Academy comments to CMS re: objection to the proposed rule on "Hospital Conditions on Participation"

Mark B. McClellan, M.D.
Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Attention: CMS-3122-P
P.O. Box 8010
Baltimore, MD 21244-8010

Dear Dr. McClellan:

I am writing on behalf of the American Academy of Family Physicians, which represents more than 93,400 family physicians and students nationwide, to offer our comments on the proposed rule on “Hospital Conditions of Participation” as published in the Federal Register on March 25, 2005. We would like to comment in particular on the proposed changes related to completion of the medical history and physical examination and to authentication of verbal orders.

The current regulations for hospital conditions of participation generally require a doctor of medicine or osteopathy to do a physical examination and medical history no more than 7 days before or 48 hours after an admission for each patient. Consistent with revised JCAHO standards, CMS proposes to expand this timeframe to within 30 days before or 24 hours after admission for each patient. Further, CMS proposes to revise the condition of participation to state the medical history and examination must be done by a physician “or other qualified individual who has been granted these privileges by the medical staff in accordance with State law.” Finally, CMS proposes that when a medical history and physical examination is completed within the 30 days before admission, the hospital must ensure that an updated medical record entry documenting an examination for any changes in the patient’s current condition is completed and documented in the patient’s medical record within 24 hours after admission.

We support the expansion of the timeframe for completion of the physical examination and medical history as proposed to within 30 days before admission. As noted, it is consistent with JCAHO standards. We do not perceive any problems with concurrently requiring an updated medical record entry documenting an examination for any changes in the patient’s current condition within 24 hours after admission when the history and physical examination is done within 30 days before admission. We anticipate that most family physicians will see their patients or otherwise make arrangements to have another physician see their patients within 24 hours of admission to the hospital. Likewise, we do not perceive any problems with revising the standard to include other qualified individuals who have been granted these privileges by the medical staff in accordance with State law. This revision will facilitate hospital compliance with the condition, especially in underserved areas where the availability of physicians to provide this service may be limited.

The current regulations for hospital conditions of participation generally state that verbal orders for the administration of drugs or biologicals must be signed or initialed by the prescribing practitioner as soon as possible. “Verbal orders” in this context includes both telephone and oral orders. CMS believes authentication enhances accountability, by which CMS means that the person who signed the entry is responsible for the care of the patient and has been recorded completely and accurately. It does not mean that the person who authenticates a verbal order is necessarily the person who gave it.

CMS proposes to retain and revise the current requirement for authentication of medical record entries. Under the proposed provision, all patient record entries must be legible, complete, dated, timed and authenticated in written or electronic form by whomever is responsible for providing or evaluating a service provided. Additionally, CMS would retain the requirement that all orders, including verbal orders, must be dated, timed, and authenticated promptly by the prescribing health care professional.

An exception to this rule would be that for five years following the effective date of the final rule, all orders, including verbal orders, must be dated, timed, and authenticated promptly by the prescribing health care professional “or another practitioner who is responsible for the care of the patient . . . and authorized to write orders by hospital policy in accordance with State law.” CMS believes this temporary exception will maintain an appropriate level of accountability while providing hospitals with flexibility until the advancement of health information technology is sufficient to allow the originating physician to authenticate his or her own orders in an efficient manner.

CMS further proposes that all verbal orders must be authenticated based on Federal and State law and that in the absence of State law designating a specific timeframe, then verbal orders must be authenticated within 48 hours. Finally, CMS proposes that with the exception of influenza and pneumococcal polysaccharide vaccines, which may be administered per physician-approved hospital policy after an assessment of contraindications, orders for drugs and biologicals must be documented and signed by a health care professional who is responsible for the care of the patient and authorized to write orders by hospital policy in accordance with State law.

We support the proposed revisions to these conditions of participation. We believe that they provide some needed flexibility in this area. Like CMS, we are hopeful that health information technology will advance sufficiently in the next five years such that the exception granted by CMS is no longer needed. If that turns out not to be the case, we hope that CMS would consider extending the exception.

We have some concerns about CMS establishing a Federal standard of 48 hours for authentication in the absence of applicable State law. As CMS notes in the proposed rule, states that do not have an applicable law typically defer to hospital policy. We think this makes sense, especially for hospitals in rural or remote areas. We do not favor CMS establishing an arbitrary Federal standard in this regard.

In conclusion, we appreciate the opportunity to comment on this proposed rule. If you or your staff has any questions about this matter, please contact Mr. Kent Moore at the American Academy of Family Physicians at 1-800-274-2237, extension 4170, or at kmoore@aafp.org.

Sincerely,

Michael Fleming, M.D.
Board Chair