Kerry Dooley Young

The path through the U.S. Senate is not yet certain for a bill intended to speed the prior authorization process of insurer-run Medicare Advantage plans, despite the measure having breezed through the House.

House leaders opted to move the Improving Seniors’ Timely Access to Care Act of 2021 (H.R. 3173) without requiring a roll-call vote. The measure was passed on Sept. 14 by a voice vote, an approach used in general with only uncontroversial measures that have broad support. The bill has 191 Democratic and 135 Republican sponsors, representing about three-quarters of the members of the House.

Alicia Ault/Frontline Medical News

“There is no reason that patients should be waiting for medically appropriate care, especially when we know that this can lead to worse outcomes,” Rep. Earl Blumenauer (D-Ore.) said in a Sept. 14 speech on the House floor. “The fundamental promise of Medicare Advantage is undermined when people are delaying care, getting sicker, and ultimately costing Medicare more money.”

Rep. Greg Murphy, MD (R-N.C.), spoke on the House floor that day as well, bringing up cases he has seen in his own urology practice in which prior authorization delays disrupted medical care. One patient wound up in the hospital with abscess after an insurer denied an antibiotic prescription, Rep. Murphy said.

The Senate currently appears unlikely to move the prior authorization bill as a standalone measure. Instead, the bill may become part of a larger legislative package focused on health care that the Senate Finance Committee intends to prepare later this year.

The House-passed bill would require insurer-run Medicare plans to respond to expedited requests for prior authorization of services within 24 hours and to other requests within 7 days. This bill also would establish an electronic program for prior authorizations and mandate increased transparency as to how insurers use this tool.
 

CBO: Cost of change would be billions

In seeking to mandate changes in prior authorization, lawmakers likely will need to contend with the issue of a $16 billion cumulative cost estimate for the bill from the Congressional Budget Office. Members of Congress often seek to offset new spending by pairing bills that add to expected costs for the federal government with ones expected to produce savings.

Unlike Rep. Blumenauer, Rep. Murphy, and other backers of the prior authorization streamlining bill, CBO staff estimates that making the mandated changes would raise federal spending, inasmuch as there would be “a greater use of services.”

On Sept. 14, CBO issued a one-page report on the costs of the bill. The CBO report concerns only the bill in question, as is common practice with the office’s estimates.

Prior authorization changes would begin in fiscal 2025 and would add $899 million in spending, or outlays, that year, CBO said. The annual costs from the streamlined prior authorization practices through fiscal 2026 to 2032 range from $1.6 billion to $2.7 billion.

Looking at the CBO estimate against a backdrop of total Medicare Advantage costs may provide important context.

The increases in spending estimated by CBO may suggest that there would be little change in federal spending as a result of streamlining prior authorization practices. These estimates of increased annual spending of $1.6 billion–$2.7 billion are only a small fraction of the current annual cost of insurer-run Medicare, and they represent an even smaller share of the projected expense.

The federal government last year spent about $350 billion on insurer-run plans, excluding Part D drug plan payments, according to the Medicare Advisory Payment Commission (MedPAC).

As of 2021, about 27 million people were enrolled in these plans, accounting for about 46% of the total Medicare population. Enrollment has doubled since 2010, MedPAC said, and it is expected to continue to grow. By 2027, insurer-run Medicare could cover 50% of the program’s population, a figure that may reach 53% by 2031.

Federal payments to these plans will accelerate in the years ahead as insurers attract more people eligible for Medicare as customers. Payments to these private health plans could rise from an expected $418 billion this year to $940.6 billion by 2031, according to the most recent Medicare trustees report.
 

Good intentions, poor implementation?

Insurer-run Medicare has long enjoyed deep bipartisan support in Congress. That’s due in part to its potential for reducing spending on what are considered low-value treatments, or ones considered unlikely to provide a significant medical benefit, but Rep. Blumenauer is among the members of Congress who see insurer-run Medicare as a path for preserving the giant federal health program. Traditional Medicare has far fewer restrictions on services, which sometimes opens a path for tests and treatments that offer less value for patients.

“I believe that the way traditional fee-for-service Medicare operates is not sustainable and that Medicare Advantage is one of the tools we can use to demonstrate how we can incentivize value,” Rep. Blumenauer said on the House floor. “But this is only possible when the program operates as intended. I have been deeply concerned about the reports of delays in care” caused by the clunky prior authorization processes.

He highlighted a recent report from the internal watchdog group for the Department of Health & Human Services that raises concerns about denials of appropriate care. About 18% of a set of payment denials examined by the Office of Inspector General of HHS in April actually met Medicare coverage rules and plan billing rules.

“For patients and their families, being told that you need to wait longer for care that your doctor tells you that you need is incredibly frustrating and frightening,” Rep. Blumenauer said. “There’s no comfort to be found in the fact that your insurance company needs time to decide if your doctor is right.”
 

Trends in prior authorization

The CBO report does not provide detail on what kind of medical spending would increase under a streamlined prior authorization process in insurer-run Medicare plans.

From trends reported in prior authorization, though, two factors could be at play in what appear to be relatively small estimated increases in Medicare spending from streamlined prior authorization.

The work already underway to create less burdensome electronic systems for these requests, such as the Fast Prior Authorization Technology Highway initiative run by the America’s Health Insurance Plans trade association.

The other factor could be the number of cases in which prior authorization merely causes delays in treatments and tests and thus simply postpones spending while adding to clinicians’ administrative work.

An analysis of prior authorization requests for dermatologic practices affiliated with the University of Utah may represent an extreme example. In a report published in JAMA Dermatology in 2020, researchers described what happened with requests made during 1 month, September 2016.

The approval rate for procedures was 99.6% – 100% (95 of 95) for Mohs surgery, and 96% (130 of 131, with 4 additional cases pending) for excisions. These findings supported calls for simplifying prior authorization procedures, “perhaps first by eliminating unnecessary PAs [prior authorizations] and appeals,” Aaron M. Secrest, MD, PhD, of the University of Utah, Salt Lake City, and coauthors wrote in the article.

Still, there is some evidence that insurer-run Medicare policies reduce the use of low-value care.

In a study published in JAMA Health Forum, Emily Boudreau, PhD, of insurer Humana Inc, and coauthors from Tufts University, Boston, and the University of Pennsylvania, Philadelphia investigated whether insurer-run Medicare could do a better job in reducing the amount of low-value care delivered than the traditional program. They analyzed a set of claims data from 2017 to 2019 for people enrolled in insurer-run and traditional Medicare.

They reported a rate of 23.07 low-value services provided per 100 people in insurer-run Medicare, compared with 25.39 for those in traditional Medicare. Some of the biggest differences reported in the article were in cancer screenings for older people.

As an example, the U.S. Preventive Services Task Force recommends that women older than 65 years not be screened for cervical cancer if they have undergone adequate screening in the past and are not at high risk for cervical cancer. There was an annual count of 1.76 screenings for cervical cancer per 100 women older than 65 in the insurer-run Medicare group versus 3.18 for those in traditional Medicare.

The Better Medicare Alliance issued a statement in favor of the House passage of the Improving Seniors’ Timely Access to Care Act.

In it, the group said the measure would “modernize prior authorization while protecting its essential function in facilitating safe, high-value, evidence-based care.” The alliance promotes use of insurer-run Medicare. The board of the Better Medicare Alliance includes executives who serve with firms that run Advantage plans as well as medical organizations and universities.

“With studies showing that up to one-quarter of all health care expenditures are wasted on services with no benefit to the patient, we need a robust, next-generation prior authorization program to deter low-value, and even harmful, care while protecting access to needed treatment and effective therapies,” said A. Mark Fendrick, MD, director of the University of Michigan’s Center for Value-Based Insurance Design in Ann Arbor, in a statement issued by the Better Medicare Alliance. He is a member of the group’s council of scholars.

On the House floor on September 14, Rep. Ami Bera, MD (D-Calif.), said he has heard from former colleagues and his medical school classmates that they now spend as much as 40% of their time on administrative work. These distractions from patient care are helping drive physicians away from the practice of medicine.

Still, the internist defended the basic premise of prior authorization while strongly appealing for better systems of handling it.

“Yes, there is a role for prior authorization in limited cases. There is also a role to go back and retrospectively look at how care is being delivered,” Rep. Bera said. “But what is happening today is a travesty. It wasn’t the intention of prior authorization. It is a prior authorization process gone awry.”

AGA’s stance: This is a huge victory for patients! Advocating for prior authorization reform has been AGA’s top priority. Learn more about prior authorization and how it impacts gastroenterology on the AGA website. 

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

The path through the U.S. Senate is not yet certain for a bill intended to speed the prior authorization process of insurer-run Medicare Advantage plans, despite the measure having breezed through the House.

House leaders opted to move the Improving Seniors’ Timely Access to Care Act of 2021 (H.R. 3173) without requiring a roll-call vote. The measure was passed on Sept. 14 by a voice vote, an approach used in general with only uncontroversial measures that have broad support. The bill has 191 Democratic and 135 Republican sponsors, representing about three-quarters of the members of the House.

Alicia Ault/Frontline Medical News

“There is no reason that patients should be waiting for medically appropriate care, especially when we know that this can lead to worse outcomes,” Rep. Earl Blumenauer (D-Ore.) said in a Sept. 14 speech on the House floor. “The fundamental promise of Medicare Advantage is undermined when people are delaying care, getting sicker, and ultimately costing Medicare more money.”

Rep. Greg Murphy, MD (R-N.C.), spoke on the House floor that day as well, bringing up cases he has seen in his own urology practice in which prior authorization delays disrupted medical care. One patient wound up in the hospital with abscess after an insurer denied an antibiotic prescription, Rep. Murphy said.

The Senate currently appears unlikely to move the prior authorization bill as a standalone measure. Instead, the bill may become part of a larger legislative package focused on health care that the Senate Finance Committee intends to prepare later this year.

The House-passed bill would require insurer-run Medicare plans to respond to expedited requests for prior authorization of services within 24 hours and to other requests within 7 days. This bill also would establish an electronic program for prior authorizations and mandate increased transparency as to how insurers use this tool.
 

CBO: Cost of change would be billions

In seeking to mandate changes in prior authorization, lawmakers likely will need to contend with the issue of a $16 billion cumulative cost estimate for the bill from the Congressional Budget Office. Members of Congress often seek to offset new spending by pairing bills that add to expected costs for the federal government with ones expected to produce savings.

Unlike Rep. Blumenauer, Rep. Murphy, and other backers of the prior authorization streamlining bill, CBO staff estimates that making the mandated changes would raise federal spending, inasmuch as there would be “a greater use of services.”

On Sept. 14, CBO issued a one-page report on the costs of the bill. The CBO report concerns only the bill in question, as is common practice with the office’s estimates.

Prior authorization changes would begin in fiscal 2025 and would add $899 million in spending, or outlays, that year, CBO said. The annual costs from the streamlined prior authorization practices through fiscal 2026 to 2032 range from $1.6 billion to $2.7 billion.

Looking at the CBO estimate against a backdrop of total Medicare Advantage costs may provide important context.

The increases in spending estimated by CBO may suggest that there would be little change in federal spending as a result of streamlining prior authorization practices. These estimates of increased annual spending of $1.6 billion–$2.7 billion are only a small fraction of the current annual cost of insurer-run Medicare, and they represent an even smaller share of the projected expense.

The federal government last year spent about $350 billion on insurer-run plans, excluding Part D drug plan payments, according to the Medicare Advisory Payment Commission (MedPAC).

As of 2021, about 27 million people were enrolled in these plans, accounting for about 46% of the total Medicare population. Enrollment has doubled since 2010, MedPAC said, and it is expected to continue to grow. By 2027, insurer-run Medicare could cover 50% of the program’s population, a figure that may reach 53% by 2031.

Federal payments to these plans will accelerate in the years ahead as insurers attract more people eligible for Medicare as customers. Payments to these private health plans could rise from an expected $418 billion this year to $940.6 billion by 2031, according to the most recent Medicare trustees report.
 

Good intentions, poor implementation?

Insurer-run Medicare has long enjoyed deep bipartisan support in Congress. That’s due in part to its potential for reducing spending on what are considered low-value treatments, or ones considered unlikely to provide a significant medical benefit, but Rep. Blumenauer is among the members of Congress who see insurer-run Medicare as a path for preserving the giant federal health program. Traditional Medicare has far fewer restrictions on services, which sometimes opens a path for tests and treatments that offer less value for patients.

“I believe that the way traditional fee-for-service Medicare operates is not sustainable and that Medicare Advantage is one of the tools we can use to demonstrate how we can incentivize value,” Rep. Blumenauer said on the House floor. “But this is only possible when the program operates as intended. I have been deeply concerned about the reports of delays in care” caused by the clunky prior authorization processes.

He highlighted a recent report from the internal watchdog group for the Department of Health & Human Services that raises concerns about denials of appropriate care. About 18% of a set of payment denials examined by the Office of Inspector General of HHS in April actually met Medicare coverage rules and plan billing rules.

“For patients and their families, being told that you need to wait longer for care that your doctor tells you that you need is incredibly frustrating and frightening,” Rep. Blumenauer said. “There’s no comfort to be found in the fact that your insurance company needs time to decide if your doctor is right.”
 

Trends in prior authorization

The CBO report does not provide detail on what kind of medical spending would increase under a streamlined prior authorization process in insurer-run Medicare plans.

From trends reported in prior authorization, though, two factors could be at play in what appear to be relatively small estimated increases in Medicare spending from streamlined prior authorization.

The work already underway to create less burdensome electronic systems for these requests, such as the Fast Prior Authorization Technology Highway initiative run by the America’s Health Insurance Plans trade association.

The other factor could be the number of cases in which prior authorization merely causes delays in treatments and tests and thus simply postpones spending while adding to clinicians’ administrative work.

An analysis of prior authorization requests for dermatologic practices affiliated with the University of Utah may represent an extreme example. In a report published in JAMA Dermatology in 2020, researchers described what happened with requests made during 1 month, September 2016.

The approval rate for procedures was 99.6% – 100% (95 of 95) for Mohs surgery, and 96% (130 of 131, with 4 additional cases pending) for excisions. These findings supported calls for simplifying prior authorization procedures, “perhaps first by eliminating unnecessary PAs [prior authorizations] and appeals,” Aaron M. Secrest, MD, PhD, of the University of Utah, Salt Lake City, and coauthors wrote in the article.

Still, there is some evidence that insurer-run Medicare policies reduce the use of low-value care.

In a study published in JAMA Health Forum, Emily Boudreau, PhD, of insurer Humana Inc, and coauthors from Tufts University, Boston, and the University of Pennsylvania, Philadelphia investigated whether insurer-run Medicare could do a better job in reducing the amount of low-value care delivered than the traditional program. They analyzed a set of claims data from 2017 to 2019 for people enrolled in insurer-run and traditional Medicare.

They reported a rate of 23.07 low-value services provided per 100 people in insurer-run Medicare, compared with 25.39 for those in traditional Medicare. Some of the biggest differences reported in the article were in cancer screenings for older people.

As an example, the U.S. Preventive Services Task Force recommends that women older than 65 years not be screened for cervical cancer if they have undergone adequate screening in the past and are not at high risk for cervical cancer. There was an annual count of 1.76 screenings for cervical cancer per 100 women older than 65 in the insurer-run Medicare group versus 3.18 for those in traditional Medicare.

The Better Medicare Alliance issued a statement in favor of the House passage of the Improving Seniors’ Timely Access to Care Act.

In it, the group said the measure would “modernize prior authorization while protecting its essential function in facilitating safe, high-value, evidence-based care.” The alliance promotes use of insurer-run Medicare. The board of the Better Medicare Alliance includes executives who serve with firms that run Advantage plans as well as medical organizations and universities.

“With studies showing that up to one-quarter of all health care expenditures are wasted on services with no benefit to the patient, we need a robust, next-generation prior authorization program to deter low-value, and even harmful, care while protecting access to needed treatment and effective therapies,” said A. Mark Fendrick, MD, director of the University of Michigan’s Center for Value-Based Insurance Design in Ann Arbor, in a statement issued by the Better Medicare Alliance. He is a member of the group’s council of scholars.

On the House floor on September 14, Rep. Ami Bera, MD (D-Calif.), said he has heard from former colleagues and his medical school classmates that they now spend as much as 40% of their time on administrative work. These distractions from patient care are helping drive physicians away from the practice of medicine.

Still, the internist defended the basic premise of prior authorization while strongly appealing for better systems of handling it.

“Yes, there is a role for prior authorization in limited cases. There is also a role to go back and retrospectively look at how care is being delivered,” Rep. Bera said. “But what is happening today is a travesty. It wasn’t the intention of prior authorization. It is a prior authorization process gone awry.”

AGA’s stance: This is a huge victory for patients! Advocating for prior authorization reform has been AGA’s top priority. Learn more about prior authorization and how it impacts gastroenterology on the AGA website. 

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

The path through the U.S. Senate is not yet certain for a bill intended to speed the prior authorization process of insurer-run Medicare Advantage plans, despite the measure having breezed through the House.

House leaders opted to move the Improving Seniors’ Timely Access to Care Act of 2021 (H.R. 3173) without requiring a roll-call vote. The measure was passed on Sept. 14 by a voice vote, an approach used in general with only uncontroversial measures that have broad support. The bill has 191 Democratic and 135 Republican sponsors, representing about three-quarters of the members of the House.

Alicia Ault/Frontline Medical News

“There is no reason that patients should be waiting for medically appropriate care, especially when we know that this can lead to worse outcomes,” Rep. Earl Blumenauer (D-Ore.) said in a Sept. 14 speech on the House floor. “The fundamental promise of Medicare Advantage is undermined when people are delaying care, getting sicker, and ultimately costing Medicare more money.”

Rep. Greg Murphy, MD (R-N.C.), spoke on the House floor that day as well, bringing up cases he has seen in his own urology practice in which prior authorization delays disrupted medical care. One patient wound up in the hospital with abscess after an insurer denied an antibiotic prescription, Rep. Murphy said.

The Senate currently appears unlikely to move the prior authorization bill as a standalone measure. Instead, the bill may become part of a larger legislative package focused on health care that the Senate Finance Committee intends to prepare later this year.

The House-passed bill would require insurer-run Medicare plans to respond to expedited requests for prior authorization of services within 24 hours and to other requests within 7 days. This bill also would establish an electronic program for prior authorizations and mandate increased transparency as to how insurers use this tool.
 

CBO: Cost of change would be billions

In seeking to mandate changes in prior authorization, lawmakers likely will need to contend with the issue of a $16 billion cumulative cost estimate for the bill from the Congressional Budget Office. Members of Congress often seek to offset new spending by pairing bills that add to expected costs for the federal government with ones expected to produce savings.

Unlike Rep. Blumenauer, Rep. Murphy, and other backers of the prior authorization streamlining bill, CBO staff estimates that making the mandated changes would raise federal spending, inasmuch as there would be “a greater use of services.”

On Sept. 14, CBO issued a one-page report on the costs of the bill. The CBO report concerns only the bill in question, as is common practice with the office’s estimates.

Prior authorization changes would begin in fiscal 2025 and would add $899 million in spending, or outlays, that year, CBO said. The annual costs from the streamlined prior authorization practices through fiscal 2026 to 2032 range from $1.6 billion to $2.7 billion.

Looking at the CBO estimate against a backdrop of total Medicare Advantage costs may provide important context.

The increases in spending estimated by CBO may suggest that there would be little change in federal spending as a result of streamlining prior authorization practices. These estimates of increased annual spending of $1.6 billion–$2.7 billion are only a small fraction of the current annual cost of insurer-run Medicare, and they represent an even smaller share of the projected expense.

The federal government last year spent about $350 billion on insurer-run plans, excluding Part D drug plan payments, according to the Medicare Advisory Payment Commission (MedPAC).

As of 2021, about 27 million people were enrolled in these plans, accounting for about 46% of the total Medicare population. Enrollment has doubled since 2010, MedPAC said, and it is expected to continue to grow. By 2027, insurer-run Medicare could cover 50% of the program’s population, a figure that may reach 53% by 2031.

Federal payments to these plans will accelerate in the years ahead as insurers attract more people eligible for Medicare as customers. Payments to these private health plans could rise from an expected $418 billion this year to $940.6 billion by 2031, according to the most recent Medicare trustees report.
 

Good intentions, poor implementation?

Insurer-run Medicare has long enjoyed deep bipartisan support in Congress. That’s due in part to its potential for reducing spending on what are considered low-value treatments, or ones considered unlikely to provide a significant medical benefit, but Rep. Blumenauer is among the members of Congress who see insurer-run Medicare as a path for preserving the giant federal health program. Traditional Medicare has far fewer restrictions on services, which sometimes opens a path for tests and treatments that offer less value for patients.

“I believe that the way traditional fee-for-service Medicare operates is not sustainable and that Medicare Advantage is one of the tools we can use to demonstrate how we can incentivize value,” Rep. Blumenauer said on the House floor. “But this is only possible when the program operates as intended. I have been deeply concerned about the reports of delays in care” caused by the clunky prior authorization processes.

He highlighted a recent report from the internal watchdog group for the Department of Health & Human Services that raises concerns about denials of appropriate care. About 18% of a set of payment denials examined by the Office of Inspector General of HHS in April actually met Medicare coverage rules and plan billing rules.

“For patients and their families, being told that you need to wait longer for care that your doctor tells you that you need is incredibly frustrating and frightening,” Rep. Blumenauer said. “There’s no comfort to be found in the fact that your insurance company needs time to decide if your doctor is right.”
 

Trends in prior authorization

The CBO report does not provide detail on what kind of medical spending would increase under a streamlined prior authorization process in insurer-run Medicare plans.

From trends reported in prior authorization, though, two factors could be at play in what appear to be relatively small estimated increases in Medicare spending from streamlined prior authorization.

The work already underway to create less burdensome electronic systems for these requests, such as the Fast Prior Authorization Technology Highway initiative run by the America’s Health Insurance Plans trade association.

The other factor could be the number of cases in which prior authorization merely causes delays in treatments and tests and thus simply postpones spending while adding to clinicians’ administrative work.

An analysis of prior authorization requests for dermatologic practices affiliated with the University of Utah may represent an extreme example. In a report published in JAMA Dermatology in 2020, researchers described what happened with requests made during 1 month, September 2016.

The approval rate for procedures was 99.6% – 100% (95 of 95) for Mohs surgery, and 96% (130 of 131, with 4 additional cases pending) for excisions. These findings supported calls for simplifying prior authorization procedures, “perhaps first by eliminating unnecessary PAs [prior authorizations] and appeals,” Aaron M. Secrest, MD, PhD, of the University of Utah, Salt Lake City, and coauthors wrote in the article.

Still, there is some evidence that insurer-run Medicare policies reduce the use of low-value care.

In a study published in JAMA Health Forum, Emily Boudreau, PhD, of insurer Humana Inc, and coauthors from Tufts University, Boston, and the University of Pennsylvania, Philadelphia investigated whether insurer-run Medicare could do a better job in reducing the amount of low-value care delivered than the traditional program. They analyzed a set of claims data from 2017 to 2019 for people enrolled in insurer-run and traditional Medicare.

They reported a rate of 23.07 low-value services provided per 100 people in insurer-run Medicare, compared with 25.39 for those in traditional Medicare. Some of the biggest differences reported in the article were in cancer screenings for older people.

As an example, the U.S. Preventive Services Task Force recommends that women older than 65 years not be screened for cervical cancer if they have undergone adequate screening in the past and are not at high risk for cervical cancer. There was an annual count of 1.76 screenings for cervical cancer per 100 women older than 65 in the insurer-run Medicare group versus 3.18 for those in traditional Medicare.

The Better Medicare Alliance issued a statement in favor of the House passage of the Improving Seniors’ Timely Access to Care Act.

In it, the group said the measure would “modernize prior authorization while protecting its essential function in facilitating safe, high-value, evidence-based care.” The alliance promotes use of insurer-run Medicare. The board of the Better Medicare Alliance includes executives who serve with firms that run Advantage plans as well as medical organizations and universities.

“With studies showing that up to one-quarter of all health care expenditures are wasted on services with no benefit to the patient, we need a robust, next-generation prior authorization program to deter low-value, and even harmful, care while protecting access to needed treatment and effective therapies,” said A. Mark Fendrick, MD, director of the University of Michigan’s Center for Value-Based Insurance Design in Ann Arbor, in a statement issued by the Better Medicare Alliance. He is a member of the group’s council of scholars.

On the House floor on September 14, Rep. Ami Bera, MD (D-Calif.), said he has heard from former colleagues and his medical school classmates that they now spend as much as 40% of their time on administrative work. These distractions from patient care are helping drive physicians away from the practice of medicine.

Still, the internist defended the basic premise of prior authorization while strongly appealing for better systems of handling it.

“Yes, there is a role for prior authorization in limited cases. There is also a role to go back and retrospectively look at how care is being delivered,” Rep. Bera said. “But what is happening today is a travesty. It wasn’t the intention of prior authorization. It is a prior authorization process gone awry.”

AGA’s stance: This is a huge victory for patients! Advocating for prior authorization reform has been AGA’s top priority. Learn more about prior authorization and how it impacts gastroenterology on the AGA website. 

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

The path through the U.S. Senate is not yet certain for a bill intended to speed the prior authorization process of insurer-run Medicare Advantage plans, despite the measure having breezed through the House.

House leaders opted to move the Improving Seniors’ Timely Access to Care Act of 2021 (HR 3173) without requiring a roll-call vote. The measure was passed on Sept. 14 by a voice vote, an approach used in general with only uncontroversial measures that have broad support. The bill has 191 Democratic and 135 Republican sponsors, representing about three-quarters of the members of the House.

Alicia Ault/Frontline Medical News

“There is no reason that patients should be waiting for medically appropriate care, especially when we know that this can lead to worse outcomes,” Rep. Earl Blumenauer (D-Ore.) said in a Sept. 14 speech on the House floor. “The fundamental promise of Medicare Advantage is undermined when people are delaying care, getting sicker, and ultimately costing Medicare more money.”

Rep. Greg Murphy, MD (R-N.C.), spoke on the House floor that day as well, bringing up cases he has seen in his own urology practice in which prior authorization delays disrupted medical care. One patient wound up in the hospital with abscess after an insurer denied an antibiotic prescription, Rep. Murphy said.

