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Effective Health Care Program Listening Session: Transcript (continued)

Dr. Straube

Sue, thank you very much. Great comments. We now have a question here in the room.

Ms. Lee

Good morning. My name is Teresa Lee, and I'm here on behalf of AdvaMed, the Advanced Medical Technology Association. AdvaMed is a trade association that represents the medical device industry, and our members include more than 1,300 medical technology manufacturers of all sizes. We appreciate that HHS has held this forum today. We at AdvaMed have been closely following AHRQ's efforts to implement section 1013 of the MMA. And we've seen a good deal of activity on this Effective Health Care Program from priority setting, to comparative effectiveness reviews, to evidence generation, to communications of research findings, all in a remarkably short time frame. We've noted the sheer volume of activity that has taken place in a remarkably short period of time. Overall we support comparative effectiveness research when it is done appropriately because it can provide valuable information for patients and physicians.

However, we believe that comparative effectiveness research is not generally appropriate for the use in the context it covers decisionmaking because the treatment that is more effective on average may not necessarily be best for a particular patient. We believe that it is critical to protect the physician's ability to make independent medical judgments for individual patients. For medical devices in particular, comparative effectiveness research poses distinct challenges. For example, medical device technologies pose a difficult moving target for technology assessors due to the iterative and continuous nature of device innovation. Medical devices have quite short life cycles compared to drugs, and their effectiveness is dependent on user training and physician experience. In studying medical devices, assessment findings can quickly become dated as the technology matures and physicians gain user experience and training. Consequently, a snapshot of comparative effectiveness of a particular device at a specific point in time may potentially understate the effectiveness of an innovation.

Today I have some very brief comments concerning the work that is currently underway. First, the priorities you've established through listening sessions and public comments are ambitious. We tend to think that if they are to be expanded, you might also address areas where there is underuse of proven interventions that would improve the effectiveness and efficiency of the Medicare and Medicaid programs which is the statutory mandate, statutory goals section 1013. We note that evidence-based practice requires practitioners to not only avoid the overuse of ineffective care, but also the underuse of effective care. In addition, we note that section 1013 requires research on improving the efficiency and effectiveness of Medicare and Medicaid through the examination of ways items and services are organized, managed, and delivered under these programs. And to date, AHRQ has not yet addressed these priorities.

In addition, we've noted that AHRQ has undertaken a number of specific research endeavors and we commend the extensive outreach efforts via the Effective Health Care Program Web site. However, in comparative effectiveness reviews and with respect to evidence generation, we note that the initial set of specific research topics were not vetted publicly. And while we believe this was due to AHRQ's desire to move quickly to implement section 1013, we think that the law's requirement for broad and ongoing consultation with stakeholders is equally important. Our concern is that these specific initiatives need to be discussed as fully as the broad research priority. For the research efforts already underway, where those topics were not openly vetted, we believe those efforts should be made to extend-efforts should be made to extend the comment period on studies as they are prepared. We also think that the times allotted for public comment on draft studies seem to be a little bit short, and that this may potentially impact the quality of the public comment.

We also want to commend AHRQ for its efforts for communicating clearly and fairly the findings of its comparative effectiveness reviews to date. We understand the importance that the agency is placing on this matter, and the results to date are commendable. We have some concern, however, with how the evidence generation efforts AHRQ is undertaking as part of the Effective Health Care Program will be handled. Our concerns do not relate to the research on the methods that are underway, but rather to the collection of observational data on particular interventions. The rationale for selecting and prioritizing the current efforts is unclear, and we think that this should be made available to stakeholders. We also think that this data, due to its observational nature, needs to be weighed carefully and should not simply be posted. We at AdvaMed appreciate this opportunity to comment on this important program. Thank you.

Dr. Straube

Teresa, thank you very much. Some very good comments. I'll take the opportunity to put a plug in again for, the Web site, because I do think again some of what you mentioned can be partially dealt with if people in between times go to that Web site and make comments on any topic. But I think your comments are well taken. We're going to go here in the room.

Ms. Shearer

Thank you. My name is Gail Shearer, and I'm from Consumer's Union. I'm the director of health policy analysis at Consumer's Union, and the director of our effort to translate evidence based medicine on behalf of consumers which is called Consumer Reports Best Buy Drugs. I'd like to start by commending you on your strong start in implementing section 1013 of the MMA. As you know, the initial funding was a small down payment in light of the scope of the task ahead, and we commend you for making the most of this early funding.

