Tagged Pharmaceuticals

Medicaid Patients In Puerto Rico Don’t Get Coverage For Drugs To Cure Hepatitis C

Drugs that can cure hepatitis C revolutionized care for millions of Americans living with the deadly liver infection. The drugs came with a steep price tag — one that prompted state Medicaid programs to initially limit access to the medications to only the sickest patients. That eased, however, in many states as new drugs were introduced and the prices declined.

But not in Puerto Rico. Medicaid patients in the American territory get no coverage for these drugs.

The joint federal-territory health care program for the poor — which covers about half the island’s population — does not pay for hepatitis C medications. They also do not cover liver transplants, a procedure patients need if the virus causes the organ to fail.

The Puerto Rico Department of Health created a separate pilot project in 2015 to provide hepatitis C medications to those sickened by the liver infection who also have HIV but expanded the program later to those with only hepatitis C. However, according to the Office of Patient Legal Services, an official territorial agency that advocates for consumers, the program ran out of funding and is no longer accepting patients only with hepatitis C.

The Puerto Rico Health Insurance Administration (ASES), which oversees Medicaid, said it is working with a pharmaceutical company to create a cost-effective system to provide these medications.

“Definitely, they need to be given coverage,” said ASES director Angela Ávila Marrero. “They need to be given care.”

Hepatitis C, a bloodborne infection, increases the risk of cirrhosis, liver cancer and death. Poor screening led many to contract the disease through tainted blood and organ transplants into the early 1990s. Today, intravenous drug use drives most of the new cases in the United States.

William Ramirez, executive director of the American Civil Liberties Union of Puerto Rico, said he is considering filing suit against Puerto Rico for failing to cover the cost of these medications for people enrolled in Medicaid.

“You’re holding back medication and thereby allowing certain people to die,” Ramirez said.

That reality is clear for Hector Marcano, 62, who stopped working roughly six years ago because of the illness. After recovering from a drug addiction, he was a case manager who worked to connect drug users to health resources.

His liver disease is leading to overall deterioration. He struggles with walking. A bout of pneumonia that left him hospitalized lingers in his racking coughs. He spends his days reading, listening to the radio and praying for the strength to keep searching for the cure.

He doesn’t understand why the government does not provide hepatitis C medications, he said, especially as there are so many people in need of them.

“So what are we waiting for?” asked Marcano. “For a pandemic to happen?”

Medicaid Costs Drive Island’s Debt Crisis

Hepatitis C afflicts approximately 3.5 million people in the United States. The virus can silently corrode the liver for years without causing symptoms.

Because of the condition’s stealthy nature and the absence of recent data, the number of people in Puerto Rico living with the virus is uncertain. Researchers on the island in 2010 estimated 2.3 percent of 21- to 64-year-old residents had the virus.

Documents provided by the Center for Health Law and Policy Innovation of Harvard Law School show medical providers reported more than 11,000 hepatitis C cases to the Puerto Rico Department of Health from 2010 to September 2016.

Cynthia Pérez Cardona, an epidemiology professor at the University of Puerto Rico and an author of multiple studies involving hepatitis C in Puerto Rico, said she is uncertain of how widespread the virus is on the island. But other statistics present a worrisome sign: A report from the island’s cancer registry found the number of new liver cancer cases increased an average of 2.1 percent annually among men and 0.7 percent among women from 1987 to 2014. Hepatitis C can cause such cancers.

Despite these warnings, Puerto Rico has fewer resources than most of the nation to care for its impoverished.

Unlike states, Puerto Rico’s federal funding for Medicaid is capped. Historically, these federal dollars have fallen far short of covering the program’s costs on the island. The territory’s crushing Medicaid expenses helped drive the island into its $70 billion debt crisis.

Under these financial constraints, said Matt Salo, executive director of the National Association of Medicaid Directors, Puerto Rico’s officials are left with a difficult choice when considering covering hepatitis C drugs.

“Rather than blowing through their cap in six months,” Salo said, “they’d blow through their cap in one month.”

Pilot Project Falls Short

In the health department’s pilot project, patients with certain conditions like uncontrolled diabetes or an active mental health condition or those who could not prove they had been sober for six months were barred.

Such restrictions rankle patients and their advocates. “You know, we do not deny lung cancer treatment for a person who smokes or diabetes treatment to a person that doesn’t eat well,” said Robert Greenwald, a professor at Harvard Law School and faculty director of the Center for Health Law and Policy Innovation.

Dr. José Vargas Vidot, a member of Puerto Rico’s Senate and a physician, submitted a petition in 2017 to various territorial agencies questioning Medicaid’s coverage of hepatitis C medications.

The Office of Patient Legal Services responded to Vargas Vidot in a letter this year confirming that the island’s Medicaid program did not cover these drugs. It also noted the health department pilot project closed its wait list after reaching 100 patients because of a lack of funding. In November, Vargas Vidot submitted legislation to require that hepatitis C medication and treatment be part of basic coverage for insurance plans and Medicaid.

