On September 20, 2018, CMS published a proposed rule that the agency states is aimed at reducing the regulatory burden for providers by revising certain aspects of the Medicare Conditions of Participation and Conditions of Coverage (Conditions of Participation) for a wide variety of providers, including hospitals, ambulatory surgery centers (ASCs), and hospices. Comments are due by November 19, 2018.

The proposed changes include:

• Hospitals
  • Revising 42 C.F.R. § 482.21 to allow multi-hospital systems to have unified and integrated Quality Assessment and Performance Improvement and unified infection control programs for all member hospitals.
  • Removing the requirement in 42 C.F.R. § 482.22(d), which states that a hospital’s medical staff should attempt to secure autopsies in all cases of unusual death and medical-legal and educational interest. In lieu of this requirement, CMS proposes deferring to state law regarding such medical-legal requirements. 
  • Allowing hospitals flexibility in establishing a medical staff policy describing the circumstances under which a pre-surgery/pre-procedure assessment for an outpatient could be used instead of a comprehensive medical history and physical (H&P) examination.
• ASCs
  • Removing the requirement in 42 C.F.R. § 416.41(b)(3) that ASCs either have a written transfer agreement with a hospital that meets certain Medicare requirements or that all physicians performing surgery in the ASC have admitting privileges at a hospital that meets certain regulatory requirements.  ASCs had expressed concern that a growing number of hospitals are declining to work with ASCs due to competition between the hospital outpatient surgery departments and ASCs, which created difficulty in meeting this regulatory requirement.  CMS determined this requirement was duplicative and now rendered obsolete by other patient protections and thus is proposing to remove it.
  • Removing the current requirements at 42 C.F.R. § 416.52(a) that require an ASC to ensure that there is a H&P examination completed not more than 30 days before the date of the scheduled surgery.  Instead, CMS proposes deferring to the facility’s established policies for pre-surgical medical H&P examinations (including any associated testing) and the operating physician’s clinical judgment.
• Hospices
  • Streamlining the hiring process for hospice aides by revising 42 C.F.R. § 418.76(a)(i)(iv) to remove the requirement that state licensure programs meet specific training and competency requirements.
  • Replacing the requirement that hospices provide a copy of medication policies and procedures to patients, families and caregivers with a requirement that hospices provide information regarding the use, storage and disposal of controlled drugs to the patient or patient representative and family.

CMS views these proposed changes as a continuation of its efforts to reduce regulatory burdens in accordance with the January 2017 Executive Order “Reducing Regulation and Controlling Regulatory Costs” (Executive Order 13771).  In developing the proposed changes, CMS reviewed 2,800 public comments submitted in response to a request for information published in 2017.

To view CMS’s fact sheet, click here.  To view the Proposed Rule, click here.