PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:
Proposed Action:
Addition of Part 825 to Title 14 NYCRR.
Statutory authority:
Mental Hygiene Law, sections 19.07(c), 19.09(b), 19.40, 32.07(a) and 32.02
Subject:
Integrated Outpatient Services.
Purpose:
To promote access to physical and behavioral health services at a single site and to foster the delivery of integrated services.
Substance of proposed rule (Full text is posted at the following State website:www.oasas.ny.gov/regs/index.cfm):
The Proposed Rule relates to standards applicable to programs licensed or certified by the Department of Health (DOH; Public Health Law Article 28), Office of Mental Health (OMH; Mental Hygiene Law Articles 31 and 33) or Office of Alcoholism and Substance Abuse Services (OASAS; Mental Hygiene Law Articles 19 and 32) which desire to add to existing programs services provided under the licensure or certification of one or both of the other agencies.
§ 825.1 Background and Intent. This section speaks to the background and intent of the Proposed Rule as applicable to all three agencies (DOH, OMH and OASAS). The purpose of the Rule is to promote increased access to physical and behavioral health services at a single site and to foster the delivery of integrated services based on recognition that behavioral and physical health are not distinct conditions.
§ 825.2 Legal Base. This section provides the Legal Base applicable to all three agencies for the promulgation of this Proposed Rule.
§ 825.3 Applicability. This section identifies providers of outpatient services or programs to which the standards outlined in the Proposed Rule would apply (e.g. providers certified or licensed or in the process of pursuing licensure or certification by at least two of the participating state agencies). Such providers would continue to maintain regulatory standards applicable to the host program’s license or certification.
§ 825.4 Definitions. This section provides definitions as used in the Proposed Rule which would be applicable to any program licensed or certified by any of the three participating state agencies and identified as the host (program requesting the addition of services). Definitions specific to a host program’s licensing agency are found in regulations of that agency. Among other things, the section defines an “integrated services provider” as a provider holding multiple operating certificates or licenses to provide outpatient services, who has also been authorized by a commissioner of a state licensing agency to deliver identified integrated care services at a specific site in accordance with the provisions of this Part.
§ 825.5 Integrated Care Models. This section describes three (3) models for host programs: (a) the Primary Care Host Model with compliance monitoring by DOH; (b) the Mental Health Behavioral Care Host Model with compliance monitoring by OMH; and (c) the Substance Use Disorder Behavioral Care Host Model with compliance monitoring by OASAS.
§ 825.6 Organization and Administration. This section requires any integrated services provider to be certified by the appropriate state agency and to revise any practices, policies and procedures as necessary to ensure regulatory compliance.
§ 825.7 Treatment Planning. This section requires treatment planning for any patient receiving behavioral health services (OMH and/or OASAS) from an integrated service provider and articulates the scope, standards and documentation requirements for such treatment plans including requirements of managed care plans where applicable.
§ 825.8 Policies and procedures. This section identifies minimum required policies and procedures for any integrated service provider.
§ 825.9 Integrated Care Services. This section identifies the minimum services required of any integrated services provider providing any of the three care models. The section also identifies services for each model which may be provided at an integrated services provider’s option.
§ 825.10 Environment. This section outlines minimum physical plant requirements necessary for certifying existing facilities which want to provide integrated care services. The section requires programs seeking certification after the effective date of this Rule or who anticipate new construction or significant renovations to comply with requirements of 10 NYCRR Parts 711 (General Standards of Construction) and 715 (Standards of Construction for Freestanding Ambulatory Care Facilities).
§ 825.11 Quality Assurance, Utilization Review and Incident Reporting. This section outlines the requirements and obligations of an integrated service provider relative to QA/UR and Incident Reporting and are detailed by the type of model as the host program.
§ 825.12 Staffing. This section outlines staffing requirements by type of model as the host program and identifies specific requirements which may be unique to the model such as subspecialty credentials of a medical director.
§ 825.13 Recordkeeping. This section requires that a record be maintained for every individual admitted to and treated by an integrated services provider. Additional requirements include designated recordkeeping staff, record retention, and minimum content fields specific to each model. Confidentiality of records is assured via patient consents and disclosures compliant with state and federal law.
