Health Law Scan

The US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued long awaited updates to the regulations at 42 CFR Part 2 (Part 2) on February 16, 2024. Part 2 is a critical set of rules protecting the privacy of patients receiving substance use disorder (SUD) treatment services and their associated clinical records.

The Medicare program is broken down into four parts. Part A covers the cost of healthcare items and services provided during inpatient hospital stays as well as skilled nursing facility, hospice, and some home health care. Part B covers certain physician services, outpatient care, medical supplies, and preventive services. Together, Parts A and B are commonly referred to as traditional Medicare or fee-for-service (FFS) because claims for each item or service are submitted to the Centers for Medicare & Medicaid Services (CMS) for reimbursement through its Medicare Administrative Contractors.

If you have had a loved one suffer from dementia, you know the emotional, physical, and financial toll of this terrible disease. With advancements in dementia treatment, however, there is renewed hope on addressing this disease and increasing emphasis on fostering innovative care models.

The US Department of Justice (DOJ) Civil Division released its annual fraud statistics on February 22, highlighted by False Claims Act (FCA) settlements and judgments exceeding $2.68 billion in fiscal year 2023. DOJ released these annual fraud statistics, detailing its wins in the prior fiscal year, in conjunction with remarks delivered by DOJ Principal Deputy Assistant Attorney General Brian Boynton at the Federal Bar Association Qui Tam Section Conference. In his remarks, Mr. Boynton outlined DOJ’s enforcement priorities for fiscal year 2024 and beyond, including priorities for the health care industry.

The Health Care Fraud and Abuse Control Program (HCFAC), an annual report jointly issued by the US Department of Justice (DOJ) and Department of Health and Human Services (HHS), can be helpful in predicting DOJ and HHS priorities for the coming year. In the FY 2022 HCFAC, DOJ and HHS not only highlighted a series of fraud and abuse enforcement wins, but also indicated increased activity by and with the US Food and Drug Administration (FDA) and the DOJ Consumer Protection Branch (CPB). This increase in activity from these regulatory agencies should be of interest to stakeholders in the pharmaceutical and medical device sectors.

Digital health—that is, medical care enhanced or made possible by the use of technology—has changed the landscape of healthcare in America. Innovation in this sector is at an all-time high and 2024 will no doubt see greater expansion and acceptance of digital health within the care continuum.

The US Department of Health and Human Services Office of Inspector General (OIG) published favorable Advisory Opinion No. 23-15 on January 3, which concluded that a consultant’s proposal to provide gift cards to existing physician practice customers in exchange for referring other physician practices to the vendor would not implicate the federal Anti-Kickback Statute (AKS).

Continuing its recent slate of high-profile indictments, convictions, and plea agreements involving healthcare executives who have violated federal healthcare laws, the US Department of Justice (DOJ) recently announced charges against a healthcare executive for her role in a Medicare fraud scheme.

As Prescribed and Health Law Scan subscribers know that the end of the holidays means the annual J.P. Morgan (JPM) Healthcare Conference is only days away. To make the most of the 2024 conference and conference-adjacent opportunities, read on for a preview of the current economic environment for dealmaking in the pharmaceutical and biotechnology industries and some practical advice on how to successfully prepare for and navigate the week’s activities shared from panelists at our inaugural Pre-JPM Conference Networking Event last month.

Since our publication on disenrollments caused by the “unwinding” of Medicaid’s continuous enrollment condition, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule on December 6, 2023 implementing the requirement under the Consolidated Appropriations Act for CMS to withhold federal Medicaid funding from states that do not report monthly unwinding data.