Contributor: Medicare Should Empower Patients With CKD to Choose Home-Based Health Therapy Options

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 2 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: patients with kidney disease. 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 FDA approved therapies.

Consider 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 iron supplements don’t work. Traditionally, this condition has required patients not yet dependent on dialysis 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, approximately 3-in-5 (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 healthcare, it make sense to allow Americans with renal anemia to be treated safely in the comfort of their own homes.

A peer-reviewed study examining patients with advanced CKD shows that “Compared with usual care, ferric citrate coordination complex treatment resulted in significantly fewer annualized hospital admissions, fewer days in hospital, and a lower incidence of the composite end point of death, provision of dialysis, or transplantation.” ¹

Unfortunately, many Medicare beneficiaries living with IDA and advanced CKD who are not on dialysis face payment barriers for accessing this oral alternative therapy. Currently, CMS does not provide Medicare coverage for ferric citrate for the treatment of IDA for individuals with CKD, though treatment is widely covered by many other public and private payers. Medicare only covers the therapy when the individual reaches kidney failure, or end-stage renal disease (ESRD).

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, Representatives Tom O'Halleran, D-Arizona; Larry Bucshon, R-Indiana; Markwayne Mullin, R-Oklahoma; and G.K. Butterfield, D-North Carolina, are championing bipartisan legislation (the Renal Anemia Innovation Support and Expansion (RAISE) Act, HR 2934) that would restore Medicare coverage for oral medications that treat renal anemia at home.

Now more than ever, patients with CKD 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.

Reference

1. Block GA, Block MS, Smits G, et al. A pilot randomized trial of ferric citrate coordination complex for the treatment of advanced CKD. J Am Soc Nephrol. 2019;30(8):1495-1504. doi:10.1681/ASN.2018101016