HLT-13-07-00002-RP Assisted Living Residence  

  • 12/26/07 N.Y. St. Reg. HLT-13-07-00002-RP
    NEW YORK STATE REGISTER
    VOLUME XXIX, ISSUE 52
    December 26, 2007
    RULE MAKING ACTIVITIES
    DEPARTMENT OF HEALTH
    REVISED RULE MAKING
    NO HEARING(S) SCHEDULED
     
    I.D No. HLT-13-07-00002-RP
    Assisted Living Residence
    PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following revised rule:
    Revised action:
    Addition of Part 1001 to Title 10 NYCRR.
    Statutory authority:
    Public Health Law, section 4662, subd. 1
    Subject:
    Regulations for assisted living residences in New York State.
    Purpose:
    To further the goals of PHL article 46-B (Assisted Living Reform Act), pursuant to PHL section 4662(1), by creating the regulatory framework necessary for implementation of the provisions therein.
    Substance of revised rule:
    The Assisted Living Reform Act creates several new licensure and certification categories: Assisted Living Residence (ALR), Enhanced ALR and Special Needs ALR. The Act defines “assisted living” and “assisted living residence” as “an entity” which provides or arranges for housing, on-site monitoring and personal care services and/or home care services (either directly or indirectly) in a home-like setting to five or more adult residents unrelated to the assisted living provider. An ALR must also provide daily food service, twenty-four hour on-site monitoring, case management services, and the development of an individualized service plan for each resident. In order to operate as an ALR, an operator must also be certified as an adult home or enriched housing program.
    The ALR licensure category is viewed as a basic level of assisted living, but one that differs from the level of care provided by adult homes or enriched housing programs in several significant ways. An additional requirement for ALRs is an individualized service plan (ISP) for each resident. The ISP describes what services will be provided and the identified provider or staff responsible. The ISP must be reviewed and updated every six months as well as whenever a resident has a significant change in needs. In addition, prospective residents, resident and their representatives are entitled to significant residency agreement and disclosure information. Case management and other services and related staff qualification and training requirements will differ as well.
    Certification as an Enhanced ALR will allow residents to age in place. This is a major new feature of the Assisted Living Reform Act. Assisted living residences with Enhanced ALR certification may retain residents who exceed the retention standards of adult homes, enriched housing programs or assisted living residences. Enhanced ALRs cannot admit residents in need of 24-hour skilled nursing care or medical care. A written evaluation from the resident's physician that the resident does not require 24-hour skilled nursing care or medical care is required prior to admission. However, Enhanced ALRs may retain residents in need of 24-hour skilled nursing care or medical care if certain conditions are met as described in this section.
    The second certification category for which ALRs may apply is the Special Needs ALR. The Special Needs ALR certification requires that ALRs that advertise or market themselves as serving individuals with special needs, including but not limited to dementia or cognitive impairments, must apply to the New York State Department of Health (the Department) for Special Needs ALR certification. All facilities currently licensed under Article 7 of the Social Services Law that operate dedicated dementia facilities and/or units will be required to apply for this designation. The Department has revised its current policy and procedures for such dementia units.
    No adult home, enriched housing program or ALR may advertise or market itself as providing specialized services to individuals with special needs unless and until the residence has been licensed as an ALR and issued a Special Needs assisted living certificate. This approval will be based in part on the submission of a special needs plan which sets forth how the special needs of such residents will be safely and appropriately met at the residence. The plan must include, but need not be limited to, a written description of specialized services, staffing levels, staff education and training, work experience, professional affiliations or special considerations relevant to serving persons with special needs, as well as any environmental modifications that have been made or will be made to protect the health, safety, and welfare of such persons in residence. The approval of any special needs program will also be based on adherence to any standards developed by the Department to ensure adequate staffing and training necessary to safely meet the needs of the specialized population proposed to be served.
    The Department proposes the following rule making for the purpose of providing a regulatory framework for implementation of the Assisted Living Reform Act of 2004.
    Section 1001.1 sets out the types of residences to which this regulation applies, as well as what other regulations will apply to assisted living residences.
    Section 1001.2 lists the applicable definitions.
    Section 1001.3 provides the requirements pertaining to certificates of incorporation and/or articles of organization. Specifically, this section sets forth the requirements for a not-for-profit corporation or business corporation to file or amend certificates of incorporation or for a limited liability company to file or amend articles of organization for the purpose of establishing and operating or fundraising on behalf of any ALR, Enhanced ALR or Special Needs ALR.
