We’re ready to start the formal part of the listening session. And the format for this, again we have a large number of people here in the room present, but we also have a very large number of people on the telephone lines. So we’re going to alternate. We’ll begin here in the room in D.C., but we’ll periodically go to the telephone lines and ask people there. I’d like to ask folks to first of all try to keep your comments to three minutes or less. I know that’s hard sometimes, but we want to try to get as many comments as we can. And for those people in the room here, we do need you to use the handheld microphones. This is being recorded this morning, so that other people in the room can hear you and people on the telephone line can hear you. If you would all identify yourself by name and the organization you’re with, that would be very helpful also. So I think we’ll start here in the room. Who would like to make a comment or statement?
My name is Randy Burkholder. I’m with the Pharmaceutical Research and Manufacturers of America and the policy department there. I first want to just thank all of the speakers who have already made comments, Dr. Straube, and Dr. Clancy, and Dr. Agwunobi, for the high quality of your thoughtful comments. And I wanted to just start by underscoring the fundamental importance of the shared commitment to the goal that Dr. Agwunobi articulated when he opened, which is the shared commitment to improving quality in health care and to transforming health care by starting with improved quality as the basis for getting better value and as the basis for reducing the cost of disease. I also want to make a point that I think we still see something of a persistent disconnect between that goal and the research agenda that has been undertaken thus far under section 1013. In regards to Dr. Wolf’s piece in the Post on Sunday and as well as the work of John Weinberg, I think they both make the fundamental point about the importance of health system’s challenges and addressing basic health system challenges if we truly are going to transform quality in this country. And the fundamental point we would make is to orient section 1013 towards engaging in those health system level issues to truly make a difference in improving quality.
I’ll try to hit on just a few other points. We certainly appreciate the opportunity to provide comments. And we do believe well-designed health outcomes research from the public and private sectors such as that described in section 1013 can help us make the fundamental quality improvements we need, can empower physician and patient decisionmaking. We recognize and appreciate the important progress that HHS has made in implementing this section of MMA over the past couple of years, most recently and notably through the rollout of the Effective Health Care Program a few months ago.
At the same time, as I indicated, we do remain concerned that key elements of this provision have not been implemented, and we believe some further steps could be taken to improve the transparency and openness of the process. I would also point out in regards to the orientation of the program that Congress, in passing its funding bill this year, affirmed both the direction AHRQ has taken in beginning with the disease-based approach to research under section 1013. It also underscored the importance of conducting research in additional areas such as the organization, delivery, and management of health care items and services, research which directly addresses points made by those such as Steven Wolf, but research that we feel has not yet been addressed by AHRQ, yet is mandated in the statute. So we believe that is an important area to consider going forward under the program.
Finally, two other quick points. One, just since enactment of MMA there has been a considerable additional research that’s affirmed the importance of this broader quality-centered research agenda mandated by Congress. Just two quick examples, an August 2005 study in the Annals of Internal Medicine found a strong link between improved quality of care and better survival among vulnerable older patients. Quality indicators in this study looked across the continuum of care, at processes of care, patient follow up, prevention, diagnosis, and treatment. Another recent study published in Medical Care found that increased compliance to prescription drug regimens improves clinical outcomes and can reduce medical costs. Finally, a lecture that I know Dr. Clancy you’re familiar with, Don Berwick’s John Eisenberg lecture in April 2005, called on health services researchers to adopt broader health systems approaches to research in order to address the fundamental health system challenges we face. We do appreciate AHRQ’s support for research that looks at this broader scope of inquiry. For example, the special emphasis notices recently published by the agency looks like it’s an example of that. We appreciate that perspective. We think it’s important to build that perspective into implementation of section 1013 as well as directed by Congress and stated in the statute.
