Why I’m Speaking Out Against the Proposed Medicare Part D Change — And Why You Should, Too

CalabereseJoseph R. Calabrese, M.D.
Director, Mood Disorders Program, University Hospitals Case Medical Center
Bipolar Disorder Research Chair & Professor of Psychiatry, CWRU School of Medicine
Dir., Bipolar Disorders Research Center

This week we are pleased to post the expert opinion of Joseph Calabrese, M.D. on the serious consequences of the proposed regulation to limit access to antidepressant, immunosuppressant and antipsychotic medications for recipients of Medicare Part D. Read the post and take action by participating in the conversation. This enables all of us to share these collective stories with our elected officials through e-mails, letters and in-person visits.

Why I’m Speaking Out Against the Proposed Medicare Part D Change —
And Why You Should, Too

Last month the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would initiate major changes to prescription drug plans under Medicare Part D. These changes would severely limit access to medications that are commonly used to treat serious mental illness and create serious challenges for people who have these mental health disorders.

Protected Class Status

Currently under Medicare Part D, there are six drug categories—immunosuppressants, antidepressants, antipsychotics, anticonvulsants, antiretroviral and antineoplastics — considered “protected,” meaning that Part D plans must provide beneficiaries access to “all or substantially all” of the available products in those categories. Of the six classes of medications, three are commonly used to treat psychiatric illness antidepressants (depression), antipsychotics (bipolar disorder and schizophrenia), and anticonvulsants (bipolar disorder). This protects enrollees from fail-first experiences and ensures patients have access to the medication their doctors consider most clinically appropriate. Often there are none or only very few medications available to treat a particular illness, such as the depressed phase of bipolar disorder.

The proposed rule would remove many of the antidepressants used to treat serious mental illness, as well as some of the immunosupressants from protected-class status in 2015, with antipsychotics removed in 2016. If a drug is not in a protected category, a plan need only offer two product selections, severely restricting both physicians’ prescribing ability and patients’ treatment options.

When it comes to the treatment of mental illness, the clinical management of real world patients often involves “trial and error.” For the treatment of the depressed phase of bipolar disorder, there are only two approved medications within the US. Not allowing patients to be treated with FDA-approved treatments for their illness, and requiring that they first fail a less expensive generic medication simply because of cost is cruel.

This proposed change is both surprising, given the progress the nation has recently made in federal mental health parity laws and coverage; and alarming, considering the devastating consequences the change could have on patients. I recently lent my support to a DBSA statement protesting the change. I want to explain why this issue is so important to me and why any concerned mental health advocate, patient or provider should feel a similar call to action.

1. One size does not fit all

Treating serious mental illness is not like treating pneumonia, where an oral antibiotic medicine is started and (in almost all instances) the illness goes away and the medication is stopped several weeks later. In contrast, the treatment of serious mental illness is almost always “trial and error,” and in many instances requires long-term treatment. In fact, the available published evidence suggests that only 25 percent to 33 percent of people who have a mental disorder experience a complete clinical response to the first two to three medications, even when prescribed in the presence of ongoing psychotherapy.

2. Age is a factor

The age of a patient is particularly important when prescribing psychiatric medications to treat serious mental illnesses such as depression, bipolar disorder and schizophrenia. Older patients tend to be considerably more difficult to treat and tend to have more side effects. Older adults can experience troublesome side effects to psychiatric medications because of their age and because these medications have not been adequately studied in older adults. Restricting seniors’ access to the full category of drugs could lead to significant decreases in quality of life and an increase in side effects .

3. The burden of co-payments

In the practice of psychiatry, co-pays or out-of-pocket costs for medications are a serious concern. It is particularly problematic in psychiatry because many mental disorders have few FDA-approved treatment options. As a result, many medications are used “off-label.” This means that they weren’t approved by the FDA for this particular use, but have been shown by investigators, such as myself, to nevertheless work in the treatment of the mental disorders. We call this “drug development by serendipity.” Lithium, the treatment of choice for bipolar disorder, for example, was discovered by accident.

