Source: https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&mc=true&r=SUBPART&n=sp42.5.485.b
Timestamp: 2020-04-10 03:26:21
Document Index: 344307461

Matched Legal Cases: ['art 485', '§485', '§485', '§485', '§485', '§485', '§485', '§485', '§485', '§485', 'art 489', '§410', '§410', '§485', '§485', '§485', 'art 493', 'art 493', '§485', '§410', '§484', '§484', 'art 484', 'art 498']

Title 42 → Chapter IV → Subchapter G → Part 485 → Subpart B
§485.50 Basis and scope.
§485.51 Definition.
§485.54 Condition of participation: Compliance with State and local laws.
§485.58 Condition of participation: Comprehensive rehabilitation program.
§485.62 Condition of participation: Physical environment.
§485.64 [Reserved]
§485.68 Condition of participation: Emergency preparedness.
§485.70 Personnel qualifications.
§485.74 Appeal rights.
This subpart sets forth the conditions that facilities must meet to be certified as comprehensive outpatient rehabilitation facilities (CORFs) under section 1861(cc)(2) of the Social Security Act and be accepted for participation in Medicare in accordance with part 489 of this chapter.
As used in this subpart, unless the context indicates otherwise, “comprehensive outpatient rehabilitation facility”, “CORF”, or “facility” means a nonresidential facility that—
(a) Is established and operated exclusively for the purpose of providing diagnostic, therapeutic, and restorative services to outpatients for the rehabilitation of injured, disabled, or sick persons, at a single fixed location, by or under the supervision of a physician except as provided in paragraph (c) of this section;
(b) Meets all the requirements of this subpart.
(c) Exception. May provide influenza, pneumococcal and Hepatitis B vaccines provided the applicable conditions of coverage under §410.58 and §410.63 of this chapter are met.
[48 FR 56293, Dec. 15, 1982, as amended at 72 FR 66408, Nov. 27, 2007]
The facility and all personnel who provide services must be in compliance with applicable State and local laws and regulations.
(a) Standard: Licensure of facility. If State or local law provides for licensing, the facility must be currently licensed or approved as meeting the standards established for licensure.
(b) Standard: Licensure of personnel. Personnel that provide service must be licensed, certified, or registered in accordance with applicable State and local laws.
The facility must provide a coordinated rehabilitation program that includes, at a minimum, physicians' services, physical therapy services, and social or psychological services. These services must be furnished by personnel that meet the qualifications set forth in §§485.70 and 484.115 of this chapter and must be consistent with the plan of treatment and the results of comprehensive patient assessments.
(a) Standard: Physician services. (1) A facility physician must be present in the facility for a sufficient time to—
(i) Provide, in accordance with accepted principles of medical practice, medical direction, medical care services, consultation, and medical supervision of nonphysician staff;
(ii) Establish the plan of treatment in cases where a plan has not been established by the referring physician;
(iii) Assist in establishing and implementing the facility's patient care policies; and
(iv) Participate in plan of treatment reviews, patient case review conferences, comprehensive patient assessment and reassessments, and utilization review.
(2) The facility must provide for emergency physician services during the facility operating hours.
(b) Standard: Plan of treatment. For each patient, a physician must establish a plan of treatment before the facility initiates treatment. The plan of treatment must meet the following requirements:
(1) It must delineate anticipated goals and specify the type, amount, frequency and duration of services to be provided.
(2) It must be promptly evaluated after changes in the patient's condition and revised when necessary.
(3) It must, if appropriate, be developed in consultation with the facility physician and the appropriate facility professional personnel.
(4) It must be reviewed at least every 60 days by a facility physician who, when appropriate, consults with the professional personnel providing services. The results of this review must be communicated to the patient's referring physician for concurrence before treatment is continued or discontinued.
(5) It must be revised if the comprehensive reassessment of the patient's status or the results of the patient case review conference indicate the need for revision.
