Health Business Blog

I was puzzled by a Health Affairs article showing the public finds arguments against treatment guidelines a lot more compelling than arguments in favor. But after reading the technical appendix, which contains the full text of the survey, I think the problem is that the researchers framed the question poorly. In particular, the researchers portrayed guidelines as unrealistically rigid.

In A National Survey Reveals Public Skepticism About Research-Based Treatment Guidelines, Gerber et al. asked respondents to rate their level of agreement with arguments for and against the use of guidelines. Arguments for guidelines (in order of percentage of respondents finding them convincing) include:

• Doctors have economic incentives to provide inappropriate care
• Following guidelines will improve care for most patients
• Doctors don’t keep up with the literature
• Doctors are unaware of better approaches followed elsewhere

Con arguments (also ordered by percentage of respondents finding them convincing) are:

• No outside group should come between doctors and patients
• Doctors will be unable to tailor care to needs of individual patients
• Guidelines are vulnerable to abuse and corruption
• Payers will use guidelines to control costs and ration care
• Guidelines can’t keep up with pace of medical innovation

About half or more of respondents found the average “pro” argument convincing while close to 80 percent felt that way about the “con” arguments. That’s discouraging to people like me who think guidelines are useful. But what caught me by surprise is that even though most people were concerned that doctors provided inappropriate care due to economic incentives and that guidelines would improve care for most people, they came out so strongly in favor of preventing an “outside group” from issuing guidelines and were so concerned that guidelines would prevent tailoring.

However, once I read in the technical appendix how the question was posed I could understand the results. In fact I would have answered the “con” questions similarly to the typical respondent. Here’s the wording:

Some people have proposed establishing an outside group to develop national treatment guidelines based on the latest scientific evidence. Doctors would be required to follow these guidelines when they treat patients. The government and insurance companies would refuse to pay for any treatments not supported by the guidelines even if a doctor thinks this treatment is best for their patient.

The researchers themselves included the emphasis on the words “even if a doctor thinks this treatment is best for their patient.” Instead, I think the researchers should have replaced the italicized words with, “unless a physician documents why this treatment is best for their patient.” Payers do tend to base payments on adherence to guidelines, but there is generally a lot more wiggle room than the authors imply. The authors’ wording certainly explains why people would be convinced that doctors would not be able to tailor treatment!

What the researchers call “guidelines” are more like mandated treatment pathways.

More appropriate wording about guidelines would probably shift results toward the “for” arguments.

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Among the many compromises in the Patient Protection and Accountable Care Act (PPACA) is the prohibition against using quality-adjusted life years (QALYs) for coverage, reimbursement or incentive programs. The idea, presumably, is to repel the suggestion that PPACA enables “rationing” or death panels.

Yet, as comparative effectiveness researchers Peter Neumann and Milton Weinstein argue in the New England Journal of Medicine (Legislating Against Use of Cost-Effectiveness Information):

At a time when health care costs loom as the greatest challenge facing our country’s well-being, legislating against the use of the standard metric in the field of cost-effectiveness analysis is regrettable.

I agree with them on this.

The authors put forward multiple arguments in favor of QALYs:

• They provide a way to make apples-to-apples comparisons across disease categories and to ascertain the effectiveness of both treatment and prevention
• QALYs are used worldwide, including by US government agencies –because they are useful
• Medical societies use QALYs in support of clinical guidelines
• QALYs aren’t perfect, but they are an important input for decision making

They also take issue with some of the attacks on QALYs:

• Although detractors argue that using QALYs would discriminate against the old and disabled (that’s the death panel paranoia) it’s not really a fair point. First, those with greater impairment typically fare well in a QALY regime, since they have more to gain from effective interventions than healthy people. Also, it’s very reasonable to evaluate medical spending against the objective of a longer, healthier life. Do we really want to argue that extending the life of a 100 year old in a coma has the same value as curing a child of leukemia?
• Those who attack QALYs engage in “magical thinking” that we can avoid tradeoffs and resource constraints

To me the “magical thinking” point best describes what’s going on in this country, with health care and politics in general. It’s time to face up to runaway health care costs, but if we insist on ignoring data and banning the use of valuable measures we’ll never get there.

