaintiff in unrelated litigation in the past. In 2005, she sued her former employer for alleged discrimination and retaliation after claiming she was mistreated and terminated for complaining about fumes. She prevailed and was awarded an arbitration award of about $266,000. In 2009, Dr. Minkina sued the original law firm that represented her in the discrimination suit for malpractice, alleging the firm’s negligence cost her the chance to go to trial. A judge dismissed the claim as frivolous and ordered Dr. Minkina to pay the firm’s legal fees. The doctor twice has been jailed for failing to fully resolve that legal payment. The case remains outstanding, and Dr. Minkina is now in bankruptcy.
 

 

 

What’s in an allocation?

Liability allocations are an integral part of multiparty medical malpractice claims, said Brian Atchinson, president and CEO for the Medical Professional Liability Association, a trade association for medical liability insurers.

“In any case involving more than one party, there is a potential allocation issue,” Mr. Atchinson said in an interview. “[Insurers] generally look to the liability and damages incurred with regard to their respective insureds in a case and work to establish an allocation that reflects actual liability.”

If the case goes to a jury and jurors find for the plaintiff, depending on the nature of the damages awarded, the jury may be called on to allocate liability among multiple defendants, he said.

Because settlements are reported to the National Practitioner Data Bank (NPDB), the proportion of liability assigned to each defendant has significance, said J. Richard Moore, a medical liability defense attorney based in Indianapolis and chair for the Defense Research Institute’s Medical Liability and Health Care Law Committee.

Vidyard Video

“The allocation matters because the amount of settlement matters,” Mr. Moore said. “A lower settlement amount suggests the physician’s insurance company made a cost-benefit business decision to end litigation without more expense, while an extremely high settlement suggests actual malpractice.”

State medical boards have varying reporting requirements. Some state boards require both the amount paid by the individual provider and the global settlement amount – if known – while other state boards require only the amount paid on behalf of the provider.

Conflicts over allocations are not common, Dr. Segal said. More frequent are disputes among physicians and insurers over the potential settling of a claim. Such conflicts underscore the importance of paying close attention to contract language when signing with an insurer, Dr. Segal said.

Whether the contract includes a consent to settle clause, for example, can markedly change the case outcome. The clause means the insurer must have the doctor’s approval to settle the case. Absent the clause, insurers generally have authority to settle all claims arising under the policy.

Other contracts may include a “hammer clause,” Dr. Segal notes. This gives doctors the ultimate vote on settling, but it stipulates that if the physician refuses a settlement offer and opts for trial, the doctor is responsible for any surplus award, should the doctor lose.

In Dr. Minkina’s case, the doctor’s contract allowed ProMutual to settle without her consent, but the contract was silent on allocations.

Dr. Segal and Mr. Moore both said the odds of Dr. Minkina prevailing are fairly low. In another case, a South Carolina doctor similarly sued the South Carolina Medical Malpractice Liability Joint Underwriting Association over an allocation of liability following a settlement. The doctor claimed he should not be assigned any portion of the $500,000 settlement, and he sued after his insurer assigned him one-seventh liability.

A trial court found in his favor, ruling the insurer breached the covenant of good faith and fair dealing by failing to treat each physician equally when determining liability. The Supreme Court of South Carolina in 2001 overturned that decision, finding the evidence did not support a bad faith finding and that the insurer’s allocation decision was reasonable.

If the Massachusetts case ends in Dr. Minkina’s favor, it will be as a result of strong evidence that the insurer placed its interests ahead of the physician’s financial and other interests, Mr. Moore said.

“If that happens, I anticipate that insurers may revise their standard policy provisions to clarify and limit the extent to which physicians have the right to be involved in allocation decisions,” he said.

agallegos@mdedge.com

When the summons arrived, Nataly Minkina, MD, took one look at the lawsuit and fainted.

Leonid Weinstein

The Boston-area internist had treated the plaintiff just once while covering for the patient’s primary care physician. During a visit for an upper respiratory infection, the patient mentioned a lump in her breast, and Dr. Minkina confirmed a small thickening in the woman’s right breast. She sent the patient for a mammogram and ultrasound, the results of which the radiologist reported were normal, according to court documents.

Five years later, the patient claimed Dr. Minkina was one of several providers responsible for a missed breast cancer diagnosis.

Even worse than the lawsuit, however, was how her former insurer resolved the case, said Dr. Minkina, now an internist at Brigham and Women’s Hospital in Chestnut Hill, Mass. The claim was settled against the defendants for $500,000, and Dr. Minkina was alloted 30% of the liability. No fault was assigned to the other physicians named, while a nurse practitioner was alloted 10%, and the medical practice was alloted 60% liability, according to court documents.

“I was very upset,” Dr. Minkina said. “First of all, I was kept in the dark. Nobody ever talked to me. I did not get a single report or any document from my attorney in 12 months. When I asked why was I assigned the [30%] liability, they said the experts gave me bad evaluations, but they would not show reports to me. I was literally scapegoated.”

When the insurer refused to reconsider the allocation, Dr. Minkina took her complaint to court. The internist now has been embroiled in a legal challenge against Medical Professional Mutual Insurance Company (ProMutual) for 7 years. Dr. Minkina’s lawsuit alleges the insurer engaged in a bad faith allocation to serve its own economic interests by shifting fault for the claim from its insureds to its former client, Dr. Minkina. The insurance company contends the allocation was a careful and rational decision based on case evidence. In late July, the case went to trial in Dedham, Mass.

ProMutual declined comment on the case; the insurer also would not address general questions about its allocation policies.

“I started this fight because I felt violated and betrayed, not to make money,” Dr. Minkina said. “I am not rich by a long shot, and I wanted to clear my name because [a] good name is all I have. Additionally, having [a] record about malpractice payment in my physician profile makes me vulnerable.”

Liability experts say the case highlights the conflicts that can arise between physicians and insurers during malpractice lawsuits. The legal challenge also raises questions about allocations of liability by insurers, how the determinations are made, and what impact they have on doctors going forward.

The proportion of liability assigned after a settlement matters, said Jeffrey Segal, MD, JD, a neurosurgeon and founder of Medical Justice, a medicolegal consulting firm for physicians.

Vidyard Video

“There’s a subtext that your piece of the pie – the part that is allocated to you – is your liability, your culpability, your guilt,” Dr. Segal said in an interview. “This has impact going down the road in terms of reputation, in terms of credibility, and potentially of your premiums going forward. There are some real-world economic consequences.”

 

 

Bad care or bad faith?

In Dr. Minkina’s case, some facts are undisputed. In 2002, Dr. Minkina, then a physician at Blue Hills Medical Associates in Braintree, Mass., referred a 55-year-old patient for a mammogram and an ultrasound after confirming some nodularity in the women’s breast. A radiologist twice reported no abnormalities which Dr. Minkina relayed to the patient, advising her to follow-up with her primary care physician and to schedule yearly mammograms. The patient did neither, according to court records. Dr. Minkina left the practice shortly after the visit.

In early 2006, the patient visited the practice, and a nurse practitioner sent her for another mammogram and an ultrasound. The mammogram report included some signs of malignancy, but the nurse misread, misunderstood, or overlooked the signs and recorded that “the benign breast condition had no changes,” according to court transcripts. Later that year, the patient visited the practice complaining of headaches and a droopy eye at which time her primary care physician diagnosed sinusitis and prescribed antibiotics. In 2007, the patient underwent a brain MRI and a breast MRI, which revealed widespread metastatic carcinoma. She and her family sued Dr. Minkina and several others in June 2007. The patient died in 2008.

The agreement between parties ends there. Dr. Minkina believes she followed the standard of care and was not responsible for the delayed breast cancer diagnosis. Given the radiologist’s negative report and the patient’s lack of visual abnormalities, she contends she adequately referred the patient to her primary care physician for further consultation and evaluation. Dr. Minkina argues the insurer allocated an unjustifiably high percentage of liability to her because she was no longer an insured and because the company had an economic incentive to allocate a disproportionate percentage of responsibility and damages.

ProMutual contends Dr. Minkina bore more responsibility than the other health care professionals named for the delayed diagnosis because of violations of standards of care and because of causation factors. The insurer’s experts asserted that when treating an older woman with a palpable lump, the standard of care is to obtain a biopsy, according to opening arguments by ProMutual defense counsel Tamara Wolfson.

The experts also concluded that, when the nurse practitioner and primary care physician saw the patient in 2006, the patient would have already had metastatic disease, and a cancer diagnosis at that time would not have saved her, according to court transcripts. Had the cancer been diagnosed in 2002 when Dr. Minkina saw the patient, the disease would have been “very treatable,” the experts further concluded.

“So, faced with negative opinions on both the standard of care and causation, [the claim representative] was very concerned that Dr. Minkina not only faced a very substantial risk of an adverse verdict in the ... suit, but a verdict that would exceed Dr. Minkina’s policy limits,” Ms. Wolfson said during opening arguments.

The evidence led to the settlement and the allocation decision, Ms. Wolfson said, adding that the majority – 60% – fell on Blue Hills Medical Associates because it lacked a good system to track and follow up with patients. There was zero benefit to ProMutual as to how the $500,000 settlement was parsed, she said during trial.

A lower court initially dismissed Dr. Minkina’s suit, but the Commonwealth of Massachusetts Appeals Court in 2015 overturned that decision, ruling the case could move forward. In 2018, the superior court agreed Dr. Minkina had a valid bad faith claim, stating that she had provided information about ProMutual’s conduct from which “a reasonable juror could infer the defendant’s bad faith in connection with its settling the underlying malpractice suit, including the allocation of liability.”

Dr. Minkina had been a plaintiff in unrelated litigation in the past. In 2005, she sued her former employer for alleged discrimination and retaliation after claiming she was mistreated and terminated for complaining about fumes. She prevailed and was awarded an arbitration award of about $266,000. In 2009, Dr. Minkina sued the original law firm that represented her in the discrimination suit for malpractice, alleging the firm’s negligence cost her the chance to go to trial. A judge dismissed the claim as frivolous and ordered Dr. Minkina to pay the firm’s legal fees. The doctor twice has been jailed for failing to fully resolve that legal payment. The case remains outstanding, and Dr. Minkina is now in bankruptcy.
 

 

 

What’s in an allocation?

Liability allocations are an integral part of multiparty medical malpractice claims, said Brian Atchinson, president and CEO for the Medical Professional Liability Association, a trade association for medical liability insurers.

“In any case involving more than one party, there is a potential allocation issue,” Mr. Atchinson said in an interview. “[Insurers] generally look to the liability and damages incurred with regard to their respective insureds in a case and work to establish an allocation that reflects actual liability.”

If the case goes to a jury and jurors find for the plaintiff, depending on the nature of the damages awarded, the jury may be called on to allocate liability among multiple defendants, he said.

Because settlements are reported to the National Practitioner Data Bank (NPDB), the proportion of liability assigned to each defendant has significance, said J. Richard Moore, a medical liability defense attorney based in Indianapolis and chair for the Defense Research Institute’s Medical Liability and Health Care Law Committee.

Vidyard Video

“The allocation matters because the amount of settlement matters,” Mr. Moore said. “A lower settlement amount suggests the physician’s insurance company made a cost-benefit business decision to end litigation without more expense, while an extremely high settlement suggests actual malpractice.”

State medical boards have varying reporting requirements. Some state boards require both the amount paid by the individual provider and the global settlement amount – if known – while other state boards require only the amount paid on behalf of the provider.

Conflicts over allocations are not common, Dr. Segal said. More frequent are disputes among physicians and insurers over the potential settling of a claim. Such conflicts underscore the importance of paying close attention to contract language when signing with an insurer, Dr. Segal said.

Whether the contract includes a consent to settle clause, for example, can markedly change the case outcome. The clause means the insurer must have the doctor’s approval to settle the case. Absent the clause, insurers generally have authority to settle all claims arising under the policy.

Other contracts may include a “hammer clause,” Dr. Segal notes. This gives doctors the ultimate vote on settling, but it stipulates that if the physician refuses a settlement offer and opts for trial, the doctor is responsible for any surplus award, should the doctor lose.

In Dr. Minkina’s case, the doctor’s contract allowed ProMutual to settle without her consent, but the contract was silent on allocations.

Dr. Segal and Mr. Moore both said the odds of Dr. Minkina prevailing are fairly low. In another case, a South Carolina doctor similarly sued the South Carolina Medical Malpractice Liability Joint Underwriting Association over an allocation of liability following a settlement. The doctor claimed he should not be assigned any portion of the $500,000 settlement, and he sued after his insurer assigned him one-seventh liability.

A trial court found in his favor, ruling the insurer breached the covenant of good faith and fair dealing by failing to treat each physician equally when determining liability. The Supreme Court of South Carolina in 2001 overturned that decision, finding the evidence did not support a bad faith finding and that the insurer’s allocation decision was reasonable.

If the Massachusetts case ends in Dr. Minkina’s favor, it will be as a result of strong evidence that the insurer placed its interests ahead of the physician’s financial and other interests, Mr. Moore said.

“If that happens, I anticipate that insurers may revise their standard policy provisions to clarify and limit the extent to which physicians have the right to be involved in allocation decisions,” he said.

agallegos@mdedge.com

When the summons arrived, Nataly Minkina, MD, took one look at the lawsuit and fainted.

Leonid Weinstein

The Boston-area internist had treated the plaintiff just once while covering for the patient’s primary care physician. During a visit for an upper respiratory infection, the patient mentioned a lump in her breast, and Dr. Minkina confirmed a small thickening in the woman’s right breast. She sent the patient for a mammogram and ultrasound, the results of which the radiologist reported were normal, according to court documents.

Five years later, the patient claimed Dr. Minkina was one of several providers responsible for a missed breast cancer diagnosis.

Even worse than the lawsuit, however, was how her former insurer resolved the case, said Dr. Minkina, now an internist at Brigham and Women’s Hospital in Chestnut Hill, Mass. The claim was settled against the defendants for $500,000, and Dr. Minkina was alloted 30% of the liability. No fault was assigned to the other physicians named, while a nurse practitioner was alloted 10%, and the medical practice was alloted 60% liability, according to court documents.

“I was very upset,” Dr. Minkina said. “First of all, I was kept in the dark. Nobody ever talked to me. I did not get a single report or any document from my attorney in 12 months. When I asked why was I assigned the [30%] liability, they said the experts gave me bad evaluations, but they would not show reports to me. I was literally scapegoated.”

When the insurer refused to reconsider the allocation, Dr. Minkina took her complaint to court. The internist now has been embroiled in a legal challenge against Medical Professional Mutual Insurance Company (ProMutual) for 7 years. Dr. Minkina’s lawsuit alleges the insurer engaged in a bad faith allocation to serve its own economic interests by shifting fault for the claim from its insureds to its former client, Dr. Minkina. The insurance company contends the allocation was a careful and rational decision based on case evidence. In late July, the case went to trial in Dedham, Mass.

ProMutual declined comment on the case; the insurer also would not address general questions about its allocation policies.

“I started this fight because I felt violated and betrayed, not to make money,” Dr. Minkina said. “I am not rich by a long shot, and I wanted to clear my name because [a] good name is all I have. Additionally, having [a] record about malpractice payment in my physician profile makes me vulnerable.”

