On December 2, 2021, the Centers for Medicare & Medicaid Services (“CMS”) issued a memorandum (the “CMS Memo”) addressing survey and enforcement of the COVID-19 vaccine requirement applicable to Medicare and Medicaid participating healthcare providers and suppliers and their staff. The CMS Memo was issued in response to preliminary injunctions against the implementation and enforcement of the Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule  published on November 4, 2021, which requires staff working in Medicare or Medicaid certified providers and suppliers (including nursing facilities, hospitals, dialysis facilities and all other provider types covered by the rule) to have the shots necessary to be fully vaccinated against COVID-19 by January 4, 2022, and receive their first shot prior to December 6, 2021 (the “Rule”).

Continue Reading CMS Suspends Vaccine Mandate Enforcement for Healthcare Workers

“The guidance reminds the public that the HIPAA Privacy Rule does not apply to employers or employment records.”[1]

On September 30, 2021, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) released guidance (the “Guidance”) entitled, “HIPAA, COVID-19 Vaccination, and the Workplace,” regarding the applicability of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule (“Privacy Rule”) to disclosures and requests for information regarding COVID-19 vaccination status. In a frequently-asked-questions format, the Guidance sets forth a series of workplace-related scenarios involving the confidentiality of an employee’s vaccination status, an employer’s ability to obtain vaccination information from its employees, and the confidentiality of such information.


Continue Reading HIPAA and COVID-19 Vaccination Status: The Office of Civil Rights Issues Workplace Guidance

Sitting in the dark before 6 am in my Los Angeles house with my face lit up by yet another Zoom screen, wearing a stylish combination of sweatpants, dress shirt and last year’s JPM conference badge dangling around my neck for old times’ sake, I wonder at the fact that it’s J.P. Morgan Annual Healthcare Conference week again and we are where we are. Quite a year for all of us – the pandemic, the healthcare system’s response to the public health emergency, the ongoing fight for racial justice, the elections, the storming of the Capital – and the subject of healthcare winds its way through all of it – public health, our healthcare system’s stability, strengths and weaknesses, the highly noticeable healthcare inequities, the Affordable Care Act, Medicaid and vaccines, healthcare politics and what the new administration will bring as healthcare initiatives.
Continue Reading Day 1 Notes for the 39th Annual J.P. Morgan Healthcare Conference, 2021

N.B.  Concurrent with the posting of this article, the Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration (“FDA”) has decided to recommend to the FDA that the FDA approve the emergency use authorization applications submitted by Pfizer and BioNTech.  It is being reported that the FDA may formally approve the applications as soon as tomorrow, Friday, December 11, 2020.  More detail regarding the recommendation and the FDA’s decision will be discussed in a follow-up article.

On Monday, December 7, 2020, California Governor Gavin Newsom announced that, “Hope is on the horizon with the [COVID-19] vaccination. We continue to accelerate our planning and preparedness for a safe and equitable vaccine distribution.”  As noted by the Governor, California expects to receive a little more than two million doses of the vaccine this month including 327,000 doses from pharmaceutical company, Pfizer, and 2.6 million doses from biotechnology maker, Moderna.
Continue Reading “Hope Is On The Horizon”: California Governor Gavin Newsom Announces COVID-19 Vaccine Distribution Plan