Tagged Drug Costs

No Cash, No Heart. Transplant Centers Require Proof Of Payment.

When Patrick Mannion heard about the Michigan woman denied a heart transplant because she couldn’t afford the anti-rejection drugs, he knew what she was up against.

On social media posts of a letter that went viral last month, Hedda Martin, 60, of Grand Rapids, was informed that she was not a candidate for a heart transplant because of her finances. It recommended “a fundraising effort of $10,000.”

Patrick Mannion received a double-lung transplant in May 2017 after being diagnosed with idiopathic pulmonary fibrosis, a progressive, life-threatening lung disease. Through a transplant fundraising organization, HelpHopeLive, he has raised nearly $115,000, twice the original goal to help pay expenses that insurance didn’t cover, including copays for costly anti-rejection drugs. (Courtesy of Patrick Mannion)

Two years ago, Mannion, of Oxford, Conn., learned he needed a double-lung transplant after contracting idiopathic pulmonary fibrosis, a progressive, fatal disease. From the start, hospital officials told him to set aside $30,000 in a separate bank account to cover the costs.

Mannion, 59, who received his new lungs in May 2017, reflected: “Here you are, you need a heart — that’s a tough road for any person,” he said. “And then for that person to have to be a fundraiser?”

Martin’s case sparked outrage over a transplant system that links access to a lifesaving treatment to finances. But requiring proof of payment for organ transplants and post-operative care is common, transplant experts say.

“It happens every day,” said Arthur Caplan, a bioethicist at the New York University Langone Medical Center. “You get what I call a ‘wallet biopsy.’”

Virtually all of the nation’s more than 250 transplant centers, which refer patients to a single national registry, require patients to verify how they will cover bills that can total $400,000 for a kidney transplant or $1.3 million for a heart, plus monthly costs that average $2,500 for anti-rejection drugs that must be taken for life, Caplan said. Coverage for the drugs is more scattershot than for the operation itself, even though transplanted organs will not last without the medicine.

For Martin, the social media attention helped. Within days, she had raised more than $30,000 through a GoFundMe account, and officials at Spectrum Health confirmed she was added to the transplant waiting list.

In a statement, officials there defended their position, saying that financial resources, along with physical health and social well-being, are among crucial factors to consider.

“The ability to pay for post-transplant care and life-long immunosuppression medications is essential to increase the likelihood of a successful transplant and longevity of the transplant recipient,” officials wrote.

In the most pragmatic light, that makes sense. More than 114,000 people are waiting for organs in the U.S. and fewer than 35,000 organs were transplanted last year, according to the United Network for Organ Sharing, or UNOS. Transplant centers want to make sure donated organs aren’t wasted.

(Story continues below.)

“If you’re receiving a lifesaving organ, you have to be able to afford it,” said Kelly Green, executive director of HelpHopeLive, the Pennsylvania organization that has helped Mannion.

His friends and family have rallied, flocking to fundraisers that ranged from hair salon cut-a-thons to golf tournaments, raising nearly $115,000 so far for transplant-related care.

Allowing financial factors to determine who gets a spot on the waiting list strikes many as unfair, Caplan said.

“It may be a source of anger, because when we’re looking for organs, we don’t like to think that they go to the rich,” he said. “In reality, it’s largely true.”

Nearly half of the patients waiting for organs in the U.S. have private health insurance, UNOS data show. The rest are largely covered by the government, including Medicaid, the federal program for the disabled and poor, and Medicare.

Medicare also covers kidney transplants for all patients with end-stage renal disease. But, there’s a catch. While the cost of a kidney transplant is covered for people younger than 65, the program halts payment for anti-rejection drugs after 36 months. That leaves many patients facing sudden bills, said Tonya Saffer, vice president of health policy for the National Kidney Foundation.

Legislation that would extend Medicare coverage for those drugs has been stalled for years.

For Alex Reed, 28, of Pittsburgh, who received a kidney transplant three years ago, coverage for the dozen medications he takes ended Nov. 30. His mother, Bobbie Reed, 62, has been scrambling for a solution.

“We can’t pick up those costs,” said Reed, whose family runs an independent insurance firm. “It would be at least $3,000 or $4,000 a month.”

Prices for the drugs, which include powerful medications that prevent the body from rejecting the organs, have been falling in recent years as more generic versions have come to market, Saffer said.

But “the cost can still be hard on the budget,” she added.

It’s been a struggle for decades to get transplants and associated expenses covered by insurance, said Dr. Maryl Johnson, a heart failure and transplant cardiologist at the University of Wisconsin School of Medicine and Public Health.

“It’s unusual that there’s 100 percent coverage for everything,” said Johnson, a leader in the field for 30 years.

GoFundMe efforts have become a popular way for sick people to raise money. About a third of the campaigns on the site target medical needs, the company said.

But when patients need to raise money, they should use fundraising organizations specifically aimed at those costs, transplant experts say, including HelpHopeLive, the National Foundation for Transplants and the American Transplant Foundation.

There’s no guarantee funds generated through such general sites such as GoFundMe will be used for the intended purpose. In addition, the money likely will be regarded as taxable income that could jeopardize other resources, said Michelle Gilchrist, president and chief executive for the National Foundation for Transplants.

Her group, which helps about 4,000 patients a year, has raised $82 million for transplant costs since 1983, she said. Such efforts usually involve a huge public-relations push. Still, 20 percent of the patients who turn to NFT each year fail to raise the needed funds, Gilchrist said.

