HEALTH CARE BRIEFING: Drug Pricing Leads Congress’ Health Agenda

By Brandon Lee and Alex Ruoff

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Congress returns this week as House and Senate Democratic leaders begin a push to enact President Joe Biden’s long-term economic strategy built around massive infrastructure and manufacturing investments.

After first enacting a $1.9 trillion Covid-19 recovery plan (Public Law 117-2) without Republican support, Biden and Democrats may look to strike deals with the GOP as they work to advance a multi-part plan that could total more than $3 trillion, Nancy Ognanovich and Emily Wilkins report.

Aside from Biden’s ambitious plan and fiscal 2022 appropriations bills lawmakers will now begin drafting after the release of the president’s initial budget proposal Friday, Congress will also look to tackle a slate of health-care measures. Some could find bipartisan paths forward, while others could advance as part of Biden and congressional Democrats’ infrastructure efforts.

  • Drug Pricing: Lawmakers on both sides of the aisle continue to preach the importance of reducing the cost of medicines at the pharmacy counter. Prominent Democrats in both chambers have endorsed directing the government to negotiate with drugmakers over the price of prescription drugs and redesigning Medicare to be more generous. Four bills introduced this year focus primarily on amending the Social Security Act to let the government directly negotiate drug prices in Medicare: H.R. 2071, H.R. 2139, S. 833, and S. 908.
  • Generics: While drug-price negotiation is focused on pricey, brand-name drugs, some lawmakers have turned their attention to easing entry for generic drugs—low-cost copies of popular medicines. H.R. 153 would ban brand-name drug companies from paying generic manufacturers to delay bringing their products to market. It would also block biologic drugmakers from paying generic counterparts to delay the launch of biosimilars.
  • Public Option: Biden’s election has given new life to supporters of a government-run health insurance plan, known as a public option. Supporters say a public option would allow the government to lower the cost of health-care services by influencing what private insurers pay doctors and hospitals. S. 386 and H.R. 1227 would create a public health insurance option that piggybacks off Medicare for individuals and small businesses.

Bloomberg Government previews all the major issues to watch in the Spring Hill Watch. Click here to download the Spring 2021 Hill Watch.

Infrastructure Leads Agenda: Biden wants to boost the American economy and compete with China with a $2.25 trillion infrastructure and public works package, Lillianna Byington reports. The package calls for investing in a wide variety of projects, from traditional spending on roads and bridges, to funds aimed at improving care for the elderly and people with disabilities.

GOP opposition could drive Democrats to turn to budget reconciliation once again to sidestep a potential filibuster, which would require a supermajority of 60 senators to break.

The plan includes about $620 billion for transportation; $580 billion for workforce development, research, and manufacturing; $400 billion for elder and disability care; and $650 billion for initiatives aimed at better quality of life at home, including lead-free pipes, broadband, and housing.

Happening on the Hill

Nominations: The Senate Finance Committee holds a hearing Thursday on the nominations of Andrea Joan Palm to be a deputy secretary, and Chiquita Brooks-LaSure to be administrator of the Centers for Medicare and Medicaid Service, both of the Health and Human Services Department.

Hearings on the Hill:

  • Fauci, Walensky Testify on Virus: The House Select Subcommittee on the Coronavirus Crisis plans a hearing Thursday on a science-driven approach to ending the Covid-19 pandemic. Witnesses include CDC Director Rochelle Walensky, National Institute of Allergy and Infectious Diseases Director Anthony Fauci, and Health and Human Services Department Covid Response Chief Science Officer David Kessler.
  • Pandemic Preparedness: The Senate Homeland Security and Governmental Affairs Committee plans a hearing Wednesday on the initial Covid-19 preparedness and response.
  • FEMA Response: The Senate Appropriations Homeland Security Subcommittee meets for a hearing Wednesday on the Federal Emergency Management Agency’s Covid-19 response.
  • Covid-19 in Native Communities: The Senate Indian Affairs Committee scheduled a hearing Wednesday on Covid-19 response in native communities and native health-care systems.
  • Substance Abuse Bills: The House Energy and Commerce Subcommittee on Health meets for a hearing on bills targeting opioid, methamphetamine and other substance use and misuse.
  • Behavioral, Mental Health Care Access: The House Education and Labor Subcommittee on Health, Employment, Labor, and Pensions scheduled a hearing Thursday on access to behavioral and mental health care.
  • Fiscal 2022 Appropriations: The House Appropriations Labor-HHS-Education Subcommittee on Thursday will review the Health and Human Services Department. HHS Secretary Xavier Becerra will testify.

Clyburn Probes Trump-Era Interference in Pandemic Response: House Select Subcommittee on the Coronavirus Crisis Chair James Clyburn (D-S.C.) Friday sent letters to three Trump administration advisors—Scott Atlas, Paul Alexander, and Steven Hatfill—seeking documents and transcribed interviews regarding their roles in the Trump administration’s pandemic response, according to a statement. Find the letters here.

Mayorkas Pressed on DHS Procurement of N95s: Sen. Tammy Duckworth (D-Ill.) on Friday pressed Homeland Security Secretary Alejandro Mayorkas on the department’s use of the Defense Protection Act and whether the agency is helping health-care providers get access to N95 respirators as supply expands. She’s also asking for an update on FEMA’s plan to improve the manufacturing, allocation and distribution of N95 masks and other personal protective equipment in response to the Covid-19 pandemic, Alex Ruoff reports.

Biden Boosts Health in $1.52 Trillion Budget Ask

Biden proposed major boosts in funding to combat inequality, disease and climate change as part of a $1.52 trillion budget request for 2022, part of his wider push to redefine the role of government in American lives.

