As a rheumatologist, I treat rheumatoid arthritis (RA) and other complex autoimmune diseases. If you have or happen to develop one of these diseases, I am thankful that science has delivered amazingly effective targeted therapeutics and biologics in recent decades. While highly effective, these treatments come with a high economic cost, so I have grown accustomed to daily battles with commercial insurance plans to get working-age patients the treatments they need. While horror stories abound regarding commercial insurers, Medicare has traditionally been a more predictable partner for my older patients. Medicare reimbursement is low — an issue worthy of a separate commentary piece — but comes on time, typically without the hassle and administrative delays of prior authorizations, assuming we use our therapeutics within FDA-approved dosing and indications.
On top of these existing challenges here in the Midwest, providers recently won a battle we did not expect to have to fight with a Medicare administrative contractor (MAC). The story deserves scrutiny from legislators and regulators nationwide.
Medicare beneficiaries rightly assume, as have I, that policy spells out the services they are entitled to receive. Lawmakers in Congress establish patients’ benefits in law, while the Centers for Medicare & Medicaid Services (CMS) develops the national rules and policies to implement them. MACs fit into this process by administering those rules regionally (with some discretion), but they are not supposed to privately create new substantive conditions of payment.
Recently, the MAC overseeing Kentucky and Ohio began auditing and denying claims for intravenous Orencia, a biologic drug used to treat RA, citing a “lack of medical necessity.” The policy affected more than a hundred patients who had mostly been on Orencia for a decade or more. These patients were forced to stop or delay treatment or switch therapies, which resulted in serious RA flares. MAC administrators had decided that most patients on intravenous Orencia, covered under Medicare Part B, should instead receive subcutaneous Orencia, covered under Medicare Part D and often at substantially higher out-of-pocket cost.
The decision was made without a formal notice-and-comment process. In fact, this requirement does not even appear in the Medicare guidance cited for this decision. Worst of all, it effectively forced dozens of patients off a life-changing therapy.
Thanks to outreach from clinicians, national advocacy organizations, angry patients, and congressional representatives, this policy was walked back. Or at least, we think so. There was no announcement of a reversal. Instead, the MAC covering Kentucky and Ohio quietly revised a fact sheet on its website, removing language that preferred subcutaneous over intravenous dosing.
This whiplash has been devastating to my own small clinic, however, as the MAC continues to withhold the equivalent of roughly three payrolls’ worth of payments for treatments we rendered in good faith during this period. They have also not answered repeated inquiries about whether denials issued under the now-removed standard will be reversed.
This situation exposed several problems that need to be addressed before this happens to other MACs, Medicare beneficiaries and clinicians:
1. The current system allowed one medical director’s opinion to acquire the force of Medicare policy without an effective check. This violates the Supreme Court’s decision in Azar v. Allina, which limits the government’s ability to create substantive Medicare payment standards through informal guidance. Yet it still took months of work, worry, and countless hours distracted from providing clinical care to get the issue elevated to a level where the policy was reconsidered.
2. There is inadequate accountability and little transparency within MAC operations. After an initial call with the MAC medical director to raise this issue, we went for weeks with response and no clue as to where our appeal stood. Providers didn’t know how to “correctly” care for our affected patients. When the disputed language did quietly disappear from the fact sheet, there was no public explanation, formal announcement, or directive regarding claims already denied.
3. There is no clearly identified chain of command to move a critical issue of patient harm from a regional MAC to CMS. As an experienced advocate, I leveraged my relationship with my congressional representative and the American College of Rheumatology to elevate this issue to CMS, but what if I hadn’t had those relationships? Our system should not require physicians to become experts in Medicare law and policy just to ensure the Medicare system follows its own rules.
Medicare beneficiaries deserve better. While in this case we’ve been able to protect access to intravenous Orencia, this experience exposed flaws that extend far beyond one drug or one MAC contractor. We should all be concerned that MACs are increasingly making unilateral decisions that negatively impact patient access. Medicare policy should be transparent and include appropriate notice and stakeholder input. And when a contractor gets it wrong, there should be a clear and rapid way to stop the harm to patients, their relationship with their doctor and the doctor’s practice. A patient’s access to Medicare-covered care should never depend on whether their physician can find someone in Washington willing to intervene. Something must change.
Author bio:
Dr. Chris Phillips is an American College of Rheumatology leading rheumatologist and owner of Paducah Rheumatology.
Photo: Stas_V, Getty Images