In those cases, the patients don’t get the organs they need. “My concern is that health care should be accessible for everyone,” she said, adding: “Ten thousand dollars is a lot to someone who doesn’t have it.”

Every transplant center in the U.S. has a team of social workers and financial coordinators who help patients negotiate the gaps in their care. Lara Tushla, a licensed clinical social worker with the Rush University transplant program in Chicago, monitors about 2,000 transplant patients. She urges potential patients to think realistically about the costs they’ll face.

“The pharmacy will not hand over a bag full of pills without a bag full of money,” she said. “They will not bill you. They want the copays before they give you the medication.”


KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Government Investigation Finds Flaws In the FDA’s Orphan Drug Program

The Food and Drug Administration has failed to ensure that drugs given prized rare-disease status meet the intent of a 35-year-old law, federal officials revealed in a report today.

The Government Accountability Office, which spent more than a year investigating the FDA’s orphan drug program, said “challenges continue” in the program that was created to spur development of drugs for diseases afflicting fewer than 200,000 patients.

The investigation began after a request from three high-profile Republican senators last year, in the wake of a KHN investigation. KHN found that the program was being manipulated by drugmakers to maximize profits and to protect niche markets for medicines being taken by millions.

The GAO uncovered inconsistent and often incomplete reviews early in the process of designating medicines as orphan drugs and recommended “executive action” to fix the system. In some cases, FDA reviewers failed to show they had checked how many patients could be treated by a drug being considered for orphan drug status; instead, they appeared to trust what drugmakers told them.

In response to GAO’s probe, the FDA issued a statement saying it is “streamlining our processes” and declined requests for interviews. Officials at the Department of Health and Human Services, which oversees the FDA, said they agreed with GAO’s recommendations.

John Dicken, director of the GAO’s health care team, said the focus of the report is “ensuring that the intent of the law is being met.”

The FDA’s rare-disease program began after Congress overwhelmingly passed the 1983 Orphan Drug Act to motivate pharmaceutical companies to develop drugs for people who lacked treatments for their conditions. Rare diseases had been ignored by drugmakers because treatments for them weren’t expected to be profitable. The law provides fee waivers, tax incentives for research and seven years of marketing exclusivity for any drug the FDA approves as an “orphan.”

The incentives, though, have proven to be more powerful and highly coveted than expected, said Avik Roy, president of the Foundation for Research on Equal Opportunity, a conservative think tank.

Many people are “starting to wonder whether or not the Orphan Drug Act over-corrected for the problem,” Roy said, noting that a third of all pharmaceutical spending in the U.S. will be on so-called rare-disease medicines in 2020.

GAO investigators examined FDA records for 148 applications submitted by drugmakers for orphan drug approval in late 2017. FDA’s reviewers are supposed to apply two specific criteria — how many patients would be served and whether there is scientific evidence the drug will treat the disease.

In nearly 60 percent of the cases, the FDA reviewers did not capture regulatory history information, including “adverse actions” from other regulatory agencies. The FDA uses experienced reviewers, Dicken noted, who may already know the history of certain submitted drugs and not see the need to document it.

And 15 percent of the time FDA reviewers failed to independently verify patient estimates provided by the drugmaker.

Of the 148 records the GAO reviewed, 26 applications from manufacturers were granted orphan status even though the initial FDA staff review was missing information.

“It is tempting to think that perhaps those approvals were sort of granted routinely without sufficient scrutiny,” said Bernard Munos, senior fellow at FasterCures and the Milken Institute.

By contrast, early Orphan Drug Act advocate Abbey Meyers said she was not concerned about the lack of population estimates because many rare diseases lack population studies that show how common a disease is.

Rather, Meyers said, she’s “disappointed that there is no government-funded agency that is willing to finance” such research.

The GAO investigation began after Scott Gottlieb, who took over as FDA commissioner in May 2017, announced a “modernization” of the rare-disease program.

Critics have long complained that drugmakers game the FDA’s approval process for orphan drugs. In January 2017, the KHN investigation, which was co-published and aired by NPR, revealed that many orphan drugs aren’t entirely new and don’t always start off treating rare diseases.

The GAO report, while not analyzing the same years, found that 38.5 percent of orphan drug approvals from 2008 to 2017 were for drugs that had been previously approved either for mass-market or rare-disease use. About 71 percent of the drugs given orphan status were intended to treat diseases affecting fewer than 100,000 people.

KHN’s investigation found that popular mass-market drugs such as cholesterol blockbuster Crestor, Abilify for psychiatric conditions, cancer drug Herceptin and rheumatoid arthritis drug Humira, the best-selling medicine in the world, all won orphan approval yet were already on the market to treat common conditions.

In addition, more than 80 orphan drugs won FDA approval for more than one rare disease — or several — each one with its own bundle of rich incentives.

Genentech’s Avastin, a cancer treatment approved for mass-market use in 2004, won three more orphan-designated approvals this year for the treatment of three rare forms of cancer. It now has 11 approved orphan uses in all, and exclusive protections that keep generics at bay won’t run out until 2025.

Sens. Orrin Hatch (R-Utah), Chuck Grassley (R-Iowa) and Tom Cotton (R-Ark.) sent a letter in March 2017 asking the GAO to investigate the program and find out whether Congress’ original intent for it was still being followed.

