By Tom Allen
Former member of the United States House of Representatives (D-ME)
Background
I represented Maine’s first Congressional District in the U.S. House from 1997 to 2009. In May 2002 I introduced the first stand-alone bill authorizing federal support for comparative effectiveness research (CER). H.R. 4832, the “Prescription Drug Comparative Effectiveness Act of 2002,” was inspired by a provision that Governor Kitzhaber (D) of Oregon had inserted into that state’s Medicaid program. I had also learned that Australia and New Zealand had established procedures to evaluate the relative effectiveness of prescription drugs used to treat the same illness or condition. Rising prescription drug prices were leaving many Medicare beneficiaries unable to afford their medications and steadily increasing the political urgency to create coverage under Medicare.
In the next Congress, my bill became the basis of a provision (sec. 1013) in the Medicare Modernization Act of 2003 (MMA), which established Part D coverage for prescription drugs. Sec. 1013 increased funding for the Agency for Health Care Research and Quality (AHRQ) by $50 million above baseline in order to conduct “systematic reviews of existing evidence” on the clinical comparative effectiveness of drugs and “other treatments.”
That first step benefitted from a broad but quiet coalition of purchasers of health services, including industry and insurance interests, as well as labor unions and consumer groups. Sec. 1013 aroused no significant lobbying opposition in part because it was slipped into the MMA with no votes in either the House or Senate nor in the conference committee. The handiwork almost certainly of Senate Majority Leader Bill Frist!
In succeeding congressional sessions, I re-introduced similar bills with higher authorized funding levels and broader application. CER developed credible bipartisan support from Gail Wilensky, former director of the agency overseeing Medicare and Medicaid for President George H. W. Bush, and Peter Orszag, director of the Congressional Budget Office under President Obama. That bipartisan aura did not last long.
Creation of PCORI
In early 2009 President Obama included authorization for CER at a $1 billion funding level in his administration’s stimulus bill, the American Recovery and Reinvestment Act of 2009 (ARRA) (Pub.L. 111–5). Shortly thereafter, the Affordable Care Act (ACA) created an independent, nongovernmental entity—the Patient-Centered Outcomes Research Institute (PCORI)—which seeks “to fund useful research likely to change practice and improve patient outcomes.” Almost everything in those two bills generated partisan disagreement.
Since its creation, PCORI has funded more than $2 billion in research and related projects. PCORI was not a topic during this year’s failed Republican effort to repeal Obamacare, but it is likely to be a focus, even perhaps a target, next year. The ACA provides that PCORI will receive no new funding after 2019 unless Congress authorizes the PCOR Trust in 2019 to make additional funds available for the following years. To avoid a break in federal CER funding through PCORI, Congress must act next year. Whether it can do so productively is, at least today, anyone’s guess.
Obstacles and Opportunities
Today, the environment for progress on evidence-based medicine (EBM) is a mix of obstacles and opportunities. As Susan Dentzer observed in the initial commentary of this series, “when it comes to health policy at the highest levels of the U.S. government, evidence has ‘left the building.’” After seven years of making “repeal and replace Obamacare” the center of their political message, congressional Republicans had no coherent option for “replace.” Moreover, they lost control of the House in large part because they tried to “repeal” Obamacare.
Chronic inattention to evidence, I believe, is a serious problem for Republicans ideologically hostile to government action. But weak congressional policy-making capability is an institutional problem that affects both parties and most of our most pressing public policy issues. In a recent Roll Call article, Rachel Oswald describes how Congress has weakened its own institutional capacity for effective policy-making.
Oswald argues that lawmakers’ lack of productivity and Congress’ loss of intellectual institutional capacity stem from a number of factors:
Congress has fewer staff today and lower levels of expertise in those who remain than it did in 1995 when Newt Gingrich became Speaker. Congressional funding and staff salaries are increasingly insufficient to attract and retain staff with the expertise needed to develop sound policy—in health care and other issue areas. Weakened institutional policy expertise could be somewhat offset by strong executive branch expertise, but that is missing in the current administration.
PCORI & AHRQ Funding
Lack of federal government policy expertise is an obstacle to innovative EBM policy. On the other hand, sustaining existing health care programs will be somewhat easier with a Democratic House come January. AHRQ and PCORI funding for evidence-based initiatives are the primary sources of federal support for improving and expanding our capacity for discovering and adopting better practices for providing quality health care for all Americans.
PCORI is most at risk because, as noted above, it can only make awards of new EBM funds after 2019 if PCORI is re-authorized by Congress next year. Positive congressional action is required, not just continuation of funding. Health care issues will have a high profile in the next Congress, partly because of the recent decision by a federal district court judge in Texas holding the ACA unconstitutional. Prescription drug prices and multiple ACA issues will likely lead to health care legislation in the House—to which a reauthorization of PCORI could be attached. That may be an opportunity for action.
