1. What is your interpretation of the word essential in the context of an essential benefit package?

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1 Proposed AHA Responses to IOM Questions on Essential Benefits Package 1. What is your interpretation of the word essential in the context of an essential benefit package? Congress use of the word essential, combined with its specification in the Affordable Care Act of the broad categories of essential services that are to be covered, seems designed to attempt to strike a balance between two important and competing priorities. On the one hand, the word essential does seem to convey a desire to ensure that only the most critical and fundamental benefits are covered in an effort to ensure that qualified health plans are affordable for consumers. At the same time, in spelling out ten broad, essential categories of services, Congress also intended that consumers purchasing health plans through an insurance exchange would have access to comprehensive health benefits that largely span the continuum of care, ranging from preventive services to rehabilitative and habilitative care. The American Heart Association/American Stroke Association agrees that in developing the essential health benefits package care should be taken to balance the need for patient access to the care they need with the assurance that the coverage is affordable. With respect to cardiovascular care, an optimal approach to determining whether specific treatments or services are essential would be to follow the recommendations of objective, peerreviewed, evidence-based guidelines developed by organizations such as the American Heart Association. Numerous research studies have shown that when evidence-based guidelines are followed, patient outcomes are improved, and in some cases, unjustified regional variations in the cost and quality of care can be reduced. The American Heart Association/American Stroke Association and partner organizations such as the American College of Cardiology and the American Academy of Neurology invest considerable time, effort and resources in the development of joint clinical practice guidelines that rate procedures or treatments and provide recommendations for their use (classes I, II, or III) based on the extent and strength of the evidence in support of the recommendations (levels A, B, or C). Stringent policies regarding conflicts of interest of writing committee members are followed. As a general matter, we recommend that cardiovascular and stroke treatments or services receiving Class I or Class IIA recommendations should be covered as an essential service. Class I recommendations are awarded to procedures or treatments where there is strong evidence (Class IA) or general expert consensus (Class IC) that they are both useful and effective. Class IIA recommendations are indicated for treatments or services for which there may be some divergence of evidence or opinion but the overall weight of the evidence supports usefulness and efficiency. Consideration could also be given to the inclusion of Class IIB recommendations as essential benefits, particularly when circumstances warrant their use for individual patients or are, in the clinical judgment of the physician, necessary. Class IIB recommendations are made when the usefulness and efficacy of a treatment or service is less well established by the evidence or expert opinion but nevertheless no restriction should preclude the ability of a provider to appropriately prescribe one of these treatments or services. i 2. How is medical necessity defined and then applied by insurers in coverage determinations? What are the advantages/disadvantages of current definitions and approaches? Currently, there is no single national definition of medical necessity used by insurers. And even within health plans, there seems to be inconsistency in how medical necessity is applied. We support moving toward a single, uniform definition of medical necessity. Having said that, an examination of the definitions of medical necessity included in a range of insurance plan contracts finds many common elements across the different definitions. The

2 National Association of Insurance Commissioners Consumer Information Subgroup, along with a statutory task force of stakeholders formed under the auspices of the Affordable Care Act, recently conducted such an examination, and samples of medical necessity definitions currently in use by insurance companies can be found on its website at: Common concepts found in the definitions in many of the health insurance contracts included: Services or products demonstrated through scientific evidence to be effective in improving health outcomes; and Health care services or products provided to an enrollee for the purpose of preventing, diagnosing, or treating an illness, injury or disease; Services or products consistent with generally accepted standards of medical practice; Clinically appropriate services in terms of type, amount, frequency, setting, and duration; Services or products that are not primarily for the convenience of the enrollee or health care practitioner. One definition we reviewed contained some additional concepts that we believe should be included in a uniform, national definition of medically necessary care. Specifically, such care should: Help restore or maintain the member s health; Prevent deterioration of or palliate the member s condition; or Prevent the reasonably likely onset of a health problem or detect an incipient problem. Including the concepts of preventing disease and restoring and maintaining health are particularly important for cardiovascular disease and stroke patients. Given that as much as 80 percent of cardiovascular disease and stroke may be preventable, it is critical that consumers have access to preventive services that enable early identification of risk factors and intervention to prevent the onset or recurrence of disease. Likewise, access to appropriate rehabilitative therapy is a critical element of care that minimizes disability and promotes the productivity of patients with many different conditions. Rehabilitation (or habilitation in the case of children) is particularly important to stroke patients in restoring and