Disease Management Advisor, July 2007

Inside:

DM programming moves from the Internet to mobile phones for added impact

New centers aim to provide DM-style, multidisciplinary care to people with ADD/ADHD

Medicaid programs find opportunities for improvement in complex patient populations

Broad-based coalition aims to make chronic disease a top priority for policymakers and presidential candidates

Clinical trials and ROI methodologies are still on the drawing board

DM programming moves from the Internet to mobile phones for added impact

One of the primary keys to effectively managing chronic disease is getting patients to the point at which they take charge of their own health. But this is a tall order, especially with diseases as complicated and laborintensive as diabetes. Just getting people to test their blood sugar on a regular basis can be a huge challenge when they have busy jobs and lifestyles that require them to be constantly on the move.

For all of these reasons, several healthcare technology companies are focused on developing applications that can deliver core DM tasks via mobile phones. The capabilities of these new offerings range from being able to exchange data and other information with patients on an almost real-time basis wherever they are located to being able to use specially equipped mobile phones to actually test blood sugar and transmit those readings to a central location. And mobile phones are not just being used to manage diabetes; they are being deployed in weight-management clinics and asthma programs, as well as other settings.

Although many of these applications are already on the market, many more are in various stages of development and pilot testing, and healthcare analysts believe that the purely Internet-based DM programs will soon be looking to mobile phones for added power and reach.

Mobile phone applications draw interest

One organization that is keeping a close eye on developments with mobile phones is the Juvenile Diabetes Research Foundation (JDRF). The idea of arming youngsters and teens with cell phones equipped with glucometers or communications tools designed to help them track their sugar and manage their disease is immediately appealing, because younger diabetics are unlikely to resist the allure of a cell phone.

Further, any step toward easing the burden of managing a disease such as diabetes is worth exploring, explains Aaron Kowalski, PhD, the research director of JDRF’s Artificial Pancreas Project, an effort focused on building a system whereby a continuous glucose sensor automatically triggers an insulin pump as needed without the patient having to intervene. Kowalski envisions that some of the technology needed for a so-called closedloop system could ultimately be consolidated onto a cell phone. “It is something that is high up on our radar screen,” he says, noting that consolidation, convenience, and ease-of-use are very important with diabetics. “It falls under the umbrella of new technologies that we are interested in.”

Although the JDRF has not yet funded any studies involving cell phone applications, a number of options are already on the market, and more will soon be available.

For example, by the end of this year, Palisades Park, NJ–based HealthPia America plans to introduce its GlucoPhone, a cell phone that is equipped with a glucometer so that patients can test their blood glucose levels wherever they are and then transmit the readings to a centralized Web location. “It is an automatic transfer to the Web site, so the patient doesn’t have to worry about writing it down, or worry about [his or her] computer crashing, or whether [he or she] has the correct software involved,” explains Kathi O’Neill, president of HealthPia America. O’Neill explains that patients have access to their individual data, but they can also give their providers access through the use of a user ID and password.

In addition to these capabilities, the company is currently pilot testing a program whereby HealthPia transmits a text message to a parent or guardian whenever new blood glucose data from the person’s child reach the HealthPia Web site. And O’Neill points out that there is obvious potential in using the GlucoPhone system in payfor- performance programs in which providers are compensated for their management of chronic disease.

“Both employers and payers are looking to drive down their costs, and diabetes is obviously high on their list of chronic diseases because of the costs and crossover implications to other diseases and the amount of resources [it requires],” says O’Neill. “It consumes 2.4 times the resources of any other chronic illness.”

New studies to focus on efficacy

Confidant, a software company based in Research Triangle Park, NC, is already on the market with mobile phone applications that can retrieve data from off-theshelf home-monitoring devices—such as glucometers, blood pressure cuffs, and scales—and then transmit those data to the company’s server, where they are interpreted based on treatment regimen thresholds that have been set for the individual ahead of time.

“Then messaging comes back [to the patient] in virtual real time to help the person understand where they are in terms of managing their disease, as well as to give some positive reinforcement,” says Tom Wall, MBA, vice president of business development and marketing for Confidant. “Essentially, it is using a mobile phone as a health coach and sort of the center of a support system.”

Wall emphasizes that the messaging built into the software is designed not to tell patients the obvious—that their sugar levels are high, for example—but rather to give them some context that will help them change behavior patterns.

