Disease Management

CFS is one of a number of diseases with an uncertain etiology and a substantial effect on patients but with few or no verified treatments

William Atkinson

According to the Centers for Disease Control and Prevention, chronic fatigue syndrome affects between 1 and 4 million Americans. At least one fourth of these are unemployed or on disability because of CFS. Yet according to the CDC, only about half of those thought to suffer from CFS have consulted a physician for their condition.

Primary symptoms include unexplained fatigue for six months or more, in addition to any number of the following: cognitive dysfunction, postexertional malaise lasting more than 24 hours, unrefreshing sleep, joint pain without redness or swelling, persistent muscle pain, headaches of a new type or severity, tender lymph nodes, and sore throat. There are more than a dozen other less common symptoms.

Health plan medical directors find the situation vexing. “Like all managed care organizations, Independence Blue Cross struggles with establishing appropriate coverage policies and clinical programs to address conditions in which there is considerable clinical controversy,” says Donald Liss, MD, the plan’s senior medical director of clinical programs and policy. “Conditions such as chronic fatigue syndrome are particularly challenging because of the nonspecific nature of the diagnostic criteria, the lack of objective studies to confirm a diagnosis, and the wide spectrum of therapies prescribed.”

Clinical executives aren’t the only ones frustrated, says Robert McDonough, MD, the head of clinical policy research and development at Aetna. “Treating physicians are struggling to come up with cures,” says McDonough.

In addition, medical directors must consider the role medication should play. “Many of these people have concurrent psychiatric disorders such as anxiety and depression,” says McDonough. “It’s not that chronic fatigue syndrome is caused by depression or anxiety, but depression and anxiety frequency coexist, and treatment of these psychiatric problems will better enable the patient to cope with the chronic fatigue syndrome.”

CFS in the literature

It has been estimated that more than 800,000 adults suffer from CFS in the United States. The annual direct cost could be more than $8,000 per patient, with the total direct cost to society as high as $7 billion.

According to Charles W. Lapp, MD, at Hunter-Hopkins Center in Charlotte, N.C., most people who complained of the symptoms of CFS before it was officially defined in the late 1980s “were considered to be hypochondriacs or crazy, because there are so many symptoms and so many systems involved.” Lapp specializes in treating CFS.

What got people interested in it again were several outbreaks in the early 1980s, including one in Lake Tahoe that got a lot of attention. “It was written up in Rolling Stone magazine and labeled the ‘yuppie flu.’” This was right after AIDS was identified. “As a result, the CDC became very interested, wondering if it was ‘AIDS Minor.’”

McDonough says that, as of right now, CFS is a “diagnosis of exclusion,” meaning that it can be made only after other medical and psychiatric causes of chronic fatigue have been excluded.

“The CDC recommends performing a thorough history and physical and some basic laboratory tests to rule out other common causes of chronic fatigue,” he says. “These include a blood count with differential, an erythrocyte sedimentation rate, a chemistry screen, and a thyroid stimulating hormone level. Additional testing may be necessary based on the history and physical and basic laboratory tests. It is only after a negative workup for other common causes of chronic fatigue that you would come to the conclusion that someone has chronic fatigue syndrome.”

While there are no formal diagnostic methods, there are criteria that are based on subjective symptoms, according to Tanya Edwards, MD, medical director of the Center for Integrative Medicine at the Cleveland Clinic. The primary symptom is unexplained, persistent, or relapsing fatigue for at least six months. Then, four or more of eight additional symptoms must persist or recur during six or more consecutive months and not predate the disease. These are:

• Impairment in short-term memory or concentration
• Sore throat
• Tender lymph nodes in the neck or armpits
• Muscle pain
• Joint pain without redness or swelling
• Headaches of a new pattern or severity
• Unrefreshing sleep
• Post-exertional malaise lasting more than 24 hours

McDonough says that, “They usually have been very highly functioning individuals, and then something happens, sometimes an infection, and they’re suddenly wiped out. It’s like they’re struck down.”

According to Edwards, before making a CFS diagnosis, physicians should first check for an untreated low-grade infection, which can have similar symptoms. There is also significant overlap with fibromyalgia.

Health plan perspectives

At Capital District Physicians’ Health Plan (CDPHP), the thinking is that CFS, as defined in the scientific medical literature, is a real syndrome, and the plan does cover evidence-based care. “We treat this the way we would any other condition, in that we make sure the diagnosis has been appropriately made and that the proposed treatments fall within the scope of what the scientific literature supports,” explains Clifford R. Waldman, MD, senior medical director.

There have been some studies of medications specific to CFS. Currently, though, the plan pays for drugs that are designed to treat the symptoms, such as antidepressants, pain medications, and sleep medications. “One thing we realize is that because a drug is labeled an antidepressant doesn’t mean that it only treats depression,” he continues. “For example, antidepressants will alter sleep patterns. As a result, they have functionality in treating a number of different things, including a number of different chronic pain syndromes.” Thus, he notes, even though it isn’t fully understood how they work, there are some studies showing the effectiveness of antidepressants for CFS.

Scientifically-based treatments

Waldman says it is important to be sure that the people treating CFS be qualified and use scientifically-based treatments. “It is always important to identify instances of either the use of treatments that are not scientifically supported or overuse of treatments that are scientifically supported.”

In fact, he says, this is an area that can be subject to abuse. “One concern we have is that it is very easy for a provider to treat CFS with alternative treatments, without scientific evidence, and to end up with anecdotal evidence that they are working,” he states. “After that, they continue these treatments, claim expertise in the field, and encourage people to come to them, even though they don’t have any studies to show that what they are doing is effective.”

It’s crucial for clinical executives to follow an evidence-based approach, says McDonough. “We’re continuing to follow the medical literature on chronic fatigue syndrome. The hope is to better elucidate the cause of this condition, whether it is infectious, immunologic, neurologic, psychological, or of some other etiology. Knowledge of the cause of chronic fatigue syndrome will lead to more effective treatments.”

For Health New England, though, CFS coverage is a bit more sticky. Is CFS a legitimate diagnosis? “Sort of,” replies Thomas Ebert, MD, vice president and chief medical officer. “It is a legitimate condition from the perspective that it is a diagnosis, and that there are codes,” he explains. “It is also linked to fibromyalgia and certain chronic viral conditions.”

Unlike diseases that have very specific laboratory or clinical descriptors that can be used to make a diagnosis, it is more difficult with CFS, where there are fewer of these kinds of markers, Ebert says. “This is one reason these patients are difficult to treat, and it is difficult to affect the course of the illness,” he adds.

As a result, there has been a lot of epidemiologic work done on patients with CFS, who often have gone from doctor to doctor and had relatively high use of the health care system.

“Because of the chronic nature of CFS, this is usually not the kind of patient that does well seeing primary care physicians who are scheduled to see patients every 10 to 15 minutes,” Ebert explains. “As a result, these patients often end up going to specialists, and often lend themselves to receiving a team approach to care, including clinical medicine and behavioral health.” In some cases, though, Ebert says, the patients just learn to live with what they have.

So does Health New England consider CFS a legitimate diagnosis? “It is less important for us to consider it than it is for our network providers to consider it a legitimate diagnosis,” he replies. “It usually doesn’t rise to the level of a disease state where we dedicate a lot of resources, so there won’t be a disease management program, as there would be for people with chronic diseases.” However, he adds, some patients with CFS may end up using some of the health plan’s case management services intermittently.

In Ebert’s experience, some patients may also want to see physicians who are not in the health plan’s network. “My experience is that they don’t have any more success when they go outside the network than when they stay in the network.”

The condition is probably legitimate, he adds, but with caveats, because there are people who have many symptoms or complaints, not all fitting CFS. “However, let’s say that we have a cohort of people who meet these conditions for the long term. This subset seems to be real. These are people who have symptoms that clearly interfere with their lives, families, and work.”

These people do tend to use a fair amount of medical services for a while. “After that, though, they tend not to, because they don’t get cured, so they just try to learn to get along,” he continues. “This is what drives them to seek providers outside of the network, including alternative care providers.”

Coverage denied

In such cases, Health New England denies coverage, except in cases where a primary care physician or specialist in the network advocates sending the person outside the network. “If this is the case, we generally support it,” he states. “If the care they receive outside the network isn’t any more helpful than the care they got inside the network, they probably aren’t going to use much of that out-of-network care anyway.”

Managing Editor Frank Diamond contributed to this article.

“I think there’s a general agreement that it is a true syndrome,” says Robert McDonough, MD, the head of clinical policy research and development at Aetna.

When we truly begin to manage the person and not the condition, there will be payoffs on both the cost and quality fronts

Emad Rizk, MD

Managing the care of members with chronic disease — especially those with multiple conditions — is one of health care’s most confounding and costly challenges. As an industry, we have come up with many valid approaches — case management, disease management, utilization management, nurse triage, and health coaching/wellness initiatives. But in nearly every health plan, these initiatives are kept in their own silos, rather than put to use in a collaborative way that meets the needs of members.

The result is that care management falls far short of its potential. We wind up with duplicate efforts and costs, low member and provider engagement, and missed opportunities for intervention. Care management — done right — can improve quality and reduce costs. We must approach care management in a more holistic fashion. And we now have the tools and the understanding to do so.

Care management involves assessing individual needs to create a coordinated plan of care that is consistent with agreed priorities. It is designed to bring optimal outcomes using cost-effective care. Historically, health plans invested in core solutions that addressed different points along the care continuum. Looking back now, we see how each was developed to address a need identified at that point in the evolution of managed care and how each solution was limited by the technology of the day. Programs and systems designed for a certain purpose did not interact with other systems. They were uncoordinated.

There has been value in this care management work, but today we have an array of siloed programs that are misaligned, often duplicative, and far less effective than if they worked in a coordinated fashion. Today we live in a care management world that has:

• Multiple care management tools
• Different, incomplete data streams
• Programs run by a diverse set of care managers, providers, and outsourced vendors
• Inefficient workflows/processes intended to share member data and coordinate outreach among these stakeholders
• Programs that are not connected, even when they target the same member

Connecting across the continuum

It is clear that we need a more holistic approach to care management. By holistic, I mean addressing all aspects of a member’s care needs — not just the disease processes and acute episodes. We need to consider the psychosocial and financial problems that affect a person’s ability to manage his or her health. And we must use the same principles of care management along the full continuum of care. All of this calls for a clean break from our reactive and fragmented approach to delivering care, which has been costly and rife with missed opportunities to improve member health.

What we need — and is too often missing — is rapid access to data that can help the full range of stakeholders identify when patients are veering off a treatment path or need adjustments in their care plans. The data currently available are too often separate from important and relevant facts that could identify opportunities to improve member outcomes. The solution is to connect data sources, audiences, and initiatives across care management disciplines. An approach that brings data sources together will break down the existing silos and deliver greater value and better outcomes.

When I use the term holistic care management, I think about how care initiatives, from a member’s vantage point, should comprehensively address his range of needs. From the plan’s vantage point, I think of integrated care management, wherein tools integrate the varied data streams and present a complete view of the member.