The administration’s outline, released by the White House on Friday, kicks off a months-long process in which Congress is likely to significantly reshape the priorities, given stiff Republican opposition to many of the proposals. But the outline showcases how Biden is trying to bend the federal government toward a much greater role in the provision of health care and education.

Combined with the $1.9 trillion pandemic-relief bill signed last month and a $2.25 trillion infrastructure-and-jobs proposal, the budget marks Biden’s third foray into using the power of the federal government to radically expand help for lower-income and middle-class Americans. A further social-spending package is also coming, all before Biden’s first 100 days have passed. Read more from Justin Sink and Erik Wasson.

$6.5 Billion Health Research Agency: The Department of Health and Human Services would get a $25 billion budget boost and a new biomedical research agency under the request. Central to Biden’s vision for HHS is a request for $6.5 billion to create what the White House calls the Advanced Research Projects Agency for Health, or ARPA-H, modeled on similar research initiatives at the Pentagon and the Department of Energy. Biden helped launch the research initiative Cancer Moonshot after his son Beau Biden died of brain cancer in 2015. A portion of the moonshot is named after Beau.

This new agency, proposed to be among the largest federal biomedical research initiatives, would expand the government’s ability to fund the development of new technologies and medicines made possible by the basic research already done at the National Institutes of Health. Read more from Alex Ruoff.

Public Health Agency Funding: Biden’s proposal includes a $9 billion overall increase in funding for the nation’s research institutions, and a $1.6 billion hike for the Centers for Disease Control and Prevention, which would be the agency’s largest funding increase in two decades. The White House requested $131.7 billion in total for HHS in fiscal 2022, a 23.5% increase over the 2021 enacted level, Ruoff reports.

$10.7 Billion Request to Combat Opioid Crisis: The Biden administration’s request for $10.7 billion from Congress to fight the U.S. opioid crisis would mark a significant uptick in funds to battle an addiction problem that has worsened during the Covid-19 pandemic. The proposed funding for fiscal 2022 reflects the Biden administration’s first-year plan to expand access to treatment for opioid use disorder and end racial and economic inequities in drug policy. Read more from Ian Lopez.

Read more:

The Coronavirus Pandemic

Vaccine Requirements Spread in U.S.: Covid-19 vaccination requirements are fast becoming facts of life in the U.S., spreading business by business even as politicians and privacy groups rail against them. Brown, Notre Dame, and Rutgers are among universities warning students and staff they need to be vaccinated in order to return to campus this fall. Some sports teams are demanding proof of vaccination or a negative test from fans as arenas reopen.

Yet it’s another matter how people prove they’ve had their shots or are Covid-free. Republican politicians and privacy advocates are bristling over so-called vaccination passports, with some seeking to restrict their use. Given the fraught politics, many companies are “not necessarily wanting to be the first in their sector to take the plunge,” said Carmel Shachar, director of the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School. Still, “we’re going to see employers start to require vaccinations if you want to come into the office, if you will have a public-facing job.” Read more from David R. Baker.

Whitmer Urges a ‘Surge’ in Vaccine Doses: The U.S. government needs to urgently “surge” vaccine doses into the state of Michigan in order to combat a spike in coronavirus cases there, Gov. Gretchen Whitmer (D) said. More contagious variants, widespread pandemic fatigue, and large numbers of people who’ve never been infected have created a critical situation in the state, she said in an interview on CBS. Kristen Brown and Tom Schoenberg have more.

J&J Shot Supply Dips as Production Falters: Weekly U.S. shipments of Johnson & Johnson’s Covid-19 vaccine are dropping to 1.5 million for this week after a one-time supply spike of 11 million the previous week. The U.S. government allocated a total of 1.5 million doses of J&J’s one-dose vaccine for shipment this week, including 700,000 for states, tribes, and territories and 800,000 for other destinations, including pharmacies and community health centers, the Department of Health and Human Services said. Josh Wingrove and Riley Griffin have more.

Pfizer Seeks to Expand Vaccine Use in Young Teens: Pfizer and its partner BioNTech said they would ask regulators in the U.S. and elsewhere to allow use of their Covid-19 vaccine in adolescents ages 12 to 15. The companies said in a statement that they had requested that the Food and Drug Administration expand the vaccine’s emergency-use authorization and that they intend to request similar rulings from other regulators worldwide in coming days. Read more from Robert Langreth.

More U.S. Headlines:

J&J Covid-19 Vaccine Under Review by EU Regulator: The European Union’s drug regulator has launched a review to assess blood clots in people who took Johnson & Johnson’s Covid-19 vaccine. Four serious cases of unusual clots accompanied by low blood platelets, one of which was fatal, have emerged after immunization with the J&J shot, the European Medicines Agency said on Friday. The regulator is now scrutinizing potential safety issues for two Covid-19 vaccines, after AstraZeneca’s shot was possibly linked to a rare blood-clotting disorder. Read more from Naomi Kresge.

More Global Headlines:

What Else to Know

Organ Procurement Groups Ready to Work With HHS: Groups that connect organ donors with waiting recipients vowed to work with the Biden administration to implement a Trump-era rule meant to bolster organ donations and transplants by requiring more accountability and better performance. After lobbying against the new rule, Joe Ferreira, president of the Association of Organ Procurement Organizations, said it’s “always supported improvement to our organ donation and transplantation system and endorse the direction of the new CMS rule.” Read more from Tony Pugh.

More Headlines:

To contact the reporters on this story: Brandon Lee in Washington at blee@bgov.com; Alex Ruoff in Washington at aruoff@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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