Kaiser Health News

Makers of brand-name drugs called out by the Trump administration for potentially stalling generic competition have hiked their prices by double-digit percentages since 2012 and cost Medicare and Medicaid nearly $12 billion in 2016, a Kaiser Health News analysis has found.

As part of President Donald Trump’s promise to curb high drug prices, the Food and Drug Administration posted a list of pharmaceutical companies that makers of generics allege refused to let them buy the drug samples needed to develop their products. For approval, the FDA requires so-called bioequivalence testing using samples to demonstrate that generics are the same as their branded counterparts.

The analysis shows that drug companies that may have engaged in what FDA Commissioner Scott Gottlieb, MD, called “shenanigans” to delay the entrance of cheaper competitors onto the market have indeed raised prices and cost taxpayers more money over time.

The FDA listed more than 50 drugs whose manufacturers have withheld or refused to sell samples and cited 164 inquiries for help obtaining them. Thirteen of these pleas from makers of generics pertained to Celgene’s blockbuster cancer drug Revlimid (lenalidomide), which accounted for 63% of Celgene’s revenue in the first quarter of 2018, according to a company press release.

The brand-name drug companies “wouldn’t put so much effort into fighting off competition if these weren’t [such] lucrative sources of revenue,” said Ameet Sarpatwari, JD, PhD, of Harvard Medical School in Boston. “In the case of a blockbuster drug, that can be hundreds of millions of dollars of revenue for the brand-name drugs and almost the same cost to the health care system.”

Indeed, a KHN analysis found that 47 of the drugs cost Medicare and Medicaid almost $12 billion in 2016. The spending totals don’t include rebates, which drugmakers return to the government after paying for the drugs upfront but are not public. The rebates ranged from 9.5% to 26.3% for Medicare Part D in 2014, the most recent year that data are available.

The remaining drugs do not appear in the Medicare and Medicaid data.

By delaying development of generics, drugmakers can maintain their monopolies and keep prices high. Most of the drugs cost Medicare Part D more in 2016 than they did in 2012, for an average spending increase of about 60% more per unit. This excludes drugs that don’t appear in the 2012 Medicare Part D data.

Revlimid cost Medicare Part D $2.7 billion in 2016, trailing only Harvoni (ledipasvir and sofosbuvir), which treats hepatitis C and is not on the FDA’s new list. The cost of Revlimid, which faces no competition from generics, has jumped 40% per unit in just 4 years, the Medicare data show, and cost $75,200/beneficiary in 2016.

Some drugs on the FDA’s list, including Celgene’s, are part of a safety program that can require restricted distribution of brand-name drugs that have serious risks or addictive qualities. Drugmakers with products in the safety program sometimes say they can’t provide samples unless the generics manufacturer jumps through a series of hoops “that generic companies find hard or impossible to comply with,” Dr. Gottlieb said in a statement.

The Department of Health & Human Services Office of Inspector General issued a report in 2013 that said the FDA couldn’t prove that the program actually improved safety, and Dr. Sarpatwari said there’s evidence drugmakers are abusing it to stave off competition from generics.

Dr. Gottlieb said the FDA will be notifying the Federal Trade Commission about pleas for help from would-be generics manufacturers about obtaining samples, and he encouraged the manufacturers to do the same if they suspect they’re being thwarted by anticompetitive practices.

Celgene spokesman Greg Geissman said the company has sold samples to generics manufacturers and will continue to do so. He stressed maintaining a balance of innovation, generic competition, and safety.

“Even a single dose of thalidomide, the active ingredient in Thalomid, can cause irreversible, debilitating birth defects if not properly handled and dispensed. Revlimid and Pomalyst (pomalidomide) are believed to have similar risks,” Mr. Geissman said.

The highest number of pleas for help related to Actelion Pharmaceuticals’ pulmonary hypertension drug Tracleer (bosentan). In 2016, that drug cost Medicare $90,700/patient and more than $304 million overall. Meanwhile, spending per unit jumped 52% from 2012 through 2016.

Actelion was acquired by Johnson & Johnson’s pharmaceutical arm, Janssen, in 2017.

Actelion spokeswoman Colleen Wilson said that the company “cooperate[s]” with makers of generic drugs and “has responded to all requests it has received directly from generic manufacturers seeking access to its medications for bioequivalence testing.”

PhRMA, the trade group for makers of brand-name pharmaceuticals, said the FDA’s list was somewhat unfair because it lacked context and responses from those it represents.

“While we must continue to foster a competitive marketplace, PhRMA is concerned that FDA’s release of the ‘inquiries’ it has received lacks proper context and conflates a number of divergent scenarios,” said PhRMA spokesman Andrew Powaleny.

Congress is considering the CREATES Act, which stands for “Creating and Restoring Equal Access to Equivalent Samples” and would foster competition in part by allowing generics manufacturers to sue brand-name drug manufacturers to compel them to provide samples.

The bill’s sponsor, Sen. Patrick Leahy (D-Vt.), said more transparency from the FDA is helpful, but more work from the agency is needed to end the anticompetitive tactics. “With billions of dollars at stake, a database alone will not stop this behavior,” Sen. Leahy said.

Cosponsor Sen. Chuck Grassley (R-Iowa), chairman of the Judiciary Committee, expressed similar sentiments, telling KHN: “The CREATES Act is necessary because it would serve as a strong deterrent to pharmaceutical companies that engage in anticompetitive practices to keep low-cost generic drugs off the market.”

The FDA hasn’t come out in support of CREATES. “They should know that this is going to require a legislative solution,” Dr. Sarpatwari said. “Why are they not stepping into this arena and saying that?”

KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation. Kaiser Health News (hyperlink to khn.org) is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Makers of brand-name drugs called out by the Trump administration for potentially stalling generic competition have hiked their prices by double-digit percentages since 2012 and cost Medicare and Medicaid nearly $12 billion in 2016, a Kaiser Health News analysis has found.

As part of President Donald Trump’s promise to curb high drug prices, the Food and Drug Administration posted a list of pharmaceutical companies that makers of generics allege refused to let them buy the drug samples needed to develop their products. For approval, the FDA requires so-called bioequivalence testing using samples to demonstrate that generics are the same as their branded counterparts.

The analysis shows that drug companies that may have engaged in what FDA Commissioner Scott Gottlieb, MD, called “shenanigans” to delay the entrance of cheaper competitors onto the market have indeed raised prices and cost taxpayers more money over time.

The FDA listed more than 50 drugs whose manufacturers have withheld or refused to sell samples and cited 164 inquiries for help obtaining them. Thirteen of these pleas from makers of generics pertained to Celgene’s blockbuster cancer drug Revlimid (lenalidomide), which accounted for 63% of Celgene’s revenue in the first quarter of 2018, according to a company press release.

The brand-name drug companies “wouldn’t put so much effort into fighting off competition if these weren’t [such] lucrative sources of revenue,” said Ameet Sarpatwari, JD, PhD, of Harvard Medical School in Boston. “In the case of a blockbuster drug, that can be hundreds of millions of dollars of revenue for the brand-name drugs and almost the same cost to the health care system.”

Indeed, a KHN analysis found that 47 of the drugs cost Medicare and Medicaid almost $12 billion in 2016. The spending totals don’t include rebates, which drugmakers return to the government after paying for the drugs upfront but are not public. The rebates ranged from 9.5% to 26.3% for Medicare Part D in 2014, the most recent year that data are available.

The remaining drugs do not appear in the Medicare and Medicaid data.

By delaying development of generics, drugmakers can maintain their monopolies and keep prices high. Most of the drugs cost Medicare Part D more in 2016 than they did in 2012, for an average spending increase of about 60% more per unit. This excludes drugs that don’t appear in the 2012 Medicare Part D data.

Revlimid cost Medicare Part D $2.7 billion in 2016, trailing only Harvoni (ledipasvir and sofosbuvir), which treats hepatitis C and is not on the FDA’s new list. The cost of Revlimid, which faces no competition from generics, has jumped 40% per unit in just 4 years, the Medicare data show, and cost $75,200/beneficiary in 2016.

Some drugs on the FDA’s list, including Celgene’s, are part of a safety program that can require restricted distribution of brand-name drugs that have serious risks or addictive qualities. Drugmakers with products in the safety program sometimes say they can’t provide samples unless the generics manufacturer jumps through a series of hoops “that generic companies find hard or impossible to comply with,” Dr. Gottlieb said in a statement.

The Department of Health & Human Services Office of Inspector General issued a report in 2013 that said the FDA couldn’t prove that the program actually improved safety, and Dr. Sarpatwari said there’s evidence drugmakers are abusing it to stave off competition from generics.

Dr. Gottlieb said the FDA will be notifying the Federal Trade Commission about pleas for help from would-be generics manufacturers about obtaining samples, and he encouraged the manufacturers to do the same if they suspect they’re being thwarted by anticompetitive practices.

Celgene spokesman Greg Geissman said the company has sold samples to generics manufacturers and will continue to do so. He stressed maintaining a balance of innovation, generic competition, and safety.

“Even a single dose of thalidomide, the active ingredient in Thalomid, can cause irreversible, debilitating birth defects if not properly handled and dispensed. Revlimid and Pomalyst (pomalidomide) are believed to have similar risks,” Mr. Geissman said.

The highest number of pleas for help related to Actelion Pharmaceuticals’ pulmonary hypertension drug Tracleer (bosentan). In 2016, that drug cost Medicare $90,700/patient and more than $304 million overall. Meanwhile, spending per unit jumped 52% from 2012 through 2016.

Actelion was acquired by Johnson & Johnson’s pharmaceutical arm, Janssen, in 2017.

Actelion spokeswoman Colleen Wilson said that the company “cooperate[s]” with makers of generic drugs and “has responded to all requests it has received directly from generic manufacturers seeking access to its medications for bioequivalence testing.”

PhRMA, the trade group for makers of brand-name pharmaceuticals, said the FDA’s list was somewhat unfair because it lacked context and responses from those it represents.

“While we must continue to foster a competitive marketplace, PhRMA is concerned that FDA’s release of the ‘inquiries’ it has received lacks proper context and conflates a number of divergent scenarios,” said PhRMA spokesman Andrew Powaleny.

Congress is considering the CREATES Act, which stands for “Creating and Restoring Equal Access to Equivalent Samples” and would foster competition in part by allowing generics manufacturers to sue brand-name drug manufacturers to compel them to provide samples.

The bill’s sponsor, Sen. Patrick Leahy (D-Vt.), said more transparency from the FDA is helpful, but more work from the agency is needed to end the anticompetitive tactics. “With billions of dollars at stake, a database alone will not stop this behavior,” Sen. Leahy said.

Cosponsor Sen. Chuck Grassley (R-Iowa), chairman of the Judiciary Committee, expressed similar sentiments, telling KHN: “The CREATES Act is necessary because it would serve as a strong deterrent to pharmaceutical companies that engage in anticompetitive practices to keep low-cost generic drugs off the market.”

The FDA hasn’t come out in support of CREATES. “They should know that this is going to require a legislative solution,” Dr. Sarpatwari said. “Why are they not stepping into this arena and saying that?”

KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation. Kaiser Health News (hyperlink to khn.org) is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Makers of brand-name drugs called out by the Trump administration for potentially stalling generic competition have hiked their prices by double-digit percentages since 2012 and cost Medicare and Medicaid nearly $12 billion in 2016, a Kaiser Health News analysis has found.

As part of President Donald Trump’s promise to curb high drug prices, the Food and Drug Administration posted a list of pharmaceutical companies that makers of generics allege refused to let them buy the drug samples needed to develop their products. For approval, the FDA requires so-called bioequivalence testing using samples to demonstrate that generics are the same as their branded counterparts.

The analysis shows that drug companies that may have engaged in what FDA Commissioner Scott Gottlieb, MD, called “shenanigans” to delay the entrance of cheaper competitors onto the market have indeed raised prices and cost taxpayers more money over time.

The FDA listed more than 50 drugs whose manufacturers have withheld or refused to sell samples and cited 164 inquiries for help obtaining them. Thirteen of these pleas from makers of generics pertained to Celgene’s blockbuster cancer drug Revlimid (lenalidomide), which accounted for 63% of Celgene’s revenue in the first quarter of 2018, according to a company press release.

The brand-name drug companies “wouldn’t put so much effort into fighting off competition if these weren’t [such] lucrative sources of revenue,” said Ameet Sarpatwari, JD, PhD, of Harvard Medical School in Boston. “In the case of a blockbuster drug, that can be hundreds of millions of dollars of revenue for the brand-name drugs and almost the same cost to the health care system.”

Indeed, a KHN analysis found that 47 of the drugs cost Medicare and Medicaid almost $12 billion in 2016. The spending totals don’t include rebates, which drugmakers return to the government after paying for the drugs upfront but are not public. The rebates ranged from 9.5% to 26.3% for Medicare Part D in 2014, the most recent year that data are available.

The remaining drugs do not appear in the Medicare and Medicaid data.

By delaying development of generics, drugmakers can maintain their monopolies and keep prices high. Most of the drugs cost Medicare Part D more in 2016 than they did in 2012, for an average spending increase of about 60% more per unit. This excludes drugs that don’t appear in the 2012 Medicare Part D data.

Revlimid cost Medicare Part D $2.7 billion in 2016, trailing only Harvoni (ledipasvir and sofosbuvir), which treats hepatitis C and is not on the FDA’s new list. The cost of Revlimid, which faces no competition from generics, has jumped 40% per unit in just 4 years, the Medicare data show, and cost $75,200/beneficiary in 2016.

Some drugs on the FDA’s list, including Celgene’s, are part of a safety program that can require restricted distribution of brand-name drugs that have serious risks or addictive qualities. Drugmakers with products in the safety program sometimes say they can’t provide samples unless the generics manufacturer jumps through a series of hoops “that generic companies find hard or impossible to comply with,” Dr. Gottlieb said in a statement.

The Department of Health & Human Services Office of Inspector General issued a report in 2013 that said the FDA couldn’t prove that the program actually improved safety, and Dr. Sarpatwari said there’s evidence drugmakers are abusing it to stave off competition from generics.

Dr. Gottlieb said the FDA will be notifying the Federal Trade Commission about pleas for help from would-be generics manufacturers about obtaining samples, and he encouraged the manufacturers to do the same if they suspect they’re being thwarted by anticompetitive practices.

Celgene spokesman Greg Geissman said the company has sold samples to generics manufacturers and will continue to do so. He stressed maintaining a balance of innovation, generic competition, and safety.

“Even a single dose of thalidomide, the active ingredient in Thalomid, can cause irreversible, debilitating birth defects if not properly handled and dispensed. Revlimid and Pomalyst (pomalidomide) are believed to have similar risks,” Mr. Geissman said.

The highest number of pleas for help related to Actelion Pharmaceuticals’ pulmonary hypertension drug Tracleer (bosentan). In 2016, that drug cost Medicare $90,700/patient and more than $304 million overall. Meanwhile, spending per unit jumped 52% from 2012 through 2016.

Actelion was acquired by Johnson & Johnson’s pharmaceutical arm, Janssen, in 2017.

Actelion spokeswoman Colleen Wilson said that the company “cooperate[s]” with makers of generic drugs and “has responded to all requests it has received directly from generic manufacturers seeking access to its medications for bioequivalence testing.”

PhRMA, the trade group for makers of brand-name pharmaceuticals, said the FDA’s list was somewhat unfair because it lacked context and responses from those it represents.

“While we must continue to foster a competitive marketplace, PhRMA is concerned that FDA’s release of the ‘inquiries’ it has received lacks proper context and conflates a number of divergent scenarios,” said PhRMA spokesman Andrew Powaleny.

Congress is considering the CREATES Act, which stands for “Creating and Restoring Equal Access to Equivalent Samples” and would foster competition in part by allowing generics manufacturers to sue brand-name drug manufacturers to compel them to provide samples.

The bill’s sponsor, Sen. Patrick Leahy (D-Vt.), said more transparency from the FDA is helpful, but more work from the agency is needed to end the anticompetitive tactics. “With billions of dollars at stake, a database alone will not stop this behavior,” Sen. Leahy said.

Cosponsor Sen. Chuck Grassley (R-Iowa), chairman of the Judiciary Committee, expressed similar sentiments, telling KHN: “The CREATES Act is necessary because it would serve as a strong deterrent to pharmaceutical companies that engage in anticompetitive practices to keep low-cost generic drugs off the market.”

The FDA hasn’t come out in support of CREATES. “They should know that this is going to require a legislative solution,” Dr. Sarpatwari said. “Why are they not stepping into this arena and saying that?”

KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation. Kaiser Health News (hyperlink to khn.org) is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The planned revival of a policy dating to Ronald Reagan’s presidency may finally present a way for President Donald Trump to fulfill his campaign promise to “defund” Planned Parenthood. Or at least to evict it from the federal family planning program, where it provides care to more than 40% of that program’s 4 million patients.

Congress last year failed to wipe out funding for Planned Parenthood, because the bill faced overwhelming Democratic objections and would not have received the 60 votes needed to pass in the Senate.

But the imposition of a slightly retooled version of a regulation, which was upheld by the Supreme Court in 1991 after a 5-year fight, could potentially accomplish what Congress could not.

The rules now under review, according to Trump administration officials, would require facilities receiving federal family planning funds to be physically separate from those that perform abortion; would eliminate the requirement that women with unintended pregnancies be counseled on their full range of reproductive options; and would ban abortion referrals.

All those changes would particularly affect Planned Parenthood.

Planned Parenthood, which provides a broad array of reproductive health services to women and men, also provides abortion services using nonfederal funds. Cutting off funding has been the top priority for anti-abortion groups, which supported candidate Trump.

“A win like this would immediately disentangle taxpayers from the abortion business and energize the grassroots as we head into the critical midterm elections,” Marjorie Dannenfelser, president of the anti-abortion Susan B. Anthony List, said in a statement.

In a conference call with reporters, Planned Parenthood officials said they would fight the new rules.

“We’ve been very clear, Planned Parenthood has an unwavering commitment to ensuring everyone has access to the full range of reproductive health care, and that includes abortion,” said Dawn Laguens, executive vice president of the Planned Parenthood Federation of America.

Here is a guide to what the proposal could do and what it could mean for Planned Parenthood and the family planning program:

What is Title X?

The federal family planning program, known as “Title Ten,” is named for its section in the federal Public Health Service Act. It became law in 1970, 3 years before the Supreme Court legalized abortion in Roe v Wade.

The original bill was sponsored by then Rep. George H.W. Bush (R-Texas) and signed into law by President Richard Nixon.

The program provides wellness exams and comprehensive contraceptive services, as well as screenings for cancer and sexually transmitted diseases for both women and men.

In 2016, the most recent year for which statistics have been published, Title X served 4 million patients at just under 4,000 sites.

Title X patients are overwhelmingly young, female, and low-income. An estimated 11% of Title X patients in 2016 were male; two-thirds of patients were under age 30; and nearly two-thirds had income below the federal poverty line.

What is Planned Parenthood’s relationship to Title X and Medicaid?

Planned Parenthood affiliates account for about 13% of total Title X sites but serve an estimated 40% of its patients. Only about half of Planned Parenthood affiliates perform abortions, although the organization in its entirety is the nation’s leading abortion provider.

Planned Parenthood also gets much more federal funding for services provided to patients on the Medicaid program (although not for abortion) than it does through Title X.

Eliminating Medicaid funding for Planned Parenthood has proved more difficult for lawmakers opposed to the organization because the federal Medicaid law includes the right for patients to select their providers. Changing that also would require a 60-vote majority in the Senate. So that particular line of funding is likely not at risk.

While opponents of federal funding for Planned Parenthood have said that other safety-net clinics could make up the difference if Planned Parenthood no longer participates in Title X, several studies have suggested that in many remote areas Planned Parenthood is the only provider of family planning services and the only provider that regularly stocks all methods of birth control.

Texas, Iowa, and Missouri in recent years have stopped offering family planning services through a special Medicaid program to keep from funding Planned Parenthood. Texas is seeking a waiver from the Trump administration so that its program banning abortion providers could still receive federal funding. No decision has been made yet, federal officials said.

Why is Planned Parenthood’s involvement with Title X controversial?

Even though Planned Parenthood cannot use federal funding for abortions, anti-abortion groups claim that federal funding is “fungible” and there is no way to ensure that some of the funding provided for other services does not cross-subsidize abortion services.

Planned Parenthood has also been a longtime public target for anti-abortion forces because it is such a visible provider and vocal proponent of legal abortion services.

In the early 1980s, the Reagan administration tried to separate the program from its federal funding by requiring parental permission for teens to obtain birth control. That was followed by efforts to eliminate abortion counseling.

Starting in 2011, undercover groups accused the organization of ignoring sex traffickers and selling fetal body parts in an effort to get the organization defunded. Planned Parenthood denies the allegations.

What happened the last time an administration tried to move Planned Parenthood out of Title X?

In 1987, the Reagan administration proposed what came to be known as the “gag rule.” Though the administration’s new proposal is not yet public, because the details are still under review by the Office of Management and Budget, the White House released a summary, saying the new rule will be similar although not identical to the Reagan-era proposal.

The original gag rule would have forbidden Title X providers from abortion counseling or referring patients for abortions, required physical separation of Title X and abortion-providing facilities and forbidden recipients from using nonfederal funds for lobbying, distributing information or in any way advocating or encouraging abortion. (The Planned Parenthood Federation of America, the umbrella group for local affiliates, has a separate political and advocacy arm, the Planned Parenthood Action Fund.)

Those rules were the subject of heated congressional debate through most of the George H.W. Bush administration and were upheld in a 5-4 Supreme Court ruling in 1991, Rust v Sullivan.

Even then, the gag rule did not go into effect because subsequent efforts to relax the rules somewhat to allow doctors (but not other health professionals) to counsel patients on the availability of abortion created another round of legal fights.

Eventually the rule was in effect for only about a month before it was again blocked by a U.S. appeals court. President Bill Clinton canceled the rules by executive order on his second day in office, and no other president tried to revive them until now.

How is the Trump administration’s proposal different from earlier rules?

According to the summary of the new proposal, released May 18, it will require physical separation of family planning and abortion facilities, repeal current counseling requirements, and ban abortion referrals.

One of the biggest differences, however, is that the new rules will not explicitly forbid abortion counseling by Title X providers.

But Planned Parenthood officials say that allowing counseling while banning referrals is a distinction without a difference.

Kashif Syed, a senior policy analyst for the organization said: “Blocking doctors from telling a patient where they can get safe and legal care in this country is the definition of a gag rule.”

What happens next?

All proposed rules are reviewed by the Office of Management and Budget. Sometimes they emerge and are published in a few days; sometimes they are rewritten, and it takes months.

Meanwhile, Planned Parenthood officials said they will not know if they will take legal action until they see the final language of the rule. But they say they do plan to use the regulatory process to fight the changes that have been made public so far.
 

KHN’s coverage of women’s health care issues is supported in part by The David and Lucile Packard Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The planned revival of a policy dating to Ronald Reagan’s presidency may finally present a way for President Donald Trump to fulfill his campaign promise to “defund” Planned Parenthood. Or at least to evict it from the federal family planning program, where it provides care to more than 40% of that program’s 4 million patients.

Congress last year failed to wipe out funding for Planned Parenthood, because the bill faced overwhelming Democratic objections and would not have received the 60 votes needed to pass in the Senate.

But the imposition of a slightly retooled version of a regulation, which was upheld by the Supreme Court in 1991 after a 5-year fight, could potentially accomplish what Congress could not.

