This fall CMS released a proposed rule entitled “Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction.” The proposed rule was developed in response to President Trump’s executive order that instructed agencies to look for ways to reduce regulatory burden. The agency also notes that the rule was informed by stakeholder feedback submitted in response to CMS requests for information (RFIs). If finalized, CMS estimates the policy would save $1.12 billion annually.

Broadly, the rule proposes policies that CMS believes will reduce regulatory burden on providers and suppliers through changing, removing, or streamlining current regulations believed to be excessively burdensome. Many of the proposals involve conditions of participation (CoP), conditions for coverage, and other participation requirements.

The rule outlines three categories for these proposals:

Proposals that simplify and streamlines processes (including but not limited to):

  • CMS proposes to remove the requirement for a written hospital transfer agreement or hospital physician admitting privileges.
  • CMS proposes replacing comprehensive medical history and physical assessment regulations with requirements that defer to the hospital outpatient, ASC's policy and physicians' judgment.
  • CMS proposes to allow multi-hospital systems to have a unified and integrated quality assessment and performance improvement program for all of their member hospitals instead of having individual staff for each separately certified hospital. 
  • CMS proposes to remove the home health agency requirements for verbal notification of patient rights to the patients’ rights elements for which the Social Security Act requires verbal notifications.
  • CMS proposes to remove the requirement that facilities document efforts to contact local, tribal, regional, state, and federal emergency preparedness officials and their participation in collaborative and cooperative planning efforts.
  • CMS proposes to remove a duplicative requirement on transplant centers that call upon providers to submit data and other information more than once for re-approval by Medicare.

Proposals that reduce the frequency of activities and revise timelines (including but not limited to):

  • CMS proposes to remove the requirement that home health agencies have to provide a copy of the clinical record to a patient upon request by the next home visit. Instead, agencies would have four business days to provide copies if patients or their families ask for them.
  • CMS proposes to revise requirements for annual reviews of emergency preparedness programs to allow facilities to instead review their plans at least every two years. Additional training would be required when a plan is significantly updated.
  • CMS proposes to revise the requirement that RHC and FQHC patient care policies are reviewed at least annually by a group of professional personnel to review every other year to reduce the frequency of policy reviews.

Proposals that are obsolete, duplicative, or that contain unnecessary requirements (including but not limited to):

  • CMS proposes to remove duplicative ownership disclosure requirements for Critical Access Hospitals.
  • CMS proposes to remove the requirement that hospital medical staff should attempt to secure an autopsy in all cases of unusual deaths and of medical-legal and educational interest. Instead, CMS proposes to defer to state law regarding medical-legal requirements.

CMS is also soliciting public comments on additional regulatory reforms for burden reduction in future rulemaking. Comments on the proposed rule are due on November 19, 2018.

Some more detail around the specific emergency preparedness requirements in the proposal.

Emergency Preparedness Requirements

  • Requirements for Emergency Plans: CMS is proposing to eliminate the requirement that hospitals document efforts to contact local, tribal, regional, State, and Federal emergency preparedness officials and that they document their participation in collaborative and cooperative planning efforts. Hospitals would still be required to include a process for cooperation and collaboration with local, tribal, regional, State and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. Only the documentation requirements would be eliminated.
  • Requirements for Annual Review of Emergency Program: Facilities participating in Medicare and Medicaid are now required to review their emergency preparedness programs annually. This includes a review of their emergency plans, policies and procedures, communication plans, and training and testing programs. CMS is proposing to revise these requirements so that facilities only have to update these programs every two years. Facilities should update their emergency preparedness program more frequently than every two years as needed (for example, if staff changes occur or lessons-learned are acquired from a real-life event or exercise).
  • Requirements for Training: CMS is proposing to revise the requirement that facilities develop and maintain a training program based on the facility’s emergency plan annually. Instead, CMS would require that facilities provide training every two years after facilities conduct initial training for their emergency program. Also, CMS proposes to require additional training when the emergency plan is significantly updated.
  • Requirements for Testing: For providers of inpatient services, CMS proposes to expand the testing requirement options such that one of the two annually required testing exercises may be an exercise of their choice (which may include one community-based full-scale exercise, an individual facility-based functional exercise, a drill, or a tabletop exercise or workshop that includes a group discussion led by a facilitator.) For outpatient providers, CMS believes that conducting two testing exercises per year is overly burdensome as these providers do not provide the same level of acuity or inpatient services for their patients. Therefore, CMS proposes to require that providers of outpatient services conduct only one testing exercise per year. Furthermore, these providers would only have to participate in either a community-based full-scale exercise or conduct an individual facility-based functional exercise every other year. In the opposite years, these providers would be allowed to conduct the testing exercise of their choice.

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