On September 26, 2019, CMS issued the Omnibus Burden Reduction (Conditions of Participation) Final Rule (“Final Rule”) that seeks to remove Medicare regulations that are “unnecessary, obsolete, or excessively burdensome on hospitals and other healthcare providers . . . .” CMS estimates that the Final Rule will cut the amount of time providers spend on paperwork by 4.4 million hours and projects an annual savings of $800 million.

In accordance with Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs,” CMS conducted a review of its regulatory health and safety standards and issued this Final Rule to revise certain regulations in an effort to reduce regulatory burden on healthcare providers and suppliers. The Final Rule finalizes the provisions of the following proposed rules:

• Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction (“Omnibus Burden reduction”), which was published on September 20, 2018;
• Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care, which was published on June 16, 2016; and
• Fire Safety Requirements for Certain Dialysis Facilities, which was published on November 4, 2016.

Outlined below, are some of the ways in which CMS intends to reduce regulatory burden on providers and suppliers.

Emergency Preparedness. The Final Rule sets forth the following changes in connection with current emergency preparedness requirements:

• Facilities no longer have to conduct an annual review of their emergency program. The facilities now must conduct a biennial review of the emergency program.
• CMS no longer requires that the emergency plan include documentation of the facility’s efforts to contact local, tribal, regional, state, and federal emergency preparedness officials.
• The Final Rule lessens the training requirement from annually to biennially. Nursing homes, however, are still required to provide annual training.
• The Final Rule promotes increased flexibility for the testing requirement for inpatient providers by allowing the two annually-required testing exercises to be an exercise of the facility’s choice. For testing requirements related to outpatient providers, the Final Rule decreases the requirement for facilities to conduct two testing exercises to one testing exercise.

Hospitals. CMS seeks to reduce regulatory burden on hospitals in some of the following ways:

• The Final Rule allows multi-hospital systems to unify and integrate their Quality Assessment and Performance Improvement (QAPI) programs. Similarly, multi-hospital systems may unify and integrate their infection control and antibiotic stewardship programs for all of their member hospitals.
• CMS has removed the requirement that a hospital’s medical staff must secure autopsies in instances of unusual deaths and of medical-legal and educational interest.
• Hospitals are provided flexibility in establishing a medical staff policy that describes circumstances under which a pre-surgery/pre-procedure assessment for an outpatient could be utilized.
• With respect to psychiatric hospitals, CMS seeks to finalize a clarification to allow the use of non-physician practitioners and MDs/DOs to document progress notes of patients receiving services.

Ambulatory Surgical Centers (“ASCs”). The Final Rule seeks to reduce regulatory burden on ASCs by:

• Removing provisions requiring ASCs to have written transfer agreements with a hospital that meets certain Medicare requirements or ensuring that all physicians performing surgery have admitting privileges in a hospital that meets certain Medicare requirements.
• “Removing the current requirements that a physician or other qualified practitioner conduct a complete comprehensive medical history and physical assessment on each patient not more than 30 days before the date of the scheduled surgery.”

Home Health Agencies (“HHAs”). CMS intends to reduce regulatory burden on home health providers in the following manner:

• The Final Rule removes the requirement that a HHA conduct a full competency evaluation of a home health aide when deficiencies are identified in the aide’s services. Now, CMS requires that HHA retrain the aide regarding the deficient skill and requires the aide to complete a competency evaluation in connection to only that skill.
• The Final Rule reduces requirements for verbal notification of all patient rights, now requiring only that a notification be given to patients concerning those rights related to payments made by federally-funded programs and potential patient financial liabilities. The requirement that HHAs provide written notice of all patient rights remains in effect.

Hospices. The Final Rule attempts to reduce regulatory burden on hospice providers in the following ways:

• CMS will now allow hospices to defer to their state licensure requirements for qualification of their hospice aides.
• Hospices are no longer required to “consult with an individual with expertise in drug management in addition to the hospice’s own expert clinicians.”
• CMS requires hospices that provide hospice care to residents of SNFs or ICFs for individuals with intellectual disabilities to work with their chosen SNF and ICF partners “to educate facility staff about the hospice philosophy of care and specific hospice practices.”

Comprehensive Outpatient Rehabilitation Facilities. To reduce regulatory burden on comprehensive outpatient rehabilitation facilities, the facilities are only required to implement a utilization review plan annually, instead of four times a year.

Portable X-Ray Services. The Final Rule removes “the four training and education requirements, which focus on the accreditation of the school where the technologist received training,” and replaces this requirement “with a streamlined qualification that focuses on the skills and abilities of the technologist.” In addition, CMS now allows portable x-ray services to be ordered via writing, telephone, or electronic means.

The regulations contained in the Final Rule become effective on November 29, 2019. The requirements regarding QAPI in CAHs, however, must be implemented by March 30, 2021. In addition, the requirements related to hospital and CAH antibiotic stewardship programs must be implemented by March 30, 2020.

Do note that the changes discussed above are only some of the ways in which the Final Rule intends to reduce regulatory burden for providers and suppliers. For additional information regarding the Final Rule, please click here for the CMS Fact Sheet or here for the Final Rule.

Footnotes for this alert are available in the formatted PDF accessible below.

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CMS Issues Omnibus Burden Reduction (Conditions of Participation) Final Rule