The rules now under review, according to Trump administration officials, would require facilities receiving federal family planning funds to be physically separate from those that perform abortion; would eliminate the requirement that women with unintended pregnancies be counseled on their full range of reproductive options; and would ban abortion referrals.

All those changes would particularly affect Planned Parenthood.

Planned Parenthood, which provides a broad array of reproductive health services to women and men, also provides abortion services using nonfederal funds. Cutting off funding has been the top priority for anti-abortion groups, which supported candidate Trump.

“A win like this would immediately disentangle taxpayers from the abortion business and energize the grassroots as we head into the critical midterm elections,” Marjorie Dannenfelser, president of the anti-abortion Susan B. Anthony List, said in a statement.

In a conference call with reporters, Planned Parenthood officials said they would fight the new rules.

“We’ve been very clear, Planned Parenthood has an unwavering commitment to ensuring everyone has access to the full range of reproductive health care, and that includes abortion,” said Dawn Laguens, executive vice president of the Planned Parenthood Federation of America.

Here is a guide to what the proposal could do and what it could mean for Planned Parenthood and the family planning program:

What is Title X?

The federal family planning program, known as “Title Ten,” is named for its section in the federal Public Health Service Act. It became law in 1970, 3 years before the Supreme Court legalized abortion in Roe v Wade.

The original bill was sponsored by then Rep. George H.W. Bush (R-Texas) and signed into law by President Richard Nixon.

The program provides wellness exams and comprehensive contraceptive services, as well as screenings for cancer and sexually transmitted diseases for both women and men.

In 2016, the most recent year for which statistics have been published, Title X served 4 million patients at just under 4,000 sites.

Title X patients are overwhelmingly young, female, and low-income. An estimated 11% of Title X patients in 2016 were male; two-thirds of patients were under age 30; and nearly two-thirds had income below the federal poverty line.

What is Planned Parenthood’s relationship to Title X and Medicaid?

Planned Parenthood affiliates account for about 13% of total Title X sites but serve an estimated 40% of its patients. Only about half of Planned Parenthood affiliates perform abortions, although the organization in its entirety is the nation’s leading abortion provider.

Planned Parenthood also gets much more federal funding for services provided to patients on the Medicaid program (although not for abortion) than it does through Title X.

Eliminating Medicaid funding for Planned Parenthood has proved more difficult for lawmakers opposed to the organization because the federal Medicaid law includes the right for patients to select their providers. Changing that also would require a 60-vote majority in the Senate. So that particular line of funding is likely not at risk.

While opponents of federal funding for Planned Parenthood have said that other safety-net clinics could make up the difference if Planned Parenthood no longer participates in Title X, several studies have suggested that in many remote areas Planned Parenthood is the only provider of family planning services and the only provider that regularly stocks all methods of birth control.

Texas, Iowa, and Missouri in recent years have stopped offering family planning services through a special Medicaid program to keep from funding Planned Parenthood. Texas is seeking a waiver from the Trump administration so that its program banning abortion providers could still receive federal funding. No decision has been made yet, federal officials said.

Why is Planned Parenthood’s involvement with Title X controversial?

Even though Planned Parenthood cannot use federal funding for abortions, anti-abortion groups claim that federal funding is “fungible” and there is no way to ensure that some of the funding provided for other services does not cross-subsidize abortion services.

Planned Parenthood has also been a longtime public target for anti-abortion forces because it is such a visible provider and vocal proponent of legal abortion services.

In the early 1980s, the Reagan administration tried to separate the program from its federal funding by requiring parental permission for teens to obtain birth control. That was followed by efforts to eliminate abortion counseling.

Starting in 2011, undercover groups accused the organization of ignoring sex traffickers and selling fetal body parts in an effort to get the organization defunded. Planned Parenthood denies the allegations.

What happened the last time an administration tried to move Planned Parenthood out of Title X?

In 1987, the Reagan administration proposed what came to be known as the “gag rule.” Though the administration’s new proposal is not yet public, because the details are still under review by the Office of Management and Budget, the White House released a summary, saying the new rule will be similar although not identical to the Reagan-era proposal.

The original gag rule would have forbidden Title X providers from abortion counseling or referring patients for abortions, required physical separation of Title X and abortion-providing facilities and forbidden recipients from using nonfederal funds for lobbying, distributing information or in any way advocating or encouraging abortion. (The Planned Parenthood Federation of America, the umbrella group for local affiliates, has a separate political and advocacy arm, the Planned Parenthood Action Fund.)

Those rules were the subject of heated congressional debate through most of the George H.W. Bush administration and were upheld in a 5-4 Supreme Court ruling in 1991, Rust v Sullivan.

Even then, the gag rule did not go into effect because subsequent efforts to relax the rules somewhat to allow doctors (but not other health professionals) to counsel patients on the availability of abortion created another round of legal fights.

Eventually the rule was in effect for only about a month before it was again blocked by a U.S. appeals court. President Bill Clinton canceled the rules by executive order on his second day in office, and no other president tried to revive them until now.

How is the Trump administration’s proposal different from earlier rules?

According to the summary of the new proposal, released May 18, it will require physical separation of family planning and abortion facilities, repeal current counseling requirements, and ban abortion referrals.

One of the biggest differences, however, is that the new rules will not explicitly forbid abortion counseling by Title X providers.

But Planned Parenthood officials say that allowing counseling while banning referrals is a distinction without a difference.

Kashif Syed, a senior policy analyst for the organization said: “Blocking doctors from telling a patient where they can get safe and legal care in this country is the definition of a gag rule.”

What happens next?

All proposed rules are reviewed by the Office of Management and Budget. Sometimes they emerge and are published in a few days; sometimes they are rewritten, and it takes months.

Meanwhile, Planned Parenthood officials said they will not know if they will take legal action until they see the final language of the rule. But they say they do plan to use the regulatory process to fight the changes that have been made public so far.
 

KHN’s coverage of women’s health care issues is supported in part by The David and Lucile Packard Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The planned revival of a policy dating to Ronald Reagan’s presidency may finally present a way for President Donald Trump to fulfill his campaign promise to “defund” Planned Parenthood. Or at least to evict it from the federal family planning program, where it provides care to more than 40% of that program’s 4 million patients.

Congress last year failed to wipe out funding for Planned Parenthood, because the bill faced overwhelming Democratic objections and would not have received the 60 votes needed to pass in the Senate.

But the imposition of a slightly retooled version of a regulation, which was upheld by the Supreme Court in 1991 after a 5-year fight, could potentially accomplish what Congress could not.

The rules now under review, according to Trump administration officials, would require facilities receiving federal family planning funds to be physically separate from those that perform abortion; would eliminate the requirement that women with unintended pregnancies be counseled on their full range of reproductive options; and would ban abortion referrals.

All those changes would particularly affect Planned Parenthood.

Planned Parenthood, which provides a broad array of reproductive health services to women and men, also provides abortion services using nonfederal funds. Cutting off funding has been the top priority for anti-abortion groups, which supported candidate Trump.

“A win like this would immediately disentangle taxpayers from the abortion business and energize the grassroots as we head into the critical midterm elections,” Marjorie Dannenfelser, president of the anti-abortion Susan B. Anthony List, said in a statement.

In a conference call with reporters, Planned Parenthood officials said they would fight the new rules.

“We’ve been very clear, Planned Parenthood has an unwavering commitment to ensuring everyone has access to the full range of reproductive health care, and that includes abortion,” said Dawn Laguens, executive vice president of the Planned Parenthood Federation of America.

Here is a guide to what the proposal could do and what it could mean for Planned Parenthood and the family planning program:

What is Title X?

The federal family planning program, known as “Title Ten,” is named for its section in the federal Public Health Service Act. It became law in 1970, 3 years before the Supreme Court legalized abortion in Roe v Wade.

The original bill was sponsored by then Rep. George H.W. Bush (R-Texas) and signed into law by President Richard Nixon.

The program provides wellness exams and comprehensive contraceptive services, as well as screenings for cancer and sexually transmitted diseases for both women and men.

In 2016, the most recent year for which statistics have been published, Title X served 4 million patients at just under 4,000 sites.

Title X patients are overwhelmingly young, female, and low-income. An estimated 11% of Title X patients in 2016 were male; two-thirds of patients were under age 30; and nearly two-thirds had income below the federal poverty line.

What is Planned Parenthood’s relationship to Title X and Medicaid?

Planned Parenthood affiliates account for about 13% of total Title X sites but serve an estimated 40% of its patients. Only about half of Planned Parenthood affiliates perform abortions, although the organization in its entirety is the nation’s leading abortion provider.

Planned Parenthood also gets much more federal funding for services provided to patients on the Medicaid program (although not for abortion) than it does through Title X.

Eliminating Medicaid funding for Planned Parenthood has proved more difficult for lawmakers opposed to the organization because the federal Medicaid law includes the right for patients to select their providers. Changing that also would require a 60-vote majority in the Senate. So that particular line of funding is likely not at risk.

While opponents of federal funding for Planned Parenthood have said that other safety-net clinics could make up the difference if Planned Parenthood no longer participates in Title X, several studies have suggested that in many remote areas Planned Parenthood is the only provider of family planning services and the only provider that regularly stocks all methods of birth control.

Texas, Iowa, and Missouri in recent years have stopped offering family planning services through a special Medicaid program to keep from funding Planned Parenthood. Texas is seeking a waiver from the Trump administration so that its program banning abortion providers could still receive federal funding. No decision has been made yet, federal officials said.

Why is Planned Parenthood’s involvement with Title X controversial?

Even though Planned Parenthood cannot use federal funding for abortions, anti-abortion groups claim that federal funding is “fungible” and there is no way to ensure that some of the funding provided for other services does not cross-subsidize abortion services.

Planned Parenthood has also been a longtime public target for anti-abortion forces because it is such a visible provider and vocal proponent of legal abortion services.

In the early 1980s, the Reagan administration tried to separate the program from its federal funding by requiring parental permission for teens to obtain birth control. That was followed by efforts to eliminate abortion counseling.

Starting in 2011, undercover groups accused the organization of ignoring sex traffickers and selling fetal body parts in an effort to get the organization defunded. Planned Parenthood denies the allegations.

What happened the last time an administration tried to move Planned Parenthood out of Title X?

In 1987, the Reagan administration proposed what came to be known as the “gag rule.” Though the administration’s new proposal is not yet public, because the details are still under review by the Office of Management and Budget, the White House released a summary, saying the new rule will be similar although not identical to the Reagan-era proposal.

The original gag rule would have forbidden Title X providers from abortion counseling or referring patients for abortions, required physical separation of Title X and abortion-providing facilities and forbidden recipients from using nonfederal funds for lobbying, distributing information or in any way advocating or encouraging abortion. (The Planned Parenthood Federation of America, the umbrella group for local affiliates, has a separate political and advocacy arm, the Planned Parenthood Action Fund.)

Those rules were the subject of heated congressional debate through most of the George H.W. Bush administration and were upheld in a 5-4 Supreme Court ruling in 1991, Rust v Sullivan.

Even then, the gag rule did not go into effect because subsequent efforts to relax the rules somewhat to allow doctors (but not other health professionals) to counsel patients on the availability of abortion created another round of legal fights.

Eventually the rule was in effect for only about a month before it was again blocked by a U.S. appeals court. President Bill Clinton canceled the rules by executive order on his second day in office, and no other president tried to revive them until now.

How is the Trump administration’s proposal different from earlier rules?

According to the summary of the new proposal, released May 18, it will require physical separation of family planning and abortion facilities, repeal current counseling requirements, and ban abortion referrals.

One of the biggest differences, however, is that the new rules will not explicitly forbid abortion counseling by Title X providers.

But Planned Parenthood officials say that allowing counseling while banning referrals is a distinction without a difference.

Kashif Syed, a senior policy analyst for the organization said: “Blocking doctors from telling a patient where they can get safe and legal care in this country is the definition of a gag rule.”

What happens next?

All proposed rules are reviewed by the Office of Management and Budget. Sometimes they emerge and are published in a few days; sometimes they are rewritten, and it takes months.

Meanwhile, Planned Parenthood officials said they will not know if they will take legal action until they see the final language of the rule. But they say they do plan to use the regulatory process to fight the changes that have been made public so far.
 

KHN’s coverage of women’s health care issues is supported in part by The David and Lucile Packard Foundation. Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Pharmaceutical companies gave at least $116 million to patient advocacy groups in a single year, reveals a new database logging 12,000 donations from large publicly traded drugmakers to such organizations.

Even as these patient groups grow in number and political influence, their funding and their relationships to drugmakers are little understood. Unlike payments to doctors and lobbying expenses, companies do not have to report payments to the groups.

The database, called “Pre$cription for Power,” shows that donations to patient advocacy groups tallied for 2015 – the most recent full year in which documents required by the Internal Revenue Service were available – dwarfed the total amount the companies spent on federal lobbying. The 14 companies that contributed $116 million to patient advocacy groups reported only about $63 million in lobbying activities that same year.

Though their primary missions are to focus attention on the needs of patients with a particular disease – such as arthritis, heart disease or various cancers – some groups effectively supplement the work lobbyists perform, providing patients to testify on Capitol Hill and organizing letter-writing and social media campaigns that are beneficial to pharmaceutical companies.

Six drugmakers, the data show, contributed a million dollars or more to individual groups that represent patients who rely on their drugs. The database identifies more than 1,200 patient groups. Of those, 594 accepted money from the drugmakers in the database.

The financial ties are troubling if they cause even one patient group to act in a way that’s “not fully representing the interest of its constituents,” said Matthew McCoy, a medical ethics professor at the University of Pennsylvania, Philadelphia, who coauthored a 2017 study about patient advocacy groups’ influence and transparency.

Notably, such groups have been silent or slow to complain about high or escalating prices, a prime concern of patients.

“When so many patient organizations are being influenced in this way, it can shift our whole approach to health policy, taking away from the interests of patients and towards the interests of industry,” Mr. McCoy said. “That’s not just a problem for the patients and caregivers that particular patient organizations serve; that’s a problem for everyone.”

Bristol-Myers Squibb provides a stark example of how patient groups are valued. In 2015, it spent more than $20.5 million on patient groups, compared with $2.9 million on federal lobbying and less than $1 million on major trade associations, according to public records and company disclosures. The company said its decisions regarding lobbying and contributions to patient groups are “unrelated.”

“Bristol-Myers Squibb is focused on supporting a health care environment that rewards innovation and ensures access to medicines for patients,” said spokeswoman Laura Hortas. “The company supports patient organizations with this shared objective.”

The first-of-its-kind database, compiled by Kaiser Health News, tallies the money from Big Pharma to patient groups. KHN examined the 20 pharmaceutical firms included in the S&P 500, 14 of which were transparent – in varying degrees – about giving money to patient groups. Pre$cription for Power is based on information contained in charitable giving reports from company websites and federal 990 regulatory filings.

It spotlights donations pharma companies made to patient groups large and small. The recipients include well-known disease groups, like the American Diabetes Association, with revenues of hundreds of millions of dollars; high-profile foundations like Susan G. Komen, a patient group focused on breast cancer; and smaller, lesser-known groups, like the Caring Ambassadors Program, which focuses on lung cancer and hepatitis C.

The data show that 15 patient groups – with annual revenues as large as $3.6 million – relied on the pharmaceutical companies for at least 20% of their revenue, and some relied on them for more than half of their revenue. The database explores only a slice of the pharmaceutical industry’s giving overall and will be expanded with more companies and groups over time.

“It’s clear that more transparency in this space is vitally important,” said Sen. Claire McCaskill (D-Mo.), who has been investigating the links between patient advocates and opioid manufacturers and is considering legislation to track funding. “This database is one step forward in that effort, but we also need Congress to act.”

What drives the money flow

The financial ties between drugmakers and the organizations that represent those who use or prescribe their blockbuster medicines have been of growing concern as drug prices escalate. The Senate investigated conflicts of interest in the run-up to the passage of the 2010 Physician Payments Sunshine Act – a law that required payments to physicians from makers of drugs and devices to be registered on a public website – but patient groups were not addressed in the bill.

Some of the patient groups with ties to trade groups echo industry talking points in media campaigns and letters to federal agencies, and do little else. And patients, supported by pharma, are dispatched to state capitals and Washington to support research funding. Some groups send patients updates on the newest drugs and industry products.

“It’s through groups like this that patients often learn about illnesses and treatments,” said Rick Claypool, a research director for Public Citizen, a consumer advocacy group that says it does not accept pharmaceutical funding.

For the patient group Caring Ambassadors Program, industry funds are needed to make up for a lack of public funding, said the group’s executive director, Lorren Sandt. According to IRS filings and published company reports, in 2015, the group received $413,000, the bulk of which came from one company, AbbVie, which makes a hepatitis C treatment and has been testing a new lung cancer drug, Rova-T, not yet approved. She said the money had no influence on the Caring Ambassadors Program’s priorities.

“There aren’t a lot of large pockets of funding outside of the pharmaceutical money,” Sandt said. “We take it where we can find it.”

Other patient groups such as the National Women’s Health Network, based in Washington, make sacrifices to avoid pharmaceutical funding. That includes operating with a small staff in a “modest” office building with few windows and outdated computers, according to executive director Cindy Pearson. “You can see the effect of our approach to funding as soon as you walk [in] the door.”

Pearson said it’s hard for patient groups not to be influenced by the funder, even if they proclaim independence. Patient groups “build relationships with their funders and feel in sync and have sympathy” for them. “It’s human nature. It’s not evil or weak, but it’s wrong.”

Charity as marketing

Patients newly diagnosed with a disease often turn to patient advocacy groups for advice, but the money flow to such groups may distort patients’ knowledge and public debate over treatment options, said Dr. Adriane Fugh-Berman, the director of PharmedOut, a Georgetown University Medical Center program in Washington that is critical of some pharmaceutical marketing practices.

“[The money flow limits] their advocacy agenda to competing branded products when the best therapy might be generics, over-the-counter drugs or diet and exercise,” she said.

AbbVie – whose specialty drug Humira made up 65% of the company’s net revenue in 2017 and is used to treat patients with autoimmune diseases, including Crohn’s disease and certain kinds of arthritis – gave $2.7 million to the Crohn’s & Colitis Foundation and $1.6 million to the Arthritis Foundation, according to the company’s public disclosures included in the database. The list price for a month’s supply of Humira, a biologic drug, is $4,872, according to Express Scripts, a pharmacy benefits manager.

Even though Humira will face competition from near-copycat drugs called biosimilars, it is expected to remain the highest-grossing drug in the United States through 2022, according to drug industry analysts at EvaluatePharma.

The Arthritis and Crohn’s foundations have been largely silent on the cost of Humira and vocal on safety concerns about biosimilars. The Arthritis Foundation has championed state laws that could add extra steps for consumers to receive biosimilars at the pharmacy counter, potentially keeping more patients on the brand-name drug. Experts say those laws could help protect Humira’s market share from generic competitors.

A coalition of patient groups, Patients for Biologics Safety & Access, opposes the automatic substitution of a cheaper biosimilar when doctors prescribe a biologic. In 2015, members of that coalition, including the Crohn’s & Colitis Foundation, the Arthritis Foundation and the Lupus Foundation of America, accepted about $9.1 million from pharmaceutical companies in the database, according to public disclosures. They include AbbVie and Johnson & Johnson, makers of blockbuster biologics.

The Arthritis Foundation did not deny receiving the money but said the foundation represents patients, not sponsors. It is “optimistic” about biosimilars’ ability to help patients and save them money, said Anna Hyde, vice president of advocacy and access. “The Foundation supports the Food and Drug Administration’s scientific standards in evaluating the safety and efficacy of biosimilars, and we support policies that encourage innovation and foster a competitive marketplace.”

The Crohn’s & Colitis Foundation maintains “more than an arm’s-length distance” from its donors in the pharmaceutical industry, who have no say over the foundation’s strategic objectives, said president and CEO Michael Osso.

He added that the foundation’s position on biosimilars is “evolving.”

Lupus Foundation CEO Sandra Raymond said she could not explain how her group, also based in Washington, was involved in the coalition. She confirmed the Lupus Foundation received $444,000 from Pfizer in 2015 but said the money was not linked to any relationship with Patients for Biologics Safety & Access.

“I never went to a meeting,” Raymond said. “A former employee signed us up for a whole host of coalitions. I think we put our name on something or someone did.”

She said the Lupus Foundation was no longer a member of the coalition. Days after Kaiser Health News reached out to the coalition, its website was updated, excluding the Lupus Foundation.

For its part, AbbVie – which overall donated $24.7 million to patient groups in 2015, according to the new database – stipulates that its grants to nonprofits are “non-promotional” and provide no direct benefit to its business, according to a company statement. The company gives to patient groups because they serve as an “important, unbiased and independent resource for patients and caregivers.”

Insulin and influence

The American Diabetes Association said in an email to KHN that it received $18.3 million in pharmaceutical funding in 2017, accounting for 12.3% of its revenue; that was down from $26.7 million in 2015. The money flowed in as insulin makers continued to hike prices in those years – up to four times per product – leading to hardships for patients.

The only “Big Three” insulin maker in the database, Eli Lilly, gave $2.9 million to the American Diabetes Association in 2015, according to disclosures from the company and its foundation. Sanofi and Novo Nordisk are the other two major insulin makers, but neither was in the S&P 500 and therefore not included in the database. Over the past 20 years, Eli Lilly has repeatedly raised prices on its best-selling insulins, Humalog and Humulin, even though the medicines have been around for decades. The drugmaker faced protests – by people demanding to know the cost of manufacturing a vial of insulin – at its Indianapolis headquarters last fall.

The ADA launched a campaign decrying “skyrocketing” insulin in late 2016 but did not call out any drugmaker in its literature. When legislators in Nevada passed a bill last year requiring insulin makers to disclose their profits to the public, the ADA did not take a public stance.

The American Diabetes Association said it doesn’t confront individual companies because it is seeking action from “all entities in the supply chain” – manufacturers, wholesalers, pharmacy benefit managers and insurers.

“As a public health organization, the ADA’s commitment and focus is on the needs of the more than 30 million people with diabetes,” said Dr. William Cefalu, its chief scientific and medical officer. “The ADA requires support from a diverse set of partners to achieve this objective.”

Eli Lilly said it contributes money to the American Diabetes Association because the two share a “common goal” of helping diabetes patients.

“We provide funding for a wide variety of educational programs and opportunities at ADA, and they design and implement those programs in ways that are aligned with their goals,” Eli Lilly said in a statement. “We’re proud to support the ADA on important work that helps millions of people living with diabetes.”

Most patient groups say that funders have little or no influence in shaping their programs and policies, but their agreements are private.

They weren’t always backed by Pharma

Into the ’80s and early ’90s, patient lobbying was generally limited and self-funded with only one or two affluent patients from an organization traveling to Washington on a given day, said Diana Zuckerman, PhD, president of the nonprofit National Center for Health Research.

But the power of patient-lobbyists became apparent after a successful campaign by AIDS patients led to government action and a national push to find drugs to treat the then-terminal disease. Dr. Zuckerman said she will never forget when two women visited her office and asked how breast cancer patients could be as effective as the AIDS patients.

“At the time, there were no breast cancer patients advocating for money or anything else. It’s hard to believe,” she said. “I still remember that conversation, because it was really a turning point.”

Soon after, breast cancer patients started visiting the Hill more frequently. Patients with other diseases followed. Over time, patients’ voices became a potent force, often with industry support.

