PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:
Action taken:
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 final rule:
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.
Final rule as compared with last published rule:
Nonsubstantive changes were made in sections 404.3, 404.7, 404.10 and 404.11.
Text of 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
Revised Regulatory Impact Statement, Regulatory Flexibility Analysis, Rural Area Flexibility Analysis and Job Impact Statement
Changes made to the last published rule do not necessitate revision to the previously published RIS, RFA, RAFA and JIS.
Assessment of Public Comment
The Office of Alcoholism and Substance Abuse Services (OASAS), Office of Mental Health (OMH) and Department of Health (DOH) received public comments from three provider associations. A fourth set of comments was received from a provider association after the due date. Many of the comments in this late submission were duplicated by other commenters. All comments received were assessed jointly by the three state agencies and are addressed more fully below.
1. Commenters had concerns over not designating a lead agency for the application process and questioning whether a providers wanting to add primary care will need to complete a DOH Certificate of Need (CON) application.
Response: The agencies have developed a web based single application that will be transmitted to all three agencies simultaneously. Providers will be contacted by the involved agencies and may be asked for additional information as necessary. The state licensing agency that originally licensed the site in question will advise the provider of the ultimate determination. There is no separate CON application needed for providers wanting to add primary care.
2. Commenters suggested the regulations are overly restrictive in requiring dual licensure/certification and suggested expanding integrated services to entities that hold only one license/certification, similar to what will be available under Delivery System Reform Incentive Payment (DSRIP) program.
Response: These regulations represent only one model of integrated care, which allows providers who are already licensed or certified by more than one agency to add services at one of their sites without needing to obtain a second license or certification. This allows the agencies to expedite approval and streamline oversight at the site where additional services are added. There are other models of integrated care available to providers, including proceeding under the current allowable thresholds or, for those providers participating in DSRIP, requesting regulatory waivers.
3. A commenter requested that integrated providers, particularly federally qualified health centers (FQHCs), be permitted to be reimbursed for multiple threshold visits per day.
Response: These regulations do not effectuate any change for reimbursement of outpatient services. Integrated providers, including FQHCs that have opted into APGs, can bill using the APG Medicaid reimbursement methodology which permits billing of multiple procedures within a single visit. Generally, integrated providers, including FQHCs are encouraged to bill using the APG reimbursement methodology which enables providers to bill for all the procedures/services rendered on a date of service on a single claim. The Department will undertake consideration of additional mechanisms for billing by FQHCs that do not utilize APGs.
4. A commenter recommended eliminating the requirement for physical separation of space between types of service providers.
Response: Under the regulations (14 NYCRR 825.10(c)(1)(i), 14 NYCRR 599-1.10(c)(1)(i) and 10 NYCRR 404.10(c)(1)(i)), examination rooms must be generally available during the hours when primary care services are offered. Such rooms can be used for behavioral health services if not being used for primary care services at that time and if appropriate for the services.
5. A commenter asked whether the boards of integrated providers must include all clinical areas of expertise which they provide.
Response: This is not specifically required by the regulations; however, providers will need to ensure that they are capable of carrying out the requirements that “the established governing bodies of licensed integrated service shall be legally responsible for quality of care and compliance with all applicable laws and regulations.” 14 NYCRR 825.6(b), 14 NYCRR 599-1.6(b) and 10 NYCRR 404.6(b).
6. A commenter requested clarification of the requirement that treatment plans identify each diagnosis for which a patient is being treated.
Response: Treatment plans may be integrated. To the extent they are, all diagnoses for which a patient is being treated should be included in the plan. The agencies are developing a guidance document which will provide additional instructions in treatment plan development.
7. A commenter noted that while the proposed regulations require that periodic reviews of treatment plans include “an evaluation of physical health status" the reviews also should include adjustments to address physical health needs.
Response: 14 NYCRR 825.7(g)(3), 14 NYCRR 599-1.7(g)(3) and 10 NYCRR 404.7(g)(3) apply to treatment plan reviews. By definition a review would include any necessary adjustments to the plan including those required to address shifting physical health needs. No change will be made.
8. Commenters requested clarification of how many professionals are required to sign a treatment plan under 14 NYCRR 825.7(g)(4), 14 NYCRR 599-1.7(g)(4) and 10 NYCRR 404.7(g)(4). Requiring multiple professionals to sign a treatment plan would be burdensome.
Response: Only one responsible staff member involved in the patient’s care needs to sign the treatment plan. The regulations have been clarified.
9. Commenters asked why primary care excludes OB/GYN services.
Response: The regulations (14 NYCRR 825.9(a)(2)(iv), 14 NYCRR 599-1.9(a)(2)(v) and 10 NYCRR 404.9(a)(2)(v)) provide that for behavioral health care models primary care services provided within the specialty of OB/GYN are limited to routine gynecologic care and family planning provided pursuant to 10 NYCRR Part 753. Other OB/GYN services are considered specialty care beyond the scope of what should be offered in these settings.
10. A commenter asked why there are different criteria for how a provider will be determined to be “in good standing” based on the licensing agency.