    Section 1001.4 describes who may be issued operating certificates to operate an ALR, Enhanced ALR or a Special Needs ALR. In addition, this section discusses what must be contained in the respective operating certificates. This section also prohibits the operator from taking certain actions with respect to the operating certificate. Also detailed is what actions must be taken by the operator in the event that the residence ceases operations. Finally, this section provides what authority the operator and the fact that such authority is limited to the operator.
    Section 1001.5 enumerates the procedure for and what information must be included in an application for licensure as an ALR and for certification as an Enhanced ALR or a Special Needs ALR. This section also describes the process that will be followed by the Department when considering applications.
    Section 1001.6 provides the general provisions to which all assisted living residences must adhere.
    Section 1001.7 discusses the admission and retention standards applicable to assisted living residences. Specifically, this section provides the standards that need to be met at the differing levels of care. This section also lists the differing levels of resident infirmity that would preclude a residence (depending on the type of certificate that the facility is operating under) from admitting and/or retaining such a resident.
    Section 1001.8 provides the consumer and resident protections. These specific protections require each residence to provide the residents with a living environment that promotes dignity, autonomy, independence and privacy in the least restrictive and most home like setting. This section provides individual residents' right as well as providing for the support of resident and family organizations. Also enumerated in this section are standards that must be followed when creating and implementing residency agreements.
    Section 1001.9 sets forth the requirements of how residents' funds and valuables are to be maintained and protected.
    Section 1001.10 lists the services that must be provided by assisted living residences. These services include, but are not limited to the following: monitoring, daily food service, case management service, personal care, health care, medication management. Depending on the operating certificate of the individual residence, the residence may expand the scope of the basic services provided and/or provide additional services.
    Section 1001.11 discusses personnel requirements. This section delineates staff training requirements, appropriate tasks for each specific training level and the staffing levels and classifications that must be present at the residence at any given time.
    Section 1001.12 proscribes what records and reports must be generated and maintained by the operator.
    Section 1001.13 lists the structural and environmental standards that must be met by both existing and newly constructed residences.
    Section 1001.14 set forth the requirement that each residence must have disaster and emergency preparedness plans. This section also provides what should be included in such plans and how often such plans should be updated.
    Section 1001.15 provides for the inspection and enforcement procedures to which each assisted living residence will be subject, and enumerates the schedule of penalties.
    Section 1001.16 details the requirements and procedures to be followed should an operator of a residence contract with a separate entity for the provision of any of the residence's management or operations.
    In addition to the sections set forth above, the residence will also be required to comply with any applicable adult care facility regulations found in Title 18 of the New York Code of Rules and Regulations Parts 485, 486, 487 and 488 and any other statutes and regulations required for maintaining a valid operating certificate issued pursuant to Title Two of Article Seven of the Social Services Law, unless superceded by a conflicting provision of the Assisted Living Reform Act, and shall obtain and maintain all other licenses, permits, registrations or other government approvals required in addition to the requirements under Article Seven.
    Revised rule compared with proposed rule:
    Substantial revisions were made in sections 1001.2(a)(10), 1001.4(n)(1), (o), 1001.5(k), 1001.6(e)(6), 1001.7(l), 1001.8(c)(2)(iii)(c), (d), (f)(4), 1001.10(l), (n)(6), 1001.11(j), (n), 1001.12(c)(3), 1001.16(b)(2), (3), (4), (6), (9), (c) and (d).
    Text of revised proposed rule and any required statements and analyses may be obtained from:
    Katherine E. Ceroalo, Department of Health, Office of Regulatory Affairs, Corning Tower, Rm. 2438, Empire State Plaza, Albany, NY 12237-0097, (518) 473-7488, fax: (518) 473-2019, e-mail: regsqna@health.state.ny.us
    Data, views or arguments may be submitted to:
    Keith McCarthy, Department of Health, Division of Home and Community-Based Services, 161 Delaware Ave., Delmar, NY 12054, (518) 408-1600, e-mail: kjm@health.state.ny.us
    Public comment will be received until:
    30 days after publication of this notice.
    Revised Regulatory Impact Statement
    Statutory Authority:
    The authority for the promulgation of these regulations is contained in Section 4662 of the Public Health Law (PHL), through Chapter 2 of the Laws of 2004 (known as the “Assisted Living Reform Act” or ALRA, PHL Article 46-B). PHL Section 4662 authorizes the Commissioner of Health to promulgate, in consultation with the Director of the State Office for the Aging, such rules and regulations as are necessary to implement the provisions of this article. Section 4662 further authorizes the Commissioner to receive and investigate complaints regarding the condition, operation and quality of care of any entities holding themselves out as “assisted living” or advertising themselves by a similar term, and to exercise all other powers and functions as are necessary to implement the provisions of Article 46-B.