Triple-A approach

To optimize health, all stakeholders must work in partnership across the care continuum, with a system capable of supporting shared objectives. It is helpful to think of a “three As” approach:

Align the key stakeholders: Create transparency and coordination of information among all relevant providers, the patient, and the plan. Develop a structure of aligned incentives among providers, patients, and plans. Clearly define shared goals based on common and accessible information.

Automate the processes: Your workflow software should integrate utilization, disease, and case management. At the core, messages should create workflow. Send data, such as notice of an unfilled prescription or a worrisome lab result, to all relevant parties, and create an opportunity to keep the patient on a stable medical course. This allows health professionals and care managers to spend their time caring for and engaging with patients rather than scurrying around to collect and organize data. Automation that sends relevant messages to the right stakeholders creates the information transparency that supports aligned action toward common goals.

Activate the member: Bring the patient into active involvement. First create a care plan that truly addresses the whole individual and that provides patients and their support systems with the necessary information and resources to be active, engaged, and compliant with the plan of care. Multimodal communication tools are needed to reach members when and where they are ready to be engaged.

I envision the ideal care management system as a wheel. The hub is the workflow engine — a rules-driven workflow system. Information flows into the hub from many sources, which are the spokes, and back out to the various constituencies. The many spokes include:

• Clinical decision support tool
• Automated authorization and coverage determination tool
• Personal health record
• Member biometric data from home monitoring
• Multimodal communication channels to and from members, providers, and plan
• Health/wellness support mechanisms
• Electronic medical record
• Utilization management
• Disease management tool
• Population assessment tool
• Analytics
• Predictive modeling for gaps in care

Most organizations can leverage existing elements by integrating them with one another. Creating paths along which data may flow can lead to additional automation and workflow process improvements to reduce administrative costs.

All stakeholders benefit. Providers have greater access to real-time authorizations and point-of-care pre-authorizations and can view status updates on individual patients without contacting their plans. Payers can more readily assess populations overall to target high-risk patients for enrollment programs. Payers also can view data to assess provider performance and can then modify contracting and payment terms. The member benefits when the plan becomes an information broker. The plan can use the data to make timely adjustments to care plans and can execute new tasks through coordinated outreach. The payer also can play a role helping providers deliver more appropriate care to members, which has medical benefits for members and economic benefits for providers.

The challenge of Edna Jones

Let’s look at what holistic care management would mean for Edna Jones, 68, who represents the 10 percent of patients in the United States who account for 70 percent of all health expenditures. She has congestive heart failure and a history of diabetes and high blood pressure. In this scenario, Edna arrives at the emergency room with shortness of breath or weakness and is treated for decompensated heart failure. Medications are given to reduce fluid volume and improve oxygenation. Edna’s nurse reviews her medications with her and then sends Edna home. Perhaps Edna’s primary care physician is notified a few days later about the episode. Without any other action to alter the course of events, the likelihood of a similar episode in a few weeks is very high. A seemingly insignificant action, such as eating some potato chips before bed, may be enough to get Edna back in the emergency room.

Holistic care management might prevent the ER visit in the first place. With a good system in place, a care manager would routinely view the pharmacy data to know whether Edna was filling her prescriptions, and the data from home monitoring devices that would show whether blood pressure or weight was creeping up. Authorization or notification data would show Edna’s care encounters in real time. Anything amiss, including a high-cost profile, could trigger immediate outreach to Edna, to ask her how she was doing and to initiate action — nutrition counseling, perhaps, or education about medication use. This approach could prevent Edna’s deterioration in health and the utilization of costly medical resources, like the ER.

If Edna needs a knee replacement, the situation becomes more complex and the risks increase. With holistic care management, the care manager would be aware of the authorization request or notification, which would trigger a workflow to ensure that discharge planning takes into account Edna’s medical needs, as well as post-surgical ones. Does she have transportation to pick up her meds? Should a nurse check on herw An integrated system makes it possible to put these pieces in place to head off problems even before the surgical claim streams in.

At my organization, we have learned that such integration of information can reduce administrative costs significantly. For example, automation can reduce authorization-related administrative costs by 50 to 70 percent. Care coordination workflow software reduces the need for staff to enter double documentation in multiple systems or data collection tools such as Excel and Access. We see decreased staff time spent creating case and disease management plans and generating letters. And, it vastly reduces staff time spent on the 60 to 80 percent of pre-authorizations that could be automatically approved in real time. Care managers are more efficient when automatic notifications and online authorizations replace phone calls and faxes. The frustration level also drops for all involved. Also, staff members are freed up to practice “exception-based” utilization management, applying their expertise to only requests that require personal review and intervention.

On the path

Integrating clinical decision tools into the workflow also reduces inappropriate medical expenditure. Centralization of information reduces duplication of testing and administration. Integration of data can target populations and individuals for disease management enrollment, and start those members on a path of improved health and diminished need for the most costly intervention.

The value of holistic care management lies in the linking of data, people, and processes. Every stakeholder who contributes data or receives insights from data can help to change the course of events to improve a member’s health. All can reach clarity very quickly on identifying opportunities to improve a member’s care and how to act on those opportunities. A care manager who can see a complete picture for each member without needing to access multiple applications will spend more time engaged with members rather than with the system. That care manager will be freed up to work with more members.

Ultimately, the best care management is propelled by effective and streamlined interactions that address the member holistically. It engages members in their own care. Plans that do not activate members can only do so much on the member’s behalf. It is the engaged, activated member who can then help to manage his or her care, as well as the associated medical costs.

Emad Rizk, MD, is president of McKesson Health Solutions.

The best care management is propelled by effective and streamlined interactions that address the member holistically, says author Emad Rizk, MD. Without that, plans can only do so much.

The value of holistic care management lies in linking the data, people, and processes that can improve a member’s health.

Some question disease management’s cost-effectiveness, but major insurers have seen enough to induce them to expand programs

Frank Diamond

Managing Editor

We’ve grown accustomed in the last year and half to seeing seemingly invincible corporations and even entire industries suddenly find themselves wishing that the government would slap a “too big to fail” label on them. Most companies, however, still swim or sink in Darwinian waters where only the fittest survive.

There is no doubt that the approximately $2.5 billion disease management industry shoots the rapids these days. Skeptics are everywhere, even though some of the best health plans in the country tout their success at managing diabetes, congestive heart failure (CHF), coronary artery disease (CAD), and chronic obstructive pulmonary disease (COPD) and are branching into other areas. (There is serious debate about how cost-effectively asthma can be managed. See “Value of Asthma DM Disputed,” below.)

A direct hit in a February 4 Business Week article titled “Take Your Meds, Exercise — and Spend Billions” asserted that the cost-cutting advantages of DM have been, to put it tactfully, overstated. Then there was the little matter of the eight Medicare DM pilot programs that were supposed to measure how much money can be saved. They were launched under the Medicare Modernization Act of 2003, but last year the Centers for Medicare & Medicaid Services pulled the plug on them because the agency failed to see any positive results.

Medicare pilot programs

Ariel Linden, DrPH, MS, president of Linden Consulting Group and a widely published researcher of DM outcomes, recalls: “Medicare said, ‘All right, we don’t know if it works or not; the literature doesn’t say you work. We’ll create these randomized control trials. We’ll give you 20,000 patients. And we’ll have 10,000 controls. We’ll let you guys run with it.’ And guess what? None of them were effective. Some of them dropped out early when they saw they weren’t working. The rest just fell flat on their faces.”

Al Lewis, JD, president of the Disease Management Purchasing Consortium, who for the most part represents the employer purchasers of DM, not the providers, agrees that DM faces a perception problem. “It’s not enough that GM makes good cars now,” Lewis observes. “For a quarter of a century they made lousy cars. So you can’t just say, oh our cars are good, and expect people to start buying them.”

Gordon K. Norman, MD, is the chairman of the board of DMAA: The Care Continuum Alliance, formerly the Disease Management Association of America. He says that there may have been too much emphasis in the past on the industry’s cost-saving value as opposed to how it improves outcomes.

“I mean no one goes to a doctor to save money,” says Norman. “No one goes to a hospital to save money. Health plans don’t invest in the things they pay for to save money. But when it comes to health management services or DM, suddenly the amount of health improvement seems to go out the window and the amount of savings becomes the only thing focused on.”

To underscore how difficult things have become, it need only be noted that Linden, Lewis, and Norman are three of DM’s biggest boosters.

Still, don’t start looking for obituaries of DM providers. Patients with chronic disease account for 75 percent of overall health spending, according to the Centers for Disease Control and Prevention, and 99 percent of Medicare spending, according to Johns Hopkins University. Many plans still consider DM one of the best methods for taking on those daunting numbers, certainly in terms of the clinical processes it employs. But does it save money?

Norman offers a clue. “The fact is that it is a two-and-a-half billion dollar industry of outsourced health management programs and I don’t think that would be the case with all the steely-eyed, green-shaded CFOs and actuaries of corporate America looking on.”

Cost avoidance

There are two reasons to want DM programs for CHF, CAD, diabetes, and COPD, Lewis says. First, the cost-avoidance benefit is great, compared to how much it costs to control the condition. Second, these conditions, by and large, are not well-controlled outside of DM programs.

“Generally speaking, for disease management to work, there have to be many avoidable admissions — admissions that are avoidable by better outpatient management, where you don’t throw money at the outpatient management, ” says Lewis. “That can happen with these four and with some of the suite of rare diseases.”

Those four diseases are the ones that are “with the patient for a longer period,” says Burton I. Orland, RPh, a consultant and member of MANAGED CARE’s Editorial Advisory Board. Managing them won’t be “an overnight success, so the HMO sees improvements over a longer period. Patients tend to stay with their MCO because of a successful DM program, so there is a value to having the MCO’s nurse case managers also follow up with the patients.”

So if DM successfully manages those four, can that success be replicated with other diseases?

A study in the December 2007 issue of the American Journal of Managed Care (see “For Further Reading,”) suggests that many in the DM industry believe that it can. The study says that “although disease management programs have traditionally focused on more severely ill patients with common chronic conditions such as diabetes mellitus … and congestive heart failure (CHF), more recently the scope of disease management has expanded to include programs aimed at all patients with a condition regardless of severity (commonly referred to as population-based disease management) and at patients with rare and costly conditions (e.g., hemophilia and autoimmune disorders).”

Judith Frampton, RN, MBA, vice president for medical management at Harvard Pilgrim Health Care, says that in some ways, DM is a victim of its own success. “Why is it that diabetes disease management programs or cardiac disease management programs aren’t creating the return on investment yield that they once did? The reason is that doctors who weren’t practicing evidence-based medicine and patients who didn’t understand self-management skills 15 years ago are practicing them now.

“Other factors have also contributed,” she says. “One example is that the kinds of drugs people have today that can help them lead active and healthy lives even though they have congestive heart failure just weren’t available 10 or 15 years ago. Pharmaceuticals and other kinds of procedures and technology have changed the face of the old DM, but the model of somebody taking the time to talk to people about what they may not know, and what they may not know about how to avoid complications, is really the approach.”

Diabetes numbers

Lewis agrees with Frampton’s assertion about DM being a victim of its own success in regions where people have good access to medical care, where the health plans are conscientious, and where there is a culture of health, as in eastern Massachusetts.