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This is the transcript of my recent podcast interview with eHealth Initiative CEO Jennifer Covich Bordenick.

David Williams: This is David E. Williams, co-founder of MedPharma Partners and author of the Health Business Blog.  I’m speaking today with Jennifer Covich, CEO of the eHealth Initiative.  Last month the organization released a benchmarking survey of Regional Extension Centers in partnership with MedPlus, the health IT subsidiary of Quest Diagnostics.

Jen, thanks for joining me today.

Jennifer Covich Bordenick:    Thanks so much David for having me.

Williams:    Please start off by explaining what Regional Extension Centers are and what role they’re supposed to play.

Covich:    The Regional Extension Centers –or RECs– were created through the HITECH Act, which is designed to promote Meaningful Use of health information technology. The RECs are supposed to help doctors implement EHRs.  They are consultants to the providers in the field and are expected to accelerate adoption.

Williams:    What were your objectives in conducting the recent survey?

Covich:    Because the program is new, we wanted to take the temperature of these organizations.  The government has never done anything like this before and we wanted to conduct a baseline survey to understand how far along these groups were and what their plans were. We intend to repeat the survey later this year to assess how far the RECs have come.

Williams:    You refer to it as a baseline survey, which is fair because the RECs are just getting started.  On the other hand they have a pretty short fuse and I’m curious about how much progress the RECs had made even after just a few months in operation.

Covich:    We did the survey this summer, and honestly they were just in the planning stages.  It did not surprise us that they hadn’t made significant progress.  Many had just been formed and had not made a lot of progress getting out in the field; most had not signed on providers yet.  They were just organizing and figuring out their model.

Williams:    Do you have a specific time frame in mind for the follow up?  Are you already starting to collect information?

Covich:    We want to do it about every six months so plan another reading this year and then again in the spring.
We just came back from a conference on the West Coast with a number of RECs. From the conversations and anecdotal evidence it sounds like they’ve made some more progress in the last three months.

Williams:    The RECs have funding from the federal government for a while but then they fairly quickly have to get their own funding. How do RECs plan to sustain themselves once that initial funding dries up?

Covich:    We asked the RECs what type of business model they were considering. About half said they were looking at subscription models or membership models.  So a physician would pay an annual fee to get services.  Others planned to serve as consultants and charge by the hour on an as-needed basis. Some others were looking to have a flat fee that a physician would pay just once to get assistance. Those were the three types of models we saw.

Williams:    How viable are those sustainability models likely to be?

Covich:    It’s going to be tough. There is a lot of competition in the market with many vendors and consultants out there.  The RECs are supposed to go out and help small practices get started, help them adopt and guide them.  So the RECs have a specific mission. It’s less of a business mission and more of a goal for them to get into the small offices with the rural providers and help those who lack the means to do this themselves.  They have a very specific population that they’re supposed to go after.

It’s going to be tough to find a financially viable business model with these groups. There is so much competition and some of the clients they serve don’t have a significant amount of funding. It will be interesting to watch over the next couple of years how this rolls out.

Williams:    There was another entity established under HITECH, called the Health Information Technology Resource Center –or HITRC. What is the HITRC and what role does it play with the RECs?

Covich:    The HITRC is the clearinghouse to support the dozens of RECs around the country. The HITRC’s job is to disseminate materials and share best practices in EHR adoption, meaningful use, and provider support.  It’s a mechanism for the RECs to learn from each other. The HITRC is supposed to be a learning center where the RECs come together, share ideas and support each other.

The HITRC is a group of contractors that ONC brought on board to provide educational services and technical assistance to the RECs.

Williams:    Beyond the HITRC, how are the RECs working with other entities including other ARRA-funded groups such as statewide health information exchanges?

Covich:    They’re going to have to work closely with the state designated entities (SDEs_ that are charged with doing health information exchange.  It’s going to be critical that the RECs coordinate closely with the SDEs.

(I apologize for all the acronyms here!)