§ 825.14 Application and Approval. This section outlines the process whereby a provider seeking to become an integrated service provider may submit an application for review and approval. Applications are standardized for use by all three licensing agencies but shall be reviewed by both the agency that regulates the services to be added and the agency with authority for the host clinic. The section identifies minimum standards for approval.
§ 825.15 Inspection. This section requires the state licensing agency with authority to monitor the host clinic to have ongoing inspection responsibility pursuant to standards outlined in this Proposed Rule. The adjunct state licensing agency will not duplicate inspections for license renewal or compliance but shall be consulted about any deficiencies relative to the added services. The section identifies specific areas of review and requires one unannounced inspection prior to renewal of an Operating Certificate or License.
A copy of the full text of the regulatory proposal is available on the OASAS website at: http://www.oasas.ny.gov/regs/index.cfm
Text of proposed rule and any required statements and analyses may be obtained from:
Trisha Schell-Guy, NYS Office of Alcoholism and Substance Abuse Services, 1450 Western Ave., Albany, NY 12203, (518) 485-2317, email: Trisha.Schell-Guy@oasas.ny.gov
Data, views or arguments may be submitted to:
Same as above.
Public comment will be received until:
45 days after publication of this notice.
Regulatory Impact Statement
Statutory Authority:
These proposed regulations concerning integrated outpatient services are being issued by the Office of Alcoholism and Substance Abuse Services (OASAS) and were developed with the Office of Mental Health (OMH), and the Department of Health (DOH). For OASAS, the regulations will appear in a new Part 825 of Title 14 of the New York Codes, Rules and Regulations. OMH and DOH each will issue an identical set of regulations which will appear in Part 825 of Title 14 of the New York Codes, Rules and Regulations (NYCRR) and Part 404 of Title 10 of the NYCRR, respectively.
These regulations are issued pursuant to the following:
Social Services Law (SSL) sections 365-a(2)(c) and 365-l(7) and Part L of Chapter 56 of the Laws of 2012, which authorize the commissioners of DOH, OMH and OASAS, with the approval of the Director of the Budget, to promulgate regulations to facilitate integrated service delivery by providers;
Section 19.07(c) of the Mental Hygiene Law (MHL) which charges the Office of Alcoholism and Substance Abuse Services with the responsibility to ensure that persons who abuse or are dependent on alcohol and/or substances and their families are provided with care and treatment that is effective and of high quality;
Section 19.07(e) of the MHL which authorizes the commissioner of the Office of Alcoholism and Substance Abuse Services to adopt standards including necessary rules and regulations pertaining to chemical dependence treatment services;
Section 19.09(b) of the MHL which authorizes the commissioner of the Office of Alcoholism and Substance Abuse Services to adopt regulations necessary and proper to implement any matter under his/her jurisdiction;
Section 19.21(b) of the MHL which requires the commissioner of the Office of Alcoholism and Substance Abuse Services to establish and enforce regulations concerning the licensing, certification, and inspection of chemical dependence treatment services;
Section 19.21(d) of the MHL which requires the Office of Alcoholism and Substance Abuse Services to establish reasonable performance standards for providers of services certified by the Office;
Section 19.40 of the MHL which authorizes the commissioner of the Office of Alcoholism and Substance Abuse Services to issue operating certificates for the provision of chemical dependence treatment services;
Section 32.01 of the MHL which authorizes the commissioner of the Office of Alcoholism and Substance Abuse Services to adopt any regulation reasonably necessary to implement and effectively exercise the powers and perform the duties conferred by article 32 of the MHL;
Section 32.07(a) of the MHL which authorizes the commissioner of the Office of Alcoholism and Substance Abuse Services to adopt regulations to effectuate the provisions and purposes of article 32 of the MHL;
Section 32.05(b) of the MHL which provides that a controlled substance designated by the commissioner of the New York State Department of Health as appropriate for such use may be used by a physician to treat a chemically dependent individual pursuant to section 32.09(b) of the MHL; and
Section 32.09(b) of the MHL which provides that the commissioner of the Office of Alcoholism and Substance Abuse Services may, once a controlled substance is approved by the commissioner of the New York State Department of Health as appropriate for such use, authorize the use of such controlled substance in treating a chemically dependent individual.