Liability experts say the case highlights the conflicts that can arise between physicians and insurers during malpractice lawsuits. The legal challenge also raises questions about allocations of liability by insurers, how the determinations are made, and what impact they have on doctors going forward.

The proportion of liability assigned after a settlement matters, said Jeffrey Segal, MD, JD, a neurosurgeon and founder of Medical Justice, a medicolegal consulting firm for physicians.

Vidyard Video

“There’s a subtext that your piece of the pie – the part that is allocated to you – is your liability, your culpability, your guilt,” Dr. Segal said in an interview. “This has impact going down the road in terms of reputation, in terms of credibility, and potentially of your premiums going forward. There are some real-world economic consequences.”

 

 

Bad care or bad faith?

In Dr. Minkina’s case, some facts are undisputed. In 2002, Dr. Minkina, then a physician at Blue Hills Medical Associates in Braintree, Mass., referred a 55-year-old patient for a mammogram and an ultrasound after confirming some nodularity in the women’s breast. A radiologist twice reported no abnormalities which Dr. Minkina relayed to the patient, advising her to follow-up with her primary care physician and to schedule yearly mammograms. The patient did neither, according to court records. Dr. Minkina left the practice shortly after the visit.

In early 2006, the patient visited the practice, and a nurse practitioner sent her for another mammogram and an ultrasound. The mammogram report included some signs of malignancy, but the nurse misread, misunderstood, or overlooked the signs and recorded that “the benign breast condition had no changes,” according to court transcripts. Later that year, the patient visited the practice complaining of headaches and a droopy eye at which time her primary care physician diagnosed sinusitis and prescribed antibiotics. In 2007, the patient underwent a brain MRI and a breast MRI, which revealed widespread metastatic carcinoma. She and her family sued Dr. Minkina and several others in June 2007. The patient died in 2008.

The agreement between parties ends there. Dr. Minkina believes she followed the standard of care and was not responsible for the delayed breast cancer diagnosis. Given the radiologist’s negative report and the patient’s lack of visual abnormalities, she contends she adequately referred the patient to her primary care physician for further consultation and evaluation. Dr. Minkina argues the insurer allocated an unjustifiably high percentage of liability to her because she was no longer an insured and because the company had an economic incentive to allocate a disproportionate percentage of responsibility and damages.

ProMutual contends Dr. Minkina bore more responsibility than the other health care professionals named for the delayed diagnosis because of violations of standards of care and because of causation factors. The insurer’s experts asserted that when treating an older woman with a palpable lump, the standard of care is to obtain a biopsy, according to opening arguments by ProMutual defense counsel Tamara Wolfson.

The experts also concluded that, when the nurse practitioner and primary care physician saw the patient in 2006, the patient would have already had metastatic disease, and a cancer diagnosis at that time would not have saved her, according to court transcripts. Had the cancer been diagnosed in 2002 when Dr. Minkina saw the patient, the disease would have been “very treatable,” the experts further concluded.

“So, faced with negative opinions on both the standard of care and causation, [the claim representative] was very concerned that Dr. Minkina not only faced a very substantial risk of an adverse verdict in the ... suit, but a verdict that would exceed Dr. Minkina’s policy limits,” Ms. Wolfson said during opening arguments.

The evidence led to the settlement and the allocation decision, Ms. Wolfson said, adding that the majority – 60% – fell on Blue Hills Medical Associates because it lacked a good system to track and follow up with patients. There was zero benefit to ProMutual as to how the $500,000 settlement was parsed, she said during trial.

A lower court initially dismissed Dr. Minkina’s suit, but the Commonwealth of Massachusetts Appeals Court in 2015 overturned that decision, ruling the case could move forward. In 2018, the superior court agreed Dr. Minkina had a valid bad faith claim, stating that she had provided information about ProMutual’s conduct from which “a reasonable juror could infer the defendant’s bad faith in connection with its settling the underlying malpractice suit, including the allocation of liability.”

Dr. Minkina had been a plaintiff in unrelated litigation in the past. In 2005, she sued her former employer for alleged discrimination and retaliation after claiming she was mistreated and terminated for complaining about fumes. She prevailed and was awarded an arbitration award of about $266,000. In 2009, Dr. Minkina sued the original law firm that represented her in the discrimination suit for malpractice, alleging the firm’s negligence cost her the chance to go to trial. A judge dismissed the claim as frivolous and ordered Dr. Minkina to pay the firm’s legal fees. The doctor twice has been jailed for failing to fully resolve that legal payment. The case remains outstanding, and Dr. Minkina is now in bankruptcy.
 

 

 

What’s in an allocation?

Liability allocations are an integral part of multiparty medical malpractice claims, said Brian Atchinson, president and CEO for the Medical Professional Liability Association, a trade association for medical liability insurers.

“In any case involving more than one party, there is a potential allocation issue,” Mr. Atchinson said in an interview. “[Insurers] generally look to the liability and damages incurred with regard to their respective insureds in a case and work to establish an allocation that reflects actual liability.”

If the case goes to a jury and jurors find for the plaintiff, depending on the nature of the damages awarded, the jury may be called on to allocate liability among multiple defendants, he said.

Because settlements are reported to the National Practitioner Data Bank (NPDB), the proportion of liability assigned to each defendant has significance, said J. Richard Moore, a medical liability defense attorney based in Indianapolis and chair for the Defense Research Institute’s Medical Liability and Health Care Law Committee.

Vidyard Video

“The allocation matters because the amount of settlement matters,” Mr. Moore said. “A lower settlement amount suggests the physician’s insurance company made a cost-benefit business decision to end litigation without more expense, while an extremely high settlement suggests actual malpractice.”

State medical boards have varying reporting requirements. Some state boards require both the amount paid by the individual provider and the global settlement amount – if known – while other state boards require only the amount paid on behalf of the provider.

Conflicts over allocations are not common, Dr. Segal said. More frequent are disputes among physicians and insurers over the potential settling of a claim. Such conflicts underscore the importance of paying close attention to contract language when signing with an insurer, Dr. Segal said.

Whether the contract includes a consent to settle clause, for example, can markedly change the case outcome. The clause means the insurer must have the doctor’s approval to settle the case. Absent the clause, insurers generally have authority to settle all claims arising under the policy.

Other contracts may include a “hammer clause,” Dr. Segal notes. This gives doctors the ultimate vote on settling, but it stipulates that if the physician refuses a settlement offer and opts for trial, the doctor is responsible for any surplus award, should the doctor lose.

In Dr. Minkina’s case, the doctor’s contract allowed ProMutual to settle without her consent, but the contract was silent on allocations.

Dr. Segal and Mr. Moore both said the odds of Dr. Minkina prevailing are fairly low. In another case, a South Carolina doctor similarly sued the South Carolina Medical Malpractice Liability Joint Underwriting Association over an allocation of liability following a settlement. The doctor claimed he should not be assigned any portion of the $500,000 settlement, and he sued after his insurer assigned him one-seventh liability.

A trial court found in his favor, ruling the insurer breached the covenant of good faith and fair dealing by failing to treat each physician equally when determining liability. The Supreme Court of South Carolina in 2001 overturned that decision, finding the evidence did not support a bad faith finding and that the insurer’s allocation decision was reasonable.

If the Massachusetts case ends in Dr. Minkina’s favor, it will be as a result of strong evidence that the insurer placed its interests ahead of the physician’s financial and other interests, Mr. Moore said.

“If that happens, I anticipate that insurers may revise their standard policy provisions to clarify and limit the extent to which physicians have the right to be involved in allocation decisions,” he said.

agallegos@mdedge.com

Black patients’ satisfaction with dermatologic care would increase if more dermatologists underwent enhanced training in skin of color, cultural competency, and empathic communication skills, a small study in JAMA Dermatology suggests.

kate_sept2004/E+

Lead author Kristina Gorbatenko-Roth, PhD, of the department of psychology at University of Wisconsin-Stout, Menomonie, Wis., and colleagues analyzed the perceptions of 19 black, adult patients who had received treatment in a skin of color clinic (SOCC). Patients were asked about their perspectives and experiences inside and outside of the clinic as it pertained to dermatologists’ interaction style, cultural awareness, and overall treatment. Two focus groups consisted of patients seen by a race-concordant dermatologist, and two focus groups consisted of patients seen by a race-discordant dermatologist. The patients also responded to a survey.

Of 19 adult black patients who participated in the study, 18 respondents were women, and the mean age was 50 years. Compared with non-SOCC dermatology treatment experiences, patients experienced higher levels of overall satisfaction with SOCC dermatologists, reporting that SOCC dermatologists were better trained to care for black patients, showed greater respect and dignity, and were more trustworthy, according to the study published Aug 21.

Care satisfaction appeared most related to doctors’ interpersonal style and specialized knowledge of black skin and hair, according to the study. Investigators gleaned nine major themes during the analysis, five of which included dermatologist behaviors: interaction style, knowledge, partnering with patients in focusing on outcomes, economic sensitivity, and shared life experiences. Four themes were specific to patients: comfort, confidence, education, and concordance preference. Across all participants, a dermatologist’s interaction style was identified as the most important factor, elements of which included oral communication, body language, and physical examination performance.

Regarding experiences outside the SOCC, participants reported that some providers performed only a cursory skin examination and appeared to avoid physical contact, which some patients interpreted as a sign of disrespect and a lack of racial sensitivity. Participants also expressed frustration with dermatologists outside the clinic who seemed to lack knowledge about black skin and hair disorders. Of all respondents, 71% reported they would prefer a black (or race concordant) dermatologist, including 91% of the race-concordant group and 33% of the race-discordant group.

The investigators wrote the findings underscore a number of needed changes to enhance the care of black dermatology patients, including enhanced dermatology residency and workforce education about treatment of skin of color and more training on culturally aware communication skills. Perceptions of racial and cost-of-care insensitivities identified by the study population also suggest the need for training in cultural competency and implicit bias, delivery of cost conscious care, and the social determinants of health.

As far as they know, the authors noted that, before this study, “little was known regarding black patients’ perceptions of their dermatology care, either within or external to an SOCC,” and that the study “appears to be the first to investigate and provide preliminary findings for addressing this knowledge gap.”

agallegos@mdedge.com

SOURCE: Gorbatenko-Roth K et al. JAMA Dermatol. 2019 Aug 21. doi: 10.1001/jamadermatol.2019.2063.

Black patients’ satisfaction with dermatologic care would increase if more dermatologists underwent enhanced training in skin of color, cultural competency, and empathic communication skills, a small study in JAMA Dermatology suggests.

kate_sept2004/E+

Lead author Kristina Gorbatenko-Roth, PhD, of the department of psychology at University of Wisconsin-Stout, Menomonie, Wis., and colleagues analyzed the perceptions of 19 black, adult patients who had received treatment in a skin of color clinic (SOCC). Patients were asked about their perspectives and experiences inside and outside of the clinic as it pertained to dermatologists’ interaction style, cultural awareness, and overall treatment. Two focus groups consisted of patients seen by a race-concordant dermatologist, and two focus groups consisted of patients seen by a race-discordant dermatologist. The patients also responded to a survey.

Of 19 adult black patients who participated in the study, 18 respondents were women, and the mean age was 50 years. Compared with non-SOCC dermatology treatment experiences, patients experienced higher levels of overall satisfaction with SOCC dermatologists, reporting that SOCC dermatologists were better trained to care for black patients, showed greater respect and dignity, and were more trustworthy, according to the study published Aug 21.

Care satisfaction appeared most related to doctors’ interpersonal style and specialized knowledge of black skin and hair, according to the study. Investigators gleaned nine major themes during the analysis, five of which included dermatologist behaviors: interaction style, knowledge, partnering with patients in focusing on outcomes, economic sensitivity, and shared life experiences. Four themes were specific to patients: comfort, confidence, education, and concordance preference. Across all participants, a dermatologist’s interaction style was identified as the most important factor, elements of which included oral communication, body language, and physical examination performance.

Regarding experiences outside the SOCC, participants reported that some providers performed only a cursory skin examination and appeared to avoid physical contact, which some patients interpreted as a sign of disrespect and a lack of racial sensitivity. Participants also expressed frustration with dermatologists outside the clinic who seemed to lack knowledge about black skin and hair disorders. Of all respondents, 71% reported they would prefer a black (or race concordant) dermatologist, including 91% of the race-concordant group and 33% of the race-discordant group.

The investigators wrote the findings underscore a number of needed changes to enhance the care of black dermatology patients, including enhanced dermatology residency and workforce education about treatment of skin of color and more training on culturally aware communication skills. Perceptions of racial and cost-of-care insensitivities identified by the study population also suggest the need for training in cultural competency and implicit bias, delivery of cost conscious care, and the social determinants of health.

As far as they know, the authors noted that, before this study, “little was known regarding black patients’ perceptions of their dermatology care, either within or external to an SOCC,” and that the study “appears to be the first to investigate and provide preliminary findings for addressing this knowledge gap.”

agallegos@mdedge.com

SOURCE: Gorbatenko-Roth K et al. JAMA Dermatol. 2019 Aug 21. doi: 10.1001/jamadermatol.2019.2063.

Black patients’ satisfaction with dermatologic care would increase if more dermatologists underwent enhanced training in skin of color, cultural competency, and empathic communication skills, a small study in JAMA Dermatology suggests.

kate_sept2004/E+

Lead author Kristina Gorbatenko-Roth, PhD, of the department of psychology at University of Wisconsin-Stout, Menomonie, Wis., and colleagues analyzed the perceptions of 19 black, adult patients who had received treatment in a skin of color clinic (SOCC). Patients were asked about their perspectives and experiences inside and outside of the clinic as it pertained to dermatologists’ interaction style, cultural awareness, and overall treatment. Two focus groups consisted of patients seen by a race-concordant dermatologist, and two focus groups consisted of patients seen by a race-discordant dermatologist. The patients also responded to a survey.

Of 19 adult black patients who participated in the study, 18 respondents were women, and the mean age was 50 years. Compared with non-SOCC dermatology treatment experiences, patients experienced higher levels of overall satisfaction with SOCC dermatologists, reporting that SOCC dermatologists were better trained to care for black patients, showed greater respect and dignity, and were more trustworthy, according to the study published Aug 21.

Care satisfaction appeared most related to doctors’ interpersonal style and specialized knowledge of black skin and hair, according to the study. Investigators gleaned nine major themes during the analysis, five of which included dermatologist behaviors: interaction style, knowledge, partnering with patients in focusing on outcomes, economic sensitivity, and shared life experiences. Four themes were specific to patients: comfort, confidence, education, and concordance preference. Across all participants, a dermatologist’s interaction style was identified as the most important factor, elements of which included oral communication, body language, and physical examination performance.

Regarding experiences outside the SOCC, participants reported that some providers performed only a cursory skin examination and appeared to avoid physical contact, which some patients interpreted as a sign of disrespect and a lack of racial sensitivity. Participants also expressed frustration with dermatologists outside the clinic who seemed to lack knowledge about black skin and hair disorders. Of all respondents, 71% reported they would prefer a black (or race concordant) dermatologist, including 91% of the race-concordant group and 33% of the race-discordant group.

