After 20 Years of Advocacy, Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Finally Become Law : Transplantation

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After 20 Years of Advocacy, Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Finally Become Law

Levan, Macey L. JD, PhD1,2; Reich, David J. MD3,4; Segev, Dorry L. L. MD, PhD1,5

Author Information
Transplantation 106(1):p 9-11, January 2022. | DOI: 10.1097/TP.0000000000003899
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INTRODUCTION

In November 2020, the US Congress passed the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act (“Immuno Bill”) indefinitely extending Medicare coverage of immunosuppressive medications for kidney transplant (KT) patients only. This was a surprisingly difficult task, and as such, a profound achievement. Advocating for KT patients to have indefinite immunosuppressive coverage was an ongoing and laborious 20-y effort by the transplant community including the American Society of Transplantation, the American Society of Transplant Surgeons, and the American Association of Kidney Patients.

Reducing dialysis costs is the primary focus behind the Immuno Bill, and as such, provides coverage only for KT patients. Analysis shows that lifetime immunosuppression coverage was cost-effective at a willingness-to-pay threshold of $100 000, $50 000, and $0 per quality-adjusted life y gained if it results in a decrease in the risk of transplant failure of 5.5%, 7.8%, and 13.3%, respectively.1 The Congressional Budget Office confirms that $400 million over 10 y will be saved through the reduction of dialysis costs.2,3

Intended to support the investment Medicare makes with end-stage renal disease (ESRD) and transplant care, bring the United States up to date with other developed nations, and to save the lives of people living with kidney disease and KT, the Immuno Bill finally became law in 2020.

Here we describe the long and challenging history of financing immunosuppressive coverage in the United States and provide insight into unwavering advocacy efforts by the transplant community that made the Immuno Bill law.4

Financing End-stage Renal Disease Care in the United States

The Centers for Medicare & Medicaid Services, a branch of the Department of Health and Human Services, is the federal agency that runs the Medicare Program and pays all costs for dialysis and KT. To qualify for Medicare, adults must be 65 y old, be disabled, or have ESRD. Covering 61 million people with total expenditures of $796.2 billion, Medicare represents 23% of the US healthcare expenditures: ESRD patients are 1% of the Medicare population but account for 7% of the budget.5 ESRD affects almost 750 000 people per year in the United States; after 1 y, those on dialysis have an average 15%–20% mortality rate, with a 5-y survival rate of 35%. Persons who receive KT have an average survival rate of about 80% after 5 y.6 Taxpayers, largely through payroll taxes, finance Medicare. In 1973 when the ESRD program began, transplantation was a bridge therapy between periods of dialysis due to high rates of graft loss and failure; today, 100% of dialysis and KT costs are covered.7,8

The Problem of Immunosuppressive Drug Coverage for Kidney Transplant Patients in the United States

Medicare coverage expanded in 1986 to cover immunosuppressive drugs for 1 y posttransplant.9 The reason for 1-y coverage was that there was already “a significant amount of insurance coverage for immunosuppressive drugs available” for those with ESRD.10 As coverage extended to 3 y, in 1993–1995, income-related disparities in outcomes of KT patients were noted.8 There were then 2 tiers of coverage: lifetime coverage for those over the age of 65 y or disabled and 36 mo of coverage for everyone else.

Without third-party coverage, private health insurance or through pharmaceutical company programs or other charities, immunosuppressive medication costs could easily have exceeded the paying capacity of most Americans. These patients often found themselves unable to secure insurance coverage, unable to afford their graft-preserving medications, facing allograft rejection or failure, and ultimately, returning to dialysis. Ultimately, beneficiaries with healthy, functioning transplants cost substantially less to treat than those with transplant failure.9,11,12

Was This Problem Unique to the United States?

Canada, Australia, and the United Kingdom provide lifetime access to immunosuppressive drugs to all KT patients and, not surprisingly, long-term survival rates are consistently higher than in the United States.13 In Singapore, employee medical savings accounts can be subsidized for dialysis and immunosuppressives.14,15 Despite lifelong immunosuppression, it should be noted that many countries above still report cost-related medication nonadherence. In a multinational cohort study of heart transplant recipients, cost-related medication nonadherence in Switzerland and Brazil was lowest (0%) and highest in Australia (9.8%).16 Although in most Western democracies, immunosuppression medications are covered under a “nationalized” healthcare system, copays are required. Additionally, for most of the global population (India, China, Asia, South America, Africa), costs for all transplant care and posttransplant medications are the sole financial responsibility of the patient.

Changing the Flawed US Law: Legislative History of the “Immuno Bill”

Prior changes to US law have improved access to KT. Amendments to the National Organ Transplant Act (1984) allowed for kidney paired donation through the Charlie Norwood Living Organ Donation Act (2007) and for HIV-to-HIV transplantation through the HIV Organ Policy Equity Act (2013).17,18 Finally, after a 20-y legislative history (Table 1), the Immuno Bill can now be included in this list.

