HLT-24-16-00003-P Specialized Programs for Residents with Neurodegenerative Diseases

6/15/16 N.Y. St. Reg. HLT-24-16-00003-P

NEW YORK STATE REGISTER

VOLUME XXXVIII, ISSUE 24

June 15, 2016

RULE MAKING ACTIVITIES

DEPARTMENT OF HEALTH

PROPOSED RULE MAKING

NO HEARING(S) SCHEDULED

 

I.D No. HLT-24-16-00003-P

Specialized Programs for Residents with Neurodegenerative Diseases

PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:

Proposed Action:

Addition of section 415.41 to Title 10 NYCRR.

Statutory authority:

Public Health Law, section 2803(2)

Subject:

Specialized Programs for Residents with Neurodegenerative Diseases.

Purpose:

To establish nursing home specialty units for residents with Huntington's Disease (HD) & Amyotrophic Lateral Sclerosis (ALS).

Substance of proposed rule (Full text is posted at the following State website:www.health.ny.gov):

A new section for Part 415 of Title 10 (Health) of the Official Compilation of Codes, Rules and Regulations of the State of New York is proposed, to be designated as section 415.41 and entitled “Specialized Programs for Residents with Neurodegenerative Diseases”.

(a) General. For purposes of the proposed regulation, “Neurodegenerative Disease” shall mean Huntington’s disease or Amyotrophic Lateral Sclerosis. “Specialized program” means a discrete unit within a nursing home that offers services and facilities for individuals with Neurodegenerative Diseases, with the goal of helping them attain or maintain the highest practicable level of physical, affective, behavioral and cognitive functioning. The program must be located in a nursing unit which is specifically designated for this purpose and physically separate from other facility units.

The proposed regulation also provides that the facility shall make information and data available to assist the Department of Health (department) in evaluating the effectiveness of specialty units and their impact on outcomes for individuals with Neurodegenerative Diseases.

(b) Admission. The proposed regulation requires nursing homes to develop written admission criteria for specialty units for individuals with Neurodegenerative Diseases. At a minimum, the resident’s medical record must document that the resident has a Neurodegenerative Disease diagnosis, cannot appropriately be served and is not safe in a less restrictive setting, and can benefit from the care and services available in a specialty unit. The proposed regulation also provides that a facility shall evaluate the effects of its admission criteria on its success in achieving its goals and objectives for the specialty unit and requires the facility to report its findings to the department annually thereafter.

(c) Assessment and Care Planning. The proposed regulation requires a home evaluation with the future resident and his or her family, as appropriate, prior to admission to discuss care needs. The proposed regulation also requires development of a care plan for each resident, which shall include a discharge plan, by an interdisciplinary resident care team. The care plan must be reviewed and modified at least once a month for the first three months following admission and then quarterly or upon a significant change in the resident’s condition thereafter.

(d) Discharge. The proposed regulation requires that a proposed discharge plan must 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 and his or her family, as appropriate, and any outside agency or resource anticipated to be involved with the resident following discharge. The resident must be discharged to a less restrictive setting when he or she no longer meets one or more of the admission criteria for the unit. Additionally, the proposed regulation provides that a facility shall evaluate the effects of its discharge criteria on its success in achieving the goals and objectives for the specialty unit and requires the facility to report its findings to the department annually thereafter.

Nursing homes with specialty units 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. In the event of a transfer to any general hospital, the facility must require a member of the specialty unit’s staff to accompany the resident, if feasible, and must communicate with the hospital and provide any relevant information about the resident at the time of transfer. The resident shall be given priority readmission status to the unit as warranted by his or her condition.

(e) Program/Unit Staffing Requirements. The facility must maintain consistent assignment of direct care staff to residents in the specialty unit. In addition, the proposed regulation requires that a specialty unit shall be managed by a program coordinator and that a physician must be responsible for medical direction of the unit. The proposed regulation also identifies other specific categories of personnel who must be assigned or available to the specialty unit, including a psychiatrist, a clinical psychologist or licensed clinical social worker, at least one registered professional nurse on each shift, a respiratory therapist, and a therapeutic recreation specialist.

Text of proposed rule and any required statements and analyses may be obtained from:

Katherine Ceroalo, DOH, Bureau of House Counsel, Reg. Affairs Unit, Room 2438, ESP Tower Building, Albany, NY 12237, [phone], email: [e-mail]

Data, views or arguments may be submitted to:

Same as above.

Public comment will be received until:

45 days after publication of this notice.

This rule was not under consideration at the time this agency submitted its Regulatory Agenda for publication in the Register.

Regulatory Impact Statement

Statutory Authority:

Public Health Law (PHL) section 2803(2)(v) provides that the Public Health and Health Planning Council shall adopt rules and regulations, subject to the approval of the Commissioner of Health, governing the standards and procedures followed by nursing homes which, at a minimum, must meet federal standards.

