Monitoring the Pulse of Health Care and Life Sciences
This post is co-authored by Seth Orkand, co-chair of Robinson+Cole’s Government Enforcement and White-Collar Defense Team and Paul Palma, law intern at Robinson+Cole. Paul is not admitted to practice law.
On March 14, 2025, as part of a spending bill to avert a federal government shutdown, Congress extended COVID-era telehealth “waivers” applicable to Medicare…
In a per curiam decision issued January 13, 2022, the U.S. Supreme Court upheld the federal health care worker vaccine mandate rule, finding that the Department of Health & Human Services (HHS) Centers for Medicare & Medicaid Services was authorized by law to issue the rule. See our previous analyses of the rule and subsequent litigation here and here for more background information on the stakes of this case.
Continue Reading U.S. Supreme Court Upholds Health Care Worker Vaccine Mandate
Following the President’s proclamation on March 13 that the COVID-19 outbreak constitutes a national emergency, Secretary of the Department of Health and Human Services (HHS) Alex Azar issued a Waiver or Modification of Requirements Under Section 1135 of the Social Security Act (full text available here) that waives or modifies certain health care laws and regulations in connection with the COVID-19 pandemic. This “1135 Waiver” applies nationwide and took effect on March 15 at 6:00 p.m., but its applicability is retroactive to March 1, 2020. The 1135 Waiver applies for a period of 60 days (subject to extension by the Secretary for successive 60-day periods) or for the duration of the COVID-19 national emergency (if earlier), except the waiver of the HIPAA Privacy Rule described below applies for only 72 hours following a hospital’s implementation of its disaster protocol.
Continue Reading HHS Issues Section 1135 Waiver, and CMS Issues Blanket Waivers of Health Care Laws, in Response to Coronavirus (COVID-19) Emergency
On September 6, 2019, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) issued OIG Advisory Opinion No. 19-05 (Advisory Opinion) permitting a community health center (Requestor) to purchase real estate from a limited liability company (LLC) owned and managed by an individual excluded from participation in federal health care programs (Proposed Arrangement). The OIG indicated the Proposed Arrangement would not result in the imposition of sanctions under the civil monetary penalties law because no claims for reimbursement from federal programs would be sought by the Requestor, nor would they use federal grant funds to finance the purchase.
Continue Reading HHS Issues Favorable Advisory Opinion Permitting Community Health Center to Purchase Real Estate from an Excluded Individual
On February 15, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a Decision Memo outlining revisions to its 2005 National Coverage Determination (NCD) for Implantable Automatic Defibrillators (ICDs) . The updated NCD includes changes to the covered indications for ICDs, new patient criteria and exceptions to waiting periods for symptomatic patients with certain…
