Joe Colucci: All Related Content

All related content for this individual is listed below.

"Do I Have Any Business Being a Doctor?" at Zocalo

  • By
  • Joe Colucci
May 20, 2013
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Our former intern, Catherine Jameson, has just written a fantastic post for Zocalo Public Square on her decision to become a doctor. It's a remarkably human story, and she demonstrates exactly the kind of compassion that doctors need to have for their patients in order to keep the medical system in check.

Go read it!

Issues:

What a week!

  • By
  • Joe Colucci
  • Catherine Jameson
May 2, 2013
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Medicaid in Oregon

 

First, the big one: yesterday afternoon kicked off a flurry of discussion - some of it rather heated - about the most recent paper (ungated version) to come out of Oregon’s Medicaid program. In case you’ve forgotten: a few years ago, Oregon had money to expand Medicaid enrollment - but they didn’t have enough to cover everyone who was eligible. So the state created a list of around 90,000 people, and enrolled 10,000 - giving people the opportunity to apply through a random lottery. That created an incredible research opportunity - the randomized design allows researchers to really see the effect of Medicaid enrollment on people’s health, and hopefully put to bed the nonsense idea that Medicaid is bad for people’s health.


The new publication is mildly disappointing in that regard - but the reaction to it has been way overblown. While the first study (which we wrote about in 2011) showed clear improvements in self-reported health, this paper is the first to report actual clinical data from the experiment. It did not find that Medicaid decreased average blood pressure, cholesterol levels, or HbA1c (glycated hemoglobin, a measure of blood sugar used as a diagnostic criterion for diabetes). The Medicaid group was far more likely to be formally diagnosed with and in treatment for diabetes. They also had much lower rates of depression (9% absolute risk reduction, meaning roughly one in eleven people was no longer depressed), and drastically lower rates of catastrophic medical spending.


As we noted, the results on cholesterol, blood pressure, and blood sugar are somewhat disappointing. But it’s crucial to put those measures in context. As usual, Aaron Carroll and Austin Frakt of The Incidental Economist have done incredible work pointing out the limits of the study, and the ways that it’s been over-interpreted. You should absolutely readtheirposts. They’ve also been active on Twitter, where Aaron has pointed out that the study may not have beenlarge enough to detect important effects on those variables, even if they were there, and that it’s not easy to reduce HB even when that’s what a study is specifically intended to do! We won’t spoil all of their points, but they’re excellent. Go read the post, and direct your friends to it.


As a final note on the Medicaid experiment, we’d like to point out that (while we appreciate the solid methodology) this is not the kind of study health care needs most. There is ample evidence that people benefit from insurance, both financially and medically. But our ability to benefit from access to medical care is currently limited by the massive flaws in the delivery system. Providing insurance to low-income people is great, but its value is drastically reduced when we’re spending a lot of that money on screening tests that cause overdiagnosis, unwanted elective surgeries, and expensive drugs that are no better than existing options. Eliminating the waste from the system is crucial to making universal coverage sustainable and affordable; we need RCTs of programs that focus on eliminating overtreatment and improving how we care for patients.


Elsewhere in the news...


This week, The New York Times Magazine featured a piece by Peggy Orenstein entitled,“Our Feel-Good War on Breast Cancer.”  The article couldn’t be more timely, as research on overdiagnosis continues to highlight the downsides of widespread screening. It’s a nuanced discussion of Orenstein’s personal experience with breast cancer, and the “survivor” culture surrounding the disease.  Definitely worth a read!


The Fountain of Youth

Last weekend, Ezra Klein posted a great example of how politics, money, and bureaucracy influence the kind of health care we receive. Health Quality Partners (HQP), created by Medicare with funds allocated by the 1997 Balanced Budget Act, provides seniors with a home visit from a nurse on either a monthly or weekly basis. The program was an incredible success, lowering spending on enrollees’ health care by 22%, improving their quality of life, and reducing their hospitalizations by 33%. But even though it’s been labeled “The Fountain of Youth,” HQP’s funding is due to expire in June of this year and it’s unlikely that a similar program will take its place.  Even more unfortunate is that HQP’s success won’t be used to inform future programs.  Instead, Medicare is creating a new generation of programs meant to shift from a fee-for-service system to a pay-for-quality system, arguing that the results of HQP were limited by its small size and that to scale-up the program would be less cost-effective than to change the payment structure that governs the entire program.  Perhaps this analysis is valid, but the situation highlights the difficulty of reshaping an existing healthcare system in which so many have a stake.  

