Shared Decision Making, Cancer Risk Assessment, and The Doctor- Patient Relationship

Welcome to my world as a practicing physician. Here is your chance to learn of the secret sacrifices we doctors make in the inner sanctum of the temple of Evidence Based Based Medicine. 

The "joys" of mandated guideline-driven shared medical decision making come to life in a one act play.

Below Dr Kildare will welcome you to his world that we doctors and patients will increasingly inhabit as we worship at the altar of evidence based, cost effective care.

This article is about lung cancer, but the issues it raises apply to all healthcare including CLL: arbitrary guidelines, lies to game the system, the intrusiveness of the computer and electronic medical record, the farce that is "mandated" shared decision making, and the general loss of intimacy and trust in the patient-doctor relation as big government and big insurance and big medicine play a more and more invasive role in the clinic and hospital.

I am no Luddite.

I celebrate the use of technology and big data. I look at cost effectiveness when sharing decisions with my patients (or with my doctors when I am the patient), but we need to remember the human connection and to pay attention to the needs of the real person in front of us and not to some statistical metric.

This is a good read:

Here is the link and below I simply cut and pasted the text.

Thank you Dr. Grannis for feeling our pain.

http://www.cancernetwork.com/blog/lung-cancer-screening-shared-decision-making-session?GUID=4DA9CFB5-590D-4180-AC65-4071506DC6BF&XGUID&rememberme=1&ts=23012015 …

A Lung Cancer Screening “Shared Decision-Making” Session

Blog | January 16, 2015 | Screening, Lung Cancer

By Frederic W. Grannis, Jr, MD

Frederic W. Grannis, Jr, MD

A ONE-ACT PLAY

DRAMATIS PERSONAE

DR. KILDARE, a private practitioner of medicine named Sonny Kildare

PATIENT, a patient named Hiram Wrisque

It is the near future. As the lights come up, a young physician, DR. KILDARE, is seated behind a desk working at a computer in a consultation room. For dramatic emphasis, he is dressed in the white smock, pants, and shoes worn by interns during the mid-20th century. A stethoscope is draped over his shoulders.

There is a knock on the door.

DR. KILDARE. Come in.

The office door opens and PATIENT enters, stage left.

PATIENT. Good morning, Dr. Kildare.

DR. KILDARE. Please sit down, sir. For the record, what is your name and date of birth?

PATIENT. I am Hiram Wrisque. I have been a patient in this medical practice for almost 50 years; a patient of your granddaddy’s until his passing. I am not sure why this visit has been scheduled? I requested to be screened for lung cancer 3 months ago.

DR. KILDARE. Well, Mr. Wrisque…

PATIENT (interrupting). Mr. Wrisque was my daddy; please call me Hy.

DR. KILDARE. All right, Hy it is. We have scheduled this doctor–patient shared decision-making discussion because it is mandated in the Centers for Medicare and Medicaid Services—we call it CMS for short—decision of February 2015 for all patients who ask their doctors to order a screening CT scan.[1]

PATIENT. Seems like a waste of time, I have done a lot of reading on the subject, and given it a lot of thought. But if we must, then let’s get on with it.

DR. KILDARE. First thing is that we need to enter your eligibility information into this computer database. What is your age?

PATIENT. I am 65 years old.

DR. KILDARE types laboriously into his computer.

PATIENT (impatient). Look, doc, I have to get my wife to her chemotherapy, so why don’t you take this sheet of information I have prepared for you, and you can have your secretary type it into the computer later. That way you can make eye contact with me instead of that computer screen. Let me sum up what it says it for you.

First thing, I smoked two packs a day for 40 years, starting at age 10. I quit 15 years ago today, when your granddaddy convinced me that my bullous emphysema and COPD were caused by smoking, and that I was at high risk of lung cancer. I have worked since high school at the nuclear power plant maintaining the asbestos insulation. Mom and dad and my older sis all died of lung cancer. My own lung cancer was resected 7 years ago and the laryngeal cancer was radiated 6 years ago. They tell me there is no evidence of recurrence of either and that I am probably cured of both. I had pneumonia twice in the past 2 years. Almost forgot to mention that I had lots of exposure to second-hand smoke as well.

