The Medicare Part D Catch-22

How the U.S. Social Safety Net Fails People with Rare Diseases

“...they have the right to do anything we can't stop them from doing.” 

― Joseph Heller, Catch-22

I am Being Denied Access to Life-Saving Medication Because my Disease is too Rare: Fighting with Medicare Part D to Maintain Access to IVIG

The story I am about to share offers a glimpse into a hidden side of our broken healthcare system—a side that remains largely unheard and unseen. My name is Beatrice Adler-Bolton, and I am one of the few lucky individuals with a super unusual and rarely-heard of disease called Chronic Relapsing Inflammatory Optic Neuropathy (CRION). Medicare Part D¹ has now suddenly denied coverage for the only medication that keeps me from going completely blind, not because of a question of efficacy, or the validity of my disease—but because the law just says they can.

My personal struggle to maintain access to my care is a reflection of a larger problem in U.S. healthcare. Sick people, especially those of us with rare diseases, face enormous challenges in getting the treatment their doctors prescribe. My current predicament is not due to lack of proof of medical necessity but an administrative loophole that disproportionately punishes patients with rare diseases. 

Living with chronic relapsing inflammatory optic neuropathy (CRION) has been a challenging and mind-bending experience. As a person with this rare autoimmune disorder that affects the optic nerve, I have sudden attacks of what then becomes semi-permanent vision loss, blurry vision, color desaturation, and pain behind the eye. I have had dozens of attacks, some so close together that the symptoms overlapped.

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One of the most critical treatments for CRION is Intravenous Immunoglobulin (IVIG), which helps keep my immune system in balance and prevent it from attacking itself. Lack of treatment or sudden withdrawal of immunosuppressive therapy can result in permanent vision loss, and the frequency of my attacks is correlated with a worse prognosis for visual outcomes. As someone who has benefited from IVIG therapy, I cannot stress enough the importance of maintaining appropriate immunosuppressive therapy and detecting and treating symptoms early to improve visual acuity outcomes if you have CRION. Literally makes the difference between sight and blindness. Not only does IVIG help me prevent further vision loss, it has also enabled me to lead a relatively normal life at times in the now distant past. CRION can be an isolating and difficult journey, but with the right treatment, it is possible to manage the disease effectively. IVIG is not for everyone but IVIG has helped me, and I hate the hoops I have to go through to maintain access. 

I was diagnosed with CRION in 2010 and applied for Social Security Disability Insurance (SSDI) in 2015. I appealed in 2017 and was finally certified as disabled in 2019. My doctors have managed my disease since 2011 with a combination of immunosuppressive drugs and regular infusions of intravenous immunoglobulin (IVIG). CRION is a disease that causes severe pain and vision loss. Attacks of my disease happen when my immune system attacks healthy cells in my body by mistake. The disease comes and goes, and there are no FDA-approved drugs specifically for treating it. The IVIG treatment helps keep my immune system in check and prevents it from attacking my healthy cells.

Since starting SSDI, I have relied on traditional Medicare for insurance coverage and Medicare Part D for prescription coverage. But unlike outpatient and hospital coverage, you don't have a choice of public or private drug coverage with Medicare Part D. All Medicare Part D plans are public-private partnerships. Drug approvals for Medicare Part D are determined by a complex process that relies on the Medicare compendia and often overlooks the specific medical needs and conditions of individual patients. As I mentioned, Medicare has already been paying for this specific IVIG medication since my Medicare coverage began in June of 2019. This most recent denial came as a shock, and at an odd time of year. 

Denied by a Technicality

During the appeals process, it was determined that my disease, CRION, did not “meet the requirements” of a medically-accepted indication as defined in section 1860(D)-2(e)(4) of the Social Security Act. This means that the medication I needed, a type of IVIG called PANZYGA 10% Solution and made by Pfizer, was not approved by Medicare Part D because it did not have my specific disease listed on it’s FDA labeling, nor did the two medical reference books (called compendia, I’ll get to those a little later) approved by Medicare Part D include an entry to support the use of any IVIG at all  for my specific condition. 

It's important to reiterate that there are currently no drugs approved by the FDA specifically for treating CRION, so there are no other alternative therapies available. All the treatments that doctors use for people with CRION are not approved for this particular disease. The standard treatment for CRION involves short-term corticosteroids followed by long-term immune-suppression and IVIG to alleviate symptoms. Long-term use of steroids is not recommended, and instead, drugs like azathioprine, methotrexate, or cyclophosphamide, paired with IVIG, are used to maintain remission. It's like taking long-term control medications for asthma, with IVIG and methotrexate serving as daily medication, and corticosteroids as a quick relief inhaler for emergencies. 

