Medicare's Patient Registry Is Slowing Alzheimer’s Treatment Access

 The burden of Alzheimer’s disease in America is significant and growing. Our healthcare system can only manage this illness at scale by massively expanding and decentralizing access to treatment.

Within five years, the United States will have more people over age 65 than under age 18. Emerging genetic research shows that Alzheimer’s can be detectable up to 20 years before symptoms arise, forecasting an explosion of the disease in the years ahead. After decades of managing only the symptoms of this disease, new medicines now enable healthcare providers to treat the disease proactively. However, patients will not be able to access these groundbreaking treatments and improve their quality of life if we do not address the significant challenges blocking their path.

The Alzheimer’s care continuum is complex, requiring patients to be screened, diagnosed, referred for treatment, and closely monitored throughout a 12-18 month treatment course. There are significant bottlenecks that arise in this process. Perhaps the most critical arises at the handoff from diagnosis to treatment at an infusion center. These local outpatient clinics, responsible for administering the new Alzheimer’s treatments monthly or bimonthly, are overwhelmed by the administrative burden imposed by the CMS patient registry requirement in order to cover treatment for Medicare beneficiaries. Infusion centers must not only ensure that patients are enrolled and re-registered every six months, but also coordinate with prescribers and imaging centers to confirm MRI and PET scan results—tests that are needed to confirm treatment progress and monitor potential side effects—before administering each infusion.

A new study by the National Infusion Center Association (NICA) found that the registry process significantly delays treatment for many patients. Infusion providers must dedicate staff solely to registry management and care coordination. In one instance, an infusion center reported delays of up to three weeks for some patients because of gaps in communication between the prescriber’s office and the imaging center—time that patients with a progressive brain disease simply cannot afford. The study also highlighted how these administrative hurdles, coupled with a lack of PET scan facilities and unclear CMS guidance, prevent some centers from offering Alzheimer’s therapies altogether.

CMS’s registry requirement was originally intended to ensure continued evidence development, but in practice it is limiting patient access to these life-saving treatments.

According to Christine Mann, Chief Commercial Officer and Executive Director of DENT Infusion Centers, “This is a vulnerable patient population that requires finesse and detailed attention along the entire journey to the chair. The numerous steps required to get patients on therapy and the requirements to keep them on therapy are challenging to navigate, and we do not want anyone who needs treatment left behind.”

The problem is further exacerbated by the lack of CMS guidance on who is responsible for specific registry tasks and how to navigate the process successfully to ensure timely payment of claims. Infusion providers state that the reimbursement does not offset the cost of care coordination, and many feel forced to dedicate resources to administrative tasks that take away from patient care.

The agency must prioritize patients over paperwork. CMS should shift the continued evidence development requirement away from a patient registry to a retroactive claims analysis. This would allow CMS to collect the necessary safety and efficacy data without placing the onus of coordination and registration on providers. Retroactive claims analysis could streamline data collection, ensure that patients continue receiving care without delay, and relieve infusion centers of unnecessary administrative burden. CMS can still achieve its goals for data collection, but without interrupting care and overburdening providers.

It’s time for CMS to modernize its approach to evidence development. Patients are already being treated in large numbers across the country. With thousands of patients undergoing treatment, there should be sufficient data on safety and efficacy to ease the restrictive registry requirements. Moreover, CMS must provide clear, public guidance on the process, ensuring infusion centers and prescribers know exactly who is responsible for what, reducing confusion and eliminating unnecessary treatment delays.

By working with providers, infusion centers, and other stakeholders, CMS can develop a streamlined process that prioritizes patient care, alleviates unnecessary burdens, and ensures the continued success of these breakthrough treatments. The clock is ticking, and as the Alzheimer’s population continues to grow, we cannot afford to wait.

Brian Nyquist, MPH, is President & Chief Executive Officer, National Infusion Center Association.

https://www.realclearhealth.com/articles/2024/11/22/medicares_patient_registry_is_slowing_alzheimers_treatment_access_1074126.html