Limiting the number of approved medications for the treatment of mental disorders places an unfair burden on consumers who have these disorders, as well as society. Restrictions are likely to result in higher morbidity, mortality and cost to the U.S. economy. The economic toll is manifested in diminished work productivity. The human toll results  in a substantial shortening of life span through suicide, which now exceeds homicides within the US.

4. Restricting access to care

The proposed regulation poses a significant impact to the physician / patient relationship. Physicians will be required to obtain pre-authorization for medication through a strict approval process. The processes are intended to manage cost by limiting medication use. In effect they become barriers to care by discouraging physicians to follow the correct course of treatment for their patient.

5. Inappropriate use of formularies

Highly restrictive formularies in the practice of psychiatry are only appropriate when the approved available treatments are numerous and safely tolerated. Unfortunately, this is not the case, and particularly so for bipolar disorder, schizophrenia, severe major depressive disorders, and the alcohol and drug use disorders.

Finally, perhaps most important, the widespread and potentially devastating impact this change would have cannot be underscored enough. About 35 percent to 40 percent of people in the United States will experience a mental illness during their lifetime. I have been practicing psychiatry for 30 years and I can predict with a very high certainty that imposing additional limitations and challenges upon this population will result in a dramatic increase in suicide attempts, and deaths due to suicide.

I am opposing this proposed rule change. I urge my fellow physicians and psychiatrists and people affected by mental illness to speak up, share their stories and fight this significant step backwards in mental health care.

Begin the discussion with your elected officials. Educate yourself on the facts. Engage in the dialogue with family and friends. By working together, the voices of physicians, patients and family members can be heard. Tell Washington not to adopt this misguided proposed CMS regulation.

Your Turn

  • As a clinician, share your clinical experience in treating patients through medication. What effect will this proposed regulation have on your ability to provide effective treatment?
  • As a patient, what has been your experience with medication? How many medications did you need to try before you were able to lead a thriving life of recovery?
21 comments
Franz Reisch
Franz Reisch

Where/who can we write/call to express our dissatisfaction with these changes? I am speaking of our elected representatives.

Thank you.

Phyllis
Phyllis

Should state agencies makedecisions onmental health medication patients have access to?

Since Medicaid and Medicare are are State funded Insurances it would be not only their decisions on what is covered but the actual Psychiatrist prescribing that particular anit-depressant or anit-psychotic. What is needed more so than any other changes is the fact that after a releases from a hospital and the patient remains on the drugs that were prescribed there, followed by the visits to the psychiatrist office. After a treatment program is completed , the persons regains personal responibility with working, volunteering and peer support. Primary doctors need to reduce the use of the heavy dosages which they had remained on for 2-4 year following the crisis. Primary doctors need to stop pushing unnecessary dangerous drugs onto people that are helping themselves to maintain a lifestyle without being heavy drugs for unnecessary reasons. For some people this ideal may work or the more severe and mentally ill persons it is an current need to function as best the can. People get sickened by the fact that their doctors do not listen or care to listen when they have their appointments and med checks. Issues like this are everyday in every Psych treatment , Day programs, and indepentant living. The State has actually no rights to voilate the decisions a certified Doctor prescribes their patients. Except in case of over drugging the cleints, or stealing drugs or using people as guinea pigs for a study without their consent. The other idecisions of the State interacting is only when it is reported for abuse or neglect of a persons within a psych. unit. Other than that the STATE is obligated to cover the most needed persons working in these areas. I am a Advocate for Mental Health and the voices and stories I hear and witness are true. Medication is need for those that are or have been diagnosis with illness, but not to contradict myself, after a certain time in a recovery those druging are immuned to your wellness and some others need to be dropped or new one prescribed. Staying on the same, the same dosages, and the same environment leads in the direction you as a individual want to take not what everyone tells you have to do. I live in Pennsylvania there was a huge evaluation study conducted by the Justice Department on a numner of states. Each state was ranked on a grading sytem that concertned the needs of others and where they being fullfilled? Pa. lost the valued questions and concerns of the mental health standards. Others states had moved ahead in the areas the Justice dept. was looking for at the time study. The grading stanards were A- E. Much hope and revised options and proposals need to be put into the hands of Human Rights Activities, Civil Rights activitist and the people to correct this pathetic way this state thinks everyone is guinea pig over a pill. Or slave to a group of idiots. Living in Pa. yes the state protects physician/patient directed treatment only when you are one of the following: Committed, abandoned,proverty,mental illness. Doctors don't treat their cleints they prescribe drugs to their cleints. Treatment centers are affordable and services are affordable through your Insurances, either that County covers the cost or the SSI, SSID patients receive workable treatment day care centers. The lleading roles of these people start the cleints into the programs. But direct care from doctors in psychiatric hospitals is only addressed when the impatient or out-patient model is setup. Their have to report back to the State on what they are prescribing and why. The HIPPO Law was designed to protect all person in the area of MH, MI, and everyday medical needs. Even that is violated by a group of maladapted fraunduant County people as well. Protect Laws need more addressing as well. Keeping outside intrusions from tapping the doctors office to see what your talking about there also. I just want to conclude that this ideal for the Med. D Prescription plans not to cover the needs of people with severe illness is a crime. No one is panicing about this issue either. and many in the public areas servicing still haven't recived enough information about it. thank you

