The pandemic has reshaped the health care system in ways no one could have imagined.
Access to care and therapies in the home setting, for instance, has transformed over the last two years. From telehealth to home health reform, many of our country’s most vulnerable patients have been able to rest, recover, and avoid the risk of COVID-19 transmission by receiving treatment in the comfort and safety of their living rooms. Thanks to widespread coverage, these convenient, patient-preferred trends have improved access, choice, and outcomes.
We must continue to build on these innovations in order to streamline care for one of America’s most vulnerable populations: kidney patients. Some 37 million Americans live with chronic kidney disease (CKD), a serious condition that occurs when the kidneys fail to effectively filter out toxic waste and extraneous fluid from the body. Without timely, regular treatment, kidney patients face a significantly elevated risk of stroke, heart disease, and premature death. Despite these dire consequences, frustrating barriers to care still exist that can be reduced by expanding patients’ access to all Food and Drug Administration (FDA) approved therapies.
Consider CKD patients dealing with a comorbidity called renal anemia that impacts more than 15% of kidney patients, including more than half of patients with Stage 5 CKD. Caused by insufficient amounts of red blood cells to carry oxygen throughout the body, renal anemia can occur early in CKD progression even if the symptoms including severe fatigue are not always obvious. In order to prevent hospitalization and debilitating complications, renal anemia patients need special drugs that help their kidneys absorb iron. Due to the unique nature of the condition, over the counter supplements don’t work. Traditionally, this condition has required non-dialysis dependent patients to make the trek to infusion centers, where they undergo an hours-long intravenous (IV) infusion process.
In the best of times, visiting infusion centers was inconvenient and burdensome, especially for patients with tricky work schedules or difficulty accessing transportation. But once COVID-19 began spreading rapidly across the country, the challenges became even greater.
Living with a serious underlying condition, CKD patients who contracted the virus faced significantly higher intensive-care unit admission and mortality rates. Among Medicare Fee-for-Service beneficiaries hospitalized with COVID-19, approxmately three-in-five (58%) have CKD. And, underscoring the increased risks associated with treatment outside of the home, CKD patients in congregate treatment settings are 17 times more likely to contract COVID-19.
Continued medical innovation has led to a safe and effective oral treatment for renal anemia that can be taken at home rather than through IV infusion in a clinical setting. With the growing popularity of telemedicine, in-home laboratory testing, and home health care, it makes sense to allow Americans with renal anemia to be treated safely in the comfort of their own homes.
Unfortunately, many renal anemia patients do not have access to these treatments because the Centers for Medicare & Medicaid Services (CMS) withdrew coverage. Peer-reviewed research shows that the the FDA-approved, pill-based treatment is more effective than intravenous treatments on a variety of indicators including fewer hospital admissions, fewer days in the hospital, and lower incidence of death.
The treatment is widely covered by other public and private payers; however, the Medicare population lacks access to these drugs because Medicare will cover the medication only when an individual has kidney failure and transitions to dialysis care.
There is no valid reason to deny vulnerable Medicare beneficiaries’ coverage for a patient-preferred drug that helps delay disease progression and improve quality of life. Nor is it fair to force patients to upend their lives and risk COVID-19 infection at infusion centers when an alternative at home treatment option exists. Put simply, Medicare must follow the science. The oral drug made it through the extremely rigorous FDA approval process and is covered by nearly every other payer — so why is it not readily available to America’s kidney disease patients?
Fortunately, Reps. Tom O'Halleran (D-Ariz.), Larry Bucshon (R-Ind.), Markwayne Mullin (R-Okla.), and G.K. Butterfield (D-N.C.) are championing bipartisan legislation (the Renal Anemia Innovation Support and Expansion (RAISE) Act, H.R. 2934) that would restore Medicare coverage for oral medications that treat renal anemia at home.
Now more than ever, America’s kidney patients need more control over their care. While many may still choose to receive IV infusions if recommended by their physicians, Medicare must cover safe, convenient, home-based options. While the worst of the pandemic may be over, it’s clear that COVID-19 is here to stay—meaning it is critical to protect this uniquely vulnerable patient population well into the future.
Wayne Winegarden, Ph.D., is a Sr. Fellow in Business and Economics and Director of the Center for Medical Economics and Innovation at the Pacific Research Institute.
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