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Archive for the 'Comparative Effectiveness' Category




Mortality Versus Survival In International Comparisons Of Cancer Care


March 20th, 2015

In a recent paper, Soneji and Yang revisit a topic we first explored in the April 2012 issue of Health Affairs — namely, whether the U.S. gets value for its cancer care. We found that life expectancy after cancer diagnosis rose more quickly for patients in the U.S. than for patients in Europe. Moreover, while spending per patient also rose more quickly in the U.S., Americans still received good value from the health care system. Compared to the gains seen in Europe, for example, each additional life-year gained in the U.S. cost roughly $20,000 in additional U.S. spending.

Soneji and Yang re-examine trends in cancer deaths in the U.S. and Europe and draw different conclusions. While we welcome the attention paid to this important issue, Soneji and Yang’s conclusions rest on fundamental flaws in their own approach and a misunderstanding of the methods we use in our study.

To understand the value of U.S. cancer care, one must ask whether the health care system performs better for U.S. cancer patients than those of other countries and at what cost. In attempting to answer this question, Soneji and Yang ask whether more people die from cancer in the U.S. or in Europe. This isn’t the right question. The total number of people dying from cancer is a misleading indicator of health system performance. Factors like poverty, pollution, smoking, diet, and exercise all contribute to the number of people acquiring cancer and dying from it, and confound the effects of cancer treatments. The bottom line is that mortality reflects treatment, but it also reflects the number of people who get cancer.

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What Kind Of Advance Care Planning Should CMS Pay For?


March 19th, 2015

Currently, Medicare does not offer a paid benefit for advance care planning (ACP). As a result, health care providers who want to assist Medicare enrollees with ACP do so voluntarily and neither they, nor their institutions, are compensated for their time and efforts. This is not only an unfair expectation on individual practitioners or health institutions, it is also medically and ethically unsound. Fortunately, two recent events have the potential to reshape the landscape of advance care planning in the U.S.

Cultural And Policy Evolution In Advance Care Planning

On September 17, 2014, the Institute of Medicine (IOM) published Dying in America: Improving Quality and Honoring Individual Preferences Near the End of Life. The report is built on two basic premises:

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Health Affairs Web First: Assessing Efforts To ‘Solve The Sustainable Growth Rate Formula Conundrum’


March 11th, 2015

On April 1, unless Congress acts to prevent it, the current Sustainable Growth Rate (SGR) fee cut will take effect, dictating a 21.2 percent reduction in Medicare physician fees. A new commentary, released today by Health Affairs as a Web First, assesses last year’s bipartisan and bicameral legislative model for how to repeal the SGR, a model likely to be used in similar efforts this year.

The 2014 legislation contained many useful steps to replace the SGR but had a major omission, authors James Reschovsky, Larisa Converse, and Eugene Rich of Mathematica Policy Research argue: It did not adequately address overhauling the current Medicare fee schedule.

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Takeaways From Health Affairs’ Big Data Twitter Chat


March 9th, 2015

Recently, we at Health Affairs hosted a Twitter chat with the Patient Centered Outcomes Research Institute (PCORI) on the topic of big data. The chat was a follow-up to the Health Affairs issue, “Using Big Data To Transform Care.

During the Twitter chat, we moderated a question-and-answer session with PCORI’s Rachael Fleurence, Comparative Effectiveness Research (CER) Methods and Infrastructure Program Director, and Sarah Greene, CER Methods and Infrastructure Associate Director, while many users joined in the conversation with #healthdatachat.

So how does PCORI define “big data?” PCORI responded with the following tweet: “rapid accrual of large quantities of diverse patient experience data.” 

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The Need For Publicly Funded Trials To Get Unbiased Comparative Effectiveness Data


February 20th, 2015

Comparative effectiveness research was one of the hotly debated components of the Affordable Care Act. The pharmaceutical industry is marketing driven, with pharmaceutical companies spending more on marketing than they do on research and development. The need for a marketing edge can also drive drug development.

As illustrated by the discussion below of Gazyva and Nexium, drugs can be developed at higher doses than the drugs they are intended to replace. When the newer, higher-dose drugs are tested against the older, lower-dose drugs, the trials are intended to show that the newer, higher dose drugs are superior to the older drugs that will soon be available as a biosimilar or generic.

It can be very difficult to tell whether the results of such trials reflect the differences between the active ingredients or simply the difference in doses, but such trials are almost certain to lead to increased use of the newer, higher-priced drugs. Because the money at stake creates such an incentive for companies to stack the deck, publicly funded trials are the only way to make sure that evidence-based medicine is based on the best possible evidence.

