The Department of Health and Human Services is making plans to expand reporting requirements for nursing homes in the event of crimes against residents. The agency also aims to propose a long-awaited update to emergency preparedness standards and change how it excludes providers from the Medicare & Medicaid programs.
Those focus areas were all included in the spring 2024 Unified Agenda, which was published over the Fourth of July holiday weekend by the Office of Management and Budget. The expansive document is a biannual roadmap of rulemaking activities across 60 agencies, including those within HHS.
This year’s regulatory priorities come with an added wrinkle. The HHS list lays out proposed and final rules expected over the next 12 months, but last month’s Supreme Court ruling revoking deference to regulatory agencies’ authority in court battles could make it more challenging for agencies like the Centers for Medicare & Medicaid Services to pursue some of their wish list items.
Members of Congress are also stepping into the fray.
Sen. Bill Cassidy (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions Committee, essentially told HHS Sec. Xavier Becerra to forgo entire parts of his agenda to honor the ruling.
“This decision is an opportunity for executive agencies to re-examine their role relative to Congress, and to return legislating to the people’s elected representatives,” Cassidy wrote in a letter dated June 30. “Despite the Court’s decision, given your agency’s track record, I am concerned about whether and how the Department of Health and Human Services will adapt to and faithfully implement both the letter and spirit of this decision.”
He asked HHS officials to answer 10 key questions about how it will operate under the new framework established in the Chevron case, including:
- Whether HHS will conduct a systematic, “action-by-action review” of its ongoing activities to identify opportunities where the Department needs to make changes to comply with or otherwise account for the decision?
- Whether HHS will pause or stop any existing rulemaking activities in light of the Court’s decision, and if not, what legal grounds it has to support its endeavors
- How HHS plans to facilitate “greater congressional involvement” in policy issues under the agency’s purview?
Skilled nursing emergencies in focus
Even with questions about legal wrangling far from resolved, HHS officials have outlined an ambitious slate of activities, many of which could affect skilled nursing operators.
CMS is still planning to update its emergency preparedness regulations, which providers have been anticipating for nearly two years. A proposed rule could hit multiple provider types and suppliers, calling on them to plan adequately for both natural and man-made disasters, including climate-related disasters, and coordinate with federal, state, tribal, regional, and local emergency preparedness systems based on lessons learned during the COVID-19 public health emergency.”
That new rule could be tucked into a proposed Healthcare System Resiliency and Modernization Rule, which could drop anytime this month or later.
By spring of 2025, CMS aims to propose a new rule requiring that “specific covered individuals” in long-term care facilities report to HHS and law enforcement entities “any reasonable suspicion that a crime has been committed against a resident of or an individual who is receiving care.” It also would prohibit retaliation for making such reports and establish procedures for imposing civil money penalties and exclusion from participation in federal healthcare programs for violating the requirements.
CMS also wants to make technical updates to the Health Insurance Portability and Accountability Act of 1996 and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act), citing increasing cyberattacks.
In its long-term actions, HHS also noted that it must act by November 2025 to finalize proposals to modify HIPAA’s Privacy Rule to strengthen individuals’ rights to access their own protected health information, including electronic information; improve information sharing for care coordination and case management for individuals; and facilitate greater family and caregiver involvement in the care of individuals experiencing health emergencies.
Meanwhile, the Office of Inspector General later this year plans to expand how it excludes providers from federal healthcare programs, adding manufacturers that misclassify outpatient drugs or provide false information related to drug pricing. That proposed rule also would modify or eliminate “aggravating and mitigating factors” used to set the length of an exclusion.
