BIO Submits Comments Re: Medicare CY 2018 Updates to the Quality Payment Program

Dear Administrator Verma:

The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) CY 2018 Updates to the Quality Payment Program 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 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. Our comments, detailed further in the balance of this letter, focus in the following areas:

•      CMS should not finalize its proposal to include Part B drug costs in the MIPS adjustment, as such a policy could severely impact patient access to high quality care and treatment.
•  CMS should finalize the proposal to update the low-volume threshold, but look to provide additional transparency around the process for future updates.
•  CMS should move forward with the proposal to provide a bonus for complex patients and small practices to protect access to care.
•  CMS should not finalize the proposed expansion of the definition of a hospital-based MIPS eligible clinician.
•      CMS should finalize the proposal of a zero percent weight for cost performance in 2018.
•  CMS should continue the process of updating the episode-based payment measures and collect robust stakeholder feedback on inclusion of these measures in MIPS.
•  CMS should ensure that any additional feedback provided on the cost performance category is comprehensive and looks at the totality of care, rather than specific subsets of care.
•  CMS should ensure the continued strengthening of the quality performance category through use of the most up-to-date, relevant quality measures, working in conjunction with measure stewards and endorsers.
•  CMS should refine the quality benchmark proposal for 2018, so as not to disadvantage certain provider specialties.
•  CMS should maintain the same five percent APM quality measure bonus cap as was in place for 2017, and not move to a ten percent cap.
•  CMS should add further clarity, transparency, and an expanded response timeline in the criteria for Physician-Focused Payment Models (PFPMs) reviewed by the Physician-Focused Technical Advisory Committee (PTAC), particularly if CMS  
       chooses to broaden the definition of PFPMs.
•  CMS should include additional meaningful narrative context to help patients understand the MIPS eligible clinician and group performance information available on Physician Compare.
•      CMS should finalize the proposed changes around the Immunization Registry Reporting Measure and performance score, and seek out future opportunities to increase provider participation in immunization registries.
•  CMS should consider adding vaccine-specific measures to the list of cost-cutting measures in the future.
•  CMS should finalize the immunization measures in the APM scoring standard and the proposed new and modified MIPS specialty measure sets for 2018, and identify opportunities to expand immunization measures in future years.
•  CMS should develop more sophisticated means to compare providers of the same or similar specialties under MIPS, such as use of CMS-approved healthcare provider taxonomy codes.
•  CMS should identify opportunities to incorporate guidelines-driven algorithms into health information technology (HIT) to help better identify and track certain disease states.
•  CMS should finalize the proposal to update the process for Qualified Clinical Data Registry annual nominations.
•  CMS should consider further expansion of measures around achieving health equity in clinical trials.