“Despite the success of the Orphan Drug Act, 95 percent of rare diseases still have no treatment options,” Hatch said in a statement Friday. “I hope that my colleagues will utilize this [GAO] report as they work to strengthen the accomplishments of the Orphan Drug Act and encourage developers to continue their investment in this patient population.” The GAO report also mentioned concerns about prices, noting that “the ability to command high prices” was one reason the rare-disease market was growing so rapidly.

The average cost per patient for an orphan drug was $147,308 in 2017 compared with $30,708 for a mass-market drug, according to a 2018 EvaluatePharma report on the 100 top-selling drugs in the U.S. Celgene’s chemotherapy drug Revlimid was the top-selling orphan with $5.4 billion in sales and $184,011 in revenue per patient.

“We have accepted culturally that it’s OK for a company to charge high prices for [orphan] drugs,” said Roy. “The end result is that a lot of these orphan drugs are $10 billion drugs, even though they are for rare diseases,” he added.

From 2008 to 2017, more than 50 percent of the drugs granted orphan status were for oncology or hematology, according to the GAO report. And nearly two-thirds of drugs approved in the program were given expedited review processes, such as accelerated approval or fast-track designation.

Prior to announcing Gottlieb’s modernization plan, the FDA had a backlog of 138 drug applications for orphan status that had been waiting more than 120 days. The backlog was cleared in August 2017 after staff from across the agency stepped in to help.


KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Government Investigation Finds Flaws In the FDA’s Orphan Drug Program

The Food and Drug Administration has failed to ensure that drugs given prized rare-disease status meet the intent of a 35-year-old law, federal officials revealed in a report today.

The Government Accountability Office, which spent more than a year investigating the FDA’s orphan drug program, said “challenges continue” in the program that was created to spur development of drugs for diseases afflicting fewer than 200,000 patients.

The investigation began after a request from three high-profile Republican senators last year, in the wake of a KHN investigation. KHN found that the program was being manipulated by drugmakers to maximize profits and to protect niche markets for medicines being taken by millions.

The GAO uncovered inconsistent and often incomplete reviews early in the process of designating medicines as orphan drugs and recommended “executive action” to fix the system. In some cases, FDA reviewers failed to show they had checked how many patients could be treated by a drug being considered for orphan drug status; instead, they appeared to trust what drugmakers told them.

In response to GAO’s probe, the FDA issued a statement saying it is “streamlining our processes” and declined requests for interviews. Officials at the Department of Health and Human Services, which oversees the FDA, said they agreed with GAO’s recommendations.

John Dicken, director of the GAO’s health care team, said the focus of the report is “ensuring that the intent of the law is being met.”

The FDA’s rare-disease program began after Congress overwhelmingly passed the 1983 Orphan Drug Act to motivate pharmaceutical companies to develop drugs for people who lacked treatments for their conditions. Rare diseases had been ignored by drugmakers because treatments for them weren’t expected to be profitable. The law provides fee waivers, tax incentives for research and seven years of marketing exclusivity for any drug the FDA approves as an “orphan.”

The incentives, though, have proven to be more powerful and highly coveted than expected, said Avik Roy, president of the Foundation for Research on Equal Opportunity, a conservative think tank.

Many people are “starting to wonder whether or not the Orphan Drug Act over-corrected for the problem,” Roy said, noting that a third of all pharmaceutical spending in the U.S. will be on so-called rare-disease medicines in 2020.

GAO investigators examined FDA records for 148 applications submitted by drugmakers for orphan drug approval in late 2017. FDA’s reviewers are supposed to apply two specific criteria — how many patients would be served and whether there is scientific evidence the drug will treat the disease.

In nearly 60 percent of the cases, the FDA reviewers did not capture regulatory history information, including “adverse actions” from other regulatory agencies. The FDA uses experienced reviewers, Dicken noted, who may already know the history of certain submitted drugs and not see the need to document it.

And 15 percent of the time FDA reviewers failed to independently verify patient estimates provided by the drugmaker.

Of the 148 records the GAO reviewed, 26 applications from manufacturers were granted orphan status even though the initial FDA staff review was missing information.

“It is tempting to think that perhaps those approvals were sort of granted routinely without sufficient scrutiny,” said Bernard Munos, senior fellow at FasterCures and the Milken Institute.

By contrast, early Orphan Drug Act advocate Abbey Meyers said she was not concerned about the lack of population estimates because many rare diseases lack population studies that show how common a disease is.

Rather, Meyers said, she’s “disappointed that there is no government-funded agency that is willing to finance” such research.

The GAO investigation began after Scott Gottlieb, who took over as FDA commissioner in May 2017, announced a “modernization” of the rare-disease program.

Critics have long complained that drugmakers game the FDA’s approval process for orphan drugs. In January 2017, the KHN investigation, which was co-published and aired by NPR, revealed that many orphan drugs aren’t entirely new and don’t always start off treating rare diseases.

The GAO report, while not analyzing the same years, found that 38.5 percent of orphan drug approvals from 2008 to 2017 were for drugs that had been previously approved either for mass-market or rare-disease use. About 71 percent of the drugs given orphan status were intended to treat diseases affecting fewer than 100,000 people.

KHN’s investigation found that popular mass-market drugs such as cholesterol blockbuster Crestor, Abilify for psychiatric conditions, cancer drug Herceptin and rheumatoid arthritis drug Humira, the best-selling medicine in the world, all won orphan approval yet were already on the market to treat common conditions.