The investigators wrote the findings underscore a number of needed changes to enhance the care of black dermatology patients, including enhanced dermatology residency and workforce education about treatment of skin of color and more training on culturally aware communication skills. Perceptions of racial and cost-of-care insensitivities identified by the study population also suggest the need for training in cultural competency and implicit bias, delivery of cost conscious care, and the social determinants of health.

As far as they know, the authors noted that, before this study, “little was known regarding black patients’ perceptions of their dermatology care, either within or external to an SOCC,” and that the study “appears to be the first to investigate and provide preliminary findings for addressing this knowledge gap.”

agallegos@mdedge.com

SOURCE: Gorbatenko-Roth K et al. JAMA Dermatol. 2019 Aug 21. doi: 10.1001/jamadermatol.2019.2063.

Planned Parenthood will no longer participate in the federal Title X family planning program in response to a Trump administration rule that prohibits physicians from counseling patients about abortion and referring patients for the procedure.

In an Aug. 19 announcement, Alexis McGill Johnson, Planned Parenthood Federation of America president and CEO, said the Title X changes, which amount to “an unethical and dangerous gag rule,” has forced the organization out of Title X after being part of the program for 50 years. Planned Parenthood health centers are the largest Title X provider, serving 40% of patients who receive care through the program.

“We believe that the Trump administration is doing this as an attack on reproductive health care and to keep providers like Planned Parenthood from serving our patients,” Ms. McGill said in a statement. “Health care shouldn’t come down to how much you earn, where you live, or who you are. Congress must act now. It’s time for the U.S. Senate to act to pass a spending bill that will reverse the harmful rule and restore access to birth control, STD testing, and other critical services to people with low incomes.”

In an Aug. 19 statement, Mia Palmieri Heck, director of external affairs for the U.S. Department of Health & Human Services said every current Title X grantee has the choice to accept their grant and comply with the changes, or reject their funding by refusing to comply.

“The new Title X regulations were final at the time the current grant awards were announced,” Ms. Heck said a statement. “Some grantees are now blaming the government for their own actions – having chosen to accept the grant while failing to comply with the regulations that accompany it – and they are abandoning their obligations to serve their patients under the program. HHS is grateful for the many grantees who continue to serve their patients under the Title X program, and we will work to ensure all patients continue to be served.”

The announcement by Planned Parenthood comes about a month after HHS gave family planning clinics more time to comply with the new rule if they are making good faith efforts to comply with the new rules. The changes to the Title X program make health clinics ineligible for funding if they offer, promote, or support abortion as a method of family planning.

So far, more than 20 states and several abortion rights organizations, including Planned Parenthood, have sued over the rules in four separate states. District judges in Oregon, Washington, and California temporarily blocked the rules from taking effect. In a June 20 decision, the 9th U.S. Circuit Court of Appeals ruled that the federal government may go forward with its plan to restrict Title X funding from clinics that provide abortion counseling or referrals. The decision overturned the lower court injunctions.

Clare Coleman, president and CEO for the National Family Planning & Reproductive Health Association, said she expects further withdrawals from the Title X program to follow Planned Parenthood’s departure.

“The administration’s Title X rule is forcing the program’s 90 grantees and nearly 4,000 service sites to make gut-wrenching choices,” Ms. Coleman said in a statement. “They can stay in the program, despite the rule’s harms and compromises to Title X’s quality of care, for the sake of continuing to offer some Title X care for low-income individuals [or] they can leave the program and forego funding in order to avoid the rule’s limits on pregnancy counseling and other essential care, contrary to HHS’s own professional standards.”

HHS has previously said that the Title X changes ensure that grants and contracts awarded under the program fully comply with the statutory program integrity requirements, “thereby fulfilling the purpose of Title X, so that more women and men can receive services that help them consider and achieve both their short-term and long-term family planning needs.” The agency recently posted guidance on its website on myths vs. facts about the changes.

Ms. Johnson meanwhile, said Planned Parenthood clinics will remain open to serve patients, and that the organization will continue to fight the Title X changes in court.



agallegos@mdedge.com




 

Planned Parenthood will no longer participate in the federal Title X family planning program in response to a Trump administration rule that prohibits physicians from counseling patients about abortion and referring patients for the procedure.

In an Aug. 19 announcement, Alexis McGill Johnson, Planned Parenthood Federation of America president and CEO, said the Title X changes, which amount to “an unethical and dangerous gag rule,” has forced the organization out of Title X after being part of the program for 50 years. Planned Parenthood health centers are the largest Title X provider, serving 40% of patients who receive care through the program.

“We believe that the Trump administration is doing this as an attack on reproductive health care and to keep providers like Planned Parenthood from serving our patients,” Ms. McGill said in a statement. “Health care shouldn’t come down to how much you earn, where you live, or who you are. Congress must act now. It’s time for the U.S. Senate to act to pass a spending bill that will reverse the harmful rule and restore access to birth control, STD testing, and other critical services to people with low incomes.”

In an Aug. 19 statement, Mia Palmieri Heck, director of external affairs for the U.S. Department of Health & Human Services said every current Title X grantee has the choice to accept their grant and comply with the changes, or reject their funding by refusing to comply.

“The new Title X regulations were final at the time the current grant awards were announced,” Ms. Heck said a statement. “Some grantees are now blaming the government for their own actions – having chosen to accept the grant while failing to comply with the regulations that accompany it – and they are abandoning their obligations to serve their patients under the program. HHS is grateful for the many grantees who continue to serve their patients under the Title X program, and we will work to ensure all patients continue to be served.”

The announcement by Planned Parenthood comes about a month after HHS gave family planning clinics more time to comply with the new rule if they are making good faith efforts to comply with the new rules. The changes to the Title X program make health clinics ineligible for funding if they offer, promote, or support abortion as a method of family planning.

So far, more than 20 states and several abortion rights organizations, including Planned Parenthood, have sued over the rules in four separate states. District judges in Oregon, Washington, and California temporarily blocked the rules from taking effect. In a June 20 decision, the 9th U.S. Circuit Court of Appeals ruled that the federal government may go forward with its plan to restrict Title X funding from clinics that provide abortion counseling or referrals. The decision overturned the lower court injunctions.

Clare Coleman, president and CEO for the National Family Planning & Reproductive Health Association, said she expects further withdrawals from the Title X program to follow Planned Parenthood’s departure.

“The administration’s Title X rule is forcing the program’s 90 grantees and nearly 4,000 service sites to make gut-wrenching choices,” Ms. Coleman said in a statement. “They can stay in the program, despite the rule’s harms and compromises to Title X’s quality of care, for the sake of continuing to offer some Title X care for low-income individuals [or] they can leave the program and forego funding in order to avoid the rule’s limits on pregnancy counseling and other essential care, contrary to HHS’s own professional standards.”

HHS has previously said that the Title X changes ensure that grants and contracts awarded under the program fully comply with the statutory program integrity requirements, “thereby fulfilling the purpose of Title X, so that more women and men can receive services that help them consider and achieve both their short-term and long-term family planning needs.” The agency recently posted guidance on its website on myths vs. facts about the changes.

Ms. Johnson meanwhile, said Planned Parenthood clinics will remain open to serve patients, and that the organization will continue to fight the Title X changes in court.



agallegos@mdedge.com




 

Planned Parenthood will no longer participate in the federal Title X family planning program in response to a Trump administration rule that prohibits physicians from counseling patients about abortion and referring patients for the procedure.

In an Aug. 19 announcement, Alexis McGill Johnson, Planned Parenthood Federation of America president and CEO, said the Title X changes, which amount to “an unethical and dangerous gag rule,” has forced the organization out of Title X after being part of the program for 50 years. Planned Parenthood health centers are the largest Title X provider, serving 40% of patients who receive care through the program.

“We believe that the Trump administration is doing this as an attack on reproductive health care and to keep providers like Planned Parenthood from serving our patients,” Ms. McGill said in a statement. “Health care shouldn’t come down to how much you earn, where you live, or who you are. Congress must act now. It’s time for the U.S. Senate to act to pass a spending bill that will reverse the harmful rule and restore access to birth control, STD testing, and other critical services to people with low incomes.”

In an Aug. 19 statement, Mia Palmieri Heck, director of external affairs for the U.S. Department of Health & Human Services said every current Title X grantee has the choice to accept their grant and comply with the changes, or reject their funding by refusing to comply.

“The new Title X regulations were final at the time the current grant awards were announced,” Ms. Heck said a statement. “Some grantees are now blaming the government for their own actions – having chosen to accept the grant while failing to comply with the regulations that accompany it – and they are abandoning their obligations to serve their patients under the program. HHS is grateful for the many grantees who continue to serve their patients under the Title X program, and we will work to ensure all patients continue to be served.”

The announcement by Planned Parenthood comes about a month after HHS gave family planning clinics more time to comply with the new rule if they are making good faith efforts to comply with the new rules. The changes to the Title X program make health clinics ineligible for funding if they offer, promote, or support abortion as a method of family planning.

So far, more than 20 states and several abortion rights organizations, including Planned Parenthood, have sued over the rules in four separate states. District judges in Oregon, Washington, and California temporarily blocked the rules from taking effect. In a June 20 decision, the 9th U.S. Circuit Court of Appeals ruled that the federal government may go forward with its plan to restrict Title X funding from clinics that provide abortion counseling or referrals. The decision overturned the lower court injunctions.

Clare Coleman, president and CEO for the National Family Planning & Reproductive Health Association, said she expects further withdrawals from the Title X program to follow Planned Parenthood’s departure.

“The administration’s Title X rule is forcing the program’s 90 grantees and nearly 4,000 service sites to make gut-wrenching choices,” Ms. Coleman said in a statement. “They can stay in the program, despite the rule’s harms and compromises to Title X’s quality of care, for the sake of continuing to offer some Title X care for low-income individuals [or] they can leave the program and forego funding in order to avoid the rule’s limits on pregnancy counseling and other essential care, contrary to HHS’s own professional standards.”

HHS has previously said that the Title X changes ensure that grants and contracts awarded under the program fully comply with the statutory program integrity requirements, “thereby fulfilling the purpose of Title X, so that more women and men can receive services that help them consider and achieve both their short-term and long-term family planning needs.” The agency recently posted guidance on its website on myths vs. facts about the changes.

Ms. Johnson meanwhile, said Planned Parenthood clinics will remain open to serve patients, and that the organization will continue to fight the Title X changes in court.



agallegos@mdedge.com




 

New Trump administration regulations will make it more difficult for immigrants to remain in the United States if they receive health care assistance – in sharp contrasts to a recent movement in medicine to address the social determinants of health.

Under longstanding immigration policy, officials can refuse to admit immigrants into the United States – or to adjust their legal status – if they are deemed likely to become a public charge.

Previously, immigration officers considered cash aid, such as Temporary Assistance for Needy Families or long-term institutionalized care, as potential public charge reasons for denial.

The new regulation, published Aug. 14 in the Federal Register, allows officials to consider previously excluded programs in their determination, including nonemergency Medicaid for nonpregnant adults, the Supplemental Nutrition Assistance Program (SNAP), and several housing programs. The final regulation continues to allow immigrants to access emergency medical care and disaster relief without public charge repercussions.

The rule is not only unethical, but it will cause medical care to be unavailable to patients who are hardworking, have families to support, and often are employed in trades that are low-paying, said Alan R. Nelson, MD, an internist-endocrinologist and former special advisor to the CEO of the American College of Physicians.

“The rule not only flies in the face of efforts to confront social determinants of health and thereby reduce disparities in care and outcomes, but will strain emergency and safety net services at the local/county level and burden hospitals and clinics with more uncompensated care,” Dr. Nelson said in an interview. “Everybody loses.”

In a joint statement, the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American Osteopathic Association, the ACP, and the American Psychiatric Association expressed concern that the new regulation will discourage immigrants from seeking needed health care since such assistance may be used to deny green cards and visas, or even lead to deportations.

“Rather than face that threat, impacted patients currently served by our members almost certainly will avoid needed care from their trusted physicians, jeopardizing their own health and that of their communities,” the medical societies stated. “Many of our members have already witnessed this chilling effect among their own patient populations, with patients avoiding health services and programs out of fear.”

The change comes amid ongoing efforts among physicians and health care professionals to address health care disparities based on cultural differences and social factors. A number of medical schools, such as the University of Pennsylvania’s in Philadelphia, are enhancing their curriculum on social determinants of health to develop more sensitive and culturally competent physicians.

Meanwhile, the American Medical Association in April announced a collaboration with UnitedHealthcare that aims to address social and environmental factors that affect patients’ health by standardizing data collection of social determinants of health. The two groups support the creation of 23 new ICD-10 codes related to social determinants that would capture such factors as access to nutritious food, adequate and safe housing, available transportation, ability to pay for medications, and ability to pay for utilities.

William Golden, MD, professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock, said there appears to be a growing disconnect between government policy and evolving trends in population health.

“There are public policy issues evolving that I think will put the health care profession at odds with some of the economic regulation being put in place,” said Dr. Golden. “I think people are increasingly realizing that to manage population health, you have to go beyond treating lab values and X-rays. Social environment is a big driver in people’s health status. It’s no surprise that people who have lower educational obtainment and who have more challenging financial situations are often in more challenged health status. Add that to people who are now potentially not having access to health coverage, and I think it’s a set up for creating a population that will present to our [emergency rooms] with significant acute care challenges.”
 

agallegos@mdedge.com

This article was updated 8/22/2019.

New Trump administration regulations will make it more difficult for immigrants to remain in the United States if they receive health care assistance – in sharp contrasts to a recent movement in medicine to address the social determinants of health.

Under longstanding immigration policy, officials can refuse to admit immigrants into the United States – or to adjust their legal status – if they are deemed likely to become a public charge.

Previously, immigration officers considered cash aid, such as Temporary Assistance for Needy Families or long-term institutionalized care, as potential public charge reasons for denial.

The new regulation, published Aug. 14 in the Federal Register, allows officials to consider previously excluded programs in their determination, including nonemergency Medicaid for nonpregnant adults, the Supplemental Nutrition Assistance Program (SNAP), and several housing programs. The final regulation continues to allow immigrants to access emergency medical care and disaster relief without public charge repercussions.

The rule is not only unethical, but it will cause medical care to be unavailable to patients who are hardworking, have families to support, and often are employed in trades that are low-paying, said Alan R. Nelson, MD, an internist-endocrinologist and former special advisor to the CEO of the American College of Physicians.

“The rule not only flies in the face of efforts to confront social determinants of health and thereby reduce disparities in care and outcomes, but will strain emergency and safety net services at the local/county level and burden hospitals and clinics with more uncompensated care,” Dr. Nelson said in an interview. “Everybody loses.”

In a joint statement, the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American Osteopathic Association, the ACP, and the American Psychiatric Association expressed concern that the new regulation will discourage immigrants from seeking needed health care since such assistance may be used to deny green cards and visas, or even lead to deportations.

“Rather than face that threat, impacted patients currently served by our members almost certainly will avoid needed care from their trusted physicians, jeopardizing their own health and that of their communities,” the medical societies stated. “Many of our members have already witnessed this chilling effect among their own patient populations, with patients avoiding health services and programs out of fear.”

