Background Medicaid is a joint federal-state health care program that provides health care coverage to low-income and medically needy individuals. At the federal level, the Centers for Medicare & Medicaid Services (CMS), within HHS, is responsible for overseeing Medicaid, while states administer their respective Medicaid programs’ day-to-day operations. Each state’s Medicaid program, by law, must cover certain categories of individuals and provide a broad array of benefits. Within these requirements, however, states have significant flexibility to design and implement their programs, resulting in more than 50 distinct state-based programs. The federal government requires coverage for certain mandatory services under Medicaid, but states may decide to include other optional services as well. Some of the largest and most commonly included services include prescription drugs, nursing facilities, home and community-based care, and hospital inpatient care. Medicaid and Prescription Drugs Although pharmacy coverage is an optional service under Medicaid, all 50 states and the District of Columbia provide coverage for prescription drugs. State Medicaid programs that opt to cover prescription drugs are generally required to cover all of the outpatient drugs of any drug manufacturer participating in the Medicaid Drug Rebate Program, including all of the drugs’ formats. State Medicaid programs do not directly purchase prescription drugs, but instead reimburse pharmacies for covered prescription drugs dispensed to Medicaid beneficiaries. Providers (including physicians, nurse practitioners, and physician assistants) and pharmacies provide health care services, seek payment, and are reimbursed for services by state Medicaid agencies. States may directly pay health care providers for services rendered using a fee-for- service system or may delegate these responsibilities to MCOs. Under managed care, the state contracts with MCOs to provide comprehensive health care services through its network of providers. MAT Medications Buprenorphine, buprenorphine-naloxone, and naltrexone may be prescribed, administered, or dispensed for use in MAT. These medications come in a variety of formats, including oral, implantable, and injectable. Buprenorphine. Buprenorphine is a partial opioid agonist, meaning it binds to opioid receptors and activates them. It reduces or eliminates opioid withdrawal symptoms, including drug cravings, and blunts the euphoria or dangerous side effects of other opioids, such as heroin. It can be used for detoxification treatment and maintenance therapy. Buprenorphine is available as a MAT medication in two oral formats—(1) tablets for sublingual (under the tongue) administration, and (2) film for sublingual or buccal (inside the cheek) administration; as a subdermal (under the skin) implant; and in an injectable format. Oral formats are often used for beneficiaries that are in the beginning stages of treatment. The implantable format is generally used for beneficiaries who are already stable on a low or moderate dosage of oral buprenorphine. The oral formats are taken daily, while the injectable format is administered monthly, and the implantable format is administered every 6 months. The medication carries a risk of abuse, particularly in oral formats where it can be used inappropriately or illegally re-sold. The injectable and implantable formats of buprenorphine are intended to minimize this risk and to increase beneficiary compliance, because the medication is administered by a provider. Buprenorphine-naloxone. Naloxone is a medication added to some oral formats of buprenorphine to reduce the chances of misuse or abuse. Buprenorphine-naloxone is available in an oral format as either a film or a tablet. It discourages people from inappropriately injecting a crushed and dissolved tablet of buprenorphine by inducing symptoms of opioid withdrawal when injected by individuals physically dependent on opioids. Naltrexone. Naltrexone is an opioid antagonist, meaning it binds to opioid receptors, but does not activate them, thereby blocking the euphoria the user would normally feel from opioids. It also may result in withdrawal symptoms if recent opioid use has occurred. Therefore, it is used for relapse prevention following complete detoxification from opioids. It can be taken daily in an oral format or as a once-monthly injection; though due to low patient compliance, SAMHSA does not recommend using oral naltrexone for OUD treatment. Naltrexone carries no known risk of abuse. For the injectable format of naltrexone, beneficiaries have to be free from opioids for at least a week before they can begin the medication. Prior Authorization and Preferred Drug Lists Subject to certain requirements, state Medicaid agencies may use different strategies, such as prior authorization and preferred drug lists (PDL), to manage the cost of prescription medications and ensure that patients are taking medications that are clinically appropriate. Prior authorization requires that certain conditions are met before services can be provided to patients, in part, to control utilization and prevent improper payments. PDLs reflect state Medicaid agencies’ determinations on whether medications, including those used for MAT, will be covered and whether these medications will be categorized as preferred or non- preferred. A PDL indicates the first-choice or preferred medication for a beneficiary’s particular medical condition. PDLs are utilized by state Medicaid agencies to incentivize providers to prescribe certain types of medications. In addition, the preferred or non-preferred categorization of medication can vary between fee-for-service and managed care plans within a state. If a medication is not listed on a PDL, prior authorization may be required. However, medications listed on a PDL may still have prior authorization requirements, such as requirements to ensure patient safety. Distribution Methods There are three distribution methods by which beneficiaries can obtain MAT medications. (See fig. 1.) 1. Retail pharmacy. After receiving a prescription from a health care provider, pharmacists at a retail pharmacy, such as CVS or Walgreens, prepare and dispense (or deliver) the medication directly to a beneficiary. The pharmacist is reimbursed for the cost of the medication by a payer, such as Medicaid or private insurance, and by any co-payment from the beneficiary. 2. External delivery from a specialty pharmacy. After receiving a prescription from a physician or other health care provider, a specialty pharmacy delivers the medication directly to the provider so the medication can be administered (injected or implanted by the provider) to the beneficiary for whom it was prescribed. The specialty pharmacy ensures that any specific requirements for a medication are maintained; for example, injectable naltrexone requires the use of refrigerated warehouses, insulated shipping containers, and temperature monitoring equipment. The specialty pharmacy is reimbursed by Medicaid or another payer. 3. Buy-and-bill. A health care provider purchases the medication from a manufacturer or distributor and stores the medication until it is dispensed or administered to the appropriate patient. After the medication is dispensed or administered, the provider bills Medicaid or another payer for the cost of the medication. Each of the distribution methods used for MAT medications has characteristics with implications for beneficiaries, providers, pharmacies, and payers. (See table 1.) Laws and Regulations for Prescribing Buprenorphine and Buprenorphine- Naloxone Medications containing buprenorphine, including buprenorphine- naloxone, are considered controlled substances, which are governed at the federal level by the Controlled Substances Act (CSA), and may be subject to state laws as well. The CSA assigns controlled substances— including narcotics, stimulants, depressants, hallucinogens, and anabolic steroids—to one of five schedules based on the substance’s medical use, potential for abuse, and risk of dependence. In addition to the laws and regulations that apply to controlled substances generally, buprenorphine—when used in the treatment of OUD—is subject to additional requirements under the CSA and implementing regulations issued by the Drug Enforcement Administration (DEA) and SAMHSA. Buprenorphine can be administered or dispensed in a SAMHSA-certified and DEA-registered opioid treatment program when used for OUD treatment. In addition, eligible providers may obtain a Drug Addiction Treatment Act of 2000 (DATA 2000) waiver from SAMHSA in order to dispense or prescribe buprenorphine, including buprenorphine- naloxone, to a limited number of patients for OUD treatment in an office- based setting, such as a doctor’s office. Until 2016, only physicians were eligible to receive a DATA 2000 waiver. However, the Comprehensive Addiction and Recovery Act of 2016 amended the CSA to allow nurse practitioners and physician assistants to receive a DATA 2000 waiver through October 1, 2021. In 2018, the SUPPORT Act eliminated the time limit, thereby permanently allowing nurse practitioners and physician assistants to obtain DATA 2000 waivers. To qualify for a waiver, providers must be appropriately licensed under state law and meet applicable certification, training, or experience requirements. Providers who prescribe, dispense, or administer buprenorphine under a DATA 2000 waiver are also subject to the CSA’s inventory and recordkeeping requirement. The waiver requirements include the following: Physicians must complete an 8-hour training course or have certain certifications or experiences, while nurse practitioners and physician assistants must complete a 24-hour training course. Physicians that receive a DATA 2000 waiver can generally treat 30 patients in their first year and may apply to increase to 100 patients after a year. Physicians that meet certain criteria can treat 100 patients in the first year and up to 275 patients after one year of prescribing at the 100- patient limit. Nurse practitioners and physician assistants may treat 30 patients in their first year with the waiver and 100 patients thereafter. State and Federal Policies, Including Some Related to Distribution Methods, Can Restrict Medicaid Beneficiaries’ Access to MAT Medications State Medicaid programs have policies related to the coverage and distribution of prescription drugs that can restrict beneficiary access to MAT medications. CMS has undertaken various coordination efforts aimed generally at addressing OUD. Federal requirements and state laws can also restrict beneficiaries’ access to the treatment medications. State Medicaid Policies on Coverage for MAT Medications, Prior Authorization Requirements, Preferred Drug Lists, and Distribution Methods May Restrict Beneficiary Access Our review of research and interviews with stakeholders found that several state Medicaid program policies related to prescription drug coverage and distribution can restrict beneficiaries’ access to MAT medications. These are policies governing coverage of MAT medications, prior authorization requirements, preferred drug lists, and limits placed on distribution methods. While some of these policies are generally used to manage utilization and costs related to a wide range of medications, the research we reviewed and stakeholders we interviewed said that these policies can also restrict beneficiaries’ access to the medications