The Centers for Medicare & Medicaid Services (CMS) recently released a final rule for Medicare Part D that codified its decision to allow Medicare Advantage plans to use step therapy, or “fail first,” for new starts of drugs for cancer and other serious diseases.1
Step therapy requirements are driven by financial interests to save money and not by what is in the best interest of patients. This final rule puts medical decision making in the hands of middlemen—health plans and pharmacy benefit managers (PBMs)—who can force use of older, less-appropriate cancer treatment or drugs simply based on cost.
With cancer, every day counts. It is a devastating, time-sensitive disease, and receiving the right drug quickly is critical. If it is delayed or denied, that means a patient’s cancer progresses unchecked, which can literally make the difference between life and death.
Even before this final rule, oncology professionals have been raising the alarm of patients facing significant difficulty accessing the evidence-based treatments prescribed for their individual cancers. This includes lengthy delays and questionable denials for access to life-saving treatment.
The Community Oncology Alliance (COA) has compiled a collection of stories relating practices’ experiences with PBMs pulled from an extensive and ever-growing database of real stories submitted by practices across the country.2 Giving Medicare middlemen more authority to place hurdles between patients, clinicians, and their prescribed therapies is making the challenge of treatment access even worse.
Even though CMS proposes an appeals process and patient safeguards to expanded “fail first” step therapy, it is inhumane to require patients receiving cancer treatment—or their already overwhelmed and distressed family members and/or caregivers—to navigate a bureaucratic appeals process. Moreover, this entire new process places an additional burden on providers caring for their patients. Indeed, today it is not uncommon for community oncology practices to report having dedicated staff assigned to spending endless hours trying to overcome denials of medication needed by critically ill patients.
While we are all concerned about the impact of sky-high drug prices, so-called solutions like “fail first” step therapy create new problems that harm patients with cancer. Our elected representatives in Washington should rescind and reconsider this rule.
1. Centers for Medicare & Medicaid Services. Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses. Federal Register. https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-10521.pdf. Published May 23, 2019. Accessed May 29, 2019.
2. Community Oncology Alliance. Horror Stories. communityoncology.org website. https://www.communityoncology.org/category/horror-stories/. Accessed May 29, 2019.