The change comes amid ongoing efforts among physicians and health care professionals to address health care disparities based on cultural differences and social factors. A number of medical schools, such as the University of Pennsylvania’s in Philadelphia, are enhancing their curriculum on social determinants of health to develop more sensitive and culturally competent physicians.

Meanwhile, the American Medical Association in April announced a collaboration with UnitedHealthcare that aims to address social and environmental factors that affect patients’ health by standardizing data collection of social determinants of health. The two groups support the creation of 23 new ICD-10 codes related to social determinants that would capture such factors as access to nutritious food, adequate and safe housing, available transportation, ability to pay for medications, and ability to pay for utilities.

William Golden, MD, professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock, said there appears to be a growing disconnect between government policy and evolving trends in population health.

“There are public policy issues evolving that I think will put the health care profession at odds with some of the economic regulation being put in place,” said Dr. Golden. “I think people are increasingly realizing that to manage population health, you have to go beyond treating lab values and X-rays. Social environment is a big driver in people’s health status. It’s no surprise that people who have lower educational obtainment and who have more challenging financial situations are often in more challenged health status. Add that to people who are now potentially not having access to health coverage, and I think it’s a set up for creating a population that will present to our [emergency rooms] with significant acute care challenges.”
 

agallegos@mdedge.com

This article was updated 8/22/2019.

New Trump administration regulations will make it more difficult for immigrants to remain in the United States if they receive health care assistance – in sharp contrasts to a recent movement in medicine to address the social determinants of health.

Under longstanding immigration policy, officials can refuse to admit immigrants into the United States – or to adjust their legal status – if they are deemed likely to become a public charge.

Previously, immigration officers considered cash aid, such as Temporary Assistance for Needy Families or long-term institutionalized care, as potential public charge reasons for denial.

The new regulation, published Aug. 14 in the Federal Register, allows officials to consider previously excluded programs in their determination, including nonemergency Medicaid for nonpregnant adults, the Supplemental Nutrition Assistance Program (SNAP), and several housing programs. The final regulation continues to allow immigrants to access emergency medical care and disaster relief without public charge repercussions.

The rule is not only unethical, but it will cause medical care to be unavailable to patients who are hardworking, have families to support, and often are employed in trades that are low-paying, said Alan R. Nelson, MD, an internist-endocrinologist and former special advisor to the CEO of the American College of Physicians.

“The rule not only flies in the face of efforts to confront social determinants of health and thereby reduce disparities in care and outcomes, but will strain emergency and safety net services at the local/county level and burden hospitals and clinics with more uncompensated care,” Dr. Nelson said in an interview. “Everybody loses.”

In a joint statement, the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American Osteopathic Association, the ACP, and the American Psychiatric Association expressed concern that the new regulation will discourage immigrants from seeking needed health care since such assistance may be used to deny green cards and visas, or even lead to deportations.

“Rather than face that threat, impacted patients currently served by our members almost certainly will avoid needed care from their trusted physicians, jeopardizing their own health and that of their communities,” the medical societies stated. “Many of our members have already witnessed this chilling effect among their own patient populations, with patients avoiding health services and programs out of fear.”

The change comes amid ongoing efforts among physicians and health care professionals to address health care disparities based on cultural differences and social factors. A number of medical schools, such as the University of Pennsylvania’s in Philadelphia, are enhancing their curriculum on social determinants of health to develop more sensitive and culturally competent physicians.

Meanwhile, the American Medical Association in April announced a collaboration with UnitedHealthcare that aims to address social and environmental factors that affect patients’ health by standardizing data collection of social determinants of health. The two groups support the creation of 23 new ICD-10 codes related to social determinants that would capture such factors as access to nutritious food, adequate and safe housing, available transportation, ability to pay for medications, and ability to pay for utilities.

William Golden, MD, professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock, said there appears to be a growing disconnect between government policy and evolving trends in population health.

“There are public policy issues evolving that I think will put the health care profession at odds with some of the economic regulation being put in place,” said Dr. Golden. “I think people are increasingly realizing that to manage population health, you have to go beyond treating lab values and X-rays. Social environment is a big driver in people’s health status. It’s no surprise that people who have lower educational obtainment and who have more challenging financial situations are often in more challenged health status. Add that to people who are now potentially not having access to health coverage, and I think it’s a set up for creating a population that will present to our [emergency rooms] with significant acute care challenges.”
 

agallegos@mdedge.com

This article was updated 8/22/2019.

It’s no secret that cancer drugs are among the most expensive medical treatments in the United States, and now, new research reveals some high-priced cancer drugs may yield little benefit for patients.

A recent analysis of 71 oncology indications approved by the Food and Drug Administration between 2011 and 2017 found that overall survival gains were marginal for drugs approved by the FDA based on overall survival (OS) data. The majority of the 71 indications (75%) demonstrated no statistically significant improvement in patient-reported outcomes (PROs), according to the study (JAMA Oncol. 2019 Jul 3 doi: 10.1001/jamaoncol.2019.1760).

More than half of the indications evaluated demonstrated neither an OS benefit nor a PRO improvement post approval, the study found.

While the researchers did not analyze cost, a number of the cancer drugs that demonstrated little benefit come with a high price tag. Cabozantinib (Cabometyx) for example, approved for the treatment of medullary thyroid carcinoma and advanced renal cell carcinoma (RCC) during the study period, did not demonstrate an overall survival benefit post approval, findings showed. Cabometyx, approved based on survival data, had a 2016 wholesale acquisition cost of $13,750 for a 1-month supply. Olaparib (Lynparza) meanwhile, approved for the treatment of advanced ovarian cancer during the study period, also showed no overall survival benefit post approval. The 2017 wholesale acquisition cost for olaparib was $13,482 for a 30-day supply.

Investigators noted in the study that evaluation of OS can be challenging or unfeasible in some instances and is complicated by factors such as use of crossover trial design.

The findings emphasize the need for a sharper eye on how regulatory authorities approve drugs, said Chadi Nabhan, MD, senior author of the study and chief medical officer at Aptitude Health based in Chicago.

Courtesy of Dr. Nabhan

Many drugs show little benefit

The JAMA Oncology study builds on other data that raise doubts about how the FDA determines value when making approval decisions for cancer drugs.

Overall survival is the most direct measure of clinical benefit used to determine value. But OS as an endpoint in clinical trials generally requires larger patient numbers and increased time for follow-up, thereby delaying approvals. This is likely why the use of surrogate endpoints to approve drugs has increased. Dr. Nabhan’s study found the use of surrogate endpoints during trials grew from 67% during the period of 2008 through 2012 to 76% during the period of 2011 through 2017. Surrogate endpoints can include tumor shrinkage, time to progression, or time to reappearance of disease.

The use of surrogate endpoints to determine value however, has long come under scrutiny. A 2019 analysis published in JAMA Internal Medicine found that most cancer drugs approved by the FDA based on response rate (RR) – the percentage of patients who experience tumor shrinkage – have less than transformational response rates, and that such indications do not have confirmed clinical benefit.

Of 59 oncology drugs with 85 unique indications, most had a response rate ranging from 20% to 59%. Of 81 available indications, the median complete response rate – defined as the percentage of patients with no visible disease and normalization of lymph nodes – was 6%. (Complete response data were not reported for four drug indications.) Investigators also reported that many of the drugs have remained on the market for years without subsequent confirmatory data.

In addition, a 2018 review of randomized clinical trials published in JAMA Internal Medicine that analyzed progression-free survival in cancer patients found the endpoint did not improve patients’ lives. A quantitative analysis of 52 articles that covered 38 randomized clinical trials involving 13,979 patients across 12 cancer types found no significant association between progression-free survival and health-related quality of life.

“These findings raise questions regarding the assumption that interventions prolonging [progression-free survival] also improve [health-related quality of life] in patients with cancer,” the study authors wrote. “Therefore, to ensure that patients are truly obtaining important benefit from cancer therapies, clinical trial investigators should measure [health-related quality of life] directly and accurately, ensuring adequate duration and follow-up.

PROs, which can encompass health-related quality of life, is a measure the FDA has encouraged investigators to use during trials – when the benefit exists. In the analysis by Dr. Nabhan, trials evaluated PROs during pivotal studies supporting initial approval in 50 of the 71 indications. Before approval, 14 drugs demonstrated a statistically significant improvement in at least one PRO, but only 1 of the 14 – ruxolitinib – was granted a PRO labeling claim at the time of approval. Post approval, a statistically significant improvement in PROs was shown for only 18 of the 71 (25%) initial indications.

Meanwhile, although overall survival is considered the optimal yardstick with which to measure drug benefit, the value of longevity – and how it should be weighted – poses further questions. A number of new oncology drugs approved based on survival data lengthen lives by a very short time, Dr. Saltz noted. In the study of 71 indications for example, the median OS gain for drugs approved based on survival data was 1.7 months.

“We crossed the absurdity boundary a long time ago with drugs in the range of $10,000 to $20,000 a month with median survival benefits of less than 2 months,” Dr. Saltz said. “That’s not very much. Then we get into a rather circuitous argument that doesn’t settle anything as to whether it’s ‘worth it or not.’ The question becomes to whom is it worth what, and who’s paying for it?”
 

Proposals aim to lower cost

Recent cost ideas that center on value-pricing seek to answer some of those questions. Outcomes-based contracts is one such proposal. Under the approach, a drug manufacturer and a payer reach an agreement that ties reimbursement to observed outcomes in patients. Rather than a payer covering all prescriptions at a single price, the initial price remains in place if a certain volume of patients achieves the agreed-upon outcome. If the threshold is not met, the drugmaker refunds some of the original price to the payer.

Outcomes-based contracting sounds like a promising approach because various parties involved in the sale have a stake in the result, Dr. Nabhan said. “If you are a manufacturer, you want to make sure the outcomes are actually good,” he said. “If you’re a physician, you want to maximize monitoring your patient and managing adverse events. If you are the payer, you want to make sure your patient stays adherent to therapy, and you want to make sure you provide access to the doctor’s office, and to the hospital when needed. There’s more skin in the game when we look at outcomes-based contracting.”

Another idea gaining popularity is long-term financing for some drugs, particularly curative treatments. The idea has various models, but generally entails a financing arrangement, such as a loan mechanism for payers or a contractual annuitization that commits payers to pay costs over time. Such financing proposals are gaining speed in response to the high-cost of new gene therapies, according to a summary in Health Affairs. The payment agreements could be augmented by government funds such as government bonds or subsidies and/or efforts to promote risk-pooling across payers.

Peter B. Bach, MD, however, believes neither long-term financing nor outcomes-based contracting are good ideas. In January 2019 testimony to the U.S. Senate Committee on Finance, Dr. Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, New York, outlined why both value-based proposals are faulty. Outcomes-based contracting does not guarantee that prices are value based, he said, because it leaves untouched how much a drug costs when it does work. In addition, the long-term financing approach only pushes drug costs into future years, he testified.

A three-tiered approach

Another novel idea would link drug prices to value, but allow costs to change with new information. The proposal would create a three-part pricing model where prices vary over fixed time intervals, according to an article published in the New England Journal of Medicine Catalyst.

First, drugmakers would agree to launch a drug with a low price, with a potentially significant increase after a specified period to observe performance. During a second period, the price would be adjusted up or down based on newly emergent evidence. After a window of higher prices to reward innovation, the cost would then decline in a third period to ensure long-term access.

The advantage is access to truly miraculous therapies in a very short time – from 3 to 5 years earlier than the current system, said Luca Pani, MD, a coauthor of the paper and professor of psychiatry at the University of Miami.

It’s no secret that cancer drugs are among the most expensive medical treatments in the United States, and now, new research reveals some high-priced cancer drugs may yield little benefit for patients.

A recent analysis of 71 oncology indications approved by the Food and Drug Administration between 2011 and 2017 found that overall survival gains were marginal for drugs approved by the FDA based on overall survival (OS) data. The majority of the 71 indications (75%) demonstrated no statistically significant improvement in patient-reported outcomes (PROs), according to the study (JAMA Oncol. 2019 Jul 3 doi: 10.1001/jamaoncol.2019.1760).

More than half of the indications evaluated demonstrated neither an OS benefit nor a PRO improvement post approval, the study found.

While the researchers did not analyze cost, a number of the cancer drugs that demonstrated little benefit come with a high price tag. Cabozantinib (Cabometyx) for example, approved for the treatment of medullary thyroid carcinoma and advanced renal cell carcinoma (RCC) during the study period, did not demonstrate an overall survival benefit post approval, findings showed. Cabometyx, approved based on survival data, had a 2016 wholesale acquisition cost of $13,750 for a 1-month supply. Olaparib (Lynparza) meanwhile, approved for the treatment of advanced ovarian cancer during the study period, also showed no overall survival benefit post approval. The 2017 wholesale acquisition cost for olaparib was $13,482 for a 30-day supply.

Investigators noted in the study that evaluation of OS can be challenging or unfeasible in some instances and is complicated by factors such as use of crossover trial design.

The findings emphasize the need for a sharper eye on how regulatory authorities approve drugs, said Chadi Nabhan, MD, senior author of the study and chief medical officer at Aptitude Health based in Chicago.

Courtesy of Dr. Nabhan

Many drugs show little benefit

The JAMA Oncology study builds on other data that raise doubts about how the FDA determines value when making approval decisions for cancer drugs.

Overall survival is the most direct measure of clinical benefit used to determine value. But OS as an endpoint in clinical trials generally requires larger patient numbers and increased time for follow-up, thereby delaying approvals. This is likely why the use of surrogate endpoints to approve drugs has increased. Dr. Nabhan’s study found the use of surrogate endpoints during trials grew from 67% during the period of 2008 through 2012 to 76% during the period of 2011 through 2017. Surrogate endpoints can include tumor shrinkage, time to progression, or time to reappearance of disease.

The use of surrogate endpoints to determine value however, has long come under scrutiny. A 2019 analysis published in JAMA Internal Medicine found that most cancer drugs approved by the FDA based on response rate (RR) – the percentage of patients who experience tumor shrinkage – have less than transformational response rates, and that such indications do not have confirmed clinical benefit.

Of 59 oncology drugs with 85 unique indications, most had a response rate ranging from 20% to 59%. Of 81 available indications, the median complete response rate – defined as the percentage of patients with no visible disease and normalization of lymph nodes – was 6%. (Complete response data were not reported for four drug indications.) Investigators also reported that many of the drugs have remained on the market for years without subsequent confirmatory data.

In addition, a 2018 review of randomized clinical trials published in JAMA Internal Medicine that analyzed progression-free survival in cancer patients found the endpoint did not improve patients’ lives. A quantitative analysis of 52 articles that covered 38 randomized clinical trials involving 13,979 patients across 12 cancer types found no significant association between progression-free survival and health-related quality of life.

“These findings raise questions regarding the assumption that interventions prolonging [progression-free survival] also improve [health-related quality of life] in patients with cancer,” the study authors wrote. “Therefore, to ensure that patients are truly obtaining important benefit from cancer therapies, clinical trial investigators should measure [health-related quality of life] directly and accurately, ensuring adequate duration and follow-up.

