Tennessee’s Opioid Epidemic: Amending TennCare Regulations to Match Recent FDA Recommendations Could Help Save Thousands

Tennessee’s Opioid Epidemic: Amending TennCare Regulations to Match Recent FDA Recommendations Could Help Save Thousands

Ben Barton[1]

In 2022, 3,826 Tennesseans died from a drug overdose.[2] Of those deaths, 3073 were from opioids.[3] These figures are rightfully shocking, as they signify that Tennessee has the third highest drug overdose mortality rate in the country, behind only West Virginia and the District of Columbia.[4] The overdose mortality rate alone does not fully encapsulate the epidemic occurring in our state; every year, over 26,000 Tennesseans require medical intervention related to overdosing on drugs, and an estimated 70,000 are addicted to opioids.[5] Data suggests that this epidemic could significantly contribute to imposing a two-billion-dollar burden on the state annually, in addition to the strain it imparts on providers and healthcare systems.[6] This especially impacts TennCare, which covers more than 23% of the state’s population and is Tennessee’s largest payer for substance disorder treatment.[7]

The overdose issue is about as nuanced and complex as it comes, and there certainly is no “one solution” that can address the multiplicity of causal factors at play. Instead, Tennessee legislature should amend existing law to bring the state in line with federal guidance and the majority of other states by (1) removing TennCare’s prior authorization requirements for the prescribing of buprenorphine and (2) expanding the restrictive prescribing quantity limit of buprenorphine from 16mg to 32mg daily for TennCare enrollees.[8] These small changes will provide better access and quality of care to thousands who are at risk of experiencing an opioid-induced overdose.

Buprenorphine is an opioid that functions as an opioid partial agonist.[9] It is FDA-approved and has decades of clinical evidence demonstrating it is a safe and effective treatment for opioid use disorder (“OUD”).[10] In a review of over 40,000 patients treated for OUD, “[o]nly treatment with buprenorphine or methadone was associated with reduced risk of overdose [and]… serious opioid-related acute care[.]”[11] Despite medical evidence demonstrating the drug’s effectiveness, Tennessee has one of the lowest dispensing rates of buprenorphine in the country.[12] This is likely because the barriers above limit many Tennesseans from receiving the potentially lifesaving treatment they need.

Tennessee is one of only four states that require prior authorization (“prior-auth”) for standard buprenorphine treatment under its Medicaid program.[13] The state took steps in the right direction in 2019 by removing prior-auth requirements for providers under TennCare’s “BeSmart” program and buprenorphine prescriptions for less than five days.[14] However, the majority of TennCare enrollees still must usually wait weeks for approval to receive the drug, which is a dangerously long window of time given that 59% of those with OUD are likely to relapse within their first week of sobriety.[15] Therefore, removing TennCare prior-auth requirements will allow enrollees to receive buprenorphine from their provider when they need it most. Additionally, prior-auth removal will allow the Tennessee Medicaid program to deliver the same access to care for its enrollees that individuals in most states can already receive regarding access to buprenorphine.

Even if finally authorized to receive buprenorphine treatment, TennCare enrollees are presented with the additional hurdle that the daily dosing they receive may not be adequate to treat their OUD. Tennessee providers are statutorily limited to prescribing a maximum of 16mg daily of buprenorphine to TennCare enrollees.[16] The stringent cap likely originates from legislative concerns regarding abuse potential, costs associated with prescribing the drug, and prior ambiguity related to FDA labeling for buprenorphine.[17] However, on December 26, 2024, the FDA published a letter clarifying that their label for buprenorphine does not set a maximum dose of 16 or 24mg a day, but that “dosage [of this drug should be] based upon . . . individual patient’s therapeutic need.”[18]

Furthermore, a growing body of evidence suggests that daily doses of buprenorphine above 16mg a day are safe, well tolerated, more effective in managing OUD, lead to improved retention in the treatment of OUD, lead to a lower risk of subsequent inpatient visits, and lead to decreased mortality.[19] This provides benefits to the patient while lowering costs to the state.[20] A survey on this topic found that only four other states presently cap buprenorphine dosing to 16mg a day.[21]

While it is my opinion that daily dosing limits should be a decision made by a physician based on FDA labeling and the needs of an individual patient, it is easy to recognize the concerns that the legislature might have regarding the unfettered prescribing of an opioid. Thus, an appropriate step in the right direction is to increase the cap to 32mg daily. Raising the ceiling will allow for greater physician discretion in the delivery of treatment for patients who might need higher doses of buprenorphine to treat their OUD effectively while balancing legislative concerns. This approach will emulate actions taken by the District of Columbia in April of 2024, which, as previously mentioned, is experiencing a similar opioid epidemic.[22]

Inarguably, Tennessee is in the pits of an opioid epidemic, which affects every Tennessean in one way or another. However, the evidence is encouraging—that maybe the state can curb the tragic annual rate of OUD-related deaths by providing quicker access to care by removing prior-auth requirements and more effective treatment by allowing providers to prescribe higher daily doses of buprenorphine to those who need it most. Further, adopting these proposals will align TennCare with federal guidance and most of the country regarding state Medicaid treatment for OUD with buprenorphine. Those interested should speak to their state representatives and voice their support for these proposals.

[1] J.D. Candidate, University of Tennessee College of Law, Tennessee Law Review Executive Notes Editor. The opinions and proposals within the blog are solely those of the author and do not represent the perspective or position of The Tennessee Law Review.

[2] Drug Overdose in Tennessee, Tenn. Dep’t of Health, https://www.tn.gov/health/health-program-areas/pdo/pdo/data-dashboard.html (last visited Jan. 31, 2025).

[3] The Opioid Epidemic, Overmountain Recovery, https://www.overmountainrecovery.org/opioid-epidemic/ (last visited Jan. 31, 2025).

[4] Drug Overdose Mortality by State, Ctrs. For Disease Control & Prevention, https://www.cdc.gov/nchs/pressroom/sosmap/drug_poisoning_mortality/drug_poisoning.htm (last visited Jan. 31, 2025).

[5] The Opioid Epidemic, supra note 3; 2022 Drug Overdose Hospital Discharges in Tennessee, Tenn. Dep’t of Health 1, 3 (Mar. 1, 2024), https://www.tn.gov/content/dam/tn/health/documents/pdo/legislative-report/Drug_Overdose_Hospital_Discharges_Report_2024.pdf.

[6] Holly Fletcher, Drug, Alcohol Abuse Saps $2 Billion from Tennessee Annually — An Under-the-Radar Impact of Opioid Epidemic, The Tennessean, https://www.tennessean.com/story/money/industries/health-care/2017/12/04/drug-alcohol-abuse-saps-2-billion-tennessee-annually-under-the-radar-impact-opioid-epidemic/909253001/ (last updated Dec. 4, 2017).

[7] Letter from John J. Dreyzehner, Commissioner, State of Tenn. Dep’t of Health, to Honorable Bill Haslam, Governor, State of Tenn. (Mar. 7, 2014) (on file with Tennessee Department of Health), https://www.tn.gov/content/dam/tn/health/documents/Drug_Poisonings_TN_2014.pdf; Portrait of TennCare, Division of TennCare, https://www.tn.gov/content/dam/tn/transparenttn/citizens-dashboard-2023/tenncare/TennCare_2022_onepager.pdf (last updated Dec. 2022).

[8] Prior authorization is defined as “an approval from a health plan that may be required before you get a service or fill a prescription in order for the service or prescription to be covered by your plan.” Prior Authorizations and Addiction Treatment, Univ. of Tenn. Sys., https://smart.ips.tennessee.edu/smart-policy-network/policy-briefs/prior-authorizations/ (last visited Jan. 31, 2025); Tennessee Nonresidential Buprenorphine Treatment Guidelines, Tenn. Dep’t of Health & Tenn. Dep’t of Mental Health & Substance Abuse Serv. 1, 19, https://www.tn.gov/content/dam/tn/health/documents/Buprenorphine-Treatment-Guidelines.pdf (last updated Oct. 31, 2023).

[9] Buprenorphine Treatment, Substance Abuse and Mental Health Services Admin., https://www.samhsa.gov/substance-use/treatment/options/buprenorphine (last visited Jan. 31, 2025) (showing an agonist mimics the effect of opioids by binding and activating the same receptors in the cells, but to a substantially weaker degree).

[10] See generally Matisyahu Shulman et al., Buprenorphine Treatment for Opioid Use Disorder: An Overview, PubMed 1, 6 (June 1, 2020), https://pmc.ncbi.nlm.nih.gov/articles/PMC6585403/#:~:text=Large%20clinical%20trials%20have%20shown,withdrawal%20%5B46%2D47%5D (providing a review of buprenorphine clinical effectiveness).

[11] Sarah E. Wakeman, et al., Comparative Effectiveness of Different Treatment Pathways for Opioid Use Disorder, Jama Network Open 1, 1 (Feb. 5, 2020), https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2760032.