“There have been reductions in events for CAD because of better-than-usual care and prevention,” says Lewis. For the other conditions, the technology is improving, but more people are being diagnosed with some of these conditions. “Diabetes, for instance. What is actually pretty impressive is that the prevalence of diabetes is actually way up in the last 10 years, but the incidence rate for people going to the hospital for diabetes is actually about flat. So technology is making an impact.”

Lewis adds that good DM involves more than just making “a ton of outbound calls,” a phrase that draws a reaction from Linden akin to how a lion responds to a rare steak being waved before its eyes.

“We Americans love simple fixes, but this isn’t a simple thing,” says Linden. “The truth of the matter is that these patients are usually very complex cases and they have got five different chronic illnesses.”

Harvard Pilgrim’s Frampton disagrees, saying that “one outbound call is not the same as another. Our nurses are clinical specialists in the area that they are working in. They are not generalist nurses, though most of them are adequately trained [for that]. But to get the nuances of the drugs, to understand the specificity of the condition, you need a specialist.”

Further, Harvard Pilgrim’s nurses do motivational interviewing. “Our outbound callers are trained in behavioral change techniques, and that makes a difference. We measure whether or not the interaction has resulted in a care plan. The care plan has to have goals that the nurse would perceive as goals, but it also has to have goals that the patient would see as goals. All of that makes it a more effective interaction.”

By way of anecdotal evidence, Frampton has hundreds of e-mails, letters, and phone calls from satisfied members. “All health care is local,” says Frampton. “Our nurses are from the area. They know Dr. Smith; they know the drugstore on the corner. Some of the call centers from some of the disease management programs are nowhere near the people that they are calling. I’m not saying it is impossible to do it from a call center, but our nurses have accents like they are from Boston or they are from Maine. It makes a difference.”

Prochaska change model

Marla Tobin, MD, medical director for Aetna’s Mid-America Region, says that Aetna’s nurse callers use the Prochaska change model in trying to determine when someone is ready to adopt a healthy lifestyle. “Our nurses are taught the Ask-Me-3 technique — What three questions should I ask my doctor today when I go in to visit? So the patient has a pertinent agenda that he goes to his doctor with. He understands his medication and diagnosis. He understands what he must do next and to take charge of his life.

“There are disease-specific things that we want people to understand as well,” adds Tobin. “We want a person with congestive heart failure to weigh himself, to understand the importance of salt in his diet, to know how to get a blood pressure reading, either taking his own or having a nurse do it. We want the coronary artery disease patient to understand what the symptoms of heart disease are.”

This saves money, according to Aetna’s in-house ROI studies. A 2008 study compares members in the Aetna Health Connections disease management program with members with similar conditions who were not enrolled in the program. Company officials say that patients in the Health Connections program had 26 percent fewer inpatient admissions for diabetes, coronary artery disease, congestive heart failure, and stroke. Overall, the medical costs were 10 percent lower — $5,452 vs. $6,040 per patient per year.

Some of this comes down to helping patients follow their prescribed pharmacy treatment. Sure, more people taking more medications can actually cost the members, the employers, and the health plan money up front, but it winds up reducing hospital admissions in the long run, says Tobin.

She calls DM programs for diabetes, asthma, CAD, CHF, and COPD the anchors of the industry. “If you want to talk volume of patients, you talk about those,” says Tobin.

There are other conditions and diseases that are ripe for the sort of intense member assistance that DM provides. In fact, the plan manages 36 diseases through Health Connections. (See “Aetna Goes Whole-Hog for DM,” below.)

“Depression is huge if you look at the cost of treatment and the number of comorbid situations,” says Tobin. “We integrate our behavioral health with our medical just for that reason. The data support that 70 percent of heart attack patients have depression before, after, or during the time of their heart attack. There are high incidences of depression for people who are off work for a long time with a disability like back pain.”

Aetna’s DM effort is not only incorporating more diseases, it is also expanding demographically. “We have DM for both adults and children,” says Tobin, “because asthma, weight management, and sickle cell are the kinds of diseases that can affect kids and really change their lives.” While debate continues about DM’s effectiveness, the commonsense connections it makes have long been evident. “If you don’t deal with the depression as well as the back pain, you are not going to get the person back to work,” Tobin continues. “We manage to where the patient is today.”

Let’s say that somebody is more concerned with getting to her daughter’s wedding in May than in talking about diabetes today. “We talk to her about things she can do to be healthier between now and May,” says Tobin. “That may be a healthier lifestyle and may be controlling her lung disease or kidney disease or some other disease. As we win her confidence and get her toward that goal, then she is willing to let us help improve her diabetes.”

Coordination

Doing DM in-house allows Aetna to coordinate medical and pharmaceutical treatments more easily. For instance, patients with rheumatoid arthritis — another condition that has become a recent candidate for DM — might use injected anti-TNF agents.

“For appropriate use of such specialty pharmacy drugs, we want the member to really understand the right way to use the medication and how to control the disease,” says Tobin. “Those agents cost a lot of money and you want to use them wisely to make sure that the patient is doing the right thing for his rheumatoid arthritis to get the most benefit from the expensive drugs you are using.

“Same thing with some of the cancer treatments. Same thing with some of the kidney diseases. You want to make sure that lifestyle, exercise, other medical conditions, and drug use programs are dovetailed and the information is exchanged between them.”

Time is the ingredient that will decide whether diseases and conditions not traditionally managed by DM could be managed, says Jodi Aronson Prohofsky, PhD, senior vice president for health management operations at Cigna.

“You want to impact people while they are still healthy — before they become ill, especially chronically ill,” says Prohofsky, citing the work undertaken by Dee W. Edington, PhD, the director of the University of Michigan Health Management Research Center. “We know that the rewards that employers will see might be five to ten years out.”

Cigna has been working on a depression DM program for about four years.

“We’re not just asking people whether they are depressed while we’re working with them on other diseases,” says Prohofsky. “We already know that depression is comorbid with a whole host of other diseases. We are combing our data, utilizing our analytics to identify people who are depressed who may have bipolar disorder, who may have an anxiety disorder, and we are proactively reaching out to them to engage them in a full-fledged DM program.”

Traditional DM puts a lot of stock in behavioral change. The same approach should apply to depression — things like medication or other treatment plan compliance, for instance.

“Or planning for the relapse, for the time when you are not going to be as healthy,” says Prohofsky.

Not just the bottom line

Talking to Prohofsky about depression DM creates the impression that she could be talking about any DM program, which is the point, she says.

“There are conditions that you want to give priority because we know there is potentially a good return on investment, such as heart disease and COPD. But there is an expanding list of diagnoses we should be looking at, such as weight complications, because of morbid obesity, depression, and a whole host of other diseases.”

Those might be conditions that Cigna reaches out to beneficiaries about because patients may not know that they have them. “Maybe they don’t realize the risks associated with it. Maybe they have a track record of just not managing it very well. What if we just said, if you need any help with any illness whatsoever or, frankly, just to retain your health, what if you were free to call in to us and we will provide you the same resources to help you manage your health? That’s where we are today.

“Things like migraine headache, chronic stress, musculoskeletal pain, or other chronic pain syndromes,” Prohofsky continues. “Depression belongs in that category as well. Those are conditions that arguably are driving higher indirect health costs for many employers because of their prevalence more than the rare individual with heart failure who might be in that employer’s workforce. But for many employers, even non-Fortune 500 employers, some of these more prevalent, less severe conditions are nonetheless robbing them of productivity in a way that they are finding it cost-effective to invest in programs that help with these conditions.”

Lewis says that as DM begins to take on rare diseases, it is not so much a question of making people change their behavior as it is a question of making sure people have all the information.

“At this point if you are a health plan and you can’t answer a simple question like What is my heart attack rate per thousand today and what was it like five years ago, then you are not doing your job,” says Lewis. “All the valid methodology is based on measuring events.”

Tobin agrees. “I’ve worked for three managed care companies and there have been considerable differences between their programs,” she says. “The differences that you see in the literature may be the fact that you’ve got apples and oranges comparisons of what works and what doesn’t work. If it is done correctly in a well-run program integrated into your health plan, it does work well.”

Managing Editor Frank Diamond can be reached at [email protected]

Many focus on DM’s savings while concern for health improvement “seems to go out the window,” says Gordon K. Norman, MD, of DMAA: The Care Continuum Alliance.

Revenues (millions)

Management of rare diseases bright spot as DM industry’s growth slows

DM vendors continue to make money, but the rate of revenue growth has slowed in recent years, according to the study “Leading Disease Management Organizations: Fall 2009,” by Health Industry Research Companies.

“DM industry revenue growth appeared to flat-line in 2009, making last year the first time in five consecutive years that DMO revenues did not grow at a double-digit pace,” says Al Lewis, JD, president of the Disease Management Purchasing Consortium. The slowdown is attributed to the recession and to lower growth rates in DM programs managing cardiovascular and respiratory diseases. One positive: “Many of the nontraditional disease states for DM, including cancer, rare diseases, and maternity, experienced strong revenue growth.”

Growth in DMO revenue by disease state

Source: Health Industry Research Companies, Summer 2009.

Plans said to do DM best are expanding programs
Health plan	Major diseases or conditions historically managed	DM categories created in 2009
Blue Cross of Alabama	Common chronic, wellness, pain	Oncology
Blue Cross of Delaware	Common chronic	Wellness
Blue Cross Blue Shield of Florida	Common chronic, rare diseases	None reported
Blue Cross Blue Shield of Massachusetts	Common chronic, ESRD, rare diseases, asthma	Wellness, oncology
Blue Cross of Nebraska	Common chronic, wellness	None reported
Blue Cross Blue Shield of Rhode Island	Common chronic, health and wellness	Low back pain
Blue Cross of Vermont	Common chronic, plus “At Risk Suite” including hyperlipidemia, obesity, metabolic syndrome	Wellness
Boston Medical Center Health Net Plan	Common chronic	Depression
Capital District Physicians’ Health Plan	Common chronic	None reported
CareFirst	Common chronic plus ESRD, wellness, health coaching, lifestyle management	None reported
ConnectiCare	Common chronic, high-risk maternity, ESRD, complex case management, transplant case management	Wellness — HRA, health coaching outsourced to WebMD
Harvard Pilgrim Health Care	Cardiac, common chronic, oncology, rare diseases	High risk pregnancy
HealthPartners	Common chronic, rare diseases, complex case management, cancer, high-risk maternity, low back pain	Low back pain
EmblemHealth	Common chronic, ESRD, complex case management, high-risk maternity, rare diseases, pediatric diseases, NICU, HIV	None reported
Providence Health Plan	Common chronic, ESRD, cancer, inflammatory bowel disease, rare diseases, maternity, complex case management including transplant	None
Summacare	Diabetes, asthma, CHF	None reported
Source: “Leading Disease Management Organizations: Fall 2009.” Eighth annual report. Health Industries Research Companies, 2009.

Cigna these days is branching out to manage things like migraine and chronic stress, says Jodi Aronson Prohofsky, PhD, the plan’s senior VP for health management operations.

“One outbound call is not the same as another,” says Judith Frampton, RN, MBA, of Harvard Pilgrim Health Care, whose nurse callers are clinical specialists.

