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Federal Register/Vol. 64, No. 127/Friday, July 2, 1999/Rules and Regulations

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Federal Register/Vol. 64, No. 127/Friday, July 2, 1999/Rules and Regulations 36070 Federal Register / Vol. 64, No. 127 / Friday, July 2, 1999 / Rules and Regulations DEPARTMENT OF HEALTH AND medical and surgical care) and (f) assess compliance with the CoPs. The HUMAN SERVICES (Standard: Seclusion and restraint for SAs conduct these surveys using the behavior management) will be State Operations Manual (SOM) (HCFA Health Care Financing Administration considered if we receive them at the Publication No. 7). The SOM contains appropriate address as provided in the the regulatory language of the CoPs as 42 CFR Part 482 ADDRESSES section, no later than 5 p.m. well as interpretive guidelines and [HCFA±3018±IFC] on August 31, 1999. We will not survey probes that elaborate on consider comments on provisions of the regulatory intent and give in-depth RIN 0938±AJ56 regulation that remain unchanged from detail about how to maintain compliance. The SOM also outlines the Medicare and Medicaid Programs; the December 19, 1997 proposed rule or survey process and provides guidance Hospital Conditions of Participation: on provisions that were changed based for State administration of the survey Patients' Rights on our consideration of public comments. program. Under § 489.10(d), the SAs AGENCY: Health Care Financing ADDRESSES: Mail comments (an original determine whether hospitals meet the Administration (HCFA), HHS. and three copies) to the following CoPs and make corresponding recommendations to us about the ACTION: Interim final rule with address: Health Care Financing comment. Administration, Department of Health hospital's certification, (that is, whether and Human Services, Attention: HCFA± the hospital has met the standards SUMMARY: This rule introduces a new 3018±IFC, P.O. Box 7517, Baltimore, required to provide Medicare and Patients' Rights Condition of MD 21207±0517. Medicaid services and receive Federal Participation (CoP) that hospitals must If you prefer, you may deliver your and State reimbursement). Under section 1865 of the Act and meet to be approved for, or to continue comments (an original and three copies) § 488.5 (Effect of JCAHO or AOA participation in, the Medicare and to one of the following addresses: Medicaid programs. This interim final accreditation of hospitals), hospitals Room 443±G, Hubert Humphrey accredited by the Joint Commission on rule with comment sets forth six Building, 200 Independence Avenue, standards that ensure minimum Accreditation of Healthcare SW., Washington, DC 20201, or Organizations (JCAHO) or the American protections of each patient's physical Room C5±16±03, 7500 Security and emotional health and safety. These Osteopathic Association (AOA) are not Boulevard, Baltimore, MD 21244± routinely surveyed for compliance by standards address each patient's right to 1850 notification of his or her rights; the the SAs but are deemed to meet the exercise of his or her rights in regard to Because of staffing and resource requirements in the CoPs based on their his or her care; privacy and safety; limitations, we cannot accept comments accreditation. by facsimile (FAX) transmission. In confidentiality of his or her records; B. Why a Patients' Rights CoP Is Needed freedom from restraints used in the commenting, please refer to file code HCFA±3018±IFC. Comments received In recent years, State surveyors, provision of acute medical and surgical patient advocacy groups, the media, and care unless clinically necessary; and timely will be available for public inspection as they are received generally the general public have brought freedom from seclusion and restraints complaints about hospitals violating used in behavior management unless beginning approximately 3 weeks after publication of a document, in Room patients' rights to our attention. These clinically necessary. violations have consisted of denying or The issue of patients' rights has been 443±G of the Department's offices at 200 Independence Avenue, SW., frustrating a patient's access to care, a longstanding concern for the Health denying a patient's full involvement in Care Financing Administration. In Washington, DC, on Monday through Friday of each week from 8:30 a.m. to his or her treatment, disregarding a December 1997, we published a patient's advance directives, denying a proposed rule that introduced the 5 p.m. (phone: (202) 690±7890). FOR FURTHER INFORMATION CONTACT: patient's access to his or her medical proposed revision of all hospital CoPs, records, or inappropriately using including a new Patients' Rights CoP. Monique Howard, OTR (410±786±3869); Julie Moyers (410±786±6772); Anita seclusion or restraints. Particularly Work to finalize the complete revision within the past year, the public, media, of