Postcard From D.C.: Kicking Around The ACA? For Tom Price, That's So 2017.

KFF Health News, May 2, 2018

The former HHS secretary, who resigned amid scandal last fall, criticized the elimination of the ACA's penalty for those who don't have insurance.

This article first appeared May 01, 2018 on Kaiser Health News.

By Emmarie Huetteman

In a surprising reversal, Dr. Tom Price said he now thinks getting rid of the individual mandate was a bad idea.

Yet this is the same Tom Price who only last summer laid the groundwork for the mandate’s eventual dismantling, saying it was “driving up the costs for the American people.”

In some of his first public remarks since resigning as secretary of Health and Human Services amid a scandal about his travel expenses last September, Price criticized the elimination of the Affordable Care Act’s penalty for those who don’t have insurance.

“There are many, and I’m one of them, who believes that that actually will harm the pool in the exchange market,” he said Tuesday, as one of several dozen keynote speakers at the annual World Health Care Congress in Washington. “Because you’ll likely have individuals that are younger and healthier not participating in that market, and consequently that drives up the costs for other folks within that market.”

At the conference, Price re-introduced himself — a third-generation physician who did “a short stint at HHS” — to insurers, drugmakers and other health industry types.

Washington could be forgiven for thinking they had met before.

As a congressman and then HHS secretary, he’d been a vocal critic of the ACA, lambasting its many elements — including the individual mandate — and pressing for the law’s full repeal. Months after Price’s resignation, that penalty was removed by Congress as part of a tax bill even as the ACA itself remained, having withstood multiple Republican attempts to kill it.

It has been seven months since Price stepped down amid reports he misspent hundreds of thousands of dollars of taxpayer money on private charter and military air travel. Price sidestepped questions Tuesday about the Trump administration and his change of heart on the individual mandate.

But Price’s re-emergence offered a snapshot of a tarnished former Trump administration official working on his next act. In January, he joined the board of the Atlanta-based Jackson Healthcare, a health care staffing and technology company.

A conference spokeswoman did not respond to inquiries about the decision to invite Price and whether he was paid to give remarks. The conference organizers played down Price’s remarks, billed as “a candid perspective” on the prospects for efforts to repeal and replace the Affordable Care Act and timed early on the third day of the four-day conference. He was conspicuously absent from the headshots of featured speakers splashed across the conference website and cagey about his plans for the future, referring only to his “advisory roles” when asked.

Gone was the Tom Price who, as a leading critic of the ACA while a Republican congressman from Georgia, attracted the attention of President Donald Trump. But it was the administration’s fight against the ACA that, by many accounts, cost him Trump’s support.

Price “better get the votes,” Trump said in a speech last July, days before the Senate rejected one of the last in a round of attempts to repeal President Barack Obama’s signature health care law. “Otherwise I will say, ‘Tom, you’re fired’.”

“From a policy standpoint, the repeal-and-replace battle last year was kind of the height of political frustration, wasn’t it?” Price mused to the audience Tuesday.

Instead of hammering the ACA, Price offered a brisk, occasionally perfunctory assessment of the health care landscape, ticking off a list of challenges (regulation, bad; wearables such as Fitbits, good) and developments (the health care market, stable; association health plans, under review). The states are doing their own assessments and reacting to it — and rightfully so, he said, pointing to decisions by Republican-led states such as Utah to expand Medicaid. (He had opposed the expansion of Medicaid as a congressman.)

On this, Price could offer an expert up-close opinion: “These are states that have looked at the situation, don’t necessarily see a solution coming out of Washington.”

Telemedicine Opening Doors To Specialty Care For Inmates

KFF Health News, May 1, 2018

States that reported using telemedicine for their prison populations said the services were most commonly employed for psychiatry and cardiology.

This article first appeared May 01, 2018 on Kaiser Health News.

By Michelle Andrews

When an inmate needs to see a medical specialist, getting that care can be complicated.

Prisons are often located in rural areas far from medical centers that have experts in cancer, heart and other disease treatments. Even if the visit just involves a trip to a hospital across town, the inmate must be transported under guard, often in shackles.

The whole process is expensive for the correctional facility and time-consuming for the patient.

Given the challenges, it’s no wonder many correctional facilities have embraced telemedicine. They use video conferencing to allow inmates to see medical specialists and psychiatrists without ever leaving the facility.

A survey by the federal Centers for Disease Control and Prevention of prison health care in 2011 found that 30 states out of 45 that responded said they used telemedicine for at least one type of specialty or diagnostic service. The participating states reported that telemedicine was most commonly used for psychiatry (62.2 percent) and cardiology (26.6 percent), according to the research, which was published in 2016.

Among the corrections facilities offering these services is Rikers Island, which houses nine jails on an island near LaGuardia Airport in New York City. It recently began to provide telehealth services for female inmates who need oncology, rheumatology and hematology services. Other specialties are expected to be added in the future.

Male inmates on Rikers have been receiving telehealth services since 2016. Roughly 40 inmates have virtual visits each month with specialists in those same areas as well as infectious disease, urology, dermatology, pulmonology and gastroenterology.

“Initially we implemented [telehealth] for the efficiency part, to avoid hours of transport,” said Dr. Ross MacDonald, chief medical officer for NYC Health + Hospitals/Correctional Health Services, which runs the health care services at Rikers. “But what we’ve learned over time is that it really improves clinical care.” Telehealth allows the referring physician at the jail to consult with the specialist at the hospital as a team, and together clarify information for the patient, MacDonald said.

Clinicians provide regular primary care at the jail. When a medical concern is identified that requires a specialist’s attention, the patient visits the jail’s medical clinic with the provider who referred her, and the two of them go over the patient’s medical history and symptoms with a specialist at NYC Health + Hospitals/Elmhurst in Queens who is visible on the monitor. If vital signs need to be checked or other tests performed, the primary care provider can handle that and relay the information to the specialist.

If after that meeting, a face-to-face exam with the specialist is necessary, that would be scheduled, MacDonald said.

“This is not meant to replace in-person visits, it’s meant to complement them,” he said.

Still, some prisoner advocates worry about the increasing use of telemedicine. Khalil Cumberbatch said he’s concerned that the video visits may heighten inmates’ feelings of isolation. Cumberbatch spent nearly a year on Rikers Island, first as he awaited trial on first-degree robbery charges in the early 2000s and later when he appealed his conviction.

He now works as the associate vice president of policy at the Fortune Society, a nonprofit organization that supports efforts to help prisoners re-enter society after incarceration.

“You’re removing contact with the outside world,” he said. “There’s a level of engagement that can be lost when you’re doing it on the screen.”

