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BIO Submits Comments re: Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses Proposed Rule

On January 25, BIO submitted comments in response to the Centers for Medicare and Medicaid Services' (CMS') Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses Proposed Rule. BIO is extremely concerned to see the Agency continue to focus on policy changes that erode the value of the Medicare benefit for seniors, placing patient access at risk. This Proposed Rule is yet another in a series of proposals that prioritize cost containment policies over patient healthcare needs. BIO respectfully requests that the Agency and Administration instead focus on holistic solutions that balance the financial sustainability of the Medicare program, while addressing patient out-of-pocket cost and access to appropriate treatment. Our concerns, detailed further in the balance of this letter, focus on the following:

I. CMS should not allow plans to restrict access in the Medicare Part D six protected classes, as plans already have flexibility to manage these drugs in a clinically appropriate manner.
II. CMS must go further in protecting beneficiaries enrolled in Medicare Advantage who may be subject to step therapy for their Part B drugs.
III. CMS should not move forward with the inclusion of drug pricing information in the explanation of benefits, and instead focus on the updates to e-Prescribing standard to appropriately share cost information.
IV. CMS must continue to work to ensure that patients see the benefit of negotiated prices reflected in their out-of-pocket (OOP) costs.
V. CMS should move forward with the proposed requirements prohibiting gag clauses.

Dear Administrator Verma,

The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS’) Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses Proposed Rule (Proposed Rule).

BIO is the world's largest trade association representing 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, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions. BIO membership includes biologics and vaccine manufacturers and developers who have worked closely with stakeholders across the spectrum, including the public health and advocacy communities, to support policies that help ensure access to innovative and life-saving medicines and vaccines for all individuals.

BIO members represent the entire biotechnology innovation ecosystem devoted to the discovery of new treatments – from universities and research institutes, to start-up biotechnology companies, to the private investors that risk massive amounts of capital to fund these companies, to the larger, established companies that play a critical role in bringing these life-changing innovations through the development and approval process and into the marketplace. Of our approximately 1,000 members, the vast majority are small companies engaged in some of the most challenging, cutting-edge research in the world. They typically have no marketed products and no profits, and thus are heavily reliant on private capital to fund their work. They take enormous risks every day to develop the next generation of biomedical breakthroughs for the millions of patients suffering from diseases for which there currently are no effective cures or treatments.

BIO is therefore extremely concerned to see the Agency continue to focus on policy changes that erode the value of the Medicare benefit for seniors, placing patient access at risk. This Proposed Rule is yet another in a series of proposals that prioritize cost containment policies over patient healthcare needs. BIO respectfully requests that the Agency and Administration instead focus on holistic solutions that balance the financial sustainability of the Medicare program, while addressing patient out-of-pocket cost and access to appropriate treatment. Our concerns, detailed further in the balance of this letter, focus on the following:

I.CMS should not allow plans to restrict access in the Medicare Part D six protected classes, as plans already have flexibility to manage these drugs in a clinically appropriate manner.
II. CMS must go further in protecting beneficiaries enrolled in Medicare Advantage who may be subject to step therapy for their Part B drugs.
III. CMS should not move forward with the inclusion of drug pricing information in the explanation of benefits, and instead focus on the updates to e-Prescribing standard to appropriately share cost information.
IV. CMS must continue to work to ensure that patients see the benefit of negotiated prices reflected in their out-of-pocket (OOP) costs.
V. CMS should move forward with the proposed requirements prohibiting gag clauses.

We recognize that too many patients – even those with insurance – cannot afford the life-saving treatments that are being developed, and we are committed to working to address this serious problem. As we have stated before, to accomplish this, we must harness – not abandon – the free market that has delivered amazing innovations for patients and made America first in the world in biomedical innovation. To this end, we urge the Administration to prioritize policies that ensure patients maintain timely access to necessary medicines, while directly reducing their OOP costs.