CMS National Training Program

CMS National Training Program
CMS’s Approach to Combatting the Opioid Epidemic July 2017 This session explains CMS’s approach to Combatting the Opioid Epidemic in detail as it relates to current data and coverage through Medicare, Medicaid, and the Marketplace. This training session was developed and approved by the Centers for Medicare & Medicaid Services (CMS), the federal agency that administers Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), and the Federally-facilitated Health Insurance Marketplace. The information in this module was correct as of July This as an informational resource for our partners. It’s not a legal document or intended for press purposes. The press should contact the CMS Press Office at Official program legal guidance is contained in the relevant statutes, regulations, and rulings.

CMS's Approach to Combatting the Opioid Epidemic
Session Objectives This session should help you Describe the opioid crisis and CMS’s approach to combat the opioid epidemic Explain opioid related services and prescription drugs covered by Medicare, Medicaid, and the Marketplace Locate opioid resources This session should help you Describe the opioid crisis and CMS’s approach to combat the opioid epidemic Explain opioid related services and prescription drugs covered by Medicare, Medicaid, and the Marketplace Locate opioid resources INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. July 2017 CMS's Approach to Combatting the Opioid Epidemic

Did You Know? An estimated 1 out of 5 patients with non-cancer pain or pain-related diagnosis are prescribed opioids. Source: CDC.gov/drugoverdose/opioids/index.html July 2017 CMS's Approach to Combatting the Opioid Epidemic

About Opioids A class of drugs used to reduce pain Comes from opium plants Sometimes called narcotics Opioid types Common prescription opioids include oxycodone (OxyContin®) hydrocodone (Vicodin®), morphine, and methadone Fentanyl® is a synthetic (man-made) opioid Many times more powerful than other opioids Approved only for treating severe pain like advanced cancer pain Heroin is an illegal opioid Opioids are a class of drugs used to reduce pain. They come from opium plants and are sometimes called narcotics. Opioid types: Common prescription opioids include oxycodone (OxyContin®), hydrocodone (Vicodin®), morphine, and methadone. Fentanyl® is a synthetic (man- made) opioid that is many times more powerful than other opioids. It was approved only for treating severe pain like advanced cancer pain. Heroin is an illegal opioid. Repeated use of opioids greatly increases the risk of developing an opioid use disorder. They have increasingly been implicated in drug overdose deaths over the last decade. Every day, 44 Americans overdose and die after taking opioid painkillers. Every year, 2 million people abuse or misuse this class of drugs. Sources: CDC.gov/drugoverdose/index.htm., SAMHSA.gov/disorders/substance-use July 2017 CMS's Approach to Combatting the Opioid Epidemic

Opioid Use Disorder Opioid Use Disorder (OUD) is one type of Substance Use Disorder (SUD) A problematic pattern of opioid use that causes clinically significant impairment or distress Diagnosis is based on specific criteria like unsuccessful efforts to cut down or control use, use resulting in social problems, and a failure to fulfill obligations at work, school, or home OUD may be referred to as “opioid abuse or dependence” or “opioid addiction” Addiction to prescription opioids is the strongest predictor for heroin addiction Opioid Use Disorder (OUD) is one type of Substance Use Disorder (SUD). The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), no longer uses the terms substance abuse and substance dependence, rather it refers to substance use disorders. An SUD is a problematic pattern of opioid use that causes clinically significant impairment or distress. Diagnosis is based on specific criteria like unsuccessful efforts to cut down or control use, use resulting in social problems, and a failure to fulfill obligations at work, school, or home. OUD may be referred to as “opioid abuse or dependence” or “opioid addiction.” The CDC identified addiction to prescription opioids as the strongest predictor for heroin addiction. Heroin is an opioid that isn't legal to prescribe. Sources: CDC.gov/drugoverdose/index.htm., SAMHSA.gov/disorders/substance-use July 2017 CMS's Approach to Combatting the Opioid Epidemic

Opioid Crisis Facts and Figures
In 2014, an estimated 1.9 million people had an opioid use disorder (OUD) related to prescription pain relievers and an estimated 586,000 had an OUD-related to heroin use In 2014, more than 28,000 people in the U.S. died from overdoses from all types of opioids combined About 14,000 out of the 28,000 deaths were prescription opioids Heroin-related deaths have tripled since 2010 The most commonly diverted drugs are opioids Nearly 80% of individuals with an opioid use disorder don’t receive treatment The opioid abuse and overdose epidemic continues to devastate American families. In 2014, an estimated 1.9 million people had an opioid use disorder (OUD) related to prescription pain relievers and an estimated 586,000 had an OUD-related to heroin use In 2014, more than 28,000 people in the U.S. died from overdoses from all types of opioids combined. About 14,000 out of the 28,000 deaths were from prescription opioids. Heroin-related deaths have also increased sharply, more than tripling since This is in part due to the increase in use of prescription opioids. The most commonly diverted drugs are opioids. “Drug diversion” is the diversion of legal drugs for illicit purposes. It involves obtaining drugs from legal and medically necessary uses towards uses that are illegal and typically not medically authorized or necessary. Nearly 80% of individuals with an opioid use disorder don’t receive treatment. Sources: CDC.gov, SAMHSA.gov/disorders/substance-use July 2017 CMS's Approach to Combatting the Opioid Epidemic