 

"We torture people before they die.”

Jonathan Rauch profiles Dr. Angelo Volandes, creator of a series of videos showing patients the reality of aggressive end-of-life treatment, in this month’s Atlantic magazine.  For the last several years, Volandes has been working on a series of videos showing patients what it's like to receive intense medical treatments like CPR, feeding tubes, and being placed on a ventilator, and helping them understand what benefits they can actually gain from medical treatment - and what they can't.  When patients see those videos, the reality of aggressive end-of-life care hits home - and they're much less likely to choose aggressive, expensive, and often futile treatments.

 

Volandes's work highlights the importance of talking about death with patients and their families, and illustrates how much of end-of-life care is actually unwanted care. His videos help doctors and patients have what Volandes refers to as “The Conversation,” a necessary but often avoided discussion about the imminence of death and the need for a patient and his or her family to decide how far they want to push the boundaries of life-saving medicine. It's good to see docs like Volandes stepping up and pushing their profession toward having more honest, productive conversations about end-of-life care. We'll all die better - and live better - for it.


California End-of-Life Care

Unfortunately, patients don't always get what they want. In fact, many dying patients are subjected to far more intense treatment than they would have chosen. The new report "End-of-Life Care in California: You Don't Always get What You Want," by Senior Fellow Shannon Brownlee, highlights those discrepancies.  Most people say they would prefer to die at home - yet huge fractions end up dying in a hospital. Hospice has been shown to have positive effects on quality of life without reducing lifespans, yet adoption of hospice remains slow.

The report also highlights the huge geographical variations in how much treatment dying people receive. In nearly every category, California lags behind other parts of the country. In many cases, Southern California particularly sticks out as a hotbed of intense treatment. Patients in that area should pay particularly close attention to this report - it has important implications for what their last few months might look like, and what we might do to make the medical system serve their needs better.

For more on the CHCF atlas, and how it connects to Rauch's story, see our post on In the Tank.

BBC: Overuse of Hysterectomies in India

  • By
  • Joe Colucci
February 7, 2013
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A BBC report from earlier this weeks makes it very clear: overuse of elective medical procedures is not just an American problem, or even just a developed-world problem. The report tells the story of women in a number of rural villages in India, where hundreds of women have been convinced, cajoled, and frightened into having hysterectomies they almost certainly didn't need.

The story suggests that the procedures are probably being done to make money for unscrupulous local doctors. The docs work in India's private medical system, but the public insurance program for the poor allows patients to see private physicians when they can't acces the public healthcare system. According to the story, the doctors often tell patients they have cancer and need an immediate hysterectomy--sometimes without even performing a biopsy, and without offering other, less invasive forms of cancer treatment. Unnecessary operations make money for the physician, but they're a huge financial burden for patients--and although the article didn't mention it, unnecessary treatments also expose patientsto needless risk of serious complications and death.

The Indian government is starting to react to the apparent epidemic of overuse. But in addition to fixing perverse financial incentives, it's important to consider the role informed and empowered patients can play in ensuring unnecessary treatments don't happen. The article notes that women find it hard to refuse a surgery that the doctor says they need right away. One young woman said she wasn't even able to discuss the surgery with her husband first. Fixing that rushed and insensitive process is crucial. Patients in rural India have just as much right to make their own decisions as patients in rural Indiana--and fortunately, there are effective tools to help them make those decisions. Even if the public medical system can't yet reach all parts of rural India, it might be possible for the government to make sure shared decision making and decision aids are available--that could save money, and help patients avoid unnecessary treatment.