In addition, more than 80 orphan drugs won FDA approval for more than one rare disease — or several — each one with its own bundle of rich incentives.

Genentech’s Avastin, a cancer treatment approved for mass-market use in 2004, won three more orphan-designated approvals this year for the treatment of three rare forms of cancer. It now has 11 approved orphan uses in all, and exclusive protections that keep generics at bay won’t run out until 2025.

Sens. Orrin Hatch (R-Utah), Chuck Grassley (R-Iowa) and Tom Cotton (R-Ark.) sent a letter in March 2017 asking the GAO to investigate the program and find out whether Congress’ original intent for it was still being followed.

“Despite the success of the Orphan Drug Act, 95 percent of rare diseases still have no treatment options,” Hatch said in a statement Friday. “I hope that my colleagues will utilize this [GAO] report as they work to strengthen the accomplishments of the Orphan Drug Act and encourage developers to continue their investment in this patient population.” The GAO report also mentioned concerns about prices, noting that “the ability to command high prices” was one reason the rare-disease market was growing so rapidly.

The average cost per patient for an orphan drug was $147,308 in 2017 compared with $30,708 for a mass-market drug, according to a 2018 EvaluatePharma report on the 100 top-selling drugs in the U.S. Celgene’s chemotherapy drug Revlimid was the top-selling orphan with $5.4 billion in sales and $184,011 in revenue per patient.

“We have accepted culturally that it’s OK for a company to charge high prices for [orphan] drugs,” said Roy. “The end result is that a lot of these orphan drugs are $10 billion drugs, even though they are for rare diseases,” he added.

From 2008 to 2017, more than 50 percent of the drugs granted orphan status were for oncology or hematology, according to the GAO report. And nearly two-thirds of drugs approved in the program were given expedited review processes, such as accelerated approval or fast-track designation.

Prior to announcing Gottlieb’s modernization plan, the FDA had a backlog of 138 drug applications for orphan status that had been waiting more than 120 days. The backlog was cleared in August 2017 after staff from across the agency stepped in to help.


KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Must-Reads Of The Week From Brianna Labuskes

Happy Friday! I don’t know about you, but I have been absolutely riveted by the ethics controversy that has sent the scientific community into a shocked-and-appalled, pearl-clutching frenzy this week. I’ll get to that in a second. First, another too-frequent example of the current pitfalls in our health system: A hospital turned down a woman’s heart transplant request because she lacked a secure source of financing for the drugs necessary for the procedure. The hospital’s suggestion for her? Use crowdfunding to raise the $10,000.

Now here’s what you may have missed as we enter that strange lull between holidays (though there certainly wasn’t a dearth of health news).

New guidelines released by the administration on Thursday, among other things, encourage states to flex their creative muscles on how to spend the subsidy money they get under the health law.

Currently, the subsidies are tied to income, and can be used only for insurance that meets federal standards and is purchased through public marketplaces. But the Centers for Medicare & Medicaid Services wants to lift those restrictions and let states do what they will with the pot of money. That could include: allowing the use of subsidies for short-term “junk insurance” plans; offering subsidies as incentive to woo in younger consumers; setting different income limitations; letting people with employer-based plans set up accounts to use the money, etc., etc.

If states acted on these options, that could steer the marketplace toward the geographical disparity that ran rampant before the health law. But it’s doubtful any state would want to take advantage of this offer in the first place. For one, it would be expensive for states to manage the pot of money. Secondly, even if a state received a waiver for the regulations, court challenges likely would follow. That could be more of a headache than it’s worth.

The Washington Post: New Insurance Guidelines Would Undermine Rules of the Affordable Care Act

Modern Healthcare: CMS Allows States to Get Creative With Federal Exchange Funds Under 1332 Waivers


The lagging numbers for this open-enrollment season are a bit at odds with what experts had seen as a stabilizing, if not quite flourishing, marketplace. While no one is Chicken Little-ing yet (there is still time left to see a boost, and the early weeks of November were busy ones for Americans), health law supporters are concerned that what they see as the administration’s attempts to “sabotage” the Affordable Care Act are coming to fruition.

Politico: Trump May Finally Be Undermining Obamacare

One statistic from the week that experts found “very troubling” was that for the first time in a decade the number of uninsured children rose, despite the improving economy and the low unemployment rate. Rural areas were particularly affected.

Los Angeles Times: Number of Uninsured Children Climbs, Reversing More Than a Decade of Progress, Report Finds


In what is certain to draw fierce pushback from patient advocacy groups and pharma alike, President Donald Trump is expanding Medicare’s negotiating power when certain drug prices rise faster than inflation. The idea has been kicking around for a while as both parties have been trying to come up with the silver bullet for high costs, but the political ramifications are unappetizing. Potentially cutting seniors off from needed drugs — whether it would play out that way or not — has always kept the idea on the back burner.

The New York Times: Trump Moves to Lower Medicare Drug Costs by Relaxing Some Patient Protections

File this under “I’m not sure that’s how it’s supposed to work”: A generic EpiPen is now available. The catch? It’s the exact same price as the one already out there.

The Hill: Generic EpiPen Not Any Cheaper Than Existing Version


FBI background checks were waived for caregivers and mental health workers who were in charge of caring for teens at an immigration detention center in Texas. The revelation ignited outrage, and the Department of Health and Human Services was quick to promise it would fingerprint the employees (officials warned it could take a while, though).

