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CMS Passes Final Rule Reducing Regulations Burdensome on Health Care Providers

The Centers for Medicare and Medicaid Services (CMS) is moving forward with its Patients over Paperwork initiative, which was created in accordance with President Trump’s Executive Order directing federal agencies to reduce burdensome regulations in order to improve the patient and provider experience, and the health care system as a whole. On September 26, 2019, CMS passed the Omnibus Burden Reduction (Conditions of Participation) Final Rule (Final Rule), with the goal of removing CMS regulations that have become extraneous or burdensome on health care providers, allowing providers to increase and improve focus on patients. CMS estimates savings resulting from the Final Rule to be 4.4 million hours of time, and $800 million annually. The Final Rule was published on September 30, 2019, and goes into effect sixty days thereafter. Hospitals and Critical Access Hospitals (CAHs), however, have six months to implement antibiotic stewardship programs and CAHs have eighteen months to implement Quality Assessment and Performance Improvement (QAPI) programs.

The three following rules, which were proposed and published separately, are finalized and consolidated in the Final Rule:

  1. Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction (“Omnibus Burden reduction”), published September 20, 2018;

  2. Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care, published June 16, 2016.

  3. Fire Safety Requirements for Certain Dialysis Facilities, published November 4, 2016.

 The Final Rule includes the following provisions for participating providers, among others:

  1. Hospitals

    1. Health systems with multiple hospitals may have unified and integrated QAPI programs, and united and integrated infection control and antibiotic stewardship programs, for all of their hospitals.

    2. Hospital medical staffs are no longer required to attempt to secure autopsies in all cases of unusual deaths and deaths of medical-legal and educational interest.

    3. Hospitals may, if they choose, establish a medical staff policy describing circumstances under which a pre-surgery/pre-procedure assessment for an outpatient may be utilized, rather than a comprehensive medical history and physical exam.

    4. Psychiatric hospitals may use non-physician practitioners and doctors of medicine/doctors of osteopathy to document patient progress notes.

  2. Home Health Agencies (HHA)

    1. HHAs are no longer required to conduct a full competency evaluation of a home health aide when aide deficiencies are identified, and instead are required to retrain the aide specific to the deficiency, and require the aide to complete a competency evaluation related to the deficiency.

    2. Although HHAs are still required to provide written notice of all patient rights to patients, verbal notification is now limited to patient rights related to payments made by Medicare, Medicaid and other federally funded programs, and to potential patient financial liabilities.

  3. Emergency Preparedness

    1. Facilities may now conduct biennial, rather than annual, reviews of their emergency program. This does not apply to long term care facilities, which must continue to conduct annual reviews. In addition, the requirement to train for emergency preparedness is reduced to every two years, rather than every year. This does not apply to nursing homes, which must continue to provide annual training.

    2. Emergency plans are no longer required to include documentation of efforts to contact local, tribal, regional, state and federal emergency preparedness officials and a facility’s participation in collaborative and cooperative planning efforts.

    3. Inpatient providers/suppliers may choose the type of emergency preparedness test they conduct – either a community-based full-scale test, or a facility-based test. These facilities must administer two emergency preparedness tests per year.

    4. Outpatient providers/suppliers may test for emergency preparedness once, rather than twice, a year.

  4. Ambulatory Surgery Centers (ASCs)

    1. The requirement that ASCs must have a written transfer agreement 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, is removed. As a replacement, ASCs are required to periodically provide their local hospital with written notice outlining the ASC operation and patient population, and must continue to have a procedure for immediate transfers to a hospital for emergency patients.

    2. The requirement that a physician or other qualified practitioner conduct a complete comprehensive medical history and physical assessment on each patient within thirty days of a scheduled surgery is removed. ASCs are instead required to establish and implement a policy to identify patients who do require such assessments prior to surgery.

  5. Hospital swing-bed providers, CAHs, Rural Health Centers (RHCs) and Federally Qualified Health Centers (FQHCs)

    1. Hospital and CAH swing-bed providers

      1. Facilities are no longer required to request or allow swing-bed patients to perform services for the facility.

      2. Facilities are no longer required to provide an ongoing activities program, employ a full-time social worker for facilities with 120+ beds, and provide 24-hour emergency dental care.

    2. CAHs

      1.  The frequency CAHs are required to review policies and procedures is reduced to every other year.

      2. CAHs are no longer required to disclose the names of people with a financial interest in the CAH.

    3. RHCs and FQHCs. The frequency of review of patient care policies and facility evaluation is reduced from annually to every two years.

  6. Transplant Centers

    1. Regulations terminology is updated to conform with and be understandable to the transplant community.

    2. The requirement that transplant centers must provide certain data in order to obtain Medicare re-approval is removed, addressing, as CMS states, the unintended consequences of the requirement that have resulted in providers potentially avoiding performing transplants on certain patients, as well as organs going unused.

  7. Community Mental Health Centers. The requirement that CMHCs update the client comprehensive assessment every thirty days is removed. CMHCs are instead required to retain the minimum thirty day assessment update for clients who receive partial hospitalization program services.

  8. Hospices

    1. Hospices are allowed to defer to state licensure requirements for qualification of hospice aides.

    2. The requirement that hospices must consult with an individual with drug management expertise in addition to the hospice’s own clinicians is removed.

    3. In order to encourage collaboration, hospices that provide hospice care to residents of Skilled Nursing Facilities or Intermediate Care Facilities for Individuals with Intellectual Disabilities are required to work with such facility partners to educate staff about the hospice philosophy of care and certain hospice practices.

  9. Comprehensive Outpatient Rehabilitation Facilities. Utilization review plans must be implemented annually, rather than quarterly.

  10. Portable X-Ray Services

    1. The four education and training requirements are removed and replaced with qualifications that focus on the skills and abilities of the technologist, rather than accreditation of the technologist’s school.

    2. Portable x-ray services may be ordered in writing, phone, or electronically, rather than ordered only in writing and when signed.

  11. Religious Nonmedical Health Care Institutions (RNHCIs). RNHCIs are no longer required to provide discharge instructions for a medical facility, and instead must provide discharge instructions to the patient and/or the patient’s caregiver upon discharge home.

This post was authored by Karen Rabinovici.

Copyright © 2019 Robinson & Cole LLP. All rights reserved.

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