Source: https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&mc=true&n=sp42.5.485.f&r=SUBPART&ty=HTML
Timestamp: 2020-04-05 14:36:10
Document Index: 183439968

Matched Legal Cases: ['art 485', '§485', '§482', '§485', '§485', '§485', '§485', '§485', '§485', '§483', 'art 493', '§485', '§485', '§409', 'art 486', '§409', '§485', '§413', '§413', 'art 483', '§483', '§483', '§483', '§483', '§483', '§483', '§483', '§483', '§413', '§483', '§483', '§483']

Title 42 → Chapter IV → Subchapter G → Part 485 → Subpart F
§485.641 Condition of participation: Quality assessment and performance improvement program.
Source: 58 FR 30671, May 26, 1993, unless otherwise noted.
(a) Statutory basis. This subpart is based on section 1820 of the Act which sets forth the conditions for designating certain hospitals as CAHs.
(b) Scope. This subpart sets forth the conditions that a hospital must meet to be designated as a CAH.
A rural health network is an organization that meets the following specifications:
(1) At least one hospital that the State has designated or plans to designate as a CAH; and
(2) At least one hospital that furnishes acute care services.
(b) The members of the organization have entered into agreements regarding—
(1) Patient referral and transfer;
(2) The development and use of communications systems, including, where feasible, telemetry systems and systems for electronic sharing of patient data; and
(3) The provision of emergency and nonemergency transportation among members.
(c) Each CAH has an agreement with respect to credentialing and quality assurance with at least—
(1) One hospital that is a member of the network when applicable;
(2) One QIO or equivalent entity; or
(3) One other appropriate and qualified entity identified in the State rural health care plan.
Staff that furnish services in a CAH must meet the applicable requirements of this section.
(1) Is a registered nurse and is licensed to practice nursing in the State in which the clinical nurse specialist services are performed in accordance with State nurse licensing laws and regulations; and
(2) Holds a master's or doctoral level degree in a defined clinical area of nursing from an accredited educational institution.
(b) Nurse practitioner. A nurse practitioner must be a registered professional nurse who is currently licensed to practice in the State, who meets the State's requirements governing the qualification of nurse practitioners, and who meets one of the following conditions:
(2) Has successfully completed a 1 academic year program that—
(3) Has successfully completed a formal educational program (for preparing registered nurses to perform an expanded role in the delivery of primary care) that does not meet the requirements of paragraph (a)(2) of this section, and has been performing an expanded role in the delivery of primary care for a total of 12 months during the 18-month period immediately preceding June 25, 1993.
(c) Physician assistant. A physician assistant must be a person who meets the applicable State requirements governing the qualifications for assistants to primary care physicians, and who meets at least one of the following conditions:
(2) Has satisfactorily completed a program for preparing physician assistants that—
(3) Has satisfactorily completed a formal educational program (for preparing physician assistants) that does not meet the requirements of paragraph (c)(2) of this section and has been assisting primary care physicians for a total of 12 months during the 18-month period immediately preceding June 25, 1993.
[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997; 77 FR 29076, May 16, 2012]
(a) Criteria for State designation. (1) A State that has established a Medicare rural hospital flexibility program described in section 1820(c) of the Act may designate one or more facilities as CAHs if each facility meets the CAH conditions of participation in this subpart F.
(2) The State must not deny any hospital that is otherwise eligible for designation as a CAH under this paragraph (a) solely because the hospital has entered into an agreement under which the hospital may provide posthospital SNF care as described in §482.58 of this chapter.
(b) Criteria for CMS certification. CMS certifies a facility as a CAH if—
The CAH and its staff are in compliance with applicable Federal, State and local laws and regulations.
(a) Standard: Compliance with Federal laws and regulations. The CAH is in compliance with applicable Federal laws and regulations related to the health and safety of patients.
(b) Standard: Compliance with State and local laws and regulations. All patient care services are furnished in accordance with applicable State and local laws and regulations.
(c) Standard: Licensure of CAH. The CAH is licensed in accordance with applicable Federal, State and local laws and regulations.
(d) Standard: Licensure, certification or registration of personnel. Staff of the CAH are licensed, certified, or registered in accordance with applicable Federal, State, and local laws and regulations.
Except for recently closed facilities as described in §485.610(a)(2), or health clinics or health centers as described in §485.610(a)(3), the facility is a hospital that has a provider agreement to participate in the Medicare program as a hospital at the time the hospital applies for designation as a CAH.
