The Centers for Medicare & Medicaid Services (CMS) has issued an “omnibus burden reduction” rule that finalizes a September 20, 2018 proposed rule intended to streamline various Medicare and Medicaid regulatory requirements, in alignment with the Administration’s “Patients over Paperwork” initiative.  The omnibus regulation also finalizes a November 4, 2016 proposed rule on fire safety requirements for certain dialysis facilities, along with June 16, 2016 proposed rule updating conditions of participation (CoPs) for hospitals and critical access hospitals (CAHs) to promote innovation, flexibility, and improvement in patient care.  CMS estimates that the rule will save providers more than $800 million annually, although certain provisions (including the hospital CAH quality of care provisions) are expected to increase provider costs.

Major provisions of the final rule include the following:

  • Emergency Preparedness Requirements. The final rule allows facilities (other than long-term care (LTC) facilities) to review and provide training on their emergency programs every two years, rather than annually.  The rule also reduces testing frequency for outpatient providers; provides more flexibility regarding testing methods; and eliminates certain documentation requirements.
  • Hospitals. The rule updates requirements for hospital Quality Assessment and Performance Improvement (QAPI) programs and infection control programs, and allows multi-hospital systems to have unified and integrated QAPI and infection control programs for all member hospitals if the arrangement meets all applicable state and local laws.  In addition, the rule requires hospitals to establish and maintain antibiotic stewardship programs.  The final rule allows hospitals to establish a medical staff policy describing the circumstances under which a pre-surgery/pre-procedure assessment for an outpatient could be utilized instead of a comprehensive medical history and physical examination.  In addition, the rule streamlines certain swing-bed provider requirements and allows discretion regarding when an autopsy is indicated in certain instances.
  • CAH, RHC, and FQHCs. The final rule requires CAHs to implement QAPI, infection prevention and control, and antibiotic stewardship programs.  In addition, the rule reduces the frequency with which CAHs, Rural Health Centers (RHCs) and Federally Qualified Health Centers (FQHCs) must perform reviews of certain policies and procedures.  The rule also removes the CoP requirement for CAHs to disclose the names of people with a financial interest in the CAH, in light of duplicative program integrity requirements.
  • Ambulatory Surgical Centers (ASCs). The final rule replaces the current requirement that ASCs have written transfer agreements or privileges with the local hospital with a requirement that ASCs periodically provide the local hospital with written notice of its operation and patient population served.  The rule also removes the requirement that a physician or other qualified practitioner conduct a complete comprehensive medical history and physical (H&P) assessment on each patient within 30 days of the scheduled  Instead, each ASC must develop and maintain a policy that identifies patients who require an H&P assessment prior to surgery, the timeframe for H&P assessment completion, and certain patient and surgery characteristics, based on nationally recognized standards of practice and guidelines and applicable state and local laws.  Upon admission, each patient must have a presurgical assessment completed by a physician or other qualified practitioner who will be performing the surgery.
  • Hospices. The rule removes federal qualification standards for hospice aides and defers to state licensure requirements; removes the requirement that the hospice staff include an individual with education and training in drug management; and addresses requirements for consultation between hospice and LTC facility staff.
  • Other Provisions. The final rule address numerous other policies, including:  home health agency verbal notification of patient rights and home health aide requirements; frequency of comprehensive outpatient rehabilitation facility utilization reviews; requirements for portable x-ray orders and conditions for coverage for portable x-ray technologists; organ transplant program re-approval requirements;  community mental health center client assessment requirements; and discharge planning in religious nonmedical health care institutions.

The final rule is scheduled to be published on September 30, 2019.  The rule is effective 60 days after publication, although hospitals and CAHs have 6 months to implement the antibiotic stewardship programs and CAHs have 18 months to implement required QAPI programs.