Health Law Scan

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community.

Section 1557 of the Affordable Care Act (ACA) prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain healthcare activities. Among other requirements, all healthcare providers that receive, directly or indirectly, federal financial assistance, including but not limited to participation in Medicare or Medicaid must now provide a notice of availability of language assistance services free of charge. The US Department of Health and Human Services’ (HHS) new set of requirements was finalized in April 2024.

The old adage—March comes in like a lion and goes out like a lamb—didn’t quite hold true for the hospice sector, which experienced a late-month flurry of activity. The government gave the hospice sector a lot to consider, from MedPAC’s suggested freeze on hospice rates to CMS’s 2025 Proposed Hospice Rule (public comments due May 28, 2024) that, if finalized as is, would include a 2.6% payment bump. CMS’s Proposed Hospice Rule lays the groundwork for the long-anticipated Hospice Outcomes and Patient Evaluation (HOPE) quality measures data collection instrument, which will be used to collect data at various points during the hospice stay, not just at admission and discharge.

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 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.

Pressure continues to mount on the US Department of Health and Human Services (HHS) to reconsider and revise its August 2022 final rule modifying the No Surprises Act independent dispute resolution (IDR) process. The rule is an attempt to revise the original IDR process, which “placed its thumb on the scale” for payors, according to the February 2022 federal district court decision in Texas Medical Association v. US Department of Health and Human Services.

Another year has come to pass, and it seems the federal Public Health Emergency (PHE) will remain in place for at least the next five months. Why? As the US Department of Health and Human Services (HHS) has continuously pledged throughout the COVID-19 pandemic, the federal government intends to give states and healthcare providers at least a 60-day notice before terminating the PHE, which has granted significant flexibilities for furnishing healthcare services covered by Medicare, including in the context of telehealth. That 60-day notice period for the current PHE expiration date came and went on November 12 with no word from Secretary Xavier Becerra that the federal government would seek to wind down PHE flexibilities at the start of 2023. As a result, the PHE in all likelihood will be extended for an additional 90 days in early January 2023, for a revised expiration date of April 11, 2023.

Last month, we had an engaging Fast Break session covering compliance topics regarding healthcare professionals’ relationships with pharmaceutical and medical device manufacturers. We were joined by Terrence Burek, senior counsel, neurology & immunology at EMD Serono, and Morgan Lewis partner Scott Memmott, who highlighted specific compliance risk areas for healthcare professionals (HCPs), as well as permissible interactions with pharmaceutical and medical device manufacturers and contracting/risk mitigation best practices.

The Centers for Medicare and Medicaid Services (CMS) announced that it had restarted the Targeted Probe and Educate (TPE) audit process, effective September 1, 2021. More recently, the Medicare Administrative Contractors for hospice have targeted “claims with revenue code 0656 [General Inpatient Care] greater than or equal to 7 days submitted with dates of service on or after January 1, 2020” for active, pre-pay medical review.

Members of our healthcare team recently published a LawFlash discussing the announcement by the US Department of Health and Human Services (HHS) that it will make $25.5 billion available in new COVID-19 relief funds to providers through the Health Resources and Services Administration (HRSA). To that end, HRSA will disburse $17 billion in Phase 4 payments remaining from the CARES Act Provider Relief Fund (PRF) to a “broad range of providers” based on lost revenues and expenses between July 1, 2020 and March 31, 2021.