Nixing clinical trial taxes

With Robert King and Alice Miranda Ollstein

BURDEN OFF THEIR SHOULDERS — Researchers, policymakers and regulators say the clinical trials that evaluate whether therapies are safe and effective aren’t diverse enough. One company, Mural Health, is launching a lobbying effort to push a policy it says will help solve the problem: nixing the tax burden for clinical trial participants, POLITICO’s Megan R. Wilson reports.

Under current law, anyone paid more than $600 to participate in a trial must pay income taxes on the amount. That’s something CEO Sam Whitaker — and some academic studies — argues hinders efforts to diversify clinical trials. Whitaker’s company handles payments to people who take part in clinical research.

“The underlying reason that we are driving this initiative is to essentially eliminate barriers that prevent low-income populations from enrolling in trials in order to help drive diversity,” Whitaker told Megan.

“There is a component of this that is about racial diversity, but there is also a component of this that is about diversification of health statuses,” he added, “so that drugs are brought to market that are effective for the American population as a whole.”

The advocacy is meant to remove a barrier for tens of millions of lower-income Americans who might worry the payments could jeopardize their access to federal benefits, including the food assistance program known as SNAP.

Even if a person isn’t at risk of losing benefits, Whitaker said, the tax requirements can remove the incentive for participation and sometimes leave patients in the red if they have costs associated with participating in the trial.

It recently hired lobbying firm Troutman Pepper Strategies to pursue the issue with Congress and federal regulators. The effort, which lobbyists at the firm acknowledge will stretch into next year, comes amid growing interest from lawmakers and the Biden administration in increasing diversity in clinical trials.

The figures: Racial minorities represent a median of 17 percent of clinical trial participants in the U.S., according to a study last year in The Lancet Regional Health – Americas.

While there is a lack of data surrounding the participation of lower-income individuals in clinical trials, the research that exists shows they’re underrepresented. Further, multiple academic studies in recent years have shown that financial burdens or low compensation for participating in clinical trials are barriers to getting people to sign up.

WELCOME TO FRIDAY THE 13TH PULSE. I’m planning to spend this spooky night watching “The Fall of the House of Usher.” The gothic horror show centers around the doomed family of a pharmaceutical company — essentially, a fictional version of the Sacklers.

Send your tips, scoops and feedback to [email protected] and [email protected] and follow along @_BenLeonard_ and @ChelseaCirruzzo.

TODAY ON OUR PULSE CHECK PODCAST, host Daniel Payne talks with POLITICO global health reporter Carmen Paun about Rep. Michael McCaul’s (R-Texas) push for bipartisan legislation against opioid trafficking — and how seeing the fentanyl crisis up close drives his efforts.

PhRMA TO SCOTUS: PROTECT ABORTION PILL ACCESS — The pharmaceutical industry’s biggest lobbyist group is asking the U.S. Supreme Court to accept a case challenging the federal regulation of abortion pills and reverse a lower court ruling that would roll back access to the drugs, Alice reports.

Background: The Biden administration and pharmaceutical company Danco recently appealed a decision from the 5th Circuit Court of Appeals that would ban pharmacy dispensing and mail delivery of mifepristone — one of two pills used to terminate a pregnancy up to 10 weeks — and undo other policies the FDA has advanced since 2016 to make the drug more accessible.

In an amicus brief filed Thursday, the Pharmaceutical Research and Manufacturers of America warned the justices that allowing the 5th Circuit’s ruling to stand “sets a precedent that — if left undisturbed — could significantly disrupt industry and stifle innovation in drug development.”

Jim Stansel, executive vice president and general counsel of PhRMA, said in a statement that its member drug companies can’t operate and submit newly invented therapies to the FDA for approval if they know the agency’s decisions can be second-guessed and overturned by courts years down the line.

AMERICANS ROLL UP SLEEVES — More than 7 million Americans — about 2 percent of the U.S. population — received their updated Covid-19 vaccine in September, HHS says.

Officials have been quick to assure the public that early vaccine rollout snafus have been resolved, and HHS said in a statement Wednesday that 91 percent of Americans can get an updated Covid vaccine within five miles of their home, Chelsea reports.

Still, some community health centers are missing doses because some states haven’t yet ordered the vaccines allocated for the bridge uninsured program, which provides free vaccines to uninsured people, The National Association of Community Health Centers told POLITICO, adding the situation is improving weekly.

And in the first weeks of the rollout, parents reported struggling to find pediatric doses. CDC Director Mandy Cohen said at a press conference in late September that pediatric doses were starting to be shipped out, but adult doses had been shipped by manufacturers first. Dr. Sandy Chung, president of the American Academy of Pediatrics, says pediatric Covid-19 doses remain a challenge due to supply, but they’re also getting reassurance that their orders will be reimbursed.

“It’s really a workflow problem. Previously, these vaccines were paid for by the government,” Chung said. “Now, we’re asking pediatricians to buy them.”

When the bivalent booster was rolled out last year, 56.6 million Americans got the jab, or around 17 percent of the U.S., a far cry from the nearly 70 percent of Americans who got their initial dose.

ARTHRITIS WOES — About half of older Americans with diagnosed arthritis also have another chronic illness, including diabetes and heart disease, the CDC said in a new report Thursday.

The study, which used national survey data from 2019-2021, found that many adults 65 and older with arthritis also had lung disease, dementia, history of stroke, heart disease, diabetes or cancer.

It also found that more than 53 million Americans 18 and over reported diagnosed arthritis. Diagnoses were higher among women, and adults 45 and older represented nearly 90 percent of all adults with arthritis.

“A recommendation from a health care provider can increase the likelihood that adults with arthritis attend education programs and engage in physical activity,” the report said.

KEEPING TABS ON NEGOTIATED DRUG PRICES — CMS will keep a close eye on Medicare Part D plans to ensure they don’t raise out-of-pocket costs for older adults and other beneficiaries on any of the 10 drugs chosen for price negotiations when negotiated rates are posted in 2026, Robert reports.

Plans in Medicare Part D, the program’s prescription drug benefit, must cover any drug chosen by CMS for price negotiation, but the agency said it will closely monitor whether plans increase the use of tools like prior authorization, which requires insurer approval before prescribing a pharmaceutical, on any of the drugs.

CMS also wants to crack down on other practices such as formulary management, referring to the list of generic and brand name drugs a Part D plan covers. Plans can at times put certain drugs on a formulary tier that requires higher out-of-pocket costs for Medicare beneficiaries.

Part D insurers have used both methods to cut down on their drug costs and usually reserve them for the priciest drugs. However, plans have at times cut deals with drugmakers to get rebates in exchange for a preferred place on the formulary.

The nation’s leading Medicare Part D plans — Humana, United Healthcare, CVS Health and Cigna — did not respond to requests for comment. AHIP, the trade group for the insurance industry, declined to comment.

Katie O’Connor is joining the National Women’s Law Center as the director of federal abortion policy. She previously was deputy chief counsel at Demand Justice.

Leslie Zelenko is joining Kountoupes, Denham, Carr & Reid as a principal. She most recently was deputy assistant secretary for legislation at HHS.

KFF Health News reports on the challenges Black women face in getting prescription PrEP.

CNN reports that Black people and young adults have the highest rates of ER visits associated with assault.

NPR reports on how Oregon is tapping into Medicaid funding to reduce homelessness.