William Ashdown
William Ashdown

Thank you, Dr. Calabrese, for your sage comments. One size does indeed not fit all. It is imperative that this new law be made to work, in its widest and most useful way. America is generations behind the rest of the world in providing healthcare for its own citizens, and every step that can be taken to move forward is of value.

It was a please to read your comments and enjoy your wisdom after many years. I only hope that the rest of your country is listening.

Paula
Paula

I am on anti-depressants, which keeps my depression under control. If my doctor is unable to percribe them for me, I could become suicidal again. And I know others that would be deeply effected by this change in Medicare. Please do not, do this to those of us, that need this help.

Barbara O'Connor
Barbara O'Connor

I was prescribed bupropion XL and took it for a month and was beginning to feel better. However even though it was a generic version of Wellbutrin, it was a a tier 2 or 3 drug. I thought it was because it was extended release and asked my doctor to give the immediate release version. I found that the price was the same. But 2 weeks into taking the new drug, I began to have the shakes so bad I was afraid I had developed Parkinson's. After about a week I realized I had started on a new medication, although the only difference was the fact that it was immediate release, and wondered if that could be the problem. I stopped the medication and was fine within 2 days. I would not have believed there could have been such a difference if I hadn't experienced it.

BonniKay
BonniKay

I have been in the mental health system since I was 17 yrs old, staying at the Oregon State Hospital for a total of 8 months. I saw Dr.Jones there who precribed stellazine and a medicine that I do not recall ( it starteed with "t").....I was on the main ward which was really scary for a teenager........I am a Christian and and I did not want to compromise my values. I cried for days upon end and asked a sweet man who just happened to be an assistant on the ward, Joe, who I believe was a Italian to help me get better.Joe referred me to Adele,the head RN who was a real bitch and you did not want to cross her path or she would give youa a shot in the leg and throw you in solitary confinement for 3 days.!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!......I was lucky tho,I found my Winnie the Pooh man, Paul who was the kindes man to me at the hospital when I was on the main ward. He would take me to cafeteria, take me for walks on the grounds and take me off the main ward to the pool hall/rec room down on the main floor. The ward I was on was on the 4th floor. There was also a Oriental guy who wanted to stand real close to me, Patrick.......I just did not trust him for some reason...........anyhow.....today, I trying to keep things on an even keel.....so far, so good, so far....my current Dr. Bartholow has me diagnosed as Bipolar with an emphasis on the depressive side......Last August 29th my 92 father died at the hand of an uncareful driver who ran him over and killed him instantly.......I can forgive, but it is very hard,expecially this past year....................his death hit me like a ton of brick on the 1st anniversary, Aug 29th, 2013.....I'm still in shock somewhat.........please advise me as to what I should do as I am 100% disabled. I volunteer at Mayo/Luther Midelfort in Eau Claire on the 4th floor Med/Surg floor and just love it....Ivolunteer every other Tues and Thurs with an occasional 3rd Thurs thrown in for good measure.......I also volunteer for things likemailings and the annual picnics and Easter Egg Hunts according to Vicky and Jen in our Volunteer Services Dept. Dear Dr. what do you suggest a 58 yr old woman do?

