Notice for Proposed Rule Making – Change in Federal Oversight for Methadone Treatment

General Barry R. McCaffrey, Director of the Office for National Drug Control Policy (ONDCP), released the Notice of Proposed Rule Making (NPRM) on July 22, 1999, in conjunction with Dr. Westley Clark, Director, Center for Substance Abuse Treatment/SAMHSA. This document provides notice to providers and regulatory agencies throughout the United States of the federal government’s intent to transition authority from FDA oversight of methadone treatment to a CSAT/SAMHSA managed accreditation system. This system will operate under the aegis of CSAT and draft accreditation guidelines are being pilot tested in approximately 180 programs in 15 states by both JCAHO and CARF.

The Association forwarded two survey documents to methadone treatment providers (Board of Directors of the Association) and all of the State Methadone Authorities, soliciting information which was included in the Association’s testimony on November 1, 1999 when the federal interagency hearing convened to receive guidance from the field.

The survey to the Board solicited information about the direct and indirect costs, which are associated with accrediting methadone treatment programs. These programs have already been accredited in a number of states. The second survey was forwarded to the State Methadone Authorities, attempting to understand how the states view the needs of methadone treatment programs, including the number of programs that are deficient according to state’s monitoring practices in addition to programs that are in need of programmatic technical assistance and physical plant improvements.

The results of these surveys were included in the Association’s formal response to the NPRM, which were presented during the hearing of November 1, 1999.

Six states have indicated that 21 treatment programs are currently in violation of FDA regulations. Ten states have reported that 45 programs are in violation of current state regulations. Five states have indicated that 5 programs are in danger of closing. Twenty-nine states have indicated that 155 programs need programmatic technical assistance. Sixteen states have indicated that 25 programs need physical plant improvements. Twenty-one states rated 172 programs as excellent. Thirty states rated 209 programs as good. Twenty-five states rated 145 programs as fair and 11 states rated 36 programs as poor.

The Association’s support for the development of standardized outcome measures and evaluating the efficacy of methadone maintenance treatment can be traced back to the development of the State Methadone Treatment Guidelines. These Guidelines were published in 1993 by CSAT following the release of several critical reports concerning the effectiveness of methadone treatment programs in the United States.

The Association’s support for accreditation is also rooted in the fact that a major segment of the healthcare system in the United States is being reviewed through such accreditation standards. We believe that accrediting methadone treatment will offer the potential of embracing such treatment as part of mainstream medicine in the United States.

It appears that the direct cost of accrediting a methadone treatment program ranges from $7,500.00 – $11,000.00 including the cost of an application (CARF only) and the cost of the on-site survey. Our Association is urging the federal government to develop a multi-year, multipurpose fund to ensure that methadone treatment programs and patients will not be adversely affected by the implementation of accreditation standards, ultimately decreasing access to care through program closure.

Such a fund would be implemented on a needs based model, which would pay for the cost of the survey. The fund would also provide financial and technical support in implementing improvements as a result of the accreditation survey.

Such improvements could be the training of personnel, implementing new information management systems and executing physical plant improvements.

The Association is aware that individual states have promulgated regulations, governing the practices of methadone programs in their respective jurisdictions. In certain states, the specific interests of elected and appointed officials have driven the complexity of particular state regulations. Eight states still do not have any methadone maintenance treatment programs, however, we have been informed that New Hampshire has recently opened an outpatient methadone to abstinence program (180 days).

We have recommended that the federal agencies, which will take primary responsibility for implementing accreditation, work in conjunction with the State Methadone Authorities to maximize the use of one accreditation standard. The Association is hopeful that individual states will adopt accreditation body findings once it is determined that the accreditation surveys are responding to the needs of the States in ensuring that good quality care is being provided within the methadone treatment programs.

The NPRM also raises questions about office based methadone treatment in private practice settings. Our Association has recommended that methadone treatment be offered in office based medical practices through the vehicle of expanding access to “Medical Maintenance Treatment” as a first stage effort. These recommendations have been listed in the text of this News Report. The recommendations include criteria for the participating treatment program, physicians and patient referrals.

The Association believes that stable patients should be given treatment options, including a referral from a methadone treatment program to an office-based practice. It is recognized that some patients may not choose such an option, however, we believe that such alternatives should be made available. Medical Maintenance operations currently exist in New York State and Maryland.

Research indicates that approximately 7% or 12,530 of the existing methadone maintenance population (179,000) would be eligible for referral to medical maintenance treatment. Our Association does not support the policy of having physicians involved in treating newly admitted patients, which have not been referred through a hub referral site, especially where treatment is available at an established methadone treatment program.

