BIO submitted comments in response to the Centers for Medicare and Medicaid Services' (CMS's) CY 2018 Updates to the Quality Payment Program Proposed Rule. BIO supports the development and implementation of the Quality Payment Program (QPP) tracks: Advanced Alternative Payment Models (APMs) and the Merit Based Incentive Payment System (MIPS), in a manner that improves overall healthcare quality, while not compromising access to the most appropriate care and treatment.

BIO submitted comments in response to the Centers for Medicare and Medicaid Services' (CMS's) Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System Proposed Policy Changes and Fiscal  Year 2018 Rates Proposed Rule on June 13, 2017. BIO supports the development and use of appropriate, evidence-based quality measures throughout the healthcare system as a component of improving efficiency and clinical outcomes; additionally, we support policy proposals driven at increasing access to innovative care. BIO's comments in the letter are divided into two sections - the first focusing on the proposals contained in the FY 2018 Proposed Rule, and the second for providing feedback on the Request for Information.

BIO submitted a report to the United States Trade Representative regarding the agency’s 2017 Special 301 Review.

BIO submitted comments to the Food and Drug Administration (FDA) on the statement of work for assessment of the Program for Enhanced Review Transparency and Communication for Original 351(k) Biologics License Applications in Biosimilar User Fee Act II. BIO supports the approach described in the BsUFA II Performance Goals of establishing a review approach for biosimilars applications patterned generally after the program established under PDUFA V for New Molecular Entity (NME) and new Biological License Applications (BLAs). BIO agrees the evaluation must be public, include input from FDA staff and sponsors, and provide recommendations at the mid-point and at the end of the program for any changes necessary for the program to succeed.