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From Bench to Bill

How a Transplant Nuance Became 1 of Only 57 Laws Passed in 2013

Boyarsky, Brian J. BA; Segev, Dorry L. MD, PhD

doi: 10.1097/SLA.0000000000001352
SURGICAL PERSPECTIVES
Free

*Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.

Reprints: Dorry L. Segev, MD, PhD, Department of Surgery, Johns Hopkins University School of Medicine, 720 Rutland Ave, Ross 771B, Baltimore, MD 21205. E-mail: dorry@jhmi.edu.

Disclosure: The authors declare no conflicts of interest.

“I’m just a bill, yes I’m only a bill, and I’m sitting here on Capitol Hill.

Well, it's a long, long journey to the capital city,

It's a long, long wait while I’m sitting in committee,

But I know I’ll be a law someday…

At least I hope and pray that I will, but today I am still just a bill.”

(Schoolhouse Rock)

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FOREWORD

I had long been frustrated by the fact that we could successfully transplant hepatitis C-positive (HCV+) organs into HCV+ recipients, but federal law prohibited parallel therapy for human immunodeficiency virus-positive (HIV+) patients. At the height of the acquired immunodeficiency syndrome (AIDS) scare in the 1980s, Congress banned the recovery of organs from HIV+ individuals as a small part of the National Organ Transplant Act (NOTA), and this restriction had never been updated to reflect changes in modern HIV care.

Then in May 2010, Brian Boyarsky, fresh out of his Bachelor's in Public Health at Johns Hopkins University, was sitting in my office trying to figure out how to spend his gap years before medical school. As part of his senior thesis comparing transplant programs in different countries, he met Elmi Muller in South Africa who had been successfully transplanting organs between HIV+ donors and recipients. I asked Brian whether he would be interested in sacrificing several years of his life to battle Congress on this issue. Based on my experience as a Health and Aging Policy Fellow in Washington, DC, I warned him that enacting change on the federal level was nearly impossible: fewer than 5% of bills introduced become law. The challenge only seemed to pique his interest.

Over the ensuing 3 years, we conducted robust policy-driven research that led to positive press, Congressional and White House attention to a nuance of transplant surgery practice, and 1 of only 57 bills passed in 2013 by the most unproductive Congress in the history of the US (Fig. 1).

FIGURE 1

FIGURE 1

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LAYING A FOUNDATION FOR POLICY CHANGE

Effectively framing a health policy argument to a congressional legislative assistant (LA) involves 3 rapid-sequence, data-driven bullet points. First, how many lives will this measure save? Second, how much will this cost taxpayers? And third, what is the political benefit-to-risk ratio specific to my constituency?

After crafting and shepherding the Charlie W. Norwood Living Organ Donation Act—a bill to clarify the legal basis for kidney paired donation—in 2007, we were keenly aware of the importance of an evidence-based approach to changing federal law. The Norwood campaign was built on the results of our Journal of the American Medical Association article in which we found that a national optimized matching algorithm would result in thousands more transplants and save $750 million Medicare dollars by decreasing costly hemodialysis and desensitization.1 This article led to major, positive press coverage, which then paved the way for Congressional advocacy and action. We sought the same for what would become the HIV Organ Policy Equity (HOPE) Act of 2013.

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FROM BENCH TO BILL

When we began, there were no data to answer an LA's inevitable first question of how many lives will be saved. This would be tied directly to the number of HIV+ deceased donors who would be appropriate for donation, but HIV+ donors were not tracked by the United Network for Organ Sharing (UNOS) because of the NOTA ban.

Instead, we studied 2 “big data” sources to make these estimates. The Nationwide Inpatient Sample allowed us to study in-hospital deaths of HIV+ patients free of contraindications to donation, and the HIV Research Network provided granular disease-specific data (such as serial CD4+ T cell counts and HIV viral loads) on a large cohort of individuals with HIV. Both data sources seemed to agree that around 500 to 600 HIV+ donors was a reasonable, and likely conservative, estimate of what would be expected in the US each year. The results were published in American Journal of Transplantation (AJT) in March 2011.2

This study became the cornerstone of our campaign: in an era where thousands of patients die on the waiting list each year, we throw away organs from 500 to 600 donors because of an antiquated law that no longer reflects the advanced care and excellent prognosis of HIV+ patients. This, coupled with encouraging HIV-negative-to-HIV-positive transplant outcomes in both kidney and liver,3–5 and Elmi Muller's promising HIV-positive-to-HIV-positive results in South Africa,6,7 provided a compelling argument for HIV-to-HIV transplantation in our country. Because transplantation saves Medicare dollars,8,9 our request was also in line with national priorities for Medicare cost containment, and would lead to a favorable Congressional Budget Office (CBO) score, an absolute necessity for Congressional consideration in the current political environment.