Depression is huge because it is comorbid with other conditions, says Aetna’s Marla Tobin, MD. For instance, depression can accompany back pain.

Disease management should be a function of primary care, some industry proponents argue. Did someone say patient-centered medical home?

Frank Diamond

Nothing bolsters the reputation of a consultant more than making a prediction that turns out to be true. Under the Medicare Modernization Act of 2003, the Centers for Medicare & Medicaid Services launched eight disease management pilot programs throughout the country. Ariel Linden, DrPH, MS, president of Linden Consulting Group and a widely published researcher of DM outcomes, published a white paper in the spring of 2008 that explained why those pilot programs would fail.

“And shortly thereafter — guess what? — Medicare pulled the plug on them,” says Linden.

In that peer-reviewed article, titled “Medicare Disease Management in Policy Context,” Linden touted an approach by which “the primary care physician leads a team of specialists, nurses, dieticians, pharmacists, and health educators to provide and coordinate care for the ill population.”

An intensive approach emanating from a physician’s office is the only way that DM will work, Linden argues. “I mean there is nothing here that adds up unless you have this entire infrastructure and you are firing on all of your spark plugs.

“You need to have the medical group; you need to have the hospital associated with it; you need to have this whole infrastructure built around it; you need the information technology that will allow health information to be transferred between all the providers and participants. (For more about DM, see our cover story.)

“There must also be someone manning the phones reaching out to patients. There should be a pharmacist available to explain medications. A behavioral change expert and social worker must be involved also.”

Jodi Aronson Prohofsky, PhD, senior vice president for health management operations at Cigna, sees value in the push to make DM a function of the provider. She notes that Cigna is participating in several medical home pilot programs, including multipayer programs in Colorado, Pennsylvania, and Vermont, and it has a Cigna-only program in New Hampshire. She says that the pilot programs have yet to generate enough information about how worthwhile it may be to rely more on primary care.

Individual preference

“We completely agree with the concept,” says Prohofsky. “But I don’t know that the whole of the system we live with today is ready. We truly believe it should be the individual’s preference. I should be able to engage in the health care system any way I prefer. One option may be through my practitioner.”

Harvard Pilgrim Health Care strives to maintain good ties with physicians, ties that help with something as complex as DM, says Judith Frampton, RN, MBA, the plan’s vice president for medical management.

“We try to understand what would be most helpful to them,” says Frampton. “Some of them want online registries; some want things faxed to their office. So we’ll send, for example, something like, ‘Here are your diabetics. I use diabetics as an example, but it is the same for any condition. Here are the people who are overdue for X, Y, and Z. If we’ve got that data wrong, just correct it. And please put a check-mark if there is somebody you really want us to call.’”

Disease management needs to have the entire primary care infrastructure built around it if it is to succeed, says consultant Ariel Linden, DrPH, MS.

Payers must manage the care of all members, regardless of how sick or well, to control escalating treatment expenditures

Jackie Mazoway

PricewaterhouseCoopers

Hard hit by the recession, employers of all sizes are reassessing the value they are getting from their health plans. Their conclusion? It is not enough. Employers want more — greater value, better information, and more help managing employee medical costs and utilization. Employers increasingly recognize that it is better to manage the health of their workforce than to manage the cost of illness, and they want their health plans to contribute.

Insurers, then, need to play a larger role in managing member care and costs if they want to survive. There is only so much they can do on the back end of a claim or through network discounts. To add value and meet employers’ needs, insurers are transforming their business models to give themselves greater influence, up front, on their members’ health. One way is to focus on prevention through health and wellness programs.

Employers want payers to play a more active role in promoting the health of their employees and effectively managing disease, especially as obesity — the forerunner of pricey chronic conditions like diabetes and heart failure — approaches epidemic proportions and occurs earlier and earlier in life. Chronic disease has a real effect on employers’ bottom lines, affecting productivity through lost time and disability. Wellness and preventive care coupled with incentives are now being considered or offered by many large employers, representing a huge growth potential for payers who want to take advantage of the market.

Medical management is evolving beyond traditional utilization metrics and beyond case and disease management. It now encompasses the broader capabilities of health management, which is designed to capture and attend to the needs of all members regardless of where they fall on the continuum of care, from the worried well to those who require end-of-life support.

Incorporating health management into the payer business model is crucial, but health care plans must be strategic about how they set up such programs. This is not a case of “one product fits all.” Insurers that invest heavily in health management programs that do not control employers’ medical expenses will find themselves at a competitive disadvantage.

Health management

Potential dividends for payers that offer health management programs include the early identification of patient risk factors for chronic disease, early intervention, better patient outcomes, market differentiation, and cost control.

The ability to identify high-risk patients is valuable. Insurers have access to a wealth of information — claims, personal health records, health risk assessments — that could provide great insight into members’ health status. In fact, some would argue that the information insurers have about their members is more comprehensive than the information that physicians have about their patients. But that information is not being used to its fullest potential.

If payers aggregate the patient clinical data siloed in their many and sometimes incompatible information technology (IT) systems and analyze it to identify trends and best practices, that information can be extremely valuable not only to clinicians, but also to health managers. If they do a better job of utilizing the information they already have and rethink their role in health management, payers can become active — rather than reactive — in managing care and costs. For example, once patients are suffering from diabetes, payers must field many claims from multiple physicians — from podiatrists to dentists — serving the same patient. Reactively managing these health care costs is much less cost-effective than proactively reaching out to patients whose body mass indexes indicate the danger of developing diabetes.

But shouldn’t physicians have access to this comprehensive patient information? Why are payers being thrust into the role of health care manager? Constrained by high overhead expenses, limited staff, and outdated IT systems, physicians are frequently unable to collect and store data, and they may be reluctant to share clinical information on their patients with insurance companies. Payers can play a potentially valuable role as physician extenders by providing doctors with more complete patient histories that can be discerned in claims. While this is not happening yet and although payers cannot give physicians direct access to their claims, the comprehensive picture that payers can paint of individual patients’ health histories (through details on hospital visits, prescriptions filled, etc.) can be of great help to primary care physicians.

Do it yourself — or not

Many payers have long outsourced their medical management programs, which has proven lucrative to vendors. But just as employers are demanding more value from their health insurers, so are insurers demanding that their health management vendors demonstrably control members’ medical expenses. Because there is no solid methodology for quantifying the savings realized by preventing illnesses and complications, payers that contract with health management companies sometimes question the return on their investment, leading them to explore the feasibility of administering those programs themselves.

The decision to operate one’s own health management programs, outsource them, or do a combination of both — as is common with most insurers — is an individual one that must take into account the cost-effectiveness of each approach and a payer’s internal resources, especially its number of administrative and clinical support staff. The decision will be heavily influenced by how well health management organizations can differentiate their service offerings and demonstrate their ability to control costs.

Whether payers outsource or administer their own health management programs, they must be as cost-effective as possible. If administering their own programs, payers must use thoughtful and extensive planning. A payer must streamline processes and resources to reach aggressive cost-cutting goals.

Most payers employ an impressive cadre of customer service representatives who tend to members’ administrative questions, and they retain clinical staff to support their members’ health care needs. But if these employees are not used effectively or do not work together, a payer’s member services offerings can be undermined.

Rethinking how their staff interacts with members can help payers lower the cost of their health management services and maximize patient outreach. This could include eliminating positions that do not add value to health management programs, redeploying existing resources, redefining staffing ratios, giving tasks to appropriate staff, and developing and deploying an effective recruiting strategy.

Payers can enhance the value that both administrative and clinical employees bring to a company if they ensure that they work together to offer comprehensive health management. For example, administrative staff can reach out to new members by calling them, welcoming them to the plan, and asking if they have any questions about their benefits.

But if payers call members to discuss their specific clinical care needs, patients are often — and understandably — reluctant to do so. For example, after a payer pieces together a member’s claims and identifies a high risk of diabetes, a customer service representative may call that member to discuss preventive care. Members often will not take the call out of fear of being dropped by their insurers.

A better approach to customized health management would be to ask a nurse to call a member both before and after an office visit. Beforehand, the nurse can start building rapport with members, reminding them of the visit and asking them if they have transportation. After members’ visits, the same nurse can follow up with individual patients with a courtesy call, making sure they understand their treatment plans.

The call may go something like this: “I understand you just saw Dr. Smith. I am calling to ask if you understand your diagnosis. Have you filled your prescriptions? Have you made an appointment with the specialist to whom you were referred?” At this point, members will most likely be more receptive to the nurses’ self-care suggestions.

Several payers are already doing this. They are especially having success with calling patients after hospital visits to prevent re-admissions. During such calls, nurses help patients reconcile their before-hospital versus after-hospital medications. Often, patients’ prescriptions will change during a hospital visit, and those changes will not be explained to them, leading to confusion and possible complications.

This in effect transforms payers’ clinical employees role to back-office physician support. When payers give patients’ primary care physicians the results of specialist visits, the names of prescriptions filled, and hospital discharge instructions, they help physicians maximize the effectiveness of patient visits. This puts payers in a position to significantly cut the risk of disease escalation and hospital readmission while also improving physician relations.

Although in-house health management programs can be expensive, it is not difficult to determine what resources are needed to conduct them. A simple review can determine a company’s staffing and budgeting needs.

For example, if an insurer decides that it wants to review its members’ hospital admissions, it must determine how many admits per 1,000 members it is averaging. That will tell the insurer how many reviews it must conduct. Then it must determine what resources it needs to do the reviews effectively. The insurer must ask itself: What is the ease of use and efficiency of my current programs? Do I need to add staff or IT resources?

Granted, hiring additional staff and investing in new IT systems can be pricey, but insurers will ultimately pay more on the back end if they do not control their members’ illnesses.

Rapidly evolving health care market trends and health care reform are causing insurers to rethink their roles, shifting from being reactive gatekeepers to being proactive and actively engaged with providers and members in health management. Whether a health plan operates its own health management program or outsources it, an effective program is becoming essential to the success of insurers’ existing business models.

Jackie Mazoway, RN, is a manager in PricewaterhouseCoopers’s health industries advisory practice.

Insurers who administer their own health management programs need to plan extensively, says Jackie Mazoway of Pricewaterhouse-Coopers.

Some would argue that the information insurers have about their members is more comprehensive than the information that physicians have about their patients.

Insurers will ultimately pay more on the back end if they do not control their members’ illnesses.

Urged on by employers, the Big 3 are going beyond traditional pharmacy benefit management, stressing consumer interactions and disease outcomes and threatening the existence of captive PBMs

Thomas Reinke

While the 14-15 percent annual increases in drug expenditures of the early 2000s have settled down to around 5 percent, there are unsettling forces at work within the PBM industry: Three giant pharmacy business managers have disrupted the basic PBM business model, there is increased pressure from employers for benefit managers to perform and to deliver more services, and there is a growing chance that most health insurers will get rid of their in-house PBMs.

Disease management companies might also find they are subject to competition from PBMs with overlapping services.

Some good is coming out of the commotion: Services to consumers have expanded, and attention has switched from dispensing prescriptions to improving medication outcomes.

Differentiating the PBM Market

The Big 3 — CVS/Caremark, Express Scripts, and Medco Health Solutions — aren’t just sitting back and enjoying their dominance. They are throwing their weight (almost half of all prescriptions) around by pursuing business strategies that differentiate them from each and from the rest of their industry.