Even some wealthy, high-profile organizations take industry money: For example, $459,000 of Susan G. Komen’s $118 million in 2015 revenue came from drugmakers in the database, according to public disclosures. Asked about the pharma money, the foundation said it has institutional processes in place to ensure that “no corporate partner – pharma or otherwise – decides our mission priorities,” including a scientific advisory board – free of sponsor influence – that reviews its research program.

Today, patient advocacy groups flush with more industry dollars fly patients in for testimony and training about how to lobby for their drugs.

Some years ago, as the groups increased in number, Dr. Zuckerman said, she started getting email invitations from advocacy groups to attend so-called lobbying days explicitly sponsored by the pharmaceutical industry. The hosts often promised training and usually some kind of keynote speaker at a luncheon in Washington – plus a potential scholarship to cover travel. Now, lobbying days involving dozens of patients from a single group are part of the landscape.

Dan Boston, president of lobbying firm Health Policy Source, said, “It would be naive to think these people on a Tuesday afternoon just happen to turn up in XYZ places,” adding that the money isn’t necessarily a bad thing. Money tends to flow toward citizen groups that already have the same priorities as their funders, he said.

Marching into the future

Patient groups have been successful at campaigning for drug approvals, at times sparking controversy.

When scientists within the FDA advised against the approval of Exondys 51, a drug to treat Duchenne muscular dystrophy, parents of children with the rare genetic disorder and patients rallied to lobby for it in Washington. They were seen as pivotal to the FDA’s 2016 decision to grant approval for the drug, made by Sarepta Therapeutics. The decision was controversial in part because the FDA noted that clinical benefits of the drug – aimed at a subset of people with Duchenne muscular dystrophy – were not yet established.

Sarepta Therapeutics, which is not featured in the database, has taken measures to support its patient base. In March, it announced an annual scholarship program – 10 grants of up to $10,000 each for students with Duchenne muscular dystrophy to attend university or trade schools. Sarepta is also among the funders of Parent Project Muscular Dystrophy, a patient advocacy group at the forefront of the push for Exondys 51’s approval.

The Pre$cription for Power database will grow to include new disclosures. Not all drugmakers are willing to disclose their company giving. Eleven of the 20 companies examined – Allergan, Baxter International, Biogen, Celgene, Endo International, Gilead Sciences, Mallinckrodt, Mylan, Perrigo Co., Regeneron Pharmaceuticals, and Vertex Pharmaceuticals – declined to disclose their company giving or did not respond to repeated calls.

Paul Thacker, a former investigator for Sen. Chuck Grassley (R-Iowa) who helped draft the Physician Payments Sunshine Act in 2010, said there is reason to question the flow of money to patient advocacy groups. The pharmaceutical industry has fostered relationships in every link of the drug supply chain, including payments to researchers, doctors and professional societies.

“There’s so much money out there, and they’ve created all of these allies, so nobody is clamoring for change,” Mr. Thacker said.

Since the Physician Payments Sunshine Act began requiring the industry to report its payments to physicians, the industry is more reluctant to co-opt them, so “pharma has to find other megaphones,” PharmedOut’s Dr. Fugh-Berman said.

And, in times of public outrage over high drug prices and soaring insurance costs, patients are particularly sympathetic messengers, she said.

“Sick consumers make for good press,” Dr. Fugh-Berman said. “They make for good testimony before Congress. They can be very powerful spokespeople for pharmaceutical companies.”

KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Pharmaceutical companies gave at least $116 million to patient advocacy groups in a single year, reveals a new database logging 12,000 donations from large publicly traded drugmakers to such organizations.

Even as these patient groups grow in number and political influence, their funding and their relationships to drugmakers are little understood. Unlike payments to doctors and lobbying expenses, companies do not have to report payments to the groups.

The database, called “Pre$cription for Power,” shows that donations to patient advocacy groups tallied for 2015 – the most recent full year in which documents required by the Internal Revenue Service were available – dwarfed the total amount the companies spent on federal lobbying. The 14 companies that contributed $116 million to patient advocacy groups reported only about $63 million in lobbying activities that same year.

Though their primary missions are to focus attention on the needs of patients with a particular disease – such as arthritis, heart disease or various cancers – some groups effectively supplement the work lobbyists perform, providing patients to testify on Capitol Hill and organizing letter-writing and social media campaigns that are beneficial to pharmaceutical companies.

Six drugmakers, the data show, contributed a million dollars or more to individual groups that represent patients who rely on their drugs. The database identifies more than 1,200 patient groups. Of those, 594 accepted money from the drugmakers in the database.

The financial ties are troubling if they cause even one patient group to act in a way that’s “not fully representing the interest of its constituents,” said Matthew McCoy, a medical ethics professor at the University of Pennsylvania, Philadelphia, who coauthored a 2017 study about patient advocacy groups’ influence and transparency.

Notably, such groups have been silent or slow to complain about high or escalating prices, a prime concern of patients.

“When so many patient organizations are being influenced in this way, it can shift our whole approach to health policy, taking away from the interests of patients and towards the interests of industry,” Mr. McCoy said. “That’s not just a problem for the patients and caregivers that particular patient organizations serve; that’s a problem for everyone.”

Bristol-Myers Squibb provides a stark example of how patient groups are valued. In 2015, it spent more than $20.5 million on patient groups, compared with $2.9 million on federal lobbying and less than $1 million on major trade associations, according to public records and company disclosures. The company said its decisions regarding lobbying and contributions to patient groups are “unrelated.”

“Bristol-Myers Squibb is focused on supporting a health care environment that rewards innovation and ensures access to medicines for patients,” said spokeswoman Laura Hortas. “The company supports patient organizations with this shared objective.”

The first-of-its-kind database, compiled by Kaiser Health News, tallies the money from Big Pharma to patient groups. KHN examined the 20 pharmaceutical firms included in the S&P 500, 14 of which were transparent – in varying degrees – about giving money to patient groups. Pre$cription for Power is based on information contained in charitable giving reports from company websites and federal 990 regulatory filings.

It spotlights donations pharma companies made to patient groups large and small. The recipients include well-known disease groups, like the American Diabetes Association, with revenues of hundreds of millions of dollars; high-profile foundations like Susan G. Komen, a patient group focused on breast cancer; and smaller, lesser-known groups, like the Caring Ambassadors Program, which focuses on lung cancer and hepatitis C.

The data show that 15 patient groups – with annual revenues as large as $3.6 million – relied on the pharmaceutical companies for at least 20% of their revenue, and some relied on them for more than half of their revenue. The database explores only a slice of the pharmaceutical industry’s giving overall and will be expanded with more companies and groups over time.

“It’s clear that more transparency in this space is vitally important,” said Sen. Claire McCaskill (D-Mo.), who has been investigating the links between patient advocates and opioid manufacturers and is considering legislation to track funding. “This database is one step forward in that effort, but we also need Congress to act.”

What drives the money flow

The financial ties between drugmakers and the organizations that represent those who use or prescribe their blockbuster medicines have been of growing concern as drug prices escalate. The Senate investigated conflicts of interest in the run-up to the passage of the 2010 Physician Payments Sunshine Act – a law that required payments to physicians from makers of drugs and devices to be registered on a public website – but patient groups were not addressed in the bill.

Some of the patient groups with ties to trade groups echo industry talking points in media campaigns and letters to federal agencies, and do little else. And patients, supported by pharma, are dispatched to state capitals and Washington to support research funding. Some groups send patients updates on the newest drugs and industry products.

“It’s through groups like this that patients often learn about illnesses and treatments,” said Rick Claypool, a research director for Public Citizen, a consumer advocacy group that says it does not accept pharmaceutical funding.

For the patient group Caring Ambassadors Program, industry funds are needed to make up for a lack of public funding, said the group’s executive director, Lorren Sandt. According to IRS filings and published company reports, in 2015, the group received $413,000, the bulk of which came from one company, AbbVie, which makes a hepatitis C treatment and has been testing a new lung cancer drug, Rova-T, not yet approved. She said the money had no influence on the Caring Ambassadors Program’s priorities.

“There aren’t a lot of large pockets of funding outside of the pharmaceutical money,” Sandt said. “We take it where we can find it.”

Other patient groups such as the National Women’s Health Network, based in Washington, make sacrifices to avoid pharmaceutical funding. That includes operating with a small staff in a “modest” office building with few windows and outdated computers, according to executive director Cindy Pearson. “You can see the effect of our approach to funding as soon as you walk [in] the door.”

Pearson said it’s hard for patient groups not to be influenced by the funder, even if they proclaim independence. Patient groups “build relationships with their funders and feel in sync and have sympathy” for them. “It’s human nature. It’s not evil or weak, but it’s wrong.”

Charity as marketing

Patients newly diagnosed with a disease often turn to patient advocacy groups for advice, but the money flow to such groups may distort patients’ knowledge and public debate over treatment options, said Dr. Adriane Fugh-Berman, the director of PharmedOut, a Georgetown University Medical Center program in Washington that is critical of some pharmaceutical marketing practices.

“[The money flow limits] their advocacy agenda to competing branded products when the best therapy might be generics, over-the-counter drugs or diet and exercise,” she said.

AbbVie – whose specialty drug Humira made up 65% of the company’s net revenue in 2017 and is used to treat patients with autoimmune diseases, including Crohn’s disease and certain kinds of arthritis – gave $2.7 million to the Crohn’s & Colitis Foundation and $1.6 million to the Arthritis Foundation, according to the company’s public disclosures included in the database. The list price for a month’s supply of Humira, a biologic drug, is $4,872, according to Express Scripts, a pharmacy benefits manager.

Even though Humira will face competition from near-copycat drugs called biosimilars, it is expected to remain the highest-grossing drug in the United States through 2022, according to drug industry analysts at EvaluatePharma.

The Arthritis and Crohn’s foundations have been largely silent on the cost of Humira and vocal on safety concerns about biosimilars. The Arthritis Foundation has championed state laws that could add extra steps for consumers to receive biosimilars at the pharmacy counter, potentially keeping more patients on the brand-name drug. Experts say those laws could help protect Humira’s market share from generic competitors.

A coalition of patient groups, Patients for Biologics Safety & Access, opposes the automatic substitution of a cheaper biosimilar when doctors prescribe a biologic. In 2015, members of that coalition, including the Crohn’s & Colitis Foundation, the Arthritis Foundation and the Lupus Foundation of America, accepted about $9.1 million from pharmaceutical companies in the database, according to public disclosures. They include AbbVie and Johnson & Johnson, makers of blockbuster biologics.

The Arthritis Foundation did not deny receiving the money but said the foundation represents patients, not sponsors. It is “optimistic” about biosimilars’ ability to help patients and save them money, said Anna Hyde, vice president of advocacy and access. “The Foundation supports the Food and Drug Administration’s scientific standards in evaluating the safety and efficacy of biosimilars, and we support policies that encourage innovation and foster a competitive marketplace.”

The Crohn’s & Colitis Foundation maintains “more than an arm’s-length distance” from its donors in the pharmaceutical industry, who have no say over the foundation’s strategic objectives, said president and CEO Michael Osso.

He added that the foundation’s position on biosimilars is “evolving.”

Lupus Foundation CEO Sandra Raymond said she could not explain how her group, also based in Washington, was involved in the coalition. She confirmed the Lupus Foundation received $444,000 from Pfizer in 2015 but said the money was not linked to any relationship with Patients for Biologics Safety & Access.

“I never went to a meeting,” Raymond said. “A former employee signed us up for a whole host of coalitions. I think we put our name on something or someone did.”

She said the Lupus Foundation was no longer a member of the coalition. Days after Kaiser Health News reached out to the coalition, its website was updated, excluding the Lupus Foundation.

For its part, AbbVie – which overall donated $24.7 million to patient groups in 2015, according to the new database – stipulates that its grants to nonprofits are “non-promotional” and provide no direct benefit to its business, according to a company statement. The company gives to patient groups because they serve as an “important, unbiased and independent resource for patients and caregivers.”

Insulin and influence

The American Diabetes Association said in an email to KHN that it received $18.3 million in pharmaceutical funding in 2017, accounting for 12.3% of its revenue; that was down from $26.7 million in 2015. The money flowed in as insulin makers continued to hike prices in those years – up to four times per product – leading to hardships for patients.

The only “Big Three” insulin maker in the database, Eli Lilly, gave $2.9 million to the American Diabetes Association in 2015, according to disclosures from the company and its foundation. Sanofi and Novo Nordisk are the other two major insulin makers, but neither was in the S&P 500 and therefore not included in the database. Over the past 20 years, Eli Lilly has repeatedly raised prices on its best-selling insulins, Humalog and Humulin, even though the medicines have been around for decades. The drugmaker faced protests – by people demanding to know the cost of manufacturing a vial of insulin – at its Indianapolis headquarters last fall.

The ADA launched a campaign decrying “skyrocketing” insulin in late 2016 but did not call out any drugmaker in its literature. When legislators in Nevada passed a bill last year requiring insulin makers to disclose their profits to the public, the ADA did not take a public stance.

The American Diabetes Association said it doesn’t confront individual companies because it is seeking action from “all entities in the supply chain” – manufacturers, wholesalers, pharmacy benefit managers and insurers.

“As a public health organization, the ADA’s commitment and focus is on the needs of the more than 30 million people with diabetes,” said Dr. William Cefalu, its chief scientific and medical officer. “The ADA requires support from a diverse set of partners to achieve this objective.”

Eli Lilly said it contributes money to the American Diabetes Association because the two share a “common goal” of helping diabetes patients.

“We provide funding for a wide variety of educational programs and opportunities at ADA, and they design and implement those programs in ways that are aligned with their goals,” Eli Lilly said in a statement. “We’re proud to support the ADA on important work that helps millions of people living with diabetes.”

Most patient groups say that funders have little or no influence in shaping their programs and policies, but their agreements are private.

They weren’t always backed by Pharma

Into the ’80s and early ’90s, patient lobbying was generally limited and self-funded with only one or two affluent patients from an organization traveling to Washington on a given day, said Diana Zuckerman, PhD, president of the nonprofit National Center for Health Research.

But the power of patient-lobbyists became apparent after a successful campaign by AIDS patients led to government action and a national push to find drugs to treat the then-terminal disease. Dr. Zuckerman said she will never forget when two women visited her office and asked how breast cancer patients could be as effective as the AIDS patients.

“At the time, there were no breast cancer patients advocating for money or anything else. It’s hard to believe,” she said. “I still remember that conversation, because it was really a turning point.”

Soon after, breast cancer patients started visiting the Hill more frequently. Patients with other diseases followed. Over time, patients’ voices became a potent force, often with industry support.

Even some wealthy, high-profile organizations take industry money: For example, $459,000 of Susan G. Komen’s $118 million in 2015 revenue came from drugmakers in the database, according to public disclosures. Asked about the pharma money, the foundation said it has institutional processes in place to ensure that “no corporate partner – pharma or otherwise – decides our mission priorities,” including a scientific advisory board – free of sponsor influence – that reviews its research program.

Today, patient advocacy groups flush with more industry dollars fly patients in for testimony and training about how to lobby for their drugs.

Some years ago, as the groups increased in number, Dr. Zuckerman said, she started getting email invitations from advocacy groups to attend so-called lobbying days explicitly sponsored by the pharmaceutical industry. The hosts often promised training and usually some kind of keynote speaker at a luncheon in Washington – plus a potential scholarship to cover travel. Now, lobbying days involving dozens of patients from a single group are part of the landscape.

Dan Boston, president of lobbying firm Health Policy Source, said, “It would be naive to think these people on a Tuesday afternoon just happen to turn up in XYZ places,” adding that the money isn’t necessarily a bad thing. Money tends to flow toward citizen groups that already have the same priorities as their funders, he said.

Marching into the future

Patient groups have been successful at campaigning for drug approvals, at times sparking controversy.

When scientists within the FDA advised against the approval of Exondys 51, a drug to treat Duchenne muscular dystrophy, parents of children with the rare genetic disorder and patients rallied to lobby for it in Washington. They were seen as pivotal to the FDA’s 2016 decision to grant approval for the drug, made by Sarepta Therapeutics. The decision was controversial in part because the FDA noted that clinical benefits of the drug – aimed at a subset of people with Duchenne muscular dystrophy – were not yet established.

Sarepta Therapeutics, which is not featured in the database, has taken measures to support its patient base. In March, it announced an annual scholarship program – 10 grants of up to $10,000 each for students with Duchenne muscular dystrophy to attend university or trade schools. Sarepta is also among the funders of Parent Project Muscular Dystrophy, a patient advocacy group at the forefront of the push for Exondys 51’s approval.

The Pre$cription for Power database will grow to include new disclosures. Not all drugmakers are willing to disclose their company giving. Eleven of the 20 companies examined – Allergan, Baxter International, Biogen, Celgene, Endo International, Gilead Sciences, Mallinckrodt, Mylan, Perrigo Co., Regeneron Pharmaceuticals, and Vertex Pharmaceuticals – declined to disclose their company giving or did not respond to repeated calls.

Paul Thacker, a former investigator for Sen. Chuck Grassley (R-Iowa) who helped draft the Physician Payments Sunshine Act in 2010, said there is reason to question the flow of money to patient advocacy groups. The pharmaceutical industry has fostered relationships in every link of the drug supply chain, including payments to researchers, doctors and professional societies.

“There’s so much money out there, and they’ve created all of these allies, so nobody is clamoring for change,” Mr. Thacker said.

Since the Physician Payments Sunshine Act began requiring the industry to report its payments to physicians, the industry is more reluctant to co-opt them, so “pharma has to find other megaphones,” PharmedOut’s Dr. Fugh-Berman said.

And, in times of public outrage over high drug prices and soaring insurance costs, patients are particularly sympathetic messengers, she said.

“Sick consumers make for good press,” Dr. Fugh-Berman said. “They make for good testimony before Congress. They can be very powerful spokespeople for pharmaceutical companies.”

KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Pharmaceutical companies gave at least $116 million to patient advocacy groups in a single year, reveals a new database logging 12,000 donations from large publicly traded drugmakers to such organizations.

Even as these patient groups grow in number and political influence, their funding and their relationships to drugmakers are little understood. Unlike payments to doctors and lobbying expenses, companies do not have to report payments to the groups.

The database, called “Pre$cription for Power,” shows that donations to patient advocacy groups tallied for 2015 – the most recent full year in which documents required by the Internal Revenue Service were available – dwarfed the total amount the companies spent on federal lobbying. The 14 companies that contributed $116 million to patient advocacy groups reported only about $63 million in lobbying activities that same year.

Though their primary missions are to focus attention on the needs of patients with a particular disease – such as arthritis, heart disease or various cancers – some groups effectively supplement the work lobbyists perform, providing patients to testify on Capitol Hill and organizing letter-writing and social media campaigns that are beneficial to pharmaceutical companies.

Six drugmakers, the data show, contributed a million dollars or more to individual groups that represent patients who rely on their drugs. The database identifies more than 1,200 patient groups. Of those, 594 accepted money from the drugmakers in the database.

The financial ties are troubling if they cause even one patient group to act in a way that’s “not fully representing the interest of its constituents,” said Matthew McCoy, a medical ethics professor at the University of Pennsylvania, Philadelphia, who coauthored a 2017 study about patient advocacy groups’ influence and transparency.

Notably, such groups have been silent or slow to complain about high or escalating prices, a prime concern of patients.

“When so many patient organizations are being influenced in this way, it can shift our whole approach to health policy, taking away from the interests of patients and towards the interests of industry,” Mr. McCoy said. “That’s not just a problem for the patients and caregivers that particular patient organizations serve; that’s a problem for everyone.”

Bristol-Myers Squibb provides a stark example of how patient groups are valued. In 2015, it spent more than $20.5 million on patient groups, compared with $2.9 million on federal lobbying and less than $1 million on major trade associations, according to public records and company disclosures. The company said its decisions regarding lobbying and contributions to patient groups are “unrelated.”

“Bristol-Myers Squibb is focused on supporting a health care environment that rewards innovation and ensures access to medicines for patients,” said spokeswoman Laura Hortas. “The company supports patient organizations with this shared objective.”

The first-of-its-kind database, compiled by Kaiser Health News, tallies the money from Big Pharma to patient groups. KHN examined the 20 pharmaceutical firms included in the S&P 500, 14 of which were transparent – in varying degrees – about giving money to patient groups. Pre$cription for Power is based on information contained in charitable giving reports from company websites and federal 990 regulatory filings.

It spotlights donations pharma companies made to patient groups large and small. The recipients include well-known disease groups, like the American Diabetes Association, with revenues of hundreds of millions of dollars; high-profile foundations like Susan G. Komen, a patient group focused on breast cancer; and smaller, lesser-known groups, like the Caring Ambassadors Program, which focuses on lung cancer and hepatitis C.

The data show that 15 patient groups – with annual revenues as large as $3.6 million – relied on the pharmaceutical companies for at least 20% of their revenue, and some relied on them for more than half of their revenue. The database explores only a slice of the pharmaceutical industry’s giving overall and will be expanded with more companies and groups over time.

“It’s clear that more transparency in this space is vitally important,” said Sen. Claire McCaskill (D-Mo.), who has been investigating the links between patient advocates and opioid manufacturers and is considering legislation to track funding. “This database is one step forward in that effort, but we also need Congress to act.”

What drives the money flow

The financial ties between drugmakers and the organizations that represent those who use or prescribe their blockbuster medicines have been of growing concern as drug prices escalate. The Senate investigated conflicts of interest in the run-up to the passage of the 2010 Physician Payments Sunshine Act – a law that required payments to physicians from makers of drugs and devices to be registered on a public website – but patient groups were not addressed in the bill.

Some of the patient groups with ties to trade groups echo industry talking points in media campaigns and letters to federal agencies, and do little else. And patients, supported by pharma, are dispatched to state capitals and Washington to support research funding. Some groups send patients updates on the newest drugs and industry products.

“It’s through groups like this that patients often learn about illnesses and treatments,” said Rick Claypool, a research director for Public Citizen, a consumer advocacy group that says it does not accept pharmaceutical funding.

For the patient group Caring Ambassadors Program, industry funds are needed to make up for a lack of public funding, said the group’s executive director, Lorren Sandt. According to IRS filings and published company reports, in 2015, the group received $413,000, the bulk of which came from one company, AbbVie, which makes a hepatitis C treatment and has been testing a new lung cancer drug, Rova-T, not yet approved. She said the money had no influence on the Caring Ambassadors Program’s priorities.

“There aren’t a lot of large pockets of funding outside of the pharmaceutical money,” Sandt said. “We take it where we can find it.”

Other patient groups such as the National Women’s Health Network, based in Washington, make sacrifices to avoid pharmaceutical funding. That includes operating with a small staff in a “modest” office building with few windows and outdated computers, according to executive director Cindy Pearson. “You can see the effect of our approach to funding as soon as you walk [in] the door.”

Pearson said it’s hard for patient groups not to be influenced by the funder, even if they proclaim independence. Patient groups “build relationships with their funders and feel in sync and have sympathy” for them. “It’s human nature. It’s not evil or weak, but it’s wrong.”

Charity as marketing

Patients newly diagnosed with a disease often turn to patient advocacy groups for advice, but the money flow to such groups may distort patients’ knowledge and public debate over treatment options, said Dr. Adriane Fugh-Berman, the director of PharmedOut, a Georgetown University Medical Center program in Washington that is critical of some pharmaceutical marketing practices.

“[The money flow limits] their advocacy agenda to competing branded products when the best therapy might be generics, over-the-counter drugs or diet and exercise,” she said.

