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Nov 24, 2015
Stefanie Pietras, Melissa Azur and Jonathan Brown Mathematica Policy Research ABSTRACT In response to the growing opioid epidemic, HHS announced a three-pronged initiative in March 2015 to: (1) improve opioid prescribing practices; (2) increase access to naloxone for overdose management; and (3) expand medication-assisted treatment (MAT) to reduce opioid dependence. In support of the initiative, ASPE contracted with Mathematica Policy Research to develop a roadmap that identifies concepts for potential quality measures that promote the appropriate use of MAT for opioid use, as well as the steps needed to develop those concepts into measures. As a guiding step in roadmap development, clinical MAT guidelines and existing measures related to MAT were reviewed. This report contains the review of clinical MAT guidelines and existing measures. DISCLAIMER: The opinions and views expressed in this report are those of the authors. They do not necessarily reflect the views of the Department of Health and Human Services, the contractor or any other funding organization. "AcknowledgmentsMathematica Policy Research prepared this review under contract to the Office of the Assistant Secretary for Planning and Evaluation (ASPE), U.S. Department of Health and Human Services (HHS) (HHSP23320100019WI/HHSP23337001T). Additional funding was provided by the HHS Substance Abuse and Mental Health Services Administration (SAMHSA). The authors appreciate the guidance of Kirsten Beronio, Alexis Horan, Emily Jones, D.E.B. Potter (ASPE) and Lisa Patton, Laura Rosas, Patricia Santora, and Dantrell Simmons (SAMHSA). The views and opinions expressed here are those of the authors and do not necessarily reflect the views, opinions, or policies of ASPE, SAMHSA or HHS. The authors are solely responsible for any errors. AbstractSummary: In response to the growing opioid epidemic, the U.S. Department of Health and Human Services (HHS) announced a three-pronged initiative in March 2015 to: (1) improve opioid prescribing practices; (2) increase access to naloxone for overdose management; and (3) expand medication-assisted treatment (MAT) to reduce opioid dependence. In support of the initiative, the HHS Office of the Assistant Secretary for Planning and Evaluation contracted with Mathematica Policy Research to develop a roadmap that identifies concepts for potential quality measures that promote the appropriate use of MAT for opioid use as well as the steps needed to develop those concepts into measures. As a guiding step in roadmap development, clinical MAT guidelines and existing measures related to MAT were reviewed. This report contains the review of clinical MAT guidelines and existing measures. Major Findings: Twenty-one MAT opioid use guidelines published between 2010 and 2015 were identified. The guidelines were largely developed using a consensus process informed by a literature review. Ninety percent of the guidelines focus on care delivered in the maintenance treatment phase, 62 percent provide information on assessment, and 62 percent address withdrawal management or detoxification. All the guidelines recommend specific medications for use in treatment and about half (57 percent) provide information on medication dosing. Two-thirds of the guidelines provide some information on psychosocial treatment. Contingency management, motivational interviewing, and cognitive behavioral approaches are the most commonly mentioned psychosocial treatments. In addition to the clinical guidelines, ten existing MAT opioid use quality measures were identified -- eight process measures and two patient satisfaction methods. Six of the process measures assess various aspects of pharmacotherapy use, including dosage and frequency of use. One measure explicitly addresses both components of MAT -- pharmacotherapy and psychosocial treatment; however, this measure assesses counseling about these treatment options, rather than utilization of MAT. One measure that was developed for use in inpatient settings has received the National Quality Forum's (NQF's) endorsement. Purpose: This project surveyed existing clinical guidelines and quality measures related to MAT. The summarized information will be used to develop a roadmap that identifies strategies HHS could use to promote the appropriate use of MAT for opioid use. Methods: This project searched for and reviewed existing MAT clinical guidelines, published from 2010 to 2015, in the National Guidelines Clearinghouse, the National Institute for Health and Clinical Excellence, online search engines, and bibliography scans. MAT quality measures were identified from searches in the National Quality Measures Clearinghouse, the NQF's Quality Positioning System, the HHS Measure Inventory, and online search engines. AcronymsThe following acronyms are mentioned in this report and/or appendices.
A. IntroductionOpioid overdoses claim 17,000 American lives annually (ASAM 2015). Deaths by opioid overdose have nearly quadrupled from 1999 to 2013 (CDC 2015). Nearly 2.5 million Americans are currently at risk for overdoses -- 1.9 million are opioid-dependent, and 517,000 are addicted to heroin (ASAM 2015). In response to the growing opioid epidemic, the U.S. Department of Health and Human Services (HHS) announced a three-pronged initiative in March 2015 to: (1) improve opioid prescribing practices; (2) increase access to naloxone for overdose management; and (3) expand medication-assisted treatment (MAT) to reduce opioid dependence (ASPE 2015). MAT is a treatment that combines medication with psychosocial treatment to treat substance use disorders (SUDs). In the United States, three medications are HHS Food and Drug Administration (FDA)-approved to treat opioid use disorders: methadone, buprenorphine and naltrexone. In support of the initiative, the HHS Office of the Assistant Secretary for Planning and Evaluation (ASPE) contracted with Mathematica Policy Research to develop a roadmap that identifies concepts for potential quality measures that promote the appropriate use of MAT for opioid use as well as the steps needed to develop those concepts into measures. As a guiding step in roadmap development, we conducted a review of clinical MAT guidelines and existing measures related to MAT. In this report, we briefly summarize the findings from the review. B. Approach to ReviewEven though the roadmap focuses on MAT for opioid use, we recognize that clinical guidelines and measures related to MAT for alcohol and other SUDs could be useful to guide the approach to developing and implementing MAT measures for opioid use. As such, we searched for and reviewed clinical guidelines that include MAT for opioid and alcohol use published between 2010 and 2015. We identified clinical guidelines through searches of the National Guidelines Clearinghouse, the National Institute for Health and Clinical Excellence (NICE), PubMed, and Google. We identified additional guidelines through bibliography searches of previously identified guidelines. We also searched for measures related to MAT for opioid and alcohol use and other SUDs through searches in the National Quality Measures Clearinghouse, National Quality Forum's (NQF's) Quality Positioning System, HHS Measure Inventory, and Google. In addition, we drew on a review of measures that Mathematica conducted earlier under the same contract. C. Summary of Medication-assisted Treatment
We identified 21 guidelines on MAT for opioid use (Table 1; Appendix A includes the verbatim guidelines) and seven guidelines on MAT for alcohol use (Table 2; Appendix D includes the verbatim guidelines) published between 2010 and 2015. Nearly all of the guidelines were developed through a consensus process and were guided by a literature review. The guidelines vary in their specificity -- some simply identify the appropriate medications to treat opioid/alcohol use (A.9, A.13, A.15, A.18) while others outline important components of treatment, including processes associated with screening and assessment, the identification of appropriate candidates for specific drugs, and considerations for special populations.
