Tag: Comparative Effectiveness Research

Essential Health Benefits: Balancing Costs, Coverage, And Necessity

The much anticipated Institute of Medicine Report on essential health benefits (EHB) was released last week with a series of recommendations that answered some questions and raised many more. The report offers a very important opportunity for researchers, policymakers, providers and patients to fill in some of the white space between the recommendations.

Background on EHB in the Affordable Care Act and some Legislative History

The Affordable Care Act (ACA) tasked the IOM to make recommendations on the methods for determining and updating the essential health benefits that must be offered by qualified health plans seeking to participate in exchanges as defined in section 1301 of the statute. The ACA identified ten categories of items and services that must be included in a package of benefits:

  • Ambulatory patient services
  • Emergency services
  • Hospitalization
  • Maternity and newborn care
  • Mental health and substance use disorder services, including behavioral health treatment
  • Prescription drugs
  • Rehabilitative and habilitative services and devices
  • Laboratory services
  • Preventive and wellness services and chronic disease management
  • Pediatric services, including oral and vision care

The Affordable Care Act did not have a conference committee report, which is the product of the House and Senate working to resolve differences between the two chambers’ versions and also helps to highlight legislative intent. So the long history of the decisions behind the language and legislative intent is not as apparent.  Briefly, Congress looked at many design models and previous bills, such as HR 3600 — one of the health reform bills put forward during the Clinton administration — which contained 61 pages of details on benefits. This approach was was felt to be too detailed and prescriptive.  Staff from Senator Kennedy’s Health, Education, Labor and Pensions Committtee used the Massachusetts language on exchange benefits and its promulgated regulations and then made important additions such as habilitative services (educational or long term services, often associated with long terms disabilities or conditions such as autism).

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How Effective is CER?

flying cadeuciiHaving the best evidence at hand is vitally important for making health care treatment decisions. But even when the right—or best—information is available, it isn’t always put to use in clinical practice.

Why? Although we are getting better at generating evidence, we’re still not doing a great job of using it.

Our progress in creating a robust pipeline of comparative effectiveness research (CER) is clear. By 2019, the Patient Centered Outcomes Research Institute (PCORI) is expected to receive an estimated $3.5 billion from the PCOR Trust Fund to fund CER. CER is not new, but the investment in PCORI represents a national appetite for a robust and reliable queue of research to overcome one of the greatest perennial challenges in health care delivery—knowing what works, for whom it will work and under what conditions.

CER offers every provider, patient and payer the promise of better care, yet its impact on patient outcomes remains on the horizon, rather than a reality in health care settings today. Why? Research published recently in the American Journal of Managed Care suggests that changes are needed in order to see more consistent translation of research findings into clinical practice. In short, at the moment, we have a hard time using what we learn from CER.

This research examined how major CER studies have impacted care. We evaluated real-world utilization trends before and after a) publication of CER findings and b) the release of relevant clinical practice guidelines (CPGs) from four high-profile CER studies published within the last decade.

The research we examined tells the story. Under the microscope were four major studies, including: PROVE-IT, an examination of cholesterol-lowering treatment strategies from 2004; MAMMOGRAPHY WITH MAGNETIC RESONANCE IMAGING (MRI), a comparison of diagnostics to detect breast cancer from 2004; SPORT a comparison of surgical and non-operative treatments for herniated disks from 2006; and COURAGE, a comparison of percutaneous coronary intervention (PCI) to optimal medical therapy (OMT) for people with coronary artery disease, from 2007.

These studies delved into pressing therapeutic questions, and the findings of each study revealed new thinking in optimizing care for patients. But, despite the shifts in care that could have—or should have—occurred, our analysis revealed no clear pattern of utilization in the first four quarters after publication. Even after the studies were incorporated into CPG, we were not able to consistently find changes in utilization or clinical practice.

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The Side Effects of Releasing Public Health Insurance Data to the Public

flying cadeucii

Three of the five largest private health insurers in the US – UnitedHealthcare, Aetna, and Humana – have decided to follow the lead of the Centers for Medicare & Medicaid Services (CMS) and release their payment information to the public. According to Bloomberg News, this data will include 5 billion individual medical claims and $1 trillion in spending.

Releasing payment information by governmental and private health insurers is an important step towards transparency. Providing researchers with access to the details of health insurance payments is an unprecedented and long-awaited opportunity to gain insights into the drivers of rising healthcare costs. Although I share the enthusiasm of many other researchers for analyzing this valuable data, I am also concerned with unanticipated consequences that may arise with unrestricted release of sensitive and complicated healthcare insurance data to the public.

Reputation of Physicians

The performance of physicians, as some of the most reputable and highly specialized professionals of our society, cannot be evaluated only based on their insurance billing history. To the untrained eye, the abnormalities in insurance charges may seem unjustifiable. Deep expertise in the medical domain is required to investigate all of the underlying causes of the abnormal prescriptions, medical procedures and equipment utilizations. Accusing physicians of malpractice or misconduct based on hasty analysis of this data and without careful examination of the unique medical context in each case, would be unfair to those who deliver medical care to patients.

