Archive for the ‘Transplantation’ category

All Hepatitis C Patients Deserve Access to Cures

July 28th, 2014

Today is World Hepatitis Day.  We should have much to celebrate. Recent FDA approvals have given liver patients and providers medications with 90-100% cure rates with shorter treatment times, fewer adverse side effects, and easier administration.  Three medical societies issued new guidance to assure that physicians were aware of the transformative nature of the new therapies and had the information needed to treat their patients.

 “Hepatitis C can be cured, and today’s drug therapies are very effective and easier for patients to take.”

— Jeffrey S. Murray, M.D. deputy director, Division of Antiviral Products, FDA Center for Drug Evaluation and Research

However, commercial health insurance plans and state Medicaid officials are restricting coverage to the most effective therapies arguing that the price of the medications — $70,000 -$170, 0000 — is too high to pay in the case of a disease with more than 3 million patients particularly in need.

Their calculations seem not to  have taken into account reductions in:

  • costs of treating severe side effects such as anemia
  • costs of treating progressive and advanced liver disease — End stage liver disease patients incur average annual costs of $59,995
  • costs of treating liver cancer ( the #2 cause of cancer death globally) — $112K annually
  • costs of liver transplant — $more than $500,000 to start, and then high annual costs for medication and monitoring
  • absenteeism
  • presenteeism
  • caregiver lost income and other expenses

Their decision also seems not to have taken into account ethics or morality either. Their main argument is that lots of people need treatment.  There is no other infectious, communicable disease that we deliberately choose, as a matter or policy, to not cure.

My only conclusion is that payors have decided that liver patients are not worth treating. They are saying that the grandfathers, grandmothers, mothers, fathers, sisters, brothers with hepatitis C ( 2/3 are Baby Boomers) are just not worth saving.  What are you saying with your silence?

Tweet: #HCVmedaccess4all

Support our  awareness campaign:

Look for more information coming:


FDA Consumer Update:

Payor, not Patient-Focused Narrative

Price Limiting Coverage

Disproportionately affects African Americans and the poor




Access to Immunosuppressive Drugs under Medicare Part D is at Risk — Transplant Community Needs to Act Now!

February 12th, 2014

New: Congressional Briefings on Preserving & Protecting the 6 Protected Classes Scheduled

Feb 12th — Noon: B340 Rayburn House Office Building

Feb 13th — Noon: Capitol Visitors Center Room SVC 200

The blog is cross-posted with permission from the National Kidney Foundation. Other comments are completely my own.

All those you have been transplanted, are waiting for a transplant, love someone who has had a transplant, donated a loved one’s organs to give the gift of life and want to make sure it is not endangered OR just folks who believe that CMS should not engage in the practice of medicine please read and make your opinion known.

Access to Immunosuppressive Drugs under Medicare Part D is at Risk

Medicare beneficiaries who do not qualify for immunosuppressive drug coverage under Medicare Part B (the Medicare program that covers outpatient care) typically receive coverage of their immunosuppressive drugs under the Medicare prescription drug program known as Medicare Part D.  Under current Medicare Part D protections, organ recipients have access to all approved immunosuppressive drugs. This protection allows physicians to tailor drug combinations to best meet the needs of the individual patients. However, a proposal released by the Centers for Medicare & Medicaid Services (CMS) on January 6, 2014 would eliminate this protection and allow Medicare Part D health plans to restrict access to immunosuppressive drugs.

Without the current protections, Part D plans, not doctors, will decide which immunosuppressive drugs patients can access. This proposal reflects a misunderstanding by CMS that immunosuppression to avoid organ rejection is a one-size fits all therapy. Patients and transplant physicians know that there is no one drug combination that works for every patient. Some patients may experience harmful side-effects with a particular drug combination that might work wonderfully for someone else.  It takes a delicate balance to properly suppress the immune system in order to preserve the organ, while minimizing side-effects for each patient.

Rest assured that NKF is engaged on this issue and is educating legislators and the media about flaws in CMS’s proposal. To date, our conversations with congressional offices are encouraging. We are also reaching out to CMS to help them better understand how immunosuppression works and why it is important to cover all immunosuppressive drugs.  However, we still need your help.  Please email and share your story about how your physician was able to find the right combination of medications for you.  Did the first combination of drugs work right away or did you need to try multiple combinations before the right one was found?  Sharing your stories with policymakers helps us grow momentum in order to get CMS to reverse this proposal.

Additional Information:

CMS fact sheet on changes.