But for sick prisoners, that may not be a priority, others say.

“Lots of them don’t want to go to the outside facility,” said Dr. Edward Levine, the medical director for prison care for Ohio State University Wexner Medical Center, which has been doing telemedicine with the Ohio Department of Rehabilitation and Correction since 1995. “These people are sick. They have to get on a bus, it’s bumpy, and there are delays, and if [they’re] not feeling well, they don’t like it.”

Levine estimates he sees up to 150 gastroenterology patients a year at Ohio’s 29 prisons through telemedicine visits. “You develop a relationship with them the same as you would if you saw them in a clinic,” he said.

Although inmates may owe copayments if they see a provider for run-of-the-mill aches and pains, they won’t generally have to pay for specialty care, whether provided on-site or through telemedicine, said Dr. Anne Spaulding, an epidemiologist and associate professor at Emory University’s public health school in Atlanta who has worked as a medical director in corrections. That’s because a medical provider typically initiates specialty care. Inmates are more commonly charged for medical visits that they initiate, she said.

Telemedicine can improve continuity of care and help patients keep chronic conditions under control. In one study of HIV-infected adults incarcerated at Illinois Department of Corrections facilities, 91 percent of telemedicine patients achieved complete suppression of the virus during the first six visits, compared with 59 percent of patients who received standard care on-site at the facilities. The study credited the results to having specialists provide evidence-based, up-to-date care through telemedicine, rather than relying on primary care physicians at the correctional facilities.

“If we can see them in real time without having to leave the facility, we get better outcomes,” said Dr. Jeremy Young, an infectious-disease specialist and associate professor of medicine at the University of Illinois at Chicago, who was the lead author of the study.

Tax-Funded Mental Health Programs Not Always Easy To Find

KFF Health News, April 30, 2018

Until there's a central information source, consumers will have to use their research skills, plus a little telephone work.

This article first appeared April 30, 2018 on Kaiser Health News.

By Emily Bazar

Back in 2008, Mary Hogden was homeless, living on the streets of Berkeley, Calif.

“I got beat up really badly out there,” says Hogden, 62. “It’s not a safe place for women.”

She landed in the hospital and then in a boarding home for adults with mental illness. But her big break came when she started volunteering for a mental health program called the Pool of Consumer Champions, run by Alameda County.

Participants, who offer each other support, also advise the county’s behavioral health division on how to better meet consumers’ needs. The county has adopted some of the group’s recommendations, Hogden says.

“People rallied around me when I was unstable and struggling with my mental health,” Hogden recalls.

She didn’t know at the time that the program was paid for by the state’s Mental Health Services Act (MHSA). But after two years as a volunteer, she became a paid staffer and learned that the program wouldn’t exist without that funding.

“I wouldn’t be where I’m at in my wellness and recovery had it not been for the Mental Health Services Act,” Hogden says.

In 2004, Californians approved the act, originally known as Proposition 63, which imposes a 1 percent tax on personal income over $1 million to help counties expand mental health care services.

The tax has raised billions, and Gov. Jerry Brown expects it will bring in roughly $1.8 billion in the coming fiscal year.

“Counties were able to take Mental Health Services Act dollars and either revamp existing programs or completely create new programs that didn’t exist at all,” says James Wagner, deputy director of Alameda County Behavioral Health Care Services.

The act has been “wildly successful” at improving the ability of counties to respond to the mental health needs of their residents, he says.

But counties and the state have faced criticism from the Little Hoover Commission, an independent state oversight agency, and others for their implementation of the law. In February, a state audit accused counties of hoarding the mental health money — and the state of failing to ensure the money was being spent.

Still, there’s no question “these programs have helped hundreds of thousands of people,” says Heidi Strunk, president of the California Coalition for Mental Health.

A 2016 compilation of MHSA-funded programs across the state lists page after page of offerings that address homelessness, suicide, caregivers, veterans, children and dozens of other topics and populations, including scholarships for college students pursuing degrees in mental health.

But what’s available — and to whom — depends on your county. For instance, most programs are for low-income residents, but that’s not true across the board. Unfortunately for consumers, researching county programs and determining whether you or your loved ones qualify may not be easy.

“It’s so hard for individuals and families to know what kind of services are available, especially because there’s no statewide standard,” says Jessica Cruz, CEO of NAMI California, an advocacy group for individuals, and their families, who have been affected by serious mental illness.

“Access is an issue,” Cruz says. “There’s not one singular place to look and see what’s available.”

Strunk’s coalition is advocating for a statewide, interactive map that will allow you to click on your county and see its Mental Health Services Act programs. NAMI California, which compiled the 2016 list of programs statewide, is working on an update, but that won’t be out until this summer, Cruz says. (Check NAMI California’s website at namica.org for the update.)

“We’re still trying to resolve issues with how to get information to the public,” Strunk says.

Until there’s a central information source, you will have to use your research skills, plus a little telephone work.

To get started, Strunk suggests Googling your county’s name and the term “MHSA coordinator.” Then call that person. You can also find your county’s MHSA plan online.

Some counties have toll-free hotlines that will help connect you with appropriate programs based on your needs. (In Orange County, for example, it’s 855-625-4657. In Alameda County, dial 800-491-9099. Riverside County residents can call 800-706-7500.)

“Each county webpage looks different,” Strunk warns. “Some counties have super user-friendly landing pages, for some counties it’s buried, and some you can’t find at all.”

MHSA programs primarily serve recipients of Medi-Cal, California’s version of the federal Medicaid program for low-income residents, and uninsured people with serious mental illnesses. But there are also services for a broader range of the population.

About 20 percent of Mental Health Services Act dollars are earmarked for “prevention and early intervention,” and these are more likely to serve a wider cross section of people.

Sharon Ishikawa, Orange County’s Mental Health Services Act coordinator, points to OC ACCEPT as one example. The program provides counseling, vocational support and other services to people — and their families — who are confronting challenges related to sexual orientation and gender identity.

“It is open to anybody with or without insurance,” says Dawn Smith, a program manager who oversees several of the county’s MHSA-funded services. “They might have a really high deductible and don’t have a way to pay that or they might not be able to afford the copay.”

But the majority of participants are uninsured, Smith says.

NAMI, which has chapters across the state, operates some MHSA-funded programs on behalf of counties, and eligibility is not based on insurance status, Cruz says.

“For us, anybody’s eligible. Anybody can come to a family-to-family class. Anybody can come to a support group. You don’t have to be referred by the county,” she explains.

NAMI Orange County runs the MHSA-funded Peer Connector program, says Diana Fernandez, one of the peer mentors.