PROs, which can encompass health-related quality of life, is a measure the FDA has encouraged investigators to use during trials – when the benefit exists. In the analysis by Dr. Nabhan, trials evaluated PROs during pivotal studies supporting initial approval in 50 of the 71 indications. Before approval, 14 drugs demonstrated a statistically significant improvement in at least one PRO, but only 1 of the 14 – ruxolitinib – was granted a PRO labeling claim at the time of approval. Post approval, a statistically significant improvement in PROs was shown for only 18 of the 71 (25%) initial indications.

Meanwhile, although overall survival is considered the optimal yardstick with which to measure drug benefit, the value of longevity – and how it should be weighted – poses further questions. A number of new oncology drugs approved based on survival data lengthen lives by a very short time, Dr. Saltz noted. In the study of 71 indications for example, the median OS gain for drugs approved based on survival data was 1.7 months.

“We crossed the absurdity boundary a long time ago with drugs in the range of $10,000 to $20,000 a month with median survival benefits of less than 2 months,” Dr. Saltz said. “That’s not very much. Then we get into a rather circuitous argument that doesn’t settle anything as to whether it’s ‘worth it or not.’ The question becomes to whom is it worth what, and who’s paying for it?”
 

Proposals aim to lower cost

Recent cost ideas that center on value-pricing seek to answer some of those questions. Outcomes-based contracts is one such proposal. Under the approach, a drug manufacturer and a payer reach an agreement that ties reimbursement to observed outcomes in patients. Rather than a payer covering all prescriptions at a single price, the initial price remains in place if a certain volume of patients achieves the agreed-upon outcome. If the threshold is not met, the drugmaker refunds some of the original price to the payer.

Outcomes-based contracting sounds like a promising approach because various parties involved in the sale have a stake in the result, Dr. Nabhan said. “If you are a manufacturer, you want to make sure the outcomes are actually good,” he said. “If you’re a physician, you want to maximize monitoring your patient and managing adverse events. If you are the payer, you want to make sure your patient stays adherent to therapy, and you want to make sure you provide access to the doctor’s office, and to the hospital when needed. There’s more skin in the game when we look at outcomes-based contracting.”

Another idea gaining popularity is long-term financing for some drugs, particularly curative treatments. The idea has various models, but generally entails a financing arrangement, such as a loan mechanism for payers or a contractual annuitization that commits payers to pay costs over time. Such financing proposals are gaining speed in response to the high-cost of new gene therapies, according to a summary in Health Affairs. The payment agreements could be augmented by government funds such as government bonds or subsidies and/or efforts to promote risk-pooling across payers.

Peter B. Bach, MD, however, believes neither long-term financing nor outcomes-based contracting are good ideas. In January 2019 testimony to the U.S. Senate Committee on Finance, Dr. Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, New York, outlined why both value-based proposals are faulty. Outcomes-based contracting does not guarantee that prices are value based, he said, because it leaves untouched how much a drug costs when it does work. In addition, the long-term financing approach only pushes drug costs into future years, he testified.

A three-tiered approach

Another novel idea would link drug prices to value, but allow costs to change with new information. The proposal would create a three-part pricing model where prices vary over fixed time intervals, according to an article published in the New England Journal of Medicine Catalyst.

First, drugmakers would agree to launch a drug with a low price, with a potentially significant increase after a specified period to observe performance. During a second period, the price would be adjusted up or down based on newly emergent evidence. After a window of higher prices to reward innovation, the cost would then decline in a third period to ensure long-term access.

The advantage is access to truly miraculous therapies in a very short time – from 3 to 5 years earlier than the current system, said Luca Pani, MD, a coauthor of the paper and professor of psychiatry at the University of Miami.

It’s no secret that cancer drugs are among the most expensive medical treatments in the United States, and now, new research reveals some high-priced cancer drugs may yield little benefit for patients.

A recent analysis of 71 oncology indications approved by the Food and Drug Administration between 2011 and 2017 found that overall survival gains were marginal for drugs approved by the FDA based on overall survival (OS) data. The majority of the 71 indications (75%) demonstrated no statistically significant improvement in patient-reported outcomes (PROs), according to the study (JAMA Oncol. 2019 Jul 3 doi: 10.1001/jamaoncol.2019.1760).

More than half of the indications evaluated demonstrated neither an OS benefit nor a PRO improvement post approval, the study found.

While the researchers did not analyze cost, a number of the cancer drugs that demonstrated little benefit come with a high price tag. Cabozantinib (Cabometyx) for example, approved for the treatment of medullary thyroid carcinoma and advanced renal cell carcinoma (RCC) during the study period, did not demonstrate an overall survival benefit post approval, findings showed. Cabometyx, approved based on survival data, had a 2016 wholesale acquisition cost of $13,750 for a 1-month supply. Olaparib (Lynparza) meanwhile, approved for the treatment of advanced ovarian cancer during the study period, also showed no overall survival benefit post approval. The 2017 wholesale acquisition cost for olaparib was $13,482 for a 30-day supply.

Investigators noted in the study that evaluation of OS can be challenging or unfeasible in some instances and is complicated by factors such as use of crossover trial design.

The findings emphasize the need for a sharper eye on how regulatory authorities approve drugs, said Chadi Nabhan, MD, senior author of the study and chief medical officer at Aptitude Health based in Chicago.

Courtesy of Dr. Nabhan

Many drugs show little benefit

The JAMA Oncology study builds on other data that raise doubts about how the FDA determines value when making approval decisions for cancer drugs.

Overall survival is the most direct measure of clinical benefit used to determine value. But OS as an endpoint in clinical trials generally requires larger patient numbers and increased time for follow-up, thereby delaying approvals. This is likely why the use of surrogate endpoints to approve drugs has increased. Dr. Nabhan’s study found the use of surrogate endpoints during trials grew from 67% during the period of 2008 through 2012 to 76% during the period of 2011 through 2017. Surrogate endpoints can include tumor shrinkage, time to progression, or time to reappearance of disease.

The use of surrogate endpoints to determine value however, has long come under scrutiny. A 2019 analysis published in JAMA Internal Medicine found that most cancer drugs approved by the FDA based on response rate (RR) – the percentage of patients who experience tumor shrinkage – have less than transformational response rates, and that such indications do not have confirmed clinical benefit.

Of 59 oncology drugs with 85 unique indications, most had a response rate ranging from 20% to 59%. Of 81 available indications, the median complete response rate – defined as the percentage of patients with no visible disease and normalization of lymph nodes – was 6%. (Complete response data were not reported for four drug indications.) Investigators also reported that many of the drugs have remained on the market for years without subsequent confirmatory data.

In addition, a 2018 review of randomized clinical trials published in JAMA Internal Medicine that analyzed progression-free survival in cancer patients found the endpoint did not improve patients’ lives. A quantitative analysis of 52 articles that covered 38 randomized clinical trials involving 13,979 patients across 12 cancer types found no significant association between progression-free survival and health-related quality of life.

“These findings raise questions regarding the assumption that interventions prolonging [progression-free survival] also improve [health-related quality of life] in patients with cancer,” the study authors wrote. “Therefore, to ensure that patients are truly obtaining important benefit from cancer therapies, clinical trial investigators should measure [health-related quality of life] directly and accurately, ensuring adequate duration and follow-up.

PROs, which can encompass health-related quality of life, is a measure the FDA has encouraged investigators to use during trials – when the benefit exists. In the analysis by Dr. Nabhan, trials evaluated PROs during pivotal studies supporting initial approval in 50 of the 71 indications. Before approval, 14 drugs demonstrated a statistically significant improvement in at least one PRO, but only 1 of the 14 – ruxolitinib – was granted a PRO labeling claim at the time of approval. Post approval, a statistically significant improvement in PROs was shown for only 18 of the 71 (25%) initial indications.

Meanwhile, although overall survival is considered the optimal yardstick with which to measure drug benefit, the value of longevity – and how it should be weighted – poses further questions. A number of new oncology drugs approved based on survival data lengthen lives by a very short time, Dr. Saltz noted. In the study of 71 indications for example, the median OS gain for drugs approved based on survival data was 1.7 months.

“We crossed the absurdity boundary a long time ago with drugs in the range of $10,000 to $20,000 a month with median survival benefits of less than 2 months,” Dr. Saltz said. “That’s not very much. Then we get into a rather circuitous argument that doesn’t settle anything as to whether it’s ‘worth it or not.’ The question becomes to whom is it worth what, and who’s paying for it?”
 

Proposals aim to lower cost

Recent cost ideas that center on value-pricing seek to answer some of those questions. Outcomes-based contracts is one such proposal. Under the approach, a drug manufacturer and a payer reach an agreement that ties reimbursement to observed outcomes in patients. Rather than a payer covering all prescriptions at a single price, the initial price remains in place if a certain volume of patients achieves the agreed-upon outcome. If the threshold is not met, the drugmaker refunds some of the original price to the payer.

Outcomes-based contracting sounds like a promising approach because various parties involved in the sale have a stake in the result, Dr. Nabhan said. “If you are a manufacturer, you want to make sure the outcomes are actually good,” he said. “If you’re a physician, you want to maximize monitoring your patient and managing adverse events. If you are the payer, you want to make sure your patient stays adherent to therapy, and you want to make sure you provide access to the doctor’s office, and to the hospital when needed. There’s more skin in the game when we look at outcomes-based contracting.”

Another idea gaining popularity is long-term financing for some drugs, particularly curative treatments. The idea has various models, but generally entails a financing arrangement, such as a loan mechanism for payers or a contractual annuitization that commits payers to pay costs over time. Such financing proposals are gaining speed in response to the high-cost of new gene therapies, according to a summary in Health Affairs. The payment agreements could be augmented by government funds such as government bonds or subsidies and/or efforts to promote risk-pooling across payers.

Peter B. Bach, MD, however, believes neither long-term financing nor outcomes-based contracting are good ideas. In January 2019 testimony to the U.S. Senate Committee on Finance, Dr. Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, New York, outlined why both value-based proposals are faulty. Outcomes-based contracting does not guarantee that prices are value based, he said, because it leaves untouched how much a drug costs when it does work. In addition, the long-term financing approach only pushes drug costs into future years, he testified.

A three-tiered approach

Another novel idea would link drug prices to value, but allow costs to change with new information. The proposal would create a three-part pricing model where prices vary over fixed time intervals, according to an article published in the New England Journal of Medicine Catalyst.

First, drugmakers would agree to launch a drug with a low price, with a potentially significant increase after a specified period to observe performance. During a second period, the price would be adjusted up or down based on newly emergent evidence. After a window of higher prices to reward innovation, the cost would then decline in a third period to ensure long-term access.

The advantage is access to truly miraculous therapies in a very short time – from 3 to 5 years earlier than the current system, said Luca Pani, MD, a coauthor of the paper and professor of psychiatry at the University of Miami.

A significant number of physicians who author practice guidelines are not reporting financial conflicts of interest, a study finds.

Lead author Ramy R. Saleh, MD, of the University of Toronto, and colleagues searched The American Society of Clinical Oncology (ASCO) website to identify all clinical practice guidelines (CPGs) for systemic therapy published between August 2013 and June 2018. Investigators analyzed self-reported author financial conflicts of interest and funding sources and also reviewed The Open Payments database to identify compensation to guideline authors. Researchers categorized conflicts of interest into two groups: research funding (which could include departmental and/or hospital funding) and nonresearch payments (including travel expenses, honoraria, employment, and stock ownership to the individual author).

The initial search identified 121 CPGs published by ASCO between August 2013 and August 2018 of which 26 guidelines were selected because of their focus on systemic treatment. Findings showed that 239 guideline authors who were not exempt from reporting received industry payments, but only 184 (77%) disclosed these payments, according to the study in Cancer. The mean total of all undisclosed payments from 2013 to 2017 received by CPG authors was $187,503 and the median was $30,500. Of the 55 authors with undisclosed conflicts of interest, 34 authors (62%) received more than $1,000 of nonresearch funding, and 19 authors (35%) received more than $5,000 per calendar year.

The majority of the authors with undisclosed conflicts were medical oncologists, the investigators found. Radiation oncologists and surgeons had similar proportions of undisclosed financial conflicts.

The researchers concluded that financial conflicts of interest among authors of ASCO guidelines are common and are not disclosed in a substantial number of cases. The findings indicate that current self-disclosure practices are not adequate for accurately reporting conflicts, they noted.

“Improved transparency of [financial conflicts of interest should become standard practice among CPG authors,” the investigators wrote. “Professional societies and journal editors need to create a mechanism to verify self-reported [financial conflicts of interest].”

Source: Saleh et. al. 2019 July 29 doi: 10.1002/cncr.32408.

A significant number of physicians who author practice guidelines are not reporting financial conflicts of interest, a study finds.

Lead author Ramy R. Saleh, MD, of the University of Toronto, and colleagues searched The American Society of Clinical Oncology (ASCO) website to identify all clinical practice guidelines (CPGs) for systemic therapy published between August 2013 and June 2018. Investigators analyzed self-reported author financial conflicts of interest and funding sources and also reviewed The Open Payments database to identify compensation to guideline authors. Researchers categorized conflicts of interest into two groups: research funding (which could include departmental and/or hospital funding) and nonresearch payments (including travel expenses, honoraria, employment, and stock ownership to the individual author).

The initial search identified 121 CPGs published by ASCO between August 2013 and August 2018 of which 26 guidelines were selected because of their focus on systemic treatment. Findings showed that 239 guideline authors who were not exempt from reporting received industry payments, but only 184 (77%) disclosed these payments, according to the study in Cancer. The mean total of all undisclosed payments from 2013 to 2017 received by CPG authors was $187,503 and the median was $30,500. Of the 55 authors with undisclosed conflicts of interest, 34 authors (62%) received more than $1,000 of nonresearch funding, and 19 authors (35%) received more than $5,000 per calendar year.

The majority of the authors with undisclosed conflicts were medical oncologists, the investigators found. Radiation oncologists and surgeons had similar proportions of undisclosed financial conflicts.

The researchers concluded that financial conflicts of interest among authors of ASCO guidelines are common and are not disclosed in a substantial number of cases. The findings indicate that current self-disclosure practices are not adequate for accurately reporting conflicts, they noted.

“Improved transparency of [financial conflicts of interest should become standard practice among CPG authors,” the investigators wrote. “Professional societies and journal editors need to create a mechanism to verify self-reported [financial conflicts of interest].”

Source: Saleh et. al. 2019 July 29 doi: 10.1002/cncr.32408.

A significant number of physicians who author practice guidelines are not reporting financial conflicts of interest, a study finds.

Lead author Ramy R. Saleh, MD, of the University of Toronto, and colleagues searched The American Society of Clinical Oncology (ASCO) website to identify all clinical practice guidelines (CPGs) for systemic therapy published between August 2013 and June 2018. Investigators analyzed self-reported author financial conflicts of interest and funding sources and also reviewed The Open Payments database to identify compensation to guideline authors. Researchers categorized conflicts of interest into two groups: research funding (which could include departmental and/or hospital funding) and nonresearch payments (including travel expenses, honoraria, employment, and stock ownership to the individual author).

