Regulatory Update: February 9, 2022

Bi-Weekly Members’ Regulatory Report

February 9, 2022

We are pleased to provide our most recent installment of the bi-weekly regulatory reports intended to keep PHA members informed on regulatory changes of interest to our industry.

1. CMS Seeks Public Comment on Request for Exception to Prohibition on Facility Expansion. On February 9, the Centers for Medicare and Medicaid Services (CMS) announced that it will seek public comment on a request by Doctors Hospital at Renaissance, Ltd. for an exception to the prohibition on facility expansion by physician-owned hospitals. The hospital’s exception request is based on its assertion that it is a high Medicaid facility. CMS has not reached a decision on the exception request, and is accepting public comment on the request until March 11, 2022. The request, dated July 21, 2021 and amended and restated as of October 14, 2021, can be found here.

2. CMS Releases Advance Notice with Payment Policy Changes for MA and Part D Plans. On February 2, CMS released an Advance Notice titled “Calendar Year (CY) 2023 Advance Notice for Medicare Advantage (MA) and Part D Plans.” The Advance Notice includes proposed payment policy changes for MA and Part D drug programs for 2023 with the goal of providing more affordable choices for consumers. Specifically, the notice details a proposed 7.98 percent increase to MA payment, which is nearly double the pay increase from the previous year. In addition, CMS stated that MA groups could potentially be judged on value-based care arrangements with providers in the future. The comment period lasts 30 days, and CMS has specifically requested feedback focused on health equity.

The 2023 Advance Notice can be found here. A CMS fact sheet on the Advance Notice can be found here.

3. Virginia and West Virginia Governors Request Limited Waiver From CMS Vaccination Rule. On January 31, Virginia Governor Glenn Youngkin and West Virginia Governor Jim Justice wrote to CMS Administrator Chiquita Brooks-LaSure requesting a limited waiver from the CMS interim rule on COVID-19 vaccinations for healthcare staff. In the letter, the governors state that they believe the vaccine requirement will contribute to greater staffing issues in healthcare facilities. The governors are seeking a limited waiver that would increase hospitals’ flexibility in interpreting the CMS rule, and could include measures such as broader conscience exemptions and delay of enforcement.

4. HHS Announces New Guidance for Providing Healthcare to People with Disabilities. On February 4, the Department of Health and Human Services’ (HHS) Office of Civil Rights issued a guidance to healthcare providers clarifying civil right protections for people with disabilities. The guidance stressed that even in times when resources are scare, such as a public health emergency, it is illegal to prevent someone with disabilities from receiving necessary healthcare benefits and services.

A FAQ document on the guidance can be found here.         

5. COVID-19 Vaccine and Testing Updates. On January 31, the Food and Drug Administration (FDA) approved Moderna’s COVID-19 vaccine Spikevax but retained the vaccine’s emergency use authorization (EUA). The vaccine is now fully approved for individuals aged 18 and older. The vaccine had already been available under the EUA since December 2020.

On February 1, the FDA announced that its vaccine advisory committee will meet on February 15 to discuss Pfizer and BioNTech’s COVID-19 vaccine for children aged 6 months to 4 years. The vaccine is currently authorized for children aged 5 to 15 and is fully approved for all patients 16 and above. The meeting announcement follows Pfizer’s announcement that it was seeking FDA authorization for the first two doses of a three-dose COVID-19 vaccine regime for children under the age of 5.

On February 3, CMS announced that it has identified a pathway for Medicare beneficiaries to access over-the-counter COVID-19 tests for free. Under the new pathway, Medicare beneficiaries will be able to pick up free tests at participating pharmacies, and the pharmacies will be reimbursed by Medicare. Medicare beneficiaries can access up to eight tests per month. CMS says that additional information on participating pharmacies will be available later this spring. A CMS Frequently Asked Question document regarding this policy can be found here.