Why Health Plans Should Go to the “MAT” in the Fight Against Opioid Addiction SEPTEMBER 2017 Contents About the Authors 3Executive Summary Julia Elitzer, MPH, DrPH, is a senior consultant in What the San Francisco office of Health Management Why Associates, a national research and consulting firm that focuses on the health care industry. How Margaret Tatar is the managing principal of 4Why Health Plans Should Go to the “MAT” Health Management Associates. in the Fight Against Opioid Addiction Methods About the Foundation What Is MAT? The California Health Care Foundation is dedicated to advancing meaningful, measur- Review of Comparative Effectiveness of MAT able improvements in the way the health care Access Barriers to MAT delivery system provides care to the people of Health Plan Actions California, particularly those with low incomes and those whose needs are not well served by Return on Investment: The Financial Case for MAT the status quo. We work to ensure that people Legislation Related to Health Plans and MAT have access to the care they need, when they Medicaid Managed Care and MAT in California need it, at a price they can afford. 6Conclusion: Next Steps for Health Plans 1 CHCF informs policymakers and industry lead- ers, invests in ideas and innovations, and 17 Appendices connects with changemakers to create a more A. AQ on Implementation of ACA and Parity Act F responsive, patient-centered health care system. B. Alkermes Registry Data, VICTORY Trial For more information, visit www.chcf.org. 20 Endnotes California Health Care Foundation 2 Executive Summary How The literature review and interviews with health plan leaders indicate that plans are working to increase treat- What ment access through multiple coordinated approaches: The opioid epidemic in the United States continues to be $$ Pharmacy benefit: an urgent health and social crisis. In 2015, the nation saw more than 33,000 opioid-related deaths, correlating with $$ Changing formularies to promote safer opioid a fourfold increase in opioid prescribing over the last 15 prescribing years, the increasing availability (and lower costs) of street $$ Eliminatingprior authorization requirements and heroin and fentanyl, and the ongoing dearth of addiction copays for MAT and naloxone treatment resources.1,2 Prescription opioid misuse, addic- tion, and overdose cost the US over $78 billion annually $$ Starting lock-in programs in health care, criminal justice, and lost productivity.3 $$ Incentivizing or training local pharmacies to furnish naloxone without a prescription Why $$ Provider network: While the epidemic requires a coordinated response from government and policymakers, law enforcement, $$ Assessing opioid use disorder prevalence and and health care, health plans have a uniquely influential ensuring sufficient MAT access in all regions role. Along with community partners, health plans can $$ Promoting new MAT access points in primary care, influence opioid prescribing across large geographies emergency departments, inpatient settings, and through comparative data, provider educational cam- the justice system through supporting trainings, paigns, practice guidelines, formulary and utilization increased reimbursement, pay-for-performance policies, and value-based payment. Plans can assess (P4P) programs, or grants network adequacy and expand their networks to ensure better access to addiction and pain treatment, and can $$ Contracting with telehealth providers incentivize integration of behavioral health services. Plans $$ Training providers to offer co-prescriptions of have a strong business case for building better access naloxone to addiction treatment regardless of whether or not sub- stance use disorders are the financial responsibility of the $$ Incentivizingbehavioral health integration through plan. Streamlining access to medication-assisted treat- P4P or direct grants ment (MAT — prescription medication combined with $$ Working to increase access to MAT for pregnant behavioral health) has been shown to lower emergency women department and hospitalization costs,4 lower hepatitis C and HIV rates, and decrease overdose deaths. $$ Working with hospitals to ensure evidence-based treatment of neonatal abstinence syndrome This report was commissioned for a health plan audience and aims to make the case for commercial and public $$ Medical management: plans to take action and make better access to MAT a top $$ Providing data analytics to identify patients at risk health plan priority, as part of a broader initiative aimed for addiction at lowering opioid-related morbidity and mortality. $$ Trainingcase managers to guide members to treatment $$ Starting care management programs for addiction $$ Notifyingprescribers of emergency department and hospital overdose admissions Why Health Plans Should Go to the “MAT” in the Fight Against Opioid Addiction 3 $$ Supportingpeer navigators in emergency departments Why Health Plans Should $$ Minimizing copays for addiction treatment Go to the “MAT” in the (medications, prescriber visits, and behavioral health) Fight Against Opioid Addiction T $$ Data analytics: he opioid epidemic in the United States continues $$ Creating dashboards to measure progress on to be an urgent health and social crisis. In 2015, opioid prescribing and MAT access, and sharing the nation saw more than 33,000 opioid-related them with providers and delegated medical deaths, correlating with a fourfold increase in opioid groups prescribing over the last 15 years, the increasing avail- ability (and lower costs) of street heroin and fentanyl, and $$ Identifyingoutlier prescribers to provide educa- the ongoing dearth of addiction treatment resources.5,6 tion and, when appropriate, refer for fraud Prescription opioid misuse, addiction, and overdose cost $$ Identifying outlier members to refer to case the US over $78 billion annually in health care, criminal management justice, and lost productivity.7 The Centers for Disease Control and Prevention (CDC) estimates that the US $$ Community engagement: spends $52.4 billion annually on the nonmedical use of opioids, $55.7 billion on misuse and addiction, and $20.4 $$ Working with local opioid safety coalitions to billion associated with overdose. In 2012, total outpatient adopt community prescribing guidelines and prescription opioid sales were estimated at $9 billion, an ensure adequate access to MAT and naloxone increase of 120% from 2002.8 $$ Over 35 of California’s 58 counties have active opioid safety coalitions; see www.chcf.org/oscn While the epidemic requires a coordinated response from government and policymakers, law enforcement, and health care, health plans have a uniquely influential role. Along with community partners, health plans can influence opioid prescribing across large geographies “We don’t require diabetics to prove they through comparative data, provider educational cam- paigns, practice guidelines, formulary and utilization are attending nutrition visits… for their policies, and value-based payment. Plans can assess insurance to cover insulin — a medicine network adequacy and expand their networks to ensure better access to addiction and pain treatment, and can that is deadly in overdose. However, incentivize integration of behavioral health services. Plans have a strong business case for building better access insurance companies frequently cut to addiction treatment regardless of whether or not sub- patients off treatment if we don’t stance use disorders are the financial responsibility of the plan. Streamlining access to medication-assisted treat- submit detailed clinical records proving ment (MAT — prescription medication combined with attendance at counseling, and drug behavioral health) has been shown to lower emergency department and hospitalization costs,9 lower hepatitis C screens showing perfect compliance — and HIV rates, and decrease overdose deaths. something we don’t see or expect in any This report was commissioned for a health plan audience other chronic disease.” and aims to make the case for commercial and public — David Kan, MD, President, CSAM plans to take action and make better access to MAT a top health plan priority, as part of a broader initiative aimed at lowering opioid-related morbidity and mortality. California Health Care Foundation 4 Methods opioid receptor agonist, meaning it fully binds to opioid receptors in the brain. Buprenorphine is a partial opioid Health Management Associates reviewed the litera- receptor agonist, meaning it acts on some opioid recep- ture and interviewed health plan leaders to understand tors (those involved with pain, motivation, and cravings), current health plan policies and practices, collect data but its moderate activity level limits respiratory suppres- and evidence where available, and explore barriers sion, the main cause of overdose death associated with and opportunities for commercial and public plans to full agonists. Other buprenorphine formulations are improve access to MAT. The report also reviewed leg- FDA-approved for pain but not addiction; more detailed islative actions affecting plans. This paper builds on information on buprenorphine is available from CHCF. the 2016 California Health Care Foundation (CHCF) Methadone and buprenorphine stabilize brain chemistry, report Changing Course: The Role of Health Plans in thereby reducing or eliminating opioid withdrawal symp- Curbing the Opioid Epidemic, which focuses on judi- toms and cravings, and improving the individual’s ability cious prescribing practices, improving patient outcomes, to plan, organize behavior, and participate in recovery. addressing overuse, and working with others to increase safety in communities. Naltrexone is a full opioid receptor antagonist, meaning it blocks opioid receptors and prevents their activation, so What Is MAT? illicit opioids taken do not produce euphoria. Naloxone, while not a medication for addiction treatment, is com- Modern addiction medicine treats opioid use disorder monly prescribed to people with addiction to prevent (OUD) as a chronic disease, since long-term opioid use accidental overdose. Naloxone, when administered in can permanently change brain chemistry function and, nasal spray or injection, fully displaces all opioids from as with other chronic diseases, there is no cure, mean- their receptors. This action restores consciousness and ing patients often require long-term management of respiration in the case of overdose, while resulting in relapse and remission. Like other chronic diseases, addic- immediate withdrawal symptoms for patients with opioid tion requires both medication and lifestyle changes, and dependence. Fentanyl and carfentanyl, increasingly used tends to relapse when treatment is unavailable or prema- illicitly, are so potent that multiple doses of naloxone are turely discontinued. typically required to restore respiration. MAT is defined by the Substance Abuse and Mental Table 1 shows the medications available, how they work, Health Services Administration (SAMHSA) as the use and how they are provided. (See page 6.) of medications in combination with counseling and behavioral therapies for the treatment of substance use disorders (SUD). Improved access to MAT is one of three federal priorities for curbing the opioid epidemic, along with addressing opioid overprescribing practices “A general principle of authorization is it and expanding distribution of naloxone, a drug that reverses the effect of opioids, for emergency treatment should serve a function of weeding out of an opioid overdose.10 Without medication treatment, inappropriate care. Since nearly all the individuals with OUD are at high risk for overdose and death.11 care we reviewed was appropriate, our authorization requirements were adding The FDA has approved three medications for treatment of OUD: (1) methadone (generic oral and injectable unnecessary administrative burden on the forms, Dolophine or Methadose), (2) buprenorphine (generic sublingual tablets or Probuphine intradermal plan and our providers, and making it more implant; buprenorphine is often combined with naloxone difficult for members to access treatment.” [available as Suboxone, Zubsolv, Bunavail, or generic sub- — Health plan leader lingual tablets], since the naloxone component can deter misuse), and (3) naltrexone (generic tablets, ReVia, or Vivitrol long-acting injectable form). Methadone is a full Why Health Plans Should Go to the “MAT” in the Fight Against Opioid Addiction 5 Table 1. Medications Used in Addiction Treatment WHERE IT CAN BE PROVIDED FDA INDICATIONS EFFECTIVENESS* ADMINISTRATION Methadone OUD. Licensed opioid treatment OUD and pain 74% to 80%12 OUD. Daily pill, liquid, and programs. management wafer forms; injectable form in hospitalized patients unable Pain. Any Drug Enforcement Agency to take oral medications (DEA)-licensed prescriber. Pain. Pill and injectable forms Buprenorphine and Prescribed by community physicians OUD and pain 60% to 90%16 OUD. Daily sublingual, buccal, buprenorphine/ and dispensed by pharmacies; available management film, and tablet, or six-month naloxone in some opioid treatment programs. (depending on intradermal device formulation and Physicians receive federal waivers after Pain. Injectable, transdermal, dose) eight hours of training; nurse practitio- and buccal film ners and physician assistants require 24 hours. Patient panels are capped at 30, 100, and 275 per provider (depending on experience and setting).13-15 Any DEA-licensed provider can prescribe buprenorphine for pain. Naltrexone No restrictions. Opioid and OUD. 10% to Daily pill or monthly injectable alcohol use 21%17 disorders Naloxone Any setting: prescribed or dispensed To reverse May require Intranasal spray, or intra- (used only for by a clinician, furnished by a pharmacy respiratory high doses for venous, intramuscular, or overdose reversal, without a prescription (legal in several suppression extremely high- subcutaneous injectable not addiction states), dispensed by lay staff in in suspected potency illicit treatment) community settings (by standing order), opioid overdose drug use (e.g., or carried by law enforcement or other fentanyl and first responders. carfentanyl) *Retention in treatment at 12 months with significant reduction or elimination of illicit drug use. Review of Comparative in two peer-reviewed articles,20 showing that methadone Effectiveness of MAT dosages greater than 60 mg and buprenorphine doses Extensive research has demonstrated the effectiveness ranging from 16 to 32 mg produce similar reductions in of opioid agonist treatment (methadone and buprenor- illicit opioid use, with subtherapeutic doses leading to phine) in opioid use disorder. A meta-analysis of 50 poorer health outcomes. studies showed methadone’s retention rate ranging from 70% to 84% at one year, buprenorphine ranging from Short-term use of buprenorphine (“detox”) is rarely effec- 60% to 90% at one year, with both treatments resulting in tive21 unless detox is followed by maintenance doses, significant reductions in overdose death, illicit drug use, since relapse generally occurs after medication dis- criminal activity, arrests, risk behaviors, HIV and hepatitis continuation.22 The risk of overdose death is increased C incidence, as well as improvements in health status, in all forms of detoxification, including both medically functioning, and quality of life.18 supervised withdrawal and unplanned discontinuation of treatment.23,24 A frequently cited 2003 Lancet arti- In 2013, SAMHSA sponsored research to analyze meta- cle randomized patients to detox (with placebo) or analyses, reviews, and individual studies from 1995 buprenorphine maintenance, and found 4 out of 20 through 201219 as part of its Assessing the Evidence Base (20%) in the detox placebo group had died and none series. SAMHSA provided an overview of the findings on had engaged in treatment at 12 months, compared to no methadone and buprenorphine maintenance treatment deaths in the buprenorphine group in the same period.25 California Health Care Foundation 6 A meta-analysis showed that the mortality rate doubled severely restricted, with high consumer costs) in commer- when buprenorphine was discontinued and tripled when cial plans. While addiction treatment is now an essential methadone was discontinued.26 health benefit, incremental dismantling and defunding of the Affordable Care Act remains an ongoing threat to Naltrexone is approved for both alcohol and opioid substance use disorder coverage. use disorder, and has both an oral (daily) and injectable (monthly) formulation. Naltrexone completely blocks Due to historical fragmentation of coverage, many opi- opioid receptor sites, which reduces cravings and pre- oid treatment programs do not accept health insurance, vents euphoria from opioid use. Naltrexone has a good and many commercial plans have difficulty ensuring a evidence base for treatment of alcohol addiction27,28 but network sufficient to meet demand. Most health plans do limited evidence supporting its use in OUD.29 A Cochrane not have medical, pharmacy, or care management staff meta-analysis of oral naltrexone showed no difference knowledgeable about addiction treatments, which can compared to placebo when comparing retention in impact policy decisions and the resources available to treatment, use of illicit opioids, or side effects. Studies providers and members. Finally, privacy restrictions, such of injectable naltrexone show lowered cravings and illicit as federal 42 CFR Part 2 regulations, result in challenges drug use compared to placebo but are limited by short to coordinating care. As more care settings become duration (two months30 to six months31) and high drop- integrated, confusion about what is and is not allowed out rates. Unpublished manufacturer registry data (see has led California to publish a State Health Information Appendix B) showed that only 34 of 403 patients (9%) met Guidance document to facilitate data sharing between goals of treatment at 12 months, and over 90% did not treatment providers.38 complete treatment, with 61 days as the median dropout rate.32 For those who drop out of treatment, overdose rates are high — heroin overdose rates were three times higher with naltrexone compared to buprenorphine or HEALTH PLAN STRATEGIES methadone in an Australian study, and almost eight times Support new MAT access points through grants, higher after treatment ended.33 Since the combination of enhanced reimbursement, or improvement initiatives: high dropout rates and lowered tolerance can contribute $$ Provide or support buprenorphine waiver train- to overdose rates, the evidence suggests that naltrexone ing programs for providers, residents, and staff should be used cautiously, especially in high-risk popula- teams; promote mentoring and coaching support tions with longer addiction durations, less social support, for new prescribers, including the Providers’ and potentially higher overdose risk.34 The evidence of Clinical Support System and the Clinician benefit for naltrexone is much stronger for employed Consultation Center’s Substance Use Warmline. patients with substantial psychosocial support (such as $$ Incentivizeproviders to become buprenorphine executives35 and health care providers36), and naltrexone prescribers through building payments into pay- is frequently used to prevent relapse for patients after for-performance (P4P) programs and increasing complete detoxification from opioids. reimbursement for inductions and medication management. $$ Incentivizebehavioral health integration, includ- Access Barriers to MAT ing providing grants for practices building new Despite the evidence that MAT is effective, only 10% of MAT or mental health services. Americans seeking treatment can access it. Barriers to $$ Work with local coalitions to identify new MAT MAT include a shortage of primary care buprenorphine access strategies, including new access points in prescribers, addiction specialists, and opioid treatment emergency departments, jails, primary care, and specialties. programs; restrictive health plan authorization require- $$ Support quality improvement initiatives in ments; lack of sufficient behavioral health workforce; stigma (leading patients to avoid opioid treatment pro- emergency departments to start buprenorphine treatment in the ED. grams); and lack of provider knowledge and training.37 $$ Work with local jails to provide all FDA-approved Prior to the Affordable Care Act, addiction treatment was not an essential health benefit, and treatment was forms of MAT during incarceration or on re-entry. unavailable in many Medicaid programs and excluded (or Why Health Plans Should Go to the “MAT” in the Fight Against Opioid Addiction 7 Research found that less than one-quarter of publicly with opioid use disorders. Buprenorphine was also more funded, and one-half of private-sector, addiction treat- often subject to quantity or prior authorization limits, ment programs reported using MAT.39 According to while oral naltrexone was not subject to the same level SAMHSA, only 21% of SUD treatment centers offered of authorization limits. methadone or buprenorphine maintenance in 2014.40 Many rural areas have no access to opioid treatment pro- A 2017 California Society of Addiction Medicine (CSAM) grams, and offer very few behavioral health resources. survey of its membership showed significant concern Substance use treatment providers for jails and prisons about the administrative barriers created by authoriza- have been slow to add MAT to their treatment regi- tion requirements.51 In particular, survey participants mens.41 As of January 2017, fewer than a dozen state were concerned about step therapy, dose limitations, departments of corrections offered MAT in their drug the burdens of proving counseling attendance, and the treatment programs for incarcerated people, beyond requirement for negative drug screens for ongoing ther- limited methadone maintenance for pregnant women, apy. Fifty-six percent of respondents found it difficult to despite two-thirds of American inmates suffering from access MAT for patients new to treatment due to insur- addiction to alcohol or other drugs.42,43 Moreover, only ance barriers, and 46% had difficulty getting approval 130 local and county jails in 21 states provided MAT, for maintenance treatment. Only 35% of physicians and just 17 states’ drug courts offered MAT,44 and many found that authorization processes “went smoothly,” of these only offered naltrexone. Arizona Medicaid with 41% experiencing situations where patients went responded to this problem by creating programs to facil- without treatment due to authorization delays. Eleven itate enrollment in Medicaid and facilitate access to MAT percent of the surveyed physicians reported that they on re-entry after incarceration.45 stopped prescribing medications for OUD and 12% reported witnessing other colleagues who stopped pre- Few primary care providers have applied for and received scribing. Often one to two hours of employee time was the federal waivers needed to prescribe buprenor- required per patient to collect documentation for clinical phine.46 Nationally, only half of waivered providers treat justifications, drug screens, and counseling, and to call any patients with buprenorphine, and those who do treat the health plan (which was required more than half the these patients work with only a small number. Barriers time). Over 38% of respondents reported that insurance for primary care providers to prescribing buprenorphine companies required treatments proven ineffective (e.g., include a lack of training and experience, administrative failure of short-term detox) before approving buprenor- burdens (including health plan authorization require- phine or methadone. ments), lack of mentorship,47 lack of available behavioral health resources,48 and concerns about the impact of Patient cost-sharing requirements also hinder access to DEA site visits on providers and staff. MAT; some plans have copayments as high as $60 or $75 per outpatient visit and $2,500 per inpatient stay.52 When Insurance Barriers to MAT patients are starting buprenorphine, recommended Insurance authorization policies can present major practice is for them to initially receive a day or a week obstacles for patients and providers, according to a of medications at any one time, leading to much higher 2014 New England Journal of Medicine article. These pharmacy copay burden compared to monthly pre- obstacles include limits on prescribed dosages, annual scriptions. Co-insurance costs can be even higher, and or lifetime medication limits, initial authorization and difficult for consumers to understand when comparing reauthorization requirements, inadequate coverage and shopping for plans. Consumers can have difficulty of counseling services, and “fail-first” criteria requiring understanding drug formularies and cost-sharing require- that other therapies be attempted prior to MAT (e.g., ments, which can make it difficult to choose a plan that requirements for initial trial of taper or detox, or failure of provides affordable treatment.53 other medication).49 A 2016 Urban Institute study50 that included health plans available in six cities (Los Angeles included) showed that prescription drug coverage was less restrictive for treatments targeted to individuals with alcohol use disorders compared to treatment for those California Health Care Foundation 8 Health Plan Actions Expanding Networks In interviews, leaders discussed challenges on the pro- Streamlining Access by Removing vider supply side, including the limited number of Authorization Requirements and Decreasing physicians treating addiction and willing to participate Financial Barriers in insurance networks. Since addiction treatment as an In an effort to decrease barriers for patients pursuing essential health benefit has only been in place since buprenorphine treatment, several large national health the 2014 implementation of the Affordable Care Act, a plans (Aetna, Anthem, Cigna, United HealthGroup, and substantial number of opioid treatment programs are others)54 removed all authorization requirements from outside of insurance networks, and plans have difficulty buprenorphine initiation and maintenance. Some plans identifying them as potential network providers. One include all formulations of buprenorphine — allowing commercial health plan leader noted that some clinicians easier access to buprenorphine for pain management who prescribe MAT “can keep their practices busy by not as well as addiction — and some limit to just the FDA- working with insurance companies” and that it is difficult approved formulations for addiction. In 2015, the to identify such providers and practices. California Department of Health Care Services (DHCS) joined several other states in removing the authorization To increase MAT use, health plan leaders said they are requirement for buprenorphine in Medi-Cal (California’s working with providers to streamline internal report- Medicaid);55 in response, buprenorphine claims doubled ing paperwork between primary care providers and the from 2015 to 2016.56 However, a 2015 study found that health plan, incentivize providers to start patients on an increasing number of Medicaid programs covering buprenorphine by increasing reimbursement to reflect MAT put prior authorization limitations in place, poten- the additional time spent with patients, and encouraging tially impacting access.57 physicians to use team-base models that allow licensed clinical social workers, nurses, or medical assistants to Recognizing that copays and deductibles can present take on some of the administrative, educational, and care significant financial barriers to treatment, especially as coordination functions to relieve the physician’s burden heroin prices continue to drop, the Massachusetts Health of prescribing MAT. Some plans have undertaken efforts Connector (the state health insurance exchange) required to identify and contract with opioid treatment programs, all participating plans to remove all patient costs associ- as well as telehealth providers of buprenorphine. One ated with MAT in 2016.58 TRICARE, the insurance plan for commercial plan created a code for providers to bill for active and retired military and family, cut all behavioral induction visits separately so that the provider would be health copays in half.59 reimbursed at a higher rate due to the increased com- plexity of the office visit. Some health plan leaders stated that pilot programs in expanded reimbursement, pay-for- performance, and training have extended buprenorphine HEALTH PLAN STRATEGIES access points in their network, and they plan to continue $$ Remove authorization requirements for MAT. these programs. $$ Remove or reduce copays for MAT (including pharmacy, medical, and behavioral health In areas of the country particularly hard-hit by the epi- services). demic, some health plans are using innovative payment $$ Remove authorization requirements and copays approaches to expand treatment networks. for naloxone. For example, Medicaid and commercial health plans in Vermont participate in a hub-and-spoke bundled pay- ment model supporting opioid treatment programs (hubs) and primary care and other outpatient offices (spokes) to deliver MAT services.60 The model aims to create primary care and specialty mutual referral relationships for opioid use disorder treatment, with standardized protocols guid- ing referrals of complex patients to the hubs and stable Why Health Plans Should Go to the “MAT” in the Fight Against Opioid Addiction 9 patients back to the spoke for ongoing buprenorphine related to IV drug use (e.g., endocarditis and osteomy- maintenance treatment. In mid-2017, California launched elitis) are often missed opportunities to start MAT. A New a federally funded, statewide hub-and-spoke program England Journal of Medicine article described a group modeled after Vermont’s.61 While Medi-Cal will reimburse of infectious disease specialists learning to prescribe treatment services, relationships with commercial health buprenorphine to inpatients to treat addiction and pre- plans are yet to be determined as of publication. vent readmission due to recurring IV drug use.65 Some plans are making efforts to identify overdose events in the ED and follow up with patients to make HEALTH PLAN STRATEGIES sure they are linked to treatment, rather than simply $$ Estimateopioid use disorder prevalence in restarted on the same dose of opioid, as is often the membership; determine the volume of opioid case.66 Partnership HealthPlan of California launched a treatment programs (“methadone clinics”) and pilot to send information obtained from inpatient utili- buprenorphine prescribers needed to meet the zation management to the primary care provider. Since demand in each region. opioid overdose does not require public health report- $$ Identifyand contract with opioid treatment pro- ing, and many hospitals do not have systems in place grams in every region (to remove travel barriers). to notify prescribers, health plans can play an important $$ Work with local coalitions to identify new MAT role in ensuring overdoses do not recur by alerting pre- access strategies, including new access points in scribers after an overdose, and recommending either emergency departments, jails, primary care, and referring patients into treatment (if they have addiction) specialties. or tapering them to a safer dose (if taking opioids for $$ Contract with MAT telehealth providers. chronic pain). $$ Build hub-and-spoke networks, where opioid treatment programs are hubs that manage To overcome challenges with patient identification (since inductions and complex patients, and spokes are admission diagnoses often are inaccurate and may not primary care providers treating milder addiction include underlying addiction as the reason for admission), and providing maintenance. some plans are using real-time notification vendors to identify patients and connect them with case manage- ment, and then even enabling case management and providers to collaborate on shared plans of care. These Patient Identification, Engagement, and tools create interfaces with electronic health records in Care Management all hospitals in a region, apply analytics, and then deploy Emergency department (ED) and inpatient admissions alerts summarizing critical information and a care plan that for complications from opioid use (including near over- can be used in real time by ED physicians, health plans, dose deaths) present a crucial opportunity for health and primary care practices. Health plans can identify high- plans to alert primary care providers, engage members in priority populations, such as patients seeking frequent or treatment, and reduce the incidence of future overdoses. early opioid refills, or those using multiple pharmacies or Research shows that the weeks immediately following an providers, to help connect these patients with care man- overdose episode are characterized by extremely high agement and steer them into addiction treatment. risk of death.62 In a landmark Yale study, treating patients with a dose of buprenorphine during their emergency “Lock-in” programs are increasingly used by Medicaid67 department stay doubled the retention rate in treatment and commercial health plans to identify patients using at 30 days. This model has been replicated in emergency multiple providers and pharmacies, both to limit access departments across Rhode Island, combined with peer to one provider and/or one pharmacy, and to refer to recovery coaches to facilitate entry into treatment.63 addiction treatment when appropriate. According to a 2016 SAMHSA report, only about 11% of privately insured patients received the recommended Finally, some plans are actively providing case manage- combination of both medication and therapeutic services ment for patients admitted to emergency departments or within the 30 days following an opioid-related hospi- detox facilities. Blue Cross Blue Shield of Massachusetts talization.64 In addition, hospitalizations for diagnoses hired social workers to contact plan members admitted California Health Care Foundation 10 to detox facilities to help them figure out next steps Data Sources and Measuring Success for treatment.68 Aetna launched a Behavioral Health Health plans track MAT use and impact through phar- Medication Assistance Program where nurses and macy data (prescriptions filled) and utilization data psychologists worked with physicians to counsel and (behavioral health visits, primary care visits, ED and hos- manage the care of patients with addiction. According to pital rates), although accurate inpatient data are elusive Aetna, this program resulted in a 30% increase in opioid since the admission diagnoses may not mention SUD. abstinence rates, a 35% reduction in hospital admissions, Research studies tend to define MAT success as lack of and a 40% decrease in total medical costs.69 Rhode illicit drug use in addition to retention and treatment, Island launched a model where patients admitted to the and avoidance of morbidity (HIV, hepatitis) and mortal- ED with addiction or after an overdose are assigned to ity (overdose). These outcomes can be difficult for health a recovery coach who meets with the patient over the plans to measure. Therefore, plans often struggle to iden- next month and helps facilitate connections to treatment. tify process and outcomes measures to define whether While health plans have yet to cover these ED visits access to MAT is sufficient, and to know if new programs (paid from state and federal funding), they cover some are meeting goals. of the ongoing counseling visits.70 A New York commer- cial health plan (not named in the publication) assigned Multiple health plans promote clinical practice guidelines members using multiple pharmacies for opioids to a cer- identified by the American Psychological Association tified addiction counselor who contacted the prescribers and the American Society of Addiction Medicine (ASAM) to alert them about the issue, and contacted the mem- as the standard for services and care delivery. Another bers to screen them for addiction and discuss treatment leader described a study in progress, showing improved options. As a result, the use of multiple prescribers and outcomes for patients using MAT: an increase in the num- pharmacies dropped significantly.71 ber of people receiving MAT correlated with decreased ED admissions. The plan will soon publish an internal study that compared maintenance treatment with tradi- tional treatment. The study found that “by increasing the HEALTH PLAN STRATEGIES coordination [between case managers, primary care pro- viders, and the health plan] to offer comprehensive and $$ Contractwith vendor to ensure notification of ED or hospital admissions for overdose; provide evidence-based treatments, there are better outcomes.” care management and treatment referral; notify The same health plan leader reflected, “We have a task prescribers. force that looks at MAT from a variety of angles. We have $$ Startdirect or delegated care management lots of resources pointing to MAT.” program for addiction; identify patients through pharmacy or utilization data, pharmacy benefits Interviewees noted that a lack of clear success metrics manager (PBM) analytic programs, or through and data points for health plans makes comparison and lock-in programs. outcome measure identification difficult between specific $$ Work with hospitalists to start buprenorphine or subsections of health plan membership. methadone treatment with inpatients hospitalized with addiction-related diagnoses (e.g., endocardi- tis or osteomyelitis). $$ Placepeer coaches or care navigators in emergency departments to guide patients to treatment. “Where I work, clinicians from other specialties $$ Develop data dashboards to compare delegated do not step forward and prescribe it due to medical groups and contracted providers on standardized measures of opioid prescribing and perceived insurance problems.” MAT utilization. — CSAM Member $$ Identify outlier and/or fraudulent prescribers; ensure patients are transferred to needed care if these practices close down. Why Health Plans Should Go to the “MAT” in the Fight Against Opioid Addiction 11 products in general, these requirements will be kept in place for prescribers with outlier and unsubstantiated HEALTH PLAN STRATEGIES prescription patterns. $$ Create dashboard to measure health plan success: opioid prescriptions and morphine milligram equivalents (MME) pmpm, multiple prescribers/ Return on Investment: pharmacies, high-dose use, buprenorphine pre- scriptions pmpm, members on MAT compared to The Financial Case for MAT members with SUD diagnoses. Cost factors in MAT were also examined as part of this $$ Promote clinical practice guidelines for safer research. Evidence summarized below shows that addic- prescribing and MAT. tion treatment decreases health costs — largely due to avoided emergency department and inpatient stays. One study found that treating injection drug users low- ers the incidence of expensive complications including Mitigating Buprenorphine Diversion endocarditis, abscesses, HIV, and hepatitis C. Treating Health plan leaders are concerned about the risk of addiction also lowers the ED and hospital costs associ- buprenorphine diversion (prescribed medications being ated with reversed opioid overdose events;76 some of sold or distributed to others) based on published reports, these studies are described below. data from emergency departments, and information from law enforcement.72 However, some leaders expressed that the risk of inadequate access to treatment outweighed the risk of inappropriate use, and that this calculation HEALTH PLAN STRATEGIES TO weighed into decisions to remove authorization require- INCREASE NALOXONE DISTRIBUTION ments from buprenorphine and buprenorphine/naloxone $$ Offer or support training on naloxone co-prescrib- products. One plan noted that 95% of buprenorphine ing (routine naloxone prescriptions with all — or authorization requests were approved, and most denied high-risk — chronic opioid prescriptions). requests were due to lack of information, leading them $$ Incentivize or train local pharmacies to furnish to decide the authorization process was not adding naloxone without a prescription. value. Another plan leader stated that while authoriza- $$ Work with local coalitions to increase dispensing tion requirements were removed from buprenorphine of naloxone in community settings (e.g., needle exchanges) under standing orders. Alternate Views on Diversion While minimizing diversion is a legitimate plan A 2014 study77 looked at the costs of care in commer- concern, some studies have shown that diverted cial integrated health systems and found that patients buprenorphine is typically used for its intended with buprenorphine plus counseling had less use of gen- purpose — reducing cravings and coping with eral medical services and lower total health care costs withdrawal symptoms — as opposed to providing compared to those with little or no addiction treatment. euphoria.73 A study documented that people in Specifically, annual health care costs with buprenorphine treatment with historical illicit use of buprenorphine treatment were $13,578, while average health care costs were twice as likely to stay in treatment as those with no addiction treatment were $31,055. Other studies with no prior experience.74 In 1995, recognizing have shown that access to therapeutic doses of buprenor- a spike in heroin deaths, the French government phine/naloxone are associated with a longer treatment systematically removed all barriers to buprenorphine period, with resources used and lower total medical costs treatment by allowing all physicians to prescribe, despite higher pharmacy acquisition costs.78 maximizing reimbursements, and minimizing cover- age barriers.75 As a result, 20% of French general practitioners prescribe buprenorphine, overdose A study looking at methadone maintenance and costs of deaths have dropped by 79%, and diversion, while care in a commercial plan demonstrated that costs were present, is described as minimal. 50% lower compared to two or more drug-free treatment visits, and 62% lower when compared to one or zero California Health Care Foundation 12 drug-free treatment visits.79 A 2014 study on buprenor- of losing custody. While attitudes are slowing changing, phine maintenance demonstrated higher pharmacy many child protection workers and judges continue to charges but lower outpatient, inpatient, ED, and total view MAT as a sign of continuing addiction and deny cus- health care charges ($28,458 vs. $49,051) for patients tody if women are taking methadone or buprenorphine. adherent to buprenorphine.80 Buprenorphine in pregnancy can lower the risk of NAS and long lengths of stay compared to morphine treat- In another study of methadone treatment, a commercial ment. One study showed the mean dose of morphine health plan’s costs for members receiving methadone required for infants exposed to buprenorphine in utero maintenance were 50% lower ($7,163) than those with was 1/10th the dose compared to methadone, with length two or more outpatient addiction treatment visits without of stay decreasing by 75%.87 While neonatal outcomes methadone ($14,157), and 62% lower than those with improved, retention in treatment for buprenorphine was one or zero outpatient addiction treatment visits without lower (67%) compared to methadone (88%), potentially methadone ($18,694).81 due to the additional counseling and case management services offered in methadone maintenance. Studies have not found problems in childhood development due to treatment of addiction with buprenorphine or metha- HEALTH PLAN STRATEGIES done in pregnancy. $$ Work with addiction treatment and OB com- munity to increase access to buprenorphine and While morphine has been considered the standard of methadone treatment for pregnant members. care for NAS treatment, a 2017 New England Journal of $$ Work with hospitals to increase their capacity Medicine randomized study showed treating neonatal to manage neonatal abstinence syndrome and abstinence syndrome with buprenorphine cut lengths of decrease the number of infants requiring NICU stay in half (15 vs. 28 days) compared to morphine, with care, including promotion of evidence-based no difference in the rate of adverse events.88 practices such as rooming in, breastfeeding, and use of buprenorphine in the treatment of infants. In summary, the opioid epidemic continues to drive up health care costs for plans, consumers, and the public, with costs of care due to opioid misuse and addiction rising to $31 billion for the insurance industry nation- MAT and Neonatal Abstinence Syndrome wide.89 This creates a pressing business case for plans to Health plans are seeing increasingly long lengths of stay work actively to prevent new cases of addiction through for neonatal abstinence syndrome (NAS).82 The National changing prescribing practices, and to ensure their net- Institute for Drug Abuse estimates the average cost of works have adequate treatment resources for people treatment for NAS as $66,700 per infant, compared to with addiction, including pregnant women, and for $3,500 without NAS.83 While evidence supports minimiz- infants with NAS. ing stimulation by rooming-in (as opposed to a bright, overstimulating neonatal intensive care environment),84 breastfeeding (in the absence of HIV), promotion of Legislation Related to Health Plans nonpharmacological soothing techniques,85 and use of and MAT standardized scoring tools to assess when medication is needed, many hospitals feel ill-equipped to manage Federal Parity Laws infants and thus transfer them to neonatal intensive care The Mental Health Parity and Addiction Equity Act units, often leading to separation of mother and infant (MHPAEA) of 2008 prohibits insurers from applying cost- at a time when bonding is a critical motivating factor for sharing and benefit limits to treatments for SUD that women’s retention in treatment.86 are more restrictive than those placed on other medi- cal services.90 Prior to the ACA, MHPAEA did not apply While MAT in pregnancy has been shown to increase to Medicaid beneficiaries or Medicare Advantage plans retention in treatment and prevent relapse, many preg- offered through group health plans, state and local gov- nant women, especially in rural areas, have no local access ernment plans, Medicaid managed care plans, and state to care, and many fear seeking treatment due to the risk Children’s Health Insurance Program plans. The ACA also Why Health Plans Should Go to the “MAT” in the Fight Against Opioid Addiction 13 requires insurers to cover substance use and behavioral In Rhode Island, 2016 legislation required health insur- health treatment as an essential health benefit. ers to provide SUD treatment to explicitly cover MAT services including buprenorphine, naltrexone, and other A 2016 federal parity task force issued a report91,92 (see clinically appropriate medications.99 Commercial health Appendix A) stating that a plan may not require prior plans must provide coverage for at least one generic authorization for buprenorphine based on safety risks opioid antagonist and device approved to treat opioid associated with the drug if prior authorization is not overdose (e.g., naloxone). Health plans may require prior required for prescription drugs with similar safety risks authorization for nongeneric versions. Coverage includes to treat medical or surgical conditions.93 MHPAEA also naloxone prescribed or dispensed via standing order or prohibits fail-first requirements if such requirements are through a collaborative practice agreement, allowing it not equivalent to the medical benefit. Finally, 30-day to be dispensed to family members or friends of people limitations to buprenorphine could be inconsistent with at risk of overdose. authorization practices for chronic medical and surgical conditions, since authorization for prescription drugs In 2016, the New York Attorney General Eric used for chronic medical conditions is typically approved Schneiderman initiated an investigation into Cigna and for 6 or 12 months. See Appendix A for federal questions Anthem’s MAT policies, alleging that authorization poli- and answers on these requirements.94 cies delayed treatment and unnecessarily put patients at risk. These investigations were part of a law that was The Centers for Medicare & Medicaid Services (CMS) passed in 2011 enabling doctors and pharmacists to Opioid Misuse Strategy Report 2016 recommended report and track controlled opioids in real time. This law that health plans promote naloxone access and cover- led to many prosecutions of health care providers who age among private payers, strengthen messaging, and illegally prescribed and diverted opioids.100 accelerate widespread adoption of MAT by collaborat- ing with SAMHSA and other Health and Human Services In 2016, New York passed legislation limiting the use agencies.95 The report includes plans for CMS to evaluate of prior authorizations for MAT, as well as limiting opi- health plan coverage laws, including SUD treatment net- oid prescriptions to seven days and requiring mandatory work adequacy, among other priorities. prescriber education on pain management.101 This comprehensive legislation followed a final report and It should be noted that federal negotiations on legis- recommendations released by the Governor’s Heroin lation to weaken the ACA continue at the time of this and Opioid Task Force.102 In February 2017, the American report’s publication. Even without repeal, the essential Medical Association sent a letter to the National health benefit definitions could be altered or eroded by Association of Attorneys General to raise awareness administrative actions. In June 2017, the Robert Wood about the consequences of insurance plan requirements Johnson Foundation and Urban Institute released an for prior authorization for MAT, urging “all attorneys analysis concluding that repealing and replacing the general to carefully review and consider taking similar ACA could significantly reduce access to mental health action to the policies of New York Attorney General Eric and SUD treatment and parity protections.96 Schneiderman.”103 In 2017, Cigna, Aetna, and Anthem announced they would end prior authorization for MAT Actions in the States across the US.104 At the state level, some policymakers are looking to legislative solutions to increase access to MAT. In 2014, New York State’s FY 2017 budget invested nearly $200 Massachusetts enacted legislation to increase SUD million to combat the heroin and opioid epidemic — an treatment access by prohibiting prior authorization for 82% increase in state spending since 2011. This figure substance use disorder and mandating coverage of 14 included $38 million to fund MAT programs that serve days of inpatient substance use treatment.97 It also cre- approximately 12,000 clients in residential or outpatient ated a commission to look at the feasibility of requiring settings.105 Governor Cuomo states that he plans to elim- insurance providers to monitor and limit the use of opi- inate prior authorization requirements and to increase oids. The commission will also investigate models for access to buprenorphine by recruiting health care pro- limiting the overprescription of opioids without limiting viders to become prescribers.106 patients’ access to necessary pain medication.98 California Health Care Foundation 14 To address the “not in my backyard” challenges of local Medicaid Managed Care and MAT resistance to building addiction treatment resources, in California the state public health department partnered with the In 32 states including California, Medicaid pays for California Health Care Foundation (CHCF) to expand addiction treatment in a separately funded payment and access to MAT by supporting locally-led community coali- delivery system, or “carve-out.” Medicaid managed care tions. Coalitions identify treatment gaps in their counties plans cover medical care, counties cover care for seri- and work to increase access to MAT through provider ous mental illness, and addiction treatment is managed trainings, launching induction clinics (allowing patients to through a separate state program. As of 2016, 27 out be initiated in treatment and then transferred to primary of California’s 58 counties did not have opioid treatment care providers when stable), starting MAT telehealth programs (OTPs), and few clinicians are stepping up to programs, and integrating addiction treatment into com- provide buprenorphine access in these counties. Only munity health centers. These coalitions also work actively one Medicaid beneficiary receives buprenorphine for to change opioid overprescribing practices and increase every four patients who receive methadone.107 access to naloxone.111 In related work, 25 community health centers across California joined a CHCF-funded In recent years, California has made a concerted effort learning collaborative to receive training and technical to increase addiction treatment access in safety-net assistance to start MAT practices in their clinics,112 and settings: eight hospitals are participating in a related collabora- tive to start MAT-initiation programs in their emergency $$ In2015, the California Department of Health Care departments.113 Services (DHCS) removed the authorization require- ment for buprenorphine in Medi-Cal (California’s While substance use treatment services are carved out Medicaid); buprenorphine claims doubled between of Medi-Cal managed care plan contracts, some local 2015 and 2016.108 Medi-Cal managed care plans launched MAT expansion projects in their networks, recognizing that promotion $$ In 2016, DHCS received approval for a Medi-Cal of MAT is a way to improve health and safety in their waiver authorizing participating county govern- membership while lowering ED and inpatient services ments to serve as managed care plans responsible associated with untreated addiction. Examples include for covering all SUD treatments for Medi-Cal enroll- sponsoring buprenorphine waiver trainings, pay-for- ees. While most counties are participating, small performance programs that incentivize physicians to rural counties do not have the resources to do so. In become waivered and to accept new patients,114 and response, Partnership HealthPlan, a public Medi-Cal fee-for-service payments on top of capitation.115 Such managed care plan, is planning to manage the addic- incentives recognize the additional time required to start tion treatment network on behalf of eight of their patients on treatment. counties, essentially “carving” SUD services back into managed care in their region. $$ In 2017, DHCS received an $89 million SAMHSA grant109 for a MAT expansion project, replicat- ing a hub-and-spoke model proven successful in Vermont.110 This model uses OTPs as specialty centers (hubs) where more complex patients can be managed, and primary care sites (spokes) where clini- cians manage stable patients and milder addiction. While the grant will serve all of California, tribal and rural communities will receive special attention, since only 2.2% of American physicians have obtained the waivers required to prescribe buprenorphine to treat opioid use disorders, and 90.4% of these physicians are practicing in urban counties. Why Health Plans Should Go to the “MAT” in the Fight Against Opioid Addiction 15 Conclusion: Next Steps $$ Data analytics. Creating dashboards to measure for Health Plans progress on opioid prescribing and MAT access, and sharing them with providers and delegated medi- Health plans, as payers both for prescription opioids and cal groups; identifying outlier prescribers to provide the medical consequences of untreated OUD, are well- education and (when appropriate) refer for fraud; positioned to address the public health crisis through identifying outlier members to refer to case increasing access to addiction treatment and safer pain management. management options, and many are taking steps to do so. Health plan leaders interviewed for this research $$ Community engagement. Working with local opioid emphasized the importance of health plans taking a safety coalitions to adopt community prescribing leading role in addressing both the roots of the crisis guidelines and ensure adequate access to MAT and (through plan-wide efforts to ensure safer prescribing naloxone (for example, over 35 of California’s 58 practices) and