HEALTH CARE BRIEFING: Democrats Set to Scale Back Ambitions

Democrats working on President Joe Biden’s big social-spending bill discussed over the weekend a proposal to limit the main tool for lowering drug prices to medicines that already face competition, people familiar with the talks said, Alex Ruoff reports.

The White House proposal, viewed as an effort to win over holdout lawmakers including Sen. Kyrsten Sinema (D-Ariz.), would exempt new drugs and many with the biggest price tags. The change would be a major shift away from earlier proposals that focused mostly on drugs that face no competition.

Drugs with government-granted exclusivity would be exempt from proposed drug-price negotiation provision, according to the people, who asked not to be identified because the talks are private. The provision is set to be included in the domestic policy package.

A person close to Democratic congressional leaders confirmed the shift in approach, which is still under debate and is meant to win support from party moderates who have balked at previous drug-pricing proposals. House Ways and Means Chair Richard Neal (D-Mass.), whose panel is key to the revenue side of Biden’s agenda, declined to comment Saturday.

The proposal is prompting backlash from some Democratic allies.

Groups that have pushed for lawmakers to lower the price of medicines in the U.S. are balking at the news that Democrats want to significantly water down legislation. “This is a sellout,” David Mitchell, founder of Patients For Affordable Drugs Now, said. “It’s a complete capitulation to pharma because it keeps the status quo.”

Biden Drives to Clinch Economic Bill: Biden and fellow Democrats are racing to reach agreement on a scaled-back version of his economic agenda, with a self-imposed deadline and his departure later this week for summits in Europe intensifying pressure on negotiations. Speaker Nancy Pelosi (D-Calif.) reiterated yesterday that about 90 percent of the tax and spending bill is worked out but decisions on some key provision still need to be made.

Among them is whether and how the plan will expand Medicare benefits. A proposal to extend Medicare to dental, vision and hearing benefits is in danger of being dropped, with dental seen as the most costly and difficult to implement. The details of Medicaid expansion and Obamacare premium credits are also in flux.

Many of Biden’s original priorities appear on track to remain in the package but at a shorter duration than originally proposed. These include Affordable Care Act premium subsidies, expanded Medicaid coverage, universal pre-kindergarten, renewable energy tax credits, earned-income tax credit expansion, housing rental vouchers and mortgage assistance and clean water funds. Read more from Erik Wasson, Laura Litvan and Ari Natter.

Progressives Still Pushing for Medicare Expansion: Supporters of expanding Medicare’s benefits say they’re still pushing to give seniors dental coverage, despite Biden signaling it’s unlikely to be part of the package.

Rep. Pramila Jayapal (D-Wash.) told reporters last week she and other progressives like Sen. Bernie Sanders (I-Vt.) are trying to work out a compromise that would give Medicare beneficiaries dental, hearing and vision coverage. Biden called expanding Medicare’s benefits a “reach” last week during a CNN town hall, noting that moderates like Sen. Joe Manchin (D-W.Va.) are opposed to the idea.

Jayapal said the White House has been open to paring back the new benefits, possibly giving seniors a voucher for coverage or limiting who could qualify. She said her preference is universal benefits. “I still feel we can get Medicare expansion of benefits it’s a matter of finding what’s acceptable to everyone,” Jayapal said, Alex Ruoff reports.

Paid Leave Proposal: Democrats’ paid family and medical leave proposal would offer workers four weeks annually, down from from an earlier version with 12 weeks—leaving the U.S. lagging much of the world in guaranteed paid time off. Biden confirmed Thursday that the latest version of what could be the country’s first nationwide paid leave plan has been whittled down. Read more from Chris Marr and Mary Biekert.

Happening on the Hill

Lawmakers Urge HHS to Soften Medicare Payment Cuts: Proposed Medicare payment cuts and a new payment model could hurt access to cancer treatment and adversely affect the radiation oncology community, a bipartisan group of lawmakers told the Biden administration last week. In three separate letters to Health and Human Services Secretary Xavier Becerra and Chiquita Brooks-LaSure, administrator of the Centers for Medicare & Medicaid Services, Senate and House members called for action to avert an estimated $300 million in cuts contained in the proposed 2022 Medicare physician fee schedule and the proposed radiation oncology payment model. Read more from Tony Pugh.