AbbVie – whose specialty drug Humira made up 65% of the company’s net revenue in 2017 and is used to treat patients with autoimmune diseases, including Crohn’s disease and certain kinds of arthritis – gave $2.7 million to the Crohn’s & Colitis Foundation and $1.6 million to the Arthritis Foundation, according to the company’s public disclosures included in the database. The list price for a month’s supply of Humira, a biologic drug, is $4,872, according to Express Scripts, a pharmacy benefits manager.

Even though Humira will face competition from near-copycat drugs called biosimilars, it is expected to remain the highest-grossing drug in the United States through 2022, according to drug industry analysts at EvaluatePharma.

The Arthritis and Crohn’s foundations have been largely silent on the cost of Humira and vocal on safety concerns about biosimilars. The Arthritis Foundation has championed state laws that could add extra steps for consumers to receive biosimilars at the pharmacy counter, potentially keeping more patients on the brand-name drug. Experts say those laws could help protect Humira’s market share from generic competitors.

A coalition of patient groups, Patients for Biologics Safety & Access, opposes the automatic substitution of a cheaper biosimilar when doctors prescribe a biologic. In 2015, members of that coalition, including the Crohn’s & Colitis Foundation, the Arthritis Foundation and the Lupus Foundation of America, accepted about $9.1 million from pharmaceutical companies in the database, according to public disclosures. They include AbbVie and Johnson & Johnson, makers of blockbuster biologics.

The Arthritis Foundation did not deny receiving the money but said the foundation represents patients, not sponsors. It is “optimistic” about biosimilars’ ability to help patients and save them money, said Anna Hyde, vice president of advocacy and access. “The Foundation supports the Food and Drug Administration’s scientific standards in evaluating the safety and efficacy of biosimilars, and we support policies that encourage innovation and foster a competitive marketplace.”

The Crohn’s & Colitis Foundation maintains “more than an arm’s-length distance” from its donors in the pharmaceutical industry, who have no say over the foundation’s strategic objectives, said president and CEO Michael Osso.

He added that the foundation’s position on biosimilars is “evolving.”

Lupus Foundation CEO Sandra Raymond said she could not explain how her group, also based in Washington, was involved in the coalition. She confirmed the Lupus Foundation received $444,000 from Pfizer in 2015 but said the money was not linked to any relationship with Patients for Biologics Safety & Access.

“I never went to a meeting,” Raymond said. “A former employee signed us up for a whole host of coalitions. I think we put our name on something or someone did.”

She said the Lupus Foundation was no longer a member of the coalition. Days after Kaiser Health News reached out to the coalition, its website was updated, excluding the Lupus Foundation.

For its part, AbbVie – which overall donated $24.7 million to patient groups in 2015, according to the new database – stipulates that its grants to nonprofits are “non-promotional” and provide no direct benefit to its business, according to a company statement. The company gives to patient groups because they serve as an “important, unbiased and independent resource for patients and caregivers.”

Insulin and influence

The American Diabetes Association said in an email to KHN that it received $18.3 million in pharmaceutical funding in 2017, accounting for 12.3% of its revenue; that was down from $26.7 million in 2015. The money flowed in as insulin makers continued to hike prices in those years – up to four times per product – leading to hardships for patients.

The only “Big Three” insulin maker in the database, Eli Lilly, gave $2.9 million to the American Diabetes Association in 2015, according to disclosures from the company and its foundation. Sanofi and Novo Nordisk are the other two major insulin makers, but neither was in the S&P 500 and therefore not included in the database. Over the past 20 years, Eli Lilly has repeatedly raised prices on its best-selling insulins, Humalog and Humulin, even though the medicines have been around for decades. The drugmaker faced protests – by people demanding to know the cost of manufacturing a vial of insulin – at its Indianapolis headquarters last fall.

The ADA launched a campaign decrying “skyrocketing” insulin in late 2016 but did not call out any drugmaker in its literature. When legislators in Nevada passed a bill last year requiring insulin makers to disclose their profits to the public, the ADA did not take a public stance.

The American Diabetes Association said it doesn’t confront individual companies because it is seeking action from “all entities in the supply chain” – manufacturers, wholesalers, pharmacy benefit managers and insurers.

“As a public health organization, the ADA’s commitment and focus is on the needs of the more than 30 million people with diabetes,” said Dr. William Cefalu, its chief scientific and medical officer. “The ADA requires support from a diverse set of partners to achieve this objective.”

Eli Lilly said it contributes money to the American Diabetes Association because the two share a “common goal” of helping diabetes patients.

“We provide funding for a wide variety of educational programs and opportunities at ADA, and they design and implement those programs in ways that are aligned with their goals,” Eli Lilly said in a statement. “We’re proud to support the ADA on important work that helps millions of people living with diabetes.”

Most patient groups say that funders have little or no influence in shaping their programs and policies, but their agreements are private.

They weren’t always backed by Pharma

Into the ’80s and early ’90s, patient lobbying was generally limited and self-funded with only one or two affluent patients from an organization traveling to Washington on a given day, said Diana Zuckerman, PhD, president of the nonprofit National Center for Health Research.

But the power of patient-lobbyists became apparent after a successful campaign by AIDS patients led to government action and a national push to find drugs to treat the then-terminal disease. Dr. Zuckerman said she will never forget when two women visited her office and asked how breast cancer patients could be as effective as the AIDS patients.

“At the time, there were no breast cancer patients advocating for money or anything else. It’s hard to believe,” she said. “I still remember that conversation, because it was really a turning point.”

Soon after, breast cancer patients started visiting the Hill more frequently. Patients with other diseases followed. Over time, patients’ voices became a potent force, often with industry support.

Even some wealthy, high-profile organizations take industry money: For example, $459,000 of Susan G. Komen’s $118 million in 2015 revenue came from drugmakers in the database, according to public disclosures. Asked about the pharma money, the foundation said it has institutional processes in place to ensure that “no corporate partner – pharma or otherwise – decides our mission priorities,” including a scientific advisory board – free of sponsor influence – that reviews its research program.

Today, patient advocacy groups flush with more industry dollars fly patients in for testimony and training about how to lobby for their drugs.

Some years ago, as the groups increased in number, Dr. Zuckerman said, she started getting email invitations from advocacy groups to attend so-called lobbying days explicitly sponsored by the pharmaceutical industry. The hosts often promised training and usually some kind of keynote speaker at a luncheon in Washington – plus a potential scholarship to cover travel. Now, lobbying days involving dozens of patients from a single group are part of the landscape.

Dan Boston, president of lobbying firm Health Policy Source, said, “It would be naive to think these people on a Tuesday afternoon just happen to turn up in XYZ places,” adding that the money isn’t necessarily a bad thing. Money tends to flow toward citizen groups that already have the same priorities as their funders, he said.

Marching into the future

Patient groups have been successful at campaigning for drug approvals, at times sparking controversy.

When scientists within the FDA advised against the approval of Exondys 51, a drug to treat Duchenne muscular dystrophy, parents of children with the rare genetic disorder and patients rallied to lobby for it in Washington. They were seen as pivotal to the FDA’s 2016 decision to grant approval for the drug, made by Sarepta Therapeutics. The decision was controversial in part because the FDA noted that clinical benefits of the drug – aimed at a subset of people with Duchenne muscular dystrophy – were not yet established.

Sarepta Therapeutics, which is not featured in the database, has taken measures to support its patient base. In March, it announced an annual scholarship program – 10 grants of up to $10,000 each for students with Duchenne muscular dystrophy to attend university or trade schools. Sarepta is also among the funders of Parent Project Muscular Dystrophy, a patient advocacy group at the forefront of the push for Exondys 51’s approval.

The Pre$cription for Power database will grow to include new disclosures. Not all drugmakers are willing to disclose their company giving. Eleven of the 20 companies examined – Allergan, Baxter International, Biogen, Celgene, Endo International, Gilead Sciences, Mallinckrodt, Mylan, Perrigo Co., Regeneron Pharmaceuticals, and Vertex Pharmaceuticals – declined to disclose their company giving or did not respond to repeated calls.

Paul Thacker, a former investigator for Sen. Chuck Grassley (R-Iowa) who helped draft the Physician Payments Sunshine Act in 2010, said there is reason to question the flow of money to patient advocacy groups. The pharmaceutical industry has fostered relationships in every link of the drug supply chain, including payments to researchers, doctors and professional societies.

“There’s so much money out there, and they’ve created all of these allies, so nobody is clamoring for change,” Mr. Thacker said.

Since the Physician Payments Sunshine Act began requiring the industry to report its payments to physicians, the industry is more reluctant to co-opt them, so “pharma has to find other megaphones,” PharmedOut’s Dr. Fugh-Berman said.

And, in times of public outrage over high drug prices and soaring insurance costs, patients are particularly sympathetic messengers, she said.

“Sick consumers make for good press,” Dr. Fugh-Berman said. “They make for good testimony before Congress. They can be very powerful spokespeople for pharmaceutical companies.”

KHN’s coverage of prescription drug development, costs and pricing is supported by the Laura and John Arnold Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Treading into ethically and legally uncertain territory, a New York end-of-life agency has approved a new document that lets people stipulate in advance that they don’t want food or water if they develop severe dementia.

The directive, finalized this month by the board for End of Life Choices New York, aims to provide patients a way to hasten death in late-stage dementia, if they choose.

Dementia is a terminal illness, but even in the seven U.S. jurisdictions that allow medical aid-in-dying, it’s not a condition covered by the laws. Increasingly, patients are seeking other options, said Timothy Quill, MD, a palliative care expert at the University of Rochester (N.Y.) and an advocate of the practice.

“Developing incapacitating dementia is certainly my and a lot of people’s worst nightmare,” he said. “This is an aggressive document. It’s a way of addressing a real problem, which is the prospect of advanced dementia.”

The document offers two options: one that requests “comfort feeding” – providing oral food and water if a patient appears to enjoy or allows it during the final stages of the disease – and one that would halt all assisted eating and drinking, even if a patient seems willing to accept it.

Supporters say it’s the strongest effort to date to allow people who want to avoid the ravages of advanced dementia to make their final wishes known – while they still have the ability to do so.

“They do not want their dying prolonged,” said Judith Schwarz, who drafted the document as clinical director for the advocacy group. “This is an informed and thoughtful choice that needs a great deal of reflection and discussion.”

But critics say it’s a disturbing effort to allow withdrawal of basic sustenance from the most vulnerable in society.

“I think oral feeding is basic care,” said Richard Doerflinger, an associate scholar with the Charlotte Lozier Institute, which opposes abortion and euthanasia. “It’s what they want here and now that matters. If they start taking food, you give them food.”

Advance directives are legally recognized documents that specify care if a person is incapacitated. They can confirm that a patient doesn’t want to be resuscitated or kept on life support, such as a ventilator or feeding tube, if they have a terminal condition from which they’re not likely to recover.

However, the documents typically say nothing about withdrawing hand-feeding of food or fluids.

The New York directive, in contrast, offers option A, which allows refusal of all oral assisted feeding. Option B permits comfort-focused feeding.

Both options would be invoked only when a patient is diagnosed with moderate or severe dementia, defined as stages 6 or 7 of a widely used test known as the Functional Assessment Staging Test (FAST). At those stages, patients would be unable to feed themselves or make health care decisions.

The new form goes further than a similar dementia directive introduced last year by another group that supports aid-in-dying, End of Life Washington. That document says that a person with dementia who accepts food or drink should receive oral nourishment until he or she is unwilling or unable to do so.

The New York document says, “My instructions are that I do NOT want to be fed by hand even if I appear to cooperate in being fed by opening my mouth.”

Whether the new directive will be honored in New York – or anywhere else – is unclear. Legal scholars and ethicists say directives withdrawing oral assisted feeding are prohibited in several states. Many care facilities are unlikely to cooperate, said Thaddeus Pope, director of the Health Law Institute at Hamline University, St. Paul, Minn., and an expert on end-of-life law. Doctors have a duty to honor patient wishes, but they can refuse if they have medical or moral qualms.

“Even solidly legal advance directives do not and cannot ENSURE that wishes are respected,” Pope said in an email. “They can only ‘help assure’ that.”

Directors at End of Life Choices New York consider the document “legally sturdy,” Schwarz said, adding, “Of course it’s going to end up in court.”

Whether assisted feeding can be withdrawn was at the center of recent high-profile cases in which patients with dementia were spoon-fed against their documented wishes because they continued to open their mouths. In a case in Canada, a court ruled that such feeding is basic care that can’t be withdrawn.

People who fill out the directives may be more likely to have them honored if they remain at home, Schwarz said. She stressed that patients should make their wishes known far in advance and choose health care agents who will be strong advocates. Legal experts say the documents should be updated regularly.

Doerflinger, however, said creating the directive and making it available misses a crucial point: People who don’t have dementia now can’t know how they’ll feel later, yet they’re deciding in advance to forgo nourishment.

“The question is: Do we, the able-bodied, have a right to discriminate against the disabled people we will later become?” Doerflinger said.

Already, though, Schwarz has heard from people determined to put the new directive in place.

Janet Dwyer, 59, of New York, said her family was horrified by her father’s lingering death after a heart attack 4 years ago and mindful of a family history of dementia. When Dwyer learned there was a directive to address terminal illness and dementia, she signed it. So did her husband, John Harney, also 59.

“Judith informed me of the Option A or Option B scenarios,” said Dwyer, who opted for A. “I said, ‘Well, that is just perfect.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente. KHN’s coverage of end-of-life and serious illness issues is supported in part by the Gordon and Betty Moore Foundation.

Treading into ethically and legally uncertain territory, a New York end-of-life agency has approved a new document that lets people stipulate in advance that they don’t want food or water if they develop severe dementia.

The directive, finalized this month by the board for End of Life Choices New York, aims to provide patients a way to hasten death in late-stage dementia, if they choose.

Dementia is a terminal illness, but even in the seven U.S. jurisdictions that allow medical aid-in-dying, it’s not a condition covered by the laws. Increasingly, patients are seeking other options, said Timothy Quill, MD, a palliative care expert at the University of Rochester (N.Y.) and an advocate of the practice.

“Developing incapacitating dementia is certainly my and a lot of people’s worst nightmare,” he said. “This is an aggressive document. It’s a way of addressing a real problem, which is the prospect of advanced dementia.”

The document offers two options: one that requests “comfort feeding” – providing oral food and water if a patient appears to enjoy or allows it during the final stages of the disease – and one that would halt all assisted eating and drinking, even if a patient seems willing to accept it.

Supporters say it’s the strongest effort to date to allow people who want to avoid the ravages of advanced dementia to make their final wishes known – while they still have the ability to do so.

“They do not want their dying prolonged,” said Judith Schwarz, who drafted the document as clinical director for the advocacy group. “This is an informed and thoughtful choice that needs a great deal of reflection and discussion.”

But critics say it’s a disturbing effort to allow withdrawal of basic sustenance from the most vulnerable in society.

“I think oral feeding is basic care,” said Richard Doerflinger, an associate scholar with the Charlotte Lozier Institute, which opposes abortion and euthanasia. “It’s what they want here and now that matters. If they start taking food, you give them food.”

Advance directives are legally recognized documents that specify care if a person is incapacitated. They can confirm that a patient doesn’t want to be resuscitated or kept on life support, such as a ventilator or feeding tube, if they have a terminal condition from which they’re not likely to recover.

However, the documents typically say nothing about withdrawing hand-feeding of food or fluids.

The New York directive, in contrast, offers option A, which allows refusal of all oral assisted feeding. Option B permits comfort-focused feeding.

Both options would be invoked only when a patient is diagnosed with moderate or severe dementia, defined as stages 6 or 7 of a widely used test known as the Functional Assessment Staging Test (FAST). At those stages, patients would be unable to feed themselves or make health care decisions.

The new form goes further than a similar dementia directive introduced last year by another group that supports aid-in-dying, End of Life Washington. That document says that a person with dementia who accepts food or drink should receive oral nourishment until he or she is unwilling or unable to do so.

The New York document says, “My instructions are that I do NOT want to be fed by hand even if I appear to cooperate in being fed by opening my mouth.”

Whether the new directive will be honored in New York – or anywhere else – is unclear. Legal scholars and ethicists say directives withdrawing oral assisted feeding are prohibited in several states. Many care facilities are unlikely to cooperate, said Thaddeus Pope, director of the Health Law Institute at Hamline University, St. Paul, Minn., and an expert on end-of-life law. Doctors have a duty to honor patient wishes, but they can refuse if they have medical or moral qualms.

“Even solidly legal advance directives do not and cannot ENSURE that wishes are respected,” Pope said in an email. “They can only ‘help assure’ that.”

Directors at End of Life Choices New York consider the document “legally sturdy,” Schwarz said, adding, “Of course it’s going to end up in court.”

Whether assisted feeding can be withdrawn was at the center of recent high-profile cases in which patients with dementia were spoon-fed against their documented wishes because they continued to open their mouths. In a case in Canada, a court ruled that such feeding is basic care that can’t be withdrawn.

People who fill out the directives may be more likely to have them honored if they remain at home, Schwarz said. She stressed that patients should make their wishes known far in advance and choose health care agents who will be strong advocates. Legal experts say the documents should be updated regularly.

Doerflinger, however, said creating the directive and making it available misses a crucial point: People who don’t have dementia now can’t know how they’ll feel later, yet they’re deciding in advance to forgo nourishment.

“The question is: Do we, the able-bodied, have a right to discriminate against the disabled people we will later become?” Doerflinger said.

Already, though, Schwarz has heard from people determined to put the new directive in place.

Janet Dwyer, 59, of New York, said her family was horrified by her father’s lingering death after a heart attack 4 years ago and mindful of a family history of dementia. When Dwyer learned there was a directive to address terminal illness and dementia, she signed it. So did her husband, John Harney, also 59.

“Judith informed me of the Option A or Option B scenarios,” said Dwyer, who opted for A. “I said, ‘Well, that is just perfect.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente. KHN’s coverage of end-of-life and serious illness issues is supported in part by the Gordon and Betty Moore Foundation.

Treading into ethically and legally uncertain territory, a New York end-of-life agency has approved a new document that lets people stipulate in advance that they don’t want food or water if they develop severe dementia.

The directive, finalized this month by the board for End of Life Choices New York, aims to provide patients a way to hasten death in late-stage dementia, if they choose.

Dementia is a terminal illness, but even in the seven U.S. jurisdictions that allow medical aid-in-dying, it’s not a condition covered by the laws. Increasingly, patients are seeking other options, said Timothy Quill, MD, a palliative care expert at the University of Rochester (N.Y.) and an advocate of the practice.

“Developing incapacitating dementia is certainly my and a lot of people’s worst nightmare,” he said. “This is an aggressive document. It’s a way of addressing a real problem, which is the prospect of advanced dementia.”

The document offers two options: one that requests “comfort feeding” – providing oral food and water if a patient appears to enjoy or allows it during the final stages of the disease – and one that would halt all assisted eating and drinking, even if a patient seems willing to accept it.

Supporters say it’s the strongest effort to date to allow people who want to avoid the ravages of advanced dementia to make their final wishes known – while they still have the ability to do so.

“They do not want their dying prolonged,” said Judith Schwarz, who drafted the document as clinical director for the advocacy group. “This is an informed and thoughtful choice that needs a great deal of reflection and discussion.”

But critics say it’s a disturbing effort to allow withdrawal of basic sustenance from the most vulnerable in society.

“I think oral feeding is basic care,” said Richard Doerflinger, an associate scholar with the Charlotte Lozier Institute, which opposes abortion and euthanasia. “It’s what they want here and now that matters. If they start taking food, you give them food.”

Advance directives are legally recognized documents that specify care if a person is incapacitated. They can confirm that a patient doesn’t want to be resuscitated or kept on life support, such as a ventilator or feeding tube, if they have a terminal condition from which they’re not likely to recover.

However, the documents typically say nothing about withdrawing hand-feeding of food or fluids.

The New York directive, in contrast, offers option A, which allows refusal of all oral assisted feeding. Option B permits comfort-focused feeding.

Both options would be invoked only when a patient is diagnosed with moderate or severe dementia, defined as stages 6 or 7 of a widely used test known as the Functional Assessment Staging Test (FAST). At those stages, patients would be unable to feed themselves or make health care decisions.

The new form goes further than a similar dementia directive introduced last year by another group that supports aid-in-dying, End of Life Washington. That document says that a person with dementia who accepts food or drink should receive oral nourishment until he or she is unwilling or unable to do so.

The New York document says, “My instructions are that I do NOT want to be fed by hand even if I appear to cooperate in being fed by opening my mouth.”

Whether the new directive will be honored in New York – or anywhere else – is unclear. Legal scholars and ethicists say directives withdrawing oral assisted feeding are prohibited in several states. Many care facilities are unlikely to cooperate, said Thaddeus Pope, director of the Health Law Institute at Hamline University, St. Paul, Minn., and an expert on end-of-life law. Doctors have a duty to honor patient wishes, but they can refuse if they have medical or moral qualms.

“Even solidly legal advance directives do not and cannot ENSURE that wishes are respected,” Pope said in an email. “They can only ‘help assure’ that.”

Directors at End of Life Choices New York consider the document “legally sturdy,” Schwarz said, adding, “Of course it’s going to end up in court.”

Whether assisted feeding can be withdrawn was at the center of recent high-profile cases in which patients with dementia were spoon-fed against their documented wishes because they continued to open their mouths. In a case in Canada, a court ruled that such feeding is basic care that can’t be withdrawn.

People who fill out the directives may be more likely to have them honored if they remain at home, Schwarz said. She stressed that patients should make their wishes known far in advance and choose health care agents who will be strong advocates. Legal experts say the documents should be updated regularly.

Doerflinger, however, said creating the directive and making it available misses a crucial point: People who don’t have dementia now can’t know how they’ll feel later, yet they’re deciding in advance to forgo nourishment.

“The question is: Do we, the able-bodied, have a right to discriminate against the disabled people we will later become?” Doerflinger said.

Already, though, Schwarz has heard from people determined to put the new directive in place.

Janet Dwyer, 59, of New York, said her family was horrified by her father’s lingering death after a heart attack 4 years ago and mindful of a family history of dementia. When Dwyer learned there was a directive to address terminal illness and dementia, she signed it. So did her husband, John Harney, also 59.

“Judith informed me of the Option A or Option B scenarios,” said Dwyer, who opted for A. “I said, ‘Well, that is just perfect.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente. KHN’s coverage of end-of-life and serious illness issues is supported in part by the Gordon and Betty Moore Foundation.

California signed up an estimated 450,000 people under Medicaid expansion who may not have been eligible for coverage, according to a report by the Health & Human Services’ chief watchdog.

In a Feb. 21 report, the HHS’s inspector general estimated that California spent $738.2 million on 366,078 expansion beneficiaries who were ineligible. It spent an additional $416.5 million for 79,055 expansion enrollees who were “potentially” ineligible, auditors found.

Auditors said nearly 90% of the $1.15 billion in questionable payments involved federal money, while the rest came from the state’s Medicaid program, known as Medi-Cal. They examined a 6-month period from Oct. 1, 2014, to March 31, 2015, when Medicaid payments of $6.2 billion were made related to 1.9 million newly eligible enrollees.

There were limitations to the California review, however. The audit extrapolated from a sample of 150 beneficiaries. The authors reported a 90% confidence level in their results – whereas 95% would be more common. That meant that the number of those ineligible could have been as low as 260,000 or as high as 630,000.