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Reforming Medicare: What Does The Public Want?


November 13th, 2014

Is Medicare adequately meeting the needs of seniors, or are there ways that its core attributes could be improved? Numerous elected officials, policymakers, and other thought leaders have offered perspectives on ways to change the program. Few efforts, however, have been directed at understanding how the public—given accurate information, a variety of options, and a valid structure for weighing the pros and cons—would change Medicare’s basic design.

The MedCHAT Project

Recently, the American Enterprise Institute and the Brookings Institution co-hosted a briefing on the results of a California project that did just that. The “MedCHAT” project, sponsored by the nonprofit, nonpartisan Center for Healthcare Decisions, asked 800 residents—the lay public, as well as health care professionals and community leaders—to consider Medicare’s current benefits and decide if those should be changed. Respondents represented the full spectrum of age, race, ethnicity, education, and income level.

Using an interactive, computer-based system, participants were asked to respond as “social decisionmakers;” they were tasked with making Medicare more responsive to the needs of current and future generations without imposing a greater cost burden on the country. The computer-based CHAT (“Choosing All Together”) program uses actuarial estimates to show the relative costs of health care benefits, allowing participants to make trade-offs with an understanding of the fiscal impact each benefit has on the program.

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Health Affairs Twitter Chat With PCORI


November 12th, 2014

Health Affairs recently partnered with the Patient Centered Outcomes Research Institute (PCORI) to produce three videos about ways patients and practitioners are incorporating patient engagement in health care decisions. The videos are hosted and reported by journalist John Dimsdale.

Twitter Chat On Patient Engagement

To further the conversation, Health Affairs and PCORI will host a Twitter chat with Sue Sheridan, director of patient engagement for PCORI, on Monday, November 17 at 2 p.m. ET on the topic of patient engagement in research.

Monday, November 17
2-3 p.m. ET
Join the conversation using #PatientHC!

Join in the conversation with the hashtag #PatientHC and follow us @Health_Affairs. Have a question about patient engagement in research? Send it along using #PatientHC.

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The Short-Term And Long-Term Outlook Of Drug Coupons


November 12th, 2014

In the October 2014 Health Affairs article, “Specialty Drug Coupons Lower Out-Of-Pocket Costs And May Improve Adherence At The Risk Of Increasing Premiums,” Catherine Starner and coauthors explore the relationship between drug coupons and specialty drugs. Specialty drugs, primarily injectables and biologics, are costly drugs used to treat complicated, chronic conditions that typically require special handling, administration, and monitoring. Starner et al. report that specialty drugs have an average monthly cost to patients and payers of about $3,500.

In their innovative study, Starner et al. find that nearly half of the patients in their sample who were prescribed specialty drugs used personal drug coupons to reduce their personal financial responsibilities. Coupons come in the form of maximum copay and monthly savings cards, and can be accessed from the brand-name manufacturer’s website, printed out, and cashed in at the pharmacy.

Manufacturers promote drug coupons as supplementary patient assistance programs that can fill gaps in insurance coverage by reducing individual patients’ responsibilities for out-of-pocket health care costs related to high-cost specialty drugs or other pharmaceutical products. For example, patients taking etanercept (Enbrel), an expensive biologic specialty drug indicated for rheumatoid arthritis, can receive savings via the Enbrel Support plan, which reduces the monthly co-pay to $0 for the first six months and $10 per month thereafter.

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The Payment Reform Landscape: Benefit And Network Design Strategies To Complement Payment Reform


November 4th, 2014

For the past ten months on Health Affairs Blog, we’ve been discussing the evidence for different models of payment reform, examining everything from pay for performance to nonpayment. But no discussion of payment reform is complete without addressing benefit and network designs and how they can help or hinder various payment reforms.  When the right payment method is paired with the right benefit and/or network design, they can work together to help reduce costs and improve care.  There are a number of payment approaches that pair well with specific benefit and network design strategies to yield higher-quality, lower-cost care. Below we discuss a few of these effective pairings.

But before we get into the specifics, why it is important to motivate providers to deliver and patients to seek higher-value care?  Health care providers may not only respond to direct financial incentives, but they are also likely to respond to knowing information about their performance is being put in front of prospective and current patients.  They also may be more willing to accept new forms of payment if acceptance means payers will encourage more patients to seek their care.