used in MAT. In what follows, we describe these policies, including selected states’ and CMS efforts to address the potential access barriers related to these policies. Coverage of MAT Medications Recent research suggests that several state Medicaid programs may not cover all MAT medications in all formats. Specifically, in 2018, SAMHSA reported that while all 50 states’ and the District of Columbia’s Medicaid programs covered oral formats of MAT medications and extended-release injectable naltrexone, it found no indication that 21 states (41 percent) covered either implantable buprenorphine, extended-release injectable buprenorphine, or both. CMS officials said that evidence of coverage may be difficult to find if the medications are billed as part of a medical procedure rather than separately as a medication. However, according to the study’s methodology, SAMHSA took steps to check whether the MAT medications were covered as a medical procedure, and did not find any evidence of such coverage. According to CMS officials, all the manufacturers of MAT medications in our review participate in the Medicaid Drug Rebate Program, and as a result, state Medicaid programs are required to cover these medications and all their formats. CMS officials stated that the agency generally investigates complaints about lack of drug coverage, but had not received any complaints regarding MAT medications. In addition, the officials said they were unaware of the SAMHSA report and had not taken action based on the report’s findings. Therefore, CMS lacks the information to confirm whether or to what extent gaps may exist in state Medicaid programs’ coverage of MAT medications in all formats, as SAMHSA’s report indicates. As such, Medicaid beneficiaries undergoing medication-assisted treatment may not have access to the medications they need for treatment and that are required by law to be covered. In addition, the SUPPORT Act includes a new requirement for state Medicaid programs to cover medication-assisted treatment, including all Food and Drug Administration-approved MAT medications, from October 2020 through September 2025. CMS officials stated that the agency is drafting guidance related to this requirement and plans to communicate the guidance to state Medicaid programs through a State Medicaid Director Letter prior to October 2020. The officials told us that they have not determined when the guidance will be issued. Prior Authorization Requirements When state Medicaid agencies cover a MAT medication, they may impose certain constraints, including requiring prior authorization from the MCO or the state Medicaid agency, before a beneficiary can receive the medication. However, these requirements can have unintended consequences, such as preventing timely access to MAT. According to SAMHSA’s 2018 report, several states use prior authorizations to ensure that patients receive behavioral therapy in addition to their MAT medications or to ensure that patients have abstained from opioids for a certain period of time, which is necessary before receiving a naltrexone injection. Further, when a patient switches from one medication to another (or another format of the same medication), prior authorization may be required for a variety of reasons, such as to ensure patient safety. Officials from a stakeholder organization representing providers and officials from a manufacturer said that prior authorization for injectable buprenorphine was particularly burdensome and that decisions on whether the state Medicaid agency will allow a prescription to be dispensed can take up to 14 days. Providers in our selected states and literature we reviewed noted that these delays could be life threatening, because patients may return to drug use and possibly overdose before receiving their medication. We were also told by officials from one manufacturer that small providers may not have the office staff to promptly process the prior authorization paperwork, creating additional delays. Potential Consequences of OUD Patients Missing Treatment A health care provider told us that patients receiving treatment for opioid use disorder (OUD) need consistent access to medication- assisted treatment (MAT) medications, just as diabetic patients need consistent access to insulin. According to a survey of providers, patients with OUD who experience delays in their MAT medications could lose motivation for their treatment, which could be life threatening. Literature we reviewed and stakeholders we interviewed described other ways that prior authorization requirements can delay access to MAT medications for Medicaid beneficiaries and other patients. The examples described include the following: Talking to patients before authorizing medications. According to literature we reviewed and officials we spoke with from a manufacturer and an organization representing providers, some insurance companies require that their staff or the pharmacist talk to the patient before approving a MAT medication when using external delivery from a specialty pharmacy. This is to affirm that the patient wants the medication and agrees that the pharmacy can bill the state Medicaid program. However, speaking directly to patients can be particularly challenging for this population. Officials representing a manufacturer of a MAT medication and officials representing a health care provider organization noted that patients undergoing residential treatment may not have access to a phone, and patients in outpatient treatment are often encouraged to change their phone numbers to reduce contact with people involved in their past drug use. Also, patients may not answer phone calls from unrecognized numbers. Medication reauthorization. Providers from the District of Columbia told us that they need to reauthorize MAT medication prescriptions every 6 months, but patients may not realize the authorization is about to expire so they run out of the medication, causing them to wait hours or days to get the new prescription filled. Transportation. Prior authorization requirements for MAT medications can result in multiple trips to the pharmacy, which is problematic for patients and beneficiaries without adequate transportation. Providers from the District of Columbia noted that sometimes prescriptions for MAT medications are not ready for patients when they arrive at the pharmacy, and repeated trips to the pharmacy can be problematic for those who lack adequate transportation. Nevertheless, the patient may need multiple trips to go back to the provider and then the pharmacy again, which can be especially challenging. Fail-first requirements. Literature we reviewed, officials we interviewed representing a provider organization, and state Medicaid officials and providers noted that some prior authorizations require that a provider cannot begin treatment with certain MAT medications until treatment with other MAT medications has failed. This literature indicated that this treatment failure can increase the risk of drug use, overdose, and death. Some states have taken steps to reduce these access barriers by removing prior authorizations through changes in state policies or laws. Officials from a nonprofit organization specializing in addressing addiction told us that, as of September 1, 2019, at least 12 states had laws that prohibited prior authorizations for substance use disorder medications, including MAT medications. States may also address prior authorizations through other means, such as policies or guidance. Among our selected states, all four have taken steps to remove prior authorization requirements. The District of Columbia began to generally allow providers to prescribe and dispense MAT medications without prior authorization in April 2019. Minnesota Medicaid officials told us that in August 2018 they removed prior authorization requirements for all MAT medications on their PDL. North Carolina Medicaid officials told us that in November 2017 they eliminated their prior authorization requirement for providers to submit a treatment plan before treating patients with any MAT medication. After the requirement was removed, the officials observed an increase in beneficiaries receiving MAT medications and an increase in the number of providers writing prescriptions for buprenorphine. The officials said North Carolina has never required prior authorization for injectable buprenorphine, but that the state does have some prior authorization requirements for certain forms of oral buprenorphine or buprenorphine-naloxone. Specifically, in order to prescribe an alternative oral medication, the provider needs to demonstrate the patient tried and failed with or is medically unable to use the buprenorphine-naloxone film. Ohio Medicaid officials told us they have no prior authorization requirements for injectable naltrexone, and they removed prior authorization requirements for oral buprenorphine in January 2019. According to the officials, the state has prior authorization requirements for implantable and injectable buprenorphine to ensure patients are initially stable on oral buprenorphine before beginning these other formats. Preferred Drug Lists According to stakeholders we interviewed, having multiple PDLs within a state or changing PDLs can create confusion for health care providers, because they need to keep track of and follow different requirements for the same MAT medication. Such confusion can result in reduced beneficiary access to MAT medications. For example, in the District of Columbia, four MCOs and the fee-for-service program have separate PDLs. Health care providers in the District of Columbia told us that the four MCOs have different dosage restrictions for the same MAT medications. A stakeholder group representing pharmacies told us that having a uniform PDL for the state makes it easier for pharmacists to comply with the relevant restrictions and minimize delays in accessing MAT medications. In addition, a PDL may change multiple times within a short time frame, which can create further problems for patients who had become comfortable with the medication they had been taking, according to officials from a provider organization. To address any possible confusion due to the use of multiple PDLs, some states have a uniform PDL for their Medicaid programs, which means that all PDLs used in the state cover the same MAT medications in the same way. Uniform PDLs can simplify the process for prescribers and eliminate some confusion for beneficiaries when they switch health plans. For example, Minnesota implemented a uniform PDL in July 2019 to ensure more consistent access for Medicaid beneficiaries and minimize disruptions if a beneficiary changes health plans. In addition, North Carolina plans to institute a uniform PDL when its Medicaid program moves to a managed care model in November 2019. Ohio also plans to institute a uniform PDL across the state in January 2020. Ohio Medicaid officials told us the uniform PDL will have both brand name and generic oral buprenorphine as preferred medications. States’ Distribution Method Policies for MAT Medications According to stakeholders we interviewed, the characteristics of each distribution method, as well as states’ policies on distribution methods, have implications for beneficiary access to MAT medications. The following describe the different ways in which the distribution methods may restrict beneficiaries’ access to MAT medications. Retail pharmacies generally offer access