“If HHS has a strong reason to believe that California is systematically making enrollment errors, it would be helpful to show that in a more robust analysis,” said Ben Ippolito, a health care economist at the American Enterprise Institute, a conservative think tank. “The federal government should ensure that states are being good stewards of federal money.”

Nonetheless, the audit highlighted weaknesses in California’s Medicaid program, the largest in the nation with 13.4 million enrollees and an annual budget topping $100 billion, counting federal and state money. Medicaid covers one in three Californians.

The inspector general found deficiencies in the state’s computer system for verifying eligibility and discovered errors by caseworkers. The Medicaid payments cited in the report covered people in the state’s fee-for-service system, managed-care plans, drug treatment programs, and those receiving mental health services.

California’s Department of Health Care Services, which runs Medi-Cal, said in a statement that it agreed with nearly all of the auditors’ recommendations and that the agency “has taken steps to address all of the findings.”

In a written response to the inspector general, California officials said several computer upgrades were made after the audit period and before publication of the report that should improve the accuracy of eligibility decisions.

Among the 150 expansion enrollees analyzed in detail, 75%, or 112, were deemed eligible for the Medicaid program in California. Auditors discovered a variety of problems with the other 38 enrollees.

During the audit period, 12 enrollees in the sample group had incomes above 138% of the federal poverty level, making them ineligible financially for public assistance, according to the report.

In other instances, beneficiaries were already enrolled in Medicare, the federal health insurance for people 65 and older or who have severe disabilities, and did not qualify for Medi-Cal. One woman indicated she didn’t want Medi-Cal but was enrolled anyway.

In 2014, the state struggled to clear a massive backlog of Medi-Cal applications, which reached about 900,000 at one point. Many people complained about being mistakenly rejected for coverage or that their applications were lost in the state or county computer systems.

California was one of 31 states to expand Medicaid under the 2010 Affordable Care Act. The health law established a higher federal reimbursement for these newly eligible patients, primarily low-income adults without children. After expansion started in 2014, the HHS inspector general’s office began reviewing whether states were determining eligibility correctly and spending taxpayer dollars appropriately.

In a similar audit released in January, the inspector general estimated that New York spent $26.2 million in federal Medicaid money on 47,271 expansion enrollees who were ineligible for coverage. (The sample size there was 130 enrollees.) Overall, New York had far fewer expansion enrollees and related spending, compared with California.

Audits of other states’ records are planned

“It is inevitable that in a big rollout of new eligibility for any public program there are going to be glitches in implementation,” said Kathy Hempstead, a health-policy expert and senior adviser at the Robert Wood Johnson Foundation. “The inspector general wants to make sure that states are being sufficiently careful.”

Nationwide, Medicaid, the state-federal health insurance program designed for the poor, is the country’s largest health insurance program, covering 74 million Americans. In the past year, Republican efforts to reduce Medicaid funding and enrollment have sparked intense political debates and loud protests over the size and scope of the public program.

The federal government footed the entire cost of Medicaid expansion during the first three years, instead of taking the usual approach of splitting the costs with states. Now, states are picking up more of the bill. Their share of the costs will grow to 10 percent by 2020.

The California audit didn’t request a specific repayment from the state, but the findings were sent to the Centers for Medicare & Medicaid Services for review. CMS officials didn’t return a request for comment.

Donald White, a spokesman for the inspector general’s office, said the agency stood by the report’s findings and declined to comment further.

This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

California signed up an estimated 450,000 people under Medicaid expansion who may not have been eligible for coverage, according to a report by the Health & Human Services’ chief watchdog.

In a Feb. 21 report, the HHS’s inspector general estimated that California spent $738.2 million on 366,078 expansion beneficiaries who were ineligible. It spent an additional $416.5 million for 79,055 expansion enrollees who were “potentially” ineligible, auditors found.

Auditors said nearly 90% of the $1.15 billion in questionable payments involved federal money, while the rest came from the state’s Medicaid program, known as Medi-Cal. They examined a 6-month period from Oct. 1, 2014, to March 31, 2015, when Medicaid payments of $6.2 billion were made related to 1.9 million newly eligible enrollees.

There were limitations to the California review, however. The audit extrapolated from a sample of 150 beneficiaries. The authors reported a 90% confidence level in their results – whereas 95% would be more common. That meant that the number of those ineligible could have been as low as 260,000 or as high as 630,000.

“If HHS has a strong reason to believe that California is systematically making enrollment errors, it would be helpful to show that in a more robust analysis,” said Ben Ippolito, a health care economist at the American Enterprise Institute, a conservative think tank. “The federal government should ensure that states are being good stewards of federal money.”

Nonetheless, the audit highlighted weaknesses in California’s Medicaid program, the largest in the nation with 13.4 million enrollees and an annual budget topping $100 billion, counting federal and state money. Medicaid covers one in three Californians.

The inspector general found deficiencies in the state’s computer system for verifying eligibility and discovered errors by caseworkers. The Medicaid payments cited in the report covered people in the state’s fee-for-service system, managed-care plans, drug treatment programs, and those receiving mental health services.

California’s Department of Health Care Services, which runs Medi-Cal, said in a statement that it agreed with nearly all of the auditors’ recommendations and that the agency “has taken steps to address all of the findings.”

In a written response to the inspector general, California officials said several computer upgrades were made after the audit period and before publication of the report that should improve the accuracy of eligibility decisions.

Among the 150 expansion enrollees analyzed in detail, 75%, or 112, were deemed eligible for the Medicaid program in California. Auditors discovered a variety of problems with the other 38 enrollees.

During the audit period, 12 enrollees in the sample group had incomes above 138% of the federal poverty level, making them ineligible financially for public assistance, according to the report.

In other instances, beneficiaries were already enrolled in Medicare, the federal health insurance for people 65 and older or who have severe disabilities, and did not qualify for Medi-Cal. One woman indicated she didn’t want Medi-Cal but was enrolled anyway.

In 2014, the state struggled to clear a massive backlog of Medi-Cal applications, which reached about 900,000 at one point. Many people complained about being mistakenly rejected for coverage or that their applications were lost in the state or county computer systems.

California was one of 31 states to expand Medicaid under the 2010 Affordable Care Act. The health law established a higher federal reimbursement for these newly eligible patients, primarily low-income adults without children. After expansion started in 2014, the HHS inspector general’s office began reviewing whether states were determining eligibility correctly and spending taxpayer dollars appropriately.

In a similar audit released in January, the inspector general estimated that New York spent $26.2 million in federal Medicaid money on 47,271 expansion enrollees who were ineligible for coverage. (The sample size there was 130 enrollees.) Overall, New York had far fewer expansion enrollees and related spending, compared with California.

Audits of other states’ records are planned

“It is inevitable that in a big rollout of new eligibility for any public program there are going to be glitches in implementation,” said Kathy Hempstead, a health-policy expert and senior adviser at the Robert Wood Johnson Foundation. “The inspector general wants to make sure that states are being sufficiently careful.”

Nationwide, Medicaid, the state-federal health insurance program designed for the poor, is the country’s largest health insurance program, covering 74 million Americans. In the past year, Republican efforts to reduce Medicaid funding and enrollment have sparked intense political debates and loud protests over the size and scope of the public program.

The federal government footed the entire cost of Medicaid expansion during the first three years, instead of taking the usual approach of splitting the costs with states. Now, states are picking up more of the bill. Their share of the costs will grow to 10 percent by 2020.

The California audit didn’t request a specific repayment from the state, but the findings were sent to the Centers for Medicare & Medicaid Services for review. CMS officials didn’t return a request for comment.

Donald White, a spokesman for the inspector general’s office, said the agency stood by the report’s findings and declined to comment further.

This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

California signed up an estimated 450,000 people under Medicaid expansion who may not have been eligible for coverage, according to a report by the Health & Human Services’ chief watchdog.

In a Feb. 21 report, the HHS’s inspector general estimated that California spent $738.2 million on 366,078 expansion beneficiaries who were ineligible. It spent an additional $416.5 million for 79,055 expansion enrollees who were “potentially” ineligible, auditors found.

Auditors said nearly 90% of the $1.15 billion in questionable payments involved federal money, while the rest came from the state’s Medicaid program, known as Medi-Cal. They examined a 6-month period from Oct. 1, 2014, to March 31, 2015, when Medicaid payments of $6.2 billion were made related to 1.9 million newly eligible enrollees.

There were limitations to the California review, however. The audit extrapolated from a sample of 150 beneficiaries. The authors reported a 90% confidence level in their results – whereas 95% would be more common. That meant that the number of those ineligible could have been as low as 260,000 or as high as 630,000.

“If HHS has a strong reason to believe that California is systematically making enrollment errors, it would be helpful to show that in a more robust analysis,” said Ben Ippolito, a health care economist at the American Enterprise Institute, a conservative think tank. “The federal government should ensure that states are being good stewards of federal money.”

Nonetheless, the audit highlighted weaknesses in California’s Medicaid program, the largest in the nation with 13.4 million enrollees and an annual budget topping $100 billion, counting federal and state money. Medicaid covers one in three Californians.

The inspector general found deficiencies in the state’s computer system for verifying eligibility and discovered errors by caseworkers. The Medicaid payments cited in the report covered people in the state’s fee-for-service system, managed-care plans, drug treatment programs, and those receiving mental health services.

California’s Department of Health Care Services, which runs Medi-Cal, said in a statement that it agreed with nearly all of the auditors’ recommendations and that the agency “has taken steps to address all of the findings.”

In a written response to the inspector general, California officials said several computer upgrades were made after the audit period and before publication of the report that should improve the accuracy of eligibility decisions.

Among the 150 expansion enrollees analyzed in detail, 75%, or 112, were deemed eligible for the Medicaid program in California. Auditors discovered a variety of problems with the other 38 enrollees.

During the audit period, 12 enrollees in the sample group had incomes above 138% of the federal poverty level, making them ineligible financially for public assistance, according to the report.

In other instances, beneficiaries were already enrolled in Medicare, the federal health insurance for people 65 and older or who have severe disabilities, and did not qualify for Medi-Cal. One woman indicated she didn’t want Medi-Cal but was enrolled anyway.

In 2014, the state struggled to clear a massive backlog of Medi-Cal applications, which reached about 900,000 at one point. Many people complained about being mistakenly rejected for coverage or that their applications were lost in the state or county computer systems.

California was one of 31 states to expand Medicaid under the 2010 Affordable Care Act. The health law established a higher federal reimbursement for these newly eligible patients, primarily low-income adults without children. After expansion started in 2014, the HHS inspector general’s office began reviewing whether states were determining eligibility correctly and spending taxpayer dollars appropriately.

In a similar audit released in January, the inspector general estimated that New York spent $26.2 million in federal Medicaid money on 47,271 expansion enrollees who were ineligible for coverage. (The sample size there was 130 enrollees.) Overall, New York had far fewer expansion enrollees and related spending, compared with California.

Audits of other states’ records are planned

“It is inevitable that in a big rollout of new eligibility for any public program there are going to be glitches in implementation,” said Kathy Hempstead, a health-policy expert and senior adviser at the Robert Wood Johnson Foundation. “The inspector general wants to make sure that states are being sufficiently careful.”

Nationwide, Medicaid, the state-federal health insurance program designed for the poor, is the country’s largest health insurance program, covering 74 million Americans. In the past year, Republican efforts to reduce Medicaid funding and enrollment have sparked intense political debates and loud protests over the size and scope of the public program.

The federal government footed the entire cost of Medicaid expansion during the first three years, instead of taking the usual approach of splitting the costs with states. Now, states are picking up more of the bill. Their share of the costs will grow to 10 percent by 2020.

The California audit didn’t request a specific repayment from the state, but the findings were sent to the Centers for Medicare & Medicaid Services for review. CMS officials didn’t return a request for comment.

Donald White, a spokesman for the inspector general’s office, said the agency stood by the report’s findings and declined to comment further.

This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Annette Katz didn’t expect to be part of a major social movement. She didn’t set out to take on a major health organization. But that all began to change when a coworker saw her fighting back tears and joined Katz to report to her union what amounted to a criminal sexual offense at a Cleveland Veterans Affairs Medical Center in 2012 and 2013.

Four years later, Katz, a licensed practical nurse at the hospital, testified in a court deposition that a male nursing assistant had shoved her into a linen closet and groped her and subjected her to an onslaught of lewd comments.

In speaking out and taking legal action, Katz joined a growing group of women who are combating sexual harassment in the medical field at every level, from patients’ bedsides to the executive boardroom.

Much as the #MeToo moment has raised awareness of sexual harassment in business, politics, media, and Hollywood, it is prompting women in medicine to take on a health system where workers have traditionally been discouraged from making waves and where hierarchies are ever-present and all-commanding. While the health care field overall has far more women than men, in many stations of power the top of the pyramid is overwhelmingly male, with women occupying the vast base.

In a recent survey, 30% of women on medical faculties reported experiencing sexual harassment at work within the past 2 years, said Reshma Jagsi, MD, who conducted the poll. That share is comparable to results in other sectors and, as elsewhere, in medicine it had been mostly taboo to discuss before last year.

“We know harassment is more common in fields where there are strong power differentials,” said Dr. Jagsi, director of the Center for Bioethics and Social Sciences in Medicine at the University of Michigan, Ann Arbor. “And we know medicine is very hierarchical.”

Workers in the health care and social assistance field reported 4,738 cases of sexual harassment from fiscal 2005 through 2015, eclipsed only by fields such as hospitality and manufacturing, where men make up a greater proportion of the workforce, according to data gathered by the Equal Employment Opportunity Commission.

A Kaiser Health News review of dozens of legal cases across the U.S. shows similar patterns in the waves of harassment cases that have cropped up in other fields, from entertainment to sports to journalism: The harassers are typically male. The alleged harasser supervises or outranks the alleged victim. There are slaps on the butt, lewd comments, and requests for sex. When superiors are confronted with reports of bad behavior, the victims, mostly women, are disbelieved, demoted, or fired.

But recently, physicians have taken to Twitter using the #MeTooMedicine tag, sharing anecdotes and linking to blogs that chronicle powerful doctors harassing them or disrobing at professional conferences.

Women who work in cardiology recently told the cardiology trade publication TCTMD that they felt the problem was particularly widespread in their specialty, where females account for 14% of the physicians. A Los Angeles anesthesiologist made waves in a blog post urging “prettier” women to adopt a “professional-looking, even severe, hair style” to be taken seriously and to consider self-defense classes.

Among those speaking out is Jennifer Gunter, MD, a San Francisco obstetrician-gynecologist, who recently wrote a blog post about being groped in 2014 by a prominent colleague at a medical conference – even naming him.

“I think nothing will change unless people are able to name people and institutions are held accountable,” she said in an interview. “I don’t think without massive public discourse and exposure that things will change.”

Lawsuits, many settled or still making their way through the courts, describe encounters.

A Florida nurse claimed that in 2014, a surgeon made lewd comments about her breasts, asking her in a room full of people if he should “refer to her as ‘JJ’ or ‘Jugs,’ ” the nurse’s lawsuit says. The nurse said she “responded that she wished to be called by her name.”

In other cases: A phlebotomist in New York alleged in a lawsuit that a doctor in her medical practice gave her a box of Valentine’s Day candy and moved in for an unwanted kiss on the mouth. A Florida medical resident alleged that a supervising doctor told her she looked like a “slutty whore.” A Nebraska nurse claimed that a doctor she traveled with to a professional conference offered to buy her a bikini, if he could see her in it, and an extra night in a hotel, if they could share the room. She declined.

A Pennsylvania nurse described the unsatisfying response she got after reporting that a colleague had pressed his pelvis against her and flipped through her phone for “naked pictures.” A supervisor to whom she reported the conduct expressed exasperation, saying “I can’t deal with this” and “What do you want?”

Kayla Behbahani, DO, chief psychiatry resident at University of Massachusetts Memorial Medical Center, did not file a lawsuit but recently wrote about sexual harassment by a subordinate. In an interview, she said her instincts were to pity the man, and also to follow a dictate that’s drilled into medical students: Don’t make waves. So, she disclosed the harassment only after another woman’s complaint launched an investigation.

“As a professional, I come from a culture where you go with the flow,” Dr. Behbahani said. “You deal with what you’re dealt. In that regard, it was a dilemma for me.”

Annette Katz, the Veterans Affairs nurse, initially didn’t complain about the harassment. A single mother with two children, she needed her job. Her attacker, MD Garrett, was also a nursing assistant but had more seniority, was a veteran, and was friends with her boss.

“I really did feel that I would lose my job,” Ms. Katz said in an interview. “I would be that troublemaker.”

But as the abuse escalated, she went to the VA inspector general and the Cleveland police.

She estimated that five times Mr. Garrett pushed her into a closet where he would ask for sex. She would “tell him ‘no’ and fight my way out of [his] grip,” her statement said. He shoved her into an unconscious patient’s bathroom and would “try to restrain me, but I eventually could break free.”

After one such assault, a colleague noticed tears in Ms. Katz’s eyes. The coworker shared with Ms. Katz that she, too, had been a target of Mr. Garrett’s lewd behavior.

Ms. Katz and the colleague filed complaints in March 2013 with their union, the police, and with their managers. That July, Mr. Garrett was indicted by a grand jury and later pleaded guilty to three counts of sexual imposition and one count of unlawful restraint. He was also dismissed from his job.

Reached by phone, Mr. Garrett said he agreed to the plea because he was facing multiple felonies and didn’t know what a jury would do. He said that even though he pleaded guilty to four misdemeanors, he did not commit the crimes of which he was accused. “There was no harassment; she and I were friends,” he said.

In 2013, Ms. Katz sued the VA, alleging that it failed to protect her from harassment and retaliated against her by refusing to give her a job-site transfer before firing her for not showing up to work.

The VA attorneys argued that the department had no direct knowledge of harassing behavior before Ms. Katz reported it, and that once it was informed, immediate action was taken. Veterans Affairs Deputy Press Secretary Lydia Blaha said in an email that anyone engaged in sexual harassment is swiftly held accountable.

The U.S. Department of Veterans Affairs agreed in February to pay $161,500 to settle Ms. Katz’s lawsuit.

Ms. Katz said it was costly and emotional to press on with her legal case but hopes it helps other women see that seeking justice is worthwhile. “I do think there are a lot of women who just suffer in silence,” she said.

Dr. Gunter, the San Francisco physician-blogger, said that needed change will come only when people who are more established across all professions stand up for those who are more junior. “Speaking quietly, going to HR – if that worked, we wouldn’t be here,” she said.

It’s ironic, she said, that as a gynecologist she’s trained to believe patients’ claims about sexual assault. In the workplace, though, it’s well known that raising such matters can backfire. She added: “Physicians should be setting a standard on this.”

KHN’s coverage of these topics is supported by the John A. Hartford Foundation and The David and Lucile Packard Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Annette Katz didn’t expect to be part of a major social movement. She didn’t set out to take on a major health organization. But that all began to change when a coworker saw her fighting back tears and joined Katz to report to her union what amounted to a criminal sexual offense at a Cleveland Veterans Affairs Medical Center in 2012 and 2013.

Four years later, Katz, a licensed practical nurse at the hospital, testified in a court deposition that a male nursing assistant had shoved her into a linen closet and groped her and subjected her to an onslaught of lewd comments.

In speaking out and taking legal action, Katz joined a growing group of women who are combating sexual harassment in the medical field at every level, from patients’ bedsides to the executive boardroom.

Much as the #MeToo moment has raised awareness of sexual harassment in business, politics, media, and Hollywood, it is prompting women in medicine to take on a health system where workers have traditionally been discouraged from making waves and where hierarchies are ever-present and all-commanding. While the health care field overall has far more women than men, in many stations of power the top of the pyramid is overwhelmingly male, with women occupying the vast base.

In a recent survey, 30% of women on medical faculties reported experiencing sexual harassment at work within the past 2 years, said Reshma Jagsi, MD, who conducted the poll. That share is comparable to results in other sectors and, as elsewhere, in medicine it had been mostly taboo to discuss before last year.

“We know harassment is more common in fields where there are strong power differentials,” said Dr. Jagsi, director of the Center for Bioethics and Social Sciences in Medicine at the University of Michigan, Ann Arbor. “And we know medicine is very hierarchical.”

Workers in the health care and social assistance field reported 4,738 cases of sexual harassment from fiscal 2005 through 2015, eclipsed only by fields such as hospitality and manufacturing, where men make up a greater proportion of the workforce, according to data gathered by the Equal Employment Opportunity Commission.

A Kaiser Health News review of dozens of legal cases across the U.S. shows similar patterns in the waves of harassment cases that have cropped up in other fields, from entertainment to sports to journalism: The harassers are typically male. The alleged harasser supervises or outranks the alleged victim. There are slaps on the butt, lewd comments, and requests for sex. When superiors are confronted with reports of bad behavior, the victims, mostly women, are disbelieved, demoted, or fired.

But recently, physicians have taken to Twitter using the #MeTooMedicine tag, sharing anecdotes and linking to blogs that chronicle powerful doctors harassing them or disrobing at professional conferences.

Women who work in cardiology recently told the cardiology trade publication TCTMD that they felt the problem was particularly widespread in their specialty, where females account for 14% of the physicians. A Los Angeles anesthesiologist made waves in a blog post urging “prettier” women to adopt a “professional-looking, even severe, hair style” to be taken seriously and to consider self-defense classes.

Among those speaking out is Jennifer Gunter, MD, a San Francisco obstetrician-gynecologist, who recently wrote a blog post about being groped in 2014 by a prominent colleague at a medical conference – even naming him.

“I think nothing will change unless people are able to name people and institutions are held accountable,” she said in an interview. “I don’t think without massive public discourse and exposure that things will change.”

Lawsuits, many settled or still making their way through the courts, describe encounters.

A Florida nurse claimed that in 2014, a surgeon made lewd comments about her breasts, asking her in a room full of people if he should “refer to her as ‘JJ’ or ‘Jugs,’ ” the nurse’s lawsuit says. The nurse said she “responded that she wished to be called by her name.”

In other cases: A phlebotomist in New York alleged in a lawsuit that a doctor in her medical practice gave her a box of Valentine’s Day candy and moved in for an unwanted kiss on the mouth. A Florida medical resident alleged that a supervising doctor told her she looked like a “slutty whore.” A Nebraska nurse claimed that a doctor she traveled with to a professional conference offered to buy her a bikini, if he could see her in it, and an extra night in a hotel, if they could share the room. She declined.

A Pennsylvania nurse described the unsatisfying response she got after reporting that a colleague had pressed his pelvis against her and flipped through her phone for “naked pictures.” A supervisor to whom she reported the conduct expressed exasperation, saying “I can’t deal with this” and “What do you want?”

Kayla Behbahani, DO, chief psychiatry resident at University of Massachusetts Memorial Medical Center, did not file a lawsuit but recently wrote about sexual harassment by a subordinate. In an interview, she said her instincts were to pity the man, and also to follow a dictate that’s drilled into medical students: Don’t make waves. So, she disclosed the harassment only after another woman’s complaint launched an investigation.

“As a professional, I come from a culture where you go with the flow,” Dr. Behbahani said. “You deal with what you’re dealt. In that regard, it was a dilemma for me.”

Annette Katz, the Veterans Affairs nurse, initially didn’t complain about the harassment. A single mother with two children, she needed her job. Her attacker, MD Garrett, was also a nursing assistant but had more seniority, was a veteran, and was friends with her boss.

“I really did feel that I would lose my job,” Ms. Katz said in an interview. “I would be that troublemaker.”

