Legislation and Public Policy

In a recent Advisory Opinion, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) determined that an arrangement involving certain physicians who have an ownership interest in a medical device company that manufactures products that may be ordered by the physician owners (the “Company”) was not considered a suspect physician-owned…

On May 11, New York Gov. Kathy Hochul announced the establishment of the Pharmacy Benefits Bureau within the State’s Department of Financial Services (DFS). The Bureau will handle the licensing and supervision of pharmacy benefit managers (PBMs), and in particular their impact on consumers and the cost of healthcare. The Bureau will also have authority…

With the proliferation of precision and individualized medicine, genetic testing and counseling will likely remain on the radar of the Department of Health and Human Services’ Office of Inspector General (OIG) and the Department of Justice for years to come. Biopharma companies and manufacturers must carefully consider the facts and safeguards applicable to any sponsored…

Regulators are now better armed to cite and fine health plans that are not complying with the Mental Health Parity and Addiction Equity Act (MHPAEA) of 2008. A recent report to Congress highlights the enforcement work to date and illustrates the extent to which many plans are noncompliant with the law. The result is that…

The increased use of telehealth services is a trend that is expected to continue long after the COVID-19 pandemic ends. In keeping with this trend, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) recently issued a favorable Advisory Opinion that allowed a federally qualified health center (FQHC) to provide free…

In December 2019, the New York State Department of Health (DOH) issued a Request for Offers (RFO) from fiscal intermediaries (FIs) to enter into contracts with the DOH to provide FI services in the Consumer Directed Personal Assistance Program (CDPAP) for persons enrolled in Medicaid fee-for-service and Medicaid managed care programs. The CDPAP provides services…

Rivkin Radler’s Shari Claire Lewis wrote an article, “FTC Appears Ready to Begin Enforcing Its Health Breach Notification Rule,” that was published in the New York Law Journal on April 18. The article discusses the Federal Trade Commission’s rule that requires manufacturers of connected medical devices, fitness trackers and other wearables, and health…

On April 12, Department of Health and Human Services (HHS) Secretary Xavier Becerra extended the COVID-19 public health emergency for another 90 days. The PHE had been scheduled to expire on April 16.

The PHE originally went into effect in January 2020, at the onset of the pandemic. It provides important flexibilities for healthcare providers,…

New York’s 2023 state budget, signed into law on April 9, included an amendment to the state’s Education Law establishing 3,600 practice hours as a threshold beyond which nurse practitioners no longer require a collaborative agreement or a collaborative relationship with a physician to practice within their educational and clinical practice area. Practitioners such as…