to oral formulations of medications. However, retail pharmacies do not typically administer injectable or implantable buprenorphine, and some retail pharmacies may choose not to offer any MAT medications. One survey of physicians found that some pharmacies may either treat individuals prescribed buprenorphine poorly or refuse to carry the MAT medications. External delivery from specialty pharmacies is often used by providers for the injectable or implantable MAT medications, because the specialty pharmacy deals with the administrative responsibilities of the prescription; however, processing delays can impede access to MAT medications through this method, according to literature we reviewed and stakeholders we interviewed. These specialty pharmacies handle the administrative responsibilities of acquiring the medication, including purchasing the medication and sending it to the provider for administration, and receiving reimbursement from the payer, such as Medicaid. Health care providers who administer these medications may still encounter logistical challenges in their acquisition and storage. Other challenges identified by literature and stakeholders include the following: The patient must return to the provider for a follow-up appointment to receive the medication, because the medication is delivered to the provider. However, if the patient does not return, stakeholders—including those representing specialty pharmacies—told us that the unused medication must be disposed of. Providers may face challenges ensuring staff are available to receive medication deliveries—particularly in rural locations or in small practices with multiple office locations that are not always staffed, according to stakeholders representing specialty pharmacies and providers. Prescriptions are not always filled by the specialty pharmacy until they have confirmed that they will be reimbursed by the payer, according to officials from one manufacturer we interviewed. The officials stated that when the claim is processed manually, it can take over 20 days to fill the prescription. In contrast, the officials said that if a claim can be processed electronically, payment and delivery of the medication can be almost immediate. Buy-and-bill distribution allows patients to have immediate access to MAT medications, because their provider has the medications in stock; however, some providers prefer not to use this method, because it places them at financial risk. In particular, smaller health care practices may not have the infrastructure or resources to deal with the administrative responsibilities associated with buy-and-bill, and they may not have the financial ability to pay for medications up front and then wait for reimbursement, according to stakeholders we interviewed. For example, one stakeholder we interviewed said that the cost for just 2 to 3 doses of injectable medication obtained through buy-and-bill could take up a significant portion of the profit margin for a smaller medical practice. Furthermore, if patients do not use these medications before they expire or if the reimbursement from the payer does not equal the cost of the medication, the provider may face a financial loss. According to providers we interviewed in our four selected states, the high cost of some medications—as much as $1,200 per dose for injectable medications—makes the financial risk of buy-and-bill too high. Providers also told us that some providers choose not to store buprenorphine, because they are concerned that they could be subject to a DEA inspection. Surveys of health care providers have found provider concerns related to these inspections. And as with specialty pharmacies, the provider must have someone available to receive deliveries, which can be difficult for smaller practices, according to providers in our selected states. How Access Barriers Can Affect Opioid Use Disorder Treatment A health care provider we interviewed described how access barriers affected a Medicaid beneficiary’s opioid use disorder treatment. This beneficiary was initially prescribed oral buprenorphine, but the medication was repeatedly stolen by the patient’s partner. The provider and beneficiary agreed that injectable buprenorphine would allow treatment to continue without the risk of theft. Initially, the provider was not able to find a specialty pharmacy with an electronic prescription system compatible with the provider’s system, which was necessary to receive the prescriptions. The provider told us that after a compatible specialty pharmacy was identified and the order was completed, the delivery was further delayed, because two staff members—as required—were not available to sign for the delivery when it arrived. Three months after the decision was made to switch medications, the delivery was completed and the provider administered the medication. Furthermore, state Medicaid policies that require or prevent the use of certain distribution methods for MAT medications can restrict providers from using methods that may be best suited for their patients or practice, which may in turn affect beneficiaries’ access to the medications, according to stakeholders. Medicaid officials and providers we interviewed told us that some states require the use of certain distribution methods when a provider prescribes a MAT medication. For example, Minnesota’s fee-for-service plan (which covers about 25 percent of the state’s Medicaid population) requires that health care providers use buy- and-bill for all physician administered medications, including those that are injected or implanted. Minnesota providers we interviewed told us that they are reluctant to prescribe either the injectable or implantable versions of MAT medications, due to payment delays or other problems they experienced when they attempted to use buy-and-bill. Stakeholders told us that access to MAT medications would be maximized if providers and beneficiaries are not restricted when choosing among the three distribution methods—and some states have removed such restrictions. Officials from one manufacturer told us that since 2016, nine states that required use of buy-and-bill for their medication have eliminated those requirements. Medicaid officials in North Carolina told us that because smaller medical practices do not want the inventory costs associated with buy-and-bill, the state has moved to allow providers to obtain the injectable buprenorphine through either buy-and-bill or a specialty pharmacy. According to the officials, this has resulted in the increased use of the medication. Similarly, Medicaid officials in the District of Columbia told us that prior to 2017, injectable MAT medications were only available through buy-and-bill—despite Medicaid reimbursements being lower than providers’ costs. In 2017, these medications became available from specialty pharmacies. CMS Has Undertaken Opioid Coordination Efforts CMS has undertaken various coordination efforts aimed generally at addressing OUD. These efforts include the following: Opioid Steering Committee—composed of CMS senior leadership and staff, according to agency officials—helps coordinate opioid policy across the agency. CMS officials told us that the bi-weekly committee meetings have included discussions about reducing barriers related to prior authorization, other utilization management practices, and implementation of the SUPPORT Act, among other opioid related topics. Action Plan to Prevent Opioid Addiction and Enhance Access to MAT—an effort by an interagency task force—is intended to address OUD barriers in Medicaid, among other things, as required by the SUPPORT Act. In September 2019, CMS held a public meeting and requested public input to develop this action plan, which it plans to issue by January 2020, as mandated by the act. State Opioid Workshop, organized by CMS, brought together state officials to share innovative practices and discuss efforts to decrease barriers to accessing treatment for OUD, according to CMS officials. The second of such workshops was held in September 2018, and CMS documentation shows that the workshop included sessions focused on MAT, including a session on states’ approaches to improving the availability and use of MAT through benefit, payment, and system design. Informational bulletins have been used by CMS to communicate information states need to manage their Medicaid programs, including recommended actions. For example, in July 2014, CMS issued a bulletin to states providing background information on MAT, examples of state-based initiatives to increase access to MAT, and resources to help ensure proper delivery of MAT services. In January 2016, CMS issued another bulletin that focused on best practices for addressing prescription opioid overdoses, misuse, and addiction, and urged states to take action to reduce the potentially dangerous usage of opioids used for pain. While this bulletin was not focused on MAT, it suggested generally that states consider reviewing benefits coverage and service utilization to ensure beneficiaries have sufficient access to MAT services, and indicated that some benefit requirements, such as prior authorizations, can reduce the use of and access to MAT. Drug Utilization Review Survey, conducted annually by CMS, contains information that the agency publishes on states’ activities related to all prescription drugs in the Medicaid program, including some limited information about MAT medications. Other CMS efforts also addressed Medicaid beneficiaries’ access to MAT. In November 2017, CMS announced a new policy to increase flexibility for states seeking a section 1115 demonstration to improve access to and quality of OUD treatment for Medicaid beneficiaries. CMS has approved section 1115 demonstrations that included OUD- related provisions for 26 states and the District of Columbia between August 2015 and November 2019. States implementing these demonstrations are expected to take action to ensure access to MAT for Medicaid beneficiaries, including by establishing a requirement that inpatient and residential settings provide access to MAT. CMS has also examined access to OUD treatment through its Innovation Accelerator Program, which provides resources to states to introduce delivery system and payment reforms in a variety of areas, including OUD. Requirements for Federal Waivers and State Laws Limit Who Can Administer the Medications Waiver Requirements for Buprenorphine Our review of literature and interviews with stakeholders show that in addition to Medicaid policies, other federal and state policies can limit Medicaid beneficiaries’ access to MAT medications. According to stakeholders we interviewed and literature we reviewed, requirements associated with DATA 2000 waivers may limit the number of providers willing to prescribe or administer buprenorphine for MAT. Stakeholders and the literature note that providers may be reluctant to obtain the DATA 2000 waiver, due to the hours of training associated with the waiver and the cost of registering with the DEA after obtaining the waiver, among other things. According to officials from a stakeholder organization representing providers and providers in one of our selected states, the requirements to obtain a DATA 2000 waiver, including the associated hours of required training—ranging from 8 hours for physicians to 24 hours for nurse practitioners and physician assistants—contributes to perceptions that prescribing buprenorphine for the treatment of