Legislative Objectives:

The legislative objective of PHL Article 28 includes the protection of the health of the residents of the State through the efficient provision and proper utilization of health services of the highest quality at a reasonable cost. The proposed amendments are consistent with this objective through the development of specialty units designed to address the unique needs of individuals with Neurodegenerative Disease and help them maintain or attain the highest practicable level of physical, affective, behavioral and cognitive functioning.

Needs and Benefits:

The purpose of the proposed amendments to 10 NYCRR Part 415 is to provide regulatory standards for nursing home specialty care units for people with Neurodegenerative Diseases. The environmental and care needs for nursing home residents with Neurodegenerative Diseases, at least before the end stages of the disease, often vary from those of other populations in need of nursing home care today. The proposed standards do not codify clinical pathways and interventions as these may change over time. Rather, they describe the service and environmental needs of people with Neurodegenerative Diseases and the nursing home’s responsibilities to meet the resident’s needs as well as, to a certain extent, their families’ needs.

Four nursing homes have taken steps to create specialty units for people with Neurodegenerative Diseases. Specifically, the following facilities either have already established specialized care units for people with Neurodegenerative Diseases or have submitted Certificate of Need (CON) applications to do so:

• Terence Cardinal Cooke Health Care Center – an established 48-bed unit in New York City;

• Ferncliff Nursing Home – an established 38-bed unit in Rhinebeck;

• Victoria Home – CON submitted for a 12-bed unit in Ossining; and

• Sitrin Health Care Center – CON submitted for a 32-bed unit in New Hartford.

These four facilities will serve as a statewide resource for individuals with Neurodegenerative Diseases, leading to better service for people living in New York and repatriation of out-of-state residents to nursing homes that are closer to their home communities and families. For example, there are currently about 50 Medicaid-eligible New Yorkers with Huntington’s disease living in out-of-state nursing homes. Many of these New Yorkers would not have had to seek nursing home care outside of New York had there been a nursing home capable of caring for them closer to their home communities and families.

Costs to Regulated Parties:

Nursing homes are not required to implement the proposed regulation since the operation of specialty units is voluntary. A nursing home may incur costs associated with the construction of a specialty unit for individuals with Neurodegenerative Diseases. The department will establish Medicaid reimbursement rates for nursing home providers for delivering appropriate services through the specialty units. A facility is unlikely to apply for approval to operate a specialty unit if it does not expect that doing so will be cost effective.

Costs to Local Governments:

Nursing homes are not required to implement the proposed regulation, as the operation of specialty units is voluntary. To the extent a nursing home operated by a local government seeks approval to operate a specialty unit, the costs will be the same as for other regulated parties who operate such units.

Costs to State Government:

The proposed rule does not impose any new costs on state government, as regulation of specialty units will be managed as part of the department’s overall nursing home surveillance activities.

Local Government Mandates:

The proposed amendments do not impose any program, mandate, service, duty or responsibility upon any county, city, town, village, school district, fire district or other special district. Implementation is voluntary.

Paperwork:

Nursing homes interested in operating a specialty unit for individuals with Neurodegenerative Diseases would need to submit and receive approval of a CON application. In addition, nursing homes are already required to maintain compliance with certain reporting, record-keeping obligations and staffing under federal and State requirements. For nursing homes interested in providing specialty care for Neurodegenerative Diseases, which is voluntary, the proposed regulations require additional reporting on admissions, discharges and outcomes and compliance with certain staffing requirements as necessary to meet the objectives of the specialty units. This additional reporting will allow the department to assess compliance and implementation.

Duplication:

The proposed regulation does not duplicate, overlap or conflict with any other State or federal rules and regulations, but sets forth additional standards for care in specialty units for individuals with Neurodegenerative Diseases.

Alternatives:

“Scatter beds” as opposed to specialty unit beds were considered but rejected. Specialty units are preferable from a clinical perspective, as they will enable residents to be cared for by an interdisciplinary care team in a customized environment, and likely will be more cost effective in providing residents with the enhanced level of service required.

Federal Standards:

The proposed amendments exceed federal standards by setting forth additional standards for care in specialty units for individuals with Neurodegenerative Diseases.

Compliance Schedule:

As implementation of the proposed amendments is voluntary, there is no compliance schedule. CON applicants will determine a compliance schedule in conformance with the scope of changes needed in their facilities to accommodate the specialty unit regulatory requirements.

Regulatory Flexibility Analysis

Effect of Rule:

Implementation of this rule is voluntary, subject to submission and approval of a Certificate of Need (CON) application. It is not known how many small nursing homes (those with less than 100 beds), or how many nursing homes owned and operated by counties and cities, will choose to implement the proposed regulation.