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The Republican Case For Waste In Health Care

Conservatives love to apply “cost-benefit analysis” to government programs—except in health care. In fact, working with drug companies and warning of “death panels,” they slipped language into Obamacare banning cost-effectiveness research. Here’s how that happened, and why it can’t stand.

Why are you reading this when you could be doing jumping jacks?

And how come you’ve gone on to read this sentence when you could be having a colonoscopy?

You and I could be doing all sorts of things right now that we have reason to believe would improve our health and life expectancy. We could be working out at the gym, or waiting in a doctor’s office to have our bodies scanned and probed for tumors and polyps. We could be using this time to eat a steaming plate of broccoli, or attending a support group to help us overcome some unhealthy habit.

Yet you are not doing those things right now, and the chances are very strong that I am not either. Why not?

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Patient Politics: the PCORI Puzzle

The new Patient-Centered Outcomes Research Institute (PCORI) has been asking different stakeholders about the most important issues to address with the hundreds of millions of dollars the quasi-governmental group will shortly be doling out in grants. Not surprisingly, the stakeholders have been more than happy to respond.

PCORI’s most recent day of dialogue, which I attended as a representative of the Society for Participatory Medicine (SPM), was characterized by genteel civility and a big question mark: “Is PCORI serious about transforming health care?” When I asked directly, I didn’t get much of an answer. The reason, I suspect, goes to PCORI’s origins. It is the offspring of a shotgun marriage between goo-goos and pinky-ringers, and no one is quite sure yet what this child will be once it grows up.

Let me pause here a moment to parse the political shorthand. “Goo-goos” are “good government” types, the kind of folks who trumpet the need for transparency in government or better public transit. Goo-goos, seeing the half trillion dollars or so of waste in U.S. health care system, called for a new national organization to carry out comparative effectiveness research in order to help Americans get the most value for our money.

The goo-goos pointed out that our current regulatory structure is designed to ensure that treatments are safe and effective, not compare them. Nor does the private sector have much incentive to pay for comparative studies that may undermine products currently selling quite nicely, thank you.

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FDA Should Add a Comparative Effectiveness Arm to Final Trials

The Food and Drug Administration’s Prescription Drug User Fee Act is up for reauthorization next year, and so is the consumer and drug industry face-off over the contentious issue of comparative effectiveness research (CER). Consumers, patients and some physicians are demanding that CER be required of all new drugs coming to market when there are already FDA-approved therapies for the same condition. They say it will give payers and patients immediate feedback on the relative worth of the latest drugs, which are always more pricey than what preceded them, especially if the older drugs are coming off patent.

Industry opposes including CER arms in final efficacy trials. The companies claim it will place additional costs on the already expensive new drug development process; provide inadequate information for actually divining the relative worth of two competing therapies; and dissuade companies from investing in follow-on drug research, which can turn up drugs that are significantly better than older drugs.

The American Enterprise Institute’s Scott Gottlieb, who served in the FDA during the Bush administration, this week offered a lengthy brief in support of the industry position. Unfortunately, he sets up a straw man in order to knock down what could be a very effective tool for lowering the cost of medicine. It behooves industry leaders to ignore his advice, and to ignore the bleating of their marketing departments’ incessant demand for follow-on drugs.


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Heart Failure or System Failure?

Today’s New England Journal of Medicine reports the results of a government-funded study of two potential approaches to giving emergency diuretics to congestive heart failure patients who show up on emergency room doorsteps gasping for breath. Should it be through a continuous drip or periodic injections? Should physicians prescribe high doses or low doses of these fluid dispersal drugs? Cost isn’t an issue since diuretics are generics. The pressing question was whether high doses caused a greater incidence of renal failure, which had been suggested by a number of smaller trials.

This comparative effectiveness study is the kind of research that never receives attention in the press. No new drugs are involved, nor does it involve a high-profile disease. But it merits closer scrutiny because of the patient population. There are more than a million patients who enter hospitals every year with acute episodes of congestive heart failure. The average age in this study was 66, i.e., Medicare was paying the tab. Three quarters had been admitted to the hospital within the past year. More than half had diabetes, and around 40 percent had implanted defibrillators. Most were on two or more drugs for high blood pressure. I searched for data on the average weight of this population, but, alas, that wasn’t included. I think you can guess.

The results were mildly interesting. It didn’t matter what approach physicians took, the outcomes were about the same. Fears of exacerbating renal failure in this vulnerable patient population from high dose diuretics appear to be overblown.

