Source: https://www.federalregister.gov/documents/2005/03/25/05-5916/medicare-and-medicaid-programs-hospital-conditions-of-participation-requirements-for-history-and
Timestamp: 2019-03-18 15:45:32
Document Index: 15538606

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Federal Register :: Medicare and Medicaid Programs; Hospital Conditions of Participation: Requirements for History and Physical Examinations; Authentication of Verbal Orders; Securing Medications; and Postanesthesia Evaluations
A Proposed Rule by the Centers for Medicare & Medicaid Services on 03/25/2005
15266-15274 (9 pages)
05-5916
Condition of Participation: Medical Staff (§ 482.22)
Condition of Participation: Nursing Services (§ 482.23)
Condition of Participation: Pharmaceutical Services (§ 482.25)
Condition of Participation: Anesthesia Services (§ 482.52)
Condition of Participation: Medical Record Services (§ 482.24)
https://www.federalregister.gov/d/05-5916 https://www.federalregister.gov/d/05-5916
Centers for Medicare & Medicaid Services (CMS), DHHS
2. By mail. You may mail written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3122-P, P.O. Box 8010, Baltimore, MD 21244-8010.
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Compliance is determined by State survey agencies (SAs) or accreditation organizations. The SAs, in accordance with section 1864 of the Social Security Act (the Act), survey hospitals to assess compliance with the CoPs. The SAs conduct surveys using the State Operations Manual (SOM) (Centers for Medicare & Medicaid Services (CMS) Publication No. 7). The SOM contains the regulatory language of the CoPs as well as interpretive guidelines and survey procedures that give guidance on how to assess provider compliance. Under § 489.10(d), the SAs determine whether a hospital meets the CoPs and make corresponding recommendations to us about a hospital's certification, (that is, whether a hospital has met the standards required to provide Medicare and Medicaid services and receive Federal and State reimbursement).
Although we do not believe that this law operates retroactively, out of an abundance of caution, we are applying the provisions of section 902(a) of the MMA to this rule since our publication of the December 19, 1997 rule was not finalized. Had section 902(a) of MMA not been enacted, the CoP provisions stipulated in this proposed rule would have been stipulated in a final regulation. However, with the passage of section 902 of the MMA, we believe it is in the spirit of the legislation to publish a new proposed regulation.Start Printed Page 15268
On January 28, 2002, our Survey and Certification Group issued a memorandum (referenced as S&C-02-15) to the Associate Regional Administrators and State Survey Agency Directors addressing our position on hospital admission and presurgical history and physical examination requirements and the timing of the history and physical examination for hospital admissions. (A copy of the memorandum can be found on our Web site at http://www.cms.hhs.gov/​medicaid/​survey-cert/​012802.asp). This proposed rule would codify the guidance provided in the January 28, 2002 memorandum, and published in the June 2003 issue of the Open Door Forum Newsletter.
We propose to revise the current medical staff requirement at § 482.22(c)(5) to specify that a medical history and physical examination must be completed no more than 30 days before or 24 hours after admission for each patient by a physician (as defined in section 1861(r) of the Act) or other qualified individual who has been granted these privileges by the medical staff in accordance with State law, and that the medical history and physical examination must be placed in the medical record within 24 hours after admission. We also propose revising the current Medical Records CoP at § 482.24(c)(2)(i) to reflect that a medical history and physical examination must be completed no more than 30 days before or 24 hours after admission, and placed in the patient's medical record within 24 hours after admission. We also propose revising § 482.22(c)(5) and § 482.24(c)(2)(i) to require 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. This updated examination must be completed and documented in the patient's medical record within 24 hours after admission.
In the December 19, 1997 proposed rule, we solicited comments on authentication of medical record entries. Many in the hospital industry supported modifying and even eliminating the requirement. Many commenters believed that authentication does not add value to the quality of the medical record, especially after the service has been delivered or after the patient has been discharged. Other commenters believed that the absence of authentication leads to questions of accountability. In a related issue, we also solicited comments on the issue of whether a timeframe should be specified for signing verbal orders. Current requirements at § 482.23(c)(2)(ii) state that verbal orders for the administration of drugs or biologicals must be signed or initialed by the prescribing practitioner as soon as possible.