Regarding process—and if I’m running over my time, just cut me off please. But we appreciate the steps AHRQ has taken as well to establish broad and ongoing process of consultation such as through these meetings, other steps as well, such as the implementation of an electronic docket for review of input you’ve received also has been valuable. We recommend a couple of additional steps to improve the openness and transparency of the program. First, AHRQ should, through an open public process, develop clear objective criteria for selecting research priority topics, and when it proposes research topics can then provide the rationale based on those criteria. Finally, we would recommend a consistent approach to soliciting comment on draft reports when they are released. We trust that will be the approach going forward, but note that in release of the first couple of reports, one has been released as final and one has been released as draft for public comment. We would hope that going forward all of those would be released as draft with opportunity for public comment. So we appreciate the opportunity to provide and thank you. We appreciate the opportunity to provide input today and we look forward to continuing working with you to support a well designed research agenda under section 1013. Thank you.
Thanks very much for your comments. I want to commend for commenters going forward, the specific suggestions are very, very helpful. So I thank you for your specific comments on how we might improve things. Another question here in the room or on the phone?
Yes, we do have a question from Tricia Leddy. Please state your organization.
The Rhode Island Medicaid Program.
Tricia, go ahead. You’re on the line.
Hi. I just wanted to comment on, from the perspective of Medicaid and running a Medicaid and SCHIP program for families. I looked at the ten priority conditions that were set, I guess it was last year. And most of those conditions focus on conditions prevalent in older people. What we struggle with in running Medicaid and SCHIP programs particularly for families are conditions that aren’t necessarily listed on that list. And I wanted to suggest that maybe some of the conditions in the future be focused on some of the areas where States struggle to know whether to cover a treatment or not. And specifically, I would suggest that for children and for adults, that behavioral health for people who are on our program, not just because they have a behavioral health condition, but that behavioral health is a very big issue. We have to decide all the time about what type of treatment is best. And because in some areas such as in Rhode Island there’s a shortage of psychiatrists and particularly child psychiatrists. Primary care physicians really struggle with these kinds of issues.
The specific conditions I would say get the most questions are depression, which I noted is on your list already, but also other mental health conditions such as bipolar disorder and schizophrenia in adults. Those three conditions result in a lot of hospitalizations. They’re the number one cause of hospitalization as a group for our disabled adult population is mental health conditions in Medicaid. And for children, conditions such as conduct disorder, and ADHD, and ADD, where there is a lot of treatment, drug treatment. There are often not available enough child psychiatrists to be able to on an ongoing basis monitor that treatment. And primary care physicians are put in the role of having to make decisions about what’s the appropriate treatment for mental health conditions in children. And those are just a couple. Another related thing that we really do struggle with as far as treatment is concerned, and this is not necessarily drug treatment but other kinds of treatment, is autism. Autism spectrum disorders are a big issue in Medicaid and SCHIP, and there are treatments that we are covering and asked to cover such as very intensive home based therapy. They’re expensive treatments. We want to make sure we’re covering the most effective treatments, and yet there is not a lot of research out there about the effectiveness of the treatments. There are a few different kinds. They have different names. There’s little research with few subjects about these treatments, and we want to make sure that those treatments that we are funding are effective for the children that have autism. So it would be great to have guidance on that. Another thing that is more and more prevalent in our society is obesity. And thus Medicaid and SCHIP often gets questions and requests to cover procedures such as surgical procedures or drugs to treat obesity. Guidance on that such as when to cover a treatment for—a surgical treatment for obesity would be useful to us. I would say another issue that results in enrollment and cost for both Medicaid and SCHIP is infertility treatment. There are 12 states including Rhode Island that have a mandate in our state health insurance laws to cover infertility treatment. Now infertility treatment is not covered on Medicaid and SCHIP. But what we’re finding from the very useful data that CDC puts out in their PRAMS data set that infertility treatment is associated with a higher rate of babies born with special health care needs resulting in neonatal intensive care admissions and other ongoing health problems. We find that a lot of these infants do end up, even if the mothers were not on Medicaid or SCHIP during pregnancy, that because of their special health care needs or because of the working or employment condition of the family changes, that these babies do end up on Medicaid and SCHIP. And some of the age ranges of the women who are having babies conceiving using infertility drugs and other treatment are from young to old, and from 20 into 40. And I wonder if there are some kind of guidelines that could be developed for when is it appropriate to use infertility drugs given that—is it only after a year, such as our state law in Rhode Island says, of not being able to conceive, or given that there would be—at least in Rhode Island–a twice as likelihood of having a baby go to the NICU after infertility treatment.