House Passes Bill to Protect More Nursing Parents: The House Friday approved legislation extending workplace accommodations for nursing parents in a 276-149 vote. The “PUMP for Nursing Mothers Act” (H.R. 3110) would widen existing protections for workers. Read more from Paige Smith.

Support for Eshoo’s ARPA-H Legislation: A group of health experts and organizations—including former FDA commissioners, Research!America and the American Association for the Advancement of Science—in a letter pushed for the passage of legislation from Rep. Anna Eshoo (D-Calif.) to create the Advanced Research Projects Agency for Health (ARPA-H), an independent biomedical research agency proposed by Biden earlier this year.

Nominations: The Senate Finance Committee holds a hearing tomorrow on nominations including Samuel R. Bagenstos to be general counsel of the Department of Health and Human Services.

More Hearings This Week:

The Coronavirus Pandemic

Benefits of Pfizer Child Shot Likely Outweigh Risks: The staff of the Food and Drug Administration said the benefits of Pfizer and BioNTech’s Covid-19 vaccine for young children likely outweigh its risks. Outside experts on the FDA’s Vaccines and Related Biological Products Advisory Committee will meet this week to evaluate Pfizer and BioNTech’s application for federal emergency authorization of their coronavirus vaccine in young children.

According to the staff report, which was posted on the FDA website late Friday, the vaccine’s capacity to prevent hospitalizations and deaths likely exceed the risk of adverse outcomes such as the heart condition myocarditis, which has been reported in some younger males who have received messenger RNA shots for Covid-19.

The FDA also posted documents from Pfizer on Friday in which the drug company said that the reduced-dose vaccine was 90.7% effective at preventing symptomatic disease in kids ages 5 to 11 in a study. Read more from Robert Langreth and Fiona Rutherford.

Free Covid-19 Treatment Required Under Medicaid: State Medicaid programs and the Children’s Health Insurance Program are required to cover treatments for Covid-19 without cost sharing, the Centers for Medicare & Medicaid Services said in guidance issued Friday. The coverage requirement includes drugs approved by the FDA for treating Covid-19, preventive therapies, specialized equipment, and treatments for post-Covid-19 conditions, also known as “long Covid,” the CMS said. Read more from Christopher Brown.

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What Else to Know

SCOTUS to Hear Arguments in Texas Abortion Case: The U.S. Supreme Court said it will hear arguments over Texas’s sharp restrictions on abortion, leaving the law in place for now while raising the stakes in what will be a transformational term for reproductive rights. The decision to let the law stay in effect came over the dissent of Justice Sonia Sotomayor. The measure bans abortion, including in cases of incest and rape, after about around six weeks, much earlier than what the Supreme Court had previously allowed. Arguments begin on an expedited basis on Nov. 1. Read more from Greg Stohr.

Biotechs Urge Guardrails as Biden Mulls Life-Saving Device Rule: Biotech startups and trade groups are rallying behind the Biden administration’s bid to repeal a rule to speed up Medicare coverage of certain innovative medical devices. The Medicare agency finalized the rule (RIN 0938-AT88) in the last days of the Trump administration to give beneficiaries faster access to devices designated as “breakthrough” by the FDA. The rule, slated to take effect Dec. 15 after being delayed multiple times by the Biden administration, would allow Medicare to start paying for such devices almost immediately after they get FDA clearance, instead of the typical nine- to 12-month turnaround time. Read more from Celine Castronuovo.

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With assistance from Alex Ruoff

To contact the reporter on this story: Michaela Ross in Washington at mross@bgov.com

To contact the editors responsible for this story: Zachary Sherwood at zsherwood@bgov.com; Giuseppe Macri at gmacri@bgov.com; Brandon Lee at blee@bgov.com

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