I'll briefly address some findings from work that we have done that demonstrate why the work that you are doing is so important for both the health and the pocketbook of the nation's consumers and taxpayers. Our project at Best Buy Drugs launched in December of 2004. We launched with three categories. We're now up to ten categories where we look at the comparative effectiveness and the comparative cost effectiveness of drugs in ten very common categories: high cholesterol, high blood pressure, arthritis pain, acid reflux disease, depression, menopause, allergies for example. Our task is to translate complex systematic reviews of the clinical evidence of effectiveness for consumers and their doctors so that they can put the findings to work for them in the selection of drugs. We've also translated our short reports into Spanish. We've prepared print materials, two-page and twelve-page booklets, in our effort to get the word out to consumers. During the month of December, we had about 150,000 visits to our site, and about 65,000 downloads from our sites, and about 65,000 downloads of our reports. So as you can see, we're getting some traction, but we're still at the beginning. And we realize that we need to focus on the challenge, as you will when your reports are completed, as how to get this important money saving and health improving information into the hands of consumers. And we look forward to working with you on that challenge.

I wanted to talk a little bit about two lessons, two key things that we've learned. First is that we can have a major health impact. This kind of information can have a major health impact. Just looking at one of the categories which turns out is the category that is most often downloaded. It's the most interest of consumers, and that is cholesterol reducing drugs or statins. In our analysis, we found that if a person needs a modest reduction in their cholesterol, they had a variety of drug choices that were equally effective in meeting their cholesterol-reducing goal. One of them, generic Lovastatin, was available at a cost of about $1 a day. Many people who need modest reduction in their cholesterol are actually spending about $5 a day. Well, in this nation we have tens of millions of people who cannot afford their statins, and if we can get this word out about equal effectiveness of drugs and help people have access to drugs at an affordable amount of money, I think that we can have a dramatic effect on health care in this country.

A second major lesson and it has to do with the potential to save taxpayers and consumers billions of dollars. Today we are releasing an update of our statin report. We've updated the clinical effectiveness information and the drugs that are available, and the price information for the cholesterol-reducing category. But we're also releasing an analysis of developments in the market place, the sales of various statins and the price over time. But what we've done today is we've done an estimate of what's at stake as we turn to a new Medicare benefit. What's at stake for taxpayers and consumers when the generic of Zocor, simvastatin becomes available in June of 2006? Our findings were very dramatic. A lot of money is at stake. We estimate that if people switch from the high priced brand drugs to generic Zocor, simvastatin when it is available, that nationwide in the year 2007 the potential savings are on the order of $8 billion a year. Now as we all know, not everybody is going to switch for one reason or another, but it's important to understand the scope of money that is at stake. And this is just for one widely used drug category. Access to information that educates the public that the lower cost drug is as effective as the higher cost drug is essential to achieving these savings.

Turning to some comments on your research priorities. In May of 2004, your first listening session, we urged you to select as priorities therapeutic categories that have a broad impact on consumers, in particular categories that include expensive drugs that are used by a large number of people. We commend your initial selection of priority areas including arthritis, cancer, diabetes, asthma, and peptic ulcer disease. We note that we have selected many of these categories as well, and the key factors in our choice of categories was both the high incidence of these diseases and the existence of drug effectiveness review projects, systematic review of the clinical evidence. And of course, our main source of information, clinical effectiveness, is the OHSU-based drug effectiveness review project. We believe that your first report provides valuable information to patients with GERD. One key task, of course, is to ensure that this valuable information gets put to use by practitioners and gets into the hands of patients. And we plan to incorporate your findings in our next update of drugs in this category. As you shape your priorities for the next year to expand to conditions of Medicaid and SCHIP, we urge you to once again focus on conditions that affect a lot of people and where there are real differences in treatment options. Some of the studies already underway will be valuable for these populations, but we also would suggest that you consider studies in the area of ADHD, asthma, obesity, and AIDS. We think they could be very valuable for these populations. Again, one of the considerations for you should be whether there is a credible database of information about treatment alternatives such as DERP or the UK-based National Institute of Clinical Health and Effectiveness, or the Cochran Collaboration. We appreciate the opportunity to provide comments, and we look forward to advancing our shared goal of providing the public with credible information about the comparative effectiveness of alternative medical treatment. Evidence based consumer friendly information is needed in the marketplace to help consumers and taxpayers get better value for their health care dollar. Thank you.

Dr. Straube

Gail, thanks very much. We have another question here in the room.

Mr. Shaw

Good morning. I'm John Shaw, and I'm a health systems engineer, and I'm with Next Wave in Albany, New York. And I wanted to suggest two priorities, one a methodology priority and the second a topic priority. And it's related to several of the other comments.