But as the abuse escalated, she went to the VA inspector general and the Cleveland police.

She estimated that five times Mr. Garrett pushed her into a closet where he would ask for sex. She would “tell him ‘no’ and fight my way out of [his] grip,” her statement said. He shoved her into an unconscious patient’s bathroom and would “try to restrain me, but I eventually could break free.”

After one such assault, a colleague noticed tears in Ms. Katz’s eyes. The coworker shared with Ms. Katz that she, too, had been a target of Mr. Garrett’s lewd behavior.

Ms. Katz and the colleague filed complaints in March 2013 with their union, the police, and with their managers. That July, Mr. Garrett was indicted by a grand jury and later pleaded guilty to three counts of sexual imposition and one count of unlawful restraint. He was also dismissed from his job.

Reached by phone, Mr. Garrett said he agreed to the plea because he was facing multiple felonies and didn’t know what a jury would do. He said that even though he pleaded guilty to four misdemeanors, he did not commit the crimes of which he was accused. “There was no harassment; she and I were friends,” he said.

In 2013, Ms. Katz sued the VA, alleging that it failed to protect her from harassment and retaliated against her by refusing to give her a job-site transfer before firing her for not showing up to work.

The VA attorneys argued that the department had no direct knowledge of harassing behavior before Ms. Katz reported it, and that once it was informed, immediate action was taken. Veterans Affairs Deputy Press Secretary Lydia Blaha said in an email that anyone engaged in sexual harassment is swiftly held accountable.

The U.S. Department of Veterans Affairs agreed in February to pay $161,500 to settle Ms. Katz’s lawsuit.

Ms. Katz said it was costly and emotional to press on with her legal case but hopes it helps other women see that seeking justice is worthwhile. “I do think there are a lot of women who just suffer in silence,” she said.

Dr. Gunter, the San Francisco physician-blogger, said that needed change will come only when people who are more established across all professions stand up for those who are more junior. “Speaking quietly, going to HR – if that worked, we wouldn’t be here,” she said.

It’s ironic, she said, that as a gynecologist she’s trained to believe patients’ claims about sexual assault. In the workplace, though, it’s well known that raising such matters can backfire. She added: “Physicians should be setting a standard on this.”

KHN’s coverage of these topics is supported by the John A. Hartford Foundation and The David and Lucile Packard Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Annette Katz didn’t expect to be part of a major social movement. She didn’t set out to take on a major health organization. But that all began to change when a coworker saw her fighting back tears and joined Katz to report to her union what amounted to a criminal sexual offense at a Cleveland Veterans Affairs Medical Center in 2012 and 2013.

Four years later, Katz, a licensed practical nurse at the hospital, testified in a court deposition that a male nursing assistant had shoved her into a linen closet and groped her and subjected her to an onslaught of lewd comments.

In speaking out and taking legal action, Katz joined a growing group of women who are combating sexual harassment in the medical field at every level, from patients’ bedsides to the executive boardroom.

Much as the #MeToo moment has raised awareness of sexual harassment in business, politics, media, and Hollywood, it is prompting women in medicine to take on a health system where workers have traditionally been discouraged from making waves and where hierarchies are ever-present and all-commanding. While the health care field overall has far more women than men, in many stations of power the top of the pyramid is overwhelmingly male, with women occupying the vast base.

In a recent survey, 30% of women on medical faculties reported experiencing sexual harassment at work within the past 2 years, said Reshma Jagsi, MD, who conducted the poll. That share is comparable to results in other sectors and, as elsewhere, in medicine it had been mostly taboo to discuss before last year.

“We know harassment is more common in fields where there are strong power differentials,” said Dr. Jagsi, director of the Center for Bioethics and Social Sciences in Medicine at the University of Michigan, Ann Arbor. “And we know medicine is very hierarchical.”

Workers in the health care and social assistance field reported 4,738 cases of sexual harassment from fiscal 2005 through 2015, eclipsed only by fields such as hospitality and manufacturing, where men make up a greater proportion of the workforce, according to data gathered by the Equal Employment Opportunity Commission.

A Kaiser Health News review of dozens of legal cases across the U.S. shows similar patterns in the waves of harassment cases that have cropped up in other fields, from entertainment to sports to journalism: The harassers are typically male. The alleged harasser supervises or outranks the alleged victim. There are slaps on the butt, lewd comments, and requests for sex. When superiors are confronted with reports of bad behavior, the victims, mostly women, are disbelieved, demoted, or fired.

But recently, physicians have taken to Twitter using the #MeTooMedicine tag, sharing anecdotes and linking to blogs that chronicle powerful doctors harassing them or disrobing at professional conferences.

Women who work in cardiology recently told the cardiology trade publication TCTMD that they felt the problem was particularly widespread in their specialty, where females account for 14% of the physicians. A Los Angeles anesthesiologist made waves in a blog post urging “prettier” women to adopt a “professional-looking, even severe, hair style” to be taken seriously and to consider self-defense classes.

Among those speaking out is Jennifer Gunter, MD, a San Francisco obstetrician-gynecologist, who recently wrote a blog post about being groped in 2014 by a prominent colleague at a medical conference – even naming him.

“I think nothing will change unless people are able to name people and institutions are held accountable,” she said in an interview. “I don’t think without massive public discourse and exposure that things will change.”

Lawsuits, many settled or still making their way through the courts, describe encounters.

A Florida nurse claimed that in 2014, a surgeon made lewd comments about her breasts, asking her in a room full of people if he should “refer to her as ‘JJ’ or ‘Jugs,’ ” the nurse’s lawsuit says. The nurse said she “responded that she wished to be called by her name.”

In other cases: A phlebotomist in New York alleged in a lawsuit that a doctor in her medical practice gave her a box of Valentine’s Day candy and moved in for an unwanted kiss on the mouth. A Florida medical resident alleged that a supervising doctor told her she looked like a “slutty whore.” A Nebraska nurse claimed that a doctor she traveled with to a professional conference offered to buy her a bikini, if he could see her in it, and an extra night in a hotel, if they could share the room. She declined.

A Pennsylvania nurse described the unsatisfying response she got after reporting that a colleague had pressed his pelvis against her and flipped through her phone for “naked pictures.” A supervisor to whom she reported the conduct expressed exasperation, saying “I can’t deal with this” and “What do you want?”

Kayla Behbahani, DO, chief psychiatry resident at University of Massachusetts Memorial Medical Center, did not file a lawsuit but recently wrote about sexual harassment by a subordinate. In an interview, she said her instincts were to pity the man, and also to follow a dictate that’s drilled into medical students: Don’t make waves. So, she disclosed the harassment only after another woman’s complaint launched an investigation.

“As a professional, I come from a culture where you go with the flow,” Dr. Behbahani said. “You deal with what you’re dealt. In that regard, it was a dilemma for me.”

Annette Katz, the Veterans Affairs nurse, initially didn’t complain about the harassment. A single mother with two children, she needed her job. Her attacker, MD Garrett, was also a nursing assistant but had more seniority, was a veteran, and was friends with her boss.

“I really did feel that I would lose my job,” Ms. Katz said in an interview. “I would be that troublemaker.”

But as the abuse escalated, she went to the VA inspector general and the Cleveland police.

She estimated that five times Mr. Garrett pushed her into a closet where he would ask for sex. She would “tell him ‘no’ and fight my way out of [his] grip,” her statement said. He shoved her into an unconscious patient’s bathroom and would “try to restrain me, but I eventually could break free.”

After one such assault, a colleague noticed tears in Ms. Katz’s eyes. The coworker shared with Ms. Katz that she, too, had been a target of Mr. Garrett’s lewd behavior.

Ms. Katz and the colleague filed complaints in March 2013 with their union, the police, and with their managers. That July, Mr. Garrett was indicted by a grand jury and later pleaded guilty to three counts of sexual imposition and one count of unlawful restraint. He was also dismissed from his job.

Reached by phone, Mr. Garrett said he agreed to the plea because he was facing multiple felonies and didn’t know what a jury would do. He said that even though he pleaded guilty to four misdemeanors, he did not commit the crimes of which he was accused. “There was no harassment; she and I were friends,” he said.

In 2013, Ms. Katz sued the VA, alleging that it failed to protect her from harassment and retaliated against her by refusing to give her a job-site transfer before firing her for not showing up to work.

The VA attorneys argued that the department had no direct knowledge of harassing behavior before Ms. Katz reported it, and that once it was informed, immediate action was taken. Veterans Affairs Deputy Press Secretary Lydia Blaha said in an email that anyone engaged in sexual harassment is swiftly held accountable.

The U.S. Department of Veterans Affairs agreed in February to pay $161,500 to settle Ms. Katz’s lawsuit.

Ms. Katz said it was costly and emotional to press on with her legal case but hopes it helps other women see that seeking justice is worthwhile. “I do think there are a lot of women who just suffer in silence,” she said.

Dr. Gunter, the San Francisco physician-blogger, said that needed change will come only when people who are more established across all professions stand up for those who are more junior. “Speaking quietly, going to HR – if that worked, we wouldn’t be here,” she said.

It’s ironic, she said, that as a gynecologist she’s trained to believe patients’ claims about sexual assault. In the workplace, though, it’s well known that raising such matters can backfire. She added: “Physicians should be setting a standard on this.”

KHN’s coverage of these topics is supported by the John A. Hartford Foundation and The David and Lucile Packard Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The nation’s opioid epidemic has been called today’s version of the 1980s AIDS crisis.

In a New Hampshire speech on March 19, President Donald Trump pushed for a tougher federal response, emphasizing a tough-on-crime approach for drug dealers and more funding for treatment. And Congress is upping the ante, via a series of hearings – including one scheduled to last March 21-22 – to study legislation that might tackle the unyielding scourge, which has cost an estimated $1 trillion in premature deaths, health care costs, and lost wages since 2001.

Dr. Leana Wen, an emergency physician by training and the health commissioner for hard-hit Baltimore, said Capitol Hill has to help communities at risk of becoming overwhelmed.

“We haven’t seen the peak of the epidemic. We are seeing the numbers climb year after year,” she said.

Provisional data from the Centers for Disease Control and Prevention suggest that almost 45,000 Americans died from opioid overdoses in the 12-month period ending July 2017, up from about 38,000 in the previous cycle. (Those data are likely to change, since many death certificates have not yet been reported to the CDC.)

“It’s not going to get any better unless we take dramatic action,” Dr. Wen said.

And the time for most meaningful change could be dwindling. Advocates say what they need most is money, which would most likely come through the government spending bill that’s due March 23. But they aren’t holding their breath.

Show me the money

The federal budget deal, which was signed into law in early February, promised $6 billion over 2 years for initiatives to fight opioid abuse. Congress is still figuring out how to divvy up those funds. The blueprint is expected to be included in the spending bill this week.

In February, a bipartisan group of senators introduced a bill that would add another $1 billion in funding to support expanded treatment and also limit clinicians to prescribing no more than 3 days’ worth of opioids at a time.

That legislation is likely to have wide support in the Senate, but its path through the House is less certain.

This cash infusion is still not going to be enough, predicted Daniel Raymond, policy director for the Harm Reduction Coalition, a national organization that works on overdose prevention.

“It’s not clear whether there’s a real appetite to go as far as we need to see Congress go,” he said. “To have a fighting chance, we need a long-term commitment of at least $10 billion per year.” Academic experts said that assessment sounded on target.

The figure is more than 3 times what’s allocated in the budget and 10 times what even the new Senate bill would provide, and far beyond the spending levels put forth by any previous packages to fight the opioid epidemic.

The difficulty in getting funding – and a key reason why the bipartisan Senate bill might stall in the House – in part goes to the heart of Republicans’ philosophy about budgeting.

The GOP, which controls both chambers of Congress, has “always been very focused on pay-fors,” said a Republican aide to the House Energy and Commerce Committee, explaining that new funding is generally expected to be accompanied by cuts in current expenditures so that overall government spending doesn’t rise. And that could limit how much money lawmakers are ultimately willing to commit to fight opioid abuse.

Some observers worry this notion is pound-foolish.

“We have an enormous set of costs ahead of us if we don’t invest now,” said Dr. Traci Green, an associate professor of emergency medicine and community health science at Boston University, who has extensively researched the epidemic.

Ahead in Congress

Meanwhile, the House could take up its version of a separate Senate-passed proposal designed to, in certain cases, make more prominent any opioid history in a patient’s medical record. The idea is to prevent doctors from prescribing opioids to at-risk patients.

In addition, the House’s Energy and Commerce Committee in late February held a hearing focused on “enforcement” – discussing, for instance, giving the federal Drug Enforcement Administration more power in drug trafficking, and whether to treat fentanyl, a particularly potent synthetic opioid, as a controlled substance. The hearings March 21-22 will tackle a slew of public health–oriented bills, such as making sure overdose patients in the emergency room get appropriate medication and treatment upon discharge, or expanding access to buprenorphine, which is used to treat addiction.

And the House Ways and Means Committee, which has jurisdiction over Medicare – the federal insurance plan for seniors and disabled people – is working to develop strategies that limit access to opioids and make treatment more available.

These are some promising ideas, Mr. Raymond said, but it’s still “playing catch-up. … The big gap is the money, and the broader vision.”

This flurry of activity comes after Congress in 2016 passed two laws directly dealing with addiction and substance abuse disorders, the Comprehensive Addiction and Recovery Act and the 21st Century Cures Act. CARA promised $181 million – although it didn’t appropriate those dollars – while the Cures Act provided $1 billion over 2 years.

It’s playing out against the backdrop of steady policy tensions.

The Trump administration, which in October declared the opioid epidemic a public health crisis, has repeatedly pushed a more punitive approach, such as harsher sentences for drug trafficking, including the death penalty, and establishing mandatory minimum sentences. That emphasis, experts said, detracts from other parts of the plan that might highlight, say, addiction treatment.

Instead, those experts emphasized treatment and prevention as well as “harm reduction” ideas such as providing more overdose-antidote medication and funding programs like syringe exchanges.

They say focusing on punishment has been ineffective in the past and neglects the heart of the issue.

Certainly, curbing the flow of illegal drugs is important, Dr. Wen said. But it’s insufficient by itself. And the size of the problem means lawmakers need to provide quicker, more direct aid – not just proposals that tinker “around the edges.”

“We would never refuse any funding, because we need it desperately,” she said. “But ask us what we need.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The nation’s opioid epidemic has been called today’s version of the 1980s AIDS crisis.

In a New Hampshire speech on March 19, President Donald Trump pushed for a tougher federal response, emphasizing a tough-on-crime approach for drug dealers and more funding for treatment. And Congress is upping the ante, via a series of hearings – including one scheduled to last March 21-22 – to study legislation that might tackle the unyielding scourge, which has cost an estimated $1 trillion in premature deaths, health care costs, and lost wages since 2001.

Dr. Leana Wen, an emergency physician by training and the health commissioner for hard-hit Baltimore, said Capitol Hill has to help communities at risk of becoming overwhelmed.

“We haven’t seen the peak of the epidemic. We are seeing the numbers climb year after year,” she said.

Provisional data from the Centers for Disease Control and Prevention suggest that almost 45,000 Americans died from opioid overdoses in the 12-month period ending July 2017, up from about 38,000 in the previous cycle. (Those data are likely to change, since many death certificates have not yet been reported to the CDC.)

“It’s not going to get any better unless we take dramatic action,” Dr. Wen said.

And the time for most meaningful change could be dwindling. Advocates say what they need most is money, which would most likely come through the government spending bill that’s due March 23. But they aren’t holding their breath.

Show me the money

The federal budget deal, which was signed into law in early February, promised $6 billion over 2 years for initiatives to fight opioid abuse. Congress is still figuring out how to divvy up those funds. The blueprint is expected to be included in the spending bill this week.

In February, a bipartisan group of senators introduced a bill that would add another $1 billion in funding to support expanded treatment and also limit clinicians to prescribing no more than 3 days’ worth of opioids at a time.

That legislation is likely to have wide support in the Senate, but its path through the House is less certain.

This cash infusion is still not going to be enough, predicted Daniel Raymond, policy director for the Harm Reduction Coalition, a national organization that works on overdose prevention.

“It’s not clear whether there’s a real appetite to go as far as we need to see Congress go,” he said. “To have a fighting chance, we need a long-term commitment of at least $10 billion per year.” Academic experts said that assessment sounded on target.

The figure is more than 3 times what’s allocated in the budget and 10 times what even the new Senate bill would provide, and far beyond the spending levels put forth by any previous packages to fight the opioid epidemic.

The difficulty in getting funding – and a key reason why the bipartisan Senate bill might stall in the House – in part goes to the heart of Republicans’ philosophy about budgeting.

The GOP, which controls both chambers of Congress, has “always been very focused on pay-fors,” said a Republican aide to the House Energy and Commerce Committee, explaining that new funding is generally expected to be accompanied by cuts in current expenditures so that overall government spending doesn’t rise. And that could limit how much money lawmakers are ultimately willing to commit to fight opioid abuse.

Some observers worry this notion is pound-foolish.

“We have an enormous set of costs ahead of us if we don’t invest now,” said Dr. Traci Green, an associate professor of emergency medicine and community health science at Boston University, who has extensively researched the epidemic.

Ahead in Congress

Meanwhile, the House could take up its version of a separate Senate-passed proposal designed to, in certain cases, make more prominent any opioid history in a patient’s medical record. The idea is to prevent doctors from prescribing opioids to at-risk patients.

In addition, the House’s Energy and Commerce Committee in late February held a hearing focused on “enforcement” – discussing, for instance, giving the federal Drug Enforcement Administration more power in drug trafficking, and whether to treat fentanyl, a particularly potent synthetic opioid, as a controlled substance. The hearings March 21-22 will tackle a slew of public health–oriented bills, such as making sure overdose patients in the emergency room get appropriate medication and treatment upon discharge, or expanding access to buprenorphine, which is used to treat addiction.

And the House Ways and Means Committee, which has jurisdiction over Medicare – the federal insurance plan for seniors and disabled people – is working to develop strategies that limit access to opioids and make treatment more available.

These are some promising ideas, Mr. Raymond said, but it’s still “playing catch-up. … The big gap is the money, and the broader vision.”

This flurry of activity comes after Congress in 2016 passed two laws directly dealing with addiction and substance abuse disorders, the Comprehensive Addiction and Recovery Act and the 21st Century Cures Act. CARA promised $181 million – although it didn’t appropriate those dollars – while the Cures Act provided $1 billion over 2 years.

It’s playing out against the backdrop of steady policy tensions.

The Trump administration, which in October declared the opioid epidemic a public health crisis, has repeatedly pushed a more punitive approach, such as harsher sentences for drug trafficking, including the death penalty, and establishing mandatory minimum sentences. That emphasis, experts said, detracts from other parts of the plan that might highlight, say, addiction treatment.

Instead, those experts emphasized treatment and prevention as well as “harm reduction” ideas such as providing more overdose-antidote medication and funding programs like syringe exchanges.

They say focusing on punishment has been ineffective in the past and neglects the heart of the issue.

Certainly, curbing the flow of illegal drugs is important, Dr. Wen said. But it’s insufficient by itself. And the size of the problem means lawmakers need to provide quicker, more direct aid – not just proposals that tinker “around the edges.”

“We would never refuse any funding, because we need it desperately,” she said. “But ask us what we need.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The nation’s opioid epidemic has been called today’s version of the 1980s AIDS crisis.

In a New Hampshire speech on March 19, President Donald Trump pushed for a tougher federal response, emphasizing a tough-on-crime approach for drug dealers and more funding for treatment. And Congress is upping the ante, via a series of hearings – including one scheduled to last March 21-22 – to study legislation that might tackle the unyielding scourge, which has cost an estimated $1 trillion in premature deaths, health care costs, and lost wages since 2001.

Dr. Leana Wen, an emergency physician by training and the health commissioner for hard-hit Baltimore, said Capitol Hill has to help communities at risk of becoming overwhelmed.

“We haven’t seen the peak of the epidemic. We are seeing the numbers climb year after year,” she said.

Provisional data from the Centers for Disease Control and Prevention suggest that almost 45,000 Americans died from opioid overdoses in the 12-month period ending July 2017, up from about 38,000 in the previous cycle. (Those data are likely to change, since many death certificates have not yet been reported to the CDC.)

“It’s not going to get any better unless we take dramatic action,” Dr. Wen said.

And the time for most meaningful change could be dwindling. Advocates say what they need most is money, which would most likely come through the government spending bill that’s due March 23. But they aren’t holding their breath.

Show me the money

The federal budget deal, which was signed into law in early February, promised $6 billion over 2 years for initiatives to fight opioid abuse. Congress is still figuring out how to divvy up those funds. The blueprint is expected to be included in the spending bill this week.

In February, a bipartisan group of senators introduced a bill that would add another $1 billion in funding to support expanded treatment and also limit clinicians to prescribing no more than 3 days’ worth of opioids at a time.

That legislation is likely to have wide support in the Senate, but its path through the House is less certain.

This cash infusion is still not going to be enough, predicted Daniel Raymond, policy director for the Harm Reduction Coalition, a national organization that works on overdose prevention.

“It’s not clear whether there’s a real appetite to go as far as we need to see Congress go,” he said. “To have a fighting chance, we need a long-term commitment of at least $10 billion per year.” Academic experts said that assessment sounded on target.

The figure is more than 3 times what’s allocated in the budget and 10 times what even the new Senate bill would provide, and far beyond the spending levels put forth by any previous packages to fight the opioid epidemic.

The difficulty in getting funding – and a key reason why the bipartisan Senate bill might stall in the House – in part goes to the heart of Republicans’ philosophy about budgeting.

The GOP, which controls both chambers of Congress, has “always been very focused on pay-fors,” said a Republican aide to the House Energy and Commerce Committee, explaining that new funding is generally expected to be accompanied by cuts in current expenditures so that overall government spending doesn’t rise. And that could limit how much money lawmakers are ultimately willing to commit to fight opioid abuse.

Some observers worry this notion is pound-foolish.

“We have an enormous set of costs ahead of us if we don’t invest now,” said Dr. Traci Green, an associate professor of emergency medicine and community health science at Boston University, who has extensively researched the epidemic.

Ahead in Congress

Meanwhile, the House could take up its version of a separate Senate-passed proposal designed to, in certain cases, make more prominent any opioid history in a patient’s medical record. The idea is to prevent doctors from prescribing opioids to at-risk patients.

In addition, the House’s Energy and Commerce Committee in late February held a hearing focused on “enforcement” – discussing, for instance, giving the federal Drug Enforcement Administration more power in drug trafficking, and whether to treat fentanyl, a particularly potent synthetic opioid, as a controlled substance. The hearings March 21-22 will tackle a slew of public health–oriented bills, such as making sure overdose patients in the emergency room get appropriate medication and treatment upon discharge, or expanding access to buprenorphine, which is used to treat addiction.

And the House Ways and Means Committee, which has jurisdiction over Medicare – the federal insurance plan for seniors and disabled people – is working to develop strategies that limit access to opioids and make treatment more available.

These are some promising ideas, Mr. Raymond said, but it’s still “playing catch-up. … The big gap is the money, and the broader vision.”

This flurry of activity comes after Congress in 2016 passed two laws directly dealing with addiction and substance abuse disorders, the Comprehensive Addiction and Recovery Act and the 21st Century Cures Act. CARA promised $181 million – although it didn’t appropriate those dollars – while the Cures Act provided $1 billion over 2 years.

It’s playing out against the backdrop of steady policy tensions.