AHRQ has a longer history of funding EBM projects and research. Its Evidence-based Practice Centers (EPCs) receive federal funding for research and projects that promise to improve the quality and effectiveness of health care. In the last two years Congress proved relatively resistant to the severe budget cuts sought by the Trump administration; substantial domestic budget cuts will be more difficult to pass in a Democratic House. Funding levels for AHRQ may be easier to maintain than for PCORI.
The Future of Health Care Quality
As a matter of public policy, the health care trifecta will continue to be access, cost, and quality. For the funders of health care in America – public, private, and non-profit – cost-effectiveness and quality will continue to be high priorities. For everyone, quality matters. There will always be trade-offs between access, cost, and quality. But those can be minimized if we make the most effective use of the resources we can bring to bear. The rapidly growing body of evidence concerning the most effective drugs, devices, procedures, even health care organizations and systems—generated by evidence-based research—is and will continue to be invaluable to policy makers and practitioners who must make those trade-offs. Therefore, opportunities abound.
The scope of EBM interests is highlighted by the July and November Commentaries in this series.
One thing seems clear. Those who are now engaged in efforts to strengthen evidence-based medicine should not be caught on the sidelines of the public policy and funding debates. The coming years offer great hope for rapid growth in EBM activity with exciting prospects for the quality of health care. Let’s not miss any chances to raise our voices in support of better independent evidence to improve the health of all Americans.
About the Author:
Thomas H. Allen is a former U.S. Congressman from Maine. During his 12 years in the House (1997-2009), he served on the Energy and Commerce Committee and on the Armed Services Committee. He was particularly active in health care issues, including prescription drug coverage for Medicare beneficiaries, as well as fisheries and climate change issues. He co-founded the House Oceans Caucus to promote a coordinated global oceans policy.
Before his election to the House in 1996, Mr. Allen practiced law in Portland for 19 years. He served on the Portland City Council, including one term as mayor. After leaving Congress he was, from 2009 to 2017, the President and CEO of the Association of American Publishers (AAP), the national trade association of the U.S. book publishing industry. Mr. Allen has degrees from Bowdoin College, Oxford University (as a Rhodes Scholar) and Harvard Law School. He is retired and lives in Portland with his wife Diana.
Mr. Allen makes an important contribution to a vital discussion. I want to thank him for eloquently discussing the history of the evidence-based practice movement. I want to provide my own personal thoughts on this topic as well (which do not represent any group or organization). More so, I want to hear from YOU, the reader, about this topic. It is ok if we disagree because in the ensuing discussion, I am sure we will all learn something.
Healthcare is increasingly complicated and expensive. There is a deluge of new drugs, procedures, tests, and devices that come out each year and are clawing for market share and profits versus current products. All of these products have many studies of variable quality evaluating them. There is so much data that caregivers like physicians are overwhelmed and cannot reasonably identify the true advances in care from products with marginal benefits or excessive risks. We don’t want caregivers spending half of each day reading studies because we need them directly interacting with patients during that time. But if they are focused on seeing patients for most of the day, how do they know what is best for the patient? Traditionally, the caregivers would be alerted to new products and some of the studies supporting them by drug representatives that come to the office. Healthcare decisions should not be made because one product is marketed better than another one or because a caregiver has read a sampling of available studies and assumes it represents the whole. A new product should be used in a specific patient because it truly has competitive advantages over competing treatments.
Systematic reviews of the literature summarize and pool the results of the available literature together so it can be efficiently read and understood by caregivers, health systems, and payers. It is the preferred data source for healthcare decision-makers and is empowering for the healthcare system, provided that the information is free of commercial bias. Where there are gaps in the literature that makes it impossible to identify the place of a new product in patient care, those gaps are identified so they can be addressed in new studies.
The creation of AHRQ and PCORI is a one-two punch for supporting better healthcare decisions. AHRQ funded Evidence-Based Practice Centers help summarize the available evidence, reconcile conflicting studies, rate the strength of a body of evidence, and determines who the data is applicable to and who it leaves out. The identified treatment gaps are then closed when new studies are conducted by PCORI or AHRQ funded investigators. In my years as director of the UConn Evidence-Based Practice Center, we have found that some new therapies are truly worthwhile while others did not offer any important advantages or are so poorly evaluated that its use is more based on speculation than science. These reviews were freely available to caregivers, payers, regulators, and health systems and free of commercial bias.
Whether we maintain the Affordable Care Act or not, the Federal Government is deeply incentivized to help maximize patient’s healthcare outcomes. It is a direct payer for healthcare through Medicare, Medicaid, SCHIP, Veteran’s Administration, Indian Health Services, and the Department of Defense. While many patients have private insurance, the Federal Government is still directly and negatively impacted financially when citizens’ drop out of the workforce, retire, or need long term care due to physical or mental disabilities. They need to be involved in supporting caregivers and health systems as they strive to bring the best evidence available to bear in treating human disease.