ASA-15-11-00005-P Service Standards for Chemical Dependence Outpatient and Opioid Treatment Programs  

  • 4/13/11 N.Y. St. Reg. ASA-15-11-00005-P
    NEW YORK STATE REGISTER
    VOLUME XXXIII, ISSUE 15
    April 13, 2011
    RULE MAKING ACTIVITIES
    OFFICE OF ALCOHOLISM AND SUBSTANCE ABUSE SERVICES
    PROPOSED RULE MAKING
    NO HEARING(S) SCHEDULED
     
    I.D No. ASA-15-11-00005-P
    Service Standards for Chemical Dependence Outpatient and Opioid Treatment Programs
    PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:
    Proposed Action:
    Repeal of Parts 822 and 828; and addition of new Part 822 to Title 14 NYCRR.
    Statutory authority:
    Mental Hygiene Law, sections 19.07(c), 19.07(e), 1909(b), 1916, 19.21(b), 19.40, 32.01, 32.07(a), 32.05(b) and 32.09(b)
    Subject:
    Service standards for Chemical dependence outpatient and opioid treatment programs.
    Purpose:
    Combine service standards of outpatient and opioid services and implement a new more cost effective payment methodology.
    Substance of proposed rule (Full text is posted at the following State website:www.oasas.state.ny.us):
    The proposed amendments to the above named regulation are being submitted for public review and comment. The proposed amendments include REPEAL of current Parts 822 and 828 and concurrent promulgation of a new regulation combining amended versions of Parts 822 and 828 as subparts of a new Part 822 regulating the majority of outpatient services (Part 816 - outpatient detoxification and Part 823- outpatient services for youth remain separate Parts). The proposed regulations include technical amendments as well as substantive changes prompted by the evolution of treatment practices and social attitudes that affect policies and program goals of NYS Office of Alcoholism and Substance Abuse (OASAS) for outpatient treatment and medically assisted treatment. The new Part 822 also implements a new structure for billing and amending the OASAS State Plan for Medicaid known as Ambulatory Patient Groups (APG). This required significant redefinition of services and review of programs for maximum regulatory compliance as well as maximum clinical success.
    The proposed new Part 822, is divided into subparts; Subparts 822-1, 822-2 and 822-3 are applicable to all outpatient services certified as chemical dependence outpatient programs or opioid treatment programs (OTP). Subpart 822-1 contains general provisions including background, legal base, incorporation by reference, a savings and renewal clause, effective date and severability provisions. Subpart 822-2 contains six subsections. The first subsection is a definitions section incorporating old definitions from the former Part 822 and Part 828. It also adds new definitions including: clinical staff, medical staff, peer advocates, episode of care, visit, patient, and various services which may be provided in outpatient or opioid treatment facilities. There are new subsections establishing recordkeeping requirements applicable to all outpatient providers and those specific to each type of provider (outpatient chemical dependence, outpatient rehabilitation, and OTP). There is a new subsection containing detailed requirements governing how programs document specific treatment services. Finally, the subsection governing the provision of services in excess of the clinical needs of a patient has been relocated to this Section. Subpart 822-3 sets forth the requirements for submission of Medicaid claims. This section also limits the volume of services that can be billed to Medicaid during a daily visit and throughout a patient's episode of care. Subpart 822-4 contains the programmatic requirements for outpatient programs and incorporates provisions necessary to utilize the APG services and billing methodologies. Subpart 822-5 contains the programmatic requirements for OTP's and incorporates the provisions necessary to utilize the APG services and billing methodologies. Programmatic changes were incorporated into the recently promulgated Part 828 (effective by emergency) that conformed OASAS regulations to new federal rules promulgated in 2001. Proposed changes also reflect agency policy and research supported treatment developments that recognize opioid addiction as a chronic illness that can be treated effectively with certain medications (medication assisted treatment) in conjunction with supportive services such as psychosocial counseling, treatment for co-occurring disorders, medical services and, vocational rehabilitation. Amendments throughout the new Part 822 reflect agency policy goals related to recovery services, language consistency, improved efficiency for providers, elevated professionalism of treatment clinicians, and more effective agency regulation.