    In order to be licensed as an assisted living residence (ALR), Article 46-B requires all residences to be certified as an adult home or enriched housing program in accordance with Article 7 of the Social Services Law (SSL). Residences that are currently unlicensed desiring to be licensed as an ALR must simultaneously submit an application for licensure as an ALR and an SSL Article 7 application to seek approval as an adult home or enriched housing program. The residence must also be in compliance with all rules and regulations applicable to such facilities (18 NYCRR Parts 485, 486, and 487 (adult homes) or 488 (enriched housing programs)) unless a provision of the ALRA supercedes the Article 7 statutory or regulatory provision. Section 122(c) of Chapter 436 of the Laws of 1997 provides that effective April 1, 1997, the functions, powers, duties and obligations of the former Department of Social Services concerning adult homes, enriched housing programs, residences for adults and assisted living programs (i.e., “adult care facilities”) are transferred to the New York State Department of Health.
    Legislative Objectives:
    In enacting Chapter 2 of the Laws of 2004, the Legislature found and declared that congregate residential housing with supportive services in a home-like setting, commonly known as “assisted living”, is an integral part of the continuum of long term care. Further, the philosophy of assisted living emphasizes aging-in-place, personal dignity, autonomy, independence, privacy and freedom of choice. The legislative objective of PHL Article 46-B is to create a clear and flexible statutory structure for assisted living that provides a definition of “assisted living residence”; that requires licensure of the residence; that requires a written residency agreement that contains consumer protections; that enunciates and protects resident rights; and that provides adequate and accurate information for consumers, which is essential to the continued development of a viable market for assisted living.
    “Assisted living” and “assisted living residence” means an entity which provides or arranges for housing, on-site monitoring, and personal care services and/or home care services (either directly or indirectly), in a home-like setting to five or more adult residents unrelated to the assisted living provider. An applicant for licensure as assisted living that has been approved in accordance with the provisions of this article must also provide daily food service, twenty-four hour on-site monitoring, case management services, and the development of an Individualized Service Plan for each resident. An operator of assisted living shall provide each resident with considerate and respectful care and promote the resident's dignity, autonomy, independence and privacy in the least restrictive and most home-like setting commensurate with the resident's preferences and physical and mental status.
    Needs and Benefits:
    For many years, it has been very difficult for consumers to compare one assisted living residence to another because, in New York State, there had been no standard definition. This opinion was echoed in a 1999 report by the federal General Accounting Office (GAO), which outlined the results of a two-year study of assisted living in four states. A major finding of the report was that consumers need clear and complete information regarding facility services, costs and policies in order to make an informed decision and that, in the states studied, seniors were not routinely provided with sufficient information to allow them to select the most appropriate setting.
    To help seniors make such informed decisions before agreeing to live in an assisted living residence, the ALRA requires every residence to provide clear and complete information to prospective residents before they sign a contract. Under this new law, ALRs must use a standard “plain language” contract — with no small print — that fully discloses what services are provided, by whom, and the cost. The law also requires ALRs to disclose to seniors the conditions under which an operator can terminate a residency agreement and what the resident can expect to happen if they can no longer pay the fees.
    The ALRA also fills the gaps in adult residential services law that in some instances allowed facilities to operate without any licensure or State surveillance. For instance, it requires certain adult residences that had operated without license (known as “look alike” facilities) to become certified as adult care facilities and therefore subject to State regulation and oversight. Any residence that then wishes to market itself as assisted living must seek an additional licensure as an Assisted Living Residence.
    In other instances, facilities had long been prevented from appropriately expanding the range of services provided to their residents as their needs changed over time. The ALRA provides a mechanism to allow those operators who wish to provide a broader range of services, known as “aging in place”, to do so by becoming licensed as an Assisted Living Residence and obtaining additional certification for Enhanced Assisted Living from the Department. Those operators seeking to provide specialized services to special needs residents, such as those with Alzheimer's or dementia, will likewise have to be licensed as an Assisted Living Residence and also obtain a Special Needs Assisted Living certificate.
    To obtain either the Enhanced Assisted Living or Special Needs Assisted Living certifications, operators must submit a plan to the Department demonstrating how they will safely and appropriately meet all of their residents' needs, and have policies in place to continually meet those needs as they change over time. The plan must include, but not be limited to, a written description of services, staffing levels, staff education and training, work experience, and any environmental modifications that have been or will be made to protect the health, safety and welfare of such residents.