But the Senate appears unlikely at this time to move the prior authorization bill as a standalone measure. Instead, the bill may become part of a larger legislative package focused on health care that the Senate Finance Committee intends to prepare later this year.

The House-passed bill would require insurer-run Medicare plans to respond to expedited requests for prior authorization of services within 24 hours and to other requests within 7 days. This bill also would establish an electronic program for prior authorizations and mandate increased transparency as to how insurers use this tool.
 

CBO: Cost of change would be billions

In seeking to mandate changes in prior authorization, lawmakers likely will need to contend with the issue of a $16 billion cumulative cost estimate for the bill from the Congressional Budget Office. Members of Congress often seek to offset new spending by pairing bills that add to expected costs for the federal government with ones expected to produce savings.

Unlike Rep. Blumenauer, Rep. Murphy, and other backers of the prior authorization streamlining bill, CBO staff estimates that making the mandated changes would raise federal spending, inasmuch as there would be “a greater use of services.”

On Sept. 14, CBO issued a one-page report on the costs of the bill. The CBO report concerns only the bill in question, as is common practice with the office’s estimates.

Prior authorization changes would begin in fiscal 2025 and would add $899 million in spending, or outlays, that year, CBO said. The annual costs from the streamlined prior authorization practices through fiscal 2026 to 2032 range from $1.6 billion to $2.7 billion.

Looking at the CBO estimate against a backdrop of total Medicare Advantage costs, though, may provide important context.

The increases in spending estimated by CBO may suggest that there would be little change in federal spending as a result of streamlining prior authorization practices. These estimates of increased annual spending of $1.6 billion–$2.7 billion are only a small fraction of the current annual cost of insurer-run Medicare, and they represent an even smaller share of the projected expense.

The federal government last year spent about $350 billion on insurer-run plans, excluding Part D drug plan payments, according to the Medicare Advisory Payment Commission (MedPAC).

As of 2021, about 27 million people were enrolled in these plans, accounting for about 46% of the total Medicare population. Enrollment has doubled since 2010, MedPAC said, and it is expected to continue to grow. By 2027, insurer-run Medicare could cover 50% of the program’s population, a figure that may reach 53% by 2031.

Federal payments to these plans will accelerate in the years ahead as insurers attract more people eligible for Medicare as customers. Payments to these private health plans could rise from an expected $418 billion this year to $940.6 billion by 2031, according to the most recent Medicare trustees report.

Good intentions, poor implementation?

Insurer-run Medicare has long enjoyed deep bipartisan support in Congress. That’s due in part to its potential for reducing spending on what are considered low-value treatments, or ones considered unlikely to provide a significant medical benefit, but Rep. Blumenauer is among the members of Congress who see insurer-run Medicare as a path for preserving the giant federal health program. Traditional Medicare has far fewer restrictions on services, which sometimes opens a path for tests and treatments that offer less value for patients.

“I believe that the way traditional fee-for-service Medicare operates is not sustainable and that Medicare Advantage is one of the tools we can use to demonstrate how we can incentivize value,” Rep. Blumenauer said on the House floor. “But this is only possible when the program operates as intended. I have been deeply concerned about the reports of delays in care” caused by the clunky prior authorization processes.

He highlighted a recent report from the internal watchdog group for the Department of Health & Human Services that raises concerns about denials of appropriate care. About 18% of a set of payment denials examined by the Office of Inspector General of HHS in April actually met Medicare coverage rules and plan billing rules.

“For patients and their families, being told that you need to wait longer for care that your doctor tells you that you need is incredibly frustrating and frightening,” Rep. Blumenauer said. “There’s no comfort to be found in the fact that your insurance company needs time to decide if your doctor is right.”
 

Trends in prior authorization

The CBO report does not provide detail on what kind of medical spending would increase under a streamlined prior authorization process in insurer-run Medicare plans.

From trends reported in prior authorization, though, two factors could be at play in what appear to be relatively small estimated increases in Medicare spending from streamlined prior authorization.

One is the work already underway to create less burdensome electronic systems for these requests, such as the Fast Prior Authorization Technology Highway initiative run by the trade association America’s Health Insurance Plans.

The other factor could be the number of cases in which prior authorization merely causes delays in treatments and tests and thus simply postpones spending while adding to clinicians’ administrative work.

An analysis of prior authorization requests for dermatologic practices affiliated with the University of Utah may represent an extreme example. In a report published in JAMA Dermatology in 2020, researchers described what happened with requests made during 1 month, September 2016.

The approval rate for procedures was 99.6% – 100% (95 of 95) for Mohs surgery, and 96% (130 of 131, with 4 additional cases pending) for excisions. These findings supported calls for simplifying prior authorization procedures, “perhaps first by eliminating unnecessary PAs [prior authorizations] and appeals,” Aaron M. Secrest, MD, PhD, of the University of Utah, Salt Lake City, and coauthors wrote in the article.

Still, there is some evidence that insurer-run Medicare policies reduce the use of low-value care.

In a study published in JAMA Health Forum, Emily Boudreau, PhD, of insurer Humana Inc, and coauthors from Tufts University, Boston, and the University of Pennsylvania, Philadelphia investigated whether insurer-run Medicare could do a better job in reducing the amount of low-value care delivered than the traditional program. They analyzed a set of claims data from 2017 to 2019 for people enrolled in insurer-run and traditional Medicare.

They reported a rate of 23.07 low-value services provided per 100 people in insurer-run Medicare, compared with 25.39 for those in traditional Medicare. Some of the biggest differences reported in the article were in cancer screenings for older people.

As an example, the U.S. Preventive Services Task Force recommends that women older than 65 years not be screened for cervical cancer if they have undergone adequate screening in the past and are not at high risk for cervical cancer. There was an annual count of 1.76 screenings for cervical cancer per 100 women older than 65 in the insurer-run Medicare group versus 3.18 for those in traditional Medicare.

The Better Medicare Alliance issued a statement in favor of the House passage of the Improving Seniors’ Timely Access to Care Act.

In it, the group said the measure would “modernize prior authorization while protecting its essential function in facilitating safe, high-value, evidence-based care.” The alliance promotes use of insurer-run Medicare. The board of the Better Medicare Alliance includes executives who serve with firms that run Advantage plans as well as medical organizations and universities.

“With studies showing that up to one-quarter of all health care expenditures are wasted on services with no benefit to the patient, we need a robust, next-generation prior authorization program to deter low-value, and even harmful, care while protecting access to needed treatment and effective therapies,” said A. Mark Fendrick, MD, director of the University of Michigan’s Center for Value-Based Insurance Design in Ann Arbor, in a statement issued by the Better Medicare Alliance. He is a member of the group’s council of scholars.

On the House floor on September 14, Rep. Ami Bera, MD (D-Calif.), said he has heard from former colleagues and his medical school classmates that they now spend as much as 40% of their time on administrative work. These distractions from patient care are helping drive physicians away from the practice of medicine.

Still, the internist defended the basic premise of prior authorization while strongly appealing for better systems of handling it.

“Yes, there is a role for prior authorization in limited cases. There is also a role to go back and retrospectively look at how care is being delivered,” Rep. Bera said. “But what is happening today is a travesty. It wasn’t the intention of prior authorization. It is a prior authorization process gone awry.”

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

The path through the U.S. Senate is not yet certain for a bill intended to speed the prior authorization process of insurer-run Medicare Advantage plans, despite the measure having breezed through the House.

House leaders opted to move the Improving Seniors’ Timely Access to Care Act of 2021 (HR 3173) without requiring a roll-call vote. The measure was passed on Sept. 14 by a voice vote, an approach used in general with only uncontroversial measures that have broad support. The bill has 191 Democratic and 135 Republican sponsors, representing about three-quarters of the members of the House.

Alicia Ault/Frontline Medical News

“There is no reason that patients should be waiting for medically appropriate care, especially when we know that this can lead to worse outcomes,” Rep. Earl Blumenauer (D-Ore.) said in a Sept. 14 speech on the House floor. “The fundamental promise of Medicare Advantage is undermined when people are delaying care, getting sicker, and ultimately costing Medicare more money.”

Rep. Greg Murphy, MD (R-N.C.), spoke on the House floor that day as well, bringing up cases he has seen in his own urology practice in which prior authorization delays disrupted medical care. One patient wound up in the hospital with abscess after an insurer denied an antibiotic prescription, Rep. Murphy said.

But the Senate appears unlikely at this time to move the prior authorization bill as a standalone measure. Instead, the bill may become part of a larger legislative package focused on health care that the Senate Finance Committee intends to prepare later this year.

The House-passed bill would require insurer-run Medicare plans to respond to expedited requests for prior authorization of services within 24 hours and to other requests within 7 days. This bill also would establish an electronic program for prior authorizations and mandate increased transparency as to how insurers use this tool.
 

CBO: Cost of change would be billions

In seeking to mandate changes in prior authorization, lawmakers likely will need to contend with the issue of a $16 billion cumulative cost estimate for the bill from the Congressional Budget Office. Members of Congress often seek to offset new spending by pairing bills that add to expected costs for the federal government with ones expected to produce savings.

Unlike Rep. Blumenauer, Rep. Murphy, and other backers of the prior authorization streamlining bill, CBO staff estimates that making the mandated changes would raise federal spending, inasmuch as there would be “a greater use of services.”

On Sept. 14, CBO issued a one-page report on the costs of the bill. The CBO report concerns only the bill in question, as is common practice with the office’s estimates.

Prior authorization changes would begin in fiscal 2025 and would add $899 million in spending, or outlays, that year, CBO said. The annual costs from the streamlined prior authorization practices through fiscal 2026 to 2032 range from $1.6 billion to $2.7 billion.

Looking at the CBO estimate against a backdrop of total Medicare Advantage costs, though, may provide important context.

The increases in spending estimated by CBO may suggest that there would be little change in federal spending as a result of streamlining prior authorization practices. These estimates of increased annual spending of $1.6 billion–$2.7 billion are only a small fraction of the current annual cost of insurer-run Medicare, and they represent an even smaller share of the projected expense.

The federal government last year spent about $350 billion on insurer-run plans, excluding Part D drug plan payments, according to the Medicare Advisory Payment Commission (MedPAC).

As of 2021, about 27 million people were enrolled in these plans, accounting for about 46% of the total Medicare population. Enrollment has doubled since 2010, MedPAC said, and it is expected to continue to grow. By 2027, insurer-run Medicare could cover 50% of the program’s population, a figure that may reach 53% by 2031.

Federal payments to these plans will accelerate in the years ahead as insurers attract more people eligible for Medicare as customers. Payments to these private health plans could rise from an expected $418 billion this year to $940.6 billion by 2031, according to the most recent Medicare trustees report.

Good intentions, poor implementation?

Insurer-run Medicare has long enjoyed deep bipartisan support in Congress. That’s due in part to its potential for reducing spending on what are considered low-value treatments, or ones considered unlikely to provide a significant medical benefit, but Rep. Blumenauer is among the members of Congress who see insurer-run Medicare as a path for preserving the giant federal health program. Traditional Medicare has far fewer restrictions on services, which sometimes opens a path for tests and treatments that offer less value for patients.

“I believe that the way traditional fee-for-service Medicare operates is not sustainable and that Medicare Advantage is one of the tools we can use to demonstrate how we can incentivize value,” Rep. Blumenauer said on the House floor. “But this is only possible when the program operates as intended. I have been deeply concerned about the reports of delays in care” caused by the clunky prior authorization processes.

He highlighted a recent report from the internal watchdog group for the Department of Health & Human Services that raises concerns about denials of appropriate care. About 18% of a set of payment denials examined by the Office of Inspector General of HHS in April actually met Medicare coverage rules and plan billing rules.

“For patients and their families, being told that you need to wait longer for care that your doctor tells you that you need is incredibly frustrating and frightening,” Rep. Blumenauer said. “There’s no comfort to be found in the fact that your insurance company needs time to decide if your doctor is right.”
 

Trends in prior authorization

The CBO report does not provide detail on what kind of medical spending would increase under a streamlined prior authorization process in insurer-run Medicare plans.

From trends reported in prior authorization, though, two factors could be at play in what appear to be relatively small estimated increases in Medicare spending from streamlined prior authorization.

One is the work already underway to create less burdensome electronic systems for these requests, such as the Fast Prior Authorization Technology Highway initiative run by the trade association America’s Health Insurance Plans.

The other factor could be the number of cases in which prior authorization merely causes delays in treatments and tests and thus simply postpones spending while adding to clinicians’ administrative work.

An analysis of prior authorization requests for dermatologic practices affiliated with the University of Utah may represent an extreme example. In a report published in JAMA Dermatology in 2020, researchers described what happened with requests made during 1 month, September 2016.

The approval rate for procedures was 99.6% – 100% (95 of 95) for Mohs surgery, and 96% (130 of 131, with 4 additional cases pending) for excisions. These findings supported calls for simplifying prior authorization procedures, “perhaps first by eliminating unnecessary PAs [prior authorizations] and appeals,” Aaron M. Secrest, MD, PhD, of the University of Utah, Salt Lake City, and coauthors wrote in the article.

Still, there is some evidence that insurer-run Medicare policies reduce the use of low-value care.

In a study published in JAMA Health Forum, Emily Boudreau, PhD, of insurer Humana Inc, and coauthors from Tufts University, Boston, and the University of Pennsylvania, Philadelphia investigated whether insurer-run Medicare could do a better job in reducing the amount of low-value care delivered than the traditional program. They analyzed a set of claims data from 2017 to 2019 for people enrolled in insurer-run and traditional Medicare.

They reported a rate of 23.07 low-value services provided per 100 people in insurer-run Medicare, compared with 25.39 for those in traditional Medicare. Some of the biggest differences reported in the article were in cancer screenings for older people.

As an example, the U.S. Preventive Services Task Force recommends that women older than 65 years not be screened for cervical cancer if they have undergone adequate screening in the past and are not at high risk for cervical cancer. There was an annual count of 1.76 screenings for cervical cancer per 100 women older than 65 in the insurer-run Medicare group versus 3.18 for those in traditional Medicare.

The Better Medicare Alliance issued a statement in favor of the House passage of the Improving Seniors’ Timely Access to Care Act.

In it, the group said the measure would “modernize prior authorization while protecting its essential function in facilitating safe, high-value, evidence-based care.” The alliance promotes use of insurer-run Medicare. The board of the Better Medicare Alliance includes executives who serve with firms that run Advantage plans as well as medical organizations and universities.

“With studies showing that up to one-quarter of all health care expenditures are wasted on services with no benefit to the patient, we need a robust, next-generation prior authorization program to deter low-value, and even harmful, care while protecting access to needed treatment and effective therapies,” said A. Mark Fendrick, MD, director of the University of Michigan’s Center for Value-Based Insurance Design in Ann Arbor, in a statement issued by the Better Medicare Alliance. He is a member of the group’s council of scholars.

On the House floor on September 14, Rep. Ami Bera, MD (D-Calif.), said he has heard from former colleagues and his medical school classmates that they now spend as much as 40% of their time on administrative work. These distractions from patient care are helping drive physicians away from the practice of medicine.

Still, the internist defended the basic premise of prior authorization while strongly appealing for better systems of handling it.

“Yes, there is a role for prior authorization in limited cases. There is also a role to go back and retrospectively look at how care is being delivered,” Rep. Bera said. “But what is happening today is a travesty. It wasn’t the intention of prior authorization. It is a prior authorization process gone awry.”

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

The path through the U.S. Senate is not yet certain for a bill intended to speed the prior authorization process of insurer-run Medicare Advantage plans, despite the measure having breezed through the House.

House leaders opted to move the Improving Seniors’ Timely Access to Care Act of 2021 (HR 3173) without requiring a roll-call vote. The measure was passed on Sept. 14 by a voice vote, an approach used in general with only uncontroversial measures that have broad support. The bill has 191 Democratic and 135 Republican sponsors, representing about three-quarters of the members of the House.

Alicia Ault/Frontline Medical News

“There is no reason that patients should be waiting for medically appropriate care, especially when we know that this can lead to worse outcomes,” Rep. Earl Blumenauer (D-Ore.) said in a Sept. 14 speech on the House floor. “The fundamental promise of Medicare Advantage is undermined when people are delaying care, getting sicker, and ultimately costing Medicare more money.”

Rep. Greg Murphy, MD (R-N.C.), spoke on the House floor that day as well, bringing up cases he has seen in his own urology practice in which prior authorization delays disrupted medical care. One patient wound up in the hospital with abscess after an insurer denied an antibiotic prescription, Rep. Murphy said.

But the Senate appears unlikely at this time to move the prior authorization bill as a standalone measure. Instead, the bill may become part of a larger legislative package focused on health care that the Senate Finance Committee intends to prepare later this year.

The House-passed bill would require insurer-run Medicare plans to respond to expedited requests for prior authorization of services within 24 hours and to other requests within 7 days. This bill also would establish an electronic program for prior authorizations and mandate increased transparency as to how insurers use this tool.
 

CBO: Cost of change would be billions

In seeking to mandate changes in prior authorization, lawmakers likely will need to contend with the issue of a $16 billion cumulative cost estimate for the bill from the Congressional Budget Office. Members of Congress often seek to offset new spending by pairing bills that add to expected costs for the federal government with ones expected to produce savings.

Unlike Rep. Blumenauer, Rep. Murphy, and other backers of the prior authorization streamlining bill, CBO staff estimates that making the mandated changes would raise federal spending, inasmuch as there would be “a greater use of services.”

On Sept. 14, CBO issued a one-page report on the costs of the bill. The CBO report concerns only the bill in question, as is common practice with the office’s estimates.

Prior authorization changes would begin in fiscal 2025 and would add $899 million in spending, or outlays, that year, CBO said. The annual costs from the streamlined prior authorization practices through fiscal 2026 to 2032 range from $1.6 billion to $2.7 billion.

Looking at the CBO estimate against a backdrop of total Medicare Advantage costs, though, may provide important context.

The increases in spending estimated by CBO may suggest that there would be little change in federal spending as a result of streamlining prior authorization practices. These estimates of increased annual spending of $1.6 billion–$2.7 billion are only a small fraction of the current annual cost of insurer-run Medicare, and they represent an even smaller share of the projected expense.

The federal government last year spent about $350 billion on insurer-run plans, excluding Part D drug plan payments, according to the Medicare Advisory Payment Commission (MedPAC).

As of 2021, about 27 million people were enrolled in these plans, accounting for about 46% of the total Medicare population. Enrollment has doubled since 2010, MedPAC said, and it is expected to continue to grow. By 2027, insurer-run Medicare could cover 50% of the program’s population, a figure that may reach 53% by 2031.

Federal payments to these plans will accelerate in the years ahead as insurers attract more people eligible for Medicare as customers. Payments to these private health plans could rise from an expected $418 billion this year to $940.6 billion by 2031, according to the most recent Medicare trustees report.

Good intentions, poor implementation?

Insurer-run Medicare has long enjoyed deep bipartisan support in Congress. That’s due in part to its potential for reducing spending on what are considered low-value treatments, or ones considered unlikely to provide a significant medical benefit, but Rep. Blumenauer is among the members of Congress who see insurer-run Medicare as a path for preserving the giant federal health program. Traditional Medicare has far fewer restrictions on services, which sometimes opens a path for tests and treatments that offer less value for patients.

“I believe that the way traditional fee-for-service Medicare operates is not sustainable and that Medicare Advantage is one of the tools we can use to demonstrate how we can incentivize value,” Rep. Blumenauer said on the House floor. “But this is only possible when the program operates as intended. I have been deeply concerned about the reports of delays in care” caused by the clunky prior authorization processes.

He highlighted a recent report from the internal watchdog group for the Department of Health & Human Services that raises concerns about denials of appropriate care. About 18% of a set of payment denials examined by the Office of Inspector General of HHS in April actually met Medicare coverage rules and plan billing rules.

“For patients and their families, being told that you need to wait longer for care that your doctor tells you that you need is incredibly frustrating and frightening,” Rep. Blumenauer said. “There’s no comfort to be found in the fact that your insurance company needs time to decide if your doctor is right.”
 

Trends in prior authorization

The CBO report does not provide detail on what kind of medical spending would increase under a streamlined prior authorization process in insurer-run Medicare plans.

From trends reported in prior authorization, though, two factors could be at play in what appear to be relatively small estimated increases in Medicare spending from streamlined prior authorization.

One is the work already underway to create less burdensome electronic systems for these requests, such as the Fast Prior Authorization Technology Highway initiative run by the trade association America’s Health Insurance Plans.

The other factor could be the number of cases in which prior authorization merely causes delays in treatments and tests and thus simply postpones spending while adding to clinicians’ administrative work.

An analysis of prior authorization requests for dermatologic practices affiliated with the University of Utah may represent an extreme example. In a report published in JAMA Dermatology in 2020, researchers described what happened with requests made during 1 month, September 2016.

The approval rate for procedures was 99.6% – 100% (95 of 95) for Mohs surgery, and 96% (130 of 131, with 4 additional cases pending) for excisions. These findings supported calls for simplifying prior authorization procedures, “perhaps first by eliminating unnecessary PAs [prior authorizations] and appeals,” Aaron M. Secrest, MD, PhD, of the University of Utah, Salt Lake City, and coauthors wrote in the article.

Still, there is some evidence that insurer-run Medicare policies reduce the use of low-value care.

In a study published in JAMA Health Forum, Emily Boudreau, PhD, of insurer Humana Inc, and coauthors from Tufts University, Boston, and the University of Pennsylvania, Philadelphia investigated whether insurer-run Medicare could do a better job in reducing the amount of low-value care delivered than the traditional program. They analyzed a set of claims data from 2017 to 2019 for people enrolled in insurer-run and traditional Medicare.

They reported a rate of 23.07 low-value services provided per 100 people in insurer-run Medicare, compared with 25.39 for those in traditional Medicare. Some of the biggest differences reported in the article were in cancer screenings for older people.

As an example, the U.S. Preventive Services Task Force recommends that women older than 65 years not be screened for cervical cancer if they have undergone adequate screening in the past and are not at high risk for cervical cancer. There was an annual count of 1.76 screenings for cervical cancer per 100 women older than 65 in the insurer-run Medicare group versus 3.18 for those in traditional Medicare.

The Better Medicare Alliance issued a statement in favor of the House passage of the Improving Seniors’ Timely Access to Care Act.

In it, the group said the measure would “modernize prior authorization while protecting its essential function in facilitating safe, high-value, evidence-based care.” The alliance promotes use of insurer-run Medicare. The board of the Better Medicare Alliance includes executives who serve with firms that run Advantage plans as well as medical organizations and universities.

“With studies showing that up to one-quarter of all health care expenditures are wasted on services with no benefit to the patient, we need a robust, next-generation prior authorization program to deter low-value, and even harmful, care while protecting access to needed treatment and effective therapies,” said A. Mark Fendrick, MD, director of the University of Michigan’s Center for Value-Based Insurance Design in Ann Arbor, in a statement issued by the Better Medicare Alliance. He is a member of the group’s council of scholars.

On the House floor on September 14, Rep. Ami Bera, MD (D-Calif.), said he has heard from former colleagues and his medical school classmates that they now spend as much as 40% of their time on administrative work. These distractions from patient care are helping drive physicians away from the practice of medicine.

Still, the internist defended the basic premise of prior authorization while strongly appealing for better systems of handling it.

“Yes, there is a role for prior authorization in limited cases. There is also a role to go back and retrospectively look at how care is being delivered,” Rep. Bera said. “But what is happening today is a travesty. It wasn’t the intention of prior authorization. It is a prior authorization process gone awry.”

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

Three large physician groups joined a class action lawsuit against Cigna, arguing that there has been intentional underpayment of medical claims submitted by patients for services covered through MultiPlan, the nation’s largest third-party network.

The American Medical Association, the Medical Society of New Jersey, and the Washington State Medical Association on Sept. 12 entered into a legal battle between the giant insurers and patients.

At issue are claims involving the firm MultiPlan as an intermediary. Cigna had not responded to this news organization at press time following multiple requests for comment.

According to the legal complaint AMA and the two state medical societies joined, MultiPlan has contracts with more than 1.2 million clinicians. Under these agreements, medical professionals agree to accept a set percentage of billed charges as payment in full, while not holding patients responsible for the difference between the original billed charges and the discounted rate.

But the complaint alleges that MultiPlan failed to stick with that bargain. In a statement, AMA President Jack Resneck Jr, MD, said the physician groups joined the legal action “to shed light on Cigna’s misconduct and create remedies so that patients and physicians can look forward to getting what they are promised.”

Dr. Resneck said Cigna’s approach “is riddled with conflicts of interest and manipulations that routinely shortchanged payments to MultiPlan Network physicians and interfered with the patient-physician relationship by ignoring the MultiPlan contracts and making incorrect statements to patients about their liability for the unpaid portion of the billed charges.”

According to the complaint, Cigna used a company called Zelis to “unilaterally re-price’’ claims at an amount far lower than that called for by the MultiPlan Contract. The three cases cited in the lawsuit stem from a 2017 spine surgery in Washington and 2018 orthopedic and 2020 breast reconstruction surgeries in New Jersey. The decisions to ignore the previous agreements and cut the reimbursement led the physicians involved to eventually bill patients for some of the money in dispute, according to the complaint.

“The providers were left in a very untenable situation,” D. Brian Hufford, an attorney involved in the case, told this news organization. “Their only choice was to go after the insurance company and sue them or they have to go after the patient. That interferes with the patient-doctor relationship.”

Mr. Hufford, who’s a partner at law firm Zuckerman Spaeder, said that these kinds of cases fall beyond the protections provided by the No Surprises Act. Plaintiffs in these cases were enrolled in what are called self-insured plans provided by employers, through which they were supposed to be allowed to seek out-of-network care.

Highly concerning are the messages that insurers send to patients through explanation of benefits (EOB) statements, Mr. Hufford said. Thus in this case against Cigna, physicians and patients have the “same interest in trying to make sure the insurance companies are paying the appropriate amounts for these services,” he said.

Cigna “is telling the patients that the provider has accepted something, and that the patient does not have to worry about paying for that, when in fact that’s not true,” Mr. Hufford said. “That goes beyond merely not complying with the plan documents, but also engaging in conduct that we believe was inappropriate.”

