October 18, 2021
This Week in Health Policy for October 18
This Week (October 18-22)
The Senate Finance Committee holds a hearing on "Health Insurance Coverage in America: Current and Future Role of Federal Programs."
The House Energy and Commerce Health Subcommittee holds a hearing on "Enhancing Public Health: Legislation to Protect Children and Families."
Last Week (October 11-15)
Health Care Highlights
Democrats weigh changes to health care priorities. Congressional Democrats are weighing changes to their evolving "human infrastructure" package, as leaders assess how to cut or reduce areas of the once-$3.5 trillion spending package to win the support of key moderates without losing progressive support. Speaker Nancy Pelosi (D-CA) told California's KQED Wednesday she doesn't expect her signature drug pricing legislation (H.R. 3), which would allow Medicare to negotiate the price of high-cost prescription drugs and penalize tax drug makers who refuse to reduce their prices, to be included in the final reconciliation package. "We'll get something of that, but it won't be the complete package that many of us having been fighting for a long time," Pelosi said. Rep. Scott Peters (D-CA), one of three moderate Democrats who blocked a drug pricing proposal from advancing out of the House Energy and Commerce Committee last month, said Thursday he's in talks with Senate Democrats and the White House about how to craft a drug pricing proposal. Senate Finance Committee Chairman Ron Wyden (D-OR) is working on his own plan, which reportedly will subject fewer medicines to government negotiation and tie prices to what the Veterans Affairs Department pays. One major unknown is Sen. Krysten Sinema (D-AZ), who hasn't publicly outlined her opinion on how to tackle the issue.
Progressives have also recently made clear that new vision, dental, and hearing benefits under Medicare must be included. Bernie Sanders (I-VT) told reporters this week it is "not negotiable" and Progressive Caucus Chair Pramila Jayapal (D-WA) said her coalition shares the sentiment. Jayapal has said that instead of cutting provisions, progressives would be open to making them effective for a shorter length of time. Moderate Democratic Senator Joe Manchin (D-WV), however, has said he doesn't support adding new benefits without first addressing the program's long-term solvency. Democrats are also now planning to cut out $3 billion in funding for President Biden's proposed biomedical research agency — the Advanced Research Projects Agency for Health (ARPA-H) due to concerns that Senate rules would prohibit its inclusion. Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) said last week they expect to include authorizing language in bipartisan "Cures 2.0" legislation they will soon introduce, which is focused on biomedical innovation.
Robert Califf emerges as top FDA Commissioner contender. Robert Califf, who ran the U.S. Food and Drug Administration (FDA) under President Barack Obama, has moved into top contention to lead the agency again, according to people familiar with the matter. Califf, a cardiologist who is currently head of clinical strategy and policy at Alphabet Inc.'s Verily and Google Health units, would replace acting FDA Commissioner Janet Woodcock if he is confirmed by the Senate. The FDA has been without a permanent leader since the start of the Biden administration despite playing a key role in the pandemic response, including controversial decisions surrounding the booster clearance process and earlier approval of Biogen Inc's Alzheimer's disease drug Aduhelm despite objections of agency advisors. Without a nominee, Woodcock wouldn't be eligible to serve as acting commissioner beyond mid-November; she can keep serving if a nominee is in place by then.
FDA advisory panel approves Moderna booster for certain populations. On Thursday (Oct. 14), an FDA advisory panel approved booster shots of Moderna's COVID-19 vaccine to people aged 65 and older along with those between 18 and 64 years old who are at high risk for medical or occupational reasons in a unanimous, 19-0 vote. The shots should be given six months after the initial inoculation, the panel said. The FDA's advisory committee will continue meeting Friday (Oct. 15) to considers booster shots for Johnson & Johnson. They will also discuss mixing and matching boosters with different shots used in initial immunizations. Pairing COVID-19 immunizations with a different booster produces as much or more antibodies as boosting with the same shot, according to preliminary results from a U.S. government-sponsored trial. Separately, the FDA is sending Merck's COVID-19 pill to an advisory committee on Nov. 30 for review, aiming to weigh data on the use of the drug to treat mild-to-moderate cases in high-risk adults.
OHSA vaccine rule expected shortly, amid pushback. On Tuesday (Oct. 12), the Labor Department's Occupational Safety and Health Administration (OSHA) submitted the initial text of an emergency standard for large employers to the White House for approval, signaling its release could soon follow. The proposed mandate would require businesses with 100 or more employees to ensure employees are vaccinated against COVID-19 or are regularly tested. Twenty-four Republican attorneys general have said they will pursue legal options against the OSHA emergency standard, amid a slew of other legal action against workplace COVID-19 vaccinate mandates, which have largely survived to date.
Congressional Democrats push for IP waiver. A bicameral group of 12 Democratic lawmakers led by Senator Elizabeth Warren (D-MA) urged the Biden administration in a letter "to take bold steps to dramatically expand global COVID-19 vaccine access and manufacturing capabilities." The letter specifically says that Moderna's contract with the U.S. may allow the government to access and share the company's COVID-19 vaccine technology. It also notes support for waiver of international intellectual property protections for COVID-19 vaccines and calls on the administration to use its participation in negotiations at the World Trade Organization (WTO) "to press the remaining opposing countries to reach an agreement." World Trade Organization Director-General Ngozi Okonjo-Iweala said Thursday (Oct. 14) she believed countries could reach a "pragmatic compromise" on the IP waiver by early December that "ensures equitable access to developing countries while preserving incentives for research and innovation."
Reports, Studies, and Journals
The Lancet: Global prevalence and burden of depressive and anxiety disorders in 204 countries and territories in 2020 due to the COVID-19 pandemic. In this study, researchers aim to quantify the impact of the COVID-19 pandemic on the prevalence and burden of major depressive disorder and anxiety disorders globally in 2020.
Kaiser Family Foundation: The Public Weighs In On Medicare Drug Negotiations. With much attention on the public's view on Medicare drug price negotiations, the latest KFF Tracking Poll finds large majorities support allowing the federal government to negotiate and this support holds steady even after the public is provided the arguments being presented by parties on both sides of the legislative debate.
Peterson-Kaiser Family Foundation Health System Tracker: COVID-19 continues to be a leading cause of death in the U.S. in September 2021. Looking at the most recent data available on deaths from COVID-19 and other causes, researchers estimate that COVID-19 was the number 2 leading cause of death in the U.S. in September 2021.
The Commonwealth Fund: Medicare Advantage vs. Traditional Medicare: How Do Beneficiaries' Characteristics and Experiences Differ? Medicare Advantage enrollees do not differ significantly from beneficiaries in traditional Medicare in terms of their age, race, income, chronic conditions, satisfaction with care, or access to care, after excluding SNP enrollees. Both groups reported waiting more than a month for physician office visits. Similar shares of Medicare Advantage and traditional Medicare enrollees report that their out-of-pocket costs make it difficult to obtain care.