Authentication requirements enhance the accountability of a practitioner for verbal orders. Accountability means that the person who signed the entry is responsible for the care of the patient, and has verified that the order 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. Authentication requirements also protect practitioners carrying out verbal orders by preventing those giving the Start Printed Page 15269orders from later denying that the order was made.
We propose to retain and revise the current requirement for authentication of medical record entries at § 482.24(c)(1). This proposed provision states that 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, we would retain the current requirement that all orders, including verbal orders, must be dated, timed, and authenticated promptly by the prescribing practitioner, with the exception being that from the effective date of the final rule, to 5 years following the effective date of the final rule, all orders, including verbal orders, must be dated, timed, and authenticated promptly by the prescribing practitioner or another practitioner who is responsible for the care of the patient as specified under § 482.12(c) and authorized to write orders by hospital policy in accordance with State law, even if the order did not originate with him or her.
We frequently receive questions about the timeframe for authentication of verbal orders and how we define “as soon as possible.” Some States have laws requiring authentication of verbal orders within 24 to 48 hours. Other State laws, however, do not address timeframes for authentication of verbal orders at all, and they defer to hospital policy. There is no consistency on this issue in the absence of a Federal requirement. Therefore, we propose revising § 482.24(c)(1)(iii) to require that all verbal orders must be authenticated based upon Federal and State law. We further propose that if there is no State law that designates a specific timeframe for authentication of verbal orders, then verbal orders must be authenticated within 48 hours. We invite public comment on this proposed approach to the timeframe for authentication of verbal orders. Hospitals would no longer be burdened by the requirement that verbal orders must be signed by the practitioner who gave the order. Any practitioner responsible for the care of the patient who is authorized by hospital policy and permitted by State law to independently write a specific order would be permitted to authenticate a verbal order, even if the order did not originate with him or her. In the interest of public health and safety, the proposed requirement would also establish a consistent timeframe for the authentication of verbal orders when State law does not specify a timeframe for such orders.
We also propose to revise related nursing service requirements at § 482.23(c)(2) that address documentation of orders for drugs and biologicals. We propose 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 be documented and signed by a practitioner who is responsible for the care of the patient as specified under § 482.12(c) and authorized to write orders by hospital policy in accordance with State law. This proposed requirement would provide hospitals, in conjunction with their medical staff, the ability to determine who may authenticate verbal orders for whom, as well as identify and implement systems and processes that meet the safety needs of their patient population.
We propose retaining the current requirements at § 482.23(c)(2)(iii) that state that verbal orders are to be used infrequently. The use of verbal orders should not be a common practice. Verbal orders should be used only to meet the urgent care needs of the patient when it is not feasible for the ordering practitioner to immediately communicate the order in written or electronic form. Verbal orders are not to be used for the convenience of the ordering practitioner. We also propose retaining the current requirement that when verbal orders are used, they must only be accepted by persons that are authorized to do so by hospital policies and procedures, consistent with State and Federal law.
We have also had ongoing dialogue with the JCAHO and have received numerous questions from the healthcare community regarding patient self-administration of medications. It is current practice for hospitals to give patients access to urgently needed drugs, such as nitroglycerine tablets and inhalers, at the bedside. It is also current practice to place selected nonprescription medications at the bedside for the patient's use (for example, lotions and creams, rewetting Start Printed Page 15270eye drops.) Hospitals have also developed formalized patient medication self-administration programs for select populations of patients in collaboration with the medical staff, nursing, and pharmacy that include the development of the necessary hospital policies and procedures to ensure patient safety and security of medications. The current hospital CoPs do not contemplate medications at the patient's bedside as the current requirement mandates that all medications be in locked storage.
Therefore, we propose to revise the provision at § 482.25(b)(2) to require that all drugs and biologicals be kept in a secure area, and locked when appropriate. We propose that drugs listed in Schedules II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act of 1970 must be kept locked within a secure area. We further propose that only authorized personnel may have access to locked areas. We believe this addresses the identified issues, affords hospitals flexibility in implementation, and is more patient-focused and outcome oriented than the current requirements.