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

Three large physician groups joined a class action lawsuit against Cigna, arguing that there has been intentional underpayment of medical claims submitted by patients for services covered through MultiPlan, the nation’s largest third-party network.

The American Medical Association, the Medical Society of New Jersey, and the Washington State Medical Association on Sept. 12 entered into a legal battle between the giant insurers and patients.

At issue are claims involving the firm MultiPlan as an intermediary. Cigna had not responded to this news organization at press time following multiple requests for comment.

According to the legal complaint AMA and the two state medical societies joined, MultiPlan has contracts with more than 1.2 million clinicians. Under these agreements, medical professionals agree to accept a set percentage of billed charges as payment in full, while not holding patients responsible for the difference between the original billed charges and the discounted rate.

But the complaint alleges that MultiPlan failed to stick with that bargain. In a statement, AMA President Jack Resneck Jr, MD, said the physician groups joined the legal action “to shed light on Cigna’s misconduct and create remedies so that patients and physicians can look forward to getting what they are promised.”

Dr. Resneck said Cigna’s approach “is riddled with conflicts of interest and manipulations that routinely shortchanged payments to MultiPlan Network physicians and interfered with the patient-physician relationship by ignoring the MultiPlan contracts and making incorrect statements to patients about their liability for the unpaid portion of the billed charges.”

According to the complaint, Cigna used a company called Zelis to “unilaterally re-price’’ claims at an amount far lower than that called for by the MultiPlan Contract. The three cases cited in the lawsuit stem from a 2017 spine surgery in Washington and 2018 orthopedic and 2020 breast reconstruction surgeries in New Jersey. The decisions to ignore the previous agreements and cut the reimbursement led the physicians involved to eventually bill patients for some of the money in dispute, according to the complaint.

“The providers were left in a very untenable situation,” D. Brian Hufford, an attorney involved in the case, told this news organization. “Their only choice was to go after the insurance company and sue them or they have to go after the patient. That interferes with the patient-doctor relationship.”

Mr. Hufford, who’s a partner at law firm Zuckerman Spaeder, said that these kinds of cases fall beyond the protections provided by the No Surprises Act. Plaintiffs in these cases were enrolled in what are called self-insured plans provided by employers, through which they were supposed to be allowed to seek out-of-network care.

Highly concerning are the messages that insurers send to patients through explanation of benefits (EOB) statements, Mr. Hufford said. Thus in this case against Cigna, physicians and patients have the “same interest in trying to make sure the insurance companies are paying the appropriate amounts for these services,” he said.

Cigna “is telling the patients that the provider has accepted something, and that the patient does not have to worry about paying for that, when in fact that’s not true,” Mr. Hufford said. “That goes beyond merely not complying with the plan documents, but also engaging in conduct that we believe was inappropriate.”

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

Three large physician groups joined a class action lawsuit against Cigna, arguing that there has been intentional underpayment of medical claims submitted by patients for services covered through MultiPlan, the nation’s largest third-party network.

The American Medical Association, the Medical Society of New Jersey, and the Washington State Medical Association on Sept. 12 entered into a legal battle between the giant insurers and patients.

At issue are claims involving the firm MultiPlan as an intermediary. Cigna had not responded to this news organization at press time following multiple requests for comment.

According to the legal complaint AMA and the two state medical societies joined, MultiPlan has contracts with more than 1.2 million clinicians. Under these agreements, medical professionals agree to accept a set percentage of billed charges as payment in full, while not holding patients responsible for the difference between the original billed charges and the discounted rate.

But the complaint alleges that MultiPlan failed to stick with that bargain. In a statement, AMA President Jack Resneck Jr, MD, said the physician groups joined the legal action “to shed light on Cigna’s misconduct and create remedies so that patients and physicians can look forward to getting what they are promised.”

Dr. Resneck said Cigna’s approach “is riddled with conflicts of interest and manipulations that routinely shortchanged payments to MultiPlan Network physicians and interfered with the patient-physician relationship by ignoring the MultiPlan contracts and making incorrect statements to patients about their liability for the unpaid portion of the billed charges.”

According to the complaint, Cigna used a company called Zelis to “unilaterally re-price’’ claims at an amount far lower than that called for by the MultiPlan Contract. The three cases cited in the lawsuit stem from a 2017 spine surgery in Washington and 2018 orthopedic and 2020 breast reconstruction surgeries in New Jersey. The decisions to ignore the previous agreements and cut the reimbursement led the physicians involved to eventually bill patients for some of the money in dispute, according to the complaint.

“The providers were left in a very untenable situation,” D. Brian Hufford, an attorney involved in the case, told this news organization. “Their only choice was to go after the insurance company and sue them or they have to go after the patient. That interferes with the patient-doctor relationship.”

Mr. Hufford, who’s a partner at law firm Zuckerman Spaeder, said that these kinds of cases fall beyond the protections provided by the No Surprises Act. Plaintiffs in these cases were enrolled in what are called self-insured plans provided by employers, through which they were supposed to be allowed to seek out-of-network care.

Highly concerning are the messages that insurers send to patients through explanation of benefits (EOB) statements, Mr. Hufford said. Thus in this case against Cigna, physicians and patients have the “same interest in trying to make sure the insurance companies are paying the appropriate amounts for these services,” he said.

Cigna “is telling the patients that the provider has accepted something, and that the patient does not have to worry about paying for that, when in fact that’s not true,” Mr. Hufford said. “That goes beyond merely not complying with the plan documents, but also engaging in conduct that we believe was inappropriate.”

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

The Centers for Disease Control and Prevention on Sept. 1 approved the use of vaccines designed to target both Omicron and the older variants of the coronavirus, a step that may aid a goal of a widespread immunization campaign before winter arrives in the United States.

The CDC’s Advisory Committee on Immunization Practices voted 13-1 on two separate questions. One sought the panel’s backing for the use of a single dose of a new version of the Pfizer COVID-19 vaccines for people aged 12 and older. The second question dealt with a single dose of the reworked Moderna vaccine for people aged 18 and older.

The federal government wants to speed use of revamped COVID-19 shots, which the Food and Drug Administration on Sept. 1 cleared for use in the United States. Hours later, CDC Director Rochelle Walensky, MD, agreed with the panel’s recommendation. 

“The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant,” Dr. Walensky said in a statement. “They can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants. This recommendation followed a comprehensive scientific evaluation and robust scientific discussion. If you are eligible, there is no bad time to get your COVID-19 booster and I strongly encourage you to receive it.”

The FDA vote on Aug. 31 expanded the emergency use authorization EUA for both Moderna and Pfizer’s original COVID-19 vaccines. The new products are also called “updated boosters.” Both contain two mRNA components of SARS-CoV-2 virus, one of the original strain  and another that is found in the BA.4 and BA.5 strains of the Omicron variant, the FDA said.

Basically, the FDA cleared the way for these new boosters after it relied heavily on results of certain blood tests that suggested an immune response boost from the new formulas, plus 18 months of mostly safe use of the original versions of the shots.

What neither the FDA nor the CDC has, however, is evidence from studies in humans on how well these new vaccines work or whether they are as safe as the originals. But the FDA did consider clinical evidence for the older shots and results from studies on the new boosters that were done in mice.

ACIP Committee member Pablo Sanchez, MD, of Ohio State University was the sole “no” vote on each question.  

“It’s a new vaccine, it’s a new platform. There’s a lot of hesitancy already. We need the human data,”  Dr. Sanchez said.

Dr. Sanchez did not doubt that the newer versions of the vaccine would prove safe.

“I personally am in the age group where I’m at high risk and I’m almost sure that I will receive it,” Dr. Sanchez said. “I just feel that this was a bit premature, and I wish that we had seen that data. Having said that, I am comfortable that the vaccine will likely be safe like the others.”

Dr. Sanchez was not alone in raising concerns about backing new COVID-19 shots for which there is not direct clinical evidence from human studies.

Committee member Sarah Long, MD, of Drexel University in Philadelphia, said during the discussion she would “reluctantly” vote in favor of the updated vaccines. She said she believes they will have the potential to reduce hospitalizations and even deaths, even with questions remaining about the data.

Dr. Long joined other committee members in pointing to the approach to updating flu vaccines as a model. In an attempt to keep ahead of influenza, companies seek to defeat new strains through tweaks to their FDA-approved vaccines. There is not much clinical information available about these revised products, Dr. Long said. She compared it to remodeling an existing home.

“It is the same scaffolding, part of the same roof, we’re just putting in some dormers and windows,” with the revisions to the flu vaccine, she said.

Earlier in the day, committee member Jamie Loehr, MD,  of Cayuga Family Medicine in Ithaca, N.Y., also used changes to the annual flu shots as the model for advancing COVID-19 shots.

“So after thinking about it, I am comfortable even though we don’t have human data,” he said.

There were several questions during the meeting about why the FDA had not convened a meeting of its Vaccines and Related Biological Products Advisory Committee (regarding these specific bivalent vaccines). Typically, the FDA committee of advisers considers new vaccines before the agency authorizes their use. In this case, however, the agency acted on its own.

The FDA said the committee considered the new, bivalent COVID-19 boosters in earlier meetings and that was enough outside feedback.

But holding a meeting of advisers on these specific products could have helped build public confidence in these medicines, Dorit Reiss, PhD, of the University of California Hastings College of Law, said during the public comment session of the CDC advisers’ meeting.

“We could wish the vaccines were more effective against infection, but they’re safe and they prevent hospitalization and death,” she said.

The Department of Health and Human Services anticipated the backing of ACIP. The Administration for Strategic Preparedness and Response  on Aug. 31 began distributing “millions of doses of the updated booster to tens of thousands of sites nationwide,” Jason Roos, PhD,  chief operating officer for HHS Coordination Operations and Response Element, wrote in a blog.

“These boosters will be available at tens of thousands of vaccination sites ... including local pharmacies, their physicians’ offices, and vaccine centers operated by state and local health officials,”Dr. Roos wrote.

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

The Centers for Disease Control and Prevention on Sept. 1 approved the use of vaccines designed to target both Omicron and the older variants of the coronavirus, a step that may aid a goal of a widespread immunization campaign before winter arrives in the United States.

The CDC’s Advisory Committee on Immunization Practices voted 13-1 on two separate questions. One sought the panel’s backing for the use of a single dose of a new version of the Pfizer COVID-19 vaccines for people aged 12 and older. The second question dealt with a single dose of the reworked Moderna vaccine for people aged 18 and older.

The federal government wants to speed use of revamped COVID-19 shots, which the Food and Drug Administration on Sept. 1 cleared for use in the United States. Hours later, CDC Director Rochelle Walensky, MD, agreed with the panel’s recommendation. 

“The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant,” Dr. Walensky said in a statement. “They can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants. This recommendation followed a comprehensive scientific evaluation and robust scientific discussion. If you are eligible, there is no bad time to get your COVID-19 booster and I strongly encourage you to receive it.”

The FDA vote on Aug. 31 expanded the emergency use authorization EUA for both Moderna and Pfizer’s original COVID-19 vaccines. The new products are also called “updated boosters.” Both contain two mRNA components of SARS-CoV-2 virus, one of the original strain  and another that is found in the BA.4 and BA.5 strains of the Omicron variant, the FDA said.

Basically, the FDA cleared the way for these new boosters after it relied heavily on results of certain blood tests that suggested an immune response boost from the new formulas, plus 18 months of mostly safe use of the original versions of the shots.

What neither the FDA nor the CDC has, however, is evidence from studies in humans on how well these new vaccines work or whether they are as safe as the originals. But the FDA did consider clinical evidence for the older shots and results from studies on the new boosters that were done in mice.

ACIP Committee member Pablo Sanchez, MD, of Ohio State University was the sole “no” vote on each question.  

“It’s a new vaccine, it’s a new platform. There’s a lot of hesitancy already. We need the human data,”  Dr. Sanchez said.

Dr. Sanchez did not doubt that the newer versions of the vaccine would prove safe.

“I personally am in the age group where I’m at high risk and I’m almost sure that I will receive it,” Dr. Sanchez said. “I just feel that this was a bit premature, and I wish that we had seen that data. Having said that, I am comfortable that the vaccine will likely be safe like the others.”

Dr. Sanchez was not alone in raising concerns about backing new COVID-19 shots for which there is not direct clinical evidence from human studies.

Committee member Sarah Long, MD, of Drexel University in Philadelphia, said during the discussion she would “reluctantly” vote in favor of the updated vaccines. She said she believes they will have the potential to reduce hospitalizations and even deaths, even with questions remaining about the data.

Dr. Long joined other committee members in pointing to the approach to updating flu vaccines as a model. In an attempt to keep ahead of influenza, companies seek to defeat new strains through tweaks to their FDA-approved vaccines. There is not much clinical information available about these revised products, Dr. Long said. She compared it to remodeling an existing home.

“It is the same scaffolding, part of the same roof, we’re just putting in some dormers and windows,” with the revisions to the flu vaccine, she said.

Earlier in the day, committee member Jamie Loehr, MD,  of Cayuga Family Medicine in Ithaca, N.Y., also used changes to the annual flu shots as the model for advancing COVID-19 shots.

“So after thinking about it, I am comfortable even though we don’t have human data,” he said.

There were several questions during the meeting about why the FDA had not convened a meeting of its Vaccines and Related Biological Products Advisory Committee (regarding these specific bivalent vaccines). Typically, the FDA committee of advisers considers new vaccines before the agency authorizes their use. In this case, however, the agency acted on its own.

The FDA said the committee considered the new, bivalent COVID-19 boosters in earlier meetings and that was enough outside feedback.

But holding a meeting of advisers on these specific products could have helped build public confidence in these medicines, Dorit Reiss, PhD, of the University of California Hastings College of Law, said during the public comment session of the CDC advisers’ meeting.

“We could wish the vaccines were more effective against infection, but they’re safe and they prevent hospitalization and death,” she said.

The Department of Health and Human Services anticipated the backing of ACIP. The Administration for Strategic Preparedness and Response  on Aug. 31 began distributing “millions of doses of the updated booster to tens of thousands of sites nationwide,” Jason Roos, PhD,  chief operating officer for HHS Coordination Operations and Response Element, wrote in a blog.

“These boosters will be available at tens of thousands of vaccination sites ... including local pharmacies, their physicians’ offices, and vaccine centers operated by state and local health officials,”Dr. Roos wrote.

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

The Centers for Disease Control and Prevention on Sept. 1 approved the use of vaccines designed to target both Omicron and the older variants of the coronavirus, a step that may aid a goal of a widespread immunization campaign before winter arrives in the United States.

The CDC’s Advisory Committee on Immunization Practices voted 13-1 on two separate questions. One sought the panel’s backing for the use of a single dose of a new version of the Pfizer COVID-19 vaccines for people aged 12 and older. The second question dealt with a single dose of the reworked Moderna vaccine for people aged 18 and older.

The federal government wants to speed use of revamped COVID-19 shots, which the Food and Drug Administration on Sept. 1 cleared for use in the United States. Hours later, CDC Director Rochelle Walensky, MD, agreed with the panel’s recommendation. 

“The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant,” Dr. Walensky said in a statement. “They can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants. This recommendation followed a comprehensive scientific evaluation and robust scientific discussion. If you are eligible, there is no bad time to get your COVID-19 booster and I strongly encourage you to receive it.”

The FDA vote on Aug. 31 expanded the emergency use authorization EUA for both Moderna and Pfizer’s original COVID-19 vaccines. The new products are also called “updated boosters.” Both contain two mRNA components of SARS-CoV-2 virus, one of the original strain  and another that is found in the BA.4 and BA.5 strains of the Omicron variant, the FDA said.

Basically, the FDA cleared the way for these new boosters after it relied heavily on results of certain blood tests that suggested an immune response boost from the new formulas, plus 18 months of mostly safe use of the original versions of the shots.

What neither the FDA nor the CDC has, however, is evidence from studies in humans on how well these new vaccines work or whether they are as safe as the originals. But the FDA did consider clinical evidence for the older shots and results from studies on the new boosters that were done in mice.

ACIP Committee member Pablo Sanchez, MD, of Ohio State University was the sole “no” vote on each question.  

“It’s a new vaccine, it’s a new platform. There’s a lot of hesitancy already. We need the human data,”  Dr. Sanchez said.

Dr. Sanchez did not doubt that the newer versions of the vaccine would prove safe.

“I personally am in the age group where I’m at high risk and I’m almost sure that I will receive it,” Dr. Sanchez said. “I just feel that this was a bit premature, and I wish that we had seen that data. Having said that, I am comfortable that the vaccine will likely be safe like the others.”

Dr. Sanchez was not alone in raising concerns about backing new COVID-19 shots for which there is not direct clinical evidence from human studies.

Committee member Sarah Long, MD, of Drexel University in Philadelphia, said during the discussion she would “reluctantly” vote in favor of the updated vaccines. She said she believes they will have the potential to reduce hospitalizations and even deaths, even with questions remaining about the data.

Dr. Long joined other committee members in pointing to the approach to updating flu vaccines as a model. In an attempt to keep ahead of influenza, companies seek to defeat new strains through tweaks to their FDA-approved vaccines. There is not much clinical information available about these revised products, Dr. Long said. She compared it to remodeling an existing home.

“It is the same scaffolding, part of the same roof, we’re just putting in some dormers and windows,” with the revisions to the flu vaccine, she said.

Earlier in the day, committee member Jamie Loehr, MD,  of Cayuga Family Medicine in Ithaca, N.Y., also used changes to the annual flu shots as the model for advancing COVID-19 shots.

“So after thinking about it, I am comfortable even though we don’t have human data,” he said.

There were several questions during the meeting about why the FDA had not convened a meeting of its Vaccines and Related Biological Products Advisory Committee (regarding these specific bivalent vaccines). Typically, the FDA committee of advisers considers new vaccines before the agency authorizes their use. In this case, however, the agency acted on its own.

The FDA said the committee considered the new, bivalent COVID-19 boosters in earlier meetings and that was enough outside feedback.

But holding a meeting of advisers on these specific products could have helped build public confidence in these medicines, Dorit Reiss, PhD, of the University of California Hastings College of Law, said during the public comment session of the CDC advisers’ meeting.

“We could wish the vaccines were more effective against infection, but they’re safe and they prevent hospitalization and death,” she said.

The Department of Health and Human Services anticipated the backing of ACIP. The Administration for Strategic Preparedness and Response  on Aug. 31 began distributing “millions of doses of the updated booster to tens of thousands of sites nationwide,” Jason Roos, PhD,  chief operating officer for HHS Coordination Operations and Response Element, wrote in a blog.

“These boosters will be available at tens of thousands of vaccination sites ... including local pharmacies, their physicians’ offices, and vaccine centers operated by state and local health officials,”Dr. Roos wrote.

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

Changes in Medicare law will help some patients who need costly rheumatology treatments, including several medicines for which competition has been kept in check for many years.

In fact, this field of medicine includes prime examples of the kinds of products that drove Congress to give the giant federal health program leverage to try to restrain rising pharmaceutical costs through negotiations. The Inflation Reduction Act, signed into law by President Joe Biden on Aug. 16, also provides some fairly quick aid for people enrolled in Medicare who struggle with pharmacy bills.

Getty

As described in an official summary from the Congressional Research Service, the law establishes:

• A cap on annual Medicare Part D out-of-pocket spending that starts in 2025 at $2,000, with planned annual adjustments thereafter.
• A limit on cost-sharing under Medicare Part D for a month’s supply of covered insulin products at $35 for 2023 through 2025, with plans for continued limits on this cost in the years after pegged to negotiated prices.
• A program under which drug manufacturers provide discounts to beneficiaries who have incurred costs above the annual deductible beginning in 2025.
• A requirement that drugmakers issue rebates to Medicare for certain brand-name drugs covered without generic equivalents for which prices increase faster than inflation.
• An obligation for Medicare Part D plans to pay for adult vaccines that are recommended by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices without requiring cost sharing.

The law’s marquee health provision sets the stage for Medicare, the nation’s largest purchaser of drugs, for the first time to leverage its clout directly in negotiating for lower costs for medicines. Democrats sought to build what amount to guardrails into this program, seeking to spare from competition new and innovative drugs and ones developed by smaller companies. Drugs likely to soon face competition from copycat versions also would fall outside of the pool for negotiations.

In effect, the design of the program would allow Medicare to negotiate in the future in cases such as those seen in recent years with blockbuster medicines often in rheumatology. That’s due in a large part to legal challenges that have helped thwart the introduction of copycat versions of these kinds of products known as biosimilars.

Etanercept (Enbrel) has been sold in the United States since 1998 and adalimumab (Humira) since 2003. Both products face competition from copycat versions called biosimilars in other nations, but the introductions of these products have been delayed in the United States until 2029 for etanercept and 2023 for adalimumab, the Office of Inspector General for the Department of Health & Human Services said in a March 2022 report. The OIG said in the report that the combined 2019 Medicare Part D tab for the two biologics was more than $5 billion.

Rheumatology drugs rival cancer medicines for dominance among the most expensive drugs for people enrolled in Medicare. The average 2020 spending for the most widely used forms of adalimumab by people in Medicare’s Part D pharmacy program topped $51,000, according to federal data. The price per dosage-unit for the drug rose about 7% from 2019 to 2020.

The pharmaceutical industry defends the high introductory costs of medicines and subsequent rising prices as necessary payback for research on products sold and the ones still in development. Since the initial Food and Drug Administration approval of adalimumab on Dec. 31, 2002, Abbott Laboratories and its AbbVie spin-off have made changes to the drug’s administration and paid for studies to expand its approved indications.

Still, the investment in adalimumab appears to have been paid well.

Abbott Labs acquired adalimumab as part of its purchase of BASF’s pharmaceutical operations in 2001, a purchase that also included the thyroid drug Synthroid. Abbott paid $7.2 billion, or roughly $12 billion in current dollars. In 2021 alone, Humira sales were $20.7 billion, with the United States accounting for $17.3 billion of the product’s revenue.
 

Losing access to treatment when moving to Medicare

Sue Lee of Crestwood, Ky., is among the patients waiting to see if the changes in Medicare law might allow her to again afford adalimumab. For now, Ms. Lee said she is hoping her plaque psoriasis stays manageable with the topical ointments and moisturizers she has been using since losing access to adalimumab. Ms. Lee, 80, took the medicine during her working years for her plaque psoriasis.

“I told people: ‘I’m on the wonder drug. Look at me. I can show my skin now. I don’t have all of these sores,’ ” she said in an interview.

But after she retired at 75, she was shocked at the tab she faced after switching from private insurance to Medicare. She said it could have cost her close to $10,000 a year to take Humira. Ms. Lee’s Social Security earnings make her ineligible for certain assistance with drug costs.

“I cried a lot,” she said about the loss of affordable access to the drug.
 

What’s the path ahead?

The American College of Rheumatology and the Coalition of State Rheumatology Organizations are among the physician groups that pressed Congress for years for action to lower drug costs. Their members have been on the frontline of the crisis in the United States among patients unable to afford medicines.

“The financial burden of skyrocketing drug prices has forced many of our patients to spread their treatment out longer than prescribed, delay care, abandon prescriptions, or forgo treatment entirely – all of which risks flare-ups, disease regression, permanent disability, and even premature death,” said Blair Solow, MD, chair of the ACR’s Government Affairs Committee, in a statement on the new Medicare provisions.

In an interview, Dr. Solow, an assistant professor of medicine in the division of rheumatic diseases at University of Texas Southwestern Medical Center, Dallas, noted that there are concerns about how changes in Medicare drug pricing might affect future development of medicines. This has been a chief criticism of the pharmaceutical industry of efforts to allow Medicare to negotiate for lower prices.

“Of note, drug companies research, create, and produce medications that will perform well in the market, not necessarily those that may be most needed,” Dr. Solow wrote. “We can hope the new medications put forth by manufacturers are those that improve the lives of patients.”

In July, the Congressional Budget Office released a report on an earlier version of the Democrats’ plans for Medicare drug negotiations that suggested the potential loss to drugmakers’ productivity may be relatively small. The CBO expects that about 1,300 drugs will be approved over the next 30 years. The legislation as proposed in July might reduce the tally by 15 drugs. The CBO said these estimates fell in the middle of the distribution of possible outcomes and are subject to uncertainty, and it is still working on an estimate of the expects effects of the final version of the law.

“CBO did not predict what kind of drugs would be affected or analyze the effects of forgone innovation on public health,” the agency said.

Dr. Solow also said there may be some challenges for physicians in explaining to patients the timeline for the new law’s Medicare provisions. People need to be aware of how long it will take to implement the plan and the potential for changes or delays.

“I think this is important, because the interpretation of the law can be done in a way that was not necessarily what Congress intended, and depending on the control of Congress and the Administration, this could impact downstream effects in how this law plays out,” she said in an interview.

CMS has substantial work ahead of it in choosing the drugs for which there will be subject to negotiations. The new law limits the number of drugs that can be negotiated to 10 annually in 2026, increasing to 20 drugs annually by 2029. Drugs would be eligible for negotiated prices from 9 years after drug approval or 13 years for biologics, until entry of a generic or biosimilar competitor.

The new law calls for taxes and other penalties for companies that refuse to negotiate or offer the agreed price, Thomas J. Hwang, MD; Aaron S. Kesselheim, MD, JD, MPH; and Benjamin N. Rome, MD, MPH, all of Harvard Medical School, Boston, wrote in an Aug. 19 viewpoint article in JAMA. U.S. lawmakers took a different approach to negotiations about drug prices than those used in other countries, they wrote.

“Notably, the Inflation Reduction Act shields new drugs from negotiated prices for the first 9-13 years on the market,” they wrote. “In contrast, most other peer countries typically negotiate drug prices at the time of market entry, and no peer country limits the number of drugs negotiated.”


 

Missed opportunities

Madelaine Feldman, MD, president of the CSRO and a rheumatologist in private practice with The Rheumatology Group in New Orleans, said in an interview that she welcomes many of the provisions of the new law, as they will help her rheumatology patients afford their medicine.

But she considers one of the provisions of the law to be a disappointment. The law further delays the start date for a federal rule intended to allow people on Medicare Part D to directly benefit from discounts negotiated on drugs. This is a point often overlooked in news reports on the law.

