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BIO Submits Comments Re: Medicare CY 2018 Part D Call Letter

BIO strongly supports CMS’s commitment to improving the quality of the Medicare Advantage (MA) and Part D programs. We consider it especially important to focus on policies that impact access to prescription drugs and biologicals for Medicare beneficiaries in MA and Part D plans. To further improve access to crucial therapies and immunizations for these patients, we urge CMS to consider the following comments, discussed in more detail below:

  • Cost-sharing in the Part D specialty tier can unduly burden patients with severe, complex diseases and is exacerbated by the fact that the dollar-per-month threshold on the specialty tier allows a broad range of therapies to be included. While we appreciated the effort in 2017 toward increasing the threshold, BIO urges CMS to continue to substantially increase the threshold for 2018 and beyond. BIO also urges CMS to review the specialty tiers to ensure they do not discourage enrollment by certain Part D-eligible individuals.
  • CMS should continue to seek information on the Part D tiering exceptions process and ensure that tiering structures do not impede beneficiary access to medically necessary and appropriate treatments.
  • CMS should ensure that the timeframe and process for formulary updates reasonably allows for the addition of new therapies.
  • CMS should work to make Medicare Plan Finder inclusive of the most up to date formulary information to best inform beneficiary prescription drug coverage choice.
  • CMS should finalize the proposal to include a new display measure around the adjudication process and should continue efforts to further increase transparency around this process to provide patients with appropriate access to needed medicines.
  • CMS should evaluate access to specialty pharmacies in considering network adequacy and patient access issues.
  • CMS should continue to encourage increased beneficiary vaccination rates and ensure MA plans deem vaccinations provided by pharmacists, in accordance with state laws, as in-network providers for these services.
  • CMS should finalize the movement of the High Risk Medication (HRM) measure from the Star Ratings to the display measures.
  • CMS should ensure that innovative model testing in the Medicare program works to maintain or improve beneficiary access to appropriate care and treatment.
  • CMS should look to include display measures consistent with the goals of the National Action Plan for Adverse Drug Event Prevention in future years.
  • CMS should finalize the clarification around "reference-based pricing"2 in Part D beneficiary cost-sharing arrangements.
  • CMS should look to further ensure market stabilization for the dually eligible population in Puerto Rico.

Dear Dr. Tudor:

The Biotechnology Innovation Organization (BIO) appreciates this opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) Draft 2018 Call Letter.1 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. Our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, including productivity and quality of life, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions.

BIO strongly supports CMS’s commitment to improving the quality of the Medicare Advantage (MA) and Part D programs. We consider it especially important to focus on policies that impact access to prescription drugs and biologicals for Medicare beneficiaries in MA and Part D plans. To further improve access to crucial therapies and immunizations for these patients, we urge CMS to consider the following comments, discussed in more detail below:

  • Cost-sharing in the Part D specialty tier can unduly burden patients with severe, complex diseases and is exacerbated by the fact that the dollar-per-month threshold on the specialty tier allows a broad range of therapies to be included. While we appreciated the effort in 2017 toward increasing the threshold, BIO urges CMS to continue to substantially increase the threshold for 2018 and beyond. BIO also urges CMS to review the specialty tiers to ensure they do not discourage enrollment by certain Part D-eligible individuals.
  • CMS should continue to seek information on the Part D tiering exceptions process and ensure that tiering structures do not impede beneficiary access to medically necessary and appropriate treatments.
  • CMS should ensure that the timeframe and process for formulary updates reasonably allows for the addition of new therapies.
  • CMS should work to make Medicare Plan Finder inclusive of the most up to date formulary information to best inform beneficiary prescription drug coverage choice.
  • CMS should finalize the proposal to include a new display measure around the adjudication process and should continue efforts to further increase transparency around this process to provide patients with appropriate access to needed medicines.
  • CMS should evaluate access to specialty pharmacies in considering network adequacy and patient access issues.
  • CMS should continue to encourage increased beneficiary vaccination rates and ensure MA plans deem vaccinations provided by pharmacists, in accordance with state laws, as in-network providers for these services.
  • CMS should finalize the movement of the High Risk Medication (HRM) measure from the Star Ratings to the display measures.
  • CMS should ensure that innovative model testing in the Medicare program works to maintain or improve beneficiary access to appropriate care and treatment.
  • CMS should look to include display measures consistent with the goals of the National Action Plan for Adverse Drug Event Prevention in future years.
  • CMS should finalize the clarification around "reference-based pricing"2 in Part D beneficiary cost-sharing arrangements.
  • CMS should look to further ensure market stabilization for the dually eligible population in Puerto Rico.