CALIFORNIA HEALTHCARE FOUNDATION In or Out: An Examination of Medicaid’s Coverage Determination Policies August 2015 Contents About the Authors 3Introduction Manatt Health Solutions is the interdis- ciplinary policy and business advisory 4Background division of Manatt, Phelps & Phillips. Manatt 4What Can We Learn from Other Major Payers? Health Solutions provides expertise in Commercial Insurance Carriers health care coverage and access, health information technology, health care financ- Public Programs ing and reimbursement, and health care restructuring. For more information, visit 5Medicaid Covered Benefits: The Basics www.manatt.com. Newly Eligible Adults and the Alternative Benefit Plan 6Medicaid Coverage Determination Standards Deborah Bachrach, JD, is a partner; Naomi Newman, MBA, MPH, is a director; and and Processes Keith Nevitt, MPP, MPH, is a senior analyst The Standard for Decisionmaking with Manatt Health Solutions. Evidence of Effectiveness The Process: Reviewing New Interventions About the Foundation Behavior Change Interventions The California HealthCare Foundation (CHCF) is leading the way to better health 13 Going Forward care for all Californians, particularly those whose needs are not well served by the 15 Appendices status quo. We work to ensure that people A. Public Payer Coverage: Decision Standards and Processes have access to the care they need, when B. ublic Payer Coverage Standards and Determination P they need it, at a price they can afford. Processes CHCF informs policymakers and industry 18 Endnotes leaders, invests in ideas and innovations, and connects with changemakers to create a more responsive, patient-centered health care system. For more information, visit www.chcf.org. © 2015 California HealthCare Foundation California HealthCare Foundation 2 Introduction M edicaid, the joint federal and state program for Medicaid enrollees but also for the entire health care that provides health insurance for low-income system. individuals, is rapidly becoming the largest purchaser of health care services in the United States. This report reviews how other large public health insur- Providing coverage for an estimated 70 million people ance programs in the US and abroad make coverage (as of February 2015), at an annual cost exceeding $460 determinations with respect to specific interventions billion, Medicaid now serves as the foundation of the (e.g., procedures, therapies, technologies, and devices) new coverage continuum established by the Affordable within a covered benefit category (Figure 1). It highlights Care Act (ACA).1 themes from research on and interviews with select state Medicaid agencies regarding their coverage determina- Given Medicaid’s size and scope, and the central role tion processes and standards, including approaches to it plays in the health insurance market, information on covering behavior change interventions. Finally, it dis- how it determines which health care services and inter- cusses policies and procedures for achieving greater ventions to cover has significant implications, not only rigor and transparency in these important public health Figure 1. The Layers of Health Coverage Decisions Examples Covered Benefit $$ The ACA established 10 essential A broad category of medical care; health benefits that must be covered by qualified health plans for all coverage of certain benefits is mandated enrollees and by Medicaid for newly by federal and state laws eligible adults. Coverage $$ A state Medicaid agency evaluates Determination a new tobacco counseling program and decides to reimburse for its use (focus of this paper) as part of its “tobacco cessation A policy decision generally made by a counseling for pregnant women” benefit. The coverage determination payer to cover a particular health intervention specifies the sub-population eligible for a particular population; the determination may for this service — pregnant women. define clinical criteria patients must meet to receive coverage for the specific treatment $$ Jane, a Medicaid beneficiary, enrolls in a tobacco cessation counseling Medical program. The Medicaid agency Necessity approves coverage of the program for Jane, who is pregnant, because A decision regarding it is deemed medically necessary the appropriateness of for her. a specific treatment for a specific individual Source: Data adapted from Alan M. Garber, Institute of Medicine, Medical Necessity, Coverage Policy, and Evidence-Based Medicine; Determination of Essential Health Benefits, 2011, www.iom.edu. In or Out: An Examination of Medicaid’s Coverage Determination Policies 3 decisions. (State policies and procedures with respect to drug coverage are governed by specific provisions of “Coverage policy, in its broadest sense, is intended federal law and were not reviewed for this report.)2 to promote value in medical care by using reimbursement to favor the use of effective care Background and avoid payment for ineffective care.” Given Medicaid’s expanded role in the health insurance — Alan M. Garber “Evidence-Based Coverage Policy” market, the time is ripe for state Medicaid agencies to Health Affairs (September 2001). revisit, or to consider for the first time, the policies and procedures they use to decide whether and under what circumstances to cover new interventions. Medicaid has been slow to adopt the kind of transparent What Can We Learn from and rigorous coverage review procedures that Medicare has long relied upon. When it was first enacted 50 years Other Major Payers? ago, Medicaid was an adjunct to the state welfare pro- State Medicaid agencies are not the only health care grams. It was not until 1996, under federal welfare payers confronting the challenge of making coverage reform, that Medicaid was delinked from welfare; in 2010 determinations. This challenge must also be addressed with the enactment of the ACA, Medicaid became the by Medicare, the federal health insurance program for foundation of the new health insurance continuum. people 65 years of age and older and for individuals with disabilities; the US Department of Veterans Affairs; com- Today, Medicaid is the first or second largest item in mercial insurance carriers; and national health insurance every state budget and the first or second largest insurer programs in other countries. in state markets. Five years ago, Medicare dominated health care policy discussions of new payment and deliv- Some programs create broad standards and allow ery models and value-based purchasing reforms. At that local actors to make coverage determinations, such as time, Medicaid was barely at the table, as it continued Canada’s Medicare program, while others, such as the to rely on antiquated fee-for-service payment method- US Medicare program and the UK’s National Institute for ologies and limited managed care programs. In the old Health and Care Excellence (NICE), have very specific world of Medicaid, cost containment meant imposing processes and protocols in place to evaluate whether a arbitrary across-the-board rate cuts or cutting eligibility treatment or service warrants coverage. These programs standards and benefits.3 Today, there is hardly a state that are summarized in Appendix A and their processes and has not embraced new integrated delivery models and standards are described in detail in Appendix B. developed value-based purchasing strategies, ranging from shared savings to bundled payments, with the goal of purchasing cost-effective, quality care for Medicaid Commercial Insurance Carriers beneficiaries and driving multi-payer reforms.4 Federal and state laws and regulations require that US health insurance carriers cover broad categories of ben- Smart coverage policies, ones that use defined processes efits, such as preventive care or emergency services, but and procedures to appropriately balance benefits and commercial carriers retain a high degree of discretion costs of new interventions, can and should be expected over specific coverage determinations. Commercial carri- to follow Medicaid’s transformation. Coverage deter- ers generally provide only high level information on their mination policies go hand in hand with value-based coverage determination processes. purchasing in assuring that payers, such as Medicaid, purchase quality, cost-effective care. Here, too, Medicaid $$ Aetnacreates medical clinical policy bulletins (CPBs), has lagged behind Medicare, but that is starting to which detail the services and procedures it considers change as Medicaid begins to exploit its potential and medically necessary, cosmetic, or experimental and assume its responsibilities as a key player in the health unproven. These classifications are based on peer- insurance market. reviewed medical journals, analyses of studies on a California HealthCare