 

UPDATE: Dr. Mohammad Zakaria Pezeshki, Associate Professor in the Department of Community Medicine at Tabriz Medical School in Tabriz, Iran, saw this post & responded with some good thoughts of his own. He points out that it's crucial to have decision aids in patient-accessible languages, and that opportunities to inform and engage patients are not limited to shared decision making. Check out the post and the rest of his blog, Earth Citizens' Health!

Ideas for a Smarter SNAP

  • By
  • Joe Colucci
January 4, 2013
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The first article in last week's Journal of the American Medical Association, coauthored by Health Policy Senior Fellow Susan Blumenthal, presents a compelling argument that the SNAP program (formerly food stamps) is contributing to the growing obesity problem, particularly among low-income children. If we want to keep people healthier in the long run--and better control our healthcare spending at the same time--it's worth thinking about ways to help SNAP beneficiaries stay a healthier size.

The problem is pretty simple. Federal food assistance programs have been very successful in reducing the number of Americans who don't get enough calories to live, but SNAP--the largest one--doesn't include any mechanism for targeting spending toward foods that provide high-quality energy and plentiful nutrients, so a lot of the money ends up getting spent on soda and other junk food. Those foods appear to contribute to obesity, which can later lead to diabetes and a host of other medical conditions.

That challenge prompted Blumenthal to lead a group that created a report, SNAP to Health, laying out some policy changes that could help reduce obesity among the SNAP population and improve our health in the future. The report is long, but worth a look--check it out! Also check out the JAMA piece here.

Please, stop talking about "health care costs."

  • By
  • Joe Colucci
January 2, 2013
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"Health care costs"  are a constant companion of budget wonks, showing up in every discussion of long-term fiscal policy and discussions of healthcare reform going back decades. But in an Atlantic piece from the end of the year, coauthored with Thom Walsh of the Dartmouth Center for Healthcare Delivery Science, we argue that talking about "costs" ignores our increasing utilization of healthcare services,  misrepresenting the real nature of our spending problem and obscuring solutions:

"...the more worrisome reason for rising spending is the quantity of high technology specialty services we undergo. We get more high tech imaging studies, more days in the ICU, more robotic surgeries than we did 40 years ago, or even 14 years ago. Sometimes that high-tech medicine leads to better outcomes, but a lot of the time it does not -- it just means we spend more. 

Given this increasing use of high-tech services, it should be easy to see why the "rising healthcare costs" frame is misleading: if we're using more and more services each year, it's hardly reasonable to blame rising costs of production. [...]

 The real problem, then, isn't merely that we're spending a larger and larger percentage of our income on healthcare -- it's that we are spending indiscriminately. Yet when healthcare spending rhetorically becomes healthcare costs, it implies that overconsumption of useless, overpriced services is not part of the problem."

Read the full piece at The Atlantic.

What 'Health Care Costs' Really Means

  • By
  • Shannon Brownlee,
  • Joe Colucci,
  • New America Foundation
December 22, 2012 |

No fiscal policy event is complete without the plaintive cry that health care costs are out of control. The phrase has become a form of rhetorical boilerplate that is often used to imply that policy makers are helpless in the face of market forces, and that the only way to reduce "costs" is either cutting benefits or rationing.

156 Questionable Procedures

  • By
  • Joe Colucci
December 10, 2012
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Australia's Medicare system took a big step toward cheaper and more effective healthcare recently by ordering a systematic compilation of procedures that are harmful, not supported by evidence, overused for a large number of patients, or of low value for some other reason. The list is based on recommendations from the British National Health Service's National Institute for Health and Clinical Excellence (NICE), evidence assessments from the Cochrane Collaboration, and other sources. The list is full of old favorites for people who pay attention to overtreatment--procedures like vertebroplasty, elective angioplasty for stable angina, PSA testing, and some arthroscopic knee surgeries. But it also includes a wide variety of specific surgical techniques and other, more technical examples of ineffective practices that we non-clinicians don't hear about or talk about as much.

It's hardly a complete list of all the ways patients get overtreated. The study didn't include pharmaceuticals, and lots of overtreatment is more the result of being in an overly-intense treatment environment (like a hospital or an ICU than the result of a specific decision to do a specific procedure. But it's certainly useful to see a good long list of ways that we can eliminate waste in the medical system--hopefully other systems outside Australia will take note, and groups like Choosing Wisely will take a look at the list, draw from it, and add their own examples!