Insurers use what are called pharmacy benefit manager (PBM) services to obtain rebates on medicines, but they don’t fully or directly share these price reductions with people enrolled in Part D plans. Instead, people in the Part D plans have their cost sharing pegged closer to listed prices, the ones set before the rebates obtained by PBMs. The PBM industry argues that the rebates, often based on the list price of the drug, serve to keep monthly insurance premiums low. But there’s been concern about perverse incentives in this approach, where more expensive drugs are preferred by PBMs, leading to higher rebates.

Congress had already delayed its implementation of the PBM rule, which would apply savings more directly to patients, until 2027 and did so again in the Inflation Reduction Act.

Implementing this rule on Medicare Part D prescription drug rebates would be a help for patients struggling to pay for costly drugs, such as those used in rheumatology, Dr. Feldman said.

“It just doesn’t make any sense to hold off on these changes if you really want to cut Medicare’s beneficiaries’ cost sharing and attempt to stop the perverse incentive that puts higher priced drugs on Part D formularies,” she said.

Changes in Medicare law will help some patients who need costly rheumatology treatments, including several medicines for which competition has been kept in check for many years.

In fact, this field of medicine includes prime examples of the kinds of products that drove Congress to give the giant federal health program leverage to try to restrain rising pharmaceutical costs through negotiations. The Inflation Reduction Act, signed into law by President Joe Biden on Aug. 16, also provides some fairly quick aid for people enrolled in Medicare who struggle with pharmacy bills.

Getty

As described in an official summary from the Congressional Research Service, the law establishes:

• A cap on annual Medicare Part D out-of-pocket spending that starts in 2025 at $2,000, with planned annual adjustments thereafter.
• A limit on cost-sharing under Medicare Part D for a month’s supply of covered insulin products at $35 for 2023 through 2025, with plans for continued limits on this cost in the years after pegged to negotiated prices.
• A program under which drug manufacturers provide discounts to beneficiaries who have incurred costs above the annual deductible beginning in 2025.
• A requirement that drugmakers issue rebates to Medicare for certain brand-name drugs covered without generic equivalents for which prices increase faster than inflation.
• An obligation for Medicare Part D plans to pay for adult vaccines that are recommended by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices without requiring cost sharing.

The law’s marquee health provision sets the stage for Medicare, the nation’s largest purchaser of drugs, for the first time to leverage its clout directly in negotiating for lower costs for medicines. Democrats sought to build what amount to guardrails into this program, seeking to spare from competition new and innovative drugs and ones developed by smaller companies. Drugs likely to soon face competition from copycat versions also would fall outside of the pool for negotiations.

In effect, the design of the program would allow Medicare to negotiate in the future in cases such as those seen in recent years with blockbuster medicines often in rheumatology. That’s due in a large part to legal challenges that have helped thwart the introduction of copycat versions of these kinds of products known as biosimilars.

Etanercept (Enbrel) has been sold in the United States since 1998 and adalimumab (Humira) since 2003. Both products face competition from copycat versions called biosimilars in other nations, but the introductions of these products have been delayed in the United States until 2029 for etanercept and 2023 for adalimumab, the Office of Inspector General for the Department of Health & Human Services said in a March 2022 report. The OIG said in the report that the combined 2019 Medicare Part D tab for the two biologics was more than $5 billion.

Rheumatology drugs rival cancer medicines for dominance among the most expensive drugs for people enrolled in Medicare. The average 2020 spending for the most widely used forms of adalimumab by people in Medicare’s Part D pharmacy program topped $51,000, according to federal data. The price per dosage-unit for the drug rose about 7% from 2019 to 2020.

The pharmaceutical industry defends the high introductory costs of medicines and subsequent rising prices as necessary payback for research on products sold and the ones still in development. Since the initial Food and Drug Administration approval of adalimumab on Dec. 31, 2002, Abbott Laboratories and its AbbVie spin-off have made changes to the drug’s administration and paid for studies to expand its approved indications.

Still, the investment in adalimumab appears to have been paid well.

Abbott Labs acquired adalimumab as part of its purchase of BASF’s pharmaceutical operations in 2001, a purchase that also included the thyroid drug Synthroid. Abbott paid $7.2 billion, or roughly $12 billion in current dollars. In 2021 alone, Humira sales were $20.7 billion, with the United States accounting for $17.3 billion of the product’s revenue.
 

Losing access to treatment when moving to Medicare

Sue Lee of Crestwood, Ky., is among the patients waiting to see if the changes in Medicare law might allow her to again afford adalimumab. For now, Ms. Lee said she is hoping her plaque psoriasis stays manageable with the topical ointments and moisturizers she has been using since losing access to adalimumab. Ms. Lee, 80, took the medicine during her working years for her plaque psoriasis.

“I told people: ‘I’m on the wonder drug. Look at me. I can show my skin now. I don’t have all of these sores,’ ” she said in an interview.

But after she retired at 75, she was shocked at the tab she faced after switching from private insurance to Medicare. She said it could have cost her close to $10,000 a year to take Humira. Ms. Lee’s Social Security earnings make her ineligible for certain assistance with drug costs.

“I cried a lot,” she said about the loss of affordable access to the drug.
 

What’s the path ahead?

The American College of Rheumatology and the Coalition of State Rheumatology Organizations are among the physician groups that pressed Congress for years for action to lower drug costs. Their members have been on the frontline of the crisis in the United States among patients unable to afford medicines.

“The financial burden of skyrocketing drug prices has forced many of our patients to spread their treatment out longer than prescribed, delay care, abandon prescriptions, or forgo treatment entirely – all of which risks flare-ups, disease regression, permanent disability, and even premature death,” said Blair Solow, MD, chair of the ACR’s Government Affairs Committee, in a statement on the new Medicare provisions.

In an interview, Dr. Solow, an assistant professor of medicine in the division of rheumatic diseases at University of Texas Southwestern Medical Center, Dallas, noted that there are concerns about how changes in Medicare drug pricing might affect future development of medicines. This has been a chief criticism of the pharmaceutical industry of efforts to allow Medicare to negotiate for lower prices.

“Of note, drug companies research, create, and produce medications that will perform well in the market, not necessarily those that may be most needed,” Dr. Solow wrote. “We can hope the new medications put forth by manufacturers are those that improve the lives of patients.”

In July, the Congressional Budget Office released a report on an earlier version of the Democrats’ plans for Medicare drug negotiations that suggested the potential loss to drugmakers’ productivity may be relatively small. The CBO expects that about 1,300 drugs will be approved over the next 30 years. The legislation as proposed in July might reduce the tally by 15 drugs. The CBO said these estimates fell in the middle of the distribution of possible outcomes and are subject to uncertainty, and it is still working on an estimate of the expects effects of the final version of the law.

“CBO did not predict what kind of drugs would be affected or analyze the effects of forgone innovation on public health,” the agency said.

Dr. Solow also said there may be some challenges for physicians in explaining to patients the timeline for the new law’s Medicare provisions. People need to be aware of how long it will take to implement the plan and the potential for changes or delays.

“I think this is important, because the interpretation of the law can be done in a way that was not necessarily what Congress intended, and depending on the control of Congress and the Administration, this could impact downstream effects in how this law plays out,” she said in an interview.

CMS has substantial work ahead of it in choosing the drugs for which there will be subject to negotiations. The new law limits the number of drugs that can be negotiated to 10 annually in 2026, increasing to 20 drugs annually by 2029. Drugs would be eligible for negotiated prices from 9 years after drug approval or 13 years for biologics, until entry of a generic or biosimilar competitor.

The new law calls for taxes and other penalties for companies that refuse to negotiate or offer the agreed price, Thomas J. Hwang, MD; Aaron S. Kesselheim, MD, JD, MPH; and Benjamin N. Rome, MD, MPH, all of Harvard Medical School, Boston, wrote in an Aug. 19 viewpoint article in JAMA. U.S. lawmakers took a different approach to negotiations about drug prices than those used in other countries, they wrote.

“Notably, the Inflation Reduction Act shields new drugs from negotiated prices for the first 9-13 years on the market,” they wrote. “In contrast, most other peer countries typically negotiate drug prices at the time of market entry, and no peer country limits the number of drugs negotiated.”


 

Missed opportunities

Madelaine Feldman, MD, president of the CSRO and a rheumatologist in private practice with The Rheumatology Group in New Orleans, said in an interview that she welcomes many of the provisions of the new law, as they will help her rheumatology patients afford their medicine.

But she considers one of the provisions of the law to be a disappointment. The law further delays the start date for a federal rule intended to allow people on Medicare Part D to directly benefit from discounts negotiated on drugs. This is a point often overlooked in news reports on the law.

Insurers use what are called pharmacy benefit manager (PBM) services to obtain rebates on medicines, but they don’t fully or directly share these price reductions with people enrolled in Part D plans. Instead, people in the Part D plans have their cost sharing pegged closer to listed prices, the ones set before the rebates obtained by PBMs. The PBM industry argues that the rebates, often based on the list price of the drug, serve to keep monthly insurance premiums low. But there’s been concern about perverse incentives in this approach, where more expensive drugs are preferred by PBMs, leading to higher rebates.

Congress had already delayed its implementation of the PBM rule, which would apply savings more directly to patients, until 2027 and did so again in the Inflation Reduction Act.

Implementing this rule on Medicare Part D prescription drug rebates would be a help for patients struggling to pay for costly drugs, such as those used in rheumatology, Dr. Feldman said.

“It just doesn’t make any sense to hold off on these changes if you really want to cut Medicare’s beneficiaries’ cost sharing and attempt to stop the perverse incentive that puts higher priced drugs on Part D formularies,” she said.

Changes in Medicare law will help some patients who need costly rheumatology treatments, including several medicines for which competition has been kept in check for many years.

In fact, this field of medicine includes prime examples of the kinds of products that drove Congress to give the giant federal health program leverage to try to restrain rising pharmaceutical costs through negotiations. The Inflation Reduction Act, signed into law by President Joe Biden on Aug. 16, also provides some fairly quick aid for people enrolled in Medicare who struggle with pharmacy bills.

Getty

As described in an official summary from the Congressional Research Service, the law establishes:

• A cap on annual Medicare Part D out-of-pocket spending that starts in 2025 at $2,000, with planned annual adjustments thereafter.
• A limit on cost-sharing under Medicare Part D for a month’s supply of covered insulin products at $35 for 2023 through 2025, with plans for continued limits on this cost in the years after pegged to negotiated prices.
• A program under which drug manufacturers provide discounts to beneficiaries who have incurred costs above the annual deductible beginning in 2025.
• A requirement that drugmakers issue rebates to Medicare for certain brand-name drugs covered without generic equivalents for which prices increase faster than inflation.
• An obligation for Medicare Part D plans to pay for adult vaccines that are recommended by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices without requiring cost sharing.

The law’s marquee health provision sets the stage for Medicare, the nation’s largest purchaser of drugs, for the first time to leverage its clout directly in negotiating for lower costs for medicines. Democrats sought to build what amount to guardrails into this program, seeking to spare from competition new and innovative drugs and ones developed by smaller companies. Drugs likely to soon face competition from copycat versions also would fall outside of the pool for negotiations.

In effect, the design of the program would allow Medicare to negotiate in the future in cases such as those seen in recent years with blockbuster medicines often in rheumatology. That’s due in a large part to legal challenges that have helped thwart the introduction of copycat versions of these kinds of products known as biosimilars.

Etanercept (Enbrel) has been sold in the United States since 1998 and adalimumab (Humira) since 2003. Both products face competition from copycat versions called biosimilars in other nations, but the introductions of these products have been delayed in the United States until 2029 for etanercept and 2023 for adalimumab, the Office of Inspector General for the Department of Health & Human Services said in a March 2022 report. The OIG said in the report that the combined 2019 Medicare Part D tab for the two biologics was more than $5 billion.

Rheumatology drugs rival cancer medicines for dominance among the most expensive drugs for people enrolled in Medicare. The average 2020 spending for the most widely used forms of adalimumab by people in Medicare’s Part D pharmacy program topped $51,000, according to federal data. The price per dosage-unit for the drug rose about 7% from 2019 to 2020.

The pharmaceutical industry defends the high introductory costs of medicines and subsequent rising prices as necessary payback for research on products sold and the ones still in development. Since the initial Food and Drug Administration approval of adalimumab on Dec. 31, 2002, Abbott Laboratories and its AbbVie spin-off have made changes to the drug’s administration and paid for studies to expand its approved indications.

Still, the investment in adalimumab appears to have been paid well.

Abbott Labs acquired adalimumab as part of its purchase of BASF’s pharmaceutical operations in 2001, a purchase that also included the thyroid drug Synthroid. Abbott paid $7.2 billion, or roughly $12 billion in current dollars. In 2021 alone, Humira sales were $20.7 billion, with the United States accounting for $17.3 billion of the product’s revenue.
 

Losing access to treatment when moving to Medicare

Sue Lee of Crestwood, Ky., is among the patients waiting to see if the changes in Medicare law might allow her to again afford adalimumab. For now, Ms. Lee said she is hoping her plaque psoriasis stays manageable with the topical ointments and moisturizers she has been using since losing access to adalimumab. Ms. Lee, 80, took the medicine during her working years for her plaque psoriasis.

“I told people: ‘I’m on the wonder drug. Look at me. I can show my skin now. I don’t have all of these sores,’ ” she said in an interview.

But after she retired at 75, she was shocked at the tab she faced after switching from private insurance to Medicare. She said it could have cost her close to $10,000 a year to take Humira. Ms. Lee’s Social Security earnings make her ineligible for certain assistance with drug costs.

“I cried a lot,” she said about the loss of affordable access to the drug.
 

What’s the path ahead?

The American College of Rheumatology and the Coalition of State Rheumatology Organizations are among the physician groups that pressed Congress for years for action to lower drug costs. Their members have been on the frontline of the crisis in the United States among patients unable to afford medicines.

“The financial burden of skyrocketing drug prices has forced many of our patients to spread their treatment out longer than prescribed, delay care, abandon prescriptions, or forgo treatment entirely – all of which risks flare-ups, disease regression, permanent disability, and even premature death,” said Blair Solow, MD, chair of the ACR’s Government Affairs Committee, in a statement on the new Medicare provisions.

In an interview, Dr. Solow, an assistant professor of medicine in the division of rheumatic diseases at University of Texas Southwestern Medical Center, Dallas, noted that there are concerns about how changes in Medicare drug pricing might affect future development of medicines. This has been a chief criticism of the pharmaceutical industry of efforts to allow Medicare to negotiate for lower prices.

“Of note, drug companies research, create, and produce medications that will perform well in the market, not necessarily those that may be most needed,” Dr. Solow wrote. “We can hope the new medications put forth by manufacturers are those that improve the lives of patients.”

In July, the Congressional Budget Office released a report on an earlier version of the Democrats’ plans for Medicare drug negotiations that suggested the potential loss to drugmakers’ productivity may be relatively small. The CBO expects that about 1,300 drugs will be approved over the next 30 years. The legislation as proposed in July might reduce the tally by 15 drugs. The CBO said these estimates fell in the middle of the distribution of possible outcomes and are subject to uncertainty, and it is still working on an estimate of the expects effects of the final version of the law.

“CBO did not predict what kind of drugs would be affected or analyze the effects of forgone innovation on public health,” the agency said.

Dr. Solow also said there may be some challenges for physicians in explaining to patients the timeline for the new law’s Medicare provisions. People need to be aware of how long it will take to implement the plan and the potential for changes or delays.

“I think this is important, because the interpretation of the law can be done in a way that was not necessarily what Congress intended, and depending on the control of Congress and the Administration, this could impact downstream effects in how this law plays out,” she said in an interview.

CMS has substantial work ahead of it in choosing the drugs for which there will be subject to negotiations. The new law limits the number of drugs that can be negotiated to 10 annually in 2026, increasing to 20 drugs annually by 2029. Drugs would be eligible for negotiated prices from 9 years after drug approval or 13 years for biologics, until entry of a generic or biosimilar competitor.

The new law calls for taxes and other penalties for companies that refuse to negotiate or offer the agreed price, Thomas J. Hwang, MD; Aaron S. Kesselheim, MD, JD, MPH; and Benjamin N. Rome, MD, MPH, all of Harvard Medical School, Boston, wrote in an Aug. 19 viewpoint article in JAMA. U.S. lawmakers took a different approach to negotiations about drug prices than those used in other countries, they wrote.

“Notably, the Inflation Reduction Act shields new drugs from negotiated prices for the first 9-13 years on the market,” they wrote. “In contrast, most other peer countries typically negotiate drug prices at the time of market entry, and no peer country limits the number of drugs negotiated.”


 

Missed opportunities

Madelaine Feldman, MD, president of the CSRO and a rheumatologist in private practice with The Rheumatology Group in New Orleans, said in an interview that she welcomes many of the provisions of the new law, as they will help her rheumatology patients afford their medicine.

But she considers one of the provisions of the law to be a disappointment. The law further delays the start date for a federal rule intended to allow people on Medicare Part D to directly benefit from discounts negotiated on drugs. This is a point often overlooked in news reports on the law.

Insurers use what are called pharmacy benefit manager (PBM) services to obtain rebates on medicines, but they don’t fully or directly share these price reductions with people enrolled in Part D plans. Instead, people in the Part D plans have their cost sharing pegged closer to listed prices, the ones set before the rebates obtained by PBMs. The PBM industry argues that the rebates, often based on the list price of the drug, serve to keep monthly insurance premiums low. But there’s been concern about perverse incentives in this approach, where more expensive drugs are preferred by PBMs, leading to higher rebates.

Congress had already delayed its implementation of the PBM rule, which would apply savings more directly to patients, until 2027 and did so again in the Inflation Reduction Act.

Implementing this rule on Medicare Part D prescription drug rebates would be a help for patients struggling to pay for costly drugs, such as those used in rheumatology, Dr. Feldman said.

“It just doesn’t make any sense to hold off on these changes if you really want to cut Medicare’s beneficiaries’ cost sharing and attempt to stop the perverse incentive that puts higher priced drugs on Part D formularies,” she said.

About two-thirds of children with juvenile idiopathic arthritis (JIA) were able to return to an inactive disease state within 12 months after a flare occurred when they took a break from medication, and slightly more than half – 55% – reached this state within 6 months, according to findings from registry data examined in a study published in Arthritis Care & Research.

Sarah Ringold, MD, MS, of the Seattle Children’s Hospital, and coauthors used data from participants in the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry to track what happened to patients when they took a break from antirheumatic drugs. They described their paper as being the first to use a large multicenter database such as the CARRA Registry to focus on JIA outcomes after medication discontinuation and flare, to describe flare severity after medication discontinuation, and to report patterns of medication use for flares.

“To date, JIA studies have established that flares after medication discontinuation are common but have generated conflicting data regarding flare risk factors,” Dr. Ringold and coauthors wrote. “Since it is not yet possible to predict reliably which children will successfully discontinue medication, families and physicians face uncertainty when deciding to stop medications, and there is significant variation in approach.”

The study will be “very helpful” to physicians working with parents and patients to make decisions about discontinuing medications, said Grant Schulert, MD, PhD, of Cincinnati Children’s Hospital, who was not involved with the study.

“It gives some numbers to help us have those conversations,” he said in an interview.

But interpreting those numbers still will present parents with a challenge, Dr. Schulert said.

“You can say: ‘The glass is half full; 55% of them could go back into remission in 6 months, a little bit higher in a year,’ ” he said. “Or the glass is half empty; some of them, even at a year, are still not back in remission.”

But “patients aren’t a statistic. They’re each one person,” he said. “They’re going to be in one of those two situations.”

There are many challenges in explaining the potential advantages and disadvantages of medication breaks to patients and families, said the study’s senior author, Daniel B. Horton, MD, MSCE, of Rutgers Robert Wood Johnson Medical School and the Rutgers Center for Pharmacoepidemiology and Treatment Science, both in New Brunswick, N.J., and the department of biostatistics and epidemiology at Rutgers School of Public Health, Piscataway, N.J.

“One of the challenges of explaining the pros and cons about stopping medicines is the uncertainty – not knowing if and when a flare will occur, if and when a flare would be well controlled, and, for treatments that are continued, if and when complications of that treatment could occur,” Dr. Horton said in an interview. “Many patients and families are afraid about what the medicines might do long-term and want to stop treatment as soon as possible, despite the risks of stopping. Another challenge is that we do not yet have accurate, widely available tests that help us predict these various outcomes. Still, it is important for clinicians to explain the risks of continuing treatment and of stopping treatment, and to give patients and families time to ask questions and share their own values and preferences. If these conversations don’t happen, patients or families may just stop the medicines even if stopping is not warranted or is likely to lead to a poor outcome.”
 

Study details

Of the 367 patients studied, 270 (74%) were female. Half of all patients in the study had extended oligoarticular/rheumatoid factor (RF)–negative polyarticular JIA, and the second most common category was persistent oligoarthritis at 25%.The median age at disease onset was 4, with a range of 2-9 years.

The median age at disease flare was 11.3, with a range of 7.5-15.7 years. At the time of flare, children had a median disease duration of 5.1 years and had been off systemic disease-modifying antirheumatic drugs (DMARDs) for a median of 205 days. In addition, at the time of flare, the median active joint count was 1 and the maximum active joint count was 33, and approximately 13% of children had 5 or more active joints.

Conventional synthetic DMARDs were the most commonly stopped medications (48%), and tumor necrosis factor inhibitors (TNFi) were second (42%), Dr. Ringold and coauthors wrote.

Independent predictors of successful recapture of inactive disease included TNFi as recapture medication and history of a non-TNFi biologic use.

Dr. Ringold and coauthors noted limitations of the registry-based study. This is “a convenience sample of patients who are cared for and consented at academic sites, and additional study may be needed to understand how these results generalize to other countries and health systems,” they wrote.

And there may have been misclassification and inclusion of patients who stopped medications for self-perceived well-controlled disease, they wrote.

“Although the intent was to include children who stopped their medications at their physician’s direction due to physician-confirmed inactive disease, patients who had been previously enrolled in the registry were included if inactive disease was listed as the reason for medication discontinuation,” they said.

Still, these results should serve as a “benchmark for future studies of medication discontinuation” in JIA, the researchers wrote.
 

‘Fortunate challenge’

In an accompanying editorial, Melissa L. Mannion, MD, MSPH, and Randy Q. Cron, MD, PhD, of the University of Alabama at Birmingham noted that pediatric rheumatologists now face what they call the “fortunate challenge” of helping patients and parents decide whether treatments can be stopped in cases where there’s been a sustained period of inactive disease.

“Once a patient has reached the goal of inactive disease, why would patients or providers want to stop medications?” Dr. Mannion and Dr. Cron wrote. “We tell our patients that we want them to be like everyone else and have no limitations on their goals. However, the burden of chronic medication to achieve that goal is a constant reminder that they are different from their peers.”

In their article, Dr. Mannion and Dr. Cron noted what they called “interesting” results observed among children with different forms of JIA in the study.

Children with “systemic JIA had the highest recapture rates at 6 or 12 months, perhaps reflecting the high percentage use of [biologic] DMARDs targeting interleukin-1 and IL-6, or maybe the timeliness of recognition (e.g., fever, rash) of disease flare,” Dr. Mannion and Dr. Cron wrote. “Conversely, children with JIA enthesitis-related arthritis (ERA) had the lowest recapture rate at 6 months (27.6%, even lower than RF-positive polyarticular JIA, 42.9%).”

Still, the editorial authors said that “additional well-controlled studies are needed to move pediatric rheumatology deeper into the realm of precision medicine and the ability to decide whether or not to wean DMARD therapy for those with clinically inactive disease.”

Pamela Weiss, MD, of Children’s Hospital of Philadelphia, said in a comment that the study by Dr. Ringold and colleagues, as well as others that address similar questions, “are critically needed to move our field towards a personalized medicine approach.” But she added that while the paper from Dr. Ringold and colleagues addresses an important question, it “should be interpreted with some caution.”

She noted, for example, that “disease flare,” which prompted reinitiation of treatment and study entry, was not always aligned with a registry visit, which makes determination of the primary exposure less stringent. The rate of recapture across JIA categories differed by as much as 20% depending upon which inactive disease assessment outcome was used – either the study’s novel but unvalidated primary outcome or the validated secondary outcome of using the clinical Juvenile Arthritis Disease Activity Score based on 10 joints. The resulting difference was marked for some JIA categories and minimal for others.

“The flare and recapture rates are likely to be vastly different for JIA categories with distinct pathophysiology – namely systemic JIA, psoriatic arthritis, and enthesitis-related arthritis,” Dr. Weiss said. “While numbers for these categories were too small to make meaningful conclusions, grouping them with the other JIA categories has limitations.”

The research was funded by a Rheumatology Research Foundation Innovative Research Award.

Dr. Ringold’s current employment is through Janssen Research & Development. She changed primary employment from Seattle Children’s to Janssen during completion of the analyses and preparation of the manuscript. She has maintained her affiliation with Seattle Children’s. Dr. Schulert has consulting for Novartis. Dr. Cron reported speaker fees, consulting fees, and grant support from Sobi, consulting fees from Sironax and Novartis, speaker fees from Lilly, and support from Pfizer for working on a committee adjudicating clinical trial side effects.

* This article was updated on 8/11/2022.

About two-thirds of children with juvenile idiopathic arthritis (JIA) were able to return to an inactive disease state within 12 months after a flare occurred when they took a break from medication, and slightly more than half – 55% – reached this state within 6 months, according to findings from registry data examined in a study published in Arthritis Care & Research.

Sarah Ringold, MD, MS, of the Seattle Children’s Hospital, and coauthors used data from participants in the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry to track what happened to patients when they took a break from antirheumatic drugs. They described their paper as being the first to use a large multicenter database such as the CARRA Registry to focus on JIA outcomes after medication discontinuation and flare, to describe flare severity after medication discontinuation, and to report patterns of medication use for flares.

“To date, JIA studies have established that flares after medication discontinuation are common but have generated conflicting data regarding flare risk factors,” Dr. Ringold and coauthors wrote. “Since it is not yet possible to predict reliably which children will successfully discontinue medication, families and physicians face uncertainty when deciding to stop medications, and there is significant variation in approach.”

