The Donut Hole Gets Real

 

Like most people my age I am taking some medications regularly and got the text message today from my pharmacy that I could pick up one of those prescriptions. The medication is a commonly prescribed medication from a group of medicine called  Non-Vitamin K antagonist oral anticoagulants or NOACs.  The medication is apixaban or Eliquis. People commonly take it to prevent blood clots or emboli and the complication including stroke, thrombosis, and pulmonary emboli. I have been taking it for about 2 years.

I usually get a prescription for 180 – 5 mg tabs and the last time I picked it up was on May 25, 2023.  At that time there was a copay of $94.  I am on Medicare A and B and a Medicare Supplemental Policy.

This time as I drove through the line the pharmacist told me the copay was $500. I asked him to clarify what had happened, but he had no idea.  Even though I had all of my previous refills at this pharmacy he had no idea what had happened and advised me to call the insurance company. When I got home that is exactly what I did. They advised me that this was the standard coverage gap for prescription drugs also known as the donut hole.  The insurance company pays for $4660 worth of medication (in my case almost all apixaban) and at that point copays stop and the patient is responsible for a flat 25% of the total cost of the medication or the $500).  When the patient incurs a total of $7,400 in pharmaceutical costs the number falls to 5% of the total, but by then it is probably a new year and the running tally resets. The customer service rep told me that I might be able to apply for assistance through company or state program, but they all had low-income requirements.

The donut hole started in 2006 as a result of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. All Medicare Part D plans have it. It initially required patients to pay 100% of the drug cost during the coverage gap.  That was reduced to the current 25% by the Affordable Care Act (ACA) passed in 2010. By 2025 there will be a cap of $2,000 for costs incurred in the coverage gap. 

It turns out that apixaban is number 10 on the list of 17 most expensive drugs purchased through Medicare programs.  In 2019, the average person taking it spent $7,234 for 12 refills per year and $2,172 in out-of-pocket costs.  A reform of this pricing has been suggested but obviously has not been done since I am paying about the 2019 list price.   The top drugs on this list are easily not affordable for many people. The cost of the top 5 agents are $16,348 to $182,162 per year with out-of-pocket costs ranging from $3,242 to $11,532 due to the coverage gap (1).  Apixaban in the single largest Medicare Part D expenditure at $12.5 billion per year (last filed in 2021).

Flashbacks of my work in acute care. For 22 years, I treated low to no income people in acute care settings. I was lucky to work with excellent social workers who would exhaust every available resource to help them with funding for medical care and housing.  Getting their medications funded was a chronic problem.  People on Social Security Disability do not get a lot of money each month.  At one point the state instituted a spenddown.  That meant if you were hypothetically making $1,000/month in disability payments, the state could demand that you spend a significant portion of your disability on medications before they would add any additional money for that purpose.  It is not possible to live very well – if at all under those financial constraints.

One of our attempts to adapt was to use the company scholarship programs to get them assistance from pharmaceutical companies. With many patients that took a great deal of coordination and filling out forms.  It also required nursing time for both the paperwork and an additional effort to manage free samples of medication. We were often scrambling to find medications in urgent situations or because one of the authorizations had lapsed.  All the samples also had to be catalogued by lot number in case there was a recall of that medication. I did not look forward to dealing with the forms or samples but realized we had to do it or some people would not get the medication they needed.

Today the tables were turned and I was looking at an arbitrary payment or I would not get the medication.  I have also heard this story many times. People unable to pick up a needed medication because of the copay – leading to an abrupt discontinuation or attempting to stretch out an existing medication until the first of the year. You really cannot stretch out an apixaban prescription.  I have read many news stories about people trying to stretch out their expensive forms of insulin resulting in medical compromise and death. I was lucky enough to have savings to cover the $500.

What are the problems with the donut hole?  I can think of at least 4:

1: It kicks the can down the road (also known as cost shifting). When confronted with these large payments, I can imagine a lot of people tell the pharmacist to forget about it and drive away. In the case of this medication that can lead to strokes, pulmonary emboli, thrombosis of large blood vessels, and/or death.  Treatment typically involves hospitalization and possible nursing home placement.  Worst case scenario might involve death, prolonged rehabilitation and the hospital or nursing home eventually seeks all of a patient’s assets to cover the accumulating bills.  All of those events could have been prevented with the prescribed medication.

2:  The structure of this billing is an incentive for pharmaceutical companies to increase prices since that will cause benefits to hit the wall earlier and cause the patient to enter the coverage gap and to pay more cash.  In fact, it is an obvious way to extract the maximum payment from both the insurance company and the patient. 

