Category: Stark

HHS OIG Releases an Updated Health Care Fraud Self-Disclosure Protocol

On November 8, 2021, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) released a revised Provider Self-Disclosure Protocol, renamed Health Care Fraud Self-Disclosure Protocol (“SDP”).  Prior to this update, the SDP had not been updated since 2013.  While many of the revisions were procedural only, some of the revisions were...

Stark Regulatory Changes Require Modifying Certain Group Practice Compensation Methodologies by January 1, 2022

There are now less than three months until changes to the federal physician self-referral law (“Stark Law” or “Stark”) group practice definition special compensation rule go into effect on January 1, 2022.  As we wrote about here, these changes include revisions to the rule related to overall profits to prohibit pooling and distributing profits from designated...

CMS Advisory Opinion Approves Parent and Wholly-Owned Subsidiary Qualifying as “Single Legal Entity” under the Stark “Group Practice” Definition

The Centers for Medicare & Medicaid Services (“CMS”) released Advisory Opinion No. CMS-AO-2021-01 in June 2021, which gave the requestor the green light to provide designated health services (“DHS”) through wholly-owned subsidiaries while the parent and subsidiaries could qualify as a “single legal entity” under the “group practice” definition of the federal physician self-referral law...

Stark Regulatory Changes Effective January 1, 2022 Require Modifying Certain Group Practice Compensation Methodologies

On January 1, 2022, changes to the federal physician self-referral law (“Stark Law” or “Stark”) group practice definition special compensation rule go into effect.  Among other things, these changes revise the rule related to overall profits to prohibit pooling and distributing profits from designated health services (“DHS”) on a service-by-service basis, which is sometimes referred...

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...