Health Care Checkup: January 29, 2021

Health Care Checkup

January 29, 2021

THE BIG PICTURE

What Happened This Week

This week, Senate Majority Leader Chuck Schumer (D-NY) announced that he is ready to begin moving toward a COVID-19 stimulus package that could pass the Senate with support from Democrats alone. Currently, Republicans have been widely opposed to supporting President Biden’s $1.9 trillion COVID stimulus proposal, as they claim the price tag is too high after December’s $908 billion package. In a press briefing on Tuesday, Leader Schumer said that the vote on a budget resolution could come as early as next week. Tying the COVID relief package to the budget resolution would allow for the Senate to utilize the budget reconciliation process to pass the stimulus package by a simple majority. However, if Democrats proceed forward along this route, then some of the provisions laid out in Biden’s plan would be excluded from the final bill due to limitations on certain policy changes that do not have a budgetary impact and on discretionary spending in the budget resolution process.

On Thursday, President Biden signed executive orders aimed at helping people gain health insurance coverage during the COVID-19 pandemic. The first Executive Order would reopen the federal marketplace that sells Affordable Care Act health plans (HealthCare.gov) for a “Special Enrollment Period.” The President also “direct[ed] federal agencies to reconsider rules and other policies that limit Americans’ access to health care.” The Agencies will be directed to re-examine policies such as the Trump-era Medicaid waivers that allowed states to impose work requirements on Medicaid beneficiaries. The President also issued a Presidential Memorandum to protect and expand access to comprehensive reproductive health care. The Memorandum also directs HHS to “take immediate action to consider whether to rescind regulations under its Title X family planning program.”

On Friday, Johnson & Johnson announced that its single-dose COVID-19 vaccine met topline efficacy and safety standards from its Phase 3 ENSEMBLE clinical trial. Results from the trial showed that Johnson & Johnson’s vaccine was 72% effective in the US and 66% effective overall at preventing moderate to severe cases of COVID-19, 28 days after vaccination. Additionally, the vaccine was 85% effective overall in preventing severe disease and 100% effective at preventing COVID-19 related hospitalization and death, as of day 28.

What to Expect Next Week: The Senate will proceed forward with the impeachment trial of former President Donald Trump. Additionally, the Senate will likely vote on the budget resolution, kicking off the budget reconciliation process which may be used for another COVID package.

Over at the House, there will be several COVID-related hearings. The Energy and Commerce Committee’s Oversight and Investigations Subcommittee will hold a hearing on Tuesday, February 2nd at 11 a.m. EST on COVID-19 vaccine distribution and administration. The hearing is entitled “No Time to Lose: Solutions to Increase COVID-19 Vaccinations in the States.” On Wednesday, February 3rd at 11 a.m. EST, the Energy and Commerce Committee’s Health Subcommittee will hold a hearing on federal COVID-19 response efforts related to vaccines, testing, and medical supply chain. The hearing is entitled “Road to Recovery: Ramping Up COVID-19 Vaccines, Testing, and Medical Supply Chain.” On Thursday, February 4th at 11:05 a.m. EST, the House Committee on Transportation and Infrastructure will hold a hearing entitled, “Protecting Transportation Workers and Passengers from COVID: Gaps in Safety, Lessons Learned and Next Steps.”

DEEP DIVE

Majority Leader Chuck Schumer Moves Toward Tying COVID Package to Budget Resolution

This week, Senate Majority Leader Chuck Schumer (D-NY) announced that he is ready to begin moving toward a COVID-19 stimulus package that could pass the Senate with support from Democrats alone. Currently, Republicans have been widely opposed to supporting President Biden’s $1.9 trillion COVID stimulus proposal, as they claim the price tag is too high after December’s $908 billion package. In a press briefing on Tuesday, Leader Schumer said that the vote on the budget resolution could come as early as next week. Tying the COVID relief package to the budget resolution would allow for the Senate to utilize the budget reconciliation process to pass the stimulus package by a simple majority. However, if Democrats proceed forward along this route, then some of the provisions laid out in Biden’s plan would be excluded from the final bill due to limitations on certain policy changes that do not have a budgetary impact and on discretionary spending in the budget resolution process. While stimulus checks and unemployment aid would not be impacted, other provisions, such as increasing the minimum wage, might be. While there is still hope that some Republicans may support parts of Biden’s plan, gaining enough Republican support in the Senate to obtain the 60 votes needed to pass the entire $1.9 trillion package is unlikely.

