N.Y. Comp. Codes R. & Regs. tit. 10, § 415.41 – Specialized programs for residents with neurodegenerative diseases.

(1) Specialized program shall mean a discrete unit with a planned array of services, staffing, equipment and physical facilities designed to serve individuals with neurodegenerative diseases, and approved pursuant to Part 710 of this Title. The program shall provide goal-directed, comprehensive and interdisciplinary services directed at attaining or maintaining the individual at his or her highest practicable level of physical, affective, behavioral, psychosocial and cognitive functioning.
(2) For purposes of this section, neurodegenerative disease shall mean Huntington’s disease or amyotrophic lateral sclerosis.
(3) For purposes of this section, and consistent with the requirements of section 415.11 of this Part, the program shall have an interdisciplinary resident care team consisting of, at a minimum, the resident’s physician, a registered professional nurse with responsibility for the resident and, depending on the resident’s diagnosis, needs and symptoms, other appropriate staff in disciplines determined to meet the resident’s needs which may include staff assigned to the unit as set forth in subdivision (e) of this section.
(4) The program shall be located in a nursing unit which is specifically designated for this purpose and physically separate from other facility units. Residents of the unit shall have access to all of the facility’s recreational and therapeutic resources, including those resources that are not located in the unit.
(5) The facility shall ensure that sufficient space, equipment and facilities are available to support the clinical, education and administrative functions of the program in accordance with the standards set forth in Parts 711 and 713 of this Title.
(6) In addition to the implementation of the quality assessment and assurance plan for this program as required by section 415.27 of this Part, the facility shall participate with the department in an evaluation of the efficacy and effectiveness of the program and its impact on residents, families and staff. The facility shall collect data and furnish records, reports and data in a format requested by the department and shall make members of the interdisciplinary resident care team available for participation in the evaluation, as requested by the department. The facility shall submit such information to the department for the period ending December 31st, no later than 90 days following the end of the calendar year, annually through calendar year 2021.
(7) This section shall be implemented as a Quality Assessment and Performance Improvement (QAPI) project, as described in guidance from the Federal Centers for Medicare and Medicaid Services.
(b) Admission.
(1) The facility shall develop written admission criteria for the specialty unit to include the criteria in paragraph (2) of this subdivision and take into account the facility’s goals and objectives regarding outcomes (e.g., minimizing self-inflicted injuries/falls, chorea-related trauma, hospitalization [length of stay], emergency department utilization, bed hold, and satisfaction surveys of residents with neurodegenerative diseases staff, families, and others) for residents who live in the specialty unit. The facility shall evaluate the effects of its admission criteria on its success in achieving its goals and objectives for the unit and report its findings to the department no later than 90 days following the end of the calendar year, annually through calendar year 2021.
(2) At a minimum, for residents admitted to the unit, there shall be documented evidence in the resident’s medical record that:
1. (i) the resident has been diagnosed with neurodegenerative disease based on a medical evaluation by a physician as determined by highly suggestive family history, neurological testing, genetic testing when available, formal consultation setting and/or formal neurological diagnostic consultation;
2. (ii) the resident cannot be managed and is not safe, and his or her needs cannot be met, in an available, less restrictive setting; and
3. (iii) the resident has the ability to benefit from the specialized care and services available in the unit.
  (c) Assessment and care planning.
(1) Any assessment of a potential resident must include the admission criteria described in paragraph (b)(2) of this section. Where feasible, one or more members of the staff of the specialty unit shall conduct an evaluation of the home or current residence, living situation or inpatient setting of the future resident and his or her family prior to admission to discuss care needs. For purposes of this paragraph, feasible means the resident’s home or other setting is within reasonable travel distance (in terms of round trip travel time) from either the facility or the home(s) of the staff member(s) conducting the home evaluation. Results of an evaluation shall be used to identify preliminary approaches and interventions appropriate for the resident for purpose of preparing a resident’s care plan.
(2) A care plan shall be prepared by the interdisciplinary resident care team for each resident, taking into account input from the resident and the resident’s family or caregivers, in conformance with the timeframes set forth in section 415.11 of this Part. Each resident’s care plan shall include care and services that are therapeutically beneficial to the resident, appropriate to the resident’s interests and selected by the resident or resident’s caregiver as appropriate. The care plan may require environmental accommodations, as well as results from any evaluation of the home or current residence, living situation, or inpatient setting of the resident.
(3) Based on the resident’s response to therapeutic interventions, as well as the progression of the disease and its impact on the resident’s functioning, health and psychosocial status, the resident shall be reassessed and the care plan, including the discharge plan described in subdivision (d) of this section, shall be reviewed and modified at least once a month for the first three months following admission and then quarterly or upon any significant change in the resident’s condition thereafter. The care plan shall be reviewed by at least three members of the interdisciplinary resident care team and shall include at least one certified nurse aide who is assigned to the resident on a permanent basis.
(4) Facility or unit staff shall initiate a discussion of advance directives in accordance with the provisions of section 400.21 of this Title with the resident and the resident’s family member or other adult, consistent with such section, as soon as practicable following the decision to admit the resident to the unit.