“Clearly, different models are emerging,” says Steve Miller, MD, who is Express Scripts’ chief medical officer. “The path we are taking is based on our behavior-centric approach,” he says. Express Scripts is developing a niche by becoming expert in consumer behavior related to medications. The goal is to find ways to change behavior that promote optimal use of medications from the point of view of quality and cost.

One approach the company uses is segmenting consumers into categories and using different methods to change each group’s behavior. It has touted a program involving Lowe’s, the home improvement store, where mail service was made standard with an opt-out option. Most mail programs are opt-in, so this approach reversed consumer choice, but Express Scripts says it has been well received, has cut costs, and has improved compliance.

“Benefit designs that eliminate copays increase compliance by 1 to 5 percent, but a company takes on a huge additional expense by absorbing the copay. We found that moving patients to mail is the single most important thing you can do to improve adherence: It increases compliance by 8 percent, and the member saves money.”

Reports say that the most common reasons that patients are noncompliant are that they forget to take their medication, they get better, or the medication seems ineffective. Express Scripts focuses on changing these perceptions and behaviors. Miller says that the company targets asthma, diabetes, and cardiovascular disease.

“The compliance rates for these conditions range from 60 percent to 70 percent, so there is a tremendous opportunity to improve things and to lower medical costs, like ER visits for asthmatics.”

The essence of Express Scripts’ approach is fine tuning of standard techniques: linguistics tailored to specific groups like the elderly or those with little education, timing of messages, and streamlining of home delivery.

Express Scripts’ business model is likely to change somewhat this year with the expected acquisition of WellPoint’s captive (owned by a health plan) PBM, Next Rx. WellPoint will become a dominant customer, with leverage to influence Express Scripts’ services by providing one third of Express Scripts’ total prescription volume. And Express Scripts’ Medicare Part D volume will grow substantially, adding requirements like medication therapy management services.

Medco, the disease manager

Medco is the largest PBM and the universally recognized leader in mail prescriptions. Its mail-order business generated $22 billion in 2008 from 106 million prescriptions. The company claims that its mail volume is more than twice that of its closest competitor. Medco is sticking with this core competency, yet doing new things.

“Medco has a clinical strategy with Therapeutic Resource Centers (TRCs) that it has set up to manage individual medical conditions such as diabetes, cancer, heart disease, and asthma,” says John Malley, national pharmacy consulting leader at Watson Wyatt. The PBM says that 1,100 specialist pharmacists work in these centers.

“The pharmacists are trained in specific diseases, with emphasis on identifying comorbidities and side effects, and on consulting with patients to improve outcomes,” says Luis Salmun, MD, vice president and head of the pulmonary/immunology TRC at Medco.

The essence of the centers is individualized medicine — understanding each patient’s response to medications, medication gaps, right-dosing, and gaps in care, says Lisa Gill, managing director of health care equity research at J.P. Morgan Securities, which has has an investment banking relationship with Medco and CVS/Caremark.

“Medco’s internal research indicated that Medco mail order customers have a higher compliance level than retail customers. This trend is true of many PBMs who own their own mail order facilities, ”says David Dross, national leader of Mercer’s pharmacy consulting practice.

Medco’s mail and disease management strategy was behind its acquisition of Liberty Medical Supply, a mail order vendor of diabetes supplies to Medicare patients; one of Medco’s TRCs is devoted to diabetes. The combination of the diabetes supply business and Medco’s own Part D prescription plans gives the company broad involvement with the elderly, a targeted growth area for PBMs.

Face time

CVS/Caremark, the other member of the Big 3, is betting on retail. It has developed several programs to drive business through the front doors of its pharmacies. “One of the missing elements in pharmacy services is face-to-face interaction between a pharmacist and patients, and this is what CVS is promoting,” says Malley.

The company has implemented a “Maintenance Choice” program in which patients can pick up their 90-day prescriptions at a CVS store instead of receiving them by mail. Patients can also get some specialty medications at the pharmacy, where a pharmacist will answer questions and show how to administer the drug. Earlier this year, CVS won an award from URAC, which accredits PBMs, for its drug therapy management program, which focuses on medication outcomes.

In 2008 CVS/Caremark boosted its storefront strategy by acquiring Long’s Drug Stores, with about 520 stores, and RxAmerica, a PBM with about 8 million members. The company now has more than 6,900 stores, about 10 percent of the nation’s 65,000 pharmacies. The PBM acquisition also added 450,000 Part D members to CVS’s Medicare membership.

Therapy management

The emerging strategies of the Big 3 center on one thing: expanding direct contact with consumers. They see both the need to respond to demands from employers and the opportunity to expand their roles from the administrative function of dispensing prescriptions to include managing patients.

“Employers are becoming more vocal; they are saying, I want accountability and results,” says Larry Boress, CEO of the Midwest Business Group on Health. More specifically: “Employers believe that PBM’s can do a lot more than just fill scripts. They have a great potential to be more active in patient management — not in preventive care, but with those who have chronic conditions, addressing and controlling them early on with the right medications.”

Helen Darling, CEO of the National Business Group on Health, says that “PBMs and the services they provide, including with plans, are very important to employers and having some competition is a good thing. Their innovations, such as Medco’s work with genomics, are very valuable.”

Boress points out that “Clinical programs were an afterthought for PBMs. Now they have come to the forefront.”

MTM blossoms

Medicare is also demanding more through the Part D program, which the Big 3 participate in either as plan sponsors, as administrators of retiree benefits, or by serving their health plan clients. Beginning in 2010, the medication therapy management programs for people with multiple chronic conditions will switch from opt-in to opt-out, vastly increasing the number of participants.

Joseph Gruber, RPh, at Mirixa, which runs a network of community pharmacies linked by a common MTM technology, says this change could increase MTM participation from about 1.4 million to 5.7 million people, boosting the demand for the consultative and therapy management services the Big 3 and other companies that have Medicare Part D plans are now offering.

The Big 3 have recognized that they are in a key position to respond to growing demands for drug therapy management services. Malmun says that they have an existing relationship with patients, who carry their ID cards; that employers promote their clinical programs to employees; that they have data systems that can accurately track medications; and that they have pharmacists who work in an environment that keeps them up to date on medications.

For insurers that have outsourced their pharmacy benefits to a PBM, patients may have more of a relationship with the PBM than with the health plan.

True to the core

While the Big 3 are expanding their services, they are also holding on to the core service that funds their expansion and keeps them in good standing with their clients — increasing the use of generics. And why not? This is a lucrative service.

CVS/Caremark admitted in its latest quarterly SEC filing that generics were important to its bottom line and that they “yield a higher gross profit rate than equivalent brand name drugs.” That is because of the use of spread pricing arrangements, where PBMs purchase generics and mark them up.

The switch from brand drugs to generics saves money for employers and other clients, but it is also good for PBM profits. It has helped to moderate the increase in gross expenditures for pharmaceuticals. PBM clients went from mid-teen increases earlier to 6.9 percent in 2007 and 4.9 percent in 2008, according to the Pharmacy Benefit Management Institute. J.P. Morgan reported a 5.4 percent increase between early 2008 and early 2009.

In the first quarter of 2009, Express Scripts increased its generic fill rate to 67.7 percent from 65.1 percent a year earlier. Caremark increased to 67.7 percent from 64.1 percent, and Medco increased to 66.8 percent from 63.3 percent. According to the Kaiser Family Foundation, the national average price of a generic is $34.34, vs. $119.51 for a brand drug, so the savings to employers from volume shifts to generics are substantial.

In spite of the predominance of generic scripts, they total only 21 percent of national drug expenditures, according to the Kaiser Family Foundation, so there is still an opportunity to save money on brand drugs for employers. That will occur naturally as brand drugs lose their patent protection. That natural conversion will also automatically fuel PBM profits if the current mark-ups continue.

The J.P. Morgan report comments that “generic profitability does not appear to be at risk in the near term,” and says that employers are satisfied with the pricing arrangements they have with PBMs and that PBMs have been able to maintain their margins.

“Margins for PBMs are still intact [for generic drugs] on the retail side,” says John Malley. “Employers may think they are getting a bargain at AWP minus 65 percent, but don’t be surprised if [PBMs] are purchasing them at AWP minus 85 percent. It’s surprising how cheap generics can be.”

J.P. Morgan sees a favorable macro environment for the PBM industry. “Generics will continue to replace brand drugs, changes in benefit designs can further encourage mail order, and specialty pharmacy will continue to grow rapidly, with opportunities for PBMs to help employers control these costs,” says Gill. There is plenty of opportunity for PBMs to improve cost effectiveness in purchasing specialty drugs and in managing specialty drug inclusion in formularies, which will save employers money and yet be profitable for the PBMs, he adds.

Can others compete?

The new business models of the Big 3, combined with their market dominance and technical resources, raise questions about the outlook for captive and mid-market freestanding PBMs.

“Pharmacy benefits are almost an afterthought for health insurers,” says Malley.

“The PBMs devote 100 percent of their attention to the 15 percent of premiums going to pharmacy benefits, while health insurers naturally assign their best people to the 85 percent that represents medical costs,” says Gill, the Wall Street analyst. “It’s very hard for the health plans to compete against the PBMs for that reason.” So captive PBMs get bought by freestanding PBMs.

About $1 billion in business is moved away from health insurers to PBMs annually in that manner, says Gill.

One justification health insurers use for operating their own PBMs is simplifying the integration of medical and pharmacy data to manage patients, says Gill. But she discounts this argument: “Pharmacy claims are adjudicated in real time, so the data are available in a timely fashion.” Gill says the data argument is valid only if health insurers also adjudicate medical claims instantaneously and need to merge the two sets of data immediately. Others say that there are long lags in transferring data to health plans and that timeliness is crucial for their medical management programs.

Boress says the integration of medical and pharmacy data is important to employers who are looking to simplify their analysis of utilization patterns. He says this analysis is more difficult when the data comes from two sources.

The advantages of captive PBMs go beyond the integration of data, says David Lassen, chief clinical officer at Prime Therapeutics, a PBM jointly owned by 11 Blue Cross plans. “Prime aims to be fully integrated with its Blue partners so we understand their health management strategy and tailor our activities to meet those objectives.”

As examples, he says Prime’s benefit designs, formularies, and utilization management programs are more tailored to his owners than the standard approaches of freestanding PBMs. He says his therapy management activities are also better integrated. “Our Blue partners place greater emphasis on holistic health goals involving wellness and chronic disease management. Our therapy management activities are directed to supplement their health management interventions, specifically to lower total health care costs.” While other PBMs do the same thing, Lassen says, the nature of his relationship with his owners improves this coordination.

Other questions about the future of captive PBMs have increased since the announcement of a $4.6 billion deal that will send Next Rx, WellPoint’s PBM, to Express Scripts. During a recent investors conference call, Cigna acknowledged that it is evaluating the future of its PBM. That sale could raise $1.3 billion for Cigna, analysts say. Insurers can fetch good prices for their captive PBMs, stock analysts say.

UnitedHealth Group operates the largest captive PBM but even so, many functions are outsourced to Medco with a contract that extends to 2012.

