The House and Senate were both in session this week, with the House officially convening for the second session of the 117th Congress. The Senate continued its work on nominations and teed up long-awaited votes on election and voting rights reforms.  Rumblings have begun on more COVID relief funding, but it is not yet clear how much might support the health sector.  The Supreme Court blocked enforcement of the Administration’s vaccine mandate for employers but ruled that vaccine mandate for certain health care facilities is enforceable.  Progress on Build Back Better (BBB) continues to be on hold in the Senate.

Congress

Senate HELP Committee Holds Hearing on COVID-19

On January 11, the Senate Committee on Health, Education, Labor and Pensions (HELP) held a hearing to discuss the federal government’s response to the ongoing pandemic and how to address new variants.

The Committee heard testimony from four key leaders in the Administration’s pandemic response efforts:  Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony Fauci, Food and Drug Administration (FDA) Acting Commissioner Janet Woodcock, and Health and Human Services (HHS) Assistant Secretary for Preparedness and Response (ASPR) Dawn O’Connell.

The witnesses faced tough questions from both sides of the aisle on the Administration’s recent efforts related to access to testing, confusion surrounding evolving CDC guidance, and increased hospitalization rates among children, among other issues.  The hearing was also marked with tense and often acrimonious exchanges between some Republican Senators and the witnesses.

New COVID Relief Package Anticipated

Efforts to craft a supplemental COVID relief package began to take shape this week, as the U.S. continues to battle the latest surge due to the omicron variant.

On January 13, President Biden announced additional commitments to fighting the pandemic, including the distribution of free masks, the deployment of military medical teams to additional states, and doubling the number of rapid tests the Administration will procure and make publicly available (up from 500 million to 1 billion), which follows on the announcement earlier this week regarding private insurance coverage for at-home tests (see related story below).

Much of the focus in Congress has been on non-health-related establishments that have been impacted, such as restaurants, bars, and gyms.  Additional details and formal funding requests are expected to come into focus in the near term, as Congress determines a legislative path forward for the relief package. 

The current continuing resolution (CR) funding the government expires on February 18, and the next appropriations bill—be it a comprehensive Omnibus for the remainder of FY 2022, or another short-term CR—provides a natural opportunity for COVID relief measures to be addressed.  However, given that waiting until mid-February would leave a relief package open for more than a month, congressional leaders could decide to move ahead more quickly.

Administration

CMS Releases Proposed NCD on Alzheimer’s Treatment, as HHS Secretary Calls for CMS to Reevaluate Medicare Part B Premium Recommendation

On January 11, the Centers for Medicare and Medicaid Services (CMS) released a proposed National Coverage Determination (NCD) on the coverage of monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s Disease (also referred to as Aduhelm).

Under the proposal, CMS would cover the qualifying treatment through coverage with evidence development (CED)—limiting the population of patients eligible for coverage of the drug to Medicare patients enrolled in qualifying clinical trials. The NCD applies to Aduhelm, amyloid beta-directed antibody indicated for the treatment of Alzheimer’s Disease, which was controversially approved by the FDA in June 2021 through the accelerated approval pathway.

If finalized in current form, CMS would review each clinical trial for coverage qualification, and trials that are determined to be outside of the CMS approved randomized controlled trials and trials supported by the National Institutes of Health (NIH) would be deemed nationally non-covered. CMS will announce a final decision by April 11, following a 30-day public comment period and evaluation. 

On January 1, Biogen reduced Aduhelm’s price by 50% from $56,000 to an annual $28,200 per patient price. In response, HHS Secretary Xavier Becerra instructed CMS to reevaluate its 2022 Medicare Part B premium recommendation, which the agency had previously substantially increased from 2021 in part because of the expected cost to the program to support use of the new Alzheimer’s treatment.

Administration Releases Guidance Requiring Private Insurance Coverage of At-home COVID Tests

On January 10, the Biden Administration announced guidance implementing plans it announced in December 2021 to require private insurers to cover and reimburse plan participants for at-home COVID-19 diagnostic tests without cost-sharing. This guidance makes it a requirement that private and group insurance plans cover at-home COVID-19 diagnostic tests at no-costs to enrollees effective January 15.

Both CMS and the Department of Labor released FAQ documents on the new guidance (found here and here, respectively), which specify:

• Plans are not required to cover testing that is required for employment purposes.

• Insurers will not be able to impose a prior authorization of any kind or require an at-home test be ordered from a health provider to be eligible for coverage.

• Plans can limit coverage to up to eight tests per covered individual per month (e.g., a family of four can get up to 32 tests per month for free).

