BIO Submits Comments Re: Hospital Inpatient Prospective Payment Systems (IPPS) Proposed Rule

Dear Administrator Verma:

The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the Center for Medicare and Medicaid Services’ (CMS’/the Agency’s) Hospital Inpatient Prospective Payment Systems (IPPS) for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System Proposed Policy Changes and Fiscal Year (FY) 2019 Rates Proposed Rule (the "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’s comments on the Proposed Rule are focused on the following areas:

•  Proposed changes to the IPPS for coverage and payment of Chimeric Antigen Receptor T-cell (CAR T) Therapy and other Transformative Therapies;
•  Updates to the Medicare Severity – Diagnosis Related Groups (MS-DRG) to appropriately account for care delivered, including for patients with rare diseases;
•      Applications for FY 2019 New Technology Add-On Payments (NTAP) and the process for determination of receipt of NTAP status;
•  Improving patient outcomes and reducing burden through meaningful measures and expanding access to vaccines through appropriate quality measures; and
•  Requirements for hospitals to make public a list of their standard charges via the Internet.