Increasing Access to Medication-Assisted Treatment (MAT) in Rural Primary Care Practices (R18)
Moderator: David Meyers
January 13, 2016, 12:00 pm CT.
Select for the related slide presentation.
Coordinator: Welcome and thank you for standing by. The following staff from AHRQ will introduce themselves.
David Meyers: I'm the Chief Medical Officer at the Agency for Healthcare Research and Quality (AHRQ).
Charlotte Mullican: I'm Senior Advisor for Mental Health Research here at AHRQ in the Center for Evidence and Practice Improvement.
Phillip Jordan: I work in the Center for Evidence and Practice Improvement and work with Charlotte on the MAT initiative.
Michelle Burr: I am in the division of Grants Management and I am a Grants Management Officer.
Kathy Carr: I am the contact for this Request for Applications (RFA) in Grants Management.
Debbie Rothstein: I am the Advisor for Extramural Research here at AHRQ in the Office of Extramural Research.
David Meyers: The Department of Health and Human Services, of which AHRQ is one of the operating divisions, has a national initiative lead by our secretary, to reduce opioid dependence, abuse, and death in the United States, looking both at illicit and non-pharmacological use of prescription drugs.
That effort is multi-pronged. It includes work to disseminate—now, Naloxone, more widely around the country. It includes efforts to improve prescribing of opioids within primary and specialty care throughout the country.
And it also has a specific focus on increasing the usage of medication-assisted treatment for all Americans who are in need of treatment. And that's where this Funding Opportunity Announcement (FOA) fits in. AHRQ is a research agency that focuses on producing new knowledge, helping people use that new evidence and put it into practice within healthcare systems.
AHRQ also produces data and measures to help the healthcare system understand how we're doing and how we can continue to improve.
And with that focus, the department turned to AHRQ and said, within medication assisted treatment, we have partners who are going to work on expanding that in the community health centers here at the Health Resources and Services Administration (HRSA). We have partners who are going to work on expanding that in communities through substance abuse centers through the Substance Abuse and Mental Health Services Administration (SAMHSA).
However, the primary care platform in the United States and the doctors and nurses serving the needs of Americans in rural areas across the country are an untapped resource. If helped, we could expand access to MAT for 1.5 million Americans who are thought to be living with substance abuse disorders—specifically, Opioid Abuse Disorder—and unable to access treatment. AHRQ is targeting this area and would like to focus on some of the most underserved folks in the country, those living in rural areas of the United States. Again, as we said, targeting primary care practices. And trying to not only to expand the delivery of the service, but specifically understand what the barriers are and how they can be overcome.
So this really is both a demonstration project—expanding access—but also a research project—increasing understanding. As we write in the FOA, "discovering and testing solution to overcoming known barriers, to the implementation of MAT in primary care."
Also as AHRQ is using an R18 mechanism, it's not just research and demonstration, it's dissemination, creating training and implementation resources that the Department of Health and Human Services and the larger American healthcare system can use in the future to expand access to this evidence-based therapy.
On Slide 5, we list some of the important definitions. This is a little bit basic, but we think it's important to review. These are all in the FOA, with the exception of rural and we'll highlight that at the end.
On Slide 6, primary care. AHRQ defines primary care as the provision of integrated, accessible healthcare services by clinicians who are accountable for addressing a large majority of personal healthcare needs, including prevention and health promotion, in partnership with patients and in the context of family and community.
On the next slide, we talk about primary care practices. This is highlighted because many of the medication-assisted treatment medications require, at this point in time, a physician to write the prescription, our expectation is that, while they may include and have contributions by physician assistants and nurse practitioners, that the majority of the primary care practices that will be worked with will also include primary care physicians.
Opioid Use Disorder is a common definition.
Moving onto Slide 9, medication assisted treatment is the use of FDA-approved opioid agonist and antagonist medications in combination with counseling and behavioral therapies, to provide a whole patient approach to the treatment and substance use disorders.
That includes screening, assessment which includes the determination of the severity of the disorder, initiation, maintenance, and ongoing support for recovery. Research shows that when treating substance abuse disorders, a combination of medication and behavioral therapies, as provided in MAT, is most successful.