Foundation 4 topic, evidence-based consensus statements, expert opinions, and guidelines from nationally recognized Medicaid Mandatory Benefits: health care organizations such as Milliman Care $$ Inpatient hospital services Guidelines.8 $$ Outpatient hospital services $$ Earlyand Periodic Screening, Diagnostic, and $$ UnitedHealthcare’s website notes that, “Medical Treatment (EPSDT) services Policies, Drug Policies and Coverage Determination $$ Nursing facility services Guidelines are developed as needed, are regularly $$ Home health services reviewed and updated, and are subject to change. They represent a portion of the resources used to $$ Physician services support UnitedHealthcare coverage decision $$ Rural health clinic services making.”9 $$ Federally qualified health center services $$ Laboratory and x-ray services $$ Family planning services Public Programs $$ Nurse midwife services Some public programs, such as the US Medicare pro- $$ Certified pediatric and family nurse practitioner gram, have detailed standards and processes for making coverage determinations. Codified in federal statutes services and regulations, these policies are clearly defined and $$ Freestanding birth center services (when licensed create opportunities for formal and informal public input or otherwise recognized by the state) for individual coverage determinations. $$ Transportation to medical care $$ Tobacco cessation counseling for pregnant In contrast, similar to the discretion granted to Canadian women provinces by the Canadian Medicare program, federal Source: “Benefits,” Medicaid, www.medicaid.gov. Medicaid law grants a significant amount of discretion to states, mandating only the categories of care a state must cover and permitting states to determine the spe- cific interventions within those categories to cover. Newly Eligible Adults and the Alternative Benefit Plan The ACA established different coverage rules for the Medicaid expansion adult group, which includes Medicaid Covered childless adults and parents above a state’s pre-2010 eli- Benefits: The Basics gibility levels. These newly eligible adults must receive an Alternative Benefit Plan (ABP) which includes: Title XIX of the Social Security Act authorizes the fed- $$ All10 essential health benefits (including mental eral government to provide matching funds to states health and substance use treatment services) to administer Medicaid programs and stipulates that, “Within broad federal rules, each state may decide eli- $$ Earlyand Periodic Screening, Diagnostic, and gible groups, types and range of services, payment Treatment (EPSDT) services for those under 21 levels for services, and administrative and operating years of age procedures.”10 $$ Careprovided by federally qualified health centers (FQHCs) and rural health centers (RHCs) Federal rules require that states cover a broad range of benefits, but what qualifies as a covered service in each $$ Family planning services and supplies11 of these categories is left up to the states. Under these Medicaid coverage rules, mental health and substance In addition, ABPs must satisfy the Mental Health Parity use treatment services are optional benefits, and, with and Addiction Equity Act (MHPAEA), which requires limited exceptions, the mental health parity law does not ABPs to cover mental health and substance use disorders apply. at a level equal to that of medical and surgical benefits.12 In or Out: An Examination of Medicaid’s Coverage Determination Policies 5 Collectively, these are the minimum benefits that states This review focuses on how states decide whether to must provide to the newly eligible adults through the ABP. cover a particular intervention and the standards and Some states (e.g., New York and California) have chosen decisionmaking criteria used in making that determina- to provide the same benefits to the newly eligible adults tion. The paper does not consider how states determine that they provide to previously eligible populations, and whether a covered intervention is considered “medically accordingly have expanded their ABP to include benefits necessary” for a specific individual. The authors found such as personal care.13, 14 that many state Medicaid programs had published defi- nitions of medical necessity, but only a handful of states Federal Medicaid law also dictates that services must be posted coverage determination standards, policies, and covered in sufficient amount, duration, and scope to rea- procedures setting out the process to initiate a Medicaid sonably achieve the purpose of that service, and allows coverage review, the evidence that would be evaluated, states to place appropriate limits on a service based on and/or the standard that would be applied in determin- criteria such as medical necessity.15, 16 ing whether to cover an intervention.18,19 While federal Medicaid law sets out coverage parameters for Medicaid enrollees, states have discretion to decide The Standard for Decisionmaking on the specific services to cover within a benefit cat- Federal statute requires that the US Medicare program egory for both standard Medicaid and the ABP offered cover items or services that are “reasonable and nec- to newly eligible adults. In addition, Medicaid managed essary for the diagnosis or treatment of illness or injury care plans can choose to cover interventions not covered or to improve the functioning of a malformed body by the state Medicaid program.17 member.”20 And though the terms “reasonable” and “necessary” leave room for interpretation, Medicare has Examples of health interventions that state Medicaid articulated this standard to guide its decisions on whether agencies are currently grappling with for coverage to cover health interventions. If policymakers decide that determination include genetic testing, sexual reassign- the items or services meet that standard, the program is ment surgery for transgender individuals, and weight expected to cover them. management programs for children. With technological advances, an increasing number of diagnostics and ther- With respect to Medicaid programs, Oregon was the apies are coming to market, putting pressure on states to only state found that has a clearly defined standard guid- establish transparent coverage determination processes ing its coverage determinations. If the service or line item and standards. is ranked above the legislature-approved funding line on the Prioritized List of Health Services, Oregon Medicaid will cover the service. (See sidebar at the top of page 7.) Medicaid Coverage The state’s Health Evidence Review Commission (HERC) applies a highly analytical methodology for developing Determination Standards the prioritized list, with explicit consideration of a ser- and Processes vice’s magnitude of benefit to a patient, impact on pain and suffering, population effects, impact on vulnerable States have broad discretion to decide which particular populations, ability to prevent complications, effective- health interventions to cover within each covered ben- ness, and cost. efit category. There is no federal guidance as to the standards states should apply, the evidence they should When the New York Department of Health (DOH) consider, or the process they should follow in making redesigned its Medicaid program in 2011, it explicitly ref- these coverage determinations. Furthermore, there is no erenced cost and cost control as appropriate criteria for central repository of state coverage policies, nor were coverage determinations so that the state could “make this report’s authors able to locate any research collect- the most efficient use possible of available resources and ing those policies. Thus, the authors began work on this maximize the public good.”22 DOH has articulated vari- paper by researching state-specific Medicaid coverage ous biostatistical methodologies for assessing the impact determination policies and procedures through inter- of health services (e.g., calculation of odds ratio and views and online searches. number needed to treat, sensitivity and specificity for California HealthCare Foundation 6 maximizes health outcomes for the Medicaid population, Prioritizing Services Based on Population and they provide stakeholders and the public with an Health Impact in Oregon understanding of the criteria which will influence a cover- Oregon’s process for determining what services to age determination. cover under Medicaid is well documented and pub- lically accessible, includes opportunities for public States reported that if a new service had the potential input, and is driven by data on the clinical, cost, and to be a budget buster, ranging in cost from $500,000 comparative effectiveness of treatments. Oregon’s to $1 million or more, the decision to cover it would be