HEALTH CARE BRIEFING: ‘Cures 2.0′ Bill Unveiled by House Duo

By Brandon Lee

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A bipartisan duo of House lawmakers announced their long-awaited bill to speed up medical innovations and create a new federal research agency today.

Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) said their legislation would transform how Medicare pays for new treatments and technologies—potentially bringing them to seniors faster—and increase access to telehealth services.

The bill also would authorize a new biomedical research agency designed to catalyze cutting-edge discoveries that’s modeled off existing programs at the departments of Defense and Energy.

“The federal government has shown, time and time again, that when it’s given the resources needed to accomplish the impossible, there’s not much it cannot do,” the pair said in a statement.

DeGette and Upton hoped to introduce the bill this summer in tandem with White House calls for the Advanced Research Projects Agency for Health, or ARPA-H. Competing priorities kept staff from working on the legislation for months, Upton said recently.

House leaders are trying to pass President Joe Biden’s proposed $2 trillion spending bill and then must shift their attention to funding the government before current appropriations expire in early December. Read more from Alex Ruoff and Jeannie Baumann.

Biden Agenda Vote Risks Delay on CBO Score

The nonpartisan Congressional Budget Office said its full cost estimate of Biden’s signature tax and spending bill may not be ready until Friday, threatening to push a planned House vote on the legislation to the weekend or later.

The CBO analysis also may show that the legislation falls short of fully paying for itself because of differences with the White House over how much revenue could be generated by stricter enforcement of tax laws by the Internal Revenue Service. Yet it’s not clear that will be enough to slow down momentum for passage in the House.

The CBO analysis is key to Speaker Nancy Pelosi’s (D-Calif.) plan to bring the roughly $2 trillion bill, known as the Build Back Better Act, to a vote in the House this week. Pelosi’s office didn’t immediately respond to a request for comment on the CBO schedule. But Illinois Representative Jan Schakowsky (D) said the vote will go forward, even if that means staying in session on Saturday.

House moderates delayed a vote on the legislation earlier this month, saying they wanted a full picture of the deficit impact of the bill. Even if the House does act this week, the measure will hit a slowdown in the Senate, where Democrats are still working to resolve disputes over taxes, Medicare spending, paid family leave and immigration. On top of that, Senate officials will likely need to work through next week’s Thanksgiving recess to scrub the House measure to make sure it complies with the chamber’s intricate rules before bringing it to the floor. Read more from Erik Wasson, Laura Davison, and Jarrell Dillard.

Also Happening on the Hill

Leahy Retirement Could Pave Way for HELP Chair Murray: Sen. Patrick Leahy’s (D-Vt.) decision to retire opens a plum spot at the top of the powerful Senate Appropriations Committee and it could result in unprecedented opportunities for women in the traditionally male-dominated chamber. His departure from Appropriations would pave the way for Sen. Patty Murray (D-Wash.) to helm the panel if she gives up her gavel on the Health, Education, Labor and Pensions Committee.

The decision by Leahy not to seek re-election could also have a ripple effect on Appropriations subcommittees. Leahy gave up his State and Foreign Operations Subcommittee chairmanship when he took the helm of the full panel. If Murray follows his example, she would open a vacancy at the Labor-HHS-Education Subcommittee. Sens. Jeanne Shaheen (D-N.H.) and Jeff Merkley (D-Ore.) are next in line to helm the subcommittee.

Shaheen said she’s “not looking at that at all,” when asked yesterday about the health subcommittee role.

Sen. Bernie Sanders (I-Vt.) would be poised to be the top Democrat at the HELP Committee if Murray assumes the senior Appropriations position. A move by Sanders also would leave open his slot at the Budget Committee, where he currently serves as chairman and has a major role in crafting Democrats’ social spending package. Nancy Ognanovich and Jack Fitzpatrick have more.

Pass PFAS Action Act, Democratic AGs Tell Senators: A Senate committee should back the PFAS Action Act to require the EPA to meet specific deadlines as it works to control “forever chemicals,” a coalition of state attorneys general said yesterday. Clearance of the House-passed bill (H.R. 2467) would “ensure urgent needs are met in a timely fashion and with sufficient appropriations,” the 19 AGs told the top Democrat and Republican of the Senate Environment and Public Works Committee, Pat Rizzuto reports.

House Energy & Commerce Announces Markup: The House Energy & Commerce Committee announced a markup of 12 bipartisan bills tomorrow, including eight bills aimed at improving public health and supporting providers and patients, according to a press release.

