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The Honorable Kathleen Sebelius
Secretary
United States Department of Health
and Human Services (“HHS”)
Hubert H. Humphrey Building
200 Independence Avenue, Southwest
Washington, DC  20201

Dear Secretary Sebelius:

The National Coalition for Cancer Survivorship (NCCS) is a national organization dedicated to improving the quality of cancer care for all cancer survivors.  We submit these comments as the Department of Health and Human Services (“HHS”) works to define the benefits (“essential health benefits”—or EHB) that must be offered in the individual and small employer health insurance markets as of 2014 pursuant to the Patient Protection and Affordable Care Act (ACA).  ACA set forth categories and criteria for the EHB and instructed the Secretary of HHS to develop and implement standards for these health plans.  As part of this process, after the passage of the law, you asked the Institute of Medicine (“IOM”) to recommend ways to determine and update the EHB.  The IOM Committee on Determination of Essential Benefits held two open workshops and received extensive public input on criteria and policy bases for EHB package scope and design. NCCS testified before the IOM Committee on January 14, 2011.

The Institute of Medicine recently released its recommendations to HHS regarding EHB.  The IOM Committee identified the need to balance the competing goals of affordability and comprehensiveness of coverage.  Among its recommendations, the IOM Committee concluded that:

• The EHB package should consider the scope and design of health insurance coverage offered by small employers today, which should then be modified to reflect the ten required categories of coverage under the ACA as well as the criteria identified in the IOM report;
• Costs must be considered in determining the initial package as well as in its updating the package;
• In evaluating costs, the cost of a EHB package should be compared to a premium target based on the average small employer plan premium in 2014;
• States should be able to design a modified EHB package as long as it meets specified criteria;
• A transparent and rigorous appeals monitoring process is the primary approach to addressing the nondiscrimination provisions in benefit design and implementation, including medical necessity reviews; and
• The Secretary should obtain ongoing external advice on updating the EHB from an advisory group.

 
NCCS submits the following recommendations in response to the IOM report and to reinforce its prior statement and testimony on EHB to the IOM Committee.   Importantly, for the purposes of defining the EHB, cancer should be considered a chronic disease and those diagnosed should be provided with care planning and coordination services.  Not only will this help cancer patients navigate and decide among their treatment options and adhere to medication and follow-up protocols,  it will also promote more efficient use of health care resources by helping avoid duplication of services by different providers.  The EHB should also ensure that patients have access to care planning services across the continuum of care, including at initial diagnosis, upon end of active treatment, and upon recurrence or change in health status or treatment plan.

In addition, the NCCS recommends that the EHB include access to off-label uses of cancer drugs.  It is estimated that over half of all uses of cancer drugs are off-label as cancer research often rapidly identifies supplemental uses of drugs approved by the Food and Drug Administration (FDA), but this research does not necessarily or rapidly lead to changes in product labeling.   In order to ensure patients access to therapies based on the best evidence, there should be no prohibition against payment for off-label uses of cancer drugs.  Finally, and very importantly, NCCS recommends that the essential benefits package clearly reflect ACA’s requirement for coverage of routine patient care costs for those enrolled in cancer clinical trials.   These recommendations are consistent with the evidence-based approach supported by the IOM report and NCCS continues to recommend that HHS incorporate these recommendations within the final EHB regulations.

Furthermore, NCCS would like to provide some additional comments on the IOM recommendations.  Recognizing that access to health coverage is inextricably intertwined with affordability, NCCS is mindful of the impact of health care and insurance costs on employers, individuals and the government.  However, it will be important that, to the extent HHS considers cost in defining the EHB, it do so without running afoul of ACA’s requirement that coverage not discriminate against individuals based upon their age, disability or expected age of life.  ACA also requires a balance among benefit categories so that the benefit package isn’t weighted in favor of a particular category. (Rosenbaum, S.; Teitelbaum, J. and Hayes, K.: “The Essential Health Benefits Provisions of the Affordable Care Act:  Implications for People with Disabilities,” The Commonwealth Fund pub. 1485 Vo. 3, March 2011).  It is critical that insurance plan designs meet the needs of the patients they are created to serve, including those with serious medical conditions such as cancer.

The IOM Committee indicated that a transparent and rigorous appeals monitoring process should be the primary approach to assuring compliance with ACA’s non-discrimination provisions.  We would respectfully recommend that it will also be important to monitor benefit design and coverage limits to ensure that they are not having a discriminatory impact. Employer plans use a variety of benefit designs and coverage limits.  These can include:  1) Coverage exclusions and limitations; 2) Medical management guidelines; 3) Tiered cost sharing under which different benefits or medications are reimbursed at different levels; 4)  Tiered provider networks; and 5) Provider payments such as incentive payments based on utilization or case management fees to actively manage complex patients.  Id.  While these tools can have an appropriate place in managing health care coverage and costs, it is important that they are not used in a way that impedes access to important health care services for patients with any particular health care condition.  To this end, for example, it will be important that health plans exercise flexibility in accommodating requests to see particular providers, especially in the case of patients with certain rare diseases, such as some cancers. 

We realize that HHS must carefully balance many important needs and concerns as it develops the EHB regulations.  Please let us know if you have any questions about our comments.  Thank you for your consideration.