Preservation of public health, public safety and general welfare.
Specific reasons underlying the finding of necessity:
The proper administration and availability of buprenorphine and other approved agents to treat opioid addiction are necessary to ensure that those persons suffering from addiction can get the most advanced and most appropriate treatment for their disease.
Subject:
Administration of "other approved agents" such as buprenorphine to treat opioid addictions.
Purpose:
To ensure that all persons will have equal access to the appropriate "approved agent" to treat their opioid addiction.
Text of emergency rule:
AMENDMENT TO: REQUIRMENTS FOR THE OPERATION OF CHEMOTHERAPY SUBSTANCE ABUSE PROGRAMS.
§ 828.1Definitions.
(a) Methadone program means a substance abuse program using methadone or other approved agents, and offering a range of treatment procedures and services for the rehabilitation of persons dependent on opium, morphine, heroin or any derivative or synthetic drug of that group.
(1) Methadone maintenance means a treatment procedure using methadone or any of its derivatives, or other approved agents, administered over a period of time to relieve withdrawal symptoms, reduce craving and permit normal functioning so that, n combination with rehabilitative services, patents can develop productive life styles.
(i) Methadone to abstinence means a treatment procedure using methadone, or other approved agents, administrated for a period exceeding 21 days, as part of a planned course of treatment involving reduction in dosage to the point of abstinence followed by drug-free treatment.
(ii) Methadone maintenance aftercare means a planned course of treatment for methadone, or other approved agents maintenance patients, directed toward the achievement of abstinence and, through the aid of supportive counseling, the continuance of a drug -free life style.
(2) Methadone detoxification means a treatment procedure using methadone, or any of its derivatives, or other approved agents, administered in decreasing doses over a limited period of time for the purpose of detoxification from opiates.
(b) Methadone clinic means a single location at which a methadone program provides methadone, or other approved agent and rehabilitative services to patients.
This notice is intended
to serve only as a notice of emergency adoption. This agency intends to adopt the provisions of this emergency rule as a permanent rule, having previously submitted to the Department of State a notice of proposed rule making, I.D. No. ASA-49-08-00007-P, Issue of December 3, 2008. The emergency rule will expire May 9, 2009.
Text of rule and any required statements and analyses may be obtained from:
Section 19.07(e) of the Mental Hygiene Law authorizes the Commissioner of the Office of Alcoholism and Substance Abuse Services ("the Commissioner") to ensure that persons who abuse or are dependent on alcohol and/or substances and their families are provided with care and treatment which is effective and of high quality.
Section 19.09(b) of the Mental Hygiene Law authorizes the Commissioner to adopt regulations necessary and proper to implement any matter under his or her jurisdiction.
Section 19.15(a) of the Mental Hygiene Law bestows upon the Commissioner the responsibility of promoting, establishing, coordinating, and conducting programs for the prevention, diagnosis, treatment, aftercare, rehabilitation, and control in the field of chemical abuse or dependence.
Section 19.40 of the Mental Hygiene Law authorizes the Commissioner to issue a single operating certificate for the provision of chemical dependence services.
Section 32.01 of the Mental Hygiene Law authorizes the Commissioner to adopt any regulation reasonably necessary to implement and effectively exercise the powers and perform the duties conferred by Article 32.
Section 32.07(a) of the Mental Hygiene Law gives the Commissioner the power to adopt regulations to effectuate the provisions and purposes of Article 32.
Section 32.09 of the Mental Hygiene Law gives the Commissioner the authority to issue operating certificates to providers of chemical dependence services.
2. Legislative Objectives
Chapter 558 of the Laws of 1999 requires the promulgation of rules and regulations to regulate and ensure the consistent high quality of services provided within the state to persons suffering from chemical abuse or dependence, their families and significant others, and those who are at risk of becoming chemical abusers. The amendment of Part 828 will allow methadone clinics to dispense buprenorphine to clients of the service as an alternative to methadone and thereby reducing the number of persons dependent on street drugs or illegally obtained prescription opioids.
3. Needs and Benefits
The use of additional agents to treat opioid addiction will decrease the number of addicted persons using street drugs such as heroine or illegally obtained prescription opioids. The need for additional and varied treatment methodology's to treat opioid addiction is apparent, and the benefit to the service to be able to offer choices to their patients is that they may be able to keep more people on a "maintenance" program then if they have only one option.
4. Costs:
a. Costs to regulated parties.