The initial search identified 121 CPGs published by ASCO between August 2013 and August 2018 of which 26 guidelines were selected because of their focus on systemic treatment. Findings showed that 239 guideline authors who were not exempt from reporting received industry payments, but only 184 (77%) disclosed these payments, according to the study in Cancer. The mean total of all undisclosed payments from 2013 to 2017 received by CPG authors was $187,503 and the median was $30,500. Of the 55 authors with undisclosed conflicts of interest, 34 authors (62%) received more than $1,000 of nonresearch funding, and 19 authors (35%) received more than $5,000 per calendar year.

The majority of the authors with undisclosed conflicts were medical oncologists, the investigators found. Radiation oncologists and surgeons had similar proportions of undisclosed financial conflicts.

The researchers concluded that financial conflicts of interest among authors of ASCO guidelines are common and are not disclosed in a substantial number of cases. The findings indicate that current self-disclosure practices are not adequate for accurately reporting conflicts, they noted.

“Improved transparency of [financial conflicts of interest should become standard practice among CPG authors,” the investigators wrote. “Professional societies and journal editors need to create a mechanism to verify self-reported [financial conflicts of interest].”

Source: Saleh et. al. 2019 July 29 doi: 10.1002/cncr.32408.

Officials at the U.S. Department of Health and Human Services have announced a new plan that they say would lay the foundation for safe importation of certain medications, with the aim of expanding drug access and lowering prescription costs for patients.

Jan Mika/iStockphoto

The action plan, unveiled July 31, outlines two pathways for drug importation from foreign markets. The first route would authorize states, wholesalers, or pharmacists to propose pilot demonstrations on how they would import drugs from Canada into the United States, provided these are versions of drugs already approved by the Food and Drug Administration. Similarly, a second pathway would allow manufacturers that sell in foreign countries the opportunity to import drugs that are versions of FDA-approved medications.

HHS Secretary Alex M. Azar II said the action plan is part of President Trump’s drug-pricing blueprint and is intended to combat the sky-high price tags on many prescription medications.

“President Trump has been clear: For too long American patients have been paying exorbitantly high prices for prescription drugs that are made available to other countries at lower prices,” Mr. Azar said in a statement. “[The] announcement outlines the pathways the administration intends to explore to allow safe importation of certain prescription drugs to lower prices and reduce out of pocket costs for American patients. This is the next important step in the administration’s work to end foreign freeloading and put American patients first.”

Wikimedia Commons/WWsgConnect/CC-SA 4.0

Under the first pathway, HHS would review plans submitted by states, pharmacists, or drugmakers that outline how the entities would import Health Canada–approved drugs that are in compliance with the federal Food, Drug, and Cosmetic Act. The importation would occur in a manner that assures the drug’s validity and meets the cost requirements of federal rule making, according to an HHS fact sheet.

Demonstration projects would be time-limited and require regular reporting to ensure safety and cost conditions are being met.

Under the second pathway, manufacturers of FDA-approved drug products would be able to import versions of those drugs that they sell in foreign countries through a special process to be outlined by the agency. As part of the process, drugmakers would need to establish that the foreign version is the same as the U.S. version. The FDA would then allow the drug to be labeled for sale in the U.S. and imported, according to the fact sheet. HHS officials said they believe that manufacturers would use this pathway to offer U.S. patients lower-cost versions of their drugs and the medications affected could potentially include those used to treat diabetes, rheumatoid arthritis, cardiovascular disorders, and cancer.

“In recent years, multiple manufacturers have stated (either publicly or in statements to the Administration) that they wanted to offer lower cost versions but could not readily do so because they were locked into contracts with other parties in the supply chain,” HHS officials stated in the fact sheet. “This pathway would highlight an opportunity for manufacturers to use importation to offer lower-cost versions of their drugs.”

HHS plans to introduce its action plan through a formal notice of proposed rulemaking, which has not yet been finalized. Some elements of the final proposal may differ from its initial descriptions to reflect further consideration of the relevant issues, the agency noted.

Acting FDA Commissioner Ned Sharpless, MD, said the agency has a unique role to play in promoting competition that can help reduce drug prices and improve access to medicine for Americans.

“Driving down drug prices requires a comprehensive approach and we must continue to look at all innovative solutions to this challenge,” Dr. Sharpless said in a statement. “[The] proposal is the result of the hard work by the dedicated staff of the FDA, in close collaboration with HHS and the White House, to identify potential pathways we can pursue to support the safe importation of certain prescription drugs.”

Sen. Lamar Alexander (R-Tenn.), chair of the Health, Education, Labor and Pensions committee, said the administration’s proposal sounds promising as long as the plan ensures the safety and efficacy of imported medications.

“This is the first administration to take concrete steps to allow importation of prescription drugs to reduce their cost and I welcome it,” Sen. Alexander said in a statement. “The key for me is whether this plan preserves the Food and Drug Administration’s gold standard for safety and effectiveness. Millions of Americans every day buy prescription drugs relying on the FDA’s guarantee of quality.”

agallegos@mdedge.com

Officials at the U.S. Department of Health and Human Services have announced a new plan that they say would lay the foundation for safe importation of certain medications, with the aim of expanding drug access and lowering prescription costs for patients.

Jan Mika/iStockphoto

The action plan, unveiled July 31, outlines two pathways for drug importation from foreign markets. The first route would authorize states, wholesalers, or pharmacists to propose pilot demonstrations on how they would import drugs from Canada into the United States, provided these are versions of drugs already approved by the Food and Drug Administration. Similarly, a second pathway would allow manufacturers that sell in foreign countries the opportunity to import drugs that are versions of FDA-approved medications.

HHS Secretary Alex M. Azar II said the action plan is part of President Trump’s drug-pricing blueprint and is intended to combat the sky-high price tags on many prescription medications.

“President Trump has been clear: For too long American patients have been paying exorbitantly high prices for prescription drugs that are made available to other countries at lower prices,” Mr. Azar said in a statement. “[The] announcement outlines the pathways the administration intends to explore to allow safe importation of certain prescription drugs to lower prices and reduce out of pocket costs for American patients. This is the next important step in the administration’s work to end foreign freeloading and put American patients first.”

Wikimedia Commons/WWsgConnect/CC-SA 4.0

Under the first pathway, HHS would review plans submitted by states, pharmacists, or drugmakers that outline how the entities would import Health Canada–approved drugs that are in compliance with the federal Food, Drug, and Cosmetic Act. The importation would occur in a manner that assures the drug’s validity and meets the cost requirements of federal rule making, according to an HHS fact sheet.

Demonstration projects would be time-limited and require regular reporting to ensure safety and cost conditions are being met.

Under the second pathway, manufacturers of FDA-approved drug products would be able to import versions of those drugs that they sell in foreign countries through a special process to be outlined by the agency. As part of the process, drugmakers would need to establish that the foreign version is the same as the U.S. version. The FDA would then allow the drug to be labeled for sale in the U.S. and imported, according to the fact sheet. HHS officials said they believe that manufacturers would use this pathway to offer U.S. patients lower-cost versions of their drugs and the medications affected could potentially include those used to treat diabetes, rheumatoid arthritis, cardiovascular disorders, and cancer.

“In recent years, multiple manufacturers have stated (either publicly or in statements to the Administration) that they wanted to offer lower cost versions but could not readily do so because they were locked into contracts with other parties in the supply chain,” HHS officials stated in the fact sheet. “This pathway would highlight an opportunity for manufacturers to use importation to offer lower-cost versions of their drugs.”

HHS plans to introduce its action plan through a formal notice of proposed rulemaking, which has not yet been finalized. Some elements of the final proposal may differ from its initial descriptions to reflect further consideration of the relevant issues, the agency noted.

Acting FDA Commissioner Ned Sharpless, MD, said the agency has a unique role to play in promoting competition that can help reduce drug prices and improve access to medicine for Americans.

“Driving down drug prices requires a comprehensive approach and we must continue to look at all innovative solutions to this challenge,” Dr. Sharpless said in a statement. “[The] proposal is the result of the hard work by the dedicated staff of the FDA, in close collaboration with HHS and the White House, to identify potential pathways we can pursue to support the safe importation of certain prescription drugs.”

Sen. Lamar Alexander (R-Tenn.), chair of the Health, Education, Labor and Pensions committee, said the administration’s proposal sounds promising as long as the plan ensures the safety and efficacy of imported medications.

“This is the first administration to take concrete steps to allow importation of prescription drugs to reduce their cost and I welcome it,” Sen. Alexander said in a statement. “The key for me is whether this plan preserves the Food and Drug Administration’s gold standard for safety and effectiveness. Millions of Americans every day buy prescription drugs relying on the FDA’s guarantee of quality.”

agallegos@mdedge.com

Officials at the U.S. Department of Health and Human Services have announced a new plan that they say would lay the foundation for safe importation of certain medications, with the aim of expanding drug access and lowering prescription costs for patients.

Jan Mika/iStockphoto

The action plan, unveiled July 31, outlines two pathways for drug importation from foreign markets. The first route would authorize states, wholesalers, or pharmacists to propose pilot demonstrations on how they would import drugs from Canada into the United States, provided these are versions of drugs already approved by the Food and Drug Administration. Similarly, a second pathway would allow manufacturers that sell in foreign countries the opportunity to import drugs that are versions of FDA-approved medications.

HHS Secretary Alex M. Azar II said the action plan is part of President Trump’s drug-pricing blueprint and is intended to combat the sky-high price tags on many prescription medications.

“President Trump has been clear: For too long American patients have been paying exorbitantly high prices for prescription drugs that are made available to other countries at lower prices,” Mr. Azar said in a statement. “[The] announcement outlines the pathways the administration intends to explore to allow safe importation of certain prescription drugs to lower prices and reduce out of pocket costs for American patients. This is the next important step in the administration’s work to end foreign freeloading and put American patients first.”

Wikimedia Commons/WWsgConnect/CC-SA 4.0

Under the first pathway, HHS would review plans submitted by states, pharmacists, or drugmakers that outline how the entities would import Health Canada–approved drugs that are in compliance with the federal Food, Drug, and Cosmetic Act. The importation would occur in a manner that assures the drug’s validity and meets the cost requirements of federal rule making, according to an HHS fact sheet.

Demonstration projects would be time-limited and require regular reporting to ensure safety and cost conditions are being met.

Under the second pathway, manufacturers of FDA-approved drug products would be able to import versions of those drugs that they sell in foreign countries through a special process to be outlined by the agency. As part of the process, drugmakers would need to establish that the foreign version is the same as the U.S. version. The FDA would then allow the drug to be labeled for sale in the U.S. and imported, according to the fact sheet. HHS officials said they believe that manufacturers would use this pathway to offer U.S. patients lower-cost versions of their drugs and the medications affected could potentially include those used to treat diabetes, rheumatoid arthritis, cardiovascular disorders, and cancer.

“In recent years, multiple manufacturers have stated (either publicly or in statements to the Administration) that they wanted to offer lower cost versions but could not readily do so because they were locked into contracts with other parties in the supply chain,” HHS officials stated in the fact sheet. “This pathway would highlight an opportunity for manufacturers to use importation to offer lower-cost versions of their drugs.”

HHS plans to introduce its action plan through a formal notice of proposed rulemaking, which has not yet been finalized. Some elements of the final proposal may differ from its initial descriptions to reflect further consideration of the relevant issues, the agency noted.

Acting FDA Commissioner Ned Sharpless, MD, said the agency has a unique role to play in promoting competition that can help reduce drug prices and improve access to medicine for Americans.

“Driving down drug prices requires a comprehensive approach and we must continue to look at all innovative solutions to this challenge,” Dr. Sharpless said in a statement. “[The] proposal is the result of the hard work by the dedicated staff of the FDA, in close collaboration with HHS and the White House, to identify potential pathways we can pursue to support the safe importation of certain prescription drugs.”

Sen. Lamar Alexander (R-Tenn.), chair of the Health, Education, Labor and Pensions committee, said the administration’s proposal sounds promising as long as the plan ensures the safety and efficacy of imported medications.

“This is the first administration to take concrete steps to allow importation of prescription drugs to reduce their cost and I welcome it,” Sen. Alexander said in a statement. “The key for me is whether this plan preserves the Food and Drug Administration’s gold standard for safety and effectiveness. Millions of Americans every day buy prescription drugs relying on the FDA’s guarantee of quality.”

agallegos@mdedge.com

At Actify Neurotherapies, a longtime provider of ketamine infusion therapy, Steven P. Levine, MD, and staff are busy making preparations for a new offering: intranasal esketamine.

Provided by Actify Neurotherapies

The nasal spray, called Spravato and developed by Janssen Pharmaceuticals, was approved by the Food and Drug Administration in March 2019 for treatment-resistant depression in adults who have failed at least two oral antidepressants of different classes.

“We’ve been anticipating this for years,” said Dr. Levine, founder and chief medical officer for Actify Neurotherapies, formerly Ketamine Treatment Centers.“Being used to giving IV ketamine every day, this really fits right into our daily practice. For us, [it means] adding a few staff members here and there to make sure we have adequate monitoring, [and] setting up recovery spaces so that patients have a nice place to spend time.”

Dr. Levine is far from alone. After the recent intranasal esketamine approval, many psychiatrists are considering how they might integrate the medication into their practice. The FDA is managing the drug under a Risk Evaluation and Mitigation Strategy (REMS) program, which requires prescriber training on esketamine risks and patient monitoring. Facilities must be licensed to dispense esketamine and are required to monitor patients in person for at least 2 hours after administration.

The rigid requirements are important for safety, but they mean that a limited number of psychiatrists will likely have the capacity to deliver the medication, said Gerard Sanacora, MD, PhD, director of the Yale Depression Research Program in New Haven, Conn., and a principal investigator for several clinical trials associated with the esketamine nasal spray. Psychiatrists interested in providing the medication have much to consider in the way of logistics, structure, and staffing.

“The requirements do [present] hurdles,” Dr. Sanacora said. “This is a medication that requires a fair amount of infrastructure. This is not going to be a treatment that is going to be given by every corner psychiatrist.”

In addition to delivery obstacles, questions remain about the ideal Spravato regimen, particularly the optimal dose frequency during maintenance and the best way to track long-term outcomes. Some have also raised concerns about the potential for esketamine/ketamine abuse following the FDA approval.

Despite the questions, one thing most psychiatrists agree on is the need for intranasal esketamine and its promising impact.

“There’s no secret that at this point: We really haven’t put a dent in the rates of depression and the rates of suicide over the past several decades,” Dr. Levine said. “We’ve needed something that’s truly new, something that’s innovative. It makes the FDA approval of intranasal esketamine a really big deal. It’s a new mechanism, a new approach to depression, and provides hope to patients and the field of psychiatry.”

Addressing delivery challenges

After the FDA approval, Jacqueline Posada, MD, was tasked with helping a small psychiatry practice develop the framework to incorporate intranasal esketamine. Dr. Posada, a consultation-liaison psychiatry fellow at the Inova Fairfax Hospital-George Washington University program in Falls Church, Va., started by creating a comprehensive screening form for esketamine candidates, developing an informed-consent protocol, and researching storage guidelines for an outpatient practice.

