Expert Insight: After 20 Years of Advocacy, Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Finally Becomes Law

Introduction

In November 2020, the United States 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-year 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 years 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 years will be saved through the reduction of dialysis costs.^2,3

Intended to support the investment Medicare makes with ESRD and transplant care, bring the U.S. up to date with other developed nations, and to save the lives 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 US 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 (CMS), 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 years old, be disabled, or have end-stage renal disease (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 one year, those on dialysis have an average 15–20% mortality rate, with a 5-year survival rate of 35%. Persons who receive KT have an average survival rate of about 80% after 5 years.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 year post-transplant.⁹ The reason for 1-year 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 years in 1993–1995 income-related disparities in outcomes of KT patients was noted.⁸ There were then two tiers of coverage: lifetime coverage for those over the age of 65 or disabled, and 36 months 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 US?

Canada, Australia, and the UK provide lifetime access to immunosuppressive drugs to all kidney transplant patients and, not surprisingly, long-term survival rates are consistently higher than in the US.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 non-adherence (CRMNA). In a multi-national cohort study of heart transplant recipients, CRMNA in Switzerland and Brazil was lowest (0%) and highest in Australia (9.8%).¹⁶ While 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 post-transplant medications are the sole financial responsibility of the patient.

Changing the Flawed U.S. 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 year legislative history (Table 1) the Immuno Bill can now be included in this list.

Table 1.

Legislative History—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) 1 Cosponsor (1D)	Richard Durbin (D-IL) 6 Cosponsors (6D)	Enacted—Signed by the President on December 27, 2020
107th (2001–2002)	------------	S. 10 01/22/2001	------------	Thomas Daschle (D-SD) 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) 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) 2 Cosponsors (2R)	Richard Durbin (D-IL) 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) 28 Cosponsors (19D, 9R)	Michael DeWine (R-OH) 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) 72 Cosponsors (45D, 27R)	Richard Durbin (D-IL) 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) 97 Cosponsors (75D, 22R	Richard Durbin (D-IL) 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) 127 Cosponsors (84D, 43R)	Richard Durbin (D-IL) 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) 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) 15 Cosponsors (9R, 6D)	Richard Durbin (D-IL) 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. 3487 11/30/2016	Michael Burgess (R-TX) 20 Cosponsors (13D, 7R)	David Vitter (R-LA) 0 Cosponsors	Died in a previous congress—bill was introduced but did not receive a vote
116th (2019–2021)	H.R. 5534 12/23/2019	S. 3353 02/27/2020	Ron Kind (D-WI) 113 Cosponsors (80D, 33R)	Bill Cassidy (R-LA) 25 Cosponsors (15R, 10D)	Enacted—Signed by the President on December 27, 2020

https://www.govtrack.us/congress/bills/

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 (i.e., tacrolimus and mycophenolate) from $10,000 per patient year in 2008 to $5000 per patient year in 2013, the costs and benefits of lifetime coverage for these medications demanded re-examination.¹⁹ Additionally, totally unrelated government matters, such as the Federal Budget Sequestration in 2013 paralyzed the legislation’s progress 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. ²⁰

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 -- where 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.

ABBREVIATIONS

Immuno Bill

Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act

CMS

Centers for Medicare and Medicaid Services

ESRD

End-Stage Renal Disease

KT

Kidney transplant