Regulatory Update: March 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. McGuireWoods, PHA’s legal counsel, produced the report.

1.         Senate Passes Joint Resolution to Repeal CMS Vaccine Mandate for Healthcare Workers. On March 2, the Senate voted 49-44 on a joint resolution that would repeal the Centers for Medicare and Medicaid Services (CMS) rule requiring that healthcare staff be vaccinated against COVID-19. The joint resolution was introduced by Senator Roger Marshall (R-KS), who argued that the rule would exacerbate staffing shortages. The resolution is not likely to pass the House. The Supreme Court upheld the CMS vaccine rule last month.

2.         COVID-19 Vaccine and Testing Updates. On February 22, the Centers for Disease Control and Prevention (CDC) changed its vaccine recommendations for males from 12-39 years of age to reduce the risk of myocarditis. The recommendation now encourages this population to wait for 8 weeks after their first dose of an mRNA COVID-19 vaccine to get their second dose. This is a longer timeframe than CDC’s previously recommended three to four weeks between doses. The CDC emphasizes that certain populations, including immunocompromised and elderly patients, should still prioritize having a shorter wait time, approximately three or four weeks, between the first and second doses of the Pfizer and Moderna vaccine.

3.         Status of the National Emergency Declaration for COVID-19. On February 22, President Biden published a notice that extended the national emergency declaration due to the COVID-19 pandemic past March 1. This allows the pandemic-related Medicare and Medicaid coverage flexibilities to continue. The notice does not specify an end date for the emergency declaration. The notice can be found here.

On March 3, a measure that would terminate the national emergency declaration for the COVID-19 pandemic passed the Senate with a vote of 48-47. The bill is not likely to pass the House and President Biden has said he would veto the bill.

4.         CMS Guidance Gives State Medicaid Programs 14 Months to Process Renewals Upon the End of the PHE and Waives Some MCO Restrictions. On March 3, the Centers for Medicare and Medicaid Services (CMS) released guidance on how state Medicaid programs should restart eligibility reviews upon the end of the public health emergency (PHE). The guidance provides states with 14 months to finish processing renewals after the PHE ends. This is two months longer than the previous timeline that provided state Medicaid programs with 12 months. The guidance also allows states to start the redetermination process up to two months before the end of the PHE. The guidance does not estimate when the PHE will end, but the Department of Health and Human Services (HHS) has committed to providing a 60-day notice. The guidance can be found here.

CMS also announced that it would waive certain restrictions on Medicaid managed care organizations (MCOs) so plans can engage with states and consumers when the PHE ends and Medicaid determination begins. The guidance can be found here

5.         FTC Issues Request for Information on the Effect of PBMs’ Practices. On February 24, the Federal Trade Commission (FTC) announced a Request for Information (RFI) to solicit public input on how Pharmacy Benefit Managers’ (PBM) practices are affecting drug affordability and access. The RFI seeks feedback on a wide range of issues in the PBM market and their impact on patients, physicians, pharmacies and other businesses across the distribution system. Public comments will be accepted until April 25, 2022. The RFI comes after FTC commissioners held a February 18 vote on a motion to study PBM’s pricing and contractual practices and their effects on independent pharmacies. The vote was 2-2, meaning that the study would not move forward.

The RFI can be found here.