The government also allowed the company who is overseeing the operation of the facility to sidestep mental health requirements — youth shelters generally must have one mental health clinician for every 12 kids, but the contractor was allowed to staff the Texas facility with just one clinician for every 100 children.

The Associated Press: Lawmakers Press for Fingerprinting of Detention Camp Staff

Very quietly, family separations at the border have resumed.

ProPublica: Family Separations Are Still Happening at the Texas Border

Also, Baltimore is suing the Trump administration over its “public charge” policy that lets immigration officials use the acceptance of government aid, such as Medicaid, against those seeking green cards. The lawsuit might be the first of its kind, but it’s doubtful it will be the last.

The Associated Press: Baltimore Sues Trump Administration Over Immigration Policy


It is indicative of just how busy this week was that I haven’t gotten to the (aforementioned) ethics scandal rocking the scientific community yet, but we got here eventually. Chinese scientist He Jiankui dropped a bombshell (unverified and un-peer reviewed) on everyone that he gene-edited human embryos to make designer babies resistant to HIV infections.

This practice crosses an ethical line that many researchers had dug deep, deep, deep in the sand. “Deeply unethical,” “crazy,” “driven by hubris,” were just a few of the reactions from fellow scientists at the shocking news. One consensus that has come out of it, though, seems to be that there’s a crucial need for binding and international guidance on editing human genes. (Oh, and this isn’t over. He says there’s another pregnancy with gene-edited embryos underway.)

Los Angeles Times: Why Geneticists Say It’s Wrong to Edit the DNA of Embryos to Protect Them Against HIV

Stat: He Took a Crash Course in Bioethics, Then Created CRISPR Babies

NPR: Science Summit Denounces Gene-Edited Babies Claim, But Rejects Moratorium

Stat: NIH Director Says There’s Work to Do on Regulating Genome Editing


Medical device policy usually flies a bit under the radar, but it was a hot topic this week. Following a damning report on spinal implants causing severe injury to some patients, the Food and Drug Administration announced that it wants to revamp its (long-criticized and decades-old) approval system.

The Associated Press: FDA Says It Will Overhaul Criticized Medical Device System

And a look at whether the agency’s “first in the world” ambition contributed to a series of high-profile malfunctions.

The Associated Press: At FDA, a New Goal, Then a Push for Speedy Device Reviews


In the miscellaneous file this week:

• The combined suicide and opioid crises are taking a particularly grim toll on the country, sending us into our longest period of generally declining life expectancy since the slice of time that includes a little thing called World War I and the worst flu pandemic in modern history. I’m not going to lie, that’s not a great comparison.

The Associated Press: Suicide, at 50-Year Peak, Pushes Down US Life Expectancy

• A gut-wrenching personal story offers insight into the loved ones left behind in cases of suicides, and how they’re plagued with a forever-unanswerable question of “why”? The entire series is worth a deep read.

USA Today: Suicide: My Mom Took Her Life at The Grand Canyon

• An epidemic of extensive backlog of rape kits languishing on shelves in police departments recently drew a lot of attention. But an even more fundamental and low-profile issue? Those departments that trash them completely before the statute of limitations is up.

CNN: Destroyed: How the Trashing of Rape Kits Failed Victims and Jeopardizes Public Safety

• Johns Hopkins vowed to transform a Florida hospital’s heart surgery unit. Then patients started dying at an alarming rate.

Tampa Bay Times: Heartbroken

• Despite changes in policy, federal prisons are still failing to offer inmates proper mental health care.

The Washington Post/The Marshall Project: Federal Prisons Are Failing Inmates With Mental Health Disorders


As you can tell, it’s a good thing I started drinking coffee (for the first time ever, cue shocked faces) this week! No, I have not been spending my time Googling its health benefits. (OK, I have.) Have a lovely, possibly caffeine-fueled weekend!

Must-Reads Of The Week From Brianna Labuskes

Happy Friday! I don’t know about you, but I have been absolutely riveted by the ethics controversy that has sent the scientific community into a shocked-and-appalled, pearl-clutching frenzy this week. I’ll get to that in a second. First, another too-frequent example of the current pitfalls in our health system: A hospital turned down a woman’s heart transplant request because she lacked a secure source of financing for the drugs necessary for the procedure. The hospital’s suggestion for her? Use crowdfunding to raise the $10,000.

Now here’s what you may have missed as we enter that strange lull between holidays (though there certainly wasn’t a dearth of health news).

New guidelines released by the administration on Thursday, among other things, encourage states to flex their creative muscles on how to spend the subsidy money they get under the health law.

Currently, the subsidies are tied to income, and can be used only for insurance that meets federal standards and is purchased through public marketplaces. But the Centers for Medicare & Medicaid Services wants to lift those restrictions and let states do what they will with the pot of money. That could include: allowing the use of subsidies for short-term “junk insurance” plans; offering subsidies as incentive to woo in younger consumers; setting different income limitations; letting people with employer-based plans set up accounts to use the money, etc., etc.

If states acted on these options, that could steer the marketplace toward the geographical disparity that ran rampant before the health law. But it’s doubtful any state would want to take advantage of this offer in the first place. For one, it would be expensive for states to manage the pot of money. Secondly, even if a state received a waiver for the regulations, court challenges likely would follow. That could be more of a headache than it’s worth.