maximizing the functional outcomes of patients, minimizing impairments, and preventing complications. Generally, private insurers rely on external medical expert societies and government agencies and task forces to determine which services are medically necessary. Medicare uses a reasonable and necessary standard for making coverage determinations. Medicare, through the Centers for Medicare and Medicaid Services (CMS), primarily relies on clinical trial data and the scientific literature, and it may consider professional society policy statements, and/or the input of groups like the Medicare Coverage Advisory Committee (MEDCAC), The AHA supports an even greater reliance on the evidence-based clinical practice guidelines developed by patient-focused medical professional organizations, and of course great care should be taken to ensure that such recommendations are not conflicted. On the other hand, there are many clinical conditions for which there is only limited evidence regarding which treatment among existing options is likely to be most effective for an individual. Clinical guidelines should not be used to supplant a physician s clinical judgment regarding the most appropriate treatment approach for an individual patient where the guidelines are inadequate or do not apply. The disadvantage of the current approach to determining medical necessity is that it is defined at the patient level and does not use a population health or a cost- benefit or community value analysis to determine coverage. It therefore can be difficult to eliminate coverage for services that are determined to have limited medical effectiveness. If there are a number of treatment options with varying levels of effectiveness and they must all be reimbursed without regard to the

3 effectiveness, demonstrated clinical outcomes, or cost, the result is the status quo high per capita health care costs yet poorer than expected health outcomes. The overarching goal when defining essential health benefits should be to optimize outcomes and value for patients. For example, if two treatments or procedures for a condition achieve the same patient outcomes, safety, and satisfaction, but one option is only half as costly as the other, then the less costly option has greater value and should be considered essential. The more expensive option might be considered essential only when the less expensive option is not tolerated by a specific patient. 3. What criteria and methods, besides medical necessity, are currently used by insurers to determine which benefits will be covered? What are the advantages/disadvantages of these current criteria and methods? We understand that as a condition of licensure or accreditation insurers frequently have a Quality Improvement (QI) Committee composed of internal medical directors, nurses, and other internal medical staff, along with outside medical or hospital experts from the local community. Among other tasks, the QI Committee establishes subcommittees in specific specialty areas, such as cardiac care, obstetrics/gynecology, behavioral health, pharmacy and therapeutics, etc., to determine specific criteria that will be used to define coverage details about a particular benefit as needed. These subcommittees focus on situations where the medical guidelines may not be clear or where there is conflicting research about various approaches to a particular treatment. They also review the existing evidence and make recommendations to the insurer about how a new benefit or medical treatment will be covered and under what circumstances including type of patient, frequency, intensity, licensed professional or facility setting, etc. For instance, a QI subcommittee might recommend that a specific treatment only be covered if provided at a center of excellence and when warranted by patient outcomes. These subcommittees may be standing committees or committees established for a limited period of time to address a particular charge, e.g., evaluating a benefit that is new, changing or has a new medical guideline or research that needs to be taken into consideration for coverage and payment purposes. We believe that QI committees function best when they function independently and use external evidence-based guidelines, along with internal and community medical experts, to make decisions about how a particular treatment or benefit will be covered. The committee process and inclusion of external experts facilitates a good working relationship with key stakeholders within the delivery system of the insurer and helps to foster better relationships with physicians and hospitals and more acceptance of proposed criteria for coverage when they are implemented. One important disadvantage is that the definition or standard of use of a particular covered benefit or service may vary at the community or state level, making it difficult to compare outcomes across medical groups, hospitals and states, especially if different carriers have slightly different criteria or methods for determining the scope of a covered benefit or service. Through their contract with enrollees, health insurers also may exclude specific services from coverage. Americans with cardiovascular disease, particularly those born with congenital heart disease, often have their condition completely excluded from a new insurance policy, if they can even get coverage at all. We are very pleased that the Affordable Care Act bans pre-existing condition exclusions, beginning in 2010 for children and in 2014 for adults. While some specific exclusions may continue to be appropriate (such as exclusions for care not rendered by an appropriate health care professional), other exclusions may be for services that would otherwise be considered to be medically necessary based on the medical evidence. Organ transplants are an example of a service that is often excluded from coverage (unless it is a state mandate or purchased as a rider benefit), although they may be the only remaining effective and evidencebased treatment option for some patients with certain forms of heart disease. When further defining the essential health benefits, the Secretary should have in place a mechanism to ensure that medically necessary services are not excluded from coverage.