So one of the underlying challenges that AHRQ is hoping that you all will solve is how to help primary care practices both prescribe medication for those who need it, and provide those supportive behavioral therapies that make MAT successful. Any application that's focused only on prescribing or only on behavioral supports would not be responsive to this FOA.
The next two slides describe those two common medications: Buprenorphine and Naltrexone. Applications may work with one, the other, or both in their application.
And on Slide 12 we define rural. This definition was not included in the original FOA. This has since been rectified with an official Notice, NOT-HS-16-003, that can be found here.
For the purposes of this FOA, applicants who use the National Center for Health Statistics, or NCHS 2013 Urban Rural Classification System—and there's a link embedded in the slides that can take you to it, as well as in the announcement—to document that their proposed areas are rural, will be considered responsive. Under this system, counties that are either micropolitan or non-core are considered rural.
With that said, we also note that applicants, if they want, can utilize another definition of rural within their application. However, if you do so it is incumbent upon you to define the definition and demonstrate how your definition is consistent with the overall aims of the funding announcement.
We've had several questions about defining rural that lead us to—reminded us that we wanted to point out to people that, not only do you have to demonstrate that the areas that you're working in for this project are rural, but that they lack adequate access to substance abuse treatment services.
I don't know this for a fact, but if it were to turn out that Palm Springs was rural, by the definition of being micropolitan, but happens to have more inpatient and substance abuse treatment facilities than anywhere else in the world, that rural area would not be responsive to this FOA.
With those definitions behind us, I'm excited to turn to the next set of slides, which really lay out for you what we're expecting in this FOA. In it, on the slides, we say, "applications should," my colleagues have pointed out to me that it probably should have said, "applications must." Each of the requirements we're about to discuss are actually required in your application to be responsive.
You must define the region you'll be working in, the set of communities, and describe the current availability of treatment for Opioid Use Disorder. After having defined the region, you need to describe a comprehensive model or models for the delivery of MAT in primary care that you believe will work, in this region and in these communities.
And as I noted earlier, your model must include both the provision of medication and the behavioral support services necessary for MAT. Once you've described your model, the expectation is that you'll describe your plan for recruiting practices and keep them engaged throughout your project.
On Slide 14, after you've now described what you're going to do and how you're going to do it, you're going to show us that you've thought through what are the major barriers to successful delivery of MAT in rural primary care practices. We expect that you will list at least five and then demonstrate how your approach is designed to overcome those barriers and how you will address and overcome them.
The next thing you must describe for us how you will evaluate your project. Examples include the effect of the initiative on expanding access to MAT in the communities you're working in, how the primary care providers and staff experience their staff satisfaction in implementing their model, the effectiveness of the model for dealing with or overcoming the barriers that you've identified.
And the final thing, again because this is an R18, you're demonstrating you can do this. You're doing research to show what works and how it can work better. And you need to have a detailed dissemination plan, which is not just publishing a paper after it's done in a peer review journal.
It's a plan that thinks about how to engage stakeholders, to make sure they're informed of the initiative's progress and its findings on an ongoing and timely way that's consistent with an R18 mechanism.
On Slide 16, now thinking just about being an applicant to an AHRQ FOA, or funding announcement, a few things we want you to highlight:
For those of you who have not applied for research grants funding from AHRQ in the past, I strongly, strongly encourage you to investigate how you establish your organization and your principal investigator as registered in the NIH Common.
Some folks do all of their work and put together a beautiful application. And they're ready to submit it 24 hours before the deadline, only to discover it takes weeks to get the registration.
We recommend that if you do not already have your registration established, you give yourself four to six weeks to make sure that you have all of the correct registrations and passwords, that your applications are ready, that you've got the numbers which will be needed to eventually submit your application.
AHRQ has, in the FOA, announced that we anticipate up to four awards. That, of course, is dependent on AHRQ's budget and the receipt of meritorious applications. Grants under this FOA are limited to $1 million total costs per year.
