WHO: The Secretary of the Department of Health and Human Services (HHS)
WHAT: Issued nationwide “blanket waivers” of the federal Stark Law (Section 1877 of the Social Security Act) pursuant to his authority Section 1135 of the Social Security Act.
WHEN: Although issued on March 30, 2020, the waivers are retroactively effective as of March 1, 2020.
WHY: HHS is waiving sanctions under the Stark Law and its underlying regulations to ensure that: (1) sufficient health care items and services are available to meet the needs of individuals enrolled in federal healthcare programs, and (2) health care providers that furnish such items and services in good faith, but are unable to comply fully with the Stark Law’s requirements as a result of the consequences of the COVID-19 pandemic, may be reimbursed for such items and services and exempted from sanctions for noncompliance.
HOW: The waiver is available to protect financial relationships that satisfy two criteria: (1) the remuneration and referrals must be solely related to “COVID-19 Purposes”; and (2) the referrals and claims must be related to a defined set of financial relationships, as set forth below.
Blog Editors
Recent Updates
- Federal Embryo Adoption Program Raises Potential Legal Questions for Reproductive Health
- Vermont’s H. 583 Restricts Private Equity and Hedge Funds with Ownership and Controlling Interests from Interfering with Clinical Judgment of Health Care Providers
- DOJ’s Second National Health Care Fraud Takedown of the Second Trump Administration Heavily Targets Medicaid Fraud
- FDA Regulations to Establish Minimum CGMP Requirements for Manufacturing, Packaging, Labeling, and Holding of Dietary Supplements
- OIG Advisory Opinion 26-14 Offers Another Favorable Path for Patient Access Through Sponsored Testing