Amy Bassano
Director of Hospital and Ambulatory Services
Centers for Medicare & Medicaid Services

RE: Calendar Year for New Clinical Laboratory Tests Payment Determinations
In Support of Cylex Request for Reconsideration of Crosswalk Decision for CPT Code 86352

From my testimony at the July 22, 2010 Public Meeting

Good morning, my name is Donna Cryer. Today is my 40th birthday. Transplantation works. 16 years ago I was the beneficiary of a very skillful surgical intervention. But I stand here today because of a complex regimen of immunosuppressive medications. I may not be able to stand here 16 years from today if appropriate reimbursement is not given to Cylex’s Immuknow.

Allow me to explain . . .
After graduating from Harvard and between my 1st and 2nd year of law school at Georgetown my body finally succumbed to more than a decade of autoimmune disease and I waited in intensive care for an organ I was eventually blessed to receive. Subsequently I served on staff as a patient affairs specialist at the united network for organ sharing and was invited back as a volunteer on the membership and professional standards committee. Currently I am a member of the board of directors of the American liver foundation and a patient representative to the U.S. Food and Drug Administration. I use Immuknow with my transplant team to manage my care.

I am here today representing myself and speaking in support of Cylex’s request for reconsideration.

I am here to remind us that what we discuss and decide here today are not abstract or academic issues but are life and death to patients like myself who rely on immunomodulation therapies and who rely on third party payors like Medicare & Medicaid to enable our access to approved and validated care.
My remarks will focus on the impact of inadequate reimbursement on patients in three areas: access, cost, and quality.

Access
Inadequate reimbursement of immuknow may prove to be an absolute bar to patient access. Medicare, particularly through ESRD, covers such a large proportion of transplant recipients that hospitals simply will not be able to take on the burden of covering the loss for performing each test and patients will lose out on a unique and necessary tool for managing our complex immunosuppressive regimens.

No other current clinical decision support tool provides for early, actionable information so a clinician can intervene to prevent rejection not just deal with complications.
A personal example: my creatinine has been rising, indicating that the immunosuppressants may be having a nephrotoxic effect. The initial reaction from my physician was to lower my dosage, but because we also did an Immunknow test we saw that my immune system is highly reactive and we risked rejection if we reduced the dosage. We are working on other therapies to reduce the impact on my kidneys. Because I had access to this test, we were able to avert the need for rescue therapy, hospitalization, and possible graft loss.

No other current clinical decision support tool allows personalized treatment, so that an individual’s immune system is balanced with graft survival, risk of infection and long-term consequences.
My doctors did a great job of saving my life and my organ but because we did not have this tool early enough my creatinine is rising, I have osteoporosis and osteonecrosis from too much prednisone, and, these high heels notwithstanding, my orthopedist has told me I’ll need knee replacements. We can do better now. Let’s do better now.

Cost
According to a National Kidney Foundation analysis Medicare will pay on avg. $100k for the 1st year of transplant or retransplant, my 1st year costs were well upwards of $300,000 – to not pay the approximately $600 for a test that can avoid the need for retransplantation seems unwise to say the least.

Let’s be clear, current practice is to use gestalt, accompanied by proxies such as levels of Immunosuppression medication in the blood, enzymes, or if we’ve waited too late, biopsies to diagnose rejection.
Medicare spends an average of $17k per year/per recipient for medication after the 1st year. (which is 80% of costs under part b if transplant is eligible under Medicare) (NKF data)

Because Immunknow use allows for personalized therapy, patients have greater confidence in the treatment plan which promotes greater compliance thereby reducing adherence-related rejection and costs.
Immunknow use in some cases results in lower costs from reduced prescription expenditures or hospital admissions.

Quality

Finally, as a patient it is extremely difficult to trust the U.S. healthcare regulatory system or have confidence in emerging therapies if one agency will not support financially what another agency has defined as the precise method of performing a test to be clinically effective and valid. That is not high quality care; that is not evidence- based medicine. Inadequate reimbursement of Immuknow does not serve patients, the practice of medicine, or the healthcare system. It removes a critical tool for managing transplant recipients and loses sight of the scale and scope of other costs related to ESRD and transplantation in the absence of this assay.

