The Honorable Kathleen Sebelius
Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201
Re: Essential Health Benefits Bulletin, issued by Center for Consumer Information and Insurance Oversight on December 16, 2011
Dear Secretary Sebelius:
The National Coalition for Cancer Survivorship (NCCS) is a non-profit organization dedicated to improving the quality of cancer care for all cancer survivors. We promote public policy that supports this goal and we provide educational and support tools to help cancer patients battle this often frightening and complicated disease. We are submitting comments on the bulletin that the Department of Health and Human Services (HHS) issued on December 16, 2011 relating to the “essential health benefits” (EHB) that will be required to be offered by most individual and small employer health plans, as well by certain public plans—including the many currently uninsured or underinsured adults who will be able to obtain more affordable coverage as of 2014. These comments build upon earlier comments that NCCS submitted on EHB to the Institute of Medicine, via testimony in January, 2011, and to HHS on December 6th, 2011. In addition, NCCS has commented on regulatory guidance issued by HHS in 2010 and 2011—with a particular focus on the needs and concerns of cancer survivors.
In our comments, we offer some overarching recommendations regarding the proposed regulatory framework for defining EHB set forth in the bulletin and some specific comments on the details included within the bulletin. NCCS also looks forward to the opportunity to help the Department further refine its regulatory approach in this area.
Cancer Care—like the Underlying Set of Diseases it aims to Treat– Is Unique
The scientific umbrella of “cancer” encompasses a wide array of diseases and each often calls for its own particular treatment or set of treatments, many of which are rapidly evolving as science advances. Some of the distinct features of cancer care include: 1) its multidisciplinary and complex nature; 2) the need to respond to rapid changes in evidence-based care as a result of clinical and scientific innovations and investigations; 3) the evolution of cancer as a chronic disease requiring quality care across the continuum of the disease; and 4) the need for access to information to facilitate patient decision-making. We believe that well-planned and well-coordinated cancer care offers broad benefits for the health care system as it promotes the most targeted and appropriate utilization of health care resources feasible.
NCCS recommends that HHS consider the needs of this growing population of Americans—now over 12 million and rapidly growing—as it further refines its regulatory approach to EHB. NCCS is also a signatory to a letter on EHB submitted today by the Cancer Leadership Council, which represents an association of patient and provider organizations working in the area of cancer.
Focus and Purpose of the Bulletin
The bulletin states that it seeks to provide information and solicit comments on the intended regulatory approach for defining the EHB under ACA. It then describes the “approach HHS plans to propose” and clarifies that the content of the bulletin only relates to services to be covered by health plans and does not address aspects of ACA that will be of similar if not equally paramount importance to cancer patients—namely the provisions of ACA that will determine how much health plan enrollees will have to pay out-of-pocket under their plans. We understand that guidance relating to the “actuarial value” and cost-sharing protections of ACA is forthcoming and we look forward to the future opportunity to comment.
In terms of procedures and opportunity for further input on EHB, NCCS understands that ACA places very tight timelines upon the states and the federal government for implementation of EHB, as well as the exchanges and other important parts of the protections within ACA. Yet, given the critical nature of covered services and cost-sharing rules to the promise of truly affordable and high quality care, NCCS strongly urges HHS to issue formal guidance in a fashion that provides an opportunity for additional input in the near term. We are concerned that an interim final rule that goes into effect immediately may not provide sufficient opportunity for comment and input prior to state legislative and regulatory action on ACA implementation (many of which are ongoing).
Historic Opportunity to Define Minimum Federal Standards that many Health Plans Must Offer
ACA set forth—for the first time—minimum federal standards for many of the private and public health plans that Americans under the age of 65 will receive in 2014 and beyond. NCCS has been supportive of this approach within the legislation and subsequent regulatory guidance since we believe that a federal floor is an important way to guarantee basic protections to cancer patients—no matter where they live in the United States. This framework of a minimum federal floor, together with flexibility for the states who oversee many types of public and private coverage, has precedent and a growing history of protecting consumers, as it did for Medicare supplemental coverage (governed by a number of pieces of federal legislation), and for coverage offered by group health plans—and to a lesser extent individual plans—under by the Health Insurance Portability and Accountability Act (HIPAA). However, ACA went much further in its patient protections than either of these previous federal laws and it will be important to make sure that any flexibility provided to the states does not erode meaningful federal benefit coverage standards.
