News & Analysis as of

Medicare Stark Law

Rivkin Radler LLP

Court: Mailing Drugs to Patients’ Homes is a Potential Stark Law Violation

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A recently issued federal court opinion confirmed that certain pre-COVID era prescribing restrictions are back in place. In July 2023, a nonprofit advocacy group, Community Oncology Alliance, filed suit against the U.S....more

Holland & Hart LLP

FMV for Provider Contracts: Regulatory Standards

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As a general rule, healthcare employers are required to pay employed physicians and other contracted providers fair market value (FMV) for their services, but many employers do not understand relevant regulatory standards. ...more

Husch Blackwell LLP

How to Wear the Investor Hat When Physicians Are the Revenue Generators

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Engaging in management and investor conversations about maintaining and growing a business is critical, no matter the industry. Whether you’re discussing normal business sustainability, organic growth, or contemplating a...more

ArentFox Schiff

Investigations Newsletter: Precision Lens Pays $12 Million to Resolve FCA and AKS Violations

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Precision Lens Pays $12 Million to Resolve FCA and AKS Violations - Late last week, Precision Lens and the estate of its former principal agreed to pay $12 million to resolve allegations regarding violations of the False...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | June 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including guidance regarding hospital...more

ArentFox Schiff

Investigations Newsletter: FCA Enforcement & Compliance Digest — Summer 2024 False Claims Act Newsletter

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Welcome to the Summer 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and...more

ArentFox Schiff

Investigations Newsletter: Florida Lab Owner Agrees to Pay Over $27 Million to Resolve Three Whistleblower Lawsuits

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Florida Lab Owner Agrees to Pay Over $27 Million to Resolve Three Whistleblower Lawsuits - Daniel Hurt, the prior owner and operator of Fountain Health Services LLC, Verify Health, Landmark Diagnostics LLC, First Choice...more

Foley & Lardner LLP

Health-Related Social Needs: Three Trends in Leveraging Community Partnerships

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Leading health authorities have increasingly emphasized how non-medical factors such as socioeconomic status, education, employment, housing, food security, and community support have an outsized impact on health outcomes. By...more

Holland & Hart LLP

Patient Inducements: Law and Limits

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Although often well-intentioned, offering free or discounted items or services to patients (e.g., gifts, rewards, writing off copays, free screening exams, free supplies, etc.) may violate federal and state laws governing...more

Mintz

EnforceMintz — Some of 2023’s Largest FCA Resolutions Involved Stark Law Allegations

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The Physician Self-Referral Law — known as the “Stark Law” — broadly prohibits physicians from profiting from self-referrals for “designated health services” (DHS) payable by Medicare or Medicaid. For example, the Stark Law...more

Bricker Graydon LLP

A Long-Awaited Change: OIG Updates its Compliance Program Guidances

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From 1998-2008, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published compliance program guidelines for various industries in the Federal Register....more

Goodwin

Additional Disclosure Required: CMS Implements Substantial Changes to Reporting Skilled Nursing Facility Ownership Information

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On November 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule that will require skilled nursing facilities (SNFs) to disclose an expanded array of ownership, managerial, and control information...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - January 26th, Atlanta, GA

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...more

Rivkin Radler LLP

NY Cardiologist Settles AKS Claims for $6.5 Million

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The U.S. Attorney’s Office for the Southern District of New York announced on September 18 that cardiologist Klaus Peter Rentrop and his practice, Gramercy Cardiac Diagnostic Services, P.C., agreed to pay $6.5 million to...more

Butler Snow LLP

Health Care Due Diligence: An Ounce of Prevention is Worth a Pound of Cure

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Due diligence properly performed in connection with the purchase and sale of a health care entity is simply different—vastly so—than due diligence performed in other contexts. Failure to recognize this reality can lead to...more

Epstein Becker & Green

Physicians Beware! Groups Providing DME, Prosthetic Devices, and Other Medical Supplies to Their Medicare Patients Risk Violating...

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When the COVID-19 Public Health Emergency (“PHE”) ended on May 11, 2023, many physician groups furnishing certain medical equipment, devices, and/or supplies to their Medicare patients became in violation of the federal...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - September 8th, Waltham, MA

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education that covers a wide variety of current and emerging...more

King & Spalding

CMS Issues IPPS and LTCH PPS Final Rule for FY 2024

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On August 1, 2023, CMS issued its annual Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Final Rule for FY 2024 (the Final Rule). In the Final Rule, CMS,...more

Stevens & Lee

New Stark Law Exception and Anti-Kickback Statute Safe Harbor Aim to Combat Physician Burnout

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Health care professionals have faced increasing burnout and mental health issues in the wake of the COVID-19 pandemic. In an effort to address these rising issues, Congress passed the Dr. Lorna Breen Health Care Provider...more

White and Williams LLP

Are Syndicated Loans Securities?

The ongoing case of Kirschner v. JP Morgan Chase Bank, N.A., which has traveled through the New York federal court system since 2018, is now before the Second Circuit, who are tasked with deciding the following: are...more

Holland & Knight LLP

Florida Legislature Shrinks Supervision Requirements Under Florida Mini-Stark Law

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New Florida legislation, Senate Bill 768 (2023), amending the Patient Self-Referral Act of 1992 (the Act), also known as the Florida "mini-Stark law," has been signed by Gov. Ron DeSantis and is set to take effect on July 1,...more

ArentFox Schiff

Physician Wellness Programs: A New Stark Law Exception and AKS Safe Harbor to Combat Burnout

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The recently passed Consolidated Appropriations Act (CAA) of 2023 includes a new Stark Law exception and Anti-Kickback Statute (AKS) safe harbor, allowing hospitals and other health care entities to offer their physicians...more

Vicente LLP

Buying a Ketamine Clinic: Why, How, and Risks to Understand

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This article is part of a continuing series of articles regarding transactional legal issues in the emerging psychedelic space. With ketamine being the only approved psychedelic drug for medical use, ketamine clinics offer a...more

Epstein Becker & Green

Hidden in Plain Sight: Lesser-Known Exceptions Recently Adopted by Congress to the Federal Physician Self-Referral Law and...

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At the end of 2022, Congress enacted the Consolidated Appropriations Act of 2023 (“CAA”), for which there has been much fanfare.   As it relates to health care, this legislation included provisions addressing issues such...more

Morgan Lewis

What Physician Organizations Need to Know: Key Considerations for the End of the PHE

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As the COVID-19 Public Health Emergency comes to an end on May 11, various regulatory flexibilities simultaneously expire, including certain waivers issued by the Centers for Medicare & Medicaid Services, among other...more

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