EHB: BIO’s Comments on the Essential Health Benefits Proposed Rule

          The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the Department of Health and Human Services' (HHS) proposed rule on the essential health benefit (EHB) provisions and actuarial value provisions of the Patient Protection and Affordable Care Act (PPACA).[1]

          BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO's members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. In that way, our member's novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, including productivity and quality of life, but also have reduced health care expenditures due to fewer physician office visits, hospitalizations, and surgical interventions.

          BIO firmly believes that to fulfill the goals of PPACA the EHB coverage standard must ensure meaningful coverage for patients enrolled in non-grandfathered health plans sold in the individual and small-group markets both inside and outside of the American Health Benefit Exchanges (“Exchanges”). Essential health benefits should guarantee that individuals have access to preventive services, medically necessary treatments, clinically appropriate treatments, and innovative treatments—all at affordable costs.

          We support the decision of the Centers for Medicare and Medicaid Services (CMS) to move forward with the approach outlined in the EHB Bulletin,granting states flexibility to select a base-benchmark plan that serves as the basis for the definition of EHB in that state.[2] BIO believes this flexibility will facilitate competition among health plans within the states, thus contributing to greater patient choice. However, we have concerns that the proposed approach to essential health benefits leaves enrollees vulnerable in critical ways, and therefore we urge CMS to consider the following comments, discussed in more detail below.

·         Because the United States Pharmacopeia (USP) Medicare Model Guidelines (MMG) classification system was originally created for use with Medicare Part D, the categories and classes may not adequately represent the range of drugs that a typical employer-based plan covers, particularly with regard to physician-administered drugs that are typically covered as part of a medical benefit and with respect to new and innovative therapies.

·         The proposed rule does not appear to ensure that patients have timely access to new and innovative therapies; therefore, BIO recommends the regular updating of the state-based EHB prescription drug benefit category and the availability of appeals and exceptions processes.

·         Specialty tiers discriminate against the most vulnerable patients and should not be permitted.

·         Meaningful oversight and enforcement of PPACA’s prohibition of discrimination is critical for meeting the needs of vulnerable patient populations.

·         CMS should provide detailed guidance to Exchanges and plans regarding acceptable and unacceptable utilization management techniques.

·         Additional protections should be established to ensure adequate provider networks.

·         CMS should ensure the incorporation of the 2008 Mental Health Parity Act, as required by Congress, in state EHB benchmarks.