On the flip side, patients are unlikely to know how their providers are paid.  But if motivated (financially and otherwise), patients may act on meaningful distinctions in price and quality by choosing higher-value providers, saving money for themselves and whoever else is footing the bill for their care.

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Exhibit Of The Month: Comparing The Cost And Value Of Specialty And Traditional Drugs


October 27th, 2014

Editor’s note: This post is part of an ongoing “Exhibit of the Month” series. Readers who’d like to highlight other noteworthy exhibits from the same issue are encouraged to make their pitch in the comments section below.

This month’s exhibits, from the article, “Despite High Costs, Specialty Drugs May Offer Value For Money Comparable To That Of Traditional Drugs,” published in the October issue of Health Affairs, compare the value and costs of specialty and traditional drugs approved by the Food and Drug Administration from 1999-2011.

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Resources Don’t Solve Design Flaws


October 21st, 2014

The first three sessions of a conference I recently attended tackled some complex and important questions: How do we extend health insurance to people such as migrant and informal workers who don’t fit neatly into mainstream coverage programs? As we increase our investment in primary care, how do we assure that the performance of the primary care system is at the highest possible level? What types of evidence should we use as we make decisions in a dynamic health care system with limited opportunities for “gold standard” randomized controlled trials?

These are excellent questions, and they were perfect topics for a cutting-edge conference discussing the challenges facing the U.S. health care system.

But this conference was not about the U.S. health care system. These were opening “satellite” sessions at the Third Global Symposium on Health Systems Research held in Cape Town, South Africa.

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A Patient Advocate’s Perspective On Paying For Value


October 9th, 2014

When patient-centered outcomes research “is used well, it can be a powerful tool in making medical care better informed, without limiting patients’ and providers’ choices.” That was the promise that I, and many others, held out with creation of the Patient-Centered Outcomes Research Institute (PCORI) in 2010. Will PCORI achieve this goal? It is increasingly clear that evolving “value-based” payment models in health care, accelerated via the Affordable Care Act (ACA), will play a central role in how that question gets answered.

The movement to place greater financial risk on providers in an effort to pay for value rather than volume will have the effect of fundamentally changing the way health care providers interact with patients. But the question in value-based payment remains: value to whom? The answer should be, of course, value to the patient. And the answer will be, intrinsically, shaped by application of evidence.

While I applaud efforts to improve and advance our health care system through payment and delivery reforms, I am also mindful that such value-based payment systems must be built upon the foundation of “patient-centeredness.” Indeed, lawmakers and policy experts have long agreed that a “patient-centered healthcare system” is the Holy Grail of bipartisan health care reform. Yet despite significant progress in advancing patient-centeredness in our health system, much more work remains to be done.

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How Engaging Patients Can Improve Care And Health Outcomes


September 26th, 2014

Patients and caregivers are gaining momentum as powerful new resources in efforts to improve the health care system. They are increasingly becoming active partners in their own care, as well as seeking to make the health care delivery system more responsive to their needs and easier to navigate. And they are increasingly engaging as collaborators in planning and conducting research, and disseminating its results, with the goal of producing evidence that can help patients and those who care for them make better-informed decisions about the clinical choices they face.

It is this last trend that led the Patient-Centered Outcomes Research Institute (PCORI) to support Health Affairs in developing a series of videos illustrating some of the ways that patients are bringing their unique experiences and community connections to efforts to improve care for themselves and others. This includes stories of how patients are becoming partners in research designed to address the outcomes important to them, taking account of their own concerns and circumstances.

Seen through this lens, being a research partner goes well beyond being the subject of a trial. Rather, it means helping to guide researchers in formulating the questions to be studied, making the right clinical comparisons, looking at appropriate populations, and focusing on the outcomes important to patients. This should greatly increase the chance that the research findings will produce relevant results that can have a real-world impact — something we plan to evaluate carefully over time.

Meaningful patient engagement is at the heart of PCORI’s approach to research, and several of the patients featured in the videos have in fact partnered with researchers in just this way in patient-centered outcomes research (PCOR) studies we fund. They recognize that PCOR, a form of comparative clinical effectiveness research that focuses on issues of concern to patients, is a vital building block for developing truly patient-centered care and health policy, more effective treatments, and better outcomes.

In the following sections, we highlight the projects mentioned in the videos to give you an idea of how patients and community members are partnering in research projects.

