ASA-49-08-00009-RP Detoxification of Substances and Stabilization Services
9/9/09 N.Y. St. Reg. ASA-49-08-00009-RP
NEW YORK STATE REGISTER
VOLUME XXXI, ISSUE 36
September 09, 2009
RULE MAKING ACTIVITIES
OFFICE OF ALCOHOLISM AND SUBSTANCE ABUSE SERVICES
REVISED RULE MAKING
NO HEARING(S) SCHEDULED
I.D No. ASA-49-08-00009-RP
Detoxification of Substances and Stabilization Services
PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following revised rule:
Proposed Action:
Amendment of Part 816 of Title 21 NYCRR.
Statutory authority:
Mental Hygiene Law, sections 19.09, 19.15, 19.40 and 22.09
Subject:
Detoxification of substances and stabilization services.
Purpose:
To amend the proposed 816 services after initial publication and comments and bring the regulation into alignment with NYS Statutory language in the 2008-2009 Article 7 bill.
Substance of revised rule:
The proposed regulations would revise Section 816 of the Mental Hygiene regulations (Requirements for Chemical Dependence Crisis Services) regarding patients who have substance abuse addictions to allow for statutory implementation of language in Part C of Chapter 58 of the Laws of 2008 as and further amended by Part C of Chapter 58 of the Laws of 2009 which amended section 2807-c(4)(I) of the Public Health law changing rates from a Diagnosis Related Group system to a per diem system.
The proposed regulation would add the following definitions in Part 816.4 Detoxification, Discrete Unit, Medically Managed Withdrawal Services, Medically Supervised Withdrawal Services-Inpatient, Medically Supervised Withdrawal Services-Outpatient, Medically Monitored, Observation Bed, Prescribing Professional, Recovery Care Plan, and update Qualified Health Professionals to include Licensed Mental Health Counselors, in order to effectively integrate operation of the proposed regulation.
The proposed regulation updates section 816.6, Standards applicable to medically managed withdrawal and stabilization services, in order to define inpatient services that can be offered in this service. The proposed regulation would establish that medically managed services could also provide medically supervised services within the same setting with no change to their Office of Alcoholism and Substance Abuse Services certification. The proposed regulation also defines the differences in the two services.
The proposed regulation was developed by OASAS staff and providers of withdrawal and stabilization services to allow for greater clinical flexibility; reduced paperwork requirements; increased patient-centered focus and a more targeted focus on withdrawal and stabilization services followed by linkage to support ongoing recovery for patients. Recommendations from the Detoxification Task Force convened by the Commissioner in the summer of 2007 included revising the Part 816 regulations, and changes designed to "identify and modify, where appropriate the regulatory requirements that currently impede development of community-based medically supervised withdrawal programs". The proposed regulations have been revised to protect patient safety and quality of care while providing greater flexibility for medical and clinical staff to exercise clinical judgment.
These changes should allow communities to develop increased community-based withdrawal and stabilization programs to meet the overall goal of the Detoxification Task Force to reduce unnecessary hospital detoxifications and increase access to community based care where safe and appropriate.
The proposed regulation also updates 816.7 Standards applicable to medically supervised withdrawal and stabilization services. The regulation changes the type of paperwork required and staffing configuration for inpatient settings.
The proposed regulation provides a separate section for 816.8 Standards applicable to medically supervised outpatient withdrawal and stabilization services. Changes to the outpatient regulation allow for a face to face visit with a medical professional including a registered nurse and for the physician to schedule visits less than daily if deemed safe and appropriate. This change addresses the biggest previous barrier to the provision of outpatient services; the need for daily physician contact.
The proposed regulation changes section 816.9, Standards applicable to medically monitored withdrawal and stabilization services, and recognizes the need for flexibility in order to maintain the highest quality in patient care. Each medically monitored withdrawal and stabilization center will be required to submit a staffing protocol that is compliant with clients' needs, federal, state and local laws and suitable for their situation. These protocols will be reviewed by the Medical Director for approval and must be submitted at all future re-certifications.
The proposed regulation would reduce the amount of paperwork in both the inpatient and outpatient medically managed and medically supervised setting. The proposed regulation no longer requires vocational and education assessments, changes the language from a biopsychosocial assessment to an assessment targeting only the information necessary to safely stabilize patients, engage them in a change process and link them to appropriate treatment services. The proposed regulation requires targeted assessments aimed at withdrawal and stabilization and linkages, thereby allowing more time for counseling services and providing more time to engage the client in the recovery process.