[12] Buprenorphine Dispensing Rate Maps, Ctrs. for Disease Control & Prevention, https://www.cdc.gov/overdose-prevention/data-research/facts-stats/buprenorphine-dispensing-maps.html (last visited Jan. 31, 2025).

[13] Heather Saunders & Kathy Gifford, State Approaches to Addressing the Opioid Epidemic: Findings from a Survey of State Medicaid Programs, Kaiser Family Found., https://www.kff.org/medicaid/issue-brief/state-approaches-to-addressing-the-opioid-epidemic-findings-from-a-survey-of-state-medicaid-programs/ (last visited Jan. 31, 2025); see Prior Authorizations and Addiction Treatment, supra note 8.

[14] See Tennessee Nonresidential Buprenorphine Treatment Guidelines, supra note 8.

[15] See Prior Authorizations and Addiction Treatment, supra note 8; Opioid Relapse Rates, Prevention and Recovery, Am. Addiction Ctrs., https://drugabuse.com/opioids/relapse/ (last visited Jan. 31, 2025).

[16] See Tenn. Code Ann. § 53-11-311 (2021).

[17] See generally 2020 Buprenorphine Report, Tenn. Dep’t of Health (Nov. 30, 2020), https://www.tn.gov/content/dam/tn/health/documents/pdo/2020%20Buprenorphine%20Report_11.30.pdf (finding that in 2018, eighty-five overdose deaths in Tennessee listed buprenorphine as a contributing cause of death); Memorandum from Marta Sokolowska, Deputy Center Director, Center for Drug Evaluation and Research, to Colleagues, Center for Drug Evaluation and Research (Dec. 26, 2024), https://www.fda.gov/media/184748/download?attachment (clarifying the FDA’s position 16mg a day is not the maximum dose of buprenorphine); Paul G. Barnett, Comparison of Costs and Utilization Among Buprenorphine and Methadone Patients, 104 Cochrane 982, 982 (2009), https://pubmed.ncbi.nlm.nih.gov/19466922/ (“The mean cost of care for the 6 months after treatment initiation was $11,597 for buprenorphine[.]”).

[18] Memorandum from Marta Sokolowska, supra note 17.

[19]Higher Doses of Buprenorphine May Improve Treatment Outcomes for People with Opioid Use Disorder, Nat’l Inst. Health, https://www.nih.gov/news-events/news-releases/higher-doses-buprenorphine-may-improve-treatment-outcomes-people-opioid-use-disorder#:~:text=Studies%20have%20shown%20that%20more,treatment%20for%20opioid%20use%20disorder (last visited Jan. 31, 2025); Listening Session: Use of High Dose Buprenorphine for Treatment of Opiod Use Disorder, Substance Abuse and Mental Health Services Admin. (Dec. 11, 2023), https://library.samhsa.gov/sites/default/files/high-dose-buprenorphine-report-pep24-02-013.pdf; Andrew A. Herring, et al., High-Dose Buprenorphine Induction in the Emergency Department for Treatment of Opioid Use Disorder, JAMA Open Network 1, 2 (July 15, 2021), https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2781956; Sara Axeen, et al., Association of Daily Doses of Buprenorphine with Urgent Health Care Utilization, JAMA Open Network 1, 1 (Sept. 25, 2024), https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2824049; Feitong Lei, Higher First 30-Day Dose of Buprenorphine Opioid Use Disorder Treatment is Associated with Decreased Mortality, 18 PubMed 319, 319 (2024), https://pubmed.ncbi.nlm.nih.gov/38598300/.

[20] Anneke L. Claypool, et al., Cost-effectiveness of Increasing Buprenorphine Treatment Initiation, Duration, and Capacity Among Individuals Who Use Opioids, 4 JAMA Health Forum 1, 1 (2023), https://pmc.ncbi.nlm.nih.gov/articles/PMC10199347/.

[21] Max Jordan Nguemeni Tiako, et al., Thematic Analysis of State Medicaid Buprenorphine Prior Authorization Requirements, JAMA Open Network 4, 6 (Jun. 15, 2023),https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2806100.

[22] Transmittal 24-16: Suboxone and Buprenorphine-Containing Products Daily Dosing Limit Increase, D.C. Dept. of Health Care Finance (Apr. 17, 2024), https://dhcf.dc.gov/sites/default/files/dc/sites/dhcf/publication/attachments/Transmittal_24-16_Suboxone_and_Buprenorphine-Containing_Products_Daily_Dosing_Limit_Increase_3.pdf.