    Merging the regulations governing outpatient chemical dependence services and medication assisted treatment will continue to reinforce the consolidation of drug and alcohol treatment into a unified system of chemical dependence treatment that began in 1992 (Chapter 223 of the Laws of 1992) with the creation of OASAS. It is the consensus of participants in an OASAS-provider consultation process that the following proposed amendments would advance the goals of guaranteeing patients the best care and treatment delivered in a manner that is also cost effective and accountable:
    822-4: Chemical Dependence Outpatient Services
    • Allow three pre-admission assessment visits to allow more time for data collection and establishing counselor-patient trust
    • Define primary focus of a pre-admission assessment
    1. Chemical use assessment;
    2. Screening for co-occurring disorders; and
    3. Other priority issues based on presenting complaint and circumstances
    • Focus on immediate issues addressed in the initial assessment
    • Eliminate the regulatory need for Level of Care for Alcohol and Drug Treatment Referral (LOCADTR)
    • Increase the stringency of diagnostic and admission criteria
    • Require a multidisciplinary team case conference to approve the comprehensive treatment/recovery plan
    • Link the comprehensive evaluation and treatment/recovery plan more tightly together; both due within 45 days of admission and containing similar criteria
    • Extend time for physician signature on the treatment/recovery plan to ten days (if he/she is not part of the multi-disciplinary team)
    • Permit programs to defer a treatment/recovery plan goal if clinically justified and focus on functional areas where a problem was identified through the evaluation
    • Require a progress note for each session; clarifies more specific criteria expected in notes on individual counseling or group sessions
    • Clarify the programmatic and billing requirements specific to programs certified to provide Outpatient rehabilitation services.
    • Re-number sections for greater ease in reading and understanding
    • Better define and specify Quality Improvement activities
    • Include patient-centered language
    • Require medical directors to become certified in an areas of addiction medicine
    • Provide for alternative assessment for referrals from an OASAS approved DWI provider/practitioner to eliminate redundancy.
    822-5: Opioid Treatment Programs
    • Conform OASAS regulations to federal regulations (42 CFR Part 8) regarding certification of opioid treatment programs (OTP)
    • Add regulations related to buprenorphine (methadone alternative) treatment, removing an obstacle to physicians to administer buprenorphine in OTPs where clients may receive supportive services
    • Provide for opioid medical maintenance (OMM), pursuant to federal waiver, for certain qualified opioid patients and providers
    • Provide guidelines for certified providers to provide services at additional locations
    • Require medical directors to become certified in an area of addiction medicine
    • Requires testing for Hepatitis only where clinically indicated and makes testing for STDs optional
    • Increase flexibility in toxicology testing
    • Eliminate the requirement for OASAS approval for methadone dosage increases above 200 milligrams
    • Recognize that treatment for opioid addiction may be provided in a residential or in-patient setting and makes provisions for regulation of such services
    • Add language that states only clients with a primary diagnosis of opioid addiction may be admitted to an OTP
    • Give OTP's discretion to allow patient to go to their private physician for the required annual physical
    • Add new language to accommodate transfer patients
    • Provide greater flexibility in counselor to patient staffing ratios
    • Allow added flexibility for providing patients with take home medication and remove agency approval on a one-time basis for up to 30 days take home dose
    • Add recall to reduce diversion
    • Define role of security guards at the OTP
    • Define aftercare
    • State specialized services that are not defined by regulation must be approved by OASAS prior to implementation
    • Require provider to establish a community relations policy and committee
    • Detail the requirements for a quality improvement policy
    • Requires 50% of the counseling staff to be CASAC or CASAC-T within four years
    The proposed amendments also contain provisions developed in consultation with an agency/provider work group tasked with effectuating a reduction in paperwork for both OASAS and its certified providers. For example, the proposed regulations will reduce the number of individual patient exemptions and general waivers from current regulation, saving providers and the agency costly administrative time. An estimated monthly average of 10 requests for waivers would be eliminated. The proposed regulation allows more flexibility in take home medication and clinic schedule changes, two areas that represent the highest number of individual patient exemptions. The proposed regulation removes a requirement for OASAS approval for methadone dosage increases above 200 milligrams. This change was based on the review of several available studies. In January 2007, 103 of 115 certified clinics requested a waiver from OASAS regarding prior OASAS approval for methadone dosage increases; granting the waiver resulted in 114 fewer individual patient exemptions regarding dosage increases during 2007. The proposed draft regulations eliminate the need for providers to submit this waiver renewal upon recertification.