The Washington Post: New Insurance Guidelines Would Undermine Rules of the Affordable Care Act

Modern Healthcare: CMS Allows States to Get Creative With Federal Exchange Funds Under 1332 Waivers


The lagging numbers for this open-enrollment season are a bit at odds with what experts had seen as a stabilizing, if not quite flourishing, marketplace. While no one is Chicken Little-ing yet (there is still time left to see a boost, and the early weeks of November were busy ones for Americans), health law supporters are concerned that what they see as the administration’s attempts to “sabotage” the Affordable Care Act are coming to fruition.

Politico: Trump May Finally Be Undermining Obamacare

One statistic from the week that experts found “very troubling” was that for the first time in a decade the number of uninsured children rose, despite the improving economy and the low unemployment rate. Rural areas were particularly affected.

Los Angeles Times: Number of Uninsured Children Climbs, Reversing More Than a Decade of Progress, Report Finds


In what is certain to draw fierce pushback from patient advocacy groups and pharma alike, President Donald Trump is expanding Medicare’s negotiating power when certain drug prices rise faster than inflation. The idea has been kicking around for a while as both parties have been trying to come up with the silver bullet for high costs, but the political ramifications are unappetizing. Potentially cutting seniors off from needed drugs — whether it would play out that way or not — has always kept the idea on the back burner.

The New York Times: Trump Moves to Lower Medicare Drug Costs by Relaxing Some Patient Protections

File this under “I’m not sure that’s how it’s supposed to work”: A generic EpiPen is now available. The catch? It’s the exact same price as the one already out there.

The Hill: Generic EpiPen Not Any Cheaper Than Existing Version


FBI background checks were waived for caregivers and mental health workers who were in charge of caring for teens at an immigration detention center in Texas. The revelation ignited outrage, and the Department of Health and Human Services was quick to promise it would fingerprint the employees (officials warned it could take a while, though).

The government also allowed the company who is overseeing the operation of the facility to sidestep mental health requirements — youth shelters generally must have one mental health clinician for every 12 kids, but the contractor was allowed to staff the Texas facility with just one clinician for every 100 children.

The Associated Press: Lawmakers Press for Fingerprinting of Detention Camp Staff

Very quietly, family separations at the border have resumed.

ProPublica: Family Separations Are Still Happening at the Texas Border

Also, Baltimore is suing the Trump administration over its “public charge” policy that lets immigration officials use the acceptance of government aid, such as Medicaid, against those seeking green cards. The lawsuit might be the first of its kind, but it’s doubtful it will be the last.

The Associated Press: Baltimore Sues Trump Administration Over Immigration Policy


It is indicative of just how busy this week was that I haven’t gotten to the (aforementioned) ethics scandal rocking the scientific community yet, but we got here eventually. Chinese scientist He Jiankui dropped a bombshell (unverified and un-peer reviewed) on everyone that he gene-edited human embryos to make designer babies resistant to HIV infections.

This practice crosses an ethical line that many researchers had dug deep, deep, deep in the sand. “Deeply unethical,” “crazy,” “driven by hubris,” were just a few of the reactions from fellow scientists at the shocking news. One consensus that has come out of it, though, seems to be that there’s a crucial need for binding and international guidance on editing human genes. (Oh, and this isn’t over. He says there’s another pregnancy with gene-edited embryos underway.)

Los Angeles Times: Why Geneticists Say It’s Wrong to Edit the DNA of Embryos to Protect Them Against HIV

Stat: He Took a Crash Course in Bioethics, Then Created CRISPR Babies

NPR: Science Summit Denounces Gene-Edited Babies Claim, But Rejects Moratorium

Stat: NIH Director Says There’s Work to Do on Regulating Genome Editing


Medical device policy usually flies a bit under the radar, but it was a hot topic this week. Following a damning report on spinal implants causing severe injury to some patients, the Food and Drug Administration announced that it wants to revamp its (long-criticized and decades-old) approval system.

The Associated Press: FDA Says It Will Overhaul Criticized Medical Device System

And a look at whether the agency’s “first in the world” ambition contributed to a series of high-profile malfunctions.

The Associated Press: At FDA, a New Goal, Then a Push for Speedy Device Reviews


In the miscellaneous file this week:

• The combined suicide and opioid crises are taking a particularly grim toll on the country, sending us into our longest period of generally declining life expectancy since the slice of time that includes a little thing called World War I and the worst flu pandemic in modern history. I’m not going to lie, that’s not a great comparison.

The Associated Press: Suicide, at 50-Year Peak, Pushes Down US Life Expectancy

• A gut-wrenching personal story offers insight into the loved ones left behind in cases of suicides, and how they’re plagued with a forever-unanswerable question of “why”? The entire series is worth a deep read.

USA Today: Suicide: My Mom Took Her Life at The Grand Canyon

• An epidemic of extensive backlog of rape kits languishing on shelves in police departments recently drew a lot of attention. But an even more fundamental and low-profile issue? Those departments that trash them completely before the statute of limitations is up.

CNN: Destroyed: How the Trashing of Rape Kits Failed Victims and Jeopardizes Public Safety

• Johns Hopkins vowed to transform a Florida hospital’s heart surgery unit. Then patients started dying at an alarming rate.

Tampa Bay Times: Heartbroken

• Despite changes in policy, federal prisons are still failing to offer inmates proper mental health care.

The Washington Post/The Marshall Project: Federal Prisons Are Failing Inmates With Mental Health Disorders


As you can tell, it’s a good thing I started drinking coffee (for the first time ever, cue shocked faces) this week! No, I have not been spending my time Googling its health benefits. (OK, I have.) Have a lovely, possibly caffeine-fueled weekend!

