In a Jan. 20 memorandum to the heads of executive departments and agencies, the Biden administration temporarily halted all pending regulations until incoming department or agency heads have the opportunity to review and approve them.
The regulatory freeze applies to all pending regulations, including those issued by the Department of Health and Human Services and its divisions, such as the Centers for Medicare & Medicaid Services and the Health Resources and Services Administration. Specifically, the regulatory freeze affects regulations in three stages of the regulatory review process:
- those not yet sent to the Office of the Federal Register (OFR);
- regulations not yet published in the Federal Register; and
- those already published but not yet effective.
Potentially affected regulations of interest to essential hospitals include:
- a final rule from the Trump administration that makes certain health clinics pass 340B Drug Pricing Program discounts on insulin and epinephrine to patients;
- the final rule establishing minimum standards in Medicaid state drug utilization review and supporting value-based purchasing for drugs covered in Medicaid, which was published in December 2020 but does not go into effect until March 2021; and
- the proposed rule including modification to Health Insurance Portability and Accountability Act privacy arrangements with a comment period deadline in March 2021.
Additionally, the official withdrawal of the Medicaid Fiscal Accountability Regulation was slated to go into effect Jan. 21, which means this formal withdrawal is swept up into the regulatory freeze.
Contact Senior Director of Policy Erin O’Malley at email@example.com or 202.585.0127 with questions.