Individuals at High Risk for Overdose
You may be at high risk for an overdose if you Take high daily doses of opioids “Doctor shop” Use a combination of drugs like opioids, benzodiazepines, central nervous system depressants, and/or other legal/illicit drugs Have a history of substance use disorders or other mental health issues Medicaid, low-income, and rural populations have a higher risk for overdose You may be at high risk for an overdose if you Take high daily doses of opioids. “Doctor shop.” This means you visit multiple doctors to obtain multiple prescriptions for otherwise illegal drugs, or to get the medical opinion that you want to hear. Use a combination of drugs like opioids, benzodiazepines, central nervous system depressants, and/or other licit/illicit drugs. Have a history of substance use disorders or other mental health issues. Medicaid, low-income, and rural populations have a higher risk for overdose. Studies have found that people with Medicaid are more likely to be prescribed opioid pain relievers, at higher doses, and for longer periods of time compared with privately insured people. Low-income people and those living in rural areas have been found to be at an increased risk for overdose. In fact, some of the states with the largest increases in poverty have also seen the largest increases in overdose deaths. The graphic indicates that since 1999, sales of prescription opioids in the U.S. have quadrupled. Source: CDC.gov July 2017 CMS's Approach to Combatting the Opioid Epidemic

CMS’ Approach to Combatting the Opioid Epidemic
This section will focus on CMS’s approach to combatting the opioid epidemic. Source: CDC.gov/drugoverdose/opioids/index.html July 2017 CMS's Approach to Combatting the Opioid Epidemic

CMS Opioid Misuse Strategy 2016
To download the CMS Opioid Misuse Strategy visit: CMS.gov/Outreach-and- Education/Outreach/Partnershi ps/Downloads/CMS-Opioid- Misuse-Strategy-2016.pdf CMS released an Opioid Misuse Strategy on January 5, The mission of CMS’s Opioid Misuse Strategy is to impact the national opioid misuse epidemic by combating non-medical use of prescription opioids, opioid use disorder, and overdose through the promotion of safe and appropriate opioid utilization, improved access to treatment for opioid use disorders, and evidence-based practices for acute and chronic pain management. The entire 30 page document can be downloaded at CMS.gov/Outreach-and-Education/Outreach/Partnerships/Downloads/CMS-Opioid-Misuse-Strategy-2016.pdf. July 2017 CMS's Approach to Combatting the Opioid Epidemic

Opioid Misuse Goals, Scope, and Focus
Decreasing opioid overdoses and overall overdose mortality Decreasing the prevalence of opioid use disorder Focus Opioid prescribing practices to reduce opioid use disorders and overdose Expanded use and distribution of naloxone Expansion of medication-assisted treatment (MAT) to reduce opioid disorders and overdose Scope The best available evidence Policies targeted to high-risk populations Each proposed element of the strategy has a reasonable expectation of delivering a measurable impact within two years The opioid misuse goals are Decreasing opioid overdoses and overall overdose mortality Decreasing the prevalence of opioid use disorder The opioid misuse scope is to use The best available evidence Policies targeted to high-risk populations Each proposed element of the strategy has a reasonable expectation of delivering a measurable impact within two years The opioid misuse focus is Opioid prescribing practices to reduce opioid use disorders and overdose Expanded use and distribution of naloxone Expansion of medication-assisted treatment (MAT) to reduce opioid disorders and overdose July 2017 CMS's Approach to Combatting the Opioid Epidemic

Medication-Assisted Treatment (MAT) for Opioid Use Addiction
MAT combines behavioral therapy and medications to treat opioid addictions Controlled Substances Non-Controlled Substances Requires a prescription Regulated by state and federal government Sometimes requires a prescription Prescribing limit depends on state and insurance plan Examples: Methadone – administered at a clinic for MAT Suboxone®(Buprenorphine/Naloxone combined) – prescribed or dispensed in doctor’s offices / used for outpatient maintenance therapy Example: Vivitrol® (Naltrexone injection) is administered in a physician’s office/used for outpatient maintenance therapy and requires a prescription Medication-Assisted Treatment (MAT) combines behavioral therapy and medications to treat opioid addictions. Controlled substances require a prescription and are regulated by both the state and federal government. Methadone used for opioid use disorders (OUD) must be obtained at an opioid treatment center (OTC). Suboxone (Buprenorphine/Naloxone combined) is prescribed or dispensed in doctor’s offices and used for outpatient maintenance therapy. Some non-controlled substances require a prescription. The amount that can be prescribed depends on the state and insurance requirements. Naloxone is administered when a patient is showing signs of opioid overdose. The medication can be given by intranasal spray, intramuscular (into the muscle), subcutaneous (under the skin), or intravenous injection. Vivitrol® (Naltrexone injection) is administered in a physician's office/used for outpatient maintenance therapy and requires a prescription. Methadone (Dolophine, Methadose), burprenorphine (Subutex, brand discontinued in the U.S.), buprenorphine combined with naloxone (Suboxone), and naltrexone (Depade, ReVia) are approved in the U.S. to treat opioid dependence. Methadone isn’t a covered treatment option by Medicare at this time for substance abuse because of the strict treatment center requirements. It’s only covered for pain management. Source: SAMHSA.gov July 2017 CMS's Approach to Combatting the Opioid Epidemic

