CMS Proposes Changes to Conditions of Participation for Hospitals to Ease Procedural Burdens

CMS Proposes Changes to Conditions of Participation for Hospitals to Ease Procedural Burdens

The Centers for Medicare and Medicaid (CMS) has proposed changes to the requirements hospitals and critical access hospitals must meet in order to participate in the Medicare and Medicaid programs. Citing an Executive Order released in January 2011, CMS states that it is seeking to change certain hospital conditions of participation (CoPs) in an effort to remove "obsolete, unnecessary or burdensome provisions."

The proposed changes include revisions to seven of the current CoPs applicable to all participating hospitals, one revision specifically for transplant centers and one applicable only to critical access hospitals, which will allow these facilities to provide certain services through contracted providers instead of directly, as is currently required. The proposed changes to the seven CoPs affecting all participating hospitals are as follows:
 
Governing Body (42 CFR § 482.12)
The current regulation states that a hospital must have an effective governing body that is legally responsible for the conduct of the hospital as an institution. CMS has interpreted this to mean that each hospital facility must have a separate governing body. To accommodate multi-hospital health systems, CMS proposes to revise this provision to allow hospitals in a multi-hospital system (defined as a system having more than one CMS certification number) to be governed by a single governing body.
 
Medical Staff (42 CFR § 482.22)
To allow hospitals more flexibility in the organization of their professional staffs, CMS has proposed several changes to the Medical Staff CoP. The first proposal is to permit hospitals to grant privileges to both physicians and non-physicians to practice at the hospital within the scope of their licenses without requiring that such practitioners be members of the hospital's medical staff. Hospitals desiring to grant privileges to non-medical staff members would still be required to follow their policies for the granting of privileges, including having the medical staff examine the credentials of each candidate and make recommendations for the granting of privileges to the governing body. CMS specifically clarifies in the proposed regulations that this applies to both physicians and non-physician practitioners and that such individuals are required to be subject to the same hospital requirements and medical staff oversight to which appointed medical staff members are subject.
 
CMS also proposes to expand the type of practitioners to whom a hospital may assign responsibility for the organization and accountability of the medical staff to include doctors of podiatric medicine. Thus, for example, in Indiana, podiatrists join doctors of medicine and osteopathy as candidates for a hospital's medical staff presidency, or equivalent position.
 
Patient Rights (42 CFR § 482.13)
Currently, hospitals are required under the CoPs to report to CMS by telephone by the end of the next business day following knowledge of a patient's death if the patient was in restraints or seclusion at the time of death, the death occurred within 24 hours of the patient being removed from restraints or seclusion, or the death occurred within one week after restraint or seclusion and it is reasonable to assume that the restraints or seclusion contributed directly or indirectly to the patient's death. CMS has proposed to modify these reporting requirements for patient deaths that involve only the use of soft two-point wrist restraints (often used, for example, to prevent ICU patients from pulling out endotracheal and other tubes) and no use of seclusion to be reported through a log or other system within seven days of the patient's death. Deaths involving the use of other types of restraints and all forms of seclusion will still need to be reported within the time frame set forth above, but CMS is considering alternative forms of reporting for these events, such as the use of facsimile and/or electronic means.
 
Infection Control (42 CFR § 482.42)
Under the current CoP for infection control, hospitals are required, among other things, to maintain a separate log identifying infection control issues and improvements. CMS has proposed to eliminate the need for a separate log, allowing hospitals flexibility in their approach to tracking and surveillance of infections. All other requirements in the infection control CoP would remain in place.
 
