BIO Submits Comments Re: Medicare CY 2018 Revisions to Payment Policies Under the Physician Fee Schedule (PFS) and Other Revisions to Part B

Dear Administrator Verma:

The Biotechnology Innovation Organization (BIO) appreciates this opportunity to comment on the calendar year (CY) 2018 Physician Fee Schedule (PFS), other revisions to Part B, and Medicare Shared Savings Program (MSSP) Proposed Rule (Proposed Rule),1 published by the Centers for Medicare & Medicaid Services (CMS) on July 21, 2017.

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 represents an industry that is devoted to discovering new treatments and ensuring patient access to them. Accordingly, we closely monitor changes to Medicare’s reimbursement rates and payment policies for their potential impact on innovation and patient access to drugs and biological. In this letter, BIO responds to CMS’s proposals in the order in which the Agency addresses each issue in the Proposed Rule, for ease of reference. However, there are several issues of particular importance to our members given the goal of ensuring patient access to necessary vaccines, treatments, and therapies.

These include the following recommendations:

CMS should not finalize its proposed reduction in payment under the PFS for services provided in off-campus provider-based departments (PBDs) of hospitals and should maintain payment at 50 percent of the OPPS rate until a lower rate is justified by thorough analyses of the cost of such services.

•  CMS should not finalize the proposed reduction for Current Procedural Terminology (CPT®)2 code 96372 (subcutaneous or intramuscular injection), which will reduce patient access to drugs administered under this code, and, if implemented, should phase in any significant reduction over time.
•  CMS should create a unique Healthcare Common Procedure Coding System (HCPCS) code and separate payment for each individual biosimilar product, including those that are based on a common reference product, to foster a robust market for biosimilars.
•  CMS should finalize its proposal to establish separate payment for additional chronic care management and behavioral health integration services.
•  CMS should ensure that it expands the Medicare Diabetes Prevention Program model only by exercising appropriate authority under the Center for Medicare and Medicaid Innovation (CMMI) waiver and in accordance with the statutory criteria for expansion of CMMI demonstration models.