Section 1115 waiver authorizes the state to limit determined by the health commissioner, the legislature, covered services to those included on a prioritized or the governor. For instance, California Medicaid offi- list of “treatment and condition pairs.” The Oregon cials noted that because its Medicaid population is so Health Evidence Review Commission (HERC) issues large, making a coverage determination could have a this prioritized list, ranking treatment-condition pairs and establishing a funding line, below which it will significant impact on the state’s budget and therefore not reimburse for services. The waiver specifically large-ticket items would need to be taken to the legisla- provides that HERC will rank the list according to ture for review. “the comparative benefits of each service to the population to be served…[using] clinical effective- Implicit in all of these examples is the standard of cost- ness, cost of treatment and public values obtained effectiveness: Is the intervention under consideration through community meetings in ordering the list.” effective for the Medicaid population and does the ben- The state uses an explicit scoring methodology, efit to the population warrant the expense? Other than placing a higher emphasis on preventive services Oregon, the authors found that no states articulated an and chronic disease management than on curative explicit threshold above which items would be covered. services.21 Notably, in Oregon, the threshold is driven by budget, not by a traditional cost-effectiveness measure (e.g., the Quality-Adjusted Life Years [QALY] threshold used by diagnostic tests, hazard ratio to assess harm) and states NICE in the UK). that its coverage determinations are driven by a combi- nation of the strength of the evidence and the size of the net impact on the population. (See sidebar below.) Minnesota’s Health Services Advisory While not a standard per se, New York’s guiding prin- Council ciples help policymakers frame their decisions based In Minnesota, the Health Services Advisory Council, on whether an intervention is well-substantiated and a 13-member panel made up of physicians, other health care providers, and a consumer representa- tive, provides leadership in designing health care benefit and coverage policies for Minnesota’s public New York State’s Process for Determining health care programs. Its charter explicitly discusses Coverage23 the use of cost-effectiveness to “guide decisionmak- According to information published by the New ing” and outlines clear cost-effective standards, York DOH, it will generally decline to cover interven- including covering interventions that are24: tions with any of the following criteria: $$ At least as effective and less costly than $$ Zero or negative net impact alternatives $$ Very low “strength of the body of evidence” $$ More effective and more costly than alterna- $$ No evidence tives, but resultant patient outcomes justify additional expenditure An intervention will generally be covered when both of the following criteria are met: $$ Less effective and less costly than alternatives, but resultant patient outcomes from the use $$ High “strength of the body of evidence” of more expensive alternatives do not justify $$ Substantial or moderate positive net impact additional expenditures In or Out: An Examination of Medicaid’s Coverage Determination Policies 7 Evidence of Effectiveness The Medicaid Evidence-Based Decisions States run a risk of wasteful spending if they do not adopt Project evidence-based coverage policies. Dr. Alan Garber, pro- vost of Harvard University and professor of health care Founded in 2006, the Medicaid Evidence-Based Decisions (MED) Project is a collaboration of 17 policy, explains: “Comprehensive assessment of evi- state agencies, housed at the Center for Evidence- dence of effectiveness is the central activity of evidence based Policy at Oregon Health & Science University, based coverage policy. It draws upon formal methods which produces tools “to help state policymak- for summarizing and integrating information, such as ers make the best, evidence-based decisions for meta-analysis and decision analysis. It compiles and ana- improving health outcomes.”28 lyzes the evidence to determine whether an intervention MED currently includes Alabama, Alaska, Arkansas, improves outcomes.”25 Colorado, Louisiana, Michigan, Minnesota, Missouri, New York, North Carolina, Oklahoma, Oregon, Similarly, in his discussion paper, “Evidence-Based Rhode Island, Tennessee, Texas, Washington, and Coverage,” Michael Bailit, president and founder of the West Virginia. The multi-state collaborative defines consulting firm Bailit Health, posits that “somewhere the project’s agenda by nominating and deciding between 25% and 50% of all US health care spending on the topics MED should research. Topics reviewed produces no benefit to the patient — and some of it recently include: produces clear harm….Payers should minimize, to the $$ Coronary computed tomographic angiography degree practical, the coverage of services without…evi- $$ Elective induction of labor dence, or with evidence of effectiveness and benefit that $$ Treatmentof obesity and overweight in adults, is inferior to that of other treatment options.”26 adolescents, and children $$ Socialsupport and community health interven- Many state representatives whom the authors interviewed tions to prevent adverse birth outcomes referenced evidence of an intervention’s effectiveness as $$ Comparativeeffectiveness of treatments for a key decisionmaking criterion and noted that they strive macular degeneration for the development of evidence-based coverage poli- cies.27 Few states, however, have systematic processes Reviews can take anywhere from two to eight for accessing the data that quantifies effectiveness, or the months depending on the level of evidence resources or expertise to evaluate it. Medicaid officials required by the state and the availability of cited small review teams and limited clinical expertise, information. particularly in the area of behavioral health, as constraints to conducting comprehensive evidence review. Medicaid Evidence-Based Decisions Project $$ Intervention under consideration (e.g., dose, To address this challenge, 17 states are participating in frequency, method of administration) the Medicaid Evidence-Based Decisions (MED) Project, a $$ Comparator(s), or alternatives against which the collaborative run by Oregon Health & Science University. intervention is compared MED provides analyses on the evidence for some health interventions pertinent to the Medicaid programs of par- $$ Outcome, or specific short- and long-term results ticipating states. of interest (e.g., morbidity, mortality, quality of life, complications, outcomes specific to the condition) Member states may nominate topics for review, after which MED compiles and assesses the studies that ana- lyze the intervention’s effectiveness, including systematic “MED is one of the most valuable investments reviews, meta-analyses, technology assessments, and we’ve made. . . it has probably saved the clinical practice guidelines. MED uses the PICO frame- work for literature review, which identifies the following: state millions.” $$ Population of interest — state Medicaid official California HealthCare Foundation 8 MED synthesizes its evidence review findings in reports, industry guidelines, commercial policies, and reports that highlighting the documented benefits and risks of the are unpublished or not peer-reviewed. intervention, the sub-populations for whom the interven- tion is effective, and other relevant information about Texas is currently developing its evidence-based cover- the intervention’s impact and safety. MED also assigns a age policy process and, as such, is compiling a list of core score of poor, moderate, or good to the quality of the evidence sources, including the US Preventive Services available evidence. Task Force (USPSTF), the Centers for Disease Control and Prevention, and MED, among others. These core After MED distributes its reports and analyses, it is up to sources are meant to ensure that internal reviewers refer- each state to decide if and how it will use the information ence reputable, high-quality sources of information when to make coverage determinations. evaluating a new treatment or service for coverage.31 Few states have systemic processes by which they review “States are sophisticated consumers of research. the evidence base for new interventions. Likewise, it appears that states generally do not systematically review They understand that research evidence informs past coverage determinations or revise determinations but doesn’t dictate policy.” for outdated, less effective services. — Mark Gibson, director Center for