As we continue to combat the unprecedented health and economic emergency caused by COVID-19, it’s critical that we take every possible step to ensure the health of vulnerable patient populations, including the nearly 38 million Americans who suffer from chronic kidney disease (CKD). Before this crisis erupted, kidney patients faced major obstacles accessing medical care. Now, with a growing body of research, government data and CDC warnings showing COVID-19’s disproportionate impact on kidney patients, especially minorities, policymakers must take proactive steps to ensure CKD patients can access care safely while avoiding exposure.
The multi-faceted kidney provider community has continued to deliver dialysis care to patients with End-Stage Renal Disease (ESRD), or kidney failure, during this crisis. But non-dialysis CKD patients still face increased risks in safely treating iron deficiency anemia (IDA)––a common complication of CKD which significantly decreases a patient’s quality of life and capacity to work, increases risk of heart attack and stroke, and accelerates the progression to kidney failure. IDA develops in the early stages of disease when the patient loses between 20 to 50 percent of normal kidney function. IDA in non-dialysis CKD patients has traditionally been treated with intravenous infusions which increase iron levels quickly enough to avoid health complications. But IV infusions are risky and painful, and as a 40-year kidney patient who has suffered from anemia I know this first-hand.
Unfortunately, Medicare patients with renal anemia must still travel to outpatient facilities to receive IV treatment. Much like dialysis patients, these patients face increased stress and risk of viral exposure when visiting outpatient care and infusion centers. To address this situation, one wise step lawmakers can take to ensure patients are able to safely treat their renal anemia would be to restore patient choice and access to the one FDA-approved oral therapy for IDA instead of intravenous infusion.
The oral therapy, ferric citrate coordination complex, is an innovative compound that has been clinically proven to effectively treat iron deficiency anemia in kidney patients not on dialysis. The drug is oral, allowing patients to remain safely at home, avoid COVID-19 exposure and bypass the added burden of visiting overwhelmed outpatient facilities. Since the FDA approval of the oral drug in 2014, ferric citrate has been hailed by physician groups, patients, and kidney advocacy organizations like the American Association of Kidney Patients as a safe and cost-effective treatment choice for renal anemia.
Yet, despite the clear advantage to kidney patient consumers, caregivers and medical professionals, the Centers for Medicare & Medicaid Services (CMS) — the federal agency responsible for administering Medicare — unilaterally decided to significantly reduce access to this patient preferred drug without soliciting patient input. In September of 2018, CMS excluded coverage for ferric citrate to treat IDA for kidney patients not on dialysis under Medicare Part D. Overnight, kidney patients on Medicare were deprived of access to the only FDA-approved oral treatment for iron deficiency anemia, adding to their disease management barriers and forcing them to rely on risky IV iron infusions. Regrettably, the CMS decision also exacerbated disparities in treatment, because unlike privately insured, Veterans Affairs and federal employees, Medicare kidney patients are now the only patients who lack access to this therapy.
The good news is that a bipartisan group of congressional leaders has recognized the gravity of the issue and moved to act on behalf of kidney patients. The Renal Anemia Innovation Support and Expansion (RAISE) Act, recently introduced by Reps. Larry Bucshon (R-Ind.), co-chair of the Kidney Caucus, Tom O’Halleran (D-Ariz.), G.K. Butterfield (D-N.C.), and Markwayne Mullin (R-Okla.) would update current Medicare policy to ensure thousands of high-risk kidney patients have their choice for home anemia treatment restored. This policy change will help keep vulnerable patients safe from COVID-19, reduce both kidney patient burden and burdens on outpatient infusion centers.
In a national health and economic crisis, there is no single “silver bullet” solution that protects all kidney patients as they access the care they need. But in a crisis, the onus rests with government, not patients, to clear away barriers the government itself has created that exacerbate patient risk. Medicare coverage of ferric citrate, in conjunction with other proactive efforts to ensure kidney CKD patients safely access the care they need, like telemedicine, is an important and smart step forward.
Conway serves as the Chair of Policy & Global Affairs for the American Association of Kidney Patients (AAKP) and is a former Chief of Staff for the U.S. Department of Labor.