Podcast: KHN’s ‘What The Health?’ Reading The Tea Leaves In Blue Wave’s Wake

This week, “What the Health?” panelists discuss, among other things, how the House Democrats’ leadership battle could affect the congressional health policy agenda.

The panelists are Mary Agnes Carey of Kaiser Health News, Margot Sanger-Katz of The New York Times, Alice Ollstein of Politico and Anna Edney of Bloomberg News.

As the post-election dust settles on Capitol Hill, the Democrats — soon to be in control of the House of Representatives — have begun the process of choosing their leadership team. How this shakes out will have a lot to do with how health policy agenda takes shape in the lower chamber.

House Democrats nominated Rep. Nancy Pelosi (D-Calif.) to retake the speaker’s gavel, but she still needs to win over more of her colleagues to secure the speaker post in January.

But all the action this week wasn’t focused on Congress. Food and Drug Administration Commissioner Scott Gottlieb unveiled a proposed overhaul of the FDA’s decades-old medical device approval process, and the Trump administration announced proposals it said would reduce Medicare prescription drug costs. Critics fear those changes could mean that some people with chronic diseases like AIDS or cancer might not have access to the drugs they need.

Among the takeaways from this week’s podcast:

  • House Democrats nominated Rep. Nancy Pelosi (D-Calif.) to retake the speaker’s gavel this week along with the rest of its leadership slate, Reps. Steny Hoyer of Maryland and Jim Clyburn of South Carolina. This is only the first step, though. The leadership positions will not be filled officially until January, when they are voted on by the full House. Although Pelosi is still wrangling for the support needed to earn her the required 218 votes, most insiders expect the Democrat’s leadership team to look much as it did the last time Democrats ruled the House chamber in 2010, when the Affordable Care Act became law. That means the House will likely be laser-focused on the necessary steps to protect the ACA. There may also be hearings on single-payer health insurance — a concept that is increasingly gaining interest and support within the caucus, and especially among some of its newest members.
  • In the background, the Texas lawsuit that could overturn the ACA’s protections for people with preexisting conditions is still pending. That decision could come any day. Keep in mind, though, that whatever the court rules, it is likely to be appealed immediately and move up the legal ladder. And, in the interim, House Democrats may still move forward with legislation to strengthen those ACA safeguards. Such a measure could get some GOP support because many Republicans seeking re-election this year said they wanted to ensure that patients with preexisting medical conditions would not lose coverage.
  • The FDA unveiled a proposed overhaul of its decades-old medical device approval system. Among its provisions, the plan includes steps to ensure that new medical devices reflect current safety and effectiveness features. Critics of the current system say it has failed to detect problems with some implants — like hip replacements that failed prematurely or surgical mesh that has been linked to pain and bleeding. The changes, if approved, could take years to implement and some might require congressional approval.
  • The Trump administration proposed a series of changes to reduce the number of prescription drugs that all Medicare drug plans must cover. The proposal focuses on drugs in six “protected classes” and involves medications such as antidepressants, antipsychotic medicines, cancer drugs and antiretrovirals to treat HIV/AIDS. Administration officials have said the proposal could cut costs for Medicare, but patient advocacy groups say it could reduce patients’ access for much-needed treatments. The proposed changes would not occur until 2020, and Congress could intervene to stop them.

Also this week, Julie Rovner interviews KHN senior correspondent Jay Hancock, who investigated and wrote the latest “Bill of the Month” feature for Kaiser Health News and NPR. It’s about a single mother from Ohio who received a wrongful bill for her multiple sclerosis treatment. You can read the story here.

If you have a medical bill you would like NPR and KHN to investigate, you can submit it here.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read too:

Mary Agnes Carey: The New York Times’ “This City’s Overdose Deaths Have Plunged. Can Others Learn From It?” by Abby Goodnough

Margot Sanger-Katz: NPR’s “Rethinking Bed Rest for Pregnancy,” by Alison Kodjak

Anna Edney: The Washington Post’s “Overdoses, Bedsores, Broken Bones: What Happened When a Private-Equity Firm Sought to Care for Society’s Most Vulnerable,” by Peter Whoriskey and Dan Keating

Alice Ollstein: Wired.com’s “The Science Is Clear: Dirty Farm Water Is Making Us Sick,” by Elizabeth Shogren and Susie Neilson

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcher or Google Play.

Democrats Taking Key Leadership Jobs Have Pocketed Millions From Pharma

Three of the lawmakers who will lead the House next year as Congress focuses on skyrocketing drug costs are among the biggest recipients of campaign contributions from the pharmaceutical industry, a new KHN analysis shows.

On Wednesday, House Democrats selected Rep. Steny Hoyer of Maryland to serve as the next majority leader and Rep. James Clyburn of South Carolina as majority whip, making them the No. 2 and No. 3 most powerful Democrats as their party regains control of the House in January.

Both lawmakers have received more than $1 million from pharmaceutical company political action committees in the past decade. Just four members of Congress hold that distinction, including Rep. Kevin McCarthy of California, whom Republicans chose as the next House minority leader earlier this month.

Adding Rep. Nancy Pelosi, the California Democrat expected to be the next speaker, the three-person House Democratic leadership team has collected more than $2.3 million total in campaign contributions from drugmakers since the 2007-08 election cycle, according to KHN’s database.