    OASAS solicited comments on the proposed regulations and possible alternatives from a cross-section of New York's upstate and downstate treatment provider community, as well as urban and rural programs. OASAS utilized statewide coalition groups, Alcoholism and Substance Abuse Providers of New York State (ASAP) and the Committee of Methadone Program Administrators (COMPA), to distribute the proposed regulation to its members and collect comments. All comments received were reviewed and incorporated wherever appropriate. The proposed regulations were also shared with the National Alliance of Methadone Advocates (NAMA), New York States Council of Local Mental Hygiene Directors, and New York State's Advisory Council, as well as posted on the OASAS website.
    Text of proposed rule and any required statements and analyses may be obtained from:
    Trisha R. Schell-Guy, Associate Counsel, OASAS, 1450 Western Avenue, Albany, NY 12203, (518) 485-6244, email: trishaguy@oasas.state.ny.us
    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
    The proposed amendments submitted for public comment include: REPEAL of Parts 822 and 828; and concurrent promulgation of a new Part 822 that incorporates provisions of Parts 822 and 828 as subparts. Amendments are primarily technical due to changes in Medicaid billing (Ambulatory Patient Groups or "APGs"), but some substantive changes reflect evolutions in treatment and social attitudes that have had an impact on agency goals for outpatient treatment including medically assisted treatment.
    The proposed Part 822, consists of subparts. Subpart 822-2 and Subpart 822-3 include common definitions, recordkeeping, documentation, billing, and excessive services sections applicable to all Part 822 certified services. Subpart 822-4, Outpatient Services, incorporates APGs; Subpart 822-5, Opioid Treatment Programs (OTP), incorporates APGs into the recently promulgated Part 828 (effective by emergency) that conformed OASAS regulations to new federal rules promulgated in 2001. Amendments throughout the new Part 822 reflect agency policy goals related to recovery services, language consistency, improved efficiency for providers, elevated professionalism of clinicians, and more effective agency regulation.
    1. Statutory Authority:
    Section 19.07(c) of the Mental Hygiene Law (MHL) charges the Office 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 authorizes the commissioner of the Office of Alcoholism and Substance Abuse Services (commissioner) to adopt standards including necessary rules and regulations pertaining to chemical dependence treatment services.
    Section 19.09(b) of the MHL authorizes the commissioner to adopt regulations necessary and proper to implement any matter under his/her jurisdiction.
    Section 19.16 of the MHL requires the commissioner to establish and maintain, either directly or through contract, a central registry for purposes of preventing multiple enrollment in opioid treatment programs.
    Section 19.21(b) of the MHL requires the commissioner to establish and enforce regulations concerning the licensing, certification, and inspection of chemical dependence treatment services.
    Section 19.40 of the MHL authorizes the commissioner to issue operating certificates for the provision of chemical dependence treatment services.
    Section 32.01 of the MHL authorizes the commissioner 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 authorizes the commissioner to adopt regulations to effectuate the provisions and purposes of article 32 of the MHL.
    Section 32.05(b) of the MHL 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.
    Section 32.09(b) of the MHL provides that the commissioner 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.
    2. Legislative Objectives:
    Article 32 of the Mental Hygiene Law (§ 32.01) enables the commissioner to regulate and assure consistent high quality of services within the state for persons suffering from chemical abuse or dependence, their families and significant others, and those at risk of becoming chemical abusers or chemically dependent. The current 14 NYCRR Part 822 establishes the requirements for outpatient services; the current 14 NYCRR Part 828 establishes the requirements for chemotherapy substance abuse treatment (methadone or other approved substance). The repealed Parts 822 and 828 are amended and combined into one new Part 822 consistent with the statutory mandate of Article 32. Merging outpatient services and medication assisted treatment reinforces the consolidation of drug and alcohol treatment into a unified system begun in 1992 with the creation of OASAS (Chapter 223 of the Laws of 1992).
    3. Needs and Benefits:
    The proposed amendments advance the goals of guaranteeing patients treatment in a manner that is cost effective and accountable. The proposed amendments are needed because of: (1) mandated implementation of APGs and development of an amended Medicaid State Plan; (2) issues identified during an on-going dialogue with OASAS certified providers and affiliated stakeholders to define a "gold standard" for treatment and/or identify "best practices" for quality patient-centered care; (3) anticipated impacts of federal health insurance reform; and (3) an ongoing collaborative effort between OASAS and certified providers to consolidate administrative requirements and reduce paperwork.