And I'll say this again—it's so important—total cost means the direct cost and the indirect cost associated with your grant. Each institution has different negotiations with HHS and internally about what the indirect rate is.
You, as the applicant, have to figure that out, of what your total cost plus your indirect costs are, such that they are less than $1 million per year. The project period can go up to three years, but cannot be described as going more than three years.
Moving forward, eligible organizations. I want to remind folks that grants are not made to individuals or to principal investigator. The grant goes to an organization.
Eligible organizations under this FOA include public and non-profit private institutions within the U.S., units of local or state governments, eligible agencies other than the federal government, and Indian and Native American tribal governments and designated organizations.
Due to AHRQ's authorizations for-profit organizations and foreign institutions are not eligible to lead applications. If an applicant assembles a team and there is a for-profit group that you think is important for your grant, they may participate. They just cannot be the lead organization that submits the actual grant.
On Slide 18, the program director (PD) and the principal investigator (PI) are described. It's very important to note that while AHRQ is a research organization, we recognize that there are many types of individuals with the knowledge, skills, and experience required to lead such a project.
There are no degree requirements for a program director or principal investigator, though it is important that the application demonstrates that the PI or the PD is accountable to the organization submitting the grant.
And this becomes important in a coalition where one organization is submitting the grant and if the PI or the PD is from another organization, it's incumbent upon you in your application to describe the governance structure such that AHRQ can have confidence that the PI and the lead organization are going to work well together and be accountable to each other.
While our colleges over at the National Institutes of Health (NIH) have created mechanisms under grants where multiple people can be stated as co-PIs, AHRQ doesn't do that. We require one single PI. You can have a large team and they can be called queens and czars and anything else that makes them feel empowered, but only one official principal investigator on the application.
I'm now going into the part that really gives you the secret of what AHRQ is looking for and this is nothing more than reading the application. And, in fact, we tried to make this in such a way that we laid out for you exactly what we were hoping to hear from you, so that you could have a highly successful application.
There is probably somebody on the phone or perhaps somebody who is not on the phone today who is going to say, but I know what AHRQ wants better than what AHRQ thought. So I'm not going to follow this.
You are allowed to submit any application you want, but in my experience following what we suggested to you we are interested in is the best way to get a highly meritorious application.
The application research section, where you lay out all the main points, is limited to 25 pages. Anything more than 25 pages, your application is either sent back unread, or truncated at 25 pages and the study section can't see the rest of it, and it is very hard to score well if that happens. So please follow the page limits.
We then describe for you the exact sections so consider using section headers using these labels. The page limits here are actually not limits. They're guidance. If you need to shift a bit, that's fine. But this gives you an idea of what we're looking for.
Describe the region, the rural region, why it's rural, and why it's under-served. Describe the model for its delivery of MAT in rural primary care practices that you propose to test.
Describe your plan for supporting practices in implementing that plan. Describe at least five barriers to implementation of MAT in rural primary care practices and how that plan you've just described will address them.
Describe an evaluation plan that shows a project timeline of how you will complete all of this work, the recruitment, the intervention, the evaluations, the dissemination, within the three-year timeframe. And do not short shift that final section on timely and ongoing lessons learned and feedback to stakeholders, the dissemination part.
On Slide 20, when you read the full FOA, it includes details of what we think should be included in each of those sections. And we encourage everybody to read the entire FOA carefully.
On Slide 21, going back to budget, which is not part of the research section, but follows next within the FOA, AHRQ does not accept modular budgets. Some folks are used to using modular budgets when funding from the Centers for Disease Control and Prevention (CDC), NIH, or private foundations. AHRQ only uses the detailed research and related budget.
As mentioned previously, the budget ceiling is for total costs, $1 million per year of direct and indirect combined. If you are creative and think, oh, I'll take $1.2 million in year one and 0.8 in year two and one million in year three, that's not responsive.
It is a total of one million each year. If you want to go in $900,000 for three years, that's fine. But you cannot go over the one-year budget total or the three-year timeframe. Matching funds are highly encouraged and welcomed. Those can include in-kind or direct contributions, but they are not required under this funding announcement.