Panel Hearing Set on Covid-19 Misinformation: The House Select Subcommittee on the Coronavirus Crisis tomorrow will hold a hearing on the monetization of coronavirus misinformation online, according to a press release.

The Coronavirus Pandemic

10th Cir. Added to Covid-19 Shot-or-Test Lottery: The U.S. Court of Appeals for the Tenth Circuit became the latest panel asked to review the Biden administration’s standard requiring a Covid-19 vaccine or weekly test. The Denver Newspaper Guild, the AFL-CIO, and the Communications Workers of America Local 37074 had requested the Denver-based court to review the Occupational Safety and Health Administration’s Covid-19 emergency standard, which was enacted earlier this month. Bruce Rolfsen has more.

Related:

Reframing of Vaccine as ‘Pre-Check’ for Worker Safety Urged: Public health leaders should reframe vaccines as a path to opt out of cumbersome masking and testing rules imposed on those who won’t get the vaccine, former health officials said. Former Baltimore health commissioner Leana Wen likened the shot to TSA PreCheck status. “It’s not that you’re forced to be vaccinated, but rather that this is a path to opt out of that other more cumbersome process,” Wen said yesterday, Jeannie Baumann reports.

FDA Regains Diagnostic Test Oversight: The Food and Drug Administration will have greater authority to ensure the reliability of at-home Covid-19 testing following the repeal of a Trump-era policy that directed the agency to not require pre-market reviews of tests developed in laboratories. Lab-developed tests, including ones administered at an urgent care center without being sent to a central lab, must now either get emergency or regular authorization before they’re sold, the FDA said. Celine Castronuovo reports.

Pfizer Shot Generated Most Antibodies in Study: Pfizer and BioNTech’s Covid-19 shot yielded the strongest immune response among four vaccines tested in a study, which found people getting Sinopharm’s inoculation may be particularly susceptible to a breakthrough infection. Levels of protective antibodies to the part of the coronavirus that SARS-CoV-2 uses to infect human cells varied widely across each of the four vaccine groups, a study in the journal Cell Host and Microbe showed. Jason Gale has more.

  • In another study, a common antidepressant appeared to reduce the risk of death in patients admitted to the hospital with severe Covid-19, according to an analysis published in the JAMA Network Open journal. Roughly 9.8% of the 470 patients with Covid-19 in the study who were taking fluoxetine, also sold under the brand name Prozac, died. That’s compared to the more than 13% of patients with similar characteristics not receiving any antidepressants, it found. Read more from Irina Anghel.

Long-Term Covid-19 Study in Children Enrolls First Volunteer: An NIH study of the long-term effects of Covid-19 in children has enrolled its first participant, the agency announced yesterday. The study aims to provide a better picture of how the disease impacts childhood development, including physical and mental health, and how the immune system responds to an infection of SARS-Cov-2. Early data indicated children were less likely to get severe cases of Covid-19, but many have suffered from both acute and long-term effects, including Multisystem Inflammatory Syndrome in Children (MIS-C), a condition that affects multiple organs and leads to severe illness. Read more from Jeannie Baumann.

Novavax Faces Shareholder Suit Over Vaccine Claims: Biotechnology company Novavax allegedly misled investors about how soon its Covid-19 vaccine would be ready for emergency-use authorization from the FDA, a new suit said. The Gaithersburg, Md.-based company overstated its manufacturing capabilities and downplayed issues that led to multiple delays of its filing with the FDA, a Nov. 12 shareholder complaint in the U.S. District Court for the District of Maryland claimed. Lydia Beyoud has more.

More Headlines:

What Else to Know Today

Data Breach Rule for Health Apps Leaves Developers in Dark: Makers of health apps are scrambling to understand the extent of their legal liability after a divided Federal Trade Commission announced they are now required to inform users about data and privacy breaches—and if they have used their customers’ health data without consent. The commission approved by a 3-2 vote a policy statement that appmakers must adhere to the FTC Health Breach Notification Rule. Christopher Brown has more.

Medicaid, Medicare Overpaid Billions, Report Finds: Federal health-care programs continue to shell out billions of dollars in improper overpayments each year, a new HHS report shows. Medicaid paid out nearly $98.4 billion in overpayments from July 2020 through June 2021, accounting for about 21.6% of total program reimbursements, the Department of Health and Human Services reported yesterday. Read more from Tony Pugh.

More Headlines:

With assistance from Jack Fitzpatrick

To contact the reporter on this story: Brandon Lee in Washington at blee@bgov.com

To contact the editors responsible for this story: Zachary Sherwood at zsherwood@bgov.com; Giuseppe Macri at gmacri@bgov.com; Michaela Ross at mross@bgov.com

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