OUD is dangerous, particularly since waivers are not required to prescribe buprenorphine for pain management. A 2019 National Academy of Sciences report also notes that treatment with buprenorphine is less risky than many other OUD treatments that do not require special training. Another study suggested that other opioids not used in the treatment of OUD—and not requiring special training—are more commonly misused, diverted, or responsible for overdoses, compared with buprenorphine. All providers who prescribe controlled substances are required to register with DEA. For providers with a DATA waiver who wish to administer injectable or implantable buprenorphine in multiple office locations, the requirement that each office location be registered with DEA may be an additional burden, as these fees are $731 for 3 years, according to DEA. DEA requires that the provider pay the registration fee for each location where controlled substances are stored, administered, or dispensed, which might not be recouped if only a small number of patients are treated at the various locations. Stakeholders we interviewed and literature we reviewed also noted a concern among some health care providers that having a waiver would subject them to increased oversight from DEA and other law enforcement agencies. Specifically, officials from an organization representing addiction providers and providers in our selected states told us that the possibility of interaction with law enforcement can intimidate some providers and can be anxiety-provoking and disruptive. Literature we reviewed reported that this can lead to providers not pursuing a waiver or ceasing to prescribe buprenorphine. Surveys of health care providers have found similar concerns. These factors can create a potential treatment barrier for patients and beneficiaries by limiting the number of available providers, according to officials from an organization representing addiction providers we interviewed and literature we reviewed. The waivers also limit how many patients, including Medicaid beneficiaries, providers may treat with MAT medications. These limits may create an additional barrier to OUD treatment, particularly for providers who specialize in addiction medicine. Studies have consistently found that providers who have waivers treat fewer OUD patients than their waiver allows—and some may not accept new patients. For example: A 2016 study of rural physicians found that more than half of providers with waivers were not accepting new patients; those with a 30-patient waiver limit were treating an average of fewer than nine patients; and more than half of the providers with waivers were not treating any patients. Providers with a 100-patient waiver limit treated an average of 57 patients, although more than one-quarter were at or approaching their patient limit. A survey of physicians, nurse practitioners, and physician assistants who obtained a waiver or increased their patient waiver limit in 2017 found that these providers were treating about one-third of their patient limit. Literature we reviewed noted that providers might not treat the maximum number of patients allowed by their waiver limit, because they are not specialists in addiction medicine, or they do not want to treat a larger number of patients with OUD. These providers may have obtained a waiver to respond to the needs of their existing patients who have OUD, rather than to add new patients. In contrast, one of these studies and officials from one organization representing health care providers in addiction medicine we interviewed noted that there are providers who are addiction medicine specialists that cannot work a full-time schedule if they are only allowed to treat 275 patients, which is the maximum allowed under the waiver rules. The study projected that a capacity range of 378 to 524 patients would be necessary for providers to practice addiction medicine full time. CMS officials told us they have taken some steps to increase the number of providers with DATA 2000 waivers through funding new planning grants in 15 states, as authorized by the SUPPORT Act. According to CMS officials, the grants cover training expenses to help providers obtain the waiver, among other things. State Laws That Prevent Certain Providers from Prescribing MAT Medications Federal laws allow certain non-physicians—such as nurse practitioners and physician assistants—to obtain a DATA 2000 waiver to prescribe and administer buprenorphine to treat OUD; however, some states’ laws may restrict their ability to do so. These laws determine the type of health care services that can be provided by different types of providers. According to literature we reviewed and stakeholders we interviewed representing physician assistants and nurse practitioners, some state laws do not allow non-physicians to write prescriptions for any controlled substances and some specifically limit their ability to write prescriptions for buprenorphine for the treatment of OUD, while others may impose no restrictions for non-physicians beyond the federal training and patient limit requirement associated with the DATA 2000 waiver. For example, officials from an organization representing providers reported that physician assistants in some states, such as Kentucky and Tennessee, cannot prescribe buprenorphine for the treatment of OUD. Further, according to officials from another organization representing providers, most states require nurse practitioners to be supervised by or have a collaborative agreement with a physician. Thus, to prescribe buprenorphine for MAT, the nurse practitioners in these states must obtain a DATA 2000 waiver and have supervision from or a collaborative agreement with a physician. North Carolina Medicaid officials told us that physician assistants and nurse practitioners in the state that have a DATA 2000 waiver must consult with a physician, but do not need to have direct affiliation with a supervising physician. The supervision requirements can affect patients’ access to MAT, including for Medicaid beneficiaries, according to stakeholders. For example, officials from an organization representing providers told us that some nurse practitioners may find it difficult to identify a qualified physician with whom they can have a collaborative agreement. In the states where nurse practitioners are not required to collaborate with a physician, these officials also told us that they see higher percentages of nurse practitioners prescribing MAT medications. Conclusions HHS has identified expanding access to medication-assisted treatment as a key component of its efforts to reduce opioid use disorder and opioid overdoses. Through our work, we identified state Medicaid policies and federal and state laws that may create barriers to treatment for Medicaid beneficiaries and other patients with OUD by restricting access to MAT medications. We also identified efforts by states and CMS to address these barriers. Under federal law, state Medicaid programs are required to cover all formats of MAT medications reviewed in our study, because all manufacturers of those medications participate in the Medicaid Drug Rebate Program. In addition, the SUPPORT Act will mandate broader coverage of MAT beginning in October 2020. However, a study by SAMHSA found that nearly half of all state Medicaid programs do not cover all formats of MAT medications in our review. Yet, CMS has not taken steps to determine whether state Medicaid programs do cover all of these MAT medications and their formats, as required. Until CMS determines the extent to which state Medicaid programs cover all MAT medications, as required—and address coverage gaps when found— Medicaid beneficiaries may not be able to obtain the most effective medications to treat their opioid use disorder. Recommendations for Executive Action We are making the following recommendation to CMS: The Administrator of CMS should determine the extent to which state Medicaid programs are in compliance with federal requirements to cover MAT medications in all formats and take actions to ensure compliance, as appropriate. (Recommendation 1) Agency Comments We provided a draft of this report to HHS for review. HHS provided written comments which are reprinted in appendix I. HHS also provided technical comments, which we incorporated as appropriate. In its written comments, HHS concurred with our recommendation. Specifically, HHS stated that it will examine the extent to which state Medicaid programs are in compliance with the requirements of the Medicaid Drug Rebate Program as it relates to the coverage of MAT medications and take actions to ensure compliance, as appropriate. HHS also reiterated its plans to develop guidance for states on the SUPPORT Act’s new requirement for states to cover MAT medications. We are sending copies of this report to the appropriate congressional committees, the Secretary of the Health and Human Services, and other interested parties. In addition, the report is available at no charge on the GAO website at http://www.gao.gov. If you or your staff have any questions about this report, please contact me at (202) 512-7114 or DeniganMacauleyM@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. GAO staff who made key contributions to this report are listed in appendix II. Appendix I: Comments from the Department of Health and Human Services Appendix II: GAO Contact and Staff Acknowledgments GAO Contact Staff Acknowledgments In addition to the contact named above, Will Simerl (Assistant Director), Carolyn Feis Korman (Analyst-in-Charge), Rebecca Hendrickson, Shirin Hormozi, Virginia Lefever, Drew Long, Leslie McNamara, and Carla Miller made key contributions to this report. Also contributing were Leia Dickerson, Carolyn Garvey, Ethiene Salgado-Rodriguez, and Emily Wilson Schwark.