We are hopeful that the high degree of deference to the states reflected within the bulletin will not result in the erosion of ACA’s important patient protections. To this end we offer the following more detailed comments and suggestions.
Proposed Federal Benchmark Standard
The bulletin proposes to interpret the federal standards to permit each state to select a benchmark plan that would serve as a reference plan, “reflecting both the scope of services and any limits offered by a ‘typical employer plan.’”
The benchmark could be chosen from four benchmark plan types (and a total of ten specific plans) in each state. Since the publication of the bulletin, HHS has published a list of the largest three small group products in each state, a list intended to provide consumers and other stakeholders additional information about the types of plans that might be selected as benchmark plans. At the same time, HHS has cautioned that the list is illustrative and that it is not an official list of plans that might be chosen as benchmarks. The list of small group products does not include any details about those products, and that information is not in all cases easily available.
Even with the benefit of supplemental information from HHS, we find it difficult to assess fully the state benchmarking process proposed by HHS. Without more details about the plan options from which each state will choose its benchmark, we cannot conclude that the approach that permits state flexibility would also protect the needs of cancer survivors and others with serious and life-threatening illnesses. In addition, some of the steps taken by HHS to provide plan issuers flexibility beyond that granted to the states in choosing their benchmarks would serve to undermine the protections that cancer survivors should enjoy from the Affordable Care Act (ACA).
An EHB Package that Protects Access to Quality Care
If in its EHB regulatory proposal HHS follows the state benchmarking approach outlined in this bulletin, NCCS believes that such approach must be accompanied by: 1) resources to assure meaningful federal oversight; 2) clearly defined federal standards for plans whose benefits are exclusively regulated at the federal level and 3) restrictions on the ability of plan issuers to make substitutions of benefits within and across the 10 benefit categories. If a state benchmarking proposal is advanced, HHS must evaluate the benchmark chosen by each state to assess its adequacy in the 10 statutory benefit categories.
In addition, any state benchmarking plan must be amended to protect against the substitution of benefits within and across the benefit categories. In the bulletin, HHS seems to acknowledge the risks associated with substitution when it asks if the concept should be evaluated in order to “mitigate the potential for eliminating important services or benefits in particular categories.” We believe that substitution of the sort that is anticipated in the bulletin could result in health plans that seriously limit or even eliminate benefits for certain populations and would as a result discriminate against those populations.
Furthermore, since it is yet unclear whether all or nearly all states will have other critical components of the ACA implementation structure in place—particularly but not limited to the health insurance exchanges, we urge HHS to provide the public with the opportunity to comment upon the benefit and cost-sharing standards that will apply to plans that HHS will regulate (sometimes referred to as “federal fallback plans”) in the event that states do not have their exchanges up and running, or only partially so.
Therefore, another approach that HHS should consider in any proposed guidance relating to EHB would be to set a federal minimum benefit standard that sets forth more details for the federal fallback plans AND more details around the benefits and services that state-regulated private and public health plans must cover. The Department has already undertaken significant work – requesting and receiving an Institute of Medicare (IOM) report on EHB packages, receipt and evaluation of a Department of Labor (DoL) survey of employer-sponsored plans, additional Department research on health plan options, and a public process to solicit stakeholder advice about EHB packages – that would inform the definition of a minimum benefit standard. The Department could in addition define ways in which states, in their private plan regulatory and oversight role, and in their joint federal-state approval and oversight role for certain public coverage, could: 1) modify the federal minimum standard to reflect state needs, or 2) define flexibility that would be permitted to plan issuers within the boundaries of the federal minimum standard.
Coverage of the Ten Statutory Categories of Services
The bulletin acknowledges a weakness within its proposed benchmark approach when it notes that states may choose a benchmark that does not include one or more of the 10 categories of benefits that are identified in the ACA. In those circumstances, the states will have to amend the chosen benchmark to ensure inclusion of the 10 benefit categories. We recommend above that HHS institute aggressive oversight –and in the case of some public program coverage—approval processes to evaluate and ensure the adequacy of each state’s benchmark.