    The ALRA provides several important opportunities for consumers and providers: greater clarity as to the definition of “assisted living”; greater assurance that the combinations of housing and services referred to as assisted living will be subject to State oversight; significant protection of consumer/resident rights; the opportunity to age in place with dignity and choice in a more home-like setting; as well as the opportunity for persons with special needs to obtain specialized care by persons with appropriate qualifications and experience. These regulations further the goals of PHL Article 46-B by creating the regulatory framework necessary for implementation of the provisions therein, including but not limited to criteria by which applications for licensure and certification can be reviewed, defining “independent senior housing”, establishing standards for the hiring of direct care staff by residences, and generally clarifying and carrying out the intent of the law.
    Costs for the Implementation of and Continuing Compliance with these Regulations to the Regulated Entity:
    PHL Section 4656(6) prescribes the fees associated with licensure and certification for assisted living. The basic biennial assisted living residence fee is $500 per facility plus an additional $50 for each ALR resident whose income exceeds 400% of the Federal Poverty Level (FPL). The maximum ALR fee required for an individual facility is $5,000. In 2006, 400% of the Federal Poverty Level represents an income level of $39,200 per individual. Financial information on residents who are below the 400% FPL threshold and are not Medicaid or SSI eligible must be maintained to verify their eligibility for an exemption to the $50 fee for residences.
    The biennial fee for Enhanced Assisted Living certification is $2,000. The biennial fee for Special Needs Assisted Living is also $2,000. Facilities applying for Enhanced Assisted Living and Special Needs Assisted Living at the same time are entitled to a discount and are only required to remit a total of $3,000 for both certifications. All applicable fees must be submitted with the initial application for licensure/certification.
    Cost to State and Local Government:
    None.
    Cost to the Department of Health:
    Passage of the ALRA has necessitated the Department hiring of staff to implement its licensure and certification provisions, specifically the review of initial applications submitted to the Department. Under this Act, through creation of a new State Finance Law Section 99-l, a special fund is created in the joint custody of the State Comptroller and the Commissioner of Health — the “Assisted Living Residence Quality Oversight Fund”.
    This fund shall consist of all money collected by the Department pursuant to PHL Article 46-B, including licensure fees, certification fees and civil penalties collected. Any interest earned on investment of monies by such fund becomes part of the fund. The fund shall be available to the Department for the purpose of implementation of PHL Article 46-B.
    Through passage of the SFY 2007–08 Budget, the Department has been authorized up to $2 million from this special revenue account for the implementation and oversight activities related to this Act. In addition, the Act provides that $500,000 is to be available from this fund to the State Office for Aging's Long-Term Care Ombudsman Program for the purposes of carrying out the provisions of Article 46-B.
    Local Government Mandates:
    None.
    Paperwork:
    In many regards, the application process for ALRs is very similar to the process that operators currently utilize to obtain certification for an adult home or enriched housing program. Likewise, with regards to obtaining an Enhanced Assisted Living or Special Needs Assisted Living Certificate, operators will have to submit an application to the Department providing a plan which sets forth how the additional needs of such residents will be safely and appropriately met, including but not limited to, a written description of services, staffing levels, staff education and training, work experience, and any environmental modifications.
    In addition to these application processes to obtain licensure as an ALR and/or certification for Enhanced and/or Special Needs Assisted Living, the Assisted Living Reform Act contains numerous provisions to ensure resident rights are protected and adequate and accurate information is available for consumers. For instance, the Act requires a written residency agreement that contains consumer protections, and enunciates and protects resident rights.
    A key provision of the Act is development of an Individualized Service Plan (ISP). A written ISP must be developed for each resident upon admission. The ISP is to be developed with the resident, resident's representative and resident's legal representative, if any; the operator; and, if necessary, a home care services agency. The initial ISP will be developed in consultation with the resident's physician. If the physician determines that the resident is not in need of home care services, a home care services agency need not participate in the development of the ISP.
    The ISP will take into account the medical, nutritional, rehabilitation, functional, cognitive and other needs of the resident. The ISP will include the services to be provided, and how and by whom services will be provided and accessed. The ISP is to be reviewed and revised as frequently as necessary to reflect the changing care needs of the resident, but no less frequently than every six months. To the extent necessary, such review and revision will be undertaken in consultation with the resident's physician.
    The ALRA requires that certain important information be disclosed to prospective residents and their representatives, pursuant to PHL Section 4658(3). Among the items to be disclosed are: a consumer guide to inform and assist the consumer in the selection of an ALR (prepared by DOH in consultation with the State Office for the Aging, consumers, operators of ALRs, and home care services providers); a statement listing the residence's licensure status and whether it has an Enhanced Assisted Living or Special Needs Assisted Living certificate; a statement that the resident shall have the right to receive services from service providers with whom the operator does not have an arrangement; a statement that the resident shall have the right to choose their health care providers, notwithstanding any agreements to the contrary; and a statement regarding the availability of Long-Term Care Ombudsman Services and the telephone number of the local and State ombudsman.