The paper describing how the list was created is here; the full list is in an appendix to that paper, here.

Health Wonk Review!

  • By
  • Joe Colucci
December 10, 2012
Alistair Cookie

Last week's Health Wonk Review is worth checking out--it has posts on a whole slew of topics, ranging from implementation of the ACA to Medicare readmissions penalties, and more. It's also stocked with Chanukah facts! Check it out here.

One of the particularly important posts covers a surprising JAMA paper looking at patients who had online access to their medical records and other information online. Contrary to the popular narrative that patients who have access to their information and can manage their medical needs will consume less healthcare, utilization among patients using the online system went up. The study is far from a complete analysis of the effects of better IT on healthcare spending, but it does pose serious problems for people who believe electronic medical records and giving patients better access to their information will make a serious difference in the healthcare system.

"The Waiting Room" at E Street Cinema

  • By
  • Joe Colucci
December 4, 2012
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E Street Cinema in DC is playing the documentary The Waiting Room, by director Peter Nicks. It profiles the emergency room at Highland Hospital in Oakland, CA, for 24 hours, profiling the patients who come in and the staff who treat them. It looks like an interesting film--check out the trailer here.

60 Minutes on HMA Admission Practices

  • By
  • Joe Colucci
December 3, 2012
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Last night, CBS's 60 Minutes aired a segment reporting on the allegations that for-profit hospital chain Health Management Associates (HMA) has committed widespread Medicare fraud, including by pressuring ER docs to admit at least 20% of their patients (and at least 50% of patients over 65!), and by using a computer system that automatically ordered tests before patients even saw a doctor. The company has denied the accusations, but they are under investigation by the Justice Department.

Obviously, if HMA was breaking the law, it should be investigated and punished. But it's important to note that similar questionable admissions happen all the time, at hospitals across the country, without any deliberate Medicare fraud. Supply-sensitive admissions are a huge and expensive problem that the 60 Minutes story didn't address. It doesn't matter to a patient who ends up getting an infection if they were admitted explicitly to make more money, or "just in case" and because there was a bed available. Preventing fraud is yet another reason we need much better evidence on when being admitted to the hospital is helpful, and when it just puts patients in harm's way.

CBS based the report on conversation with a large number of former HMA employees, as well as on some documents that apparently show the pressure from inside the organization. We've asked to see the documents, and will update this post to reflect anything we hear about that request from CBS.

Watch the full segment here!

Do Prestigious Residencies Mean Better Doctors?

  • By
  • Shannon Brownlee,
  • Joe Colucci,
  • New America Foundation
November 13, 2012 |

Each fall, medical students in their fourth and final year select a medical specialty and apply to residency programs. Residency, which lasts anywhere from three to eight years, is run by teaching hospitals. It's when newly minted MDs learn the hands-on, practical skills of doctoring -- how to make diagnoses, perform surgeries, order and interpret tests, etc. They also learn how to deal with patients and families, and work with other caregivers.

Cancer Screening: Emotion vs. Data

  • By
  • Joe Colucci
November 1, 2012
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We've just closed out a month where everything from the White House to professional football players' cleats turned pink to raise awareness of breast cancer. Every year during October, there's a constant focus on raising money for breast cancer research, and on reminding women to get screened. The mantra is always, "Early detection saves lives."

As we've written before, it's an article of faith for many patient advocates and medical organizations that cancer screening is an unadulterated good. But a new study in the Lancet on breast cancer screening provides yet more evidence that while mammography can save lives, screening also causes serious harms. They find that for every woman whose life is saved, three other women will be overdiagnosed and face unnecessary treatment. That doesn't even count the harm caused by false positives on screening mammograms, which lead to unnecessary stress as well as biopsies and other tests. It's worth noting that the population in the Lancet study includes women over 50, in line with the US Preventive Services Task Force's recommendations. Expanding screening to women under 50 means that fewer of the women screened will have harmful cancers, so the harm of overdiagnosis is more likely to outweigh benefits from catching cancer early.

