ARTICLE
13 December 2006

CMS Issues Final Regulations Revising Hospital Conditions of Participation

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On Monday, November 27, 2006, the Centers for Medicare and Medicaid Services ("CMS") issued final regulations amending five Conditions of Participation ("CoPs") that apply to hospitals participating in the Medicare program.
United States Food, Drugs, Healthcare, Life Sciences

On Monday, November 27, 2006, the Centers for Medicare and Medicaid Services ("CMS") issued final regulations amending five Conditions of Participation ("CoPs") that apply to hospitals participating in the Medicare program. The revisions are effective January 26, 2007. The affected CoPs are Medical Staff; Nursing Services; Medical Record Services; Pharmaceutical Services; and Anesthesia Services. Below, we summarize the changes.

Medical Staff: The currently effective CoP requires that history and physicals ("H&Ps") performed prior to hospitalization must be performed no more than seven days prior to admission. The current CoP also limits who can perform H&Ps to physicians or, for patients admitted only for oromaxillofacial surgery, to maxillofacial surgeons granted privileges to perform H&Ps in accordance with state law.

The revised CoP expands the time requirements and revises the authorization provisions: H&Ps must be completed within 30 days before hospitalization, or 24 hours after admission. If the H&P is completed before admission, an updated medical record entry documenting an examination for any changes in the patient's condition must be completed and documented in the medical record within 24 hours after admission. Under the revised CoP, H&Ps must be performed by a physician, oromaxillofacial surgeon, or other qualified individual in accordance with state law and hospital policy.

Nursing Services: The revised CoP clarifies the current requirement that orders for drugs and biologicals must be documented and signed by a practitioner who is responsible for the care of the patient and who is authorized to write orders under hospital policy and in accordance with state law. The revised CoP also reinforces current requirements that verbal orders should be used infrequently and accepted only by persons authorized by hospital policy and procedures that are consistent with both state and federal law.

Medical Record Services: The revised CoP reinforces the current requirement that all medical records be authenticated, and requires all patient medical records to be legible, complete, dated, and timed. The current CoP requires an order to be authenticated by the practitioner who ordered, provided, or evaluated the service; the revised CoP expands this authorization for a five year period following January 26, 2007, during which time authentication may be performed by the ordering practitioner or another practitioner who is responsible for the patient's care and is authorized, by hospital policy in accordance with state law, to write orders. The revised CoP changes the current requirement that orders be authenticated "as soon as possible," and specifies that unless state law designates a specific timeframe for authentication, all verbal orders must be authenticated within 48 hours. Finally, the CoP is revised to be consistent with the new H&P deadlines described above.

Pharmaceutical Services: The current CoP states that drugs and biologicals must be kept in a locked storage area. The revised CoP relaxes this requirement somewhat, stating that all drugs and biologicals must be kept in a secure area and locked when appropriate. The revised CoP also requires Schedule II, III, IV, and V drugs to be kept locked within a secure area. Under the revised CoP, only authorized personnel may have access to the locked areas.

Anesthesia Services: The current CoP requires the individual who administers anesthesia to an inpatient to perform and document a post anesthesia follow-up report. The revised CoP allows any individual qualified to administer anesthesia to perform and document the post anesthesia evaluation.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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