    Duplication:
    This regulation does not duplicate any other state or federal law or regulation. PHL Section 4656(1) requires that, in order to operate as an assisted living residence, an operator shall be certified as an adult home or enriched housing program pursuant to Title 2 of Article 7 of the Social Services Law. PHL Section 4656(2) goes on to require the assisted living operator to comply with all applicable statutes, rules and regulations required for maintaining a valid operating certificate for an adult home/enriched housing program.
    In PHL Section 4656(7), this lack of duplication is emphasized, stating that the requirements of PHL Article 46-B “shall be in addition to those required of an adult care facility. In the event of a conflict between any provision of this article and a provision of Article 7 of the Social Services Law or a regulation adopted thereunder, the applicable provision of [PHL Article 46-B] or the applicable regulation shall supersede Article 7 of the Social Services Law or the applicable regulation thereunder to the extent of such conflict.” In addition, the application process provides for a streamlined procedure for review of character and competence for those existing operators of adult homes and enriched housing programs who are in “good standing” with the Department in terms of compliance. Operators are being requested to submit only those application materials that are updated information or that is different from what they may have submitted to the Department in previous applications.
    Alternative Approaches:
    No alternative approaches were considered. Section 7 of Chapter 2 of the Laws of 2004 prohibits the Department from issuing emergency regulations in regard to PHL Article 46-B.
    Federal Requirements:
    This regulatory amendment does not exceed any minimum standards of the federal government for the same or similar subject areas.
    Compliance Schedule:
    As Section 7 of the Laws of Chapter 2 of the Laws of 2004 prohibits the Department from issuing emergency regulations in regard to PHL Article 46-B, this regulation will take effect upon publication of a notice of adoption in the New York State Register.
    In terms of compliance schedule, the “Assisted Living Reform Act” became effective 120 days after being signed into law. Since the Governor signed the bill on October 26, 2004, the Act was effective as of February 23, 2005.
    The Act states that any entity which qualifies as an ALR pursuant to PHL Article 46-B and operating as an ALR on or before the effective date shall, within 60 days of such effective date (that is, by April 25, 2005) apply to be licensed or certified with the Commissioner of Health in accordance with the provisions of Article 46-B upon approval of all licenses and certification for which the entity has applied.
    Given the very short timeframe for implementation provided under the Act, the ALR application was not available to applicants until June 3, 2005. Therefore, the Department extended the deadline for submission of the application to August 3, 2005. This regulation will enable the Department to act upon those applications, and perform the oversight functions necessary for implementing the provisions of the Act.
    Revised Regulatory Flexibility Analysis
    Effect of Rule:
    There are 500 existing adult homes and enriched housing programs in New York State. Of those, 371 have been identified as being certified for 100 or fewer beds and considered a small business (74%).
    To date, 226 existing adult homes and enriched housing programs have applied for licensure as Assisted Living Residences (ALRs). An additional 46 applications have been received by the Department by facilities proposing to be certified as an adult home/enriched housing program and subsequently licensed as an ALR.
    The Department has advised prospective applicants that, in order to be licensed as an ALR, the facility's entire capacity will have to be subject to such licensure. Currently with regards to adult care facilities, for example, a 100-bed facility could be comprised of 80 adult home beds and 20 enriched housing program beds. If this same facility desired licensure as an ALR, all 100 beds would have to be licensed as such. It is expected the majority of facilities applying for ALR licensure will be for 100 or fewer beds and, thereby, considered a small business.
    Local governments are not affected by this rule, unless they intend to apply to the Department to operate an ALR.
    Compliance Requirements:
    In order to comply with these requirements, any entity wishing to establish, operate, provide, conduct, or offer “assisted living” in New York state, or hold itself out as an entity which otherwise meets the definition of “assisted living” or by a similar term, must apply and obtain approval of the Department to operate as an adult care facility (either an adult home or an enriched housing program) and as an assisted living residence. This shall not apply to Assisted Living Programs (ALPs) approved by the Department pursuant to SSL Section 461-l.
    Professional Services:
    All facilities required to obtain licensure as an ALR must have staff trained and qualified to provide the care and services the residence has been approved by the Department to provide.
    Compliance Costs:
    PHL Section 4656(6) prescribes the fees associated with licensure and certification for assisted living. The basic biennial assisted living residence fee is $500 per facility plus an additional $50 for each ALR resident whose income exceeds 400% of the Federal Poverty Level (FPL). The maximum ALR fee required for an individual facility is $5,000. In 2006, 400% of the Federal Poverty Level represents an income level of $39,200 per individual. Financial information on residents who are below the 400% FPL threshold and are not Medicaid or SSI eligible must be maintained to verify their eligibility for an exemption to the $50 fee.