Nursing Services (42 CFR § 482.23)
Several changes have been proposed in the CoP pertaining to nursing services. These are:
 
  • eliminate the need for separate nursing care plans if the nursing plan of care for a patient is developed and kept current as part of an interdisciplinary care plan;
  • allow for drugs and biologicals to be prepared and administered on the order of, and for such orders to be documented and signed off by, practitioners other than the practitioners currently permitted to do so under the regulations (doctors of medicine and osteopathy, podiatrists, doctors of dentistry and optometry, chiropractors, and clinical psychologists), as long as the additional practitioners are acting within the scope of their state's practice laws and have been granted hospital privileges to order drugs and biologicals;
  • permit the use of standing orders, order sets and protocols for the administration of medications (see further discussion under "Medical Records" below);
  • eliminate the requirement for non-physicians to have special training in administering blood and intravenous medications; and
  • allow hospitals to develop policies permitting patients and/or their caregivers to self-administer certain types of medications at the bedside.  
Medical Records (42 CFR § 482.24)
The medical record CoP currently allows for the authentication of orders, including verbal orders, by either the ordering practitioner or another practitioner (as defined in Nursing Services above) responsible for the care of the patient. The reference to allowing "another practitioner" to authenticate orders was scheduled to be removed as of Jan. 26, 2012, but due to delays in the universal implementation of electronic medical records, CMS has proposed to leave in this exception to the general rule. CMS also proposes to remove the requirement that orders be authenticated within 48 hours, instead permitting hospitals to either follow state law on the subject or, if state law is silent, to establish a timeframe via hospital policy.
 
In addition to the proposed changes in the nursing services CoP pertaining to the use of standing orders, CMS also proposes revisions to the medical record CoP for the same purpose. Under these proposed regulatory changes, hospitals would be allowed to use standing orders, order sets and protocols for patient orders as long as the hospital meets certain requirements in the development, use and review of such orders, such as ensuring that the medical staff reviews and approves order sets and protocols and that they are consistent with nationally recognized and evidence-based guidelines. CMS offers additional guidance regarding its expectations for hospitals as they develop the policies and protocols for the development, use and monitoring of standing orders, protocols and order sets.
 
Outpatient Services (42 CFR § 482.54)
CMS has proposed to offer hospitals more flexibility in the managerial oversight of their outpatient services departments. At present, a hospital is required to assign one individual to assume responsibility for the leadership of its outpatient department. The proposed revision would allow hospitals to assign such responsibility to one or more persons, so if, for example, a hospital's outpatient department provides a broad range of services, individuals with expertise in various service areas can share the leadership responsibilities.
 
In addition to the proposed regulatory changes, CMS has also outlined some of the options it considered in developing the proposed revisions, and is seeking comments on the following specific issues:
 
  • Medical Staff CoP: CMS considered allowing multi-hospital health systems to have a single medical staff for all hospitals in the system. Considering that CMS has historically stated that hospitals within a multi-hospital system having different provider numbers must have separate medical staffs (systems having just one provider number have been allowed to have a unified medical staff), and its definition of a multi-hospital system in the provisions concerning the governing body CoPs, (i.e. a system having more than one provider number), CMS's call for feedback on this issue seems particularly appropriate in order to clarify its position on this issue.
  • Medical Record Services CoP: The medical record CoP requires a history and physical (H&P) to be performed on each patient prior to the patient's hospital visit. The H&P may be completed up to 30 days prior to the admission or registration, in which case the hospital is required to ensure documentation of an updated examination to include any changes in the patient's condition. In order to clarify its intent, CMS has considered revising the regulations to state that the update note to the H&P must document an examination for any changes in the patient's condition since the time the H&P was performed that may be significant for the planned course of treatment. If, after examination, it is clear that no changes have occurred since the H&P was performed, it would be adequate for the practitioner to note "no change."
  • Physical Environment CoP: Finally, CMS is considering adopting either the 2012 or other version of the Life Safety Code as the standard bearer for determining hospitals' compliance with the physical environment CoP.
The full text of the proposed regulations and CMS's commentary may be found at CMS’s website. Please contact Margaret Emmert at margaret.emmert@icemiller.com or (317) 236-2169 or Sherry Fabina-Abney at sherry.fabina-abney@icemiller.com or (317) 236-2446 or any member of Ice Miller’s Health Care Practice for further information or if you have any questions regarding these proposed regulations.
 
 

This publication is intended for general information purposes only and does not and is not intended to constitute legal advice. The reader must consult with legal counsel to determine how laws or decisions discussed herein apply to the reader's specific circumstances.