CMS’s Final Medicare Part D Ruling Preserves Patient Access to Certain Cancer Drugs
Medicare Part D will continue to give patients access to certain cancer drugs, according Centers for Medicare and Medicaid Services’ (CMS’s) final ruling issued May 16, 2019 (https://federalregister.gov/d/2019-10521). The final rule does not allow for utilization controls like step therapy and prior authorizations for patients who are already in an established treatment regimen; does not restrict drugs that have had certain price increases over a specified time period; and does not restrict new formulations of an existing protected class drug.
Under the current policy, certain classes of drugs, including those for cancer, are protected in Medicare Part D from some formulary restrictions. To reduce costs, CMS had proposed in November 2018 (https://federalregister.gov/d/2018-25945) to give insurers flexibility to exclude drugs from formulary in certain circumstances and add utilization controls, such as prior authorizations and step therapy, which requires patients to try and fail first on a lesser expensive drug before receiving a more costly one prescribed by their health provider.
ONS joined patient advocates in issuing letters to Department of Health and Human Services Secretary Azar expressing concerns with the proposed rule, including that prior authorizations add administrative burden to nurse workload and patients can suffer delays in treatment. Another voiced concern was about risks of patients faring well on a certain cancer drug having to suddenly change their regimen.
Although CMS took the positive step to strengthen and make more timely the appeals process for Part B drugs covered by Medicare Advantage plans, concerns remain that health plans can still implement restrictive utilization controls such as step therapy for Medicare Part B drugs, which are typically provided in a physician or nurse practitioner’s office and include infused and injected cancer drugs like chemotherapy.