(a) Standard: Agreements with network hospitals. In the case of a CAH that is a member of a rural health network as defined in §485.603 of this chapter, the CAH has in effect an agreement with at least one hospital that is a member of the network for—
(2) The development and use of communications systems of the network, including the network's system for the electronic sharing of patient data, and telemetry and medical records, if the network has in operation such a system; and
(3) The provision of emergency and nonemergency transportation between the facility and the hospital.
(b) Standard: Agreements for credentialing and quality assurance. Each CAH that is a member of a rural health network shall have an agreement with respect to credentialing and quality assurance with at least—
(1) One hospital that is a member of the network;
(3) The governing body of the CAH must ensure that when telemedicine services are furnished to the CAH's patients through an agreement with a distant-site telemedicine entity, the agreement is written and specifies that the distant-site telemedicine entity is a contractor of services to the CAH and as such, in accordance with §485.635(c)(4)(ii), furnishes the contracted services in a manner that enables the CAH to comply with all applicable conditions of participation for the contracted services, including, but not limited to, the requirements in this section with regard to its physicians and practitioners providing telemedicine services.
(a) Standard: Number of beds. Except as permitted for CAHs having distinct part units under §485.647, the CAH maintains no more than 25 inpatient beds. Inpatient beds may be used for either inpatient or swing-bed services.
(b) Standard: Length of stay. The CAH provides acute inpatient care for a period that does not exceed, on an annual average basis, 96 hours per patient.
(a) Standard: Governing body or responsible individual. The CAH has a governing body or an individual that assumes full legal responsibility for determining, implementing and monitoring policies governing the CAH's total operation and for ensuring that those policies are administered so as to provide quality health care in a safe environment.
(b) Standard: Disclosure. The CAH discloses the names and addresses of—
(1) The person principally responsible for the operation of the CAH; and
(2) The person responsible for medical direction.
[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997; 84 FR 51827, Sept. 30, 2019]
(a) Standard: Staffing—(1) The CAH has a professional health care staff that includes one or more doctors of medicine or osteopathy, and may include one or more physician assistants, nurse practitioners, or clinical nurse specialists.
(2) Any ancillary personnel are supervised by the professional staff.
(3) The staff is sufficient to provide the services essential to the operation of the CAH.
(4) A doctor of medicine or osteopathy, nurse practitioner, clinical nurse specialist, or physician assistant is available to furnish patient care services at all times the CAH operates.
(5) A registered nurse, clinical nurse specialist, or licensed practical nurse is on duty whenever the CAH has one or more inpatients.
(b) Standard: Responsibilities of the doctor of medicine or osteopathy. (1) The doctor of medicine or osteopathy—
(ii) In conjunction with the physician assistant and/or nurse practitioner member(s), participates in developing, executing, and periodically reviewing the CAH's written policies governing the services it furnishes.
(i) Participate in the development, execution and periodic review of the written policies governing the services the CAH furnishes; and
(2) The physician assistant, nurse practitioner, or clinical nurse specialist performs the following functions to the extent they are not being performed by a doctor of medicine or osteopathy:
(i) Provides services in accordance with the CAH's policies.
(ii) Arranges for, or refers patients to, needed services that cannot be furnished at the CAH, and assures that adequate patient health records are maintained and transferred as required when patients are referred.
(3) Whenever a patient is admitted to the CAH by a nurse practitioner, physician assistant, or clinical nurse specialist, a doctor of medicine or osteopathy on the staff of the CAH is notified of the admission.
(d) Standard: Periodic review of clinical privileges and performance. The CAH requires that—
(1) The quality and appropriateness of the diagnosis and treatment furnished by nurse practitioners, clinical nurse specialist, and physician assistants at the CAH are evaluated by a member of the CAH staff who is a doctor of medicine or osteopathy or by another doctor of medicine or osteopathy under contract with the CAH.
(2) The quality and appropriateness of the diagnosis and treatment furnished by doctors of medicine or osteopathy at the CAH are evaluated by—
(ii) One Quality Improvement Organization (QIO) or equivalent entity;
(iv) In the case of distant-site physicians and practitioners providing telemedicine services to the CAH's patient under an agreement between the CAH and a distant-site hospital, the distant-site hospital; or
(v) In the case of distant-site physicians and practitioners providing telemedicine services to the CAH's patients under a written agreement between the CAH and a distant-site telemedicine entity, one of the entities listed in paragraphs (d)(2)(i) through (iii) of this section.