CMS proposed rule$File/MAJan62014.pdf

Foley Hoag analysis

Submit comments on!submitComment;D=CMS-2014-0007-0002

Learn more about the Medicare Access for Patients Rx Coalition


Let Patient Safety Guide FTC Decisions on Biosimilar Naming

February 4th, 2014

Today the Federal Trade Commission is conducting an workshop to determine, in part, if follow-on versions of biologic medications will have the same name as the original versions of the medications or if they will be designated by a distinguishable name or code so if there is an adverse event the doctors, patients, and regulatory agencies can track back and find the responsible product.  They would still be on the market, still be (presumably) at a lower cost, but just not able to hide.  What do you think?

Below is a link to my views in a conversation with  former Asst. Commission of FDA, Peter Pitts and a blog post from the Alliance for Patient Access which includes a letter signed my major patient associations.

Drugwonks Interview:

Blog Post from the Alliance for Patient Access

By Brian Kennedy, Alliance for Patient Access

As a representative of an organization that advocates for greater patient access to approved therapies and appropriate clinical care, I am hopeful that when biosimilars are introduced into the U.S. market (later this year or early next), patients nationwide will have increased access to certain life-altering and life-saving treatments. It’s disappointing though that the Federal Trade Commission (FTC) is driving a discussion about market access and competition for biologics and biosimilars this week, yet they left important perspectives – namely patients, providers with experience prescribing biologics, and health system pharmacists – out of that dialogue.
While the U.S. Food and Drug Administration (FDA) – not the FTC – ultimately sets federal policy around the approvals pathway for biosimilars, any public discussion driven by a federal government agency is going to get attention; because of the FTC’s omission of these important perspectives, the Alliance for Patient Access (AfPA), along with the California Healthcare Institute (CHI) and thirteen other health advocacy organizations, signed a letter that has been submitted to the FTC and urges that patient safety and consumer protection be at the forefront of the FTC’s considerations, particularly when discussing the issue of the naming of biosimilar products.
Before approving biosimilars in the U.S., FDA will first need to establish naming policy for these products. Given the vast differences between chemical compounds and biologics – including biosimilars, the FDA should require distinguishable names for all biologic products, rather than requiring biosimilars and their innovator reference product to share the same name.
Patients across the country will be best served if distinguishable names are required for all biologics. By providing clarity of which medication is being recommended at the point of prescription, distinguishable names facilitate the process of determining the cause of an adverse effect and allowing patients and their medical teams route back to the origin of the problem. Issues that may be particular to a specific biological product may even be entirely untraceable without distinguishable names or other distinct identifiers.
Accordingly, through the way it sets naming policy, FDA can provide the best possible protection for patients, while simultaneously ensuring the highest credibility for biosimilars as they enter the marketplace.

Original Post and letter:

FTC Workshop  on Competitive Impacts of State Regulations and Naming Conventions Concerning Follow-on Biologics:


Next-Generation Non-Profits: Liver Edition

November 6th, 2012


I cannot believe that it has been months since I posted.  It has been a whirlwind since July 30th when I started as President & CEO of the American Liver Foundation.  I have traveled almost 15,000 miles learning and listening to staff and volunteers in our 16 chapters around the country so that I can do the best job possible on behalf of the 30 million people in the U.S. ( like me) affected by liver disease.  During one of those trips I also had the privilege of doing an Ignite presentation at the Stanford Medicine X Conference as an e-patient scholar.  Thank you, Stanford Medicine X planners, for inviting and integrating 35 e-patients rather than the customary 1 or 2 at most meetings.

Top of mind for me was and is, what does a Next-Generation Non-Profit look like?  How do you create one?  How do you transform a last-generation traditional non-profit into one?  Thank you to Sarah Krug, Executive Director of Cancer 101 and President of the Society for Participatory Medicine for sparking many of these discussions.

Since this was a tech-y, design type crowd I kept my slides to a single number and spoke from there. Next Generation Non-Profits in Numbers_cryer

Here are my numbers decoded.

10, 792 = Days since my initial diagnosis with ulcerative colitis. 10, 792 days ago I became a patient.

18 = years since my liver transplant.   I consider myself blessed to receive this gift of life.

16,036 = number of people on the waiting list for liver transplants.  Only about 6,000 people receive transplants each year.

100 = types of liver disease. Babies are born with genetic/metabolic disorders, teenagers can develop autoimmune conditions, the CDC recommends every Baby Boomer be tested for Hepatitis C

25,000,000 = people living with at least one chronic condition.  This is not a liver-specific quandry.