Tricia, again, I think you made some very helpful suggestions there. We’re going to have to move on to the next question asker. Thank you for your comments. We appreciate them very much. We’ll go here in the room and we have a question up front.
Good morning. My name is Dave Milzman and I’m a practicing emergency physician here in the District for almost 20 years. I’m representing today the American College of Emergency Physicians. Myself and almost 30,000 other physicians certainly appreciate this opportunity to address you. As you know, we are on the front line 24-7, providing not only care for all urgencies and emergencies, but as our self-dubbed health care safety net. We feel that we are a very active participant in all of the diseases under 1013 that you have elucidated. We see all forms of those diseases from acute exacerbations of COPD, asthma. We see the failures of arthritis treatments. We see acute problems with ischemic disease, as well as a high rate of recidivism with many of these diseases when both pharmacologic and surgical treatments fail. Based on this, we would like to let you all know that the American College of Emergency Physicians very much shares your research agenda. And based on that, that we want to let you all know that we feel that there’s a serious need for the acute care perspective that we offer more than anyone in terms of significant numbers in the assessment of any device, drug, or other technology. That based on rates of repeat visitors, for instance, depression, we see a lot of those patients on a recurring basis that might not be picked up if you’re basing it just on office care numbers. And in addition to the national ambulatory care registries, still these are retrospective, but any prospective evaluation we feel should involve our perspective. And I’ll easily stay my three minutes.
Based on the Institute of Medicine report, there continues to be a need to support the foundation for emergency medicine research at AHRQ. And we also strongly urge AHRQ and HHS to give a significant consideration of your priority conditions in their acute care phase in the emergency department when assessing what drugs are actually available to the general public. There are many drugs that just aren’t available within the emergency department setting or the ambulatory setting that many Americans either cannot afford or cannot get access to based on their payer plans. And in the end while we fully support the guidelines for your patient registries which we do appreciate, we know better than anyone that these registries, without including more of the acute care perspective in them, would be mistaken. And lastly, we just ask that you give priority to the continued support of emergency medicine in this and in all future evaluations, and that the American public is very well aware of our availability on the 24-7 basis. And we do appreciate the continued support. Thank you.
Dr. Milzman, thank you for your comments. Operator, before we take the next questioner on the line and then we’ll come back here, have we made it clear to everyone on the telephone line how they get into the question queue?
That is correct. If you’d like to ask a question press *1 at this time and please limit your remarks to a maximum of three minutes.
Okay. And do we have someone on the line then?
Yes, our next question comes from Doris Lotz. Please state your organization.
My name is Dr. Doris Lotz. I am the Medicaid Medical Director for the State of New Hampshire. And what I would like to say is that there is so much opportunity in Medicaid and so few internal resources that we rely very much on Federal agencies like yourselves to do this kind of research and to make it publicly available so that we can build policy off of it. That being said, there’s no specific topic that I would like to draw your attention to. What I’d rather do is talk about specific contents for each topic that you may take on in your research agenda. Specifically, in reinforcing some statements that were made earlier, we need cost effectiveness information. It’s very helpful certainly to talk about what exists out there with respect to comparing clinical treatment one to another. But without the cost effectiveness information, it’s incomplete. In addition, I’d like to ask that part of your research agenda be to look at more head to head comparisons for which those little industry interests or research funds to do. We need the kind of information that takes new drugs, new technologies, new pieces of equipment, and compares that to what is currently out there that is certainly less exciting but perhaps more cost conscious. And that research is not being sponsored by anyone else. So I find often times that the best treatment is a value judgment and we need information on cost effectiveness and information on how emerging technologies, emerging new medical interventions compare to existing ones to really set an appropriate policy agenda, especially for public payers like Medicaid.