Background Medical Center Performance: SAIL VHA began using the SAIL system in 2012 to measure, evaluate, and benchmark the quality, efficiency, and productivity of medical centers, and to highlight successful strategies of high-performing medical centers. SAIL includes 29 performance measures (27 quality measures and two measures of overall efficiency and capacity) in areas such as acute-care mortality, access to care, and employee satisfaction. (See appendix I for the full list of SAIL measures.) SAIL is a diagnostic tool that allows VHA to assess medical centers’ performance relative to their peers, and determine how much absolute improvement they have made in the past year based on relevant clinical data. VHA publishes SAIL results quarterly to provide information to network and medical center officials regarding improvement opportunities at each medical center. SAIL data are also available on VHA’s intranet site. VHA staff can view a wide range of detailed information about their medical center, compare performance to other medical centers, and (for those staff with medical-record-level access) view information on patients with a particular medical condition. Network and Medical Center Director Performance Appraisal Process VHA conducts annual performance appraisals for all network and medical center officials. The appraisal process begins when officials from VHA’s office of Workforce Management and Consulting transmit a performance plan template to the network directors. The template identifies performance priorities and expectations for the upcoming appraisal period and criteria to be used to measure performance outcomes and ratings for each performance element. Network directors use the template to develop performance plans that include targets and time frames—the schedule of when performance targets are to be achieved during the year—with each of the medical center directors in their network. According to VA policy, performance plans resulting from the template should be finalized within 30 days of the start of the appraisal period. After expectations have been set for a medical center director, the director, in turn, sets performance expectations for the department heads within the medical center. VHA Primarily Uses SAIL and Its Associated Star Ratings to Assess and Manage Medical Center Performance VHA Primarily Uses SAIL and Its Star Ratings to Assess Medical Center Performance VHA officials told us they primarily use the SAIL system to assess the performance of medical centers. Specifically, VHA uses SAIL data to calculate and assign each medical center an annual star rating of 1 (lowest) to 5 (highest) stars as an assessment of overall quality. SAIL documentation states that the goal of the star ratings is for low-performing medical centers to learn from the best practices of high-performing ones, although all medical centers have the opportunity to improve. VHA applies a weighting and calculation methodology to each of SAIL’s 27 quality measures to determine a single composite score for each medical center. The scores are then ranked and grouped by percentile and the associated medical centers are assigned initial star ratings based on their relative ranking. For example, the lowest performing 10 percent of medical centers as determined by SAIL’s 27 quality measures are assigned a 1-star rating, and the next lowest performing 20 percent of medical centers are assigned a 2-star rating. (See fig. 1.) After the initial star rating is determined by SAIL measures each year, VHA officials can make changes to the rating if a medical center meets certain conditions. For example, SAIL documentation states that a medical center that initially received a 5-star rating will be reduced to a 4- star rating if it has a high mortality rate. In addition, VHA officials told us they can decide to increase a 1-star medical center’s rating to a 2-star rating if the medical center outperforms the bottom 10 percent of U.S. hospitals in certain criteria as measured by external systems such as the Centers for Medicare & Medicaid Services’ Hospital Compare website. We found that the percentage of medical centers that received a final 1- star rating ranged from 4 percent to 10 percent from fiscal years 2013 through 2018. VHA officials publish the final annual star ratings for each medical center both internally and externally. See figure 2 for the number of medical centers that received each final star rating for fiscal years 2013 through 2018. Although the specific medical centers within each star-rating category could change from year to year, we found that the fiscal year 2018 star ratings for 110 of the 127 medical centers (87 percent) that received star ratings in fiscal year 2013 did not differ by more than 1 star from their fiscal year 2013 star rating. For example, eight of the 10 1-star medical centers in fiscal year 2013 received either a 1- or 2-star rating in fiscal year 2018. (See fig. 3.) In addition, 44 of the 127 medical centers had the same rating in fiscal year 2018 as they did in fiscal year 2013. At the end of the 6-year period of our review, only one medical center differed by more than 2 stars from its fiscal year 2013 star rating, decreasing from 5 stars to 2. VHA Uses Tools from the SAIL System to Manage Medical Center Performance VHA officials told us they use SAIL tools on VHA’s intranet when conducting site visits to medical centers and for other performance management efforts. The SAIL system includes several performance management tools that present data in greater detail than SAIL’s quarterly data release and enable officials to identify areas for improvement. VHA, network, and medical center officials we interviewed mentioned three in particular: Opportunity matrix – This matrix shows how a medical center ranks compared to others on all SAIL performance measures based on quarterly data. Each performance measure is labeled by quintile, with the first quintile comprising the top 20 percent of medical centers and the fifth quintile comprising the bottom 20 percent. Officials told us they use this tool to focus improvement efforts by examining specific measures for which a medical center needs improvement. Geometric control charts – These charts, referred to as G-Charts, allow officials to monitor on a daily basis what VHA considers to be rare occurrences. For example, one G-Chart allows VHA to monitor patient safety indicators that contain information on occurrences of specific medical conditions, such as cardiac arrest, pneumonia, and sepsis. Medical center officials can use these charts to examine the occurrence of events over time, analyze patient-level data, and quickly detect changes in the frequency of these events. Other events that the charts allow VHA to monitor include inpatient complications and deaths. Symphony action triggers – Symphony is an online tool that tracks over 100 performance measures daily, related to medical center access, outcomes, and productivity, and includes an early warning system to notify network and medical center officials of results that require attention. Officials can use Symphony to view patient-level information to understand the details of particular events and determine solutions. VHA officials also told us that they use these tools to manage medical center performance as part of their ongoing support of lower performing medical centers. Specifically, officials who oversee SAIL identify lower performing medical centers using SAIL and conduct site visits as part of VHA’s Strategic Action for Transformation initiative. This initiative utilizes a four-tiered, escalating approach based on the severity of concern at a medical center. In order of increasing severity, the four levels are watch, high-risk, critical, and VA receivership. One-star medical centers are automatically placed on the high-risk list, along with some 2-star medical centers with decreasing performance. If performance continues to decrease, medical centers are considered critical, and can be escalated to VA “receivership,” at which point VHA officials may step in to correct ongoing problems and replace network or medical center leadership officials. As of January 2019, VHA officials told us no medical center had entered VA receivership since the initiative began. VHA officials told us that they may also conduct site visits or hold calls with medical center leadership by request, although their focus is on lower performing medical centers. In addition to the SAIL tools, which report data on performance measures across the entire medical center, VHA officials told us that they may also use other data sources as part of medical center performance management. For example, several program offices—such as primary care, mental health, and surgery—have dashboards that track performance and quality of care specific to those offices. In addition, VA’s Inpatient Evaluation Center focuses on mortality data, including estimates of expected patient mortality. VHA’s Appraisal Process for Assessing Network and Medical Center Directors’ Performance Relies Heavily on Medical Center Performance Information We found that VHA relies heavily on medical center performance information to assess the performance of its network and medical center directors. VA’s Senior Executive Service Part V. Performance Appraisal System handbook states that directors are assessed using five appraisal elements established by the Office of Personnel Management: (1) Results Driven, (2) Leading People, (3) Leading Change, (4) Business Acumen, and (5) Building Coalitions. The five elements are included in VHA’s performance plan template, which forms the basis for network and medical center directors’ performance plans. The handbook designates a relative weight for each element used to calculate a director’s rating. (See fig. 4.) The handbook states that a director is rated in each element on a scale of level 1 to level 5, with 5 being the highest level. Each rating is then multiplied by the weight for its corresponding element, and the results are added to generate a summary score. According to the handbook, the summary score is used to identify potential recipients of pay increases and monetary awards. The most heavily weighted appraisal element in the handbook, Results Driven, represents 40 percent of a director’s overall performance and is based entirely on medical center performance information. Specifically, for fiscal year 2018, SAIL results comprised 25 percent of the overall rating and included measures such as patient mortality, length of stay, and readmissions. Other medical center performance information comprised the remaining 15 percent of the overall rating. (See fig. 5.) Medical center performance information is also used when assessing directors’ performance across other appraisal elements. For example, in VHA’s fiscal year 2018 performance plan template, the Leading Change appraisal element included the implementation of suicide prevention initiatives, using medical center performance in the SAIL mental health domain as criteria. In addition, the Leading People element included performance information from VA’s All Employees’ Survey, which included medical center staff. Although medical center performance information plays a prominent role in the performance assessment process, VHA officials told us that there are other considerations that may result in medical center directors receiving a rating that is higher than that indicated by the star rating of the medical center. For example, VHA officials told us that when calculating a medical center director’s rating for the Results Driven element, they consider whether the medical center’s overall performance improved or deteriorated compared to the previous year’s performance. These officials also stated that they take into consideration the length of a director’s tenure, such as cases where a director started at a low- performing medical center partway through the rating year and would not have had sufficient time to improve the medical center’s performance from the previous year. In our review, we also found that the release of VHA’s performance plan template is often delayed, which can limit its effectiveness as a means of assessing directors’ performance. Specifically, in fiscal years 2016, 2017, and 2018, VHA released the performance plan template to network directors in November or December, close to the end of the first quarter of the performance appraisal period. Directors at two of the medical centers in our review expressed frustration with the delay and not having a full year to meet performance expectations, but directors at the two other medical centers stated that they find the process clear and are able to anticipate performance expectations. Officials from VHA’s office of Workforce Management and Consulting, which sends out the template, told us that they have been working in recent years to shorten the template’s development and review process within VHA; however, the delays may continue because of late changes from VA or the Office of Personnel Management. In our December 2016 review of human