October 11, 2021
This Week in Health Policy for October 11
This Week (October 11- 15)
The House Veterans' Affairs Health Subcommittee holds a hearing on pending veterans health legislation. H.R. 2819 (117), the "Solid Start Act of 2021"; H.R. 2916 (117), the "VA Cannabis Research Act of 2021"; H.R. 4575 (117), the "Veteran Peer Specialist Act of 2021"; H.R. 4794 (117), the "Making Advances in Mammography and Medical Options for Veterans Act"; H.R. 5029, the "Expanding the Families of Veterans Access to Mental Health Services Act"; H.R. 5073 (117), the "Revising and Expediting Actions for the Crisis Hotline for Veterans Act"; H.R. 5317 (117), the "VA Governors Challenge Expansion Act of 2021"; the "Veterans Census-Enabled National Treatment Equitable Resources Supplement (Vet CENTERS) for Mental Health Act of 2021"; legislation authorizing VA to furnish seasonal influenza vaccines to individuals who are eligible for COVID-19 vaccines under the SAVE LIVES Act, P.L. 117-4; legislation to expand eligibility for hospital care, medical services, and nursing home care from the Department of Veterans Affairs to include veterans of World War II; the "Department of Veterans Affairs Nurse and Physician Assistant Retention and Income Security Enhancement (VA Nurse and Physician Assistant RAISE) Act"; legislation to improve VA's Veterans Justice Outreach Program; and legislation to require VA to report to Congress within one year of enactment on the Veterans Integration to Academic Leadership program, which supports student veteran mental health.
Last Week (October 4 - 8)
Health Care Highlights
Democrats work to come to agreement on a trimmed down reconciliation package. President Joe Biden and congressional Democrats are jockeying to trim down their $3.5 trillion "human infrastructure" package to as little as $1.5 trillion, which could mean paring back certain health care priorities. Senator Joe Manchin (D-WV) this week reiterated his insistence on a $1.5 trillion ceiling, however progressives, led by Rep. Pramila Jayapal (D-WA), say they will support a minimum size of $2.5 trillion. Key moderate Senator Kyrsten Sinema (D-AZ) has still not publicly divulged her view on a topline spending number. A major question is whether a smaller topline number means including a list of provisions that is narrower than in the House bill, or the same roster of proposals with a shorter duration and limited benefits. Moderates, for example, are pushing to means-test a measure adding dental, vision, and hearing benefits to Medicare and are also mulling whether to rescind billions of dollars meant to encourage states to expand their Medicaid program, in part to pay for a federal Medicaid-like coverage plan in those states. None of the 12 states that have so far declined to expand Medicaid have accepted the offer of more federal funds. Progressives, however, are hoping to retain all of the programs in a final bill by funding many of them for shorter durations and therefore lowering the bill's ultimate price tag.
Also this week, the Senate cleared a $480 billion increase in the federal debt limit to allow Treasury to meet the nation's obligations into at least early December, setting up another must-act date on the issue alongside the expiration of government funding on December 3. The only deadline between now and December will be the expiration of the highway authorization October 31, which Democrats set as a self-imposed deadline for a reconciliation agreement and House vote on the bipartisan infrastructure framework.
Biden leans in on vaccine mandates. In a trip to Chicago this week, President Joe Biden touted his administration's COVID-19 vaccinate mandates, which will apply to more than 100 million people in the coming weeks, and increased pressure on private employers to act. President Biden said "We know there is no other way to beat the pandemic than to get the vast majority of Americans vaccinated … We're still not there. We have to beat this thing." Before the trip, the White House released a report that said 3,500 U.S. organizations already have a vaccine mandate, including 40% of hospitals and 25% of businesses, following Biden's directive that federal workers and contractors be vaccinated and that the Occupational Safety and Health Administration (OSHA) draft regulations for companies to require businesses with more than 100 employees to ensure workers are fully vaccinated or face weekly testing. Federal workers will have to prove they're vaccinated by November 8 or face unpaid suspension followed by termination, according to new guidance, and Biden said the OSHA regulations would be issued shortly.
Pfizer and BioNTech request authorization for COVID-19 vaccine for children 5-11. Earlier this week, Pfizer Inc. and BioNTech SE requested authorization from the Food and Drug Administration (FDA) for their COVID-19 vaccine for children ages 5 to 11, which is one-third of the adult dosage. An FDA advisory committee is planning to review the data on October 26 and the Centers for Disease Control and Prevention (CDC) will set a meeting for the week of November 1. BioNTech Chief Executive Ugur Sahin also told the Financial Times this week that a new formulation of his company's COVID-19 vaccine could be necessary by mid-2022 to protect against mutations of the virus, warning that a "next generation virus" could be harder for the immune system to tackle than the existing variants. The FDA's advisory committee will also meet on October 14 and 15 to discuss the use of booster doses of Moderna and Johnson & Johnson's COVID-19 vaccines.
