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CMS Issues Proposed Rule to Increase Efficiency, Transparency, and Reduce Regulatory Burden

The Centers for Medicare & Medicaid Services (CMS) recently issued a proposed rule aiming to reduce regulatory burdens in accordance with the January 2017 Executive Order entitled, “Reducing Regulation and Controlling Regulatory Costs.”  The proposal revises the applicable conditions of participation (CoP) for providers and conditions for coverage (CFC).  Specifically, the proposed rule seeks to simplify and streamline processes, reduce the frequency of certain activities through the revision of timeline requirements, and remove requirements that are duplicative or unnecessary.

To simplify and streamline processes, CMS proposes to:

  • Reduce the specificity of discharge requirements for Religious Nonmedical Health Care Institutions (RNHCI) and only require that an RNHCI assess the need for a discharge plan for patients likely to suffer adverse consequences if there is no plan;
  • Remove the “Standard Hospitalization” requirement. Specifically, CMS proposes to remove the requirements that ambulatory surgical centers (ASC) have written transfer agreements with certain hospitals and ensure that physicians performing surgery in the ASC have admitting privileges at a Medicare-participating hospital or local nonparticipating emergency services hospital.  This revision aims to reduce competition barriers between physicians performing surgery in ASCs and hospitals providing outpatient surgical services;
  • Replace current requirements for pre-surgical comprehensive medical history and physical assessments with requirements that give a certain amount of deference to the ASC’s policy and operating physician’s clinical judgment. Such changes would allow assessments to be tailored to the patient and type of surgery being performed.  ASCs would still be required to include pre-existing conditions, appropriate test results, and allergies to drugs or biologics in the medical records, in addition to medical history and physical examination, when performed;
  • Remove the requirement that interdisciplinary groups at hospice care facilities staff an individual with specialty knowledge of hospice medications;
  • Replace the requirement that hospices provide a copy of medication policies and procedures to patients with a requirement that hospices provide information regarding the use, storage, and disposal of controlled drugs to improve the effectiveness of the education;
  • Move the requirements for hospice facility staff orientation from the hospice section of the regulation to the section related to the “Written Agreement” standard. This revision will allow negotiation of orientation terms between the hospices, skilled nursing facilities, and Intermediate Care Facilities for Individuals with Intellectual Disabilities;
  • Implement a new provision allowing hospitals that are part of a system of separately certified hospitals, but governed by a single system governing body, to adopt a unified and integrated Quality Assessment and Performance Improvement program, while still taking into consideration unique needs of the separately certified hospitals and applicable state and local laws;
  • Allow hospitals to establish a medical staff policy describing the circumstances under which staff could utilize a pre-surgery/pre-procedure assessment for an outpatient instead of a comprehensive medical history and physical examination;
  • Implement a new standard that would allow multiple-hospital systems with separately certified hospitals, but using a single system governing body, to adopt a unified and integrated infection control program for all member hospitals, while taking into account the unique needs of the individual hospitals;
  • Clarify the scope of authority for non-physician practitioners or Doctors of Medicine/Doctors of Osteopathic Medicine to document progress notes for patients receiving psychiatric hospital services;
  • Change transplant center regulation terminology to conform with terminology that is widely used and understood within the transplant community;
  • Streamline transplant center requirements by removing the provision that requires transplant centers to submit clinical experience, outcomes, other data, and other special procedures required to obtain Medicare re-approval;
  • Limit Social Security Act verbal notice requirements of patient rights to those rights related to potential patient financial liabilities and payments made by Medicare, Medicaid, and other federally funded programs;
  • Revise portable x-ray technologist qualification requirements to align with current qualification requirements of radiologic technologists in hospitals, which are focused on the qualifications of the individual performing services;
  • Remove the requirement that physician or non-physician practitioner orders for portable x-ray services must be written and signed;
  • Replace, by cross-reference, the content requirements for portable x-ray orders with the requirements for x-ray orders, when the requirements are also applicable to portable x-rays; and
  • Streamline emergency preparedness plans by removing the requirement that facilities document participation in collaborative and cooperative planning efforts and efforts to contact emergency preparedness officials, while still requiring participation in such efforts.

The proposed rule seeks to reduce the frequency of activities and revise the timeline for several requirements as follows:

  • Removing the requirement that Home Health Agencies provide a copy of a patient’s clinical record upon request by the next home visit, and instead requiring the copy to be provided within four business days;
  • Requiring Critical Access Hospitals (CAH) and their professional personnel to conduct a biennial review of policies and procedures, at a minimum, instead of an annual review;
  • Amending the utilization review plan requirements for Comprehensive Outpatient Rehabilitation Facilities to reduce the frequency of utilization reviews from quarterly to annually;
  • Removing the Community Mental Health Center requirement that clients receive an updated assessment every 30 days, instead of requiring patient assessment updates based on client needs and standards of practice, unless the client is receiving partial hospitalization;
  • Requiring Rural Health Center and Federally Qualified Health Centers to conduct biennial review of patient care policies and program evaluations instead of annual reviews; and
  • Revising emergency preparedness requirements for Medicare and Medicaid providers to:
  • Review emergency preparedness program plans, policies, and procedures biennially, or more frequently if necessary, instead of annually;
  • Require biennial emergency plan training and additional training after significant updates to the plan, instead of annual training;
  • Allow for one of the two annually-required testing exercises for inpatient providers and suppliers to be an exercise of the facility’s choice, while still requiring the second annual test to be a full scale community exercise; and
  • Allow for one annual testing exercise instead of two annual exercises for outpatient providers, with additional testing left to the facilities’ discretion.

To remove duplicative or unnecessary requirements, CMS proposes to:

  • Remove the requirement that state licensure programs for hospice aids meet specific training and competency standards for aides to qualify for work at a Medicare-participating hospice, allowing hospices to defer to state training and competency requirements that the states have tailored to their population;
  • Remove the requirement for hospitals to direct medical staff to attempt to secure autopsies in all cases of unusual deaths, medical-legal interest, and educational interest, deferring to states regarding the medical-legal interest requirements;
  • Remove several hospital and CAH swing-bed requirement cross-references, including:
  • The cross reference that gives a resident the right to choose or refuse to perform services for the facility;
  • The cross reference that requires the facility to provide an ongoing activity program based on the resident’s comprehensive assessment and care plan directed by a qualified professional specified in the regulation;
  • The cross reference requiring hospital and CAH swing-bed providers with more than 120 beds to employ a social worker on a full-time basis; and
  • The cross reference requiring hospital and CAH swing-bed provider facilities to assist residents in obtaining routine and 24-hour emergency dental care.
  • Revise the requirement that a home health aide complete a full competency evaluation when found deficient in one or more skills, instead requiring a competency evaluation related only to the deficient skills;
  • Remove the CAH CoP requirement to disclose the names of people with a financial interest in the CAH, as this requirement is already referenced in the provider agreement rules and program integrity requirements.

The CMS proposed rule is available at: