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TitleActionFR DocPublishedAgency NameExcerptsAbstractHTMLPDF
TitleActionFR DocPublishedAgency NameExcerptsAbstractHTMLPDF
Medication Assisted Treatment for Opioid Use Disorders Reporting RequirementsRule2016-2327709/27/2016Health and Human Services DepartmentThis final rule outlines annual reporting requirements for practitioners who are authorized to treat up to 275 patients with covered medications in an office-based setting. This final rule will require practitioners to provide informat … This final rule outlines annual reporting requirements for practitioners who are authorized to treat up to 275 patients with covered medications in an office-based setting. This final rule will require practitioners to provide information on their annual caseload of patients by month, the number of patients provided behavioral health services and referred to behavioral health services, and the features of the practitioner's diversion control plan. These reporting requirements will help the Department of Health and Human Services (HHS) ensure compliance with the requirements of the final rule, ``Medication Assisted Treatment for Opioid Use Disorders,'' published in the Federal Register on July 8, 2016.medication-assisted-treatment-for-opioid-use-disorders-reporting-requirementsFR-Doc-2016-23277
Medication Assisted Treatment for Opioid Use Disorders; CorrectionRule2016-2167409/09/2016Health and Human Services DepartmentThe Health and Human Services Department (HHS) is correcting a final rule that appeared in the Federal Register on July 8, 2016. The final rule increased the maximum number of patients to whom an individual practitioner may dispense o … The Health and Human Services Department (HHS) is correcting a final rule that appeared in the Federal Register on July 8, 2016. The final rule increased the maximum number of patients to whom an individual practitioner may dispense or prescribe certain medications, including buprenorphine, from 100 to 275. Practitioners are eligible for the increased patient limit if they have prescribed covered medications to up to 100 patients for at least one year pursuant to secretarial approval, provided that they meet certain criteria and adhere to several additional requirements aimed at ensuring that patients receive the full array of services that comprise evidence- based medication-assisted treatment (MAT) and minimize the risks that medications provided for treatment are misused or diverted. One pathway through which practitioners may become eligible to increase their patient limit is by obtaining additional credentialing from one of several credentialing bodies. In the final rule, the name of one of the credentialing bodies listed was incorrect. This action provides the correct name.medication-assisted-treatment-for-opioid-use-disorders-correctionFR-Doc-2016-21674
Medication Assisted Treatment for Opioid Use DisordersRule2016-1612007/08/2016Health and Human Services DepartmentThis final rule increases access to medication-assisted treatment (MAT) with buprenorphine and the combination buprenorphine/ naloxone (hereinafter referred to as buprenorphine) in the office-based setting as authorized under the … This final rule increases access to medication-assisted treatment (MAT) with buprenorphine and the combination buprenorphine/ naloxone (hereinafter referred to as buprenorphine) in the office-based setting as authorized under the United States Code. Section 303(g)(2) of the Controlled Substances Act (CSA) allows individual practitioners to dispense or prescribe Schedule III, IV, or V controlled substances that have been approved by the Food and Drug Administration (FDA). Section 303(g)(2)(B)(iii) of the CSA allows qualified practitioners who file an initial notification of intent (NOI) to treat a maximum of 30 patients at a time. After 1 year, the practitioner may file a second NOI indicating his/her intent to treat up to 100 patients at a time. This final rule will expand access to MAT by allowing eligible practitioners to request approval to treat up to 275 patients under section 303(g)(2) of the CSA. The final rule also includes requirements to ensure that patients receive the full array of services that comprise evidence-based MAT and minimize the risk that the medications provided for treatment are misused or diverted.medication-assisted-treatment-for-opioid-use-disordersFR-Doc-2016-16120