(3) The CAH staff consider the findings of the evaluation and make the necessary changes as specified in paragraphs (b) through (d) of this section.
[58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997; 70 FR 68728, Nov. 10, 2005; 79 FR 27155, May 12, 2014; 84 FR 51827, Sept. 30, 2019]
(a) Standard: Patient care policies. (1) The CAH's health care services are furnished in accordance with appropriate written policies that are consistent with applicable State law.
(2) The policies are developed with the advice of members of the CAH's professional healthcare staff, including one or more doctors of medicine or osteopathy and one or more physician assistants, nurse practitioners, or clinical nurse specialists, if they are on staff under the provisions of §485.631(a)(1).
(3) The policies include the following:
(i) A description of the services the CAH furnishes, including those furnished through agreement or arrangement.
(ii) Policies and procedures for emergency medical services.
(iii) Guidelines for the medical management of health problems that include the conditions requiring medical consultation and/or patient referral, the maintenance of health care records, and procedures for the periodic review and evaluation of the services furnished by the CAH.
(iv) Rules for the storage, handling, dispensation, and administration of drugs and biologicals. These rules must provide that there is a drug storage area that is administered in accordance with accepted professional principles, that current and accurate records are kept of the receipt and disposition of all scheduled drugs, and that outdated, mislabeled, or otherwise unusable drugs are not available for patient use.
(v) Procedures for reporting adverse drug reactions and errors in the administration of drugs.
(vi) Procedures that ensure that the nutritional needs of inpatients are met in accordance with recognized dietary practices. All patient diets, including therapeutic diets, must be ordered by the practitioner responsible for the care of the patients or by a qualified dietitian or qualified nutrition professional as authorized by the medical staff in accordance with State law governing dietitians and nutrition professionals and that the requirement of §483.25(i) of this chapter is met with respect to inpatients receiving post CAH SNF care.
(viii) Policies and procedures that address the post-acute care needs of patients receiving CAH services.
(4) These policies are reviewed at least biennially by the group of professional personnel required under paragraph (a)(2) of this section and updated as necessary by the CAH.
(b) Standard: Patient services—(1) General: (i) The CAH provides those diagnostic and therapeutic services and supplies that are commonly furnished in a physician's office or at another entry point into the health care delivery system, such as a low intensity hospital outpatient department or emergency department. These CAH services include medical history, physical examination, specimen collection, assessment of health status, and treatment for a variety of medical conditions.
(ii) The CAH furnishes acute care inpatient services.
(2) Laboratory services. The CAH provides basic laboratory services essential to the immediate diagnosis and treatment of the patient that meet the standards imposed under section 353 of the Public Health Service Act (42 U.S.C. 236a). (See the laboratory requirements specified in part 493 of this chapter.) The services provided include the following:
(4) Emergency procedures. In accordance with requirements of §485.618, the CAH provides medical services as a first response to common life-threatening injuries and acute illness.
(c) Standard: Services provided through agreements or arrangements. (1) The CAH has agreements or arrangements (as appropriate) with one or more providers or suppliers participating under Medicare to furnish other services to its patients, including—
(i) Services of doctors of medicine or osteopathy;
(ii) Additional or specialized diagnostic and clinical laboratory services that are not available at the CAH; and
(iii) Food and other services to meet inpatients' nutritional needs to the extent these services are not provided directly by the CAH.
(2) If the agreements or arrangements are not in writing, the CAH is able to present evidence that patients referred by the CAH are being accepted and treated.
(3) The CAH maintains a list of all services furnished under arrangements or agreements. The list describes the nature and scope of the services provided.
(4) The person principally responsible for the operation of the CAH under §485.627(b)(2) of this chapter is also responsible for the following:
(i) Services furnished in the CAH whether or not they are furnished under arrangements or agreements.
(ii) Ensuring that a contractor of services (including one for shared services and joint ventures) furnishes services that enable the CAH to comply with all applicable conditions of participation and standards for the contracted services.
(d) Standard: Nursing services. Nursing services must meet the needs of patients.
(1) A registered nurse must provide (or assign to other personnel) the nursing care of each patient, including patients at a SNF level of care in a swing-bed CAH. The care must be provided in accordance with the patient's needs and the specialized qualifications and competence of the staff available.
(2) A registered nurse or, where permitted by State law, a physician assistant, must supervise and evaluate the nursing care for each patient, including patients at a SNF level of care in a swing-bed CAH.
