On February 8, 2008, the Centers for Medicare and Medicaid Services (CMS) issued revised Interpretive Guidelines (Guidelines) for Hospital Conditions of Participation (COPs) pertaining to requirements for history and physical examinations (H&Ps), authentication of verbal orders, securing medications and post-anesthesia evaluations. The Guidelines correspond to the amended Hospital COPs published on November 27, 2006. The changes to the COPs were also discussed in a CMS Survey and Certification Group letter published on January 26, 2007. They further discuss additional changes (which correspond with the COPs) that were incorporated into the 2008 Outpatient Prospective Payment System (OPPS), which became effective January 1, 2008. The Guidelines are effective immediately.

History and Physical Examinations (H&Ps)  
In its November 2006 COPs, CMS issued a revised rule requiring that an H&P be completed no more than 30 days before, or 24 hours after, admission for each patient. This requirement is consistent with Joint Commission standards. Within 24 hours after each patient admission, the H&P must be placed in the patient’s medical record. The Guidelines suggest that the Medical Staff Bylaws include the above requirement. The H&P may be handwritten or transcribed, but must always be placed within the patient’s medical record within 24 hours of admission or registration, or prior to a surgery or procedure requiring anesthesia, whichever comes first. In addition, an H&P is required prior to surgery and to procedures requiring anesthesia services, regardless of whether care is being provided on an inpatient or outpatient basis. Thus, an H&P completed 24 hours after the patient’s admission, but after the surgical procedure, procedure requiring anesthesia, or other procedure requiring an H&P, would not be in compliance with this requirement.

The new COP expanded the permissible professional categories of individuals who may perform an H&P. The new rule allowed physicians, oromaxillofacial surgeons, or “other qualified individuals in accordance with state law and hospital policy” to perform H&Ps. The Guidelines interpret such “other qualified practitioners” as including nurse practitioners or physician assistants. The Guidelines further state that while more than one qualified practitioner may participate in performing an H&P for a single patient, the practitioner who authenticates the H&P will be held responsible for its contents.

The revised COP mandates that an H&P performed prior to admission (within at least 30 days before admission) must be updated within 24 hours of admission or prior to surgery, whichever comes first. The Guidelines explain that this update must be completed and documented by a licensed practitioner credentialed and privileged by the hospital’s medical staff. If the individual performing the update finds no change in the patient’s condition since the last H&P was completed, he or she may indicate in the subject’s medical record that the H&P was reviewed, the patient was examined, and “no change” occurred in the subject’s condition. On the other hand, if the practitioner finds that an H&P done prior to admission was incomplete, inaccurate or otherwise unacceptable, he or she must then disregard the existing H&P and “conduct and document in the medical record a new H&P within 24 hours after admission or registration, but prior to surgery or procedure requiring anesthesia.”

Authentication of Verbal Orders
The COPs emphasize that hospitals should use verbal orders sparingly, if at all. The Guidelines reiterate that verbal orders must not be a common practice as they increase the risk of miscommunication, which could contribute to a medication or other error, resulting in an adverse patient event. Hospitals are expected to develop appropriate policies and procedures that govern the use of verbal orders and minimize their use. Examples of such policies include: describing limitations or prohibitions on the use of verbal orders; listing the elements required for inclusion the verbal order process; describing situations in which verbal orders may be used; defining the personnel who may issue and receive verbal orders; and establishing protocols for clear and effective communication, verification, and authentication of verbal orders. Verbal orders must be immediately documented in the patient’s medical record and signed by the individual receiving the order. CMS expects the nationally accepted “read back” verification practice to be used for every verbal order. Verbal orders may only be accepted by persons authorized to do so by hospital policy and procedures, which must be consistent with federal and state law.

All orders, including verbal ones, must be dated, timed and authenticated promptly by the ordering practitioner. Indeed, the Guidelines state that the hospital should ensure that all orders are authenticated “readily or immediately.” The receiver of any verbal order must date, time and sign the verbal order according to hospital policy, which CMS expects to include “read back” and verification processes. Where the ordering practitioner cannot authenticate his or her verbal order, it is now acceptable for another practitioner who is responsible for the patient’s care to authenticate that verbal order. CMS provided this exception in order to take account of differences among hospitals in their rate of the adoption of the electronic medical record systems. Finally, if there is no state law that designates a specific timeframe for the authentication of verbal orders, such orders must be authenticated within 48 hours.

Securing Medications
The most recent COPs mandate that all drugs and biologicals must be kept in a “secure area.” That area must be locked when appropriate. Previously, the rule required that such materials be kept in a locked storage area. In addition, drugs listed in Schedules II-V must be locked within a secure storage area available only to authorized personnel.

The Guidelines explain that “a ‘secure area’ means that drugs and biologicals are stored in a manner to prevent unmonitored access by unauthorized individuals.” Such materials must not be stored in areas readily accessible to unauthorized persons. All controlled substances must be locked, but hospitals are permitted flexibility in the storage of noncontrolled drugs and biologicals. Moreover, when a patient care area is not staffed, both controlled and noncontrolled substances are expected to be locked. Finally, mobile nursing medication carts, anesthesia carts, epidural carts, and other medication carts containing Schedule II-V drugs must be locked within a secured area that prevents unmonitored access.

Completion of Post-Anesthesia Evaluation
The new COPs require that a post-anesthesia evaluation for inpatients be completed and documented within 48 hours of surgery by any individual qualified to administer anesthesia. This revision to the COPs provided additional flexibility for hospitals and anesthesia professionals from the previous rule, which required that only the individual who administered the anesthesia could perform the post-anesthesia evaluation.

The Guidelines specify that such an evaluation is required any time general, regional or monitored anesthesia has been administered to a patient. However, because the American Society of Anesthesiology (ASA) guidelines do not define moderate or conscious sedation as anesthesia, CMS will not expect a post-anesthesia evaluation for patients receiving conscious sedation. The post-anesthesia evaluation must be completed and documented by a practitioner qualified to administer anesthesia, including a qualified anesthesiologist, an MD or DO, dentist, or certified registered nurse anesthetist (CRNA), or an anesthesiologist’s assistant who is under the supervision of an anesthesiologist who is immediately available if called. Finally, CMS suggests that hospitals consult recognized guidelines for post-anesthesia care. One example cited is the reference “Practice Guidelines for Post-Anesthetic Care, Anesthesiology,” Volume 96, No. 3 (March 2002), which CMS apparently endorses.

All hospitals are encouraged to review their current policies and procedures regarding the four outlined COPs and Guidelines discussed above.

For further information, please contact your regular Hinshaw attorney.

This alert has been prepared by Hinshaw & Culbertson LLP to provide information on recent legal developments of interest to our readers. It is not intended to provide legal advice for a specific situation or to create an attorney-client relationship.