Ávila Marrero said ASES is in talks with a drugmaker to create a network separate from the Medicaid program to provide medications to the patients. She said she hopes the arrangement will allow the government to get lower prices for the drugs. But no agreements have yet been reached for such a program.

Despite its success in states, suing to get coverage may not be the best option for Puerto Rico because the debt rescue package passed by Congress in 2016 includes a provision that bars creditors from taking legal action to collect from the territory.

That could apply to a lawsuit filed against the territory for not covering hepatitis C treatment in its Medicaid program, said Phillip Escoriaza, a health and federal grants law attorney in Washington, D.C., who practiced in Puerto Rico. And even if the case can go forward, it would enter the docket for a special bankruptcy court with more than 165,000 other claims, as of Dec. 14. It may be in the Puerto Rican government’s interest for things to take a long time, said Escoriaza. Once there, it could stall for years — time hepatitis C patients such as Marcano might not have.

Podcast: KHN’s ‘What The Health?’ Ask Us Anything!

This week, KHN’s “What the Health?” panelists answered questions submitted by listeners.

Among the topics covered were why Medicare doesn’t cover most dental care, how to address high drug prices and what federal officials do with all that data they collect from health care providers.

This week’s panelists for KHN’s “What the Health?” are Julie Rovner of Kaiser Health News, Joanne Kenen of Politico, Stephanie Armour of The Wall Street Journal and Paige Winfield Cunningham of The Washington Post.

The panel addressed questions including the following:

  • “Besides your podcast, what resources, including books and journals, do you recommend people read to build basic knowledge about the U.S. payer system?”
  • “What is the likelihood that Congress will pass legislation to include full dental care in Medicare, say in the next 10 years?”
  • “CMS collects an extraordinary amount of data from its various quality reporting programs. … What does the agency do with this data and is there any evidence quality reporting improves patient outcomes or achieves other policy aims?”
  • “Do you have a view on whether Medicare paying less money for prescription drugs would lead to drug companies charging more to private insurers?”
  • “There’s been a lot of back-and-forth lately between the National Institutes of Health, the Department of Health and Human Services and the media regarding fetal tissue research. HHS is currently doing a review, and the Trump administration just posted a ban to the NIH labs to stop procuring any new fetal tissue. This jeopardizes many research studies, especially those studying HIV. What do you think the long-term consequences of this will be?”

To hear all our podcasts, click here.

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

Podcast: KHN’s ‘What The Health?’ Ask Us Anything!

This week, KHN’s “What the Health?” panelists answered questions submitted by listeners.

Among the topics covered were why Medicare doesn’t cover most dental care, how to address high drug prices and what federal officials do with all that data they collect from health care providers.

This week’s panelists for KHN’s “What the Health?” are Julie Rovner of Kaiser Health News, Joanne Kenen of Politico, Stephanie Armour of The Wall Street Journal and Paige Winfield Cunningham of The Washington Post.

The panel addressed questions including the following:

  • “Besides your podcast, what resources, including books and journals, do you recommend people read to build basic knowledge about the U.S. payer system?”
  • “What is the likelihood that Congress will pass legislation to include full dental care in Medicare, say in the next 10 years?”
  • “CMS collects an extraordinary amount of data from its various quality reporting programs. … What does the agency do with this data and is there any evidence quality reporting improves patient outcomes or achieves other policy aims?”
  • “Do you have a view on whether Medicare paying less money for prescription drugs would lead to drug companies charging more to private insurers?”
  • “There’s been a lot of back-and-forth lately between the National Institutes of Health, the Department of Health and Human Services and the media regarding fetal tissue research. HHS is currently doing a review, and the Trump administration just posted a ban to the NIH labs to stop procuring any new fetal tissue. This jeopardizes many research studies, especially those studying HIV. What do you think the long-term consequences of this will be?”

To hear all our podcasts, click here.

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

Pharma Is Back To Raising Drug Prices, But Increases Aren’t Quite As Eye-Popping As Industry Tries To Avoid Spotlight

“Clearly, more caution is in the air and many major multinationals such as Pfizer and Novartis, which found themselves making the headlines several months back, have yet to implement their January increases,” said Raymond James analyst Elliot Wilbur. President Donald Trump said on Wednesday that he expects drug prices to drop despite pharmaceutical companies lifting their self-imposed hiatus on price increases.

Pharma Is Back To Raising Drug Prices, But Increases Aren’t Quite As Eye-Popping As Industry Tries To Avoid Spotlight

“Clearly, more caution is in the air and many major multinationals such as Pfizer and Novartis, which found themselves making the headlines several months back, have yet to implement their January increases,” said Raymond James analyst Elliot Wilbur. President Donald Trump said on Wednesday that he expects drug prices to drop despite pharmaceutical companies lifting their self-imposed hiatus on price increases.

How Sen. Orrin Hatch Changed America’s Health Care

Sen. Orrin Hatch, the Utah Republican retiring from 42 years in the Senate as a new generation is sworn in, leaves a long list of achievements in health care. Some were more controversial than others.

