Covid funding impasse threatens access to free treatments

Mar 17, 2022

Presented by

With help from Megan Messerly, Alice Miranda Ollstein and Katherine Ellen Foley

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QUICK FIX

— Congress' pandemic funding stalemate puts free access to life-saving therapies at risk.

— An internal document shows the Biden administration wants the WHO to push health care companies to voluntarily share their technologies during the next pandemic.

— About half the states have determined how they'll prioritize processing Medicaid renewals when the public health emergency ends.

WELCOME TO THURSDAY PULSE — Your morning host is about to take some time off to enjoy California wine country. Any recommendations? Talk to me: lgardner@politico.com or on Twitter @Gardner_LM.

A message from PhRMA:

According to a new poll , Americans would like to see Congress focus more on reducing the overall costs of health care coverage such as premiums, deductible, and copays (71%) over reducing the costs of prescription drugs (29%). This extends across party lines; 73% of Democrats and 64% of Republicans would like to see Congress focus on reducing overall costs of coverage. Read more.

Driving The Day

FREE COVID TREATMENTS MAY EVAPORATE WITHOUT NEW FUNDING — The free Covid-19 therapeutics that many Americans have relied on to avoid hospitalization during the pandemic may soon come with hefty price tags for patients as Congress flounders on devoting more money to pandemic response, POLITICO's Adam Cancryn writes. The Biden administration is currently debating how to wind down the federal subsidies that have made pricey treatments like monoclonal antibodies free to patients in need if lawmakers don't come through with more money.

Officials have ramped up efforts to map out the logistics of a transition, weighing which treatments to stop funding first and what the consequences will be for the vulnerable and uninsured, four people with knowledge of the deliberations told Adam. The White House hadn't expected a need to shift some treatments to the commercial market — meaning patients would need to go through private insurance or pay out-of-pocket — anytime soon.

Accessibility also at risk: A reduced federal role means poor patients could get priced out of some therapies — monoclonals can cost as much as $2,000 a course — further exacerbating health inequities. Plus, the two antiviral drugs available to treat Covid are authorized for emergency use, meaning they can't be sold commercially yet unless Congress acts.

U.S. TO WHO: LET'S SHARE — The Biden administration wants the World Health Organization to push manufacturers to voluntarily share the technology behind their medical products during the next pandemic in an effort to improve global health equity, according to a Department of Health and Human Services document obtained by POLITICO's Erin Banco. The paper offers a look at the administration's efforts to ensure low- and middle-income countries have equal access to data, vaccines and treatments as part of a potential pandemic treaty or some other international accord.

Government officials have been publicly quiet about the WHO talks thus far. According to the document, the administration believes voluntary licensing and technology transfers — steps companies around the world, including American vaccine makers, refused to do for Covid— would help achieve greater equity.

MEDICAID REDETERMINATIONS LOOM — There's a big problem, Megan writes: Only a little more than half of states have figured out how they're going to prioritize processing Medicaid renewals when the continuous coverage requirement is lifted, according to the latest annual survey of Medicaid and Children's Health Insurance Program officials, which was released Wednesday.

"How states approach the unwinding will affect the extent to which eligible individuals retain Medicaid and those who are no longer eligible transition to other coverage sources," said Tricia Brooks, a research professor at Georgetown University, which collaborated on the study with the Kaiser Family Foundation.

The survey estimates about 13 percent of state Medicaid enrollees will be disenrolled from their coverage when the continuous coverage requirement is lifted at the end of the public health emergency, based on 20 states that reported projected disenrollment numbers. At the high end is Hawaii, with an estimated 31 percent loss, while West Virginia is projected to lose 8 percent of its beneficiaries.

Of the 48 states that have established a timeframe for processing redeterminations, the survey found 41 plan to take nine to 12 months, with the rest taking anywhere from three to nine months to complete the work. CMS has recommended that states take 14 months to complete redetermination and process no more than one-ninth of their caseload each month to prevent eligible people from losing their health insurance because of procedural errors.

Idaho's Medicaid program told POLITICO it plans to take just four months. "Idaho never stopped completing any of our renewals, so staff remain current on all processes, and we would not need up to the available 14 months to ramp up and complete the redetermination process on all participants," agency spokesperson Niki Forbing-Orr said.