I’m afraid this is going to be the conclusion of much comparative effectiveness research, which received a major shot in the arm through the 2009 stimulus bill and will receive a continuous injection of funds from the Affordable Care Act, presuming the Republicans in Congress aren’t successful in de-funding the bill. Physician and hospital practice will have better evidence about what to do in certain situations, but radical changes in procedures that have a dramatic impact on cost will be elusive.Continue reading…

More Can Also Be Less: We need a more complete public discussion about comparative effectiveness research

Media coverage of the government’s new investment in comparative effectiveness research leans heavily toward the effects of such research on new drugs and technologies: Will such evaluations lead to restricted access to the latest innovations?  Will insurance no longer cover a drug that might give my aunt another year to live? Will such research hinder the development of a drug that could cure my nephew of type I diabetes?

The focus on how results from comparative effectiveness research might affect new approaches  obscures for the public and for policymakers the vital role of such research in evaluating current approaches to diagnosis and treatment that may not only be ineffective but in fact harmful to us.

I am now slogging through chemotherapy for stomach cancer almost certainly caused by receiving high doses of radiation for Hodgkin lymphoma, which was the standard treatment until long-term side effects (heart problems, additional cancers) emerged in the late 1980s.  So I am especially attuned to the need for registries and trials to track the short- and long-term effectiveness of treatments.

So choosing a surgeon in September to remove my tumor shone a bright light for me on the importance of research to evaluate current practices. Two of the three surgeons I consulted wanted to follow “standard treatment procedures” and leave a six-centimeter cancer-free margin around my tumor. This meant taking my whole stomach out, because of the anatomy of my stomach and its arterial supply.

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HIT Trends Summary for October 2010

This is a summary of the HIT Trends Report for October 2010.  You can get the current issue or subscribe here.

The evolving health information exchange market. The HIE segment was center-stage this month with a game-changing announcement by Surescripts. It will combine its national physician directory and EMR connectivity with apps from its strategic investment in Kryptiq to offer physician-to-physician clinical messaging beginning in December, extending its dominant market position.  As first to market with these functions, it will likely cement its standing as the country’s premiere neutral national network.  It also enables a platform for additional web services from collaborating partners in the future.  We are also reminded this month in Healthcare IT News of the relative dominance of Epic in the IDN and large practice market with the startling statistic that 75% of Wisconsin residents are in the databases of its state user group.  Using Epic tools and with patient consent physicians in the state can see patient information across institutions.  And there’s a story this month that Verizon is expanding its vision as an HIE by adding clinical lab and imaging results to its networking services with leading transcription companies.  These three lenses:  (1) Surescripts as the leading national network; (2) Epic as the leading national EMR; and (3) Verizon as the leading national telecom, exemplify the rapidly changing dynamics in this segment.

EHRs and HIT have become central to transformation of clinical practice. One large driver is the announcement by the insurance commission of the inclusion of HIT as well as wellness and care management as medical expenses for insurers under PPACA.  In the past these areas were generally allocated to the administrative budget of health plans which limited participation.  This will increase payer investment.  A CMS exec, Anthony Rogers, reported to Healthcare IT News on early results of CMS accountable care organization (ACO) pilots.  He noted that practices with EMRs were getting most of the $36M in incentives and said, “If that’s not a business case [for EHRs], I don’t know what is.”   The Patient-Centered Primary Care Collaborative, the organization driving medical homes released two reports this month also highlighting HIT’s role in transformation.  One report looks at best practices to engage patients in a medical home project using HIT.  It’s a compendium of 15 essays by a diverse set of experts on different perspectives about using health IT to engage patients, plus snapshots of two dozen case examples.  The other report focuses on five ways to implement HIT effectively to enable clinical decision support.  And CSC released a roadmap for HIT in ACOs with an elegant six factor model:  member engagement; medical management; clinical information exchange; quality reporting; business intelligence; and  risk and revenue management.

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How Come Comparative Effectiveness Research is All the Rage?

Comparative Effectiveness Research (CER) is suddenly a hot topic at all the health care conferences. How come? Everybody agrees that we have to decrease per-capita cost and increase quality. Why? Government programs like Medicare and Medicaid foot more than 50% of our nation’s health bill, and if everything stays the same these programs will go belly up (bankrupt) in 8 years. Big problem.

Health and Human Services (HHS) has defined comparative effectiveness research as conducting and synthesizing research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat, and monitor health conditions in “real world” settings. In other words, CER is figuring out what treatments, tests, and drugs work and which ones don’t work.

John E. Wennberg spent a whole career at Dartmouth studying American medicine, and he comes to the startling conclusion that 60% of Medicare is spent on supply sensitive care (physician visits, consultations, imaging exams, and hospital and ICU admissions) and 25% on preference sensitive care (PSA tests, mammography, and elective surgery). Although we assume that this care is based on solid scientific evidence, Wennberg states that “medical science is virtually silent on such matters” as how often to see a patient, what test to order, and whether to admit a patient to the hospital or ICU. Some evidence based medicine experts state that only about 20% of what physicians do is based on sound science.

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