Response: The regulations set forth a process for expediting approval of the addition of services at a site in lieu of licensure or certification by a second agency; therefore, the provider needs to be in good standing according to the standards of each agency by which it is licensed or certified. All providers will be evaluated using the same criteria after they have been approved to deliver integrated services.
11. A commenter asked why the regulations require integrated providers to be members of a Health Home if being a member of a DSRIP performing provider system (PPS) would be sufficient.
Response: The enabling legislation derives from Health Home legislation and therefore Health Home affiliation is required. The objective of the integrated services initiative are consistent with the objective of the health homes program. Membership in a DSRIP PPS alone is not sufficient.
12. A commenter asked if unannounced inspections occur prior to approval for joint licensure or only prior to renewal?
Response: The inspections contemplated by 14 NYCRR 825.15, 14 NYCRR 599-1.15 and 10 NYCRR 404.15 will occur after approval.
13. A commenter raised a concern about the ability of “busy clinical staff” to meet with agency inspectors and provide requested clinical records.
Response: A key benefit to the integrated licensure regulations is that clinics providing services of multiple State agencies will only be subject to an inspection by one (“host”) State agency, rather than an inspection by each agency. The agencies are mindful of staff time and resources; however to ensure compliance and continued authorization for delivery of integrated services routine inspections are necessary.
14. A commenter asked if fiscal viability reviews will be based on the viability of the integrated services or the entire organization and asked if this requirement could be eliminated.
Response: The requirement is necessary to examine how the operation of an integrated services program will impact the overall fiscal integrity of the provider.
15. A commenter stated that there is duplication and inconsistency between the integrated services regulation and existing regulations for clinics or diagnostic and treatment centers and recommended that 14 NYCRR 825.3(c), 14 NYCRR 599-1.3(c) and 10 NYCRR 404.3(c) be eliminated.
Response: These sections cannot be eliminated because they provide the basis for integrated service providers operating pursuant to the standards of the state agency that initially licensed or certified the provider at the site at which services will be added. The guidance document will provide clarification to the extent any specific inconsistencies are identified.
16. A commenter requested that the definition of primary care services be changed to include “any qualified practitioner working within their defined scope of practice.” Another commenter recommended that the definition of primary care services be expanded to include other professionals.
Response: The regulations were designed to allow providers to add primary care services in certain settings where behavioral health care services are offered. The requested clarification could allow the inclusion of specialty care, which is not appropriate for these settings.
17. Commenters expressed concern that the regulations would restrict providers who do not apply to become an integrated services provider from marketing themselves as delivering integrated services.
Response: These regulations are intended to facilitate one model of delivering integrated care. There is no prohibition on other models that exist or may exist so long as otherwise allowable. 14 NYCRR 825.6(a), 14 NYCRR 599-1.6(a) and 10 NYCRR 404.6(a) have been clarified to reflect this by removing the word “only.”
18. Commenters expressed concerns about the potential conflict between the treatment planning requirements in the regulation and those of Medicaid managed care companies.
Response: The regulations were designed to allow providers to comply with the requirements of Medicaid managed care plans, therefore 14 NYCRR 825.7(c)(2), 14 NYCRR 599-1.7(c)(2) and 10 NYCRR 404.7(c)(2) were clarified by adding “notwithstanding this section.”
19. A commenter asked if the treatment planning section of the regulations replace the treatment planning section in Part 822 or 599.
Response: Providers licensed by OMH or certified by OASAS still need to follow 14 NYCRR Parts 599 and 822, respectively. The treatment planning section in these regulations applies to the extent that integrated services are offered. The agencies are developing a guidance document that will provide additional instruction in treatment plan development.
20. A commenter stated that the treatment planning requirements of “factors” to be considered (14 NYCRR 825.7(e), 14 NYCRR 599-1.7(e) and 10 NYCRR 404.7(e)) are too prescriptive and should be made more flexible.
Response: The factors identified are critical to ensuring a patient’s behavioral health needs are appropriately assessed and identified and that an acceptable plan of care is developed. These are the minimum factors to be considered and providers may choose to expand on them.
21. A commenter recommended that the language related to discharge planning be eliminated because many patients will never be discharged and always require continuing care.
Response: Planning for “discharge” from behavioral health treatment is a critical part of the treatment planning process. The agencies are developing a guidance document that will provide additional instruction on continuing care and discharge planning.
22. A commenter stated that problem areas in a treatment plan should not be limited to patient-identified problem areas but should also include provider-identified problem areas.
Response: These are the minimum areas to be considered and providers may choose to expand on them and include provider-identified areas.
23. A commenter recommended that that list of identified psychotherapy services identified in 14 NYCRR 825.9, 14 NYCRR 599-1.8 and 10 NYCRR 404.9 should permit the use of telemedicine.
Response: These regulations do not prohibit the use of telemedicine to the extent otherwise permitted.
24. Commenters raised concerns over limiting substance use disorder counseling to two distinct methods, individual and group, both of which require face-to face delivery.
Response: 14 NYCRR 828.9(c)(3), 14 NYCRR 599-1.9(c)(3) and 10 NYCRR 404.9(c)(3) state “Integrated services providers of substance use disorder services shall offer, at a minimum, each of the following services…” The regulations do not prohibit the use of telemedicine to the extent otherwise permitted.
