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Mark TL, Parish W, Zarkin GA. Association Between Medicare and FDA Policies and Prior Authorization Requirements for Buprenorphine Products in Medicare Part D Plans. JAMA. 2019;322(2):166–167. doi:10.1001/jama.2019.6581
Approximately 1.2% of Medicare beneficiaries misused opioid prescriptions in 2016, double the prevalence in 2006.1 Buprenorphine, either alone or with naloxone, is an effective medication for opioid use disorder and is covered under Medicare Part D.
As of January 2018, 57% of Medicare Part D plans required prior authorization to prescribe buprenorphine-naloxone for opioid use disorder, and 66% required prior authorization to prescribe buprenorphine.2 Health plans use prior authorization to encourage appropriate medication use and contain spending; however, it can also reduce the probability that a patient receives prescribed medications and lead to worse outcomes.3
In September 2017, the US Food and Drug Administration (FDA) announced a labeling change for buprenorphine products that emphasized the importance of preventing barriers to obtaining medications for opioid use disorder.4 In April 2018, the Centers for Medicare & Medicaid Services (CMS) announced that it would not approve Part D formularies that required prior authorization for buprenorphine products more frequently than once per year, citing the FDA labeling change.5 We analyzed whether prior authorization requirements for buprenorphine products under Medicare Part D changed after these announcements.
We used formulary files for stand-alone Medicare Part D and Medicare Advantage prescription drug plans for the 2017, 2018, and 2019 plan years, which began in October of the previous calendar year. Formulary files indicate whether a Part D plan covers a medication, and whether a medication requires prior authorization. We examined brand-name buprenorphine-naloxone (Suboxone films, Bunavail films, and Zubsolv tablets), generic buprenorphine-naloxone, and generic buprenorphine monotherapy for opioid use disorder.
We calculated the number of plans that covered each product and required prior authorization. We analyzed the differences before and after the FDA and CMS announcements (from 2017/2018 to 2019). The reported proportions were weighted by plan enrollment so that the proportions represent enrollees who have coverage or are exposed to prior authorization. We used Cochran-Armitage tests to determine statistical significance with a 2-tailed P < .05 indicating significance. Analyses were conducted using Stata version 15.1 (StataCorp).
There were 2485 plans in 2017, 2889 in 2018, and 3415 in 2019 (Table). Coverage for brand-name buprenorphine-naloxone was 99% during all plan years. The percentage of plans that required prior authorization decreased from 88% (95% CI, 85%-90%) for 2017 to 74% (95% CI, 71%-77%) for 2018 to 3% (95% CI, 3%-4%) for 2019 (P < .001).
The proportion of plans providing coverage for generic buprenorphine-naloxone increased (55% for 2017 and 2018 and 63% for 2019) and the proportion requiring prior authorization decreased from 96% (95% CI, 95%-97%) to 73% (95% CI, 70%-77%) to 0.09% (95% CI, 0.04%-0.13%) (P < .001). Generic buprenorphine without naloxone was covered by 96% to 100% of plans. Prior authorization requirements decreased from 87% (95% CI, 84%-89%) for 2017 to 74% (95% CI, 71%-77%) for 2018 to 58% (95% CI, 55%-61%) for 2019 (P < .001).
The proportion of Part D plans requiring prior authorization for buprenorphine products decreased between 2017 and 2019, with a steep decline between 2018 and 2019 that was associated with policy changes made by the FDA and CMS. The 2017 to 2018 reduction that occurred prior to the FDA and CMS policy announcements may have been stimulated by other efforts such as the New York attorney general’s investigation of health plans for parity violations related to their use of prior authorization for opioid use disorder medications.6 The data are important because Medicare policy is often viewed as a standard that is subsequently adopted by private health plans and Medicaid.
This study is limited in that it does not analyze the effect of prior authorization policies on buprenorphine use and subsequent outcomes. Additional research regarding the benefits of requiring prior authorization compared with the risk of imposing barriers to opioid use disorder treatment is needed.
Accepted for Publication: April 27, 2019.
Corresponding Author: Tami L. Mark, PhD, RTI International, 6110 Executive Blvd, Ste 903, Rockville, MD 20857 (email@example.com).
Author Contributions: Drs Mark and Parish had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: All authors.
Acquisition, analysis, or interpretation of data: Mark, Parish.
Drafting of the manuscript: Mark, Parish.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Mark, Parish.
Obtained funding: Mark.
Administrative, technical, or material support: Mark.
Conflict of Interest Disclosures: All 3 authors are salaried employees of RTI International. Their work is funded through federal and state agency contracts and grants.
Funding/Support: This research was funded under grants from the Laura and John Arnold Foundation.
Role of the Funder/Sponsor: The Laura and John Arnold Foundation had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
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