CMS Opioid Misuse Strategy
CMS Priority Areas Implement more effective person-centered and population-based strategies to reduce the risk of opioid use disorders, overdoses, inappropriate prescribing, and drug diversion Expand the use and distribution of naloxone Expand screening, diagnosis, and treatment of opioid use disorders, to include increasing access to medication-assisted treatment (MAT) Increase the use of evidence-based practices for acute and chronic pain management The CMS Opioid Misuse Strategy’s priority areas are Implement more effective person-centered and population-based strategies to reduce the risk of opioid use disorders, overdoses, inappropriate prescribing, and drug diversion Expand the use and distribution of naloxone Expand screening, diagnosis, and treatment of opioid use disorders, to include increasing access to medication-assisted treatment (MAT) Increase the use of evidence-based practices for acute and chronic pain management July 2017 CMS's Approach to Combatting the Opioid Epidemic

Awareness Education Technical Assistance Data as a Tool Policy Diversion Awareness CMS’s approach to decrease opioid overdose, mortality, and use disorder is to use awareness, education, technical assistance, data as a tool, policy, and diversion awareness to impact Prescribing behavior Opioid Use Disorder (OUD)/Medication-Assisted Treatment (MAT) Naloxone distribution Pain management approaches July 2017 CMS's Approach to Combatting the Opioid Epidemic

Priority Area 1 Implement more effective person-centered and population-based strategies to reduce the risk of opioid use disorders, overdoses, inappropriate prescribing, and drug diversion Objectives Current Activities Increase the number of providers that utilize evidence based guidelines to prescribe opioids Develop additional tools for patients, caregivers, and clinicians to use opioids appropriately Provide stakeholders with accurate, timely, and actionable information on how to use clinical and pharmaceutical data to decrease overdoses Provide stakeholders with accurate and timely information and tools to decrease the occurrence of drug diversion Medicare Part D Prescriber Enrollment – CMS requires all providers who wish to write prescriptions for people with Medicare Part D beneficiaries to be enrolled in the Medicare Part D program or have a valid opt-out affidavit on file Overutilization Monitoring System (OMS) – Provides to Part D plan sponsors quarterly reports on high risk beneficiaries with potential prescription opioid overutilization; sponsors then provide CMS with the outcome of their review of each case MACRA: Merit-based Incentive Payment System (MIPS) - Merit- based incentive payment system linking clinician payments to quality and value; includes opioid-related quality measures and clinical improvement activities related to prescription drug monitoring programs (PDMP) Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey – Removal of pain management questions from payment scoring calculation to mitigate perception of financial pressure to overprescribe opioids Priority Area 1 is to Implement more effective person-centered and population-based strategies to reduce the risk of opioid use disorders, overdoses, inappropriate prescribing, and drug diversion. Objectives are to Increase the number of providers that utilize evidence based guidelines to prescribe opioids Develop additional tools for patients, caregivers, and clinicians to use opioids appropriately Provide stakeholders with accurate, timely, and actionable information on how to use clinical and pharmaceutical data to decrease overdoses Provide stakeholders with accurate and timely information and tools to decrease the occurrence of drug diversion Current activities include Medicare Part D Prescriber Enrollment – CMS requires all providers who wish to write prescriptions for people with Medicare Part D beneficiaries to be enrolled in the Medicare Part D program or have a valid opt-out affidavit on file. The most recent guidance we issued on the Part D Prescriber Enrollment Requirement, “Phased Implementation of the Medicare Part D Prescriber Enrollment Requirement by January 1, 2019,” was issued on November 1, In that memo, CMS not only announced a delay in enforcement, but also stated they would implement a multifaceted phased approach prior to enforcement. CMS is still delaying all enforcement of this requirement until January 1, 2019, and is no longer planning to implement a phased approach before January 1, 2019 (per a May 30, 2017 CMS memo). Therefore, stakeholders should not expect any additional guidance regarding the phased approach. However, CMS is still considering strategies to reduce burden on stakeholders and will notify stakeholders as appropriate. Questions may be addressed to Overutilization Monitoring System (OMS) – Provides to Part D plan sponsors quarterly reports on high risk beneficiaries with potential prescription opioid overutilization; sponsors then provide CMS with the outcome of their review of each case MACRA: Merit-based Incentive Payment System (MIPS) - Merit-based incentive payment system linking clinician payments to quality and value; includes opioid-related quality measures and clinical improvement activities related to prescription drug monitoring programs (PDMP) Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey – Removal of pain management questions from payment scoring calculation to mitigate perception of financial pressure to overprescribe opioids July 2017 CMS's Approach to Combatting the Opioid Epidemic

Awareness for Providers and People with Medicare
Surgeon General’s Letter To Doctors Explanation of Benefits Inserts Examples of awareness for providers and people with Medicare are Surgeon General’s letter to doctors that was sent in August 2016 to ask for provider’s help in solving the opioid epidemic. Explanation of Benefits inserts that provide facts about the opioid epidemic and steps for people with Medicare to take. July 2017 CMS's Approach to Combatting the Opioid Epidemic