resource management practices at VHA, we also reported on delays in the release of VHA’s performance plan template. We reported that the delay limited medical center officials’ ability to use the template as a tool to align expectations and performance, which is inconsistent with leading practices on employee performance management. We recommended that VHA accelerate its efforts to develop a modern, credible, and effective performance management system, including the timely release of the performance plan template. VA partially concurred with our recommendation and has made limited progress in implementing it. As of December 2018, this recommendation remains open and we reiterate the need for VHA to implement it. VHA Has Not Assessed for Implementation Previous Recommendations Made to Ensure SAIL’s Effectiveness in Assessing Medical Center Performance Although SAIL is used in the assessment of both medical centers’ and directors’ performance, VHA officials have not assessed and implemented as appropriate the recommendations from previous evaluations of the SAIL system to ensure its effectiveness. This is inconsistent with federal standards for internal control, which state that management should remediate identified internal control deficiencies on a timely basis. This remediation may include assessing the results of reviews to determine appropriate actions, and, once decisions are made, completing and documenting corrective actions on a timely basis. VHA officials told us that since it was established in 2012, there have been two evaluations of SAIL: The first evaluation was an internal review, which VHA officials told us was completed in February 2014 and submitted to the director of VHA’s Office of Analytics and Business Intelligence and reviewed by the then Under Secretary for Health and Principle Deputy Under Secretary for Health. The internal review, which had 22 recommendations, found issues related to the validity and reliability of SAIL as a tool for measuring performance and fostering accountability. For example, it included a recommendation that VHA no longer use aggregate star ratings for accountability, or for presenting medical center quality and efficiency information to stakeholders. Rather, the recommendation called for VHA to work to identify valid and reliable approaches for presenting this information. The second evaluation was an external review, which VHA officials told us was submitted to the Office of the Principal Deputy Under Secretary for Health in April 2015. The external review included 19 recommendations for short- and long-term improvements to SAIL, such as a recommendation to examine the potential for misclassifying medical centers—i.e., assigning star ratings that do not reflect medical centers’ pattern of performance on the underlying measures. The review noted two ways such misclassification could occur: (1) two medical centers with summary scores that are close together could receive different star ratings, or (2) two medical centers with widely different summary scores could receive the same star rating. The findings of the previous SAIL evaluations are similar to concerns that officials from the four networks and four medical centers in our review expressed about SAIL’s effectiveness, including whether the star ratings were an accurate reflection of medical center performance. For example, officials from one medical center told us that, because the mortality measure has a higher weight relative to other SAIL measures, it can amplify the importance of a small difference between medical centers. As a result, a 1-star medical center may appear to be performing much more poorly on this measure than it is in practice; and officials from two medical centers told us that the length-of-stay measure may not be an accurate reflection of quality of care, as there are valid clinical reasons why some veterans need a longer length of stay that may not be reflected in the diagnostic and procedure codes for that stay. Therefore, the difference in performance on the length of stay measure between two medical centers may be the result of how data were entered into the medical record and coded, rather than actual differences in quality of care. In addition, VHA officials also expressed concerns about SAIL and how it is currently being used to assess medical center performance. For example, VHA officials who oversee SAIL told us it was designed to be an internal performance improvement tool, but is now also being used as a performance accountability tool. The external review included a recommendation that VHA consider whether the primary purpose of SAIL is improvement or accountability, as SAIL would need to be redesigned to do both. One VHA official told us that SAIL is being used in punitive ways through the Strategic Action for Transformation initiative. For example, at one medical center, officials told us that they received a letter from VHA’s Executive in Charge about the medical center’s low performance only a few months after its star level increased from 1 to 2 stars. Officials said the letter warned them that medical center leadership could be removed if performance does not improve. Medical center officials described this as counterproductive for their improvement efforts, as it was demoralizing while not identifying any specific areas for improvement. VHA officials confirmed that, other than their routine reviews to determine the need for annual adjustments to SAIL measures and other minor adjustments to the system, they have not assessed or implemented as appropriate the recommendations from the internal and external SAIL evaluations. In addition, although the Under Secretary for Health received a response to the internal review’s recommendations from an individual program office, VHA officials told us no action was taken on the response or to formally assess the recommendations from the internal review. Officials noted that two reasons for the lack of action taken to assess recommendations for implementation were leadership turnover and attention diverted to other issues, such as concerns about extended wait times for medical appointments at VHA medical facilities. In addition, officials stated that the evaluations were not widely distributed within VHA. As a result, officials we spoke with from several VHA offices were unaware that SAIL had ever been evaluated. To address the federal internal control standard for timely remediation of identified deficiencies, federal agencies assign responsibility and authority for carrying out and documenting corrective actions. VHA officials told us they did not formally assign responsibility to an office to assess recommendations from previous evaluations of SAIL. As a result, when the officials who received both evaluations left VHA, there were no other individuals or offices responsible for ensuring that recommendations were acted on. VHA officials who oversee SAIL told us that they are planning to use the 2015 external review as part of their plans to make changes to SAIL and its measures. However, there is no documentation available describing the planned changes to SAIL or how those planned changes will incorporate the results of the external review. If changes made to SAIL run counter to the evidence, it could potentially diminish the integrity of the system to effectively evaluate performance. Conclusions VHA primarily uses the SAIL system to assess and compare the performance of medical centers. Veterans can also view SAIL data to compare medical center performance when making health care decisions. Officials from the networks and medical centers in our review expressed concerns about how SAIL is being used and whether star ratings are an accurate reflection of medical center quality. SAIL has been evaluated twice, and both evaluations have found similar concerns with SAIL. However, VHA has yet to use the results of those evaluations to address identified concerns and make evidence-based improvements to the SAIL system. Specifically, VHA has not taken action to ensure that officials assess the recommendations from SAIL evaluations, document their decisions, and implement recommendations as appropriate. If changes to SAIL are implemented without this assessment of existing evaluations, VHA may make changes that run counter to the evidence, potentially diminishing the integrity of the system to effectively evaluate performance. Recommendations We are making the following two recommendations to VA: The Under Secretary for Health should assess recommendations from two previous evaluations of SAIL. This assessment should include the documentation of decisions about which recommendations to implement and assignment of officials or offices as responsible for implementing them. (Recommendation 1) The Under Secretary for Health should implement, as appropriate, recommendations resulting from the assessment of the two previous SAIL evaluations. (Recommendation 2) Agency Comments We provided VA with a draft of this report for review and comment. VA provided written comments, which are reprinted in appendix II. In its written comments, VA concurred with both of the report’s recommendations, and identified actions it is taking to implement them. We are sending copies of this report to the appropriate congressional committees, the Secretary of Veterans Affairs, the Under Secretary for Health, and other interested parties. In addition, the report is available at no charge on the GAO web site at http://www.gao.gov. If you or your staff have any questions about this report, please contact me at (202) 512-7114 or at draperd@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. GAO staff who made key contributions to this report are listed in appendix III. Appendix I: VHA Strategic Analytics for Improvement and Learning (SAIL) Performance Measures Number of measures 2 Risk adjusted complication Index In‐Hospital risk adjusted mortality (SMR) Measure 30‐day risk adjusted mortality (SMR30) Desired Direction of Measure Lower 3 Severity adjusted average length of stay (ALOS) %Acute admission reviews met InterQual criteria %Acute continued stay reviews met InterQual criteria Inpatient core measures mean percentage (ORYX) HEDIS outpatient core measure mean percentage (chart abstract) HEDIS outpatient core measure mean percentage (population based) 5 HCAHPS score (patient rating of hospital) Rating of primary care provider Rating of specialty care provider Care Transition (inpatient) Stress discussed (PCMH) 2 Best Places to Work score Hospital-wide all conditions 30-day readmission rate 5 Timely Appointment, Care and Information – PCMH Timely Appointment, Care and Information – SC Same Day Appointment When Needed – PCMH Call center speed in picking up calls 3 Mental health population coverage Mental health continuity of care Mental health experience of care 2 Stochastic frontier analysis (= 1/SFA) The acronyms VHA used in the table are as follows: SMR=standard mortality ratio; HEDIS=Healthcare Effectiveness Data and Information Set; HCAHPS= Hospital Consumer Assessment of Healthcare Providers and Systems; PCMH=patient-centered medical home; ACSC=ambulatory care sensitive conditions; SC=specialty care. Appendix II: Comments from the Department of Veterans Affairs Appendix III: GAO Contact and Staff Acknowledgments GAO Contact Debra A. Draper, (202) 512-7114 or draperd@gao.gov. Staff Acknowledgments In addition to the contact named above, Janina Austin, Assistant Director; Sarah Harvey and Malissa G. Winograd, Analysts-in-Charge; Jennie F. Apter; Frederick Caison; and Alexander Cattran made key contributions to this report. Also contributing were Vikki Porter and Jennifer Whitworth. Related GAO Products VA Health Care: Actions Needed to Improve Oversight of Community- Based Outpatient Clinics. GAO-18-375. Washington, D.C.: Apr. 12, 2018. Veterans Health Care: Additional Actions Could Further Improve Policy Management. GAO-17-748. Washington, D.C.: Sept. 22, 2017. Veterans Affairs: Improved Management Processes Are Necessary for IT Systems That Better Support Health Care. GAO-17-384. Washington, D.C.: June 21, 2017. VA Health Care: Improvements Needed in Data and Monitoring of Clinical Productivity and Efficiency. GAO-17-480. Washington, D.C.: May 24, 2017. Veterans Health Administration: Management Attention Is Needed to Address Systemic, Long-standing Human Capital Challenges. GAO-17-30. Washington D.C.: Dec. 23, 2016. Veterans Health Care: Improvements Needed in Operationalizing Strategic Goals and Objectives. GAO-17-50. Washington D.C.: Oct. 21, 2016. VA Health Care: Processes to Evaluate, Implement, and Monitor Organizational Structure Changes Needed. GAO-16-803. Washington D.C.: Sept. 27, 2016.


Background Medicare Coverage Options Beneficiaries have several Medicare options from which to select, which can have important consequences for their out-of-pocket expenses and access to care. These decisions include the following: What type of coverage? The first coverage decision faced by Medicare beneficiaries is choosing between original Medicare or MA. Original Medicare includes coverage for Medicare Part A services, such as inpatient hospital stays, and for Medicare Part B services, such as outpatient hospital care and physician office visits. Under MA—the private plan alternative to original Medicare—beneficiaries enroll in MA plans that generally must provide coverage for all the services included under original Medicare, and may also offer extra benefits. MA plans generally establish a network of health care providers to provide services to enrolled beneficiaries. Add prescription drug coverage? Beneficiaries in original Medicare and those in certain MA plans may also choose whether to add prescription drug coverage (Medicare Part D). Prescription drug plans are administered by private insurance companies that contract with CMS. Beneficiaries in original Medicare obtain drug coverage by purchasing a separate prescription drug plan (PDP), while those in MA generally obtain coverage by selecting a MA plan that offers prescription drug benefits. MA prescription drug plans and separate PDPs vary in the amount beneficiaries need to pay and in the drugs that are covered. Add supplemental coverage? Beneficiaries in original Medicare can also purchase Medicare supplemental insurance—known as Medigap plans—offered by private insurance companies. These plans help pay for Medicare’s required cost sharing and some out-of-pocket costs not covered under original Medicare, such as emergency health care during international travel. Figure 1 illustrates the decisions beneficiaries have to make when selecting their Medicare coverage options. Medicare Cost and Access Considerations Two research studies we reviewed indicate that cost is a key consideration for Medicare beneficiaries when selecting Medicare coverage. Beneficiaries may want to know what their likely out-of-pocket costs will be monthly, annually, or both. Beneficiaries may also want to know what their costs may be if they have a change in health status, such as by experiencing an illness. Beneficiaries may be responsible for several specific types of health care costs, including the following: Premiums—Beneficiaries generally make monthly payments to purchase coverage. Medicare Part A generally does not require beneficiaries to pay a premium. Part B premiums are established by statutory formula and are means-tested so that beneficiaries with higher incomes pay higher premiums. The premiums charged by MA plans and Part D plans are established by each plan and can vary widely. Beneficiaries in original Medicare who opt to purchase Medigap will also pay a monthly premium for coverage, with the amount of the premium varying across the 10 standardized plans and by the different companies offering these plans. Cost sharing—Beneficiaries are typically responsible for paying a portion of the costs for the services they receive as either a copayment or coinsurance. A copayment is a fixed dollar amount for each doctor visit, medical service, or medication. With coinsurance, a beneficiary pays a percentage of the allowed charge for each health care service or medication. Deductibles—Beneficiaries must pay out-of-pocket a specified annual amount of expenses before Medicare will begin paying for approved services or medications. MA plans establish out-of-pocket maximums or set limits on the amount a beneficiary will have to spend a year. In contrast, original Medicare has no limit on beneficiary out-of-pocket costs. In 2019, two Medigap plans provide maximum out-of-pocket limits, and beneficiaries with these plans do not have to pay costs above the limits. The same two research studies identified access to particular health care providers as another key consideration for beneficiaries when selecting Medicare coverage. Beneficiaries in original Medicare may see any doctor or use any facility that accepts Medicare payment, and referrals are not needed to see specialists. In contrast, MA beneficiaries must typically use the MA plan’s network of health care providers, including doctors, hospitals, and outpatient facilities, and referrals are generally needed to see specialists. Further, beneficiaries in MA plans that allow access to out-of-network providers may be required to pay more when receiving services from such providers. MA provider networks can change during the year and from year to year. Medicare Plan Finder (MPF) According to CMS officials, MPF was launched in 1998 in response to the Balanced Budget Act of 1997, which required the Department of Health and Human Services—the agency responsible for overseeing CMS—to maintain MA plan information on the internet, among other things. According to CMS, MPF is a primary CMS resource for beneficiaries to compare costs and coverage of different Medicare health and prescription drug coverage options in their area, including comparing original Medicare to MA plans, and Part D plans. As illustrated in figure 2, the MPF landing page—the first web page users see when accessing MPF— includes a section where beneficiaries start the process of searching for and comparing coverage options (see A in fig. 2), and a section providing links to additional decision support tools for beneficiaries (see B in fig. 2). Beneficiaries begin searching in MPF by entering their zip code and following a 4-step process that moves them through different MPF website pages. Step 1—Basic search: Beneficiaries provide responses to requested information, including identifying whether they have Medicare coverage and whether they would like to add prescription drug coverage to their search. Step 2—Enter drugs: Beneficiaries may add a list of prescription drugs, along with the dosage and dosing frequency, to identify which plans cover these drugs and the cost sharing amount under each plan. Step 3—Select pharmacies: Beneficiaries select up to two pharmacies that they prefer for obtaining their medications. Step 4—Refine plan results: Beneficiaries see a list of available coverage options—original Medicare, MA plans, and separate PDPs—based on the zip code they entered. Beneficiaries can filter these search results by variables such as monthly premium or deductible amounts, and then they can sort those results by variables such as lowest estimated annual costs or lowest plan deductible. Beneficiaries can then select up to three choices, view specific coverage and cost details for each, and do a detailed side-by-side comparison of each. The plan results page shows this comparison and includes beneficiaries’ estimated annual out-of- pocket costs for each coverage option they choose to review. The additional decision support tools available on the MPF landing page that beneficiaries may use to help select their Medicare health and drug coverage include the following: 1. Help with Your Medicare Choices, which uses filtering questions to help new beneficiaries understand their Medicare coverage choices; 2. Estimate Medicare Costs, which helps beneficiaries compare the average estimated costs of original Medicare options, such as original Medicare with a prescription drug plan and a Medigap plan, to the costs of MA with prescription drug coverage; and 3. Find and Compare Medigap Policies, which helps beneficiaries find information on the different standardized Medigap plans offered by zip code. Since its inception, MPF has undergone many modifications as new parts were added to the Medicare program, such as the addition of Medicare Part D. According to CMS officials, the agency has also taken steps to make additional changes to improve the website, including technology updates to improve system stability and performance, such as page load times and error rates. In addition, CMS seeks feedback from stakeholders, such as the customer service representatives at the 1-800- MEDICARE help line, SHIP personnel, and others, which according to agency officials, has resulted in additional changes. Changes have included allowing beneficiaries to log into their Medicare account to access some of their existing data, such as their prescription drugs, and the addition of a help feature that can connect beneficiaries to 1-800- MEDICARE customer service representatives for live help. Stakeholders and Research Indicated Medicare Plan Finder Is Difficult to Use and Provides Incomplete Information, and CMS Is Redesigning It to Make Improvements Challenges Navigating and Understanding Information in Medicare Plan Finder Make It Difficult for Beneficiaries to Use, According to Stakeholders and Research Stakeholders, research studies, and SHIP directors responding to our survey generally indicated that MPF is difficult for beneficiaries to navigate and understand. All 13 stakeholder groups we interviewed reported that MPF is challenging for Medicare beneficiaries to use. Specifically, most stakeholders cited difficulty navigating as beneficiaries click through multiple complex pages in order to find and compare coverage options. For example, two stakeholders noted that beneficiaries must answer questions about their current Medicare health and drug coverage and then go through a series of pages and steps before they can view detailed information on their coverage options. One of these stakeholders also told us that MPF navigation is cumbersome because users cannot jump directly to certain pages or sections that address their needs, such as viewing the availability of preferred pharmacies. One of the stakeholders we interviewed also noted the lack of prominent instructions on how to use MPF contributed to difficulties navigating the four steps. Finally, in our interviews two stakeholders also noted that navigation is difficult because beneficiaries are uncertain of the information needed to make different comparisons or identify specific plans. For example, the ability to filter and sort plan information does not appear until later in the plan search process, where users are