3:  It is another classic example of how politicians work to subsidize businesses in a non-transparent way.  I know more about medical billing than most people but I had no idea I was turning over $500 today until I was advised by the pharmacist.  

4:  This is a clear example of why the Republican and Libertarian ideas about "free market" healthcare are false.  In other words, we would choose to pay for what we really wanted in a free market and pay those market prices.  Obviously, anyone would pay $500 (or more) to prevent a stroke - but not if it means not eating.  The politicians involved will say: “well yes – but there is no free market.”  Of course, there is no free market. The market is actively manipulated to optimize profits for health care companies and minimize guidance from physicians.  That is the political system in the US. No doctor that I know of wants to prescribe a medication and hear at some point that the patient could not afford to take it. Sometime that news is very slow and the prescribing doctor does not find out until they see the patient back in a couple of months.

Don't ever think that American "free market" capitalism is a big deal in health care.  It is a big deal when politicians work with businesses to give them access to your assets and allows other businesses with more focal products like pharmaceuticals to charge whatever they want. There is no better example than the donut hole.  The cost savings that these companies promised is not from cost containment, but from rationing and that is a big difference. 

 

George Dawson, MD, DFAPA

 

References:

Dusetzina SB. Relief in Sight - Estimated Savings under Medicare Part D Redesign. N Engl J Med. 2021 Dec 23;385(26):e93. doi: 10.1056/NEJMp2116586. Epub 2021 Nov 10. PMID: 34758246.

Supplementary 1:

I downloaded this list of medication arranged by total Medicare Part D expenditure from the CMS web site on 8/26/2023.  The most recent data they have is for 2021.  Medications for psychiatric indications do not appear until # 24 Invega Sustenna and #31 Latuda.  More than a little interesting because psychiatrists have endured medication based attacks for over 20 years - primarily on grossly inflated conflict of interest concerns, pharmaceutical company profits concerns, and drug safety.  Many of those attacks continue today even though most of these medications are inexpensive generics and much of the rhetoric has lost its punch.  These same critics apparently have no similar concerns about significantly more profitable and higher risk medications.  That adds to my commentary in this post. 

Supplementary 2:  The Medicare Part Drugs selected for HHS negotiations with manufacturers include the following.    There is some overlap with the most expensive medication listed above but Farxiga, Entresto, Enbrel, and the list of diabetes mellitus medication are not on that list. For more information on the list click on the link at the bottom of the table. 

Medicare Drugs Selected by HHS for Price Negotiations

Eliquis

Jardiance

Xarelto

Januvia

Farxiga

Entresto

Enbrel

Imbruvica

Stelara

Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill

https://www.hhs.gov/about/news/2023/08/29/hhs-selects-the-first-drugs-for-medicare-drug-price-negotiation.html

 

 

Graphic Credit:

Evan-Amos, Glazed Donut Public domain, via Wikimedia Commons"

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https://commons.wikimedia.org/wiki/File:Glazed-Donut.jpgalt="Glazed-Donut

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The Whale

I finally saw this movie as it hit my subscription networks. It is an interesting story from many perspectives that is expertly told and acted. It raises several perspectives relevant to psychiatry but thankfully that explicit connection was left out of the production.  As the final credits rolled – I noticed that it was adapted from a play.  This is the closest I would come to seeing a play.  I do not think that I am constitutionally able to watch plays. They all seem contrived, overacted, and at times require a level of immediate and shared imagination that I do not possess.  I prefer solid ground as a jumping off point – even if things go awry from there.

The stark reality of this film is the home of Charlie (played by Brendan Fraser).  We meet him as he is teaching an online course in creative writing and see a typical Zoom interface. Charlie is the only one without a visual display.  He explains that his camera is broken. The scene cuts to his home. It is a dismal setting.  We see that Charlie is massively obese, barely able to ambulate and then with great effort, and in very poor health. At one point his nurse and friend Liz (played by Hong Chau) enters and tells him that he has hypertension and congestive heart failure to the point he needs to be seen emergently or he will be dead in a few days.  His poor health is displayed many times as he starts laughing but that rapidly turns into a cough and then chest pain. Over the course of the story, we learn that Charlie was not always like this but after losing his lover Alan to suicide he began overeating and gained a massive amount of weight. We see him binge eating at several points in the film – in one case biting off a fourth of a large meatball and cheese sub sandwich and obstructing his own airway to the point that Liz had to jump on his back to dislodge the food. After chastising him she picks the remaining sandwich off the floor and hands it to him.