High drug prices surfaced as a major campaign issue in 2018. With almost half of Americans saying they were worried about prescription drug costs last summer, many Democrats told voters they’d tackle the issue in the next Congress. But the large amount of money going to key Democrats, and Republicans, raises questions about whether Congress will take on the pharmaceutical industry.

In the past decade, members of Congress from both parties have received about $81 million from 68 pharma PACs run by employees of companies that make drugs and industry trade groups.

Brendan Fischer, who directs federal reform programs at the nonpartisan Campaign Legal Center, said drugmakers, like other wealthy industries, “shower money” on congressional leaders who are mulling legislation that could affect the pharmaceutical industry.

“Both Democrats and Republicans have discussed taking action on prescription drug prices, and drug companies likely expect that big contributions will help them maintain access to, and influence over, powerful lawmakers,” he said.

McCarthy, who has close ties to President Donald Trump, has received more than $1.08 million from drugmaker PACs since 2007. According to the latest data, which runs through September, he received about $250,000 this election cycle.

The fourth lawmaker to top $1 million is Sen. Richard Burr, a North Carolina Republican who serves on both the Senate Committee on Health, Education, Labor and Pensions and the Senate Committee on Finance. North Carolina is also home to a number of research universities and drugmakers’ headquarters.

While campaign contributions may seem tantalizing as a metric for influence, industries are not necessarily buying votes with their cash. More likely, they are buying access — a sizable donation from a drugmaker’s PAC may increase the chances its lobbyists get a meeting with an influential lawmaker, for example.

Clyburn, who like Hoyer has served as a top Democratic leader since 2007, has received more from drugmaker PACs over the past decade than any other member of Congress — more than $1.09 million. During the 2018 election cycle, he received at least $170,000, despite trouncing his Republican opponent in his safely Democratic district.

A party leader and the highest-ranking African-American in Congress, Clyburn has had ties to the pharmaceutical industry over the years. In 2013, he was a featured speaker at a conference hosted by PhRMA, the industry’s leading trade group. The conference was held at the James E. Clyburn Research Center at the Medical University of South Carolina, a hub for biopharmaceutical research.

This fall, Hoyer topped the million-dollar mark in drugmaker PAC contributions over the past decade, collecting more than $1.02 million since 2007 and more than $128,000 this election cycle.

“Mr. Hoyer’s positions on legislation are based on what is in the best interest of his constituents and the American people, and he has made it clear the new Congress will tackle rising health care and prescription drug costs,” said Mariel Saez, a Hoyer spokeswoman.

Clyburn, McCarthy and Pelosi’s offices did not respond to requests for comment.

Pelosi, in contrast to her deputies, has received nearly $193,000 total from drugmaker PACs the past decade. In the month before the midterm elections, she intensified her calls for action to control drug prices, saying on Election Day that she believed Democrats could find “common ground” with Trump on addressing the problem.

Senior committee members also tend to draw huge sums from the industries they oversee. Rep. Frank Pallone of New Jersey, the Democrat who is expected to chair the House Committee on Energy and Commerce, received nearly $169,000 this election cycle from drugmaker PACs, according to KHN’s database. Since 2007, he has collected more than $840,000.

Similarly, Rep. Greg Walden, the Oregon Republican who is finishing his term as chair of the committee, received $302,300, the most of any member this election cycle in contributions from drugmaker PACs.

By contrast, Rep. Elijah Cummings — the Maryland Democrat who is expected to head the House Committee on Oversight and Government Reform — has attracted minimal drugmaker cash, receiving just $18,500 since the 2007-08 election cycle. He has made it clear that he intends to target pharmaceutical companies next year as he investigates climbing drug costs.

Pharma Cash To Congress

Every year, pharmaceutical companies contribute millions of dollars to U.S. senators and representatives as part of a multipronged effort to influence health care lawmaking and spending priorities. Use this tool to explore the sizable role drugmakers play in the campaign finance system, where many industries seek to influence Congress. Discover which lawmakers rake in the most money (or the least) and which pharma companies are the biggest contributors. Or use our search tool to look up members of Congress by name or home state, as well as dozens of drugmakers that KHN tracks.


Methodology

Kaiser Health News uses campaign finance reports from the Federal Election Commission (FEC) to track donations from political action committees (PACs) registered with the FEC by pharmaceutical companies. Totals include donations to the principal campaign committees and leadership PACs for current members of Congress. We include only donations to members for election cycles in which they hold office (even if they weren’t in office for the full cycle, in the case of special elections). Donations are assigned to the quarter in which they were given, regardless of when they are reported by the receiving committee or PAC. Exact amounts can change as amendments and refunds are reported; KHN will update the analysis quarterly. Occasionally, refunds are reported in a different cycle from the original contribution, resulting in a negative total for the cycle.

There is a legal limit to how much each PAC can give to a member of the Senate or House of Representatives: $5,000 per election (including primaries and general elections) and per committee, or $10,000 per cycle. Each cycle is two calendar years, e.g. Jan. 1, 2017-Dec. 31, 2018.

When calculating changes in contributions from one cycle to another, we compare the latest quarter in the current cycle to the same point in the previous cycle for all drugmakers and for members of the House, who run for re-election every two years. For senators, who run for re-election every six years, we compare the current cycle to the cycle six years prior. We use the ProPublica Congress API to gather some information about past and present members. We use both Open Secrets and CQ Political Moneyline to collect additional information about PACs and verify our work.


KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.