May 23, 2005
Mark McClellan, MD, PhD
Centers for Medicare & Medicaid Services
Department of Health and Human Services
PO Box 8010
Baltimore, Maryland 21244-1850
Dear Dr. McClellan:
The purpose of this letter is to comment on the Centers for Medicare & Medicaid Services' (CMS') proposed rule changes to the Medicare and Medicaid Hospitals Conditions of Participation (COP) as published in the March 25, 2005 Federal Register. The American Health Information Management Association (AHIMA) is a professional association representing 50,000 educated health information management (HIM) professionals who work throughout the healthcare industry. HIM professionals serve the healthcare industry and the public by managing, analyzing, and utilizing data and records vital for patient care and making it accessible to healthcare providers and appropriate researchers when it is needed most.
Managing the records for health care has been a role for HIM professionals for over seventy-five years, and AHIMA members are now working diligently to ensure that we soon have a standard electronic health record that will make some of the aspects of your proposed rule moot. In recent years, AHIMA has worked with the Joint Commission for the Accreditation of Health Organizations (JCAHO) and members of your Center for Medicare Services for the last 15 years to ensure that the conditions of participation for Medicare provide the industry with a complete and accurate record and history of patient care. Currently we are working on a variety of projects with the Health Level Seven (HL7), the Office of the Coordinator for Health Information Technology (ONCHIT), and other groups to ensure that in the future electronic health records (EHRs) will provide the same complete and accurate record only in an environment that will permit better health and safety than in the paper environment.
It is with this history, work, and vision, that we have reviewed the proposed rule changes for the COP's requirements for history and physical examinations, and the authentication of verbal orders. Our members have experienced the frustrations you have expressed in the overview of this proposal, and it is with this experience in mind that we make the following comments.
Completion of the Medical History and Physical Examination
AHIMA acknowledges the background and recommendations in your March 25, 2005 proposed rules and in previous instructions and clarifications regarding this section (§ 482.22 - Medical Staff). AHIMA members have noted that as CMS has clarified the Hospital Admission and Presurgical History and Physical Examination Requirements, there have been no apparent situations that would not support the recommendations for the timelines associated with your proposed rule.
Verbal Orders and Authentication
The proposed requirements for verbal orders generated considerable discussion among our members seeking to balance patient safety, "common practice," and administrative problems associated with such orders.
AHIMA supports the concept that section 482.24 (Medical Record Services) requirements should be temporary and reviewed in the next five years. AHIMA is actively working with healthcare systems vendors, and others acknowledged above, promoting the adoption of a standard EHR and the capability for all orders to be immediately authenticated, as they are dictated or written, electronically. We look forward to CMS working closely with our HIM professionals and the healthcare industry to ensure implementation and use of such EHRs and other order-entry processes (e.g. computerize physician order entry - CPOE), as well as to achieve a consensus standard on what constitutes appropriate authentication.
Patient safety is a key component of the proposed rule and was also a key component of AHIMA's discussion on section 482.24. From an administrative perspective, we appreciate the approach of allowing other qualified practitioners to sign an order and resolve some of the administrative barriers discussed, but we are concerned that there are legal liabilities to such a practice that run contrary to the philosophy of patient safety, and the proposed change may be illegal on a state basis. If legality is not an issue, then, at a minimum, we suggest that the requirement be modified to indicate that the qualified practitioners have some relationship to the patient's care, the medical service, or the medical practice. Such a requirement may exist informally since there is a liability associated in the signing of such an order, but a regulation stating it would be appropriate. If the purpose of permitting another practitioner to sign a verbal order is patient safety, then the practitioner should be more narrowly defined to ensure that they have the knowledge of the case, or service, to evaluate an order before signing it.
AHIMA also supports the requirement for a 48-hour timeframe for authentication, as long as this requirement remains consistent with CMS contracted accreditation agencies, and is the rule in the absence of state law. However, CMS should require hospitals and practitioners to take steps to limit the use of verbal orders, in the absence of EHR/COPE information technologies. Further, our HIM professionals suggest that when verbal orders are given, they should be completely repeated back to the practitioner as a preventative step for patient safety.
If AHIMA can provide any further information, or if there are any questions or concerns with regard to this letter and its recommendations, please contact either myself at (202) 659-9440 or e-mail firstname.lastname@example.org, or Michelle Dougherty, RHIA, AHIMA's manager of practice leadership at (312) 233-1914 or e-mail email@example.com.
Dan Rode, MBA, FHFMA
Vice President, Policy and Government Relations
Michelle Dougherty, RHIA
Donald T. Mon, PhD, Vice President Practice Leadership, AHIMA