• Plans are incentivized to set up preferred pharmacy and retailer programs in which they cover the costs upfront, eliminating the need for consumers to submit a claim for reimbursement. The guidance also specifies that even if insurers make tests available for upfront coverage through preferred pharmacies or retailers, they are still required to reimburse tests purchased by enrollees outside of that network. For tests purchased outside of preferred networks, insurers will be required to reimburse enrollees up to $12 per test or less if the test is priced below that. The reimbursement appears to be per test, so an enrollee would be reimbursed at a rate of $24 if they purchased a two-pack of tests.

Regarding traditional Medicare coverage, the January 10 announcement does not change existing policy.  In its FAQ document, CMS reiterated that: “Medicare pays for COVID-19 diagnostic tests performed by a laboratory, such as PCR and antigen tests, with no beneficiary cost sharing when the test is ordered by a physician, non-physician practitioner, pharmacist, or other authorized health care professional…At this time original Medicare cannot pay for at-home tests through this program.”  Regarding Medicaid and CHIP coverage, CMS advises beneficiaries to contact their state Medicaid or CHIP agency for information, as coverage rules for at-home tests may vary by state.

Courts 

On January 13, the Supreme Court released two emergency opinions that change the landscape of the three federal vaccine rules. In sum:

• A 5-4 Supreme Court majority let CMS enforce its vaccine mandate nationwide, impacting specified health care facilities.

• A 6-3 majority blocked the U.S. Occupational Safety and Health Administration (OSHA) from enforcing its vax-or-test Emergency Temporary Standard (ETS) applicable to large employers.

• The third federal vaccine rule – the federal contractor vaccine mandate – remains subject to multiple legal challenges and, at this time, the government is blocked from enforcing the mandate nationwide. The Supreme Court has not yet weighed in on this mandate.

With these rulings, the CMS Rule is now enforceable in every state, across the full spectrum of the facilities covered by the rule.  The exact deadlines for enforcement may shift; however, as CMS has yet to issue updated specific guidance in response to the rulers and entities remain without clarity on state law interactions and the potential for future litigation. The OSHA “vax-or-test” ETS is stayed nationwide. Moreover, given that the OSHA ETS is a temporary standard lasting only six months, it is unlikely that the other litigation will come to a close with enough time for OSHA to win and begin any meaningful enforcement prior to the expiration date. These issues remain fluid and will likely lead to additional questions from providers and large employers.

Quick Hits

• On January 14, the Administration officially extended the COVID-19 public health emergency (PHE) for an additional 90 days.  The PHE previously had a January 16 expiration date, and the Administration has indicated that a 60-day notice will be given before any expiration.

• The Senate HELP Committee advanced the nomination of Dr. Robert Califf to serve as FDA Commissioner to the full Senate for consideration.  The committee voted 13-8 in favor of the nomination, with two Democrats joining six Republicans in voting against the nomination, and four Republicans joining nine Democrats in voting in favor.

• The White House Office of Science and Technology Policy (OSTP) issued a Request for Information (RFI) seeking input from community health stakeholders, technology developers, and other interested parties about how digital health technologies are used, or could be used in the future, to transform community health, individual wellness, and health equity.  Comments on the RFI are due by February 28.

• The Medicare Payment Advisory Commission (MedPAC) held a two-day public meeting, focusing on payment adequacy and updates across multiple payment systems, a value incentive program for post-acute care, the development of a multi-track population-based payment model, and status reports on Medicare Advantage (MA) and Medicare Part D.

• The CMS Office of Minority Health published a new report that presents an analysis of historical trends in inequities by race, ethnicity, sex, and geography among Medicare Advantage (MA) beneficiaries nationwide, and sets forth the extent to which there has been progress in reducing or eliminating initial inequities in those areas.

• The Health Resources and Services Administration (HRSA) updated comprehensive preventive care and screening guidelines for women and for infants, children, and adolescents that insurers must cover without out-of-pocket costs under the Affordable Care Act.  Double electric breast pumps, obesity counseling and screening for suicide risk among adolescents and young adults are the new additions.

• HHS released an Issue Brief summarizing the Affordable Care Act’s (ACA’s) preventive services provisions, including updated estimates of the number of people benefiting from these provisions nationwide.

• HHS released new data on ACA enrollment numbers, showing that a record 14.2 million people have selected plans for 2022 health coverage since the start of the open enrollment period in November 2021.

• Health Affairs published a blog post on Medicare strategy authored by CMS leaders:  Building On The CMS Strategic Vision: Working Together For A Stronger Medicare