R

Nancy Granger
Nancy Granger

It would be such a setback to strides made towards recovery oriented treatment, where the correct brain chemical balance is such an important part of recovery.

Tiffany York
Tiffany York

I have been fortunate enough to have insurance so far since I was diagnosed with bipolar disorder and was able to find the right medication soon after.In the off brand form ofcourse. However if I had to rely on medicare/medicade to get it for me and and if it it had taken multiple trials like it does for many. Just to have funding cut back and no longer be able to recieve my meds. I really don't know how I would function as a mother, a coworker or as a functioning member of society. Please keep this going. Thank you.

Tara Muhlhausen
Tara Muhlhausen

I am a bipolar patient newly adding prescription treatment after a terrifying few months. I am deeply depressed and needed to wait 3 weeks after prescription was written for mood stabilizers, because I could not afford the out of pocket cost. After a mixed episode at work, I was terminated from my job of over 9 years. Refusing to put more than a few gallons of gas in my car's gas tank for months... Close enough to being suicidal to know ...not to keep my tank full. All while I waited for state funded insurance before I could begin my full treatment. Lucky for me, the depression is the worst part now. Unfortunately, until I had my insurance I could not increase my anti depressant.

I don't know still, after more than 3 mos, if this is the right pharmaceutical cocktail for me yet. But to think that I would need to be regulated based on what a paper pusher says is ludicrous.

Maureen Falkowitz
Maureen Falkowitz

I have been active in the Colts Neck (NJ) chapter of DBSA (Depression and Bipolar Support Alliance) since 2004. Throughout these years, I have encountered many people suffering with depression, bipolar disorder, and other mental health difficulties. In most instances, psychiatrists have to try many different drugs before a solution can be found for individual patients. Those who find the "right" drug, or combination of drugs, soon after their diagnosis, are pitifully few. I myself have found a long-term solution with an anti-seizure drug. It provides an "off-label" solution for me. I shudder to think what will happen to me, and others like me, who will be restricted from using this drug in the future. The only solution will be having the psychiatrists change the diagnosis from "bipolar disorder" to "epilepsy" to get around this stupidity.

linda saliamonas
linda saliamonas

As a former Child Welfare Caseworker and advocate, I have seen first hand how lives are affected by withholding of appropriate medication. In addition to the pain and havoc that will occur to individuals and families, the cost to society will be measured, not only by suicide, but by violence, homelessness, and abuse and neglect. This is another "penny wise and pound foolish" attempt to fix a broken system by applying a band aid, which will in turn put pressure on another oozing place. There is no more large scale waste that can be cut from budgets; real people are now barely getting by.

The Med Diva
The Med Diva

As a senior writer for a national Medicare Part D plan, I am often tasked with writing letters to our members that explain why their coverage was denied or what procedures they have to take to go through the appeal process or to obtain a prior authorization. These rules are only going to restrict access even more and confuse or anger many beneficiaries who need these medications to stay healthy or live a more normal life. Thank you for a very thorough article on this important topic.