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Relative Value Health Insurance And Pay For Performance For Insurers: Complements, Not Substitutes


September 19th, 2014

Background

The quest for value dominates contemporary health policy.  Value, properly defined, is not about cost-savings but about the balance of costs and health benefits — improving the average cost-effectiveness of health interventions.  In choosing which care is funded, insurers are a crucial but commonly neglected driver of health system value.

Insurers can increase health system value by covering fewer cost-ineffective interventions or covering more cost-effective interventions.  Perhaps the earliest attempt to reform insurance, managed care, attempted to pursue both goals, but by the time it was implemented it widely focused (or was perceived to focus) on cost-containment.

A recent insurance reform proposal, known as Relative Value Health Insurance (RVHI), received considerable attention, for instance, in The Upshot, The Incidental Economist, and Forbes.  RVHI enables insurers to reduce their contractual obligation to cover “usual and customary” care.  This and similar earlier proposals rely on the insurers’ natural incentive to cut costs.  Less well-covered, however, are proposals to alter the very incentives of insurers to improve health, which we will call “pay-for-performance-for-insurers” (P4P4I).

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Lessons Learned: Bringing Big Data Analytics To Health Care


July 14th, 2014

Big data offers breakthrough possibilities for new research and discoveries, better patient care, and greater efficiency in health and health care, as detailed in the July issue of Health Affairs. As with any new tool or technique, there is a learning curve.

Over the last few years, we, along with our colleagues at Booz Allen, have worked on over 30 big data projects with federal health agencies and other departments, including the National Institutes of Health (NIH), Centers for Disease Control (CDC), Federal Drug Administration (FDA), and the Veterans Administration (VA), along with private sector health organizations such as hospitals and delivery systems and pharmaceutical manufacturers.

While many of the lessons learned from these projects may be obvious, such as the need for disciplined project management, we also have seen organizations struggle with pitfalls and roadblocks that were unexpected in taking full advantage of big data’s potential.

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New Health Affairs July Issue: The Impact Of Big Data On Health Care


July 8th, 2014

Health Affairs explores the promise of big data in improving health care effectiveness and efficiency in its July issue. Many articles examine the potential of approaches such as predictive analytics and address the unavoidable privacy implications of collecting, storing, and interpreting massive amounts of health information.

Big data can yield big savings, if they are used in the right ways.

David W. Bates of the Brigham and Women’s Hospital and coauthors analyze six use cases with strong opportunities for cost savings: high-cost patients; readmissions; triage; decompensation (when a patient’s condition worsens); adverse events; and treatment optimization when a disease affects multiple organ systems.

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Lessons From Abroad And At Home: How PCORI Can Improve Quality Of Care (And Prove It) By 2019


May 2nd, 2014

The Patient-Centered Outcomes Research Institute (PCORI) was established with the passing of the Affordable Care Act in 2010 to oversee and set guidelines for comparative effectiveness research (CER). PCORI was also designed with a sustainable funding model, having received $210 million from 2010 to 2012 and expected appropriations of $150 million annually via fees imposed on Medicare and private health insurance companies. The international comparative effectiveness research community has recognized PCORI as the most funded CER initiative in existence, far surpassing the annual budgets of comparable international programs such as U.K.’s National Institute for Health and Clinical Excellence (NICE).

Despite the considerable resources designated to PCORI, its future remains tenuous. For one, the ACA legislation also created a “sunset date” of September 2019, giving PCORI seven years to convince Congress to reauthorize funding for the institute. Further, legislative efforts have already been made to repeal PCORI; H.R. 3827 was introduced by Rep. Brett Guthrie (R-KY) in January 2012, asking for immediate elimination of PCORI.

While PCORI is the first national comparativeness effectiveness research institute to be established in the U.S., it fortunately can draw several lessons from its international counterparts which have been operating for two decades. The U.K.’s NICE, considered by most to be the most comprehensive and effective CER program, will be the main comparator for this analysis.

PCORI must address two themes that are at tension with one another. On one hand, PCORI needs to foster stakeholder involvement in order to establish itself as a legitimate body of CER knowledge that is relevant and accepted in clinical practice. However, it also must avoid the pitfalls of having a democratic, iterative process that moves too slowly to issue findings and recommendations in a timely manner.

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What’s Past Is Prologue: Making The Case For PET Beta-Amyloid Imaging Coverage


April 9th, 2014

Editor’s note: This post is published in conjunction with the April issue of Health Affairs, which features a series of articles on Alzheimer’s disease.