Priority Area 2 Expand the use and distribution of naloxone Objectives Current Activities Increase the use and distribution of naloxone for Medicare beneficiaries Increase the use and distribution of naloxone for Medicaid beneficiaries Ensure that qualified health plans (QHPs) include naloxone on their formularies Promote naloxone access and coverage among private payers Informational Bulletin – Released “Best Practices for Addressing Prescription Opioid Overdoses, Misuse, and Addiction” with recommendations to increase the use of naloxone for reversing opioid overdose Technical Assistance – Providing technical assistance to states on Substance Use Disorder (SUD) policy, programs, and payment, including guidance to increase the use of naloxone for reversing opioids overdose Formulary Considerations - Medicare Part D – Require naloxone on all plan sponsor formularies Marketplace - Essential Health Benefits (EHB) require that naloxone be included on all plan formularies Priority Area 2 is to Expand the use and distribution of naloxone. Objectives Increase the use and distribution of naloxone for Medicare beneficiaries Increase the use and distribution of naloxone for Medicaid beneficiaries Ensure that qualified health plans (QHPs) include naloxone on their formularies Promote naloxone access and coverage among private payers Current Activities Informational Bulletin – Released “Best Practices for Addressing Prescription Opioid Overdoses, Misuse, and Addiction” with recommendations to increase the use of naloxone for reversing opioid overdose Technical Assistance – Providing technical assistance to states on Substance Use Disorder (SUD) policy, programs, and payment, including guidance to increase the use of naloxone for reversing opioids overdose Formulary Considerations are to require naloxone on all Medicare Part D plan sponsor formularies and for the Marketplace Essential Health Benefits (EHB) to require that naloxone be included on all plan formularies Naloxone may be used for opioid overdose in an emergency situation but not for Medication-Assisted Treatment (MAT). It blocks or reverses the effects of opioid medication for overdoses, including extreme drowsiness, slowed breathing, or loss of consciousness. Naloxone is administered when a patient is showing signs of opioid overdose. The medication can be given by intranasal spray, intramuscular (into the muscle), subcutaneous (under the skin), or intravenous injection. Some states have passed legislation that allows family members or friends to administer naloxone while waiting for EMS. July 2017 CMS's Approach to Combatting the Opioid Epidemic

Priority Area 3 Expand screening, diagnosis, and treatment of opioid use disorders, to include increasing access to Medication-Assisted Treatment Objectives Current Activities Identify and address barriers to access to treatment and medication-assisted treatment (MAT) services Identify and address coverage barriers to expansion of screening that leads to treatment Informational Bulletin - Released Informational Bulletin on MAT for Substance Use Disorders with CDC, SAMHSA and NIH Technical Assistance – Providing assistance to states to develop and implement policies and legislation to potentially expand screening, diagnosis and treatment of opioid use disorders and increase access to MAT through: Cooperative Agreements Medicaid Innovation Accelerator Program - technical support to states around SUD policy, delivery & payment reforms Section 1115 demonstrations Policy – Working to assure that Part D formulary and plan benefit designs do not hinder access to MAT services Priority 3 is to expand screening, diagnosis, and treatment of opioid use disorders, to include increasing access to Medication-Assisted Treatment. Objectives Identify and address barriers to access to treatment and medication-assisted treatment (MAT) services Identify and address coverage barriers to expansion of screening that leads to treatment Current Activities Informational Bulletin - Released Informational Bulletin on MAT for Substance Use Disorders with CDC, SAMHSA and NIH Technical Assistance – Providing assistance to states to develop and implement policies and legislation to potentially expand screening, diagnosis and treatment of opioid use disorders and increase access to MAT through cooperative agreements, Medicaid Innovation Accelerator Program (technical support to states around SUD policy, delivery & payment reforms), and Section 1115 demonstrations Policy – Working to assure that Part D formulary and plan benefit designs do not hinder access to MAT services July 2017 CMS's Approach to Combatting the Opioid Epidemic

Priority Area 4 Increase use of evidence-based practices for acute and chronic pain management Objectives Current Activities Expand the use of best practices for evidence based pain management Encourage the use of non- pharmacologic, non-opioid pharmaceuticals, and multi-modal analgesia (MMA) as first options for pain management CDC Pain Management Guidelines – Disseminates CDC Guideline through CMS QIO-QIN efforts to reduce adverse drug events for opioids Transforming Clinical Practice Initiative’s Practice Transformation Networks – Will leverage these peer-based networks to disseminate best practices and provide technical assistance around evidence- based pain management practices Choosing Wisely Program - Implemented through CMS’ Partnership for Patients Hospital Engagement Network, this educational program facilitates conversations between patients and providers regarding medication options Priority 4 is to increase use of evidence-based practices for acute and chronic pain management. Objectives Expand the use of best practices for evidence based pain management Encourage the use of non-pharmacologic, non-opioid pharmaceuticals, and multi- modal analgesia (MMA) as first options for pain management Current Activities CDC Pain Management Guidelines – Disseminates CDC Guideline through CMS QIO- QIN efforts to reduce adverse drug events for opioids Transforming Clinical Practice Initiative’s Practice Transformation Networks – Will leverage these peer-based networks to disseminate best practices and provide technical assistance around evidence-based pain management practices Choosing Wisely Program - Implemented through CMS’ Partnership for Patients Hospital Engagement Network, this educational program facilitates conversations between patients and providers regarding medication options July 2017 CMS's Approach to Combatting the Opioid Epidemic

Collaboration with HHS
CMS engages with other HHS operating divisions to share best practices and coordinate efforts Released Informational Bulletin on MAT for Substance Use Disorders with CDC, SAMHSA and NIH Facilitated Surgeon General’s letter campaign to 2.3 million clinicians to “Turn the Tide” on the prescription drug epidemic Disseminates CDC Guideline for Prescribing Opioids for Chronic Pain through CMS QIO-QIN efforts to reduce adverse drug events for opioids Discussions with CDC, FDA and NIH about expanding the evidence base to inform coverage determinations for alternative therapies CMS engages with other HHS operating divisions to share best practices and coordinate efforts. Examples include: Released Informational Bulletin on MAT for Substance Use Disorders with CDC, SAMHSA and NIH Facilitated Surgeon General’s letter campaign to 2.3 million clinicians to “Turn the Tide” on the prescription drug epidemic Disseminates CDC Guideline for Prescribing Opioids for Chronic Pain through CMS QIO-QIN efforts to reduce adverse drug events for opioids Discussions with CDC, FDA and NIH about expanding the evidence base to inform coverage determinations for alternative therapies July 2017 CMS's Approach to Combatting the Opioid Epidemic

Collaboration Forums HHS Behavioral Health Coordinating Council and Principals meetings CMS/CDC/FDA/NIH quarterly meetings Office of National Drug Control Policy meetings National Pain Strategy Implementation Steering Committee meetings Healthcare Fraud Prevention Partnership (HFPP) CMS participated in the creation of an HFPP-branded White Paper entitled “Healthcare Payer Strategies to Reduce the Harms of Opioids: The Healthcare Fraud Prevention Partnership’s Commitment to the Management of Opioid Misuse and Opioid Use Disorder.” There are multiple collaboration forums. HHS Behavioral Health Coordinating Council and Principals meetings CMS/CDC/FDA/NIH quarterly meetings Office of National Drug Control Policy meetings National Pain Strategy Implementation Steering Committee meetings Healthcare Fraud Prevention Partnership (HFPP) CMS participated in the creation of an HFPP-branded White Paper entitled “Healthcare Payer Strategies to Reduce the Harms of Opioids: The Healthcare Fraud Prevention Partnership’s Commitment to the Management of Opioid Misuse and Opioid Use Disorder.” The purpose of this White Paper was to describe best practices for serious consideration by all healthcare payers and other relevant stakeholders to effectively address and minimize the harms of opioids while ensuring access to medically-necessary therapies and reducing fraud, waste, and abuse. The HFPP White Paper can be found on the CMS website at HFPP.cms.gov/. July 2017 CMS's Approach to Combatting the Opioid Epidemic

Medicare, Medicaid and the Marketplace— Opioid Use Disorders Coverage
In this section we will discuss Medicare, Medicaid, and the Marketplace opioid use disorder coverage for opioid use disorders (OUD) treatment and initiatives. July 2017 CMS's Approach to Combatting the Opioid Epidemic

Medicare In this section we’ll discuss Medicare coverage for opioid use disorders treatment and initiatives. A research letter published in the July 20, 2016, JAMA Psychiatry found that Medicare beneficiaries had the highest and most rapidly growing rate of “opioid use disorder.” Six out of every 1,000 recipients struggle with the condition, compared to 1 out of every 1,000 patients covered through commercial insurance plans. For data, visit KHN.org/news/study-medicare-beneficiaries-may-face-treatment-gap- for-painkiller-abuse-misuse. July 2017 CMS's Approach to Combatting the Opioid Epidemic

Medicare Coverage of Drug Treatment
Medicare will cover drug treatment if Services are from Medicare-participating provider or facility Doctor states that services are medically necessary Doctor sets up your plan of treatment Medicare covers prescription drugs for drug treatment Part A when administered during a hospital stay Part B when injected at a doctor’s office Part D from pharmacy when prescribed for Medication- Assisted Treatment (MAT) Medicare will cover alcohol and drug treatment if services are from Medicare-participating provider or facility, doctor states that services are medically necessary and/or sets up your plan of treatment. Medicare Part A pays for hospitalization for substance abuse treatment. Medicare Part B pays for substance abuse treatment services from a clinic or hospital outpatient department. A doctor sets up a plan of treatment. Covered services include: Psychotherapy Patient education regarding diagnosis and treatment Post-hospitalization follow-up Structured Assessment and Brief Intervention (SBIRT) services: Assessment to quickly determine the severity of substance use and identify the appropriate level of treatment. Brief intervention or advice focuses on increasing insight and awareness regarding substance use and motivation toward behavioral change. Referral to treatment provides those identified as needing more extensive treatment with access to specialty care. Alcohol misuse screening and counseling Part A covers prescription drugs for drug treatment when administered during a hospital stay and Part B when injected at a doctor’s office. Part D covers prescription drugs for drug treatment when prescribed for Medication-Assisted Treatment (MAT). Note- Methadone is covered under Part A for inpatient detox. It is not covered under Part D unless for pain management. For more information visit CMS.gov/Outreach-and-Education/Medicare-Learning Network MLN/MLNMattersArticles/Downloads/SE1604.pdf, or CMS.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/Part-D- Benefits-Manual-Chapter-6.pdf July 2017 CMS's Approach to Combatting the Opioid Epidemic

