The Centers for Medicare & Medicaid Services (CMS), a federal agency in the US Department of Health and Human Services (HHS) that administers the Medicare program and works in partnership with state governments to administer Medicaid, the Children’s Health Insurance Program (CHIP), and health insurance portability standards, has issued a final rule designed to modernizes and improves the Medicare Advantage and Part D programs. These changes will ensure that patients have greater transparency into the cost of prescription drugs in Part D and, at the same time, enable Medicare Advantage plans to negotiate better prices for physician-administered medicines in Part C.
The current Part D policy requires sponsors to include on their formularies all drugs in six categories or classes: 1) antidepressants; 2) antipsychotics; 3) anticonvulsants; 4) immunosuppressants for treatment of transplant rejection; 5) antiretrovirals; and 6) antineoplastics; except in limited circumstances. And under the same policy, Part D sponsors are only permitted to impose prior authorization and step therapy requirements for beneficiaries initiating therapy for 5 of the 6 protected classes, with no prior authorization or step therapy allowed for antiretrovirals. The final regulatory provision codifies this existing policy, which has been in effect since 2006.
In a statement made the president of the American Society of Clinical Oncology (ASCO), Monica M. Bertagnolli, MD, FACS, FASCO, said: ?We applaud the Centers for Medicare & Medicaid Services (CMS) for listening to ASCO and other stakeholders by not finalizing a proposal that would have significantly impacted access to drugs within the Six Protected Classes. The CMS final rule effectively maintains many of the protections for Medicare beneficiaries with cancer and other chronic illnesses under Medicare Part D. While we support efforts to control drug prices, optimal cancer care requires patient access to the most medically appropriate drug, at the most opportune time, based on the highest quality evidence.
?We are disappointed, however, that CMS finalized its proposal to allow the use of step therapy for protected class prescription drugs under Medicare Advantage and Medicare Part B. Step therapy requires patients to try and fail to have a desired clinical outcome on a lower cost medication before they can access the medication prescribed by their health care provider. This not only delays patient access to proper treatments, it potentially leads to irreversible disease progression and other significant patient health risks.
?ASCO is dedicated to working with policymakers to lower the cost of prescription drugs and strengthen the nation?s healthcare delivery system, but we must also preserve access to high-quality care for all Americans with cancer. We look forward to working with the Administration on a solution for rising cancer care costs that does not put Medicare beneficiaries at risk.?