4 4. What principles, criteria, and process(es) might the Secretary of HHS use to determine whether the details of each benefit package offered will meet the requirements specified in the Affordable Care Act? As we recommended in our response to question one, coverage of treatments and services recommended by evidence-based clinical guidelines should be the driving criterion for determining whether the specific benefits of a health plan meet the essential health benefit requirements of the ACA. In circumstances where the recommendations are not clear, the HHS Secretary should, at a minimum, set standards and not leave these standards to individual plan or issuer interpretation. For example, requiring coverage based on the classes and level of evidence, e.g. coverage for class I and class IIA, and for class IIB recommendations in certain circumstances that we addressed in our response to question 1. In addition, standards should be set for acceptable and unacceptable sources of evidence. An acceptable source, for example, could rely on nationally recognized, evidence-based guidelines that meet standards for avoiding conflicts of interest. For instance, the AHA s guidelines and statements represent objective critical reviews of the scientific literature and clinical trials, supplemented and supported by consensus views of leading experts. In addition, the new Patient-Centered Outcomes Research Institute will hopefully help fill in existing gaps in the evidence base so that it can be used to inform the development of the benefit package. When assessing the value of different treatments, perhaps one rubric that the Secretary could apply would be to evaluate the cost of the benefit versus its utility/outcome for the population. As we also referenced in our response to question 2, if, for example, two treatments or procedures for a condition achieve the same patient outcomes, safety, and satisfaction, but one option is only half as costly as the other, then the less costly option has greater value and should be considered essential. The more expensive option might be considered essential only when the less expensive option is not tolerated by a specific patient. This, of course, requires the performance of robust comparative effectiveness research. With respect to process, we strongly recommend that the HHS Secretary establish an advisory committee or council to make recommendations to the Secretary. The AHA feels strongly that sensitive decisions about which services and items that must be covered should not be made solely by government or by health plan employees. Instead, we believe that a multi-stakeholder committee, including strong consumer and patient representation, is the preferred way to shape a benefit package that is grounded in science, and especially in the ever evolving science of clinical medicine and in the best interest of consumers and patients. As stated above, comparative effectiveness research should provide an improved and growing evidence base for these decisions. The U.S. Preventive Services Task Force serves as a framework for the type of advisory panel that can help to inform the decisions of the HHS Secretary, although this model should be improved upon by including a broader range of expertise on the committee. In terms of composition, the above advisory panel/committee/council should represent the interests of all stakeholders patients, consumers, providers, employers and insurers. It should also include experts with a wide range of medical expertise, including primary care and specialty expertise, who can represent the health care needs of diverse segments of the population, including children, women, communities of color, and those of disadvantaged socio-economic status, patients with chronic conditions, and people with disabilities. At a minimum, the process for defining essential health benefits must be transparent, with significant opportunities for public review, testimony, and comment. An earlier version of health care reform legislation that was approved by the Senate Committee on Health, Education, Labor, and Pensions, specified a number of considerations that such a committee should use when making its recommendations. We believe the following criteria

5 represent the type of balanced approach that should be taken when defining essential health benefits: the clinical effectiveness and appropriateness of the benefits covered; the affordability of the benefits covered; the financial protection of enrollees against high healthcare expenses; access to necessary healthcare services, including primary and preventive health services; existing State laws that require coverage of health care items or services in the individual and group markets; and the potential of additional or expanded benefits to increase costs and the interactions between the addition or expansion of benefits and reductions in existing benefits. 