Category: Stark

The “Regulatory Sprint to Coordinated Care” – Overview and Links to Further Resources from Dorsey & Whitney

In 2018, the U.S. Department of Health and Human Services (“HHS”) launched the “Regulatory Sprint to Coordinated Care” to accelerate a transformation of the healthcare system, with a focus on removing “unnecessary obstacles” to coordinated care (the “Regulatory Sprint”). Several HHS agencies requested comments and information from the public and have published new or proposed...

White Papers: Understanding the Final Rules to Revise the Stark Law, Anti-Kickback Statute and Beneficiary Inducement Civil Monetary Penalty Regulations

In just two weeks, on January 19, 2021, a sweeping set of changes to the federal physician self-referral law (or “Stark Law”) and anti-kickback statute (“AKS”) regulations go into effect.  These changes, which are part of the U.S. Department of Health and Human Services (“HHS”) “Regulatory Sprint to Coordinated Care,” are the most significant changes...

Much-Anticipated Final Rules to Revise Stark Law, Anti-Kickback Statute, Beneficiary Inducement CMP Regulations Released under “Regulatory Sprint to Coordinated Care”

On November 20, 2020, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) each released their much-anticipated final rules to revise the federal self-referral law (or “Stark Law”) regulations, the safe harbors under the federal anti-kickback statute (AKS), and regulations under the...

CMS Issues Explanatory Guidance on Stark Law Blanket Waivers

As we explained in our prior blog post, on March 30, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued certain blanket waivers of sanctions under the federal physician self-referral law (or “Stark Law”) for “COVID-19 Purposes” (the “Stark Blanket Waivers”), which are available here. On April 21, 2020, CMS issued explanatory guidance, available...

OIG Initiatives to Ease Provider Burdens Related to COVID-19

The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) has taken numerous steps to minimize regulatory burdens for providers who need to make their primary focus delivering patient care during the COVID-19 national emergency. These steps, along with recent steps taken by other agencies to provide temporary regulatory flexibility, provide further...

New CMS COVID-19 Blanket Waivers for Health Care Providers

On March 30, 2020, the Centers for Medicare & Medicaid Services (“CMS”) published a compilation of COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers (each, a “Blanket Waiver”). Section 1135 of the Social Security Act gives CMS the authority to issue waivers that ease requirements for providers affected by an emergency if: (1) the...

Stark Law Blanket Waivers Related to “COVID-19 Purposes” Announced

The COVID-19 pandemic has led to rapid and drastic changes to health care delivery in the United States, including as it relates to arrangements between health care providers and physicians that may implicate the federal physician self-referral law, or “Stark Law.” On March 30, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued much-anticipated...

2020 CPI-U and DHS Code List Updates Posted on CMS Website

The Centers for Medicare & Medicaid Services (“CMS”) recently posted two annual updates related to the physician self-referral law (“Stark Law” or “Stark”) on its Stark website: (1) CPI-U updates related to the nonmonetary compensation exception and medical staff incidental benefits exception; and (2) CPT/HCPCS codes used to identify certain categories of Stark designated health...

Escobar in Action: Physician-owners’ fraud claims against hospital defeated in Fifth Circuit appeal for lack of materiality

Following the passage of the Affordable Care Act (“ACA”), which placed new limits on physician-owned hospitals, St. Luke’s Health System (“System”) took action to change one of its hospital’s ownership structures through a buy-out of the physicians’ partnership interests pursuant to the Texas Securities Act (“TSA”). The TSA allows rescission for the original price paid...

CMS Finalizes Changes to the Stark Advisory Opinion Regulations; 2020 DHS Code List and CPI-U Updates

In the calendar year 2020 Medicare physician fee schedule final rule (“PFS”), which was published in the Federal Register on November 15, 2019 (available here), CMS finalized changes to the advisory opinion process under the federal physician self-referral law (“Stark Law” or “Stark”).  CMS also published its annual update to CPT/HCPCS codes used to identify...