Medicaid, Children’s Health Insurance Programs, and Exchanges

Ms. Marilyn Tavenner, B.S.N., M.H.A.
Acting Administrator
Centers for Medicare & Medicaid Services
Room 445–G, Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201

Re: CMS–2334–P; Medicaid, Children’s Health Insurance Programs, and Exchanges: Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal Processes for Medicaid and Exchange Eligibility Appeals and Other Provisions Related to Eligibility and Enrollment for Exchanges, Medicaid and CHIP, and Medicaid Premiums and Cost Sharing

Dear Ms. Tavenner:

The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the Department of Health and Human Services’ (HHS) Centers for Medicare & Medicaid Services (CMS) proposed rule on the Medicaid, Children’s Health Insurance Programs (CHIP) and Exchanges Eligibility and Essential Health Benefits (EHB) provisions of the Patient Protection and Affordable Care Act (PPACA).

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 members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, including productivity and quality of life, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions.

Access to these cutting-edge technologies is of particular concern to Medicaid and CHIP beneficiaries, who may have the greatest need for these new technologies while at the same time face barriers to access due to their low-income status. BIO firmly believes that to fulfill the goals of PPACA, coverage standards for Medicaid beneficiaries enrolled in Alternative Benefit Plans must ensure meaningful coverage for this vulnerable population. Furthermore, any cost-sharing requirements for prescription drugs imposed on Medicaid beneficiaries should be designed to ensure that all drugs remain affordable and accessible.

While we support CMS’ efforts to move forward to adopt the changes to state Medicaid and CHIP programs required by PPACA, we have concerns that the proposed provisions leave particularly at-risk populations vulnerable in critical ways, and therefore we urge CMS to consider the following comments, discussed in more detail below.

• As noted in our comments to the November 26, 2012 EHB proposed rule, attached as an appendix here, we continue to have concerns about the adequacy of the EHB prescription drug benefit, which will apply to Medicaid beneficiaries enrolled in Alternative Benefit Plans effective January 1, 2014.
• Allowing states to charge up to an $8 “co-payment” for non-preferred drugs to the poorest Medicaid beneficiaries will adversely impact patient access and adherence to medication. We are especially concerned that allowing states to impose cost-sharing on adults for Advisory Committee on Immunization Practices (ACIP)-recommended vaccines would hinder Medicaid beneficiaries from obtaining these vital preventive services. We request CMS clarify the cost-sharing requirements for vaccines across the different components of the Medicaid program and we strongly urge CMS to encourage states to adopt policies that prohibit cost-sharing for these services across all components of their Medicaid programs.
• We anticipate significant complexities associated with applying both the existing requirements of the Medicaid statute, such as section 1927 of the Social Security Act (SSA), and the EHB requirements to Alternative Benefit Plans. We urge CMS to address these ambiguities in any final rule.
• By focusing on cost-effectiveness alone, the definition of “preferred drugs” does not allow for an adequate consideration of individualized patient needs.