5. What type of limits on specific or total benefits, if any, could be allowable in packages given statutory restrictions on lifetime and annual benefit limits? What principles and criteria could/should be applied to assess the advantages and disadvantages of proposed limits? Because the health reform law has begun phasing in a ban on annual dollar limits on essential benefits, health plans are not surprisingly starting to shift to other types of limits, such as limits on the number of physician visits or the number of outpatient therapy visits. At the same time, however, we recognize the need to balance coverage with affordability. Again, we feel strongly that looking to the evidence base is the best way to approach such issues. The best interests of patients as a whole -- as recommended by evidence-based clinical guidelines -- should be the primary consideration. We don t want to suggest that patients should be able to get whatever care they want in the quantities they want and for as long as they want. But patients should have an assurance that the full continuum of evidence-based care that they need will be available without arbitrary limits. 6. How could an appropriate balance among the ten categories of essential care be determined so that benefit packages are not unduly weighted to certain categories? The ten categories are: ambulatory patient services; emergency services; hospitalization; maternity and newborn care; mental health and substance use disorders services, including behavioral health treatment; prescription drugs; rehabilitative and habilitative services and devices; laboratory services; preventive and wellness services and chronic disease management; pediatric services, including oral and vision care. We agree that it is important to achieve some balance across the categories of services. Some services (such as rehabilitation and mental health and substance abuse services in particular) are much more likely to be used by enrollees with high medical costs. Benefit design should not be used to cherry-pick healthier individuals, which may result in adverse selection between health plans inside and outside of an exchange. It is also important that enrollees have access to necessary and appropriate prevention, care and treatment across the continuum of care as represented by the categories of services. At the same time, however, spending allocations by categories should not be set arbitrarily and may need to be adjusted over time to reflect advances in medicine and scientific progress. Although we recognize that the statute requires the HHS Secretary to look to the typical employer plan to inform the defining of essential health benefits, the Secretary s definition for essential health benefits will require information from a number of sources. The median or average use of services in current employer plans is one possible source of information but will need to be modified to account for systemic sources of bias against coverage of certain categories of service.

6 7. How could it be determined that essential benefits are not subject to denial to individuals against their wishes on the basis of age, expected length of life, present or predicted disability, degree of medical dependency or quality of life? Are there other factors that should be determined? This is a difficult but important question. Given the sensitivity many Americans have about rationing of care, particularly for the elderly, the disabled or those with incurable illnesses, we believe that the clinical judgment of a patient s individual provider must be considered, but that further educating both patients and providers is an essential next step. The needs of vulnerable patient populations, including the critically ill and individuals with rare diseases, must be taken into consideration when developing the essential benefits package. The practice of medicine must take into consideration each patient s values and goals. Patients and their families could likely benefit from additional information that helps them better understand their range of treatment options, the advantages and disadvantages of each option, and how to ensure that their decisions and wishes are followed. Physicians and other health care providers need further education about how best to communicate with patients about their treatment options with sensitivity and compassion, while ultimately respecting the decisions made by patients and their families. Clarity on advance directives and medical power of attorney issues will be essential. 8. How could it be determined that the essential health benefits take into account the health care needs of diverse segments of the population, including women, children, persons with disabilities, and other groups? Working to ensure adherence to evidence-based guidelines can go a long way towards ensuring that all segments of the population, including the groups mentioned above as well as other groups such as racial/ethnic groups subject to disparities in health care, receive the recommended treatments. We recognize that there are diseases or conditions for which the evidence base isn t very strong (for instance, with respect to rare disorders or conditions in children). We hope that the work of the new Patient-Centered Outcomes Research Institute will begin to close some of these gaps in the evidence base. However, in many cases, there will exist some general consensus among experts or a certain level of evidence that can be extrapolated about the most appropriate treatment(s) for a condition that can be used to form the basis for a recommendation. In addition, the inclusion of a broad range of patient stakeholders on an advisory council or committee, as well as medical experts familiar with the level of evidence available for specific disease conditions, could help to address the health care needs of a diverse population. 