Weekly Health Care Policy Update - March 5, 2021

In this issue:

Biden Administration Announces Additional Staff Appointments
Biden Administration Announces Merck and J&J COVID-19 Vaccine Manufacturing Deal
Senate Considers President Biden’s $1.9 Trillion American Rescue Plan
CMS Issues Guidance on Requirements for Plans to Cover COVID-19 Testing and Vaccination
FCC Establishes Emergency Broadband Benefit Program
FAIR Health Releases Report on Pediatric Mental Health During COVID-19
New York State Legislature to Pass Bill Modifying Governor Cuomo’s Emergency Powers
Governor Cuomo Issues Executive Order 202.96
NYS DOH Delays Implementation Date for Pharmacy Carve-Out

Administration Updates

Biden Administration Announces Additional Staff Appointments
Today (March 5^th), the Biden Administration announced additional policy staff serving at the White House. Some health-related positions on the list include:

Charles Anderson, Director of Economic Policy and Budget for the COVID-19 Response Team
Sam Berger, Director of Strategic Operations and Policy for the COVID-19 Response Team
Catherine Oakar, Special Assistant to the President for Community, Public Health, and Disparities
Terri Tanielian, Special Assistant to the President for Veterans Affairs
Donald K. Sherman, Special Assistant to the President for Racial and Economic Justice.

On March 2^nd, the Department of Health and Human Services (HHS) also announced staff appointments. Though some names have been announced previously, the list includes:

Rachel Pryor, Counselor for Health Policy
Beth Lynk, Deputy Assistant Secretary for Public Affairs (Health Care)
Jeff Hild, Deputy Assistant Secretary for Legislation (Human Services)
Sarah Boateng, Chief of Staff for the Assistant Secretary for Health
Adam Beckman, Special Advisor to the Surgeon General
Loyce Pace, Director of the Office of Global Affairs
Cindy Huang, Director of the Office of Refugee Resettlement
Elizabeth Fowler, Deputy Administrator and Centers for Medicare and Medicaid Innovation Director
Andi Fristedt, Deputy Commissioner for Policy for the Food and Drug Administration (FDA)

The list of HHS appointments is available here.

Biden Administration Announces Merck and J&J COVID-19 Vaccine Manufacturing Deal
On March 2^nd, President Biden announced that two of the largest U.S. pharmaceutical companies, Merck and Johnson & Johnson (J&J), will collaborate to expand production of the J&J single-dose COVID-19 vaccine. Through the Defense Production Act, the Administration will provide $105 million to retrofit two Merck facilities to be able to manufacture the J&J vaccine. These efforts will move up the schedule to produce 100 million doses of the J&J vaccine by one month, to the end of May, and will double manufacturing capacity for the J&J vaccine in the long run.

The press release is available here.

Legislative Updates

Senate Considers President Biden’s $1.9 Trillion American Rescue Plan
This week, the Senate took up consideration of President Biden’s proposed $1.9 trillion pandemic aid bill, the American Rescue Plan (ARP) Act of 2021. The revised Senate version of the bill modifies the $350 billion Coronavirus State and Local Relief Fund to:

Require that small states receive at least the amount they received under the original Coronavirus Relief Fund in the CARES Act;
Prohibit states from using funds to cut taxes;
Divides local allocations into two equal payments spaced 12 months apart; and
Adds a new $10 billion Critical Infrastructure Projects program to help states with capital projects enabling work, education, and health monitoring, including remote options.

It also proposes the following healthcare-related changes, among others:

Adds a new $8.5 billion allocation for payments to health care providers “located in a rural area” for health care related expenses and lost revenues that are attributable to COVID-19;
Increases premium assistance for COBRA continuation coverage from 85% to 100%, effectively eliminating premiums for eligible individuals, through September 30^th;
Establishes a minimum wage index for hospitals in all-urban states for Medicare payments starting October 1^st;
Expands eligibility for the most generous cost-sharing reductions (matching the previous provision of maximum premium tax credits) to individuals who receive any amount of unemployment compensation during 2021;
Waives the Medicare requirement for ambulance reimbursement that services must include transportation to a hospital or clinic during the COVID-19 public health emergency;
Extends the duration of the option for states to provide Medicaid and CHIP 12-month postpartum coverage to five years;
Delays the sunset of the limit on maximum rebate amounts under Medicaid for single source drugs and innovator multiple source drugs to 2024; and
Adds $420 million for grants for certified community behavioral health centers (CCBHCs).

The Congressional Budget Office (CBO) has scored the cost of the entire bill at $1.88 trillion. Senate and House Democrats are likely to consider the bill this weekend and may pass it as early as Saturday, with an deadline of the current expiration of the additional federal unemployment benefits on March 14^th.

Regulatory Updates

CMS Issues Guidance on Requirements for Plans to Cover COVID-19 Testing and Vaccination
On February 26^th, the Centers for Medicare & Medicaid Services (CMS) issued new guidance on the requirement for all plans and issuers to cover COVID-19 testing and related services without any cost-sharing requirements, prior authorization, or other medical management requirements, as contained in the Families First Coronavirus Response Act (FFCRA). Although this guidance does not establish new legal requirements, it clarifies existing ones. Notable clarifications include:

Plans may not use medical screening criteria to deny coverage or impose cost sharing on a claim for COVID-19 diagnostic testing, including for asymptomatic individuals with no known exposure. Plans should assume that any test provided by a licensed provider “reflects an ‘individualized clinical assessment’” and should be covered as required.
Plans must cover tests regardless of provider (e.g., state-administered sites) or type of test (e.g., point-of-care tests).
However, plans are still not required to cover testing that is not for individual diagnostic purposes (e.g., testing for workforce safety or public health surveillance).
Plans may encourage members to choose providers who have negotiated COVID-19 testing rates to help avoid providers who “are using the public health emergency as an opportunity to impose extraordinarily high charges.”
Plans must cover the cost of COVID-19 vaccine administration, even if not billed for the vaccine.
Plans may not deny coverage of COVID-19 vaccines because an individual is not in a category recommended for prioritization.

