Same patient, same drug, same insurer — coverage denied

From STATNews

By Tara Bannow March 2, 2023

Janice Morales-Ferrer is a planner. It’s helped her get ahead in her career and in raising three young kids. But it’s hard to plan when you’ve got a rare disease, especially one with no standard treatment regimen or predictable outcome.

“I’m a data-driven person,” said the 46-year-old Boston area resident. “It’s frustrating for me to not be able to plan how long I can live for my kids. There’s no data. You don’t know what your prognosis is. You keep going and you hope for the best.”

Morales-Ferrer has focal segmental glomerulosclerosis, a rare kidney disease that results in scarring in the parts of the kidneys that filter blood. Even with treatment, many FSGS patients eventually progress to kidney failure and need dialysis or transplants. Recurrence is common after transplants.

Until a few weeks ago, things were looking even more dire. Morales-Ferrer’s insurance company was refusing to pay for the same infusion medication, Rituxan, that it had covered during her first bout of FSGS, one that her doctor credited with sending her disease into remission for years. She wrangled with them for weeks, facing down three separate denials, one of which forced her to cancel an important infusion. Her story offers a window into the confounding, seemingly irrational world of insurance coverage, one that’s given rise to a network of billing gurus dedicated to helping patients fight denials.

“The medication is right there,” she said. “My doctor is ready to offer it to me, but they’re blocking it. It’s mind-boggling.”

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The Access to Rare Indications Act could be a game changer for millions of Americans

By Darcy Krueger and Emanual Maverakis

June 1, 2022

The term “medically necessary” is the yardstick by which insurance companies, including Medicare and Medicaid, decide if they will pay for a particular treatment. For the millions of Americans living with rare diseases, most of which do not have FDA-approved treatments, identifying a treatment as medically necessary can be a lifeline — or the end of the line.

A white paper released in April by the influential Institute for Clinical and Economic Review offers several misguided proposals that attempt to balance public interest in incentivizing innovation with payer cost containment goals in rare diseases. The proposals are unlikely to benefit people living with rare diseases, clinicians like us who care for them, or those trying to bring rare treatments to market.

A far more thoughtful approach is embodied in the Access to Rare Indications Act (H.R. 6160), introduced in the House of Representatives by Reps. Doris Matsui (D-Calif.), Mike Thompson (D-Calif.), Mike Kelly (R-Penn.) and Markwayne Mullin (R-Okla.). The bill recognizes that the vast majority of people with rare diseases don’t have an FDA-approved treatment, meaning their disease is not listed on the treatment’s label, and their clinicians shouldn’t have to struggle to convince payers that medically accepted off-label treatments are medically necessary. Specifically, this bill seeks to give people with rare diseases the same level of insurance coverage for off-label treatments as patients with “common” conditions such as cancer and insomnia.

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