A little bit further down the road Meaningful Use will require health information exchange.  Doctors will have to be set up in their offices to do some health information exchange and the RECs will have to help with that. This will tie directly to the work of the SDE. Therefore it’s critical that those groups work closely together, and that their goals and efforts are aligned.

Williams:    All this talk is a bit wonkish. However, I know that the objective of the funding and also a role that your group plays is to try to make sure that patients see some benefit at some point.

From the work the RECs are doing, what benefits are patients likely to see and when?

Covich:    That’s a really important point, because this is ultimately about the patient. Once you get past all the policy, wonkishness, regulations, rules and acronyms, this is about helping the patient at the point of care and ensuring that patients and providers have the information they need.  It means when I take my daughter to the pediatrician they have the lab results, and that the immunization results are put into the system right away and show up across town at the clinic.  It’s about connecting organizations to help patients. We can’t lose sight of that.

There is a tendency for folks to get all caught up in contracting and agreements and rules and stages, but we really need to focus on the fact that this about improving patient care.

Williams:    I’ve been speaking today with Jennifer Covich, CEO of the eHealth Initiative. We’ve been talking about a recent benchmarking survey on Regional Extension Centers.  Jen, thanks so much for your time.

Covich:    Sure, thanks David.

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Regional Extension Centers (RECs) are charged with helping physicians achieve “meaningful use” of electronic health records in time to receive federal incentives under ARRA. Recently the eHealth Initiative and MedPlus (the health IT subsidiary of Quest Diagnostics) released a benchmarking survey to provide a snapshot of the progress the RECs are making in their first few months of operation.

In this podcast interview, eHealth Initiative CEO Jennifer Covich Bordenick explains what RECs are and shares survey findings about their progress to-date, how RECs expect to sustain their operations after federal funding dries up, how RECs are working with other entities such as health information exchanges and the Health IT Resource Center, and what benefits patients can expect.

The survey results are available here.

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This is the transcript of my recent podcast interview with NEHI Executive Director Valerie Fleishman.

David Williams:            This is David E. Williams, co-founder of MedPharma Partners and author of the Health Business blog.  I’m speaking today with Valerie Fleishman.  She is Executive Director of the New England Health Care Institute sometimes known as NEHI.  NEHI recently released an issue brief called From Evidence to Practice, Making Comparative Effectiveness Research Findings Work for Providers and Patients and we’ll be talking about that today.  Valerie, it’s nice to have you with me.

Valerie Fleishman:            Thanks David.

Williams:            Before we dig into the details, can you explain what comparative effectiveness research (CER) is?

Fleishman:            At its most basic level, comparative effectiveness research is about finding out what works in medicine and health care.  Its fundamental goal is to assist consumers, patients, clinicians and others to make more informed decisions at the point of care. The new federally funded comparative effectiveness research is set up to look at very broad areas of the health care system.  It’s set up to compare different drugs, to compare different medical devices, tests, surgeries or even whole ways of delivering health care.

Williams:            You alluded to the fact that there are some provisions on comparative effectiveness research in the Affordable Care Act (ACA).  How does the Affordable Care Act address comparative effectiveness?

Fleishman:            Comparative effectiveness research was first established as part of the Recovery Act in 2009 as part of the stimulus legislation. That legislation had in it a $1.1 billion investment for comparative effectiveness research and laid the foundation for what appeared in the Affordable Care Act in March. There are several relevant provisions in the Affordable Care Act:

One, it establishes a non-profit corporation called the Patient Centered Outcomes Research Institute (PCORI).  That institute is set up as a non-governmental, private entity to oversee the federally funded investment that we’re making in comparative effectiveness research. The ACA says that the institute will identify priorities for comparative effectiveness research, will help to carry out the research agenda, create advisory panels, establish peer review processes, and will also in part be responsible for releasing the research findings and coordinating the research that gets done.

Another ACA provision –and something discussed in all debates on CER– is the importance of transparency and patient protections.  Transparency includes how the research is done, what the methodologies are used and what the results are.