TABLE 1. - Legislative history of the Immuno Bill
Congress Introduced in the House Introduced in the Senate House sponsor and cosponsors Senate sponsor and cosponsors Bill status
106th (1999–2000) H.R. 5276 09/25/2000 S. 2399 08/11/2000 Dave Camp (R-MI) and 1 cosponsor (1D) Richard Durbin (D-IL) and 6 cosponsors (6D) Enacted—signed by the President on December 27, 2020
107th (2001–2002) S. 10 01/22/2001 Thomas Daschle (D-SD) and 32 cosponsors (32D) Died in a previous Congress—bill was introduced but did not receive a vote
107th (2001–2002) S. 1204 07/19/2001 Richard Durbin (D-IL) and 11 cosponsors (11D) Died in a previous Congress—bill was introduced but did not receive a vote
108th (2003–2004) H.R. 2223 05/22/2003 S. 178 01/16/2003 Dave Camp (R-MI) and 2 cosponsors (2R) Richard Durbin (D-IL)and 2 cosponsors (1D, 1R) Died in a previous Congress—bill was introduced but did not receive a vote
109th (2005–2006) H.R. 2051 05/03/2005 S. 173 01/26/2005 Dave Camp (R-MI) and 28 cosponsors (19D, 9R) Michael DeWine (R-OH) and 3 cosponsors (2D, 1R) Died in a previous Congress—bill was introduced but did not receive a vote
110th (2007–2009) H.R. 3282 08/01/2007 S. 2320 11/07/2007 Dave Camp (R-MI) and 72 cosponsors (45D, 27R) Richard Durbin (D-IL) and 9 cosponsors (6D, 3R) Died in a previous Congress—bill was introduced but did not receive a vote
111th (2009–2010) H.R. 1458 03/12/2009 S. 565 03/10/2009 Dave Camp (R-MI)and 97 cosponsors (75D, 22R Richard Durbin (D-IL)and 18 cosponsors (16D, 2R) Died in a previous Congress—bill was introduced but did not receive a vote
112th (2011–2013) H.R. 2969 09/20/2011 S. 1454 07/29/2011 Michael Burgess (R-TX) and 127 cosponsors (84D, 43R) Richard Durbin (D-IL) and 21 cosponsors (17D, 3R, 1I) Died in a previous Congress—bill was introduced but did not receive a vote
113th (2013–2015) H.R. 1428 04/09/2013 Michael Burgess (R-TX) and 127 cosponsors (78D, 49R) Died in a previous Congress—bill was introduced but did not receive a vote
113th (2013–2015) H.R. 1325 03/21/2013 S. 323 02/13/2013 Michael Burgess (R-TX) and 15 cosponsors (9R, 6D) Richard Durbin (D-IL) and 18 cosponsors (14D, 3R, 1I) Died in a previous Congress—bill was introduced but did not receive a vote
114th (2015–2017) H.R. 6139 09/22/2016 S. 348711/30/2016 Michael Burgess (R-TX) and 20 cosponsors (13D, 7R) David Vitter (R-LA) and 0 cosponsors Died in a previous Congress—bill was introduced but did not receive a vote
116th (2019–2021) H.R. 553412/23/2019 S. 335302/27/2020 Ron Kind (D-WI) and 113 cosponsors (80D, 33R) Bill Cassidy (R-LA) and 25 cosponsors (15R, 10D) Enacted—signed by the President on December 27, 2020
D, Democrat; R, Republican.

The technical nature of the Immuno Bill made it challenging for lawmakers to digest and prevailing attitudes that “rich” hospitals and pharmaceutical companies could pay the high cost of immunosuppressant drugs. When the availability of generic immunosuppressive medications dramatically reduced the cost of the most commonly used drugs (ie, tacrolimus and mycophenolate) from $10 000 per patient y in 2008 to $5000 per patient y in 2013, the costs and benefits of lifetime coverage for these medications demanded reexamination.1 Additionally, totally unrelated government matters, such as the Federal Budget Sequestration in 2013, paralyzed the progress of legislation for several years. The Immuno Bill became law in 2020 when Congress introduced and passed the legislation as part of a larger, bicameral Medicare reform package extending title XVIII of the Social Security Act after expert testimony and evidence of the cost-effectiveness of the bill.19

When a Compelling Cause Calls, Persistence and Politics Are Key

Changing law for compelling medical and financial reasons should be obvious and easy but requires many things. You need an important problem with a good solution, persistent advocacy efforts by many key stakeholders, and most importantly, you need a political environment that supports change.

Ultimately, like many bipartisan, bicameral legislative efforts, the “ready to go” Immuno Bill was tacked on to another bill—the COVID relief bill—wherein its passage was finally successful. In other words, the background politics can be a rollercoaster, so when advocating for legislative change, be ready to buckle up for the ride.

ACKNOWLEDGMENT

The authors thank Samantha Klitenic, JD for her research assistance.

REFERENCES

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