The program is for people, regardless of income, who have a family member or friend who is struggling with mental illness, a learning disorder or a behavioral problem. Participants can have a one-hour phone call each week for up to 12 weeks with peer mentors who have had personal experience finding help for themselves or loved ones, Fernandez explains.

Fernandez has five children, and two have struggled with dyslexia and attention deficit hyperactivity disorder (ADHD).

Last week, Fernandez spoke with a man who told her he felt suicidal. She stayed on the phone and connected him with the county’s crisis assessment team, then waited until she knew he was on his way to the hospital.

That situation was unusual, she says. More typically, Fernandez helps parents of children who are struggling in school, or caregivers who are emotionally and physically spent.

“We assure clients that they are normal and typical for what they’re going through,” she says. “That gives them a feeling of hope they may not have had before.”

How A Drug Company Under Pressure For High Prices Ratchets Up Political Activity

KFF Health News, April 30, 2018

Pharma businesses overall made political donations of $12.1 million last year, down from a $13.6 million election-year surge in 2016 but 9 percent higher than 2015.

This article first appeared April 30, 2018 on Kaiser Health News.

By Jay Hancock and Elizabeth Lucas

Business looked challenging for Novo Nordisk at the end of 2016. As pressure mounted over the pharma giant’s soaring insulin prices, investors drove its stock down by a third on fears that policymakers would take action, limit prices and hurt profits.

Then things got worse. A Massachusetts law firm sued the company and two other pharma firms on behalf of patients, claiming that high insulin prices of hundreds of dollars a month forced diabetics to starve themselves to minimize their blood sugar while skimping on doses. At least five states began investigating insulin makers and their business partners.

As scrutiny rose, Novo Nordisk engaged in what analysts say is a time-honored response to public criticism. It aggressively ratcheted up spending to spread its influence in Washington and to have a louder say in the debates over drug prices.

The drugmaker’s political action committee spent $405,000 on federal campaign donations and other political outlays last year, more than in 2016 — an election year — and nearly double its allocation for 2015, data compiled by Kaiser Health News show.

“We remain committed to being part of the discussion,” said Tricia Brooks, head of government relations and public affairs for Novo Nordisk, acknowledging scrutiny over insulin prices but saying the company has many other issues to work on with policymakers. “I don’t want us to run away from it and hide or keep our head down and wait for it to roll over.”

Novo Nordisk also spent $3.2 million lobbying Congress and federal agencies in 2017, its biggest-ever investment in directly influencing U.S. policymakers, according to the Center for Responsive Politics.

Part of that surge included summoning more than 400 Novo Nordisk employees to contact lawmakers and their staffs on Capitol Hill, “a huge increase from anything we’ve ever done before,” Brooks said.

Taken together, the increases represent a “major corporate policy shift” for the company and appear to be a classic business response to growing political risk, said Kent Cooper, a former Federal Election Commission official who has tracked political money for decades.

The pharma industry as a whole has behaved similarly, cranking up political contributions and lobbying. Meanwhile, despite much talk about change, Congress and the Trump administration have done little to control drug prices or threaten drug-company profits.

Pharma businesses overall made political donations of $12.1 million last year, down from a $13.6 million election-year surge in 2016 but 9 percent higher than the haul for 2015, according to the KHN analysis. Pharma industry lobbying expenses surpassed $171 million last year, the highest level since 2009, during negotiations over the Affordable Care Act, according to CRP.

“It’s been hot in the health care arena for — how many years now?” said Steven Billet, who teaches lobbying and PAC management at George Washington University. “Anybody in this world now is sitting there thinking, “When I go back to the board next year, I’m going to ask for 15 percent more in my [lobbying and campaign finance] budget. Because this isn’t going away.’”

Like most big corporations, Novo Nordisk runs a political action committee, or PAC, which solicits employee donations and gives the proceeds to political candidates’ campaigns. The company is Danish. Only workers who are U.S. citizens or permanent residents are allowed to support the PAC.

Like many PACs, Novo Nordisk spreads money to both parties, concentrating on powerful committee members and other leaders. Since 2013 it has given $22,500 to House Speaker Paul Ryan, a Republican, and $20,472 to South Carolina’s James Clyburn, a member of the Democratic House leadership.

Brooks gave the PAC $4,370 last year, the data show. Some employees gave as little as $20 or $30.

The firm’s influence-seeking has grown along with its U.S. sales, which went from hundreds of millions of dollars in the early 2000s to some $9 billion last year. Its biggest business is diabetes, including various types of insulin whose list prices have more than doubled in recent years.

The wholesale list price for a vial of Novo Nordisk’s Levemir, a long-acting insulin, went from $144.80 in 2012 to $335.70 in January, when the price rose 4 percent, according to Connecture, a research firm.

Even Alex Azar, a former Eli Lilly executive who became Health and Human Services secretary in January, said in his confirmation hearing that “insulin prices are high, and they’re too high.” Along with Novo Nordisk and Sanofi, Lilly is one of the three big insulin makers under investigation by state attorneys general for price increases that seem suspiciously similar in size and timing.

Sanofi and Lilly both spent more last year on political donations and federal lobbying than Novo Nordisk. Lilly’s political spending was $548,100 for 2017, up 12 percent from 2015, the previous off-election year, the data show. Sanofi’s was $527,200, down from 2015.

But potential insulin price limits threaten Novo Nordisk more than those companies because diabetes-related drugs account for an exceptionally big portion of its business, analysts said. Several proposals under consideration by Congress could lower insulin prices or limit future increases.

One would allow the Medicare program for seniors to negotiate prices for covered drugs, thus lowering the cost.

Other proposals would make it easier for competing, “biosimilar” alternatives to break through the thicket of patents created by sellers of complex drugs such as insulin. Others would bring more transparency, requiring companies to publish and justify price increases.

None of the proposals has made it out of congressional committees. In the face of inaction by Washington, Novo Nordisk’s stock has recovered much of the ground it lost in 2016.

Novo Nordisk rejects suggestions that it coordinated price increases with competitors. So do Sanofi and Lilly.

List prices such as those tracked by Connecture don’t reflect what patients or their insurers ultimately pay, said Novo Nordisk spokesman Ken Inchausti. Growing discounts and rebates substantially reduced the reported list price, he said.

Even including discounts, however, the company’s net profit margin for 2017 was 34 percent, its highest since at least 2000, when it was half that high.

Official filings show Novo Nordisk lobbyists have been weighing in on numerous measures related to drug prices, including proposals to import less expensive drugs from Canada.

