Are Elected Officials in Bed with the Dialysis Industry?

People who are diagnosed as needing organ transplants are end-stage patients.  That means medical science has run out of alternatives to extend life and a transplant is the last and most beneficial approach.  Transplants are not cures but they can offer a considerable extension of life provided the patient adheres to the program and has on-going, expert medical care.

At least twice very day a transplant recipient must take the daily dose of anti-rejection drugs.  They are effective but expensive.  They can run as high as $1,500 a month and if you quit taking them you can and likely will die.  If you are of retirement age or disabled your Kidney transplant is covered by Medicare and most of the cost of the drugs as well.  If you are under 65 and not disabled and diagnosed with End Stage Renal Disease (ESRD) your kidney transplant will still be covered by Medicare but your anti-rejection drugs will only be covered for 36 months and then you are on your own (detailed explanation below).

If after 36 months you go into rejection because you can’t afford the meds, Medicare will pay for dialysis and even pay for another transplant but not for the drugs which would prevent needing either.  The drugs would be a fraction of the cost of the two alternatives that are covered.  At best that is just plain dumb!

Someone said a long time ago that, “If you like either sausage or the law, you should watch neither being made.”  Well, that certainly applies to this issue.  Another of my favorite expressions which also applies here is, “No one’s life, liberty or property are safe when the legislature is in session.”  These two expressions apply perfectly to the anti-rejection medicine silliness.

The entire situation and what to do about it is explained below.

The Current State Of Access to Post transplant Care

By

Christine S. Rizk, JD, and Sanjiv N. Singh, MD, JD

http://virtualmentor.ama-assn.org/2012/03/pfor3-1203.html

Virtual Mentor. March 2012, Volume 14, Number 3: 250-255. American Medical Association

This article provides historical perspective on the evolution of coverage for kidney transplant patients and attempts to identify what initiatives would most effectively and efficiently improve their survival.

As of January 24, 2012, in the United States, there were 112,767 waitlist candidates on the various national transplant registries [2]. Of those candidates, 90,563 were waiting for kidneys, but in 2011 only 13,430 kidney transplants were performed [3]. The need for kidneys far outweighs the availability of suitable donor organs, and some postulate that the Patient Protection and Affordable Care Act of 2010 (ACA) may worsen the shortage by eliminating barriers to insurance coverage based on preexisting conditions, lifetime coverage caps, and required periods of pretransplant dialysis [4].

Even more critical from a clinical, economic, and moral perspective is the fact that the additional end-stage renal disease (ESRD) patients now expected to receive transplants by 2014 will be most vulnerable in the posttransplant phase of care. Coverage for pre transplant dialysis and maintenance drugs for ESRD, but not post transplant care, receives strong support in Washington from large dialysis and pharmaceutical companies, which derive significant profits from dialysis, ESRD drugs, and dialysis-related services [5]. For ESRD patients, dialysis is covered by Medicare for life [6].

For posttransplant care, however, Medicare coverage is limited, providing only 80 percent of the cost of immunosuppressive medications for 36 months after transplantation (for those whose Medicare entitlement is based on ESRD) and no coverage thereafter. Despite the fact that effective and long-term immunosuppression is essential for survival of transplant patients [7], the vast majority are left to fund 20 percent of the cost for the first 3 years of immunosuppressive drugs ($13,000 to $15,000 total cost per year per patient) [8], and, for patients under 65 who are not disabled, all of the cost of immunosuppressive drugs thereafter [9].

Not surprisingly, this system leads to noncompliance. Many patients cope with the financial burden by “spreading out” their anti-rejection drugs, taking them less often or not at all [10, 11]. A recent meta-analysis reports that “about 22.6 of 100 adult transplant patients per year fail to take anti-rejection drugs” [12]. If allograft failure occurs due to nonadherence or a patient is considered unable to pay for posttransplant costs, with few exceptions, she is typically not relisted [13, 14]. According to a study focusing on medication nonadherence among transplant patients, nonadherence was more prevalent among kidney recipients than among recipients of other organs and more prevalent in the United States than in Europe [12].

