How The Government Shutdown Affects Health Programs

How The Government Shutdown Affects Health Programs

KFF Health News, January 3, 2019

Outstanding bills are putting the squeeze on some important health-related initiatives as the shutdown drags on.

This article first appeared January 03, 2019 on Kaiser Health News.

By Shefali Luthra

There seems to be no end in sight for the current partial government shutdown, the third since the beginning of the Trump administration.

For the vast majority of the federal government's public health efforts, though, it's business as usual.

That's because Congress has already passed five of its major appropriations bills, funding about three-fourths of the federal government, including the Department of Health and Human Services and the Department of Veterans Affairs.

But seven bills are outstanding — including those that fund the Interior, Agriculture and Justice departments — and that puts the squeeze on some important health-related initiatives.

The shutdown itself is not about health policies. It's the result of differences of opinion between the administration and congressional Democrats regarding Trump's so-called border wall. But it's far-reaching, nonetheless. Here's where things stand:

Funding for "big-ticket" health programs is already in place, alleviating much of the shutdown's immediate potential impact.

Since HHS funding is set through September, the flagship government health care programs — think Obamacare, Medicare and Medicaid — are insulated.

That's also true of public health surveillance, like tracking the flu virus, a responsibility of the Centers for Disease Control and Prevention. The National Institutes of Health, which oversees major biomedical research, is also fine. It's a stark contrast to last January's shutdown, which sent home about half of HHS's staff.

But some other public health operations are vulnerable because of complicated funding streams.

Although the Food and Drug Administration falls under the HHS umbrella, it receives significant funding for its food safety operations through the Department of Agriculture, which is entirely caught up in the shutdown.

The USDA provided an estimated $2.9 billion last year to the FDA for these oversight efforts, which involve everything from food recalls to routine facility inspections and cosmetics regulation. Not having those dollars now means, according to the FDA contingency plan, that about 40 percent of the agency — thousands of government workers — is furloughed.

The FDA's responsibilities for drug approval and oversight are funded by user fees and are not affected. Regulation of tobacco products is also continuing.

Health services for Native Americans are also on hold.

Because Congress has yet to approve funding for the Indian Health Service, which is run by HHS but gets its money through the Department of the Interior, IHS feels the full weight of the shutdown. The only services that can continue are those that meet "immediate needs of the patients, medical staff, and medical facilities," according to the shutdown contingency plan.

That includes IHS-run clinics, which provide direct health care to tribes around the country. These facilities are open, and many staffers are reporting to work because they are deemed "excepted," said Jennifer Buschik, an agency spokeswoman. But they will not be paid until Congress and the administration reach a deal.

Other IHS programs are taking a more direct hit. For example, the agency has suspended grants that support tribal health programs, as well as preventive health clinics run by the Office of Urban Indian Health Programs.

Public health efforts by Homeland Security and the EPA face serious constraints.

The Department of Homeland Security's Office of Health Affairs assesses threats posed by infectious diseases, pandemics and biological and chemical attacks. It is supposed to be scaling back, according to the department's shutdown contingency plan. This office is just one component of the 204-person Countering Weapons of Mass Destruction Office, which is retaining about 65 employees during the funding gap.

Other DHS health workers are likely to work without pay — for instance, health inspectors at the border, said Peter Boogaard, who was an agency spokesman under the Obama administration. According to DHS's plan, the vast majority of border patrol employees will continue working through the shutdown.

The Environmental Protection Agency has also run out of funding. According to its contingency plan, it's keeping on more than 700 employees without pay, including those who work on Superfund sites or other activities where the "threat to life or property is imminent." (More than 13,000 EPA workers have been furloughed.)

That limits the agency's capacity for activities including inspecting water that people drink and regulating pesticides.

But it's not just regulation. The public health stakes are visceral — and sometimes, frankly, pretty gross.

Just look at the National Park Service, which has halted restroom maintenance and trash service for lack of funding. On Sunday, Yosemite National Park in California closed its campgrounds. On Wednesday, Joshua Tree National Park, also in California, did the same.

Why? Per a park service press release: "The park is being forced to take this action for health and safety concerns as vault toilets reach capacity."

How Sen. Orrin Hatch Changed America's Health Care

How Sen. Orrin Hatch Changed America's Health Care

KFF Health News, January 2, 2019

Utah's Orrin Hatch is leaving the Senate, after 42 years. The Republican led bipartisan efforts to provide health care to more kids and AIDS patients. He also thrived on donations from the drug industry.

This article first appeared January 02, 2019 on Kaiser Health News.

By Erik Neumann, KUER

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."

Judge Who Invalidated Obamacare Has Been A 'Go-To Judge' For Republicans, Critics Say

Judge Who Invalidated Obamacare Has Been A 'Go-To Judge' For Republicans, Critics Say

KFF Health News, December 21, 2018

Because Judge Reed O'Connor is getting a lot of ideological lawsuits brought to him, it's making his voting record more controversial.

This article first appeared December 20, 2018 on Kaiser Health News.

By Ashley Lopez, KUT

Angela Lautner knew her thirst was unusual, even for someone directing airplanes, outside in the Memphis summer heat.

