Health Care Checkup: December 18, 2020

Health Care Checkup

December 18, 2020

THE BIG PICTURE

What Happened This Week

Democrats and Republicans in the House and Senate have been rushing to finalize ongoing negotiations surrounding an omnibus spending package to appropriate federal funds for the remainder of fiscal year 2021, along with an additional COVID package. Lawmakers have until midnight tonight to secure a deal or pass another short-term continuing resolution to avoid a government shutdown. While it has been reported that Members are close to finalizing the legislation, it is likely that Congress will remain in session throughout the weekend to get it done. Currently, Members are discussing a COVID package that would total around $900 billion and potentially include a restoration of federal unemployment benefits as well as $300 billion in small business relief, $25 billion in rental assistance, and $16 billion for COVID-19 testing and vaccine distribution. The package will also likely contain a fresh round of stimulus checks between $600 or $700 per individual. The most contentious issues – state and local funding and liability reform – will likely not be included. Stay tuned as the negotiations are ongoing.

On Thursday, the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) held a meeting to discuss whether it should recommend to FDA that Moderna’s COVID vaccine should be authorized for emergency use. Members of VRBPAC voted 20 to 0, with one abstention, that the benefits of Moderna’s vaccine outweigh any risks. Issuance of Emergency Use Authorization (EUA) from the FDA is likely to occur as early as today.

On Monday, health care workers across the nation began receiving Pfizer’s vaccine. The vaccine will first be given to front-line health care workers, as well as residents of long-term care facilities. The vaccine will then be distributed to essential workers and vulnerable populations with pre-existing conditions. Vaccinations for the general population is likely to occur in the Spring and Summer of 2021.

What to Expect Next Week: If Congress does not complete legislation to appropriate Federal funds for fiscal year 2021 over the weekend, the negotiations will spill over into next week. However, a deal will likely be struck before the Christmas holiday. Other than the omnibus spending package, it will be a relatively quiet week for Congress as both the House and Senate will be out of session for the holidays. On Saturday, ACIP will be meeting to decide whether to recommend Moderna’s COVID vaccine. On Sunday, ACIP will vote on the allocation of initial supplies of the vaccine for phase 1B and 1C. The agenda for ACIP’s meeting can be found here.

DEEP DIVE

Congress Pushes to Finalize Omnibus Spending Package as December 18 Deadline Looms

Democrats and Republicans in the House and Senate have been working this week to finalize ongoing negotiations surrounding an omnibus spending package to appropriate federal funds for the remainder of fiscal year 2021, along with an additional COVID package. Last week, Congress passed, and the President signed, a one-week stopgap measure, H.R. 8900, which extended the government funding deadline from December 11 to December 18. As this new deadline swiftly approaches, lawmakers are trying to reach a funding resolution that would include COVID-19 relief. Currently, Members are discussing a COVID package that would total around $900 billion and potentially include a restoration of federal unemployment benefits as well as $300 billion in small business relief, $25 billion in rental assistance, and $16 billion for COVID-19 testing and vaccine distribution. On Wednesday, Senate Majority Whip John Thune (R-SD) said that the package will likely contain a fresh round of stimulus checks between $600 or $700 per individual. Congress must reach a deal by the December 18 deadline to avoid a government shutdown. However, it was reported on Wednesday evening that Senate Majority Leader Mitch McConnell (R-KY) warned Republicans via a phone call to be prepared to stay in the District through the weekend as the legislative text is finalized. Along with appropriations and COVID legislation, the package is also likely to extend several expiring Medicare, Medicaid and public health programs. It may also include a deal struck by key committee leaders to end surprise medical billing.

COVID-19 Vaccine Updates

On Friday, December 11, the U.S. Food and Drug Administration (FDA) granted Pfizer Emergency Use Authorization (EUA) for its COVID-19 vaccine. The decision came after the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) convened to discuss whether to recommend FDA authorize Pfizer’s vaccine for emergency use. On Saturday, December 12, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation advising that individuals aged 16 years and older receive Pfizer’s vaccine for the prevention of COVID. On Monday, health care workers across the nation began receiving Pfizer’s vaccine. The vaccine will first be given to front-line health care workers, as well as to residents of long-term care facilities. The vaccine will then be distributed to essential workers and vulnerable populations with pre-existing conditions. Vaccination for the general population is likely to occur in the spring and summer of 2021.

Also this week, the FDA released documents asserting that Moderna Inc.’s COVID-19 vaccine is both safe and effective at preventing COVID in individuals aged 18 and over. The FDA found that the vaccine was 95.6% effective in people of ages 18 to 65 and 86.4% effective in people of ages 65 and over. On Thursday, VRBPAC held a meeting to discuss whether Moderna’s COVID vaccine should be authorized for emergency use. Members of VRBPAC voted 20 to 0, with one abstention, that the benefits of Moderna’s vaccine outweigh any risks. Issuance of EUA from the FDA is likely to occur as early as today. On Saturday and Sunday, ACIP will meet to review Moderna’s vaccine data and vote on whether to recommend the vaccine for public distribution. ACIP will also be voting on how to allocate initial supplies for the COVID-19 vaccine for phase 1B and 1C.

