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.

Through the issuance of Inauguration Day executive orders, the Trump Administration signaled its apparent intent to tackle drug pricing reforms over the next four years. However, Biden-era policies are likely to limit a comprehensive overhaul of existing reforms in the near term.

Through its passage, the Inflation Reduction Act (IRA) ushered in several reforms directed at rising prescription drug costs, aiming to lower costs for Medicare enrollees and reduce spending by the federal government. Included in these reforms is the establishment of the Medicare Prescription Payment Plan (M3P), a monthly installment plan that allows enrollees to pay back prescription drug costs overtime instead of all at once at the pharmacy. While M3P will reduce monthly out-of-pocket costs for enrollees, it requires plan sponsors to cover all up-front costs until payments are collected. Given the potential for non-payment, Medicare Part D plans would be well advised to prepare and account for potential financial losses.

As noted in our recent LawFlash, the US Department of Justice’s (DOJ’s) COVID-19 Fraud Enforcement Task Force (CFETF) recently released its annual compilation report of its efforts to combat fraud related to pandemic relief programs since 2020. Accompanying the report, Deputy Attorney General Lisa Monaco and the Biden administration announced strong support for creating and securing funding for future data analytics tools like those used by the Pandemic Response Accountability Committee’s (PRAC) Pandemic Analytics Center of Excellence (PACE).

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 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.

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.

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.