I support Cylex’s request and ask that CMS please grant this request for reconsideration of the crosswalk decision for CPT Code 86352.
Thank you very much.

Disclosure note: I am a consultant to Cylex ( I asked to work with them because I believe in this test), but not paid for this testimony.

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Sixteen years ago this September, I was blessed to receive a liver transplant. Having been diagnosed with two auto-immune conditions as a teen, I was more than receptive to discussions with my transplant team of surgeons, physicians, and nurses on how to suppress my immune system so that I would not reject the organ.  Only recently have I realized that something was missing from that discussion.

With the five year patient survival rates for liver transplants at approximately 70%, depending on initial diagnosis, most recipients can expect to recover and return to work, school families – LIFE.  However, the longterm consequences of overimmunosuppression are seldom discussed, except for increased susceptibility to infections and increased risk of cancer.  After talks with my orthopedist about my diagnosis of osteoporosis, my primary care physician about a rise in my creatinine, and alerts about implications of immunosuppression on hypertension and cardiovascular risk, I have come to better appreciate that harmonizing the immune system rather than knocking it out should be the goal of post-transplant management.

Although approaches and protocols certainly differ by transplant center and even by transplant team, my sense is that the prevailing philosophy is still to prescribe as much immunosuppression as the individual will bear to preserve the organ.  I would like to argue that the goal of transplantation today should be to balance and optimize the individual’s immune system for graft survival and long term optimal health.

The tools most transplant centers use to monitor and manage immunosuppression are, for the most part, blunt instruments that measure levels of immunosuppressive medication in the blood or damage to organs.  I have recently been tested using an immune system function assay called ImmuKnow made by Cylex  (http://www.cylex.net/hcp.html) and found that despite therapeutic levels of immunosuppressive medication (I take Prograf and Imuran) my immune system is still highly active.  This empowered me to push back on my transplant hepatologist’s recommendation to reduce my immunosuppression further. We were able to have a discussion based on my personal immune system response and look for other ways to ameliorate some of my symptoms in a way that does not expose me to increased risk of rejection.

I’ve been surprised to find out that although there is this FDA-cleared test that gives such useful information to guide therapy, supported by more than 120 studies and 200 publications, most transplant centers haven’t yet adopted it and few other patients know about it.  Although my insurance covers the test (why not, compared to the cost of my medication or unthinkable, another transplant) some insurance companies, have denied coverage or are in the process of making that decision.  If you’ve used ImmuKnow or would like to have access to it in the future consider contacting the following fine insurance executives:

BCBS Patients in PA should send comments to:

Virginia Calega, MD

Highmark Blue Shield

Medical Management and Policy

125th Ave Suite P4105

Pittsburgh, PA 15222

Phone: (412) 544-7000
email: virginia.calega@highmark.com

Assistant: Marcine Benton

Ext: 42640

Subject: Cellular Function Assay

Policy Number: Z-24 Miscellaneous Services

Effective 2/15/10 – Highmark BCBS , general policy bulletin – lists 86352 (and a number of codes) as Investigational (no documentation of review of specific medical literature, clinical utility or patient impacted has been noted in the policy bulletin)

BCBS Patients in Texas should send comments to:

Allan Chernov, MD

Blue Cross Blue Shield of Texas

Medical Director

1001 East Lookout Dr

Suite B – 10.408

Richardson, TX 75082

Email: allan_chernov@bcbstx.com

Phone: (972) 766-1149

Assistant :

Holly Rock: 972-766-2011

Subject: Immune Cell Function Assay in Solid Organ Transplantation

Policy #:  MED207.147

Effective: 1/1/10 – BCBS Texas is considered experimental, investigational and unproven  (need to hear from patients about real world experience and how this is important to their quality of life , care and treatment)