Smaller freestanding PBMs have a difficult time competing against the Big 3, especially for contracts with large employers. They tend to focus on the next lower tier of employers, and there is extra overhead when you administer many contracts. In addition, they do not have the purchasing leverage of the high-volume PBMs or the depth and breadth of technical expertise.

One strategy that small PBMs use to compete is completely transparent pricing. These companies offer a cost-plus model that passes through 100 percent of rebates and eliminates hidden spread pricing. In exchange, they charge administrative fees for retail and mail order prescriptions and for added services.

Navitus, a PBM owned by Dean Health System, an integrated health plan and provider organization in Wisconsin, administers pharmacy benefits for the state under a cost-plus model that has been successful for the state for a long time in terms of cost savings and customer satisfaction.

“Traditional pricing arrangements often create conflict among employers, PBMs, and drug wholesalers that shortchange the employer,” says Bob Palmer, CEO of Dean Health Plan in Wisconsin. “Transparency pricing models properly align the incentives of PBMs and employers and therefore establish the best kind of working relationship.”

Transparency models have an established niche in the PBM industry because of their straightforward approach. In addition, consumer organizations are lobbying states to enact laws to require disclosure of rebate and discount terms. Maine and Maryland have enacted such laws.

Reluctant to change

One competitive issue for all PBMs is that it is difficult to get employers to switch vendors. “Pharmacy is a sticky business,” says Gill. Employers are reluctant to switch vendors because of the work and cost involved and — more importantly — because of the hassle it creates for employees in learning the rules and procedures of a new company. In addition, the J.P. Morgan survey has consistently shown that employers are satisfied with their PBMs. In the latest survey, 44 percent said they were very satisfied; in contrast, 16 percent said that they were relatively dissatisfied and none at all were very dissatisfied. These factors benefit large PBMs and make it difficult for small ones to grow.

Gill says that the future of all PBMs is tied to change. “The business is not just about dispensing prescriptions. It has moved on to a much broader array of services: to use the most appropriate medications at the best cost, to do the most good for consumers. The model is moving toward expanded services.”

Tom Reinke specializes in health and business topics. Reach him regarding this article at [email protected].

For further reading

Academy of Managed Care Pharmacy. Sound Medication Therapy Management Programs, Version 2.0, With Validation Study. J Manag Care Pharm. 2008 January;14:(1 Suppl):S-b. http://bit.ly/2g9cvj

McDonald RC. Managing the intersection of medical and pharmacy benefits. J Manag Care Pharm. 2008 May;14(4 Suppl):S7-11. http://bit.ly/2F1XrJ

Kaiser Family Foundation. Prescription Drug Trends. September 2008. (PDF included) Available at: http://bit.ly/3BwRE5

Pharmacy Benefit Management Institute. Prescription Benefit Cost and Plan Design Report, 2008-2009 edition. Available at: http://bit.ly/1YVNNC

The emerging strategies of the Big 3 PBMs center on one thing: expanding direct contact with consumers.

Express Scripts’ chief medical officer, Steve Miller, MD, says the company is following “a path based on our behavior-centric approach” by becoming expert in consumer behavior related to medications.

“Employers are becoming more vocal; they are saying, I want accountability and results,” says Larry Boress, CEO of the Midwest Business Group on Health. “PBMS can do a lot more than just fill scripts.”

Prime Therapeutics’ benefit designs, formularies, and utilization management programs are more tailored than the standard approaches of freestanding PBMs, says chief clinical officer David Lassen.

Patients are responding to online programs that help them improve or maintain their health and become better consumers

Thomas Reinke

Health insurers face ever-changing expectations from their primary customers — employers — and one challenge that has been tough to meet is getting consumer buy-in on wellness and health promotion. In some cases, employers go around their health plan to vendors that offer new approaches.

“Employers are expecting that health plans and providers will do the lion’s share of the work in motivating employees to be more proactive about health care choices and decisions,” says David Lansky, PhD, CEO of the Pacific Business Group on Health. “Their frustration is that they don’t see this working very well, and health insurance costs keep going up. So they have turned to wellness and disease management companies as add-on services for what they think health plans and doctors should be doing routinely.”

The Center for Health System Change looked at the problems with engaging patients and reported that strategies such as consumer-directed health plans with cost sharing provisions, cost and quality transparency efforts, wellness programs, and disease management programs have had limited success.

Experts say that first-generation efforts by health insurers to engage patients were blunt instruments. Tactics like generic patient reminders, standard-script telephone calls, and dissemination of off-the-shelf educational materials were often viewed by consumers as monitoring or supervising their care, rather than supporting them and encouraging them.

In addition, cost-sharing strategies were criticized for giving patients incentive to forego services and medications instead of choosing cost-effective providers. Also, information to help patients evaluate providers was often irrelevant because it was not specific to the patient’s medical problem.

Yet considerable hope is pinned to greater involvement of consumers in making cost, quality, and utilization decisions about their health care. “Going through the consumer is the last stop en route to any lasting improvements in the health system,” says Lansky.

Consumers must be engaged on three fronts: health promotion, including chronic disease management; making informed treatment choices for acute conditions; and choosing cost-effective providers. That’s a tall order.

Changing behavior

Progress is being made in finding smarter approaches to change health behaviors or manage chronic diseases. Experts say that subjective tactics are giving way to evidence-based approaches and that the Internet is emerging as the vehicle to connect consumers with these approaches. Theories on behavior change have existed for years and several care management companies use them in their health and wellness programs.

One of these new patient-engagement approaches incorporates the transtheoretical model (TTM), which draws from several change theories. Researchers at the University of Rhode Island developed the transtheoretical model beginning in 1979. It incorporates several different theories of psychotherapy, hence the name “transtheoretical.”

A company called Pro-Change Behavior Systems, founded in 1998 by researchers at the University of Rhode Island, has developed an Internet-based behavior change application based on the TTM, called the Lifestyle Management Program Suite.

It has programs for smoking cessation, stress management, weight management, depression prevention, exercise, and medication adherence for hypertension and for high cholesterol. This application has been adopted by several care management vendors as the core of their health promotion programs. “It is an interactive program that guides the user through the five stages of change,” says Kerry Evers, PhD, senior vice president.

The stages are precontemplation, contemplation, preparation, action, and maintenance.

The software is an expert system where pathways to stimulate change are determined dynamically. The software interprets user responses and tailors its next action to that user input.

“The key to the program is figuring what intervention message to give the participant at a particular point in time,” says Evers. “If the program determines that the user has made some changes, it will encourage further changes or reinforce past action based on the science and statistical decision making.”

For example, if a participant indicates that he sought information about a health problem it will reinforce that step and encourage the next step.

The key challenge is to get the participant to agree to change behavior, even if he does not think he is ready for change. “The research shows that for consumers who are not planning to change, one key intervention component is assessing what benefits might be important to them and providing information on those personal benefits,” says Evers.

“The research says that the key to getting buy-in from consumers when they are not planning to change is assessing what benefits might be important to them and providing information on those personal benefits,” says Evers.

“In a clinical trial for our stress management program, 60 percent of participants started effectively managing their stress,” says Evers. These results can be obtained from three interactive sessions, for a total of one to one and a half hours, over a six-month period.

Recruitment is important. “For employers, the culture of the organization, executive level support, quality of messaging to employees, and incentives are all very important,” says Evers. She explains that while there are mixed results on the effectiveness and use of incentives, this is currently a major focus area for the field.

Stanford patient ed

Pro-Change Behavior Systems got the gold in URAC’s 2009 Best Practices In Health Care Consumer Empowerment and Protection awards. John DuMoulin, a URAC VP, says that URAC found widespread use of Pro-Change’s Internet-based transtheoretical model programs.

A slightly different Internet approach has been developed at the Stanford [University] Patient Education Center. It has been working on chronic disease self-management courses for arthritis, heart disease, diabetes, and cancer for 30 years. These courses started as small-group sessions in community settings, often by hospitals. They have been used in 17 foreign countries and in hospitals operated by Kaiser Permanente and Group Health Cooperative in Seattle.

Recently, Stanford developed an Internet version of the courses, following the format of its classroom program. The Internet course is led by an actual instructor, and the participants interact online.

For example, the Internet chronic disease self-management course covers heart disease, lung disease, and type 2 diabetes. The online instructor has one of these conditions and leads group interactions that motivate and instruct participants in behaviors to improve their health.

“Our programs are based upon self-efficacy theory, which says that the strength of one’s belief that he can do something is a good predictor of his motivation and potential for success,” says Kate Lorig, RN, DrPH, the center’s director.

The self-management program teaches people to set goals and manage their health in three areas: medical management, such as medication adherence or diet; role management, which is solving problems, making decisions, and accomplishing goals; and emotional management, which is responding to emotional ups and downs, including depression.

“Negative and problematic emotions are very common and are a major reason that people don’t change their behavior,” Lorig says.

All Stanford programs have been evaluated for effectiveness in large randomized controlled trials before they are released, she adds.

Pro-Change Behavior Systems and Stanford license their products to vendors, and those vendors often package these programs with other services, so information on the cost per participant is hard to determine.

There are limited published results for Internet-based behavior change programs, largely because they are new, as are employer-based wellness programs.

One worksite-based clinical trial compared the Pro-Change TTM programs to two other health promotion strategies — motivational interviewing, and health risk assessment plus intervention. The focus was to determine which interventions helped employees move away from risks such as inactivity, obesity, stress, and smoking.

Significant results

The results at six months showed that motivational interviewing and Internet-based TTM tailored programs both had statistically significant results in meeting risk criteria for stress and exercise. There were no statistically significant differences between motivational interviewing and TTM (Prochaska 2008). The study did not measure changes in the utilization or cost of health care services. Proponents of Internet intervention tout its cost advantage over motivational interviewing.

The Internet is also being used to help consumers with more complex concerns, like evaluating acute care treatment choices. The American Cancer Society (ACS) invites consumers to its Web site to use an interactive decision-support tool that solicits information about their cancer and their preferences and helps them evaluate alternatives such as surgery, chemotherapy, or radiation.

The software is from Nexcura, a health information company owned by Thomson Reuters. The visitors to the ACS site tend to be aggressive information seekers who demonstrate their willingness to rely on the ACS site and the Internet by creating an online account with personal information.

The tool also requires some work from the user. “The first section for a new user usually takes 20 to 30 minutes to complete,” says Alicia Moffat, Nexcura’s VP for operations. “The visitors to the ACS site as a whole are highly motivated; we have found that the drop-off rate is only 40 percent to 50 percent.” In contrast, says Moffat, drop-off can be as high as 80 percent in a commercial site with online tools.

Cigna has been able to get members of its consumer-directed health plans to use online tools to evaluate and select high quality, cost-effective providers.

“Sixty percent of CDHP members have signed up to use our transparency tools; this compares to 30 percent in our HMO and PPO plans,” says Jeffrey Kang, MD, Cigna’s CMO.

“The number of people consulting our online cost comparison tools, which were separate until integrated with Care Connections, has increased dramatically in just one fiscal quarter,” says Kang. “For example, the number of people comparing hospital and/or facility costs for cardiac catheterization increased more than 50 percent.”