    For example, the proposed amendments improve patient-centered care and reduce paperwork by deferring the completion deadline to 45 days after admission for key clinical documents (comprehensive evaluations and treatment/recovery plans) that require multiple impersonal forms and interviews.
    Most significantly, the regulations provide clinical and Medicaid billing guidance to support conversion of the current Medicaid outpatient threshold visit reimbursement system to the APG methodology. APGs disaggregate the current Medicaid threshold rates and service categories into discrete service categories and payment levels that more accurately define provided services and reflect the Medicaid reimbursable costs associated with delivering a particular service. The regulation anticipates the movement to "medical homes" inherent in recent federal health insurance reforms by requiring provider medical directors to be certified by the American Society of Addiction Medicine (ASAM) and to prescribe buepenorphine and methadone for treatment of heroine addiction. This requirement is part of larger OASAS policy priority to raise the standard of professionalism for all clinicians in the field of addiction treatment.
    4. Costs:
    Additional costs, if any, are primarily up front, and offset by improved treatment outcomes, increased efficiency, and clearer compliance directives; in some cases, anticipated additional costs are mitigated by grandfathering and extended terms for compliance.
    a. Costs to regulated parties:
    Service providers are regulated parties. Providers' revenue from Medicaid reimbursements may be affected by APG implementation depending on the type of program and the array of services a provider offers. Currently a provider receives a threshold visit fee that is the same regardless of the amount or type of services provided in a visit. Under the APG methodology, a provider may bill for multiple services provided during a visit and will receive a fee for each service reflecting the resources utilized to provide the service. In addition, some dual-certified providers now receive an Article 28 reimbursement based on the Department of Health diagnosis and treatment center reimbursement methodology. Reimbursement for these providers' may be affected if their dual certification status changes because generally an Article 28 reimbursement fee is greater than the Article 32 OASAS clinic fee.
    To reduce any negative impact of APG reimbursement OASAS will phase in introduction of APG reimbursement over three periods by using a blend of the current fee structure and the APG reimbursement methodology. During all phases of APG implementation, OASAS will be carefully monitoring any impact of the transition to APGs on not-for-profit providers' state aid funding.
    Providers may incur some up-front administrative costs associated with the phased-in implementation of the APG billing methodology; however this may be balanced by reduced staff time in other areas such as processing individual and general regulatory waivers made unnecessary by the proposed regulatory revisions. In addition, extensive input and involvement of providers and regulatory personnel prior to promulgation of this regulation means both providers and agency staff have been anticipating the changes from APGs and other amendments for some time and have been preparing in advance for implementation. OASAS had already been providing additional technical assistance to OTPs.
    Phased-in timelines for new requirements related to Qualified Health Professionals (QHPs) began with promulgation of the emergency Part 828; therefore, providers are already requiring medical directors to be certified in Addiction Medicine and to be buprenorphine certified and working towards the goal of 50% of staff as QHPs. Most OASAS outpatient programs already meet or exceed the QHP requirement because Credentialed Alcohol and Substance Abuse Counselors trainees are counted towards the 50% requirement. The requirement that within four years of hiring, medical directors shall be ABMS (American Board of Medical Specialties) or ASAM (American Society of Addiction Medicine) certified reflects an agency policy priority to raise the standard of professionalism for clinicians in the field of addiction treatment. Cost impact on regulated parties would arise when a medical director needs to complete a course of training to achieve certification currently a one-time cost of $1600-$1800 for the certification test, plus ASAM membership. OASAS estimates approximately 100 currently ASAM certified medical directors; current medical directors are grandfathered, and a four year grace period for new hires will also mitigate any current regional shortage of certified addiction physicians. Medical directors will also be required to become certified to prescribe bueprenorphine at a cost of approximately $160.00 for an on-line course. Although providers will incur additional costs because of these certification requirements, the agency sees this as an essential requirement in order to secure the central role of addiction treatment professionals in the future heath care marketplace.
    Providers will not incur any additional costs for materials.
    b. Costs to the agency, state and local governments:
    OASAS does not anticipate increased administrative costs. Costs to the agency and state government may increase due to the requirement of medical director Board certifications. Costs for training and memberships, although primarily one-time costs, will be reflected in provider operating costs and therefore state aid funding.
    Counties, cities, towns or local districts will incur no additional costs.
    5. Local Government Mandates:
    There are no new mandates or administrative requirements placed on local governments.
