President Biden hit the ground running, signing a batch of Executive Orders just hours after he was sworn in as the 46th President of the United States. A couple of these Executive Orders could have an impact on the healthcare industry:
- Modernizing Regulatory Review – Directs the Office of Management and Budget (OMB) to produce a set of recommendations for improving and modernizing regulatory review. It will be interesting to see what the OMB comes up with dovetails against recent regulations finalized on Securing Updated Necessary Statutory Evaluations Timely (which set expiration dates and review requirements for regulations), Transparency and Fairness in Civil Administrative Enforcement Actions (which requires enforcement actions to be based on statutes/regulations and not guidance), and Good Guidance Practices (which covers a lot of the same ground as the Transparency and Fairness rule, but also establishes required agency publication of all guidance in a guidance repository).
- Executive Order on Preventing and Combating Discrimination on the Basis of Gender Identity or Sexual Orientation – Directs the head of each agency to review all existing orders, regulations, guidance, and any other agency actions that may be inconsistent with the policy that all persons should receive equal treatment under the law, no matter their gender identity or sexual orientation, and consider revising, suspending, or rescinding such orders, guidance, and actions. Also directs each agency to develop a plan to carry out these actions by April 30, 2021. This could have an impact on the healthcare industry because, in June of 2020, the Office for Civil Rights, Office of the Secretary of Health and Human Services, and the Centers for Medicare & Medicaid Services published a final rule that revised Section 1557 regulations. One such revision modified 45 CFR Part 92 to remove gender identity as a class protected against discrimination, making it no longer illegal for programs administered by the Department of Health and Human Services or for health programs that receive financial assistance (e.g., Medicare Advantage Plans, federally facilitated Qualified Health Plans, etc.) to discriminate against individuals on the basis of their gender identity. This is an example of regulatory language we may see restored as a result of review process directed by this Executive Order.
Additionally, the White House issued a Memorandum the afternoon of January 20th from Ronald Klain, President Biden’s Chief of Staff.
- Regulatory Freeze Pending Review – Prohibits the OMB from issuing any rules, unless an emergency situation applies, until an agency head appointed by President Biden (or their designee) reviews and approves the rule. For rules that have been published in the Federal Register but have not yet taken effect, this Memorandum directs the OMB to consider postponing the rules’ effective dates for 60 days after the date of the Executive Order until 3/22/21 or after and to consider opening a 30-day public comment period during this period of time.
While this Memorandum doesn’t change any regulations in and of itself, it puts us on notice that we may see a pause in the release of new regulations. Additionally, it puts us on notice that some significant rules that have been issued but not taken effect (for example, Removal of Safe Harbor Protection for Pharma Rebates, Transparency in Pricing, Access to Affordable Life Saving Medications, and Secure Electronic Prior Authorization for Medicare Part D) are going to be reviewed by the Biden administration and could have their effective dates postponed and/or a new 30-day public comment period could be opened on the rule. BluePeak Advisors will be monitoring the Federal Register for any rules that have their effective dates postponed or a comment period opened. It is important to note that if no changes are made to final rules that have already been released, no further information will be announced on the final rule. So, it’s important to keep moving toward the implementation dates set forth in the final rules until HHS and CMS communicate otherwise.
Do you want to find out when changes are announced to final rules? How about receiving summaries of new, significant proposed and final rules that impact your health plan? Contact us today to learn more about joining our BluePeak Advantage program so you can receive summaries of these key communications and more!