To go along with the Lancet study, the New England Journal of Medicine has a new Perspective piece by Drs. Steve Woloshin, Lisa Schwartz, William Black, and Barnett Kramer. They make a forceful argument against one-sided pro-screening campaigns that present the benefits of screening, while ignoring the harms. The piece is linked to a great slide show with some of the most egregious pro-screening advertizements.

Answer Me This...

  • By
  • Joe Colucci
October 25, 2012

With the last of the three debates completed and the presidential election just around the corner, the New America Foundation has pulled together this video with people from our various policy teams to ask the candidates a few final questions about how they plan to govern. Check us out, tell us what you think, and if you seeeither candidate answering any of the questions, let us know--tweet to us at @NewHealthDialog and @NewAmerica!

News roundup!

  • By
  • Joe Colucci
October 12, 2012
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Overtreatment has hit the popular press in a big way over the last couple of weeks. We haven't been able to highlight every article as it's come out, so here they are all in one place. Take some time this afternoon & catch up!

"The Cost of Assuming Doctors Know Best" - In The Atlantic, Shannon Brownlee & I outline the shared decision making program implemented at Group Health Cooperative in Washington State, and argue that it should be a strong signal to hospitals across the country to start their own SDM programs.

"Unnecessary care: are doctors in denial and is profit driven healthcare to blame?" - Jeanne Lenzer discusses the Avoiding Avoidable Care conference, previews our efforts to eliminate overtreatment, and poses the inevitable question: what has to change about payment structures for medicine to put the patient first?

"Is the USA’s problem ours too?" - Margaret McCartney assesses the risk of overtreatment in a truly government-run healthcare system, and finds that the UK faces many of the same challenges that the American healthcare system does, including rampant overuse & poor reaction to evidence.

"Patient power needs to be built on strong intellectual foundations" - Former NHS head Nigel Crisp argues that "the balance of power in health systems needs to be shifted so that people are enabled to live the life that they want rather than having to fit in with professional and commercial views."

Video: The harms of overtreatment - The video supplement to Jeanne Lenzer's article includes interviews with Shannon Brownlee, Dr. Vikas Saini of the Lown Institute, and the story of Michael Skolnik and the harms of overtreatment.

"The Epidemic of Excess Medical Treatment" - Dr. Marty Makary, Johns Hopkins surgeon and author of Unaccountable: What Hospitals Won't Tell You and How Transparency Can Revolutionize Health Care, describes the numerous reversals of medical advice to come out in recent years and the massive scale of overtreatment in the US.

Dr. Marty Makary on the Diane Rehm Show - Dr. Makary is the sole guest for a full hour of excellent discussion on one of public radio's best interview programs.

"Psychiatrist Contends the Field Is ‘Committing Professional Suicide'" - Maia Szalavitz describes tje problems with the relationship between psychiatry and the pharmaceutical industry--a relationship that's getting so close and so corrupting that one psychiatrist says his fellows are “committing professional suicide.”

"How Hospitals Can Stop Killing So Many Patients" - On her Forbes column, Kare Anderson lays out some things that patients can do to avoid being harmed by the inefficiencies and patterns of overuse in American hospitals.

Health Wonk Review, October Surprise Edition - Finally, this week's Health Wonk Review has a whole slew of other posts worth reading. Check it out!

Longer Looks: The Time Is Now For Community Health Workers; Patients Sharing ... | News-Medical.Net

October 5, 2012

Here's the icing on the cake in terms of health care spending: Patients also tend to choose less invasive (and therefore less expensive) treatment options (Shannon Brownlee and Joe Colucci, 9/28). Earlier, related KHN story: Study: Decision Aids Show ...

Shared Decision-Making Leads to Better Health Outcomes, Lower Costs, Two Experts Say | MinnPost

October 1, 2012

“The habit of assuming the doctor knows best has created a system where huge numbers of patients aren’t getting the treatment they would have chosen if they were fully informed,” write the article’s authors, Shannon Brownlee and Joe Colucci of the New American Foundation.