In some cases, the guidelines provide little information to allow the reader to assess the strength and quality of the evidence used in support of the guideline recommendations. Slightly more than half (61 percent) of the opioid guidelines rated the strength of or include any comment about the level of evidence used to support the guidelines, and guideline developers used different standards in rating the evidence. As indicated by the guideline developers, given the limitations of the current scientific evidence and the need to account for other factors such as feasibility, risk/benefit ratios, patient and provider values and preferences, and costs, nearly all of the guidelines are based upon a blend of expert opinion and scientific rigor. D. Variation in Key Features of Medication-assisted Treatment Clinical GuidelinesStages of Treatment. Both opioid and alcohol use MAT guidelines tend to focus on stages of treatment -- assessment, withdrawal management (also referred to as detoxification), and maintenance -- whereby the recommended dosage of medication and frequency and intensity of MAT vary with the stage of treatment and the client's needs. All of the guidelines recommend specific medications appropriate for use in a given treatment stage, and some of the guidelines list contraindications with other medications (A.3, A.5, A.10, A.21). Treatment Setting. In the United States the treatment setting is directly linked to the appropriate use of MAT. Methadone may be prescribed only in opioid treatment programs (OTPs); buprenorphine may be prescribed in OTPs and in office-based opioid treatment (OBOT) settings by certified physicians; and naltrexone may be prescribed by any provider licensed to prescribe medication (42 CFR Part 8; Drug Addiction Treatment Act of 2000). Despite the importance of treatment setting, the clinical guidelines inconsistently provide information on the recommended treatment setting. Several guidelines do not specify the treatment setting or broadly assume the setting to be an outpatient facility. FDA-Approved Medications. Nearly all of the guidelines focus on FDA-approved medications for MAT, but a few also mention other medications, mostly to be used in combination with FDA-approved medications or as a "second tier" treatment if the patient does not respond to the FDA-approved medications. A few guidelines, notably ASAM's 2015 guidelines, recommend the off-label use of clonidine for opioid withdrawal management (A.5, A.8, A.17, A.21); clonidine has been used extensively in the United States for this purpose (A.5). Other medications recommended throughout the collective guidelines included lofexide for opioid withdrawal (approved in the United Kingdom) (A.11, A.17), diamorphine (heroin) for opioid dependence (A.11, A.17), and baclofen and nalmefene (United Kingdom) for alcohol dependence. Psychosocial Treatment. Most of the guidelines contain broad recommendations for psychosocial treatment in conjunction with the use of medications, but they vary in the strength of the recommendations. Among the guidelines that mention specific treatments, contingency management (CM) (A.3, A.6, A.10, A.17, A.21), motivational interviewing (A.3, A.6, A.20), and cognitive behavioral approaches (A.6, A.8, A.12, A.17, A.20, A.21) are most commonly mentioned. These treatments are typically presented as a "menu option" rather than a strong recommendation for or endorsement of the treatment. The lack of strong recommendations for specific evidence-based practices (EBTs) may reflect the state of the evidence in support of psychosocial treatment for MAT. For example, panelists involved in the development of the buprenorphine guideline (A.1) received summaries of the relevant evidence and were then asked to rate guidelines specific to cognitive behavioral therapy (CBT) and CM. Given disagreement over the best type of counseling to accompany buprenorphine treatment, the final guideline included a broad recommendation for EBT. A few guidelines also include statements about the frequency of psychosocial treatment, specifying that it should be more frequent earlier in treatment and may be reduced during the maintenance phase (A.1, A.4). Finally, some guidelines emphasize the importance of linking patients to community-based services (A.4, A.5) and family supports (A.3, A.4, A.5) and supplementing psychotherapy with self-help/mutual-help groups (A.3. A.4, A.12, A.21). Diversion, Drug Testing and Compliance. Several guidelines provided recommendations for addressing diversion (transfer of MAT medications from a licit to an illicit channel of distribution or use) and compliance with treatment as intended. For example, multiple guidelines recommend consulting the Prescription Drug Monitoring Program (PDMP) before induction (initiation of MAT medication) and periodically afterwards to confirm compliance with prescribed drugs and identify unreported use of