Evidence-Based Policy, OHSU As part of its new benefit review process, New York has committed to reviewing “those services with high pro- grammatic costs, high utilization, or new or emerging States and Implementation of Evidence- evidence” on a “regular and recurrent basis” as part Based Coverage of its redesigned benefits coverage determination pro- New York established a process for evidence compilation cess.32 Idaho cited an example in which their utilization and evaluation. The state also uses the PICO framework management contractor identified an increased use of to guide the search for evidence regarding services under spinal surgeries. Idaho then reviewed the evidence and consideration for coverage. It has established a hierar- ultimately altered its coverage policies by using nar- chy of evidence based on the susceptibility of a type of rower clinical criteria to specify the eligible population, evidence to bias. Systematic review of randomized con- supported by evidence of effectiveness for that sub- trolled trials with or without meta-analysis are at the top population.33 MED research may also help states identify of the hierarchy, single expert and case reports are at the covered treatments for which there is little evidence of bottom, with observational studies in the middle. After effectiveness, as may organizations that undertake com- gathering evidence, the state engages in an appraisal parative effectiveness reviews like the Patient Center process to assess the “methodological quality, risk of bias Outcomes Research Institute (PCORI), created by the and applicability to the PICO and research questions.”29 ACA in 2010, and the New England Comparative Finally, the state grades the quality of the evidence, indi- Effectiveness Public Advisory Council (CEPAC).34 cating the degree to which future research likely will or will not alter the estimate of effect. As a member of MED, New York leverages available MED reports in its review The Process: process. Reviewing New Interventions Historically, as New York noted in adopting its Evidence- In Oregon, HERC relies heavily on “high quality” evi- Based Review Process for Coverage Determinations, dence to help make decisions, relying on “medium or few states have established processes for reviewing new lower quality” evidence only when necessary.30 HERC interventions. However, this is beginning to change. does not specifically define what “high quality” or “medium quality” means, but rather provides examples In 2013, New York adopted a dossier requirement — a under each category. HERC’s high-quality sources include systematic intake process enabling stakeholders to sub- MED, the Agency for Healthcare Research and Quality, mit requests for a coverage determination. The dossier the UK’s NICE, and the Cochrane Database of Systematic process requires the submission of information on clini- Reviews. “Medium and lower quality sources” include cal evidence, outcomes, impacts of the service on the In or Out: An Examination of Medicaid’s Coverage Determination Policies 9 Figure 2. The New York DOH Evidence-based Review Process’s Hierarchy of Evidence target population, costs, and any coverage of the service by other payers. Alabama has implemented a similar pro- cess.35 After years of being inundated with requests from Type I vendors and manufacturers, Texas is developing a topic Least Systematic review of RCTs with referral form to gather information about clinical evi- susceptible or without meta-analysis dence, outcomes, population impact, costs, other payers to bias who cover the service, and supporting publications that Type II demonstrate evidence of effectiveness.36 Multiple RCTs These intake processes help the Medicaid agency gather available evidence, assess the intervention’s potential benefit to the Medicaid population, and understand its Individual RCTs cost. One state reported that, after instituting the dossier process, it saw a noticeable drop in the number of review Type III: Observational Studies requests that were not well supported. Prospective cohort States that have a review process require its use by an individual or entity requesting coverage for a new service including manufacturers, providers, patients, and advo- Retrospective cohort cacy groups. For states without this process, stakeholders can directly contact Medicaid agency officials. California officials reported a willingness to speak to anyone interested in raising a health intervention for coverage Case control consideration.37 Medicaid agencies themselves may also initiate cover- age reviews. Oregon’s HERC reviews the new Current Cross sectional Procedural Terminology (CPT) codes released annually to determine whether they should be covered.38 In addi- tion, Texas is developing an analytics system to rapidly identify services for coverage determinations. The sys- Case series tem will, among other things, look for major swings in use, such as a spike in the use of “miscellaneous” billing Type IV Expert panel “The topic referral form is just one way MOST in the door, a vendor could always go susceptible to bias Single expert and case directly to the Legislature.” — Texas Medicaid official Note: RCTs are randomized controlled trials. Source: Data from “Evidence-based Review Process for Coverage Determinations: Dossier Methods Guidance,” New York Department of codes, the decrease in use of old billing codes, or both. Health, last modified November 2013, www.health.ny.gov. These analyses may trigger an initial review or a review of a past coverage determination, respectively. Though vendors and providers were cited as the most common external sources for coverage requests, gov- ernors and state legislators also initiate coverage determination reviews, albeit to a much lesser degree. California HealthCare Foundation 10 Opportunity for Public Comment A Unique Model: A Review Process Driven Once a review has been initiated, the opportunity for by the California Legislature public input and participation in the coverage determi- In 2002, legislation authorized the creation of The nation process varies greatly by state. In Oregon, HERC California Health Benefits Review Program (CHBRP) holds public meetings at least once a month, frequently within the University of California’s Office of the incorporates time for public comment into these meet- President.39 CHBRP responds to requests from the ings, and accepts written and oral testimony from the state legislature to provide independent analyses public during the public comment period.42 In New York, of the medical, financial, and public health impacts after the Department of Health reviews a dossier sub- of proposed legislation regarding health insurance mission, it offers a 30-day period to the general public benefit mandates and repeals, specifically legisla- during which additional sources of evidence may be sub- tion that requires (or repeals the requirement) that mitted.43 Idaho indicated that public input is not formally a health insurer and/or health care service plan do one of the following: collected on most coverage determinations unless the decision requires administrative rule changes or sub- $$ Permitan enrollee to obtain health care mission of an amendment to the state’s Medicaid State treatment or services from a particular type of health care provider Plan.44 $$ Offeror provide coverage for the screening, diagnosis, or treatment of a particular disease or condition Behavior Change Interventions At the outset of this research, the authors sought to focus $$ Offeror provide coverage of a particular on the policies and procedures states used in deciding type of health care treatment or service, or of medical equipment, medical supplies, or whether to cover interventions intended to advance drugs used in connection with a health care healthy behaviors. However, as described below, while treatment or service such interventions present different challenges, states do not evaluate behavior change interventions differently At the conclusion of its review, CHBRP prepares a from medical interventions. written report reviewing relevant data on the legisla- tion’s public health, medical, and financial impacts, as defined in CHBRP’s authorizing statute. The program is funded through a small annual assess- Behavior change intervention. An intervention ment of health plans and insurers in California. It aimed at changing an individual’s behavior to pre- was set to sunset on December 31, 2015, but was vent that person from acquiring a chronic condition recently reauthorized to continue operating through or continuing a harmful behavior, or to mitigate the June 2017.40 effects of harmful behaviors or medical conditions. As a result of this broad mandate, CHBRP’s analyses span both legislation regarding covered