Original article

The Cost of Assuming Doctors Know Best

  • By
  • Joe Colucci,
  • Shannon Brownlee,
  • New America Foundation
September 28, 2012 |

In most industries, quality-improving and cost-cutting innovations don't sit around for years while people keep muddling through with old technology. When an innovation is ready for widespread use, it disrupts the market, whether the market wants it or not. In the process, some entrepreneur usually makes a killing.

Tara Parker-Pope Highlights Overtreatment Harms

  • By
  • Joe Colucci
August 27, 2012
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Tara Parker-Pope, Well columnist for the New York Times website, highlighted overtreatment as a serious problem in a blog post yesterday. The post describes several people's direct experiences with unnecessary testing and treatment, and does a good job conveying the physical, emotional, and financial harm that comes from a disorganized system prone to overtreatment.

Overtreatment is a human issue, and reducing the personal harm it causes is at least as important as controlling healthcare spending growth. But healthcare spending is a crucial political issue, so it was smart to put the post on the Times's current campaign issues channel, The Agenda. Tackling overtreatment will be a defining issue of the next few years--either because we make crucial progress toward eliminating overse and reducing total medical spending, or because the next President ignores the problem while we continue on the ruinous path of letting healthcare strangle the rest of our economy.

Given the importance of the issue, though, I wish the post had looked a little bit closer at the policy issues involved. Most importantly, the post doesn't address the causes of overtreatment, including the financial incentives faced by clinicians and hospitals, lack of research on what treatments are effective, and physicians' failure to communicate to patients about their treatment options. The thing is, there are huge differences in policy between the two tickets on those issues. Since the post appeared on The Agenda, it could have done a lot more to point out those differences--like the fact that the ACA moves Medicare away from paying for the volume of services and toward rewarding higher-quality, more cost-effective care, or that it funds patient-centered outcomes research to determine which treatments actually work. On the other hand, Romney's running mate, Paul Ryan, recently parroted the absurd idea that IPAB is a "death panel," even though it is specifically prohibited from rationing care. That kind of rhetoric is hard to square with the notion that a Romney/Ryan administration would be willing to take any political risk to push back against unnecessary care.

Finally, on a related note, Dr. Aaron Carroll of The Incidental Economist has pulled together an incredibly useful set of politically difficult truths about reducing healthcare spending, in a set of posts titled "Why is this so hard to understand?" All of them are important and worth reading:

Part 1: When Medicare spending goes up, seniors’ premium costs go up.

Part 2: You can be for reducing Medicare spending, or you can be for increasing Medicare spending, but you can’t be for both.

Part 3: If you spend more on Medicare, someone has to pay for it.

Part 4: Don’t argue that reducing government involvement is the way to reduce spending.

Guest post on Delve Into '12!

  • By
  • Joe Colucci
August 17, 2012
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We don't often weigh in on electoral politcs here on New Health Dialogue, but the introduction of Paul Ryan into the race as Mitt Romney's running mate has distinctly shifted the focus of the debate onto Medicare, at least for the moment, and the editor of Delve Into '12, the New America campaign blog, asked for our thoughts.

You should definitely check out the full post (here) and the rest of their campaign commentary, but if you're short on time, here's an excerpt from the end of our post:

[...T]he Ryan budget slashes government healthcare spending, but it does relatively little to reduce total health spending. (In fact, if Ryan’s plan was implemented, it could reduce Medicare’s bargaining power and actually increase total spending.) While the ACA includes specific programs aimed at reducing waste (for instance by giving doctors incentives to reduce spending on ineffective treatments, funding research on which treatments actually benefit patients, and making it easier for cheaper generic drugs to get approved), the Ryan plan’s main savings mechanism is competition among private insurers. In theory, giving people a choice of insurer should reduce healthcare spending –people will choose plans that offer  better value, forcing inefficient plans out of the market. But competition among private insurers has failed to control spending in the private insurance market for decades, so some skepticism of its ability to rein in spending on the elderly is warranted. If that doesn’t actually work and total medical spending doesn’t go down, the Ryan budget saves money by shifting spending from the federal government to individuals.