We have also urged the federal agencies to develop a series of technical assistance documents to assist programs with different patient census sizes throughout the country. Such publications would serve as “how to” documents, including model policy procedure manuals, model diversion management plans, model quality assurance packages in addition to other elements of the accreditation system.

The NPRM also raises the issue of lifting the prohibition of LAAM take home dosages. We support removing such a prohibition since we now have more than five years of experience in administering LAAM to patients in methadone treatment programs.

We have also supported the NPRM’s intent to provide greater clinical flexibility in determining take home dosages for patients, who have met the criteria under current federal law, ensuring stability prior to giving any take home medication. The Association has opted to support the second variation, which was proposed in the NPRM, allowing individual methadone treatment programs to dispense take home medication for up to fourteen days following one year of treatment and up to a thirty-one day supply following two years of treatment, providing that the patient has met the criteria as stipulated in the Proposed Rule.

In summary, the Association supports the federal government’s intent to shift regulatory oversight away from process oriented regulations to outcome oriented accreditation standards of care. We have urged the federal government not to create a two tiered system of regulatory oversight holding methadone treatment programs accountable to accreditation standards and individual practitioners to a lesser standard of care. We believe that the development of such a two tiered system would create instability throughout the entire system of treatment and would be counter to the intent of the Proposed Rule.

We are also hopeful that individual states will either adopt accreditation standards or accept the results of accreditation surveys in lieu of their own state regulatory inspections as a means of avoiding duplication of effort and cost.

Finally, we view the Proposed Rule as only one piece of a federal strategy to increase access to care, to improve the quality of care currently offered, to expand new opportunities for patients and to educate the public about the value of methadone treatment. Accrediting methadone treatment programs will not significantly increase access to care. An infusion of funds at the federal and state levels of government is required to improve treatment access and quality.

Visit the aatod conference website for more details…www.aatodconference.com.

@aatod1984
  • View the latest #aatod2024 Conference Video Message from the Host Committee Chair, Katro Henderson. We look forward to seeing you next month in Las Vegas for the world’s premier training conference event for the Treatment of Opioid Use Disorder. #OUD #somuchmorethanmedication

https://youtu.be/i6u3qUS95jU
  • 💻 Access the 3/27 SAMHSA Webinar Recording on 42 CFR Part 8, Clinical ➡️ bit.ly/3TIEZdW.

#ICYMI This comprehensive webinar provided an overview of the rule changes and provided a discussion with SAMHSA regarding the implications of the changes.
  • 💻 Webinar Recording is Now Available
AATOD is pleased to share the March 20th SAMHSA Webinar Recording on 42 CFR Part 8, Administrative.  We encourage you to view this recording to assist you in determining how you will need to prepare for full implementation of these regulations. 

➡ https://youtu.be/pgWZUpDhi94?si=obomo4LXRIwJPiC8
  • 3/28 Expanding Access to #Methadone in Correctional Facilities will focus on opportunities to expand access to methadone in correctional facilities, including recent developments with the SAMHSA 2024 final rule on the use of methadone.

Register ➡️ bit.ly/3Vz1RPE
  • Invitation to SAMHSA Webinars on 42 CFR Part 8 💻 

On February 2, 2024, the final rule for 42 CFR Part 8 was published. The effective date for these regulations is April 2, 2024, with an implementation date of October 2, 2024. 

In preparation for implementation of the revisions, SAMHSA will provide two preliminary webinars for OTPs.  The first will focus on administrative areas; the second will focus more on clinical content. These will be held on March 20th (from 2-3pm EST) and March 27th, 2024 (from 2- 3pm EST).  

REGISTER ➡ https://conta.cc/3TF9CSQ

View the final rule ➡ https://lnkd.in/e_iu-AtG.

There will be an opportunity to receive an overview of the rule changes and discuss with SAMHSA the implications of the changes. 

We encourage you to attend these important meetings to assist you in determining how you will need to prepare for full implementation of these regulations. 

This webinar series will be moderated by Mark W. Parrino, MPA (AATOD President). Speakers include Yngvild Olsen, MD, MPH (Director - CSAT), Robert Baillieu, MD, MPH, FAAFP (Physician and Senior Advisor - SAMHSA/CSAT, and Patti Juliana, PhD, LCSW
(Director - CSAT’s Division of Pharmacologic Therapies).