The company lobbies Washington on a wide range of issues including diabetes prevention, budget matters, chronic disease and making obesity an accepted medical disease that insurers will pay to prevent, Brooks said.

But last year’s increase in campaign donations and lobbying doesn’t look like business as usual for Novo Nordisk, said Billet, a former AT&T lobbyist who directs GWU’s Legislative Affairs program.

“I’m not surprised,” he said. “They’ve obviously had some issues recently. This is maybe a predictable enough element in their strategy.”

Male OB-GYNs Are Rare. Is That A Problem?

KFF Health News, April 27, 2018

The gender that at one time dominated the field is now at some schools considered a diversity hire.

This article first appeared April 27, 2018 on Kaiser Health News.

By Alex Olgin, WFAE

As she left a 12-hour day on the labor and delivery shift, Dr. Katie Merriam turned off her pager.

"I don't know what I'd do without it, you know? It's another limb. I always know where it is," she said, laughing.

The third-year resident in obstetrics and gynecology at the Carolinas Medical Center hospital in Charlotte, N.C., works in a medical specialty dominated by women, treating women. She feels a special connection to her patients, Merriam said.

"You just, you can feel what they feel and understand why they feel certain ways. I do feel a special bond," she said.

Nationally, 82 percent of doctors matching into OB-GYN residency programs are women. Many OB-GYN patients say they prefer female doctors. Merriam's residency class is a bit of an anomaly — half of its members are men. Though it's nice to work with so many women, Merriam said, she and some of her female colleagues also like the perspective that men bring to the work environment.

"No one could really pinpoint about what balance they bring, but there's something nice about having them," she said.

It's important to have men in the field, she said, if only to continue to give patients options in their choice of providers. But most of her friends and other women she talks to, she said, want female doctors.

Blake Butterworth, a fourth-year obstetrics and gynecology resident at the Medical University of South Carolina in Charleston, said he doesn't take it personally when he hears that sort of thing from a patient.

"I don't get discouraged; I don't get offended," Butterworth said. "I gladly hand that patient off."

He's one of only two male residents in the program of 24 at MUSC and said he finds it rewarding when he can win a new patient's confidence.

"I have patients that clearly express disdain to have to see a guy," he said. "Then I develop rapport with her. And she says, 'I expected you to be X, Y, Z, and you were better than that.'"

Butterworth said he chose obstetrics and gynecology because it lets him develop long-term relationships with patients — providing routine OB-GYN care and more complicated surgeries, if need be.

"Once you really get into it, and get involved in it, I don't think that bias [that the field is best left to women] holds true," he said.

Butterworth said he believes it is incumbent on male OB-GYNs to talk to male medical students about the benefits of having men in the field. Students need to know it's OK to have an interest in the field, he said, and that they will find work.

In fact, says Dr. Ashlyn Savage, an associate professor of obstetrics and gynecology at MUSC, it may be the opposite.

"In an effort to really diversify the applicant pool, we will apply in some cases different screening standards to decide who we are going to interview," Savage said. "For example, we might consider an applicant with a slightly lower board score — just to enhance how many men we are interviewing and considering."

It has been a challenge to find male OB-GYNs for the program, she said. The gender that at one time dominated the field is now at some schools considered a diversity hire. But Savage questions whether balancing the number of men and women in the specialty is as important as racial or ethnic diversity.

"The interesting thing to me is the primary motivation to [seek a diverse candidate pool] is so that patients have the opportunity to seek out physicians who might...feel like themselves," she said. "In this particular case...all of the patients for OB-GYNs are women."

Among practicing OB-GYNs in the U.S., a little fewer than half are men, according to the American College of Obstetricians and Gynecologists, formerly known as the American Congress of Obstetricians and Gynecologists. But ACOG predicts that 10 years from now, two-thirds of the doctors in that specialty will be female.

Still, male doctors hold many key posts in OB-GYN professional organizations.

"Leadership tends to be held by people who are older," Savage said. "And we are still in a scenario where [more of] our older faculty tend to be men."

A study published last fall found that women are underrepresented in leadership roles in medical school departments of obstetrics and gynecology throughout the country. That ratio was most lopsided in men's favor in the South.

It's perhaps only a matter of time before that, too, changes. Savage said she recently learned that her program's incoming class of OB-GYN residents next year will be all female.

Dissecting The Rhetoric Vs. Reality Of Trump's Tough Talk On Drug Prices

KFF Health News, April 27, 2018

Trump promised a speech on prescription drug prices, and it's expected anytime.

This article first appeared April 27, 2018 on Kaiser Health News.

By Sarah Jane Tribble

President Donald Trump has railed against the high price of prescription drugs and famously bemoaned how pharmaceutical companies are “getting away with murder.” Yet, many Americans aren’t seeing a change in what they pay out-of-pocket.

Trump promised a speech on prescription drug prices, and it’s expected anytime.

Here’s a look at the rhetoric thus far versus the results.

"You’ll be seeing drug prices falling very substantially in the not-too-distant future, and it’s going to be beautiful."

What’s Happening:

The White House and administration leaders, including Health and Human Services Secretary Alex Azar and Food and Drug Administration Commissioner Scott Gottlieb, say increasing competition is a priority. Gottlieb — whom Trump has called a star — said the FDA has approved a record number of generic drugs and eliminated a backlog in approvals.

The agency is looking for ways to boost price competition for biologics, which are made from natural sources and are among the most expensive drugs on the market. Currently, pharmacists cannot substitute a lower-cost “biosimilar” version when the doctor prescribes a biologic. FDA has proposed “interchangeability” rules that could change the status quo.

The Outlook:

Driving down drug prices through competition may take awhile. That’s because even after gaining FDA approval, generic drugs often have trouble being launched, according to Chip Davis, president of the Association for Accessible Medicines, a trade group for makers of generics and biosimilars. Only three of nine biosimilars approved are available for patients, largely due to patent protections.

"We have to get the prices of prescription drugs way down and unravel the tangled web of special interests that are driving prices up for medicine and for really hurting patients."

What’s Happening:

To say health care is complicated is an understatement. The system that dictates how patients get prescriptions and what they pay includes an array of buyers and payers, such as insurance companies and pharmacy benefit managers. In February, the White House pitched the idea of passing on the discounts and rebates negotiated by PBMs, the financial middlemen between insurers and drugmakers, to seniors who buy drugs through Medicare Part D. This idea, first floated under President Barack Obama’s administration, would mean seniors would pay less out-of-pocket but could also increase premiums if insurers took on added costs.