Medicare Drug Plan Coverage Rules
Plans must cover a range of drugs Coverage and rules vary by plan Plans can manage access to drug coverage through Formularies Prior authorization Step therapy Quantity limits Medicare drug plan coverage rules include Plans must cover a range of drugs Coverage and rules vary by plan Plans can manage access to drug coverage through Formularies (list of covered drugs) Prior authorization (doctor requests before service) Step therapy (type of prior authorization) Quantity limits (limits quantity over period of time) July 2017 CMS's Approach to Combatting the Opioid Epidemic

Medicaid In this section we’ll discuss the efforts to improve opioid use disorders treatment issues for people with Medicaid. July 2017 CMS's Approach to Combatting the Opioid Epidemic

Medicaid Treatment Services
States have the option to cover substance use disorder (SUD) treatment services like counseling, psychosocial and behavioral health therapies States may choose to offer pharmacy benefits Optional for adults Varies by state and the drug If a state elects to provide coverage of prescribed drugs as an optional service, they’re required to provide coverage of drugs meeting the definition of covered outpatient drugs when they’re prescribed for medically accepted indications In most cases, providers are permitted to prescribe preferred drugs without seeking prior authorization SUD services are required for individuals under age 21 and the newly eligible adult group (aged with income at or under 133 percent of the FPL) in states that have expanded Medicaid Most SUD services are optional Medicaid benefits for most populations. States have the option to cover substance use disorder (SUD) treatment services like counseling, psychosocial and behavioral health therapies. States may choose to offer pharmacy benefits. They are optional for adults and they vary by state and the drug. If a state elects to provide coverage of prescribed drugs as an optional service, they’re required to provide coverage of drugs meeting the definition of covered outpatient drugs when they’re prescribed for medically accepted indications. In most cases, providers are permitted to prescribe preferred drugs without seeking prior authorization. SUD services are required for individuals under age 21 and the newly eligible adult group (aged with income at or under 133 percent of the FPL) in states that have expanded Medicaid. For more information, see the CMCS Informational Bulletins: Medication-Assisted Treatment for Substance Use Disorders, July 11, 2014, and Best Practices for Addressing Prescription Opioid Overdoses, Misuse and Addiction, January 28, 2016. July 2017 CMS's Approach to Combatting the Opioid Epidemic

Medicaid Pharmacy Program Drug Use Management Strategies
Preferred drug list Clinical criteria Step therapy Prior authorization Quantity limits Drug utilization review Prescription Drug Monitoring Program State Medicaid programs may choose to design benefits requirements. The Medicaid Pharmacy Program outlines the following drug use management strategies Preferred drug list: Providers are permitted to prescribe preferred drugs without seeking prior authorization. By removing a drug from a preferred drug list to a non-preferred, it would limit the use to only those patients for whom treatment with other medications is ineffective. Clinical criteria: If a medication remains on the preferred list, claims would be authorized only when the recipient satisfies the clinical criteria established to ensure appropriate utilization of the drug. Step therapy: It requires that another drug is tried prior to a specific drug. Prior authorization: Medicaid won’t pay for a drug unless the provider has obtained permission before prescribing the drug. Quantity limits: Medicaid may impose quantity limits on medications as a way to promote safe and appropriate use of the medication, ensuring that they are not overprescribed. Drug Utilization Review: Retrospective and concurrent drug utilization review can identify inappropriate prescribing practices. Prescription Drug Monitoring Program (PMDP): Data is collected from pharmacies, outpatient clinics and others on dispensed, controlled substance prescriptions. Each state designates an agency to oversee their program and program can vary by state. PMDPs have been shown to prevent drug diversion. July 2017 CMS's Approach to Combatting the Opioid Epidemic

Medicaid Drug Utilization Review Annual Report
State Medicaid fee-for-service agencies must report drug utilization review (DUR) program activities and processes to CMS every year Ensures appropriate drug utilization, including appropriate opioid utilization CMS compiles all DUR information for the CMS Medicaid Drug Utilization Review State Comparison/Summary Report Posted every year on Medicaid.gov State Medicaid fee-for-service agencies are required to report annually to CMS their drug utilization review (DUR) program activities and processes to ensure appropriate drug utilization, including appropriate opioid utilization, which could include placing quantity limits on opioids, monitoring the concurrent use of opioids and benzodiazepines, employing PDMP requirements, and using tools that measure morphine milligram equivalents (MME) per day. CMS also inquires about the use of patient review and restriction programs (i.e. lock-in programs) to address potential prescription opioid misuse or abuse. CMS compiles this collected information within the CMS Medicaid Drug Utilization Review State Comparison/Summary Report, which is posted annually on Medicaid.gov: Medicaid.gov/medicaid/prescription-drugs/drug- utilization-review/index.html. July 2017 CMS's Approach to Combatting the Opioid Epidemic