Before the practice could move forward, however, Dr. Posada learned that building regulations for the office prohibited “medical procedures” from occurring in the space. While the 10-doctor practice is associated with George Washington University, Washington, it is located several blocks away in an office setting.

“It was pretty disappointing,” Dr. Posada said. “Our organization is looking for another spot that allows psychiatry to administer a medical procedure. There’s a lot of people who are in private practice who are in a type of office building that may restrict medical procedures. Depending on the type of space they are renting, they need to know what is allowed in their office building.”

Patient privacy is also a primary consideration when delivering the medication. Dr. Posada said she and her staff had contemplated conducting the 2-hour patient monitoring in a group setting, but that idea was quickly thwarted.

“Our plan was in 15- to 20-minute appointments, administer the esketamine, and have maybe 5-10 people monitored in a room with barriers between each chair,” she said. “We were advised by our privacy officer that that could hinder patient confidentiality and was not a viable option for administering the medication in our practice.”

Practices should also determine a long-term treatment plan for each patient receiving esketamine, Dr. Sanacora said, particularly in light of data suggesting that a substantial number of patients will relapse if treatment is stopped. A long-term treatment plan should be considered prior to, or at the same time that esketamine treatment is initiated.

Comanagement of patients by clinicians is another essential part of esketamine treatment, Dr. Sanacora added.

“It is going to be important for the community clinicians not directly offering the treatment to develop close and ongoing relationships with the clinicians and sites that are offering this treatment to optimize the care of their patients,” he said. “Conversely, it is going to be imperative that the esketamine providers develop effective and efficient methods of maintaining close communications with the referring clinicians.”

Reimbursement comes with upfront cost

As far as payment, Dr. Levine expects that the nasal spray will be widely reimbursed. Clinics must first purchase the medication and insurers will reimburse them later for the drug, a method commonly referred to as “buy and bill.” The upfront cost could be too expensive for some physicians.

“That’s not something psychiatrists are used to, storing a controlled substance on site, having the financial outlay of keeping inventory of an expensive drug, and waiting for reimbursement,” Dr. Levine said.

Practices can also bill an evaluation and management code for the treatment as well as for observation time. At this point, it appears insurers will not cover psychotherapy delivered at the same time, which is disappointing, he said.

Sanjay J. Mathew, MD, a psychiatry professor and vice chair for research at Baylor College of Medicine, Houston, said because many psychiatrists who specialize in psychopharmacology and who see treatment-resistant depression patients do not accept private insurance or Medicare/Medicaid, patient access to the drug may be limited.

“Given the REMS and the need for 2-hour monitoring following the treatment, I believe that primarily, specialized clinics and centers for ‘interventional psychiatry’ will be the early adopters,” he said. “The typical office-based psychiatrist who does not accept insurance, and does not have means to store and dispense a controlled substance or monitor patients, may not readily adopt this new approach.”

Experts say abuse potential low

Meanwhile, the potential for abuse with intranasal esketamine is low, considering the REMS requirements, said Mark S. Gold, MD, an addiction medicine specialist. If practices follow the guidelines, which restrict patients from taking the medication home, misuse is not likely.

However, the drug’s counterpart, ketamine, which has been abused globally for decades, may see an uptick in illicit use after the recent FDA approval of esketamine, Dr. Gold said. Ketamine is currently produced in clandestine labs for use on the club scene and for date rape purposes, Dr. Gold said. Most recently, ketamine has been mixed with cocaine and referred to as “Calvin Klein” for street use.

“You do have the unintended consequence when a medication is approved, [that] the general public may not be sophisticated enough to understand dose, duration, and supervised administration, and think that street ketamine is equally a medication,” Dr. Gold said. “You have the capacity for black market ketamine to undercut the price and be distributed in a form that can be extremely dangerous and life threatening. Just calling it ketamine provides confusion and the opportunity for black market sales distribution and increases in use.”

Dr. Mathew hopes the REMS designation will not only aid in risk mitigation for esketamine, but also result in valuable postapproval information with respect to longer term safety and efficacy. Questions that still need to be addressed include the best antidepressant regimens in conjunction with intranasal esketamine, the ideal long-term monitoring method, and the potential impact of benzodiazepines on response to Spravato.

“These answers will come with more research – phase 4 postmarketing studies – and also clinical experience in the community, as clinicians begin to prescribe esketamine,” Dr. Mathew said. “Input from organizations, such as the American Society of Ketamine Physicians, will be important as well.”

Dr. Levine, Dr. Posada, and Dr. Gold reported no disclosures. Dr. Sanacora served as principal investigator for several clinical trials associated with intranasal esketamine. Dr. Mathew served as a consultant to several pharmaceutical companies, including Janssen.

agallegos@mdedge.com

At Actify Neurotherapies, a longtime provider of ketamine infusion therapy, Steven P. Levine, MD, and staff are busy making preparations for a new offering: intranasal esketamine.

Provided by Actify Neurotherapies

The nasal spray, called Spravato and developed by Janssen Pharmaceuticals, was approved by the Food and Drug Administration in March 2019 for treatment-resistant depression in adults who have failed at least two oral antidepressants of different classes.

“We’ve been anticipating this for years,” said Dr. Levine, founder and chief medical officer for Actify Neurotherapies, formerly Ketamine Treatment Centers.“Being used to giving IV ketamine every day, this really fits right into our daily practice. For us, [it means] adding a few staff members here and there to make sure we have adequate monitoring, [and] setting up recovery spaces so that patients have a nice place to spend time.”

Dr. Levine is far from alone. After the recent intranasal esketamine approval, many psychiatrists are considering how they might integrate the medication into their practice. The FDA is managing the drug under a Risk Evaluation and Mitigation Strategy (REMS) program, which requires prescriber training on esketamine risks and patient monitoring. Facilities must be licensed to dispense esketamine and are required to monitor patients in person for at least 2 hours after administration.

The rigid requirements are important for safety, but they mean that a limited number of psychiatrists will likely have the capacity to deliver the medication, said Gerard Sanacora, MD, PhD, director of the Yale Depression Research Program in New Haven, Conn., and a principal investigator for several clinical trials associated with the esketamine nasal spray. Psychiatrists interested in providing the medication have much to consider in the way of logistics, structure, and staffing.

“The requirements do [present] hurdles,” Dr. Sanacora said. “This is a medication that requires a fair amount of infrastructure. This is not going to be a treatment that is going to be given by every corner psychiatrist.”

In addition to delivery obstacles, questions remain about the ideal Spravato regimen, particularly the optimal dose frequency during maintenance and the best way to track long-term outcomes. Some have also raised concerns about the potential for esketamine/ketamine abuse following the FDA approval.

Despite the questions, one thing most psychiatrists agree on is the need for intranasal esketamine and its promising impact.

“There’s no secret that at this point: We really haven’t put a dent in the rates of depression and the rates of suicide over the past several decades,” Dr. Levine said. “We’ve needed something that’s truly new, something that’s innovative. It makes the FDA approval of intranasal esketamine a really big deal. It’s a new mechanism, a new approach to depression, and provides hope to patients and the field of psychiatry.”

Addressing delivery challenges

After the FDA approval, Jacqueline Posada, MD, was tasked with helping a small psychiatry practice develop the framework to incorporate intranasal esketamine. Dr. Posada, a consultation-liaison psychiatry fellow at the Inova Fairfax Hospital-George Washington University program in Falls Church, Va., started by creating a comprehensive screening form for esketamine candidates, developing an informed-consent protocol, and researching storage guidelines for an outpatient practice.

Before the practice could move forward, however, Dr. Posada learned that building regulations for the office prohibited “medical procedures” from occurring in the space. While the 10-doctor practice is associated with George Washington University, Washington, it is located several blocks away in an office setting.

“It was pretty disappointing,” Dr. Posada said. “Our organization is looking for another spot that allows psychiatry to administer a medical procedure. There’s a lot of people who are in private practice who are in a type of office building that may restrict medical procedures. Depending on the type of space they are renting, they need to know what is allowed in their office building.”

Patient privacy is also a primary consideration when delivering the medication. Dr. Posada said she and her staff had contemplated conducting the 2-hour patient monitoring in a group setting, but that idea was quickly thwarted.

“Our plan was in 15- to 20-minute appointments, administer the esketamine, and have maybe 5-10 people monitored in a room with barriers between each chair,” she said. “We were advised by our privacy officer that that could hinder patient confidentiality and was not a viable option for administering the medication in our practice.”

Practices should also determine a long-term treatment plan for each patient receiving esketamine, Dr. Sanacora said, particularly in light of data suggesting that a substantial number of patients will relapse if treatment is stopped. A long-term treatment plan should be considered prior to, or at the same time that esketamine treatment is initiated.

Comanagement of patients by clinicians is another essential part of esketamine treatment, Dr. Sanacora added.

“It is going to be important for the community clinicians not directly offering the treatment to develop close and ongoing relationships with the clinicians and sites that are offering this treatment to optimize the care of their patients,” he said. “Conversely, it is going to be imperative that the esketamine providers develop effective and efficient methods of maintaining close communications with the referring clinicians.”

Reimbursement comes with upfront cost

As far as payment, Dr. Levine expects that the nasal spray will be widely reimbursed. Clinics must first purchase the medication and insurers will reimburse them later for the drug, a method commonly referred to as “buy and bill.” The upfront cost could be too expensive for some physicians.

“That’s not something psychiatrists are used to, storing a controlled substance on site, having the financial outlay of keeping inventory of an expensive drug, and waiting for reimbursement,” Dr. Levine said.

Practices can also bill an evaluation and management code for the treatment as well as for observation time. At this point, it appears insurers will not cover psychotherapy delivered at the same time, which is disappointing, he said.

Sanjay J. Mathew, MD, a psychiatry professor and vice chair for research at Baylor College of Medicine, Houston, said because many psychiatrists who specialize in psychopharmacology and who see treatment-resistant depression patients do not accept private insurance or Medicare/Medicaid, patient access to the drug may be limited.

“Given the REMS and the need for 2-hour monitoring following the treatment, I believe that primarily, specialized clinics and centers for ‘interventional psychiatry’ will be the early adopters,” he said. “The typical office-based psychiatrist who does not accept insurance, and does not have means to store and dispense a controlled substance or monitor patients, may not readily adopt this new approach.”

Experts say abuse potential low

Meanwhile, the potential for abuse with intranasal esketamine is low, considering the REMS requirements, said Mark S. Gold, MD, an addiction medicine specialist. If practices follow the guidelines, which restrict patients from taking the medication home, misuse is not likely.

However, the drug’s counterpart, ketamine, which has been abused globally for decades, may see an uptick in illicit use after the recent FDA approval of esketamine, Dr. Gold said. Ketamine is currently produced in clandestine labs for use on the club scene and for date rape purposes, Dr. Gold said. Most recently, ketamine has been mixed with cocaine and referred to as “Calvin Klein” for street use.

“You do have the unintended consequence when a medication is approved, [that] the general public may not be sophisticated enough to understand dose, duration, and supervised administration, and think that street ketamine is equally a medication,” Dr. Gold said. “You have the capacity for black market ketamine to undercut the price and be distributed in a form that can be extremely dangerous and life threatening. Just calling it ketamine provides confusion and the opportunity for black market sales distribution and increases in use.”

Dr. Mathew hopes the REMS designation will not only aid in risk mitigation for esketamine, but also result in valuable postapproval information with respect to longer term safety and efficacy. Questions that still need to be addressed include the best antidepressant regimens in conjunction with intranasal esketamine, the ideal long-term monitoring method, and the potential impact of benzodiazepines on response to Spravato.

“These answers will come with more research – phase 4 postmarketing studies – and also clinical experience in the community, as clinicians begin to prescribe esketamine,” Dr. Mathew said. “Input from organizations, such as the American Society of Ketamine Physicians, will be important as well.”

Dr. Levine, Dr. Posada, and Dr. Gold reported no disclosures. Dr. Sanacora served as principal investigator for several clinical trials associated with intranasal esketamine. Dr. Mathew served as a consultant to several pharmaceutical companies, including Janssen.

agallegos@mdedge.com

At Actify Neurotherapies, a longtime provider of ketamine infusion therapy, Steven P. Levine, MD, and staff are busy making preparations for a new offering: intranasal esketamine.

Provided by Actify Neurotherapies

The nasal spray, called Spravato and developed by Janssen Pharmaceuticals, was approved by the Food and Drug Administration in March 2019 for treatment-resistant depression in adults who have failed at least two oral antidepressants of different classes.

“We’ve been anticipating this for years,” said Dr. Levine, founder and chief medical officer for Actify Neurotherapies, formerly Ketamine Treatment Centers.“Being used to giving IV ketamine every day, this really fits right into our daily practice. For us, [it means] adding a few staff members here and there to make sure we have adequate monitoring, [and] setting up recovery spaces so that patients have a nice place to spend time.”

Dr. Levine is far from alone. After the recent intranasal esketamine approval, many psychiatrists are considering how they might integrate the medication into their practice. The FDA is managing the drug under a Risk Evaluation and Mitigation Strategy (REMS) program, which requires prescriber training on esketamine risks and patient monitoring. Facilities must be licensed to dispense esketamine and are required to monitor patients in person for at least 2 hours after administration.

The rigid requirements are important for safety, but they mean that a limited number of psychiatrists will likely have the capacity to deliver the medication, said Gerard Sanacora, MD, PhD, director of the Yale Depression Research Program in New Haven, Conn., and a principal investigator for several clinical trials associated with the esketamine nasal spray. Psychiatrists interested in providing the medication have much to consider in the way of logistics, structure, and staffing.

“The requirements do [present] hurdles,” Dr. Sanacora said. “This is a medication that requires a fair amount of infrastructure. This is not going to be a treatment that is going to be given by every corner psychiatrist.”

In addition to delivery obstacles, questions remain about the ideal Spravato regimen, particularly the optimal dose frequency during maintenance and the best way to track long-term outcomes. Some have also raised concerns about the potential for esketamine/ketamine abuse following the FDA approval.

Despite the questions, one thing most psychiatrists agree on is the need for intranasal esketamine and its promising impact.

“There’s no secret that at this point: We really haven’t put a dent in the rates of depression and the rates of suicide over the past several decades,” Dr. Levine said. “We’ve needed something that’s truly new, something that’s innovative. It makes the FDA approval of intranasal esketamine a really big deal. It’s a new mechanism, a new approach to depression, and provides hope to patients and the field of psychiatry.”

Addressing delivery challenges

After the FDA approval, Jacqueline Posada, MD, was tasked with helping a small psychiatry practice develop the framework to incorporate intranasal esketamine. Dr. Posada, a consultation-liaison psychiatry fellow at the Inova Fairfax Hospital-George Washington University program in Falls Church, Va., started by creating a comprehensive screening form for esketamine candidates, developing an informed-consent protocol, and researching storage guidelines for an outpatient practice.

Before the practice could move forward, however, Dr. Posada learned that building regulations for the office prohibited “medical procedures” from occurring in the space. While the 10-doctor practice is associated with George Washington University, Washington, it is located several blocks away in an office setting.

“It was pretty disappointing,” Dr. Posada said. “Our organization is looking for another spot that allows psychiatry to administer a medical procedure. There’s a lot of people who are in private practice who are in a type of office building that may restrict medical procedures. Depending on the type of space they are renting, they need to know what is allowed in their office building.”