“People pricing colonoscopies online increased nearly 40 percent, and those comparing costs for MRIs and CAT scans jumped more than 35 percent,” reports Joe Mondy, assistant vice president for IT communications at Cigna. Cigna reports that 55,000 members visit its Care Connections Web site each day.

Mondy says that Cigna’s tools have become interactive and that information on providers’ fees appears next to information on providers’ quality. Other companies’ Web sites and public sites do not integrate fee and quality information; consumers must go to separate locations to find this information, he says.

Style or substance

“Health insurers have viewed health promotion programs as a marketing tool, so they tend to have gone with things that are sexy or flashy,” says Lorig. “With rare exceptions, they have not gone with programs that are evidence-based.”

Evers shares this view: “There is extensive research on behavior change that is directly applicable to health behaviors and this knowledge has been built into effective programs.”

Lorig also says that insurers have followed a one-size-fits-all approach, “but these are opt-in programs, and when you want people to opt in, you have to offer them choices.”

He adds: “Tailoring is in vogue, but the health plans say, I have learned something about you and I will tell you what you should do. Health promotion or disease management programs need to let participants tailor their goals and the process for getting there. We found that patients are the best judges of what they can accomplish.”

That is the essence of the latest Internet-based programs.

Tom Reinke specializes in health and business topics.

“Health insurers have viewed health promotion programs as a marketing tool,” going for sexy or flashy, says Kate Lorig RN, DrPH, director of the Stanford University Patient Education Center.

Harvard Pilgrim Health Care has striven methodically to become superior in cardiac care. Its numbers tell the story.

Lola Butcher

Contributing Editor

The statistics for cardiovascular disease and stroke can seem overwhelming: 1 in 3 American adults has at least one type of cardiovascular disease; more than 1.2 million will have a heart attack this year; and 795,000 will experience a stroke.

Cardiovascular disease, which accounts for more than 30 percent of U.S. deaths, is expected to ring up direct and indirect costs of $475 billion in 2009, far more than any other disease category.

But another statistic — the death rate from cardiovascular disease declined by more than 26 percent from 1995 to 2005 — gives health plans something positive to focus on. The grim reaper that is cardiovascular disease can be fought successfully.

That’s what Harvard Pilgrim Health Care (HPHC), a not-for-profit plan covering more than 1 million members in Massachusetts, New Hampshire, and Maine, has focused on for most of this decade — and with good effect.

The rate of emergency room visits and inpatient stays for cardiac events for Harvard Pilgrim members fell from 3.31 per 1,000 members in 2000 to 2.29 in 2007; the national average was 3.5 cardiac events per thousand or greater for each of those years.

HPHC has been named the No. 1 health plan in the country by the National Committee for Quality Assurance for the past four years. Lydia Bernstein, the plan’s director of clinical programs, discussed the programs that are helping Harvard Pilgrim brandish a sword against heart disease and stroke.

Prevention and DM

Through its Healthy Returns worksite program, Harvard Pilgrim sends nurses and health educators to offices and factories to help plan members lose weight, stop smoking, and lower their blood pressure. The program, which is purchased by employers, offers financial incentives to workers who reach their goals.

Now in its fifth year, Healthy Returns has racked up some impressive results: 75 percent of participants with a body mass index reduction goal achieved their weight loss; 81 percent of those with a blood pressure goal were successful; and 76 percent of smoking-cessation participants quit tobacco.

Harvard Pilgrim’s cardiac disease management program targets members with cardiac diagnoses who are identified through insurance claims. Nurse care managers contact patients by telephone to do a clinical assessment, set goals, and develop a care management plan.

“Depending on the patient’s acuity level, they will follow up in two weeks, or three months, or six months,” Bernstein says.

The program, in which more than 90 percent of eligible members participate, is responsible for Harvard Pilgrim’s success in reducing ER visits and inpatient stays related to cardiac emergencies, Bernstein says.

Harvard Pilgrim puts members who have vascular disease or who have had a heart attack into a registry. Twice a year, those members are given a cholesterol fact sheet and a reminder about the importance of getting their cholesterol checked regularly.

The health plan also sends its primary care physicians a list of their cardiac patients and the date of their most recent low-density lipoprotein test. The goal is to encourage the physician practices to contact patients who are due for the test and to persuade them to have the test done.

Starting this year, every patient who receives a new prescription for a beta blocker receives a mailing reinforcing the message that the medicine must be taken for the rest of the patient’s life.

P4P programs

A pioneer in the pay-for-performance movement, Harvard Pilgrim awards bonuses to physician practices based on their Healthcare Effectiveness Data and Information Set (HEDIS) scores.

The program, adjusted each year, is based on several measures. This year’s program includes “cholesterol management for patients with cardiovascular disease.”

Bernstein declined to reveal how much money the plan devotes to its P4P initiatives, but she says HPHC uses public recognition to add an extra incentive for top performance. Physician practices that exceed the national 90th percentile performance on at least 8 of 10 preventive and chronic care HEDIS measures are named to the plan’s physician group honor roll, generating good publicity for the doctors and an invitation to an awards ceremony in their honor.

Honor roll

Similarly, Harvard Pilgrim names network hospitals to an honor roll if they rank among the top 25 percent on the performance measures reported on the Centers for Medicare & Medicaid Services’ Hospital Compare Website, which include 12 heart-related measures, and on Leapfrog patient safety measures.

To encourage physician practices to improve the quality of care they deliver, Harvard Pilgrim annually awards grants to support initiatives that help manage chronic diseases, increase the use of health information technology to improve patient care, or reduce disparities in patient care.

“Some of the projects have been to increase cholesterol screening and LDL control in patients of cardiovascular disease,” Bernstein says. “There was a grant to improve cardiovascular disease prevention and treatment in primary care. And there were a number of practices that have focused on reducing health disparities, including in the treatment of cardiovascular disease.”

The health plan provides physicians and nurses who serve as consultants to the grant recipients, helping them to meet their goals. At the end of each year, the grant recipients share the lessons learned from their initiative with other practices in the Harvard Pilgrim network. Now in its ninth year, the quality grant program has distributed more than $11 million to more than 140 initiatives since its inception.

Medication management

Harvard Pilgrim operates two medication programs designed to improve health outcomes for its patients, with particular attention to those who take warfarin, often prescribed to prevent blood clots in patients with certain cardiovascular conditions.

Medication safety: Because patients on chronic warfarin should have blood tests at least every 28 days, the plan notifies their physicians if the tests are not being conducted on schedule. All patients on chronic warfarin also receive educational mailings reminding them of the importance of the monthly tests.

Medication reconciliation: After a 2004 pilot program found that many recently hospitalized patients were at risk of adverse drug events because they were taking their medications improperly, Harvard Pilgrim implemented a medication reconciliation program throughout the system. Pharmacists and nurse care managers work together, using an electronic medical record, to make sure newly discharged patients are not prescribed medications that are likely to interact with one another. Within three days of a patient’s discharge, a nurse calls each patient to determine whether the patient is taking medications as prescribed. If problems are identified, the nurse contacts the physician.

During the program’s pilot phase, the pharmacists and nurses identified 150 actual or potential medication safety issues — drug-drug interactions, side effects, and compliance issues — in just 241 evaluations. Many of the problems involved warfarin, cardiac medications, and statins.

About 17 percent of HPHC members discharged from the hospital in 2008 received medication reconciliation assessments, and potential drug-drug interactions were identified in 79 percent of the cases. “It shows that there is a value and a need for this type of program,” Bernstein says.

HPHC’s 80 nurse care managers have been trained to support the medication reconciliation program, and two clinical pharmacists (full-time equivalent of 1.2) and a pharmacy intern work on it. Bernstein estimates the annual cost of the program to be about $115,000, which covers the pharmacy staff time. She believes the program may save the health plan nearly $1.4 million a year in avoided hospitalizations because patients taking warfarin are better managed.

Cardiac & diabetes DM programs seem to have had quite an effect

Harvard Pilgrim not only awards bonuses to effective doctors based on HEDIS scores, but gives them public recognition as well, notes Lydia Bernstein, the plan’s director of clinical programs.

DM programs will have amazing patient-monitoring technology at their call. The challenge will be to make good use of the data.

Steven S. Eisenberg, MD

This article is excerpted from Chapter 6 of The Next Generation of Disease Management: 2009 and Beyond, edited by Jill Brown and Al Lewis.

I am not a soothsayer but I daresay that it is a pretty easy bet that the future of DM will be tied to increasingly available and increasingly sophisticated technological improvements. So let’s take a look at what seems to be coming down the pike and maybe what might still be around the corner.

We start and end with the movement of data. The amount of that data has already grown exponentially and the thirst for more data and more types of data is continuing unabated. Places to store that data continue to get more efficient, larger, and cheaper, allowing the growth to continue. Warehouses in the hundreds and thousands of terabytes have been in existence for some time. Personal computers can come with a terabyte¹ drive now, something that would have been considered unheard of even five short years ago. The databases of the future will hold much greater amounts of data in a smaller footprint; seamlessly integrate different types of data from a variety of different sources; and allow for “virtual” data warehouses and datamarts by seamlessly gathering and collating data from different and remote sources and creating a virtual picture of the data linked and integrated together. In fact, all of this can be done today. It just is not yet cheap, quick, and/or particularly easy.

The data of today are moved in a variety of ways that is also getting quicker, cheaper and easier over time. It moves over telephone lines, via fax machines, and using the interactive voice response techniques discussed previously. It moves over large and small wired networks with names like local-area networks and wide-area networks at speeds that even a few years ago were not possible. Increasingly, the data move wirelessly, through the “ether,” as it used to be called, using technologies such as wireless local-area networks, broadband wireless, and Bluetooth. What technology will be the next big thing is up for grabs, but it will doubtless follow the same pattern of quicker, cheaper, better, and easier that will allow the movement of ever larger volumes and types of data between devices, places, and platforms without the need for human intervention. Doubtless, too, it will still include things like telephony, in whatever form that takes in the future, but it will also increasingly focus on the use of devices — which are evolving into “smart” devices.

Some of the future in those devices is already here, but just is not yet well known, widespread, or heavily adopted. The devices that are common tools in today’s DM programs are already starting to become yesterday’s devices. New tools are being introduced daily, and there is starting to be some blurring of who is interested in and involved in these technologies, as is often seen as an industry matures. For example:

• Smart pillboxes already on the market not only audibly and/or visually remind people to take their medications but also track that usage and report it electronically to a data center through a telephone line or via wireless upload technology.
• Today’s implanted cardiac defibrillators contain electronics and communications technologies that allow data to be captured and uploaded indicating when and how the unit triggered a shock to the heart. The information also is tied to algorithms that can predict when a patient is getting worse and whether the implant is functioning correctly. The implant can have its parameters changed remotely, based on an assessment of the data generated by the unit. Medtronic, one of the leaders in the implantable medical device industry, already has links to a call center and is able to monitor over 100,000 patients who have implanted devices².
• The reader is probably familiar with insulin pumps that have been around for a long time now, but may not be as aware that implantable tiny catheters, available since 2005, can monitor blood sugar levels by being placed under the skin.
• There is also a leather wallet available which not only does everything your standard wallet does but also has a single lead electrocardiogram (EKG) that can be triggered by simply holding the wallet against your chest. It can transmit a rhythm strip via telephone or cell phone almost instantaneously.
• Another device can actually analyze a tiny blood sample looking for blood changes indicative of a cardiac event (myocardial infarction or heart attack) as well as provide an EKG and symptom checklist that can be uploaded to a medical facility for rapid assessment, hopefully preventing a serious cardiac event. That same patient could also be instructed to self-inject with lidocaine (a local anesthetic also used to prevent certain serious heart arrhythmias) to prevent an arrhythmia on the way to the hospital, using an available device that is almost identical to an EpiPen (containing epinephrine and used for people prone to serious allergic reactions).
• A company in the United Kingdom has developed a small patch worn on the chest that can monitor a patient’s vital signs including respirations, oximetry (the amount of oxygen in the blood), patient movement, temperature and electrocardiogram.