“What we do is look for trends in the data, so, for instance, what a diabetic may not know is that they have a pattern of readings at a certain time of the day,” Wall says. “In some cases, they don’t remember when they last tested, let alone what their last reading was, so rather than reporting that they just posted a 300 reading, we would say that they are consistently high in the mornings, or that they have issues around weekends.” In addition, Wall points out that the software facilitates graphic representations of trends, so that patients can view their data in any number of ways.

Although the patient is getting regular feedback, the caregiver—which may be a provider, DM company, case manager, or payer representative—will receive notices if the patient falls out of certain parameters that have been established ahead of time. In response, Wall notes that the caregiver can send a text message to the patient or give him or her a phone call with specific instructions.

The company is working with a variety of DM companies, payers, and provider groups that are interested in using the phone applications to stay in close touch with chronically ill patients and help them better manage their disease. For example, the company just announced that it is working with Honolulu-based Ho’okele Personal Health Planners, a company that offers a suite of services designed to help chronically ill patients better manage their disease and navigate the complicated healthcare system. Other customers include a weight-management clinic in North Carolina that is using Confidant applications to stay on top of patients once they have left the clinical setting. “They have participants who come to their campus, spend two to four weeks, and lose a considerable amount of weight, but their issue is that when the patients go back to their routines at home, they lose that structure,” says Wall. “They are using our product in conjunction with some other service offerings they have so that, when people leave the campus, they can take our product home with them and stay connected.”

To date, Confidant has completed several small trials and pilot studies that have been mainly focused on usability and comfort with the technology. However, Wall explains that the company is now in the process of implementing larger pilots that will compare patient groups that have access to the Confidant applications with control groups engaged in usual care. The focus of these studies will be to establish not just comfort with the technology, but also efficacy in terms of clinical outcomes and financial impact.

Patient engagement is critical

San Francisco–based BeWell Mobile Technology offers services that are somewhat similar to Confidant’s, although rather than communicating directly with other devices, BeWell’s programming relies exclusively on patient-reported information. Established in 2004, BeWell offers two main products: its Diabetes Assistant and Asthma Assistant programs—software applications that are customized to address the needs of a particular patient population.

“Our job is to figure out what the clinical team is trying to do clinically so that we can then support that with our technology,” says Peter Boland, PhD, business development director at BeWell. “So it really gets down to understanding what are the underlying drivers, the underlying symptoms, and the underlying triggers that relate to [the condition and population.]”

By mapping out all of the various symptoms and issues that are important to a clinical team to monitor and manage in a given population, Boland says BeWell can then design the software so that it regularly prompts patients to provide feedback about these matters of concern.

Once the patient has inputted his or her responses, the data are transmitted to the BeWell server, where they are analyzed according to parameters that have been established ahead of time by the clinical team. The analyzed data are then transmitted to the caregiver server so that care managers can see which patients are most at risk for exacerbations and therefore require priority attention.

“This gives the nurse case manager information on how to organize [his or her] day and [his or her] time and what needs to be done in terms of intervention,” says Boland. In addition to keeping caregivers apprised of the clinical matters that they have stipulated, patients receive almost instantaneous feedback every time they submit answers to questions, says Boland. This information ranges from motivational messaging and education about their condition to trend reports that provide a graphic representation of the data that have been collected for the past week or month.

“What we are really trying to do is get people to self-manage their disease. That is the real key, and that means they have to have more information about their illness and what they can do about it, and they have to be motivated,” says Boland. “We are not just talking about avoiding the ER but [making sure that patients] are on top of their illness, managing their condition, and leading full and productive lives. There are very tangible rewards.”

Although BeWell has customers already using both of its initial applications for patient care as well as for research purposes, Boland acknowledges that the pathway to reimbursement is a continuing challenge.

“We are in discussions with some very large DM vendors, and what it comes down to is the ROI,” he says. “They just don’t have the sense yet of just how powerful this ubiquitous technology can be in healthcare. We are trying to amass the documentation to answer those questions.”

Reimbursement remains a stumbling block to comprehensive care

New centers aim to provide DM-style, multidisciplinary care to people with ADD/ADHD

The conditions most often referred to as attention deficit disorder (ADD) and attention deficit hyperactive disorder (ADHD) affect anywhere from eight million to 12 million Americans, according to some estimates. However, a large percentage of these individuals has never received a proper diagnosis, and many experts suggest that even those in treatment for the condition are often receiving less than optimal care.

Part of the problem is that both children and adults with ADD/ADHD often have other, related problems as well, ranging from specific learning disabilities to behavioral health problems such as depression and anxiety.

In most of these cases, treatment requires much more than a visit to the doctor’s office or a prescription or two. Rather, it may also require ongoing involvement on the part of teachers, coaches, therapists, and other specialists.