The proposed regulation expands clinical flexibility by providing individualized treatment when a patient is interested in withdrawal and stabilization services. By triaging the patient, a more efficient and cost effective level of care determination can be made allowing for more individualized withdrawal assessment and stabilization.
The proposed Part 816 regulation supports implementation of the enacted 2008-2009 Health and Mental Hygiene Budget and Part C of Chapter 58 of the Laws of 2008 as and further amended by Part C of Chapter 58 of the Laws of 2009 which amended section 2807-c(4)(I) of the Public Health law to reconfigure reimbursement for hospital based medically managed withdrawal / detoxification; and, authorize the reimbursement methodology for a 48 hour detoxification observation period.
Revised rule compared with proposed rule:
Substantial revisions were made in sections 816.4, 816.6, 816.7, 816.9, 816.12 and 816.51.
Text of revised proposed rule and any required statements and analyses may be obtained from
The proposed Chemical Dependence Withdrawal and Stabilization Services regulation is being re-submitted for public review and comment. Proposed 816 was produced as a result of a task force convened by the Commissioner to make recommendations to detoxification services in the State of New York. As a result not a lot of comments were received by the agency. However, all comments that were received were reviewed and considered. In addition, the proposed Part 816 Chemical Dependence Withdrawal and Stabilization Services must be amended in order for OASAS to be in alignment with New York State statutory language of the enacted 2008-2009 Health and Mental Hygiene Budgets, and Part C of Chapter 58 of the Laws of 2008 as and further amended by Part C of Chapter 58 of the Laws of 2009. This chapter amended Section 2807-c of the Public Health Law to: reconfigure reimbursement for hospital based medically managed withdrawal / detoxification; and, authorizes the reimbursement methodology for a 48 hour detoxification observation period and had an effective date of December 1, 2008.
Chemical dependence is a chronic illness which can be treated effectively when medications are administered under conditions consistent with their pharmacological efficacy, and when withdrawal and stabilization services include necessary supportive services such as psychosocial counseling, treatment for co-occurring disorders, and medical services as needed. Chemical dependence withdrawal and stabilization is the first step in facilitating recovery from addiction for many patients. The proposed regulation sets forth standards to guide withdrawal and stabilization services.
1. Statutory Authority:
Section 19.07(e) of the Mental Hygiene Law authorizes the Commissioner ("the Commissioner") of the Office of Alcohol and Substance Abuse Services (OASAS) 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.
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.
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 state regulations and aligning the regulation with NYS statutory language. (Part C of Chapter 58 of the Laws of 2008 and as further amended by Part C of Chapter 58 of the Laws of 2009 which amended Public Health law § 2087-c (4)(l)). 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 this regulation will establish a new standard for all facilities, which will assist withdrawal programs to provide better health care services and withdrawal from chemical dependence.
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 of the Mental Hygiene Law, enabling the Commissioner to establish best practices for treating chemical dependency.
3. Needs and Benefits:
Detoxification is a medical intervention that manages an individual safely through the process of withdrawal (McCorry et. al. 2000). Three components of successful detoxification have been identified in the Treatment Improvement Protocol (TIP) #45: evaluation, stabilization and linkage to treatment (CSAT, 2006). The American Society of Addiction Medicine (ASAM) recognizes five levels of care for detoxification services and recognizes that patients should be placed in the least restrictive setting.
In 2007 alone 72,099 patients, who represent 24% of all patients being admitted in addiction treatment, entered hospital and community based withdrawal and stabilization services in New York State. Among the 2007 admissions to Medically Managed Detox the number of patients, 10,029 representing 19%, arrived at another level of care within 14 days of discharge. Among the 2007 admissions to Medically Supervised Withdrawal the number of patients, 8,265 representing 40%, arrived at another level of care within 14 days of discharge. Finally the median numbers are:
Within Medically Managed Detox, 32,983 clients (i.e., UNIQUE PEOPLE) were admitted in 2007, for a total of 51,747 admissions.
73% of clients were admitted once.
15% were admitted twice.
10% were admitted 3 to 6 times.
The remaining 1.5% (n=504) of the clients were admitted 7 or more times, (n=5,185) account for 10% of the 51,747 admissions.
Within Medically Supervised Withdrawal 15,034 clients (i.e., UNIQUE PEOPLE) were admitted in 2007 for a total of 20,352 admissions.