Thank you very much. I can tell that enthusiasm is really starting to pick up here in the room, and I’m sensing on the phone as well. Since we will be here until 11:30, if you don’t get a chance to put your two cents or two hundred dollars, however you want to think about it, to state your comments today, we very, very much welcome comments which you can submit through the Web site. And you can submit them any time. For those folks who have spoken up quite passionately and articulately about Medicaid and SCHIP, I just wanted to clarify one point. You’re quite right that the first round of priorities was focused on the Medicare population. This was the decision of then-Secretary of Health and Human Services Tommy Thompson. We are quite explicitly looking to broaden that mandate for here. So your comments will be heard. I can assure you of that.
Thank you. Next question is here in the room.
Good morning. This is Isis Montalvo from the American Nurses Association. Thank you for the opportunity to comment on the Effective Health Care Program at AHRQ’s listening session. The American Nurses Association considers the registered nurse component a critical component in any health care program. As you proceed in establishing priorities and reviewing your Effective Health Care Program, we ask that you consider including language that evaluates the entire health care process. The nurse is in a pivotal role in assessing, planning, implementing, and evaluating interventions. For example, teaching weight management and intake and output measurements for the congestive heart failure patients. Teaching patients and families to change injection sites when administering insulin. Evaluating a patient's response to therapy and how compliant the patient is in following their treatment. As you proceed in selecting a new condition or selecting a comparative review from existing conditions, the Effective Health Care Program would benefit from inclusion of all related nursing interventions and identification and evaluation of those nursing outcomes. Thank you.
Thank you very much. We’re going to the phone line now. Next question.
We have a question from Sue Tolleson-Rinehart. Please state your organization.
Good morning. I’m calling from the UNC CERTs at the University of North Carolina at Chapel Hill. The UNC CERTs is the nation’s only center for education and research on therapeutics devoted to pediatric therapeutics use. We have a global concern. Children are not small adults, as we all know, and the history of concern for the protection of children as human subjects, combined with an absence of obvious economic incentive has in the past significantly reduced the number of drugs actually labeled for pediatric indications. If you put these two things together you see an urgent need for more and more pediatric therapeutics effectiveness research of all kinds for all conditions affecting children. Recent legislation has improved this situation somewhat. But even now by the FDA’s count, 50 to 75 percent of drugs used to treat the pediatric population are not labeled for pediatric use. We need more comparative effectiveness research and pediatric therapeutic use across the board.
Now to three more specific questions related to SCHIP. North Carolina like many other states, created a separate SCHIP program. Now, like other states again, it is moving at least some of its SCHIP age groups into Medicaid in an effort to reduce costs and increase enrollment. This change and general questions of delivery of high quality care to SCHIP-eligible children suggests several areas of research, not restricted to diseases or conditions, but for questions of therapeutic use generally. North Carolina is presently experimenting with a voluntary academic detailing program to reduce Medicaid drug costs with the ultimate goal of moving toward an effective formulary. We urge more systematic research on the comparative effectiveness and cost effectiveness of drugs both common and more exotic used to treat children and the effectiveness of the use of formularies to improve quality and efficiency, and perhaps to standardize pediatric treatment. Our State’s Medicaid primary care managed care structure which is now beginning to include SCHIP-eligible children under the age of six is experimenting with the use of standing orders for prescriptions to transfer prescriptions to appropriate in-network medications so long as there’s no clinical reason not to do so to reduce cost and improve effectiveness. We urge more research on strategies such as the use of standing orders to evaluate comparative effectiveness and to improve quality and efficiency. And finally, in North Carolina, specialists, pediatricians, and others, will be reimbursed 30 percent less in the Medicaid fee schedule than under the SCHIP schedule as it had been constituted. As SCHIP-eligible children under the age of six are moved into an expanded Medicaid program, will this change reduce the incentive for specialists to see children in these public programs? The literature does suggest that such reductions in incentives can reduce access to care. So we urge more research on such questions of access to pediatric specialty care for children relying on public programs as a part of the larger consideration of effective care. And the UNC CERTs thanks HHS and AHRQ for this opportunity to participate this morning in the discussion on ways to make care of our nation’s children more effective. Thank you.
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