benefits (broad categories of health benefits) and cover- Whereas, in the past, medical innovation was driven age determinations (specific services within a largely by new surgical procedures and new medications, covered benefit category). A review of 2014 and today, behavior change interventions are on the rise. 2015 analyses, however, found that, in practice, CHBRP’s reports tend to focus more on the latter, These interventions take many forms and may include: likely because proposed legislation focuses more rapid interventions or screenings to assess substance use closely on coverage determinations than on covered disorder risk and connect at-risk people with resources, benefits.41 such as the Screening, Brief Intervention, and Referral to Treatment (SBIRT) program; high-touch care mod- els, such as repeated interactions with a nurse through the Nurse-Family Partnership (NFP) program; or virtual interventions, such as a technology application aimed at helping people to quit smoking. In or Out: An Examination of Medicaid’s Coverage Determination Policies 11 The emergence of these behavior change models of care specialists (for instance, individuals who have recov- are being driven by a variety of factors, including: ered from substance use disorders or other mental or behavioral health issues) rather than traditional $$ The increase of incentives to focus on prevention licensed providers. For these programs, Medicaid instead of treatment, resulting from the shift from agencies must grapple with ensuring appropriate fee-for-service reimbursement to a value-based sys- regulation of providers and establishing reimburse- tem, promoted by the ACA and commercial insurers ment mechanisms for them. alike $$ The growing burden of chronic conditions, such as diabetes, for which there is no cure, and for which “The process for considering a behavioral health behavioral modifications can greatly reduce the risk intervention for coverage is the same as for other of complications or the onset of the disease $$ The recognition of the role of social determinants services, but behavioral health and preventive of health, leading to an increasing acknowledge- care services always seem to have many more ment that health interventions must address a patient’s socio-economic environment to be effective layers to consider.” and have a sustained impact — Texas Medicaid official $$ The increasing coverage of behavioral health services, including the mental health parity require- In discussions with officials about how and why their state ment, for Medicaid’s newly eligible populations and decided to cover SBIRT and NFP, it became clear that Qualified Health Plan enrollees emerging behavior change interventions must have both a strong evidence base and a strong advocacy commu- $$ Advances in technology that have made it easier nity to secure coverage. to expand the reach of health care from the doctor’s office to the patients’ homes, phones, and computers When asked whether they would consider coverage for virtual coaching programs focused on weight manage- Evaluating whether to cover a behavior change interven- ment and diabetes prevention (e.g., Omada Health’s tion presents certain challenges, including: Prevent Program), most state officials responded that if $$ Effectiveness is hard to ascertain. Programs that there was strong evidence of the program’s success, they are behavioral in nature are often community-based, would consider covering the service.49 Certainly the path which makes it difficult to control confounding factors to coverage of interventions like SBIRT and NFP suggests that, in randomized controlled trials, can be isolated that Medicaid programs are receptive; compelling evi- and managed. dence and focused advocacy are key. It is also likely that as some states decide to cover these benefits and dem- $$ Adherence to protocol is difficult to ensure. Even onstrate positive impact for their population, other states if an intervention proves effective in a study setting, will follow suit. effectively deploying it to a population of patients presents its own set of challenges. By their very As opposed to surgical interventions and drugs, for which nature, the success of behavior change programs are there are manufacturers who stand to benefit financially, dependent upon human interactions and repeated behavior change programs are more reliant upon gov- behaviors as opposed to biological or chemical ernmental agencies, nonprofits, and providers — all of processes (e.g., medications) or one-time interven- whom likely have fewer resources than industry to invest tions (e.g., surgery). As a result of their interpersonal in conducting effectiveness studies — to demonstrate and longitudinal nature, it is difficult to ensure that effectiveness and advocate for coverage. behavioral change interventions are implemented according to protocol. By offering incentives to cover certain services, the fed- $$ Provider reimbursement and oversight is challeng- eral government serves as an effective advocate for new ing. Behavior change interventions may be provided programs that promote behavior change and preventive by unlicensed providers, such as peer support health care. For example, the ACA established that any California HealthCare Foundation 12 from Colorado noted that the 1% FMAP increase influ- Case Studies: enced their decision to cover all grade A and B USPSTF SBIRT and NFP Behavior Change Programs services.51 Screening, Brief Intervention, and Referral to Treatment (SBIRT) is an evidence-based practice used to identify, reduce, and prevent problematic use, abuse, and dependence on alcohol and illicit Going Forward drugs. When asked why they decided to cover Historically, state decisions to cover new interventions SBIRT, states mentioned that the program is backed were made informally, often triggered by a vendor, con- by strong evidence of its effectiveness — SBIRT can sumer, or provider, at times with the backing of one or result in health care cost savings that range from more elected officials. The review process was likewise $3.81 to $5.60 for each $1.00 spent — and a strong informal, with no written procedures or review standards. advocacy campaign, supported by the federal government’s Substance Abuse and Mental Health This is all changing with the growing role of Medicaid Services Administration.45 Currently, SBIRT is cov- in the health insurance market and states’ value-based ered by Medicaid in 16 states.46 Some states, such purchasing goals. In addition, smart coverage determina- as Texas, only cover SBIRT for specific subpopula- tions, ones that have defined processes and procedures tions, such as people under 18, and are debating that balance benefits and costs of new interventions, are whether to expand the program. Oregon covers central to Medicaid effectively managing its resources. SBIRT for all Medicaid beneficiaries and selected it as an explicit quality measure for its Coordinated There are several core features that states may want to Care Organizations (the state’s Medicaid Managed consider incorporating into their coverage determination Care program). policies: The Nurse-Family Partnership (NFP) is a com- $$ A defined process by which third parties may initi- munity-based intervention of ongoing home visits ate a coverage review. Alabama and New York have from registered nurses to low-income, first-time mothers to provide the care and support they need recently implemented a dossier process, and Texas to have a healthy pregnancy, provide responsible is planning on implementing a similar process, which and competent care for their children, and become includes, among other elements, a requirement that more economically self-sufficient. NFP implement- the third party provide evidence of the effectiveness ing agencies exist in 43 states, the US Virgin Islands, of the new intervention. This intake process helps the and six Tribal communities. Although there is no Medicaid agency gather available evidence, assess comprehensive coverage category for preventive the intervention’s potential benefit to the Medicaid nursing home visits in Medicaid, NFP agencies are population, and understand its cost. A formal process able to access some form of Medicaid reimburse- for public input into the coverage review is an addi- ment in 21 of the 43 states.47 NFP produced a tional mechanism to ensure that the state has access number of controlled trials and published results to complete information before making a coverage detailing the impact of its program, including determination. improved prenatal health, fewer childhood injuries, fewer subsequent pregnancies, increased intervals $$ A systematic approach to securing and evaluating between births, increased maternal employment, evidence of