On November 12, 2021, the Centers for Medicare & Medicaid Services (CMS) issued finalized guidance (“Guidance”) clarifying that hospitals can share space, services, or personnel with another hospital or health care provider so long as they demonstrate independent compliance with
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Massachusetts DPH Issues Two Orders To Ensure Continued Availability of Health Care Provider Workforce
To ensure the continued availability of health care workers, on November 12, 2021, the Massachusetts Department of Public Health (DPH) issued Order 2021-13 (COVID-19 Public Health Emergency Order No. 2021-13), extending licensure reciprocity for certain out-of-state providers to…
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HHS Again Requires FDA Premarket Review for COVID-19 Tests
On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to enforce premarket review requirements for…
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DOJ Focused on Toxicology Testing – EKRA and Anti-Kickback Statute Violations Abound
On November 4, 2021, the Department of Justice (DOJ) announced the conviction of several South Florida addiction treatment facility operators following a seven-week trial. The initial indictment was filed in September 2020, charging ten defendants for their alleged conduct in…
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CMS Issues Emergency Regulation Requiring COVID-19 Vaccination for Health Care Facility Workers
On November 4, 2021, the Centers for Medicare & Medicaid Services (CMS) issued heavily anticipated emergency regulations requiring COVID-19 vaccination of eligible staff at health care facilities that participate in the Medicare and Medicaid programs. CMS issued an Interim Final…
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OCR Announces 20th Settlement Under Right of Access Initiative
The Office for Civil Rights (OCR) recently announced that it has entered into the 20th settlement under its Right of Access Initiative. The settlement with Children’s Hospital and Medical Center in Nebraska includes an $80,000 payment by the hospital for failing…
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Biden COVID-19 Action Plan Expands Vaccine Mandates, Testing, and Treatment to Combat Spread of Virus
On September 9, 2021 President Biden announced a COVID-19 Action Plan entitled “Path out of the Pandemic” (the “Plan”) which comprises a six-pronged national strategy aimed at combatting COVID-19. The Plan includes a number of important provisions related to health…
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Connecticut Governor Issues Executive Order to Expand Patient and Provider Access to COVID-19 Vaccination Information
On August 19, 2021, Connecticut Governor Ned Lamont issued Executive Order No. 13C (the “Order”) to expand access to COVID-19 vaccination information for patients and providers (and school nurses) as public health authorities continue to promote vaccination efforts, implement recommendations…
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New Legislation Updates Laws Related to Hospital Admission and Discharge Practices
On June 7, 2021, Connecticut Governor Ned Lamont signed into law Public Act 21-26 “An Act Concerning Various Revisions to the Public Health Statutes” (the “Act”). This Act makes notable changes to laws affecting hospital and health system…
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CMS Issues Advisory Opinion Clarifying Physician Self-Referral Law Group Practice Structure
In June 2021, the Centers for Medicare and Medicaid Services (CMS) issued a notable interpretation of the Physician Self-Referral Law (aka the Stark Law) in Advisory Opinion No. CMS-AO-2021-01 (Advisory Opinion) regarding whether a physician practice can furnish designated health…
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