The Outlook:

Late last year, the administration released a request for public comment on this idea, and pressure is building for the administration to take action. “It’s the one thing you could say that has immediate benefit to consumers,” said John Rother, president of the National Coalition on Health Care. But House Minority Leader Nancy Pelosi said she isn’t convinced much will really change: “At this point, no one is surprised that President Trump has found another reason not to act on prescription drug costs,” Pelosi said in a statement to Kaiser Health News. “While President Trump is making more excuses, Democrats will be discussing real solutions.”

"I have directed my administration to make fixing the injustice of high drug prices one of our top priorities for the year. And prices will come down substantially. Watch."

What’s Happening:

The White House has pitched moving drugs covered under Medicare Part B into the popular Part D program. Part B is the bucket of Medicare that covers drugs that are administered in hospital outpatient settings and doctor’s offices, including expensive chemotherapy and rheumatoid arthritis infusions. Insurers compete for business in Part D and negotiate prices for their members, but there is no such price negotiation in Part B. Total drug spending in the Part B program was about $26 billion in 2015, and the upward trend is ominous.

The Outlook:

While providers and insurers are likely to fight it, there’s no reason the idea wouldn’t work, said Tom Scully, the former Centers for Medicare & Medicaid Services administrator who designed the Medicare prescription drug programs in the early 2000s. He worked closely with HHS’ current leader, Azar, who was then general counsel for HHS. “There’s no reason to have Part B,” said Scully, adding that moving the drugs under Part D would require price negotiation. “If you really want to drive down drug prices, you have to put somebody’s money at risk other than the taxpayers’.”

"For Medicare, for Medicaid, we have to get the prices way down, so that’s what we’re going to be talking about."

Trump, Jan. 31, 2017, while holding a listening session with pharmaceutical industry leaders

What’s Happening:

When the White House announced Trump’s forthcoming speech, it also noted that it would coincide with a formal request for information from Health and Human Services on various drug-pricing ideas. The request leaves the door wide open for proposed changes in Medicare and Medicaid. Several experts predict the administration will test payment models through demonstrations under the broad authority of the Center for Medicare & Medicaid Innovation, or CMMI.

The Outlook:

Ideas such as moving drugs to Part D as well as allowing certain states to create drug lists under their Medicaid formularies, as Massachusetts has requested, and other value-based pricing models would be possible under a CMMI demonstration, said Andrea Harris, who leads the health care team at Height Capital Markets. Still, this process could take awhile, and Harris said, “I don’t think anything will meaningfully impact drug-related stocks between now and the midterms [elections].”

"Prescription drug prices are out of control. The drug prices have gone through the roof. … The drug companies, frankly, are getting away with murder.”

What’s Happening:

While there has been no direct proposal that would force the pharmaceutical industry to lower the launch price of its drugs, the industry lost a battle last month when Congress reduced how much seniors would pay for prescription drugs in Medicare. It was a rare loss and signaled that the powerful industry may be in a defensive position. And Trump has another card to play with the Federal Trade Commission.

The Outlook:

Trump has nominated Joe Simons, a Washington antitrust lawyer, to lead the FTC. During his nomination hearings in February, he said he’s “very concerned” with price increases for prescription drugs. The agency, which polices anticompetitive behavior, has several vacancies to fill.

'Rapid Autopsy' Programs Seek Clues To Cancer Within Hours Of Death

KFF Health News, April 26, 2018

Rapid-autopsy technology has been available for decades. But only in recent years have more hospitals been launching and expanding programs.

This article first appeared April 26, 2018 on Kaiser Health News.

By JoNel Aleccia

After Keith Beck died of bile duct cancer last year, family members said more than 900 people showed up to pay respects to the popular athletic director at the University of Findlay in northwestern Ohio.

Many were former students who recalled acts of kindness during Beck's nearly 30-year career: $20 given to a kid who was broke, textbooks bought for a student whose parents were going through bankruptcy, a spot cleared to sleep on Beck's living room floor.

But few knew about Beck's final gesture of generosity. The 59-year-old had agreed to a "rapid autopsy," a procedure conducted within hours of his death on March 28, 2017, so that scientists could learn as much as possible from the cancer that killed him.

"He was 100 percent for it," recalled his ex-wife, Nancy Beck, 63, who cared for Beck at the end of his life. "It wasn't the easiest thing to do, but it was important."

Beck donated his body to a rapid-autopsy research study at the Ohio State University, part of a small but growing effort by more than a dozen medical centers nationwide. The idea is to obtain tumor tissue immediately after death — before it has a chance to degrade. Scientists say such samples are the key to understanding the genetics of cancers that spread through the body, thwarting efforts to cure them.

"People are recognizing that cancer is more heterogeneous than we realize," said Dr. Sameek Roychowdhury, a medical scientist at OSU's Comprehensive Cancer Center. "Different parts of your body may have different cancer cells, even though they originated from the same cancer."

In Beck's case, results from the rapid autopsy showed he had developed a mutation that caused the experimental drug he was taking, known as an FGFR inhibitor, to stop working. Roychowdhury and colleagues plan to report on Beck's case in an upcoming paper.

"This is helping us shape how we develop this new drug," Roychowdhury said. "How can we make a better drug? Or can we make a better drug combination?"

Rapid-autopsy technology has been available for decades. Researchers at the University of Washington in Seattle have been using the technique to study prostate cancer since 1991. Scientists at the University of Nebraska Medical Center launched a now-robust program in 2000.

But only in recent years have more hospitals been launching and expanding programs, said Dr. Jody Hooper, director of the Legacy Gift Rapid Autopsy Program at Johns Hopkins Medicine in Baltimore. At last count, there were 14 similar programs in the U.S.

Funding for them varies, Hooper said, but typically they're supported by a mix of cancer program resources, grants and researcher fees.

Scientists recognize the value of examining tissue from multiple sites soon after death and obtaining larger samples than they could while a patient was living. Cancer cells can be retrieved during such autopsies and kept alive, allowing researchers to experiment with ways to treat — or kill — them.

"It's the power of sampling over the entire body at the same time," said Hooper, who conducts about one rapid autopsy a month, often providing tissue for up to a half-dozen researchers interested in different questions.

Most programs focus on cancer, but efforts are underway to expand the practice, possibly to shed light on virus reservoirs in HIV patients, for instance.

Speed is essential to preserve RNA and DNA, the building blocks of cells, which can degrade quickly after death. It's best to obtain specimens of living cells within six hours of death and other tissue within 12 hours, Hooper said.

The need for speed is also what makes such autopsies challenging. Families must consent to the procedure, often while freshly grieving their loved one's death. And the logistics surrounding retrieving a body, conducting an autopsy and then returning the body for a funeral are often complicated. Traffic is unpredictable and "one time, there was a blizzard," Hooper said.