I am in otherwise good health and can even play two sets of doubles tennis a couple times a week.

DR. KILDARE. Thank you for organizing that risk information for me. It is very helpful and makes it clear to me that I must recommend that you are not a good candidate for screening.

PATIENT. What?

DR. KILDARE. Yes, although you have a number of risk factors, Hy, you don’t meet the Medicare criteria for insurance coverage because you quit smoking 15 years ago.

PATIENT. Well first thing, doc, I asked to be screened 3 months ago, and it took all of this time to get the appointment.

DR. KILDARE (defensive). I am a very busy man and couldn’t get you in earlier.

PATIENT (exasperated). I have just about every risk factor for lung cancer imaginable and very clearly have a high risk of dying of lung cancer and yet you are telling me that I can’t be screened? That’s just plain nuts.

DR. KILDARE (irritated that this discussion is taking longer than anticipated). Here, Mr. Wrisque—sorry, Hy. I would like you to read this copy of an article from Chest by an eminent physician at Memorial Sloan Kettering named Dr. Peter Bach, who also wrote the guideline on lung cancer screening for the American College of Chest Physicians.[2] He explains how you don’t meet the criteria used in the National Lung Screening Trial and that it would be irresponsible to screen you without good evidence.[3]

PATIENT (cutting in). I told you I have read a lot on the subject. I read this article, and it makes no sense to me. Dr. Bach says elsewhere that if I get screened with CT scans and they find a lung cancer, that I have only a one out of five—20%—chance of survival,[4] but all studies, including the National Lung Screening Trial and International Early Lung Cancer Action Program show that the chance of survival with cancers detected by CT screening at 5 and even 10 years and beyond is between 60% to 90%.

DR. KILDARE. Hy, you need to leave this up to the experts.

PATIENT. Don’t be condescending with me, Sonny! I even went to the Web site at Memorial Hospital in New York and entered my personal information into their lung cancer risk calculator—I am told it was written by Dr. Bach himself. It told me that my risk of lung cancer is very high, that I have a 4% chance—that’s one out of twenty-five risk—of getting lung cancer in the next 6 years![5]

What’s more, this calculator didn’t ask if I had a previous cancer caused by cigarettes. Why, Dr. Bach himself has published data that indicates that because I had lung and laryngeal cancers in the past that my risk of lung cancer is at least 20%.[6]

DR. KILDARE (now flustered). Yes, all of that may be true, but since you had the good sense to quit smoking 15 years ago, your risk is now lower.

PATIENT. I understand that, but it’s still high enough that I am greatly concerned for my future. An article I read by Dr. Robert McKenna in Los Angeles, perhaps the busiest lung cancer surgeon in the country, informs me that more than half of the ex-smokers he operates on for lung cancer had quit more than 15 years earlier.[7]

DR. KILDARE. I am sorry that you are disappointed, Hy, but the Medicare rules are very clear.

PATIENT: This shared decision-making sure seems to happen on a one-way street.

DR. KILDARE. I suppose that you could pay for the CT out of pocket.

PATIENT. Look, doc, I am retired on a fixed income and have a lot of expenses for my wife’s medical care. It just isn’t possible for me to pay for screening. What’s more, it isn’t fair to put me in this bind when people with much lower risk will be covered by CMS or private insurance. On top of that, I asked at the hospital and they told me they can’t screen me without your say-so or they might lose their status as an expert center.

DR. KILDARE (whispering). You didn’t hear this from me, Hy, but if you, let’s say, revise your time estimate (he winks) on how long ago you quit, you would be eligible.

PATIENT. You mean if I lie to you. Sorry, but that’s not the way I was raised.

DR. KILDARE (worried). I was certainly not advising you to lie. That would not be ethical on my part.