We're getting to the end of the formal part of the presentation. The next few sections of slides, describe how the peer reviewers will look at your application. We've described to you why AHRQ is doing this and what we expect to see in your application. Here's what we are going to tell the reviewers to look for.
This section is detailed in the FOA so that you know what we are going to tell the reviewers. So again, some people skip them, saying that's not for me. That's for the reviewer. And we think that's a big mistake.
There are five sections. I'm not going to give you the details on each of these, but we do describe them in the slides. The first is the overall significance of your project. How likely is it that your plan can support primary care practices in providing MAT successfully?
Will you develop new information about barriers? Can you demonstrate that your plan will tackle the barriers that you've identified? Those are the kinds of things that show up and are significant.
On Slide 24, a lot of things about who compromises your team. Who have you brought to the table? Do they have the skills necessary? Do they have the experience? Have they worked together?
If you're bringing together a coalition, which we think many of you will, do you have a governance structure and the leaders approach? That's what they'll look at in that section.
On Slide 25, innovation is discussed and this is very important to point out and we wrote it in the FOA. The goal of the FOA is to both increase access to MAT and in and of itself that is not innovative.
Successful projects may in fact propose using multiple best practices in supporting rural primary care and initiating and sustaining the delivery of MAT. The FOA also requires a multi-level evaluation, but does not specifically require innovation in your evaluation measures.
So we just ask, under innovation, is this likely to engage practices? Is it likely to overcome the barriers? Do you bring together a coalition that is likely to make this project successful?
On Slide 26, the approach which is often seen as the heart of the application, your research plan, the 25 page section. A lot of that shows up here in approach. We can't go through all the criteria. There are actually many, many.
But it's divided into three areas which show you again what we're highlighting. How are you implementing? How are you evaluating? How are you disseminating what you learn?
The final criteria is the environment. This does not necessarily refer to the community environment. It's the research environment. It brings together a number of other factors that have been highlighted.
Are you bringing together partners with unique expertise? Are you aware of special circumstances in the area that you're working on? Are there other projects that you are aware of that you're either going to avoid duplication, align with, or collaborate with?
Are you leveraging local and regional expertise? Those are the kind of questions that come up in environment. After a peer review, which we'll talk a little bit about how you can help us make sure that is the best review possible for you; AHRQ will use the following four criteria in selecting the funded application.
The first and potentially most important is the scientific and technical review done by your peers. The second is the availability of funds; we hope to be able to fund up to four. That could change up or down.
Responsiveness to goals and objectives of the FOA. A very meritorious application, that's not really shooting for the center of what we were looking for, could get skipped over for an equally meritorious one that really meets those needs that we talked about.
And then the final one is the relevance and fit with AHRQ research priorities. We guarantee if you come in for this FOA, you're in that circle, but also geographic balance. If three different applications from the State of Ohio come in that have not been coordinating, all with overlapping areas, it's very unlikely that all three of you will get funded.
So we highly encourage folks to think about who are the other likely partners and applicants in their region. Coming in together may strengthen both of you, whereas coming in apart, while it may make you think you have more autonomy, often we find this self-defeating in the end.
On Slide 29, February 1 are when Letters of Intent are due. We'll talk about that in a moment. Your applications are due March 4. Four to six weeks before that, make sure you start your registration process, if you've not already done it. In fact, there's no reason to not start that now.
The peer review will most likely take place sometime this summer. And we expect that the grants will be awarded and have start dates in September of 2016.
Quickly, on Letters of Intent, they are not required, but they are highly encouraged and nonbinding.
So if you put one in and then don't put in your application, we don't keep track and later come down and say we're never going to fund you again. What they do, however, is let us know what size, what expertise, what regions of the country do we want to make sure we have experts on to review your applications.
So it actually is very helpful to applicants to put in a Letter of Intent, to make sure that you get the best quality review possible. A very short, simple letter. Here are the things you need to have in it—who's the lead application, give us a name, and give us a contact, the institution and key personnel so we don't ask people who are coming in to be peer reviewers.