Legislative History

Congress has continually struggled with the tension between supporting low-income patients and controlling the costs of government-funded health care. The legislative history of renal-transplant drug coverage highlights this struggle.

The Social Security Act Amendments of 1965, which created Medicare and Medicaid, initiated medical insurance for seniors, families with dependent children, the blind, and the disabled [15]. At the SSA’s inception, Medicare provided for prescription drugs that were administered in the physician’s office but did not provide coverage for outpatient prescription drugs [14].

In 1972, on the eve of President Richard Nixon’s reelection, after much debate and political pressure to expand health care insurance, amendments were passed that provided increased coverage in specific areas. They specifically designated chronic kidney disease patients “disabled” for the purpose of receiving Medicare coverage but only after at least 3 months of dialysis and only for 12 months after transplantation [16].

Undoubtedly, these amendments were the original and now obviously outdated roots of the notion that posttransplant care benefits should be time-limited. At the time, such a notion was defensible. Dialysis was then a cost-effective and, more importantly, still superior way to extend lives, while kidney transplantation was a risky medical procedure on the frontier of available therapies. In the decades that would follow, however, renal transplantation outpaced dialysis in mortality reduction and overall clinical outcomes [17]. Meanwhile, the number of eligible patients who used dialysis far exceeded expectations, and the ESRD entitlement became quite costly [14].

In the last 3 decades, the dialysis entitlement has remained largely intact while posttransplant entitlements have waxed and waned in small stutters.

• As a response to the increased costs of dialysis, Congress passed an amendment in 1978 extending Medicare posttransplant coverage from 1 year to 3 years; however, this amendment did not cover the cost of outpatient immunosuppressive medications [14].

• In 1984, Congress passed the National Organ Transplant Act of 1984 to ban the sale of organs [18]; extended coverage for immunosuppressive drugs was considered but ultimately left out of the bill, mostly due to funding concerns and political bargaining [14].

• Posttransplant drug coverage gained some traction in the Omnibus Budget Reconciliation Act of 1987 which included Medicare coverage of 80 percent of a kidney transplant recipient’s immunosuppressive drug costs (including outpatient immunosuppressive prescription drugs) for 1 year after transplant [14, 19]. This was eventually extended, in 1997, to cover 36 months of immunosuppressive drug costs [9].

• In 2000, Congress extended Medicare coverage of immunosuppressive drug costs to the life of the patient, but only for those who are disabled or over 65. This often leaves those patients most at risk for nonadherence and noncompliance—i.e., younger kidney recipients under 65—uninsured after 3 years [14].

Despite decades of legislative history and clinical data revealing the obvious gaps in posttransplant care entitlements, extending the duration of coverage for immunosuppressive-drug costs was not included in the ACA. In a provocative piece published in 2010 in the Clinical Journal of the American Society of Nephrology, Cohen and colleagues assert that “in response to pressure from the corporate dialysis community and their kidney coalition, several members of Congress acted to prevent the patient immunosuppressive provision from being included in the final health care reform package. Some of these opposing voices on Capitol Hill have been generously supported by the large dialysis providers for years” [5].

It is theoretically possible that the ACA’s insurance exchanges will include lifetime coverage for immunosuppressive drugs. These exchanges will not be implemented until 2014, however. Moreover, it is not clear exactly what type of coverage will be offered and whether such lifetime coverage will be offered in the lower-priced options, where it is most needed [9].