(d) Discharge.
(1) The facility shall develop written discharge criteria for the specialty unit, which at a minimum shall address the provisions of paragraph (5) of this subdivision.
(2) The resident and his or her family and caregivers shall be notified of discharge criteria upon admission.
(3) A written discharge plan shall be developed within 30 days of admission for each resident as part of the overall care plan and shall include input from all professionals caring for the resident, the resident’s family and caregivers, as appropriate, and any outside agency or resource anticipated to be involved with the resident following discharge. The discharge plan shall be reviewed and modified at least once a month for the first three months following admission and then quarterly or upon any significant change in the resident’s condition thereafter.
(4) When the interdisciplinary resident care team determines that discharge of a resident to another facility or community-based program is appropriate, a discharge plan shall be implemented which is designed to assist and support the resident, family and caregivers in the transition to the new setting. The resident, his or her family, and caregivers, as appropriate, shall receive preparation for discharge from the specialty unit through the facility’s educational and counseling services.
(5) The resident shall be discharged to a less restrictive setting when he or she no longer meets the minimum admission criteria for the unit set forth in paragraph (b)(2) of this section or meets other discharge criteria established pursuant to paragraph (1) of this subdivision.
(6) The facility shall evaluate the effects of its discharge criteria on its success in achieving its goals and objectives for the unit and report its findings to the department no later than 90 days following the end of the calendar year, annually through calendar year 2021.
1. (i) The facility shall have a written agreement with a general hospital or hospitals providing for the transfer of residents in need of emergency or acute inpatient care services. Such hospital(s) shall have expertise in caring for individuals with neurodegenerative diseases, except in cases where a general hospital with such expertise is not available within a distance and time considered reasonable by accepted emergency medical standards.
2. (ii) In the event a resident of a specialty unit requires transfer to a general hospital:
  1. (a) When feasible and practicable, a resident who is transferred to a hospital shall be accompanied by an informed member of the program’s direct care staff to ensure continuity of care. For purposes of this paragraph, feasible means that round trip travel time between the facility and the hospital is reasonable.
  2. (b) When it is not feasible for a staff member to accompany the resident to the hospital, the resident’s physician, or the specialty unit’s medical director, or their designee, shall communicate with a physician or another health care practitioner at the receiving hospital at the time of the transfer.
  3. (c) In either case, the staff member or physician shall provide to the receiving hospital appropriate documentation and other information that may be needed at the time of transfer to ensure continuity of care.
  4. (d) The resident shall be given priority readmission status to the unit as his or her condition may warrant.
  5. (e) All transfers shall be conducted in compliance with all other applicable law, including without limitation, section 415.3(h) of this Part.
    (e) Program/unit staffing requirements.
(7)
(1) The facility shall maintain a level of direct care staff to residents that is appropriate for the required degree of care for the residents in the program unit.
(2) The facility shall ensure that any direct care staff assigned to the unit have been thoroughly trained and educated with regard to the special needs of unit residents, are competent to work in the unit, and are familiar to unit residents.
(3) The assignment of direct care staff must be sufficient to enable timely and appropriate care as determined by resident assessment and to protect both resident and staff safety. In addition to the staff assigned to the unit as specified in this subdivision, the facility shall make available other staff as necessary for the provision of care and services set forth in each resident’s care plan.
(4) The unit shall be managed by a program coordinator who has formal education, training and experience in the administration of a program that focuses on the care and management of individuals with neurodegenerative diseases. The program coordinator shall be dedicated only to the specialty unit. The program coordinator shall be responsible for the operation and oversight of the program. Other responsibilities of the program coordinator shall include:
1. (i) planning for and coordination of direct care and services;
2. (ii) screening prospective admissions;
3. (iii) developing and implementing in-service and continuing education programs, in collaboration with the interdisciplinary resident care team, for all staff in contact or working with these residents;
4. (iv) participating in the facility's decisions regarding resident care and services that affect the operation of the unit; and
5. (v) ensuring the development and implementation of a program plan and policies and procedures specific to this program.
(5) A physician who preferably has specialized training in the care of individuals with neurodegenerative diseases shall be responsible for the medical direction and medical oversight of this program and shall assist with the development and evaluation of policies and procedures governing the provision of medical services in this unit. If, at the time the physician is appointed as medical director of the unit, he or she does not have experience in providing care to individuals with neurodegenerative diseases, he or she shall have access to physicians who do have such experience.
(6) A psychiatrist shall be available on staff or on a consulting basis (including via telemedicine in conformance with applicable law) to the residents and to the program at a level consistent with residents’ care plans. The facility shall exercise best efforts to utilize a psychiatrist who has clinical experience working with individuals who have neurodegenerative diseases.
(7) A clinical psychologist or a licensed clinical social worker shall be available on staff or on a consulting basis (including via telemedicine in conformance with applicable law) to staff, residents, and residents’ family members and caregivers at a level consistent with residents’ care plans. The facility shall exercise best efforts to utilize a clinical psychologist or a licensed clinical social worker who has clinical experience working with individuals who have neurodegenerative diseases.