Given that these needs do not fit easily into the traditional healthcare delivery model built around 20- minute office visits with a single provider, a group of specialists has begun to offer an alternative approach that attempts to deliver under one roof all of the different forms of care that a person with ADD/ADHD might need. Now available in four cities, with plans for rapid expansion in the near future, ADD Health and Wellness Centers are not only attempting to give patients and their referring providers the kind of multidisciplinary approach to treatment that guidelines recommend, but also collecting the kind of data that the company’s founders hope will soon give providers more definitive answers about the types of therapies that are most effective for this unique population of patients.

Care is fragmented

The healthcare challenges that go along with ADD/ ADHD are strikingly similar to the difficulties associated with other chronic conditions that require multidisciplinary care, according to Robert Baurys, who is now the CEO of ADD Health & Wellness Centers but previously built a company focused on providing care to patients with fibromyalgia and fatigue. “Like our previous business, the number of people who are diagnosed, or are in the process of being diagnosed or misdiagnosed is almost identical,” he says. Further, he emphasizes that in both cases, the highly fragmented nature of healthcare in this country is a huge obstacle to effective treatment.

With respect to ADD/ADHD, Baurys points out that it is typical for there to be several practitioners who don’t talk to each other working with a family. “It is an enormous disconnect, and our firm belief is that people are willing to pay a premium if services are very coordinated and customized to their needs.”

Whether the approach will be successful remains to be seen, but Baurys points out that the four ADD Wellness Centers now open in Boston, Dallas, Austin, and Houston, have amassed a caseload of 700 patients in a little more than five months. And although referrals are coming from traditional providers, school guidance counselors, and even employers, the lion’s share of families working with the centers comprises families who initiated contact themselves.

An accurate diagnosis is essential

It seems logical that the first step in working with a new patient is getting an accurate diagnosis, but this is a task that is not always done well in the community, according to Theresa Lavoie, PhD, the director of psychology services at ADD Health & Wellness Centers. “For us, that means understanding what symptoms are [attributable] to ADHD and which symptoms aren’t,” she says, noting that many conditions, such as sleep disorders, for example, are associated with attention difficulties but are not ADHD. “Additionally, very often what is co-occurring with ADHD, such as depression, anxiety, or a learning disability, is overlooked and not treated.”

To get an accurate diagnosis, Lavoie explains that most patients will undergo a comprehensive neuropsychological evaluation, a process that includes a variety of standardized tests and procedures designed to give clinicians a good sense of an individual’s cognitive and behavioral abilities. “This always begins with an extensive assessment of someone’s history, so we are looking at clinical history, family history, medical history, academic history, and a general sense of current functioning,” says Lavoie, noting that this initial phase of the evaluation is typically conducted by a psychologist or social worker.

Some patients will not need any further evaluation, but in many cases, patients will then be referred on to a neuropsychologist, who will administer an extensive battery of tests to, among other things, identify discrepancies between an individual’s capabilities or IQ and his or her academic or work-related performance. “[This part of the evaluation] also looks at attention very thoroughly,” adds Lavoie. “We are looking at sustained attention, divided attention, the ability to shift one’s attention, auditory attention, and visual attention.” This is particularly important, she stresses, because many people with ADD/ADHD have difficulty with organization, time management, problem solving, and higher-order reasoning.

Treatment planning emphasizes strengths

The results of the neuropsychological evaluation will determine what interventions come next for most patients. In the case of children or teenagers, Lavoie notes that these interventions often include contacting the school system to request certain accommodations and working with parents to help them understand their child’s needs both in the classroom and at home. Additionally, many patients are referred to a physician for further evaluation—especially in cases in which the psychologist or neuropsychologist believes that medication may offer some benefits.

“Very often, parents are resistant [to putting their child on medication],” says Lavoie, but she still often makes the referral so that parents can, at least, become more educated about when medications can be helpful or not helpful, and get their concerns addressed. In addition, Lavoie points out that physicians also conduct nutritional assessments, offering families guidance about dietary strategies that can help patients compensate for their difficulties with attention. For example, although skipping breakfast can affect anyone’s energy level, Lavoie stresses that these difficulties are exacerbated in a person with ADHD. Similarly, she explains that by guiding families toward more proteins and less carbohydrates, patients can avoid some of the spikes in energy, characteristic of some people with ADHD, that are typically followed by emotional valleys or what Lavoie refers to as “crashes.”