The study will be “very helpful” to physicians working with parents and patients to make decisions about discontinuing medications, said Grant Schulert, MD, PhD, of Cincinnati Children’s Hospital, who was not involved with the study.

“It gives some numbers to help us have those conversations,” he said in an interview.

But interpreting those numbers still will present parents with a challenge, Dr. Schulert said.

“You can say: ‘The glass is half full; 55% of them could go back into remission in 6 months, a little bit higher in a year,’ ” he said. “Or the glass is half empty; some of them, even at a year, are still not back in remission.”

But “patients aren’t a statistic. They’re each one person,” he said. “They’re going to be in one of those two situations.”

There are many challenges in explaining the potential advantages and disadvantages of medication breaks to patients and families, said the study’s senior author, Daniel B. Horton, MD, MSCE, of Rutgers Robert Wood Johnson Medical School and the Rutgers Center for Pharmacoepidemiology and Treatment Science, both in New Brunswick, N.J., and the department of biostatistics and epidemiology at Rutgers School of Public Health, Piscataway, N.J.

“One of the challenges of explaining the pros and cons about stopping medicines is the uncertainty – not knowing if and when a flare will occur, if and when a flare would be well controlled, and, for treatments that are continued, if and when complications of that treatment could occur,” Dr. Horton said in an interview. “Many patients and families are afraid about what the medicines might do long-term and want to stop treatment as soon as possible, despite the risks of stopping. Another challenge is that we do not yet have accurate, widely available tests that help us predict these various outcomes. Still, it is important for clinicians to explain the risks of continuing treatment and of stopping treatment, and to give patients and families time to ask questions and share their own values and preferences. If these conversations don’t happen, patients or families may just stop the medicines even if stopping is not warranted or is likely to lead to a poor outcome.”
 

Study details

Of the 367 patients studied, 270 (74%) were female. Half of all patients in the study had extended oligoarticular/rheumatoid factor (RF)–negative polyarticular JIA, and the second most common category was persistent oligoarthritis at 25%.The median age at disease onset was 4, with a range of 2-9 years.

The median age at disease flare was 11.3, with a range of 7.5-15.7 years. At the time of flare, children had a median disease duration of 5.1 years and had been off systemic disease-modifying antirheumatic drugs (DMARDs) for a median of 205 days. In addition, at the time of flare, the median active joint count was 1 and the maximum active joint count was 33, and approximately 13% of children had 5 or more active joints.

Conventional synthetic DMARDs were the most commonly stopped medications (48%), and tumor necrosis factor inhibitors (TNFi) were second (42%), Dr. Ringold and coauthors wrote.

Independent predictors of successful recapture of inactive disease included TNFi as recapture medication and history of a non-TNFi biologic use.

Dr. Ringold and coauthors noted limitations of the registry-based study. This is “a convenience sample of patients who are cared for and consented at academic sites, and additional study may be needed to understand how these results generalize to other countries and health systems,” they wrote.

And there may have been misclassification and inclusion of patients who stopped medications for self-perceived well-controlled disease, they wrote.

“Although the intent was to include children who stopped their medications at their physician’s direction due to physician-confirmed inactive disease, patients who had been previously enrolled in the registry were included if inactive disease was listed as the reason for medication discontinuation,” they said.

Still, these results should serve as a “benchmark for future studies of medication discontinuation” in JIA, the researchers wrote.
 

‘Fortunate challenge’

In an accompanying editorial, Melissa L. Mannion, MD, MSPH, and Randy Q. Cron, MD, PhD, of the University of Alabama at Birmingham noted that pediatric rheumatologists now face what they call the “fortunate challenge” of helping patients and parents decide whether treatments can be stopped in cases where there’s been a sustained period of inactive disease.

“Once a patient has reached the goal of inactive disease, why would patients or providers want to stop medications?” Dr. Mannion and Dr. Cron wrote. “We tell our patients that we want them to be like everyone else and have no limitations on their goals. However, the burden of chronic medication to achieve that goal is a constant reminder that they are different from their peers.”

In their article, Dr. Mannion and Dr. Cron noted what they called “interesting” results observed among children with different forms of JIA in the study.

Children with “systemic JIA had the highest recapture rates at 6 or 12 months, perhaps reflecting the high percentage use of [biologic] DMARDs targeting interleukin-1 and IL-6, or maybe the timeliness of recognition (e.g., fever, rash) of disease flare,” Dr. Mannion and Dr. Cron wrote. “Conversely, children with JIA enthesitis-related arthritis (ERA) had the lowest recapture rate at 6 months (27.6%, even lower than RF-positive polyarticular JIA, 42.9%).”

Still, the editorial authors said that “additional well-controlled studies are needed to move pediatric rheumatology deeper into the realm of precision medicine and the ability to decide whether or not to wean DMARD therapy for those with clinically inactive disease.”

Pamela Weiss, MD, of Children’s Hospital of Philadelphia, said in a comment that the study by Dr. Ringold and colleagues, as well as others that address similar questions, “are critically needed to move our field towards a personalized medicine approach.” But she added that while the paper from Dr. Ringold and colleagues addresses an important question, it “should be interpreted with some caution.”

She noted, for example, that “disease flare,” which prompted reinitiation of treatment and study entry, was not always aligned with a registry visit, which makes determination of the primary exposure less stringent. The rate of recapture across JIA categories differed by as much as 20% depending upon which inactive disease assessment outcome was used – either the study’s novel but unvalidated primary outcome or the validated secondary outcome of using the clinical Juvenile Arthritis Disease Activity Score based on 10 joints. The resulting difference was marked for some JIA categories and minimal for others.

“The flare and recapture rates are likely to be vastly different for JIA categories with distinct pathophysiology – namely systemic JIA, psoriatic arthritis, and enthesitis-related arthritis,” Dr. Weiss said. “While numbers for these categories were too small to make meaningful conclusions, grouping them with the other JIA categories has limitations.”

The research was funded by a Rheumatology Research Foundation Innovative Research Award.

Dr. Ringold’s current employment is through Janssen Research & Development. She changed primary employment from Seattle Children’s to Janssen during completion of the analyses and preparation of the manuscript. She has maintained her affiliation with Seattle Children’s. Dr. Schulert has consulting for Novartis. Dr. Cron reported speaker fees, consulting fees, and grant support from Sobi, consulting fees from Sironax and Novartis, speaker fees from Lilly, and support from Pfizer for working on a committee adjudicating clinical trial side effects.

* This article was updated on 8/11/2022.

About two-thirds of children with juvenile idiopathic arthritis (JIA) were able to return to an inactive disease state within 12 months after a flare occurred when they took a break from medication, and slightly more than half – 55% – reached this state within 6 months, according to findings from registry data examined in a study published in Arthritis Care & Research.

Sarah Ringold, MD, MS, of the Seattle Children’s Hospital, and coauthors used data from participants in the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry to track what happened to patients when they took a break from antirheumatic drugs. They described their paper as being the first to use a large multicenter database such as the CARRA Registry to focus on JIA outcomes after medication discontinuation and flare, to describe flare severity after medication discontinuation, and to report patterns of medication use for flares.

“To date, JIA studies have established that flares after medication discontinuation are common but have generated conflicting data regarding flare risk factors,” Dr. Ringold and coauthors wrote. “Since it is not yet possible to predict reliably which children will successfully discontinue medication, families and physicians face uncertainty when deciding to stop medications, and there is significant variation in approach.”

The study will be “very helpful” to physicians working with parents and patients to make decisions about discontinuing medications, said Grant Schulert, MD, PhD, of Cincinnati Children’s Hospital, who was not involved with the study.

“It gives some numbers to help us have those conversations,” he said in an interview.

But interpreting those numbers still will present parents with a challenge, Dr. Schulert said.

“You can say: ‘The glass is half full; 55% of them could go back into remission in 6 months, a little bit higher in a year,’ ” he said. “Or the glass is half empty; some of them, even at a year, are still not back in remission.”

But “patients aren’t a statistic. They’re each one person,” he said. “They’re going to be in one of those two situations.”

There are many challenges in explaining the potential advantages and disadvantages of medication breaks to patients and families, said the study’s senior author, Daniel B. Horton, MD, MSCE, of Rutgers Robert Wood Johnson Medical School and the Rutgers Center for Pharmacoepidemiology and Treatment Science, both in New Brunswick, N.J., and the department of biostatistics and epidemiology at Rutgers School of Public Health, Piscataway, N.J.

“One of the challenges of explaining the pros and cons about stopping medicines is the uncertainty – not knowing if and when a flare will occur, if and when a flare would be well controlled, and, for treatments that are continued, if and when complications of that treatment could occur,” Dr. Horton said in an interview. “Many patients and families are afraid about what the medicines might do long-term and want to stop treatment as soon as possible, despite the risks of stopping. Another challenge is that we do not yet have accurate, widely available tests that help us predict these various outcomes. Still, it is important for clinicians to explain the risks of continuing treatment and of stopping treatment, and to give patients and families time to ask questions and share their own values and preferences. If these conversations don’t happen, patients or families may just stop the medicines even if stopping is not warranted or is likely to lead to a poor outcome.”
 

Study details

Of the 367 patients studied, 270 (74%) were female. Half of all patients in the study had extended oligoarticular/rheumatoid factor (RF)–negative polyarticular JIA, and the second most common category was persistent oligoarthritis at 25%.The median age at disease onset was 4, with a range of 2-9 years.

The median age at disease flare was 11.3, with a range of 7.5-15.7 years. At the time of flare, children had a median disease duration of 5.1 years and had been off systemic disease-modifying antirheumatic drugs (DMARDs) for a median of 205 days. In addition, at the time of flare, the median active joint count was 1 and the maximum active joint count was 33, and approximately 13% of children had 5 or more active joints.

Conventional synthetic DMARDs were the most commonly stopped medications (48%), and tumor necrosis factor inhibitors (TNFi) were second (42%), Dr. Ringold and coauthors wrote.

Independent predictors of successful recapture of inactive disease included TNFi as recapture medication and history of a non-TNFi biologic use.

Dr. Ringold and coauthors noted limitations of the registry-based study. This is “a convenience sample of patients who are cared for and consented at academic sites, and additional study may be needed to understand how these results generalize to other countries and health systems,” they wrote.

And there may have been misclassification and inclusion of patients who stopped medications for self-perceived well-controlled disease, they wrote.

“Although the intent was to include children who stopped their medications at their physician’s direction due to physician-confirmed inactive disease, patients who had been previously enrolled in the registry were included if inactive disease was listed as the reason for medication discontinuation,” they said.

Still, these results should serve as a “benchmark for future studies of medication discontinuation” in JIA, the researchers wrote.
 

‘Fortunate challenge’

In an accompanying editorial, Melissa L. Mannion, MD, MSPH, and Randy Q. Cron, MD, PhD, of the University of Alabama at Birmingham noted that pediatric rheumatologists now face what they call the “fortunate challenge” of helping patients and parents decide whether treatments can be stopped in cases where there’s been a sustained period of inactive disease.

“Once a patient has reached the goal of inactive disease, why would patients or providers want to stop medications?” Dr. Mannion and Dr. Cron wrote. “We tell our patients that we want them to be like everyone else and have no limitations on their goals. However, the burden of chronic medication to achieve that goal is a constant reminder that they are different from their peers.”

In their article, Dr. Mannion and Dr. Cron noted what they called “interesting” results observed among children with different forms of JIA in the study.

Children with “systemic JIA had the highest recapture rates at 6 or 12 months, perhaps reflecting the high percentage use of [biologic] DMARDs targeting interleukin-1 and IL-6, or maybe the timeliness of recognition (e.g., fever, rash) of disease flare,” Dr. Mannion and Dr. Cron wrote. “Conversely, children with JIA enthesitis-related arthritis (ERA) had the lowest recapture rate at 6 months (27.6%, even lower than RF-positive polyarticular JIA, 42.9%).”

Still, the editorial authors said that “additional well-controlled studies are needed to move pediatric rheumatology deeper into the realm of precision medicine and the ability to decide whether or not to wean DMARD therapy for those with clinically inactive disease.”

Pamela Weiss, MD, of Children’s Hospital of Philadelphia, said in a comment that the study by Dr. Ringold and colleagues, as well as others that address similar questions, “are critically needed to move our field towards a personalized medicine approach.” But she added that while the paper from Dr. Ringold and colleagues addresses an important question, it “should be interpreted with some caution.”

She noted, for example, that “disease flare,” which prompted reinitiation of treatment and study entry, was not always aligned with a registry visit, which makes determination of the primary exposure less stringent. The rate of recapture across JIA categories differed by as much as 20% depending upon which inactive disease assessment outcome was used – either the study’s novel but unvalidated primary outcome or the validated secondary outcome of using the clinical Juvenile Arthritis Disease Activity Score based on 10 joints. The resulting difference was marked for some JIA categories and minimal for others.

“The flare and recapture rates are likely to be vastly different for JIA categories with distinct pathophysiology – namely systemic JIA, psoriatic arthritis, and enthesitis-related arthritis,” Dr. Weiss said. “While numbers for these categories were too small to make meaningful conclusions, grouping them with the other JIA categories has limitations.”

The research was funded by a Rheumatology Research Foundation Innovative Research Award.

Dr. Ringold’s current employment is through Janssen Research & Development. She changed primary employment from Seattle Children’s to Janssen during completion of the analyses and preparation of the manuscript. She has maintained her affiliation with Seattle Children’s. Dr. Schulert has consulting for Novartis. Dr. Cron reported speaker fees, consulting fees, and grant support from Sobi, consulting fees from Sironax and Novartis, speaker fees from Lilly, and support from Pfizer for working on a committee adjudicating clinical trial side effects.

* This article was updated on 8/11/2022.

New devices that use artificial intelligence (AI) to diagnose skin cancer – such as smartphone apps – have been popping up over the past few years, but there is some concern over the accuracy of these tools.

So far, the U.S. Food and Drug Administration has cleared two devices. Both are computer-aided skin lesion classification devices meant to help clinicians assess cases of suspected melanoma.

Both were given a class III designation. That classification is intended for products that are considered to have a high risk of harm because of flawed design or implementation. Many such devices are under development, and there has been a proposal to include these devices in class II, which is less restrictive.

The FDA turned to one of its expert panels for advice. At a meeting held on Aug. 29, experts on the panel offered differing views and expressed concerns about the accuracy of these devices.

This was the second day of meetings of the general and plastic surgery devices panel of the FDA’s Medical Devices Advisory Committee. On the previous day, the panel held a wide-ranging discussion about expanding use of skin lesion analyzer devices.

The FDA sought the expert panel’s advice concerning a field that appears to be heating up quickly after relatively quiet times.

Two devices have been approved by the FDA so far, but only one is still being promoted – SciBase AB’s Nevisense. The Swedish company announced in May 2020 that it had received FDA approval for Nevisense 3.0, the third generation of their Nevisense system for early melanoma detection, an AI-based point-of-care system for the noninvasive evaluation of irregular moles.

The other device, known as MelaFind, was acquired by Strata Skin Sciences, but the company said in 2017 that it discontinued research and development, sales, and support activity related to the device, according to a filing with the Securities and Exchange Commission.

But there’s been a swell in recent years in the number of publications related to the use of AI and machine learning, which could give rise to new tools for aiding in the diagnosis of skin conditions, including cancer. Google is among the companies that are involved in these efforts.

So, the FDA asked the expert panel to discuss a series of questions related to how the agency should weigh the risks of computer-aided devices for melanoma diagnosis. The agency also asked the panel to provide feedback about how well risks associated with such devices and tools might be managed and to offer suggestions.

The discussion at the July 29 meeting spun beyond narrow questions about reclassification of the current class III devices to topics involving emerging technology, such as efforts to apply AI to dermatology.

“Innovation continues. Medical device developers are anxious to plan how they might be able to develop the level of evidence that would meet your expectations” for future products, Binita Ashar, MD, a senior official in FDA’s Center for Devices and Radiological Health, told the panel.


 

Company CEO backs tougher regulation

Simon Grant, the chief executive of SciBase, which markets Nevisense, the first and only skin cancer–detecting device currently on the U.S. market, sought to make a case for sticking with the tougher class III regulations.

Speaking during the public comment session, Mr. Grant said switching to class II designations would weaken the standards used in clearing products that analyze skin lesions so as to put patients at risk.

Under the FDA’s rules, the agency designates as class III devices that present potential unreasonable risk of illness or injury. Only about 10% of devices fall into this category. Such devices include implantable pacemakers and breast implants, as well as SciBase’s Nevisense.

About 43% of medical devices fall into the class II category, which includes powered wheelchairs and some pregnancy test kits, the FDA website says.

Class I medical devices pose minimal potential for harm and tend to be simpler in design. These include enema kits and elastic bandages, the FDA says.

Mr. Grant told the meeting that in his career he has worked on two class III products and about 20 class II products. (He had previously worked at medical startups Synectics Medical and Neoventa, as well as established multinationals such as Medtronic.)

“I can tell you that – practically – the FDA has many fewer sticks and much less control when it comes to class II devices,” he said. He offered an example of a manufacturer of a class II device having more latitude in making small changes to products without notifying the FDA.

In his hypothetical example, such a change could have unintended consequences, and “with AI systems, small changes can result in large and nonlinear or even random effects,” Mr. Grant said. “But it’s too late if the product is on the market and the harm has already occurred,” he said.

The American Society for Dermatologic Surgery Association also protested the reclassifying of approved computer-aided melanoma detection class III devices.

In a statement posted on the FDA website as part of the materials for the meeting, the ASDSA raised a series of concerns about the prospects of expanded U.S. use of tools for assisting in diagnosing melanoma, including ones that would be marketed to consumers.

“To the extent that algorithms and devices for patient self-diagnosis of skin lesions are already widely available, they should be required to include detailed disclaimers that include that they are for entertainment and educational purposes and not a diagnostic device, that they are not approved by dermatologists or a recognized medical regulatory authority for self-diagnosis,” the ASDSA said.

Devices and algorithms in screening tools “are not highly regulated and remain unproven. They may result in wrong diagnoses, missed diagnoses, or over- or underdiagnosis,” the ASDSA added. “Both patients at low risk and those at high risk are better served by scheduling an in-person examination with a board-certified dermatologist, who can also help them determine the appropriate future skin screening schedule that is most appropriate for them.”

 

‘Stepping stone’

However, there is strong consumer demand for better information about skin conditions, and many patients face hurdles in going to dermatologists.

Google research has shown that consumers are seeking “a stepping stone” between the information they can easily find online and what they could get from a medical professional, said Lily Peng, MD, PhD, a director of product management for the health AI team at Google. Dr. Peng was a scheduled presenter at the July 29 meeting.

Consumers often are looking for more information on common conditions such as acne and poison ivy, and they sometimes face challenges in getting access to clinicians, she said.

“There are many unmet needs for consumers experiencing skin issues, many of which are lower-acuity conditions. There’s a big opportunity to increase accessibility and relevance of health journeys for consumers,” Dr. Peng said. “We have heard from consumers that they would like to have a self-help tool for nonserious conditions so they can decide when to seek medical attention.”

Dr. Peng’s presentation was not directly related to the question of class II or class III designation for existing products. Instead, her talk served as a glimpse into the work already underway in creating apps and tools for consumers.

Google researchers have published a number of studies in recent years about the use of AI to improve dermatology diagnosis.

A 2020 article reported on Google’s test of a form of AI known as deep learning system (DLS) to provide a differential diagnosis of skin conditions. On 963 validation cases, where a rotating panel of three board-certified dermatologists defined the reference standard, the DLS was noninferior to six other dermatologists and was superior to six primary care physicians (PCPs) and six nurse practitioners (NPs), according to a summary of the article.

A 2021 report published in JAMA Network Open said that use of an AI tool was associated with a higher agreement rate with dermatologists’ reference diagnoses for both PCPs and NPs.

In a 2021 blog post, Google scientists wrote that their AI model that powers a tool for checking skin conditions had earned European clearance, known as a CE mark, as a class I medical device.

SkinVision has an app that the company says “is available worldwide (with the exception of the USA and Canada).” The firm’s website includes a link where people in the United States and Canada can sign up for notifications about when SkinVision will be available in these nations. 


 

‘Not ready for prime time’

The FDA panel did not cast formal votes at the July 29 meeting. Rather, the members engaged in broad discussions about risks and potential benefits of new tools for aiding in the detection of skin cancer.

Among the key issues discussed was a question of whether the FDA could impose requirements and restrictions, known as special controls, to provide “reasonable assurance of safety and effectiveness” for computer-aided devices that provide adjunctive diagnostic information to dermatologists about lesions suspicious for melanoma.

Among the potential special controls would be clinical performance testing in regards to rates of the sensitivity (true-positive rate) and specificity (true-negative rate).

The FDA could also look at requirements on software validation and verification and cybersecurity testing, as well as directions on labeling so as to mitigate risk.

Dermatologists serving on the panel called for caution in proceeding with steps that would make it easier for companies to market tools for aiding in melanoma diagnosis than it would be within the class III framework used for MelaFind and Nevisense.

Many expressed concerns about the need to design studies that would answer questions about how well new tools could accurately identify concerning lesions.

The phrase “not ready for prime time” was used at least three times during the discussion.

FDA panelist Maral Skelsey, MD, a skin cancer specialist from Chevy Chase, Maryland, said that over the years, she had used both Nevisense and MelaFind.

She said she had found MelaFind “unusable,” owing in large part to the high number of false positives it generated. The device also was limited as to where on patients’ bodies it could be used.

However, she spoke with enthusiasm about the prospects for better devices to aid in diagnosis of skin lesions. “It’s an area where we’re on the verge, and we really need these devices. There’s a need for patients to be able to examine themselves, for nondermatologists to be able to assess lesions,” Dr. Skelsey said.

But this field is “just not ready for prime time” yet, even with special controls, Dr. Skelsey said. To loosen approval standards too quickly could be a “detriment to what’s coming down the pipeline,” she said.

“It’s harmful to things that are likely to be around the corner,” she said.

FDA panelist Renata Block, PA-C, who works in a Chicago dermatology practice, pressed for maintaining a class III designation. “We are not ready for prime time yet, though the data that is coming down the pipeline on what we have is quite exciting,” Ms. Block said.

FDA panelist Karla V. Ballman, PhD, a statistician from Weill Cornell Medicine, New York, said there would need to be a clear standard for clinical performance before proceeding toward reclassification of devices for aid in detecting melanoma. “I just don’t think it’s ready for prime time at this point and should remain in class III,” she said.

But there was support from some panelists for the idea of a lower bar for clearance, combined with special controls to ensure patient safety.

In expressing her view, FDA panelist Katalin Roth, MD, JD, professor of medicine, George Washington University, Washington, said she was an outlier in her support for the agency’s view that these risks could be managed and that future tools could allow more patients to take a step on the pathway toward critical diagnoses.

“I deal with a lot of people with cancer as a palliative care physician,” Dr. Roth said. “I think what we’re missing here is the issue of time. Melanoma is a terrible disease, and missing the diagnosis is a terrible thing, but I think special controls would be sufficient to counter the concerns of my colleagues on the committee.”

The FDA’s Dr. Ashar ended the meeting with questions posed to one panelist, Veronica Rotemberg, MD, PhD, a dermatologist at Memorial Sloan Kettering Cancer Center in New York.

Dr. Rotemberg has for years been working in the field of research on developing AI and other computer-based tools for detecting and diagnosing melanoma, the deadliest form of skin cancer.

She has been publicly skeptical of the performance of commercial apps that scan moles and other lesions and that claim to identify which are cancerous. A May blog post on the Memorial Sloan Kettering website highlighted a recent British Journal of Dermatology article in which Dr. Rotemberg and coauthors reported on their evaluations of commercial apps. They judged them to be on average only 59% accurate, the blog post said.

However, during an earlier discussion at the meeting, she had spoken more positively about the prospects for using special controls in the near term to mitigate risk, although she said she would have a “very long list” of these requirements.

In the closing exchange with Dr. Ashar, Dr. Rotemberg outlined steps that could potentially ensure the safe use of tools to aid in melanoma screening. These included a need for postmarketing surveillance, which would require evaluation over time of algorithms used in tools meant to detect skin cancer.

“We need to have a mechanism for sampling,” Dr. Rotemberg said. “Most of our data is electronic now anyway, so comparing an algorithm and performance with biopsy results should not be that challenging.”

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

New devices that use artificial intelligence (AI) to diagnose skin cancer – such as smartphone apps – have been popping up over the past few years, but there is some concern over the accuracy of these tools.

So far, the U.S. Food and Drug Administration has cleared two devices. Both are computer-aided skin lesion classification devices meant to help clinicians assess cases of suspected melanoma.

Both were given a class III designation. That classification is intended for products that are considered to have a high risk of harm because of flawed design or implementation. Many such devices are under development, and there has been a proposal to include these devices in class II, which is less restrictive.

The FDA turned to one of its expert panels for advice. At a meeting held on Aug. 29, experts on the panel offered differing views and expressed concerns about the accuracy of these devices.

This was the second day of meetings of the general and plastic surgery devices panel of the FDA’s Medical Devices Advisory Committee. On the previous day, the panel held a wide-ranging discussion about expanding use of skin lesion analyzer devices.

The FDA sought the expert panel’s advice concerning a field that appears to be heating up quickly after relatively quiet times.

Two devices have been approved by the FDA so far, but only one is still being promoted – SciBase AB’s Nevisense. The Swedish company announced in May 2020 that it had received FDA approval for Nevisense 3.0, the third generation of their Nevisense system for early melanoma detection, an AI-based point-of-care system for the noninvasive evaluation of irregular moles.

The other device, known as MelaFind, was acquired by Strata Skin Sciences, but the company said in 2017 that it discontinued research and development, sales, and support activity related to the device, according to a filing with the Securities and Exchange Commission.

But there’s been a swell in recent years in the number of publications related to the use of AI and machine learning, which could give rise to new tools for aiding in the diagnosis of skin conditions, including cancer. Google is among the companies that are involved in these efforts.

So, the FDA asked the expert panel to discuss a series of questions related to how the agency should weigh the risks of computer-aided devices for melanoma diagnosis. The agency also asked the panel to provide feedback about how well risks associated with such devices and tools might be managed and to offer suggestions.