"We had coolers of Gatorade and water for people to always have access to," Lautner recalled of her job as a ground services agent. "But the amount of thirst that I felt was just incredible."

She had no appetite and she lost an unusual amount of weight. Then after a trip to the emergency room, Lautner, who was 22, was diagnosed with Type 1 diabetes. The diagnosis was life-changing.

To start, it meant that for the rest of her life she would require insulin injections every day to stay alive. Unlike Type 2 diabetes, which can sometimes be controlled by diet, people with Type 1 diabetes need daily insulin injections to regulate their blood sugar.

Lautner's diagnosis also meant she was no longer allowed to become a commercial airline pilot in the U.S. — a lifelong dream that she was training for in flight school at the time.

"I cried harder over losing my dream to fly than I did at the diagnosis of Type 1 diabetes," Lautner said.

But after 18 years living with diabetes, Lautner now says the hardest thing about the diagnosis is accessing insulin — the expensive drug she needs to keep her alive. She has had to borrow money from her parents to pay for insurance; she has spent hours on the phone with drug companies; she has switched brands of insulin to save costs; and she even moved to a new state, Kentucky, with a more generous Medicaid plan.

Last year, Lautner noticed other people with Type 1 diabetes tweeting similar stories under the hashtag #Insulin4All. She read the stories of Shane Patrick Boyle and Alec Raeshawn Smith, two men who died because they could not afford their insulin. It was an epiphany.

"I thought, 'My goodness, there's more people than me. I'm not the only one out here,' " she said.

Since then, Lautner has joined a group of consumer activists, people who need insulin to live and are angry about the sky-high prices. They are putting pressure on the three main companies that make insulin: Sanofi of France, Novo Nordisk of Denmark and Eli Lilly and Co. in the U.S.

Taking On The Drugmakers

The cost of insulin nearly tripled from 2002 to 2013 and has doubled again since then. The list price is over $300 for a single vial of medicine, and most people with Type 1 diabetes need multiple vials every month to live. That cost is typically lower with insurance or with discount programs. Still, for some people the price is unmanageable.

There's been some action by lawmakers on the issue. In October, Minnesota's attorney general sued insulin manufacturers alleging price gouging, and a bipartisan caucus in the U.S. Congress issued a report in November urging action to bring insulin prices down.

But prices are still going up, so consumer activists like Lautner are taking things into their own hands.

Nonprofit group T1International, which advocates for Type 1 diabetes around the world, with a particular focus on insulin prices, has started holding rallies outside the Indianapolis headquarters of pharmaceutical giant Eli Lilly and Co.

Lautner joined more than 70 people who came together to demonstrate there in September. They were asking for three things: transparency about how much it costs to make a vial of insulin and how much profit comes from each vial, and a commitment from the company to lower the list price of insulin.

Protesters hailed from at least 12 states, mainly Ohio, Illinois, Indiana and Kentucky, but also from as far away as New York. Lautner, who now lives outside Cincinnati, rented a school bus with a dozen others to make the 112-mile trip.

"Insulin is kind of the face of the drug pricing crisis in America," said Elizabeth Pfiester, founder of T1International who has Type 1 diabetes herself. "We literally die without it," she said. "We're fighting for our lives."

This was the third time the group had protested at Eli Lilly headquarters. Last fall, when the group held its first protest there, Pfiester said, it was "the first time where people living with Type 1 were able to physically stand and show that people are angry enough to come out."

Eli Lilly declined a request for an interview, but in statement a spokesperson said, "We understand why people are making their voices heard."

Protesting is one arm of their advocacy efforts; the group is also lobbying at the state and national level, and conducting online awareness-raising campaigns under the hashtag #Insulin4All.

Advocacy At The State Level

Last spring, the fight got even more personal for Angela Lautner. She got a letter from her insurance company saying they were no longer going to pay for the insulin she was taking. They wanted to switch her to a different brand.

Most people with Type 1 diabetes use two types of insulin: short-acting insulin to counteract the carbohydrates consumed with meals, and long-acting insulin to keep blood sugar stable throughout the day.

Lautner has found that the long-lasting insulin brand Lantus works best with her body; it keeps her blood sugars low, but not so low that she becomes dangerously hypoglycemic, risking death. But her insurer was dropping its coverage of Lantus in favor of a different long-lasting insulin, Basaglar.

"The problem that I immediately saw was that [Basaglar] had not worked for my body," Lautner said. "So I go into my doctor's office with this letter and I'm like, 'What am I going to do?'"

Lautner's doctor connected her to Sanofi's drug discount program, where she was able to get a month's supply of Lantus for a couple of hundred dollars. So she decided to pay for the insulin herself.

"I'm fortunate enough to have an emergency fund," Lautner said.

But she knows others aren't so lucky.

This year, Lautner organized her own group of diabetes activists in Kentucky, Ohio and Indiana, called KOI Insulin4All. They've met with legislators in all three states about establishing emergency insulin prescription refills and about making the cost of insulin more transparent.

There are similar groups starting up in Oklahoma, Pennsylvania, Minnesota and Illinois. In November, activists protested outside the Cambridge, Mass., office of Sanofi. All of them are pushing for the same thing — to make the voices of people with diabetes heard.

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