Long-term maintenance therapy has been proven to be crucial in stabilizing CRION patients like me, because while early detection and treatment can improve outcomes—it’s maintaining long term and consistent access to that treatment that is what is really crucial. Dozens of studies have shown that IVIG paired with immunosuppression is the best combination for maintaining remission in CRION patients. But citing the dozens of peer reviewed studies which support our case do nothing to advocate that I deserve this medication, or that Medicare Part D is required to pay for it in the eyes of the law. 

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The Burden of Proof

While Medicare Part D provides assistance with drug costs for many individuals, there are significant hurdles across the board when it comes to off-label drug coverage. The requirements to substantiate claims for off-label use are uniquely burdensome and often result in beneficiaries being denied the coverage we desperately need. Medicare Part D only covers off-label use if the drugs are listed in officially recognized compendia, which unfortunately are not easily or readily publicly accessible. Without access to this crucial information, many people are left without access to the pay-walled administrative material needed to support our case at the determination appeal.

This poses a major challenge for patients like me seeking coverage for off-label use of medications like IVIG, despite ample peer-reviewed evidence supporting their effectiveness. The inability to argue for medical necessity without the drugs being listed in the compendia creates a ‘Catch-22’ situation in which, “...they have the right to do anything we can't stop them from doing.” Restrictions like these particularly affect individuals with rare diseases, as off-label drug treatments are often the only option available to us. Consequently, these appeals and denials become an additional administrative burden² imposed solely on certain patients, leaving us without access to vital medication simply because we have a rare disease.

Under Medicare Part D, off-label drugs are covered if they are deemed safe and effective as listed in the officially recognized compendia. However, the responsibility of proving inclusion falls on the beneficiary, placing a significant burden on individuals seeking coverage. The lack of accessibility to these compendia becomes a critical barrier. While peer-reviewed medical journals can establish the medically accepted indications for off-label drugs in anticancer chemotherapy, the rules for proving coverage differ for all other diseases and conditions. Unlike Medicare Part D, private insurance, Medicaid, and Medicare Parts A and B, all allow patients and their doctors to provide proof of medical-necessity using peer-reviewed studies in medical literature. Medicare Part D is unique in its usage of the privately managed compendia as a gatekeeping mechanism on top of the regular restrictions imposed by individual plan formularies and Pharmacy Benefit Managers (I’ll get to those in a moment). This leaves people with rare diseases and disabilities like me in a really difficult position, being denied vital medication solely for the sake of controlling costs and because the Part D plan can.

The Consequences of Denial

The situation for patients like me, on SSDI with CRION is dire, as there are no FDA-approved drugs specifically for us, and all available therapies are off-label. It’s possible what is happening to me will go unnoticed, because I may likely be one of the only, if not the only CRION patient on SSDI. The very fact that CRION is a rare disease offers my Medicare Part D company the legal leverage to statistically punish in the name of controlling costs and protecting the deficit. As a smaller than small number of patients in the grand scheme of disease based advocacy means no one will care. This means that patients with CRION will continue to be left without any FDA-approved drugs or entries in the compendium, despite the severity of their condition and the ease with which the federal government could act in a multitude of ways to make an exception—as it has done on a case by case basis for other rare diseases with much larger patient populations than mine.

The challenges of treating CRION are compounded by the fact that it is an idiopathic disease, meaning that the exact cause is unknown. Optic neuropathy, which arises from direct involvement of the optic nerve itself, is a common symptom of the disease. This disease is so rare that there are not even enough patients for coordinated advocacy groups to form to raise awareness about the condition. Due to the small number of patients with CRION, there are few studies on the disease, with most studies having no more than 150 participants and often drawing from global pools of patients, some of whom have been dead for decades. This however is not a lack of research—it is a lack of value, in a system driven by the economic valuation of life. This abandonment further exacerbates the difficulty of treating patients like me, disabled, on SSDI and with CRION. 