the effectiveness and value of the new and improved school readiness.48 intervention. A handful of states are strengthening their use and scrutiny of clinical evidence regard- ing the effectiveness of new interventions for the Medicaid population. Those states are explicitly state could receive a one point increase in their Federal defining the sources and standards of evidence that Medical Assistance Percentage (FMAP) for all expen- must be incorporated in their review processes. ditures related to clinical preventive services and adult vaccines provided they covered all preventive services $$ A systematic evaluation of high-cost, high- receiving a grade of A or B from the USPSTF and all utilization services. Not surprisingly, most states vaccines recommended by the Advisory Committee on focus their coverage determination resources on Immunization Practices (ACIP).50 State Medicaid officials new interventions. However, conducting systematic In or Out: An Examination of Medicaid’s Coverage Determination Policies 13 reviews of highly used, high-cost services and refin- Managed care plans have the flexibility to test new and ing the indications for their use based on evidence of innovative interventions. To encourage plans to do so, effectiveness can help states curb wasteful spending. state officials noted the importance of ensuring that the Reviewing comparative effectiveness studies can also plans, as well as the Medicaid program, share in any sav- help align coverage policies with promoting the most ings that accrue from these innovations. efficacious interventions. Organizations like PCORI, CEPAC, and MED can make this task easier for states. By refining their coverage determination standards and processes, state Medicaid agencies are in a position $$ A defined standard by which the state will evalu- to promote the adoption of effective new health inter- ate whether to cover the intervention. Many states ventions and prevent wasteful spending on ineffective have an implicit cost-effectiveness standard, weigh- interventions. Many states are embracing this responsi- ing the benefits of the intervention against its costs. bility by enhancing the analytic rigor and transparency States will be well served by developing, refining, with which they make coverage determinations, thus pro- and systematizing their approaches to cost-benefit viding strong examples from which others can learn. analysis and developing more explicit standards by which to make decisions. Finally, while behavior change interventions may not be backed by the same quality of evidence as new drugs or surgeries (for which it is easier to conduct randomized controlled trials, and for which there is typically a vendor who stands to gain financially by demonstrating effec- tiveness), they represent important opportunities to drive intervention upstream and prevent costly downstream health care interventions, such as diabetes treatment for people with obesity or emergency room visits for people with substance use issues. Review of such interventions will require additional attention and clinical expertise from states. As part of their delivery system reform efforts, states should consider piloting promising behavior-change interventions, possibly in partnership with Medicaid Managed Care plans, as a way to build up the evidence base for those interventions. While there may not be a vendor or provider with a large financial interest in dem- onstrating the effectiveness of these interventions, state Medicaid agencies, as major payers of costly health care services, do have an interest.52 California HealthCare Foundation 14 Appendix A. Public Payer Coverage: Decision Standards and Processes Coverage Determination Public Covered Standard or Guidance for Process for Specific Services Program Population Covered Services and Treatments Highlights US Medicare Individuals Covers items or services that Uses National Coverage $$ Defined formal submission 65+ and those are “reasonable and necessary Determination (NCD) and Local and review process with certain for the diagnosis or treatment Coverage Determination (LCD) $$ Rigorous review of clinical disabilities of illness or injury or to improve Processes to allow program evidence and consulta- the functioning of a malformed officials to: tion with subject matter body member,” within the $$ Review existing evidence of experts as needed categories of covered benefits:5 an intervention’s impact $$ Public comment period, $$ Hospital services $$ Assess whether the interven- enabling a degree of $$ Ambulatory services tion meets the “reasonable transparency and public and necessary” standard input into the decision- $$ Prescription drugs making process $$ Determine whether it meets that standard for the entire $$ Defined timeline for Medicare population or for reaching a decision a sub-population that meets certain clinical requirements US Veterans Provides basic and preventive Relies on the judgment of $$ Definition of the criteria Department care to individuals “only if it the treating health care “to promote, preserve, of Veterans is determined by appropriate professional(s) regarding the and restore” health Affairs (VA) healthcare professionals that standard of care and potential $$ Reliance on judgment of the care is needed to promote, impact for the given patient. the treating health care preserve, or restore the health professional(s) of the individual and is in accord with generally accepted standards of medical practice.”6 The United All United Requires that the Secretary of The UK’s National Institute for $$ Defined review process Kingdom’s Kingdom State provide, “to such extent Health and Care Excellence incorporates both clinical National residents as he considers necessary”:7 (NICE) makes recommenda- evidence and cost effec- Health Service tions to the NHS regarding tiveness $$ Hospital accommodation (NHS) medicines, medical devices, $$ Incremental $$ Medical, dental, ophthalmic, diagnostic techniques, surgical Cost-Effectiveness Ratio, nursing, and ambulance procedures, and health promo- which looks at the cost services tion activities, using both per Quality-Adjusted Care for pregnant women, clinical evidence review and $$ Life Year gained, is used women who are breastfeed- cost-effectiveness analysis. to help guide coverage ing, and young children recommendations $$ “Such other services or facilities for the prevention of illness, the care of persons suffering from illness and the after-care of persons who have suffered from illness as he considers are appropriate as part of the health service” $$ Any other service required for the “diagnosis and treat- ment of illness” Canada’s All legal Provides block grants to Delegated to the provinces $$ Coverage determination Medicare residents of provinces, allowing them to processes vary by province Canada make coverage determinations within general guidelines and requirements. Source: Compiled by Manatt Health. In or Out: An Examination of Medicaid’s Coverage Determination Policies 15 Appendix B. Public Payer Coverage Standards and Determination Processes US Medicare: “Reasonable and Necessary” $$ Ifthe new item or service is a substantial clini- Medicare is the largest single purchaser of health care cal advance and likely to result in significantly in the US, spending $58 billion on direct patient care in improved health outcomes. 2012.53 It provides health benefits for people ages 65 and over and people with disabilities. Federal statute A formal NCD request must, amongst other things, requires that Medicare cover items or services that are “clearly identify the statutorily-defined benefit category “reasonable and necessary for the diagnosis or treat- the requestor believes the benefit belongs in, be accom- ment of illness or injury or to improve the functioning of panied by sufficient, supporting evidence, and address a malformed body member.”54 There has never been a relevance, usefulness, or medical benefits of the item or regulation clarifying the definition of “reasonable and service to the Medicare population.”56 Note that by stat- necessary.” Medicare covers the following broad catego- ute, Medicare is not permitted to consider cost. ries of services: External requests to initiate the NCD review process must $$ Part A: Hospital Services be made by formal request, but federal rules emphasize $$ Part B: Outpatient Services the importance of informal discussions with CMS prior to filing a formal request to avoid unnecessary delays. $$ PartC (“Medicare Advantage”): Includes at a A formal NCD request must include all of the following minimum all the items and services available elements:57 under Part A and Part B to individuals enrolled in a Medicare Advantage plan $$ Be submitted in writing (email or hard copy) $$ Part D: Prescription drugs $$ Clearlyidentify the statutorily-defined benefit category the requestor believes the benefit Medicare has a National Coverage Determination (NCD) belongs in, process that applies to services for the entire Medicare $$ Be accompanied by sufficient supporting population regardless of geography. It also has a Local evidence Coverage Determination (LCD) process, which applies to Medicare populations within a sub-region of the coun- $$ Provide relevance, usefulness, or medical try. As of August 2013, about 15% of active Medicare benefits of the item or service to the Medicare coverage determinations were made at the national level population through the NCD process, while 85% were made at the $$ Fully explain the design, purpose, and method local level.55 of using the item or service The NCD process begins with a formal request, which Once CMS opens the review process, it publishes a comes either internally from the Centers for Medicare & tracking sheet on its website to provide public notice Medicaid Services (CMS) or externally from the public. and usually opens a 30-day public comment period. Medicare may initiate the NCD internally, under a num- CMS then begins a formal evidence review process ber of circumstances, including: and issues a proposed decision within six months of $$ When members of the public have raised “sig- the beginning of the NCD review. Reviews can take up nificant questions about the health outcomes to nine months if a technology assessment or meeting attributable to the use of the items or services for of the Medicare Evidence Development and Coverage the Medicare beneficiary population,” prompting Advisory Committee (MEDCAC) is needed.58 Medicare to evaluate the service, CMS may refer a topic to the MEDCAC when CMS would $$ New evidence arises, like independent expert advice in making decisions or $$ Local coverage policies on a particular item or to address broad, significant issues relevant to cover- service vary in language or implementation, or age determinations. “MEDCAC has provided expertise California HealthCare Foundation 16 and input to help CMS consider the appropriateness US Department of Veterans Affairs: of a framework for the evaluation of diagnostic tests; Well-Defined Standards in assessing the strength of the evidence for multi-fac- Federal regulations that govern medical benefits pack- torial, non-invasive, “lifestyle” modifying interventions ages for veterans specify the hospital, outpatient, and to treat cardiac disease; or in clarifying what constitutes extended care services that constitute the “medical the standard of care in wound therapy. CMS may also benefits package.”65 The regulations note that the pack- make use of the MEDCAC for horizon scanning to help age of basic and preventive care “will be provided to identify developing technologies that may be appropri- individuals only if it is determined by appropriate health- ate for Medicare coverage.” CMS will refer a matter to care professionals that the care is needed to promote, the MEDCAC when there is not enough available evi- preserve, or restore the health of the individual and is dence, when available evidence is inconclusive, or if CMS in accord with generally accepted standards of medical believes the NCD process would be better informed by practice.”66 Determination of necessary care is based on a broader deliberation that includes patient advocates.59 the following definitions: $$ Promote health. Enhance the quality of life or Within six to nine months, and after a rigorous review of daily functional level of the veteran, identify a the evidence, Medicare will issue a final determination: predisposition for development of a condition either to issue an NCD and cover the benefit, to issue or early onset of disease which can be partly or a non-coverage NCD, to issue an NCD with limitations, totally ameliorated by monitoring or early diagno- or to issue a decision that no NCD is required. NCDs sis and treatment, and prevent future disease with and without limitations, and non-NCDs apply to the entire Medicare population. After a decision is issued, $$ Preserve health. Maintain the current quality of there is another 30-day comment period, followed by a life or daily functional level of the veteran, pre- final NCD and decision memorandum no later than 60 vent the progression of disease, cure disease, or days after the end of the comment period. extend life span. $$ Restore health. Restore the quality of life or daily If no NCD is required, local Medicare Administrative functional level that has been lost due to illness or Contractors (MAC), of which there are 12 for the entire injury country, are then granted authority to make the coverage determination, known as a local coverage determination A key strength of the VA’s coverage guidance is that it (LCD).60 The LCD process is similar to the NCD process, defines a standard by which to assess whether an item or but decisions apply only to states covered by the juris- service should be covered. diction of the local MAC in question. As a result, there is some regional variation as to which services Medicare Canada’s Medicare covers. Canada’s single payer system, known as Medicare, makes coverage determinations in much the same way that the While the NCD process requires a rigorous review of Medicaid system of the US does in that the national pro- evidence and is intended to be evidence-driven and polit- gram delegates to the provinces the authority to make ically neutral, some suggest there have been instances coverage determinations. Specifically, the Canadian gov- when it has been influenced by interest groups, leading ernment gives block grant money to individual provinces to coverage of services with no proven health benefit.61 and territories and requires that they cover very broad categories of health services and hospital services while One study found that coverage determinations between leaving the details of the specific treatments up to the 2008-2012 were 20 times less likely to be positive than individual provinces and territories. Provinces also have those made in 1999-2002.62 Other studies have looked the discretion to cover additional services, such as the more closely at evidence-based medicine63 and cover- country’s national prescription drug program, ambulance age determination in Medicare as well as the variation in services, and optometric services, and they may choose local coverage determinations.64 to cover them fully or partially.67 In or Out: An Examination of Medicaid’s Coverage Determination Policies 17 The UK’s National Health Service: Endnotes A Focus on Cost-Effectiveness 1.Total Monthly Medicaid & CHIP Enrollment, Kaiser Family The National Institute for Health and Care Excellence Foundation, kff.org; State Expenditure Report, National (NICE) was established in 1999 by the National Health Association of State Budget Officers (NASBRO), www.nasbo.org. Service (NHS) to evaluate drugs and other treatments. NICE is charged with making recommendations and 2.Coverage of new medications approved by the FDA is governed by Section 1927 of the Social Security Act, which “technology appraisals” on medicines, medical devices, require state Medicaid agencies to put new medications for diagnostic techniques, surgical procedures, and health which the manufacturer is providing a rebate on formulary promotion activities. Recommendations are based both unless the agency finds the medication has no “clinically on clinical evidence and on a cost effectiveness analysis meaningful therapeutic advantage.” (CEA).68 These recommendations drive coverage deter- 3.D. Bachrach, Payment Reform: Creating a Sustainable Future minations by NHS, but NICE guidance is not mandatory. for Medicaid, Center for Health Care Strategies, May 2010. 4.Fostering State Policy to Support Integrated Delivery Systems: NICE does not have a rigid CEA requirement, but in Summary of a Discussion Among State Policymakers and general believes those interventions with an Incremental Delivery System Leaders, National Academy for State Health Cost-Effectiveness Ratio (ICER) of less than £20,000 per Policy, April 2012, www.nashp.org. Quality-Adjusted Life Years gained are considered to be 5.42 U.S.C. § 1395y (a)(1)(A), www.gpo.gov. cost effective. Interventions with an ICER above £20,000 6.Ibid. necessitate more careful consideration, and those above 7.National Health Service Act 2006, c. 41, Part 1, Provision of £30,000 would require a very strong case for inclusion in particular services. Accessed May 21, 2015, coverage.69 www.legislation.gov.uk. 8.“Utilization Management – Health Care Professionals.” 2015. Topics for an appraisal are generally identified by the Aetna. Accessed March 9: www.aetna.com. National Institute for Health Research Horizon Scanning 9.