Ultimately, the Ryan budget's laser-like focus on reducing the federal deficit has led to a glaring oversight in the proposal’s healthcare component. Policy should be focused on reducing total healthcare spending, including private insurance premiums and out-of-pocket payments, not just on reducing what the federal government spends. Healthcare spending has become a drag on the economy, accounting for up to two percentage points of unemployment—and that drag isn’t dependent on whether it’s funded by the government or the private sector. That’s the much more important challenge, and the Ryan budget ignores it completely.

Enjoy the weekend!

For Your Thursday Enjoyment: Health Wonk Review!

  • By
  • Joe Colucci
August 16, 2012
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Hosted this week by Dr. Jaan Sidorov at the Disease Management Care Blog, it's "A Brainy Health Wonk Review on Health Reform, the Affordable Care Act and Lots More!" Go check it out.

Health Wonk Review will be back on September 13th, hosted by Louise Norris of the Colorado Health Insurance Insider Blog.

Profile of Dr. Bernard Lown in the Boston Globe

  • By
  • Joe Colucci
July 31, 2012
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Boston Globe health reporter Chelsea Conaboy has a brief profile of Dr. Bernard Lown in the most recent edition of the Boston Globe Magazine. It covers some of the most important moments in a truly remarkable life, including our conference this April on Avoiding Avoidable Care. Check out the piece here.

If you haven't seen it yet, you can also read more by and about Dr. Lown at his blog.

The Bad Old Days

  • By
  • Joe Colucci
July 17, 2012
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Austin Frakt tweeted a news release from AcademyHealth this afternoon that brought painful flashbacks to the health policy world.

The House Appropriations Committee has released its proposed 2013 budget for the Departments of Labor, Health and Human Services and Education, in which it "terminates" the Agency for Healthcare Research and Quality (AHRQ). The budget proposal also cuts $150 million from PCORI's funding source, and prohibits any federal agency covered by the committee's jurisdiction from performing patient-centered outcomes research with other funds.

The proposal is, quite simply, insane. It's a direct attack on the only federal agency that produces research on the health care sector and the delivery system--research that is crucial to any effort to reduce unnecessary care, improve patient safety, and curb the increase in healthcare spending.

This budget marks a return to the bad old days, when Congress stood up against science and killed the Agency for Health Care Policy and Research. It's not clear whether this is just dangerous political posturing that will die on the House floor or in the Senate, or if it's dangerous political posturing that might actually pass, but either way we'll be watching the story and keeping you posted. In the meantime, The Incidental Economist is collecting stories about AHRQ funding of valuable (or not-so-valuable) projects.

This program has received funding from AHRQ in the past, including funding for the Avoiding Avoidable Care meeting. That funding has not colored our perspective on this--we would be ardent supporters of the Agency and of evidence-based medicine regardless.

12 Ways Health Care Could Be Improved If the House Wanted to Hold More Than Symbolic Votes

  • By
  • Shannon Brownlee,
  • Joe Colucci,
  • New America Foundation
July 12, 2012 |
It was Groundhog Day at the House of Representatives Wednesday as it once again voted to repeal Obamacare. All told, House Republicans have voted to repeal, defund or otherwise invalidate part of the Affordable Care Act between 31 and 33 times, depending on how you count.

Letting Big Pharma Review Its Own Drugs — What Could Go Wrong?

  • By
  • Shannon Brownlee,
  • Joe Colucci,
  • New America Foundation
July 11, 2012 |

 

Programs:

We need universal Phase IV clinical trials!

  • By
  • Joe Colucci
July 5, 2012
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PharmedOut, a project of the Georgetown University Medical Center, had its third annual conference a couple weeks ago in DC. The meeting was called “Missing The Target: When Practitioners Harm More Than Heal,” and it addressed some of the most important issues in health policy—issues that have been disturbingly absent from the public discussion. While the news media and members of Congress have spent the last several years discussing insurance coverage (or, more often, what the most recent vacuous coverage-related talking point means for the political horse race), issues of patient safety have been left on the sidelines. The PharmedOut meeting was a welcome opportunity to return to focusing on patients.