HHS also solicits advice regarding the definition of rehabilitative and habilitative services and devices, including guidance about whether these services relate to the creation, maintenance, or restoration of skills and functions. The bulletin also suggests that plans may exercise their own discretion in determining which habilitative services to offer, or they may define habilitative services much as rehabilitative services are defined, which means the emphasis would be on physical therapy, occupational therapy, and speech therapy. We recommend that HHS provide more specific guidance about rehabilitative and habilitative services.
Cancer survivors have significant rehabilitative and habilitative needs that relate to the management of the late and long-term effects of cancer and cancer treatment. And cancer patients are not alone in their intensive needs related to long-term rehabilitation. We believe that the inclusion of rehabilitative and habilitative services and devices in the statute is an acknowledgement of the needs of long-term cancer survivors and individuals living with other serious chronic diseases and the need for health plans that provide access to appropriate services so that those individuals retain or regain skills and function in order to lead productive lives. HHS can honor the intent of Congress by articulating specific guidance to the states, so that any amendment to a benchmark for rehabilitative and habilitative services ensures access to adequate services.
Standards of Coverage for Prescription Drugs
The bulletin offers the states great flexibility in the benchmarking process and in general includes limited guidance on specific benefits. The bulletin’s guidance on prescription drug coverage, in contrast, is specific and recommends restrictive coverage standards. According to the bulletin, the benchmark should include only one product per class or category and should reject the “protected classes” policy of the Medicare Part D prescription drug program.
NCCS believes the drug coverage standards in the bulletin are inadequate to protect the access of cancer patients to appropriate medications. Over the course of his or her disease and treatment, a cancer patient may require access to combination therapies that include more than one drug in a class or category and access to many different drugs in a class or category over a period of time and sometimes for treatment of recurrence. Cancer patients may respond differently to the drugs in a class or category, receiving benefit from one but not another in the same class. As a result, it is critically important that cancer patients have access to all drugs in a class or category. The protected classes policy of Medicare Part D, which calls for inclusion on a formulary of “all or substantially all” drugs in a class or category, should be incorporated into the EHB. Antineoplastics are one of the protected classes in Medicare Part D and should be afforded the same treatment in the EHB package.
In addition to adopting the protected classes policy, we recommend that HHS also require that state benchmark plans adopt as an absolute minimum standard the Part D policy requiring two drugs per class or category. Such policy should be accompanied by an expedited exceptions policy that would apply to formulary or utilization management requirements.
The definition of an EHB package must be accompanied by a definition of medical necessity that will identify the treatments within the EHB package that will be covered for the individual. We recommend that medical necessity be defined in a fashion that reflects, or cross-references, one or more accepted national standards of medical necessity and includes health care services or products that the health care professional would provide to the patient for the prevention, diagnosis, or treatment of an illness, disease, or injury or their symptoms. The care should be evidence-based or in accordance with the generally accepted standards of medical practice and should be clinically appropriate in terms of type, frequency, site, and duration of care. Only with such a definition will cancer patients, and their providers, have the assurance of meaningful coverage of the latest evidence-based cancer therapies, while providing the provider with an important role in the process of coverage determination. Such a definition is also critically important to cancer patients’ ability to appeal insurer decisions pursuant to ACA’s appeals and external review protections.
As NCCS has previously commented, it is of paramount importance that cancer patients have access to an expedited appeals process to challenge the medical necessity decisions of their plans.
Transparent Process for Establishing and Updating the EHB
In its report on the determination of the EHB package, the IOM recommended a transparent and public process for updating the package. We propose instead that HHS immediately embrace a transparent process for defining the EHB package. This could be done by the publication of a proposed rule on the EHB package; if a state benchmarking process is recommended in the proposed rule, the proposal should be accompanied by sufficient detail about benchmark choices to permit stakeholder assessment of the process. The EHB proposal should be published consistent with the Administrative Procedure Act and afford the public a 90-day comment period.
NCCS appreciates the opportunity to comment on the EHB bulletin and looks forward to having the opportunity to comment on the proposed rule for the EHB package.