NICA Responds to Step Therapy in Medicare Advantage Plans
In comments submitted to the Centers for Medicare and Medicaid Services (CMS), the National Infusion Center Association (NICA) expressed its concern with the CMS policy allowing Medicare Advantage (MA) plans to utilize step therapy, also known as “fail first”, strategies for Part B drugs. NICA penned its comments on behalf of the hundreds of thousands of patients across the country who require provider-administered injectable or infusible medications to manage chronic autoimmune diseases, as well as the infusion providers who treat them.
“NICA supports the administration’s goals to reduce cost across the Medicare program while ensuring access to medically necessary Medicare-covered benefits. Medicare Advantage (MA) plans need to have tools at their disposal to control unnecessary utilization of medical benefit drugs and manage overall costs,” wrote Brian Nyquist, MPH, executive director of NICA. “However, there is great concern that permitting the application of step therapy in MA plans for Part B drugs may not achieve these goals and rather produce unintended consequences. Particularly, in the absence of strong safeguards to ensure beneficiaries are protected.”
Step therapy is a utilization management technique frequently used by health insurers to control costs by forcing patients to try medications preferred by the insurer before approving the medication that was prescribed by the patient’s doctor.
NICA opposes insurer practices to intervene in the patient-physician relationship, superseding the prescribing authority of the prescriber, and dictate a treatment protocol for patients.
As such, NICA is opposed to step therapy for biologics and other provider-administered intravenous/injectable drugs because these policies have the potential to produce poorer health outcomes, reduce quality of life, unnecessarily increase health care consumption, and increase costs.
“For some medications, step therapy – or ‘fail first’ policies – may be reasonable; such as when clinical risk is low, the time to fail is short, and the cost to fail is low,” said Nyquist. “However, for biologics and most medical benefit drugs, step therapy is inappropriate because the clinical risk is high, the time to fail is long, and the cost to fail is high.”
Should CMS move forward in implementing step therapy in MA plans for Part B drugs, NICA recommended the following safeguards in order to mitigate increased clinical risk, cost, and delayed treatment:
• Step therapy requirements must not increase beneficiaries’ out-of-pocket costs or clinical risk (e.g., immunogenicity);
• Step therapy requirements must not be discriminatory (e.g., specific to a disease state or specialty);
• Step therapy guidelines must align with clinical guidelines and be supported by clinical evidence
• Step therapy requirements must not step across benefit plans (e.g., Part D drug before Part B drug or vice versa);
• MA plans utilizing step therapy policies must be transparently denoted and displayed on the MA plan finder portal;
• A transparent and expeditious exception process should exist, like those that many states are establishing in a statute, with a mandatory response time of 72-hours, or 24-hours in the case of a medical emergency;
• “Look-back” periods must be consistent with clinical guidelines and appropriate for the beneficiaries’ condition(s), so patients who have completed step therapy requirements are not subjected to the same step therapy requirements again in order to restart therapy;
• Protections for beneficiaries that become “new” patients after the “look -back” period (e.g., compiled with step therapy requirements, but discounted therapy for > 108 days and are seeking to restart therapy).
NICA concluded its comments to CMS by praising the administration’s efforts to control the rising cost of drugs and out-of-pocket spending for patients and reiterated its commitment to working with CMS to develop “all win” solutions that lower drug spend while ensuring patients’ access to Medicare-covered benefits.
“There are many complex, multi-faceted challenges facing the sustainability of our health care system, concluded Nyquist. “As the cost of expensive biologics and other specialty medications continue to increase, it is important to explore strategies to reduce unnecessary consumption of these high-cost drugs and mitigate Medicare’s cost burden, while preserving access to these medications for those that desperately need them.”