On September 17, 2018, the Centers for Medicare and Medicaid Services (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 input from previous Requests for Information (RFI) was used to inform the proposals in the rule. These efforts also tie into the agency-wide initiatives Patients Over Paperwork and Meaningful Measures.

Broadly, the rule proposes policies that the agency 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:

1. Proposals that simplify and streamline processes
2. Proposals that reduce the frequency of activities and revise timelines
3. Proposals that are obsolete, duplicative, or that contain unnecessary requirements

The agency estimates that these updates will save healthcare providers $1.12 billion annually. Further, the agency estimates that these policies along with those finalized in rules from 2017 and 2018 will generate savings estimated at $5.2 billion from 2018 to 2021.

The proposed rule is scheduled for release in the Federal Register on September 20, 2018. Comments on the proposed rule will be due on November 19, 2018.

Proposals that Simplify and Streamline Processes

The below provisions fall under the first category, “Proposals that Simplify and Streamline Processes.”

Ambulatory Surgical Centers (ASC)

• CMS is proposing to remove the requirement for a written hospital transfer agreement or hospital physician admitting privileges. Other requirements currently in place would continue to require that ASCs have an effective procedure for immediate transfer to a hospital. ASCs would not be precluded from obtaining hospital transfer agreements or physician admitting privileges.
• ASC requirements would now defer to a facility’s established policies for pre-surgical medical histories and physician examinations and the operating physician’s judgement. ASCs would have to establish and implement a policy that identifies patients who require a history and physical examination prior to surgery. Clinicians would still have to perform a pre-surgical assessment for each ASC patient; the current 30-day rule would just be replaced with the above proposal.

Hospitals

• CMS is proposing to allow a system governing body for a hospital system consisting of multiple separately certified hospitals to elect to have a unified and integrated Quality Assessment and Performance Improvement (QAPI) program for all of its member hospitals. This decision would need to be in line with applicable state and local laws.
• Hospitals would be given flexibility to establish a medical staff policy describing circumstances where a pre-surgery/pre-procedure assessment for an outpatient would be used instead of a comprehensive medical history and physical examination. Hospitals would need to document this assessment in a patient’s medical record.
• Similar to the proposal for the QAPI program, a system governing body for a system of multiple separately certified hospitals could elect to have a unified and integrated infection control program. Hospitals would have to demonstrate certain elements of such a program.

Home Health Agencies

• For Home Health Agencies (HHA), CMS is proposing to remove the requirements for verbal (spoken) notification of patient rights to the patients’ rights elements for which the Social Security Act requires verbal notifications. This would apply to verbal notice for rights related to payments made by Medicare, Medicaid, and other federal funded programs, and potential patient financial liabilities.

Hospices

• The requirement to have on hospice staff an individual with specialty knowledge of hospice medications is proposed for removal.
• The requirement to provide a copy of medication policies and procedures to patients, families, and caregivers would be replaced with a requirement to provide information regarding the use, storage, and disposal of controlled drugs to the patient and patient representative and family.
• The agency is proposing to move the requirement for facility staff orientation from a standalone requirement to the section of the rule related to the written agreement between hospices and skilled nursing facilities (SNFs) and intermediate care facilities for individuals with intellectual disabilities will allow both entities to negotiate the terms for assuring staff orientation. Additionally, the agency believes that this will give hospice more freedom to develop innovative approaches and avoid duplicating orientation with hospices using the same staff.

Other

• 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 would be eliminated. The facilities would still be required to include this process- only documentation would be eliminated.

Additional proposals related to Religious Nonmedical Health Care Institutions (RNHCIs) discharge planning; psychiatric hospitals; data submission and re-approval processes for transplant centers; and portable x-ray orders and technologists were proposed in this category.

Proposals that Reduce the Frequency of Activities and Revise Timelines

The below provisions fall under the second category, “Proposals that Reduce the Frequency of Activities and Revise Timelines.”

Home Health Agencies

• Home Health Agencies (HHAs) would no longer have to provide a copy of the clinical record to a patient upon request by the next home visit. However, the requirement that a copy of the record must be provided within four business days upon request would be retained.

Critical Access Hospitals

• Professional personnel at critical access hospitals (CAH) would be required to, at minimum, conduct a biennial review of policies and procedures. This would be a change from the current annual requirement.

Emergency Preparedness

• CMS is proposing increased flexibility with compliance for the requirement on most Medicare and Medicaid facilities to annually review emergency preparedness programs.
• Facilities would now have to provide training on their emergency program biennially after facilities conduct the initial training. Additional training would be required when a plan is significantly updated.
• The type of acceptable testing exercises that may be conducted for one of two annually required testing exercises for inpatient providers would be expanded. CMS is also proposing to revise the requirement for outpatient providers such that only one testing exercise is required annually. This may be either one community-based full-scale exercise or an individual facility-based functional exercise every other year and in opposite years.

Additional proposals related to comprehensive outpatient rehabilitation facility (CORF) utilization review plans; community mental health center (CMHC) requirements; and rural health clinics (RHC) and federal qualified health centers (FQHC) were proposed in this category.

Proposals that are Obsolete, Duplicative, or that Contain Unnecessary Requirements

The below provisions fall under the third and final category, “Proposals That Are Obsolete, Duplicative, or That Contain Unnecessary Requirements.”

Hospitals

• CMS is proposing 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 is proposing to deter to state law regarding medical-legal requirements.
• For hospital swing-bed providers, the following cross-references are proposed for removal
  • Gives a resident the right to choose to, or refuse to, perform services for the facility is proposed for removal.
  • Requires a facility provide an ongoing activity program based on the resident’s comprehensive assessment and care plan

Home Health Agencies

• CMS is proposing that home health aides would only be required to complete retraining and a competency evaluation directly related to skills found to be deficient instead of the current require to complete a full competency evaluation when an aide is found to be deficient in a skill.

Hospices

• The requirement that a state licensure program meeting specific training and competency requires in order for the license to qualify a hospice aide to work at a Medicare-participating hospice would be removed. CMS would instead defer to state licensure requirements.

Additional proposals related to CAH swing-bed providers and CAH disclosure requirements were proposed in this category.