    6. Paperwork / Reporting:
    Clarification and streamlining of documentation and reporting requirements will facilitate compliance and avoid confusion/inconsistencies that have previously resulted in regulatory citations, audit disallowances and other sanctions. Paperwork will be reduced by reducing requests for patient exemptions and regulatory waivers and by eliminating duplicate information gathering wherever possible. For example, the requirement that OASAS approve methadone dosage increases above 200 milligrams is removed. Programs providing treatment for a patient population with a high turnover rate, such as OTPs, need not repeat admission procedures under certain conditions. Similarly, alternative assessments are permitted for referrals from an OASAS approved DWI provider/practitioner to eliminate redundancy. The deferral of the completion deadline to 45 days after admission for key clinical documents (comprehensive evaluations and treatment/recovery plans) also means a significant amount of paperwork is not completed for those patients who may not be appropriate for admission or who drop out in the early stages of treatment.
    7. Duplications:
    There are no duplications of other state or federal requirements.
    8. Alternatives:
    Subpart 822-4: Implementation of APGs is required of all Mental Hygiene Offices and Dept. of Health.
    Subpart 822-5: Implementation of APGs is required of all Mental Hygiene Offices and Dept. of Health.
    The alternative of promulgating amendments to Parts 822 and 828 as separate Parts, rather than as a single combined outpatient regulation as proposed, would defeat the agency policy goal of merging outpatient services and medication assisted treatment to reinforce the consolidation of drug and alcohol treatment into a unified system begun in 1992 with the creation of OASAS (Chapter 223 of the Laws of 1992). Because of the mandated implementation of APGs affecting all outpatient services, combining them into one regulation is the most efficient regulatory structure.
    9. Federal Standards:
    822-4: No federal standards exceed the regulatory requirements of this subpart.
    822-5: Federal regulations set minimum standards for OTPs. New York's regulations are more stringent than federal standards.
    10. Compliance Schedule:
    Providers must comply with the proposed changes beginning July 1, 2011. All standards of Medical Assistance reimbursement applicable to chemical dependence outpatient and opioid treatment programs shall be contingent on approval the state plan amendment associated with APG's and Federal financial participation. Operating certificates issued by the Office prior to the promulgation of the new Part 822 for the operation of a programs subject to regulations of the former Parts 822 and 828 remain in effect until the term of such operating certificate has been renewed or such operating certificate is suspended or revoked through process of law.
    Regulatory Flexibility Analysis
    Effect of Rule (Types / Numbers):
    For purposes of this regulatory flexibility analysis, small businesses were considered to be chemical dependence outpatient and opioid treatment providers. The proposed amendments will impact approximately 481 certified providers of outpatient services and all 115 certified providers of opioid treatment. Some of these providers are small businesses.
    Compliance Requirements:
    Regardless of program size, it is anticipated that there will be no new reporting or recordkeeping imposed on local governments or small businesses. There are no new mandates or administrative requirements placed on local governments.
    Professional Services and Compliance Costs:
    The requirement that within four years of hiring, medical directors shall be ABMS (American Board of Medical Specialties) or ASAM (American Society of Addiction Medicine) certified reflects an agency policy priority to raise the standard of professionalism for clinicians in the field of addiction treatment. Cost impact on outpatient and opioid treatment providers would arise when a medical director needs to complete a course of training to achieve certification currently a one-time cost of $1600-$1800 for the certification test, plus ASAM membership. Medical directors will also be required to become certified to prescribe bueprenorphine at a cost of approximately $160.00 for an on-line course. Phased-in timelines for new requirements related to Qualified Health Professionals (QHPs) began with promulgation of the current emergency Part 828; therefore, opioid treatment providers are already requiring medical directors to be certified in Addiction Medicine and to be buprenorphine certified and working towards the goal of 50% of staff as QHPs. Most OASAS outpatient programs already meet or exceed the QHP requirement because Credentialed Alcohol and Substance Abuse Counselors trainees are counted towards the 50% requirement. Although providers will incur additional costs because of these certification requirements, the agency sees this as an essential requirement in order to secure the central role of addiction treatment professionals in the future heath care marketplace.