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VISIBILITY

Congressional LAs seldom read medical journals; they get their medical news from the New York Times, the Wall Street Journal, and the Washington Post. The first major news article covering our campaign turned out to be the most important one: a front-page, above-the-fold New York Times article on April 11, 2011—just a few weeks after our AJT article was published. The article linked the details of our proposal to reverse NOTA with the story of a 45-year-old HIV+ man from Los Angeles. What followed was a frenzy of favorable articles and interviews from most major news outlets around the world.

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ADVOCACY

Aside from the positive press, it was imperative to have the support of all of the major national transplant and AIDS advocacy groups in the US (Table 1), leveraging the human, financial, and political power of each organization. Within weeks of the AJT publication, every major AIDS and transplant group officially supported our campaign, and some—particularly HIV Medicine Association—even dedicated substantial person-time to our cause. The person-time and advocacy contributed by many societies, including HIV Medicine Association, American Society of Nephrology, American Society of Transplantation, and American Society of Transplant Surgeons, just to name a few, was critical to the success of this endeavor.

TABLE 1

TABLE 1

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MAIN SPONSORS

By August 2011, we felt confident that our campaign was ready for Capitol Hill. The first priority was identifying main sponsors on both sides of the aisle in both the House of Representatives and the Senate—a bipartisan, bicameral approach. After failed attempts to engage Senate Health, Education, Labor, and Pensions (HELP) Committee members Barbara Mikulski and Kay Hagan, we sought broader support from the medical community through endorsement of the American Medical Association. Around that time, we met with Barbara Boxer's health LA. Boxer, a Senator from California, where the first HIV+ transplants were performed, had a strong voting record on HIV/AIDS legislation. Within the first few minutes of our conversation, Senator Boxer's health LA asked for draft legislative language. That afternoon, we drafted a bill; by evening, as Senator Boxer sent off the draft language to the Department of Health and Human Services for technical comment, she signed on as champion in the Senate. Our interactions with Senator Boxer's office, and subsequently with a number of congressional members, were bolstered by the support of Peter Stock from University of California, San Francisco (UCSF) whose pioneering work established the safety and efficacy of organ transplantation in the HIV+ individual in the United States.

However, some Capitol Hill veterans warned us that Senator Boxer was too liberal, and her leadership might associate unnecessary partisanship with our nonpartisan quest. After all, her “conservative rating” by the American Conservative Union was a mere 4%. To strike bipartisan balance, we sought the support of a more conservative Senator: Tom Coburn of Oklahoma, who, aside from a 100% conservative American Conservative Union rating, was a physician who would add legitimacy to our medical arguments. To add momentum to a successful meeting with his health LA, we asked Alan Hawxby, a transplant surgeon at the University of Oklahoma, to follow-up with a letter specifically outlining the potential impact on Coburn's constituency. Several weeks later, Senator Coburn signed on as the Republican leader in the Senate. His support was a major victory for our effort: once legislators saw 2 champions with such drastically different political ideologies, they were convinced that HIV-to-HIV transplantation was an issue that need not be argued along party lines.

A brief call to the Human Rights Campaign advocacy group led to the support of school nurse-turned-Democratic Congresswoman Lois Capps as leader in the House. Similar to our approach in the Senate, we sought a conservative congressman with a medical background to balance the ticket: Republican Andy Harris, a Johns Hopkins anesthesiologist, signed on as lead Republican sponsor just days after an in-person meeting with his staff followed by a letter of support from his former colleagues at Johns Hopkins.

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COSPONSORS AND CONGRESSIONAL BRIEFING

Between 2011 and 2012, we conducted marathon visits to Capitol Hill, covering up to 10 offices a day with brief 10- to 15-minute meetings. We focused on educating Senate HELP and House Energy and Commerce Committee members, members of the Kidney Caucus, Doctor's Caucus, and those with a positive voting record on transplant issues. We were able to perfect our pitch such that all of our meetings resulted in support for our campaign.

Once we had personally introduced the issue to approximately 75 congressional offices, we organized a Congressional briefing sponsored by the AIDS groups in our coalition and moderated by an ABC News journalist. The briefing was a standing-room-only panel discussion, where more than 100 LAs attentively listened to the convincing evidence for HIV-to-HIV transplantation in the US, presented by physicians and a particularly eloquent HIV+ kidney recipient. The briefing was overwhelmingly successful, and was even written about positively in Congressional Quarterly, which provides Congressional staffers with news of current events on the Hill.