other drugs (A.3, A.5, A.10, A.20); conducting toxicology tests and urine screens to test for opioids (absence may indicate diversion), benzodiazepines and other substances (A.1, A.3, A.5, A.10, A.20); and conducting recall visits for pill counts (A.3, A.5, A.20). Special Populations. Several guidelines provide information on the use of MAT for opioid and alcohol use in special populations. The guideline information may identify and present targeted opportunities to develop measures that encourage the appropriate use of MAT for these populations. We briefly summarize the relevant recommendations: Pregnant Women. The guidelines consistently recommend that pregnant women should receive opioid MAT during the maintenance phase of treatment rather than during withdrawal management or abstinence (A.2, A.5, A.6, A.7, A.17, A.19, A.21). Most of the guidelines provide information regarding the preferred MAT medications (A.2, A.6, A.14, A.15, A.17, A.19, A.21) and dosage (A.5); however, animal studies have shown an adverse effect on fetuses, and adequate, well-controlled studies in humans have yet to be conducted (A.3). Despite the lack of adequate research to support the use of MAT medication in pregnant women, some of the guidelines suggest that the potential benefits of MAT medications for some pregnant women may outweigh potential risks (A.3, A.4, A.6, A.21). Some guidelines that include pregnant women also recommend specific treatment settings (A.2, A.6), depending on the phase of MAT treatment and the stage of the woman's pregnancy (A.2, A.5), and emphasize the importance of care coordination (A.2, A.4, A.5, A.21). Patients with Co-occurring Mental Disorders. Individuals with SUDs often have co-occurring mental health conditions. The guidelines emphasize the importance of screening for mental health conditions as part of the assessment phase of MAT as well as ongoing monitoring of the condition throughout treatment (A.1, A.4, A.5, A.10, A.21). The guidelines recommend either providing a referral for the treatment of the co-occurring condition or treating it on site. In addition, the guidelines provide information on the risk of drug interactions between MAT medications and benzodiazepines, (a medication commonly used to treat anxiety) (A.1, A.3, A.4, A.10, A.21). The guidelines also point to care coordination as an important component of care (A.1, A.4, A.10, A.21). Adolescents. Most of the guidelines provide little information on the use of MAT for adolescents. Buprenorphine, one of the three medications approved by the FDA for use in the treatment of opioid disorders, is the only medication approved by the FDA for use with adolescents. Under certain circumstances and in some states, adolescents age 16 years and older may also receive methadone treatment (Mann, Frieden, Hyde, Volkow, and Koob 2014). The FDA has not approved the use of any of the medications for MAT for alcohol use in adolescents under age 18. The guidelines generally emphasize that treatment should be developmentally appropriate and involve the family. HIV Population. Some of the guidelines emphasize the integration of care for individuals with HIV and opioid use disorder, suggesting that antiretroviral therapy (ART) and opioid maintenance therapy should be offered in the same care setting when possible (A.7, A.13). Guidelines indicate that buprenorphine and methadone are appropriate for patients with HIV (A.7, A.13, A.21), but drug interactions should be monitored (A.21). Prison Population. The recommendations for MAT for incarcerated individuals are similar to those for the general population; that is, all three MAT medications should be considered and accompanied by psychosocial treatment (A.5). The guidelines recommend the initiation of opioid maintenance therapy before prison release to help reduce subsequent overdose-related mortality (A.5, A.7). The guidelines also stress the importance of continuity of care when an individual returns to the community (A.7, A.21). E. Summary of Medication-assisted Treatment Quality Measures
MAT Opioid Use Measures. We identified ten measures (Table 3) that incorporate MAT -- eight process measures (that rely on administrative data and/or medical record review) and two patient satisfaction measures (that rely on patient surveys and are limited to HIV-positive patients). Only one identified measure -- focused on adults discharged from inpatient settings -- has received the NQF's endorsement. Only one measure explicitly addresses both components of MAT -- pharmacotherapy and psychosocial treatment. However, this measures assesses counseling about these treatment options, rather than utilization of MAT. The remaining process measures assess various aspects of pharmacotherapy use, including dosage and frequency of use. MAT Alcohol Use Measures. We identified ten measures specifically related to alcohol that might be useful in the future development