On September 26, 2019, CMS issued a Final Rule that CMS intends will reform certain Medicare regulations related to standards and certifications that CMS identified as “unnecessary, obsolete, or excessively burdensome.” CMS estimates that these reforms will eliminate 4.4 million hours of time previously spent on paperwork, with an overall total projected savings to providers of $800 million annually. These changes are effective November 29, 2019.
The Final Rule (84 Fed. Reg. 51732 (Sept. 30, 2019)) implements President Trump’s January 30, 2017 Executive Order titled “Reducing Regulation and Controlling Regulatory Costs” (Exec. Order No. 13771) and CMS’s “Patients over Paperwork” initiative. The Final Rule encompasses policies that the agency had set forth in three separate proposed rules: Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction (“Omnibus Burden Reduction”), published September 20, 2018; Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care, published June 16, 2016; and Fire Safety Requirements for Certain Dialysis Facilities, published November 4, 2016. Some of the changes as adopted in the Final Rule are highlighted below.
Emergency Preparedness Procedures for Providers and Suppliers
CMS made significant changes to 42 C.F.R. § 403.748 regarding emergency preparedness procedures. For example, CMS eliminated the requirement that facilities conduct an annual review of their emergency program. Facilities can now perform this review every other year. CMS also eliminated the requirement that a facility’s emergency plan include documentation of efforts to contact local, tribal, regional, State, and federal emergency preparedness officials and of a facility’s participation in collaborative and cooperative planning efforts. Certain related testing and training requirements are also reduced under the Final Rule.
Hospitals, Critical Access Hospitals, and Swing Bed Providers
Under the Final Rule, CMS revised 42 C.F.R. § 482.21(f) to allow multi-hospital systems the option to have unified and integrated Quality Assessment and Performance Improvement (QAPI) programs and unified and integrated infection control and antibiotic stewardship programs for all of their member hospitals. Previously, each hospital in the system was required to have individual programs. CMS also removed the requirement at § 482.22(d) that a hospital’s medical staff must attempt to secure autopsies in all cases of unusual deaths and of medical-legal and educational interest. The Final Rule also revises §§ 482.22, 482.24, and 482.51 to give hospitals flexibility to establish a medical staff policy that utilizes a limited outpatient assessment instead of requiring a comprehensive medical history and physical examination prior to routine procedures and surgeries.
For hospitals that provide long-term care “swing bed” services, CMS removed the requirement at § 483.10(f)(9) for a facility to request or allow swing-bed patients to perform services for the facility. Additionally, CAH providers of long-term care swing bed services will no longer be required under § 485.645(d)(4) to provide an ongoing activities program that is directed by a qualified professional because the patient’s activity needs are addressed in the nursing care plan. The Final Rule also removes the requirements at § 482.58(b)(5) for hospital swing-bed providers and § 485.645(d)(5) for CAH swing-bed providers that require these facilities with more than 120 beds to employ a social worker on a full-time basis. Finally, facilities are no longer required to assist in obtaining routine and 24-hour emergency dental care under § 482.58(b)(8) for hospital swing-bed providers and § 485.645(d)(8) for CAH swing-bed providers.
Ambulatory Surgical Centers (ASCs)
CMS removed the requirement at 42 C.F.R. § 416.41(b)(3) that ASCs must have a written transfer agreement with a hospital that meets certain Medicare requirements or that all physicians performing surgery in the ASC have admitting privileges in a hospital that meets certain Medicare requirements. Instead, ASCs will now be required to periodically provide the local hospital with written notice that outlines the ASC operation and patient population served by the ASC facility. However, ASCs must continue to have a procedure to immediately transfers to a hospital when patient care requirements are beyond the capabilities of the ASC. The Final Rule also revised the requirement at § 416.52(a) that a physician or other 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. Now, CMS will defer to the ASC’s policy and the operating physician’s clinical judgment to ensure that patients receive the appropriate pre-surgical assessments tailored to the patient and the type of surgery being performed.
Transplant Centers
The Final Rule removes the requirements at 42 C.F.R. § 482.82 for transplant centers to submit clinical experience, outcomes, and other data in order to obtain Medicare re-approval. CMS has indicated that this policy attempts to avoid transplant programs potentially avoiding performing transplant procedures on certain patients and many organs going unused. See 84 Fed. Reg. at 51789. Transplant centers seeking initial Medicare approval will still be required to comply with the data submission, clinical experience, and outcome requirements.
Home Health and Hospice
Under the Final Rule, Home Health Agencies are no longer required under 42 C.F.R. § 484.80 to conduct a full competency evaluation of a home health aide when deficiencies are identified in the aide’s services. Instead, CMS now requires retraining of the aide in the identified deficient skills and requires the aide to complete a competency evaluation related only to those skills. Hospices will be allowed, under the Final Rule revising § 418.76(a)(1)(iv), to defer to State licensure requirements for qualification of their hospice aides, regardless of the State licensure content or format, thus allowing states to set forth training and competency requirements that meet the needs of their populations. Hospices also will no longer be required under § 418.106(a)(1) to consult with an individual with expertise in drug management in addition to the hospice’s own expert clinicians.
Comprehensive Outpatient Rehabilitation Facilities and Community Mental Health Centers
The Final Rule revises 42 C.F.R. § 485.66 to reduce the frequency of the implementation of a utilization review plan from four times per year to annually, which will allow an entire year to collect and analyze data to inform changes to the facility and the services provided. For Community Mental Health Centers, the Final Rule removes the requirement at 42 C.F.R. § 485.914 that requires updates to the client comprehensive assessment every 30 days and instead retains the minimum 30-day assessment update only for those clients who receive partial hospitalization program services.
The Final Rule is available here. The CMS fact sheet is available here.