Legislative Objectives:
Pursuant to SSL sections 365-a(2)(c) and 365-l(7) and Part L of Chapter 56 of the Laws of 2012, the commissioners of the Office of Mental Health (OMH), Office of Alcoholism and Substance Abuse Services (OASAS) and the Department of Health (DOH) are authorized, with the approval of the Director of the Budget, to promulgate regulations to facilitate integrated service delivery by providers.
Since 2012, OASAS, OMH and DOH have pursued an Integrated Licensure Pilot Project pursuant to this authority. The goals of that project have been to streamline the approval and oversight process for clinics interested in providing services under the licensure of more than one agency (OMH, DOH, OASAS) at one or more location(s), thereby:
- Providing an efficient approval process to add new services to a site that is not licensed for those services.
- Establishing a single set of administrative standards and survey process under which providers will operate and be monitored.
- Providing single state agency oversight of compliance with administrative standards for providers offering multiple services at a single site.
In addition, the project sought to improve the quality and coordination of care provided to people with multiple needs, by:
- Promoting integrated treatments records that comply with applicable Federal and State confidentiality requirements.
- Making optimal use of clinical resources jointly developed by OASAS and OMH that support evidence-based approaches to integrated dual disorders treatment.
- Ensuring that optimal clinical care and not revenue drive the program model.
- Providing an opportunity for optimal clinical care in a single setting creating cost efficiencies and increasing quality.
Highlights of the Project have included the formation of an interagency workgroup (OMH, DOH, OASAS) to develop a single set of administrative standards and a single application for licensure or certification. Though a provider may have multiple licenses, they are overseen by a single State agency utilizing a single review instrument.
It was from the Project that development of this regulatory proposal was conceived, to be used by all three State oversight agencies to promote consistency in the provision of integrated services. This regulatory proposal is therefore crafted utilizing the principles of the Integrated Licensure Project (the “Project”) as its basis:
- to allow a single outpatient clinic provider to deliver the desired range of cross-agency (DOH, OMH, OASAS) clinic services under a single license
- the clinic provider would need to possess licenses from at least 2 of the 3 participating State agencies within their network
- the current license of the clinic site would serve as the “host”, allowing that State agency to assume all surveillance activities relative to the site
- the desired “add-on” services would be requested via the State agency currently with primary oversight responsibility for such services
Needs and Benefits:
Physical and behavioral health conditions (i.e., mental illness and/or substance use disorders) often occur at the same time. Persons with behavioral disorders frequently experience chronic illnesses such as hypertension, diabetes, obesity, and cardiovascular disease. These illnesses can be prevented and are treatable. However, the difficulty in navigating complex healthcare systems calls for the implementation of regulatory changes to facilitate the ability of individuals with behavioral health disorders to seek treatment for their physical conditions.
Primary care settings have, at the same time, become a gateway to the behavioral health system, as people seek care for mild to moderate behavioral health needs (e.g., anxiety, depression, or substance use) in primary health care settings. Health care providers have long recognized that many patients have both physical and behavioral health care needs, yet physical and behavioral health care services have traditionally been provided and paid for separately. Even behavioral health services have traditionally been treated in a bifurcated system (e.g., substance use disorder treatment is treated separately from mental health treatment).
The term “integrated care” describes the systematic coordination of primary and behavioral health care services. The growing awareness of the prevalence and cost of comorbid physical and behavioral health conditions, and the increased recognition that integrated care can improve outcomes and achieve savings, has led to increasing acceptance of delivery models that integrate physical and behavioral health care. Moreover, most patients prefer to have their physical and behavioral health care delivered in one place, by the same team of clinicians. Accordingly, these regulations will prescribe standards for the integration of physical and behavioral health care services in certain outpatient programs licensed by DOH, OMH, and/or OASAS.