Katherine Collins
Katherine Collins

For any of us who have lived with someone suffering from mental illness, we know the long process of finding the right medication and proper dosage that works for our loved ones. Many drugs, particularly those that treat bipolar disease (i.e. Lamictal) must be started at very low doses and increased gradually. The general wait and see period for anti-depressants is 4 weeks. And if that doesn't work, the dosage is increased or a new medication is introduced. This is already a long period of suffering for the patient and frustrating for the families. This proposed Medicare D change would only prolong the process and the suffering. Please speak against these changes.

Michelle Prephan
Michelle Prephan

Please review this plan with Nami, DBSA, psychiatrists. APNS & nurses that work in mental health field. I have worked as a psychiatric nurse for over 30 years. I have seen the advances that have been made in treatment with better outcomes and the fewer side effects. Often times it is trial and error to find out what medication will work best for each patient. Please do not take away or limit medications needed for recovery.

Donna M. Burck
Donna M. Burck

I think Medicare is discriminating, and it has too many rules and regulations. Only the people who can afford medical insurance from major companies like Nationwide, CareFirst and Prudential, etc., can afford the best of care, However, the people on Medicare, get the bottom of the barrel in the form of healthcare! It infuriates me to no end! Medicare tells physicians how they treat their patients, how long they can stay hospitalized, what tests they may have...it's maddening! And, also, unfair. When is the disparity going to end?! Unemployment, gas, food and housing costs have all gone up, that's well established. My question is, what good is having all of the other costs, if people aren't well enough to work, feed their families, and put a roof over their family's heads?! Medicare needs a complete overhaul. Moreover, more medications and medical equipment are made overseas or in Mexico or Canada. Which, that fact in itself, takes away jobs from Americans in the first place. The rest of the world is probably laughing at us right now. I know it doesn't sound like I'm proud to be American, but nothing can be further from the truth. I just wish we had better leadership right now.

Donna M. Burck
Donna M. Burck

I think Medicare is discriminating, and it has too many rules and regulations. Only the people who can afford medical insurance from major companies like Nationwide, CareFirst and Prudential, etc., can afford the best of care, However, the people on Medicare, get the bottom of the barrel in the form of healthcare! It infuriates me to no end! Medicare tells physicians how they treat their patients, how long they can stay hospitalized, what tests they may have...it's maddening! And, also, unfair. When is the disparity going to end?! Unemployment, gas, food and housing costs have all gone up, that's well established. My question is, what good is having all of the other costs, if people aren't well enough to work, feed their families, and put a roof over their family's heads?! Medicare needs a complete overhaul. Moreover, more medications and medical equipment are made overseas or in Mexico or Canada. Which, that fact in itself, takes away jobs from Americans in the first place. The rest of the world is probably laughing at us right now. I know it doesn't sound like I'm proud to be American, but nothing can be further from the truth. I just wish we had better leadersho

Denver Nobles
Denver Nobles

The brain is an organ, why is it not treated as so. "Mental Health as a Physical Health issue 'One Mind, One Body, One Spirit' ". My soon to be seminar.

Sally
Sally

I have Bipolar I Rapid Cycling. A set of meds may work for me for two or three years, and that is a big win. To remove meds from the available group for my doctor to use in my treatment would condemn me to frequent suffering and greater instability.