The Trump administration, which in October declared the opioid epidemic a public health crisis, has repeatedly pushed a more punitive approach, such as harsher sentences for drug trafficking, including the death penalty, and establishing mandatory minimum sentences. That emphasis, experts said, detracts from other parts of the plan that might highlight, say, addiction treatment.

Instead, those experts emphasized treatment and prevention as well as “harm reduction” ideas such as providing more overdose-antidote medication and funding programs like syringe exchanges.

They say focusing on punishment has been ineffective in the past and neglects the heart of the issue.

Certainly, curbing the flow of illegal drugs is important, Dr. Wen said. But it’s insufficient by itself. And the size of the problem means lawmakers need to provide quicker, more direct aid – not just proposals that tinker “around the edges.”

“We would never refuse any funding, because we need it desperately,” she said. “But ask us what we need.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The child is well-known in the halls in which state bureaucrats oversee health care for millions of Californians – not by name, but by a number: $21 million.

His medications alone cost state taxpayers that much in a single year, not including other health care. The boy, whose identity has not been released, was California’s most expensive Medicaid patient in recent years. His case was singled out in a tweet last year by the state’s top health care official to highlight the public insurance program’s extraordinary obligations as a backstop for low-income patients.

How on earth can a single child’s treatment cost that much? The answer: He has hemophilia and needs large quantities of a pricey drug – known as clotting factor – that makes blood coagulate.

Hemophilia drugs are among the most costly drugs in the nation, and taxpayers are footing the bill for many patients on Medicaid who could never afford them on their own. Officials in California and other states are doing what they can to manage the costs, but it’s a daunting task that highlights the complexity and secrecy of prescription drug pricing.

Tab for 145 kids: $195 million

The California boy whose drugs cost $21 million in a single year was an extreme case, and the circumstances of his care have not been disclosed because of confidentiality protections. Still, medications to treat hemophilia on average annual cost more than $270,000 per patient, according to a 2015 Express Scripts report, and they can easily soar past $1 million annually.

In contrast to more common diseases like hepatitis C, hemophilia treatment is not a state “budget buster” per se: about 4,000 patients live in California. About 1,100 of them are covered by Medi-Cal or two other government-funded programs for chronically ill children in California, according to Jennifer Kent, director of the state Department of Health Care Services and author of last year’s tweet. But the amount of money spent per person dwarfs that spent on people with other serious diseases.

One Stanford University study of 34,000 California kids with severe chronic diseases found that the tiny portion of children who needed blood factor accounted for 41% of the state’s outpatient drug spending on this entire patient population. About $195 million was spent on just 145 kids over a 3-year period, although some of that money came back to the state in rebates from drug companies – a portion of the cost that Medicaid can recoup after purchase.

Caitlin Carroll, director of public affairs for PhRMA, the pharmaceutical industry lobbying group, said high development costs and the complicated and lengthy manufacturing process play a role in how hemophilia drugs are priced. She added that federally mandated rebates significantly reduce the cost of blood factor. They amount to 17% of the average manufacturer price per unit.

Manufacturers also note that some newer and more expensive hemophilia drugs last longer and do not need to be administered as frequently, so they can prove less costly to payers overall.

Even so, some patients require a monumental investment to survive.
 

‘Extremely fortunate’

Colleen Tuite’s son Kevin, a 7-year-old, has severe hemophilia with a complication known as an inhibitor – an antibody that makes his regular blood-factor infusions less effective. Inhibitors can dramatically increase the cost of care, because massive doses of blood factor or expensive, specialized blood products known as bypassing agents may be needed.

Ms. Tuite and her husband initially were Kevin’s foster parents, then adopted the boy as a toddler. Because he has been a foster child, Kevin qualifies for Medi-Cal until he is 26.

The Monrovia, Calif., family also has private health insurance, which pays for about half of Kevin’s medical bills. These can run upward of $200,000 per month, Ms. Tuite said.

“We definitely would not have been able to adopt him without the help of Medi-Cal,” Ms. Tuite said. “We’ve been extremely fortunate.”

With the support of drug manufacturers and hemophilia advocacy groups, patients and their families have significant political clout. Some experts say they also have a moral claim on public resources: In the early days of the AIDS epidemic, thousands of the nation’s hemophilia patients died after they contracted HIV through transfusions before the virus was eliminated from the blood supply.

State health officials say the costs of hemophilia are hard to anticipate and control, even with rebates.

“We do a really aggressive job of collecting rebates on our pharmacy costs,” said Ms. Kent, California’s top Medicaid official. “But there’s just not any way around blood factor. It is just a very, very expensive product. It’s nonnegotiable for people that require it.”

In 2016, California’s Medicaid program paid at least $205 million for medications used to treat hemophilia, according to a Kaiser Health News analysis of federal Medicaid data. That figure doesn’t account for the federal rebates.

States can negotiate “supplemental” rebates with drugmakers for individual medications – but those must be kept secret under federal and some state laws. Such secrecy is becoming increasingly controversial as states continue to confront spiraling drug prices.

Limited options for states

In 2016, Pfizer sued Texas’ state health agency for giving data on the drug company’s supplemental Medicaid rebates to state lawmakers who requested it. The drugmaker alleged that releasing the confidential information would undermine the company’s competitiveness and give away trade secrets, and warned that the discounts it gave Texas could disappear.

In early October, a judge ruled that lawmakers should be able to obtain some of that data, noting dryly that “in Pfizer’s view, legislators are not necessary to carry out the state’s Medicaid program.”

Instead of seeking additional rebates from manufacturers for blood factor, some states, including Washington and Oregon, have chosen to require patients to get their blood factor from federally designated Hemophilia Treatment Centers only. That allows state Medicaid programs to take advantage of a federal drug-discount program known as “340B.”

However, officials in California said they studied that option and determined it wouldn’t save them any more money than the rebates they negotiate with drugmakers.

Whatever their approach, state health officials say they are struggling against forces they are nearly powerless to change.

“There aren’t a lot of options available to Medicaid programs in terms of controlling costs, because we don’t set the initial costs,” said Deborah Weston, pharmacy program manager for Oregon’s Medicaid program.
 

Kaiser Health News data correspondent Sydney Lupkin contributed to this report. KHN’s coverage of these topics is supported by Laura and John Arnold Foundation and Heising-Simons Foundation. This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The child is well-known in the halls in which state bureaucrats oversee health care for millions of Californians – not by name, but by a number: $21 million.

His medications alone cost state taxpayers that much in a single year, not including other health care. The boy, whose identity has not been released, was California’s most expensive Medicaid patient in recent years. His case was singled out in a tweet last year by the state’s top health care official to highlight the public insurance program’s extraordinary obligations as a backstop for low-income patients.

How on earth can a single child’s treatment cost that much? The answer: He has hemophilia and needs large quantities of a pricey drug – known as clotting factor – that makes blood coagulate.

Hemophilia drugs are among the most costly drugs in the nation, and taxpayers are footing the bill for many patients on Medicaid who could never afford them on their own. Officials in California and other states are doing what they can to manage the costs, but it’s a daunting task that highlights the complexity and secrecy of prescription drug pricing.

Tab for 145 kids: $195 million

The California boy whose drugs cost $21 million in a single year was an extreme case, and the circumstances of his care have not been disclosed because of confidentiality protections. Still, medications to treat hemophilia on average annual cost more than $270,000 per patient, according to a 2015 Express Scripts report, and they can easily soar past $1 million annually.

In contrast to more common diseases like hepatitis C, hemophilia treatment is not a state “budget buster” per se: about 4,000 patients live in California. About 1,100 of them are covered by Medi-Cal or two other government-funded programs for chronically ill children in California, according to Jennifer Kent, director of the state Department of Health Care Services and author of last year’s tweet. But the amount of money spent per person dwarfs that spent on people with other serious diseases.

One Stanford University study of 34,000 California kids with severe chronic diseases found that the tiny portion of children who needed blood factor accounted for 41% of the state’s outpatient drug spending on this entire patient population. About $195 million was spent on just 145 kids over a 3-year period, although some of that money came back to the state in rebates from drug companies – a portion of the cost that Medicaid can recoup after purchase.

Caitlin Carroll, director of public affairs for PhRMA, the pharmaceutical industry lobbying group, said high development costs and the complicated and lengthy manufacturing process play a role in how hemophilia drugs are priced. She added that federally mandated rebates significantly reduce the cost of blood factor. They amount to 17% of the average manufacturer price per unit.

Manufacturers also note that some newer and more expensive hemophilia drugs last longer and do not need to be administered as frequently, so they can prove less costly to payers overall.

Even so, some patients require a monumental investment to survive.
 

‘Extremely fortunate’

Colleen Tuite’s son Kevin, a 7-year-old, has severe hemophilia with a complication known as an inhibitor – an antibody that makes his regular blood-factor infusions less effective. Inhibitors can dramatically increase the cost of care, because massive doses of blood factor or expensive, specialized blood products known as bypassing agents may be needed.

Ms. Tuite and her husband initially were Kevin’s foster parents, then adopted the boy as a toddler. Because he has been a foster child, Kevin qualifies for Medi-Cal until he is 26.

The Monrovia, Calif., family also has private health insurance, which pays for about half of Kevin’s medical bills. These can run upward of $200,000 per month, Ms. Tuite said.

“We definitely would not have been able to adopt him without the help of Medi-Cal,” Ms. Tuite said. “We’ve been extremely fortunate.”

With the support of drug manufacturers and hemophilia advocacy groups, patients and their families have significant political clout. Some experts say they also have a moral claim on public resources: In the early days of the AIDS epidemic, thousands of the nation’s hemophilia patients died after they contracted HIV through transfusions before the virus was eliminated from the blood supply.

State health officials say the costs of hemophilia are hard to anticipate and control, even with rebates.

“We do a really aggressive job of collecting rebates on our pharmacy costs,” said Ms. Kent, California’s top Medicaid official. “But there’s just not any way around blood factor. It is just a very, very expensive product. It’s nonnegotiable for people that require it.”

In 2016, California’s Medicaid program paid at least $205 million for medications used to treat hemophilia, according to a Kaiser Health News analysis of federal Medicaid data. That figure doesn’t account for the federal rebates.

States can negotiate “supplemental” rebates with drugmakers for individual medications – but those must be kept secret under federal and some state laws. Such secrecy is becoming increasingly controversial as states continue to confront spiraling drug prices.

Limited options for states

In 2016, Pfizer sued Texas’ state health agency for giving data on the drug company’s supplemental Medicaid rebates to state lawmakers who requested it. The drugmaker alleged that releasing the confidential information would undermine the company’s competitiveness and give away trade secrets, and warned that the discounts it gave Texas could disappear.

In early October, a judge ruled that lawmakers should be able to obtain some of that data, noting dryly that “in Pfizer’s view, legislators are not necessary to carry out the state’s Medicaid program.”

Instead of seeking additional rebates from manufacturers for blood factor, some states, including Washington and Oregon, have chosen to require patients to get their blood factor from federally designated Hemophilia Treatment Centers only. That allows state Medicaid programs to take advantage of a federal drug-discount program known as “340B.”

However, officials in California said they studied that option and determined it wouldn’t save them any more money than the rebates they negotiate with drugmakers.

Whatever their approach, state health officials say they are struggling against forces they are nearly powerless to change.

“There aren’t a lot of options available to Medicaid programs in terms of controlling costs, because we don’t set the initial costs,” said Deborah Weston, pharmacy program manager for Oregon’s Medicaid program.
 

Kaiser Health News data correspondent Sydney Lupkin contributed to this report. KHN’s coverage of these topics is supported by Laura and John Arnold Foundation and Heising-Simons Foundation. This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The child is well-known in the halls in which state bureaucrats oversee health care for millions of Californians – not by name, but by a number: $21 million.

His medications alone cost state taxpayers that much in a single year, not including other health care. The boy, whose identity has not been released, was California’s most expensive Medicaid patient in recent years. His case was singled out in a tweet last year by the state’s top health care official to highlight the public insurance program’s extraordinary obligations as a backstop for low-income patients.

How on earth can a single child’s treatment cost that much? The answer: He has hemophilia and needs large quantities of a pricey drug – known as clotting factor – that makes blood coagulate.

Hemophilia drugs are among the most costly drugs in the nation, and taxpayers are footing the bill for many patients on Medicaid who could never afford them on their own. Officials in California and other states are doing what they can to manage the costs, but it’s a daunting task that highlights the complexity and secrecy of prescription drug pricing.

Tab for 145 kids: $195 million

The California boy whose drugs cost $21 million in a single year was an extreme case, and the circumstances of his care have not been disclosed because of confidentiality protections. Still, medications to treat hemophilia on average annual cost more than $270,000 per patient, according to a 2015 Express Scripts report, and they can easily soar past $1 million annually.

In contrast to more common diseases like hepatitis C, hemophilia treatment is not a state “budget buster” per se: about 4,000 patients live in California. About 1,100 of them are covered by Medi-Cal or two other government-funded programs for chronically ill children in California, according to Jennifer Kent, director of the state Department of Health Care Services and author of last year’s tweet. But the amount of money spent per person dwarfs that spent on people with other serious diseases.

One Stanford University study of 34,000 California kids with severe chronic diseases found that the tiny portion of children who needed blood factor accounted for 41% of the state’s outpatient drug spending on this entire patient population. About $195 million was spent on just 145 kids over a 3-year period, although some of that money came back to the state in rebates from drug companies – a portion of the cost that Medicaid can recoup after purchase.

Caitlin Carroll, director of public affairs for PhRMA, the pharmaceutical industry lobbying group, said high development costs and the complicated and lengthy manufacturing process play a role in how hemophilia drugs are priced. She added that federally mandated rebates significantly reduce the cost of blood factor. They amount to 17% of the average manufacturer price per unit.

Manufacturers also note that some newer and more expensive hemophilia drugs last longer and do not need to be administered as frequently, so they can prove less costly to payers overall.

Even so, some patients require a monumental investment to survive.
 

‘Extremely fortunate’

Colleen Tuite’s son Kevin, a 7-year-old, has severe hemophilia with a complication known as an inhibitor – an antibody that makes his regular blood-factor infusions less effective. Inhibitors can dramatically increase the cost of care, because massive doses of blood factor or expensive, specialized blood products known as bypassing agents may be needed.

Ms. Tuite and her husband initially were Kevin’s foster parents, then adopted the boy as a toddler. Because he has been a foster child, Kevin qualifies for Medi-Cal until he is 26.

The Monrovia, Calif., family also has private health insurance, which pays for about half of Kevin’s medical bills. These can run upward of $200,000 per month, Ms. Tuite said.

“We definitely would not have been able to adopt him without the help of Medi-Cal,” Ms. Tuite said. “We’ve been extremely fortunate.”

With the support of drug manufacturers and hemophilia advocacy groups, patients and their families have significant political clout. Some experts say they also have a moral claim on public resources: In the early days of the AIDS epidemic, thousands of the nation’s hemophilia patients died after they contracted HIV through transfusions before the virus was eliminated from the blood supply.

State health officials say the costs of hemophilia are hard to anticipate and control, even with rebates.

“We do a really aggressive job of collecting rebates on our pharmacy costs,” said Ms. Kent, California’s top Medicaid official. “But there’s just not any way around blood factor. It is just a very, very expensive product. It’s nonnegotiable for people that require it.”

In 2016, California’s Medicaid program paid at least $205 million for medications used to treat hemophilia, according to a Kaiser Health News analysis of federal Medicaid data. That figure doesn’t account for the federal rebates.

States can negotiate “supplemental” rebates with drugmakers for individual medications – but those must be kept secret under federal and some state laws. Such secrecy is becoming increasingly controversial as states continue to confront spiraling drug prices.

Limited options for states

In 2016, Pfizer sued Texas’ state health agency for giving data on the drug company’s supplemental Medicaid rebates to state lawmakers who requested it. The drugmaker alleged that releasing the confidential information would undermine the company’s competitiveness and give away trade secrets, and warned that the discounts it gave Texas could disappear.

In early October, a judge ruled that lawmakers should be able to obtain some of that data, noting dryly that “in Pfizer’s view, legislators are not necessary to carry out the state’s Medicaid program.”

Instead of seeking additional rebates from manufacturers for blood factor, some states, including Washington and Oregon, have chosen to require patients to get their blood factor from federally designated Hemophilia Treatment Centers only. That allows state Medicaid programs to take advantage of a federal drug-discount program known as “340B.”

However, officials in California said they studied that option and determined it wouldn’t save them any more money than the rebates they negotiate with drugmakers.

Whatever their approach, state health officials say they are struggling against forces they are nearly powerless to change.

“There aren’t a lot of options available to Medicaid programs in terms of controlling costs, because we don’t set the initial costs,” said Deborah Weston, pharmacy program manager for Oregon’s Medicaid program.
 

Kaiser Health News data correspondent Sydney Lupkin contributed to this report. KHN’s coverage of these topics is supported by Laura and John Arnold Foundation and Heising-Simons Foundation. This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The Trump administration on March 5 approved Arkansas’ request for a Medicaid work requirement but deferred a decision on the state’s request to roll back its Medicaid expansion that has added 300,000 adults to the program.

Arkansas had sought to reduce the number of people eligible for Medicaid by allowing only those with incomes below the federal poverty level, or about $12,140 for an individual, to qualify. For the past 4 years, Arkansas Medicaid covered everyone with incomes under 138% of the poverty level, or about $16,750. The new policy would have cut the number of people eligible for Medicaid in the state by about 60,000 people.

Seema Verma, administrator of the Centers for Medicare & Medicaid Services, who announced the decision, has said her goal as head of the program was to grant states more flexibility in running their Medicaid programs than they’ve had before.

Arkansas follows Indiana and Kentucky this year in winning CMS’ approval for the work requirement. Arkansas plans to start the new requirement affecting adults under age 50 years by June, making it the first to do so.

Ms. Verma recused herself on CMS’ decisions involving Indiana and Kentucky because she used to consult with those state Medicaid agencies before joining the Trump administration in 2017. As a health care consultant, she also worked with Arkansas. But Ms. Verma decided to personally approve the Arkansas waiver on Monday and flew to Little Rock, Ark., to make the announcement with Gov. Asa Hutchinson (R).

CMS officials did not respond to questions about why she did not recuse herself again.

But a top Senate Democrat lambasted Ms. Verma’s decision.

“She pledged during her confirmation to recuse herself from working on many states’ Medicaid waivers to avoid conflicts of interest, including Arkansas, Sen. Ron Wyden (D-Ore.) said in a statement. “The Trump administration has simply made a mockery of the HHS ethics process.”

It is unclear why she deferred deciding on Arkansas’ request to scale back its Medicaid decision. Deferring a decision on rolling back expansion could be a way of rejecting the application but in a less politically harsh way. Arkansas was one of the few Southern states to expand Medicaid under the ACA, a decision that brought hundreds of millions of federal dollars into the state.

Nine other states have requests pending with CMS to enact a Medicaid work requirement.

In Arkansas, enrollees who don’t work or volunteer at least 80 hours a month could lose coverage as early as September. The work requirement exempts many people, such as those with opioid addiction and parents with dependent children.

Ms. Verma said the work requirement “is about helping people rise out of poverty to achieve the American dream.”

But advocates for the poor blasted the move, noting most Medicaid enrollees already work, go to school, or are taking care of sick relatives.

“The Trump administration’s approval of Arkansas’ harsh work requirement in Medicaid will likely set back the state’s considerable progress under the Affordable Care Act in increasing coverage and improving access to care, health and financial stability for low-income Arkansans,” said Judith Solomon, vice president for health policy at the left-leaning Center on Budget and Policy Priorities.

Arkansas officials said they need the work requirement because without it many enrollees won’t seek out work or job training. Since January 2017, fewer than 5% of Medicaid enrollees who were referred to the state Department of Workforce Services to help with job training followed through and accessed services.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The Trump administration on March 5 approved Arkansas’ request for a Medicaid work requirement but deferred a decision on the state’s request to roll back its Medicaid expansion that has added 300,000 adults to the program.

Arkansas had sought to reduce the number of people eligible for Medicaid by allowing only those with incomes below the federal poverty level, or about $12,140 for an individual, to qualify. For the past 4 years, Arkansas Medicaid covered everyone with incomes under 138% of the poverty level, or about $16,750. The new policy would have cut the number of people eligible for Medicaid in the state by about 60,000 people.

Seema Verma, administrator of the Centers for Medicare & Medicaid Services, who announced the decision, has said her goal as head of the program was to grant states more flexibility in running their Medicaid programs than they’ve had before.

Arkansas follows Indiana and Kentucky this year in winning CMS’ approval for the work requirement. Arkansas plans to start the new requirement affecting adults under age 50 years by June, making it the first to do so.

Ms. Verma recused herself on CMS’ decisions involving Indiana and Kentucky because she used to consult with those state Medicaid agencies before joining the Trump administration in 2017. As a health care consultant, she also worked with Arkansas. But Ms. Verma decided to personally approve the Arkansas waiver on Monday and flew to Little Rock, Ark., to make the announcement with Gov. Asa Hutchinson (R).

CMS officials did not respond to questions about why she did not recuse herself again.

But a top Senate Democrat lambasted Ms. Verma’s decision.

“She pledged during her confirmation to recuse herself from working on many states’ Medicaid waivers to avoid conflicts of interest, including Arkansas, Sen. Ron Wyden (D-Ore.) said in a statement. “The Trump administration has simply made a mockery of the HHS ethics process.”

It is unclear why she deferred deciding on Arkansas’ request to scale back its Medicaid decision. Deferring a decision on rolling back expansion could be a way of rejecting the application but in a less politically harsh way. Arkansas was one of the few Southern states to expand Medicaid under the ACA, a decision that brought hundreds of millions of federal dollars into the state.

Nine other states have requests pending with CMS to enact a Medicaid work requirement.

In Arkansas, enrollees who don’t work or volunteer at least 80 hours a month could lose coverage as early as September. The work requirement exempts many people, such as those with opioid addiction and parents with dependent children.

Ms. Verma said the work requirement “is about helping people rise out of poverty to achieve the American dream.”

But advocates for the poor blasted the move, noting most Medicaid enrollees already work, go to school, or are taking care of sick relatives.

“The Trump administration’s approval of Arkansas’ harsh work requirement in Medicaid will likely set back the state’s considerable progress under the Affordable Care Act in increasing coverage and improving access to care, health and financial stability for low-income Arkansans,” said Judith Solomon, vice president for health policy at the left-leaning Center on Budget and Policy Priorities.

Arkansas officials said they need the work requirement because without it many enrollees won’t seek out work or job training. Since January 2017, fewer than 5% of Medicaid enrollees who were referred to the state Department of Workforce Services to help with job training followed through and accessed services.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

The Trump administration on March 5 approved Arkansas’ request for a Medicaid work requirement but deferred a decision on the state’s request to roll back its Medicaid expansion that has added 300,000 adults to the program.

Arkansas had sought to reduce the number of people eligible for Medicaid by allowing only those with incomes below the federal poverty level, or about $12,140 for an individual, to qualify. For the past 4 years, Arkansas Medicaid covered everyone with incomes under 138% of the poverty level, or about $16,750. The new policy would have cut the number of people eligible for Medicaid in the state by about 60,000 people.

Seema Verma, administrator of the Centers for Medicare & Medicaid Services, who announced the decision, has said her goal as head of the program was to grant states more flexibility in running their Medicaid programs than they’ve had before.