Compliance Requirements:

Nursing homes are already required to maintain compliance with record-keeping obligations and staffing under federal and State requirements. For nursing homes interested in providing specialty care for Neurodegenerative Diseases, which is voluntary, the proposed regulations require additional reporting on admissions, discharges and outcomes and compliance with certain staffing requirements as necessary to meet the objectives of the specialty units. This additional reporting will allow the department to assess compliance and implementation.

Professional Services:

Implementation is voluntary. The professional staff needed to comply with the proposed specialty unit regulations do not vary from the professional staff required to comply with current nursing home rules and regulations, except that the proposed regulation expresses a preference for professional staff with experience in meeting the unique needs of individuals with Neurodegenerative Diseases.

Compliance Costs:

Implementation of the proposed regulation is voluntary, subject to submission and approval of a CON application. A nursing home may incur costs associated with the construction of a specialty unit for individuals with Neurodegenerative Diseases. The department will establish Medicaid reimbursement rates for nursing home providers for delivering appropriate services through the specialty units. A facility is unlikely to apply for approval to operate a specialty unit if it does not expect that doing so will be cost effective.

Economic and Technological Feasibility:

The proposed regulation is economically and technically feasible. In particular, implementation is voluntary, and a nursing home is unlikely to propose construction and operation of a specialty unit unless it is cost-effective for the facility.

Minimizing Adverse Impact:

As implementation of the proposed rule is voluntary, a nursing home is unlikely to propose construction and operation of a specialty unit unless it is cost-effective for the facility.

Small Business and Local Government Participation:

The department created a stakeholder advisory group, which helped guide the development of the proposed regulation. The members of this group include representatives of small businesses, nursing homes specifically interested in serving individuals with Neurodegenerative Diseases, as well as family members and advocates for individuals with Neurodegenerative Diseases, and clinical experts with experience caring for such individuals. In addition, a copy of this notice of proposed rulemaking will be posted on the department’s website. The notice will invite public comments on the proposal and include instructions for anyone interested in submitting comments, including small businesses and local governments.

The proposed regulation provides that the facility shall make information and data available to assist the department in evaluating the effectiveness of specialty units and their impact on outcomes for individuals with Neurodegenerative Diseases. Such evaluation will be conducted four years after the adoption of the proposed regulations and the department will consider whether changes are warranted to the programmatic requirements. This period of time is designed to ensure that there is sufficient experience to allow the department to assess implementation.

Rural Area Flexibility Analysis

Types and Estimated Numbers of Rural Areas:

While there are a number of nursing homes located in rural areas throughout the State, implementation of the proposed rule is voluntary. Nursing homes in rural areas will not be affected differently than those in non-rural areas.

Reporting, Recordkeeping and Other Compliance Requirements and Professional Services:

Nursing homes are already required to maintain compliance with certain reporting, record-keeping obligations and staffing under federal and State requirements. For nursing homes interested in providing specialty care for Neurodegenerative Diseases, which is voluntary, the proposed regulations require additional reporting on admissions, discharges and outcomes and compliance with certain staffing requirements as necessary to meet the objectives of the specialty units. This additional reporting will allow the department to assess compliance and implementation.

Costs:

Implementation of the proposed rule is voluntary, subject to the submission and approval of a Certificate of Need application. A nursing home may incur costs associated with the construction of a specialty unit for individuals with Neurodegenerative Diseases. The department will establish Medicaid reimbursement rates for nursing home providers for delivering appropriate services through the specialty units. A facility is unlikely to apply for approval to operate a specialty unit if it does not expect that doing so will be cost effective.

Minimizing Adverse Impact:

As implementation of the proposed rule is voluntary, a nursing home is unlikely to propose construction and operation of a specialty unit unless it is cost-effective for the facility.

Rural Area Participation:

The department created a stakeholder advisory group, which helped guide the development of the proposed regulation. The group’s members are located throughout the state and include family members and advocates for individuals with Neurodegenerative Diseases, clinical experts with experience caring for individuals with Neurodegenerative Diseases, and representatives of nursing homes interested in serving such individuals. In addition, a copy of this notice of proposed rulemaking will be posted on the department’s website. The notice will invite public comments on the proposal and include instructions for anyone interested in submitting comments, including individuals and entities located in rural areas.

The proposed regulation provides that the facility shall make information and data available to assist the department in evaluating the effectiveness of specialty units and their impact on outcomes for individuals with Neurodegenerative Diseases. Such evaluation will be conducted four years after the adoption of the proposed regulations and the department will consider whether changes are warranted to the programmatic requirements. This period of time is designed to ensure that there is sufficient experience to allow the department to assess implementation.

Job Impact Statement

No Job Impact Statement is required pursuant to section 201-a(2)(a) of the State Administrative Procedure Act. It is apparent, from the nature of the proposed amendment, that it will not have an adverse impact on jobs and employment opportunities.