Administration of “Other Approved Agents” Such as Buprenorphine to Treat Opioid Addictions
This regulatory impact statement, regulatory flexibility analysis, rural area flexibility analysis and/or job impact statement
pertain(s) to a notice of emergency rule making, I.D. No. ASA-17-08-00007-E, printed in the State Register on April 23, 2008.
Regulatory Impact Statement
The proposed emergency revision to Part 828 — Requirements for the operation of chemotherapy substance abuse programs will revise methadone regulations that have existed for 24 years without change. The amendment to the definitions of Part 828 are being adopted by emergency because the need to allow alternative chemotherapy options to methadone clinics is in the interest of the publics health, safety and welfare.
Opioid addiction is a chronic illness which can be treated effectively with medications that are administered under conditions consistent with their pharmacological efficacy, and when treatment includes necessary supportive services such as psychosocial counseling, treatment for co-occurring disorders, medical services and, when appropriate, vocational rehabilitation. Medication assisted treatment can be effective in facilitating recovery from opioid addiction for many patients. The proposed regulation sets forth standards to guide opioid addiction treatment.
1. Statutory Authority:
Section 19.07(e) of the Mental Hygiene Law authorizes the Commissioner of the Office of Alcoholism and Substance Abuse Services (“the Commissioner”) to adopt standards including necessary rules and regulations pertaining to chemical dependence services.
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 19.21(b) of the Mental Hygiene Law requires the Commissioner to establish and enforce certification, inspection, licensing and treatment standards for alcoholism, substance abuse, and chemical dependence facilities.
Section 19.21(d) of the Mental Hygiene Law requires the Commissioner to promulgate regulations which establish criteria to evaluate chemical dependence treatment effectiveness and to establish a procedure for reviewing and evaluating the performance of providers of services in a consistent and objective manner.
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 32.05 of the Mental Hygiene Law requires providers to obtain an operating certificate issued by the Commissioner in order to operate chemical dependence services including but not limited to methadone.
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(b) of the Mental Hygiene Law gives the Commissioner the power to withhold an operating certificate for a Methadone provider until statutory requirements are satisfied.
The relevant sections of the Mental Hygiene Law cited above, allow the Commissioner to regulate how chemical dependency services are administered. This regulation will alter the way those services are administered, providing greater flexibility within the State regulations in alignment with Federal rules promulgated by SAMHSA in 2003. The objective is in line with the legislative intent behind the enactment of Sections 19, 22 and 32 of the Mental Hygiene Law, allowing the Commissioner to certify, inspect, license and establish treatment standards for all facilities that treat chemical dependency. Revising policy and procedures with regard to opioid treatment, will establish a standard for all facilities, which is in the best interest of the patient, and will assist opioid treatment programs to provide better health care services and recovery from opioid addiction.
2. Legislative Objectives:
Chapter 558 of the Laws of 1999 requires the promulgation of rules and regulations to regulate and assure the consistent high quality of services provided within the State to persons suffering from chemical abuse or dependence, their families and significant others, as well as those who are at risk of becoming chemical abusers. The legislature enacted Section 19, enabling the Commissioner to establish best practices for treating chemical dependency.
3. Needs and Benefits:
Research supports that opioid addiction is a chronic illness that can be treated effectively with medications when administered under conditions consistent with their pharmacological efficacy and when treatment includes necessary supportive services such as psychosocial counseling, treatment for co-occurring disorders, medical services and when appropriate vocational rehabilitation (CSAT, 2001). Medication assisted treatment can be effective in facilitating recovery from opioid addiction for many patients.
Approximately 40,000 patients, who represent 36% of patients currently being served in addiction treatment, are in opioid treatment programs in New York State. OASAS Part 828 regulations were written more than 24 years ago and have not been revised despite the fact that SAMHSA promulgated an amendment to the rules in 2003 that allowed opioid treatment programs to offer Buprenorphine treatment along with methadone. The proposed emergency regulation would allow chemotherapy programs to provide Buprenorphine for the maintenance or detoxification treatment of dependence on opioids such as heroin or prescription pain relievers. Consistency between Federal and State regulations is a benefit to providers.
In addition, New York State law currently allows Buprenophine to be administered by physicians in their private practices in addition to OTP clinics. However, the current OASAS regulation Part 828 does not permit Buprenophrine administration. Buprenorphrine treatment for opioid dependence is well served in the OTP setting, since clients will receive additional services such as counseling, toxicology and medical support. The proposed emergency revision will address this problem and patients will benefit from this added service.
4. Costs:
Additional costs are expected to be minimal. Any costs incurred by providers or the State will be offset by better treatment outcomes and healthier patients, which will result in lower costs for medical and other services.
a. Costs to regulated parties:
Regulated parties include patients and providers of substance abuse services. Patients should not incur additional costs as Buprenorphine is covered by Medicaid. Cost to providers remains the same.
There should be no additional costs for materials.
b. Costs to the agency, state and local governments:
OASAS is not expected to see increased cost related to administering the rule. The decision to provide buprenorphine is voluntary, and the current Part 828 methadone clinics will not be forced to provide it. There will be anticipated cost increases for state and local governments due to the weekly rate of Buprenorphine which is $ 235.00 and the difference of a weekly rate for Methadone of $136.02. In addition, providers may need some addition staffing for the induction phase of Buprenophine. However, it is important to realize that the number of people treated is not changing only their options about treatment. Patients may opt to be placed on Buprenorphine while receiving other services such as toxicology testing and counseling whereas Medicaid patients who opt for Buprenorphine treatment at physicians offices do not receive the benefit of these additional services. There will be no additional costs to counties, cities, towns or local districts.
5. Local Government Mandates:
There are no new mandates or administrative requirements placed on local governments.
6. Paperwork:
Amended Part 828 regulations would not change the paperwork currently required.
7. Duplications:
There is no duplication of other state or federal requirements.
8. Alternatives:
The only other alternative is to keep the existing regulation in place. This would be detrimental to both the opioid treatment providers and patients being served.
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 Part 828 will be completed within three months of the adoption of the regulation.
Regulatory Flexibility Analysis
Effect of the Rule: The proposed amendments to Part 828 will impact certified and or funded providers. It is expected that the amendment of the methadone regulation will result in better patient care. Local Government will not be effected by the rule. Business that provide Buprenorphine may benefit from increased sales of the drug because of a wider distribution.
Compliance Requirements: Providers will document the use of Buprenorphine in compliance with federal standards. This rule is voluntary and does not place any additional requirements on small businesses or local governments. It is not expected that there will be significant changes in compliance requirements. Since providers are already required to provide utilization review, it is not expected that this regulation, will have significant additional costs.
Professional Services: It is not expected that programs will need to utilize additional professional services.
Compliance Costs: No additional costs are expected. This rule is voluntary, therefore compliance is not mandatory.
Economic and Technological Feasibility: The economic and technological feasibility of compliance with this voluntary rule by small businesses and local governments is such that the implementation may require certain businesses to increase their sale and production of Buprenorphine in order to comply with the demand for the drug.
Minimizing Adverse Impact: Part 828 has been carefully reviewed to ensure minimum adverse impact to providers. Any impact this rule may have on small businesses and the administration of State or local government, will either be a positive impact or the minimal costs for materials and compliance are so small that they will be absorbed into the already existing economic structure.
Small Business and Local Government Participation: These amendments were adopted on an emergency basis.
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.