Arkansas follows Indiana and Kentucky this year in winning CMS’ approval for the work requirement. Arkansas plans to start the new requirement affecting adults under age 50 years by June, making it the first to do so.

Ms. Verma recused herself on CMS’ decisions involving Indiana and Kentucky because she used to consult with those state Medicaid agencies before joining the Trump administration in 2017. As a health care consultant, she also worked with Arkansas. But Ms. Verma decided to personally approve the Arkansas waiver on Monday and flew to Little Rock, Ark., to make the announcement with Gov. Asa Hutchinson (R).

CMS officials did not respond to questions about why she did not recuse herself again.

But a top Senate Democrat lambasted Ms. Verma’s decision.

“She pledged during her confirmation to recuse herself from working on many states’ Medicaid waivers to avoid conflicts of interest, including Arkansas, Sen. Ron Wyden (D-Ore.) said in a statement. “The Trump administration has simply made a mockery of the HHS ethics process.”

It is unclear why she deferred deciding on Arkansas’ request to scale back its Medicaid decision. Deferring a decision on rolling back expansion could be a way of rejecting the application but in a less politically harsh way. Arkansas was one of the few Southern states to expand Medicaid under the ACA, a decision that brought hundreds of millions of federal dollars into the state.

Nine other states have requests pending with CMS to enact a Medicaid work requirement.

In Arkansas, enrollees who don’t work or volunteer at least 80 hours a month could lose coverage as early as September. The work requirement exempts many people, such as those with opioid addiction and parents with dependent children.

Ms. Verma said the work requirement “is about helping people rise out of poverty to achieve the American dream.”

But advocates for the poor blasted the move, noting most Medicaid enrollees already work, go to school, or are taking care of sick relatives.

“The Trump administration’s approval of Arkansas’ harsh work requirement in Medicaid will likely set back the state’s considerable progress under the Affordable Care Act in increasing coverage and improving access to care, health and financial stability for low-income Arkansans,” said Judith Solomon, vice president for health policy at the left-leaning Center on Budget and Policy Priorities.

Arkansas officials said they need the work requirement because without it many enrollees won’t seek out work or job training. Since January 2017, fewer than 5% of Medicaid enrollees who were referred to the state Department of Workforce Services to help with job training followed through and accessed services.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

At 87, Maxine Stanich cared more about improving the quality of her life than prolonging it.

She suffered from a long list of health problems, including heart failure and chronic lung disease that could leave her gasping for breath.

When her time came, she wanted to die a natural death, Stanich told her daughter, and signed a “do not resuscitate” directive, or DNR, ordering doctors not to revive her should her heart stop.

Yet a trip to a San Francisco emergency room for shortness of breath in 2008 led Stanich to get a defibrillator implanted in her chest – a medical device to keep her alive by delivering a powerful shock. At the time, Stanich didn’t fully grasp what she had agreed to, even though she signed a document granting permission for the procedure, said her daughter, Susan Giaquinto.

That clarity came only during a subsequent visit to a different hospital, when a surprised ER doctor saw a defibrillator protruding from the DNR patient’s thin chest. To Stanich’s horror, the ER doctor explained that the device would not allow her to slip away painlessly and that the jolt would be “so strong that it will knock her across the room,” said Giaquinto, who accompanied her mother on both hospital trips.

Surgery like this has become all too common among those near the end of life, experts say. Nearly one in three Medicare patients undergo an operation in the year before they die, even though the evidence shows that many are more likely to be harmed than to benefit from it.

The practice is driven by financial incentives that reward doctors for doing procedures, as well as a medical culture in which patients and doctors are reluctant to talk about how surgical interventions should be prescribed more judiciously, said Rita Redberg, M.D., a cardiologist who treated Stanich when she sought care at the second hospital.

“We have a culture that believes in very aggressive care,” said Dr. Redberg, who at the University of California–San Francisco specializes in heart disease in women. “We are often not considering the chance of benefit and chance of harm, and how that changes when you get older. We also fail to have conversations about what patients value most.”

While surgery is typically lifesaving for younger people, operating on frail, older patients rarely helps them live longer or returns the quality of life they once enjoyed, according to a 2016 paper in Annals of Surgery.

The cost of these surgeries – typically paid for by Medicare, the government health insurance program for people over 65 – involve more than money, said Amber Barnato, MD, professor at the Dartmouth Institute for Health Policy and Clinical Practice. Older patients who undergo surgery within a year of death spent 50 percent more time in the hospital than others, and nearly twice as many days in intensive care.

And while some robust octogenarians have many years ahead of them, studies show that surgery is also common among those who are far more frail.

Eighteen percent of Medicare patients have surgery in their final month of life and 8% in their final week, according to a 2011 study in The Lancet.

More than 12% of defibrillators were implanted in people older than 80, according to a 2015 study. Doctors implant about 158,000 of the devices each year, according to the American College of Cardiology. The total cost of the procedure runs about $60,000.

Procedures performed in the elderly range from major operations that require lengthy recoveries to relatively minor surgery performed in a doctor’s office, such as the removal of nonfatal skin cancers, that would likely never cause any problems.

Research led by Eleni Linos, MD, has shown that people with limited life expectancies are treated for nonfatal skin cancers as aggressively as younger patients. Among patients with a nonfatal skin cancer and a limited time to live, 70 percent underwent surgery, according to her 2013 study in JAMA Internal Medicine.

When less is more

Surgery poses serious risks for older people, who weather anesthesia poorly and whose skin takes longer to heal. Among seniors who undergo urgent or emergency abdominal surgery, 20% die within 30 days, studies show.

With diminished mental acuity and an old-fashioned respect for the medical profession, some aging patients are vulnerable to unwanted interventions. Stanich agreed to a pacemaker simply because her doctor suggested it, Giaquinto said. Many people of Stanich’s generation “thought doctors were God … They never questioned doctors – ever.”

Margaret Schwarze, MD, a surgeon and associate professor at the University of Wisconsin, said that older patients often don’t feel the financial pain of surgery because insurance pays most of the cost.

When a surgeon offers to “fix” the heart valve in a person with multiple diseases, for example, the patient may assume that surgery will fix all of her medical problems, Dr. Schwarze said. “With older patients with lots of chronic illnesses, we’re not really fixing anything.”

Even as a doctor, Dr. Redberg said, she struggles to prevent other doctors from performing too many procedures on her 92-year-old mother, Mae, who lives in New York City.

Dr. Redberg said doctors recently treated her mother for melanoma – the most serious type of skin cancer. After the cancer was removed from her leg, Dr. Redberg’s mother was urged by a doctor to undergo an additional surgery to cut away more tissue and nearby lymph nodes, which can harbor cancerous cells.

“Every time she went in, the dermatologist wanted to refer her to a surgeon,” Dr. Redberg said. And “Medicare would have been happy to pay for it.”

But her mother often has problems with wounds healing, she said, and recovery would likely have taken 3 months. When Dr. Redberg pressed a surgeon about the benefits, he said the procedure could reduce the chances of cancer coming back within 3-5 years.

Dr. Redberg said her mother laughed and said, “I’m not interested in doing something that will help me in 3-5 years. I doubt I’ll be here.”

Finding solutions

The momentum of hospital care can make people feel as if they’re on a moving train and can’t jump off.

The rush of medical decisions “doesn’t allow time to deliberate or consider the patients’ overall health or what their goals and values might be,” said Jacqueline Kruser, MD, an instructor in pulmonary and critical care medicine and medical social sciences at the Northwestern University.

Many hospitals and health systems are developing “decision aids,” easy-to-understand written materials and videos to help patients make more informed medical decisions, giving them time to develop more realistic expectations.

After Kaiser Permanente Washington introduced the tools relating to joint replacement, the number of patients choosing to have hip replacement surgery fell 26%, while knee replacements declined 38%, according to a study in Health Affairs. (Kaiser Permanente is not affiliated with Kaiser Health News, which is an editorially independent program of the Kaiser Family Foundation.)

In a paper published last year in JAMA Surgery and the Journal of Pain and Symptom Management, Dr. Schwarze, Dr. Kruser and colleagues suggested creating narratives to illustrate surgical risks, rather than relying on statistics.

Instead of telling patients that surgery carries a 20% risk of stroke, for example, doctors should lay out the best, worst and most likely outcomes.

In the best-case scenario, a patient might spend weeks in the hospital after surgery, living the rest of her life in a nursing home. In the worst case, the same patient dies after several weeks in intensive care. In the most likely scenario, the patient survives just 2-3 months after surgery.

Dr. Schwarze said, “If someone says they can’t tolerate the best-case scenario – which involves them being in a nursing home – then maybe we shouldn’t be doing this.”

Maxine Stanich was admitted to the hospital after going to the ER because she felt short of breath. She experienced an abnormal heart rhythm in the procedure room during a cardiac test – not an unusual event during a procedure in which a wire is threaded into the heart. Based on that, doctors decided to implant a pacemaker and defibrillator the next day.

Dr. Redberg was consulted when the patient objected to the device that was now embedded in her chest. She was “very alert. She was very clear about what she did and did not want done. She told me she didn’t want to be shocked,” Redberg said.

After Dr. Redberg deactivated the defibrillator, which can be reprogrammed remotely, Stanich was discharged, with home hospice service. With nothing more than her medicines, she survived another 2 years and 3 months, dying at home just after her 90th birthday in 2010.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente. KHN’s coverage related to aging and improving care of older adults is supported in part by The John A. Hartford Foundation.

At 87, Maxine Stanich cared more about improving the quality of her life than prolonging it.

She suffered from a long list of health problems, including heart failure and chronic lung disease that could leave her gasping for breath.

When her time came, she wanted to die a natural death, Stanich told her daughter, and signed a “do not resuscitate” directive, or DNR, ordering doctors not to revive her should her heart stop.

Yet a trip to a San Francisco emergency room for shortness of breath in 2008 led Stanich to get a defibrillator implanted in her chest – a medical device to keep her alive by delivering a powerful shock. At the time, Stanich didn’t fully grasp what she had agreed to, even though she signed a document granting permission for the procedure, said her daughter, Susan Giaquinto.

That clarity came only during a subsequent visit to a different hospital, when a surprised ER doctor saw a defibrillator protruding from the DNR patient’s thin chest. To Stanich’s horror, the ER doctor explained that the device would not allow her to slip away painlessly and that the jolt would be “so strong that it will knock her across the room,” said Giaquinto, who accompanied her mother on both hospital trips.

Surgery like this has become all too common among those near the end of life, experts say. Nearly one in three Medicare patients undergo an operation in the year before they die, even though the evidence shows that many are more likely to be harmed than to benefit from it.

The practice is driven by financial incentives that reward doctors for doing procedures, as well as a medical culture in which patients and doctors are reluctant to talk about how surgical interventions should be prescribed more judiciously, said Rita Redberg, M.D., a cardiologist who treated Stanich when she sought care at the second hospital.

“We have a culture that believes in very aggressive care,” said Dr. Redberg, who at the University of California–San Francisco specializes in heart disease in women. “We are often not considering the chance of benefit and chance of harm, and how that changes when you get older. We also fail to have conversations about what patients value most.”

While surgery is typically lifesaving for younger people, operating on frail, older patients rarely helps them live longer or returns the quality of life they once enjoyed, according to a 2016 paper in Annals of Surgery.

The cost of these surgeries – typically paid for by Medicare, the government health insurance program for people over 65 – involve more than money, said Amber Barnato, MD, professor at the Dartmouth Institute for Health Policy and Clinical Practice. Older patients who undergo surgery within a year of death spent 50 percent more time in the hospital than others, and nearly twice as many days in intensive care.

And while some robust octogenarians have many years ahead of them, studies show that surgery is also common among those who are far more frail.

Eighteen percent of Medicare patients have surgery in their final month of life and 8% in their final week, according to a 2011 study in The Lancet.

More than 12% of defibrillators were implanted in people older than 80, according to a 2015 study. Doctors implant about 158,000 of the devices each year, according to the American College of Cardiology. The total cost of the procedure runs about $60,000.

Procedures performed in the elderly range from major operations that require lengthy recoveries to relatively minor surgery performed in a doctor’s office, such as the removal of nonfatal skin cancers, that would likely never cause any problems.

Research led by Eleni Linos, MD, has shown that people with limited life expectancies are treated for nonfatal skin cancers as aggressively as younger patients. Among patients with a nonfatal skin cancer and a limited time to live, 70 percent underwent surgery, according to her 2013 study in JAMA Internal Medicine.

When less is more

Surgery poses serious risks for older people, who weather anesthesia poorly and whose skin takes longer to heal. Among seniors who undergo urgent or emergency abdominal surgery, 20% die within 30 days, studies show.

With diminished mental acuity and an old-fashioned respect for the medical profession, some aging patients are vulnerable to unwanted interventions. Stanich agreed to a pacemaker simply because her doctor suggested it, Giaquinto said. Many people of Stanich’s generation “thought doctors were God … They never questioned doctors – ever.”

Margaret Schwarze, MD, a surgeon and associate professor at the University of Wisconsin, said that older patients often don’t feel the financial pain of surgery because insurance pays most of the cost.

When a surgeon offers to “fix” the heart valve in a person with multiple diseases, for example, the patient may assume that surgery will fix all of her medical problems, Dr. Schwarze said. “With older patients with lots of chronic illnesses, we’re not really fixing anything.”

Even as a doctor, Dr. Redberg said, she struggles to prevent other doctors from performing too many procedures on her 92-year-old mother, Mae, who lives in New York City.

Dr. Redberg said doctors recently treated her mother for melanoma – the most serious type of skin cancer. After the cancer was removed from her leg, Dr. Redberg’s mother was urged by a doctor to undergo an additional surgery to cut away more tissue and nearby lymph nodes, which can harbor cancerous cells.

“Every time she went in, the dermatologist wanted to refer her to a surgeon,” Dr. Redberg said. And “Medicare would have been happy to pay for it.”

But her mother often has problems with wounds healing, she said, and recovery would likely have taken 3 months. When Dr. Redberg pressed a surgeon about the benefits, he said the procedure could reduce the chances of cancer coming back within 3-5 years.

Dr. Redberg said her mother laughed and said, “I’m not interested in doing something that will help me in 3-5 years. I doubt I’ll be here.”

Finding solutions

The momentum of hospital care can make people feel as if they’re on a moving train and can’t jump off.

The rush of medical decisions “doesn’t allow time to deliberate or consider the patients’ overall health or what their goals and values might be,” said Jacqueline Kruser, MD, an instructor in pulmonary and critical care medicine and medical social sciences at the Northwestern University.

Many hospitals and health systems are developing “decision aids,” easy-to-understand written materials and videos to help patients make more informed medical decisions, giving them time to develop more realistic expectations.

After Kaiser Permanente Washington introduced the tools relating to joint replacement, the number of patients choosing to have hip replacement surgery fell 26%, while knee replacements declined 38%, according to a study in Health Affairs. (Kaiser Permanente is not affiliated with Kaiser Health News, which is an editorially independent program of the Kaiser Family Foundation.)

In a paper published last year in JAMA Surgery and the Journal of Pain and Symptom Management, Dr. Schwarze, Dr. Kruser and colleagues suggested creating narratives to illustrate surgical risks, rather than relying on statistics.

Instead of telling patients that surgery carries a 20% risk of stroke, for example, doctors should lay out the best, worst and most likely outcomes.

In the best-case scenario, a patient might spend weeks in the hospital after surgery, living the rest of her life in a nursing home. In the worst case, the same patient dies after several weeks in intensive care. In the most likely scenario, the patient survives just 2-3 months after surgery.

Dr. Schwarze said, “If someone says they can’t tolerate the best-case scenario – which involves them being in a nursing home – then maybe we shouldn’t be doing this.”

Maxine Stanich was admitted to the hospital after going to the ER because she felt short of breath. She experienced an abnormal heart rhythm in the procedure room during a cardiac test – not an unusual event during a procedure in which a wire is threaded into the heart. Based on that, doctors decided to implant a pacemaker and defibrillator the next day.

Dr. Redberg was consulted when the patient objected to the device that was now embedded in her chest. She was “very alert. She was very clear about what she did and did not want done. She told me she didn’t want to be shocked,” Redberg said.

After Dr. Redberg deactivated the defibrillator, which can be reprogrammed remotely, Stanich was discharged, with home hospice service. With nothing more than her medicines, she survived another 2 years and 3 months, dying at home just after her 90th birthday in 2010.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente. KHN’s coverage related to aging and improving care of older adults is supported in part by The John A. Hartford Foundation.

At 87, Maxine Stanich cared more about improving the quality of her life than prolonging it.

She suffered from a long list of health problems, including heart failure and chronic lung disease that could leave her gasping for breath.

When her time came, she wanted to die a natural death, Stanich told her daughter, and signed a “do not resuscitate” directive, or DNR, ordering doctors not to revive her should her heart stop.

Yet a trip to a San Francisco emergency room for shortness of breath in 2008 led Stanich to get a defibrillator implanted in her chest – a medical device to keep her alive by delivering a powerful shock. At the time, Stanich didn’t fully grasp what she had agreed to, even though she signed a document granting permission for the procedure, said her daughter, Susan Giaquinto.

That clarity came only during a subsequent visit to a different hospital, when a surprised ER doctor saw a defibrillator protruding from the DNR patient’s thin chest. To Stanich’s horror, the ER doctor explained that the device would not allow her to slip away painlessly and that the jolt would be “so strong that it will knock her across the room,” said Giaquinto, who accompanied her mother on both hospital trips.

Surgery like this has become all too common among those near the end of life, experts say. Nearly one in three Medicare patients undergo an operation in the year before they die, even though the evidence shows that many are more likely to be harmed than to benefit from it.

The practice is driven by financial incentives that reward doctors for doing procedures, as well as a medical culture in which patients and doctors are reluctant to talk about how surgical interventions should be prescribed more judiciously, said Rita Redberg, M.D., a cardiologist who treated Stanich when she sought care at the second hospital.

“We have a culture that believes in very aggressive care,” said Dr. Redberg, who at the University of California–San Francisco specializes in heart disease in women. “We are often not considering the chance of benefit and chance of harm, and how that changes when you get older. We also fail to have conversations about what patients value most.”

While surgery is typically lifesaving for younger people, operating on frail, older patients rarely helps them live longer or returns the quality of life they once enjoyed, according to a 2016 paper in Annals of Surgery.

The cost of these surgeries – typically paid for by Medicare, the government health insurance program for people over 65 – involve more than money, said Amber Barnato, MD, professor at the Dartmouth Institute for Health Policy and Clinical Practice. Older patients who undergo surgery within a year of death spent 50 percent more time in the hospital than others, and nearly twice as many days in intensive care.

And while some robust octogenarians have many years ahead of them, studies show that surgery is also common among those who are far more frail.

Eighteen percent of Medicare patients have surgery in their final month of life and 8% in their final week, according to a 2011 study in The Lancet.

More than 12% of defibrillators were implanted in people older than 80, according to a 2015 study. Doctors implant about 158,000 of the devices each year, according to the American College of Cardiology. The total cost of the procedure runs about $60,000.

Procedures performed in the elderly range from major operations that require lengthy recoveries to relatively minor surgery performed in a doctor’s office, such as the removal of nonfatal skin cancers, that would likely never cause any problems.

Research led by Eleni Linos, MD, has shown that people with limited life expectancies are treated for nonfatal skin cancers as aggressively as younger patients. Among patients with a nonfatal skin cancer and a limited time to live, 70 percent underwent surgery, according to her 2013 study in JAMA Internal Medicine.

When less is more

Surgery poses serious risks for older people, who weather anesthesia poorly and whose skin takes longer to heal. Among seniors who undergo urgent or emergency abdominal surgery, 20% die within 30 days, studies show.

With diminished mental acuity and an old-fashioned respect for the medical profession, some aging patients are vulnerable to unwanted interventions. Stanich agreed to a pacemaker simply because her doctor suggested it, Giaquinto said. Many people of Stanich’s generation “thought doctors were God … They never questioned doctors – ever.”

Margaret Schwarze, MD, a surgeon and associate professor at the University of Wisconsin, said that older patients often don’t feel the financial pain of surgery because insurance pays most of the cost.

When a surgeon offers to “fix” the heart valve in a person with multiple diseases, for example, the patient may assume that surgery will fix all of her medical problems, Dr. Schwarze said. “With older patients with lots of chronic illnesses, we’re not really fixing anything.”

Even as a doctor, Dr. Redberg said, she struggles to prevent other doctors from performing too many procedures on her 92-year-old mother, Mae, who lives in New York City.

Dr. Redberg said doctors recently treated her mother for melanoma – the most serious type of skin cancer. After the cancer was removed from her leg, Dr. Redberg’s mother was urged by a doctor to undergo an additional surgery to cut away more tissue and nearby lymph nodes, which can harbor cancerous cells.

“Every time she went in, the dermatologist wanted to refer her to a surgeon,” Dr. Redberg said. And “Medicare would have been happy to pay for it.”

But her mother often has problems with wounds healing, she said, and recovery would likely have taken 3 months. When Dr. Redberg pressed a surgeon about the benefits, he said the procedure could reduce the chances of cancer coming back within 3-5 years.

Dr. Redberg said her mother laughed and said, “I’m not interested in doing something that will help me in 3-5 years. I doubt I’ll be here.”

Finding solutions

The momentum of hospital care can make people feel as if they’re on a moving train and can’t jump off.

The rush of medical decisions “doesn’t allow time to deliberate or consider the patients’ overall health or what their goals and values might be,” said Jacqueline Kruser, MD, an instructor in pulmonary and critical care medicine and medical social sciences at the Northwestern University.

Many hospitals and health systems are developing “decision aids,” easy-to-understand written materials and videos to help patients make more informed medical decisions, giving them time to develop more realistic expectations.

After Kaiser Permanente Washington introduced the tools relating to joint replacement, the number of patients choosing to have hip replacement surgery fell 26%, while knee replacements declined 38%, according to a study in Health Affairs. (Kaiser Permanente is not affiliated with Kaiser Health News, which is an editorially independent program of the Kaiser Family Foundation.)

In a paper published last year in JAMA Surgery and the Journal of Pain and Symptom Management, Dr. Schwarze, Dr. Kruser and colleagues suggested creating narratives to illustrate surgical risks, rather than relying on statistics.

Instead of telling patients that surgery carries a 20% risk of stroke, for example, doctors should lay out the best, worst and most likely outcomes.

In the best-case scenario, a patient might spend weeks in the hospital after surgery, living the rest of her life in a nursing home. In the worst case, the same patient dies after several weeks in intensive care. In the most likely scenario, the patient survives just 2-3 months after surgery.

Dr. Schwarze said, “If someone says they can’t tolerate the best-case scenario – which involves them being in a nursing home – then maybe we shouldn’t be doing this.”

Maxine Stanich was admitted to the hospital after going to the ER because she felt short of breath. She experienced an abnormal heart rhythm in the procedure room during a cardiac test – not an unusual event during a procedure in which a wire is threaded into the heart. Based on that, doctors decided to implant a pacemaker and defibrillator the next day.

Dr. Redberg was consulted when the patient objected to the device that was now embedded in her chest. She was “very alert. She was very clear about what she did and did not want done. She told me she didn’t want to be shocked,” Redberg said.

After Dr. Redberg deactivated the defibrillator, which can be reprogrammed remotely, Stanich was discharged, with home hospice service. With nothing more than her medicines, she survived another 2 years and 3 months, dying at home just after her 90th birthday in 2010.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente. KHN’s coverage related to aging and improving care of older adults is supported in part by The John A. Hartford Foundation.