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CLSA Comments to Administration on IPI Proposal ANPRM– December 2018

December 31, 2018

The Honorable Seema Verma
Administrator
Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244

Re: International Pricing Index Model for Medicare Part B Drugs [Docket Number CMS-5528-ANPRM]

Dear Administrator Verma:

On behalf of the California Life Sciences Association (CLSA) – the premier statewide public policy and business leadership organization representing California’s life science innovators, including medical device, diagnostic, biotechnology and pharmaceutical companies, research universities and private, non-profit institutes, and venture capital firms – we are writing to express our serious concerns with the Centers for Medicare & Medicaid Services’ (CMS) advanced notice of proposed rulemaking of the International Price Index (IPI) Model for Medicare Pat B Drugs (the ANPRM). This proposal, and its aggressively accelerated timeline, would make sweeping changes to payment mechanisms for Medicare Part B covered drugs that will directly and negatively impact California’s most vulnerable seniors’ access to life-saving therapies. Given the breadth of our concerns detailed herein and the adverse effects that will be directly felt by Medicare beneficiaries if these changes were to be implemented, we respectfully request that CMS withdraw the proposed rule.

California is home to a thriving life sciences community with more than 3,400 companies providing approximately 311,226 jobs throughout the state.1 The efforts of California’s innovative companies and research institutions have led to groundbreaking therapies and technologies to diagnose, treat and prevent conditions such as cancer, cardiovascular disease, diabetes, HIV/AIDS, chronic pain, Alzheimer’s, Parkinson’s Disease, rare diseases, and others. In 2018, California companies advanced research and development into more 1,300 new therapies – at least 433 of those medicines are to treat cancer.2 California innovators share one core mission: the desire to improve the health and well-being of patients in need.

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