(c) Standard: Coordination of services. The facility must designate, in writing, a qualified professional to ensure that professional personnel coordinate their related activities and exchange information about each patient under their care. Mechanisms to assist in the coordination of services must include—
(1) Providing to all personnel associated with the facility, a schedule indicating the frequency and type of services provided at the facility;
(2) A procedure for communicating to all patient care personnel pertinent information concerning significant changes in the patient's status;
(3) Periodic clinical record entries, noting at least the patient's status in relationship to goal attainment; and
(4) Scheduling patient case review conferences for purposes of determining appropriateness of treatment, when indicated by the results of the initial comprehensive patient assessment, reassessment(s), the recommendation of the facility physician (or other physician who established the plan of treatment), or upon the recommendation of one of the professionals providing services.
(d) Standard: Provision of services. (1) All patients must be referred to the facility by a physician who provides the following information to the facility before treatment is initiated:
(i) The patient's significant medical history.
(ii) Current medical findings.
(iii) Diagnosis(es) and contraindications to any treatment modality.
(iv) Rehabilitation goals, if determined.
(2) Services may be provided by facility employees or by others under arrangements made by the facility.
(3) The facility must have on its premises the necessary equipment to implement the plan of treatment and sufficient space to allow adequate care.
(4) The services must be furnished by personnel that meet the qualifications of §485.70 and the number of qualified personnel must be adequate for the volume and diversity of services offered. Personnel that do not meet the qualifications specified in §485.70 may be used by the facility in assisting qualified staff. When a qualified individual is assisted by these personnel, the qualified individual must be on the premises, and must instruct these personnel in appropriate patient care service techniques and retain responsibility for their activities.
(5) A qualified professional must initiate and coordinate the appropriate portions of the plan of treatment, monitor the patient's progress, and recommend changes, in the plan, if necessary.
(6) A qualified professional representing each service made available at the facility must be either on the premises of the facility or must be available through direct telecommunication for consultation and assistance during the facility's operating hours. At least one qualified professional must be on the premises during the facility's operating hours.
(7) All services must be provided consistent with accepted professional standards and practice.
(e) Standard: Scope and site of services—(1) Basic requirements. The facility must provide all the CORF services required in the plan of treatment and, except as provided in paragraph (e)(2) of this section, must provide the services on its premises.
(2) Exceptions. Physical therapy, occupational therapy, and speech-language pathology services may be furnished away from the premises of the CORF including the individual's home when payment is not otherwise made under Title XVIII of the Act. In addition, a single home environment evaluation is covered if there is a need to evaluate the potential impact of the home environment on the rehabilitation goals. The single home environment evaluation requires the presence of the patient and the physical therapist, occupational therapist, or speech-language pathologist, as appropriate.
(f) Standard: Patient assessment. Each qualified professional involved in the patient's care, as specified in the plan of treatment, must—
(1) Carry out an initial patient assessment; and
(2) In order to identify whether or not the current plan of treatment is appropriate, perform a patient reassessment after significant changes in the patient's status.
(g) Standard: Laboratory services. (1) If the facility provides its own laboratory services, the services must meet the applicable requirements for laboratories specified in part 493 of this chapter.
(2) If the facility chooses to refer specimens for laboratory testing, the referral laboratory must be certified in the appropriate specialties and subspecialties of services in accordance with the requirements of part 493 of this chapter.
[48 FR 56293, Dec. 15, 1982, as amended at 56 FR 8852, Mar. 1, 1991; 57 FR 7137, Feb. 28, 1992; 73 FR 69941, Nov. 19, 2008; 82 FR 4591, Jan. 13, 2017]
The facility must provide a physical environment that protects the health and safety or patients, personnel, and the public.
(a) Standard: Safety and comfort of patients. The physical premises of the facility and those areas of its surrounding physical structure that are used by the patients (including at least all stairwells, corridors and passageways) must meet the following requirements:
(1) Applicable Federal, State, and local building, fire, and safety codes must be met.
(2) Fire extinguishers must be easily accessible and fire regulations must be prominently posted.
(3) A fire alarm system with local (in-house) capability must be functional, and where power is generated by electricity, an alternate power source with automatic triggering must be present.
(4) Lights, supported by an emergency power source, must be placed at exits.
(5) A sufficient number of staff to evacuate patients during a disaster must be on the premises of the facility whenever patients are being treated.
(6) Lighting must be sufficient to carry out services safely; room temperature must be maintained at comfortable levels; and ventilation through windows, mechanical means, or a combination of both must be provided.
(7) Safe and sufficient space must be available for the scope of services offered.
(b) Standard: Sanitary environment. The facility must maintain a sanitary environment and establish a program to identify, investigate, prevent, and control the cause of patient infections.
(1) The facility must establish written policies and procedures designed to control and prevent infection in the facility and to investigate and identify possible causes of infection.
(2) The facility must monitor the infection control program to ensure that the staff implement the policies and procedures and that the policies and procedures are consistent with current practices in the field.
(3) The facility must make available at all times a quantity of laundered linen adequate for proper care and comfort of patients. Linens must be handled, stored, and processed in a manner that prevents the spread of infection.
(4) Provisions must be in effect to ensure that the facility's premises are maintained free of rodent and insect infestation.
(c) Standard: Maintenance of equipment, physical location, and grounds. The facility must establish a written preventive maintenance program to ensure that—
(1) All equipment is properly maintained and equipment needing periodic calibration is calibrated consistent with the manufacturer's recommendations; and
(2) The interior of the facility, the exterior of the physical structure housing the facility, and the exterior walkways and parking areas are clean and orderly and maintained free of any defects that are a hazard to patients, personnel, and the public.
(d) Standard: Access for the physically impaired. The facility must ensure the following:
(1) Doorways, stairwells, corridors, and passageways used by patients are—
(i) Of adequate width to allow for easy movement of all patients (including those on stretchers or in wheelchairs); and
(ii) In the case of stairwells, equipped with firmly attached handrails on at least one side.
(2) At least one toilet facility is accessible and constructed to allow utilization by ambulatory and nonambulatory individuals.
(3) At least one entrance is usable by individuals in wheelchairs.
(4) In multi-story buildings, elevators are accessible to and usable by the physically impaired on the level that they use to enter the building and all levels normally used by the patients of the facility.
(5) Parking spaces are large enough and close enough to the facility to allow safe access by the physically impaired.
The Comprehensive Outpatient Rehabilitation Facility (CORF) must comply with all applicable Federal, State, and local emergency preparedness requirements. The CORF must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements:
(a) Emergency plan. The CORF must develop and maintain an emergency preparedness plan that must be reviewed and updated at least every 2 years. The plan must do all of the following:
(3) Address patient population, including, but not limited to, the type of services the CORF has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
(5) Be developed and maintained with assistance from fire, safety, and other appropriate experts.
(b) Policies and procedures. The CORF must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:
(1) Safe evacuation from the CORF, which includes staff responsibilities, and needs of the patients.
(4) The use of volunteers in an emergency and other emergency staffing strategies, including the process and role for integration of State or Federally designated health care professionals to address surge needs during an emergency.
(c) Communication plan. The CORF must develop and maintain an emergency preparedness communication plan that complies with Federal, State, and local laws and must be reviewed and updated at least every 2 years. The communication plan must include all of the following:
(iv) Other CORFs.
(i) Federal, State, tribal, regional and local emergency preparedness staff.
(3) Primary and alternate means for communicating with the CORF's staff, Federal, State, tribal, regional, and local emergency management agencies.
(4) A method for sharing information and medical documentation for patients under the CORF's care, as necessary, with other health care providers to maintain the continuity of care.
(5) A means of providing information about the CORF's needs, and its ability to provide assistance, to the authority having jurisdiction or the Incident Command Center, or designee.
(d) Training and testing. The CORF must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years.
(1) Training program. The CORF must do all of the following:
(v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures.
(2) Testing. The CORF must conduct exercises to test the emergency plan at least annually. The CORF must do the following:
(A) When a community-based exercise is not accessible, conduct an individual, facility-based functional exercise every 2 years; or
(B) If the CORF experiences an actual natural or man-made emergency that requires activation of the emergency plan, the CORF is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the emergency event.
(iii) Analyze the CORF's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the CORF's emergency plan, as needed.
(e) Integrated healthcare systems. If a CORF is part of a healthcare system consisting of multiple separately certified healthcare facilities that elects to have a unified and integrated emergency preparedness program, the CORF may choose to participate in the healthcare system's coordinated emergency preparedness program. If elected, the unified and integrated emergency preparedness program must do all of the following:
[81 FR 64035, Sept. 16, 2016, as amended at 84 FR 51826, Sept. 30, 2019]
This section sets forth the qualifications that must be met, as a condition of participation, under §485.58, and as a condition of coverage of services under §410.100 of this chapter.
(a) A facility physician must be a doctor of medicine or osteopathy who—
(1) Is licensed under State law to practice medicine or surgery; and
(2) Has had, subsequent to completing a 1-year hospital internship, at least 1 year of training in the medical management of patients requiring rehabilitation services; or
(3) Has had at least 1 year of full-time or part-time experience in a rehabilitation setting providing physicians' services similar to those required in this subpart.
(b) A licensed practical nurse must be licensed as a practical or vocational nurse by the State in which practicing, if applicable.
(c) An occupational therapist and an occupational therapy assistant must meet the qualifications in §484.115 of this chapter.
(d) An orthotist must—
(1) Be licensed by the State in which practicing, if applicable;
(2) Have successfully completed a training program in orthotics that is jointly recognized by the American Council on Education and the American Board for Certification in Orthotics and Prosthetics; and
(3) Be eligible to take that Board's certification examination in orthotics.
(e) A physical therapist and a physical therapist assistant must meet the qualifications in §484.115 of this chapter.
(f) A prosthetist must—
(2) Have successfully completed a training program in prosthetics that is jointly recognized by the American Council on Education and the American Board for Certification in Orthotics and Prosthetics; and
(3) Be eligible to take that Board's certification examination in prosthetics.
(g) A psychologist must be certified or licensed by the State in which he or she is practicing, if that State requires certification or licensing, and must hold a masters degree in psychology from and educational institution approved by the State in which the institution is located.
(h) A registered nurse must be a graduate of an approved school of nursing and be licensed as a registered nurse by the State in which practicing, if applicable.
(i) A rehabilitation counselor must—
(2) Hold at least a bachelor's degree; and
(3) Be eligible to take the certification examination administered by the Commission on Rehabilitation Counselor Certification.
(j) A respiratory therapist must complete one the following criteria:
(1) Criterion 1. All of the following must be completed:
(i) Be licensed by the State in which practicing, if applicable.
(ii) Have successfully completed a nationally-accredited educational program for respiratory therapists.
(iii)(A) Be eligible to take the registry examination administered by the National Board for Respiratory Care for respiratory therapists; or
(B) Have passed the registry examination administered by the National Board for Respiratory Care for respiratory therapists.
(2) Criterion 2: All of the following must be completed:
(ii) Have equivalent training and experience as determined by the National Board for Respiratory Care.
(k) A respiratory therapy technician must—
(2) Have successfully completed a training program accredited by the Committees on Allied Health Education and Accreditation (CAHEA) in collaboration with the Joint Review Committee for Respiratory Therapy Education; and
(i) Be eligible to take the certification examination for respiratory therapy technicians administered by the National Board for Respiratory Therapy, Inc,; or
(ii) Have equivalent training and experience as determined by the National Board for Respiratory Therapy, Inc.
(l) A social worker must—
(2) Hold at least a bachelor's degree from a school accredited or approved by the Council on Social Work Education; and
(3) Have 1 year of social work experience in a health care setting.
(m) A speech-language pathologist must meet the qualifications set forth in part 484 of this chapter.
[48 FR 56293, Dec. 15, 1982. Redesignated and amended at 50 FR 33034, Aug. 16, 1985; 51 FR 41352, Nov. 14, 1986; 60 FR 2327, Jan. 9, 1995; 72 FR 66408, Nov. 27, 2007; 73 FR 69941, Nov. 19, 2008; 74 FR 62014, Nov. 25, 2009; 82 FR 4591, Jan. 13, 2017]
The appeal provisions set forth in part 498 of this chapter, for providers, are applicable to any entity that is participating or seeks to participate in the Medicare program as a CORF.
[48 FR 56293, Dec. 15, 1982, as amended at 52 FR 22454, June 12, 1987]