The first thing is the Institute of Medicine wrote an order in one of their recent reports. The order is for partnering with health systems engineers. And health systems engineers are focused on addressing the issues in that 45 percent that we're not doing yet. And the clinical area that I wanted to focus on is also a problem and issue in the Medicaid population and that's pediatric asthma. I'm also a parent of asthmatic children. I spent six years on the board of directors of the American Lung Association in New York, and I'm currently the board president for the Healthy Schools Network where asthma is one of the major health issues for children in schools.

And let me try to tie those two together and see how it might help. Dr. Clancy mentioned that getting the question right is a big part of the process. That's what the system engineers are taught to do. So we're going to collect everything like you say and see what's out there currently, but then we go a little step further. We're sometimes accused of over specifying what it is we're looking at. So we take the traditional description that we get from the literature, and then we try to get inside it. And getting inside it, we go talk to the patient, we talk to and perhaps follow around the sharp end care givers. Those that are actually providing care to the people who are receiving the care. And that gives us a better perspective on issues that may be missed otherwise. And if we're talking about getting care to the consumers, that's a big part of it. We're also taught to look beyond the normal definition of the problem, to look at the environmental construct, to look at things that may have a big impact on the problem that are beyond the direct definition of the solution. And lastly, we're taught to look at materiality, to constantly throughout the process make sure we're focused on important parts.

So let me apply that to pediatric asthma. If we look at Eddy, Eddy is a first grader who depends on Medicaid or SCHIP for controlling his asthma. The traditional view of asthma is the chronic disease that requires close monitoring to keep it under control. Eddy can't do it himself. He requires caregivers to do it, which is typically his parents. So we're focused on making sure they know how to do it. But Eddy, right now as we speak, is in the school yard, in the school, looking at his friends kicking up the dust, looking at the school buses idling over here, looking at the construction over there, and environmental factors are a big part of triggering or exacerbating asthma. If we look at the medical solutions, including an AHRQ report released just a few months ago, looking at suggestions for improvement, from my perspective I looked at it. There was no recognition of school environment or caregivers. Applying materiality to that, here are half of the caregivers that are monitoring my child's condition and the environment where they are spending a third of their time is missing. So that's part of what incorporating systems engineering can do. If anyone is interested in going into that further, a mile down E Street, the Healthy Schools Network is meeting with its national coalition members, talking about how to integrate health care, education, and the environment and looking at the total picture from the perspective of my child. Thank you.

Dr. Straube

Thank you. Interesting perspective. I think we're going to go to the phone lines for one or more questions.


Okay. Our next question comes from Kathleen Weaver. Please state your organization.

Dr. Weaver

This is Dr. Kathleen Weaver from Oregon Health Policy and Research. I'm the director for the health resource commission there, has been working with Oregon Health Sciences University Evidence Based Practice Center for the past four years. And we've done 16 comparative drug studies and have 6 new ones that are underway. We've had a tremendous experience in working with this drug evaluation review project, or DERP as it was mentioned by Gail Shearer from Consumer Union. And they're now working with the DERP. The DERP is a combination of 15 different Medicaid States and COTA, which is the Center for Evaluation of Technology from Canada, which allows different Medicaid States to pool their resources to buy these particular reports. We found that having the ability to be in on developing the key questions is so important because if you don't ask the right questions, you don't get the right answers. And also, the ability to comment on draft reports. What I think you're going to find is, from AHRQ's standpoint is, that when your reports when finalized are going to be utilized a lot more because people have access to be participating early on.

The health resource commission is now expanding and going on to look at things outside of drug comparison things. And one of the ones that was mentioned already we applied if you would go in this direction is the treatment of obesity, the surgical versus non-surgical treatment. In that case, it leased a preliminary check of the type of systematic reviews. There's almost an excessive amount of literature so we'll help to sort through this. One of the other areas we're looking at is in the area of chemical dependency. And I would hope that perhaps maybe this could be added to the list of things that you look at. Specifically, methamphetamine use which is on the West Coast a huge problem. In this case, preliminary look shows that there's not-there's minimal literature or systematic reviews. So perhaps doing this one would then point towards gaps in the research where things need to be done. Also, I would like to commend the new areas that are key questions that were just recently posted. We particularly are excited about the comparison with ACE versus ARBs because although we compare drugs within a class, we've not compared different classes. So this would be helpful for us. Also, we've not taken on combination drugs such as the lipid-lowering, where you're going to look at a combination of drugs. And we welcome your looking at stents versus CABG and the effectiveness of Alzheimer's drugs. People probably know in Britain these are usually not considered effective at this point. So anyway, we think it's a great process, and we look forward to working with you. Thank you.