Hatch played key roles in shepherding the 1983 Orphan Drug Act to promote drug development for rare diseases, and the 1984 National Organ Transplant Act, which helped create a national transplant registry. And in 1995, when many people with AIDS were still feeling marginalized by society and elected leaders, he testified before the Senate about reauthorizing funding for his Ryan White CARE Act to treat uninsured people who have HIV.

“AIDS does not play favorites,” Hatch told other senators. “It affects rich and poor, adults and children, men and women, rural communities and the inner cities. We know much, but the fear remains.”

Hatch, now 84, co-sponsored a number of bills with Democrats over the years, often with Sen. Ted Kennedy of Massachusetts. The two men were sometimes called “the odd couple,” for their politically mismatched friendship.

In 1997, the two proposed a broad new health safety net for kids — the Children’s Health Insurance Program.

“This is an area the country has made enormous progress on, and it’s something we should all feel proud of — and Senator Hatch should too,” said Joan Alker, executive director of Georgetown University’s Center for Children and Families.

Before CHIP was enacted, the number of uninsured children in America was around 10 million. Today, it’s under half that.

Hatch’s influence on American health care partly came from the sheer number of bills he sponsored — more than any other living lawmaker — and because he was chairman of several powerful Senate committees.

“History was on his side because the Republicans were in charge,” said Dr. David Sundwall, an emeritus professor in public health at the University of Utah and Hatch’s health director in the 1980s.

When Ronald Reagan was elected president in 1981, the Senate became Republican-controlled for the first time in decades. Hatch was appointed chairman of what is now known as the Health, Education, Labor and Pensions Committee. The powerful legislative group has oversight of the Food and Drug Administration, Centers for Disease Control and Prevention and the National Institutes of Health.

“He was virtually catapulted into this chairmanship role,” Sundwall said. “This is astonishing that he had chairmanship of an umbrella committee in his first term in the Senate.”

In 2011, Hatch was appointed to the influential Senate Finance Committee, where he later became chairman. There he helped oversee the national health programs Medicare, Medicaid and CHIP.

Hatch’s growing influence in Congress did not go unnoticed by health care lobbyists. According to the watchdog organization Center for Responsive Politics, in the past 25 years of political campaign funding, Hatch ranks third of all members of Congress for contributions from the pharmaceutical and health sector. (That’s behind Democratic senators who ran for higher office — President Barack Obama and presidential nominee Hillary Clinton).

“Clearly, he was PhRMA’s man on the Hill,” said Dr. Jeremy Greene, referring to the trade group that represents pharmaceutical companies. Green is a professor of the history of medicine at Johns Hopkins University School of Medicine. Though Hatch did work to lower drug prices, Greene said, the senator’s record was mixed on the regulation of drug companies.

For example, an important piece of Hatch’s legislative legacy is the 1984 Hatch-Waxman Act, drafted with then-Rep. Henry Waxman, an influential Democrat from California. While the law promoted the development of cheaper, generic drugs, it also rewarded brand-name drug companies by extending their patents on valuable medicines.

The law did spur sales of cheaper generics, Greene said. But drugmakers soon learned how to exploit the law’s weaknesses.

“The makers of brand-name drugs began to craft larger and larger webs of multiple patents around their drugs,” aiming to preserve their monopolies after the initial patent expired, Greene said.

Other brand-name drugmakers preserved their monopolies by paying makers of generics not to compete.

“These pay-for-delay deals effectively hinged on a part of the Hatch-Waxman Act,” Greene said.

Hatch also worked closely with the dietary supplement industry. The multibillion-dollar industry specializing in vitamins, minerals, herbs and other “natural” health products, is concentrated in his home state of Utah.

“There was really no place for these natural health products,” said Loren Israelsen, president of the United Natural Products Alliance and a Hatch staffer in the late 1970s.

As the industry grew, there was a debate over how to regulate it: Should it be more like food or like drugs? In 1994, Hatch sponsored the Dietary Supplement Health and Education Act, known as DSHEA, which treats supplements more like food.

“It was necessary to have someone who was a champion who would say, ‘All right, if we need to change the law, what does it look like,’ and ‘Let’s go,’” Israelsen said.

Some legislators and consumer advocacy groups wanted vitamins and other supplements to go through a tight approval process, akin to the testing the Food and Drug Administration requires of drugs. But DSHEA reined in the FDA, determining that supplements do not have to meet the same safety and efficacy standards as prescription drugs.

That legislative clamp on regulation has led to ongoing questions about whether dietary supplements actually work and concerns about how they interact with other medications patients may be taking.

DSHEA was co-sponsored by Democrat Tom Harkin, then a senator from Iowa.

While that kind of bipartisanship defined much of Hatch’s career, it has been less evident in recent years. He was strongly opposed to the Affordable Care Act, and in 2018 called supporters of the heath law among the “stupidest, dumb-ass people” he had ever met. (Hatch later characterized the remark as “a poorly worded joke.”)

In his farewell speech on the Senate floor in December, Hatch lamented the polarization that has overtaken Congress.

“Gridlock is the new norm,” he said. “Like the humidity here, partisanship permeates everything we do.”

This story is part of a partnership that includes KUER, NPR and Kaiser Health News.


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