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DOJ Continues to Target Health Care Companies - False Claims Act Settlements and Judgments in Fiscal Year 2021

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

CMS Continues Its Focus on Hospital Pricing Transparency

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

What to Expect, Part III: Modified AKS Safe Harbor for Personal Services & Management Contracts

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

What to Expect, Part II: New Stark Law Definitions for Physician Compensation

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

New Warning for Health Care Providers Paying for Marketing

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

OCR Waives HIPAA Penalties Against Providers Using Electronic COVID-19 Vaccine Scheduling

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

Potential Delay in Long-Awaited Stark Law and Anti-Kickback Statute Rules

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

CMS to Audit and Monitor Hospital Price Transparency

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

What to Expect: HHS Issues Final Rules on Stark, AKS & CMP Laws

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

Balancing Hospital Visitations and Religious Freedoms During a Pandemic

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

CMS Issues Guidance to State Medicaid Directors for Adoption of Value-Based Care

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

CMS Announces New Payment Model for Rural Providers

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

FDA Recommends Naloxone Prescription for Patients Receiving Opioids or Medications Used to Treat Substance Use Disorder

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

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