Dr. Straube

Thanks very much for your comments. We'll go back to the room here.

Ms. Weber

Good morning. My name is Jennifer Weber, and I'm the Manager of National Nutrition Policy for the American Dietetic Association. I'm also a registered dietician and a public health specialist. The American Dietetic Association represents 65,000 food and nutrition professionals and is guided by philosophy based on sound science and evidence based practice. We've already cited the Washington Post as a scientific resource today so I'm going to point you all to the New York Times. For those of you who read the New York Times on Monday, you saw a compelling story about the impact of diabetes on individuals and communities. It's a crime. Little did I know that today's New York Times would be an exclamation point on my comments.

Diabetes is a disease where food and activity habits can be both preventive and treatment. For those with diabetes, research documents the value of nutrition services and the management of the disease. Persons who receive medical nutrition therapy, or MNT, services are likely to require fewer hospitalizations and medications, and have reduced incidence of complications. Not only is the person's quality of life enhanced, but additional costs from complications are cost to taxpayers. Diabetes is a research priority for the effective health care program, but AHRQ has yet to identify the priority and evaluate the behavioral aspects of diabetes prevention and treatment under section 1013. Furthermore, it has not been looked at the role of nutrition and activity lifestyle modification when drugs are taken. Without including these lifestyle modifications, the comparative effectiveness of different medical interventions cannot be fully assessed. We know that diet and activity are safe, work, and cost effective, but most people don't know how to implement, or do not have the resources needed to help implement lifestyle changes. And apparently, according to today's New York Times, no financial incentive. Look at the photos and read the New York Times articles. It is evident that drug intervention alone is doomed to fail. It is access to preventive care and disease management that matters.

We believe that MNT, a proven cost effective intervention for diabetes, is an underutilized service which may significantly improve the prevention and treatment of diabetes. The underutilization of MNT can be attributed in part to the fact that the service is not well known or understood, and that it's not universally covered outside the Medicare program. AHRQ can help consumers, health care providers, and others make informed choices among treatment options, including MNT, by including lifestyle modification in the Effective Health Care Program. Making lifestyle modification in diabetes a research priority under section 1013 would go a long way towards shaping policy that supports a healthier nation.

Dr. Straube

Thank you for those comments. Appreciate that. We'll take another question here in the room.

Dr. Anderson

Good morning and thank you for taking my comments. My name is Dr. Carol Anderson and I'm a legislative fellow with the American Dental Education Association. We're pleased to offer comments on your priorities for research under the AHRQ Effective Health Care Program. As you know, dental services are a small part of the Federal Medicaid and SCHIP budget, but these services are a continual target for cuts. Cuts that have an immediate and devastating effect on our most vulnerable citizens, and have long lasting consequences. The challenge to provide dental services to the underserved will only be exacerbated as the health care programs face further budgetary restrictions.

Recognizing the challenges faced by dental professionals in providing care to Medicaid and SCHIP beneficiaries, ADEA strongly encourages AHRQ to consider the following dental health services research areas as priorities and strongly urges you to incorporate dental considerations into current and planned projects.

Number one, an evaluation and comparison of state based dental Medicaid innovations that have sought to increase dentist participation and increase utilization of services by mirroring such programs within the commercial dental benefit sector. Two states have reformed their Medicaid program by contracting with a single vendor to administer the dental program the same way they administer the private insurance program. At least four other states have established unique programs to address barriers that dentists and communities have identified within the program, namely inadequate reimbursement, administrative complexities, high appointment failure rates, and lack of oral health literacy in the patient population. Many other states have attempted program reform with little to no success. And this is believed to be a result of focusing a limited programmatic reform as opposed to a comprehensive reform approach.

Number two, studies on the effect of incentives such as state tax credit, loan repayment, and scholarships increasing dentist participation in Medicaid and SCHIP. Several Federal and State programs have used the strategy to improve the distribution of dentists within states and communities, and increase services. Such an evaluation would assist in determining whether these incentives are cost effective and do improve recruitment and retention of dental providers within public programs. Number three, an examination of whether a correlation exists between graduation indebtedness of dentists and their participation in Medicaid and SCHIP. Dentists are small business owners and practices differ from medical practices with much higher overhead costs. Past reports by Health and Human Services' Office of the Inspector General and the U.S. General Accounting Office have indicated that there are limitations-that one limitation to dentist participation in public programs is inadequate reimbursement. And we need further research to determine how to develop a balance between the two. ADEA appreciates AHRQ's consideration of our comments. Thank you very much.