(3) All drugs, biologicals, and intravenous medications must be administered by or under the supervision of a registered nurse, a doctor of medicine or osteopathy, or, where permitted by State law, a physician assistant, in accordance with written and signed orders, accepted standards of practice, and Federal and State laws.
(4) A nursing care plan must be developed and kept current for each inpatient.
(e) Standard: Rehabilitation Therapy Services. Physical therapy, occupational therapy, and speech-language pathology services furnished at the CAH, if provided, are provided by staff qualified under State law, and consistent with the requirements for therapy services in §409.17 of this subpart.
[58 FR 30671, May 26, 1993; 58 FR 49935, Sept. 24, 1993, as amended at 59 FR 45403, Sept. 1, 1994; 62 FR 46037, Aug. 29, 1997; 72 FR 66408, Nov. 27, 2007; 73 FR 69941, Nov. 19, 2008; 75 FR 70844, Nov. 19, 2010; 76 FR 25564, May 5, 2011; 77 FR 29076, May 16, 2012; 78 FR 50970, Aug. 19, 2013; 79 FR 27156, May 12, 2014; 81 FR 68871, Oct. 4, 2016; 82 FR 32260, July 13, 2017; 84 FR 51827, 51883, Sept. 30, 2019]
(a) Standard: Records system—(1) The CAH maintains a clinical records system in accordance with written policies and procedures.
(2) The records are legible, complete, accurately documented, readily accessible, and systematically organized.
(3) A designated member of the professional staff is responsible for maintaining the records and for ensuring that they are completely and accurately documented, readily accessible, and systematically organized.
(4) For each patient receiving health care services, the CAH maintains a record that includes, as applicable—
(i) Identification and social data, evidence of properly executed informed consent forms, pertinent medical history, assessment of the health status and health care needs of the patient, and a brief summary of the episode, disposition, and instructions to the patient;
(ii) Reports of physical examinations, diagnostic and laboratory test results, including clinical laboratory services, and consultative findings;
(iii) All orders of doctors of medicine or osteopathy or other practitioners, reports of treatments and medications, nursing notes and documentation of complications, and other pertinent information necessary to monitor the patient's progress, such as temperature graphics, progress notes describing the patient's response to treatment; and
(iv) Dated signatures of the doctor of medicine or osteopathy or other health care professional.
(b) Standard: Protection of record information. (1) The CAH maintains the confidentiality of record information and provides safeguards against loss, destruction, or unauthorized use.
(2) Written policies and procedures govern the use and removal of records from the CAH and the conditions for the release of information.
(3) The patient's written consent is required for release of information not required by law.
(c) Standard: Retention of records. The records are retained for at least 6 years from date of last entry, and longer if required by State statute, or if the records may be needed in any pending proceeding.
The CAH must develop, implement, and maintain an effective, ongoing, CAH-wide, data-driven quality assessment and performance improvement (QAPI) program. The CAH must maintain and demonstrate evidence of the effectiveness of its QAPI program.
Adverse event means an untoward, undesirable, and usually unanticipated event that causes death or serious injury or the risk thereof.
Error means the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. Errors can include problems in practice, products, procedures, and systems; and
Medical error means an error that occurs in the delivery of healthcare services.
(b) Standard: QAPI Program Design and scope. The CAH's QAPI program must:
(1) Be appropriate for the complexity of the CAH's organization and services provided.
(2) Be ongoing and comprehensive.
(3) Involve all departments of the CAH and services (including those services furnished under contract or arrangement).
(4) Use objective measures to evaluate its organizational processes, functions and services.
(5) Address outcome indicators related to improved health outcomes and the prevention and reduction of medical errors, adverse events, CAH-acquired conditions, and transitions of care, including readmissions.
(c) Standard: Governance and leadership. The CAH's governing body or responsible individual is ultimately responsible for the CAH's QAPI program and is responsible and accountable for ensuring that the QAPI program meets the requirements of paragraph (b) of this section.
(d) Standard: Program activities. For each of the areas listed in paragraph (b) of this section, the CAH must:
(1) Focus on measures related to improved health outcomes that are shown to be predictive of desired patient outcomes.
(2) Use the measures to analyze and track its performance.
(3) Set priorities for performance improvement, considering either high-volume, high-risk services, or problem-prone areas.