BCBS Patients in Illinois should send comments to:

Kim Reed, MD

Blue Cross and Blue Shield of Illinois

Medical Director

300 East Randolph Street

Chicago, Illinois  60601

Email: reedk@bcbsil.com

Phone: (312) 653-5487

Subject: Immune Cell Function Assay in Solid Organ Transplantation

Policy #:  MED207.147

Effective: 1/1/10 – BCBS Illinois is considered experimental, investigational and unproven  (need to hear from patients about real world experience and how this is important to their quality of life , care and treatment)

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Since I bought a new car 2 weeks ago, I’ve noticed every car advertisement whether in print, on tv, or on the radio.  Similarly, 2 years ago, when we began facing conception challenges I started noticing advertising for fertility clinics. It’s as if they sprang up like the soldiers made from dragon’s teeth in the original Jason and the Argonauts movie – suddenly they are everywhere.

The further along in this journey I travel the more these ads bother me.  I appreciate their presence, acknowledging that these are medical issues that can be treated and that there is no shame in seeking treatment, however, the ads usually read something like this:

“ Where Dreams come to Life” or some other mystical, aspirational marketing statement.

List of Services: the higher tech the better, as if we are in some fertility arms race — “egg donation, Intracytoplasmic  Sperm Injection ( ICSI), Preimplantation Genetic Diagnosis . . .”

“ Nationally Acclaimed, Highly Successful”

I understand, just like cardiac or prostate cancer centers that advertise their new Da Vinci robot, we are supposed to be comforted by and attracted to the facility with the latest and greatest, also practices need a certain volume to amortize the cost of expensive equipment of highly sought after sub-specialists like geneticists.

However, I wish that there was a center brave, bold, and honest enough to put forward the following:

There are no guarantees

We will work with you to 1^st help get you and your partner in the best physical shape pre-conception.

Then we will leverage the best of Eastern and Western Medicine to optimize your own reproductive cycle.

We have meditation and yoga classes and resources on site since this process is inherently stressful.

This will solve a high percentage of couples’ conception challenges.

As for the rest we will THEN apply only so much medicine, science, and surgery as is necessary to reach your particular family building goal whether that be your own genetic child, a pregnancy, or give you the information you need to assess when adoption or childfree living are options.  We will not pressure you into believing that all these are the same.

This may take a month or several years.  Depending on your insurance coverage it will likely be expensive.

We are your partner and will do everything we know for you.  The rest is really in God’s Hands.

Call us.

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Today is the next to last day of National Infertility Awareness Week. I applaud Resolve® The National Infertility Association for sponsoring a wave of activities including media and advocacy visits to Capitol Hill. The most striking part of this effort, to me, has been Project IF.

Project IF is RESOLVE’s ongoing public education project. The goal is to make sure the public…
• understands that infertility is a disease that affects 1 in 8 couples of reproductive age;
• acknowledges that there are many ways to build a family;
• understands that the disease infertility impacts the physical, emotional, and financial health of those that are facing it;
• knows when to seek the advice of a specialist.

The online abbreviation for infertility is “IF”. And when you’re faced with infertility there are so many “IFs” involved. “What IF we can’t afford treatment?” “What IF it doesn’t work?” The “IFs” are endless… When you’re a friend or family member of someone with infertility there are many IFs you can’t always understand. “What IF we aren’t grandparents?” “What IF my friend doesn’t come to my baby shower?”

These “What IFs” have run through the mind of everyone I know struggling with this issue including myself. Thank you to all the bloggers who have taken up the challenge to expose your personal What IFs to the world towards creating greater understanding, empathy, and action. The best example, amongst many heartfelt and heartbreaking entries this week was Keiko Zoll’s video seen here on her Hannah Wept, Sarah Laughed: Redefining Faith & Womanhood in the Face of Infertility blog.

However, after reading and watching so many of my sisters pulling back the veil of the oft-troubling thoughts that ravage our minds and hearts, I wanted to put forward something a little different.