In September of 2013, CMS issued its final decision memo that concluded positron emission tomography- amyloid beta (PET Aβ) imaging is “not reasonable or necessary”, finding “insufficient evidence” that use of this diagnostic tool would improve health outcomes for patients with dementia or neurodegenerative disease. As such, PET Aβ imaging to help diagnose Alzheimer’s disease (AD) is not a covered service for Medicare beneficiaries except for those enrolled in CMS-approved clinical trials.

CMS’ final decision underscores the emerging new paradigm for coverage decision-making, requiring innovators not only to demonstrate to FDA’s satisfaction that their products are effective, but also to prove to CMS and other payors that their use will improve clinical outcomes. This paradigm will increase confidence in the value and health benefit of new technologies, although it will make the path to coverage more difficult and uncertain for diagnostic developers.

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PCORI’s Research Will Answer Patients’ Real-World Questions


March 25th, 2014

As a physician, I know the challenge of helping patients determine which health care options might work best for them given their personal situation and preferences. Too often they — and their clinicians — must make choices about preventing, diagnosing and treating diseases and health conditions without adequate information. The Patient-Centered Outcomes Research Institute (PCORI) was created to help solve this problem — to help patients and those who care for them make better-informed health decisions.

Established by Congress through the Patient Protection and Affordable Care Act as an independent research institute, PCORI is designed to answer real-world questions about what works best for patients based on their particular circumstances and concerns. We do this primarily by funding comparative clinical effectiveness research (CER), studies that compare multiple care options. But more research by itself won’t improve clinical decision-making. Patients and those who care for them must be able to easily find relevant evidence they can trust. That’s why our mandate is not just to fund high-quality CER and evidence synthesis but to share the results in ways that are meaningful to patients, clinicians and others. We’re also charged with improving the methods used in conducting those studies and enhancing our nation’s capacity to do such research.

We will be evaluated ultimately on whether the research we fund can change clinical practice and help reduce the variations and disparities that stand between patients and better outcomes. We’re confident that the work we’re funding brings us and the audiences we serve closer to that goal.

Recently, some questions have been raised in health policy circles about our holistic approach to PCORI’s work. That view holds that direct comparisons of health care options — especially those involving high-priced interventions — should be the dominant if not sole focus of PCORI’s research funding approach as a path to limiting the use of expensive, less-effective options.

We agree that discovering new knowledge on how therapies compare with one another is a critical mandate of PCORI and is essential to improving the quality and effectiveness of care. However, ensuring that patients and those who care for them have timely access to and can use this knowledge, so that they can effectively apply it to improve their decisions, is also very important. That is the reasoning behind our integrated approach path that addresses the gaps in available evidence, and also studies how best to make the evidence available and usable.

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Recent Health Policy Briefs: Specialty Pharmaceuticals And Medicare Hospital Readmissions


November 25th, 2013

The latest Health Policy Brief from Health Affairs and the Robert Wood Johnson Foundation explains many of the current debates surrounding the use of specialty pharmaceuticals. Specialty pharmaceuticals—drugs and biologics used to treat chronic, serious, or life-threatening diseases—are complex to manufacture and distribute, often difficult to administer, and may require special patient monitoring. They are a rapidly growing share of the costs borne by both public and private health plans. A patient could pay a few thousand dollars a month to use them, and the annual total cost for some products could exceed $100,000. This policy brief discusses the potential impact of specialty pharmaceuticals on consumers and the health care industry and some of the key challenges for policy makers.

The immediately preceding Health Policy Brief describes the Medicare Hospital Readmissions Reduction Program (HRRP), established as part of the Affordable Care Act. This program imposes financial penalties on hospitals with higher than expected readmissions. The program aims to create an incentive for hospitals to reduce the number of patients who return to the hospital within 30 days for treatment of three key conditions: acute myocardial infarction (that is, heart attack), heart failure, or pneumonia. The HRRP, in operation for only two years, already has shown results. Despite this success, some policy makers fear unintended consequences for safety-net hospitals, potentially putting vulnerable populations at risk.

Health Policy Briefs are aimed at policy makers, congressional staffers, and others needing short, jargon-free explanations of health policy basics. Sign up for an e-mail alert about upcoming briefs. The briefs are also available from the Robert Wood Johnson Foundation’s website. Please feel free to forward the briefs to any of your colleagues who are tracking health issues. And after you’ve taken a look, we welcome your feedback at: hpbrief@healthaffairs.org.

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