79% of clients were admitted once.
13% were admitted twice.
7% were admitted 3 to 6 times.
The remaining 0.5% (n=72) of the clients admitted 7 or more times, (n=604) account for 3% of the 20,352 admissions.
The purpose of this regulatory change is to capitalize on better linkage and engagement to prevent multiple admissions without sustained recovery. Patients are more likely to enter and remain in subsequent substance abuse treatment if they believe that the services will help them with life problems (Fiorentine et. al. 1999). Better linkages to inpatient or outpatient rehabilitation have been found when case managers are able to directly link patients through a warm-hand-off or provide incentives. (Chutuape, et.al. 2001; CSAT 2006).
Furthermore, information disseminated in the process of rewriting, reorganizing, and promulgating the Part 816 regulation will provide both patients and withdrawal and stabilization services clear understanding of the intent of the regulation. This will result in better implementation and homogeneous services, improving patient care and more efficient use of staff resources.
Here are the significant comments that were received and addressed in the following manner for the Proposed Part 816.
ISSUE
OASAS RESPONSE
The current proposed renumbering of sections of the Part 816 regulation would result in significant database and certification issues.
Section entitled Incorporation by Reference moved to the end of the regulation to prevent a major overhaul of the specific modalities being renumbered.
Use of inconsistent language (examples such as crisis services and recovery plan)
All references to crisis services or detoxification services were removed and changed to withdrawal and stabilization services.
Substance abuse changed to chemical dependence
Consistent language use of recovery care plan which is now better defined.
Add savings clause language
OASAS added language to help with the administrative tasks involved in issuing new operating certificates due to change in renumbering of services.
Each level of care or service category needs to be defined by its purpose, its target population. The specific provisions necessary to provide the level of medical needs also should be included in each section to ensure that they are followed.
This is the way the regulations were previously written. More latitude is now being given to providers in the way of clinical judgment and there is an accompanying document that defines clinical criteria for admission at each level.
In addition, OASAS has posted this on their website and held trainings throughout NYS for providers.
This comment did not come from a provider currently rendering services therefore they may not have known/and or participated in the above.
"Background and Intent" section should help users to understand the place of the regulated services in the system and explain the interrelationships of the regulated categories as necessary.
In this case it should explain the need and intent behind the changes in the names of categories particularly the deletion of the category of "crisis services" and the addition of "stabilization" to the names of the new categories.
You use and define the term "pharmacological services" in a very impractical and unusual way.
Definition changed
The proposed definition of "recovery care plan" is inadequate to properly reflect its significance and importance to the State goals of maximizing the "successful linkage" and minimizing repeated hospital detoxifications.
Definition changed
Staffing patterns rewritten and being interpreted to reduce staffing.
Staffing pattern changed to previous regulation language.
Sentence structure
Some sentences changed to better clarify the intent.
Add definition for discrete unit.
Language was proposed in the 30 day amendment for discrete units. This language was added to the regulation pending budget approval in 2009.
Medically monitored withdrawal and stabilization services will recognize the need for flexibility.
Each medically monitored withdrawal and stabilization center will be required to submit a staffing protocol that is compliant with clients' needs, federal, state and local laws and suitable for their situation. These protocols will be reviewed by the Medical Director for approval and must be submitted at all future re-certifications.
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:
There should be no additional costs to regulated parties as a result of this regulation. The regulation changes the focus of withdrawal and stabilization services from treatment to stabilization and discharge planning.
b. Costs to the agency, state and local governments:
OASAS is not expected to see increased cost related to administering the rule. OASAS will need to modify the program review instrument currently used to certify chemical dependence withdrawal services along with providing technical assistance; however this is not expected to result in any undue hardship for OASAS.
Additionally, there is an anticipated cost saving with the regulation changing from a Diagnosis Related Group to a per diem rate. Also, patients will be moved from a more intensive service to a lower level of care more effectively thereby reducing costs to the federal, state and local government.
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:
Updated Part 816 regulations decrease the amount of individual patient assessments and treatment plans saving providers considerable time and effort. Assessments are now targeted for this distinct population. Time previously spent on vocation and educational assessments is now eliminated. Services are now focused on withdrawal and stabilization and discharge planning. On average, 60% of counselors' time is spent filling in required paperwork which could now be dedicated to serving the patient population.