Cost Savings for the Federal Government

Continuing the current limitations on coverage of posttransplant medications is actually costing the health care system more money in the long term. Studies have shown that it is less costly to continue covering the cost of immunosuppressive drugs for kidney transplant patients after 36 months than it is to cover the costs of resuming dialysis for the same population. For example, a University of Maryland study concluded that it was more cost-effective to continue covering immunosuppressive drugs than it was to pay for dialysis, finding that “the breakeven point was 2.7 years for all of the cases [it] analyzed and for 30 percent of all patients who did not need to be readmitted to the hospital during the year after their transplant, the breakeven point was only 1.7 years” [10]. A study conducted by the Institute of Medicine (IOM) also concluded that lifetime coverage of immunosuppressive drugs would lead to cost savings because it would reduce nonadherence and thereby improve kidney allograft survival, reducing long-term reliance on dialysis [12].

Current Legislation

The Comprehensive Immunosuppressive Drug Coverage for Kidney Transplants Patients Act of 2011, currently pending in committee in both the House and the Senate, would extend coverage of immunosuppressive drugs for kidney transplant patients for the lifetime of the kidney [20, 21]. The bill is bicameral, bipartisan, and supported by the transplant community [22]. As noted by Cohen et al, however, similar attempts have failed in the past, most recently with the proposed Durbin amendment to the ACA [5]. Similar attempts by Congress in 2003 and 2007 to extend lifetime immunosuppressive coverage also failed in the wake of funding concerns and political jockeying [14].

Conclusion

Extending immunosuppressive drug coverage for the lifetime of kidney patients is a cost-effective way for the federal government to increase the value of health care by improving clinical outcomes for those with ESRD while avoiding the costs of resuming dialysis and allograft failure. Low-income kidney transplant patients currently suffer heavy financial burdens and are denied access to transplant relisting because of their inability to pay for critical drugs. There is a clinical, economic, and moral imperative to, at long last, bridge this coverage gap—a gap that lies at the core of effective transplant care and detracts from the movement for comprehensive coverage begun by the Affordable Care Act.

Transplant Living http://tinyurl.com/brwj3je  suggests you contact your Senators and Congressional Representatives to urge their support of the measure that would extend anti-rejection medication coverage from 36 months to lifetime.

Sample language

Dear Representative :

I am contacting you to request that you cosponsor important legislation for chronic kidney disease patients. H.R. 2969, the “Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2011,” was introduced by Representatives Burgess and Kind to help kidney transplant recipients obtain the life-saving immunosuppressive medications that are necessary to maintain the viability of their new kidney.

Individuals with chronic kidney failure require kidney dialysis or a transplant to survive, and are eligible for Medicare regardless of age or other disability. There is no time limit on Medicare coverage for dialysis patients. However, transplant recipients who are not aged or disabled retain Medicare eligibility only for 36 months following their transplant. After their Medicare ends, they often face the challenge of obtaining group health insurance or other coverage, greatly increasing the risk of organ rejection if they cannot afford their required medications. If the transplanted kidney fails, they return to dialysis or receive another transplant, both of which are more costly (Medicare spends more than $77,000 annually on a dialysis patient and about $19,100 per year for a kidney transplant recipient, after the year of the transplant).

H.R. 2969 would extend Medicare Part B eligibility, and only for immunosuppressive medications. Coverage for any other health needs would end 36 months after the transplant, as under current law. The legislation also requires group health plans to maintain coverage of immunosuppressive drugs if they presently include such a benefit in their coverage. Lifetime immunosuppressive coverage will improve long term transplant outcomes, enable more kidney patients who lack adequate insurance to consider transplantation, and reduce the number of kidney patients who require another transplant. Nobody should lose a transplant because they are not able to pay for the drugs to maintain it. On behalf of thousands of transplant recipients, I respectfully request your support of this legislation.

Sincerely,

 

Bob Aronson of Bob’s Newheart is a 2007 heart transplant recipient, the founder of Facebook’s nearly 2,500 member Organ Transplant Initiative and the author of most of these donation/transplantation blogs.

You may comment in the space provided or email your thoughts to me at bob@baronson.org. And – please spread the word about the immediate need for more organ donors. There is nothing you can do that is of greater importance. If you convince one person to be an organ and tissue donor you may save or positively affect over 60 lives. Some of those lives may be people you know and love.