White House announces $1 billion investment in rapid tests. On Wednesday (Oct. 6), the Biden administration announced a $1 billion purchase of rapid at-home coronavirus tests, an additional investment that White House COVID-19 response czar Jeff Zients said will put the U.S. on track to quadruple rapid tests by December along with previous investments in testing and the additional authorization of ACON Laboratories Inc.'s at-home test earlier this week. Americans are increasingly turning to rapid tests to meet requirements for work, school, and public events, however supplies are becoming scarce. Australian company Ellume announced a voluntary recall of about 195,000 tests last week after the discovery that roughly 427,000 tests contained a component that increased the risk of a false positive.
Longtime NIH Director Francis Collins retiring. Dr. Francis Collins announced this week he will step down as director of the National Institutes of Health (NIH) after leading the agency for 12 years. Collins said he thought now was the right time to retire because the work toward making COVID-19 vaccines and other tools available put the agency in a "in a very solid place." A White House spokesperson said President Biden is expected to pick an NIH director before Collins steps down. His retirement leaves the Biden administration with the need to select two top health picks, amid a looming deadline to find a permanent head of the FDA. Under the Vacancies Act, acting FDA Commissioner Janet Woodcock can't serve past November 15 unless Biden nominates someone to fill the job permanently. If there's a nominee in place, Woodcock can continue to serve as the nominee moves through the confirmation process. Leadership of both agencies will be critical in the coming months as the pandemic remains a top priority and the FDA must evaluate booster shots and vaccines in kids. The Biden administration also has plans for a sweeping $65 billion pandemic preparedness plan as well as a new entity at the NIH to develop biomedical breakthroughs — the Advanced Research Projects Agency for Health (ARPA-H), which is currently funded in the Democratic reconciliation package.
CMS releases 2022 MA Star Ratings. On Friday (October 8), the Centers for Medicare & Medicaid Services (CMS) released the 2022 Star Ratings for Medicare Advantage (MA) and Medicare Part D prescription drug plans. "The Medicare Advantage and Part D Star Ratings are important tools in the toolbox for beneficiaries to use as they consider Medicare coverage options," said CMS Administrator Chiquita Brooks-LaSure. Medicare Open Enrollment begins October 15, 2021 and ends December 7, 2021. Of the 322 MA plans with prescription drug coverage that received a rating, roughly 68% earned four stars or higher on a scale of one to five stars, with five being the highest. For 2021 plans, 49% scored four stars or more. A greater percentage of seniors are also currently enrolled in plans that will have four stars or more next year, according to CMS. Weighted by enrollment, 90% of MA members are in plans with four stars or higher, compared with just 77% for 2021.
FDA rules eases path for low-risk medical devices. A final rule issued by the FDA this week aims to create a more efficient pathway for getting new, low-risk equipment on the market. The rule lays out criteria and procedures for manufacturers to request a de novo review, which allows devices without a previously approved comparative device to be designated as a lower-risk class device and get a quicker path to approval. Under the final rule, a device maker could ask to have its product reviewed under the de novo pathway if the company requested a review under the faster, less cumbersome 510(k) pathway but the FDA found there wasn't a product that was substantially equivalent already. The rule also provides a way for combination products to use the de novo pathway to get the device approved, instead of going through the premarket pathway, which tends to take longer because it's designed to regulate the riskiest category of devices.
Reports, Studies, and Journals
Medicaid and CHIP Payment and Access Commission: An Updated Look at Rates of Churn and Continuous Coverage in Medicaid and CHIP. Overall, researchers found that about 8 percent of full-benefit Medicaid and CHIP beneficiaries disenrolled and re-enrolled within a year, which is higher than MACPAC's previous estimates but similar to other recent studies. They also found substantial state variation in rates of churn and average lengths of coverage that appears to be explained in part by state policy differences.
BPC: Why the U.S. Must Bridge Health and Health Care. BPC's Future of Health Care leaders released a report on September 30 with recommendations to better integrate, coordinate, and ultimately improve the health and health care performance and outcomes. The recommendations focus on improving access to and coverage and financing of non-medical and preventive services, and increasing access to care through workforce solutions.
Health Care Cost Institute: 2019 Health Care Cost and Utilization Report. HCCI's annual reports examine year-over-year and 5-year cumulative trends in health care spending for individuals with employer-sponsored insurance, segmented by health care service category.
Washington Council EY's latest "DC Dynamics" podcast includes discussion of the Build Back Better plan, reconciliation, and what lies ahead on health care. Listen on Apple Podcasts or Spotify.