Beyond the initial evaluations and consultations, Lavoie notes that most patients continue to come to the ADD Health & Wellness Centers as often as once or even twice a week for therapy or coaching or to attend regular support group meetings. In many cases, these activities are aimed not so much at providing treatment but rather at helping patients develop strategies they can use to overcome the obstacles that go along with ADD/ADHD.

Lavoie refers to the larger process surrounding these activities as asset-based treatment planning. “What we are talking about is helping people understand what their strengths are and how to use them to maximize their performance, achieve their goals, and to function most effectively,” she says.

This may involve helping a child or teenager break down large tasks into small pieces that they can accomplish over time. In the case of an adult, it may involve assistance with career planning.

Interestingly, although most people associate ADD/ ADHD with children, Lavoie estimates that 40% of the company’s patients are adults. Many of these individuals have difficulty holding a job, and others may be highly successful at work but have experienced years of difficulty with managing relationships in their personal lives.

Curiously, Lavoie notes that a high percentage of the adult patients who come to the centers for help are entrepreneurs. “If we have a group of 10 people, in almost every instance, seven or eight will be self-employed,” she says. “They may be very successful but struggling with an aspect of ADHD.” 

Adults with ADHD come with complications

Treating adults with ADD/ADHD often comes with extra layers of complications, according to David Rabiner, PhD, a senior research scientist at Duke University in Durham, NC, who has done extensive work focusing on interventions for ADHD. “For many adults, they didn’t just develop ADHD; they have had it throughout their lives, and in the absence of any treatment, that often leads to a variety of difficulties,” he says, noting that issues such as depression, anxiety, and substance abuse are not uncommon in these individuals, and they need to be addressed along with the core ADHD.

In addition, Rabiner points out that clinicians usually don’t have the same kind of insight into how the person has functioned throughout his or her life or access to as many sources of information with an adult patient. “When you are [dealing] with a child, you often know how they are doing because you have the child there, and you are speaking to their parents and teachers,” says Rabiner. “But when you are speaking to a 25- or 35- year-old adult, your only source may be that adult.”

Despite a growing awareness of ADD/ADHD in adults, Rabiner suggests that internists may not be as attuned as pediatricians are to the problem. And he notes that there is no question that there is a large population of undiagnosed adults who could benefit from treatment.

Consequently, although Rabiner is not involved with the ADD Health & Wellness Centers, he believes that the idea of offering a cadre of care services and interventions, all coordinated from a central location, is attractive in the case of both adults and children.

“In many communities, if parents want to get good, state-of-the-art evaluation and treatment for their child with ADHD, they just don’t know where to go,” he says. “There are some pediatricians who do an excellent job with this, but there are others who just don’t have the time or experience to do that, and there are many kids with ADHD who have more complex kinds of cases where a multi-model approach that incorporates a number of different interventions may be quite necessary.”

Outcomes data will offer specifics

Finding state-of-the-art care is difficult in many communities, but the biggest obstacle to effective diagnosis and treatment of ADD/ADHD may well be the reimbursement policies of payers.

Although some children with less complex cases respond well to medication or straightforward behavioral therapy, Rabiner points out that few traditional practitioners have the time to carry out the kind of thorough, comprehensive approach to evaluation and treatment recommended in guidelines that have been established by the American Academy of Pediatrics.

Although the ADD Health & Wellness Centers do not submit claims but rather provide clients with the appropriate paperwork to handle that aspect themselves, Lavoie acknowledges that clients have had great difficulty obtaining reimbursement for neuropsychological evaluations and some of the other services as well. Also, Baurys points out that clients with preferred provider organization coverage tend to have better success at obtaining out-of-network reimbursement for services than do clients with HMOs.

However, by collecting and publishing outcomes data, Baurys is hopeful that traditional payers will ultimately see value in the multidisciplinary approach offered through the centers. To assemble these data, personnel from the centers plan to test clients at no charge every 90 days, looking at parameters that correlate highly with attention as well as depression, anxiety, quality of life, and self-reported symptoms.

When this information is reported in conjunction with financial data, Baurys believes that traditional payers will take notice.

“When people come to us . . . we see how many tests they have had, how many times they have been to different therapists, and how many medications they have changed back and forth. You just see an enormous waste in the system,” he says. “I think as we publish our outcomes data, and we can show specifics . . . about what people are getting, we will have a much firmer foot to stand on in terms of validating [our position] in the marketplace.”