of MAT measures for opioid use, three of which assess the provision of MAT at various stages of treatment (e.g., post-discharge, post-withdrawal) (Appendix C provides details of the measures). One measure assessed receipt of evidence-based psychological interventions while the other measures addressed precursors to MAT: screening and brief interventions/counseling. NQF has endorsed four of the ten measures. Other Related Measures. In addition to the above measures, we identified 58 measures (Appendix D) that reflect concepts that could be applied to MAT or are known to be important supports for MAT. They include, for example, measures related to assessment; screening; and access to, timeliness of, and retention in treatment; use of psychosocial treatment; and care coordination. The measures are largely process measures, and three have received NQF's endorsement. F. SummaryThe guidelines provide recommendations on the use of MAT across treatment phases with an emphasis on the maintenance phase. Most of the guidelines were developed based upon expert opinion and scientific literature. Some guidelines focus on special populations and over half mention psychosocial treatment. The strength of the recommendation varies from general recommendations to provide psychosocial treatment to suggestions of specific types of psychosocial treatment. The variation in the evidence supporting the guidelines, along with differences in the specificity of the guidelines' recommendations, may present challenges to the development and positioning of measures. Existing measures related to MAT largely focus on receipt of FDA-approved medications over a specified period. None of the identified MAT for opioid use measures assesses the use of pharmacotherapy and psychosocial treatment. The lack of consensus regarding specific evidence-based psychosocial treatments effective in the treatment of opioid use disorders may contribute to the dearth of quality measures; however, it could also indicate a gap and an opportunity for improving the appropriate use of MAT. In the next phase of this project, we will use the information gathered to date to identify potential measure concepts and the steps needed to develop the concepts into measures that meet NQF endorsement standards. The selection of the most appropriate guideline(s) to inform development of the measures may depend on the projected treatment setting, phase of treatment, and target population. ReferencesAmerican Society of Addiction Medicine (ASAM). "Opioid Addiction Disease 2015 Facts and Figures." Available at http://www.asam.org/docs/default-source/advocacy/opioid-addiction-disease-facts-figures.pdf. Centers for Disease Control and Prevention (CDC). Morbidity and Mortality Weekly Report. 2015. "QuickStats: Rates of Deaths from Drug Poisoning and Drug Poisoning Involving Opioid Analgesics--United States, 1999-2013," Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6401a10.htm. Mann, C., T. Frieden, P.S. Hyde, N.D. Volkow, and G.F. Koob. Informational Bulletin. 2014. "Medication Assisted Treatment for Substance Abuse Disorders," Available at http://www.medicaid.gov/Federal-Policy-Guidance/Downloads/CIB-07-11-2014.pdf. Office of the Assistant Secretary for Planning and Evaluation (ASPE). ASPE Issue Brief. 2015. "Opioid Abuse in the U.S. and HHS Actions to Address Opioid-Drug Related Overdoses and Deaths." Available at https://aspe.hhs.gov/basic-report/opioid-abuse-us-and-hhs-actions-address-opioid-drug-related-overdoses-and-deaths. Appendix A. Medication-assisted Treatment for Opioid Use Clinical Guidelines: Excerpts From Relevant SectionsLIST OF TABLES
Appendix B. Medication-assisted Treatment for Alcohol Use Clinical Guidelines: Verbatium Excerpts From Relevant Guideline SectionsLIST OF TABLES
Appendix C. Alcohol Use: Medication-assisted Treatment and Other Related Measures
Appendix D. Substance Use: Medication-assisted Treatment and Other Related Measures
Project Information and Additional ReportsDEVELOPMENT AND TESTING OF BEHAVIORAL HEALTH QUALITY MEASURESThis report was prepared under contract #HHSP2332010016WI between the U.S. Department of Health and Human Services (HHS), Office of Disability, Aging and Long-Term Care Policy (DALTCP) and Mathematica Policy Research. For additional information about this subject, you can visit the DALTCP home page at http://aspe.hhs.gov/office-disability-aging-and-long-term-care-policy-daltcp or contact the ASPE Project Officers, D.E.B. Potter and Alexis Horan, at HHS/ASPE/DALTCP, Room 424E, H.H. Humphrey Building, 200 Independence Avenue, S.W., Washington, D.C. 20201; , . Reports Available Development of Quality Measures for Inpatient Psychiatric Facilities: Final Report Review of Medication-Assisted Treatment Guidelines and Measures for Opioid and Alcohol Use Strategies for Measuring the Quality of Psychotherapy: A White Paper to Inform Measure Development and Implementation |