The proposed regulation provides more clinical expertise in the management of patients. The previous regulations provided for inpatient treatment in an abbreviated amount of time that was not conducive to recovery. The proposed regulations will encourage the appropriate use of a broader array of withdrawal and stabilization services. Hospitals will be required to more thoroughly assess patients for appropriate level of care and community providers have been provided more flexibility in providing community-based care. This approach to detoxification has been supported by consensus opinion (CSAT, 2006).
The proposed regulation also includes changes to allow more flexibility by reducing paperwork, targeting interventions to withdrawal and stabilization and linkages which in fact allow clinicians more time for individual contact.
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 place OASAS in violation of New York State law. In an effort to elicit comments on the proposed regulations and possible alternatives, these amendments were shared with New York's treatment provider community, representing a cross-section of upstate and downstate, as well as urban and rural programs. OASAS used a statewide coalition of representatives of both hospital and community based organizations that provide withdrawal and stabilization services. The regulation was published in the NYS Register and more comments were received, reviewed and more changes were made. Additionally, these regulations were also shared with the New York State's Conference of Local Mental Hygiene Directors, New York State's Advisory Council, Alcoholism and Substance Abuse Providers of NYS., Inc., and New York State chemical dependency providers.
9. Federal Standards:
Federal standards governing Medicaid requirements for these services are currently incorporated into Part 816.
10. Compliance Schedule:
Part 816 was promulgated by emergency on December 1, 2008 in order to be compliant with statutory language. Part 816 also appeared in the NYS Register in December for comment and review. Providers were informed that they will be reviewed on the new regulation as of one year after promulgation.
References
Center for Substance Abuse Treatment. Detoxification and Substance Abuse Treatment. Treatment Improvement Protocol (TIP) Series 45. DHHS Publication no. (SMA) 06-4131. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2006.
Chutuape, M.A., Jasinski, D.R., Fingerhood, M.I., and Stitzer, M.I. One- Three- and Six- Month Outcomes After Brief Inpatient Opiate Detoxification. American Journal of Drug and Alcohol Abuse 27(1): 19-44, 2001.
Fiorentine, R., Nakashima, J., and Anglin,M.D. Client Engagement in Drug Treatment. Journal of Substance Abuse Treatment 17(3): 199-206, 1999.
McCorry, F., Garnick, D.W., Bartlett, J., Cotter, F., and Chalk, M> Developing Performance Measures for Alcohol and Other Drug Services in Managed Care Plans. Washington Circle Group. Joint Commission Journal on Quality Improvement 26(11): 633-643, 2000.
Revised Regulatory Flexibility Analysis
Effect of Rule: The proposed Part 816 will impact certified and/or funded providers. It is expected that the development of Withdrawal and Stabilization services will require providers to amend some of their policies and procedures. The new service will result in greater clinical flexibility; reduced paperwork requirements; increased patient-centered focus and a more targeted focus on withdrawal and stabilization and linkage to support ongoing patient recovery. These new services will result in better patient treatment outcomes. Local health care providers may see an increase in patients seeking crisis withdrawal and stabilization services due to less restrictive procedures. 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 will not be affected because any nominal increase in cost will be offset by better patient outcomes.
Compliance Requirements: It is expected that there will be some changes in compliance requirements and the development of protocols. Providers will be expected to assess patients within the hospital and determine the appropriate level of care with a focus on linking patients as they progress and move through the continuum of care. The proposed changes affect internal policies however, it is not expected that the Proposed regulation, will have additional costs.
Professional Services: Additional professional services are not expected.
Compliance Costs: Some programs may need additional formally trained staff to meet the proposed requirements.
Economic and Technological Feasibility: Compliance with the recordkeeping and reporting requirements of the proposed Part 816 is expected to have a nominal economic impact on small businesses and government.
Minimizing Adverse Impact: Part 816 has been carefully reviewed to ensure minimum adverse impact to providers by NYS Alcoholism and Substance Abuse Providers of NYS, Inc., New York State's Council of Local Mental Hygiene Directors and New York State's Advisory Council, Greater New York Hospital Association, Healthcare of New York, and a statewide representative coalition from hospital and community based organizations that provide withdrawal and stabilization services. All comments received were reviewed and numerous changes were made. 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 have nominal costs. Compliance requirements are small and will be absorbed into the already existing economic structure. The positive impact for patients and the NYS health care system, out- weigh any potential minimal costs.
