The Department of Justice recently reported that in fiscal year 2021, it received more than $5.6 billion in settlements and judgments. Of that total, over $5 billion relates to matters that involved the health care industry....more
The Centers for Medicare & Medicaid Services’ (“CMS”) message this year has been consistent – hospitals need to comply with CMS’ Hospital Transparency Rule. This rule requires hospitals and health systems to disclose a...more
The Office of Inspector General’s (“OIG”) new Anti-Kickback Statute (“AKS”) regulations modify the safe harbor for personal services and management contracts (42 CFR § 1001.952(d)) in a manner that allows providers...more
5/24/2021
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Health Care Providers ,
Hospitals ,
Management Contracts ,
New Rules ,
OIG ,
Personal Services ,
Physicians ,
Proposed Rules ,
Safe Harbors ,
Stark Law ,
Value-Based Care
The Centers for Medicare & Medicaid Services’ (“CMS”) new final rule amending the implementing regulations of the Physician Self-Referral Law (“Stark Law”), in part, defines fundamental terms, such as “fair market value” and...more
A recent $100 million verdict serves as a grim reminder for health care providers of the risk of paying independent contractors to market services. In United States v. Mallory, et al., the United States Court of Appeals for...more
On February 24, 2021, the Office for Civil Rights at the U.S. Department of Health and Human Services (“OCR”) announced that it will not impose penalties against covered entities or their business associates that use online...more
3/4/2021
/ Coronavirus/COVID-19 ,
Covered Entities ,
Data Storage ,
Encryption ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
Penalties ,
PHI ,
Secure Scheduling ,
Vaccinations
A January 20, 2021 memo issued by the Biden Administration may freeze the implementation of the Stark Law and Anti-kickback Statute (“AKS”) final rules that went into effect on January 19, 2021. According to the U.S....more
2/18/2021
/ Anti-Kickback Statute ,
Biden Administration ,
Civil Monetary Penalty ,
CRA ,
Final Rules ,
GAO ,
Health Care Providers ,
Regulatory Freeze ,
Safe Harbors ,
Stark Law ,
Value-Based Care
On January 1, 2021, hospitals and health systems will be required to comply with Hospital Price Transparency requirements or face possible penalties from the Centers of Medicare and Medicaid Services (CMS). This rule requires...more
The U.S. Department of Health and Human Services (“HHS”) recently issued two corresponding final rules amending the implementing regulations of the Physician Self-Referral Law (“Stark Law”), the Anti-Kickback Statute (“AKS”),...more
On October 20, 2020, the Office for Civil Rights (“OCR”) settled two religious discrimination complaints involving access to clergy during the Public Health Emergency. Both complaints arose from a hospital’s failure to permit...more
10/30/2020
/ Anti-Discrimination Policies ,
Clergy Members ,
Coronavirus/COVID-19 ,
First Amendment ,
Freedom of Religion ,
Hospitals ,
OCR ,
Personal Protective Equipment ,
Policies and Procedures ,
Public Accommodation ,
Public Health Emergency ,
Religious Discrimination ,
Social Distancing ,
Virus Testing ,
Visitors
On September 15, the Centers for Medicare & Medicaid Services (CMS) issued guidance to state Medicaid directors encouraging states to adopt value-based care (VBC) models for their healthcare systems. Under a VBC model,...more
On August 11, the Center for Medicare & Medicaid Services ("CMS") announced the creation of its new Community Health Access and Rural Transformation (“CHART”) Model. The CHART Model seeks to provide new seed funding and...more
In an attempt to reduce the risk of death from opioid overdose, the U.S. Food and Drug Administration (“FDA”) issued a Drug Safety Communication recommending that providers discuss the availability of Naloxone, the opioid...more