PATIENT. But it is ethical for Medicare and Medicaid to ration access to a test that can save me and other people like me from suffering and premature death?

DR. KILDARE. Well, Hy, we seem to have reached an impasse, and I certainly don’t see this as rationing healthcare. I see no point in continuing this discussion further.

PATIENT reaches into his shirt pocket and takes out a pack, a brand recognizable by its prominent red logo, strips off the cellophane covering, opens the flip-top box and extracts a filtered cigarette.

OK, doc, you leave me with no alternative.

DR. KILDARE (agitated). Wait…what are you doing? You can’t do that here; it is against the law. Put out that match immediately or I will have to ask you to leave my office.

PATIENT (blowing a smoke ring from the cigarette he has just lit). I had no other choice, Sonny. Now that I am a current smoker again, I meet the damned Medicare criteria, so please just tell your computer to arrange for my screening CT scan ASAP. Now I have to be going. You have yourself a nice day.

DR. KILDARE shrugs resignedly and begins slowly typing the order into his computer as Hiram Wrisque exits stage left. 

REFERENCES

1. Proposed Decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N). http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=274. Accessed January 14, 2015. (Scenario assumes that Final CMS decision of February 2015 will be substantially unaltered.)

2. Detterbeck FC, Mazzone PJ, Naidich DP, Bach PB. Screening for lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013;143(5 Suppl):e78S-92S.

3. Mazzone P, Powell CA, Arenberg D, et al. Components Necessary for High Quality Lung Cancer Screening: American College of Chest Physicians and American Thoracic Society Policy Statement. Chest. 2014 Oct 30. [Epub ahead of print]

4. Bach PB, Gould MK. When the average applies to no one: personalized decision making about potential benefits of lung cancer screening. Ann Intern Med.2012;157:571-3.

5. Memorial Sloan Kettering Cancer Center: Lung Cancer Screening Decision Tool. http://nomograms.mskcc.org/Lung/Screening.aspx. Accessed January 14, 2015.

6. Lou F, Huang J, Sima CS, et al. Patterns of recurrence and second primary lung cancer in early-stage lung cancer survivors followed with routine computed tomography surveillance. J Thorac Cardiovasc Surg. 2013;145:75-81

7. Mong C, Garon EB, Fuller C, et al. High prevalence of lung cancer in a surgical cohort of lung cancer patients a decade after smoking cessation. J Cardiothorac Surg. 2011;6:19.

- See more at: http://www.cancernetwork.com/blog/lung-cancer-screening-shared-decision-making-session?GUID=4DA9CFB5-590D-4180-AC65-4071506DC6BF&XGUID&rememberme=1&ts=23012015#sthash.sHKKeEg2.dpuf

Will Your Insurance Cover a Clinical Trial?

This important information is from the CLL ACOR list.

I am one lucky dude to live in California, for many reasons, including clinical trial coverage. 

A quick look at the link below suggests that coverage is pretty good in most states, and even better with private carriers compared to government plans.

Thank you Liz for sharing this:

Subject: Will Your Insurance Cover a Clinical Trial?

Whether an insurance company pays for routine care costs in a clinical trial varies by state law. In some states, only clinical trials for children are covered. In others, only costs associated with phase III trials are covered. There are many variations. Under the Affordable Care Act (Obamacare), all insurance carriers must pay for routine care in clinical trials in all states starting January 1, 2014. 

Until 2014, here is a link to current clinical trial coverage laws by state: http://bit.ly/CTStateLaws

Many drug manufacturers also offer financial assistance to make investigational (not yet FDA approved) drugs available to patients in need for off-label use by certain doctors, usually principal investigators. As Karni writes below if you have concerns about costs, ask the research coordinators on the trial. They often have their own strategies and billing tactics to help a patient get coverage and afford a trial.

Liz Hart McMillan

Director, Hope for Lymphoma

P.O. Box 5096

East Hampton, NY 11937

New Computer, New Engine, New Operating System, Same Old Me

My cold is almost gone.