    The biennial fee for Enhanced Assisted Living certification is $2,000. The biennial fee for Special Needs Assisted Living is also $2,000. Facilities applying for Enhanced Assisted Living and Special Needs Assisted Living at the same time are entitled to a discount and are only required to remit a total of $3,000 for both certifications. All applicable fees must be submitted with the initial application for licensure/certification.
    Economic and Technological Feasibility:
    As the majority of such existing facilities are small businesses, it should be economically and technologically feasible for small businesses to comply with the regulations.
    Minimizing Adverse Impact:
    The “Assisted Living Reform Act” created a Task Force on Adult Care Facilities and Assisted Living Residences, “to update and revise the requirements and regulations applicable to [ACFs and ALRs] to better promote resident choice, autonomy and independence. The Task Force consists of ten appointed members (six appointed by the Governor, two by the Senate, and two by the Assembly), as well as four ex-officio members (the Commissioner of Health, the Director of the State Office for the Aging, the Commissioner of the Office of Mental Health, and the Chair for the Commission on Quality of Care and Advocacy for Persons with Disabilities). Beginning with their first meeting in April 2005, the Task Force also makes recommendations with respect to “minimizing duplicative or unnecessary regulatory oversight.” In order to minimize adverse impact, the Department has consulted with the Task Force on the principles contained within this regulatory package.
    Small Business and Local Government Participation:
    As stated above, the Task Force on Adult Care Facilities and Assisted Living Residences first convened in April 2005, and has met a total of thirteen times through October 2007. In addition to ex-officio members of four State agencies, the Task Force includes representatives of the ACF and assisted living industry, home care representatives, and consumer advocates.
    Rural Area Flexibility Analysis
    Pursuant to section 202-bb of the State Administrative Procedure Act, a rural area flexibility analysis is not required. These provisions apply uniformly throughout New York State, including all rural areas.
    The proposed rule will not impose an adverse economic impact on rural adult care facilities or assisted living residences.
    Job Impact Statement
    A Job Impact Statement is not included because it is apparent from the nature and purpose of this regulation that it will not have a substantial adverse impact on jobs and employment activities.
    Assessment of Public Comment
    The proposed assisted living residences regulation is intended to create the regulatory framework necessary for implementation of the provisions of the Assisted Living Reform Act of 2004 (ALRA), including but not limited to, the following elements: establishing the criteria by which applications for licensure and certification will be reviewed; establishing standards for admission and retention, consumer and resident protections, resident services, personnel, records and reports, structural and environmental standards, management contracts; defining “independent senior housing”; establishing standards for the hiring of direct care staff by residences; and generally clarifying and carrying out the intent of the law. Overall, the comments on the proposed regulation addressed many varied interests and issues. A total of 946 written comments were received from individuals and organizations during the 45-day public comment period which expired on May 14, 2007.
    A majority of the comments were submitted by residents of facilities which will need to become licensed as assisted living residences. Most of these individuals expressed views strongly in favor of this regulation, stating the proposed regulations provides the protections and oversight needed when residing in an assisted living residence. In particular, these comments support the proposed rules regarding nurse staffing for enhanced assisted living and special needs assisted living, the development of individualized service plans and disclosures that the facilities are required to make to residents.
    Some individuals and organizations commented on issues associated with whether the proposed regulations properly address or exceed the legislative intent of the Assisted Living Reform Act, or are duplicative of current requirements for adult care facilities. Commentors also noted open issues relating to the affordability of the assisted living residence model resulting from the regulation proposed. The Department is confident that the proposed regulations are consistent with both the legislative intent and the letter of the ALRA. The ALRA established the Task Force on Adult Care Facilities and Assisted Living Residences to “gather information regarding the various ways in which existing requirements and guidelines unduly infringe on affordability of care and services, individual resident choice, autonomy and independence, examine and evaluate such requirements and guidelines, and make recommendations” with regard to, among other things, minimizing duplicative or unnecessary regulatory oversight; ensuring that the indigent have adequate access to, and that there are a sufficient number of, enhanced assisted living residences; and developing affordable assisted living.
    Since the inaugural meeting on April 14, 2005, the Task Force has met thirteen times and provided invaluable input on all objectives accomplished for implementing the Act, including consultation on the principles contained within the proposed regulatory package. The Task Force — which, in addition to ex-officio members of four State agencies, includes representatives of the adult care facility (ACF)/assisted living industry, home care representatives, and consumer advocates — will continue to meet to address those issues not yet resolved within this regulatory package.
