The Honorable Kathleen Sebelius
Secretary
Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201

Re: CMS-9980-P, Patient Protection and Affordable Care Act; Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation

Dear Secretary Sebelius:

The National Coalition for Cancer Survivorship (NCCS) appreciates the opportunity to comment on the proposed rule setting standards related to essential health benefits, actuarial value, and accreditation. NCCS is a national organization representing survivors of all types of cancer in education and policy efforts to improve the quality of cancer care. We seek to advance quality care from the point of diagnosis and across the cancer continuum.

The Affordable Care Act (ACA) represents an important opportunity to bring many cancer survivors who are currently uninsured or underinsured into the health care system and improve their access to good health care. To realize the promise of the ACA, essential health benefits must be defined in a way that facilitates care planning and coordination and ensures access to comprehensive care including properly targeted therapies accompanied by supportive care. Our comments are guided by the principle that cancer patients must be engaged in treatment decision-making, based on communication with their care team and solid information about all therapeutic options and the benefits and side effects of treatment options.

Prescription Drug Benefits

NCCS commends the decision of the Department of Health and Human Services (HHS) to amend the standard for prescription drug coverage that was included in the December 2011 bulletin. The proposed rule would impose a requirement that health plans offering essential health benefits (EHB) offer the greater of one drug in every category or class or the same number of prescription drugs in each category and class in the EHB-benchmark plan. This standard is stronger than that of the 2011 bulletin, and there are indications that the EHB benchmark in some states will have comprehensive coverage of drugs in most categories and classes.

However, the standard does not offer all cancer patients in all states an assurance that they will have access to a formulary that will permit quality treatment. The coverage standard of the proposed rule is not adequate in an age when cancer patients may require combination drug therapies, different drugs in a class or category over the course of illness and treatment, and a range of drugs for supportive care. Moreover, the “one drug per class or category” standard lags behind the movement toward targeted, or personalized, cancer treatments.

We recommend the following changes in the prescription drug coverage standards of the proposed rule:

• Incorporation of the protected classes policy that is implemented in the Medicare Part D program. Through this policy, which provides coverage of “all or substantially all” drugs in certain classes or categories, cancer patients could be given assurance that they will have access to the drugs necessary for treatment, including in some cases targeted therapies.
• An appeals process that plan enrollees may utilize in those cases when they require access to drugs not covered by their plans. The proposed rule says that a health plan “must have procedures in place that allow an enrollee to require clinically appropriate drugs not covered by the health plan.” We recommend that the final rule offer more specific guidance about the standards for appeal, including firm timelines for review and decision.
• A clear standard for updating formularies to include important therapeutic developments. The proposed rule does not set a clear standard for updating formularies to incorporate new drugs. NCCS recommends that the final rule define a process for review by the plan’s Pharmacy and Therapeutic Committee within 90 days of approval of new treatments by the Food and Drug Administration (FDA).
• Review of the use of US Pharmacopeia (USP) to evaluate plan coverage of prescription drugs. Although the USP classification system is utilized in the Medicare Part D program, it may not be appropriate for use in evaluating exchange and non-grandfathered individual and group plans with a different population whose needs are not the same as those of the Medicare Part D population.
Habilitative and Rehabilitative Services and Prevention and Wellness Services and Chronic Disease Management

Two of the ten categories of benefits that were identified in the Affordable Care Act – the category of habilitative and rehabilitative services and the category of prevention and wellness services and chronic disease management – point the direction toward reforming the delivery of care by their suggestion of benefits for care management and coordination. However, the HHS decision to define EHB through a benchmarking process, instead of offering definition to the services and treatments that might be available through these benefit categories, undermines the potential for health delivery reform. Current plans that will be referenced in the benchmarking process are by and large inadequate in their coverage of services that would encourage care planning, coordination, and management.

We recommend that HHS, in the final rule on EHB, offer more guidance about the standards for rehabilitative and habilitative services and chronic disease management. Benchmarks might be subject to supplemental benefits to meet the standards articulated by HHS, but such definition would provide value to cancer patients and many others with serious and life-threatening and chronic diseases and would also, in the long run, provide value to the health care system. We believe that habilitative services, if more aggressively defined, would be important to childhood cancer patients to help them develop critical skills and functions. Rehabilitative services might also be available to adult survivors to assist in the maintenance or restoration of functions and abilities during and after cancer treatment. Finally, chronic disease management should be defined in a way that would permit access to cancer care planning at the point of diagnosis and monitoring, management, and treatment of the late and long-term effects of cancer and cancer treatment, which are experienced by many cancer survivors.

Coverage for Individuals Participating in Approved Clinical Trials

The ACA sets a standard for coverage of routine patient care costs for individuals participating in approved clinical trials. We urge that HHS clarify in the rule that a plan will not offer EHB unless it includes clinical trials coverage as defined in the ACA. The Department has offered a clarification with regard to the provisions of the ACA establishing standards for certain preventive services without cost-sharing, and it should do the same regarding the clinical trials coverage provision.

Care in a clinical trial often represents the best option for quality care for a cancer patient, and it is important that EHBs include coverage of clinical trials as defined by the ACA.

Patient Cost-Sharing for Out-of-Network Care

NCCS is concerned about the treatment of out-of-network cost-sharing in the proposed rule and urges changes to this standard. The proposed rule provides that an enrollee’s cost-sharing for out-of-network care will not count in the calculation of the enrollee’s annual dollar limit on out-of-pocket expenditure or the annual dollar limit on deductibles. This standard for treatment of out-of-network cost-sharing creates a potentially serious burden for cancer patients. It is unlikely that plans will be able to maintain a network of providers that will meet the needs of all enrollees with cancer. Those with rare or hard-to-treat cancers may not be able to rely on network providers for all elements of their care. These enrollees may find themselves in the untenable position of enjoying cost-sharing protections for network care that is inappropriate or inadequate and no cost-sharing protections for the out-of-network care they must have.
We strongly recommend that plans be required to implement an exceptions process that would permit enrollees to count the cost-sharing associated with out-of-network care toward annual cost-sharing and deductible limits.

*****

We appreciate the opportunity to comment on the proposed rule on EHB and actuarial value. We applaud the improvements in the definition of EHB from the original 2011 bulletin on EHB to the pending proposed rule.

Sincerely,

Nina Wendling
Executive Director

Via Electronic Filing

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