The Centers for Disease Control and Prevention (CDC) has issued guidance for healthcare facilities in response to the COVID-19 virus including asking all U.S. healthcare facilities to “explore alternatives to face-to-face triage and visits.”
The CDC has issued this recommendation to help contain the spread of the virus, protect healthcare workers from unnecessary exposure, and protect the health of patients who do not require face-to-face medical visits (particularly patients with underlying health issues including those with heart, kidney and weakened immune systems).
In light of this guidance, the Centers for Medicare & Medicaid Services’ (CMS) decision not to cover an FDA-approved, at-home medicine for patients with chronic kidney disease (CKD) is irresponsible. With most Americans ordered to shelter-in-place, vulnerable kidney patients shouldn’t be forced into crowded hospitals for several hours of infusions when they could be taking an oral alternative in the safety and comfort of their own homes.
Known as Auryxia (ferric citrate), this medicine is the only FDA-approved oral therapy for iron deficiency anemia (anemia) in patients with CKD who are not on dialysis. Anemia is a large risk for the CKD patient population and if left untreated it increases risks for cardiovascular disease, progression to end-stage renal disease, and premature death.
Auryxia’s benefits are well documented. One recent study in the Journal of the American Society of Nephrology demonstrated that oral ferric citrate reduced the number of hospital admissions, lowered the number of days spent in the hospital for patients admitted, and reduce the use of dialysis. With more than 37 million Americans living with CKD, Auryxia has the potential to provide great value to patients.
CMS originally covered Auryxia following the FDA’s approval of the medicine. But in September 2018, CMS reversed course. Now, Medicare will pay for intravenous drugs that must be administered in a clinical setting (under Medicare Part B) but Auryxia, which can be taken by patients in their homes, isn’t covered by Medicare (Part D).
As I’ve argued previously, this decision harms CKD patients. The intravenous drugs Medicare covers present greater risk for many patients and are often more expensive for taxpayers when compared to Auryxia. Therefore, CMS’ decision increases overall health care spending while potentially worsening kidney patients medical stability and outcomes.
CMS’ decision is even more troubling because, unlike Medicare patients, many CKD patients with private insurance already have access to Auryxia. As a consequence, the CMS decision effectively creates two unequal classes of CKD anemia patients – one that has a choice in their treatment options and one that is denied choice and faces increased health risks.
Also troubling, the decision to not cover Auryxia demonstrates that CMS prioritizes the decisions of its bureaucrats over the medical judgement of doctors because nephrologists are often unable to prescribe the treatment they believe is most efficacious for their CKD patients on Medicare.
While these problems existed prior to the COVID-19 crisis, now the healthcare system must also manage the current coronavirus pandemic. Since CMS’ policy encourages CKD patients to use face-to-face medical services to receive their anemia treatments rather than an effective at-home medicine, it unnecessarily increases risks for CKD patients and their health care providers and works against effective management of COVID-19.
Due to their underlying health conditions and typical comorbidities, CKD patients are at high risk of severe illness from COVID-19. Forcing them to leave their homes creates unnecessary risks for this vulnerable patient population.
These concerns were recently emphasized by Paul T. Conway, Chair of Policy and Global Affairs for the American Association of Kidney Patients (a transplant recipient who has managed CKD and anemia for forty years), who asserted that “unnecessary trips to a hospital or healthcare clinic are troubling because the coronavirus imposes higher health and economic risks for patients managing their highly complex disease.”
Conway, a veteran of three presidential administrations and former Virginia Deputy Secretary of Health and Human Resources further stated,
This is a classic case of a tone-deaf staff decision originating in the bowels of the agency that needs to be elevated and reversed by senior CMS appointed leaders. CMS staff has undermined the public commitments of agency leadership that status quo decision-making has truly transformed to a patient-centric and value-based framework. Worse, in the midst of the coronavirus pandemic, CMS staff are defending an action that exacerbates real fears of exposure among the medically vulnerable Medicare CKD population and disregards the enormous efforts these patients and their families are engaged in to carefully follow CDC, NIH and White House guidance to stay home and stay healthy.
The coronavirus also worsens the existing problem of patient adherence to their medically necessary treatments. Some infusion centers have closed as physicians are trying to reduce the exposure of immune-compromised patients to potentially infected persons, making it more difficult for patients to get treatment. Further, concerns about potential exposure to the coronavirus, or actual exposure to the virus, could cause some patients to miss necessary infusion treatments altogether.
Missed treatments could lead to downstream consequences in the short and long term. Short term, patient nonadherence could lead to more hospitalizations and higher risks of blood transfusions at a time when there is a severe national blood shortage. Long term, nonadherence could lead to more patients being diagnosed with cardiovascular disease and end-stage renal disease. These outcomes will increase the stress on the healthcare system when CDC guidance is attempting to do the opposite.
Empowering doctors to prescribe an oral therapy to CKD patients who can benefit from it increases the likelihood that patients will adhere to their medication regimen, decreases the number of untreated anemia cases, and, importantly, allows vulnerable patients to remain safely at home without risking exposure at infusion centers.
The CMS decision to stop covering Auryxia was never sound. Costs from this policy have increased significantly due to the coronavirus. CMS can eliminate these costs and support the CDC’s attempts to manage the COVID-19 pandemic by changing its reimbursement policy and allowing millions of patients to take their anemia medicines at home – rather than making an unnecessary trip to a hospital or medical clinic.