Regulatory – The Department of Health and Human Services is planning to expand the reporting requirements for nursing homes in the event of crimes against residents.
The government also intends to propose a long-awaited update to emergency preparation criteria as well as a modification in how providers are excluded from Medicare and Medicaid programs.
The Office of Management and Budget announced the spring 2024 Unified Agenda over the Fourth of July holiday weekend which includes all of these key areas. The comprehensive publication provides a biannual roadmap of regulation activity across 60 agencies, including those under HHS.
This year’s regulatory priorities include an additional wrinkle. The HHS list lays out proposed and final rules planned over the next 12 months, but last month’s Supreme Court decision denying respect to regulatory agencies’ authority in court disputes might make it more difficult for agencies like the Centers for Medicare and Medicaid Services to pursue some of their wish list items.
Members of Congress are also joining the fray.
Sen. Bill Cassidy (R-LA), the ranking member of the Senate Health, Education, Labor, and Pensions Committee, essentially instructed HHS Secretary Xavier Becerra to abandon large portions of his program in order to comply with the verdict.
“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 stated in a letter dated June 30, 2019. “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 ten essential questions regarding how they will function under the new framework created 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 are in focus
Even though legal issues remain unresolved, HHS officials have detailed an ambitious list of operations, many of which may harm skilled nursing businesses.
CMS is still preparing to revise its emergency preparedness standards, which providers have been expecting for nearly two years.
A proposed rule could affect a variety of provider types and suppliers, requiring them to adequately plan for both natural and man-made disasters, including climate-related disasters, as well as coordinate with federal, state, tribal, regional, and local emergency preparedness systems based on lessons learned from the COVID-19 public health emergency.”
That new rule could be incorporated into a proposed Healthcare System Resiliency and Modernization Rule, which might be issued this month or later.
CMS plans to propose a new rule in the spring of 2025 requiring “specific covered individuals” in long-term care facilities to notify to HHS and law enforcement bodies any reasonable suspicion that a crime has been committed against a resident of or an individual who is receiving care.
It would also prohibit retribution for filing such reports and provide processes for imposing civil monetary penalties and barring participation in federal healthcare programs for violating the requirements.
CMS also intends to make technical modifications 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 increased cyberattacks.
In its long-term actions, HHS also stated that it must finalize proposals to modify HIPAA’s Privacy Rule by November 2025 in order to strengthen individuals’ rights to access their own protected health information, including electronic information; improve information sharing for individual care coordination and case management.
and facilitate greater family and caregiver involvement in the care of individuals experiencing health emergencies.
Meanwhile, the Office of Inspector General intends to broaden its exclusion criteria for federal healthcare programs later this year, including manufacturers who misclassify outpatient pharmaceuticals or offer inaccurate information about prescription pricing.
The proposed regulation would also change or eliminate the “aggravating and mitigating factors” used to determine the length of an exclusion.
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