The insurance is in process for OSU. Life is on hold until I get an OK then a date to start.

The rate of paperwork expansion is ridiculous. Exciting new projects, but like an infant, they need a ton of nurturing before they can be left on their own.

My wife's Volvo has blown its third engine. This one lasted only 17 months, 5 months longer than the warantee. It happened when in the car poll lane of the 605 freeway so we have much to be grateful for. It could have been a much worse story. As it is, it is only money.

And I have almost finished a twisted migration from my good old lovable MACBOOK to a brand new sexy MACBOOK AIR (last year's model to save big money and wildly increase the difficulty of the process) and then upgraded that to LION. I have needed to learn to swipe in all kinds of new directions and have a new vocabulary of gestures.

These changes are not for the faint of heart, but they are most done, and my old computer sits forlornly by. As with an alcoholic, I needed to make a clean break, so all new emails and documents will live on my new virtual home. I suspect my white plastic laptop feels much like Woody from Toy Story. Life moves on.

It has been a challenging few days. I even went internet silent for a day, as both computers were in the shop for the migration. Talk about withdrawal. It was an act of cutting away the unessential that rivaled Yom Kippur. Went to bed early and read a lot. That's a good thing.

Amazing how I am so linked to this keyboard. It brings you to me and me to you, but it does pull me away from the flesh and blood right next to me.

Blue Angel

An angel swooped in from my past and called from Blue Shield with good news. My former part time case manager who helped me so much with my transplant three years ago got things back on track with clear lines of communication and clearer directions on what is needed for the answer on whether Dr. Byrd's consult costs will be covered by next week.

More importantly, she has promised to stay involved when I apply for the trial coverage.

I am very grateful, and cautiously optimistic and I am very pleased with Blue Shield.

All's well that ends well.

BLUE SHIELD BLUES

I am being very nice, honest, though at times it is not easy, answering the same questions over and over again after waiting on hold to cheery recordings of all the same tips about how to save my insurance company money.

Today is my third day of hours on the phone with Blue Shield of California member services, prior authorization, appeals, case managers, and supervisors, and who knows what and who else trying to get authorization for the Ohio State University consultation with Dr. Byrd for my clinical trial with PCI-32765.

It seems that their right hand doesn't know what the right wrist and the right pinkie is doing.

It's an appeal. It's a prior authorization, It's wrapped in with the clinical trial. No, it's back to a prior authorization. It's Super-Conflated.

After hours on hold and multiple lateral passes yesterday, I thought that when I finally got a phone number and a reference number from a case manager for my local oncologist to use with clear instructions of what he needed to do, the path was clear to a yes or no.

Boy, was I naive. His nurse got the same polite run around that I did today.

But everyone (even me), is very sweet and tries to be oh so helpful.

Remember all I am trying for is authorization for the relatively cheap mandatory consult to assess whether I am a candidate for the trial, not for the pricey trial itself. I understand quite sensibly that once it is ascertained that I indeed qualify, OSU will then apply for the trial coverage, and that is the real critical action. I am quite confident that will work out. And I am very confident that I will be in the trial by February.

I suspect, again probably naively, that the authorization for the trial itself is a more traveled route and an easier path to navigate.

This is just a fun and informative diversion in learning how the other big blue (not IBM but Blue Shield or BS) works.

The trial is the goal. I can pay for the consult, but not the trial. This is the practice run. I am keeping detailed records. I am hoping that I don't need them.

I am keeping my eyes on that prize. For a chance for real durable disease control. The excitement of a healthy and lengthy old age, a new drug that offers a true truce with my leukemia: these joyful possibilities almost get lost in these side battles.

I remain realistically confident that 2012 will be the beginning of the end of CLL struggles.

And very polite and helpful.

Insurance woes with Clinical Trial NCT01217749 at OSU using PCI 32765 and Ofatumumab

It looks like a tough decision I made to take the next step in my treatment path could be undermined by the big bad insurance company and the university teaching hospital with its inflated fees.