The discussion at the July 29 meeting spun beyond narrow questions about reclassification of the current class III devices to topics involving emerging technology, such as efforts to apply AI to dermatology.

“Innovation continues. Medical device developers are anxious to plan how they might be able to develop the level of evidence that would meet your expectations” for future products, Binita Ashar, MD, a senior official in FDA’s Center for Devices and Radiological Health, told the panel.


 

Company CEO backs tougher regulation

Simon Grant, the chief executive of SciBase, which markets Nevisense, the first and only skin cancer–detecting device currently on the U.S. market, sought to make a case for sticking with the tougher class III regulations.

Speaking during the public comment session, Mr. Grant said switching to class II designations would weaken the standards used in clearing products that analyze skin lesions so as to put patients at risk.

Under the FDA’s rules, the agency designates as class III devices that present potential unreasonable risk of illness or injury. Only about 10% of devices fall into this category. Such devices include implantable pacemakers and breast implants, as well as SciBase’s Nevisense.

About 43% of medical devices fall into the class II category, which includes powered wheelchairs and some pregnancy test kits, the FDA website says.

Class I medical devices pose minimal potential for harm and tend to be simpler in design. These include enema kits and elastic bandages, the FDA says.

Mr. Grant told the meeting that in his career he has worked on two class III products and about 20 class II products. (He had previously worked at medical startups Synectics Medical and Neoventa, as well as established multinationals such as Medtronic.)

“I can tell you that – practically – the FDA has many fewer sticks and much less control when it comes to class II devices,” he said. He offered an example of a manufacturer of a class II device having more latitude in making small changes to products without notifying the FDA.

In his hypothetical example, such a change could have unintended consequences, and “with AI systems, small changes can result in large and nonlinear or even random effects,” Mr. Grant said. “But it’s too late if the product is on the market and the harm has already occurred,” he said.

The American Society for Dermatologic Surgery Association also protested the reclassifying of approved computer-aided melanoma detection class III devices.

In a statement posted on the FDA website as part of the materials for the meeting, the ASDSA raised a series of concerns about the prospects of expanded U.S. use of tools for assisting in diagnosing melanoma, including ones that would be marketed to consumers.

“To the extent that algorithms and devices for patient self-diagnosis of skin lesions are already widely available, they should be required to include detailed disclaimers that include that they are for entertainment and educational purposes and not a diagnostic device, that they are not approved by dermatologists or a recognized medical regulatory authority for self-diagnosis,” the ASDSA said.

Devices and algorithms in screening tools “are not highly regulated and remain unproven. They may result in wrong diagnoses, missed diagnoses, or over- or underdiagnosis,” the ASDSA added. “Both patients at low risk and those at high risk are better served by scheduling an in-person examination with a board-certified dermatologist, who can also help them determine the appropriate future skin screening schedule that is most appropriate for them.”

 

‘Stepping stone’

However, there is strong consumer demand for better information about skin conditions, and many patients face hurdles in going to dermatologists.

Google research has shown that consumers are seeking “a stepping stone” between the information they can easily find online and what they could get from a medical professional, said Lily Peng, MD, PhD, a director of product management for the health AI team at Google. Dr. Peng was a scheduled presenter at the July 29 meeting.

Consumers often are looking for more information on common conditions such as acne and poison ivy, and they sometimes face challenges in getting access to clinicians, she said.

“There are many unmet needs for consumers experiencing skin issues, many of which are lower-acuity conditions. There’s a big opportunity to increase accessibility and relevance of health journeys for consumers,” Dr. Peng said. “We have heard from consumers that they would like to have a self-help tool for nonserious conditions so they can decide when to seek medical attention.”

Dr. Peng’s presentation was not directly related to the question of class II or class III designation for existing products. Instead, her talk served as a glimpse into the work already underway in creating apps and tools for consumers.

Google researchers have published a number of studies in recent years about the use of AI to improve dermatology diagnosis.

A 2020 article reported on Google’s test of a form of AI known as deep learning system (DLS) to provide a differential diagnosis of skin conditions. On 963 validation cases, where a rotating panel of three board-certified dermatologists defined the reference standard, the DLS was noninferior to six other dermatologists and was superior to six primary care physicians (PCPs) and six nurse practitioners (NPs), according to a summary of the article.

A 2021 report published in JAMA Network Open said that use of an AI tool was associated with a higher agreement rate with dermatologists’ reference diagnoses for both PCPs and NPs.

In a 2021 blog post, Google scientists wrote that their AI model that powers a tool for checking skin conditions had earned European clearance, known as a CE mark, as a class I medical device.

SkinVision has an app that the company says “is available worldwide (with the exception of the USA and Canada).” The firm’s website includes a link where people in the United States and Canada can sign up for notifications about when SkinVision will be available in these nations. 


 

‘Not ready for prime time’

The FDA panel did not cast formal votes at the July 29 meeting. Rather, the members engaged in broad discussions about risks and potential benefits of new tools for aiding in the detection of skin cancer.

Among the key issues discussed was a question of whether the FDA could impose requirements and restrictions, known as special controls, to provide “reasonable assurance of safety and effectiveness” for computer-aided devices that provide adjunctive diagnostic information to dermatologists about lesions suspicious for melanoma.

Among the potential special controls would be clinical performance testing in regards to rates of the sensitivity (true-positive rate) and specificity (true-negative rate).

The FDA could also look at requirements on software validation and verification and cybersecurity testing, as well as directions on labeling so as to mitigate risk.

Dermatologists serving on the panel called for caution in proceeding with steps that would make it easier for companies to market tools for aiding in melanoma diagnosis than it would be within the class III framework used for MelaFind and Nevisense.

Many expressed concerns about the need to design studies that would answer questions about how well new tools could accurately identify concerning lesions.

The phrase “not ready for prime time” was used at least three times during the discussion.

FDA panelist Maral Skelsey, MD, a skin cancer specialist from Chevy Chase, Maryland, said that over the years, she had used both Nevisense and MelaFind.

She said she had found MelaFind “unusable,” owing in large part to the high number of false positives it generated. The device also was limited as to where on patients’ bodies it could be used.

However, she spoke with enthusiasm about the prospects for better devices to aid in diagnosis of skin lesions. “It’s an area where we’re on the verge, and we really need these devices. There’s a need for patients to be able to examine themselves, for nondermatologists to be able to assess lesions,” Dr. Skelsey said.

But this field is “just not ready for prime time” yet, even with special controls, Dr. Skelsey said. To loosen approval standards too quickly could be a “detriment to what’s coming down the pipeline,” she said.

“It’s harmful to things that are likely to be around the corner,” she said.

FDA panelist Renata Block, PA-C, who works in a Chicago dermatology practice, pressed for maintaining a class III designation. “We are not ready for prime time yet, though the data that is coming down the pipeline on what we have is quite exciting,” Ms. Block said.

FDA panelist Karla V. Ballman, PhD, a statistician from Weill Cornell Medicine, New York, said there would need to be a clear standard for clinical performance before proceeding toward reclassification of devices for aid in detecting melanoma. “I just don’t think it’s ready for prime time at this point and should remain in class III,” she said.

But there was support from some panelists for the idea of a lower bar for clearance, combined with special controls to ensure patient safety.

In expressing her view, FDA panelist Katalin Roth, MD, JD, professor of medicine, George Washington University, Washington, said she was an outlier in her support for the agency’s view that these risks could be managed and that future tools could allow more patients to take a step on the pathway toward critical diagnoses.

“I deal with a lot of people with cancer as a palliative care physician,” Dr. Roth said. “I think what we’re missing here is the issue of time. Melanoma is a terrible disease, and missing the diagnosis is a terrible thing, but I think special controls would be sufficient to counter the concerns of my colleagues on the committee.”

The FDA’s Dr. Ashar ended the meeting with questions posed to one panelist, Veronica Rotemberg, MD, PhD, a dermatologist at Memorial Sloan Kettering Cancer Center in New York.

Dr. Rotemberg has for years been working in the field of research on developing AI and other computer-based tools for detecting and diagnosing melanoma, the deadliest form of skin cancer.

She has been publicly skeptical of the performance of commercial apps that scan moles and other lesions and that claim to identify which are cancerous. A May blog post on the Memorial Sloan Kettering website highlighted a recent British Journal of Dermatology article in which Dr. Rotemberg and coauthors reported on their evaluations of commercial apps. They judged them to be on average only 59% accurate, the blog post said.

However, during an earlier discussion at the meeting, she had spoken more positively about the prospects for using special controls in the near term to mitigate risk, although she said she would have a “very long list” of these requirements.

In the closing exchange with Dr. Ashar, Dr. Rotemberg outlined steps that could potentially ensure the safe use of tools to aid in melanoma screening. These included a need for postmarketing surveillance, which would require evaluation over time of algorithms used in tools meant to detect skin cancer.

“We need to have a mechanism for sampling,” Dr. Rotemberg said. “Most of our data is electronic now anyway, so comparing an algorithm and performance with biopsy results should not be that challenging.”

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

New devices that use artificial intelligence (AI) to diagnose skin cancer – such as smartphone apps – have been popping up over the past few years, but there is some concern over the accuracy of these tools.

So far, the U.S. Food and Drug Administration has cleared two devices. Both are computer-aided skin lesion classification devices meant to help clinicians assess cases of suspected melanoma.

Both were given a class III designation. That classification is intended for products that are considered to have a high risk of harm because of flawed design or implementation. Many such devices are under development, and there has been a proposal to include these devices in class II, which is less restrictive.

The FDA turned to one of its expert panels for advice. At a meeting held on Aug. 29, experts on the panel offered differing views and expressed concerns about the accuracy of these devices.

This was the second day of meetings of the general and plastic surgery devices panel of the FDA’s Medical Devices Advisory Committee. On the previous day, the panel held a wide-ranging discussion about expanding use of skin lesion analyzer devices.

The FDA sought the expert panel’s advice concerning a field that appears to be heating up quickly after relatively quiet times.

Two devices have been approved by the FDA so far, but only one is still being promoted – SciBase AB’s Nevisense. The Swedish company announced in May 2020 that it had received FDA approval for Nevisense 3.0, the third generation of their Nevisense system for early melanoma detection, an AI-based point-of-care system for the noninvasive evaluation of irregular moles.

The other device, known as MelaFind, was acquired by Strata Skin Sciences, but the company said in 2017 that it discontinued research and development, sales, and support activity related to the device, according to a filing with the Securities and Exchange Commission.

But there’s been a swell in recent years in the number of publications related to the use of AI and machine learning, which could give rise to new tools for aiding in the diagnosis of skin conditions, including cancer. Google is among the companies that are involved in these efforts.

So, the FDA asked the expert panel to discuss a series of questions related to how the agency should weigh the risks of computer-aided devices for melanoma diagnosis. The agency also asked the panel to provide feedback about how well risks associated with such devices and tools might be managed and to offer suggestions.

The discussion at the July 29 meeting spun beyond narrow questions about reclassification of the current class III devices to topics involving emerging technology, such as efforts to apply AI to dermatology.

“Innovation continues. Medical device developers are anxious to plan how they might be able to develop the level of evidence that would meet your expectations” for future products, Binita Ashar, MD, a senior official in FDA’s Center for Devices and Radiological Health, told the panel.


 

Company CEO backs tougher regulation

Simon Grant, the chief executive of SciBase, which markets Nevisense, the first and only skin cancer–detecting device currently on the U.S. market, sought to make a case for sticking with the tougher class III regulations.

Speaking during the public comment session, Mr. Grant said switching to class II designations would weaken the standards used in clearing products that analyze skin lesions so as to put patients at risk.

Under the FDA’s rules, the agency designates as class III devices that present potential unreasonable risk of illness or injury. Only about 10% of devices fall into this category. Such devices include implantable pacemakers and breast implants, as well as SciBase’s Nevisense.

About 43% of medical devices fall into the class II category, which includes powered wheelchairs and some pregnancy test kits, the FDA website says.

Class I medical devices pose minimal potential for harm and tend to be simpler in design. These include enema kits and elastic bandages, the FDA says.

Mr. Grant told the meeting that in his career he has worked on two class III products and about 20 class II products. (He had previously worked at medical startups Synectics Medical and Neoventa, as well as established multinationals such as Medtronic.)

“I can tell you that – practically – the FDA has many fewer sticks and much less control when it comes to class II devices,” he said. He offered an example of a manufacturer of a class II device having more latitude in making small changes to products without notifying the FDA.

In his hypothetical example, such a change could have unintended consequences, and “with AI systems, small changes can result in large and nonlinear or even random effects,” Mr. Grant said. “But it’s too late if the product is on the market and the harm has already occurred,” he said.

The American Society for Dermatologic Surgery Association also protested the reclassifying of approved computer-aided melanoma detection class III devices.

In a statement posted on the FDA website as part of the materials for the meeting, the ASDSA raised a series of concerns about the prospects of expanded U.S. use of tools for assisting in diagnosing melanoma, including ones that would be marketed to consumers.

“To the extent that algorithms and devices for patient self-diagnosis of skin lesions are already widely available, they should be required to include detailed disclaimers that include that they are for entertainment and educational purposes and not a diagnostic device, that they are not approved by dermatologists or a recognized medical regulatory authority for self-diagnosis,” the ASDSA said.

Devices and algorithms in screening tools “are not highly regulated and remain unproven. They may result in wrong diagnoses, missed diagnoses, or over- or underdiagnosis,” the ASDSA added. “Both patients at low risk and those at high risk are better served by scheduling an in-person examination with a board-certified dermatologist, who can also help them determine the appropriate future skin screening schedule that is most appropriate for them.”

 

‘Stepping stone’

However, there is strong consumer demand for better information about skin conditions, and many patients face hurdles in going to dermatologists.

Google research has shown that consumers are seeking “a stepping stone” between the information they can easily find online and what they could get from a medical professional, said Lily Peng, MD, PhD, a director of product management for the health AI team at Google. Dr. Peng was a scheduled presenter at the July 29 meeting.

Consumers often are looking for more information on common conditions such as acne and poison ivy, and they sometimes face challenges in getting access to clinicians, she said.

“There are many unmet needs for consumers experiencing skin issues, many of which are lower-acuity conditions. There’s a big opportunity to increase accessibility and relevance of health journeys for consumers,” Dr. Peng said. “We have heard from consumers that they would like to have a self-help tool for nonserious conditions so they can decide when to seek medical attention.”

Dr. Peng’s presentation was not directly related to the question of class II or class III designation for existing products. Instead, her talk served as a glimpse into the work already underway in creating apps and tools for consumers.

Google researchers have published a number of studies in recent years about the use of AI to improve dermatology diagnosis.

A 2020 article reported on Google’s test of a form of AI known as deep learning system (DLS) to provide a differential diagnosis of skin conditions. On 963 validation cases, where a rotating panel of three board-certified dermatologists defined the reference standard, the DLS was noninferior to six other dermatologists and was superior to six primary care physicians (PCPs) and six nurse practitioners (NPs), according to a summary of the article.

A 2021 report published in JAMA Network Open said that use of an AI tool was associated with a higher agreement rate with dermatologists’ reference diagnoses for both PCPs and NPs.

In a 2021 blog post, Google scientists wrote that their AI model that powers a tool for checking skin conditions had earned European clearance, known as a CE mark, as a class I medical device.

SkinVision has an app that the company says “is available worldwide (with the exception of the USA and Canada).” The firm’s website includes a link where people in the United States and Canada can sign up for notifications about when SkinVision will be available in these nations. 


 

‘Not ready for prime time’

The FDA panel did not cast formal votes at the July 29 meeting. Rather, the members engaged in broad discussions about risks and potential benefits of new tools for aiding in the detection of skin cancer.

Among the key issues discussed was a question of whether the FDA could impose requirements and restrictions, known as special controls, to provide “reasonable assurance of safety and effectiveness” for computer-aided devices that provide adjunctive diagnostic information to dermatologists about lesions suspicious for melanoma.

Among the potential special controls would be clinical performance testing in regards to rates of the sensitivity (true-positive rate) and specificity (true-negative rate).

The FDA could also look at requirements on software validation and verification and cybersecurity testing, as well as directions on labeling so as to mitigate risk.

Dermatologists serving on the panel called for caution in proceeding with steps that would make it easier for companies to market tools for aiding in melanoma diagnosis than it would be within the class III framework used for MelaFind and Nevisense.

Many expressed concerns about the need to design studies that would answer questions about how well new tools could accurately identify concerning lesions.

The phrase “not ready for prime time” was used at least three times during the discussion.

FDA panelist Maral Skelsey, MD, a skin cancer specialist from Chevy Chase, Maryland, said that over the years, she had used both Nevisense and MelaFind.

She said she had found MelaFind “unusable,” owing in large part to the high number of false positives it generated. The device also was limited as to where on patients’ bodies it could be used.

However, she spoke with enthusiasm about the prospects for better devices to aid in diagnosis of skin lesions. “It’s an area where we’re on the verge, and we really need these devices. There’s a need for patients to be able to examine themselves, for nondermatologists to be able to assess lesions,” Dr. Skelsey said.

But this field is “just not ready for prime time” yet, even with special controls, Dr. Skelsey said. To loosen approval standards too quickly could be a “detriment to what’s coming down the pipeline,” she said.

“It’s harmful to things that are likely to be around the corner,” she said.

FDA panelist Renata Block, PA-C, who works in a Chicago dermatology practice, pressed for maintaining a class III designation. “We are not ready for prime time yet, though the data that is coming down the pipeline on what we have is quite exciting,” Ms. Block said.

FDA panelist Karla V. Ballman, PhD, a statistician from Weill Cornell Medicine, New York, said there would need to be a clear standard for clinical performance before proceeding toward reclassification of devices for aid in detecting melanoma. “I just don’t think it’s ready for prime time at this point and should remain in class III,” she said.

But there was support from some panelists for the idea of a lower bar for clearance, combined with special controls to ensure patient safety.

In expressing her view, FDA panelist Katalin Roth, MD, JD, professor of medicine, George Washington University, Washington, said she was an outlier in her support for the agency’s view that these risks could be managed and that future tools could allow more patients to take a step on the pathway toward critical diagnoses.

“I deal with a lot of people with cancer as a palliative care physician,” Dr. Roth said. “I think what we’re missing here is the issue of time. Melanoma is a terrible disease, and missing the diagnosis is a terrible thing, but I think special controls would be sufficient to counter the concerns of my colleagues on the committee.”

The FDA’s Dr. Ashar ended the meeting with questions posed to one panelist, Veronica Rotemberg, MD, PhD, a dermatologist at Memorial Sloan Kettering Cancer Center in New York.

Dr. Rotemberg has for years been working in the field of research on developing AI and other computer-based tools for detecting and diagnosing melanoma, the deadliest form of skin cancer.

She has been publicly skeptical of the performance of commercial apps that scan moles and other lesions and that claim to identify which are cancerous. A May blog post on the Memorial Sloan Kettering website highlighted a recent British Journal of Dermatology article in which Dr. Rotemberg and coauthors reported on their evaluations of commercial apps. They judged them to be on average only 59% accurate, the blog post said.

However, during an earlier discussion at the meeting, she had spoken more positively about the prospects for using special controls in the near term to mitigate risk, although she said she would have a “very long list” of these requirements.

In the closing exchange with Dr. Ashar, Dr. Rotemberg outlined steps that could potentially ensure the safe use of tools to aid in melanoma screening. These included a need for postmarketing surveillance, which would require evaluation over time of algorithms used in tools meant to detect skin cancer.

“We need to have a mechanism for sampling,” Dr. Rotemberg said. “Most of our data is electronic now anyway, so comparing an algorithm and performance with biopsy results should not be that challenging.”

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

A federal advisory panel stressed the need for further research about potential expanded use of devices in detection of skin cancer, with U.S. regulators readying for challenges in determining how well these tools need to work and how to address longstanding issues of racial equity in this field of medicine.

The Food and Drug Administration has scheduled two meetings to gather expert feedback about managing an expected expansion in the use of skin lesion apps and devices. Outside of the United States, there are apps promoted as being able to help spot skin lesions that should trigger a medical visit.

AGA Institute

The general and plastic surgery devices panel of the FDA’s Medical Devices Advisory Committee began work on this topic on July 28, with a wide-ranging discussion about potential expanded use of computer-aided, skin lesion analyzer (SLA) devices. On Friday, the panel is considering an FDA proposal to shift the designation for an approved device for aiding dermatologists in skin cancer diagnoses from the most stringent regulatory category, class III, to the less restrictive class II.

The FDA called the meeting amid growing interest in using technology to aid in finding cancers, with some of these products already marketed to consumers outside of the United States. There are presently no legally marketed, FDA-cleared or FDA-approved SLA devices indicated for use by clinicians other than dermatologists or the lay public, the agency said in a briefing memo for the meeting. There are two devices with FDA approval, though, for aiding dermatologists. The FDA approved SciBase’s Nevisense in 2017 and Mela Sciences’ MelaFind, which has fallen out of use, in 2012. Both are class III devices.

But some companies intend to offer products for consumers in the United States. The company SkinVision, for example, has developed an app of the same name, which is intended to detect suspicious-looking skin spots via smartphone photos. SkinVision’s website says the product has been offered to consumers in Australia for remote skin checks since 2015. People in the Netherlands and United Kingdom also can use SkinVision, according to the company’s website. SkinVision says the company is working on providing the app for U.S. customers, “but we are not quite there yet.”

During the meeting, FDA panelists repeatedly emphasized the potential risks of these devices in terms of sensitivity (how often a test correctly generates a positive result) and of specificity (how often a test correctly generates a negative result).

New tools intended to aid in detection of skin cancer might produce too many false positives and thus trigger floods of worried patients seeking care and often facing unnecessary biopsies, the FDA panelists said. But more worrisome would be FDA clearance of tools that delivered too many false negative results, leaving people unaware of their cancers.

The standards would have to be set very high for new products, especially those intended for consumers, said FDA panelist Murad Alam, MD, a dermatologist and vice chair of the department of dermatology at Northwestern University, Chicago. Current technologies for analyzing skin lesions are not yet up to that task. Dr. Alam likened the situation to the hopes for self-driving cars.

“It sounds great in principle. If you read the predictions from 20 years ago, it should already have happened,” Dr. Alam said. “But we’re still struggling with that because there are serious points of failure.”

FDA panelist Veronica Rotemberg, MD, PhD, a dermatologist at Memorial Sloan Kettering Cancer Center, New York, also argued for well-designed studies to understand how consumers and clinicians would react to new tools.

“We have to define what prospective information, in the intended use setting, we need to feel comfortable saying that these tools could be in a layperson’s hand or a primary care person’s hand,” Dr. Rotemberg said.

The studies would not need to be large, especially in the case of nonmelanoma skin cancer, which is common, she added.

“There’s too much nuance here for us to be able to say: ‘This is what would happen,’ without testing it,” Dr. Rotemberg said. “I do not think these prospective studies would be very burdensome, but they would help us understand what the burden would be and what the costs would be and what the potential harms would be.”

Because of rules against disclosing corporate information, the FDA cannot tell the public about the kinds of inquiries it already may have fielded from companies interested in selling skin cancer detection tools.

But in response to a question during the FDA meeting, Binita Ashar, MD, a top official in the FDA’s Center for Devices and Radiological Health, said there is interest in having these kinds of products sold in the United States as well.

“I can tell you that this a very timely discussion and questions that we’re posing to you are the questions that we’re encountering or that we have been grappling with,” Dr. Ashar said.

FDA panelists noted that many patients cannot get access easily to dermatology visits.

Companies seeking to develop SLA devices likely will market their tools as attempts to fill a gap that now exists in medical care.

But there will be challenges ahead in explaining to patients how to interpret readings from these tools, the FDA panelists said. Consumers should know these tools are meant to assist in diagnosis, and not to make it.

“I’m not sure the layperson will hear that,” said FDA panelist Paula E. Bourelly, MD, a dermatologist from Olney, Md.

As a result, use of SLA tools could create tension between physicians and patients, with consumers demanding biopsies after seeing readings they don’t understand.

“I do have great concerns about the layperson feeling overly confident and reducing the provider to a technician,” she said.

The FDA panelists were not asked to cast formal votes on any issues discussed during the meeting They instead engaged in broad discussions around questions posed by the FDA in three key areas:

• What standards should be used to confirm lesion diagnosis in clinical testing of the accuracy of SLA devices?
• What would be acceptable true false-positive and false-negative results (sensitivity and specificity) for different diagnoses and users?
• How can the FDA address health equity considerations based on variable incidence of skin lesions?

Developing standards

The FDA asked the panel to consider several scenarios for SLA devices and to discuss how standards might vary depending on the user of the device, whether it would be dermatologists, other clinicians, or consumers.

The agency sought comments in particular about using histological diagnosis (core specimen processing with a consensus diagnosis from an expert dermatopathologist panel). In the briefing document for the meeting, the FDA argued that this approach provides the greatest certainty in the diagnosis.

“Device developers, however, cite concerns, both practical and ethical, in requiring biopsy of all lesions, particularly those that appear benign,” the FDA said. “They have proposed alternate means of defining ground truth, including consensus opinion of experts (of visual or dermoscopic examination of the lesion[s]), opinion of one expert (visual or dermoscopic examination), or other methods.”

In summarizing the discussion on this question, the FDA panel chairman, Hobart W. Harris, MD, MPH, a surgeon from the University of California, San Francisco, noted that there was broad support for histological data in clinical trials of SLA devices, with some allowance for cases where more hybrid approaches would be used.

There were also suggestions offered about designing trials and the need for biopsies of lesions that are clearly benign, as this would help gather data to help in developing algorithms.

Dr. Alam said care should be taken in explaining to study participants that they might have to undergo biopsies that they didn’t need, as part of the larger effort to gather data. This should be detailed in the consent form, he said.

“But I also think this is a relatively minor risk,” Dr. Alam said, comparing these biopsies to the blood samples that patients in many clinical studies routinely give.

“Are all of those blood draws necessary to track the change in whatever parameters that are being tracked? Probably not,” Dr. Alam said. “I think it would be possible to explain to a reasonable patient what this entails.”

Dr. Alam noted that companies might face extra hurdles in enrolling study participants and keeping them in the trials if the FDA seeks this kind of biopsy data. “But I don’t think inconvenience to the study sponsor is a good argument” for not seeking this kind of data, he added.