Please view our video “Thank You From the Bottom of my Donor’s heart” on http://www.organti.org This video was produced to promote organ donation so it is free and no permission is needed for its use.

If you want to spread the word personally about organ donation, we have another PowerPoint slide show for your use free and without permission. Just go to http://www.organti.org and click on “Life Pass It On” on the left side of the screen and then just follow the directions. This is NOT a stand-alone show; it needs a presenter but is professionally produced and factually sound. If you decide to use the show I will send you a free copy of my e-book, “How to Get a Standing “O” that will help you with presentation skills. Just write to bob@baronson.org and usually you will get a copy the same day.

Also…there is more information on this blog site about other donation/transplantation issues. Additionally we would love to have you join our Facebook group, Organ Transplant Initiative The more members we get the greater our clout with decision makers.

Medicare Pays For Your Transplant But Not Anti-Rejection Drugs?

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According to the American Society of Transplantation (AST) “Organ transplant recipients expect to and must take immunosuppressive medications for the lifetime of their transplanted organ. Thus, organ transplantation should be viewed as a treatment rather than a cure. Similar to many chronic diseases, the need for medical therapy goes on indefinitely. If immunosuppressive medications are discontinued for any significant length of time, rejection of the transplanted organ is inevitable in all but a small minority of patients.”  http://www.a-s-t.org/index2.cfm?Section=public_policy&Sub1Section=key_position_statements&content=immunosuppressive_drug.cfm  (AST is an international organization of transplant professionals dedicated to advancing the field of transplantation through the promotion of research, education, advocacy, and organ donation to improve patient care www.a-s-t.org )

     

As I understand current law, Medicare will pay the cost of a transplant for eligible patients, they will even pay for a second transplant if necessary but they will only pay for expensive anti-rejection drugs for thirty six months.  There have been several attempts to change this situation but to date none have been successful.

 

In a special report on the issue of Medicare coverage of immunosuppressive drugs, AST also says,   

“Extended coverage of immunosuppressive medications makes good fiscal sense, as well. Patients who stop their immunosuppressive medications run the risk of rejection of the transplanted organ. This usually leads to a prolonged hospitalization, at a cost of several thousand dollars a day. Thus, the amount of money necessary to cover the cost of immunosuppressive medications could be spent in a matter of days for one hospitalization related to rejection. If a kidney transplant recipient’s kidney fails, a return to thrice weekly dialysis sessions is necessary, at an expense above and beyond the cost of immunosuppressive medications for the same time period. Loss of other transplanted organs ultimately leads to death or the need for another organ transplant, at a cost of hundreds of thousands of dollars.”  The AST Executive Committee approved this report on April 26, 2006.  They summarize their position in the following manner:

·         Extension of coverage for immunosuppressive medications for the lifetime of the transplanted organ

·         Access to insurance coverage for the lifetime of the transplanted organ

“AST supports initiatives that ensure the coverage of immunosuppressive medications for the lifetime of a transplanted organ, regardless of age and ability to pay. Ultimately, this will lead to improved transplant success rates and the greater ability of transplant recipients to return to a normal life.”

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Calling the current coverage policy “one of the great paradoxes in federal health policies,” US Representatives Dave Camp (R-MI) and Ron Kind (D-WI) introduced HR 3282 – the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2007 – despite their good intentions, however, the bill still has not passed congress. 

 

If the Medicare policy I have described is bothersome to you, then write to your members of congress, the U.S. Senate, The U.S. Department of Health and Human Services and President Obama.

 

Please comment in the space below or email your thoughts to  me at bob@baronson.org

 

Please read and comment on my World Wide Issues blogs on http://blogsbybob.wordpress.com.   Also…visit my Facebook site, Organ Transplant Patients, Friends and You at  http://tinyurl.com/225cfh  OR — my Facebook home page  http://www.facebook.com/home.php