When I think of how to describe the infertility experience I ask people to picture a roller coaster or a swing. Emotions and moods going up and down. Most of us just want off the ride. So although there are many lows there are also highs and reason’s for hope and that’s what I want to add to this conversation.

What IF . . .
• I end up with not one, not two, but three kids (from 3 healthy singleton pregnancies) like 3 of my friends who went through IVF and then had subsequent natural conceptions
• I get pregnant next month
• All the things that I am doing to make myself the healthiest “vessel” establish life-long habits that enhance my life whether I get pregnant or not
• The meditation classes I take make me a better wife, daughter, sister, boss and business person
• I am a better mother when this is all said in done because I had to learn patience and endurance
• The clarity with which I know that I love my child even now is so powerful it changes the world

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In the “I wish I knew then what I know now” category are a laptop hard drive and full bookcase of information on fertility that I have amassed in the past 2 ½ years. Fertility challenges are something that few women envision encountering (although 1 in 7 couples may experience) and I, like so many, went straight to What to Expect When You’re Expecting.  After 6 months (I’m over 35) and a few blood tests I realized what I needed was more like What to Expect When You’re Expecting Expecting and Expecting, But Never Seem To Get Pregnant.  Through trial and error I have amassed some essential resources that I would like to share with any woman experiencing difficult conception.  This pared-down collection of must-haves reflects my belief that understanding your cycle in detail, creating a mind-body connection capable of withstanding the inherent stresses in the challenged fertility process, and optimizing your nutrition are the key elements to a successful fertility journey whether you get pregnant or not.

The DCPatient Fertility Toolkit

Books:

• Taking Charge of Your Fertility by Toni Weschler, MPH
• Navigating the Land of If: Understanding Infertility & Exploring Your Options by Melissa Ford
• The Infertility Cure by Randine Lewis, MD
• Conquering Infertility by Alice Domar, PhD
• The Fertility Diet by Jorge Chavarro, MD Walter Willett, MD, Patrick Skerret

Meditation/Mind-Body Connection:

• Circle +Bloom http://www.circlebloom.com/
• Listen to the February 24^th Real Women on Health! Blog Radio Show featuring Circle +Bloom http://bit.ly/au3ce2

Body/Mind-Body Connection:

• Pulling Down the Moon – information and appointments for acupuncture, yoga, and other complementary therapies http://www.pullingdownthemoon.com/

Supplements:

• FertileAid http://www.fertilaid.com/

Websites:

www.resolve.com

www.conceivingconcepts.com

That’s it!

Although it wouldn’t be fair to leave out my personal go-to fertility coach and meditation workshop instructor/acupuncturist – Connie Barrow http://www.fertilepossibilities.com/ and Lisa Eaves http://www.heal-from-within.com/

Let me know if you find this helpful and feel free to recommend the essential elements of your fertility toolkit.

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Challenges to the process of conceiving a child are not usually mentioned among the top things to be thankful for when one goes around the dinner table on Thursday, but after 2 years and counting of walking this rocky road to motherhood I realize that I have several things on which I’d like to express gratitude.

1. I give thanks for greater knowledge and appreciation for the miracle of my female body and the reproductive process. I would be embarrassed by how little I knew if the average women knew any more.  It is a disservice to women that we are not taught more and earlier.
2. I give thanks for a stronger marriage and an enhanced appreciation for my husband’s strength, sensitivity, love, and the great gift he has given me of a safe place to pour all my disappointment, frustration, and fears.
3. I give thanks for doctors who listen and truly practice medicine. Reproductive endocrinology is as much art and science and requires a level of personalization physically and emotionally that is not necessary in other specialties.  Also, there is as much unknown as known.  I am grateful for finally finding a physician with the humility and skill to meet me where I am and work with what my body can do.
4. I give thanks to God.  Fertility is faith. Faith that my body is innately fertile. Faith that diligently seeking God’s plan for my life is worthwhile in itself. Faith that as I draw nearer to Him He draws nearer to me.

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