Biden Administration Moves to Boost Vaccine Supply and Increase Transparency

On Tuesday, President Biden announced plans to increase weekly COVID-19 vaccine supplies to states, tribes, and territories; to increase transparency for states, tribes, and territories to help with their vaccination efforts; and to purchase 200 Million additional doses of the vaccine for delivery by this summer. For at least the next three weeks, the Biden Administration will increase the weekly vaccine supply from 8.6 million doses to a “minimum” of 10 million doses. While this increase of 1.4 million doses per week will be helpful, it is still a far cry from meeting the current demand. Supply is unlikely to meet demand until late summer or early fall, based on the current rate of vaccine distribution. However, the vaccine supply may soon increase drastically, as Johnson & Johnson is expected to apply to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization for its COVID vaccine in the coming weeks. To provide greater transparency around vaccine distribution, the Department of Health and Human Services (HHS) plans to provide three-week allocation estimates, as opposed to the current one-week forecast. The Administration hopes this change will “give state and local leaders greater certainty around supply.” Additionally, the Administration is working to purchase an additional 100 million doses of both Pfizer’s and Moderna’s COVID vaccines. 200 million extra doses would increase the total U.S. vaccine supply to roughly 600 million. With these additional doses, the U.S. should have enough to vaccinate around 300 million Americans by the end of this summer.

President Biden Signed Executive Orders Aimed at Helping Americans Gain Health Coverage

On Thursday, President Biden signed Executive Orders aimed at helping people gain health insurance coverage during the COVID-19 pandemic. The first Executive Order would reopen the federal marketplace that sells Affordable Care Act health plans (HealthCare.gov) for a “Special Enrollment Period.” The annual sign-up period for health insurance through HealthCare.gov concluded in December 2020, and enrollment grew by approximately 7% compared to the previous year. Therefore, reopening the federal marketplace has the opportunity to reach many Americans who did not sign up at the end of last year but who nonetheless need coverage during the current health crisis. HHS will open HealthCare.gov for this special enrollment period from February 15, 2021 – May 15, 2021. The President also “direct[ed] federal agencies to reconsider rules and other policies that limit Americans’ access to health care.” The Agencies will be directed to re-examine policies such as the Trump-era Medicaid waivers that allowed states to impose work requirements on Medicaid beneficiaries. The waivers have been criticized by Democrats for tying Medicaid recipients’ health coverage to state work requirement standards. Additionally, the agencies will re-examine policies that reduce affordability of coverage, undermine the Health Insurance Marketplace, make it more difficult to enroll in Medicaid and the ACA, and policies that undermine protections for people with pre-existing conditions. The President also issued a Presidential Memorandum to protect and expand access to comprehensive reproductive health care. The Memorandum will also direct HHS to “take immediate action to consider whether to rescind regulations under its Title X family planning program” promulgated by the prior administration. More information can be found here.

Johnson & Johnson Announces Promising Results from Phase 3 Clinical Trial

On January 29, Johnson & Johnson announced that its single-dose COVID-19 vaccine met topline efficacy and safety standards from its Phase 3 ENSEMBLE clinical trial. Results from the trial showed that Johnson & Johnson’s vaccine was 72% effective in the US and 66% effective overall at preventing moderate to severe cases of COVID-19, 28 days after vaccination. Additionally, the vaccine was 85% effective overall in preventing severe disease and 100% effective at preventing COVID-19 related hospitalization and death, as of day 28. The vaccine also demonstrated protection against multiple variants of the virus, including the South Africa variant. However, the vaccine was only 57% effective overall in South Africa, where the new variant is dominating new cases. Johnson & Johnson plans to file for an EUA with the FDA in early February.

Biden Administration Freezes Trump-era Drug Rebate Rule

On Friday, HHS paused a Trump-era safe harbor rule that would replace current drug rebates with fixed-fee arrangements. The rule, which was finalized by HHS in November 2020, would revise the anti-kickback statute (AKS) safe harbor rule to exclude manufacturer rebates paid to Medicare Part D plans. This change would exclude both direct payments and those paid through a pharmacy benefits manager (PBM). While the HHS rule was intended to lower drug prices by giving drug manufacturers the opportunity to lower the prices they set for their products, it does not force them to lower prices. Additionally, the Government Accountability Office (GAO) found the rule to violate the Congressional Review Act. The rule was slated to go into effect on January 29, 2021. However, this freeze will delay the effective date to March 22, 2021. This delay will give HHS officials time to further review the rule.

New Congressional Committee Appointments Announced

On Monday, House Appropriations Committee Chair Rosa DeLauro (D-CT) announced the Democratic rosters for the House Appropriations Committee’s 12 subcommittees in the 117th Congress, including the Subcommittee Chairs and the full Committee Vice Chair. On Tuesday, House Speaker Nancy Pelosi (D-CA) announced appointments for the Armed Services Committee, the Budget Committee, the Ethics Committee, the Foreign Affairs Committee, the Committee on House Administration, the Small Business Committee, the Select Committee on the Climate Crisis, the Select Committee on the Modernization of Congress, and the Select Subcommittee on the Coronavirus Crisis. In her announcement, Speaker Pelosi stated that she was “particularly pleased to announce the appointments of new Members to the Select Committees, which will be key forces to advance justice and progress in the Congress and Country.” Additionally, on Thursday, Kay Granger (R-TX), Republican Leader of the House Appropriations Committee, announced Republican subcommittee assignments for the 117th Congress.