Leaving a loophole where certain kinds of clearly benign lesions don’t require a biopsy would eventually erode the quality of the research done on these devices. “That bar will be moved to accommodate the convenience of the sponsor, to make the study feasible,” Dr. Alam said. “And pretty soon, you’ll be missing a lot of patients that really should have biopsies.”
 

Acceptable rates of false positives, false negatives

The FDA panel chair noted that his colleagues had strongly urged review standards that would require that the devices improve on the rates of successful catches of suspicious lesions and lower false positives. But they did not endorse specific targets regarding the sensitivity and specificity rates.

“No one seems to be comfortable with providing or preordaining” these targets, Dr. Harris said.

Panelist Deneen Hesser, MSHSA, RN, urged a deep recognition of the power of a FDA clearance in the view of consumers.

“We need to be cognizant of what the term ‘FDA approved’ means to the lay individual,” said Ms. Hesser, who served as the patient representative on the panel. “A patient who sees that those tools are FDA approved will assume that each of those is the gold standard” in terms of expectations for delivering accurate results.

Like many of the panelists, Dr. Rotemberg urged the FDA to gather data about how patients would react to different messages encoded in consumer-oriented products.

Memorial Sloan Kettering Cancer Center

“If the device says: ‘You should see a dermatologist for this’ and no other information, that’s very different from [saying]: ‘That lesion is suspicious for melanoma,’ ” Dr. Rotemberg said.

Despite the likely difficulties in conducting trials, the FDA needs to have the data to answer key questions about patient and physician reactions to readings from new tools, Dr. Rotemberg said.

“We don’t know how many additional biopsies we would cause with a specificity of 80%” for a new SLA tool, Dr. Rotemberg said, giving an example. “We don’t know how confident a dermatologist might be to say: ‘Actually, I’m not suspicious about that lesion and we can just fudge it or not biopsy it.’ We don’t know any of that until we study it in real life.”

The panelists also urged the FDA to seek to ensure that new tools used in analyzing skin lesions improve the quality of diagnosis.
 

Addressing equity

The FDA also asked the panel to weigh in on whether the agency should clear SLA tools in cases where the existing study data is drawn heavily from people considered to be at higher risk for skin cancer.

No credit needed per U.S. gov work.

“To ensure generalizability across the entire U.S. population, should FDA require SLAs indicated for use beyond cancerous lesions be tested in a representative U.S. population?” the FDA asked.

The three most common skin cancers – melanoma, basal cell carcinoma, and squamous cell carcinoma – are more prevalent in people with Fitzpatrick I and II skin types, who tend to get sunburns, not tans. But people of color are more likely to develop melanoma in areas that are not sun exposed, such as the sole of the foot or under fingernails or toenails.

“Due in part to lower expected risk and screening, these melanomas are often detected late,” the FDA said in the briefing document.

There was broad consensus among panelists that the FDA should encourage companies to enroll people with all skin types and tones.

But they also looked for ways that the FDA could clear devices based on initial studies conducted largely with people considered to be at higher risk, with the agency then requiring follow-up trials to see how these products would work for the general U.S. population.

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

A federal advisory panel stressed the need for further research about potential expanded use of devices in detection of skin cancer, with U.S. regulators readying for challenges in determining how well these tools need to work and how to address longstanding issues of racial equity in this field of medicine.

The Food and Drug Administration has scheduled two meetings to gather expert feedback about managing an expected expansion in the use of skin lesion apps and devices. Outside of the United States, there are apps promoted as being able to help spot skin lesions that should trigger a medical visit.

AGA Institute

The general and plastic surgery devices panel of the FDA’s Medical Devices Advisory Committee began work on this topic on July 28, with a wide-ranging discussion about potential expanded use of computer-aided, skin lesion analyzer (SLA) devices. On Friday, the panel is considering an FDA proposal to shift the designation for an approved device for aiding dermatologists in skin cancer diagnoses from the most stringent regulatory category, class III, to the less restrictive class II.

The FDA called the meeting amid growing interest in using technology to aid in finding cancers, with some of these products already marketed to consumers outside of the United States. There are presently no legally marketed, FDA-cleared or FDA-approved SLA devices indicated for use by clinicians other than dermatologists or the lay public, the agency said in a briefing memo for the meeting. There are two devices with FDA approval, though, for aiding dermatologists. The FDA approved SciBase’s Nevisense in 2017 and Mela Sciences’ MelaFind, which has fallen out of use, in 2012. Both are class III devices.

But some companies intend to offer products for consumers in the United States. The company SkinVision, for example, has developed an app of the same name, which is intended to detect suspicious-looking skin spots via smartphone photos. SkinVision’s website says the product has been offered to consumers in Australia for remote skin checks since 2015. People in the Netherlands and United Kingdom also can use SkinVision, according to the company’s website. SkinVision says the company is working on providing the app for U.S. customers, “but we are not quite there yet.”

During the meeting, FDA panelists repeatedly emphasized the potential risks of these devices in terms of sensitivity (how often a test correctly generates a positive result) and of specificity (how often a test correctly generates a negative result).

New tools intended to aid in detection of skin cancer might produce too many false positives and thus trigger floods of worried patients seeking care and often facing unnecessary biopsies, the FDA panelists said. But more worrisome would be FDA clearance of tools that delivered too many false negative results, leaving people unaware of their cancers.

The standards would have to be set very high for new products, especially those intended for consumers, said FDA panelist Murad Alam, MD, a dermatologist and vice chair of the department of dermatology at Northwestern University, Chicago. Current technologies for analyzing skin lesions are not yet up to that task. Dr. Alam likened the situation to the hopes for self-driving cars.

“It sounds great in principle. If you read the predictions from 20 years ago, it should already have happened,” Dr. Alam said. “But we’re still struggling with that because there are serious points of failure.”

FDA panelist Veronica Rotemberg, MD, PhD, a dermatologist at Memorial Sloan Kettering Cancer Center, New York, also argued for well-designed studies to understand how consumers and clinicians would react to new tools.

“We have to define what prospective information, in the intended use setting, we need to feel comfortable saying that these tools could be in a layperson’s hand or a primary care person’s hand,” Dr. Rotemberg said.

The studies would not need to be large, especially in the case of nonmelanoma skin cancer, which is common, she added.

“There’s too much nuance here for us to be able to say: ‘This is what would happen,’ without testing it,” Dr. Rotemberg said. “I do not think these prospective studies would be very burdensome, but they would help us understand what the burden would be and what the costs would be and what the potential harms would be.”

Because of rules against disclosing corporate information, the FDA cannot tell the public about the kinds of inquiries it already may have fielded from companies interested in selling skin cancer detection tools.

But in response to a question during the FDA meeting, Binita Ashar, MD, a top official in the FDA’s Center for Devices and Radiological Health, said there is interest in having these kinds of products sold in the United States as well.

“I can tell you that this a very timely discussion and questions that we’re posing to you are the questions that we’re encountering or that we have been grappling with,” Dr. Ashar said.

FDA panelists noted that many patients cannot get access easily to dermatology visits.

Companies seeking to develop SLA devices likely will market their tools as attempts to fill a gap that now exists in medical care.

But there will be challenges ahead in explaining to patients how to interpret readings from these tools, the FDA panelists said. Consumers should know these tools are meant to assist in diagnosis, and not to make it.

“I’m not sure the layperson will hear that,” said FDA panelist Paula E. Bourelly, MD, a dermatologist from Olney, Md.

As a result, use of SLA tools could create tension between physicians and patients, with consumers demanding biopsies after seeing readings they don’t understand.

“I do have great concerns about the layperson feeling overly confident and reducing the provider to a technician,” she said.

The FDA panelists were not asked to cast formal votes on any issues discussed during the meeting They instead engaged in broad discussions around questions posed by the FDA in three key areas:

• What standards should be used to confirm lesion diagnosis in clinical testing of the accuracy of SLA devices?
• What would be acceptable true false-positive and false-negative results (sensitivity and specificity) for different diagnoses and users?
• How can the FDA address health equity considerations based on variable incidence of skin lesions?

Developing standards

The FDA asked the panel to consider several scenarios for SLA devices and to discuss how standards might vary depending on the user of the device, whether it would be dermatologists, other clinicians, or consumers.

The agency sought comments in particular about using histological diagnosis (core specimen processing with a consensus diagnosis from an expert dermatopathologist panel). In the briefing document for the meeting, the FDA argued that this approach provides the greatest certainty in the diagnosis.

“Device developers, however, cite concerns, both practical and ethical, in requiring biopsy of all lesions, particularly those that appear benign,” the FDA said. “They have proposed alternate means of defining ground truth, including consensus opinion of experts (of visual or dermoscopic examination of the lesion[s]), opinion of one expert (visual or dermoscopic examination), or other methods.”

In summarizing the discussion on this question, the FDA panel chairman, Hobart W. Harris, MD, MPH, a surgeon from the University of California, San Francisco, noted that there was broad support for histological data in clinical trials of SLA devices, with some allowance for cases where more hybrid approaches would be used.

There were also suggestions offered about designing trials and the need for biopsies of lesions that are clearly benign, as this would help gather data to help in developing algorithms.

Dr. Alam said care should be taken in explaining to study participants that they might have to undergo biopsies that they didn’t need, as part of the larger effort to gather data. This should be detailed in the consent form, he said.

“But I also think this is a relatively minor risk,” Dr. Alam said, comparing these biopsies to the blood samples that patients in many clinical studies routinely give.

“Are all of those blood draws necessary to track the change in whatever parameters that are being tracked? Probably not,” Dr. Alam said. “I think it would be possible to explain to a reasonable patient what this entails.”

Dr. Alam noted that companies might face extra hurdles in enrolling study participants and keeping them in the trials if the FDA seeks this kind of biopsy data. “But I don’t think inconvenience to the study sponsor is a good argument” for not seeking this kind of data, he added.

Leaving a loophole where certain kinds of clearly benign lesions don’t require a biopsy would eventually erode the quality of the research done on these devices. “That bar will be moved to accommodate the convenience of the sponsor, to make the study feasible,” Dr. Alam said. “And pretty soon, you’ll be missing a lot of patients that really should have biopsies.”
 

Acceptable rates of false positives, false negatives

The FDA panel chair noted that his colleagues had strongly urged review standards that would require that the devices improve on the rates of successful catches of suspicious lesions and lower false positives. But they did not endorse specific targets regarding the sensitivity and specificity rates.

“No one seems to be comfortable with providing or preordaining” these targets, Dr. Harris said.

Panelist Deneen Hesser, MSHSA, RN, urged a deep recognition of the power of a FDA clearance in the view of consumers.

“We need to be cognizant of what the term ‘FDA approved’ means to the lay individual,” said Ms. Hesser, who served as the patient representative on the panel. “A patient who sees that those tools are FDA approved will assume that each of those is the gold standard” in terms of expectations for delivering accurate results.

Like many of the panelists, Dr. Rotemberg urged the FDA to gather data about how patients would react to different messages encoded in consumer-oriented products.

Memorial Sloan Kettering Cancer Center

“If the device says: ‘You should see a dermatologist for this’ and no other information, that’s very different from [saying]: ‘That lesion is suspicious for melanoma,’ ” Dr. Rotemberg said.

Despite the likely difficulties in conducting trials, the FDA needs to have the data to answer key questions about patient and physician reactions to readings from new tools, Dr. Rotemberg said.

“We don’t know how many additional biopsies we would cause with a specificity of 80%” for a new SLA tool, Dr. Rotemberg said, giving an example. “We don’t know how confident a dermatologist might be to say: ‘Actually, I’m not suspicious about that lesion and we can just fudge it or not biopsy it.’ We don’t know any of that until we study it in real life.”

The panelists also urged the FDA to seek to ensure that new tools used in analyzing skin lesions improve the quality of diagnosis.
 

Addressing equity

The FDA also asked the panel to weigh in on whether the agency should clear SLA tools in cases where the existing study data is drawn heavily from people considered to be at higher risk for skin cancer.

No credit needed per U.S. gov work.

“To ensure generalizability across the entire U.S. population, should FDA require SLAs indicated for use beyond cancerous lesions be tested in a representative U.S. population?” the FDA asked.

The three most common skin cancers – melanoma, basal cell carcinoma, and squamous cell carcinoma – are more prevalent in people with Fitzpatrick I and II skin types, who tend to get sunburns, not tans. But people of color are more likely to develop melanoma in areas that are not sun exposed, such as the sole of the foot or under fingernails or toenails.

“Due in part to lower expected risk and screening, these melanomas are often detected late,” the FDA said in the briefing document.

There was broad consensus among panelists that the FDA should encourage companies to enroll people with all skin types and tones.

But they also looked for ways that the FDA could clear devices based on initial studies conducted largely with people considered to be at higher risk, with the agency then requiring follow-up trials to see how these products would work for the general U.S. population.

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

A federal advisory panel stressed the need for further research about potential expanded use of devices in detection of skin cancer, with U.S. regulators readying for challenges in determining how well these tools need to work and how to address longstanding issues of racial equity in this field of medicine.

The Food and Drug Administration has scheduled two meetings to gather expert feedback about managing an expected expansion in the use of skin lesion apps and devices. Outside of the United States, there are apps promoted as being able to help spot skin lesions that should trigger a medical visit.

AGA Institute

The general and plastic surgery devices panel of the FDA’s Medical Devices Advisory Committee began work on this topic on July 28, with a wide-ranging discussion about potential expanded use of computer-aided, skin lesion analyzer (SLA) devices. On Friday, the panel is considering an FDA proposal to shift the designation for an approved device for aiding dermatologists in skin cancer diagnoses from the most stringent regulatory category, class III, to the less restrictive class II.

The FDA called the meeting amid growing interest in using technology to aid in finding cancers, with some of these products already marketed to consumers outside of the United States. There are presently no legally marketed, FDA-cleared or FDA-approved SLA devices indicated for use by clinicians other than dermatologists or the lay public, the agency said in a briefing memo for the meeting. There are two devices with FDA approval, though, for aiding dermatologists. The FDA approved SciBase’s Nevisense in 2017 and Mela Sciences’ MelaFind, which has fallen out of use, in 2012. Both are class III devices.

But some companies intend to offer products for consumers in the United States. The company SkinVision, for example, has developed an app of the same name, which is intended to detect suspicious-looking skin spots via smartphone photos. SkinVision’s website says the product has been offered to consumers in Australia for remote skin checks since 2015. People in the Netherlands and United Kingdom also can use SkinVision, according to the company’s website. SkinVision says the company is working on providing the app for U.S. customers, “but we are not quite there yet.”

During the meeting, FDA panelists repeatedly emphasized the potential risks of these devices in terms of sensitivity (how often a test correctly generates a positive result) and of specificity (how often a test correctly generates a negative result).

New tools intended to aid in detection of skin cancer might produce too many false positives and thus trigger floods of worried patients seeking care and often facing unnecessary biopsies, the FDA panelists said. But more worrisome would be FDA clearance of tools that delivered too many false negative results, leaving people unaware of their cancers.

The standards would have to be set very high for new products, especially those intended for consumers, said FDA panelist Murad Alam, MD, a dermatologist and vice chair of the department of dermatology at Northwestern University, Chicago. Current technologies for analyzing skin lesions are not yet up to that task. Dr. Alam likened the situation to the hopes for self-driving cars.

“It sounds great in principle. If you read the predictions from 20 years ago, it should already have happened,” Dr. Alam said. “But we’re still struggling with that because there are serious points of failure.”

FDA panelist Veronica Rotemberg, MD, PhD, a dermatologist at Memorial Sloan Kettering Cancer Center, New York, also argued for well-designed studies to understand how consumers and clinicians would react to new tools.

“We have to define what prospective information, in the intended use setting, we need to feel comfortable saying that these tools could be in a layperson’s hand or a primary care person’s hand,” Dr. Rotemberg said.

The studies would not need to be large, especially in the case of nonmelanoma skin cancer, which is common, she added.

“There’s too much nuance here for us to be able to say: ‘This is what would happen,’ without testing it,” Dr. Rotemberg said. “I do not think these prospective studies would be very burdensome, but they would help us understand what the burden would be and what the costs would be and what the potential harms would be.”

Because of rules against disclosing corporate information, the FDA cannot tell the public about the kinds of inquiries it already may have fielded from companies interested in selling skin cancer detection tools.

But in response to a question during the FDA meeting, Binita Ashar, MD, a top official in the FDA’s Center for Devices and Radiological Health, said there is interest in having these kinds of products sold in the United States as well.

“I can tell you that this a very timely discussion and questions that we’re posing to you are the questions that we’re encountering or that we have been grappling with,” Dr. Ashar said.

FDA panelists noted that many patients cannot get access easily to dermatology visits.

Companies seeking to develop SLA devices likely will market their tools as attempts to fill a gap that now exists in medical care.

But there will be challenges ahead in explaining to patients how to interpret readings from these tools, the FDA panelists said. Consumers should know these tools are meant to assist in diagnosis, and not to make it.

“I’m not sure the layperson will hear that,” said FDA panelist Paula E. Bourelly, MD, a dermatologist from Olney, Md.

As a result, use of SLA tools could create tension between physicians and patients, with consumers demanding biopsies after seeing readings they don’t understand.

“I do have great concerns about the layperson feeling overly confident and reducing the provider to a technician,” she said.

The FDA panelists were not asked to cast formal votes on any issues discussed during the meeting They instead engaged in broad discussions around questions posed by the FDA in three key areas:

• What standards should be used to confirm lesion diagnosis in clinical testing of the accuracy of SLA devices?
• What would be acceptable true false-positive and false-negative results (sensitivity and specificity) for different diagnoses and users?
• How can the FDA address health equity considerations based on variable incidence of skin lesions?

Developing standards

The FDA asked the panel to consider several scenarios for SLA devices and to discuss how standards might vary depending on the user of the device, whether it would be dermatologists, other clinicians, or consumers.

The agency sought comments in particular about using histological diagnosis (core specimen processing with a consensus diagnosis from an expert dermatopathologist panel). In the briefing document for the meeting, the FDA argued that this approach provides the greatest certainty in the diagnosis.

“Device developers, however, cite concerns, both practical and ethical, in requiring biopsy of all lesions, particularly those that appear benign,” the FDA said. “They have proposed alternate means of defining ground truth, including consensus opinion of experts (of visual or dermoscopic examination of the lesion[s]), opinion of one expert (visual or dermoscopic examination), or other methods.”

In summarizing the discussion on this question, the FDA panel chairman, Hobart W. Harris, MD, MPH, a surgeon from the University of California, San Francisco, noted that there was broad support for histological data in clinical trials of SLA devices, with some allowance for cases where more hybrid approaches would be used.

There were also suggestions offered about designing trials and the need for biopsies of lesions that are clearly benign, as this would help gather data to help in developing algorithms.

Dr. Alam said care should be taken in explaining to study participants that they might have to undergo biopsies that they didn’t need, as part of the larger effort to gather data. This should be detailed in the consent form, he said.

“But I also think this is a relatively minor risk,” Dr. Alam said, comparing these biopsies to the blood samples that patients in many clinical studies routinely give.

“Are all of those blood draws necessary to track the change in whatever parameters that are being tracked? Probably not,” Dr. Alam said. “I think it would be possible to explain to a reasonable patient what this entails.”

Dr. Alam noted that companies might face extra hurdles in enrolling study participants and keeping them in the trials if the FDA seeks this kind of biopsy data. “But I don’t think inconvenience to the study sponsor is a good argument” for not seeking this kind of data, he added.

Leaving a loophole where certain kinds of clearly benign lesions don’t require a biopsy would eventually erode the quality of the research done on these devices. “That bar will be moved to accommodate the convenience of the sponsor, to make the study feasible,” Dr. Alam said. “And pretty soon, you’ll be missing a lot of patients that really should have biopsies.”
 

Acceptable rates of false positives, false negatives

The FDA panel chair noted that his colleagues had strongly urged review standards that would require that the devices improve on the rates of successful catches of suspicious lesions and lower false positives. But they did not endorse specific targets regarding the sensitivity and specificity rates.

“No one seems to be comfortable with providing or preordaining” these targets, Dr. Harris said.

Panelist Deneen Hesser, MSHSA, RN, urged a deep recognition of the power of a FDA clearance in the view of consumers.

“We need to be cognizant of what the term ‘FDA approved’ means to the lay individual,” said Ms. Hesser, who served as the patient representative on the panel. “A patient who sees that those tools are FDA approved will assume that each of those is the gold standard” in terms of expectations for delivering accurate results.

Like many of the panelists, Dr. Rotemberg urged the FDA to gather data about how patients would react to different messages encoded in consumer-oriented products.

Memorial Sloan Kettering Cancer Center

“If the device says: ‘You should see a dermatologist for this’ and no other information, that’s very different from [saying]: ‘That lesion is suspicious for melanoma,’ ” Dr. Rotemberg said.

Despite the likely difficulties in conducting trials, the FDA needs to have the data to answer key questions about patient and physician reactions to readings from new tools, Dr. Rotemberg said.

“We don’t know how many additional biopsies we would cause with a specificity of 80%” for a new SLA tool, Dr. Rotemberg said, giving an example. “We don’t know how confident a dermatologist might be to say: ‘Actually, I’m not suspicious about that lesion and we can just fudge it or not biopsy it.’ We don’t know any of that until we study it in real life.”

The panelists also urged the FDA to seek to ensure that new tools used in analyzing skin lesions improve the quality of diagnosis.
 

Addressing equity

The FDA also asked the panel to weigh in on whether the agency should clear SLA tools in cases where the existing study data is drawn heavily from people considered to be at higher risk for skin cancer.

No credit needed per U.S. gov work.

“To ensure generalizability across the entire U.S. population, should FDA require SLAs indicated for use beyond cancerous lesions be tested in a representative U.S. population?” the FDA asked.

The three most common skin cancers – melanoma, basal cell carcinoma, and squamous cell carcinoma – are more prevalent in people with Fitzpatrick I and II skin types, who tend to get sunburns, not tans. But people of color are more likely to develop melanoma in areas that are not sun exposed, such as the sole of the foot or under fingernails or toenails.

“Due in part to lower expected risk and screening, these melanomas are often detected late,” the FDA said in the briefing document.

There was broad consensus among panelists that the FDA should encourage companies to enroll people with all skin types and tones.

But they also looked for ways that the FDA could clear devices based on initial studies conducted largely with people considered to be at higher risk, with the agency then requiring follow-up trials to see how these products would work for the general U.S. population.

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

Scientists seeking to stay ahead of an evolving SARS-Cov-2 virus are looking at new strategies, including developing intranasal vaccines, according to speakers at a conference on July 26.

The Biden administration held a summit on the future of COVID-19 vaccines, inviting researchers to provide a public update on efforts to try to keep ahead of SARS-CoV-2.

Scientists and federal officials are looking to build on the successes seen in developing the original crop of COVID vaccines, which were authorized for use in the United States less than a year after the pandemic took hold.

But emerging variants are eroding these gains. For months now, officials at the Centers for Disease Control and Prevention and Food and Drug Administration have been keeping an eye on how the level of effectiveness of COVID vaccines has waned during the rise of the Omicron strain. And there’s continual concern about how SARS-CoV-2 might evolve over time.

“Our vaccines are terrific,” Ashish K. Jha, MD, the White House’s COVID-19 response coordinator, said at the summit. “[But] we have to do better.”

Among the approaches being considered are vaccines that would be applied intranasally, with the idea that this might be able to boost the immune response to SARS-CoV-2.

At the summit, Akiko Iwasaki, PhD, of Yale University, New Haven, Conn., said the intranasal approach might be helpful in preventing transmission as well as reducing the burden of illness for those who are infected with SARS-CoV-2.

“We’re stopping the virus from spreading right at the border,” Dr. Iwasaki said at the summit. “This is akin to putting a guard outside of the house in order to patrol for invaders compared to putting the guards in the hallway of the building in the hope that they capture the invader.”

Dr. Iwasaki is one of the founders of Xanadu Bio, a private company created last year to focus on ways to kill SARS-CoV-2 in the nasosinus before it spreads deeper into the respiratory tract. In an editorial in Science Immunology, Dr. Iwasaki and Eric J. Topol, MD, director of the Scripps Research Translational Institute, urged greater federal investment in this approach to fighting SARS-CoV-2. (Dr. Topol is editor-in-chief of Medscape.)

Titled “Operation Nasal Vaccine – Lightning speed to counter COVID-19,” their editorial noted the “unprecedented success” seen in the rapid development of the first two mRNA shots. Dr. Iwasaki and Dr. Topol noted that these victories had been “fueled by the $10 billion governmental investment in Operation Warp Speed.

“During the first year of the pandemic, meaningful evolution of the virus was slow-paced, without any functional consequences, but since that time we have seen a succession of important variants of concern, with increasing transmissibility and immune evasion, culminating in the Omicron lineages,”  wrote Dr. Iwasaki and Dr. Topol.

Recent developments have “spotlighted the possibility of nasal vaccines, with their allure for achieving mucosal immunity, complementing, and likely bolstering the circulating immunity achieved via intramuscular shots,” they added.
 

An early setback

Scientists at the National Institutes of Health and the Biomedical Advanced Research and Development Authority (BARDA) have for some time been looking to vet an array of next-generation vaccine concepts, including ones that trigger mucosal immunity, the Washington Post reported in April.

At the summit on July 26, several participants, including Dr. Jha, stressed the role that public-private partnerships were key to the rapid development of the initial COVID vaccines. They said continued U.S. government support will be needed to make advances in this field.

One of the presenters, Biao He, PhD, founder and president of CyanVac and Blue Lake Biotechnology, spoke of the federal support that his efforts have received over the years to develop intranasal vaccines. His Georgia-based firm already has an experimental intranasal vaccine candidate, CVXGA1-001, in phase 1 testing (NCT04954287).

The CVXGA-001 builds on technology already used in a veterinary product, an intranasal vaccine long used to prevent kennel cough in dogs, he said at the summit.

The emerging field of experimental intranasal COVID vaccines already has had at least one setback.

The biotech firm Altimmune in June 2021 announced that it would discontinue development of its experimental intranasal AdCOVID vaccine following disappointing phase 1 results. The vaccine appeared to be well tolerated in the test, but the immunogenicity data demonstrated lower than expected results in healthy volunteers, especially in light of the responses seen to already cleared vaccines, Altimmune said in a release. 