(8) A social worker shall be available either on staff or on a consulting basis to work with the residents, staff and family as needed. The facility shall exercise best efforts to utilize a social worker who has experience working with individuals who have neurodegenerative diseases.
(9) There shall be at least one registered professional nurse readily available during each shift in the unit. The facility shall exercise best efforts to utilize registered professional nurses who have training and experience in caring for individuals with neurodegenerative diseases. This registered professional nurse may not be the specialty unit program coordinator required under paragraph (4) of this subdivision.
(10) A therapeutic recreation specialist certified by a nationally recognized body which is acceptable to the department shall be responsible for the therapeutic recreation program.
(11) A respiratory therapist shall be available to residents who are no longer able to maintain normal oxygen and carbon dioxide levels.
(f) Program/unit service and environmental requirements.
(1) The program shall consist of a variety of medical, behavioral, counseling, recreational, exercise, nutritional and other services appropriate to the needs of each individual resident.
(2) Specific services that shall be available to residents who need them include but are not limited to: neurology; pulmonary specialist; psychotherapy; physical, occupational, respiratory and speech therapy; specialized eating and nutritional interventions to maximize independence and prevent unplanned weight loss and dehydration; technology to enable the resident to communicate effectively with staff, family members, caregivers, friends, and other residents; and oral care. Consults as needed shall be provided by but are not limited to surgical, podiatry, optometry, ophthalmology, orthopedic, cardiac, gastroenterology, dental, and hearing licensed professionals.
(3) The therapeutic recreation program shall incorporate the principles of rehabilitation, occupational, physical, nutritional, and speech therapies.
(4) Appropriate activities that accommodate individual residents’ interests shall be available at times that accommodate their waking hours.
(5) Support groups for staff, residents, and residents’ family members and caregivers shall be established and facilitated by the social worker or other counseling professional.
(6) The environment shall be customized to meet the needs and characteristics of residents and minimize injuries to residents and staff.
1. (i) Each resident’s living space shall be customized to safely accommodate his or her specific movement and motor control characteristics, and changes in movement and motor control characteristics as the resident’s disease evolves.
2. (ii) Such customization may include, but is not limited to, padding around hard surfaces that could harm the resident, staff or visitors; self-protective equipment such as soft helmet, elbow and knee pads; broda chairs (including shower/commode, bariatric, geriatric and glider chairs) with HD special padding if needed; and adequate space to accommodate high amplitude involuntary movements without injury to either the resident, staff or visitors.
3. (iii) The unit shall include, in their new construction designs, small recreational and dining room areas where residents can be with their families in privacy and comfort.
4. (iv) Units shall include central bathing and toilet facilities that can accommodate two-person assists. In-room toilets and bathing accommodations shall be modified or restricted to ensure resident safety and privacy as described in subparagraphs (i) and (ii) of this paragraph.
(7) The unit shall be equipped and staff shall be trained as necessary for the provision and management of non-invasive ventilation for residents for whom this service is appropriate. Supervision shall be provided by a respiratory therapist and pulmonary specialist.
(8) Residents shall not be prevented from participating in research projects and clinical trials that have been approved by an Institutional Review Board (IRB) that is registered with the Federal Office of Human Research Protection (OHRP) in the United States Department of Health and Human Services and in compliance with the human subjects research requirements at 45 CFR part 46 as determined by OHRP. To the extent practicable, facilities may facilitate residents’ participation in such research and trials by, for example, becoming trial sites, providing transportation to the trial site, providing assistance to enroll in the research, and working with families to facilitate participation.
(9) The facility shall provide outdoor access to residents.
(g) Program/unit training requirements.
(1) The facility shall ensure that all staff assigned to the direct care of the residents have pertinent experience or have received training in the care and management of people with neurodegenerative diseases.
(2) Training shall be appropriate to the functions and responsibilities of specific staff in the unit and shall include but not be limited to:
1. (i) the neurodegenerative disease itself, e.g., signs and symptoms, genetics, diagnosis, management, progression/history of the disease, prognosis and epidemiology;
2. (ii) how each type of staff can contribute to better quality of care and quality of life for residents;
3. (iii) injury prevention for the resident, staff and visitors;
4. (iv) creating an organized environment that minimizes stressors, maintains routines and encourages/maximizes independent functioning and decision-making;
5. (v) ensuring adequate hydration and nutrition; and
6. (vi) providing and encouraging cognitive stimulation and socialization through passive and active participation in appropriate activities.
(3) Families and informal supports, including the resident’s friends and caregivers, shall also have access to this training as appropriate to their activities in the unit.
(4) The facility shall ensure that educational programs are conducted for staff who do not provide direct care but who come in contact with the residents on a regular basis such as housekeeping and dietary aides. The educational programs shall familiarize staff with the goals of the specialty unit and the needs of residents with neurodegenerative diseases.

(a) General.