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Omnibus Burden Reduction (Medicare Conditions of Participation) Final Rule CMS-3346-F Part 1

By October 31, 2019C&A Blog

The Omnibus Burden Reduction for Medicare Conditions of Participation, Final Rule, was issued September 26, 2019 by the Centers for Medicare & Medicaid Services (CMS) and removes Medicare regulations identified as unnecessary, outdated, or difficult to sustain on hospitals and other healthcare providers.

The new ruling contributes to CMS’s Patients over Paperwork initiative by saving providers an estimated 4.4 million hours of time previously spent on paperwork with an overall total projected savings to providers of $800 million annually.

CMS is finalizing three distinct rules in to one final rule for administrative efficiency and to promote transparency.  A summary of the reduction measures is provided for emergency preparedness, hospitals including swing bed & critical access along with ambulatory surgery centers.

Emergency Preparedness:

  • “Emergency program: Decreased the requirements for facilities to conduct an annual review of their emergency program to a biennial   Long term care (LTC) facilities will continue to review their emergency program annually.
  • Emergency plan:Eliminating the requirement requiring the 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.
  • Training:Decreasing the training requirement from annually to every two years. Nursing homes will still be required to provide annual training.
  • Testing (for inpatientproviders/suppliers): Allows flexibility for one of the two annually required testing exercises may be an exercise of the facility’s choice.
  • Testing (for outpatientproviders/suppliers): Decreasing the requirement for facilities to conduct two testing exercises to one testing exercise annually”.


  • “Allowing multi-hospital systems to have unified and integrated Quality Assessment and Performance Improvement (QAPI) programs and unified and integrated infection control and antibiotic stewardship programs for all their member hospitals;
  • Removing the requirement for a hospital’s medical staff to attempt to secure autopsies in all cases of unusual deaths and of medical-legal and educational interest.
  • Allowing hospitals the flexibility to establish a medical staff policy describing the circumstances under which a pre-surgery or pre-procedure assessment for an outpatient could be utilized, instead of a comprehensive medical history and physical examination; and
  • For psychiatric hospitals only: Allow the use of non-physician practitioners and Doctor of Medicine or Doctors of Osteopathy (MD/DOs) to document progress notes of patients receiving services in psychiatric hospitals.

Hospital swing-bed providers and Critical Access Hospitals:

Swing-bed providers:

  • Removing the requirement for a facility to request or allow swing-bed patients to perform services for the facility;
  • Removing the requirement for the facility 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;
  • Removing the requirement for facilities with more than 120 beds to employ a qualified social worker on a full-time basis because of the hospital swing-bed and CAH bed limit requirements; and
  • Removing the requirement for facilities to assist residents in obtaining routine and 24-hour emergency dental care.

Critical Access Hospitals only:

  • Reducing the frequency for CAHs to perform a review of all their policies and procedures; and
  • Removing the duplicative requirement for CAHs to disclose the names of people with a financial interest in the CAH.

Ambulatory Surgical Centers

  • Removing the provisions requiring ASCs to have a written transfer agreement with a hospital that meets certain Medicare requirements or ensuring that all physicians performing surgery in the ASC have admitting privileges in a hospital that meets certain Medicare requirements.
    • Instead, ASCs will be required to periodically provide the local hospital with written notice that outlines the ASC operation and patient population served by the ASC facility All ASCs must continue to have an effective procedure for immediate transfers to a hospital for patients requiring emergency medical care beyond the capabilities of the ASC; and
  • 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.
    • CMS is finalizing the requirement that each ASC establish and implement a policy that identifies patients who require an H&P prior to surgery”.

Changes to Promote Innovation

Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care, published June 16, 2016. The benefits of these finalized requirements will include:

  • “Changing the term “Licensed Independent Practitioner” in the hospital Patient’s Rights CoP to “Licensed Practitioner.”
  • Updating the hospital CoPs to specify that hospital QAPI programs must incorporate existing quality indicator data, including patient care data submitted to, or received from, quality reporting and quality performance programs to increase flexibility.
  • Clarifying requirements for nursing services that have been ambiguous or confusing due to unnecessary distinctions between hospital inpatient and outpatient services. This change will add flexibility to account for the variety of ways through which a hospital might meet its nurse staffing requirements;
  • Updating hospital requirements for infection prevention and control programs, which do not fully conform to current standards of practice for the surveillance, prevention, and control of HAIs and other infectious diseases.
    • Requiring that hospital programs demonstrate adherence to nationally recognized infection prevention and control guidelines for reducing the transmission of infections within their hospitals.
  • Requiring hospitals to establish and maintain antibiotic stewardship programs to help reduce inappropriate antibiotic use and antimicrobial resistance.
    • By requiring that hospitals have antibiotic stewardship programs that are not only active and hospital-wide, but also demonstrate adherence to nationally recognized guidelines for the optimization of antibiotic use through stewardship.
    • These changes are aimed at effectively reducing the development and transmission of HAIs and antibiotic-resistant organisms that ultimately will greatly improve the care and safety of patients while adding cost benefits for hospitals;
  • Adding flexibility to the hospital CoPs by specifying that a unified and integrated infection prevention and control program may also include a unified and integrated antibiotic stewardship program for a multi-hospital system;
  • Allowing registered dietitians in CAHs to order therapeutic diets for patients in accordance with State scope-of-practice laws to allow for flexibility and to produce savings in this area;
  • Requiring CAHs to have infection prevention and control and antibiotic stewardship programs like those being finalized for hospitals;
  • Requiring CAHs to develop, implement, and maintain proactive QAPI programs.
    • This requirement replaces the current reactive annual evaluation requirement and provides greater flexibility for improving health care”.


Look for our December newsletter for further updates on additional “Omnibus Burden Reduction” for transplant centers, home health, hospice, portable x-rays and more.

The complete final rule [CMS-3346-F] can be viewed at: https://www.federalregister.gov/documents/2019/09/30/2019-20736/medicare-and-medicaid-programs-regulatory-provisions-to-promote-program-efficiency-transparency-and



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

January 30, 2017 Executive Order “Reducing Regulation and Controlling Regulatory Costs” (Executive Order 13771)

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.


Sherri Aleksejczyk

Author Sherri Aleksejczyk

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