Health Policy Report (2/8)

Capitol Hill Update

Congress has formally kicked off the budget reconciliation process for additional virus relief legislation, passing a resolution that instructs 25 committees across both chambers to begin drafting the bill. Speaker Nancy Pelosi (D-CA) stated that House committees will mark up the $1.9 trillion relief package next week, with the goal of getting it on the floor for consideration by the week of February 15. While the lower chamber focuses on efforts to move the relief package, Senators will be engaged in the impeachment trial of former President Donald Trump, which will begin in earnest on Tuesday.

Biden to Use Defense Production Act to Increase COVID-19 Supplies

The Biden administration announced Friday that it would implement its authority under the Defense Production Act (DPA) to increase manufacture of critical COVID-19 supplies such as tests, gloves, and vaccine supplies. White House officials explained that the administration had identified shortfalls in 12 critical categories of supplies after the President signed an Executive Order directing U.S. agencies to use the DPA, and that the law will be used to address these shortages. Additionally, the Defense Department has been directed to deploy more than 1,000 active military personnel to support state vaccination sites, as early as February 15 in California. Administration officials did not announce how much had been invested or which specific suppliers had been chosen to boost production, but explained it would assist industry partners in building new plants and production lines in the U.S.

Under the initiative, the administration has invested in six suppliers to produce at least 61 million at-home and point-of-care COVID-19 tests to be available by this summer. The DPA will also be used to increase the supply of raw materials and equipment needed to produce vaccines and surgical gloves. To accomplish this, the administration plans to build rubber and glove manufacturing factories to produce more than a billion surgical gloves a month by the end of the year. Additionally, Biden will use the DPA to give Pfizer priority access to components it needs to manufacture its COVID-19 vaccine.

Johnson & Johnson Submits Emergency Use Authorization Request for COVID-19 Vaccine

Last Thursday, Johnson & Johnson (J&J) submitted an emergency use authorization (EUA) application to the Food and Drug Administration (FDA) for its COVID-19 vaccine candidate. The J&J candidate is the only single dose vaccine and was shown to be 66 percent effective in global clinical trials and 72 percent effective in U.S. clinical trials. Additionally, the vaccine candidate is 85 percent protective against the most serious symptoms and hospitalization. J&J is also evaluating a two-dose version of its vaccine candidate, but results won’t be available for several more months.

The FDA advisory committee will meet February 26 to discuss the application and promised to review the request “as expeditiously as possible, taking into consideration the discussion by the advisory committee, while still doing so in a thorough and science-based manner.” J&J announced it expects to have the vaccine available to ship immediately following authorization.

CDC Study Shows Mask Mandates Slowed COVID-19 Hospitalizations

A Centers for Disease Control and Prevention (CDC) study released last Friday found that statewide mask mandates have helped slow the rate of COVID-19 hospitalizations and infections. Data showed that in 10 states that required masks, the COVID-19 hospitalization rate slowed by 5.5 percent in adults under 65 within three weeks, compared to hospitalization data from four weeks before the mandates. The CDC explained the findings are evidence that mask-wearing remains a key component of a broader public health strategy to combat the pandemic and reduce further strain on the health system. The study monitored hospitalization rates in California, Colorado, Connecticut, Maryland, Michigan, Minnesota, New Mexico, New York, Ohio and Oregon between mid-April and mid-July. Additionally, on Friday, the CDC released a report showing more than 90 percent of individuals at six universities across the country complied with mask requirements. The studies’ results come as the Biden administration emphasizes the importance of mask mandates in tackling COVID-19, and Biden chief of staff Ron Klain last Thursday confirmed reports the administration is considering sending masks to all Americans.

Supreme Court to Consider Medicaid Work Requirement Case March 29

The Supreme Court announced last Monday it would hear oral arguments in the case concerning the validity of the Trump administration’s Medicaid work requirement waivers on March 29. President Biden recently signed an Executive Order directing the Department of Health and Human Services to review the work requirement waivers, although the administration does not yet appear to have issued a new policy. Additionally, the Centers for Medicare and Medicaid Services (CMS) is still reviewing 1115 demonstration protections put in place by former administrator Seema Verma before resigning from her position.

The day before President Biden’s inauguration, the Trump administration submitted arguments to the Supreme Court that Medicaid work requirements improve beneficiary health and independence, indirectly advance the Medicaid program’s objective of achieving coverage for beneficiaries, and assist states in extending their budgets to encompass more individuals. The Trump administration stated the lower courts’ reading that the demos don’t meet Medicaid program objectives was too limited. More than 100 stakeholder advocacy groups have called for HHS Secretary Nominee Xavier Becerra to immediately rescind all of Trump’s Medicaid work requirement demonstrations.