Posts Tagged ‘transplant’

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 nkfadvocacy@kidney.org 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. http://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-Sheets/2014-Fact-sheets-items/2014-01-06.html

CMS proposed rule http://op.bna.com/hl.nsf/id/bbrk-9f4szl/$File/MAJan62014.pdf

Foley Hoag analysis http://www.foleyhoag.com/publications/alerts-and-updates/2014/january/cms-proposes-changes-to-six-protected-class-rule-under-medicare-part-d

Submit comments on www.regulations.gov http://www.regulations.gov/#!submitComment;D=CMS-2014-0007-0002

Learn more about the Medicare Access for Patients Rx Coalition http://maprx.info/

 

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.

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.

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  (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)