Placeholder Banner

BIO Submits Comments Re: CY 2019 Medicare Physician Fee Schedule and Other Revisions to Part B

September 14, 2018

The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) Medicare Physician Fee Schedule (PFS) and Other Revisions to Part B for calendar year (CY) 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; and Medicaid Promoting Interoperability Program ("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 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 biologicals.

As a threshold matter, we raise our concern with the implementation of a policy that can have such impacts in limiting access for beneficiaries in MA via the application of step therapy, as detailed in the Administration’s August 7th memo.2 As detailed in our letter to the Administration, we are particularly concerned with the lack of specificity or detail in this memo around critical patient protections and appropriate implementation, including ensuring: sufficient oversight by CMS; clear clinical criteria for step therapy policies; transparency into, and communication of, step therapy policies to beneficiaries and robust beneficiary protections; timely exceptions and appeals processes; sufficient protections for those on existing therapies; and protection for beneficiaries from higher cost-sharing.

Inappropriately applying or implementing stringent utilization management tools, especially without adequate parameters or guardrails, can force inappropriate treatment choices and negatively impacting patient health outcomes. These potential consequences are especially concerning when considering that this new policy is intended to impact those Medicare beneficiaries seeking treatment for the most serious, often life-threatening conditions, such as cancer, autoimmune disorders, ESRD, and hemophilia – conditions that already are complex for providers and patients to manage appropriate and that often can require immediate access to the most effective therapy available in order to avoid life-threatening or irreversible negative complications. Policies such as step therapy that delay access to the most appropriate therapy in an effort to reduce upfront expenditures are not only harmful for patients, but they are short-sighted, as there is substantial potential for increased overall healthcare costs and adverse patient outcomes due to avoidable hospitalizations, doctors’ visits, and procedures.

We therefore strongly urge the Agency to reverse course on this new policy, given its potential for serious negative impacts for Medicare beneficiary access to timely and appropriate treatment. However, if CMS insists on proceeding with this new policy, we believe there are a number of critical steps CMS must take to provide further predictability and transparency to Medicare beneficiaries in order to avoid detrimental disruptions in care under this new MA step therapy policy. We caution CMS against future action in rulemaking that may create barriers to patient access to the most timely and appropriate treatment for drugs delivered through Part B.

Download Full Comments Below
BIO Final Comments CY 19 PFS Proposed Rule 10 September 2018
See the full comment letter here:
Discover More
On November 9, BIO submitted comments on the FDA Draft Guidance, Drug-Drug Interaction Assessment for Therapeutic Proteins. In the comments, BIO thanks the FDA for the opportunity to submit comments but requests that the Guidance include a…
On August 6, BIO submitted comments on the NMPA Draft Technical Guideline on Clinical Trials of Cellular Immunotherapy Products. In the comments, BIO thanks NMPA for the opportunity to submit comments but argues for a more robust commenting period…
October 30, 2020 Re: Docket No. FDA–2020-D-1564: FDA Draft Guidance, Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation. Dear Sir/Madam: The Biotechnology…