CMS Issues Proposed Rule Regarding Hospital Conditions of Participation

08 November 2011 Publication
Author(s): Alan H. Einhorn Maria E. Gonzalez Knavel Judith A. Waltz Gary D. Koch

Legal News Alert: Health Care

On October 24, 2011, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule entitled “Medicare and Medicaid Programs; Reform of Hospital and Critical Access Hospital Conditions of Participation.” The proposed rule is intended to allow flexibility and reduce procedural burdens on providers with respect to the requirements for participation in the Medicare and Medicaid programs. Some of the most significant proposed changes relate to the requirements for a governing body of a hospital system, medical staff policies, and changes to nursing services and standing orders. Comments are due by December 23, 2011.

The following is a summary of the most significant proposed changes to the Conditions of Participation (CoPs):

Governing body. The current governing body CoP has been interpreted by CMS surveyors in some cases to require that each hospital facility have its own separate governing body. The proposed changes to the CoP would permit multi-hospital systems to have just one governing body overseeing the entire hospital system to enable more efficient and effective oversight. This proposed change should ease the administrative burden on hospital systems with respect to their governance structures.

Medical staff. The medical staff CoP relates to the organization and accountability of the hospital medical staff. The proposed rule includes language intended to clarify provisions, which would modernize hospitals’ medical staffing policies and increase flexibility by allowing a hospital to grant privileges to both physicians and non-physicians, regardless of whether they also are appointed to the hospital’s medical staff. Thus, technical medical staff membership would not be a requirement for a hospital’s governing body to grant practice privileges to practitioners. The medical staff would continue to be limited by state law and, therefore, would not be permitted to grant a practitioner any privileges beyond those allowed in the state where the hospital is located. It is important to note that those practitioners granted practice privileges who are not appointed to the medical staff would be subject to the same hospital requirements, medical staff bylaws, and medical staff oversight required under the CoPs as the individuals on the medical staff.

Nursing services. The proposed changes to the nursing services CoP intend to ease administrative burden by allowing hospitals that use an interdisciplinary care plan to have the nursing services plan integrated into the overall hospital interdisciplinary care plan, rather than requiring a separate stand-alone nursing care plan. In addition, the proposed CoP would allow drugs and biologicals to be prepared and administered on the orders of an expanded set of qualified practitioners and would allow orders for drugs and biologicals to be documented and signed by an expanded set of qualified practitioners. The intent of this change is to allow hospitals to utilize more fully their practitioners and allow for more efficient care practices. Additionally, the proposed changes to the CoP would allow hospitals to use standing orders when certain requirements are met. The proposed rule would allow for the preparation and administration of drugs and biologicals on the orders contained within pre-printed and electronic standing orders, order sets, and protocols for patient orders, if the orders meet the proposed requirements in the medical record services CoP (see below).

Medical record services. The proposed rule would allow a hospital to use standing orders, order sets, and protocols for patient orders if the hospital: 1) establishes that such orders and protocols have been reviewed and approved by the medical staff in consultation with the hospital’s nursing and pharmacy leadership; 2) demonstrates that such orders and protocols are consistent with nationally recognized and evidence-based guidelines; 3) ensures that the periodic and regular review of such orders and protocols is conducted by the medical staff, in consultation with the hospital’s nursing and pharmacy leadership, to determine the continuing usefulness and safety of the orders and protocols; and 4) ensures that such orders and protocols are dated, timed, and authenticated promptly in the patient’s medical record by the ordering practitioner or another practitioner responsible for the care of the patient and authorized to write orders by hospital policy in accordance with state law. CMS makes clear in its discussion of this change that in all cases, protocols and standing orders must be medically necessary and that hospital policies and procedures should address well-defined clinical scenarios as a standard of practice of the use of such orders, as well as the process by which a standing order is developed, approved, monitored, initiated by authorized staff, and authenticated by physicians or practitioners responsible for the care of the patient. CMS also expresses its expectation that specific criteria for authorized personnel to initiate the execution of the standing order be clearly identified in the protocol for the order and that such an order must be added to a patient’s medical record at the time of initiation or as soon as possible thereafter.

The proposed medical record services CoP also would allow hospitals to defer to hospital policy and state law for the establishment of timeframes for the authentication of orders, including verbal orders. CMS notes that it encourages hospitals to keep the use of verbal orders to a minimum and to establish policies to discourage their use.

Patients' rights. The proposed CoP would modify the reporting requirements for hospitals when the circumstances of a patient’s death involve only the use of soft two-point wrist restraints and no use of seclusion. CMS notes that there is not research demonstrating a causal relationship between the use of soft two-point wrist restraints and patient deaths.

Infection control. The preamble to the proposed rule notes that advances in infection control surveillance systems have made the need for a separate infection log obsolete. Therefore, CMS proposes eliminating the requirement and instead allowing hospitals flexibility in their approach to the tracking and surveillance of infections.

Outpatient services. This proposed CoP would allow hospitals increased flexibility in determining the management structure of outpatient services by removing the requirement for a single director of outpatient services. The proposed change would allow hospitals to tailor their outpatient service management to the scope and complexity of the services offered by the hospital.

The additional proposed changes to the CoPs would revise or clarify the rules related to the following: 1) transplant center process requirements — organ recovery and receipt; 2) critical-access hospital definitions and provision of services; 3) pharmaceutical services and infection control; 4) personnel qualifications; and 5) critical-access hospital surgical services.

Although hospitals obviously should not revise their policies until this proposed rule is issued as a final rule — since there may be changes — the proposed revisions may assist in long-range planning for the potential impact to operations. The proposed rule also offers an opportunity for stakeholders to provide comments on specific provisions, which perhaps could further ease the administrative burdens of CoP compliance without compromise of patient care.

Legal News Alert is part of our ongoing commitment to providing up-to-the-minute information about pressing concerns or industry issues affecting our clients and our colleagues. If you have any questions about this update or would like to discuss this topic further, please contact your Foley attorney or any of the following individuals:

Elizabeth S. Elson
Los Angeles, California

Gary D. Koch
Tampa, Florida

Alan H. Einhorn
Boston, Massachusetts

Maria E. Gonzalez Knavel
Milwaukee, Wisconsin

Judith A. Waltz
San Francisco, California

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