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

On August 24, 2020, the Centers for Medicare & Medicaid Services (CMS) announced an “extension of the timeline” for publication of a final rule addressing changes to the Physician Self-Referral Law (or Stark Law) regulations.  In its announcement, CMS set a new deadline of August 31, 2021 for publication of a final rule.
Continue Reading CMS Extends Timeline for Finalizing Changes to Physician Self-Referral (Stark) Law Regulations to August 2021

On July 2, 2020, the Centers for Medicare and Medicaid Services (CMS) released guidance documents on the allowance of telehealth encounters for the Eligible Professional and Eligible Clinician electronic clinical quality measures (eCQMs) used in CMS quality reporting programs for the 2020 and 2021 performance periods. The guidance applies to eCQMs used in the:

  • Quality Payment Program: The Merit-based Incentive Payment System (MIPS) and Advanced Alternative Payment Models (Advanced APMs)
  • APM: Comprehensive Primary Care Plus (CPC+)
  • APM: Primary Care First (PCF)
  • Medicaid Promoting Interoperability Program for Eligible Professionals


Continue Reading CMS Releases Guidance on the Allowance of Telehealth Encounters in eCQMs

On July 6, 2020, the Centers for Medicare and Medicaid Services (CMS) proposed its calendar year 2021 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) rule. ESRD PPS rules are promulgated on an annual basis, providing updates to payment policies and rates for renal dialysis services furnished to beneficiaries. The 2021 proposed rule also proposes to update the acute kidney injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities to individuals with AKI, and proposes changes to the ESRD Quality Incentive Program. In addition to the annual technical updates, the 2021 rule proposes, at a high level:

  • Changes to the eligibility criteria and determination process for the transitional add-on payment adjustment for new and innovative equipment and supplies (TPNIES), and defining “new” to be within three years, beginning on the date of the FDA marketing authorization;
  • Expansion of the TPNIES to include new and innovative capital-related assets that are home dialysis machines, used in the home for a single patient;
  • Updates to the outlier policy and outlier services fixed-dollar loss amounts as well as the Medicare allowable payment amounts;
  • An addition to the ESRD PPS base rate to include calcimimetics in the ESRD PPS bundled payment;
  • A change to the low-volume payment adjustment eligibility criteria and attestation requirement to account for the COVID-19 public health emergency; and
  • An update to the ESRD PPS wage index to adopt the new Office of Management and Budget (OMB) delineations with a transition period.


Continue Reading CMS Proposes 2021 End-Stage Renal Disease Prospective Payment System Rule