News & Analysis as of

Anti-Kickback Statute Social Security Act

The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The... more +
The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -
Arnall Golden Gregory LLP

OIG Approves Arrangement Regarding Patient Assistance Funds for Patients With Certain Rare Diseases, Pending Medicare Part D...

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-02 (the “Opinion”) to a nonprofit organization that provides...more

Arnall Golden Gregory LLP

OIG Approves Arrangement Incentivizing Medigap Policyholders to Seek Treatment From PHO Network Hospitals

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-01 (the “Opinion”), to a Medicare Supplemental Health Insurance...more

King & Spalding

OIG Updates COVID-19 Administrative Enforcement FAQs With Question Regarding Ambulance Providers’ Waiver or Discount of Certain...

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On May 5, 2021, OIG issued guidance on its COVID-19 Administrative Enforcement FAQs page stating that an ambulance provider or supplier waiving or discounting Medicare beneficiary cost-sharing obligations presents a low risk...more

ArentFox Schiff

Changes to Stark Law Definitions Impact Innovative Relationships and “Commercially Reasonable” Considerations

ArentFox Schiff on

The Final Rule of the Stark Law revises the definitions of Fair Market Value and includes a definition of General Market Value to better align with actual practices without unduly restricting innovative relationships between...more

King & Spalding

HHS Finalizes Rule Challenging Drug Manufacturer Rebates to PBMs and Payors

King & Spalding on

Final Rule Closely Resembles Previously Withdrawn 2019 Proposed Rule - INTRODUCTION - On November 20, 2020, as part of a release of several drug pricing rules, the U.S. Department of Health and Human Services (“HHS”)...more

King & Spalding

He Actually Did It: Trump Administration Implements Medicare Part B “Most Favored Nation” Drug Pricing Reform

King & Spalding on

On November 20, 2020, 60 days before the end of his Administration, President Trump announced a series of major drug pricing regulations. This Alert summarizes the Most Favored Nation Model (“MFN Model”) for Medicare Part B...more

King & Spalding

OIG Issues Advisory Opinion on Arrangement for Charitable Organization to Buy and Forgive Patient Debt from Providers

King & Spalding on

On July 24, 2020, OIG issued an Advisory Opinion (AO), AO 20-04, regarding whether an arrangement where a charitable organization purchases or receives donations of unpaid medical debt from health care providers, and then...more

Dickinson Wright

Stark Law and Anti-Kickback Statute Waivers for COVID-19

Dickinson Wright on

In light of the COVID-19 pandemic, on March 30, 2020, the Secretary of the U.S. Department of Health and Human Services (the “Secretary”) released blanket waivers (the “Waivers”) under Section 1135 of the Social Security Act...more

Holland & Knight LLP

Healthcare Law Update: July 2019

Holland & Knight LLP on

CMS Regulation - District Court Strikes Down Rule Mandating Price Disclosure in DTC Pharmaceutical Advertisements - The U.S. Department of Health and Human Services (HHS), together with the Centers for Medicare &...more

McDermott Will & Emery

New OIG Exclusion Regulations About to Go into Effect

The Office of Inspector General (OIG) recently published a final rule regarding its exclusion authorities. The final rule goes into effect March 21, 2017, and expands OIG’s authority to exclude certain individuals and...more

Hogan Lovells

HHS OIG Finalizes New Exclusion Rules as Administration Exits

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With just a week left before a new administration takes office, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized changes to the regulations authorizing OIG to exclude...more

Baker Donelson

Rural Hospital Cardiac Catheterization Lab Cost Savings Program issued favorable OIG Advisory Opinion

Baker Donelson on

On December 31, 2012 the U.S. Department of Health and Human Services Office of Inspector General ("OIG") issued a favorable Advisory Opinion No.12-22 for a hospital cardiology group compensation arrangement that includes a...more

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