Here is what I wrote my online friends in the CLL community. This is aggravating stuff, but not the real bad stuff. Bad stuff is crashing or skyrocketing counts and worse. This is about money and a tilted system of health insurance. What could be bad, but I am not there yet is the removal of choice, the removal of a hope. I would hate that, but I am not there yet.

Soon I will post why this is my favored course of action today, but right now I am just trying to find a way to make it a realistic possibility. This is only the beginning. The door is not shut yet. I just need the pass code. Or the route to the backdoor. Or....

Hi,

My CLL needs treatment again, and after much thought and research, my first choice is Clinical Trial NCT01217749 at OSU using PCI 32765 and Ofatumumab, BUT my insurance, ANTHEM HMO covers nothing non emergent out of state.

What I understand about the trial is that the meds are free but everything else (usual standard of care is the coy term used) would be at my expense at the wrack rate- pricy for the individual payor (unlike the insurers who often pay pennies on the dollar). Labs, doctors' visits, BMB, CT scans all would be my responsibility. Maybe over a $100,000 for the whole deal.

Do I have this right?

Any advice?

Is it possible to negotiate to get a discount rate or a flat rate for the study?

Is it possible to get the bulk of the work-up done in my home state where my only cost is the co-pay?

Any other thoughts? Insights?

It is hard enough to make a treatment decision, even it is a preliminary and tentative one.

As the old joke goes: Besides bankruptcy, what other side effects does this treatment have?

Thanks as always. I bet there is a way to make this trial happen if it should. Just another challenge. Compared to CLL, this should be easy.

On a less challenging note, I am excited to be off to ASH next week as a accredited reporter (I keep picturing Jimmy Olson at the Daily Planet). Lots of good stuff on CLL especially PC! -32765 and CAL 101 and lenalidomide. In addition to trying to save my own skin by learning the latest on CLL and transplants and ITP, I am looking to help other family docs learn more about hematology and will be videotaping interviews with several experts.

Email if you have any burning questions or thoughts on what you or a good primary care provider should know about blood disorders. I will let you know when I post the videos.

We are all in this together (well maybe not the insurance companies).

Brian

I always have the rebbe to help me:

"Life is a very narrow bridge. The important thing is not to be afraid".- Rebbe Nachman of Bratslav

"Tell me why it is hard to make arrangements with yourself" Neil Young

Communication breakdown,

It's always the same,

I'm having a nervous breakdown,

Drive me insane!

Led Zeppelin

What's new you've been asking?

You've heard it before. 

Nothing. Nada. Rien du tout. Bupkahs. 

Stillness is not my strength. 

Add to that a communication breakdown and it makes for a frustrating frozen moment. My insurance authorization for my appointment at UCSD was fumbled on the two yard line. In the fourth quarter. With one second left on the clock.

My scheduled appointment for a second opinion on a second transplant is suddenly on hold after office hours on the day before the appointment, waiting for a last minute paperwork reprieve that would allow me to keep the hard to get chance to see the double agent, Dr. Castro, who moves with grace in both the world of CLL and transplant medicine. A rare man in deed. I need his take on the advisability and timing and risky details of second dose of a stranger's stem cells. Or goosing my immune system with lenolidomide, the princely stepchild of thalidomide. That certainly would be entering unknown territory. Or other options I haven't even considered.

There is still a chance I will get the go ahead tomorrow.

In reality, nothing will be decided until the computer that controls an x-ray unit is used to slice through my gut, and using complex algorithms reconstructs my interior geometry. Moving nodes that are less than a half an inch across to begin with will be scanned for any change.  Not by inches, but by millimeters will my future be decided. That CT scan won't happen for another month.

In Vegas, I would be a card counter. I want all the edge I can get.  I want to know what is knowable. I want some to time to compute the odds and then make my move. 

I should still get the information and time I need. 

I am just not good at waiting.