its consequences (by ensuring streamlined counties have active opioid safety coalitions; see addiction treatment access, and safer management of www.chcf.org/oscn). opioid-dependent patients with chronic pain). Both commercial and Medicaid health plan leaders The literature review and interviews with health plan focused on the need to counteract bias against medi- leaders indicate that plans are working to increase treat- cation-assisted addiction treatment by focusing on the ment access through multiple coordinated approaches: evidence — lowered overdose rates and increased reten- tion in treatment — and to directly address the stigma $$ Pharmacy benefit. Changing formularies to pro- associated with MAT that still prevents many medical mote safer opioid prescribing; eliminating prior communities from stepping up to expand access. Some authorization requirements and copays for MAT and leaders called for aggressive action on network access naloxone; starting lock-in programs; incentivizing or for addiction similar to that used for any other specialty training local pharmacies to furnish naloxone without in high demand and low supply. a prescription. In terms of return on investment, the research shows that $$ Provider network. Assessing OUD prevalence paying for OUD saves insurers costs in the long run.116 and ensuring sufficient MAT access in all regions; MAT reduces expensive ED visits and hospitalizations promoting new MAT access points in primary care, due to overdose and other opioid-related morbidities.117 emergency departments, inpatient settings, and Further, the costs associated with ineffective treatment corrections by supporting trainings, increased reim- go beyond relapse and can include higher risks for infec- bursement, P4P programs, or grants; contracting tious disease due to IV drug use. with telehealth providers; training providers to offer co-prescriptions of naloxone; incentivizing behavioral While plans have a clear business case for change, the health integration through P4P or direct grants; work- health plan leaders stressed that their commitment went ing to increase access to MAT for pregnant women; beyond return on investment. Plans are poised to play a and working with hospitals to ensure evidence-based critical role in a systemwide effort to turn the epidemic treatment of neonatal abstinence syndrome. around: to prevent a new generation of people depen- dent on or addicted to opioids, to safely treat those with $$ Medical management. Providing data analytics to chronic pain at risk due to long-term opioid use, and to identify patients at risk for addiction; training case ensure that all members with addiction have easy access managers to guide members to treatment; starting to effective treatment. Plans cannot do this alone, but the care management programs for addiction; notifying epidemic won’t end unless they take action. prescribers for ED and hospital overdose admis- sions; supporting peer navigators in emergency departments; and minimizing copays for addiction treatment (medications, prescriber visits, and behav- ioral health). FOR MORE TOOLS, GO TO ▸ SMART CARE CALIFORNIA California Health Care Foundation 16 Appendix A. AQ on Implementation of ACA and Parity Act F A frequently asked questions document released to clarify the 2016 final report of the federal parity task force specifically addressing prior authorization for buprenorphine as a potential parity violation.118 Q. My plan requires prior authorization from the plan’s utilization reviewer that buprenorphine is medically necessary for the treatment of my opioid use disorder. . . . Although there are prescription drugs to treat medical/surgical conditions that have similar safety risks, my plan does not impose similar prior authorization requirements on those drugs. Is this permissible? A. No. A plan may impose an NQTL [non-quantitative treatment limit], includ- ing a prior authorization requirement for buprenorphine, if, under the terms of the plan as written and in operation, the processes, strategies, evidentiary standards, and other factors considered by the plan in implementing its prior authorization requirement with respect to buprenorphine to treat an opioid use disorder are comparable to, and applied no more stringently than, those used in applying its prior authorization requirement with respect to medical/surgical benefits in the prescription drug classification under MHPAEA [Mental Health Parity and Addiction Equity Act]. In this scenario, the plan imposes the prior authorization requirement due to stated safety concerns. However, the prior authorization requirement is applied more stringently to buprenorphine when used to treat opioid use disorder than it is applied to prescription drugs with similar safety risks to treat medical/ surgical conditions. Accordingly, the plan’s prior authorization requirement on buprenorphine does not comply with the MHPAEA. Q. My plan requires that I meet specific nonpharmacological fail-first require- ments (for example, that I have tried counseling alone, failed at recovery, and resumed substance use) before it will authorize coverage for buprenorphine to treat my opioid use disorder. While comparable evidentiary standards and other factors indicate that similar fail-first requirements could be imposed on certain prescription drugs covered by my plan for medical/surgical condi- tions, the plan does not impose fail-first requirements in these instances. Is this permissible? A. No. A fail-first requirement is an NQTL that must comply with the require- ments of MHPAEA. A plan or issuer cannot impose a fail-first requirement on coverage for buprenorphine for opioid use disorder unless, under the terms of the plan as written and in operation, the processes, strategies, evidentiary standards, and other factors considered by the plan in designing and imposing this fail-first requirement are comparable to, and applied no more stringently than, the processes, strategies, evidentiary standards, or other factors used in applying fail-first requirements to medical/surgical benefits in the prescription drug classification under MHPAEA. Why Health Plans Should Go to the “MAT” in the Fight Against Opioid Addiction 17 In this case, the plan is imposing a nonpharmacological requirement that the individual fail first at recovery with counseling alone before the plan will autho- rize coverage of benefits for buprenorphine. While comparable evidentiary standards and other factors indicate that similar fail-first requirements could be appropriate before authorizing coverage for certain other prescription drugs covered by the plan’s first requirement that applies for medical/surgical condi- tions, the plan does not in fact impose fail-first requirements in any of these instances. Accordingly, the fail-first requirement imposed on buprenorphine is an NQTL that the plan applies more stringently to a substance use disorder condition than medical/surgical conditions. This disparity violates MHPAEA. Q. My group health plan states that it follows nationally recogized treatment guidelines for setting prior authorization requirements for prescription drugs, but requires prior authorization for my buprenorphine/naloxone combination at each refill (every 30 days) for my opioid use disorder, which is not consistent with nationally-recognized treatment guidelines. Is this permissible? A. No. In setting the NQTL of prior authorization for the substance use disorder medication, buprenorphine/naloxone, a plan or issuer must apply comparable processes, strategies, evidentiary standards, and other factors no more strin- gently to buprenorphine/naloxone than those applied to medical/surgical medications. The plan states that it fellows nationally-recognized guidelines. However, these guidelines, such as the American Society of Addiction Medicine (ASAM) national practice guidelines, do not support 30-day authorization practices for buprenorphine/naloxone. Furthermore, the plan does not devi- ate from nationally-recognized treatment guidelines when establishing prior authorization requirements for any prescription drugs to treat medical/surgical conditions. Accordingly, although the plan asserts that its process of setting the NQTL of prior authorization — following nationally-recognized treat- ment guidelines — is comparable as written, in operation, the plan’s process departs from and provides less coverage than recommended under nationally- recognized treatment guidelines for buprenorphine/naloxone, in violation of MHPAEA. However, as an alternative to simply mirroring nationally-recognized treatment guidelines, many plans and issuers use Pharmacy and Therapeutics (P&T) com- mittees in deciding how to cover prescription drugs and evaluating whether to follow or deviate from nationally-recognized treatment guidelines for setting the prior authorization requirements. The Departments note that while the use of P&T committees to inform prior authorization requirements for prescription drugs in this manner may not violate MHPAEA per se, these processes must also comply with MHPAEA’s NQTL standard in operation. For example, if the plan deviates from nationally-recognized treatment guidelines for buprenor- phine/naloxone based on P&T committee reports, then use of the P&T committee would be evaluated for compliance with MHPAEA’s NQTL require- ments (for example, by evaluating whether the P&T committee is comprised of comparable experts for MH/SUD