So what is going to happen to me without my medicine? The truth is, we don’t know. In cases of CRION, the excruciating ocular pain becomes an unwelcome companion. While some patients may not experience this torment, my condition is marked by severe, relentless pain that is only effectively managed by IVIG. However, the past two weeks have been a nightmare as I have been denied access to IVIG, and my pain has returned with a vengeance. You see, CRION is not a singular entity; it encompasses a complex web of debilitating symptoms. In my case, CRION manifests in its most severe form.

Typically, CRION episodes result in severe visual impairment, encompassing a myriad of distressing symptoms. Visual acuity plummets, colors fade away, vision blurs, and patches of the optic field vanish, both centrally and peripherally. My beleaguered optic nerves, exhausted optic tract, and vulnerable optic chiasm have borne the brunt of numerous CRION relapses since 2010. The intervals between these episodes have been unpredictable, ranging from agonizingly short to agonizingly long. Without the crucial PANZYGA (IVIG) treatment, relapses become all too frequent, posing a significant risk to both my life and my vision. Brain scans, revealing inflammation and contrast enhancement of the optic nerves, confirm the destructive nature of this condition. Demolishing myelin sheaths, the protective covering around nerve fibers, demyelination disrupts vital nerve signaling, giving rise to a plethora of neurological symptoms.

Every day without IVIG increases the potential for irreversible damage inflicted by my overactive immune system on these critical myelin sheaths. The consequences are dire—my life hangs in the balance, and the last remaining parts of my vision teeter on the precipice of being obliterated by rampant, unchecked inflammation.

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The Fight Ahead

This is what my body will be going through as I prepare for the fight ahead. I have submitted my third appeal and am awaiting a date for my hearing with the Administrative Law Judge. The expectation is that this hearing will not go my way, and what comes after that is uncertain. But what I do know is that I’m going to keep pushing, and keep trying to access the meds that I need. I’m ineligible for co-pay coupons or drug company assistance programs because those are restricted and not available to people like me on Medicare. My PANZYGA 10% Solution costs around $20,000 a month. On SSDI my income is restricted to $13,000 a year. There is no amount of crowd-funding or fundraising or hustle in the universe that is going to make paying out of pocket anything other than a sick joke. 

As an autoimmune disorder, CRION requires a delicate balance and Medicare Part D is now throwing a wrench into that tempestuous self-cannibalizing cellular system with abandon. CRION and my body’s need for IVIG is the reason I am disabled, this is why I am certified disabled by SSDI, this is why I have Medicare Part D, and this is why Medicare Part D is claiming they have no legal obligation to pay for the IVIG they have already been paying for since 2019.

This is where I stand, with a lot of background knowledge, and so much expertise to lean on specifically in this area, and already left with so few options to maintain even the most basic access to my “evidence-based” care. I know folks with other rare diseases, or with rare, stigmatized, and/or understudied diseases like ME/CFS, MCAS, or Long Covid might be reading this and feeling like the future is bleak, to echo Mariame Kaba: Let this radicalize you rather than lead you to despair. 

It’s hard to believe something like this could happen. But once you understand some of the context of how this policy was crafted, the cruelty and abandonment become clear, ideology falls into place and it all starts to make more sense. The most important thing to understand about why Medicare Part D ended up like this, is that—fundamentally—it is a compromise between two opposing groups, who did not necessarily also have competing interests: those advocating for an expansion of traditional Medicare and those pushing for a greater role in traditional Medicare for private health insurance companies. Medicare Part D, which was on-paper intended to provide disabled individuals and seniors with access to prescription drugs, was from the moment of its passage, a source of frustration for many. One of the reasons for this is that the program was designed to incorporate cost-saving measures, which often come at the expense of patient care.

The “Flaws” in Medicare Part D are Actually Design Features

Medicare Part D was born out of a contentious and dramatic political landscape obsessed with minimizing the debt/eugenic burden of the surplus class. The 2000 presidential campaign witnessed competing Medicare drug-reform proposals from both major candidates dominate the discourse: Vice President Al Gore advocated for a voluntary benefit within Medicare, while Texas Governor George W. Bush favored a federal subsidy to help low-income beneficiaries purchase drug coverage through private insurers that was part of a larger package of Medicare reform intended to use block grants to introduce all sorts of gimmicks like health savings accounts (HSAs) and drug savings cards, and cost-control schemes like mandatory managed care. However, 9/11, the economic downturn in 2001, the invasion of Afghanistan, all coupled with the significant tax cut for the rich, drastically changed the landscape of what Bush could pursue. 

During his first term as president and one month before the U.S. invasion of Iraq, in February 2003, President Bush made a significant shift in his medicare reform strategy abandoning a series of general reforms, for a targeted prescription-drug-only coverage option intended to achieve an increase Medicare's reliance on private health plans. Calling it a “Framework to Modernize and Improve Medicare,” President Bush’s new idea was to only offer prescription drug plans to Medicare recipients on private Medicare Advantage plans, as an incentive to encourage people to switch to the public/private plans. 

This move faced resistance from President Bush’s own Republican party members, who felt the bill did not go far enough in incentivizing beneficiaries to switch to private health plans. Conservative groups like The Heritage Foundation and The National Taxpayers Union criticized the proposed benefits as a disaster for the federal deficit, warning that Medicare Part D was burdensome to taxpayers and going to ruin the economy for the next generation. Once Bush’s plan hit congress, it slowly expanded to include all Medicare beneficiaries, but the favor remained heavily weighted toward the needs of private insurers. The chaotic congressional drama surrounding Medicare Part D reached its climax with a controversial vote in the House and subsequent attempts to defeat the bill in the Senate. 

This confusion led to a moment of fatal compromise between two groups locked in a debt-and-death-spiral ideological conflict, and resulted in one of the most tragically and darkly-funny paragraphs I have ever read that I think actually offers some really good context to underscore, just how far the actual needs of Medicare patients were from lawmaker’s minds. This quote comes from a November 25, 2003 editorial in The Washington Post, called “The Grand Finale,” summarizing Medicare Part D’s chaotic congressional drama, and paints an unforgettable picture of this program’s inception: 

FOR SHEER political drama, it would be hard to beat the past few days on Capitol Hill. Between the normally apolitical hours of 3 and 6 on Saturday morning, the House voted, by the tiniest of margins, to pass a hugely controversial Medicare bill. During the vote, which was of unprecedented length, the House Republican leadership cajoled, berated and twisted arms, barely controlling a conservative revolt, while President Bush, jet-lagged from his trip to Europe, called up recalcitrant members one by one. On Monday it was the Senate's turn. Opponents of the bill used a bag of parliamentary tricks in an attempt to defeat what Sen. Edward M. Kennedy (D-Mass.) has called an "attack on Medicare as we know it." Nevertheless, two attempts to waylay the bill were defeated by some of the bribes and threats that won the day in the House, along with the fears of some Democratic senators of blocking a big new entitlement bill so soon before an election. 

Despite the initial promise of providing drug coverage for elderly and disabled Americans, Medicare Part D was doomed to fail to meet the need of beneficiaries due to several painfully obvious factors. Firstly, the limitations of a market-based for-profit healthcare system inherently prioritize the interests of insurance companies and pharmaceutical corporations over those of patients. Secondly, the ideological insistence on market "solutions" for a massive social problem failed to recognize that healthcare is not a commodity that can be bought and sold like any other product. Thirdly, the arbitrary budgetary constraints placed on Medicare Part D meant that cost-saving measures were prioritized over patient care. Finally, the failure of managed care in rural America meant that many patients in these areas were left without access to necessary medications. These factors all contributed to a system that has had severe consequences for those who rely on it for their prescription healthcare needs.

In the end, as paranoia about cost dominated the discussions around Medicare Part D, the solution came in the form of heavy reliance on Pharmacy Benefit Managers (PBMs) and promises from insurance companies that they would act responsibly. Both Republicans and Democrats shared a naive hope that PBMs and insurance companies would diligently monitor prescribing patterns and promote the use of more affordable medications. However, despite all the enthusiasm for public/private partnerships, these Medicare innovations have produced a lack of compelling data to support the notion that pharmacy benefit management leads to significant savings, in either managed care or fee-for-service programs. It's a parasitic grift through and through.³ This reliance on PBMs and private insurance companies to manage care for the most vulnerable through public/private partnerships has not abated despite concrete evidence of their ineffectiveness, and an abundance of evidence that their intermediary services only serve to exacerbate the material issues faced by Medicare Part D beneficiaries and contribute to the extractive abandonment they experience.