There may be a change in the reporting requirements or the documentation requirements which may have a fiscal impact on regulated parties.
b. Costs to the agency, state and local governments.
The state and local impact of the amendment of 828 will be minimal if at all. There is a difference between the reimbursement rates between methadone and buprenorphine. The weekly rates for buprenorphine are between $170.78 and 259.78, depending on the dose, and for methadone the weekly reimbursement rates are $136.05. Therefore it may cost the state, federal or local governments more money to provide buprenorphine. However, the number of persons receiving buprenorphine may not rise because the dispensing of this approved agent is completely voluntary.
5. Local Government Mandates
The proposed rule does not impose any new local government mandates.
6. Paperwork
The proposed rule does not impose additional paperwork requirements.
7. Duplication
The proposed rule does not duplicate of other state or federal regulations.
8. Alternatives
The only alternative to the proposed regulation is to continue to use only methadone in clinics regulated under 828.
9. Federal Standards
The CSAT Federal regulations preserve States' authority to regulate OTPs. The Federal regulations are considered minimal and the States are authorized to determine appropriate additional regulations. Federal regulations for dispensing Buprenorphine in opioid treatment programs are more restrictive than minimal Federal regulations for dispensing in physicians. In support of reducing opioid dependence it is demonstrated that there are numerous benefits which include improved retention in treatment for patients, making OTP's more attractive to new patients, and giving patients more control over their treatment experience. In addition, patient quality of life may be improved through the reduction in daily attendance at an OTP clinic.
10. Compliance Schedule
It is expected that full implementation of these Part 828 amendments shall become effective immediately.
Regulatory Flexibility Analysis
Effect of the Rule: The proposed emergency revision to Part 828 will impact certified and/or funded providers. It is expected that the emergency revision will require providers to amend some of their policies and procedures in their treatment modality. These new services will result in better patient treatment outcomes. Local health care providers may see an increase in patients seeking medication assisted treatment for opioid addiction due to more treatment options. As a result of patients receiving these services, local governments may see a decrease in services associated with active illicit drug use such as arrests and emergency room visits. Also, local governments and districts may see a nominal increase in cost due to the weekly Buprenorphine rate but this should be offset by better patient outcomes.
Compliance Requirements: It is expected that there will be no significant changes in compliance requirements. Since providers are already required to provide utilization review, it is not expected that this regulation, will have additional costs.
Professional Services: While it is expected that programs may require additional professional services the impact is nominal because induction of Buprenorphine lasts only a few days.
Compliance Costs: Some programs may need to formally train staff to understand the pharmacology of Buprenorphine.
Economic and Technological Feasibility: Compliance with the recordkeeping and reporting requirements of the emergency revision to Part 828 is not expected to have an economic impact or require any changes to technology for small businesses and government.
Minimizing Adverse Impact: This is an emergency adoption, no public comment is required, however, the subject matter experts within our agency, including the Medical Director have concluded that, in line with the Federal Standards, the addition of buprenorphine through emergency regulation is necessary for the health, safety and welfare of the public. Any impact this rule may have on small businesses and the administration of State or local governments and agencies will either be a positive impact or the nominal costs and compliance are small and will be absorbed into the already existing economic structure. The positive impact for our patients and our health care system, out weigh any potential minimal costs.
Small Business and Local Government Participation: This is and emergency adoption, therefore even though there have been informal conversations with persons affected by this regulation and the subject matter experts within the agency have decided that this emergency is necessary to protect the health, safety and welfare of the public, a formal outreach to the business community was not performed. Small businesses should not be affected by this change, and local governments running methadone clinics are not required to provide buprenorphine.
Rural Area Flexibility Analysis
A rural area flexibility analysis is not provided since these proposed regulations would have no adverse impact on public or private entities in rural areas. The majority of Methadone providers are located in NYC. There are a few others upstate, but they are in cities, of various sizes. There are only three providers located in Ulster, Broome and Montgomery which may be considered a rural area however they are in towns where the density is greater than 150 people per square mile. The compliance, recordkeeping and paperwork requirements are the minimum needed to insure compliance with state and federal requirements and quality patient care.
Job Impact Statement
The implementation of emergency regulation Part 828 will have a minimal impact on jobs in that it may require some additional staffing during the induction phase of Buprenorphine. This regulation will not adversely impact jobs outside of the agency.
Assessment of Public Comment
The agency received no public comment since publication of the last assessment of public comment.