conditions, as compared to the experts for medical/surgical conditions, and how such experts evaluated nationally- recognized treatment guidelines in setting prior authorization for medications for both MH/SUD and medical/surgical conditions). California Health Care Foundation 18 Appendix B. Alkermes Registry Data, VICTORY Trial Most published studies reviewing the effectiveness of injectable naltrexone (Vivitrol) in opioid use disorder are short: two to six months in duration. The best available data on 12-month retention in treatment are from the Alkermes VICTORY (Vivitrol’s Cost and Treatment Outcomes Registry) registry. While these data were not published, they were presented in a presentation at the American Society of Addiction Medicine Conference, April 13, 2014. REASONS FOR DISCONTINUATION PRIOR TO 12 MONTHS n PERCENTAGE Lost to follow up 199 49.4% Withdrawal by patient 60 14.9% Study terminated by sponsor 30 7.4% Patient feels treatment goal met 22 5.5% Other 21 5.2% Physician intended planned course of treatment met 12 3.0% Insurance loss or loss of coverage for Vivitrol™ 11 2.7% Lack of efficacy by patient 10 2.5% Noncompliance 10 2.5% Incarcerated 9 2.2% Relocated 9 2.2% Death 5 1.2%* Time constraints 3 0.7% Withdrawal symptoms or re-entered detox 2 0.5% *Three ODs: 21, 55, and 115 days post last dose; one drowning: 28 days post last dose; one suicide: 34 days post last dose. Source: Vocci, Frank, et al. “The Extended-Release Naltrexone (XR-NTX) Opioid Dependence Registry: Clinical and Functional Effectiveness.” Paper presented at the American Society of Addiction Medicine conference, Orlando, FL, April 13, 2014, www.asam.org. Why Health Plans Should Go to the “MAT” in the Fight Against Opioid Addiction 19 Endnotes 1.“Increases in Drug and Opioid-Involved Overdose Deaths — 16.Garcia-Portilla et al., “Long Term Outcomes”; J. Kakko et al., United States, 2010–2015,” Morbidity and Mortality Weekly “1-Year Retention and Social Function After Buprenorphine- Report 65 (December 30, 2016): 1445-52, www.cdc.gov. Assisted Relapse Prevention Treatment for Heroin Dependence in Sweden: A Randomized, Placebo- 2.These data include heroin. Controlled Trial,” Lancet 361 (February 22, 2003): 662-68, 3.Curtis S. Florence et al., “The Economic Burden of www.ncbi.nlm.nih.gov. Prescription Opioid Overdose, Addiction, and Dependence 17.Frank J. Vocci et al., “The Extended-Release Naltrexone in the United States, 2013,” Medical Care 54, no. 10 (October (XR-NTX) Opioid Dependence Registry: Clinical and 2016): 901-6, doi:10.1097/MLR.0000000000000625. Functional Effectiveness” (presentation at the American 4.J. Tkacz et al., “Relationship Between Buprenorphine Society of Addiction Medicine conference, Orlando, FL, Adherence and Health Service Utilization and Costs Among April 13, 2014), www.asam.org. Opioid Dependent Patients,” Journal of Substance Abuse 18.Kakko et al. “1-Year Retention.” Treatment 46, no. 4 (April 2014): 456-62, doi:10.1016/j. jsat.2013.10.014. 19.Catherine A. Fullerton et al., “Medication-Assisted Treatment with Methadone: Assessing the Evidence,” Psychiatric 5.“Increases in Drug and Opioid-Involved Overdose Deaths — Services 65, no. 2 (February 2014): 146-57, doi:10.1176/ United States, 2010–2015,” Morbidity and Mortality Weekly appi.ps.201300235. Report 65 (December 30, 2016): 1445-52, www.cdc.gov. 20.Fullerton et al., “Medication-Assisted Treatment.” 6.These data include heroin. 21.Gavin Bart, “Maintenance Medication for Opiate Addiction: 7.Curtis S. Florence et al., “The Economic Burden of The Foundation of Recovery,” Journal of Addictive Diseases Prescription Opioid Overdose, Addiction, and Dependence 31, no. 3 (July 2012): 207-25, doi:10.1080/10550887.2012.69 in the United States, 2013,” Medical Care 54, no. 10 4598. (October 2016): 901-6, doi:10.1097/MLR.0000000000000625. 22.Fullerton et al., “Medication-Assisted Treatment.” 8.“CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016,” Morbidity and Mortality Weekly Report 23.I. A. Binswanger et al., “Mortality After Prison Release: Opioid 65 (March 18, 2016): 1-49, www.cdc.gov. Overdose and Other Causes of Death, Risk Factors, and Time Trends from 1999 to 2009,” Annals of Internal Medicine 9.J. Tkacz et al., “Relationship Between Buprenorphine 159, no. 9 (November 5, 2013): 592-600, doi:10.7326/0003- Adherence and Health Service Utilization and Costs Among 4819-159-9-201311050-00005; M. D. Stein et al., “Overdose Opioid Dependent Patients,” Journal of Substance Abuse History Is Associated with Postdetoxification Treatment Treatment 46, no. 4 (April 2014): 456-62, doi:10.1016/j. Preferences for Persons with Opioid Use Disorder,” Substance jsat.2013.10.014. Abuse (July 10, 2017): 1-5, doi:10.1080/08897077.2017.1353 10.Opioid Abuse in the U.S. and HHS Actions to Address 570. Opioid-Drug Related Overdoses and Deaths, Health and 24.Stein MD et al., “Overdose History Is Associated with Post- Human Services, March 26, 2015, aspe.hhs.gov. Detoxification Treatment Preference for Persons with Opioid 11.TI-17-014 MAT Expansion Project, California Opioid Use Disorder,” Subst Abus. 2017:0. Maintenance Providers, 2016, californiamethadone.org (PDF). 25.Kakko and Svanborg, “One-Year Retention.” 12.Maria Paz Garcia-Portilla et al., “Long Term Outcomes 26.Luis Sordo et al., “Mortality Risk During and After Opioid of Pharmacological Treatments for Opioid Dependence: Substitution Treatment: Systematic Review and Meta-Analysis Does Methadone Still Lead the Pack?,” British Journal of of Cohort Studies,” BMJ 357 (April 26, 2017), doi:10.1136/ Clinical Pharmacology 77, no. 2 (February 2014): 272-84, bmj.j1550. doi:10.1111/bcp.12031. 27.“Treatment Improvement Protocol (TIP) Series (No. 49, 13.Xenia Bion, “Moving from Stigma to Science in Treating 2009),” Substance Abuse and Mental Health Services Addiction,” California Health Care Foundation Blog, Administration, www.ncbi.nlm.nih.gov. Compared with using December 17, 2016, www.chcf.org. placebo, short-term naltrexone treatment (less than or equal 14.“The Case for Medication-Assisted Treatment,” Pew to 12 weeks) significantly improves relapse rates during Charitable Trusts, February 1, 2017, www.pewtrusts.org. active treatment and is linked with a lower percentage of drinking days, fewer drinks per drinking day, longer times 15.“Summary: Major Components of the HHS Final Rule. to relapse, more days of abstinence, and lower total alcohol Effective August 8, 2016,” American Society of Addiction consumption during treatment. Medicine, 2016, www.asam.org. California Health Care Foundation 20 28.Stewart B. Leavitt, “Evidence for the Efficacy of Naltrexone 38.“State Health Information Guidance (SHIG) on Sharing in the Treatment of Alcohol Dependence (Alcoholism),” Sensitive Health Information,” California Health and Human Addiction Treatment Forum, March 2002, Services Agency, www.chhs.ca.gov. www.samhsa.gov (PDF). 39.H. K. Knudsen, P. M. Roman, and C. B. Oser, “Facilitating 29.Angela L. Stotts, Carrie L. Dodrill, and Thomas R. Factors and Barriers to the Use of Medications in Publicly Kosten, “Opioid Dependence Treatment: Options in Funded Addiction Treatment Organizations,” Journal Pharmacotherapy,” Expert Opinion on Pharmacotherapy 10, of Addiction Medicine 4, no. 2 (June 2010): 99-107, no. 11 (2009): 1727-40, doi:10.1517/14656560903037168. doi:10.1097/ADM.0b013e3181b41a32; H. K. Knudsen, A. J. Abraham, and P. M. Roman, “Adoption and Implementation 30.Maria A. Sullivan et al., “Naltrexone Treatment for of Medications in Addiction Treatment Programs,” Journal Opioid Dependence: Does Its Effectiveness Depend on of Addiction Medicine 5, no. 1 (March 2011): 21-27, Testing the Blockade?,” Drug and Alcohol Dependence doi:10.1097/ADM.0b013e3181d41ddb. 133, no. 1 (November 1, 2013): 80-85, doi:10.1016/j. drugalcdep.2013.05.030; P. 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T1-17-014 MAT Expansion Project, californiamethadone.org (PDF). 1 08.“Medi-Cal Update: Pharmacy” Medi-Cal, Bulletin 848, May 2015, files.medi-cal.ca.gov. 1 09.“California Medication Assisted Treatment (MAT) Expansion Project” and California Department of Health Services SAMHSA Grant,” californiamethadone.org. 1 10.“Vermont Hub-and-Spoke Model,” Addiction Policy Forum, March 22, 2017, www.addictionpolicy.org. 1 11.For more information, see CHCF’s “California Opioid Safety Coalitions Network,” www.chcf.org/oscn. 1 12.“Treating Addiction in the Primary Care Safety Net,” Center for Care Innovations, www.careinnovations.org. 1 13.Susan Anthony, “Emergency Care for the Opioid Epidemic: Leaders Discuss Medication-Assisted Treatment in the ED,” California Health Care Foundation, September 2016, www.chcf.org. 1 14.“Drug Medi-Cal Benefit: What’s New in Planning for Drug Medi-Cal Model?,” Partnership HealthPlan of California, June 2017, www.partnershiphp.org. 1 15.Central California Alliance for Health created a fee-for- service payment program on top of capitation to encourage primary care providers to prescribe buprenorphine, as well as developing incentive payments for PCPs obtaining a buprenorphine waiver. 1 16.Livingston, “Insurers Slowly Removing Barriers.” 1 17.Livingston, “Insurers Slowly Removing Barriers.” 1 18.Excerpted from October 27, 2016 publication, FAQS About Affordable Care Act Implementation Part 34 and Mental Health and Substance Use Disorder Parity Implementation, from the White House Parity Task Force Report, www.dol.gov (PDF). California Health Care Foundation 24