25. Commenters raised concerns over the creation of additional, expensive and/or redundant environmental/physical plant standards and the dichotomy in the standards between providers currently licensed and those licensed after the effective date of the regulations.
Response: The regulations provide additional flexibility to accommodate existing space for providers adding primary care services. Providers with three or fewer examination rooms need to follow only the environmental/physical plant standards as set forth in the new regulations. Prospective providers that have never obtained a license or certification from any of the three agencies prior to the effective date of the new regulations and therefore are not using any licensed or certified space will be required to follow existing Article 28 standards in the provision of primary care.
26. A commenter stated that the creation of additional burdens based on whether there are 3 or less examination rooms creates a potential barrier to behavioral health providers that want to add primary care.
Response: The additional requirements are necessary in settings with over 3 examination rooms to ensure patient health and safety in light of the higher volume of primary care visits.
27. A commenter suggested that the state adopt the 2010 edition of NFPA 101 Life Safety Code instead of referencing the outdated 2000 edition.
Response: The regulations rely on the most recently adopted version of the Life Safety Code but includes categorical waivers that have been issued by CMS based on the 2012 Life Safety Code to provide a standard that is consistent with NFPA current updates.
28. A commenter stated that the quality assurance requirements for providers of primary care should not be in addition to those already required of primary care providers under 10 NYCRR 405.6.
Response: The quality assurance requirements contained in 14 NYCRR 825.11(a)(1), 14 NYCRR 599-1.11(a)(1) and 10 NYCRR 404(a)(1) apply only to those providers adding primary care. They are not additional requirements for Article 28 providers adding behavioral health services.
29. A commenter stated that the regulations have criteria for medical directors where primary care and substance use disorder services are provided but inquired as to whether integrated service providers adding mental health are required to have a medical director. If so, there should be discretion as to whether this is a full-time or part-time medical director.
Response: The regulations require providers adding primary care or substance use disorder services to utilize a medical director. Providers adding mental health services do not have a similar requirement; however, such providers will already have a medical director in place due to their existing licensure or certification by DOH or OASAS.
30. A commenter stated that the development of integrated care records is essential and recommended that the regulations be amended to state that patient consent to integrated care constitutes compliance with state and federal disclosure requirements.
Response: The regulations reflect the importance of integrated patient records. The regulations do not prohibit the use of patient consent for purpose of providing integrated care. The agencies are developing a guidance document which will provide additional instruction on recordkeeping and consent issues.
31. A commenter seeks clarification on whether the authority to provide integrated services extends system-wide or is site-specific.
Response: The approval is site specific; however providers can have multiple sites approved. There is no limit on the number of sites for which a provider can seek approval.
32. A commenter asked about how the new deeming law authorizing OMH and OASAS to accept hospital accreditation from a national organization in lieu of separate, duplicate state surveys will interact with the survey process for integrated service providers.
Response: The new deeming law has not been operationalized in ambulatory behavioral health settings yet. OMH and OASAS have started to work on a plan to allow deeming in these settings. This plan will address integrated service providers.
33. Commenters raised concerns over billing and rates not being addressed in the regulation and the need to have one billing process to streamline the system.
Response: The agencies will provide Medicaid billing and claiming guidance which addresses the complexities in each service category. Generally, providers will be encouraged to submit a single APG claim for each visit (including those comprising multiple service types) with all the procedures/services rendered on that date of service using the host’s assigned Integrated Services rate codes. Medicaid managed care plans will be notified of the Department of Health’s Medicaid billing/reimbursement policies as they relate to the types integrated services rendered by rendering providers.
34. A commenter stated that CASAC was eliminated from the qualified health professional list in outpatient mental health clinics and recommended that CASACs should be part of the joint license for billing purposes.
Response: Currently CASAC’s are not considered qualified health professionals in OMH and DOH clinics. CASACs can be used for delivery of substance use disorder services in any approved integrated setting that has authority from OASAS to deliver substance use disorder services, provided that all other applicable staffing requirements are met.
35. A commenter recommended adding language to the policies and procedures section about using electronic medical records and sharing information.
Response: The regulations do not prohibit electronic medical records and information sharing. The manner of recordkeeping is left up to the provider.
36. A commenter asked why group counseling for substance use disorder treatment is limited to 15 people when there is no such limit for other disciplines.
Response: These requirements are consistent with current OASAS requirements and best practices in substance use disorder treatment.
37. A commenter requested clarification of “staff and appropriate equipment” needed to deliver primary care services.
Response: Provider must ensure that they have the staff and equipment necessary to provide services that are consistent with prevailing standards of care.
38. A commenter asked what the periodic reviews of primary care services with behavioral health services entail in the context of a quality assurance program.
Response: Periodic reviews are required as part of a provider’s quality assurance program, which must be designed to verify that providers have processes in place for the provision of quality and appropriate care.
39. A commenter recommended that the quality assurance, utilization review and incident reporting sections be consolidated into a single set as they are overly burdensome and do not foster true integration.
Response: These sections were designed to promote flexibility for participating providers.