In the statement, Scot Roberts, PhD, chief scientific officer at Altimmune, noted that the study participants lacked immunity from prior infection or vaccination. “We believe that prior immunity in humans may be important for a robust immune response to intranasal dosing with AdCOVID,” he said.

At the summit, Marty Moore, PhD, cofounder and chief scientific officer for Redwood City, Calif.–based Meissa Vaccines, noted the challenges that remain ahead for intranasal COVID vaccines, while also highlighting what he sees as the potential of this approach.

Meissa also has advanced an experimental intranasal COVID vaccine as far as phase 1 testing (NCT04798001).

“No one here today can tell you that mucosal COVID vaccines work. We’re not there yet. We need clinical efficacy data to answer that question,” Dr. Moore said.

But there’s a potential for a “knockout blow to COVID, a transmission-blocking vaccine” from the intranasal approach, he said.

“The virus is mutating faster than our ability to manage vaccines and not enough people are getting boosters. These injectable vaccines do a great job of preventing severe disease, but they do little to prevent infection” from spreading, Dr. Moore said.

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

Scientists seeking to stay ahead of an evolving SARS-Cov-2 virus are looking at new strategies, including developing intranasal vaccines, according to speakers at a conference on July 26.

The Biden administration held a summit on the future of COVID-19 vaccines, inviting researchers to provide a public update on efforts to try to keep ahead of SARS-CoV-2.

Scientists and federal officials are looking to build on the successes seen in developing the original crop of COVID vaccines, which were authorized for use in the United States less than a year after the pandemic took hold.

But emerging variants are eroding these gains. For months now, officials at the Centers for Disease Control and Prevention and Food and Drug Administration have been keeping an eye on how the level of effectiveness of COVID vaccines has waned during the rise of the Omicron strain. And there’s continual concern about how SARS-CoV-2 might evolve over time.

“Our vaccines are terrific,” Ashish K. Jha, MD, the White House’s COVID-19 response coordinator, said at the summit. “[But] we have to do better.”

Among the approaches being considered are vaccines that would be applied intranasally, with the idea that this might be able to boost the immune response to SARS-CoV-2.

At the summit, Akiko Iwasaki, PhD, of Yale University, New Haven, Conn., said the intranasal approach might be helpful in preventing transmission as well as reducing the burden of illness for those who are infected with SARS-CoV-2.

“We’re stopping the virus from spreading right at the border,” Dr. Iwasaki said at the summit. “This is akin to putting a guard outside of the house in order to patrol for invaders compared to putting the guards in the hallway of the building in the hope that they capture the invader.”

Dr. Iwasaki is one of the founders of Xanadu Bio, a private company created last year to focus on ways to kill SARS-CoV-2 in the nasosinus before it spreads deeper into the respiratory tract. In an editorial in Science Immunology, Dr. Iwasaki and Eric J. Topol, MD, director of the Scripps Research Translational Institute, urged greater federal investment in this approach to fighting SARS-CoV-2. (Dr. Topol is editor-in-chief of Medscape.)

Titled “Operation Nasal Vaccine – Lightning speed to counter COVID-19,” their editorial noted the “unprecedented success” seen in the rapid development of the first two mRNA shots. Dr. Iwasaki and Dr. Topol noted that these victories had been “fueled by the $10 billion governmental investment in Operation Warp Speed.

“During the first year of the pandemic, meaningful evolution of the virus was slow-paced, without any functional consequences, but since that time we have seen a succession of important variants of concern, with increasing transmissibility and immune evasion, culminating in the Omicron lineages,”  wrote Dr. Iwasaki and Dr. Topol.

Recent developments have “spotlighted the possibility of nasal vaccines, with their allure for achieving mucosal immunity, complementing, and likely bolstering the circulating immunity achieved via intramuscular shots,” they added.
 

An early setback

Scientists at the National Institutes of Health and the Biomedical Advanced Research and Development Authority (BARDA) have for some time been looking to vet an array of next-generation vaccine concepts, including ones that trigger mucosal immunity, the Washington Post reported in April.

At the summit on July 26, several participants, including Dr. Jha, stressed the role that public-private partnerships were key to the rapid development of the initial COVID vaccines. They said continued U.S. government support will be needed to make advances in this field.

One of the presenters, Biao He, PhD, founder and president of CyanVac and Blue Lake Biotechnology, spoke of the federal support that his efforts have received over the years to develop intranasal vaccines. His Georgia-based firm already has an experimental intranasal vaccine candidate, CVXGA1-001, in phase 1 testing (NCT04954287).

The CVXGA-001 builds on technology already used in a veterinary product, an intranasal vaccine long used to prevent kennel cough in dogs, he said at the summit.

The emerging field of experimental intranasal COVID vaccines already has had at least one setback.

The biotech firm Altimmune in June 2021 announced that it would discontinue development of its experimental intranasal AdCOVID vaccine following disappointing phase 1 results. The vaccine appeared to be well tolerated in the test, but the immunogenicity data demonstrated lower than expected results in healthy volunteers, especially in light of the responses seen to already cleared vaccines, Altimmune said in a release. 

In the statement, Scot Roberts, PhD, chief scientific officer at Altimmune, noted that the study participants lacked immunity from prior infection or vaccination. “We believe that prior immunity in humans may be important for a robust immune response to intranasal dosing with AdCOVID,” he said.

At the summit, Marty Moore, PhD, cofounder and chief scientific officer for Redwood City, Calif.–based Meissa Vaccines, noted the challenges that remain ahead for intranasal COVID vaccines, while also highlighting what he sees as the potential of this approach.

Meissa also has advanced an experimental intranasal COVID vaccine as far as phase 1 testing (NCT04798001).

“No one here today can tell you that mucosal COVID vaccines work. We’re not there yet. We need clinical efficacy data to answer that question,” Dr. Moore said.

But there’s a potential for a “knockout blow to COVID, a transmission-blocking vaccine” from the intranasal approach, he said.

“The virus is mutating faster than our ability to manage vaccines and not enough people are getting boosters. These injectable vaccines do a great job of preventing severe disease, but they do little to prevent infection” from spreading, Dr. Moore said.

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

Scientists seeking to stay ahead of an evolving SARS-Cov-2 virus are looking at new strategies, including developing intranasal vaccines, according to speakers at a conference on July 26.

The Biden administration held a summit on the future of COVID-19 vaccines, inviting researchers to provide a public update on efforts to try to keep ahead of SARS-CoV-2.

Scientists and federal officials are looking to build on the successes seen in developing the original crop of COVID vaccines, which were authorized for use in the United States less than a year after the pandemic took hold.

But emerging variants are eroding these gains. For months now, officials at the Centers for Disease Control and Prevention and Food and Drug Administration have been keeping an eye on how the level of effectiveness of COVID vaccines has waned during the rise of the Omicron strain. And there’s continual concern about how SARS-CoV-2 might evolve over time.

“Our vaccines are terrific,” Ashish K. Jha, MD, the White House’s COVID-19 response coordinator, said at the summit. “[But] we have to do better.”

Among the approaches being considered are vaccines that would be applied intranasally, with the idea that this might be able to boost the immune response to SARS-CoV-2.

At the summit, Akiko Iwasaki, PhD, of Yale University, New Haven, Conn., said the intranasal approach might be helpful in preventing transmission as well as reducing the burden of illness for those who are infected with SARS-CoV-2.

“We’re stopping the virus from spreading right at the border,” Dr. Iwasaki said at the summit. “This is akin to putting a guard outside of the house in order to patrol for invaders compared to putting the guards in the hallway of the building in the hope that they capture the invader.”

Dr. Iwasaki is one of the founders of Xanadu Bio, a private company created last year to focus on ways to kill SARS-CoV-2 in the nasosinus before it spreads deeper into the respiratory tract. In an editorial in Science Immunology, Dr. Iwasaki and Eric J. Topol, MD, director of the Scripps Research Translational Institute, urged greater federal investment in this approach to fighting SARS-CoV-2. (Dr. Topol is editor-in-chief of Medscape.)

Titled “Operation Nasal Vaccine – Lightning speed to counter COVID-19,” their editorial noted the “unprecedented success” seen in the rapid development of the first two mRNA shots. Dr. Iwasaki and Dr. Topol noted that these victories had been “fueled by the $10 billion governmental investment in Operation Warp Speed.

“During the first year of the pandemic, meaningful evolution of the virus was slow-paced, without any functional consequences, but since that time we have seen a succession of important variants of concern, with increasing transmissibility and immune evasion, culminating in the Omicron lineages,”  wrote Dr. Iwasaki and Dr. Topol.

Recent developments have “spotlighted the possibility of nasal vaccines, with their allure for achieving mucosal immunity, complementing, and likely bolstering the circulating immunity achieved via intramuscular shots,” they added.
 

An early setback

Scientists at the National Institutes of Health and the Biomedical Advanced Research and Development Authority (BARDA) have for some time been looking to vet an array of next-generation vaccine concepts, including ones that trigger mucosal immunity, the Washington Post reported in April.

At the summit on July 26, several participants, including Dr. Jha, stressed the role that public-private partnerships were key to the rapid development of the initial COVID vaccines. They said continued U.S. government support will be needed to make advances in this field.

One of the presenters, Biao He, PhD, founder and president of CyanVac and Blue Lake Biotechnology, spoke of the federal support that his efforts have received over the years to develop intranasal vaccines. His Georgia-based firm already has an experimental intranasal vaccine candidate, CVXGA1-001, in phase 1 testing (NCT04954287).

The CVXGA-001 builds on technology already used in a veterinary product, an intranasal vaccine long used to prevent kennel cough in dogs, he said at the summit.

The emerging field of experimental intranasal COVID vaccines already has had at least one setback.

The biotech firm Altimmune in June 2021 announced that it would discontinue development of its experimental intranasal AdCOVID vaccine following disappointing phase 1 results. The vaccine appeared to be well tolerated in the test, but the immunogenicity data demonstrated lower than expected results in healthy volunteers, especially in light of the responses seen to already cleared vaccines, Altimmune said in a release. 

In the statement, Scot Roberts, PhD, chief scientific officer at Altimmune, noted that the study participants lacked immunity from prior infection or vaccination. “We believe that prior immunity in humans may be important for a robust immune response to intranasal dosing with AdCOVID,” he said.

At the summit, Marty Moore, PhD, cofounder and chief scientific officer for Redwood City, Calif.–based Meissa Vaccines, noted the challenges that remain ahead for intranasal COVID vaccines, while also highlighting what he sees as the potential of this approach.

Meissa also has advanced an experimental intranasal COVID vaccine as far as phase 1 testing (NCT04798001).

“No one here today can tell you that mucosal COVID vaccines work. We’re not there yet. We need clinical efficacy data to answer that question,” Dr. Moore said.

But there’s a potential for a “knockout blow to COVID, a transmission-blocking vaccine” from the intranasal approach, he said.

“The virus is mutating faster than our ability to manage vaccines and not enough people are getting boosters. These injectable vaccines do a great job of preventing severe disease, but they do little to prevent infection” from spreading, Dr. Moore said.

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

Republican and Democratic members of the House called for changes in how insurer-run Medicare plans manage the prior authorization process, following testimony from a federal watchdog organization about improper denials of payment for care.

About 18% of payment denials in a sample examined by the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) either met Medicare coverage rules or the rules of the insurance plan.

As such, they should not have been denied, according to the OIG. That was the finding of an April OIG report, based on a sample of 2019 denials from large insurer-run Medicare plans.

Erin Bliss, an assistant inspector general with the OIG, appeared as a witness at a June 28 Energy and Commerce Subcommittee on Oversight and Investigations hearing to discuss this investigation and other issues with prior authorization and insurer-run Medicare, also known as the Advantage plans.

Most of these payment denials of appropriate services were due to human error during manual claims-processing reviews, Ms. Bliss told the subcommittee, such as overlooking a document, and to system processing errors, such as a Medicare insurance plan failing to program or update a system correctly.

In many cases, these denials were reversed, but patient care was still disrupted and clinicians lost time chasing clearances for services that plans already had covered, Ms. Bliss said in her testimony.

The April report was not the OIG’s first look into concerns about insurer-run plans inappropriately denying care through prior authorizations. The OIG in 2018 reported that insurer-run Medicare plans overturned 75% of their own denials during 2014-2016 when patients and clinicians appealed these decisions, overturning approximately 216,000 denials each year.

‘Numerous hoops’ unnecessary for doctors, patients

Lawmakers at the hearing supported the idea of the need for prior authorization as a screening tool to prevent unneeded care.

But they chided insurance companies for their execution of this process, with clinicians and patients often frustrated by complex steps needed. Medicare Advantage plans sometimes require prior authorization for “relatively standard medical services,” said Subcommittee on Oversight and Investigations Chair Diana DeGette (D-Colo.).

“Our seniors and their doctors should not be required to jump through numerous hoops to ensure coverage for straightforward and medically necessary procedures,” Rep. DeGette said.

Several lawmakers spoke at the hearing about the need for changes to prior authorization, including calling for action on a pending bill intended to compel insurers to streamline the review process. The Improving Seniors’ Timely Access to Care Act of 2021 already has attracted more than 300 bipartisan sponsors. A companion Senate bill has more than 30 sponsors.

The bill’s aim is to shift this process away from faxes and phone calls while also encouraging plans to adhere to evidence-based medical guidelines in consultation with physicians. The bill calls for the establishment of an electronic prior authorization program that could issue real-time decisions.

“The result will be less administrative burden for providers and more information in the hands of patients. It will allow more patients to receive care when they need it, reducing the likelihood of additional, often more severe complications,” said Rep. Larry Bucshon, MD, (R-Ind.) who is among the active sponsors of the bill.

“In the long term, I believe it would also result in cost savings for the health care system at large by identifying problems earlier and getting them treated before their patients have more complications,” Rep. Bucshon added.
 

Finding ‘room for improvement’ for prior authorizations

There’s strong bipartisan support in Congress for insurer-run Medicare, which has grown by 10% per year over the last several years and has doubled since 2010, according to the Medicare Payment Advisory Commission (MedPAC). About 27 million people are now enrolled in these plans.

But for that reason, insurer-run Medicare may also need more careful watching, lawmakers made clear at the hearing.

“We’ve heard quite a bit of evidence today that there is room for improvement,” said Rep. Bucshon, a strong supporter of insurer-run Medicare, which can offer patients added benefits such as dental coverage.

Rep. Ann Kuster (D-N.H.) said simplifying prior authorization would reduce stress on clinicians already dealing with burnout.

“They’re just so tired of all this paperwork and red tape,” Rep. Kuster said. “In 2022 can’t we at least consider electronic prior authorization?”

At the hearing, Rep. Michael C. Burgess, MD, (R-Tex.) noted that his home state already has taken a step toward reducing the burden of prior authorization with its “gold card” program.

In 2021, a new Texas law called on the state department of insurance to develop rules to require health plans to provide an exemption from preauthorization requirements for a particular health care service if the issuer has approved, or would have approved, at least 90% of the preauthorization requests submitted by the physician or provider for that service. The law also mandates that a physician participating in a peer-to-peer review on behalf of a health benefit plan issuer must be a Texas-licensed physician who has the same or similar specialty as the physician or clinician requesting the service, according to the state insurance department.

Separately, Rep. Suzan DelBene (D-Wash.), the sponsor of the Improving Seniors’ Timely Access to Care Act, told the American Medical Association in a recent interview that she expects the House Ways and Means Committee, on which she serves, to mark up her bill in July. (A mark-up is the process by which a House or Senate committee considers and often amends a bill and then sends it to the chamber’s leadership for a floor vote.)

In a statement issued about the hearing, America’s Health Insurance Plans (AHIP) noted that there has been work in recent years toward streamlining prior authorization. AHIP said it launched the Fast Prior Authorization Technology Highway (Fast PATH) initiative in 2020 to study electronic procedures for handling these reviews.

“The findings of this study showed that ePA delivered improvements with a strong majority of experienced providers reporting faster time to patient care, fewer phone calls and faxes, better understanding of [prior authorization] requirements, and faster time to decisions,” AHIP said.

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

Republican and Democratic members of the House called for changes in how insurer-run Medicare plans manage the prior authorization process, following testimony from a federal watchdog organization about improper denials of payment for care.

About 18% of payment denials in a sample examined by the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) either met Medicare coverage rules or the rules of the insurance plan.

As such, they should not have been denied, according to the OIG. That was the finding of an April OIG report, based on a sample of 2019 denials from large insurer-run Medicare plans.

Erin Bliss, an assistant inspector general with the OIG, appeared as a witness at a June 28 Energy and Commerce Subcommittee on Oversight and Investigations hearing to discuss this investigation and other issues with prior authorization and insurer-run Medicare, also known as the Advantage plans.

Most of these payment denials of appropriate services were due to human error during manual claims-processing reviews, Ms. Bliss told the subcommittee, such as overlooking a document, and to system processing errors, such as a Medicare insurance plan failing to program or update a system correctly.

In many cases, these denials were reversed, but patient care was still disrupted and clinicians lost time chasing clearances for services that plans already had covered, Ms. Bliss said in her testimony.

The April report was not the OIG’s first look into concerns about insurer-run plans inappropriately denying care through prior authorizations. The OIG in 2018 reported that insurer-run Medicare plans overturned 75% of their own denials during 2014-2016 when patients and clinicians appealed these decisions, overturning approximately 216,000 denials each year.

‘Numerous hoops’ unnecessary for doctors, patients

Lawmakers at the hearing supported the idea of the need for prior authorization as a screening tool to prevent unneeded care.

But they chided insurance companies for their execution of this process, with clinicians and patients often frustrated by complex steps needed. Medicare Advantage plans sometimes require prior authorization for “relatively standard medical services,” said Subcommittee on Oversight and Investigations Chair Diana DeGette (D-Colo.).

“Our seniors and their doctors should not be required to jump through numerous hoops to ensure coverage for straightforward and medically necessary procedures,” Rep. DeGette said.

Several lawmakers spoke at the hearing about the need for changes to prior authorization, including calling for action on a pending bill intended to compel insurers to streamline the review process. The Improving Seniors’ Timely Access to Care Act of 2021 already has attracted more than 300 bipartisan sponsors. A companion Senate bill has more than 30 sponsors.

The bill’s aim is to shift this process away from faxes and phone calls while also encouraging plans to adhere to evidence-based medical guidelines in consultation with physicians. The bill calls for the establishment of an electronic prior authorization program that could issue real-time decisions.

“The result will be less administrative burden for providers and more information in the hands of patients. It will allow more patients to receive care when they need it, reducing the likelihood of additional, often more severe complications,” said Rep. Larry Bucshon, MD, (R-Ind.) who is among the active sponsors of the bill.

“In the long term, I believe it would also result in cost savings for the health care system at large by identifying problems earlier and getting them treated before their patients have more complications,” Rep. Bucshon added.
 

Finding ‘room for improvement’ for prior authorizations

There’s strong bipartisan support in Congress for insurer-run Medicare, which has grown by 10% per year over the last several years and has doubled since 2010, according to the Medicare Payment Advisory Commission (MedPAC). About 27 million people are now enrolled in these plans.

But for that reason, insurer-run Medicare may also need more careful watching, lawmakers made clear at the hearing.

“We’ve heard quite a bit of evidence today that there is room for improvement,” said Rep. Bucshon, a strong supporter of insurer-run Medicare, which can offer patients added benefits such as dental coverage.

Rep. Ann Kuster (D-N.H.) said simplifying prior authorization would reduce stress on clinicians already dealing with burnout.

“They’re just so tired of all this paperwork and red tape,” Rep. Kuster said. “In 2022 can’t we at least consider electronic prior authorization?”

At the hearing, Rep. Michael C. Burgess, MD, (R-Tex.) noted that his home state already has taken a step toward reducing the burden of prior authorization with its “gold card” program.

In 2021, a new Texas law called on the state department of insurance to develop rules to require health plans to provide an exemption from preauthorization requirements for a particular health care service if the issuer has approved, or would have approved, at least 90% of the preauthorization requests submitted by the physician or provider for that service. The law also mandates that a physician participating in a peer-to-peer review on behalf of a health benefit plan issuer must be a Texas-licensed physician who has the same or similar specialty as the physician or clinician requesting the service, according to the state insurance department.

Separately, Rep. Suzan DelBene (D-Wash.), the sponsor of the Improving Seniors’ Timely Access to Care Act, told the American Medical Association in a recent interview that she expects the House Ways and Means Committee, on which she serves, to mark up her bill in July. (A mark-up is the process by which a House or Senate committee considers and often amends a bill and then sends it to the chamber’s leadership for a floor vote.)

In a statement issued about the hearing, America’s Health Insurance Plans (AHIP) noted that there has been work in recent years toward streamlining prior authorization. AHIP said it launched the Fast Prior Authorization Technology Highway (Fast PATH) initiative in 2020 to study electronic procedures for handling these reviews.

“The findings of this study showed that ePA delivered improvements with a strong majority of experienced providers reporting faster time to patient care, fewer phone calls and faxes, better understanding of [prior authorization] requirements, and faster time to decisions,” AHIP said.

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

Republican and Democratic members of the House called for changes in how insurer-run Medicare plans manage the prior authorization process, following testimony from a federal watchdog organization about improper denials of payment for care.

About 18% of payment denials in a sample examined by the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) either met Medicare coverage rules or the rules of the insurance plan.

As such, they should not have been denied, according to the OIG. That was the finding of an April OIG report, based on a sample of 2019 denials from large insurer-run Medicare plans.

Erin Bliss, an assistant inspector general with the OIG, appeared as a witness at a June 28 Energy and Commerce Subcommittee on Oversight and Investigations hearing to discuss this investigation and other issues with prior authorization and insurer-run Medicare, also known as the Advantage plans.

Most of these payment denials of appropriate services were due to human error during manual claims-processing reviews, Ms. Bliss told the subcommittee, such as overlooking a document, and to system processing errors, such as a Medicare insurance plan failing to program or update a system correctly.

In many cases, these denials were reversed, but patient care was still disrupted and clinicians lost time chasing clearances for services that plans already had covered, Ms. Bliss said in her testimony.

The April report was not the OIG’s first look into concerns about insurer-run plans inappropriately denying care through prior authorizations. The OIG in 2018 reported that insurer-run Medicare plans overturned 75% of their own denials during 2014-2016 when patients and clinicians appealed these decisions, overturning approximately 216,000 denials each year.

‘Numerous hoops’ unnecessary for doctors, patients

Lawmakers at the hearing supported the idea of the need for prior authorization as a screening tool to prevent unneeded care.

But they chided insurance companies for their execution of this process, with clinicians and patients often frustrated by complex steps needed. Medicare Advantage plans sometimes require prior authorization for “relatively standard medical services,” said Subcommittee on Oversight and Investigations Chair Diana DeGette (D-Colo.).

“Our seniors and their doctors should not be required to jump through numerous hoops to ensure coverage for straightforward and medically necessary procedures,” Rep. DeGette said.

Several lawmakers spoke at the hearing about the need for changes to prior authorization, including calling for action on a pending bill intended to compel insurers to streamline the review process. The Improving Seniors’ Timely Access to Care Act of 2021 already has attracted more than 300 bipartisan sponsors. A companion Senate bill has more than 30 sponsors.

The bill’s aim is to shift this process away from faxes and phone calls while also encouraging plans to adhere to evidence-based medical guidelines in consultation with physicians. The bill calls for the establishment of an electronic prior authorization program that could issue real-time decisions.

“The result will be less administrative burden for providers and more information in the hands of patients. It will allow more patients to receive care when they need it, reducing the likelihood of additional, often more severe complications,” said Rep. Larry Bucshon, MD, (R-Ind.) who is among the active sponsors of the bill.

“In the long term, I believe it would also result in cost savings for the health care system at large by identifying problems earlier and getting them treated before their patients have more complications,” Rep. Bucshon added.
 

Finding ‘room for improvement’ for prior authorizations

There’s strong bipartisan support in Congress for insurer-run Medicare, which has grown by 10% per year over the last several years and has doubled since 2010, according to the Medicare Payment Advisory Commission (MedPAC). About 27 million people are now enrolled in these plans.

But for that reason, insurer-run Medicare may also need more careful watching, lawmakers made clear at the hearing.

“We’ve heard quite a bit of evidence today that there is room for improvement,” said Rep. Bucshon, a strong supporter of insurer-run Medicare, which can offer patients added benefits such as dental coverage.

Rep. Ann Kuster (D-N.H.) said simplifying prior authorization would reduce stress on clinicians already dealing with burnout.

“They’re just so tired of all this paperwork and red tape,” Rep. Kuster said. “In 2022 can’t we at least consider electronic prior authorization?”

At the hearing, Rep. Michael C. Burgess, MD, (R-Tex.) noted that his home state already has taken a step toward reducing the burden of prior authorization with its “gold card” program.

In 2021, a new Texas law called on the state department of insurance to develop rules to require health plans to provide an exemption from preauthorization requirements for a particular health care service if the issuer has approved, or would have approved, at least 90% of the preauthorization requests submitted by the physician or provider for that service. The law also mandates that a physician participating in a peer-to-peer review on behalf of a health benefit plan issuer must be a Texas-licensed physician who has the same or similar specialty as the physician or clinician requesting the service, according to the state insurance department.

Separately, Rep. Suzan DelBene (D-Wash.), the sponsor of the Improving Seniors’ Timely Access to Care Act, told the American Medical Association in a recent interview that she expects the House Ways and Means Committee, on which she serves, to mark up her bill in July. (A mark-up is the process by which a House or Senate committee considers and often amends a bill and then sends it to the chamber’s leadership for a floor vote.)

In a statement issued about the hearing, America’s Health Insurance Plans (AHIP) noted that there has been work in recent years toward streamlining prior authorization. AHIP said it launched the Fast Prior Authorization Technology Highway (Fast PATH) initiative in 2020 to study electronic procedures for handling these reviews.

“The findings of this study showed that ePA delivered improvements with a strong majority of experienced providers reporting faster time to patient care, fewer phone calls and faxes, better understanding of [prior authorization] requirements, and faster time to decisions,” AHIP said.

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