“Medical & Drug Policies and Coverage Determination Centre at the University of Birmingham, and can be Guidelines.” 2015. United Healthcare Online. Accessed brought to the Institute’s attention by the public. In March 9: www.unitedhealthcareonline.com. addition, companies can suggest technologies for con- 10. 42 C.F.R.§430.0, www.ecfr.gov. sideration through UKPharmaScan. 11.Medicaid and Children’s Health Insurance Programs: Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, The national process as a whole is strengthened by the Fair Hearing and Appeal Processes, and Premiums and Cost incorporation of both clinical evidence and cost effective- Sharing; Exchanges: Eligibility and Enrollment Final Rule, HHS ness criteria in the coverage recommendation process. and CMS, July 15, 2013, www.federalregister.gov. 12.Final Rule: Medicaid and Children’s Health Insurance Programs: Essential Health Benefits in Alternative Benefit Plans, www.federalregister.gov. 13.“Medicaid Benefit Designs for Newly Eligible Adults: State Approaches,” The Commonwealth Fund, May 11, 2015, www.commonwealthfund.org. 14.“14-018 Adds Adult Dental to ABP” 2014 Approved State Plan Amendments (SPA), Department of Health Care Services, July 30, 2014, www.dhcs.ca.gov. 15.Medicaid regulations allow states to place appropriate limits on a service, based on criteria such as “medical necessity,” 42 C.F.R. § 440.230(d).  16.42 C.F.R. § 440.230(b) & 42 U.S.C. §§ 1396a(a)(10)(B), 1396a(a) (17), www.law.cornell.edu. California HealthCare Foundation 18 17.In recently released draft Medicaid managed care regulations, 32. Redesigning the Medicaid Program, New York State CMS clarified that “managed care plans have . . . the flexibility Department of Health, Medicaid Redesign Team (MRT), under risk contracts to provide alternative services or services www.health.ny.gov. in alternative settings in lieu of covered services or settings 33.Manatt Health Solutions interview with California Medicaid if cost-effective, on an optional basis, and to the extent the Officials, May 11, 2015. managed care plan and the enrollee agree that such setting or service would provide medically appropriate care.” Medicaid 34.Patient Centered Outcomes Research Institute (PCORI)’s and Children’s Health Insurance Program (CHIP) Programs; mission is to help people “make informed healthcare Medicaid Managed Care, CHIP Delivered in Managed Care, decisions, and improves healthcare delivery and outcomes, Medicaid and CHIP Comprehensive Quality Strategies, and by producing and promoting high-integrity, evidence-based Revisions Related to Third Party Liability. A Proposed Rule information that comes from research guided by patients, by the Centers for Medicare & Medicaid Services on June 1, caregivers, and the broader healthcare community,” 2015.” Federal Register: www.federalregister.gov. www.pcori.org. New England Comparative Effectiveness Public Advisory Council (CEPAC)’s goal is to “aid patients, 18.“Medical Necessity,” National Academy for State Health physicians and policymakers in New England in the application Policy, www.nashp.org. and use of comparative effectiveness information to improve 19.See NY’s dossier process: www.health.ny.gov; Alabama’s the quality and value of healthcare in the region.” Sample dossier process: www.medicaid.alabama.gov; Colorado’s topics covered include ADHD and treatment-resistant Benefits Collaborative Process: www.colorado.gov. depression, cepac.icer-review.org. 20.42 U.S.C. § 1395y (a)(1)(A), www.gpo.gov. 35.See: Request for covered services, Alabama Medicaid Agency. Accessed May 20, 2015: www.medicaid.alabama.gov. 21.As of January 1, 2015, the Oregon Health plan covers Prioritized List lines 1 through 476. For more information on 36.Manatt Health Solutions interview with Texas Medicaid the prioritization methodology see: www.oregon.gov/oha/herc Officials, April 16, 2015. and www.oregon.gov/oha/healthplan. 37.Manatt Health Solutions interview with California Medicaid 22. Redesigning the Medicaid Program, New York State Officials, April 17, 2015. Department of Health, Medicaid Redesign Team (MRT), 38.Manatt Health Solutions interview with Oregon Medicaid www.health.ny.gov. Officials, April 21, 2015. 23. New York Department of Health Evidence-Based Review 39.See CHBRP Authorizing Statute: www.chbrp.org. Process for Coverage Determinations: Dossier Methods Guidance, New York Department of Health, 40.“Health Care Coverage,” Senate Bill 125, June 2015, www.health.ny.gov (PDF). leginfo.legislature.ca.gov. 24. Health Services Advisory Council Charter, Minnesota 41.See CHBRP’s directory of Completed Analyses: Department of Human Services, www.dhs.state.mn.us. www.chbrp.org. 25.A. Garber, “Evidence-Based Coverage Policy,” Health Affairs, 42.“Get Involved!” Health Evidence Review Commission, Oregon September, 2001. Health Authority, www.oregon.gov. 26.Bailit Health Purchasing, Evidence-Based Coverage: A 43.Basic Benefit: Evidence Based-Dossier Submission Process, Discussion Paper for DHCS. July, 2008. New York Department of Health, www.health.ny.gov. 27.See Missouri’s Departments of Social Services, Health and 44.Manatt Health Solutions interview with Idaho Medicaid Senior Services and Mental Health’s recommendations on use Officials, May 11, 2015. of evidence-based practice as the underpinning for policy 45.“SBIRT: Screening, Brief Intervention, and Referral to development, dss.mo.gov. Treatment Opportunities for Implementation and Points for 28.“Medicaid Evidence Based Decisions Project (MED),” OHSU, Consideration” SAMHSA-HRSA Center for Integrated Health www.ohsu.edu. Solutions, www.integration.samhsa.gov. 29. New York Department of Health Evidence-Based Review 46.“SBIRT Reimbursement” Institute for Research, Education and Process for Coverage Determinations: Dossier Methods Training in Addictions, my.ireta.org. Guidance, New York Department of Health, 47.Public Policy Agenda: 114th Congress, Nurse-Family www.health.ny.gov (PDF). Partnership, March 2015. Accessed May 21, 2015: 30.Health Evidence Review Commission Quality of Evidence www.nursefamilypartnership.org. Statement, www.oregon.gov. 48.“Proven Results,” Nurse-Family Partnership. Accessed May 20, 31.Manatt Health Solutions interview with Texas Medicaid 2015: www.nursefamilypartnership.org. Officials, April 16, 2015. In or Out: An Examination of Medicaid’s Coverage Determination Policies 19 49.California HealthCare Foundation (CHCF)’s Health Innovation 64.“Learning from Medicare: Coverage Policy.” July 2011. HCFO. Fund has invested in Omada. With CHCF’s support, Omada www.hcfo.org. will translate their Prevent program into Spanish and pilot the 65.38 C.F.R. § 17.38, www.gpo.gov. product with underserved patients. 66. Ibid. 50.Guidance on Affordable Care Act Section 4106, CMS, February 2013, www.medicaid.gov. 67. Canada Health Act Annual Report 2013-2014, Government of Canada, Health Canada, 2015, www.hc-sc.gc.ca. 51.Manatt Health Solutions interview with Colorado Medicaid Officials, June 2, 2015. 68.“NICE Technology Appraisal Guidance.” 2015. NICE. Accessed March 19: www.nice.org.uk. 52.Note: The authors did not explore how states that launched pilots under delivery system reform initiatives evaluate those 69.“The Guidelines Manual.” Chapter 7, Section 3. November programs for broader inclusion in their covered benefit 2012. NICE. Accessed March 19: www.nice.org.uk. package. 53. Health Care Spending and the Medicare Program: A Databook, MedPac, June 2014. 54.42 U.S.C. § 1395y (a)(1)(A), www.gpo.gov. 55. Local Coverage Determinations Create Inconsistency in Medicare Coverage, Office of the Inspector General, Department of Health and Human Services, January 2014, oig.hhs.gov. 56.“How to Request an NCD,” CMS. www.cms.gov. 57. Ibid. 58.“Factors CMS Considers in Referring Topics to the Medicare Evidence Development & Coverage Advisory Committee,” CMS, December 2006, www.cms.gov 59.Medicare Program; Revised Process for Making National Coverage Determinations, Federal Register, Vol. 78, No. 152. August 7, 2013, www.cms.gov. 60.Medicare Administrative Contractors (MAC) Jurisdictions, CMS, www.cms.gov. 61.Neumann, Peter J., and Chambers, James D., Medicare’s Enduring Struggle to Define “Reasonable and Necessary” Care. N Engl J Med 2012; 367:1775-1777, November 8, 2012. 62.Chambers, James D., Matthew Chenoweth, Michael J. Cangelosi, Junhee Pyo, Joshua T. Cohen, and Peter J. Neumann. 2015. “Medicare Is Scrutinizing Evidence More Tightly For National Coverage Determinations.” Health Affairs 34 (2): 253–60. doi:10.1377/hlthaff.2014.1123. 63.Foote, Susan Bartlett, and Robert J. Town. 2007. “Implementing Evidence-Based Medicine Through Medicare Coverage Decisions.” Health Affairs 26 (6): 1634–42. doi:10.1377/hlthaff.26.6.1634. California HealthCare Foundation 20