the hospital CoPs continues; Panicker, RN, LCSW (410±786±5646); or Rachael Weinstein, RN (410±786±6775). and the Congress have grown however, the Patients' Rights CoP is increasingly concerned about the need being finalized separately in an I. Background to ensure basic protections for patient accelerated time frame as recent reports A. General health and safety in hospitals, especially have evidenced a pressing need for the with regard to the use of restraints and codification and enforcement of these On December 19, 1997, we published seclusion. The Hartford Courant, a fundamental rights. Of particular a proposed rule entitled ``Medicare and Connecticut newspaper, heightened concern is the danger posed to patient Medicaid Programs; Hospital Conditions public awareness of this issue with a health and safety by violations of basic of Participation; Provider Agreements series of articles in October 1998 citing patients' rights, such as freedom from and Supplier Approval'' at 62 FR 66726 the results of a study that identified 142 restraints and seclusion. to revise the entire set of conditions of deaths from seclusion or restraints use The Patients' Rights CoP, including participation (CoPs) for hospitals that in behavioral health treatment facilities the standard regarding seclusion and are found at 42 CFR part 482. The CoPs over the past 10 years. The majority restraints, applies to all Medicare- and are the requirements that hospitals must were adolescent deaths. Medicaid-participating hospitals, that is, meet to participate in the Medicare and short-term, psychiatric, rehabilitation, Medicaid programs. These CoPs are C. Intent To Examine Restraint and long-term, children's, and alcohol-drug. intended to protect patient health and Seclusion in Other Settings DATES: Effective Date: These regulations safety and to ensure that high quality Federal regulations for nursing homes are effective on August 2, 1999. care is provided to all patients. The already stress the right to be free of Comment date: Comments on 42 CFR State survey agencies (SAs), under restraints, and over the past 10 years, 482.13(e) (Standard: Restraint for acute contract with us, survey hospitals to significant strides have been made in VerDate 18-JUN-99 18:34 Jul 01, 1999 Jkt 183247 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\02JYR2.XXX pfrm01 PsN: 02JYR2 Federal Register / Vol. 64, No. 127 / Friday, July 2, 1999 / Rules and Regulations 36071 reducing inappropriate restraints used We have endeavored to incorporate In addition, although not specifically in this care setting. The Patients' Rights the protections of the Bill of Rights into mentioned in the CBRR, patient safety CoP will further extend these the structures and operations of the necessitates that all hospitals should protections to another major provider of providers and plans that provide care to publicly disclose whether and when health care. However, this rule will not our beneficiaries. Some of the rights they provide emergency services. cover all care settings. As we finalized included in the proposed section • Protection of Whistleblowers: this rule, various stakeholders lobbied § 482.10 (now § 482.13) have direct Hospitals should be prohibited from for a much broader application of the correlates in the Consumer Bill of penalizing or seeking retribution against seclusion and restraint provisions. We Rights, but other significant protections health care professionals or other health are looking into the advisability of provided by the CBRR were not workers for advocating on behalf of their adopting a cross-cutting restraints and mentioned in the December 1997 patients. Individuals would be assured seclusion standard that would affect proposed rule. Even though some of of this right in the Patients' Rights other kinds of health care entities with these protections currently exist due to section. • whom we have provider agreements and requirements on hospitals that are not Respect and Nondiscrimination: the inpatient psychiatric services for affected by the revisions to the CoPs, we While the preamble discusses the individuals under age 21 benefit. We are have decided not to add new regulatory applicable Federal and State laws that requesting comment on whether we requirements to the Patients' Rights prohibit discrimination, an explicit should set forth the same requirements standard without subjecting them to a patient right to nondiscrimination is not as promulgated in this rule or whether more public vetting than is provided by currently included and would be added more stringent standards would be an interim final rule. We therefore ask to the Patients' Rights section. appropriate. For example, is the current for comment on the following additional E. Other Patients' Rights standard for continual monitoring of consumer rights, which we believe The remainder of the hospital
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