Two states, Florida and Oklahoma, haven't decided whether they'll forgo enhanced federal matching dollars and start disenrolling people from Medicaid before the end of the public health emergency, according to the survey. Pennsylvania was also included in the report as being undecided, but a spokesperson told POLITICO it plans to maintain coverage through the PHE's duration.

A message from PhRMA:

In Congress

E&C TO WEIGH DRUG BILLS AS USER FEE DEADLINE LOOMS — The House Energy and Commerce Health Subcommittee holds a hearing today on nearly two dozen bills focused on the "future of medicine." The measures, ranging from clinical trial overhauls to oversight of the FDA's accelerated approval process, could be candidates for riders on the must-pass FDA user fee reauthorization package later this year.

Of note: Rep. Anna Eshoo's bill, H.R. 5585, to establish the Advanced Research Projects Agency for Health as an agency independent of NIH, is on deck. The Senate HELP Committee approved legislation, S. 3799, earlier this week to create the advanced biomedical research agency and house it within NIH, as President Joe Biden has advocated.

DRUG PRICING HEARING HIGHLIGHTS DEEP DIVISIONS — Senate Democrats touted Wednesday's hearing on high drug prices as a cornerstone of their efforts to revive a narrower version of the Build Back Better package that flamed out at the end of last year. This time, they're focusing squarely on lowering health and energy costs. But the hearing shined a light on the major hurdles and divisions that still stand in the way of that goal, Alice reports.

The window for action is closing: Democrats' ability to pass a bill under reconciliation with 50 Senate votes ends in September. The closer they get to the 2022 midterms, the harder it will be to pass major legislation. Democrats could lose control of one or both chambers of Congress after that.

"You've got an opportunity to do it right now when Democrats and Republicans can work together," said Sen. Chuck Grassley (R-Iowa), the committee's former chair. "If we want to reduce drug prices, then we need to do it now."

Democrats are skeptical of partial solutions: While Senate Majority Leader Chuck Schumer reiterated Wednesday he plans to bring up Sen. Raphael Warnock's bill to limit out-of-pocket costs for insulin to $35 a month, some Democrats are questioning that strategy.

"Setting out-of-pocket caps without [government price] negotiation just passes the high prices on to somebody else, usually taxpayers," committee Chair Ron Wyden (D-Ore.) lamented. "That's not sustainable."

Most Republicans are opposed to the narrow insulin-only measure as well as broader negotiation: Throughout the hearing, GOP senators and conservative witnesses argued that Warnock's bill would destroy competition and innovation in the insulin market and that the Build Back Better proposals would, in ranking member Mike Crapo's words, "hand a competitive edge to our global rivals, including the Chinese Communist Party."

We still don't know what Manchin will support: The West Virginian who controls the fate of Democrats' drug price reform dreams doesn't sit on the Senate Finance Committee and thus didn't divulge what policies he could get behind. While he has voiced support generally for tackling high drug costs, he's sent mixed messages on what provisions he does and doesn't favor, making consensus in the party difficult.

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Public Health

ZELLER SPEAKS ON STATE OF FDA TOBACCO REGULATION — Mitch Zeller, the outgoing head of the FDA's Center for Tobacco Products, acknowledged the agency's struggle to keep up with the ever-changing tobacco product landscape this week at the Society for Research on Nicotine and Tobacco's annual meeting in Baltimore, POLITICO's Katherine Ellen Foley reports. The office has 53,000 pending e-cigarette applications and is on track to propose rules to ban the sale of menthol cigarettes and flavored cigars in April.

"We have been Charlie Brown and the football," he said. "We have been Lucy'd more times than we can count. And then we just pick ourselves up and try again."

Reading the room: SRNT primarily features scientists focused on smoking cessation, with a sprinkle of policymakers in the mix. None of the handful of researchers Katherine spoke with had ever used nicotine products.

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What We're Reading

The billions invested in Covid-19 research and mRNA vaccine manufacturing are expected to yield dividends for decades as scientists look to use the technology to combat diseases from influenza to cancer, Kaiser Health News writes.

A message from PhRMA:

According to a new poll , voters overwhelmingly support policies that would lower out-of-pocket costs and bring greater transparency and accountability to the health insurance system.

We need to make the cost of medicine more predictable and affordable. Government price setting is the wrong way. The right way means covering more medicines from day one, making out-of-pocket costs more predictable and sharing negotiated savings with patients at the pharmacy counter.

Learn more .