Legislation and Public Policy

On November 20, 2024, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released the “Nursing Facility ICPG,” an industry-specific compliance program guidance for nursing facilities. 

Background

The Nursing Facility ICPG serves as a voluntary, nonbinding tool to assist facilities in reducing risks related to fraud, waste, and abuse, while…

The Law

The Corporate Transparency Act (the CTA), a law enacted by Congress requiring certain business entities to disclose beneficial ownership information (a BOI Report) to FinCEN, went into effect on January 1, 2024, and obligates reporting companies formed before January 1, 2024, to file BOI Reports on or before January 1, 2025.

The Challenge…

By January 1, 2025, millions of existing businesses must have filed certain information with the Financial Crimes Enforcement Network (FinCEN) to remain in compliance with the Corporate Transparency Act (CTA). As this deadline approaches, concern is growing among lawmakers. During a House Financial Services Committee hearing, committee members highlighted that many businesses have “no idea”…

On Thursday, December 12, in the next installment of Rivkin Radler’s Healthcare Compliance Lunch & Learn series, Rivkin Radler Partner Eric D. Fader will present an update on the regulatory landscape for the provision of telehealth services, including the latest trends and recent changes to federal and state laws and rules. The program will take…

On October 31, Elevance Health filed suit against the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) to challenge the 2025 Star Ratings system used for Medicare Advantage and Part D plans. CMS published the final Star Ratings to the public on October 10 through the…

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. Department of Health and Human Services (HHS) regarding provisions of the Stark Law. Stark prohibits physicians from referring Medicare and Medicaid patients to…

On October 20, 2024, several significant consumer protection laws will go into effect, directly affecting healthcare providers throughout New York State. Introduced through the FY 2025 Executive Budget, these new laws reshape how providers must handle patient consent to pay for medical services and the use of credit cards for payment.

Separate Consent for Payment…

On August 23, Johnson & Johnson (J&J) announced changes to its 340B Drug Pricing Program discount available to disproportionate share hospital (DSH) Covered Entities on purchases of two of J&J’s most popular drugs, STELARA and XARELTO.

As of October 15, J&J will make a 340B discount on these drugs available through a rebate. According to…

On September 19, Rivkin Radler’s Jeff Kaiser will participate on a panel at Practising Law Institute’s “Life Sciences 2024: Navigating Legal Challenges in Drug and Device Industries” program in New York City.

Held at PLI’s NY Conference Center at 1177 Avenue of the Americas and also available to view online, the program will cover the…