On the patient protection side there have been concerns about how well comparative effectiveness research will identify outcomes in different sub populations.  So a provision in ACA specifies that comparative effectiveness research must take into account different subpopulations to avoid one-size-fits-all results.

It also talks about how none of the reports or findings can be used as mandates, guidelines or policy recommendations and that the findings cannot be used as sole evidence in making determination decisions.

Third, it sets up really a trust fund so comparative effectiveness research can be funded on an ongoing basis. The $1.1 billion put in as part of the stimulus was really just for the first couple of years. The trust fund creates a pool of funding of about $600 million per year from both the Medicare trust and a fee on health plans.

Williams:            What impact will patients and physicians feel at the point of care? How soon we might see some impact?

Fleishman:            Great question.  It’s certainly going to take a while. If history is any guide, unless we really change how we get this information into patients’ and clinicians’ hands faster it, in many cases will take a long time.  The IOM has shown that it can take as many as 17 years to get evidence based medicine into clinical practice. Frankly today, even under the best of circumstances, it’s virtually impossible for patients –unless they’re reading The New England Journal of Medicine or JAMA or certain Internet resources– to get access to the best clinical information, particularly in a way that’s digestible.

Williams:            There’s a lot of controversy about the use of comparative effectiveness research and whether it’s actually some kind of a code for rationing or other things that would be negative for the patient.

Fleishman:            That certainly was the focus during the initial debate on comparative effectiveness research when it was part of or being considered as part of the stimulus bill. I think there are some valid concerns. There has been a fair bit of backlash against  the terminology or the concept of evidence based medicine. People fear that it might mean cookbook medicine; that my doctor won’t be able to select the right treatment for me but will give me what works for everybody else, which may not be the best decision for me.

Second, there is this concern based on what we’ve seen it happen in other countries that comparative effectiveness research could be used for cost reduction purposes and rationing.  That has been part of the debate.  It’s why this $1.1 billion in the stimulus bill probably got more attention than almost anything else in the legislation even though it was a tiny, tiny fraction of the total investment in the bill. That’s why in the legislation establishing the Patient Centered Outcomes Research Institute there has been very explicit language that these studies cannot be used to change Medicare decisions.

Williams:            You talked earlier about the IOM findings about how long dissemination of new information takes in the medical profession. Are any things in place now that might accelerate that adoption? In particular what about health information technology?

Fleishman:            There is an enormous opportunity, particularly when you look at the definition of meaningful use and you think about the computerized physician order entry systems and others that will be part of this. Meaningful use clearly stipulates that these systems have to have some form of clinical decision support. One of the hurdles to adoption for CER is that clinicians themselves don’t have ready access to the latest information on what the evidence says about different forms of treatments or procedures. Providing the information technology infrastructure and tools to clinicians at the point of care so they can have access to the data will go a long way toward making the data accessible.

But technology is really only one of the hurdles. Even if physicians have access to the data, it may not necessarily change behavior.

Williams:            I’ve been speaking today with Valerie Fleishman, Executive Director of the New England Health Care Institute about comparative effectiveness research.  Valerie, thanks for your time today.

Fleishman:            Thanks so much David.

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The New England Healthcare Institute (NEHI) recently released From Evidence to Practice: Making CER Findings Work for Providers and Patients, an issue brief focused on outlining a robust dissemination strategy for comparative effectiveness research (CER).

In this podcast interview, NEHI Executive Director Valerie Fleishman explains CER, describes the CER provisions contained in ARRA and the Affordable Care Act, and discusses the challenges involved in disseminating CER information and affecting clinical practice.

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NEHI Exec Director discusses comparative effectiveness [ 13:11 ] Play Now | Play in Popup | Download

Nice day for apple picking. May or may not get around to blogging.

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The Hospitalist hosts a debate on whether or not doctors should interact with and accept gifts from pharmaceutical reps.

On the “con” side, Dr. O’Neil Pyke argues that samples and free lunches affect physician decisions:

Let’s not kid ourselves: There is a good reason the pharmaceutical industry spends more than $12 billion per year on marketing to doctors. In 2006, Rep. Henry Waxman (D-Calif.) said, “It is obvious that drug companies provide these free lunches so their sales reps can get the doctor’s ear and influence the prescribing practices.” Most doctors would never admit any such influence. It would be, however, disingenuous for any practicing physician to say there is none.