11, 473 = Twitter followers of @epatientDave ( on that date) — one  measure of online patient advocacy.   Note the large gap between the number of patients and the number of epatients.  I see opportunity there.

42 = Patient advocacy groups that meet the standards of the National Health Council, the umbrella group for traditional nonprofit organizations from the American Heart Association and the American Cancer Society, and a leader in policy around chronic disease and medical research

5 = minutes, less now, to make the argument that uniting the energy of epatients with the structure and reach of the traditional patient advocacy organization we can do a better job of creating patient-defined and patient-driven change in healthcare

36= The American Liver Foundation, my organization, is 36 years old. The oldest and largest patient advocacy organization in the liver space.

1 = I am the first patient to be CEO of the Foundation and one of the only patients to lead a major patient advocacy organization (Take a moment. Think about it.)

2= questions comprise the new strategic filter for everything we do as the Foundation — (1) does it solve a problem for a patient or a patient family?  (2) are we solving the problem in the most innovative and effective way possible?

20 = number of Board members I needed to convince that these were the right questions to be asking, the right direction to go in.  And just to explode any misconceptions that next-generation non-profits is about age, or even the sole province of patients, my biggest supporter has been practicing medicine as literally as long as I have been alive.  Next-generation non-profits are about impact.

8 = active partnerships between the Foundation and other associations

14 = pilots pending with academic medical institutions

3 = satellite sites for the patient-centered advocacy forum we held to get insights directly from patients to form the basis of our policy agenda

4 = government or quasi-governmental agencies ( pop quiz — name them in the comment section!) with new (past 2-3 years) patient/stakeholder engagement positions that we invited to the forum to interact with our patients

82 = corporate partnerships being pursued across sectors from food (fatty liver disease) to medical imaging to pharmaceutical

16 = chapters around the country, because at the end of the day it is about meeting individual needs, often face to face, or based on the specifics of the community

10, 792 = days from now I hope that there is no American Liver Foundation because we would have been so successful in eliminating liver disease.  My vision is that next-generation nonprofits are not about their own self-perpetuation, but about meeting their mission. I hope that 10, 792 days from now no one else’s little girl becomes a patient.



Launch of American Liver Foundation Innovation Council Today

June 8th, 2012

Good morning, Chicago!  Looks like a great day to start something new.

Today is the launch of the American Liver Foundation’s Innovation Council.  (@ALF_USA) Chaired by Dr. Danny Sands (@Dzsands) (@S4PM), Director of Healthcare Business Transformation at Cisco, and Dr. Nancy Reau, Assistant Professor of Medicine at the University of Chicago, the ALF Innovation Council is intended to bring together creative minds from across silos in healthcare to help us solve key problems facing liver disease patients and their families.

The program will also feature a panel of patients discussing their various experiences with liver disease and a presentation of the state of liver disease and treatment today.

If you are reading this blog post, it is likely that you have been unable to join us in person, but we’d still love your input.

Please comment on the four questions below or tweet us this afternoon (we start at 1pm CT) using the hashtag #ALF_IC.    Many thanks to the Innovator companies who are helping to spark our imaginations.

Step One: Detection/Diagnosis : Moderator Nancy Reau, MD

Key Issue/Question: How can we expand the number of patients in rural and underserved communities accurately diagnosed with liver disease?

Innovation Example: OraSure Rapid Test (rapid diagnostic test for HIV and HCV) @OraSureTech


Step Two: Newly Diagnosed/Treatment Selection: Moderator Danny Sands, MD

Key Issue/Question: How can we accelerate the understanding of a patient and their family of their diagnosed condition and how they are going to navigate an increasingly complex set of options?

Innovation Example: Inquisit Health (peer-to-peer web platform) @InquisitHealth


Step Three: In-Treatment: Moderator John Kontor, MD

Key Issue/Question: How can we optimize therapies by helping patients overcome barriers to adherence?

Innovation Example: Ginger io (smartphone/SMS/adherence and behavior feedback program)


Step Four: Survivorship: Donna Cryer, JD @DCpatient

Key Issue/Question: What are the best long term outcomes for liver patients and how do we achieve them?

Innovation Example: Galileo Analytics (data mining and visualization tool)



Liver Disease Word Cloud

June 3rd, 2012

Wordle: Liver Disease


Learn more:  American Liver Foundation


My Birthday Wish: Patient-Centric Reimbursement

August 6th, 2010

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.

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.

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.


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.

Redefining Success in Transplantation

June 27th, 2010

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  ( 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

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


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


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)