COMPA Challenges CSAT “Dear Colleague” Letter

Published July 22, 2009

Since methadone was approved for the treatment of opioid dependence in 1973, the Food and Drug Administration (FDA) and now the Center for Substance Abuse Treatment  (CSAT), regulations have allowed patients to receive an unsupervised dose for Sundays and Holidays if the clinic is closed.   However, on January 24, 2008, the OTP system was shocked when the Director of CSAT, Dr. H. Westley Clark, sent a “Dear Colleague” letter to all US OTPs advising them that CSAT did not interpret these regulations to allow unsupervised doses when clinics are closed for those patients deemed “unstable” – clinics must either make “arrangements” for dosing those patients directly or open daily to provide supervised medication. 

NYS operates over 100 clinics nearly all of which now close on Sundays and Holidays and have done so for over 40 years.  Neither COMPA or OASAS have been able to document adverse occurrences resulting from clinics being closed; though both COMPA and OASAS realize that some diversion may occur as newly admitted patients or those not progressing in treatment are given take home medication for Sunday and for legal holidays.  At COMPA’s request, the Legal Action Center and AATOD began to examine if the “Dear Colleague” letter was sufficient to implement such drastic change.  COMPA’s concerns were validated when The Legal Action Center affirmed that current regulations do permit take home medication for patients on Sundays and Holidays (click here to see letter from Legal Action Center).   Despite the Legal Action Center opinion and AATOD’s consultation with accreditation agencies, insurance underwriters and patient advocacy groups, all of which agreed, CSAT held firm to the Dear Colleague letter of January 24, 2008 position.

COMPA, with OASAS support (click here to see letter from OASAS Chief Counsel, Rob Kent, Esq), continues to fight this costly new unfunded mandate.  By urging methadone transformation in NYS, COMPA has tried to make methadone treatment easier  to access in numerous ways - by untreated opioid dependent persons, advocating for relaxed regulation, elimination of waiting lists upstate and lower threshold care in NYC as well as adequate reimbursement for both Medicaid and working poor patients.  NY is the largest state impacted; COMPA, alongside AATOD has argued that CSAT must follow the rules for changing Federal Regulations – by posting notice in the Federal Register, allowing public commentary and debate before instituting a new rule - a transparent process.  Commissioner Karen Carpenter-Palumbo met with Dr. Clark in April to express OASAS concern about this new rule and the impact to NYS.  Most recently, AATOD wrote to HHS Secretary Sebellius to urge that CSAT follow the federal process for issuing new regulatory mandates – especially one so costly to our patients, to our programs and to the entire treatment system. 

Watch our Web Site for updates as this story progresses!