And all of your partners, so again, we make sure to have the right expertise. And these can be sent in electronically to our colleague, Phillip, who you heard from earlier.
On Slide 31, it reiterates something you'll find in the FOA. If you have questions about the science, what did AHRQ mean by this research question, send to Mr. Phillip Jordan.
If you have questions about how AHRQ does peer review, our colleague, Dr. Vo can help you with that. And for anything related to budgeting or financial matter questions, both now and after your applications are in, those go to Ms. Carr, whom you heard from earlier.
Okay. With that, thank you for hanging in there with us, we're going to switch over to the question section. We're going to start this, to get it moving, with some things we've heard from folks already. A few of them we've taken in. A few more will come on the fly and then we'll go to open questions.
On Slide 32, if a clinic cares for patients from rural communities, but is itself not in a rural area, may an application focus its initiative around that clinic? And the answer is no. The intention of this FOA is to support the delivery of MAT in rural communities through engagement of primary care practices within those rural communities.
Another question received, since Naloxone is an evidence-based tool for the prevention of overdose deaths, may an applicant propose a project to expand distribution of Naloxone in rural communities?
The answer is no. That kind of application would not be considered responsive to this FOA. While part of a larger opioid strategy, this FOA is focused on MAT and the two main medications, Buprenorphine and Naltrexone prescribed by primary care and supported with behavioral therapy.
Researchers, however, interested in this concept of Naloxone are encouraged to visit the Health Resources and Services Administration (HRSA), Office on Rural Health, which has a current initiative on increasing the dissemination of Naloxone in communities.
Another question received: May an applicant propose to incorporate virtual behavior support that is provided by nurses outside of the rural community, if it is linked to MAT provided within rural primary care practices?
And the answer is yes.
And we actually call out in the FOA that we're interested in the use of tele training and tele health as adjuncts to delivering MAT. So if that's what you're interested in, we think there are possibilities for you within this FOA.
Final Preselected Question: May an applicant propose to provide MAT in rural areas that crosses over state borders? And the answer is yes. Applications can propose to work in multiple, contiguous, or noncontiguous states and regions, as long as each of the areas worked in is defined as rural and underserved.
Participant Question: Are there any requirements about what the million dollars can be used for? Can we use it to hire practice assistants to go into practices? Can we use funds for technology? Is it up to us how we use the million dollars?
Kathy Carr: It's up to the grantee how they would like to utilize those funds, as long as they are allowable. I would definitely refer to the grant policy statement on allowable costs. And also work closely with your institution. They can help guide you.
David Meyers: Okay. So the answer was yes. You have to explain how you're going to use it. It has to meet your overall goals, but remember there are some things about allowable funds. Staff support time is definitely allowable.
Buying a new car for the PI, not allowable. And that your grants management office within your institution can help you understand allowable and non-allowable.
Kathy Carr: Yes, they're allowable, allocable, reasonable and necessary, are the keys to determining appropriate costs.
Participant Question: Are there limits to the number of rural regions that can be chosen as the target area?
David Meyers: No, absolutely not. Somebody who says we're going to work with one clinic in one rural area probably won't have as much significance as another application who demonstrates we're working across three states and nine counties with a total of 125 practices.
Both of those can be submitted. They both, potentially, are responsive to this FOA. But the one with the larger reach is likely to viewed as more significant. Absolutely, you can work in multiple areas. And do the regions need to be geographically contiguous? As we said, no.
That is not a requirement under this FOA, though the applicant has to demonstrate that they have the ability to engage with people in these different areas, that they have the proper partners.
Participant Question: Should the application speak to funding for just one year or for three years? Should the plan just describe funding for $1 million for one year, or $1 million per year over three years?
David Meyers: Great question. It's the three year. You need to describe in the application your entire project and your budget for the entire three-year period. That actually was related to the slide where we said AHRQ does not support modular budgets, which other institutions do. They say tell us what you're going to do in year one and then one paragraph at the end about the future.
That's not the way this goes. You need to describe the whole project, year one, two and three, your whole timeline, your whole budget.