Costs:
Costs to Private Regulated Parties:
There are no additional costs to participating providers for this initiative. Integrated service sites will likely benefit from administrative process improvements related to facility licensure and recertification, which will be coordinated by a single host agency pursuant to this rule. Absent the process set forth in the regulations, providers would have to obtain the approval of another agency to provide such services and would be subject to the oversight of the other agency. Accordingly, the proposed regulations may reduce the administrative costs that would otherwise be incurred as a result of adding services. In addition, the ability of providers to integrate primary care and behavioral health services will improve the overall quality of care for individuals with multiple health conditions and will reduce overall health and behavioral health care costs.
Costs to Local Government:
The proposed regulations will not impose any additional costs on local governments. To the extent that a local government operates a provider that will be able to integrate services under the expedited process established by the regulations, it will benefit from the administrative efficiencies created by the regulations. In addition, as previously noted, the ability of providers to integrate primary care and behavioral health services will improve the overall quality of care for individuals with multiple health conditions and will reduce overall health and behavioral health care costs, which could have a beneficial impact on the local government.
Costs to OASAS:
Approving and overseeing the addition of integrated services as set forth in the proposed regulations would not add any administrative burdens or costs to OASAS, since it otherwise would have to approve and oversee the addition of substance use disorder services and OMH and DOH will approve and oversee the addition of mental health and primary care services, respectively.
Costs to Other State Agencies:
Approving and overseeing the addition of integrated services as set forth in the proposed regulations would not add any administrative burdens or costs to OMH or DOH, since they otherwise would have to approve and oversee the addition of mental health and primary care services and OASAS will approve and oversee the addition of substance use disorder services.
Local Government Mandates:
This regulatory proposal will not result in any additional imposition of duties or responsibilities upon county, city, town, village, school or fire districts.
Paperwork:
Providers will be required to submit an application to deliver integrated services. The application has been significantly streamlined from a standard certification or licensing application, and providers will not be required to maintain any more documentation than already required under the regulations of their oversight agency. Under the regulations, integrated services providers will be able to use a single integrated record for patients receiving services, instead of maintaining two or three separate records currently required for patients receiving services at multiple sites.
Duplication:
This is a new initiative intended to streamline the administrative licensure and recertification processes for providers that qualify under this rule and hold multiple licenses or certifications. Without the proposed regulations, providers with multiple licenses or certifications would be subject to all the rules and site survey requirements imposed by each agency through which they are licensed.
Alternatives:
“Integrated licensure” is one model for providers to integrate physical and behavioral health services in a single location. Alternative models continue to be pursued (e.g., ambulatory services thresholds in clinics, the Collaborative Care Demonstration, the Delivery System Reform Incentive Payment (DSRIP) Program, the Patient Centered Medical Home and the Geriatric Services Demonstration). Such alternative models have not been rejected by the State oversight agencies. Rather, the barriers to the expansion of each alternative model continue to be examined for possible adoption on broader scales.
Federal Standards:
The regulatory amendment does not exceed any minimum standards of the federal government for the same or similar subject areas.
Compliance Schedule:
The regulatory amendment would be effective immediately upon adoption.
Regulatory Flexibility Analysis
Effect of Rule:
The proposed new Part 836 will impact all approximately 590 providers of substance use disorder services certified by the Office of Alcoholism and Substance Abuse Services (OASAS or “Office”).
Compliance Requirements and Professional Services:
Regardless of type of program, location (rural, urban or suburban), or operation by local governments or small businesses, it is anticipated that there will be minimal impact on reporting and recordkeeping and no need for engagement of professional services because providers are already required to maintain treatment records and application to operate as an integrated services provider is optional.
Costs:
Regardless of type of program, location or size of business (rural, urban or suburban), or operation by local governments or small businesses, there will be no additional costs to providers or local governmental units resulting from these regulations.
Economic / Technological Feasibility:
Regardless of type, size and location of business (rural, urban or suburban), or operation by local governments or small businesses, the proposed regulations require no new equipment or technological improvements.
Minimizing Adverse Economic Impacts:
The proposed amendments were presented to the OASAS Executive Team and Advisory Council and then distributed for comment to members of the provider/stakeholder community. Comments from all, including speculation about economic impact, have been addressed and incorporated into the final regulation wherever necessary.