The medical community has repeatedly requested that we modify the current hospital anesthesia regulation that requires the individual who administers the anesthesia to write the follow up report. The medical community requested that CMS allow the postanesthesia report to be written by an individual qualified to administer anesthesia. This issue has been identified as particularly important by the PRIT, open door forums participants and through general questions submitted to CMS. Discussions with the health care community continue to indicate that the current postanesthesia evaluation requirement at § 482.52(b)(3) is: (1) Not consistent with the current preanesthesia evaluation requirement; (2) not reflective of current practice; and (3) an unnecessary burden for hospitals and practitioners that provide anesthesia. This requirement has also been a priority issue for the American Medical Association (AMA). These ongoing discussions have served as the impetus for us to propose revisions to this requirement in the current anesthesia services CoP. The proposed revision of this regulation would be consistent with the current regulation at § 482.52(b)(1) addressing preanesthesia reports. This requirement states, “A preanesthesia evaluation by an individual qualified to administer anesthesia under paragraph (a) of this section performed within 48 hours prior to surgery.” Implementation of the proposed change allowing the postanesthesia evaluation report to be written by an individual qualified to administer anesthesia would give hospitals greater flexibility in meeting the needs of patients and impose less burden than the current requirement.
This proposed requirement would clarify 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 would be documented and signed by a practitioner who is responsible for the care of the patient as specified under § 482.12(c) and authorized to write these orders by hospital policy in accordance with State law.
This proposed provision would require that all orders, including verbal orders, be dated, timed, and authenticated promptly by the prescribing practitioner, except as noted in subsection (ii).Start Printed Page 15271
All orders, including verbal orders, would have to be dated, timed, and authenticated promptly by the prescribing practitioner, except for a 5-year period of time beginning with the effective date of the final rule. During this 5-year time period, all orders, including verbal orders must be dated, timed and authenticated promptly by a practitioner who is responsible for the care of the patient as specified under § 482.12(c) and authorized to write orders by hospital policy in accordance with State law. This exception is time limited in anticipation that the advancement of health information technology will facilitate a prescribing practitioner authenticating his or her own orders.Start Printed Page 15272
Verbal orders would be required to be authenticated based upon Federal and State law. If there were no State law that designated a specific timeframe for the authentication of verbal orders, then verbal orders would need to be authenticated within 48 hours. Records must include evidence of a medical history and physical examination completed no more than 30 days before or 24 hours after admission, and placed in the patient's medical record within 24 hours after admission. When the medical history and physical examination are completed within 30 days before admission, the hospital must ensure that documentation of an examination of the patient's current condition is placed in the medical record within 24 hours after admission.
Centers for Medicare & Medicaid Services, Office of Strategic Operations and Regulatory Affairs, Regulations Development and Issuances Group, Attn: Jim Wickliffe, CMS-3122-P Room C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244-1850; and
We have examined the impact of this proposed rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
We are not preparing analyses for either the RFA or section 1102(b) of the Act because we have determined that this proposed rule would not have a significant economic impact on a substantial number of small entities or a significant impact on the operations of a substantial number of small rural hospitals. However, we lack data to quantify the effects of this proposed rule on small entities or small rural hospitals. We invite public comment on the impact of this proposed rule on small entities and small rural hospitals. Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule that may result in an expenditure in any 1 year by State, local, or tribal governments, in Start Printed Page 15273the aggregate, or by the private sector, that exceeds the inflation adjusted threshold of $110 million. This proposed rule would place no additional burden for implementation on State, local, or tribal governments or on the private sector.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR chapter IV, part 482 as set forth below:
Authority: Secs. 1102 and 1871 of the Social Security Act, unless otherwise noted (42 U.S.C. 1302 and 1395hh).
(2) 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 practitioner who is authorized to write orders by hospital policy and in accordance with State law, and who is responsible for the care of the patient as specified under § 482.12(c).
(ii) For the period from the effective date of the final rule, to 5 years following the effective date of the final rule, all orders, including verbal orders, must be dated, timed, and authenticated by the prescribing practitioner or another practitioner who is responsible for the care of the patient as specified under § 482.12(c) and authorized to write orders by hospital policy in accordance with State law.
Start Printed Page 15274