Even a quick and incomplete glance, such as this one that takes just one brief look back at the recent historical record of Medicare Part D, reveals that so little care was taken to address the actual material needs of elders and disabled people, particularly those with rare diseases. Instead, the total focus was on incentivizing beneficiaries to switch to private health plans while ignoring the significant financial burden that many people faced and would continue to face in accessing the drugs prescribed by their doctors. The design of the program disproportionately benefited private insurers and pharmaceutical companies, in the name of patients struggling to afford their medications, while ignoring them. This blatant lack of care and overt abandonment is the administrative norm, and it is the reason why I, like many others, am going without medication that I need for another week, despite reams of peer-reviewed scientific evidence showing that it could save me. It's a stark reminder of the ongoing consequences of not severing health from capital, or of believing that a peer-reviewed study will save us when we’re up against the crushing power and actuarially-induced iatrogenic pain of the economic valuation of life.

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Lastly, I would like to express my gratitude and acknowledge the support received from kind folks on Twitter who helped me in accessing resources like the American Hospital Formulary Service – Drug Information (AHFS-DI) and DRUGDEX Information System. By using these resources to substantiate my case to Medicare, I have a fighting chance. The support and solidarity from everyone who has reached out has been greatly appreciated. If you are facing a similar circumstance or have in the past with your Medicare Part D, please feel free to reach out. I would be really curious to hear how others may have navigated this in the past, though from what I am told it’s a pretty unusual circumstance to be facing. 

We have a great episode coming out tomorrow in the main feed. Take care of yourselves. As always, Medicare for All now, solidarity forever. Stay alive another week.

1. Medicare Part D is a federal program that was created to provide seniors and people with disabilities access to prescription drug coverage. The program was implemented in 2006 and operates as an optional plan that can be added to traditional Medicare or to Medicare Advantage plans. Private insurance companies offer the plans, which are approved by Medicare and provide coverage for a variety of prescription drugs. While the program was designed to help seniors and people with disabilities access necessary medications, there are a number of challenges and issues associated with its implementation. One of the most significant challenges is the complex and often confusing system for determining which drugs are covered and at what cost.

One of the most well-known examples of brutal cost-saving measures put in place by Medicare Part D is the infamous "donut hole," a coverage gap in which beneficiaries must pay for their medications entirely out-of-pocket until they reach a certain catastrophic coverage threshold. In 2023, the donut hole begins after a beneficiary and their plan have spent $4,660 on covered drugs. Once in the donut hole, beneficiaries must pay 25% of the cost of their drugs until they reach the catastrophic coverage threshold of $7,400 in out-of-pocket costs. The donut hole is a harsh reality for many Medicare beneficiaries, especially those with chronic conditions who rely on expensive medications. According to a Kaiser Family Foundation Study, “Half of all Medicare beneficiaries lived on incomes below $29,650 per person in 2019; one in four had incomes below $17,000 per person.” The consequence of the donut hole is that it puts a financial burden on patients they cannot bear, forcing many to ration their medications, which can have severe consequences both short and long term.

2.  Administrative burdens refer to the extra work that people have to do to navigate complex administrative procedures. They can take many forms, such as filling out forms, providing documentation, and dealing with bureaucracy. These burdens have a particularly acute effect on poor people's movements, as they consume valuable time and resources that could be spent on organizing, activism, rest, or literally anything else. As a result, administrative burdens are often used as a policy tool to limit access to resources or services without appearing to be doing so overtly. They have a distributive effect, as they affect some groups more than others. Burdens matter for whether we gain access to vital resources, and they can determine who is and is not a member of society. While administrative burdens are often portrayed as necessary for oversight or data collection, they can also reflect political choices made to achieve an ideological goal. These choices can be reflected in the maintenance of burdens even when changing circumstances call for governments to minimize them. 

When people face administrative burdens, they experience three types of costs. The first type of cost is learning costs, which stem from the challenge of gathering information about public services and understanding how to apply for them. This can include determining whether there are any available services that meet their needs, identifying eligibility requirements, and navigating the application process. The second type of cost is psychological costs, which involve feeling stigmatized, powerless, and frustrated when dealing with the stresses of bureaucracy. This can include a sense of loss of personal power or autonomy when interacting with the state, or the stigma of applying for or participating in a program that has negative connotations. The third type of cost is compliance costs, which are the tangible burdens associated with following the rules. These costs can include waiting in line, completing forms, providing documentation, paying application fees, or even hiring someone to help with paperwork. When all three types of costs are combined, they can create a substantial burden on individuals, particularly those who are already struggling with health issues and limited resources.

3.  If you would like to learn more about the evils of PBMs, I highly recommend Tim Faust’s book Health Justice Now.