Patient privacy is also a primary consideration when delivering the medication. Dr. Posada said she and her staff had contemplated conducting the 2-hour patient monitoring in a group setting, but that idea was quickly thwarted.

“Our plan was in 15- to 20-minute appointments, administer the esketamine, and have maybe 5-10 people monitored in a room with barriers between each chair,” she said. “We were advised by our privacy officer that that could hinder patient confidentiality and was not a viable option for administering the medication in our practice.”

Practices should also determine a long-term treatment plan for each patient receiving esketamine, Dr. Sanacora said, particularly in light of data suggesting that a substantial number of patients will relapse if treatment is stopped. A long-term treatment plan should be considered prior to, or at the same time that esketamine treatment is initiated.

Comanagement of patients by clinicians is another essential part of esketamine treatment, Dr. Sanacora added.

“It is going to be important for the community clinicians not directly offering the treatment to develop close and ongoing relationships with the clinicians and sites that are offering this treatment to optimize the care of their patients,” he said. “Conversely, it is going to be imperative that the esketamine providers develop effective and efficient methods of maintaining close communications with the referring clinicians.”

Reimbursement comes with upfront cost

As far as payment, Dr. Levine expects that the nasal spray will be widely reimbursed. Clinics must first purchase the medication and insurers will reimburse them later for the drug, a method commonly referred to as “buy and bill.” The upfront cost could be too expensive for some physicians.

“That’s not something psychiatrists are used to, storing a controlled substance on site, having the financial outlay of keeping inventory of an expensive drug, and waiting for reimbursement,” Dr. Levine said.

Practices can also bill an evaluation and management code for the treatment as well as for observation time. At this point, it appears insurers will not cover psychotherapy delivered at the same time, which is disappointing, he said.

Sanjay J. Mathew, MD, a psychiatry professor and vice chair for research at Baylor College of Medicine, Houston, said because many psychiatrists who specialize in psychopharmacology and who see treatment-resistant depression patients do not accept private insurance or Medicare/Medicaid, patient access to the drug may be limited.

“Given the REMS and the need for 2-hour monitoring following the treatment, I believe that primarily, specialized clinics and centers for ‘interventional psychiatry’ will be the early adopters,” he said. “The typical office-based psychiatrist who does not accept insurance, and does not have means to store and dispense a controlled substance or monitor patients, may not readily adopt this new approach.”

Experts say abuse potential low

Meanwhile, the potential for abuse with intranasal esketamine is low, considering the REMS requirements, said Mark S. Gold, MD, an addiction medicine specialist. If practices follow the guidelines, which restrict patients from taking the medication home, misuse is not likely.

However, the drug’s counterpart, ketamine, which has been abused globally for decades, may see an uptick in illicit use after the recent FDA approval of esketamine, Dr. Gold said. Ketamine is currently produced in clandestine labs for use on the club scene and for date rape purposes, Dr. Gold said. Most recently, ketamine has been mixed with cocaine and referred to as “Calvin Klein” for street use.

“You do have the unintended consequence when a medication is approved, [that] the general public may not be sophisticated enough to understand dose, duration, and supervised administration, and think that street ketamine is equally a medication,” Dr. Gold said. “You have the capacity for black market ketamine to undercut the price and be distributed in a form that can be extremely dangerous and life threatening. Just calling it ketamine provides confusion and the opportunity for black market sales distribution and increases in use.”

Dr. Mathew hopes the REMS designation will not only aid in risk mitigation for esketamine, but also result in valuable postapproval information with respect to longer term safety and efficacy. Questions that still need to be addressed include the best antidepressant regimens in conjunction with intranasal esketamine, the ideal long-term monitoring method, and the potential impact of benzodiazepines on response to Spravato.

“These answers will come with more research – phase 4 postmarketing studies – and also clinical experience in the community, as clinicians begin to prescribe esketamine,” Dr. Mathew said. “Input from organizations, such as the American Society of Ketamine Physicians, will be important as well.”

Dr. Levine, Dr. Posada, and Dr. Gold reported no disclosures. Dr. Sanacora served as principal investigator for several clinical trials associated with intranasal esketamine. Dr. Mathew served as a consultant to several pharmaceutical companies, including Janssen.

agallegos@mdedge.com

Family planning clinics will have more time to comply with a Trump administration rule that prohibits physicians from counseling patients about abortion and bars them from referring women for the procedures.

The Department of Health & Human Services does not intend to bring enforcement actions against taxpayer-funded clinics if they are making good-faith efforts to comply with the new rules, according to a memo issued July 20. Such good faith efforts include a written assurance by Aug. 19 that clinics are not providing abortions nor including abortion in their family planning methods, according to the emailed guidance sent by Diane Foley, MD, HHS Deputy Assistant Secretary at the Office of Population Affairs (OPA). Clinics must also detail an action plan describing the steps they will take to comply with the Title X changes and start those actions immediately, according to the memo, obtained by this news organization.

“In the past, the U.S. Department of Health & Human Services, Office of Population Affairs, has exercised enforcement discretion in appropriate circumstances,” according to the memo. “Given the circumstances surrounding the implementation of the final rule, OPA does not intend to bring enforcement actions against Title X recipients that are making, and continue to make, good-faith efforts to comply with the final rule. OPA is committed to working with grantees to assist them in coming into compliance with the requirements of the final rule.”

The decision comes a week after HHS warned family planning clinics that receive federal money to immediately stop providing referrals and counseling on abortion or face revocation of funding. An email from HHS on July 15 stated that the agency was requiring immediate compliance of the Title X changes consistent with recent court rulings. The warning came just before the start of a national Title X grantee meeting held in Washington.

The changes to the Title X program make health clinics ineligible for funding if they offer, promote, or support abortion as a method of family planning. Title X grants generally go to health centers that provide reproductive health care – such as STD testing, cancer screenings, and contraception – to low-income individuals. Under the rule, the government will withdraw financial assistance to clinics if they allow counseling or referrals associated with abortion, regardless of whether the money is used for other health care services. The rule also imposes physical separation requirements for health centers that offer abortions.

More than 20 states and several abortion rights organizations sued over the rules in four separate states. District judges in Oregon, Washington, and California temporarily blocked the rules from taking effect. In a June 20 decision, the 9th U.S. Circuit Court of Appeals ruled the federal government may go forward with its plan to restrict Title X funding from clinics that provide abortion counseling or that refer patients for abortion services. The decision overturned the lower court injunctions.

In the July 20 memo, Dr. Foley wrote that, in addition to the Aug. 19 requirements, clinics must send written confirmation by Sep. 18 outlining the steps taken to comply with the Title X changes and provide any relevant documentation needed for HHS to verify the compliance. By March 4, 2020, a written statement must be submitted affirming the clinic is in compliance with the requirement for physical separation between Title X services and abortion services.

The National Family Planning & Reproductive Health Association, a plaintiff in one of the challenges, called the administration’s July 20 memo “wholly insufficient” and said the clinics need more guidance about how to move forward with the rule changes.

“It’s just absurd to think that a few bullet points amount to guidance,” association officials said in a July 21 statement. “We urge [the agency] to take the time to properly expand on and better describe how it will interpret aspects of the rule – using examples that reflect the wide range of provider settings and administrative structures present in Title X. Once again, [the agency] falls far short of linking the rule to day-to-day practice, leaving the entire family planning network in the dark on how they need to operate to stay in the program.”

At presstime, HHS had not responded to a message seeking comment on the requirements. In her note, Dr. Foley wrote that more guidance on the changes were forthcoming and that grantees unable to meet the required time line may request a deadline extension from the agency.

HHS has previously said that the Title X changes ensure that grants and contracts awarded under the program fully comply with the statutory program integrity requirements, “thereby fulfilling the purpose of Title X, so that more women and men can receive services that help them consider and achieve both their short-term and long-term family planning needs.”

agallegos@mdedge.com

Family planning clinics will have more time to comply with a Trump administration rule that prohibits physicians from counseling patients about abortion and bars them from referring women for the procedures.

The Department of Health & Human Services does not intend to bring enforcement actions against taxpayer-funded clinics if they are making good-faith efforts to comply with the new rules, according to a memo issued July 20. Such good faith efforts include a written assurance by Aug. 19 that clinics are not providing abortions nor including abortion in their family planning methods, according to the emailed guidance sent by Diane Foley, MD, HHS Deputy Assistant Secretary at the Office of Population Affairs (OPA). Clinics must also detail an action plan describing the steps they will take to comply with the Title X changes and start those actions immediately, according to the memo, obtained by this news organization.

“In the past, the U.S. Department of Health & Human Services, Office of Population Affairs, has exercised enforcement discretion in appropriate circumstances,” according to the memo. “Given the circumstances surrounding the implementation of the final rule, OPA does not intend to bring enforcement actions against Title X recipients that are making, and continue to make, good-faith efforts to comply with the final rule. OPA is committed to working with grantees to assist them in coming into compliance with the requirements of the final rule.”

The decision comes a week after HHS warned family planning clinics that receive federal money to immediately stop providing referrals and counseling on abortion or face revocation of funding. An email from HHS on July 15 stated that the agency was requiring immediate compliance of the Title X changes consistent with recent court rulings. The warning came just before the start of a national Title X grantee meeting held in Washington.

The changes to the Title X program make health clinics ineligible for funding if they offer, promote, or support abortion as a method of family planning. Title X grants generally go to health centers that provide reproductive health care – such as STD testing, cancer screenings, and contraception – to low-income individuals. Under the rule, the government will withdraw financial assistance to clinics if they allow counseling or referrals associated with abortion, regardless of whether the money is used for other health care services. The rule also imposes physical separation requirements for health centers that offer abortions.

More than 20 states and several abortion rights organizations sued over the rules in four separate states. District judges in Oregon, Washington, and California temporarily blocked the rules from taking effect. In a June 20 decision, the 9th U.S. Circuit Court of Appeals ruled the federal government may go forward with its plan to restrict Title X funding from clinics that provide abortion counseling or that refer patients for abortion services. The decision overturned the lower court injunctions.

In the July 20 memo, Dr. Foley wrote that, in addition to the Aug. 19 requirements, clinics must send written confirmation by Sep. 18 outlining the steps taken to comply with the Title X changes and provide any relevant documentation needed for HHS to verify the compliance. By March 4, 2020, a written statement must be submitted affirming the clinic is in compliance with the requirement for physical separation between Title X services and abortion services.

The National Family Planning & Reproductive Health Association, a plaintiff in one of the challenges, called the administration’s July 20 memo “wholly insufficient” and said the clinics need more guidance about how to move forward with the rule changes.

“It’s just absurd to think that a few bullet points amount to guidance,” association officials said in a July 21 statement. “We urge [the agency] to take the time to properly expand on and better describe how it will interpret aspects of the rule – using examples that reflect the wide range of provider settings and administrative structures present in Title X. Once again, [the agency] falls far short of linking the rule to day-to-day practice, leaving the entire family planning network in the dark on how they need to operate to stay in the program.”

At presstime, HHS had not responded to a message seeking comment on the requirements. In her note, Dr. Foley wrote that more guidance on the changes were forthcoming and that grantees unable to meet the required time line may request a deadline extension from the agency.

HHS has previously said that the Title X changes ensure that grants and contracts awarded under the program fully comply with the statutory program integrity requirements, “thereby fulfilling the purpose of Title X, so that more women and men can receive services that help them consider and achieve both their short-term and long-term family planning needs.”

agallegos@mdedge.com

Family planning clinics will have more time to comply with a Trump administration rule that prohibits physicians from counseling patients about abortion and bars them from referring women for the procedures.

The Department of Health & Human Services does not intend to bring enforcement actions against taxpayer-funded clinics if they are making good-faith efforts to comply with the new rules, according to a memo issued July 20. Such good faith efforts include a written assurance by Aug. 19 that clinics are not providing abortions nor including abortion in their family planning methods, according to the emailed guidance sent by Diane Foley, MD, HHS Deputy Assistant Secretary at the Office of Population Affairs (OPA). Clinics must also detail an action plan describing the steps they will take to comply with the Title X changes and start those actions immediately, according to the memo, obtained by this news organization.

“In the past, the U.S. Department of Health & Human Services, Office of Population Affairs, has exercised enforcement discretion in appropriate circumstances,” according to the memo. “Given the circumstances surrounding the implementation of the final rule, OPA does not intend to bring enforcement actions against Title X recipients that are making, and continue to make, good-faith efforts to comply with the final rule. OPA is committed to working with grantees to assist them in coming into compliance with the requirements of the final rule.”

The decision comes a week after HHS warned family planning clinics that receive federal money to immediately stop providing referrals and counseling on abortion or face revocation of funding. An email from HHS on July 15 stated that the agency was requiring immediate compliance of the Title X changes consistent with recent court rulings. The warning came just before the start of a national Title X grantee meeting held in Washington.

The changes to the Title X program make health clinics ineligible for funding if they offer, promote, or support abortion as a method of family planning. Title X grants generally go to health centers that provide reproductive health care – such as STD testing, cancer screenings, and contraception – to low-income individuals. Under the rule, the government will withdraw financial assistance to clinics if they allow counseling or referrals associated with abortion, regardless of whether the money is used for other health care services. The rule also imposes physical separation requirements for health centers that offer abortions.

More than 20 states and several abortion rights organizations sued over the rules in four separate states. District judges in Oregon, Washington, and California temporarily blocked the rules from taking effect. In a June 20 decision, the 9th U.S. Circuit Court of Appeals ruled the federal government may go forward with its plan to restrict Title X funding from clinics that provide abortion counseling or that refer patients for abortion services. The decision overturned the lower court injunctions.

In the July 20 memo, Dr. Foley wrote that, in addition to the Aug. 19 requirements, clinics must send written confirmation by Sep. 18 outlining the steps taken to comply with the Title X changes and provide any relevant documentation needed for HHS to verify the compliance. By March 4, 2020, a written statement must be submitted affirming the clinic is in compliance with the requirement for physical separation between Title X services and abortion services.

The National Family Planning & Reproductive Health Association, a plaintiff in one of the challenges, called the administration’s July 20 memo “wholly insufficient” and said the clinics need more guidance about how to move forward with the rule changes.

“It’s just absurd to think that a few bullet points amount to guidance,” association officials said in a July 21 statement. “We urge [the agency] to take the time to properly expand on and better describe how it will interpret aspects of the rule – using examples that reflect the wide range of provider settings and administrative structures present in Title X. Once again, [the agency] falls far short of linking the rule to day-to-day practice, leaving the entire family planning network in the dark on how they need to operate to stay in the program.”

At presstime, HHS had not responded to a message seeking comment on the requirements. In her note, Dr. Foley wrote that more guidance on the changes were forthcoming and that grantees unable to meet the required time line may request a deadline extension from the agency.

HHS has previously said that the Title X changes ensure that grants and contracts awarded under the program fully comply with the statutory program integrity requirements, “thereby fulfilling the purpose of Title X, so that more women and men can receive services that help them consider and achieve both their short-term and long-term family planning needs.”

agallegos@mdedge.com