Dr. Straube

Thank you for those comments. I think we'll go to the phone line for the next question, please.


Our next question comes from Lawrence Brown. Please state your organization.

Dr. Brown

Hi. This is Dr. Lawrence Brown. I'm an assistant professor at the University of Tennessee Health Science Center in Memphis. And one of the things that I'd like to put forward as a focus area and it's been alluded to a couple of times and that is the fact that medication alone, although it's very beneficial, it's the appropriate use of medications that really needs to be primary focus. And within the final role of CMS's final role, they mentioned that they felt that MTM programs, the medication therapy management programs, would become a real cornerstone of the Medicare program because again, getting seniors medications without making sure they have programs that get them to use them appropriately, especially those with multiple chronic conditions and multiple medications, a lot of seniors are having tough times managing their medications.

And now that they have access to them, I really think the medication therapy management programs will be very important. Having said that, in terms of specific areas of research, it will be really important to know which models of medication therapy management programs really have the best quality and best outcomes. For instance, many of the PDPs, and MAPDs have in-house medication therapy management programs where they may have pharmacists in-house to provide the services through a call center based, or maybe nurses providing the services through a call center based program. You also have pharmacists and other qualified health professionals who are providing medication therapy management in the community setting, or I guess in a face to face visit. So there should be some comparison between those two models to see which one actually provides the best quality care, the best benefit to the patient, and fits in well within the health care system. Or, if there's even a modified version of the combination of the two where you have the call center taking care of minor issues with referral to pharmacists or other health care providers in the community setting for more intensive or advanced care. So again, I would just hope that you would look to trying to answer that question as to which model is most important because it seems like it is a program that will be slow to take off because of people's lack of understanding, but will become an integral part of the health care system. And it would be good to get some early answers to the questions about which model is most effective both from a cost standpoint and outcome standpoint. Thank you very much for taking my comment.

Dr. Straube

Dr. Brown, thank you. Very good comments. We're going to next back to the room here in DC

Mr. Sperling

Thank you, I'm Andrew Sperling representing the National Alliance on Mental Illness. NAMI is the largest national organization representing people with severe mental illness and their families. NAMI shares the goals of section 1013 and AHRQ in improving quality and getting better value for America's health care dollar. We commend AHRQ for undertaking both reviews on depression, particularly the one on off-level use of atypical anti-psychotic medications as commonly done as many use as mood stabilizers in the treatment of bipolar disorder. And it's very important this review be undertaken, and we commend you for that. In the field of psychiatric medicine and severe mental illness we are making progress on clinical research, on treatment in real world settings. This is critically important.

NIMH has three major studies, some of which have been released in their first stages, some of which are moving forward. There's the CATIE study on schizophrenia. The Star*D study on treatment resistant depression. It was just released last week, the first stage last week, and the Step-BD study on treatment of bipolar disorder. What's important about those is it's no longer-it's not just comparative advocacy, it's also treatment in real world settings, and it undertakes the really complex nature of these disorders. And we encourage AHRQ and CMS to recognize the complexity of the treatment of illnesses such as schizophrenia and bipolar disorder and major depression. They're episodic illnesses. They don't follow a pre-determined course. They often are accompanied by many, many co-morbidities including substance abuse, diabetes, other types of complicated co-morbidities. And there's an enormous challenge of ongoing treatment adherence. When the very symptoms of an illness like schizophrenia is the better someone gets, the more under control their symptoms get, the less likely they are to adhere over time. And it's an enormous challenge. And we need more research on that.

And finally, most importantly, the treatment needs to be individualized. This is something we believe you need to recognize. And along those lines, Dr. Clancy noted earlier that this undertaking is not about implementation of uniform treatment guidelines for any particular disorder, and we commend AHRQ for that. We think that's the route you want to go. But unfortunately, we're increasingly seeing comparative effectiveness research being labeled as "evidence based practice," and then being used as pay arch (phonetic) because we state Medicaid programs as a justification for a restrictive policy such as prior authorization, step therapy, and in many cases outright removal of therapeutic options from preferred drug lists. We believe that this is not what comparative effectiveness studies need to be used for. We're already seeing this in association with the first stage of the CATIE trial where you have some of the newer atypical anti-psychotic medication compared against only one of the older agents. And we see payers already using just the first stage of this, we believe, in an inappropriate way to restrict access to the newer more effective medication to treat schizophrenia. So we strongly support what AHRQ is doing, and we support section 1013, but we just want to make sure the comparative effectiveness trials are not essentially unjustifiable used as the basis for restrictive policies both in Medicare and SCHIP and Medicaid. Thank you.

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