Strategies aim to support PCPs and target gaps in care

Medicaid programs find opportunities for improvement in complex patient populations

Aged, blind, and disabled (ABD) Medicaid beneficiaries are among the most complicated and expensive patients to manage. Although they account for less than one-third of all Medicaid enrollees, they are responsible for nearly three-quarters of the agency’s healthcare spending.

However, this population also presents multiple opportunities for cost savings, according to Melanie Bella, senior vice president of the Center for Health Care Strategies (CHCS) in Hamilton, NJ. Speaking during a teleconference cosponsored by CHCS and the Government Innovators Network at Harvard University’s John F. Kennedy School of Government in Cambridge, MA, Bella stressed that realizing sustained financial benefits from this population requires strategic vision rather than simply slicing reimbursements and services.

“These [strategies] are not getting at the root cause of spending, which really has to do with utilization, whether it is misuse, overuse, or underuse of services,” she said. However, what can work, according to Bella, are quality improvement interventions that are targeted toward the true drivers of healthcare spending in this population. And as subsequent speakers at the conference illustrated, this is where effective case finding, DM, and comprehensive solutions can make a significant dent in both clinical and financial returns.

P4P program drives improved outcomes

The teleconference “Medicaid Best Buys: Managed Care Models for Aged, Blind, and Disabled Beneficiaries” was held on May 29 and was the fourth in a series of CHCS-sponsored presentations focused on disseminating strategies that the organization believes can offer the most powerful returns—from both clinical and financial standpoints.

David Kelley, MD, MPA, chief medical officer for Pennsylvania’s Department of Public Welfare, outlined several strategies that his state has implemented as part of Access Plus, a fee-for-service program operating in 42 rural counties and covering about 290,000 lives. “In this model, we are trying to establish for both kids and adults a medical home,” said Kelley, describing the program as an enhanced primary care/case management model. However, because the population includes a high percentage of recipients with chronic diseases and other complex healthcare needs, a primary focus of the model is to provide support, in terms of specialty care and care coordination, to PCPs who are the centerpiece of the medical home concept.

Consequently, the state has put in place a complex case management unit, including 24 full-time RNs, to help manage and coordinate care for those patients with highly complex needs. In addition, the state is working closely with McKesson Health Solutions, a Broomfield, CO–based DM vendor that is providing services to patients with diabetes, coronary artery disease, CHF, asthma, chronic obstructive pulmonary disease, and the array of comorbidities that typically go along with these diseases.

“McKesson mainly uses a telephonic model [originating] from both Colorado and Pennsylvania, but there are also community-based nurses involved as well as community- based, nonclinical care coordinators in the field to help coordinate services,” said Kelley. “The other thing that is very important in working with McKesson is the coordination between their DM nurses and our special needs unit nurses, because many times, they are handing off cases to one another.”

To get providers engaged in the DM process, McKesson also oversees a pay-for-performance (P4P) program that applies chiefly to PCPs who provide a medical home for Access Plus patients. “We are paying providers to assist with DM enrollment and for identifying appropriate candidates for DM,” said Kelley. In addition, providers can receive P4P funds for encouraging patients to participate in DM, for participating in care plan development, and for completing certain disease-specific evidence- based care practices.

“We pay for the additional effort that we know goes on in the care of very complex patients,” said Kelley. And 12-month data suggest that the approach is delivering improved clinical outcomes on a number of measures.

In addition, Kelley noted that half of all DM participants dropped from level three, the highest severity level of illness, to level one or two. And he pointed out that conservative calculations suggest that one-year cost-savings from the DM program are in the $27 million range. “We feel confident in that number. We feel [it represents] true cost savings attributable to the DM population,” said Kelley, adding that the ROI was about 1.3.

IT system links critical data sources

Noting that the typical ABD high-utilizer has no PCP or medical home and frequently uses the ER for primary care, it is easy to see how expenses pile up for these complex patients, particularly when you consider that there is often very little information linking these various points of utilization and no integration of pharmacy, laboratory, or behavioral health data, explains Coleen Kivlahan, MD, MSPH, senior vice president of medical affairs for Schaller Anderson, Inc., an Arizona-based healthcare company that manages more than 100,000 ABD recipients in several states. This is precisely why Schaller Anderson decided to invest heavily in IT with the aim of finding out who these patients are and where opportunities exist for improved care coordination, added Kivlahan.

The process begins with predictive modeling software that Schaller Anderson uses in concert with pharmacy data, and a series of risk tools to identify which patients are at highest risk. “We are looking at 12-month claims costs across the board, including labs, durable medical equipment, procedures, and pharmacy. And then, finally, we look at care gaps or evidence-based care concerns or considerations for these patients,” said