Roychowdhury said he and one of his clinical fellows are on call at all times.

"The patients have our cellphone numbers, as well as the next of kin," he said.

Broaching the subject with patients and families requires tact and compassion. Most patients are enrolled in clinical trials and learn about the autopsies from their doctors or pathologists like Hooper. Many are willing, even eager, to cooperate, she said.

"These are mostly patients with metastatic cancer," she said. "They've made their peace with the outcome long before."

For some, the rapid autopsy is simply the final phase of the clinical trial.

"They want to do something not only for themselves, but also to help others," Roychowdhury said.

That's how Linda Boyed, 52, of Lewis Center, Ohio, sees it. Like Beck, she has bile duct cancer and is enrolled in a trial to treat it. The drugs are working now, but Boyed said she has agreed to a rapid autopsy after death so scientists can learn from her when they're no longer effective.

"I have a strong Christian faith," she said. "I believe we're put on this Earth to help each other."

Because the rapid autopsies are paid through program funds and grants, there's no cost to the families. Bodies are returned within a day and in a condition that doesn't affect funeral plans.

"My emphasis is that it was all done with dignity and respect," said Nancy Beck. "We felt honored to be able to do this."

Performing the autopsy after treating a patient in life is an honor for doctors, too, Roychowdhury said.

"This was once a living, breathing person that came into my office every other week," he said. "The thing I want to think about each day is that they've given so much so that others can benefit.

"Everyone has something to teach us after death."

Hospitals Lure Diabetes Patients With Self-Care Courses, But Costs Can Weigh Heavily

KFF Health News, April 26, 2018

The classes, targeting a disease that affects 30 million Americans, have become a revenue generator for hospitals and an opportunity for marketing and branding.

This article first appeared April 26, 2018 on Kaiser Health News.

By Julie Appleby

When a routine physical revealed mildly elevated blood-sugar levels, Michael Phillips was strongly encouraged to sign up for a diabetes self-management class.

Phillips never asked about the cost of the two half-day sessions he attended in a conference room at St. Mary’s Hospital in Athens, Ga., and doesn’t recall the instructor mentioning it.

But the 64-year-old retired bank analyst was flabbergasted when he opened his bill after attending.

“What, $1,044 for a class?" said Phillips, who fought the bill with the hospital and his insurer, Blue Cross Blue Shield of Georgia. “The hospital is charging an exorbitant rate, but BCBS is going along with it — why aren’t they screaming about being gouged?"

There are about 1.5 million Americans newly diagnosed with Type 2 diabetes each year. Unlike Type 1 diabetes, an autoimmune disease in which people produce no insulin that begins in childhood, Type 2 diabetes is a condition of adulthood, typically associated with weight and a sedentary lifestyle.

Diabetes self-management programs teach patients how to monitor their blood sugars, what to eat and the importance of exercise as strategies to delay or avoid the disease’s serious complications.

Patients like Phillips, with early or mild diabetes, can modify their habits so that their blood sugar returns to normal.

But the classes, targeting a disease that affects 30 million Americans, have also become a revenue generator for hospitals and an opportunity for marketing and branding.

“If you can get 25 in the class and charge $500 each, you can make a lot of money," said Gerard Anderson, a professor of health policy and management Johns Hopkins University Bloomberg School Public Health. An additional incentive is that the classes bring “people into the hospital that they expect will need the hospital in the future."

Phillips' class had about a dozen students, who got a free lunch, free parking and a sample of Glucerna, a nutrition drink formulated for diabetics. The instructor noted that St. Mary’s operates a gym that participants could join for a fee.

Diabetes is among the costliest of medical conditions. The American Diabetes Association estimates that average medical expenditures for those diagnosed with diabetes are 2.3 times higher than those without.

The classes, say experts, are a chance to rein in some of that spending. When Harvard Law School researchers ran the numbers in 2015, they found an estimated savings of $1,309 over three years for every Medicare Advantage patient who completed an education program.

But for many patients, the cost of the classes can either become a barrier to actually attending, or leave them with unanticipated bills.

After St. Mary’s billed Phillips’ insurer $1,044 for the two half-day classes he attended, Blue Cross Blue Shield of Georgia, in turn, lowered that to $626, or the “allowed amount" it had negotiated with St. Mary’s. Because he had not yet met his $3,500 annual deductible, Phillips is responsible for the entire $626.

Phillips, who took early retirement from his job in 2005 to care for his elderly parents, said he likely would not have attended had he known the price. He’d expected the instruction to cost about $50, noting that he’d already paid $120 for a one-on-one session with one of the hospital’s certified diabetes educators or CDEs.

Medicare sets an average reimbursement of $356 for an entire nine-hour group course, with the beneficiary’s share of that amount estimated at $71.

St. Mary’s said it is proud of its fully accredited program, which helps diabetes patients manage their condition.

"Our charges are in line with other similarly recognized programs in the state," according to a written statement from Mark Ralston, public relations director for the St. Mary’s Health Care System.

“Prior to enrollment, we send patients a letter that includes information that there will be a charge," the statement said, noting that the amount “the patient will pay depends on the patient's insurance coverage."

Ralston also noted that, because St. Mary’s is a Catholic health care system, “we are always happy to work with patients who have financial difficulties, up to and including applications for charity care."

Phillips’ charges seem high even though they were for a program that might actually save the insurer money over the long term, said William Custer, who studies health care markets as the director of the Center for Health Services Research at Georgia State University.

He questioned why the insurer didn’t drive a harder bargain.

“If the course has a benefit in terms of increasing health and reducing utilization, Blue Cross has an incentive to cover it and an incentive to negotiate," said Custer.

Blue Cross is one of the state and the region’s major insurers, Custer said, so it should have negotiated a better price.

Colin Manning, a spokesman for the insurer said, “We do have questions about the amount charged for this class and we are reaching out to St. Mary’s Hospital to discuss reimbursement for this service."

Diabetes management courses vary considerably in length and format, and even more so in price.

Internet searches and phone calls uncovered some cost examples, ranging from a $396, nine-hour course in Ohio to one in Wisconsin that lasted six hours and had a $420 price.

One of the most expensive — a 7½-hour diabetes self-management group course that included two-hour individual sessions with a dietitian and a diabetes educator — cost $1,700 in Washington state.

Howard County General Hospital in Maryland has decided to bypass insurance and charge patients $50 upfront for a six-hour course taught by a certified diabetes educator. That price was selected because in many cases it was less than what people with insurance would pay in copayments or deductibles under the former price, which was billed to insurers at a rate of about $1,000.