    Outpatient and opioid treatment providers' revenue from Medicaid reimbursements may be affected by Ambulatory Payment Group (APG) implementation depending on the type of program and the array of services a provider offers. Currently a provider receives a threshold visit fee that is the same regardless of the amount or type of services provided in a visit. Under the APG methodology, a provider may bill for multiple services provided during a visit and will receive a fee for each service reflecting the resources utilized to provide the service. In addition, some dual-certified providers now receive an Article 28 reimbursement based on the Department of Health diagnosis and treatment center reimbursement methodology. Reimbursement for these providers may be affected if their dual certification status changes because generally an Article 28 reimbursement fee is greater than the Article 32 OASAS clinic fee.
    To reduce any negative impact of APG reimbursement OASAS will phase in introduction of APG reimbursement over three periods (2 twelve-month periods and 1 final 6 month period) by using a blend of the current fee structure and the APG reimbursement methodology. During all phases of APG implementation, OASAS will be carefully monitoring any impact of the transition to APGs on not-for-profit providers' state aid funding.
    Providers may incur some up-front administrative costs associated with the phased-in implementation of the APG billing methodology; however this may be balanced by reduced staff time in other areas such as processing individual and general regulatory waivers made unnecessary by the proposed regulatory revisions. In addition, extensive input and involvement of providers and regulatory personnel prior to promulgation of this regulation means both providers and agency staff have been anticipating the changes from APGs and other amendments for some time and have been preparing in advance for implementation. OASAS had already been providing additional technical assistance to OTPs.
    It is expected that over time all providers (regardless of size) will realize cost savings from more efficient delivery of services. Providers will not incur any additional costs for materials.
    There will be no impact on costs of local governments.
    Economic / Technological Feasibility:
    Small businesses will be able to comply with the economic and technological aspects of this rule.
    Minimizing Adverse Economic Impacts:
    The proposed amendments incorporate the work of several agency/stakeholder workgroups whose tasks included developing a "gold standard" for treatment; identifying "best practices" for quality patient-centered care; reducing the administrative burden on clinical staff while improving efficiency and productivity; and fulfilling the legislative mandate to implement the APG reimbursement system throughout the OASAS outpatient system. Potential adverse economic impact and the approaches specified in section 202-b(1) of the State Administrative Procedure Act were addressed by all workgroups because the primary goals are to improve patient care, cost effectiveness and efficiency.
    Small Business and Local Government Participation:
    The need for many of these changes was initially identified through a process of on-going statewide dialogue between OASAS, OASAS certified providers, and affiliated stakeholders begun in the summer of 2007. The proposed amendments were presented to the OASAS Executive Team and Advisory Council and were distributed for comment to members of the provider/stakeholder community. Comments from the provider/stakeholder community and local government groups were reviewed and incorporated where appropriate. The lengthy process of amending and consolidating outpatient and opioid treatment into one regulation for all outpatient services together with adding the provisions necessary to effectuate the new APG reimbursement methodology has disseminated information among providers resulting in a better understanding of the intent of the consolidated regulation: to enable implementation of homogeneous services under one unified APG payment methodology, improve patient care and enable a more efficient use of provider resources.
    Rural Area Flexibility Analysis
    Types / Numbers:
    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:
    AlleganyHamiltonSchenectady
    CattaraugusHerkimerSchoharie
    CayugaJeffersonSchuyler
    ChautauquaLewisSeneca
    ChemungLivingstonSteuben
    ChenangoMadisonSullivan
    ClintonMontgomeryTioga
    ColumbiaOntarioTompkins
    CortlandOrleansUlster
    DelawareOswegoWarren
    EssexOtsegoWashington
    FranklinPutnamWayne
    FultonRensselaerWyoming
    GeneseeSt. LawrenceYates
    GreeneSaratoga
    The following 9 counties have certain townships with population densities of 150 persons or less per square mile:
    AlbanyErieOneida
    BroomeMonroeOnondaga
    DutchessNiagaraOrange
    The proposed amendments to Part 822 will impact approximately 481 certified providers of outpatient services; proposed amendments to Subpart 822-5 of Part 822 will impact all 115 certified providers of opioid treatment. Some of these providers may be located in rural areas although the vast majority of opioid treatment providers are located in urban areas.
    Compliance Requirements:
    There will be no new reporting or recordkeeping imposed on providers in rural areas as a result of these amendments.
