Steven Shapiro will be a speaker on a webinar offered by the American Herbal Products Association (AHPA) entitled “Compliance with FDA’s Revised Nutrition Labeling Regulations for Herbal Supplements.” Scheduled for October 29 from 1-3 pm, the program will offer an overview of new federal nutrition labeling requirements, which take effect Jan. 1, 2020, for manufacturers

In an October 21 blog post titled “The Future of Medicare Program Integrity,” Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma described a new five-pronged approach to combat waste, fraud, and abuse in the Medicare program. The five “pillars” of the initiative are:

• Stop bad actors. CMS works with the Office of

On October 10, the New York State Department of Financial Services released a proposed amendment to the state’s Out-of-Network Law. If approved, the amendment would require insurance companies and healthcare providers to comply with several new requirements to better protect consumers from “surprise” medical bills.

Insurers that receive a claim for services rendered by a

As part of the U.S. Department of Health and Human Services’ “Regulatory Sprint to Coordinated Care,” the U.S. Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) coordinated their efforts in issuing proposed changes to the federal fraud and abuse laws which prohibit certain patient referrals. The changes are intended

As Medicare open enrollment approaches, the Centers for Medicare & Medicaid Services (CMS) announced on August 27 the launch of a redesigned Medicare Plan Finder tool. This new tool makes it easier for customers to compare pricing, coverage, and drug plans of Medicare, Medicare Advantage, Medigap, and Part D programs. The Plan Finder tool is

The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) recently issued a favorable Advisory Opinion (No. 19-05) involving a proposed transaction with an excluded individual. Healthcare entities and providers must always use caution when contemplating proposed transactions with an individual who is excluded from participating in Medicare, Medicaid or other federally

The online appointment booking service Zocdoc has received a favorable Advisory Opinion from the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) confirming that Zocdoc’s new per-click or per-booking fee model does not violate the federal Anti-Kickback Statute (AKS). Without AKS concerns, Zocdoc may now allow Medicare, Medicaid, and other federal

On October 10, Rivkin Radler’s Jeff Kaiser will be a panelist at the Practising Law Institute (PLI) program, “Life Sciences 2019: Navigating Legal Challenges in the Drug and Device Industries.” Jeff will speak on “Enforcement Trends Impacting the Drug and Device Industries,” including developments under the False Claims Act, federal Anti-Kickback Statute, off-label promotion, and

Last week, the 11th Circuit Court of Appeals handed down its long-awaited decision in United States v. AseraCare, Inc. The case, brought under the False Claims Act (FCA) and argued way back in March 2017, alleged that AseraCare, a for-profit multi-state hospice chain, had submitted false claims to the Medicare program for patients who were

On September 5, the Centers for Medicare & Medicaid Services (CMS) announced the issuance of a final rule that will allow the agency to deny or revoke a healthcare provider’s or supplier’s federal program enrollment if it is “affiliated” with another previously revoked organization. The rule had originally been proposed more than three years ago.