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Do the new regulations allow for exceptional circumstances or hardships by granting exceptions to the regulations?

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Do the new regulations allow for exceptional circumstances or hardships by granting exceptions to the regulations?

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Yes. The new Federal regulations permit SAMHSA to consider requests for exemption from the requirements set forth under 42 CFR 8.11 and 8.12 (42 CFR 8.11(h)). For example, a private practitioner (physician) who wishes to treat a limited number of patients in a rural area with no accessible Opioid Treatment Program (OTP), may seek to provide medical maintenance treatment with methadone and LAAM in his/her private office practice. For more information, refer to the CSAT “Dear Colleague Letter on Medical Maintenance” March 30, 2000, which is available on the SAMHSA Website (http://dpt.samhsa.gov). Examples of patient exceptions include hardship exceptions based on physical disabilities, unusual transportation/distance factors, employment issues, etc. These are requested by the program physician in writing and sent to the state methadone authority (SMA) and CSAT for review and possible approval. 12. Do privately owned clinics have to comply with the new Federal regulations? Yes.

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Yes. The new Federal regulations permit SAMHSA to consider requests for exemption from the requirements set forth under 42 CFR 8.11 and 8.12 (42 CFR 8.11(h)). For example, a private practitioner (physician) who wishes to treat a limited number of patients in a rural area with no accessible Opioid Treatment Program (OTP), may seek to provide medical maintenance treatment with methadone and LAAM in his/her private office practice. For more information, refer to the CSAT “Dear Colleague Letter on Medical Maintenance” March 30, 2000, which is available on the SAMHSA Website (http://dpt.samhsa.gov). Examples of patient exceptions include hardship exceptions based on physical disabilities, unusual transportation/distance factors, employment issues, etc. These are requested by the program physician in writing and sent to the state methadone authority (SMA) and CSAT for review and possible approval. 12. Do privately owned clinics have to comply with the new Federal regulations? Yes. All clinic

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