PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:
Proposed Action:
Addition of Part 404 to Title 10 NYCRR.
Statutory authority:
Public Health Law, section 2803
Subject:
Integrated Outpatient Services.
Purpose:
To establish standards applicable to programs licensed or certified by the DOH, OMH or OASAS to add existing program services.
Substance of proposed rule (Full text is posted at the following State website:www.health.ny.gov):
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.
§ 404.1 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.
§ 404.2 Legal Base. This section provides the Legal Base applicable to all three agencies for the promulgation of this Proposed Rule.
§ 404.3 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.
§ 404.4 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.
§ 404.5 Integrated Care Models. This section describes three (3) models for host programs: (a) 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.
§ 404.6 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.
§ 404.7 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.
§ 404.8 Policies and procedures. This section identifies minimum required policies and procedures for any integrated service provider.
§ 404.9 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.
§ 404.10 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).
§ 404.11 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.
§ 404.12 Staffing. This section outlines staffing requirements by type of model as the host program and identifies specific requirements which may be unique to the primary care host model such as subspecialty credentials of a medical director.
§ 404.13 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.
§ 404.14 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.
§ 404.15 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 DOH website at: http://www.health.ny.gov/regulations/proposed rulemaking.
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, (518) 473-7488, email: regsqna@health.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.
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:
These proposed regulations concerning integrated outpatient services are being issued by the Department of Health (DOH) and were developed with the Office of Mental Health (OMH), and the Office of Alcoholism and Substance Abuse Services (OASAS). For DOH, the regulations will appear in a new Part 404 of Title 10 of the New York Codes, Rules and Regulations. OMH and OASAS each will issue an identical set of regulations which will appear in Part 14 of the New York Codes, Rules and Regulations (NYCRR).
These regulations are issued pursuant to: (1) 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; and (2) Public Health Law (PHL) § 2803, which authorizes the Public Health and Health Planning Council to adopt rules and regulations, subject to the approval of the Commissioner of Health, to effectuate the purposes of PHL Article 28. OMH and OASAS will reflect their statutory authorities in their regulatory impact statements.
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 processes 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 health care systems calls for the implementation of regulatory changes to facilitate the ability of individuals with behavioral health disorders to seek integrated 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 the Department of Health:
Approving and overseeing the addition of integrated services as set forth in the proposed regulations would not add any administrative burdens or costs to DOH, since it otherwise would have to approve and oversee the addition of primary care services. OMH and OASAS will approve and oversee the addition of behavioral health services.
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 OASAS, since they otherwise would have to approve and oversee the addition of behavioral health services. DOH will approve and oversee the addition of primary care 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 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
No regulatory flexibility analysis is required pursuant to section 202-(b)(3)(a) of the State Administrative Procedure Act. The proposed amendment does not impose an adverse economic impact on small businesses or local governments, and it does not impose reporting, record keeping or other compliance requirements on small businesses or local governments.
Rural Area Flexibility Analysis
No rural area flexibility analysis is required pursuant to section 202-bb(4)(a) of the State Administrative Procedure Act. The proposed amendments will not impose any adverse impact or significant reporting, record keeping or other compliance requirements on public or private entities in rural areas. There are no professional services, capital, or other compliance costs imposed on public or private entities in rural areas as a result of the proposed amendments.
Job Impact Statement
No job impact statement is required pursuant to section 201-a(2)(a) of the State Administrative Procedure Act. The proposed amendments will not have a substantial adverse impact on jobs and employment opportunities.