(e) Standard: Program data collection and analysis. The program must incorporate quality indicator data including patient care data, and other relevant data, in order to achieve the goals of the QAPI program.
[84 FR 51828, Sept. 30, 2019]
The CAH must have and implement written protocols that:
(a) Incorporate an agreement with an OPO designated under part 486 of this chapter, under which it must notify, in a timely manner, the OPO or a third party designated by the OPO of individuals whose death is imminent or who have died in the CAH. The OPO determines medical suitability for organ donation and, in the absence of alternative arrangements by the CAH, the OPO determines medical suitability for tissue and eye donation, using the definition of potential tissue and eye donor and the notification protocol developed in consultation with the tissue and eye banks identified by the CAH for this purpose;
(b) Incorporate an agreement with at least one tissue bank and at least one eye bank to cooperate in the retrieval, processing, preservation, storage and distribution of tissues and eyes, as may be appropriate to assure that all usable tissues and eyes are obtained from potential donors, insofar as such an agreement does not interfere with organ procurement;
(c) Ensure, in collaboration with the designated OPO, that the family of each potential donor is informed of its option to either donate or not donate organs, tissues, or eyes. The individual designated by the CAH to initiate the request to the family must be a designated requestor. A designated requestor is an individual who has completed a course offered or approved by the OPO and designed in conjunction with the tissue and eye bank community in the methodology for approaching potential donor families and requesting organ or tissue donation;
(d) Encourage discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential donors;
(e) Ensure that the CAH works cooperatively with the designated OPO, tissue bank and eye bank in educating staff on donation issues, reviewing death records to improve identification of potential donors, and maintaining potential donors while necessary testing and placement of potential donated organs, tissues, and eyes take place.
(f) For purposes of these standards, the term “organ” means a human kidney, liver, heart, lung, pancreas, or intestines (or multivisceral organs).
A CAH must meet the following requirements in order to be granted an approval from CMS to provide post-CAH SNF care, as specified in §409.30 of this chapter, and to be paid for SNF-level services, in accordance with paragraph (c) of this section.
(a) Eligibility. A CAH must meet the following eligibility requirements:
(1) The facility has been certified as a CAH by CMS under §485.606(b) of this subpart; and
(b) Facilities participating as rural primary care hospitals (RPCHs) on September 30, 1997. These facilities must meet the following requirements:
(c) Payment. Payment for inpatient RPCH services to a CAH that has qualified as a CAH under the provisions in paragraph (a) of this section is made in accordance with §413.70 of this chapter. Payment for post-hospital SNF-level of care services is made in accordance with the payment provisions in §413.114 of this chapter.
(d) SNF services. The CAH is substantially in compliance with the following SNF requirements contained in subpart B of part 483 of this chapter:
(1) Resident rights (§483.10(b)(7), (c)(1), (c)(2)(iii), (c)(6), (d), (e)(2) and (4), (f)(4)(ii) and (iii), (g)(8) and (17), (g)(18) introductory text, and (h) of this chapter).
(2) Admission, transfer, and discharge rights (§483.5 definition of transfer & discharge, §483.15(c)(1), (c)(2), (c)(3), (c)(4), (c)(5), (c)(7), (c)(8), and (c)(9) of this chapter).
(3) Freedom from abuse, neglect and exploitation (§483.12(a)(1), (a)(2), (a)(3)(i), (a)(3)(ii), (a)(4), (b)(1), (b)(2), (c)(1), (c)(2), (c)(3), and (c)(4) of this chapter).
(4) Social services (§483.40(d) of this chapter).
(5) Comprehensive assessment, comprehensive care plan, and discharge planning (§483.20(b), and §483.21(b) and (c)(2) of this chapter), except that the CAH is not required to use the resident assessment instrument (RAI) specified by the State that is required under §483.20(b), or to comply with the requirements for frequency, scope, and number of assessments prescribed in §413.343(b) of this chapter).
(6) Specialized rehabilitative services (§483.65 of this chapter).
(7) Dental services (§483.55(a)(2), (3), (4), and (5) and (b) of this chapter).
(8) Nutrition (§483.25(g)(1) and (g)(2) of this chapter).
[63 FR 26359, May 12, 1998, as amended at 64 FR 41544, July 30, 1999; 67 FR 50120, Aug. 1, 2002; 69 FR 49272, Aug. 11, 2004; 81 FR 68871, Oct. 4, 2016; 82 FR 32260, July 13, 2017; 84 FR 51828, Sept. 30, 2019]