Health Law Scan

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.

In the first win for defendants facing Illinois Biometric Information Privacy Act (BIPA) litigation before the Illinois Supreme Court, the Court in Mosby v. Ingalls Memorial Hospital held that BIPA excludes from its protections the biometric information of healthcare workers where that information is collected, used, or stored for healthcare treatment, payment, or operations.

Estimates show that Medicaid enrollment grew by more than 20 million (approximately 31%) during the public health emergency (PHE) and the top Medicaid managed care organizations (MCOs) experienced a 44.1% increase in managed care enrollment between March 2020 and March 2023. This increase has been largely attributed to the continuous enrollment condition, which conditioned certain federal funding on maintaining all Medicaid enrollments during the PHE. In spring of 2023, the continuous enrollment condition ended and states were given a year to redetermine the eligibility of 94 million Medicaid enrollees.

The US Department of Health and Human Services Office of Inspector General (OIG) posted on October 25, 2023 Advisory Opinion No. 23-08, in which OIG rejected a proposed arrangement from a cochlear implant device manufacturer (the requestor) that would provide a free hearing aid to certain qualified patients who received a cochlear implant.

The US Department of Health and Human Services Office of Inspector General (OIG) released its new General Compliance Program Guidance (GCPG) on November 6, 2023. The GCPG is designed to serve as a reference guide for the healthcare compliance community and other healthcare stakeholders.

The US Drug Enforcement Administration (DEA) issued a temporary rule on October 6, 2023 extending COVID-19–era flexibilities through December 31, 2024. With this extension, the DEA will continue to waive provisions under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 that prohibit practitioners from prescribing controlled substances to patients without first conducting an in-person encounter.

If your organization has faced a Medicare audit in the last decade, you may have experienced a significant delay in the Medicare appeals process due to a monumental backlog of claims pending in front of administrative law judges (ALJs). As a result, the Office of Medicare Hearings and Appeals (OMHA) has initiated several pilot programs and received a significant boost in funding following a federal court decision requiring OMHA to develop a plan to reduce this backlog.

The Biden administration recently announced its much-anticipated proposed rule for implementing a minimum staffing “floor” for nursing homes in the United States and further launched a nursing home accountability initiative. These efforts are seismic for the long-term care nursing home community and will bring new challenges and scrutiny to a health industry sector battered with healthcare personnel shortages, pandemic recovery obstacles, changing reimbursement models, and regulatory scrutiny.

The US Department of Health and Human Services, Office for Civil Rights (OCR), announced a settlement agreement on June 15, 2023 with not-for-profit community hospital Yakima Valley Memorial Hospital (Yakima) related to Yakima employees’ snooping in medical records that resulted in the breach of protected health information (PHI).