On Tuesday, the Department of Health and Human Services (HHS) announced that the federal government will give states and territories approximately $227 million to distribute COVID-19 vaccines and conduct testing. The CDC will divide among all 50 states $140 million for “vaccine preparedness” and $87 million for COVID-19 tracking and testing.

FDA Approves First Over-the-Counter Fully at-Home COVID-19 Test

On Tuesday, the FDA authorized the first COVID-19 diagnostic test that can be purchased without a prescription and completed fully at home. The diagnostic kit, which was produced by the Australian diagnostics company Ellume, is the first of its kind in the U.S. The antigen test can be used by individuals of ages 2 and over to detect proteins of the SARS-CoV-2 virus with 96% accuracy from a nasal swab sample. Ellume has stated that it is ramping up manufacturing and is currently on track for over 100,000 tests per day in January 2021. The company predicts it will be able to deliver 20 million test kits to the U.S. within the first 6 months of 2021. FDA Commissioner Dr. Stephen Hahn released a statement, noting that “Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test, and find out their results in as little as 20 minutes.” The test will be available at pharmacies, drug stores, and online sites for approximately $30. Additional details can be found here.

CMS Releases 2019 National Health Expenditures

On Thursday, the Centers for Medicare and Medicaid Services (CMS) announced that its Office of the Actuary released National Health Expenditures for 2019. Total national health care spending in 2019 grew by 4.6%. Spending for health care goods and services accounted for 84% of total health care spending in 2019 and increased by 5.2%. Private health insurance spending accounted for 31% of total health care spending and increased by 3.7% to $1.2 trillion. Medicare accounted for 21% of total health care spending and grew by 6.7% to reach $799.4 billion. Medicaid accounted for 16% of total health care spending and increased by 2.9% to reach $613.5 billion. Out-of-pocket spending, which includes direct consumer payments such as copayments, deductibles, and spending not covered by insurance, accounted for 11% of total health care spending and grew by 4.6%. Hospital spending accounted for 31% of total health care spending and increased by 6.2% to $1.2 trillion. Physician and clinical services spending accounted for 20% of total health care spending and increased by 4.6% to $772.1 billion. Retail prescription drug spending accounted for 10% of total health care spending and increased by 5.7% to $369.7 billion in 2019. More information can be found here.

CMS Announces New Model for Medicaid Managed Care Organizations Serving Dual Eligibles

On Thursday, CMS announced a new opportunity for “dual eligibles” (those who qualify for both Medicare and Medicaid) to receive better coordinated care. The new Model is the first initiative that CMS has designed to “harness the power of [Medicaid Managed Care Organizations] to coordinate Medicare and Medicaid services and improve health outcomes for the population of dually eligible beneficiaries who are in both Medicaid managed care and Medicare fee-for-service.” The Model encourages Medicaid managed care organizations to partner with providers and suppliers to better coordinate care, which would help to improve quality and reduce FFS costs. In December 2020, CMS’s Center for Medicare and Medicaid Innovation (Innovation Center) developed a new type of Direct Contracting Entity that will allow for this coordination to occur and will provide participating MCOs with incentives. Additional information can be found here.

Key Congressional Committees Announce New Democratic Members

On Thursday, both the House Committee on Energy and Commerce (E&C) and the House Committee on Ways and Means (W&M) announced new Democratic members. The E&C Committee announced the appointment of Representatives Angie Craig (D-MN), Lizzie Fletcher (D-TX), Kathleen Rice (D-NY), Kim Schrier (D-WA), and Lori Trahan (D-MA) to serve on the Committee in the 117th Congress. Additionally, the W&M Committee announced the nomination of Congresswoman Stacey Plaskett (D-VI) to serve on the Committee in the 117th Congress.

Trump Administration Continues Push for $200 Drug Discount Cards

During the 2020 presidential campaign, President Donald Trump promised supporters that he would provide Medicare beneficiaries with $200 drug discount cards to help lower prescription drug prices. The proposal was previously rejected by the Special Interest Group for Inventory Information Approval System Standards (SIGIS), which sets the standards for health benefit cards. The advisory panel claimed that the cards did not meet the government’s standards, as health benefit cards are generally used to shop for medical goods and services, not solely for prescription drugs. However, SIGIS approved the cards on Monday, ending its weeks-long opposition to the cards. The cards have been largely criticized due to their staggering $7.9 billion dollar price tag and their uncertain legality. On Tuesday, the Office of Management and Budget (OMB) instructed the health department to halt work on the cards, so whether the cards will ship out by January 1, 2021 (as the Trump Administration has stated) remains unclear.

SENATE HEARINGS AND EXECUTIVE SESSIONS

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HOUSE HEARINGS AND EXECUTIVE SESSIONS

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