All of this is available today and I do not doubt that there are more out there that we just have not heard about yet.

At the time that this chapter was being written, the giant computer chip maker Intel had just received clearance from the Food and Drug Administration to market its in-home personal health system. What is being called the Intel Health Guide was devised to allow medical professionals to monitor people with chronic conditions. It combines an in-home device with Web connectivity and a communications interface to allow for home monitoring of various conditions. Intel has already completed a number of pilot studies and is in the process of doing others. It is expected that the tool will be on the market in 2009. ADT Security Services Inc., the home security company, offers a monitoring service for elderly adults that allows them to use the existing connectivity, including voice communications, of their home burglar alarm system and ADT’s existing call-center structure to call for medical help should they need it while in the home. Walgreens, the pharmacy chain, is beginning to market a somewhat similar concept and service.

And therein lies the future of technology in the DM arena. To use a grossly overused term from the early 1990s, there has been a paradigm shift taking place. But perhaps the most interesting thing is that it is taking place somewhat quietly and naturally. That paradigm shift is away from the concept of technology being able to do something for you or in place of your having to do it to the concept of the technology as a tool to allow you to keep doing things for yourself. It is an important distinction, one that is changing not only the way that devices will be used, but the devices themselves.

The driving force behind much of this development is the aging of the American population and, in particular, those post-World War II babies called the “Baby-Boom generation.” Those folks who are now beginning to enter retirement in increasingly large numbers have been caring for their aging parents (who are living longer) and are looking forward to a future where they want to be able to remain independent, active, and healthy in their own homes. The concomitant increases in chronic diseases, the stress that an increase in older Americans will place on the entire medical infrastructure, our growing waistlines, and an increasing comfortableness with technology is bringing together a “perfect storm” of needs, desires, economic realities and quicker/better/cheaper technology that is set to take off.

What has started with a series of tools focused on monitoring elderly parents’ safety and daily well-being is going to rapidly morph into a system of connected technologies that will not only assist in but encourage healthy behaviors. These systems will also allow the early detection of changes that may indicate the onset of disease or the worsening of an existing condition and make sure that the needed information, not just data, is transmitted and gets to the appropriate place in order that it may be acted upon. The very human need and desire to live better and live longer and to remain active as an independent contributing member of society is driving the development of “smart” technology. And it is that smart technology that is the future of DM, both as an industry and in a much more global sense.

“Smart” technology and “smart” devices don’t just passively gather data and transmit it. They have the ability to interact with the data and with other devices to not only allow the monitoring of everything from vital signs to blood chemistries to heart rhythms but also the way someone is walking or talking or the amount of exercise they do (or don’t do) and the food choices that they make. They can find patterns in seemingly unrelated things and may hold some promise for early identification/diagnosis of some diseases. They can learn over time and they can share the data and the learning with other devices, centralized or remote monitoring stations or networks and, of course, with medical professionals. They can give warnings, they can provide advice, they can tell you it’s time you get yourself to your doctor, or they can help prevent an unnecessary doctor visit. And if you do need to go, they can help your doctor figure out what is wrong with you more quickly.

This is not rocket science, either. Some of this is already available today. A toilet that monitors the chemical composition of your urine and feces looking for metabolic or other problems has been available as a consumer item in Japan for a number of years. Intel and other technology companies such as Honeywell have been working on building “smart” homes using today’s technologies to allow these “smart” tools to be linked with a variety of sensors built into the home itself to allow the monitoring of elderly individuals. Intel has extended this to include things such as motion detectors, pressure sensors in furniture, cameras, transmitters embedded in common household items, and sensors in carpeting, walls, and even clothing. All these tools can communicate with each other and through a network to allow a picture of an elderly person’s activities to be built and monitored for changes in routine that may indicate someone getting in trouble. The Defense Advanced Research Projects Agency (DARPA)³ has developed a T-shirt that a patient can wear that allows nonintrusive remote monitoring of vital signs. The nonintrusive part is the key, as it is the ability of these smart devices to do their work without being obvious and without interfering with the day-to-day activities of people that will allow the widespread usage and acceptance of these devices.

What else might be coming? According to Carol Lewis, author of Emerging Trends in Medical Device Technology: Home is Where the Heart Monitor Is,⁴ the list includes such things as a toothbrush that can sense, evaluate and monitor the bacteria present in your mouth, diagnose an infection, and maybe even determine not only when but which antibiotic is needed. Other products that Lewis says already are on the drawing board:

• Computer glasses that can help a person remember things and people through a tiny in-front-of-the-eye display;
• Skin mapping that can monitor a person who is prone to develop melanoma; and
• A smart bandage that can tell if a wound has gotten infected.

All of this will introduce new challenges regarding privacy, security, and the meaning of the concept of “personal space” — issues that are well beyond the scope of these discussions. But they will happen and they are happening, and what may currently be still thought of as science fiction may be available to you in the not-too-distant future as something that is intended not to take your place or do something for you to make your life easier, but to make your life better by helping to keep you healthier and more active. DM will embrace these technologies and incorporate them into the day-to-day activities of a program and a patient. The current and ongoing blending of DM with wellness and other less traditional spaces will likely accelerate some of this.

Some of this technology, in the form of hardware, already exists. Some will need to be developed, and all will continue to be refined, improved and miniaturized, and made faster and less expensive. But the factor that ultimately determines when these tools will become available and commonplace is likely not the hardware but the software. Creating the various sensors and devices to measure a whole variety of parameters is much further ahead than creating the systems needed to take all of that data in; analyze it; find the right patterns within it to show or predict problems; and then make the output concise and usable in a form that provides information to a patient or health care provider that can be acted upon.

Some of this is technical and has to do with systems, processors, and software capable of integrating ever-larger amounts and types of data. But a lot of it is also clinical and will require a very deep understanding of human disease and human behavior so that those who will create these complex algorithms and other means of pattern recognition and predictive modeling will not only ultimately know how to put such a wondrous computation together, but, perhaps more importantly, will know what questions to ask in the first place.

It will eventually be this ability to pick out that one important piece of information from the morass of data that will be the key to allowing the use of that information to determine how someone is doing and whether they are in need of further intervention; what may help them do better than they already are doing; or what may prevent them from getting worse over time.

We already have some of the capabilities of collecting some of these data but we do not even know how often some of the data ought to be collected, let alone what particular pattern(s) may provide that early identification of a problem that could not only prevent a hospitalization or ER visit but maybe even the complication or the disease itself. Physicians are never going to have the time to spend going through volumes and volumes of data, so it is likely going to be up to the computers themselves to not only collect the data, but to integrate, correlate, and analyze it to find the things that the DM nurse or the physician needs to know about and act upon.

These series of devices/computers will talk to one another and learn from one another through what has been called by the Institute of Electrical and Electronics Engineers (IEEE) “proactive computing,”^1,2 where computers will be able to “sense, calculate, and act on behalf of a person with or without human interaction, as best fits the circumstances.” As the commoditization of these powerful sensors and processors continues, proactive computing will evolve “where computers anticipate the needs of people around them,”^1,2 allowing the propagation and interaction with networks of sensors that infuse the patient’s milieu, including home and work and anywhere they may go.

In an article entitled “Remote Medical Monitoring” in the April 2008 issue of IEEE’s Computer magazine, the authors predict that “telemedicine (the delivery of primary care in situ, wherever the patient may be, via information and communications technologies, or ICT) will be revolutionized by the decreasing cost and increasing power of the ICT that are becoming ubiquitous in our lives.” They also point out, correctly, that the potential implications of that on public health are staggering.⁵

The DM company and call center of the future will be one of the hubs where this information is collected, collated, analyzed, stored, and then acted upon by the routing of that information to the place that will allow the best and the most appropriate interaction.

In that world of the future, that routing may be to the patient’s physician; to the patients themselves; to a caregiver; to a DM nurse or health educator; or, perhaps increasingly, back to the patient’s series of computers and sensors themselves to modify their interaction with the patient and help that patient achieve optimal health. We may or may not end up with the autodiagnostic full-body scanners seen in many science fiction movies or the handheld tricorder (medical hand-held multi-scanner) that Dr. McCoy from the original Star Trek series pioneered. But what we do end up with will likely eventually provide much the same level of information.

Notes

1. A terabyte, a measure of computer storage capacity, is 2 to the 40th power, or approximately a thousand billion bytes (that is, a thousand gigabytes). Source: WhatIs.com. In most computer systems, a byte is a unit of data that is eight binary digits long. A byte is the unit most computers use to represent a character such as a letter, number, or typographic symbol (such as “g,” “5” or “?”). A byte can also hold a string of bits that need to be used in some larger unit for application purposes (for example, the stream of bits that constitute a visual image for a program that displays images or the string of bits that constitutes the machine code of a computer program). Source: SearchStorage.com.
2. Remote Control for Health Care by Barnaby J. Feder; Published Sept. 10, 2006; The New York Times (business section).
3. DARPA is part of the U.S. Department of Defense. The wearable system called the “smart T-shirt” has already been used successfully to monitor the vital signs of climbers on an expedition to Mount Everest.
4. “Emerging Trends in Medical Device Technology: Home is Where the Heart Monitor Is,” Carol Lewis; FDA Consumer magazine, May-June 2001.
5. “Remote Medical Monitoring” Jurik, A.D.; Weaver, A.C.; IEEE Computer magazine; Volume 41, Issue 4, April 2008 Page(s): 96-99.

Steven S. Eisenberg, M.D., is senior vice president and chief science officer at LifeMasters Supported SelfCare Inc., based in Irvine, Calif. Contact Eisenberg at [email protected].

Copyright ©2009 by Atlantic Information Services Inc. Reprinted with permission from Atlantic Information Services Inc., 1100 17^th Street, NW, #300, Washington, D.C. 20036, 202-775-9008, www.AISHealth.com

For more information on The Next Generation of Disease Management: 2009 and Beyond visit www.aishealth.com/Products/bdm.html

It is the ability of smart devices to do their work without being obvious and without interfering with the day-to-day activities of people that will allow their widespread usage and acceptance.

Physicians are never going to have the time to spend going through volumes and volumes of data, so it is going to be up to the computers themselves to integrate, correlate, and analyze.

The call center of the future will be a hub where information is collected, analyzed, stored, and then acted upon by routing it to the place that allows for the most appropriate interaction, says Steven S. Eisenberg, MD.