The presentations will be followed by Q&A, and these webinars will become available to the public for On-Demand viewing via the AATOD website. Certificates of Attendance will be provided per request.
  • Don’t miss out on the chance to show your support, share your products/services and secure your sponsorship at the AATOD 2024 Conference, �The world’s premier training conference event for the Treatment of Opioid Use Disorder. #aatod2024

The 2024 AATOD Conference will attract over 1,600 physicians, social workers, nurses, counselors, program administrators, executive directors, and other treatment providers from many countries. The registrants are decision-makers with purchasing power for their treatment centers and are looking for new products, services, and information to improve their patient treatment.

To become an exhibitor today —> https://bit.ly/48ZKMRX
  • TREATING OPIOID USE DISORDER: SO MUCH MORE THAN MEDICATION

💻 View the latest Conference Video Message from AATOD's President, Mark W. Parrino bit.ly/48y815w,
for the most up-to-date details regarding the upcoming #aatod2024 Conference -
The world's premier training conference event for the treatment of Opioid Use Disorder. #OUD 

Registration ➡️ www.aatodconference.com
  • TREATING OPIOID USE DISORDER: SO MUCH MORE THAN MEDICATION #aatod2024

TODAY is the last day to take advantage of the discounted registration rate. #aatod2024 is the world’s premier training conference event for the treatment of #OUD.

For registration and hotel information ➡️ bit.ly/3Ue57Q6.

We look forward to seeing you in Las Vegas!
  • #aatod2024 Conference Update. Comprehensive Listing/Descriptions of Workshops, Posters, and Hot Topic Roundtable Conference Sessions are now available ➡️ http://bit.ly/3Ue57Q6.

The workshop committee is pleased to present a dynamic workshop lineup that includes extremely rich and diverse educational content for all disciplines. You will hear from experts who will share the latest research and developments relating to opioid use disorders and treatment. The workshop lineup will include state of the art information on diverse areas of focus such as patient care and best practices, building community partnerships and collaborations, public policy and regulatory changes, workforce development, quality assurance, and financial reimbursement. There will be workshops that focus on emerging treatment trends and developments such as the fentanyl epidemic, mobile opioid treatment programs, regulatory changes, expansion of treatment services in rural areas, integrating treatment with the corrections systems, and integrating harm reduction initiatives. For those newer to the field or those who want a refresher on the basics, we have once again included a “Foundations” track which will include selections on the fundamentals of medication assisted treatment.

The conference will continue to be the world’s premier training and education event for the treatment of opioid use disorders.  We hope to see you in Las Vegas!
  • Patient access to OTPs saves lives every day.

AATOD has been working with policymakers and regulatory authorities to increase access to opioid treatment programs (OTPs) though the expansion of mobile vans and Medication Assisted Treatment in correctional facilities in the United States. 

Please support AATOD's mission by making an online donation ➡️ https://bit.ly/3uDOeDC #givingtuesday
View the latest #aatod2024 Conference Video Message from the Host Committee Chair, Katro Henderson. We look forward to seeing you next month in Las Vegas for the world’s premier training conference event for the Treatment of Opioid Use Disorder. #OUD #somuchmorethanmedication

https://youtu.be/i6u3qUS95jU
View the latest #aatod2024 Conference Video Message from the Host Committee Chair, Katro Henderson. We look forward to seeing you next month in Las Vegas for the world’s premier training conference event for the Treatment of Opioid Use Disorder. #OUD #somuchmorethanmedication https://youtu.be/i6u3qUS95jU
5 days ago
View on Instagram |
1/10
💻 Access the 3/27 SAMHSA Webinar Recording on 42 CFR Part 8, Clinical ➡️ bit.ly/3TIEZdW.

#ICYMI This comprehensive webinar provided an overview of the rule changes and provided a discussion with SAMHSA regarding the implications of the changes.
💻 Access the 3/27 SAMHSA Webinar Recording on 42 CFR Part 8, Clinical ➡️ bit.ly/3TIEZdW. #ICYMI This comprehensive webinar provided an overview of the rule changes and provided a discussion with SAMHSA regarding the implications of the changes.
1 week ago
View on Instagram |
2/10
💻 Webinar Recording is Now Available
AATOD is pleased to share the March 20th SAMHSA Webinar Recording on 42 CFR Part 8, Administrative.  We encourage you to view this recording to assist you in determining how you will need to prepare for full implementation of these regulations. 

➡ https://youtu.be/pgWZUpDhi94?si=obomo4LXRIwJPiC8
💻 Webinar Recording is Now Available AATOD is pleased to share the March 20th SAMHSA Webinar Recording on 42 CFR Part 8, Administrative. We encourage you to view this recording to assist you in determining how you will need to prepare for full implementation of these regulations. ➡ https://youtu.be/pgWZUpDhi94?si=obomo4LXRIwJPiC8
2 weeks ago
View on Instagram |
3/10
3/28 Expanding Access to #Methadone in Correctional Facilities will focus on opportunities to expand access to methadone in correctional facilities, including recent developments with the SAMHSA 2024 final rule on the use of methadone.