Medicaid Opportunities for States to Address Mental Health and Substance Use Disorder (SUD) Final Mental Health and SUD parity rule for Medicaid and Children’s Health Insurance Program (CHIP) Strengthens access to mental health and SUD benefits for low-income Americans Plans must disclose information on mental and SUD benefits upon request State must disclose reasons for denying reimbursement or payment for services CMS and federal partners work with states to improve their SUD services Innovation Accelerator Program for better SUD delivery system reforms and primary care and mental health integration Health Homes that focus on mental health and SUD Certified Community Behavioral Health Centers Section 1115 SUD demonstration opportunity There are many ways that states can address mental health and Substance Use Disorder (SUD) for their Medicaid program. Final Mental Health and SUD parity rule for Medicaid and Children’s Health Insurance Program (CHIP) (March 2016) Final Rule strengthens access to mental health and substance use disorder benefits for low- income Americans aligning with protections already required of private health plans. It maintains state flexibility while guaranteeing Medicaid enrollees are able to access mental health and substance abuse services in the same manner as medical benefits. (Ex. Comparable co-pays, out- of-pocket costs, limits on outpatient, etc) Plans must disclose information on mental health and substance use disorder benefits upon request, including the criteria for determinations of medical necessity It also requires the state to disclose the reason for any denial of reimbursement or payment for services with respect to mental health and substance use disorder benefits CMS in cooperation with federal partners works with states to improve their services for individuals with Medicaid who have mental health conditions and SUD. Innovation Accelerator Program (IAP)—The goal of the IAP initiative on SUDs is to support participating states for better SUD delivery system reforms and primary care and mental health integration Health Homes that focus on mental health and SUD. Health homes as defined by the Affordable Care Act offers coordinated care to individuals with multiple chronic health conditions including mental health/substance use disorders. Work with the Substance Abuse and Mental Health Administration (SAMHSA) on Certified Community Behavioral Health Centers Section 1115 SUD demonstration opportunity For more information visit Medicaid.gov/Medicaid/benefits/bhs/index July 2017 CMS's Approach to Combatting the Opioid Epidemic

Medicaid Section 1115 Demonstration Opportunity—Substance Use Disorder (SUD) State Medicaid Director letter in July 2015 to support states to introduce benefit, program, and delivery system reforms for individuals with SUD Streamlined 1115 SUD opportunity that provides more flexibilities for states Focus on benefit design, standards of care, care coordination, comprehensive opioid strategies, and quality monitoring Four states approved as of 1/1/17 (California, Massachusetts, Virginia, Maryland) A number of states submitted applications Medicaid Section 1115 Demonstration Opportunity Substance Use Disorder (SUD) was announced in a State Medicaid Director letter in July 2015 to support states to introduce benefit, program, and delivery system reforms for individuals with SUD. It is a streamlined 1115 SUD opportunity that provides more flexibilities for states and focuses on benefit design, standards of care, care coordination, comprehensive opioid strategies, and quality monitoring. Four states were approved as of 1/1/17 (California, Massachusetts, Virginia, Maryland) and a number of states submitted applications. July 2017 CMS's Approach to Combatting the Opioid Epidemic

Medicaid Innovation Accelerator Program (IAP) Substance Use Disorder (SUD)— Program Area Overview High Intensity Learning Collaborative: cohort of six states designing and planning SUD delivery system reforms with IAP support ( ) Targeted Learning Opportunities: web-based learning series to support states on SUD strategies ( ) National Learning Webinars to share what we’ve learned from IAP SUD work with states, partners, and stakeholders 1115 SUD Strategic Design Support to assist states with developing § SUD demonstration proposals and planning targeted reforms Tools and Resources Medication-Assisted Treatment (MAT) data analytics tools MAT clinical pathway and rate design tools Overview of ASAM Criteria guidelines Prescription opioid management strategies Medicaid Innovation Accelerator Program (IAP) Substance Use Disorder (SUD) Program Area Overview includes High Intensity Learning Collaborative: cohort of six states designing and planning SUD delivery system reforms with IAP support ( ) Targeted Learning Opportunities: web-based learning series to support states on SUD strategies ( ) National Learning Webinars to share what we’ve learned from IAP SUD work with states, partners and stakeholders 1115 SUD Strategic Design Support to assist states with developing § 1115 SUD demonstration proposals and planning targeted reforms Tools and Resources Medication-Assisted Treatment (MAT) data analytics tools MAT clinical pathway and rate design tools Overview of ASAM Criteria guidelines Prescription opioid management strategies July 2017 CMS's Approach to Combatting the Opioid Epidemic

The Health Insurance Marketplace
In this section we’ll discuss coverage for substance use treatment for people in the Health Insurance Marketplace. July 2017 CMS's Approach to Combatting the Opioid Epidemic

The Marketplace—Mental Health and Substance Use Coverage
All Marketplace plans must cover the essential health benefits (EHB) Specific benefits depend on your state and the health plan but must include coverage for Mental and behavioral health services Substance use disorder services Prescription drug coverage All Marketplace plans cover essential health benefits (EHB). Specific benefits depend on your state and the health plan but must include coverage for mental and behavioral health services, substance use disorder services, and prescription drug coverage. July 2017 CMS's Approach to Combatting the Opioid Epidemic