Before they made the switch about a year and a half ago, patients would often cancel after learning how much they would owe, said Mike Taylor, a clinical manager and diabetes educator who runs the hospitals program. “We would literally lose half the appointments we would schedule."

The Maryland hospital also offers free classes by a lay instructor.

Meanwhile, thinking his original bill was in error, Phillips in late January appealed St. Mary’s $1,044 charge to his insurer. It was denied a month later as the insurer noted the bill was “coded correctly." Hospitals can charge what they like for their services.

And after being contacted by the hospital billing office in early April to confirm he was aware of his bill’s “delinquent status," he wrote a second appeal letter.

Phillips said the class was well-taught, though he noted that he was already dieting before he took the class. He “followed what they said" and he has lost 31 pounds. His blood sugar, he added, is also back in the normal range.

“At least now I’m well-informed about what to eat and not eat if I ever do have diabetes," he said wryly.

Peak Health Plan Premiums Give Rise To Activism - And Unconventional Solutions

KFF Health News, April 25, 2018

The situation in Charlottesville has left many residents at their wits' end about how to pay for their health insurance, thrusting the costs of coverage into the center of local politics.

This article first appeared April 25, 2018 on Kaiser Health News.

By Rachel Bluth

CHARLOTTESVILLE, Va. — When Garnett and Dave Mellen sent their 19-year-old daughter, Gita, off to college an hour away at Virginia Commonwealth University last fall, they didn’t expect to follow her.

But in November, the family received notice that its monthly health insurance premium in Charlottesville would triple for 2018, from $1,200 to an unaffordable $3,600.

So, the Mellens, both longtime local business owners, packed their bags and spent time with Gita in her off-campus apartment in Richmond.

“My whole life has been rearranged around trying to get health insurance,” Garnett Mellen, 56, said, as she explained that claiming residency with her daughter in the new ZIP code had cut their premiums by more than half.

Charlottesville now claims the dubious distinction of having the highest individual-market health insurance costs in the country — prompting families like the Mellens to look for extreme solutions.

An exodus of carriers, which was blamed on losses caused by the instability of the Obamacare marketplace, created a coverage vacuum, leaving locals and insurance regulators scrambling.

Only one carrier — Virginia Beach-based Optima Health — decided to continue to participate in the individual market, but it did so with monthly premium increases that were, on average, in the high double-digits and for some consumers as much as 300 percent, according to people interviewed for this story.

It’s a problem that’s likely to be replicated elsewhere, said Timothy Jost, an emeritus professor of law at Washington and Lee University in Virginia and expert on the health law.

“In many states, it’s going to be hard to maintain a functional individual market,” he said. “Charlottesville is sort of ahead of everybody else in this … but this is the direction things are heading.”

Insurers nationwide that intend to participate in the individual market face spring deadlines to file forms for 2019 plans and rate proposals. In Virginia, these dates are April 20 and May 4, respectively.

The situation in Charlottesville has left many residents at their wits’ end about how to pay for their health insurance, prompting the evolution of an angry and rebellious civic movement and thrusting the costs of coverage into the center of local politics.

Charlottesville for Reasonable Health Insurance, a grass-roots organization and Facebook group of more than 700 people, has already claimed small victories in the state legislature, such as propelling the passage of a bill that will alleviate the cost burden for some of its members.

But its highest priority has been pressing state regulators to explain and possibly reconsider the decision that allowed for the stunning premium increase.

In the midst of various bureaucratic fits and starts, the state Bureau of Insurance (BOI) responded to the group April 11 by reiterating that Optima’s rates were “actuarially justified.” Ian Dixon, one of the group’s organizers, said it plans to appeal this finding to the State Corporation Commission.

“We’re not going away, that’s for sure,” said Dixon. “They’re hoping they can wait us out. … They would drag this out for a year if they could.”

At the same time, the group has expanded its focus to other issues on health care costs, such as price transparency and regulatory reform.

How It Came To This

The trouble started in summer 2017, when the state’s major insurance carriers announced they would be leaving the individual market in Virginia, saying the market was “shrinking and deteriorating” — pointing to the instability of Obamacare under the Trump administration.

Their departures left Albemarle County, home to Charlottesville, bare — meaning residents had no insurance options.

When Optima opted to continue to offer plans in and around Charlottesville, state insurance regulators breathed a collective sigh of relief.

But Optima’s decision came with updated rate increase proposals, which gained the OK of the under-the-gun BOI, led by Commissioner Scott White.

“I think the [regulators] decided they were willing to accept almost anything to get someone to cover Albemarle County and Charlottesville,” Jost said.

About 15 miles north of Charlottesville on U.S. 29, there’s a billboard that some residents now view with bitter irony. It features a smiling man with the message: “I chose Optima.”

On one hand, Optima did fill a void and offer health plans where no other insurer would. Still, many residents found their only choice came with a 300 percent boost in premium costs. They felt that state regulators had fallen short of their consumer-protection responsibilities.

“Any assumption that I had … that I thought [the Bureau of Insurance would be] protecting the people … was completely naive,” said Sarah Stovall, 40, who works for a small software company, lives in Charlottesville with her husband and two sons and has struggled to find affordable coverage.

But Ken Schrad, the director of the Division of Information Resources for the State Corporation Commission, said the bureau is still questioning Optima, checking its math and evaluating its actuarial decisions.

He couldn’t answer specific questions about a matter he said is pending.

Schrad said the bureau reached out to carriers and worked with them last summer when it was clear that much of the commonwealth wouldn’t be covered.

“It wasn’t a question of what the premiums would be,” Schrad said. “It was whether there would be any coverage.

“[Filings] must be based on actuarially sound decisions, and that’s all the bureau can review. The market is the market.”

A Movement Is Born

Stovall, 40, teamed up with Dixon, 38, a web app developer, to manage the emerging Facebook group, which was originally set up as a support system for people in search of new insurance options in a short window of time. Soon, Karl Quist, 46, who had been actively calling the BOI to lodge complaints, joined the effort.

“The three of us did not know each other before November,” Dixon said. “We feel like we’re relatives now.”

Others quickly piled on, including the Mellens and Gail Williamson, 64, a part-time secretary at a private school who needed insurance for herself and her husband, who owns a business restoring antiques.

Like many of the people in the group, the Williamsons made too much money to qualify for federal subsidies, but too little to be able to afford the $3,725 monthly premium that Optima would have charged them.

Sharing their knowledge, many Charlottesville for Reasonable Health Insurance members have resorted to imperfect jury-rigged policies that do not come with many of the coverage guarantees that protect patients from unexpected costs under the Affordable Care Act.