Medication Assisted Treatment for Opioid Use Disorders Reporting RequirementsProposed Rule2016-1606907/08/2016Health and Human Services DepartmentOn March 30, 2016, the U.S. Department of Health and Human Services (HHS) published a Notice of Proposed Rulemaking (NPRM) to increase the highest patient limit for qualified physicians to treat opioid use disorder under secti … On March 30, 2016, the U.S. Department of Health and Human Services (HHS) published a Notice of Proposed Rulemaking (NPRM) to increase the highest patient limit for qualified physicians to treat opioid use disorder under section 303(g)(2) of the Controlled Substances Act (CSA). On July 6, 2016, HHS published a final rule based on the NPRM but delayed finalizing the reporting requirements outlined in the NPRM. In this Supplemental Notice of Proposed Rulemaking (SNPRM), HHS seeks further comment on the same reporting requirements outlined in the NPRM. These reporting requirements would require annual reporting by practitioners who are approved to treat up to 275 patients under subpart F to help HHS ensure compliance with the requirements of the ``Medication Assisted Treatment for Opioid Use Disorders'' final rule published elsewhere in this issue of the Federal Register. HHS will consider the public comments on this SNPRM as well as any comments already received on the March 30, 2016 NPRM before issuing a final rule pertaining to the reporting requirements.medication-assisted-treatment-for-opioid-use-disorders-reporting-requirementsFR-Doc-2016-16069
Medication Assisted Treatment for Opioid Use DisordersProposed Rule2016-0712803/30/2016Health and Human Services DepartmentThe Secretary of the Department of Health and Human Services (the Secretary) (HHS) proposes a rule to increase the highest patient limit for qualified physicians to treat opioid use disorder under section 303(g)(2) of the Controlled S … The Secretary of the Department of Health and Human Services (the Secretary) (HHS) proposes a rule to increase the highest patient limit for qualified physicians to treat opioid use disorder under section 303(g)(2) of the Controlled Substances Act (CSA) from 100 to 200. The purpose of the proposed rule is to increase access to treatment for opioid use disorder while reducing the opportunity for diversion of the medication to unlawful use.medication-assisted-treatment-for-opioid-use-disordersFR-Doc-2016-07128
Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction; Proposed Modification of Dispensing Restrictions for Buprenorphine and Buprenorphine Combination as Used in Approved Opioid Treatment Medications; CorrectionRule2015-1442106/18/2015Health and Human Services DepartmentThe Health and Human Services Department (HHS) is correcting a final rule that appeared in the Federal Register of December 6, 2012. The document modified the dispensing requirements buprenorphine and buprenorphine combination produ … The Health and Human Services Department (HHS) is correcting a final rule that appeared in the Federal Register of December 6, 2012. The document modified the dispensing requirements buprenorphine and buprenorphine combination products approved by the Food and Drug Administration (FDA) for opioid dependence and used in federally certified and registered opioid treatment programs. In particular, this rule allows opioid treatment programs more flexibility in dispensing take-home supplies of buprenorphine after the assessment and documentation of a patient's responsibility and stability to receive opioid addiction treatment medication. However, an inadvertent removal of paragraphs was made. This correction reinstates the missing paragraphs.opioid-drugs-in-maintenance-and-detoxification-treatment-of-opiate-addiction-proposed-modificationFR-Doc-2015-14421
Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction; Proposed Modification of Dispensing Restrictions for Buprenorphine and Buprenorphine Combination as Used in Approved Opioid Treatment MedicationsRule2012-2941712/06/2012Health and Human Services DepartmentThis final rule amends the federal opioid treatment program regulations by modifying the dispensing requirements for buprenorphine and buprenorphine combination products approved by the Food and Drug Administration (FDA) for opioid dep … This final rule amends the federal opioid treatment program regulations by modifying the dispensing requirements for buprenorphine and buprenorphine combination products approved by the Food and Drug Administration (FDA) for opioid dependence and used in federally certified and registered opioid treatment programs. In particular, this rule would allow opioid treatment programs more flexibility in dispensing take-home supplies of buprenorphine--removing restrictions on the time a patient needs to be in treatment in order to receive take-home supplies--after the assessment and documentation of a patient's responsibility and stability to receive opioid addiction treatment medication. Opioid treatment programs that use these products in the treatment of opioid dependence will continue to adhere to all other federal treatment standards established for methadone.opioid-drugs-in-maintenance-and-detoxification-treatment-of-opiate-addiction-proposed-modificationFR-Doc-2012-29417
Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction; Buprenorphine and Buprenorphine Combination; Approved Opioid Treatment Medications UseProposed RuleE9-1428606/19/2009Health and Human Services DepartmentThis proposed rule amends the Federal opioid treatment program regulations by modifying the dispensing requirements for buprenorphine and buprenorphine combination products approved by FDA for opioid dependence and used in fede … This proposed rule amends the Federal opioid treatment program regulations by modifying the dispensing requirements for buprenorphine and buprenorphine combination products approved by FDA for opioid dependence and used in federally certified and registered opioid treatment programs. Opioid treatment programs that use these products in the treatment of opioid dependence will adhere to all other Federal treatment standards established for methadone.https://www.federalregister.gov/documents/2009/06/19/E9-14286/opioid-drugs-in-maintenance-and-detoxification-treatment-of-opiate-addiction-buprenorphine-andFR-Doc-E9-14286
Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction; Addition of Buprenorphine and Buprenorphine Combination to List of Approved Opioid Treatment MedicationsRule03-1146905/22/2003Health and Human Services DepartmentThis interim final rule amends the Federal opioid treatment program regulations by adding buprenorphine and buprenorphine combination products to the list of approved opioid treatment medications that may be used in federally certi … This interim final rule amends the Federal opioid treatment program regulations by adding buprenorphine and buprenorphine combination products to the list of approved opioid treatment medications that may be used in federally certified and registered opioid treatment programs. The Food and Drug Administration (FDA) recently approved Subutex[reg] (buprenorphine) and Suboxone[reg] (buprenorphine in fixed combination with naloxone) for the treatment of opiate dependence. These two products will join methadone and ORLAAM[reg] as medications that may be used in opioid treatment programs for the maintenance and detoxification treatment of opioid dependence. Opioid treatment programs that choose to use these new products in the treatment of opioid dependence will adhere to the same Federal treatment standards established for methadone and ORLAAM[reg]. The Secretary invites public comments on this action.https://www.federalregister.gov/documents/2003/05/22/03-11469/opioid-drugs-in-maintenance-and-detoxification-treatment-of-opiate-addiction-addition-ofFR-Doc-03-11469
Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction; Repeal of Current Regulations and Issuance of New Regulations: Delay of Effective Date and Resultant Amendments to the Final RuleRule01-674503/19/2001Health and Human Services DepartmentIn accordance with the memorandum of January 20, 2001, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Review Plan,'' published in the Federal Register on January 24, 2001, this action temporarily del … In accordance with the memorandum of January 20, 2001, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Review Plan,'' published in the Federal Register on January 24, 2001, this action temporarily delays for 60 days the effective date of the rule entitled ``Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction; Repeal of Current Regulations and Issuance of New Regulations'' published in the Federal Register on January 17, 2001 (66 FR 4076). It also amends the final rule published on January 17 to extend by 60 days the dates outlines in the rule for transitional certification of opioid treatment programs so as to be consistent with extending the effective date by that amount of time. That rule repealed the existing narcotic treatment regulations enforced by the Food and Drug Administration (FDA), and created a new regulatory system based on an accreditation model. It also shifted administrative responsibility and oversight of the program from FDA to SAMHSA.https://www.federalregister.gov/documents/2001/03/19/01-6745/opioid-drugs-in-maintenance-and-detoxification-treatment-of-opiate-addiction-repeal-of-currentFR-Doc-01-6745
Opioid Drugs in Maintenance and Detoxification Treatment of Opiate Addiction;Rule01-72301/17/2001Health and Human Services DepartmentThe Department of Health and Human Services and the Substance Abuse and Mental Health Services Administration (SAMHSA) are issuing final regulations for the use of narcotic drugs in maintenance and detoxification treatment of opioid ad … The Department of Health and Human Services and the Substance Abuse and Mental Health Services Administration (SAMHSA) are issuing final regulations for the use of narcotic drugs in maintenance and detoxification treatment of opioid addiction. This final rule repeals the existing narcotic treatment regulations enforced by the Food and Drug Administration (FDA), and creates a new regulatory system based on an accreditation model. In addition, this final rule shifts administrative responsibility and oversight from FDA to SAMHSA. This rulemaking initiative follows a study by the Institute of Medicine (IOM) and reflects recommendations by the IOM and several other entities to improve opioid addiction treatment by allowing for increased medical judgment in treatment.https://www.federalregister.gov/documents/2001/01/17/01-723/opioid-drugs-in-maintenance-and-detoxification-treatment-of-opiate-addictionFR-Doc-01-723
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