Register ➡️ bit.ly/3Vz1RPE
3/28 Expanding Access to #Methadone in Correctional Facilities will focus on opportunities to expand access to methadone in correctional facilities, including recent developments with the SAMHSA 2024 final rule on the use of methadone. Register ➡️ bit.ly/3Vz1RPE
3 weeks ago
View on Instagram |
4/10
Invitation to SAMHSA Webinars on 42 CFR Part 8 💻 

On February 2, 2024, the final rule for 42 CFR Part 8 was published. The effective date for these regulations is April 2, 2024, with an implementation date of October 2, 2024. 

In preparation for implementation of the revisions, SAMHSA will provide two preliminary webinars for OTPs.  The first will focus on administrative areas; the second will focus more on clinical content. These will be held on March 20th (from 2-3pm EST) and March 27th, 2024 (from 2- 3pm EST).  

REGISTER ➡ https://conta.cc/3TF9CSQ

View the final rule ➡ https://lnkd.in/e_iu-AtG.

There will be an opportunity to receive an overview of the rule changes and discuss with SAMHSA the implications of the changes. 

We encourage you to attend these important meetings to assist you in determining how you will need to prepare for full implementation of these regulations. 

This webinar series will be moderated by Mark W. Parrino, MPA (AATOD President). Speakers include Yngvild Olsen, MD, MPH (Director - CSAT), Robert Baillieu, MD, MPH, FAAFP (Physician and Senior Advisor - SAMHSA/CSAT, and Patti Juliana, PhD, LCSW
(Director - CSAT’s Division of Pharmacologic Therapies).

The presentations will be followed by Q&A, and these webinars will become available to the public for On-Demand viewing via the AATOD website. Certificates of Attendance will be provided per request.
Invitation to SAMHSA Webinars on 42 CFR Part 8 💻 On February 2, 2024, the final rule for 42 CFR Part 8 was published. The effective date for these regulations is April 2, 2024, with an implementation date of October 2, 2024. In preparation for implementation of the revisions, SAMHSA will provide two preliminary webinars for OTPs.  The first will focus on administrative areas; the second will focus more on clinical content. These will be held on March 20th (from 2-3pm EST) and March 27th, 2024 (from 2- 3pm EST).  REGISTER ➡ https://conta.cc/3TF9CSQ View the final rule ➡ https://lnkd.in/e_iu-AtG. There will be an opportunity to receive an overview of the rule changes and discuss with SAMHSA the implications of the changes. We encourage you to attend these important meetings to assist you in determining how you will need to prepare for full implementation of these regulations. This webinar series will be moderated by Mark W. Parrino, MPA (AATOD President). Speakers include Yngvild Olsen, MD, MPH (Director - CSAT), Robert Baillieu, MD, MPH, FAAFP (Physician and Senior Advisor - SAMHSA/CSAT, and Patti Juliana, PhD, LCSW (Director - CSAT’s Division of Pharmacologic Therapies). The presentations will be followed by Q&A, and these webinars will become available to the public for On-Demand viewing via the AATOD website. Certificates of Attendance will be provided per request.
4 weeks ago
View on Instagram |
5/10
Don’t miss out on the chance to show your support, share your products/services and secure your sponsorship at the AATOD 2024 Conference, �The world’s premier training conference event for the Treatment of Opioid Use Disorder. #aatod2024

The 2024 AATOD Conference will attract over 1,600 physicians, social workers, nurses, counselors, program administrators, executive directors, and other treatment providers from many countries. The registrants are decision-makers with purchasing power for their treatment centers and are looking for new products, services, and information to improve their patient treatment.

To become an exhibitor today —> https://bit.ly/48ZKMRX
Don’t miss out on the chance to show your support, share your products/services and secure your sponsorship at the AATOD 2024 Conference, �The world’s premier training conference event for the Treatment of Opioid Use Disorder. #aatod2024 The 2024 AATOD Conference will attract over 1,600 physicians, social workers, nurses, counselors, program administrators, executive directors, and other treatment providers from many countries. The registrants are decision-makers with purchasing power for their treatment centers and are looking for new products, services, and information to improve their patient treatment. To become an exhibitor today —> https://bit.ly/48ZKMRX
1 month ago
View on Instagram |
6/10
TREATING OPIOID USE DISORDER: SO MUCH MORE THAN MEDICATION