    Due to the volume of comments submitted, the issues and responses to those issues which follow will focus on those potentially necessitating a substantive change to the regulatory package.
    Issue:
    Some providers commented that the proposed minimum nurse staffing standards for Enhanced and Special Needs Assisted Living Residences fail to take into account the actual needs of the resident population, and conflict with both the letter and spirit of the law which is to ensure access to care and services tailored specifically to the individual needs of the resident as determined by the resident, his/her family and representatives, health care provider and the operator, through development of the individualized service plan (ISP). They express the view that most ACF-level residents discharged to a higher level of care require an increased need for personal care services and/or supervision, rather than skilled nursing care, and that the burden for obtaining the necessary health care services to remain in an EALR is upon the resident and not the facility. Therefore, they argue, the requirements as proposed are unnecessary and excessive.
    Response:
    The proposed minimum nurse staffing requirement for enhanced assisted living residences (EALRs) and special needs assisted living residences (SNARLs) has been revised to significantly reduce the number of hours of coverage required. A registered professional nurse (RN) will need to be on duty and onsite at the residence, for eight hours per day, seven days a week. (By contrast, the original proposed regulation would have required on site coverage by an RN or LPN at least sixteen hours per day, seven days a week, as well as on site coverage by a RN eight hours a day, five days a week.) In addition, an RN must be on call and available for consultation 24 hours a day, seven days a week. RNs would be responsible in an EALR for such necessary nursing services as resident assessments, supervision of aides, and treatments as identified on the ISP. It is important to note that the regulations will require that the operator arrange for additional nursing coverage where determined to be necessary by the resident's physician and/or the ISP process.
    Issue:
    A segment of the industry commented that the provisions pertaining to management contracts should be deleted in their entirety, arguing there exists no statutory reference to the matter and they fail to take into consideration the assisted living business model that exists today in other states, where professionally managed assisted living companies operate through contracts with management companies. Commentors suggested that, at most, the Department of Health review of management contracts should be limited to whether the text of the contract is in compliance with regulation and whether the facility is being operated in compliance with all applicable statutes and regulations. Commentors also indicated that these provisions will negatively impact economic development in New York state, by impeding development of new projects and continued operation of existing communities by experienced, professionally managed organizations.
    Response:
    The Department of Health believes in the need to regulate management agreements for ACFs/ALRs to assure that only duly approved operators are given independent authority for the operation of the facility, as well as the need to conduct character and competency reviews on proposed managers. The provisions within the proposed regulatory package for management contracts have been revised to address specific recommendations made by industry representatives. In particular, the regulations would be modified to: (1) add a provision that the Department must provide a written response within 90 days after the submission by an applicant or operator of a proposed management agreement, provided that the Department has received all information necessary for its review; (2) increase the duration for approved management contracts from 3 years to 5 years; (3) eliminate the requirement that the operator demonstrate that “goals and objectives” of the management contract have been met; (4) clarify that for an already approved contract, only revisions related to a substantive change in terms of power delegated, management fees, the term of the agreement, and changes to the management entity itself or its principals, must receive the prior written approval of the Department; and (5) develop in consultation with the industry a model Management Agreement. Further, while the provision pertaining to contractor's fees has been deleted in its entirety, language has been added to require that management contracts contain the method and amount of payment for management services provided to the ALR. In addition, the regulation has been amended to add a provision authorizing the Department to terminate a management agreement should the residence provide a severe and persistent substandard level of care.
    Issue:
    A segment of the industry submitted comments about the proposed definition of “Independent Senior Housing” (ISH). Some commentators requested additional clarification with regard to such terms and phrases as: “arranges for or coordinates”, “personal care”, “directly or indirectly”, “supervision”, and “monitoring”. One commentator suggested additional criteria which could be incorporated into the standards relating to ISH with regard to actions which would be indicators of the provisions or arrangement of personal care and/or homecare services.
    Response:
    The terms “personal care” and “supervision” are defined in ACF regulations. The term “monitoring” is defined both in the ALRA and these proposed regulations. The Department has revised the proposed standards relating to ISH to incorporate the above-noted comment regarding indicators that personal care and/or home care is being provided to the extent that licensure as an ACF or ALR may be necessary. The Department believes the proposed regulation clearly identifies when an entity is subject to ACF certification and when it is subject to ALR licensure, as required under the ALRA.
    Issue:
    Comments were made that the ALR Medical Evaluation (DOH 3122) is quite lengthy and detailed, potentially exceeding the information required of nursing homes. ACFs have traditionally had difficulty getting the current 2-page form completed by physicians in its entirety or accurately. Therefore, DOH is urged to consider: (1) revising the Medical Evaluation form from its proposed 5-page length, and (2) outreach and education to physicians regarding the form and the ALR. In addition, the industry requested the Department allow flexibility regarding who can complete the form to include Physician Assistants.
