On July 16, 2019, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule, entitled “Requirements for Long-Term Care Facilities: Regulatory Provisions To Promote Efficiency, and Transparency,” that, if finalized, will change the requirements for skilled nursing facility (SNF) and nursing facility (NF) compliance programs, as well as make a number of other changes to the Requirements of Participation (RoPs). According to CMS, the proposals “balance resident safety and quality of care, while also providing regulatory relief for facilities.”

Section 6102 of the Affordable Care Act added subsection 1128I(b) (42 USC 1320a-7j(b)) to the Social Security Act. The statute requires SNFs and NFs to have a compliance and ethics program that is effective in preventing and detecting criminal, civil and administrative violations and promoting quality of care. On October 4, 2016, CMS issued a final rule that significantly revised the RoPs, including the RoP related to compliance and ethics programs, that SNFs and NFs must meet to participate in the Medicare and Medicaid programs.

In the proposed rule, CMS removes many of the RoPs implemented in the final rule that were not expressly required by the statute. Specifically, CMS proposes to:

• Remove the requirement that each facility designate a compliance officer and a designated compliance liaison for operating organizations with five or more facilities.
  • Instead, such organizations would be required to develop a compliance and ethics program that is appropriate for the complexity of the organization and its facilities and assign a specific individual within the high-level personnel of the operating organization to the overall responsibility of overseeing compliance.
• Remove the annual review requirement.
  • Instead, organizations would be required to undertake a periodic assessment of its compliance program to identify any necessary changes. Interestingly, the CMS commentary within the proposed rule states that the new requirement would be “biennial” review. However, the actual text of the revised regulation says “periodic.”
• Eliminate the requirement for a ‘‘compliance and ethics program contact person’’ to whom individuals may report suspected violations.
  • Instead, facilities would be expected have a process for individuals to report suspected violations. The requirement that facilities have a method for reporting suspected violations anonymously is not being eliminated.
• Remove the language in 42 CFR § 483.85(c)(2) mentioning specific examples of “high level personnel” that should be assigned overall responsibility to oversee the compliance and ethics program.
  • Instead, CMS says it will hold facilities responsible for the effective operation of their compliance and ethics programs.
• Remove the requirement for mandatory compliance and ethics training for organizations with five or more facilities.

Comments to the proposed rule are due no later than 5:00 p.m. on September 16, 2019. If the proposed changes are finalized, they will become effective once the final rule is published.

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