To implement Executive Order 13563, the Centers for Medicare and Medicaid Services (CMS) published on October 18, 2011, two proposed rules affecting hospital and critical access hospital (CAH) conditions of participation and regulatory requirements for non-hospital providers, respectively, and a final rule impacting ambulatory surgical centers’ (ASCs) health and safety standards.  Section 6 of Executive Order 13563, entitled “Improving Regulations and Regulatory Review,” obligates federal agencies to identify regulations that are “outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned.”  On May 18, 2011, in response to Executive Order 13563, the Secretary of the U.S. Department of Health and Human Services (HHS) published a Preliminary Plan for Retrospective Review of Existing Rules. In furtherance of this Plan, the proposed hospital and CAH rule (CMS-3244-P) would, among other things, amend hospital and CAH conditions of participation (42 C.F.R. Part 482 and Part 485, respectively) as follows:

  1. Governing Body Requirements (§482.12).  The proposed change would allow integrated multi-hospital systems to have a single governing body.
  2. Patient Rights (§482.13).  The proposed rule would modify the reporting requirements for patient deaths involving only the use of soft two-point wrist restraints and no use of seclusion.
  3. Medical Staff (§482.22).  Under the proposed rule, hospitals would, among other things, be permitted to grant privileges to both physicians and non-physicians to practice within their scope of practice, regardless of whether they are also appointed to the hospital’s medical staff. 
  4. Nursing Services (§482.23).  For hospitals using interdisciplinary plans of care in providing patient care, the proposed rule would permit the care plan for nursing services to be developed and maintained as part of the hospital’s overall interdisciplinary care plan.
  5. Medical Record Services (§482.24).  The proposed rule would retain the documentation requirement that all orders, including verbal orders must be dated, timed, and authenticated promptly by the ordering practitioner, but would indefinitely add the exception (i.e., remove the 5-year sunset) allowing authentication by the ordering practitioner or “another practitioner who is responsible for the care of the patient under §482.12(c) and authorized to write orders by hospital policy in accordance with State law.” 
  6. Infection Control (§482.42).  CMS would give hospitals flexibility to track surveillance of infections, instead of requiring the prescriptive use of infection control logs. 
  7. Outpatient Services (§482.54).  The proposed rule would give greater flexibility to hospitals in determining the management structure of outpatient services by, among other things, permitting hospitals to assign more than one individual to be responsible for outpatient services.
  8. Transplant Center Requirements-—Organ Recovery and Receipt (§482.92).  CMS would remove certain blood type verification requirements for transplant centers in order to eliminate the need for duplicative, overlapping processes.

According to CMS, the above modifications and certain other clarifying changes could save hospitals over $900 million per year.

CMS’s proposed rule affecting non-hospital provider regulations (CMS-9070-P) is aimed at (i) removing unnecessarily burdensome requirements, (ii) removing obsolete regulations, and (iii) responding to stakeholder concerns.  Examples of the proposed changes include updating unnecessary e-prescribing technical requirements and limiting the situations in which a provider or supplier’s billing privileges can be revoked.  These changes, according to CMS, may save suppliers and providers up to $200 million in the first year.  Finally, CMS’s final rule affecting ASC health and safety standards (CMS-3217-F) modified ASC regulations to, among other things, change the timing of the notice of patient rights from “in advance of the date of the procedure” to “prior to the start of the surgical procedure.”

The proposed rules and final rule are scheduled to be published in the Federal Register on October 24, 2011.  Comments on the two proposed rules are due by December 23, 2011.  HHS’s Preliminary Plan for Retrospective Review of Existing Rules is available by clicking here.  CMS’s proposed hospital and CAH conditions of participation rule is available by clicking here.  The proposed rule affecting non-hospital providers and suppliers is available by clicking here.  CMS’s final ASC rule is available by clicking here