refining plan results. This makes it hard for users to narrow options specific to their needs because they first must go through all the options presented. Specifically, beneficiaries will first see a list of plans available in their zip code—on average 24 plans—and then must narrow down that list before they can compare up to three selected plans. A 2018 report conducted jointly by two advocacy groups cited difficulties locating the filter and sort functions in MPF, which contributed to navigation problems. CMS user testing conducted on MPF found that overall beneficiaries are confused about how to find a MA plan on MPF. For example, this testing showed that some users had difficulties with the steps for refining plan results because they overlooked or ignored the filters. A 2017 CMS study noted that MPF navigation is difficult and is better suited for specialist users who assist beneficiaries in determining their coverage options, such as 1-800 MEDICARE customer service representatives and SHIP counselors. Further, CMS officials said the study found that beneficiaries would benefit if navigation through the site were more tailored to the tasks they were undertaking. Our survey of SHIP directors, who provide assistance to Medicare beneficiaries and therefore are familiar with MPF usability, also found that it is difficult for beneficiaries to navigate and find information. Specifically, 73 percent (29 of 40) of the SHIP directors who responded to our survey reported that it is difficult or very difficult for beneficiaries to find information in MPF. While SHIP directors reported that it is easier for SHIP counselors to find information, they noted that some also experience difficulty. Eighteen percent (7 of 40) SHIP directors reported that it is difficult for SHIP counselors to find information in MPF. (See fig. 3.) In addition to website navigation, it is also difficult for beneficiaries to understand the information in MPF, according to stakeholders, research studies, and SHIP directors responding to our survey. All seven beneficiary advocacy groups interviewed reported that beneficiaries find it challenging to understand information in MPF. For example, some stakeholders noted that beneficiaries do not always understand terminology, such as the differences between cost sharing, copayment, and out-of-pocket costs. Most stakeholders also noted that beneficiaries struggle to understand cost estimates and interpret how much they will have to pay. CMS user testing of MPF in 2018 found that beneficiaries were overwhelmed by the number and complexity of options from which they had to choose. According to a 2018 research study conducted by two advocacy groups, the website explains health coverage terminology poorly and does not use plain language. As a result, users with low health insurance literacy may not understand, for example, the cost differences between generic versus brand-name drugs. Sixty-five percent (26 of 40) of the SHIP directors we surveyed reported that the information in MPF is difficult or very difficult for beneficiaries to understand, while 23 percent (9 of 40) reported that it is difficult for SHIP counselors to understand information (see fig. 4). SHIP directors identified health coverage terminology as a challenge, with 38 percent (15 of 40) reporting that MPF does a poor or very poor job explaining health coverage terminology, such as non-network providers, drug formularies, and drug tiers to beneficiaries. According to Stakeholders, Medicare Plan Finder Provides Incomplete Information on Costs and Coverage, Making it Difficult to Compare Medicare Options MPF provides incomplete estimates of beneficiaries’ costs under original Medicare, making it difficult to compare coverage options, according to stakeholders and SHIP directors responding to our survey. The cost estimates on the plan results pages are incomplete because they do not include the effect of Medigap—which helps cover beneficiaries’ cost sharing responsibilities under original Medicare. As a result, beneficiaries who want to use MPF to compare original Medicare with a Medigap plan to specific MA plans are unable to do so. Most—4 of 7—beneficiary advocacy group stakeholders that we interviewed noted that beneficiaries must leave MPF to obtain information about Medigap plans, such as the specific benefits covered under those plans and their estimated costs. Six of seven beneficiary advocacy groups that we interviewed noted that MPF’s incomplete information on estimated beneficiary costs is a concern because beneficiaries need this information for understanding and comparing their Medicare options. CMS’s other coverage decision support tools—Help with Your Medicare Choices and Estimate Medicare Costs—provide general information intended to help beneficiaries understand and compare their Medicare options. However, these tools are separate links; their information is not included on the plan results pages in MPF. The SHIP directors we surveyed also noted lack of information as a concern, with 75 percent (30 of 40) reporting that the lack of Medigap information in MPF limits the ability of beneficiaries to compare original Medicare and MA plans. Further, SHIP directors surveyed reported more general concerns with MPF’s cost estimates, with 80 percent (32 of 40) reporting that improvements are needed to better estimate total annual beneficiary costs, and 63 percent (25 of 40) of the SHIP directors reporting that MPF does a poor or very poor job comparing the costs of original Medicare to MA. Stakeholders and SHIP directors responding to our survey reported that MPF also provides incomplete information on MA plan provider networks. According to a CMS-sponsored study, determining if specific providers are in an MA plan provider network is a key factor for beneficiaries when making coverage decisions, and beneficiaries stated in user testing that they must have this information. However, to obtain information on the providers in specific MA plans, MPF users must exit the website and go to the individual plan websites. Most stakeholders—10 of 13—cited the lack of information on provider networks as a shortcoming for beneficiaries in using MPF to select a plan, with one group stating that MPF users may need to call individual plans to determine if providers are in a plan’s network. SHIP directors also cited this issue as a problem, as 85 percent (34 of 40) who responded to our survey reported that the lack of a provider directory limits MPF as a resource for beneficiaries to compare MA plans. Without provider information, beneficiaries are not able to use MPF to narrow their options to MA plans that include desired providers or make comparisons among these plans. CMS Is Redesigning MPF in an Effort to Improve its Usability and the Completeness of Cost Information According to CMS officials, the agency is redesigning MPF to make it more usable for beneficiaries and is planning to release the redesigned MPF in early August 2019. With the redesign, CMS plans to improve the navigation of MPF by providing more prominent explanations on how to use MPF; reducing the steps users must take to get to more detailed coverage information; configuring MPF so users can more easily switch between different topics inside MPF, such as switching between MA plan information and Part D plan information; and improving the filter and sort functions so users can narrow down their coverage options more quickly. CMS also plans to make information easier to understand by simplifying and reducing the volume of information on the pages and revising frequently misunderstood terms with more user-friendly language. As part of the redesign, CMS is also taking steps to provide more complete cost information in MPF to help compare coverage options, according to agency officials. CMS plans to provide more information to the redesigned MPF to help beneficiaries understand their coverage options and decide whether original Medicare or MA is right for them. CMS officials also told us in June 2019 that the redesigned MPF will allow beneficiaries to do estimated cost comparisons of MA to all their original Medicare options, such as original Medicare with a Medigap plan and a prescription drug plan. Officials also told us that CMS is incorporating the functionality of the additional decision support tools currently available on the MPF landing page—Help with Your Medicare Choices and Estimate Medicare Costs—into the redesigned MPF to help beneficiaries understand their coverage options and compare their estimated costs across these options. In June 2019, CMS officials stated these additional tools will also continue to appear as separate links on the MPF landing page. CMS officials also told us that they are currently examining how to integrate MA plan provider information, but this is not part of the redesigned MPF being released in August 2019. The officials said they are working with the plans to develop requirements to help support the integration of provider directories into future versions of MPF. According to CMS, the redesign of MPF is not finalized and CMS will continue to evaluate the extent to which the changes will make MPF easier for beneficiaries to use and whether it provides complete information for making coverage decisions. As of June 2019, CMS officials told us they are continuing to gather feedback from stakeholders, such as 1-800-MEDICARE customer service representatives and SHIP personnel, and conduct user testing on a redesigned MPF model. CMS then plans to publicly launch the redesigned MPF to a subset of users in early August 2019. Once launched, CMS plans to incorporate feedback from this subset of users to confirm the core features that will be released in the redesigned MPF prior to the Medicare open enrollment period starting October 15, 2019. According to CMS officials, the development of the redesigned MPF is an incremental process that will involve continuous changes based on feedback and user testing. According to the agency, CMS will know more about how well the redesigned MPF addresses user needs after it is used by beneficiaries. Agency Comments We provided a draft of this report to the Department of Health and Human Services for review and comment. The Department of Health and Human Services provided technical comments, which we incorporated as appropriate. As agreed with your office, unless you publicly announce the contents of this report earlier, we plan no further distribution until 30 days from the report date. At that time, we will send copies of this report to the Secretary of Health and Human Services and other interested parties. In addition, the report will be available at no charge on GAO’s website at http://www.gao.gov. If you or your staff have any questions about this report, please contact me at (202) 512-7114 or cosgrovej@gao.gov. Contact points for our Office of Congressional Relations and Office of Public Affairs can be found on the last page of this report. GAO staff who made key contributions to this report are listed in appendix I. Appendix I: GAO Contact and Staff Acknowledgments GAO Contact Staff Acknowledgments In addition to the contact named above, Tim Bushfield, Assistant Director; Maggie G. Holihan, Analyst-in-Charge; Sylvia Diaz Jones; Anne Hopewell; Dennis A. Antonio; and Dan Ries made key contributions to this report. Also contributing were Cathy Hamann, Krister Friday, Ethiene Salgado-Rodriguez, Julie Flowers, and Jennifer Rudisill.