Small Business and Local Government Participation: The proposed regulations were shared with New York's treatment provider community including, NYS Alcoholism and Substance Abuse Providers of NYS, Inc.., Greater New York Hospital Association, Healthcare of New York, the Council of Local Mental Hygiene Directors and the Advisory Council on Alcoholism and Substance Abuse Services and a statewide representative coalition from hospital and community based organizations that provide withdrawal and stabilization services.
Revised Rural Area Flexibility Analysis
1. Types and estimated number of rural areas: There are six (6) certified providers of medically managed detoxification services that are located in rural areas of the State five of which are public.
2. Reporting, recordkeeping and other compliance requirements; and professional services: There will be new documenting requirements to maintain clients in the higher level of care that will have some impact on providers.
3. Costs: There will be minimum impact for rural providers to implement Part 816.
4. Minimizing adverse impact: Regulatory reform of detoxification rates was driven by language in the Article 7 bill from the Executive. In order to achieve optimal results, OASAS solicited input from over 40 providers of service representing each modality statewide. This group met for a period of six months and the hospitals agreed that it was important to align detoxification care with detoxification rates. Hospitals also realized this could increase opportunities for Outpatient detoxification units with increased income.
5. Rural Area Participation: These amendments were shared with New York's treatment provider community and included a cross-section of upstate and downstate, as well as urban and rural programs.
Revised Job Impact Statement
The implementation of Part 816 may have minor impact on staffing at hospital based detoxification units. Hospital based units under the current Part 816 solely operate as medically managed units which requires more staffing than any other withdrawal service. Under the Proposed 816 hospital based units can now operate two levels of care simultaneously; medically managed and medically supervised. Staffing for medically supervised services may require less staffing.
In addition, the regulation allows for flexibility within the medically monitored withdrawal and stabilization programs. This could potentially change the staffing within the medical compliment and may adversely impact some LPN's.
Assessment of Public Comment
Comments received on the Proposed Part 816
The Proposed 816 was created as a result of a task force convened by the Commissioner to make recommendations to Detoxification services in the State of New York. As a result not a lot of comments were received by the agency. However, all comments that were received were reviewed and listed below are the issues that were raised and addressed in the following manner:
ISSUE
OASAS RESPONSE
The current proposed renumbering of sections of the Part 816 regulation would result in significant database and certification issues.
Section entitled Incorporation by reference moved to the end of the regulation to prevent a major overhaul of the specific modalities being renumbered.
Use of inconsistent language (i.e, crisis svcs and recovery plan)
All references to crisis services or detoxification services were removed and changed to withdrawal and stabilization services.
Substance abuse changed to chemical dependence.
Consistent language use of recovery care plan which is now better defined.
Add savings clause language
OASAS added language to help with the administrative tasks involved in issuing new operating certificates due to change in renumbering of services.
Each level of care or service category needs to be defined by its purpose, its target population. The specific provisions necessary to provide the level of medical-ness also need to be included in each section to ensure that they are followed.
This is the way regulations were previously written. More latitude is now being given to providers in the way of clinical judgment and there is an accompanying document that defines clinical criteria for admission at each level.
In addition, OASAS has posted this on their website and held trainings throughout NYS for providers.
This comment did not come from a provider currently rendering services therefore they may not have known/and or participated in the above.
Background and Intent" section should help users to understand the place of the regulated services in the system and explain the interrelationships of the regulated categories as necessary.
In this case it should explain the need and intent behind the changes in the names of categories particularly the deletion of the category of "crisis services" and the addition of "stabilization" to the names of the new categories.
You use and define the term "pharmacological services" in a very impractical and unusual way.
Definition changed
The proposed definition of "recovery care plan" is inadequate to properly reflect its significance and importance to the State goals of maximizing the "successful linkage" and minimizing repeated hospital detoxifications.
Definition changed
Staffing patterns rewritten and being interpreted to reduce staffing
Staffing pattern changed to previous regulation language.
Sentence structure
Some sentences changed to better clarify the intent.
Add definition for discrete unit
Language was proposed in the 30 day amendment for discrete units. This language was added to the regulation pending budget approval in 2009.
Medically monitored withdrawal and stabilization services will recognize the need for flexibility.
Each medically monitored withdrawal and stabilization center will be required to submit a staffing protocol that is compliant with clients needs, federal, state and local laws and suitable for their situation. These protocols will be reviewed by the Medical Director for approval and must be submitted at all future re-certifications.