The food theme is prominent over the several days duration of the film. Charlie gets a pizza delivered every day and he leaves the money in the mailbox.  The delivery driver talks with him through the door and eventually they address each other by their first names. At the last delivery the driver asks Charlies repeatedly if he is OK and appears to walk away.  As Charlie opens the door, he notices the driver is off to his left looking at him and appearing mildly shocked. Neither of them speaks but Charlie goes back in the house obviously upset and binge eats the pizza along with several additional items he adds from his refrigerator.

Charlie’s self-destructive eating and the associated self-loathing is a prominent theme throughout along with the expression of disgust.  He actively seeks confirmation that he is disgusting on a physical basis but only gets it spontaneously from his daughter Ellie (played by Sadie Sink).  Ellie is an angry teenager, performing suboptimally in school and she directs much anger at Charlie for abandoning her at 8 years of age when he left for the relationship with Alan.   Charlie actively seeks a relationship with her and at one point promises her a large sum of money just to spend more time with him, even though the time he has left is measured in days. He repeatedly apologized for his “bad decisions” in the past and emphasizes that he wants to try to make things right.  He would go as far as helping her write essays that might allow her to pass to the next grade in high school.

Two other characters are introduced over the course of the film.  Thomas (played by Ty Simpkins) shows up at Charlie’s door one day as a Christian missionary. He presents himself as a person intent on saving Charlie through God and Christianity.  He comes into dialogues with both Liz and Ellie.  Liz pointedly tells him to stay away from Charlie - that there are people who do not need to be saved.  She also points out the significant flaws in the local church that Thomas is affiliated with. Her father is the pastor of that church and Alan was her brother. Her father tried to arrange a marriage for Alan and described his suicide as a tragic accident. In his conversation with Ellie, Thomas discloses enough details of his life and why he might be estranged from his parents that Ellie is able to track them down. That eventually leads to reconciliation.

Charlie’s ex-wife Mary (played by Samantha Morton) appears toward the end of the film. There is a detailed discussion of the mistakes that were made and Mary’s chance meeting of Alan in a WalMart parking lot.  Even though there is a lot of tension, there is still an obvious level of caring between Charlie and Mary. Mary discusses Charlie’s unflagging optimism as one of his attributes that she misses. At some point it becomes obvious that the large sum of money that Charlie intends to give to Ellie may have come at a cost to his own health.  He has no health insurance and Liz points out what additional services he could have received.  Charlie refuses medical care and emergency services based on the cost, although that refusal is also consistent with his self-destructive path. He hears Liz describe the stress that he is putting her through but is unfazed.

Throughout the film, an essay about Moby Dick is referred to. The basic message of the essay is that the author can deny aspects of his own life and introspection about it – by focusing on killing whales. We eventually learn that this essay was written by Ellie when she was in the 5^th grade.  Charlie asks people to read him the essay when he is in a medical crisis with chest pain, shortness of breath, and diaphoresis.  He finds it comforting.  He also retypes the essay and gives it to her for school and she becomes enraged when she finds out. Charlie emphasizes that he only meant to show her that he appreciated her intelligence and creativity.

At a psychological level, Charlie is dependent and self-effacing. His motivation appears to be trying to correct past mistakes, especially abandoning Ellie, even though that was a complicated process that he was only partially responsible for. His reaction in these problematic scenarios is to accept the blame and go far beyond that to see himself as a disgusting person and ultimately a physically disgusting person (his characterization) that he produced by excessive eating.   

Several reviewers commented on the empathy in the film, but I really did not see any. Nobody seems interested in what happened to Charlie and how he got into this predicament – only that he is in it. They are attached to Charlie for various reasons but also out of their own self-interest.  As in real life, a lot of emotion happens in those settings as people are frustrated with Charlie when he does not accept their advice.

A relevant psychiatric dimension is the issue of involuntary treatment. In these last days of his life we see that Charlie has very high blood pressure, congestive heart failure, and possible angina that necessitate emergency care. Liz confirms that she has discussed his situation with an emergency medicine physician who concurs with her opinion.  Charlie even Googles his numerical blood pressure to confirm that it is an emergency. And through the film, he says he will not be treated and Liz agrees that she will not force the issue. But suppose that she wanted to.  What might happen in this situation?  Charlie could be transported to the ED, treated, and agree with admission for stabilization. He has no apparent psychiatric diagnosis, but it does not take too much imagination to see how any extended dialogue would get into the area of self-care and self-destruction to the point that the attending physician would consider an emergency hold. It is not uncommon to see people who have secluded themselves and not taken care of themselves admitted to inpatient psychiatric units with as many medical problems as Charlie. Suicide by food or lack of self-care is less dramatic than other methods but it can produce the same result.

Would Charlie be seen as depressed?  Probably – but is that the real problem? Moral injury seems to be a more proximate cause superimposed on a man who accepts all of the bad things happening in his life as his fault and reacts according. It allows him a veneer of optimism, while never having to confront the realty that human relationships are more complicated than that.  

Psychiatric speculation aside, this is a complex film that you must see.  The writing and acting is excellent.  The interpersonal drama has unique dynamics and is first rate.  I hope to see all these actors in other projects. It is a well thought out story line – right down to Charlie’s Zoom exit from his creative writing class. And importantly there is a clear message that there are all kinds of people out there struggling through life as best as they can every day. Those struggles may prove resistant to the insights and best advice from others.   

 

George Dawson, MD, DFAPA

I Have Hit A Wall

 I am currently working on two complex posts that will require a lot of research and graphics work but hopefully will be worth it at the end. I thought I would include a few comments about this here basically to document the progress and to see if anyone has already done the more detailed neuroscience post.  I also plan on taking a break by posting on a topic that I can more easily cover about – subclinical hypothyroidism.  That will hopefully appear in the next few days. There is a long history of endocrinology interfacing with psychiatry and as a research fellow in that field I am very aware of the associated concepts.

The complex posts are the neuroscience of a central autonomic network (CAN) and the borderline personality disorder concept. I am very interested in the CAN because of the issue of cardiac anxiety. In other words – can the heart itself be a source of anxiety and if that is the case should it be addressed differently?  And what are the implications for nosology?  The current DSM approach is agnostic when it comes to potential mechanisms of anxiety, but should it be? Considering the wide variety of medical approaches for anxiety including a few that are cardioselective – it would be useful to know if the anxiety originates in the brain or somewhere else and if that implies a different type of treatment.

The borderline personality disorder concept has always been controversial – but various psychiatrists and researchers also have a history of addressing the controversies and providing solutions for patients.  Most importantly those techniques have demonstrated efficacy for reducing suicidal ideation and self-injurious behaviors. Despite those advances an editorial in a recent British journal called for the abandonment of that diagnostic class and substituting an older diagnosis. Much of the justification for replacing the diagnosis seems to suggest that it is a pejorative label.  Having worked in a multitude of medical settings I can attest to the fact that pejoratives exist everywhere in medicine and it has very little to do with diagnostic criteria. It is largely related to countertransference issues by health care workers who are unaware of that concept and who are psychologically unable to maintain a neutral stance in emotionally taxing situations with patients. Changing a diagnosis is unlikely to change that predicament. I could generate a long list of what I have heard patients referred to – but is counterproductive and does not address the issue. I am not suggesting that every health care worker needs training in countertransference management.  Maintaining a professional stance can occur with appropriate coaching, education, and supervision.  As an example, I was asked to consult during a grand rounds on this topic presented by Emergency Medicine and comment on physician reactions in common situations.    

The basic problem with the CAN concept is not the basic structures involved but the initial signals and connectivity.  As an example, I am looking at my diagram of the subfornical organ and note there are 10 major efferent connections and 6 major afferent connections with some overlap.  The subfornical organ is one very small component of the CAN.  Not sure about my ability to diagram that complexity but I am going to give it a try.

I am also hoping this comment about hitting this wall provides me with some insights on how to approach this work. My only full-time job these days is blogging. After doing several presentations in the past year – I know I am much more enthusiastic about what I am researching and presenting than anybody who attends those presentations. I am also aware of the biases in society against old people and retired people. But I can’t let any of that get to me. I will stop when it is obvious that I have nothing left to contribute or I am stopped by a health problem.   

When you are a blogger – it seems like it is always feast or famine.  I have been very productive and posted what I think are excellent posts that nobody reads.  At other times and seemingly out of the blue there are bursts of reader activity that are hard to decipher with the available tools on blogger.  A friend of mine read through a few of my posts and said: “That is a lot of work.”  I appreciated that comment because it captured the reality of many posts and the implicit “for nothing.”  I still think there is an undercurrent of thinking that all bloggers or influencers get paid for what they post.  I have never been reimbursed for what you see written here and all the permissions that I have acquired over the years specifies the non-profit aspect. 

Finally – if you do read what I post here I appreciate it. Take the time to let me know if you want to see any psychiatry or medicine specific topic and I will do my best to write about it. If you look back over the years of posts – several firsts have been posted here that are not seen anywhere else – both in psychiatry and medicine in general. I see that as validation of some of my approaches.

In the meantime – stay tuned!

 

George Dawson, MD, DFAPA

 

 

Graphics Credit:

Atrribution:

I, Xauxa, CC BY-SA 3.0 <http://creativecommons.org/licenses/by-sa/3.0/>, via Wikimedia Commons

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