    Professional Services and Compliance Costs:
    The requirement that within four years of hiring, medical directors shall be ABMS (American Board of Medical Specialties) or ASAM (American Society of Addiction Medicine) certified reflects an agency policy priority to raise the standard of professionalism for clinicians in the field of addiction treatment. Cost impact on outpatient and opioid treatment providers throughout the state would arise when a medical director needs to complete a course of training to achieve certification currently a one-time cost of $1600-$1800 for the certification test, plus ASAM membership. Medical directors will also be required to become certified to prescribe bueprenorphine at a cost of approximately $160.00 for an on-line course. Phased-in timelines for new requirements related to Qualified Health Professionals (QHPs) began with promulgation of the current emergency Part 828; therefore, opioid treatment providers are already requiring medical directors to be certified in Addiction Medicine and to be bueprenorphine certified and working towards the goal of 50% of staff as QHPs. Most OASAS outpatient programs already meet or exceed the QHP requirement because Credentialed Alcohol and Substance Abuse Counselors trainees are counted towards the 50% requirement. Although providers will incur additional costs because of these certification requirements, the agency sees this as an essential requirement in order to secure the central role of addiction treatment professionals in the future heath care marketplace.
    Regardless of location, outpatient and opioid treatment providers' revenue from Medicaid reimbursements may be affected by Ambulatory Payment Group (APG) implementation depending on the type of program and the array of services a provider offers. Currently a provider receives a threshold visit fee that is the same regardless of the amount or type of services provided in a visit. Under the APG methodology, a provider may bill for multiple services provided during a visit and will receive a fee for each service reflecting the resources utilized to provide the service. In addition, some dual-certified providers now receive an Article 28 reimbursement based on the Department of Health diagnosis and treatment center reimbursement methodology. Reimbursement for these providers may be affected if their dual certification status changes because generally an Article 28 reimbursement fee is greater than the Article 32 OASAS clinic fee.
    To reduce any negative impact of APG reimbursement OASAS will phase in introduction of APG reimbursement over three periods (2 twelve-month periods and 1 final 6 month period) by using a blend of the current fee structure and the APG reimbursement methodology. During all phases of APG implementation, OASAS will be carefully monitoring any impact of the transition to APGs on not-for-profit providers' state aid funding.
    Regardless of location, providers may incur some up-front administrative costs associated with the phased-in implementation of the APG billing methodology; however this may be balanced by reduced staff time in other areas such as processing individual and general regulatory waivers made unnecessary by the proposed regulatory revisions. In addition, extensive input and involvement of providers and regulatory personnel prior to promulgation of this regulation means both providers and agency staff have been anticipating the changes from APGs and other amendments for some time and have been preparing in advance for implementation. OASAS had already been providing additional technical assistance to OTPs.
    It is expected that over time all providers, regardless of location (rural, urban or suburban), will realize cost savings from more efficient delivery of services. Providers will not incur any additional costs for materials.
    Minimizing Adverse Economic Impacts:
    The proposed amendments incorporate the work of several agency/stakeholder workgroups whose tasks included developing a "gold standard" for treatment; identifying "best practices" for quality patient-centered care; reducing the administrative burden on clinical staff while improving efficiency and productivity; and fulfilling the legislative mandate to implement the APG reimbursement system throughout the OASAS outpatient system. Potential adverse economic impact and the approaches specified in section 202-bb(2) of the State Administrative Procedure Act were addressed by all workgroups because the primary goals are to improve patient care, cost effectiveness and efficiency.
    Opportunity for Rural Area Participation:
    The need for many of these changes was initially identified through a process of on-going statewide dialogue between OASAS, OASAS certified providers, and affiliated stakeholders throughout the state begun in the summer of 2007. The proposed amendments were presented to the OASAS Executive Team and Advisory Council and were distributed for comment to members of the provider/stakeholder community. Comments from the provider/stakeholder community, including providers in rural areas, and local government groups were reviewed and incorporated where appropriate. The lengthy process of amending and consolidating outpatient and opioid treatment into one regulation for all outpatient services together with adding the provisions necessary to effectuate the new APG reimbursement methodology has disseminated information among providers resulting in a better understanding of the intent of the consolidated regulation: to enable implementation of homogeneous services under one unified APG payment methodology, improve patient care and enable a more efficient use of provider resources.
    Job Impact Statement
    The proposed Part 822 should 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 amendments because the amendments do not deviate from the staffing requirements set forth under the former Part 822 and Part 828 which have been merged into the proposed Part 822. The proposed Part 822 contains clarifications to existing provider actions. Although not required, treatment providers may hire additional staff, such as Peer Advocates, to provide new services that are available under the proposed Part 822 resulting in increased employment opportunities in New York State.

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