On the “pro” side, Dr. Dawn Brezina says:

Although pharmaceutical representatives brief physicians on new medications in an effort to encourage the use of their brand-name products, they also provide substantive information on the drugs that serves an educational purpose.

The Aristotelian Golden Mean is superior to extreme positions, and I submit that the best road is the center. Listen to what the drug company representatives have to say, just like you listen to a car salesman: You can learn from both—as long as you research the data and form your own opinion.

I see the merit of both arguments but tend somewhat toward the “con.” On the “con” side it’s certainly the case that drug companies successfully influence physician behavior. Physicians also underestimate or dismiss the extent that they are influenced, including by small gifts.

On the “pro” side I agree that reps may have something to offer and that it’s safe to consume if docs do their own research. Unfortunately it’s too easy not to bother.

My proposal is as follows: physicians should take a course in how drug companies establish their sales and marketing budgets, how they evaluate the success of their spending, and how they compensate their reps. After that they should feel free to see reps if they still think it’s a good idea.

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The Forum for Collaborative HIV Research and the HIV Medicine Association seek nominations for five minority clinicians working in underserved settings. Winners will attend the November 2010 National Summit on HIV Diagnosis, Prevention and Access to Care in Washington, DC as award recipients.

Nominees should be physicians, nurses or physician assistants whose attendance will contribute to the mission of the Summit and who stand to benefit by attending.

The Summit’s mission is to address and support the continued implementation of CDC’s recommendations for increased HIV testing and to further identify and build upon strategies for HIV diagnosis, prevention, linkage to and retention in care. The objective is to highlight the progress made in the four years since the recommendations were released and plan how to move from pilot and demonstration projects to sustainable programs.

If you wish to nominate someone, please provide the following information to Ben Hauschild from the Forum for Collaborative HIV research via email by Monday, October 11.

• Nominee’s first and last name
• Degrees
• Position
• Contact information
• Affiliation (organization or program)
• How the nominee’s participation would contribute to the Summit
• How the nominee would benefit from participating in the Summit

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Cincinnati Children’s Hospital has demonstrated an ability to reduce the use of CT scans in kids with traumatic brain injury, which reduces costs, shortens length of stay, cuts radiation exposure and associated cancer risk. From AuntMinnie (Head CT frequency, costs drop for kids after rule change):

“We got them out of the hospital faster, reduced their radiation dose and therefore their cancer risk, and saved money all at the same time while making the parents happier and less frustrated — and, most importantly, not missing any injuries or not having any kids come back because we didn’t scan them,” [Prinicipal Investigator Dr. Richard] Falcone said.

The change affected kids with traumatic brain injury who received a first CT scan and then were admitted to the hospital. Under the new guideline, kids with a rating of 13 to 15 on the Glasgow coma scale were allowed to skip the second scan. Before implementation of the guideline, average length of stay was 2.3 days with 1.6 CT scans and $24,000 of hospital charges. Post-guideline implementation length of stay dropped to 1.7 days, CT scans went down to 1.3 and charges fell to $14,000.

“We got them out of the hospital faster, reduced their radiation dose and therefore their cancer risk, and saved money all at the same time while making the parents happier and less frustrated — and, most importantly, not missing any injuries or not having any kids come back because we didn’t scan them,” Falcone said.

“It raises the question, at least, that maybe there can be still fewer scans and we can reduce them even further,” he said. “It’s really a small minority of kids that need this repeat scan, and our feeling is that there’s still maybe too many kids getting a scan.”

The US health care system generally works against these sorts of changes. Fewer scans often mean less revenue for the provider organization, doctors order extra scans as part of defensive medicine –or so we’re told– and the ideologues would call this rationing. Yet we need these sort of changes for the health care system to survive and thrive. Let’s hope that evidence based medicine, comparative effectiveness research, patient safety, and accountability all increase. If so we can expect to see more improvements like this one.

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