Participation of Affected Parties:
The proposed regulation amendments were presented to the Behavioral Health Services Advisory Council and distributed for comment to members of the provider/stakeholder community including provider associations. OASAS reviewed and addressed comments received and some changes were made in the proposed regulation.
Rural Area Flexibility Analysis
Types / Numbers:
The proposed amendments to Part 825 may impact approximately 590 providers of outpatient substance use disorder services certified by the Office of Alcoholism and Substance Abuse Services (OASAS or “Office”). The number impacted will depend on the number of providers that choose to apply to become an authorized integrated service provider. Some of these providers may be located in rural areas although the majority of treatment providers are located in urban areas.
Rural areas are defined as counties with a population less than 200,000 and, for counties with a population greater than 200,000, includes towns with population densities of 150 persons or less per square mile. The following 44 counties have a population less than 200,000:
Allegany
Hamilton
Schenectady
Cattaraugus
Herkimer
Schoharie
Cayuga
Jefferson
Schuyler
Chautauqua
Lewis
Seneca
Chemung
Livingston
Steuben
Chenango
Madison
Sullivan
Clinton
Montgomery
Tioga
Columbia
Ontario
Tompkins
Cortland
Orleans
Ulster
Delaware
Oswego
Warren
Essex
Otsego
Washington
Franklin
Putnam
Wayne
Fulton
Rensselaer
Wyoming
Genesee
St. Lawrence
Yates
Greene
Saratoga
The following 9 counties have certain townships with population densities of 150 persons or less per square mile:
Albany
Erie
Oneida
Broome
Monroe
Onondaga
Dutchess
Niagara
Orange
Reporting / Recordkeeping, Professional Services:
Regardless of location (rural, urban or suburban), or operation by local governments or small businesses, it is anticipated that there will be minimal impact on reporting and recordkeeping and no need for engagement of professional services because providers are already required to maintain treatment records and comply with existing treatment regulations and Medicaid billing regulations associated therewith.
Costs:
Regardless of location or size of business (rural, urban or suburban), or operation by local governments or small businesses, providers may incur some up-front administrative costs associated with incorporation of new services into existing records and billing systems; however this costs is expected to be minimal and should be offset by increased revenues generated by the ability to provide additional integrated services. Further, provision of integrated services is optional; providers do not need to apply and can maintain their existing certification or license authorizing them to provider only substance use disorder services, mental health services or primary care services.
Economic / Technological Feasibility:
Regardless of size and location of business (rural, urban or suburban), or operation by local governments or small businesses, the proposed amendments require no new equipment or technological improvements.
Minimizing Adverse Economic Impacts:
The proposed regulation was presented to the OASAS, OMH and DOH Executive Teams, the Public Health and Health Planning Council and Behavioral Health Services Advisory Council. It was also distributed for comment to members of the provider/stakeholder community, including providers that are participating in the pilot, providers certified by OASAS, providers licensed by the Office of Mental Health and providers licensed by the Department of Health. There were no comments received about economic impact. Further, the mufti-agency workgroup that developed these regulations anticipated no adverse economic impact because the purpose of these regulations is to reduce administrative burden on programs while improving efficiency and productivity; improve patient care through delivery of integrated services and fulfill the legislative mandate to allow for establish operating, reporting and construction requirements, as well as joint survey requirements and procedures for entities operating under the auspices of one or more agencies in order to integrate the delivery of health and behavioral health services in an efficient and effective manner.
Participation of Affected Parties:
The proposed regulation amendments were presented to the Behavioral Health Services Advisory Council and distributed for comment to members of the provider/stakeholder community including provider associations. OASAS reviewed and addressed comments received and some changes were made in the proposed regulation.
Job Impact Statement
No job impact statement is required pursuant to section 201-a(2)(a) of the State Administrative Procedure Act. The proposed Part 825 will have no substantial adverse impact on jobs or economic opportunities in New York State. No reduction in the number of jobs and employment opportunities is anticipated as a result of the proposed regulation.