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THE BILL

With true DC panache, the HOPE Act was introduced in the Senate on Valentine's Day in 2013. By this time, most health LAs were not just aware of our issue, but were well-educated and eager to support it. After the bill was introduced, our objectives shifted to reconnecting with these LAs to ask for either official co-sponsorship or a “yes” vote, and to ask for help in building support among their Congressional colleagues.

By November 2013, approximately 3 years and 6 months after our effort began and 9 months after the HOPE Act was introduced, it passed both committees and chambers unanimously and was 1 of only 57 bills signed into law by President Barack Obama in 2013. The HOPE Act mandates that the Secretary of Health and Human Services develop criteria for the conduct of clinical research involving HIV+ deceased donor organs. This process is ongoing and is due to be completed by November 2015.

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LESSONS LEARNED

Important patterns have become clear from our experiences and discussions on the Hill. First, a bicameral, bipartisan strategy is preferable and powerful. Physician-legislators are important allies who can help legitimize the medical justification behind the proposed policies. Knowing the committee that will inevitably vet the bill, and educating and engaging members of this committee during the process, can keep a bill from the common fate of stalling in committee.

Second, the key players on Capitol Hill are the LAs. This energetic army is charged with covering the front lines, meeting with various interest groups, vetting proposed legislation, and drawing their member's attention to bills they think their member should support, both ideologically and politically. The constituency is critically important to a Member of Congress, such that a Member from Oklahoma needs to hear evidence that the bill will positively affect the citizens of Oklahoma, and a Member from California responds well to the supportive words of a physician from UCSF. The LAs are rarely medical professionals, but are incredibly hard-working, brilliant individuals who spend hundreds of hours researching topics for their members; helping an LA by generating and clearly presenting supporting data will help place a bill ahead of the hundreds of others that the LA likely heard about that week alone.

Finally, although champions are critically important, a champion is ultimately ineffective without the backing of the entire medical community, including general medical organizations to demonstrate priority, specialty medical organizations to discuss risk/benefit and need, and patient advocacy groups to connect the proposed legislation with the constituency. Advocacy groups not only lend moral support, but also have tremendous resources and connections on the Hill that can synergize with the efforts of the medical community.

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I’M JUST A BILL

At the bill signing in the Oval Office, President Obama joked, “We’re all so excited today because we haven’t been doing this [signing bills] very often.” In the current gridlocked atmosphere in Washington, DC, where so many commonsense reforms are needlessly politicized, we were able to develop and pass a law that will expand the supply of solid organs for transplantation to the more than 118,000 individuals currently on the waitlist. Although critically important for our field, this bill was admittedly a speck on the US policy map, yet somehow one of very few specks that made it into law in 2013. We hope that the story of the HOPE Act provides inspiration that a few well-intentioned people, with appropriate epidemiologic research, positive press, and the backing of national organizations, can actually effect change.

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REFERENCES

1. Segev DL, Gentry SE, Warren DS, et al. Kidney paired donation and optimizing the use of live donor organs. JAMA 2005; 293:1883–1890.
2. Boyarsky BJ, Hall EC, Singer AL, et al. Estimating the potential pool of HIV-infected deceased organ donors in the United States. Am J Transplant 2011; 11:1209–1217.
3. Stock PG, Barin B, Murphy B, et al. Outcomes of kidney transplantation in HIV-infected recipients. N Engl J Med 2010; 363:2004–2014.
4. Locke JE, Mehta S, Reed RD, et al. A national study of outcomes among HIV-infected kidney transplant recipients. J Am Soc Nephrol 2015; 26:2222–2229.
5. Locke JE, Reed RD, Mehta SG, et al. Center-level experience and kidney transplant outcomes in HIV-infected recipients. Am J Transplant 2015; 15:2096–2104.
6. Muller E, Kahn D, Mendelson M. Renal transplantation between HIV-positive donors and recipients. N Engl J Med 2010; 362:2336–2337.
7. Muller E, Barday Z, Mendelson M, et al. HIV-positive-to-HIV-positive kidney transplantation—results at 3 to 5 years. N Engl J Med 2015; 372:613–620.
8. Loubeau PR, Loubeau JM, Jantzen R. The economics of kidney transplantation versus hemodialysis. Prog Transplant 2001; 11:291–297.
9. Voelker R. Cost of transplant vs dialysis. JAMA 1999; 281:2277.
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