The Marketplace—Other Protections
All essential health benefits (EHB) plans Are prohibited from discriminating based on an individual's age, expected length of life, present or predicted disability, degree of medical dependency, quality of life, or other health conditions Issuers are allowed to use reasonable medical management Must comply with “parity" protections between mental health and substance use disorders benefits and medical benefits. No yearly or lifetime dollar limits on coverage for EHB benefits All enrollee’s cost sharing for EHB benefits must count towards the plan’s annual limitation on cost sharing There are other protections for Marketplace plans. All Essential Health Benefits (EHB) plans are prohibited from discriminating based on an individual's age, expected length of life, present or predicted disability, degree of medical dependency, quality of life, or other health conditions. Issuers are allowed to use reasonable medical management. All EHB plans must comply with “parity" protections between mental health and substance use disorders benefits and medical benefits. There are no yearly or lifetime dollar limits on coverage for EHB benefits. All enrollee’s cost sharing for EHB benefits must count towards the plan’s annual limitation on cost sharing. July 2017 CMS's Approach to Combatting the Opioid Epidemic

Resources This section provides additional substance use disorder resources. July 2017 CMS's Approach to Combatting the Opioid Epidemic

Medicare Part D Opioid Prescribing Mapping Tool
Allows providers, local health officials, and others to: Learn about their community’s Medicare opioid prescription rate Make geographic comparisons of Medicare Part D opioid prescription claims go.CMS.gov/opioidheatmap This Medicare Part D opioid drug mapping tool gives providers, local health officials, and others the data to become knowledgeable about their community's Medicare opioid prescription rate. It shows geographic comparisons, at the state, county, and ZIP code levels, of de-identified Medicare Part D opioid prescription claims—prescriptions written and then submitted to be filled—within the United States. It is helpful to look at your regions for the percentage of opioid claims. The tool is available at Go.CMS.gov/opioidheatmap. July 2017 CMS's Approach to Combatting the Opioid Epidemic

Substance Abuse & Mental Health Services Administration (SAMHSA) Resources Behavioral Treatment Services Locator SAMHSA National Helpline Treatment program locators (buprenorphine and methadone) for opioid addiction There are multiple resources available on the SAMHSA website, SAMHSA.gov/find-help. The graphic shows a portion of the SAMHSA website with the following resources: behavioral health treatment services locator, SAMHSA National Helpline, and treatment program locators (buprenorphine and methadone) for opioid addiction. July 2017 CMS's Approach to Combatting the Opioid Epidemic

Other Resources for Providers
Here are a few of the federal resources that are available for providers. The “Assess. Manage. Monitor.” guidelines from the CDC provide recommendations for the prescribing of opioid pain medication for treatment of chronic pain lasting longer than 3 months or past the normal tissue healing outside of active cancer treatment, palliative care, and end-of-life. The checklist for prescribing opioids for chronic pain can be found at CDC.gov/drugoverdose/prescribing/guideline. The Medication-Assisted Treatment of Opioid Use Disorder Pocket Guide offers guidance for doctors on the use of medication-assisted treatment for patients with opioid use disorder. Screening, Brief Intervention, and Referral to Treatment (SBIRT) Services is an approach to the delivery of early intervention and treatment to people with substance use disorders and those at risk of developing these disorders. The screening quickly assesses the severity of substance use and identifies the appropriate level of treatment. It contains a brief intervention about substance use and behavioral change and referral to more extensive treatment. To explore SBRIT, go to Integration.samhsa.gov/clinical-practice/sbirt. Other national resources for providers can be found at CDC.gov and at CMS.gov/Outreach-and-Education/Medicare-Learning-Network- MLN/MLNProducts/downloads/SBIRT_Factsheet_ICN pdf. July 2017 CMS's Approach to Combatting the Opioid Epidemic

HHS Opioid Resources HHS Opioids Initiative HHS.gov/opioids/ Centers for Disease Control and Prevention CDC.gov/drugoverdose/opioids/index.html U.S. Food and Drug Administration FDA.gov/drugs/drugsafety/informationbydrugclass/ucm htm\ National Institute on Drug Abuse Drugabuse.gov/publications/research-reports/prescription- drugs/opioids The United States Department of Health and Human Services (HHS) has made it a priority to address opioid abuse, dependence, and overdose. Several agencies within HHS have joined the effort. HHS Opioids Initiative HHS.gov/opioids/. Centers for Disease Control and Prevention CDC.gov/drugoverdose/opioids/index.html U.S. Food and Drug Administration FDA.gov/drugs/drugsafety/informationbydrugclass/ucm htm\ National Institute on Drug Abuse Drugabuse.gov/publications/research- reports/prescription-drugs/opioids. July 2017 CMS's Approach to Combatting the Opioid Epidemic

This Training is Provided by the
CMS National Training Program (NTP) To view all available NTP training materials, or to subscribe to our list, visit CMS.gov/outreach-and- education/training/CMSNationalTrainingProgram. Stay connected. Contact us at or follow us @CMSGov #CMSNTP This training is provided by the CMS National Training Program (NTP). To view all available NTP materials, or to subscribe to our list, visit CMS.gov/outreach-and-education/training/CMSNationalTrainingProgram. Contact us at Follow #CMSNTP.

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