    Response:
    For the most part, the question does not seem to be related to the value of the data being gathered via the Medical Evaluation, but rather the cooperation of the resident's physician in completing the evaluation. Therefore, the Department has conducted an examination of those items which can be completed by someone other than the physician, and have explored ways to achieve compliance/cooperation from physicians on the remainder. The Department has also re-evaluated the various forms to be completed upon a resident's admission to an ALR (and annually), and have identified efficiencies and eliminated duplication. The regulatory proposal has been amended in certain instances to, where not previously noted, specify the form to be used for the activity undertaken. This will help to eliminate the appearance of duplication.
    Issue:
    Some commentators have stated that the provision prohibiting the requirement of a guarantor of payment as a condition of admission has no basis in law. They believe the language, as proposed, is difficult to interpret. They state that the ability to require a guarantor is central to the financial viability of ALRs, with far-reaching consequences to the potential expansion of assisted living in New York State.
    Response:
    The proposed regulations do not attempt to bar “guarantors of payment”, but to clarify that the operator cannot mandate that a prospective resident or other person agree to a guarantor of payment as a condition of admission unless the operator has reasonably determined, on a case by case basis, that the prospective resident would lack either the current capacity to manage financial affairs and/or the financial means to assure payment due under the residency agreement. The proposed regulations have been revised to set this forth in a clearer manner.
    Issue:
    Some comments were received from industry representatives stating that it is not appropriate to require operators to submit information responsive to any Department of Health request within 30 days or suffer an administrative withdrawal and forfeiture of fees, especially in light of the absence of a specified time for the Department to respond to applicants during the review process. Further, for multi-state operators, gathering information from all states in which they operate can often take more than 30 days.
    Response:
    Applicants for licensure/certification of ACFs historically submit incomplete applications, requiring Department of Health staff to continually follow up with requests for the additional missing documentation. Prolonged response delays from applicants have subsequently resulted in initial, “complete” information becoming outdated or no longer pertinent, thereby resulting in the need for a “current” re-submission and the wasting of initial staff time spent reviewing material. More recently, as applicants have increasingly become more “corporate” in nature, there has been a tendency for changes in major aspects of submitted applications (i.e., individuals in entity, name of entity, landlord, parent company, lease provisions) while review of the initial application materials is still underway. While the regulation, as proposed, attempts to direct applicants to submit required materials while the information contained within is still pertinent, the regulation has been amended to extend this timeframe from 30 to 60 days. In addition, with regard to Department review of waiver requests and management agreements, the regulations have also been amended to provide for a response to an operator within 90 days of receipt of all information necessary for the Department to make a determination.
    Issue:
    Some comments were received from industry representatives expressing concern that the proposed environmental and structural standards exceed what is currently required under regulation for ACFs. They believed the intent of the new law equated basic ALR with the ACF and, as such, their buildings would not require changes. Such commentators contend there is no rational basis for applying different or more stringent standards to ALRs when they serve the very same residents with the very same needs as those now served by many ACFs. They express concern that the proposed environmental and structural standards will discourage participation by existing operators.
    Response:
    The regulations proposed are necessary to modernize the building standards for ACFs/ALRs, which have not been updated in years, to reflect the change in resident populations over that time. The Department recognizes the impact this will have on older existing facilities, yet believes the State must balance that with the need to protect a frailer resident population, in the enhanced ALR where individuals can age in place and in special needs ALRs where individuals with dementia or other special needs will reside, as well as in the general ALR. Further, it must be remembered that the proposed regulation provides for a process by which an applicant can request a waiver of a non-statutory requirement in regulation, which must include a description of what will be done to achieve or maintain the purpose of the regulation to be waived and to protect the health, safety and well-being of the residents.
    Issue:
    Some commentators representing segments of the industry have expressed concern regarding the creation of “Family Organizations”, citing the lack of reference to such in statute. Such commentators argue that, as in the ACF setting, ALR residents may or may not choose to be actively involved in their resident councils. As such, it should be the residents' choice and ultimate decision as to whether they want their family members to be involved in the facility and, if so, whether it should be in the forum of a formal organization.
    Response:
    The proposed revisions emphasize that this provision is to be no different than the current “food committee” requirement for ACFs, established by Chapter 58 of the Laws of 2007. Residents, or families and resident representatives in this case, are not required to form a committee/organization. Yet, if they decide to do so, the operator must assist and facilitate such meetings. Comments received from residents and their advocates are very supportive of this provision.

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