💻 View the latest Conference Video Message from AATOD's President, Mark W. Parrino bit.ly/48y815w,
for the most up-to-date details regarding the upcoming #aatod2024 Conference -
The world's premier training conference event for the treatment of Opioid Use Disorder. #OUD 

Registration ➡️ www.aatodconference.com
TREATING OPIOID USE DISORDER: SO MUCH MORE THAN MEDICATION 💻 View the latest Conference Video Message from AATOD's President, Mark W. Parrino bit.ly/48y815w, for the most up-to-date details regarding the upcoming #aatod2024 Conference - The world's premier training conference event for the treatment of Opioid Use Disorder. #OUD Registration ➡️ www.aatodconference.com
2 months ago
View on Instagram |
7/10
TREATING OPIOID USE DISORDER: SO MUCH MORE THAN MEDICATION #aatod2024

TODAY is the last day to take advantage of the discounted registration rate. #aatod2024 is the world’s premier training conference event for the treatment of #OUD.

For registration and hotel information ➡️ bit.ly/3Ue57Q6.

We look forward to seeing you in Las Vegas!
TREATING OPIOID USE DISORDER: SO MUCH MORE THAN MEDICATION #aatod2024 TODAY is the last day to take advantage of the discounted registration rate. #aatod2024 is the world’s premier training conference event for the treatment of #OUD. For registration and hotel information ➡️ bit.ly/3Ue57Q6. We look forward to seeing you in Las Vegas!
3 months ago
View on Instagram |
8/10
#aatod2024 Conference Update. Comprehensive Listing/Descriptions of Workshops, Posters, and Hot Topic Roundtable Conference Sessions are now available ➡️ http://bit.ly/3Ue57Q6.

The workshop committee is pleased to present a dynamic workshop lineup that includes extremely rich and diverse educational content for all disciplines. You will hear from experts who will share the latest research and developments relating to opioid use disorders and treatment. The workshop lineup will include state of the art information on diverse areas of focus such as patient care and best practices, building community partnerships and collaborations, public policy and regulatory changes, workforce development, quality assurance, and financial reimbursement. There will be workshops that focus on emerging treatment trends and developments such as the fentanyl epidemic, mobile opioid treatment programs, regulatory changes, expansion of treatment services in rural areas, integrating treatment with the corrections systems, and integrating harm reduction initiatives. For those newer to the field or those who want a refresher on the basics, we have once again included a “Foundations” track which will include selections on the fundamentals of medication assisted treatment.

The conference will continue to be the world’s premier training and education event for the treatment of opioid use disorders.  We hope to see you in Las Vegas!
#aatod2024 Conference Update. Comprehensive Listing/Descriptions of Workshops, Posters, and Hot Topic Roundtable Conference Sessions are now available ➡️ http://bit.ly/3Ue57Q6. The workshop committee is pleased to present a dynamic workshop lineup that includes extremely rich and diverse educational content for all disciplines. You will hear from experts who will share the latest research and developments relating to opioid use disorders and treatment. The workshop lineup will include state of the art information on diverse areas of focus such as patient care and best practices, building community partnerships and collaborations, public policy and regulatory changes, workforce development, quality assurance, and financial reimbursement. There will be workshops that focus on emerging treatment trends and developments such as the fentanyl epidemic, mobile opioid treatment programs, regulatory changes, expansion of treatment services in rural areas, integrating treatment with the corrections systems, and integrating harm reduction initiatives. For those newer to the field or those who want a refresher on the basics, we have once again included a “Foundations” track which will include selections on the fundamentals of medication assisted treatment. The conference will continue to be the world’s premier training and education event for the treatment of opioid use disorders. We hope to see you in Las Vegas!
3 months ago
View on Instagram |
9/10
Patient access to OTPs saves lives every day.

AATOD has been working with policymakers and regulatory authorities to increase access to opioid treatment programs (OTPs) though the expansion of mobile vans and Medication Assisted Treatment in correctional facilities in the United States. 

Please support AATOD's mission by making an online donation ➡️ https://bit.ly/3uDOeDC #givingtuesday
Patient access to OTPs saves lives every day. AATOD has been working with policymakers and regulatory authorities to increase access to opioid treatment programs (OTPs) though the expansion of mobile vans and Medication Assisted Treatment in correctional facilities in the United States. Please support AATOD's mission by making an online donation ➡️ https://bit.ly/3uDOeDC #givingtuesday
5 months ago
View on Instagram |
10/10

OTPs offer life-saving care beyond methadone services. A recent study found that Hepatitis C virus treatment initiated through OTP telehealth visits resulted in faster adoption of direct-acting antiviral therapy and higher cure rates. Learn more: https://ow.ly/I1NQ50RcE9g

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