Participant Question: So if grantees are awarded that first year, can they reasonably expect to receive funding for years two and three?
David Meyers: In general, yes. There is a requirement for a non-competing continuing application form that you fill out at about nine months into the year. That gets reviewed. Assuming you're doing what you said you were going to do, you get continued funding.
Participant Question: I'm assuming just from the RFA that in describing your plan to enroll sites. It’s not necessary to actually name your sites in the application, but rather a region?
David Meyers: An application who can come in saying we have Letters of Intent from these ten clinics and we hope to get 20 eventually might be stronger than one that says we've never visited this region, but here's our plan. We think people will come running to sign up. That might be a little more risky.
But actually having them signed on the dotted line in advance and saying these are the exact places is not at all necessary. It is very much that plan for recruitment and engagement and saying we've worked in this community before. We're working with "Dr. Smith," a thought-leader in this community. He's going to make introductions for us.
Or, we're working with the medical society. They're our partner. They're going to help us. So there are many different ways to do that, but it is absolutely not required that you're able to identify in advance. What you need to do is show your peer reviewers that your plan is likely to succeed.
Participant Question: And then some sort of phased enrollment of sites over the first couple of years. Would that be responsive?
David Meyers: Absolutely. If your plan is to work with clinics for six months and that is the training you're going to provide them. And you're going to do waves and do that over the first few years of the grant that would be completely responsive.
You have to, again, show that your plan can be done. And it can't go to the very end with no evaluation, or that the evaluation will happen after the grant ends. But absolutely all of your practices don't have to start in the first few months of the grant.
Participant Question: I was wondering if AHRQ would consider obstetrics to be a part of primary care?
David Meyers: Yes, it does. And you would have to explain in the FOA that they are interested, these obstetrics practices, in providing MAT.
If there is a maternity care provider who wants to be able to provide MAT as part of their practice, both the medication and the behavioral support services and you're going to work with them, I think that would be responsive, if they're in a rural, underserved area.
Participant Question: Would practices that already have a waiver to prescribe Buprenorphine, but let's say they aren't really treating any patients yet, or treating just a small number of patients, would they be eligible for participation in the implementation?
David Meyers: Yes, they absolutely would. One of the things we know is that many more physicians have gone through the training and even gotten their registration than are actively prescribing.
And so part of the barriers that one might identify are why are these physicians notproviding MAT? And we are going to help them with whatever barriers those are, so that they become active deliverers of MAT within their communities. So that would be fine.
Participant Question: If we have identified an existing barrier to the expansion of these services for a practice that involves direct services, are we able to use any of the million dollars to purchase direct clinical services?
David Meyers: Great question. And the general answer to that is no. We are interested in sustainability and teaching others, the actual paying for the delivery of the services is generally not considered responsive under this FOA.
There is the potential, I think, of a very narrow kind of set of things that if you were testing whether adding this one little piece that was not the major issue and had a reason to believe that piece, some day in the future, could be provided in another way, you might be able to set up.
But generally paying for MAT would not be responsive. So it's mostly no. There may be some ways. And if it's helpful, you might want to follow up with us for more specifics.
Participant Question: If the principal investigator is part of a for-profit agency but is collaborative with a lead agency that is a non-profit or unit state government, would they still be eligible to serve as the PI?
David Meyers: And the answer is it can. However, it is extremely important that it does not appear, and not be in reality, that the nonprofit is just a front and all of the money is going to flow directly from the nonprofit to the for-profit to do everything with just the name of the nonprofit tacked on top.
So if it's just the PI, for example, salary is going to be covered, but the rest of the organization isn't, and there's the demonstration of accountability of how that PI is going to work, that is possible.
As you're getting closer, you may want to contact us and have your situation reviewed more carefully.
I want to close by thanking all of you for taking the time today to listen. This is a very important initiative for AHRQ, and we believe can make a real impact on the health of Americans and the state of our primary care system.
We encourage you to think hard about this and come up with your best ideas. We look forward to working with many of you closely in the future. If you have any questions, again, please contact Phillip Jordan for scientific questions or Ms. Carr for financial questions.