Kimberly Allen
Kimberly Allen

My experiences with medications and seniors are exactly what this doctor indicates. As a former Administrator of a dual diagnosis treatment center, I am well-familiar with our Medical Director often having to use generics. We knew with our seniors that if a drug was severely restricted, generics may not work, and due to limitations, our patients may suffer side effects, yet often we had little choice but to watch our clients decompensate or have bad side effects related to generic medications. This of course causes patients to resist taking those meds. The other option we had was to ask families to pay out-of-pocket for meds that our Medical Doctor prescribed. I can honestly say that I have watched families mortgage their homes to keep up proper care for their older family members, while other families had no additional monies to contribute. In addition, they did not truly understand that living with unmedicated or improperly medicated major depression or bipolar disorder is a feeling that one cannot truly describe. I can say from experience that bipolar disorder feels truly life-threatening to experience if your meds are "off". As a licensed chemical dependency counselor, I can say that it is perhaps more terrible to watch another person suffer. It is my opinion that "trial and error” is often what kills us, as it is tough to stay resilient and not just sit down and give up, even at a young age. It is particularly tough when the stigma quickly steps in to escort patients in yet another "failure" in treatment. So yes; I agree with the doctor - using a less expensive generic medication and allowing lethargy and suicide to take over simply because of cost is cruel to all concerned. I will always recall a conversation I once overheard while working with a large managed behavioral healthcare organization. The issue on the table was reducing cost for medications for an employer group that potentially had a "sick" senior population. One individual in the room made a "joke" and stated, "I know what will hold down cost! Let's take away their medications and all of the bipolars will kill themselves!" Take away medications and many people may kill themselves. Agreed. Joke's on me! It's just not funny; that's all.

Certainly I am not implying that everyone in managed healthcare feels that joke is funny. What I am saying is that I have seen the actuarial tables and research on the expense of seniors and mentally ill seniors. Yet there is no comparison between seeing the data, versus seeing the often slow death of seniors with brain diseases who did not have proper medications and expert clinical oversight. Yes, it often takes time to find an appropriate medication balance and augmentation is often necessary. I also know that medications have not been adequately studied in older adults and this too will take time, yet studying older adults is mandatorily part of the solution. Still, it is clear that health providers and family members can provide qualitative data now. We can all handily see the decrease in quality of life and an increase in side effects when medications do not work and the patient only has minimal choice in what they may take. It is also clear that the government can measure the cost of medications, yet what is so disturbing about the potential decision listed above is that it feels as though the government looks at senior "consumers" as primarily a cost and a burden to society. As a licensed chemical dependency counselor and licensed insurance agent myself, I am angered by this turning of the tide in health care. Also, I lost my own father to bipolar disorder and post-traumatic stress disorder related to the Vietnam war. I can tell you that formal education is for naught when you watch individuals who won victories in war and made lasting sacrifices to this country, struggle in darkness. I have stood by the beds of those whose families can pay "fee for service" and pay out-of-pocket for the proper medications that give their family members respite. I have stood by even more beds of seniors whose families cannot do so, and are compelled to take what they can get. Those seniors must have been part of the line in the ledgers of the government that lead them to consider this decision. They are no longer "The Greatest Generation". They appear to be the "Forgotten Generation". They are perhaps the "joke" I repeated above (?) "Just take away their medications and let them kill themselves. That will hold down the cost".

I suggest that the government write down their individual "numbers" in red ink. Don't forget my father. I don't.

Or, we may consider the solutions. The solutions lie in research, in stigma reduction and in having appropriate formularies that work. Also, in educational sessions for seniors, for medical healthcare providers and for emergency rooms. Seniors must take their medications. Peer support groups will help, and are of low cost. The media needs some public-service announcements on recognizing depression and other mental disorders and how to seek help as promptly as possible. The appropriate answers are there if we take the time to consider them.

Jim Blaha
Jim Blaha

As a patient, too, two, to many.

Laura Steinberg, M.D.
Laura Steinberg, M.D.

While I completely agree with Dr. Calabrese's stance against this new proposed rule, it is not true that in general Medicare provides worse coverage and interferes more in patients' treatment than private insurance. I am a psychiatrist and psychoanalyst and I am in network for Medicare only and not private insurance precisely because Medicare does not interfere. Unlike the vast majority of private insurance plans, they fully cover psychotherapy and psychoanalysis without any prior authorizations or limitations on number of sessions and did so even prior to mental health parity laws. (The only exception is some of the Medicare Advantage plans which are operated by private insurance companies do require authorizations and place limits on number of sessions). I have never had Medicare question or deny any test I have ordered. Private insurance companies also can and so deny (i.e. refuse to authorize) hospital admissions and tell doctors when patients have to be discharged. Most patients are truly not aware of how much their private insurance dictates their healthcare.