New Regulations for Medical Records

Centers for Medicare and Medicaid Services (CMS) recently published revisions to the Conditions of Participation for Hospitals that took effect on January 26, 2007. These revisions affect four areas: the patient's initial medical history and physical examination; authentication of records; securing of medications; and post-anesthesia evaluations.

I. Initial Medical History and Physical Examination

A physical examination and medical history must now be completed no more than 30 days prior to admission or 24 hours thereafter. Prior conditions required the examination and history within 7 days of admission or 48 hours thereafter. The new conditions also require that when the history and examination are completed 30 days prior to the patient's admission, an entry must be made, within 24 hours of admission, which documents an examination for any changes in the patient's condition.

The new conditions also change who may complete the required physical examination and medical history. Under the new condition, a physician, oromaxillofacial surgeon, or other qualified individual may complete the examination and history. The definition of physician now includes podiatrists, optometrists, and dentists, acting within the scope of their profession. Thus, the new condition is far broader than its predecessor, which permitted only doctors of osteopathy and medicine, and in limited circumstances, oromaxillofacial surgeons, to complete the history and examination.

II. Authentication of Records

All medical entries must now not only be legible, complete, dated, and authenticated, but timed as well. Thus, medical entries must now include the time an order was given or a service furnished.

The new conditions also address the verification of verbal orders. All verbal orders must be authenticated in accordance with state law; in Indiana, verification must occur within 48 hours. In addition, revisions to the nursing services and medical record services sections provide a hospital flexibility to determine "who may authenticate orders for whom." Orders for drugs and biologicals must be signed by a physician who is responsible for the patient's care and authorized to write orders by hospital policy. Finally, while orders must be authenticated by the ordering physician, for a five year period beginning January 26, 2007, an order may be authenticated not only by the ordering physician but also by a physician responsible for the patient's care. These changes create the opportunity for a covering physician to authenticate the order of the prescribing physician. CMS will re-evaluate this provision at the conclusion of the five year period.

III. Securing Medications

Previously, hospitals needed to keep all drugs and biologicals in a locked storage area. Hospitals and anesthesiologists argued this regulation was not practical. Patients kept some nonprescription medications, such as eye drops, at their bedside. Further, anesthesiologists objected to keeping non-controlled drugs in a locked container when they were already stored in a secure surgical suite. The new conditions of participation take these concerns into account and require only that drugs and biologicals be stored in a secure area, and "locked when appropriate." Schedule II, III, IV, and V drugs, however, must still be kept locked within a secure area and access to the area limited to authorized personnel.

IV. Post-anesthesia Evaluation

The CMS's final revision affected the completion of a post-anesthesia evaluation. The prior condition required the individual who administered the anesthesia to complete the post-anesthesia evaluation within 48 hours after the surgery. The new condition permits any individual qualified to administer anesthesia to complete the post-anesthesia evaluation.

If they have not done so already, healthcare providers should implement these new conditions of participation as soon as possible. For further information on the implementation of these new conditions, please contact Kevin Woodhouse or Blaire Henley.

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Kevin C. Woodhouse is partner in Ice Miller's health law practice group. He represents various health care related clients in addressing federal and state legislative and regulatory issues, compliance issues, contracts, joint ventures, health planning, and various managed care issues. Kevin can be reached directly at (317) 236-2154 or kevin.woodhouse@icemiller.com.

Blaire M. Henley is an associate in Ice Miller's litigation section, concentrating her practice in the areas of health care and risk management. Blaire can be reached directly at (317) 236-2399 or blaire.henley@icemiller.com.

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.