Instead of paying $2,920 a month for Optima’s least generous family health plan, Quist is saving $2,300 a month by purchasing two non-ACA-compliant plans, one for sickness and one for accidents.

Williamson has settled on a “silly little” three-month policy for $1,400 per month, plus an extra $35 a month in supplemental accident insurance for her husband.

“If I won the lottery, the first thing I’d do before giving my kids any money would be to buy health insurance for everyone in that group,” Williamson said.

Washington and Lee’s Jost said he worries about the impact of such cobbled-together coverage.

He said having these plans could damage the ACA market further by skimming the healthier people away from the more comprehensive coverage, leaving behind those who are ill or have chronic conditions.

“It makes the situation worse because the only people who are going to pay premiums that high are people who are desperate,” Jost said.

Forward Motion

Over the past months, the community-based effort has evolved beyond being an ad hoc information clearinghouse into a powerful organizing tool.

For instance, it has raised almost $20,000 to hire lawyer Jay Angoff, a former federal and state insurance official, to appeal to Optima and state regulators about the Charlottesville-area rates.

Dixon, Stovall and Quist also regularly pile into Stovall’s minivan, drive to Richmond and become lobbyists for their cause.

“The insurance companies pay people very good money to lobby for them on a regular basis,” Stovall said. “Meanwhile, I have to take off work, Ian [Dixon] has to leave his business for a day.”

“On some level, I have faith that if we keep pushing, I don’t know what the eventual outcome will be, but we’ll find some type of justice,” Dixon added.

Their greatest victory came with the passage of SB 672. This law redefined what a “small employer” is so that self-employed people can buy insurance in the small-group market.

The group sought this change because many people, including Dixon, found that the cost of adding an employee to a company of one allowed them to save money by obtaining insurance as a small group, though it still added significant overhead costs to these businesses.

Many in the group see this success as only a band-aid fix. Though it allows some people to obtain cheaper insurance, it doesn’t address the root of the problem: Optima’s rate increases.

For Garnett Mellen, though, the issue seems resolved, at least for now. She found a job with health benefits in Charlottesville, which enabled her and her husband to move back there.

It’s a big relief — both for her and for Gita, her college-aged daughter.

“She [was] not entirely happy with us being there,” Mellen said.

4 New Ways Consumers Can Avoid Fines For Not Having Health Insurance

KFF Health News, April 24, 2018

Under the new rules, people can apply for a hardship exemption that excuses them from having to have health insurance if they, for example, live in an area where there is just one insurer selling marketplace plans.

This article first appeared April 24, 2018 on Kaiser Health News.

By Michelle Andrews

There are already more than a dozen reasons people can use to avoid paying the penalty for not having health insurance. Now the federal government has added four more “hardship exemptions” that let people off the hook if they can’t find a marketplace plan that meets not only their coverage needs but also reflects their view if they are opposed to abortion.

It’s unclear how significant the impact will be, policy analysts said. That’s because the penalty for not having health insurance will be eliminated starting with tax year 2019, so the new exemptions will mostly apply to penalty payments this year and in the previous two years.

“I think the exemptions … may very marginally increase the number of healthy people who don't buy health insurance on the individual market,” Timothy Jost, emeritus professor of law at Washington and Lee University in Virginia who is an expert on health law.

Under the new rules, people can apply for a hardship exemption that excuses them from having to have health insurance if they:

  • Live in an area where there are no marketplace plans.
  • Live in an area where there is just one insurer selling marketplace plans.
  • Can’t find an affordable marketplace plan that doesn't cover abortion.
  • Experience “personal circumstances” that make it difficult for them to buy a marketplace plan, including not being able to find a plan in their area that gives them access to specialty care they need.

The first new exemption isn’t relevant for consumers this year. Since the Affordable Care Act’s marketplaces opened, there have been no “bare” counties that lack insurers.

However, in about half of the U.S. counties — in which 26 percent of enrollees live — there is only one marketplace insurer this year, according to the Kaiser Family Foundation. (Kaiser Health News is an editorially independent program of the foundation.)

As for the abortion exemption, in many places it won’t be an issue either. Women in 31 states didn’t have access to a marketplace plan that covered abortion in 2016, according to a Kaiser Family Foundation analysis. Still, a few states — California, New York and Oregon — generally require abortion coverage in their marketplace plans, and women who live there might have trouble finding a plan that excludes that coverage, experts said.

The ACA established several different types of exemptions from the penalty for not having coverage. Among them are exemptions for not being able to find coverage that is considered affordable or being without insurance for less than three consecutive months in a year. People claim these more common exemptions when they file their tax returns.

Hardship exemptions that had already been on the books protected people who faced eviction, filed for bankruptcy or racked up medical debt, among other difficulties. Consumers apply for these exemptions by submitting an application to the ACA insurance marketplace.

The new hardship exemptions apply to people in all 50 states, according to an official at the federal Centers for Medicare & Medicaid Services, which oversees the health law’s insurance marketplaces. To apply, people generally need to provide a brief explanation of the circumstances that made it a hardship for them to buy a marketplace plan, along with any available documentation, when they submit their application to marketplace officials. They can apply for the current calendar year or going back two years, to 2016.

It’s difficult to gauge how many people will try to take advantage of the changes, said Tara Straw, a senior policy analyst at the Center on Budget and Policy Priorities.

“People aren’t sure how to apply or if they’re eligible, and that discourages them from applying,” Straw said.

The penalty for not having health insurance in 2018 is the greater of $695 or 2.5 percent of household income.

During the 2017 filing season, there were more than 106 million tax returns reporting that all family members had health insurance, and nearly 11 million tax returns that claimed an exemption from the requirement to have it, according to a report from the Treasury Department’s inspector general for tax administration. In addition, more than 4 million returns reported paying penalties totaling nearly $3 billion for not having health insurance.

People often don’t realize they may owe a penalty until it’s time to do their taxes, said Alison Flores, a principal tax research analyst at H&R Block’s Tax Institute. H&R tax preparers first work to see if clients can qualify for an exemption that can be claimed on their tax returns. If that doesn’t work, they move on to the hardship exemptions. The preparers help people get the hardship exemption application, but it’s up to consumers to send it to the marketplace and get the exemption certificate.

The federal guidance about the new exemptions was released April 9, shortly before the end of the income tax filing season. People who’ve already filed their taxes and qualify for the new exemptions for 2016 or 2017 and get marketplace approval can file an amended tax return to receive a refund of any penalty they paid, said Katie Keith, a health policy consultant who writes regularly about health reform.

“You have to really be motivated,” Keith said.

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