One of the most compelling moments came during Dr. Amy Friedman’s talk. Dr. Friedman is a transplant surgeon, and frequently speaks to groups of surgeons. She asks them a number of questions during these presentations—her favorite of which is “True or false: All medical devices used in the US have been proven safe and effective.” A large majority of the surgeons she talks to know that the answer is “true.”

The trouble is, of course, it’s not.

I can understand members of the public getting that wrong--after all, the Food and Drug Administration is responsible for making sure that all foods, cosmetics, pharmaceuticals, and medical devices are safe, and that the latter two are effective. But it's inexcusable for doctors to be so ignorant of the weaknesses in our regulatory system.The fact is, there are gaping holes in device approval processes, to the extent that many medical devices in use today have never been tested for effectiveness.

When the FDA started regulating medical devices in 1976, the agency established rules that assumed any device already in use was  safe and effective (unless it was already known not to be), and those devices continued to be sold. That grandfather clause included a number of basic and obviously safe devices, like tongue depressors and scissors, but it also covered higher-tech devices like the implantable pacemaker (invented 1958).

The FDA also waives testing requirements for "low or moderate risk” devices that are "substantially equivalent” to devices already on the market, in what’s known as the 510(k) process. For those devices, the device maker doesn't have to get approval from the FDA to sell it--they just have to give the FDA notification before they sell it. That means minor modifications to existing devices don’t require new clinical trials. When used intelligently, the rule is entirely appropriate--there's no need to redo clinical trials for small tweaks to products that can't affect the safety or effectiveness of the device. As the FDA has applied it, though, the 510(k) rule has become a giant loophole, and the vast majority (over 90%) of newly approved devices are approved through that pathway.

The problem is simple if you think of medical devices as undergoing evolution: each new device is slightly different from its parent (known as the "predicate" device). Once it's on the market, the modified device can be used as a predicate for another modification. Over time, compounding small changes can get you a tool or implant that bears no resemblance to the original device that actually went through clinical trials. Worse, some of the original predicates are those devices the FDA grandfathered in, and may never have gone through clinical trials.

The holes in the approval process have caused real harm. Take the example of metal-on-metal artificial hips: DePuy ASR hips were approved based on substantial equivalence to another hip with a metal head and a ceramic or polyethylene socket joint, so they were never tested prior to market. It was only after thousands of people received the hip that it became clear that the metal-on-metal joint was scraping off bits of cobalt-chromium alloy into patients’ bodies—and worse, the hips were failing early and often. If clinical trials had been conducted, thousands of patients might have been saved the pain and hassle of a failed hip and an extra operation to fix it.

There’s a better way to do device approvals—a middle ground between requiring randomized trials for every minute change in a device’s design and letting device manufacturers run completely free. We should be tracking what happens to patients after they receive new or experimental devices. We should develop a national, automated database that registers each patient who receives a recently-approved device, and monitor those patients for device-related complications for several years. During that time, all patients receiving the new device should be informed that their device is still semi-experimental, and that they are part of a Phase IV clinical trial to find out more about what the device actually does. If that information makes patients want to use older, better-understood devices, that's not a reason to claim regulations are holding back progress in medicine--it's giving patients complete information, and letting them choose the care they want. Forcing patients to use new, unproven devices (by failing to tell them about the experimental status) is no more ethical than denying patients new treatments in favor of old.

Tracking outcomes in a large-scale database works: a similar registry was a key part of the Australian research that discovered problems with DePuy hips. Reporting doesn't don’t have to be intrusive or an administrative burden, either. Wal-Mart and Amazon collect data on every transaction, every day, to better understand their customers and manage their inventory; customers hardly even notice. Even the data analysis can be largely automatic.

Tracking new, untested devices is a no-brainer. There are legitimate privacy concerns with such a database, but large datasets with  medical, personal, and financial information are routinely scrubbed so researchers can’t find private information about any individual. There’s no excuse for continuing to let Wal-Mart do better at understanding what affects its sales than researchers and doctors do at understanding how to make patients healthy.

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