The full guidance is available here.

Other Updates

FCC Establishes Emergency Broadband Benefit Program
On February 26^th, the Federal Communications Commission (FCC) formally adopted a Report and Order to establish the $3.2 billion Emergency Broadband Benefit Program. This program, established in the 2020 year-end Consolidated Appropriations Act, will provide qualified households with support of up to $50 per month for broadband internet service and up to $100 for a one-time purchase of a computer or tablet. Benefits may be provided on an individual basis or through bulk purchasers (i.e., entities such as health care providers or nursing facilities who may purchase service in bulk for eligible households) but must be passed through to the household.

Eligible households are those who:

Qualify for the existing Lifeline program, which offers discounts on voice or broadband internet service. This includes, among others, any household with a Medicaid enrollee;
Qualify for an existing low-income or pandemic relief program offered by a participating broadband provider;
Have children who receive free or reduced-price school meals;
Have experienced a substantial loss of income since February 29, 2020; or
Have received a Pell grant in the current award year.

The program is expected to open for eligible households within the next 60 days.

The full announcement is available here.

FAIR Health Releases Report on Pediatric Mental Health During COVID-19
On March 2^nd, FAIR Health, a national not-for-profit organization focused on health care cost data, released a study highlighting the impact of COVID-19 on pediatric mental health. The study noted that in March and April 2020, the volume of mental health claim lines for ages 13-18 increased substantially over the same period in 2019. During these months, the volume of such claims roughly doubled while total claims declined by more than half. FAIR Health also found substantial increases in specific areas, such as intentional self-harm, overdoses and substance use disorders, and obsessive-compulsive disorders and generalized anxiety disorders.

The full white paper is available here.

Congressional Hearings

Tuesday, March 9^th:

At 10am, the Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing to “examine the COVID-19 response, focusing on an update from the frontlines.” More information is available here.

New York State Updates

New York State Legislature to Pass Bill Modifying Governor Cuomo’s Emergency Powers
On March 2^nd, leaders of the New York State Assembly and Senate announced their intention to pass legislation to transition away from the temporary emergency powers granted to Governor Cuomo in March 2020 at the start of the COVID-19 pandemic. Under current legislation, these powers are set to expire on April 30^th. The legislation would remove the Governor’s ability to enact new directives, but would extend all current directives by 30 days and allow the Governor to continue to extend or modify existing actions that are “critical to public health” in 30-day increments, with notice to the legislature, until the end of the state-declared COVID-19 emergency. These include, for example, Executive Orders that manage the spread or reduction of COVID-19, facilitate the vaccination process, or require the use of face coverings.

To extend or modify these directives, the Governor must provide notification and an opportunity to comment five days in advance to relevant Senate and Assembly chairs and leadership. The notification must include appropriate justification for the extension or modification, including the reason it is needed to address public health or safety concerns related to the COVID-19 pandemic. If an order applies to a specific municipality, the Governor must also notify and allow for comment from the leaders of that municipality. If required in order to address an imminent threat to public health or safety, the Governor may bypass the five-day notification requirement, but must provide a specific certification of necessity from the Commissioner of Health in advance. The Legislature retains the ability to repeal any directive or Executive Order by a concurrent resolution. Directives may only be modified to:

Alter the numeric amount or percentage of individuals, businesses, vaccination locations, providers/administrators, or other entities impacted by the directive; or
Place additional restrictions or reduce restrictions related to testing, quarantine, social distancing, air quality or filtration, vaccine eligibility, or mask requirements.

The bill would go into effect immediately once passed and remain in effect through the end of the state-declared COVID-19 emergency. The bill also permits the Legislature to terminate the emergency at any time through concurrent resolution. The legislation would not change any emergency powers of the Governor that existed before the temporary emergency legislation of March 2020.

The text of the bill is available here. The Legislature’s press release is available here. The Governor addressed the bill and his agreement with the new procedures in a press conference yesterday, the transcript of which is available here. The Legislature intends to pass the bill this Friday.

Governor Cuomo Issues Executive Order 202.96
On February 26^th, Governor Cuomo signed Executive Order 202.96 (available here), which extends all previous directives not otherwise modified or expired through March 28^th. The Order also repeals the directives contained in Executive Order 202.95 that required schools and school districts to report to the State Department of Health (DOH) on a weekly basis the number of completed COVID-19 vaccinations among staff, instead requiring every local health department to report the number of eligible P-12 teachers and staff vaccinated to DOH upon request.

DOH Delays Implementation Date for Pharmacy Carve-Out
On February 26^th, DOH announced that the implementation date for the transition of the Medicaid pharmacy benefit from managed care to fee-for-service has been delayed from April 1^st to May 1^st. This carve-out is part of the Medicaid Redesign Team (MRT) II proposals and was included in the State Fiscal Year 2020-21 budget. This implementation delay will provide additional time for required activities and deliverables, including mailing notifications of changes to the benefit package to members, ensuring managed care system readiness for pharmacy claims denials, enrolling providers in Medicaid fee-for-service, and making necessary changes to member materials and identification cards.

The DOH presentation that announced the implementation delay and provided other updates on the transition is available here. DOH has also updated several resources and materials to reflect the implementation date change, which may be accessed here.

Updated Guidance Documents
Recently released New York State and City COVID-19 guidance documents are listed below.

This Week’s SPG Updates

Please find below links to updated SPG resource documents and all other updates distributed by SPG this week.