On December 2, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a memorandum to state survey agencies indicating that it will not enforce its Interim Final Rule (the “Rule”) regarding health care worker vaccinations while there are court-ordered injunctions against the Rule in place.
Continue Reading CMS Issues Memorandum Stating It Will Not Enforce Its COVID-19 Vaccine Mandate While There are Court-Ordered Injunctions in Place

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 the Medicare Conditions of Participation (CoPs). This Guidance, which finalizes the prior draft guidance issued on May 3, 2019, explains how CMS and state agency surveyors will evaluate a hospital’s space sharing or contracted staff arrangements when assessing the hospital’s compliance with the Medicare CoPs.  The Guidance took effect immediately upon publication on November 12, 2021.

As relayed by CMS, hospitals have increasingly co-located with other hospitals or other healthcare entities as they seek efficiencies and develop different delivery systems of care. Co-location occurs when two Medicare certified hospitals or a Medicare certified hospital and another healthcare entity are located on the same campus or in the same building and share space, staff, or services.
Continue Reading CMS Finalizes Guidance on Hospital Co-Location

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 Rule (IFR) in response to the COVID-19 “Path out of the Pandemic” Action Plan announced by President Biden on September 9, 2021, that per CMS is intended to protect the health and safety of residents, patients and staff at health care facilities. See our previous analysis of the Plan here.

Below please find key takeaways regarding the new COVID-19 vaccination requirements for health care facilities and staff:
Continue Reading CMS Issues Emergency Regulation Requiring COVID-19 Vaccination for Health Care Facility Workers

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 care, including implementation of COVID-19 vaccine requirements and an expansion of resources available for treatment of COVID-19. The Plan signals significant changes upcoming for health care organizations, their employees, and their patients.

The following summary addresses certain parts of the Plan with specific implications for health care, but please continue to check R+C blogs and legal updates for follow-up analysis of the specific guidance and rules that are released in furtherance of the Plan.
Continue Reading Biden COVID-19 Action Plan Expands Vaccine Mandates, Testing, and Treatment to Combat Spread of Virus

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 services (DHS) through a wholly-owned subsidiary and still qualify as a group practice (as defined under the Physician Self-Referral Law) for purposes of compliance with various Physician Self-Referral Law exceptions.
Continue Reading CMS Issues Advisory Opinion Clarifying Physician Self-Referral Law Group Practice Structure

On November 20, 2020, the Centers for Medicare and Medicaid Services (CMS) published its long-awaited and highly anticipated final rule updating regulations promulgated under the Physician Self-Referral or “Stark” law (the OIG simultaneously published updates to the Anti-Kickback Statute regulations). Among other things, CMS introduced new Stark exceptions for certain “value-based arrangements,” the donation

On November 20, 2020, the Department of Health & Human Services (HHS) released heavily anticipated final rules revising the regulatory exceptions to the Physician Self-Referral Law (also known as the Stark Law), the Anti-Kickback Statute (AKS) safe harbors, and the Beneficiary Inducements Civil Monetary Penalties (CMP) regulations.  The changes to the regulations go into effect on January 19, 2021 (except for one change to the Physician Self-Referral Law that becomes effective January 1, 2022). In a separate rule also released November 20th, HHS removed safe harbor protection for rebates involving prescription pharmaceuticals and created a new safe harbor for certain point-of-sale reductions in price on prescription pharmaceuticals and pharmacy benefit manager service fees.

The full text of each rule is available below.


Continue Reading Physician Self-Referral Law (Stark), Anti-Kickback Statute, and Beneficiary Inducement CMPs – HHS Releases Final Rules

On November 2, 2020, the Centers for Medicare & Medicaid Services (CMS) finalized its 2021 End-Stage Renal Disease Prospective Payment System Rule. Among other things, the final rule expands Medicare payments for in-home dialysis equipment and supplies as part of an effort to encourage in-home care for populations vulnerable to COVID-19. We previously wrote about the proposed rule here.
Continue Reading CMS Finalizes 2021 End-Stage Renal Disease Prospective Payment System Rule Expanding Payments for In-Home Dialysis Equipment and Supplies

Excerpt of a contributed article published in Medical Economics on November 3, 2020.

These waivers could lead to lasting flexibilities for physicians — if a few bad apples don’t spoil the bunch

On October 19, 2020, the Administrator of the Centers for Medicare & Medicaid Services (CMS) highlighted recent actions taken by the federal government

On October 14, 2020, the Centers for Medicare & Medicaid Services (CMS) expanded the list of telehealth services covered by Medicare during the COVID-19 Public Health Emergency. CMS also announced it would be providing additional support to state Medicaid and Children’s Health Insurance Program (CHIP) agencies in delivering telehealth services. CMS added the telehealth services using, for the first time, an expedited process that does not involve rulemaking which had been established by CMS in May 2020.
Continue Reading CMS Announces New Telehealth Services Covered by Medicare and Provides States with Medicaid and CHIP Telehealth Expansion Assistance