9. By what criteria and method(s) should the Secretary evaluate state mandates for inclusion in a national essential benefit package? What are the cost and coverage implications of including current state mandates in requirements for a national essential benefit package? Although state coverage mandates have been an important strategy for some disease groups, the vast majority of evidence-based benefits that cardiovascular disease patients need are covered by insurers without the need for enactment of state mandates. Having said that, the HHS Secretary, perhaps via the Advisory Board, should evaluate state mandates for inclusion using an evidence-based population or community health criteria so that the value of purchasing the coverage is transparent to the individuals and the benefits seem reasonable and appropriate each year. Such an approach can help to address variations in utilization, quality of care, and disparities in outcomes that exist today across geographic regions of our country Traditionally, the individual market and the small group insurance market have been exempt from a number of state mandated benefits and services because there was not a sufficient group of people to share the risk or cost of high cost care or catastrophic events, and large employer plans governed by ERISA have also been exempt from state mandates. Although the individual

7 mandate expands the risk pool, the essential benefit package will need to take into consideration the impact on premiums if mandated benefits and services are included. The goal of the health reform law is to create individual and small group market pools that create a viable method for sharing the risk of high cost services without significantly increasing premiums. This is an admirable policy goal, but in reality, care must be taken in making certain the initial level of benefits and services in the essential benefit package are economically sustainable over the long term. 10. What criteria and method(s) should HHS use in updating the essential package? How should these criteria be applied? How might these criteria and method(s) be tailored to assess whether: (1) enrollees are facing difficulty in accessing needed services for reasons of cost or coverage, (2) advances in medical evidence or scientific advancement are being covered, (3) changes in public priorities identified through public input and/or policy changes at the state or national level? As we recommended in our response to question four above, we believe an ongoing advisory committee or council should be established to make recommendations to the Secretary on updating the essential health benefits package based on the latest evidence. Again, this panel should represent the interests of all stakeholders patients, consumers, providers, employers and insurers -- and include experts with a wide range of medical expertise and who can represent the health care needs of diverse segments of the population. At a minimum, there must be ongoing mechanisms in place to regularly track access to health care services, and in particular, whether patients with qualified health plans have difficulty accessing needed services for reasons of coverage or cost. With respect to enrollees facing difficulty accessing needed services for reasons of cost or coverage, HHS may want to establish criteria for determining if the cost of a particular service has become unreasonable based on the utility model proposed above or other factors. In such cases, the Secretary may want to implement payment mechanisms that would encourage the use first of alternative services that may have higher value (i.e. the same medical efficacy at a lower cost), such as by implementing lower cost sharing to encourage utilization of more effective, affordable services. The more expensive option might be considered essential only when the less expensive option is not tolerated by a specific patient. One consideration for the Secretary will be how specific to make the initial essential benefits package. On one hand, it should be specific enough for patients to have some certainty that necessary care is covered. On the other hand, if the package is too detailed, updating it on a regular basis becomes time consuming and may result in a lag in the coverage of new therapies. In any event, advances in medical evidence or scientific advancement can be addressed by having a periodic review of a particular category of services. Each category could be on a schedule for review so that only certain categories were reviewed each year. All of the advances for a particular area would need to be finalized early enough each year so that they can be priced and incorporated into premiums and documented in the plan brochures for fall open enrollments and become effective in January of the following year. Major scientific advances, such as large clinical trials of highly beneficial new therapies, could be included on an ad hoc basis as they occurred. This is already done by CMS in cooperation with the AHA/ASA and professional societies in an on-going manner. i Gibbons, RJ, Smith, S, Antman, E. American College of Cardiology/American Heart Association Clinical Practice Guidelines: Part I; Where Do They Come From? Circulation. 2003;107: