Clinical consequences drive the need for pharmacy integration

THE INTEGRATION OF pharmacy and medical data has gone a step further into the coordination of services. A whitepaper published in March 2009 by several pharmacy organizations attributes a new focus on collaboration to an uptick in clinical consequences and costs of medication misuse and non-adherence; a shift from acute to chronic care; the increasing role of pharmacists; and the growing number and complexity of medications.

“Coordinating pharmacy and medical benefits paints a total picture of compliance without a gap in data, and thus, impacts outcomes,” says Nita Stella, senior vice president, ActiveHealth Management, a care management company headquartered in New York City. “In addition, sharing information can increase medication safety and effectiveness by triggering alerts to flag drug-to-drug interactions, contraindicated drugs and non-compliance.”

Integration is an effective vehicle for identifying high-risk members and putting value-based benefit design into place. For example, an integrated system could identify high-risk members and lower copayments for those individuals or for an entire class of drugs, such as stains, to encourage compliance.

David Dross, leader of the managed pharmacy practice for Mercer Inc. in Houston, says that integration is easier if one vendor is managing both sides of the equation. While he believes that a carve-out pharmacy is willing to share its data, he says the medical vendor could be the “fly in the ointment” because there may be a fee attached to the provision of data.

The Clinical Pharmacy Cardiac Risk Service (CPCRS) at Kaiser Permanente Colorado combines KP HealthConnect, an electronic health record (EHR), with an electronic care registry, proactive patient outreach, wellness and medication management.

After high-risk patients for coronary artery disease are identified, they are referred to CPCRS. The program has served 21.000 patients since 1998.

“We are able to determine who has a cardiovascular event and deliver continuity of care cost-efficiently by integrating pharmacy and nursing teams with patients and their doctors and using technology and other tools to address problems,” says Jon Rasmussen, chief of clinical pharmacy, cardiovascular services. “Primary care physicians and cardiologists spend an inordinate amount of time with chronic care patients, so we’re looking for ways that pharmacists and nurses can relieve some of the burden. If these cardiac patients are managed consistently through collaboration, that frees up physicians to address acute issues.”

Results show the number of those meeting their LDL cholesterol goals increased from 26% to 73%, and screening for cholesterol rose from 55% to 97% during an average length of participation in the program of 2.3 years.

In addition, participants in the CPCRS program had an 88% reduced risk of dying from a cardiac-related cause when enrolled in the program within 90 days of a heart attack.

When members are close to release from the program, Kaiser Permanente rehabilitation nurses set up phone calls to discuss diet, exercise, depression, smoking cessation and medications. In a seamless process, Rasmussen says, after discharge, participants work closely with clinical pharmacists for long-term medication management.

Although the program has been successful by saving lives, reducing hospitalizations and recouping investment, it hasn’t been without its challenges. Among them have been getting clinicians to communicate via the EHR, developing multifunctional teams and making sure that “we target the right person with the right treatment at the right time,” he says.

THE FOUNDATION OF INTEGRATION

CIGNA is another insurer that relies on pharmacy to reduce medical costs through evidence-based medicine.

“Data sharing between the pharmacy benefit manager and the insurer is the foundation of integration,” says Claire Marie Burchill, vice president of strategy, product and marketing for CIGNA Pharmacy Management based in Bloomfield, Conn.

Many of CIGNA’s pharmacy programs demonstrate integration with the medical side with an emphasis on adherence. Although they are pharmacy-related, they have a large impact on medical cost reductions, such as emergency room visits and hospitalizations.

CIGNA’s Outcome Improvement Programs, which combine the use of prescriptions drugs, disease management and behavioral coaching, saw results in 2008:

• a 74% medication adherence rate led to 50% of those in the cholesterol program reaching their goals;
• a 78% decrease in LDL and the avoidance of 262 heart attacks annually saved $6.6 million;
• a 34% increase in use of drugs for treating asthma led to fewer emergency room visits and hospitalizations, cutting costs for participants by 50%;
• an adherence rate of 84% for diabetes drugs resulted in 13% fewer emergency room visits and 18% fewer hospitalizations; and
• a 35% increase in completion of depression treatment plans realized an 18% reduction in medical and behavioral healthcare costs.

Dovetailing with the program is CIGNA’s new CoachRx, an interactive Web site to enhance medication adherence with home delivery. A self-assessment helps members identify barriers to adherence and allows them to request daily reminders for self-care.

Those who need additional assistance can call toll-free for medication coaching sessions with a clinical pharmacist, who works with case managers. The coaching team will help find the most appropriate and cost-effective medications for a member, discuss possible side effects and reinforce the importance of taking prescribed medications as directed.

“In this way, we have used one intermediary to maximize health,” Burchill says.

To address high-cost drugs with the potential for side effects and infections, CIGNA offers TheraCare, a medication therapy management program targeting individuals using specialty injectable medications for 16 chronic conditions, such as multiple sclerosis.

“We still have a way to go in integrating pharmacy and medical benefits because the Rx benefit is administered in silos,” says Steve Mullenix, senior vice president of communications and industry relations for the National Council for Prescription Drug Programs (NCPDP). “Medicare Part D’s Medication Therapy Management Program is a step in the right direction, but we are still trying to buy drugs as inexpensively as possible without knowing the impact of the full picture. The right hand doesn’t know what the left hand is doing.”

For example, if a pharmacist dispenses a drug but it’s not refilled, that requires communication so that some action can be taken to encourage compliance.

Mullenix, whose organization focuses on developing consistent standards is concerned that without standardization, it will be difficult to create interoperability between proprietary systems.

“We are a proponent of a team approach to healthcare, including patients and pharmacists, who have become medication experts and need to be reimbursed for their guidance,” he says.

American Diabetes Association revises diabetes guidelines

The American Diabetes Association (ADA) has revised clinical practice recommendations for diabetes diagnosis to promote hemoglobin A1c as a faster, easier diagnostic test that could help reduce the number of undiagnosed patients and better identify patients with prediabetes. The new recommendations are published in the January supplement of Diabetes Care.

“There are several revisions and updates included in the American Diabetes Association’s 2010 Clinical Practice Recommendations that will potentially impact how health plans care for the many individuals with type 1 and type 2 diabetes and those at risk for diabetes,” says Richard M. Bergenstal, MD, president, Medicine and Science, American Diabetes Association and Executive Director, International Diabetes Center. “A significant change is that the ADA now recommends the A1C test can be used to diagnose diabetes or identify those at high risk for developing diabetes. Patients can prevent complications and suffering, and health plans can minimize long costs if diabetes is detected and treated effectively early or if diabetes can be prevented.

The A1c test, which measures average blood glucose levels for a period of up to 3 months, was previously used only to evaluate diabetic control with time. An A1c level of approximately 5% indicates the absence of diabetes, and according to the revised evidence-based guidelines, an A1c score of 5.7% to 6.4% indicates prediabetes, and an A1c level of 6.5% or higher indicates the presence of diabetes.

Extensive revisions to the section “Diabetes Self-Management Education” are based on new evidence. The goals of diabetes self-management education are to improve adherence to the standard of care, to educate patients regarding appropriate glycemic targets, and to increase the percentage of patients achieving target A1c levels.

“The 2010 Standards or Medical Care present new data to emphasize how important it is to teach diabetes self-management so health plans need to be sure they have a recognized education program in place that facilitates patient centered team care,” Bergenstal says. “There is also new evidence reviewed that will give health plans information on effective strategies to improve diabetes care and develop treatment targets in the outpatient and inpatient setting. Educating patients and providers that good diabetes care means control of blood glucose (while avoiding hypoglycemia and excessive weight gain), as well as controlling blood pressure and cholesterol is critical to preventing complications. Effective and appropriate use of new technologies like insulin pump and continuous glucose monitoring are also reviewed in light of new studies released in the last year and health plans should review this data to be able to effectively communicate with patients and providers.”

Deeper data points revealed in health risk assessments

The employee health risk assessment (HRA) remains a powerful tool for employers, but uncertainty over incentive guidelines and frustration over participation rates can stall even the most innovative programs. The goal of an HRA is two-fold.

HRAs provide employees with measures of their current health status and future health risks as well as actions they can take immediately to improve health. Additionally, employers can use the HRA information—aggregated and de-identified—to develop a wellness strategy.

“Most employers recognize that you can’t manage what you do not measure,” says Michael Taitel, vice president, Alere Center for Health Intelligence. “If you are trying to manage the health of your population, you can’t achieve that goal unless you have the data that shows the prevalence of health risks, chronic conditions, and absenteeism and presenteeism rates in your population.”

More data can be better when it comes to health measurement. Alere offers a Health and Productivity Assessment (HPA), which analyzes the effects of specific health problems on work performance and absence.

“For example, we ask them to indicate if they are missing work because of a health condition,” Taitel says. “In another series of questions, we ask them to rate and compare their performance to other employees. So simply looking at risks alone only gives part of the picture.”

For example, many HRAs assess the presence of depression.

“We understand that depression plays a key role in an employer’s productivity losses, as well as overall benefit costs, so we believe it is an important component to study,” Taitel says.

Another feature of an effective HRA includes a link into personal health support interventions so that employees may be steered into programs that can provide assistance. Employees who require assistance may also be identified for contact by a health coach or for participation in special wellness or prevention programs.

DRIVING PARTICIPATION IN HRAS

According to “Wellness Programs, Survey & Sample Series,” published in February 2009 by Brookfield, Wisc.-based International Foundation of Employee Benefit Plans, only about 14% of employers have indicated participation rates in HRAs above 75%, while 18% of employers indicated participation rates of 51% to 75%.

Bryce Williams, director of prevention and wellness at Blue Cross Blue Shield of Massachusetts (BCBSMA), believes that best-in-class participation begins at 80%.

“When [80%] of a population completes an HRA, the data becomes more meaningful and informative to future program strategy,” Williams says.

LURING EMPLOYEES WITH CASH

Incentives are the most popular tool to encourage participation, and there are a number of carrot-and-stick approaches, according to Carl R. Mowery, managing director of SMART Business Advisory and Consulting LLC, a business advisory services firm based in Devon, Pa.

“Some employers have even required employees, as a condition of participation in the healthcare program, to complete an annual health assessment,” Mowery says. “Others will give discounts on premiums for those who complete a health assessment, and others will provide cash or gift certificates to the employees.”

The Equal Employment Opportunity Commission (EEOC) issued an informal opinion letter stating that requiring employees to participate in an HRA may violate provisions of the Americans with Disabilities Act (ADA). However, HIPAA had earlier outlined a recommendation that noted the incentive can’t be greater than 20% of the cost of the health plan. Most employers are currently following the HIPAA guidelines.

Much discussion has taken place on how to apply incentives for completing HRAs. The company can opt to pay cash or the incentive may be tied to reduced health insurance premiums.

“The important thing to keep in mind is that incentives do not have to be costly,” says Taitel.

In CIGNA’s experience, its clients with the best overall HRA completion rates have offered a reduced premium or cash payment.

“Incentives play an instrumental role as a mechanism to engage individuals to participate in HRAs and in other programs designed to improve lifestyle behaviors,” says Emelia DeMusis, CIGNA product manager. “Levels of participation in HRAs have been found to vary significantly depending on the type of incentive that is used to motivate participation.”

While DeMusis says that optimal participation rate is obviously 100%, she believes that “even at levels below 100%, such as 20% to 40%, there can be medical savings.”

WALKING THE TALK

Participation is greater when it is supported by management and when it is linked to a more comprehensive intervention, specifically when it becomes an instrument used to help shape the corporate culture.

Incentives are a useful tool, but the best thing employers can do to encourage participation is ensure there is organizational commitment to the process, Alere’s Taitel says.

“Top leaders must become wellness champions,” he says.

In fact, in a peer-reviewed study Taitel led last year, researchers found that the strongest predictors of HRA completion are the monetary value of incentives and the employer’s level of communication and organizational commitment.

In the study, organizational commitment was a metric that included communications, the level of employee involvement through committees and internal champions, and visible executive management leadership support through advocacy, program participation and allocation of resources.

“Perhaps the most important finding was that the higher the organizational commitment, the lower the incentive cost needed to be,” Taitel says.

BSBSMA’s Williams agrees. Communicating with employees in advance of an HRA launch can ensure employees have a clear understanding of what data from their HRA will be shared with their health plan and their employer, he says.

CASE IN POINT

Visible senior management support, an engaging wellness platform and meaningful data have been demonstrated at SPS New England (SPS), a Salisbury, Mass.-based construction services company with 211 subscribers.

Under SPS’s wellness program, which is offered through BCBSMA, employees who elect to participate receive a higher contribution (up to 20%) from the company on their health insurance premiums depending on several wellness factors. SPS’s goal is 100% participation, says the company’s CEO and chairman, Wayne Capolupo.

Participation includes completing the BCBSMA online HRA, as well as being individually screened for tobacco use and three health metrics (BMI, blood pressure and cholesterol) and setting goals to maintain or improve those metrics over the coming year. BCBSMA wellness consultants work with SPS to run analytics on the HRA data and identify population health risks, which inform future interventions.

“SPS’s company contributions to health insurance premiums are based not only on employee participation but also on whether employees meet the health goals they set for themselves,” Capolupo says. “In the long run, it is our hope that by focusing employees on their own health issues and high-risk behaviors, and providing services to attenuate those risks, that employee wellness will improve and lost time and claims will be reduced. As a result, SPS’s health insurance premium will be reduced.”

DIG DEEPER

Historically, HRAs were mortality based and data didn’t go far. Today, data analytics get more mileage out of HRAs.

“Analysis of HRA data at the population level is used to support client decision making by analyzing how current health risks impact future health status, costs, productivity and disability, by identifying the most appropriate health strategies to support a population and by monitoring health status and health changes over time.” CIGNA’s DeMusis says.

By employing the University of Michigan HRA and Trend Management System, CIGNA is able to forecast costs and health status, use targeted improvement strategies and recommend the optimal outreach method to engage individuals, according to DeMusis.

But, in today’s economy, can employers afford to implement full-scale HRAs? Overwhelmingly, experts believe employers can’t afford not to implement an HRA as part of an overall wellness program.

“These programs can help employers reduce turnover, increase productivity, improve employee health and help potentially high-risk individuals from becoming future high-cost claimants,” says SMART Consulting’s Mowery.

HRAs typically cost just pennies per member per month. It’s a small investment with high potential for return.

However, there’s no real ROI for an HRA alone, according to Taitel, who asserts that the value of an HRA comes in measuring the changes in health risks over time. Large employers can link HRAs to claims data to see actual changes in costs.

However, the real key is link HRAs back to meaningful interventions. To secure true value, employers must take the information and use it to build tailored and useful health and wellness programs.

Tracey Walker is a senior editor with Advanstar Communications.

We’re All In This Together

As a physician, Reed Tuckson, MD, has seen his share of suffering. He specifically recalls a hospital patient he treated who had congestive heart failure and diabetes. The woman was discharged home, but many social services in her community had been cut, leaving her without meal delivery, transportation or health aid.

When Dr. Tuckson saw her again, she was in the emergency room, septic and malnourished with decubitus ulcers. She had missed every one of her follow up appointments. Medical science could certainly help treat her conditions, however, what the woman truly needed was support beyond the scope of medicine alone.

Dr. Tuckson, who today serves as executive vice president and chief of medical affairs for UnitedHealth Group, believes optimal healthcare delivery requires pulling the pieces of medical and social services together in a comprehensive way, “so that lovely, wonderful woman is not in a wheelchair at two in the morning, unable to breathe, hungry and in pain.” He says the experience with that particular patient still resonates with him.

During his first week on the job with UnitedHealth Group in 2000, he listened in on telephone support calls between care coordinators and plan members and heard them working to solve complex health and social issues not unlike those of his former hospital patient. As he listened in, he heard the insurer’s resources at work. He says the mission to improve health of populations as well as individuals is what drives him.

“The highest level of our mission requires us to find the common connection with the missions of the other stakeholders, because none of us can do alone what actually has to be done on behalf of each individual person,” Dr. Tuckson says. The insurer’s role—which he believes is generally misunderstood by those outside of the industry—is one of collaboration with providers, employers, patients and policymakers. Insurers have experience with the types of value determinations and cost-effectiveness strategies that many are insisting on to reshape the healthcare system overall.

Making Decisions

Dr. Tuckson believes the industry must be more explicit about what patient-centered healthcare delivery should look like and how it should function, then share the vision beyond the purview of its own ranks. That vision isn’t clear enough now to influence change. In order to generate a meaningful conversation that might lead to improvements in the system, the nation must take a long hard look at making choices and engaging consumers, he says.

“What’s so frustrating about the health reform debate in Washington,” he says, “is that it is so completely uninformed about the real issues: How do we make decisions that are personally appropriate that advance our chance for affordable access for the services that we need as individuals—both medical services and medically necessary social services?”

For example, preventive medicine, which many believe can lead to reduced costs and improved health if encouraged more widely, is often dependent on community situations. And the issues are twofold. First, an individual’s community environment plays a role in health. Lack of affordable and healthy food, unsafe neighborhoods and negative media images create inherent challenges to healthy lifestyles. Also, a lack of health clinics to deliver needed prevention can compound the problem.

It’s unreasonable to expect individuals in traditionally underserved populations with little optimism for the future to make healthy lifestyle choices a priority. Many skip preventive health services because they are struggling simply to get a hot meal on the table each night, Dr. Tuckson says.

“If gunshots are ringing through your community, it is very difficult to think about going jogging in the evening or planting a community garden, if there’s no actual earth in which to plant,” he says. “Those are real challenges that are stated the most dramatically.”

It Can Be Done

United Health Foundation, which was established by UnitedHealth Group in 1999, has committed $23 million to four community health centers in Miami, New Orleans, New York City and Washington, D.C., since 2003. Published studies from the George Washington University Medical Center have documented that these clinics, which are located in medically underserved communities, provide high-quality care that equals or exceeds care provided in the private sector, based on national quality benchmarks without risk adjustment.

The clinics have transformed from “centers of last resort to centers of choice,” according to Dr. Tuckson, who serves on the foundation’s board. In September, the university reported that three of the clinics had exceeded the national average of 30% for the percentage of diabetes patients with blood pressure under 130/80 mm Hg. New York (46%), Miami (40%) and New Orleans (39%) beat the benchmark. The same three also exceed the national average of 73% for the percentage of patients with diabetes receiving at least one LDL-cholesterol test—Miami reached 84%, New York reached 82%, and New Orleans reached 98%.

Through innovation, the clinics have been able to serve patients with chronic conditions who need a high level of comprehensive care. There’s no reason why the model of care, which has been able to make the most of scarce resources, should be limited to just one project, one population or to a certain type of coverage category, Dr. Tuckson says.

“The lessons we learn from the health centers ought to be applied to the rest of society and vice versa,” he says.

When considering underserved populations, he also says it’s important to recognize that absolutely every person in every community has a set of unique issues—medical and social—that require multidimensional responses from the healthcare system overall. Individualizing care for each person has become an emerging trend that complements the opportunity for managing care from a population perspective, regardless of what that population might be.

“When it comes to healthcare, it is exceedingly important to realize we’re all in it together,” he says. “The sense of ghetto-izing or segregating certain people, ethnicities or cultures is becoming inappropriate.”

Bringing It All Together

Three emerging factors are accelerating the ability for health plans to push comprehensive care forward:

Improved data analytics now afford opportunities to identify members with a variety of health needs;

Improved health data can also indicate the health needs proactively and with greater specificity; and

Consumerism is increasing members’ engagement levels in their health.

Certainly much of what enables comprehensive care stems from technology, but the tools still have yet to provide for true integration of care delivery among the healthcare silos. While the pace of such progress is frustrating, Dr. Tuckson says the partnership among payers, providers and other stakeholders is helping to overcome the siloed infrastructure more than ever before. The idea of integrated delivery of care has been talked about conceptually for more than a decade, but only now is the healthcare industry beginning to stitch the fragments together, he says.

For example, medical home projects nationwide are bringing care teams together and offering appropriate reimbursement for coordinated clinical approaches. The coordinated approaches are supported by data analytics that provide a snapshot of the comprehensive health needs of each individual person, he says.

“Putting that data into the primary care physician’s office as part of their traditional clinical capabilities and working in partnership allows for more comprehensive management of the individual,” he says. “That’s the next area. That will be defined, obviously, by how fast we can move the health information technology infrastructure.”

UnitedHealth Group launched a patient-centered medical home pilot in February in which it provides technology, infrastructure and care-coordination support to select primary care physicians in Arizona. There are more than 100 medical home pilots underway nationally, and tracking the data over time will inform plans’ future strategies.

Financial Footing

While furthering integrated care, population management and individualization is all well and good, the benevolent side of the mission only tells half the story. Healthcare has become an economic strategy in the United States. The bleak statistics of runaway costs on pace to reach $4 trillion are repeated so often that average Americans have begun to recite them by heart.

Dr. Tuckson says legitimate value determinations are needed to evaluate the relative cost and quality of medical procedures, drugs and devices. Once the value picture is sketched out with some degree of quantification, the individual member or patient is enabled to make clinically and economically smart care choices with his or her providers.

“There has to be a way in which people and society choose what they want and what they are willing to afford within the reality that there has to be controls,” he says. “The easiest part of that conversation would be that people should have access to care that works and is cost-effective. That ought to be a given, however, we also know we have a very suboptimal research infrastructure available to answer that question for expensive and increasingly important interventions, especially given the pace of discovery.”

The genius of America’s inventors and scientists has produced a difficult dilemma in which medical advances that save lives, improve quality of life and reduce pain and suffering also create an unaffordable inflationary spiral. New and improved treatments don’t come cheap. Likewise, the discrete evaluation of emerging procedures and products might prove that each has merit but fails to judge each one’s merit against comparable treatments.

Comparing the effectiveness of treatments head-to-head through scientifically sound research—comparative effectiveness research (CER)—has become cx. Federal health agencies have just begun to dole out $1.1 billion in stimulus funding for CER.

According to Dr. Tuckson, CER will also need to be taken a step further to create protocols in real-world clinical practice based on research results. He says CER funding is promising but it’s not likely to produce the scope of research needed nor the speed at which it must be delivered to improve the health of Americans affordably. His plea is that stakeholders fight “so much harder for the research infrastructure that delivers the answers to these questions.”

Clinical Expertise

Once the federally sponsored CER begins drawing conclusions, specialty societies, such as the American Academy of Pediatrics for example, could then take a lead role in translating research into best practices then in communicating the guidance to physicians. Specialty societies will need more support for that to happen, however, because they currently don’t have the resources to turn that kind information around in a timely manner.

“It is terribly inappropriate to leave those kind of choices to our industry, uninformed by the best of our nation’s clinical science expertise,” Dr. Tuckson says. “At United, we put our money where our mouth is by putting money into these societies, but with the level of scale that’s needed, no one company can do this by itself.”

He says he is “deeply saddened” when health insurers use their experience to make value decisions, then are criticized for it. Other stakeholders need to be involved, and he says he looks forward to having honest conversations at the national level to address the shared goals of value determinations and controlling the rising cost trends.

No one wants their insurer to exclude any service from the benefit package, Dr. Tuckson says, but on the other hand, no one is pleased by the amount of waste and misuse of services that are prevalent in the U.S. system. The fundamental contradiction of these two attitudes have become more evident in recent policy discussions. It makes for a frustrating process when trying to bend the cost curve and design benefits appropriately.

That’s why Dr. Tuckson believes when it comes to healthcare, everyone is in it together. No matter what operational challenges health plans must confront, sensible contracting, providing affordable access, and maintaining dynamic partnerships with providers and community organizations remain the plans’ responsibility.

“All pieces of that puzzle must all work together,” he says. “And we have to be part of that, acting on behalf of the needs of the person. If we lose sight of that, we do so at our peril.”

Reed Tuckson, MD, on…

The politics of health reform

“Health reform is talked about almost as if it were a political football game, and you’re either on one side or you’re on another. People use terms—public plan, health exchange, single payer—and that sort of lets you know if you’re on this team or that team…I refuse to be on any of those teams. It’s silliness.”

Holding down costs

“You have to get at controlling the inflation of unit costs for physician and hospital reimbursement. You have to get at the issue of appropriateness in the access to services and controlling waste and inefficiency in the delivery.”

Health insurers as stakeholders

“We in our industry clearly understand what it means to try to control unit costs and be fair to the hospitals and physicians who are delivering the care. We absolutely understand what it means to try and take the waste out of the system and all the challenges that come from doing that every day. We also know the anger and the frustration that occurs when you do it. We bring a set of experiential knowledge that is essential when trying to find solutions to problems, more so than anyone.”

Health insurance exchanges

“The health insurance exchange concept today as discussed is a philosophical placeholder for a political or social agenda, as opposed to being something that everyone understands what it means, how it would work and the ways in which it is going to deal with the two fundamental issues on the table: How will it deal with unit cost pricing and how will it deal with utilization and the control of utilization of healthcare services?”

Expansion of Medicaid

“Expanding Medicaid, public insurance, is an important part of the mosaic. It will take a mosaic to achieve our goals, and public insurance is going to be very important in that regard, just as private insurance will be important in that regard.”

Insurers being called ‘dishonest’

“When it comes to health and human survival, this is a profound social ethic that requires and demands the best of all of us. To deliberately and mean-spiritedly deny the participation and challenge the ethical integrity of a major stakeholder in the solution to this problem is to do potential violence to the opportunity for optimal solutions and thereby optimal health of the nation.”
Reed Tuckson, MD, UnitedHealth Group, Executive Vice President and Chief of Medical Affairs
Reed Tuckson, MD, has more than 25 years of experience in healthcare leadership and has been a member of several bipartisan federal advisory committees on genetics, infant mortality, children’s health, violence, radiation testing and healthcare reform. Previously he served as senior vice president for professional standards for the American Medical Assn. In February, Black Enterprise named him one of the “100 Most Powerful Executives in Corporate America.” He earned a bachelor’s degree in zoology from Howard University and his medical degree from the Georgetown University School of Medicine.

CVS Caremark researches pharmacy benefit plan design

Research from CVS Caremark, Woonsocket, R.I., illustrates how innovative pharmacy benefit plan design can impact generic utilization. The study underscores how pharmacy benefit managers (PBMs) can work with plan sponsors to manage costs and improve health outcomes by working to change plan participant behavior through increased engagement.

The survey found that implementing a $0 copay structure for generic medications can be an effective strategy to increase generic dispensing, with the generic dispensing rate (GDR) increasing to 60.8% (a 4.2% increase) during the study period.

“Our 2009 Benefit Planning Survey found that clients are more interested in identifying opportunities to change plan participant behavior, rather than shift costs,” says Jack Bruner, executive vice president, CVS Caremark.

In addition to an improvement in GDR during the study period, the analysis found that the average participant cost share for generic medications decreased almost 10%. In addition, the average plan cost per 30 days of therapy also declined slightly, despite the reduction in generic copayment rates. Use of three key preventative drug classes also increased significantly (participants on cholesterol lowering therapy increased 13%, on antihypertensive therapy increased 7% and on diabetic therapy increased 9%) as a proportion of eligible patients.

“While some plan designs work to drive generic utilization by increasing brand medication copayments, this study demonstrates that lowering the generic copayment can also be an effective strategy to increase GDR,” says Bruner. “In addition, the data indicates that lowering the generic copayment may also be associated with an increase in participants taking key preventative drugs, which could positively impact adherence and overall health outcomes.”

The study was designed to evaluate the results of plan design changes, including implementation of a $0 copay for generic medications, on the GDR; plan participant cost and impact of plan participant behavior changes on health outcomes. During the study period, participants were allowed to fill prescriptions for generic medications at a preferred retail pharmacy network at a $0 copay.

The study included 15,000 plan participants covered by a self-funded employer group who were continuously enrolled under the benefit for the duration of the study period, which lasted from Dec. 1, 2007 until July 31, 2009.

Intense family programs address motivation to reduce risk associated with weight

METABOLIC SYNDROME IS THE most widely distributed disorder of metabolism throughout the world. It contributes to the occurrence of the most common and costly chronic diseases in adults and children in the United States. These include: obesity, hypertension, atherosclerosis, and type 2 diabetes. Recognizing risk factors for metabolic syndrome and identifying effective ways to treat the underlying obesity helps reverse the features of metabolic syndrome in adults and children.

Clinical presentation usually centers around this group of conditions. Consider the following case study of a mother and child.

THE MOTHER

C.V. (initials used to protect patient’s privacy) is a 43-year-old woman presenting with fatigue, and a 10-pound weight loss over the previous two months. She admitted to urinating somewhat more, and had a history of recurrent yeast infections. During the previous five years, she had gained more than 40 pounds. She has a history of high blood pressure for the past three years and has been on enalapril. She has been overweight most of her life and has failed several attempts at weight loss.

Her past medical history includes two pregnancies, both complicated by gestational diabetes. Both of her children had weights at birth that exceeded nine pounds. Her family history includes obesity in both parents and her children. Her father died of complications of diabetes.

At her physical exam, she had an elevated blood pressure, was obese and had a Body Mass Index (BMI) well above a healthy range. Her waist circumference was 45 inches.

Laboratory studies showed elevated blood sugar, high cholesterol, triglycerides and a high hemoglobin A1c of 8.8%, (normal is 4% to 6%). She was placed on a weight-loss diet and exercise program for six weeks. On a return visit, her weight was unchanged. Her fasting blood sugar was elevated as well.

She was started on metformin, instructed on glucose monitoring and was scheduled for follow-up.

Through the next year, she continued to show elevated blood glucose levels and was not able to lose weight. She was started on a sulfonylurea, and warned that if her diabetes control worsened she would require insulin shots.

THE CHILD

C.V.’s son, J.V. (initials used to protect patient’s privacy), was a seven-year-old boy who had been overweight for most of his life, and during the previous year had gained 32 pounds.

He had multiple hospital admissions for asthma. Over the previous year, he had spent several weeks in the pediatric ICU for status asthmaticus. He was on multiple medications for asthma; for the past year had been on three courses of prednisone.

His physical exam showed that he was tall for his age and had a high BMI, indicating obesity. His waist measured 36.2 inches. Vital signs showed high blood pressure. His physical exam showed a diminished lung capacity and wheezing, and darkening of the neck area and the underarm area, called acanthosis nigricans. He had liver enlargement.

Initial laboratory studies showed normal glucose levels, but abnormally high cholesterol and triglycerides. In addition his diabetes marker, Hgb A1c, was elevated, but not yet diabetic.

He also had elevated liver enzymes, indicating non-alcoholoic liver disease, seen in some obese children.

He and his family were referred to participate in a proprietary weight loss program. This program, approved by the state Medicaid program for the treatment of childhood obesity, was taught by a dietitian, a social worker and exercise instructor, lasting for eight weeks. The program is based on four principles:

Nutrition education;

Promoting physical activity with onsite exercise;

Building and maintaining a child’s self-esteem; and

Supporting the parents and family during lifestyle changes.

The family attended three, eight-week sessions. During that time, the child lost 28 pounds. His lab studies showed a marked improvement, including a return to normal cholesterol and triglyceride levels, and his diabetes marker fell into the normal range. Additionally, his liver enzymes returned to normal, showing that his liver was restored.

His asthma abated, and during the time that he attended the weight-loss program, he was not hospitalized for asthma. His medical expenses related to asthma were significantly reduced.

In addition, his mother, C.V., noted in the first patient example, lost more than 20 pounds. Her blood pressure fell, and her attending physician took her off blood pressure medications. Also her dosage of diabetes medications was reduced. She was told that she may soon be able to stop her oral medications, and that she will not require insulin for management of diabetes.

METABOLIC DISORDERS

The epidemic of childhood obesity portends a flood of medical problems for this generation of children, even before they reach adulthood. The seeds of cardiovascular disease are already present in the obese seven-year-old patient’s example, and appeared at a much younger age in him than they did in his mother. Some have speculated that this might be the first generation where children do not outlive their parents. The seriousness of this problem requires creative efforts of many to find a solution, if we are to save future generations from costly and deadly medical problems.

Childhood obesity is also associated with worsening childhood asthma, as illustrated in this case. The expenses related to the care of children with asthma drain healthcare dollars. The cost of treating childhood obesity, when associated with asthma would result in immediate and substantial savings of healthcare dollars.

Directing adults into weight loss programs is often difficult. They typically lack motivation, time and/or financial resources. The treatment of the adult with obesity has shown limited success. As seen in this case, the adult involved remained obese.

By linking the health of the child with the parent, the parent has a vested interest in improving the life and health of the child. As shown here, the interaction between the parent and child strengthens the motivation of the adult.

Managed care executives should consider:

Screening for obesity, using BMI curves. A recent report by a major hospital showed that children whose BMI was greater than the 95th percentile accounted for greater than 75% of hospitalized patients. As shown in this case, obesity was a strong risk factor for worsening asthma, which required multiple hospital admissions.

Recognizing metabolic syndrome as a risk for cardiovascular disease in children as well as adults.

Instituting family-based weight management programs, which focus on childhood obesity. In the process of treating the child, the health of the whole family is improved through lifestyle changes that often are neglected when focused on the parent alone.

Naomi D. Neufeld MD, FACE, is a pediatric endocrinologist and founder and CEO of the non-profit KidShape Foundation, Los Angeles.

Online management comes of age for chronic conditions

ONLINE PATIENT SELF-MANAGEMENT provides a dynamic and economically feasible means for physicians to interact with patients. It can extend the practice of medicine to reach more patients, more frequently to improve their health outcomes.

Those with obesity, for example, are at increased risk for cardiometabolic disorders: type 2 diabetes, high blood pressure, high cholesterol, cardiovascular disease as well as premature death. The complications of type 2 diabetes alone add about $23 billion a year to the nation’s healthcare costs, with obesity-related illnesses resulting in more than $117 billion in annual healthcare expenditures.

Yet, the ability of the medical community to create significant and sustainable changes in patient lifestyle choices has been limited for a variety of reasons. Healthcare providers have been restricted by the availability of clinical personnel, the cost of providing the needed services in an exclusively one-on-one environment, and by the difficulties patients have in accessing information and support.

Managing large numbers of patients with varying levels of risk is the biggest challenge for managed care. There is a delicate balance of providing the right mix of services to improve outcomes based on each person’s needs and risks.

Today, chronic care is being dramatically altered by the confluence of several trends, such as patients wanting an active role in managing their own health and a collaborative relationship with their healthcare providers and their health plan; widespread, low-cost internet access; advanced Web 2.0 technologies; wireless health monitoring devices, such as accelerometers, blood glucose meters, scales, and blood pressure sensors; and plans’ integrating population-based risk assessments with disease management and wellness services.

Patient self-management supported by information technology is becoming an important factor in the way providers deliver healthcare. Clinicians can support patient behavior change in an economical, practical, and profitable manner. Health plans can offer a new paradigm of care delivery with improved services to its members that are an extension of the onsite clinical setting.

Creating and maintaining such multidimensional education and support systems requires a wide range of technologies. Using modern software development methodologies ensures requirements and solutions that will evolve through collaboration between these cross-functional teams. Additionally, healthcare organizations can contract for services, rather than buying programs and the computer hardware on which to run them, in what is usually referred to as a software-as-a-service (SaaS) model.

For example, the Virtual Lifestyle Management service (VLM) is an online program based on the Diabetes Prevention Program (DPP), a weight management approach developed by the University of Pittsburgh faculty under a federal research grant from the National Institutes of Health. Through Web-based technology, the VLM delivers the DPP research-proven lifestyle interventions aiming to enhance the efficiency and success of healthcare provider weight management programs.

The DPP was a multi-year study with 3,234 adults with pre-diabetes in 27 U.S.-based centers, in which an intensive behavior change intervention was used to increase patients’ physical activity, improve nutrition and decrease weight by 5% to 7%.

The DPP decreased the progression to diabetes by 58% (5% vs. 11% for the control) and by 71% for those individuals over 60 years of age. It was more effective than the diabetes drug tested (metformin). The intervention consisted of face-to-face, individual counseling sessions with a skilled coach at a per patient cost of about $3,540 over three years.

A recent 50 person year-long pilot study of the DPP, delivered online as the VLM service, demonstrated 38% of the participants lost at least 7% of their body weight.

To be successful, these programs must be:

• Grounded in behavior change theory and clinical expertise;
• Evidence based;
• Flexible in design and implementation;
• Able to allow choice of media and alternative learning pathways while providing continuous feedback and engagement; and
• Integrated with clinical practice, and technology including EMRs and biometric devices.

The industry is moving to a medical model in which patients are given the tools they want and need for self-management with the process remaining under medical guidance and oversight. A new means of interaction is necessary if the industry is to have a functionally useful role in patient self-management and behavior change. The one-on-one paradigm typically cannot deliver, in a cost-effective way, what is needed.

—Neal Kaufman, MD

Neal Kaufman, MD, MPH, founded DPS Health, and is co-founder of the UCLA Center for Healthier Children, Families and Communities. He is a professor of pediatrics and public health at the UCLA Schools of Medicine and Public Health.

New Web Sites Educate About Triglycerides and HDL Cholesterol

New Web sites Educate about Triglycerides and HDL Cholesterol

We’re All In This Together

As a physician, Reed Tuckson, MD, has seen his share of suffering. He specifically recalls a hospital patient he treated who had congestive heart failure and diabetes. The woman was discharged home, but many social services in her community had been cut, leaving her without meal delivery, transportation or health aid.

When Dr. Tuckson saw her again, she was in the emergency room, septic and malnourished with decubitus ulcers. She had missed every one of her follow up appointments. Medical science could certainly help treat her conditions, however, what the woman truly needed was support beyond the scope of medicine alone.

Dr. Tuckson, who today serves as executive vice president and chief of medical affairs for UnitedHealth Group, believes optimal healthcare delivery requires pulling the pieces of medical and social services together in a comprehensive way, “so that lovely, wonderful woman is not in a wheelchair at two in the morning, unable to breathe, hungry and in pain.” He says the experience with that particular patient still resonates with him.

During his first week on the job with UnitedHealth Group in 2000, he listened in on telephone support calls between care coordinators and plan members and heard them working to solve complex health and social issues not unlike those of his former hospital patient. As he listened in, he heard the insurer’s resources at work. He says the mission to improve health of populations as well as individuals is what drives him.

“The highest level of our mission requires us to find the common connection with the missions of the other stakeholders, because none of us can do alone what actually has to be done on behalf of each individual person,” Dr. Tuckson says.

The insurer’s role—which he believes is generally misunderstood by those outside of the industry—is one of collaboration with providers, employers, patients and policymakers. Insurers have experience with the types of value determinations and cost-effectiveness strategies that many are insisting on to reshape the healthcare system overall.

Making Decisions

Dr. Tuckson believes the industry must be more explicit about what patient-centered healthcare delivery should look like and how it should function, then share the vision beyond the purview of its own ranks. That vision isn’t clear enough now to influence change. In order to generate a meaningful conversation that might lead to improvements in the system, the nation must take a long hard look at making choices and engaging consumers, he says.

“What’s so frustrating about the health reform debate in Washington,” he says, “is that it is so completely uninformed about the real issues: How do we make decisions that are personally appropriate that advance our chance for affordable access for the services that we need as individuals—both medical services and medically necessary social services?”

For example, preventive medicine, which many believe can lead to reduced costs and improved health if encouraged more widely, is often dependent on community situations. And the issues are twofold. First, an individual’s community environment plays a role in health. Lack of affordable and healthy food, unsafe neighborhoods and negative media images create inherent challenges to healthy lifestyles. Also, a lack of health clinics to deliver needed prevention can compound the problem.

It’s unreasonable to expect individuals in traditionally underserved populations with little optimism for the future to make healthy lifestyle choices a priority. Many skip preventive health services because they are struggling simply to get a hot meal on the table each night, Dr. Tuckson says.

“If gunshots are ringing through your community, it is very difficult to think about going jogging in the evening or planting a community garden, if there’s no actual earth in which to plant,” he says. “Those are real challenges that are stated the most dramatically.”

It Can Be Done

United Health Foundation, which was established by UnitedHealth Group in 1999, has committed $23 million to four community health centers in Miami, New Orleans, New York City and Washington, D.C., since 2003. Published studies from the George Washington University Medical Center have documented that these clinics, which are located in medically underserved communities, provide high-quality care that equals or exceeds care provided in the private sector, based on national quality benchmarks without risk adjustment.

The clinics have transformed from “centers of last resort to centers of choice,” according to Dr. Tuckson, who serves on the foundation’s board. In September, the university reported that three of the clinics had exceeded the national average of 30% for the percentage of diabetes patients with blood pressure under 130/80 mm Hg. New York (46%), Miami (40%) and New Orleans (39%) beat the benchmark. The same three also exceed the national average of 73% for the percentage of patients with diabetes receiving at least one LDL-cholesterol test—Miami reached 84%, New York reached 82%, and New Orleans reached 98%.

Through innovation, the clinics have been able to serve patients with chronic conditions who need a high level of comprehensive care. There’s no reason why the model of care, which has been able to make the most of scarce resources, should be limited to just one project, one population or to a certain type of coverage category, Dr. Tuckson says.

“The lessons we learn from the health centers ought to be applied to the rest of society and vice versa,” he says.

When considering underserved populations, he also says it’s important to recognize that absolutely every person in every community has a set of unique issues—medical and social—that require multidimensional responses from the healthcare system overall. Individualizing care for each person has become an emerging trend that complements the opportunity for managing care from a population perspective, regardless of what that population might be.

“When it comes to healthcare, it is exceedingly important to realize we’re all in it together,” he says. “The sense of ghetto-izing or segregating certain people, ethnicities or cultures is becoming inappropriate.”

Bringing It All Together

Three emerging factors are accelerating the ability for health plans to push comprehensive care forward:

Improved data analytics now afford opportunities to identify members with a variety of health needs;

Improved health data can also indicate the health needs proactively and with greater specificity; and

Consumerism is increasing members’ engagement levels in their health.

Certainly much of what enables comprehensive care stems from technology, but the tools still have yet to provide for true integration of care delivery among the healthcare silos. While the pace of such progress is frustrating, Dr. Tuckson says the partnership among payers, providers and other stakeholders is helping to overcome the siloed infrastructure more than ever before. The idea of integrated delivery of care has been talked about conceptually for more than a decade, but only now is the healthcare industry beginning to stitch the fragments together, he says.

For example, medical home projects nationwide are bringing care teams together and offering appropriate reimbursement for coordinated clinical approaches. The coordinated approaches are supported by data analytics that provide a snapshot of the comprehensive health needs of each individual person, he says.

“Putting that data into the primary care physician’s office as part of their traditional clinical capabilities and working in partnership allows for more comprehensive management of the individual,” he says. “That’s the next area. That will be defined, obviously, by how fast we can move the health information technology infrastructure.”

UnitedHealth Group launched a patient-centered medical home pilot in February in which it provides technology, infrastructure and care-coordination support to select primary care physicians in Arizona. There are more than 100 medical home pilots underway nationally, and tracking the data over time will inform plans’ future strategies.

Financial Footing

While furthering integrated care, population management and individualization is all well and good, the benevolent side of the mission only tells half the story. Healthcare has become an economic strategy in the United States. The bleak statistics of runaway costs on pace to reach $4 trillion are repeated so often that average Americans have begun to recite them by heart.

Dr. Tuckson says legitimate value determinations are needed to evaluate the relative cost and quality of medical procedures, drugs and devices. Once the value picture is sketched out with some degree of quantification, the individual member or patient is enabled to make clinically and economically smart care choices with his or her providers.

“There has to be a way in which people and society choose what they want and what they are willing to afford within the reality that there has to be controls,” he says. “The easiest part of that conversation would be that people should have access to care that works and is cost-effective. That ought to be a given, however, we also know we have a very suboptimal research infrastructure available to answer that question for expensive and increasingly important interventions, especially given the pace of discovery.”

The genius of America’s inventors and scientists has produced a difficult dilemma in which medical advances that save lives, improve quality of life and reduce pain and suffering also create an unaffordable inflationary spiral. New and improved treatments don’t come cheap. Likewise, the discrete evaluation of emerging procedures and products might prove that each has merit but fails to judge each one’s merit against comparable treatments.

Comparing the effectiveness of treatments head-to-head through scientifically sound research—comparative effectiveness research (CER)—has become cx. Federal health agencies have just begun to dole out $1.1 billion in stimulus funding for CER.

According to Dr. Tuckson, CER will also need to be taken a step further to create protocols in real-world clinical practice based on research results. He says CER funding is promising but it’s not likely to produce the scope of research needed nor the speed at which it must be delivered to improve the health of Americans affordably. His plea is that stakeholders fight “so much harder for the research infrastructure that delivers the answers to these questions.”

Clinical Expertise

Once the federally sponsored CER begins drawing conclusions, specialty societies, such as the American Academy of Pediatrics for example, could then take a lead role in translating research into best practices then in communicating the guidance to physicians. Specialty societies will need more support for that to happen, however, because they currently don’t have the resources to turn that kind information around in a timely manner.

“It is terribly inappropriate to leave those kind of choices to our industry, uninformed by the best of our nation’s clinical science expertise,” Dr. Tuckson says. “At United, we put our money where our mouth is by putting money into these societies, but with the level of scale that’s needed, no one company can do this by itself.”

He says he is “deeply saddened” when health insurers use their experience to make value decisions, then are criticized for it. Other stakeholders need to be involved, and he says he looks forward to having honest conversations at the national level to address the shared goals of value determinations and controlling the rising cost trends.

No one wants their insurer to exclude any service from the benefit package, Dr. Tuckson says, but on the other hand, no one is pleased by the amount of waste and misuse of services that are prevalent in the U.S. system. The fundamental contradiction of these two attitudes have become more evident in recent policy discussions. It makes for a frustrating process when trying to bend the cost curve and design benefits appropriately.

That’s why Dr. Tuckson believes when it comes to healthcare, everyone is in it together. No matter what operational challenges health plans must confront, sensible contracting, providing affordable access, and maintaining dynamic partnerships with providers and community organizations remain the plans’ responsibility.

“All pieces of that puzzle must all work together,” he says. “And we have to be part of that, acting on behalf of the needs of the person. If we lose sight of that, we do so at our peril.”

Reed Tuckson, MD, on…

The politics of health reform

“Health reform is talked about almost as if it were a political football game, and you’re either on one side or you’re on another. People use terms—public plan, health exchange, single payer—and that sort of lets you know if you’re on this team or that team…I refuse to be on any of those teams. It’s silliness.”

Holding down costs

“You have to get at controlling the inflation of unit costs for physician and hospital reimbursement. You have to get at the issue of appropriateness in the access to services and controlling waste and inefficiency in the delivery.”

Health insurers as stakeholders

“We in our industry clearly understand what it means to try to control unit costs and be fair to the hospitals and physicians who are delivering the care. We absolutely understand what it means to try and take the waste out of the system and all the challenges that come from doing that every day. We also know the anger and the frustration that occurs when you do it. We bring a set of experiential knowledge that is essential when trying to find solutions to problems, more so than anyone.”

Health insurance exchanges

“The health insurance exchange concept today as discussed is a philosophical placeholder for a political or social agenda, as opposed to being something that everyone understands what it means, how it would work and the ways in which it is going to deal with the two fundamental issues on the table: How will it deal with unit cost pricing and how will it deal with utilization and the control of utilization of healthcare services?”

Expansion of Medicaid

“Expanding Medicaid, public insurance, is an important part of the mosaic. It will take a mosaic to achieve our goals, and public insurance is going to be very important in that regard, just as private insurance will be important in that regard.”

Insurers being called ‘dishonest’

“When it comes to health and human survival, this is a profound social ethic that requires and demands the best of all of us. To deliberately and mean-spiritedly deny the participation and challenge the ethical integrity of a major stakeholder in the solution to this problem is to do potential violence to the opportunity for optimal solutions and thereby optimal health of the nation.”

Cardiometabolic Care Links

MANAGED HEALTHCARE EXECUTIVE, its sister publication brands and the Web portal ModernMedicine.com, under parent company Advanstar Communications’ Life Sciences, are collaborating in a coordinated, interdisciplinary initiative to address a major public health concern: cardiometabolic disorders and weight.

This groundbreaking initiative emphasizes core competencies, best practices and shared responsibility among all stakeholders in the member/patient’s healthcare ecosystem. We investigate cardiometabolic disorders and how they interrelate to significantly increase cardiovascular risk. We provide the tools and information that primary care physicians, specialists, midlevels, nurses, pharmacists, managed care professionals and the pharmaceutical industry need to work together to address this growing problem and ultimately improve patient outcomes.

TREATING CARDIOMETABOLIC disorders as a whole is greater than the sum of the parts. However, when defining the disorders and creating clinical diagnostic guidelines, recommendations have been put to the test by a variety of healthcare organizations.

In essence, cardiometabolic disorders manifest through interrelated health issues in an individual—primarily hypertension, elevated fasting glucose, reduced high-density lipoprotein, abdominal obesity and elevated trigylcerides—which promote the development of atherosclerotic cardiovascular disease (ASCVD) and type 2 diabetes. Persons with cardiometabolic disorders also have a propensity for inflammation and thrombosis. While guidelines differ in their specificity, they agree that a combination of metabolic and underlying risk factors comprise the disorders.

Managed care’s role includes disease management and integration of programs and data to better assist members in self-care. Working with physicians, managed care’s opportunity is to collaborate in an effort to avoid costly complications.

“Metabolic syndrome is not a disease,” says Gordon Norman, MD, executive vice president of science and innovation for Alere LLC, based in Marietta, Ga., which provides health support solutions. “It is a cluster of factors without one pathophysiological mechanism but linked together and contributing to morbidity.”

The U.S. Department of Health & Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) note the close relationship between glucose, blood pressure and lipid control, which can reduce the risk of cardiovascular disease. For example, blood pressure control reduces the risk of cardiovascular disease among persons with diabetes by 33% to 50%, while increased levels of HDL can reduce complications by 20% to 50%.

Guidelines developed by the World Health Organization (WHO), the International Diabetes Federation (IDF) and the National Cholesterol Education Program’s Adult Treatment Panel III (ATP III), backed by a collaboration between the American Heart Assn. (AHA) and the National Heart, Lung and Blood Institute (NHLBI), vary—which risk factors actually constitute cardiometabolic disorders and what biometrics define risk.

For example, ATP III guidelines say that if a person has three or more of the five primary risk factors, that is sufficient for a diagnosis of “metabolic syndrome,” while the IDF emphasizes central obesity, defining a diagnosis when a person has obesity plus any two other risk factors. WHO focuses on glucose intolerance/resistance plus two other factors.

ATP III also categorizes metabolic syndrome into major risk factors and underlying risk factors, such as obesity, physical activity and poor diet; and emerging factors, including elevated triglycerides, glucose intolerance and insulin resistance.

While many experts warn that diabetes is one of the major results of cardiometabolic disorders, the WHO doesn’t even consider elevated fasting glucose a risk; although, it does factor in the kidney disorder microalbuminuria—an indication of just how variable the guidelines are.

All three sets of guidelines, however, create ranges for blood pressure, triglycerides, HDL cholesterol, fasting glucose and waist circumference that qualify a person as diagnosed with metabolic syndrome. They all provide recommendations for mitigating the risks, including physical activity and changes in diet, followed by appropriate medications, if lifestyle changes are not enough.

The American Diabetes Assn. goes so far as to call the criteria for cardiometabolic disorders “ambiguous or incomplete,” says the medical value of diagnosing the syndrome is “unclear,” considers the treatment of cardiometabolic disorders no different than the treatment for each of the components, and finally, questions the usefulness of including diabetes in the definition of “metabolic syndrome.”

The Endocrine Society created its own workgroup and guidelines that address persons with the various components of cardiometabolic disorders but who have not been diagnosed with cardiovascular disease (CVD) or type 2 diabetes.

“Our objective is to make physicians aware of those with metabolic risk so they can screen for diabetes and CVD, recommend lifestyle changes, measure waist circumference as part of a routine clinical examination and help patients control high blood pressure,” says James Rosenzweig, MD, director of diabetes services, Boston Medical Center, and associate professor, Boston University School of Medicine.

Mary Jane Osmick, MD, vice president and medical director, LifeMasters Supported SelfCare in Irvine, Calif., notes the discrepancies in the three sets of guidelines in a two-part series on metabolic syndrome that she co-authored inCase-in-Point. She notes that none of the definitions is based on prospective clinical trials, but instead on expert consensus panels.

The differences in definitions and guidelines also make it difficult to gauge the prevalence of cardiometabolic disorders. In a study of participants in the National Health and Nutrition Examination Survey (NHANES) 2003–2006, based on ATP III criteria, approximately 34% of adults met the criteria for metabolic syndrome. An estimated 47 million U.S. residents have cardiometabolic disorders. Males and females 40–59 years of age were about three times as likely as those 20–39 years of age to meet the criteria.

Compare the guidelines by visiting www.managedhealthcareexecutive.com/chart.

MORE CONFUSION

Not only is there no consensus on the definition of cardiometabolic disorders and the guidelines for diagnosing them, but the cluster of risk factors poses another issue: whether it should be treated as a single condition/syndrome or each underlying factor should be treated independently. Unfortunately, while many primary care physicians understand the relationship between the components of cardiometabolic disorders, they don’t have the time or the appropriate reimbursement to manage all of the factors simultaneously.

Persons with cardiometabolic disorders are estimated to have twice the risk of developing CVD and a five-fold greater risk of developing type 2 diabetes, according to information from the National Heart, Lung, and Blood Institute. Experts disagree on how effectively the disorder predicts cardiovascular risk and whether the disorder has a single underlying cause. Because of that, physicians might not identify patients requiring preventive treatment.

Dr. Osmick outlines two primary treatment goals: addressing the underlying causes of cardiovascular risk, namely obesity and lack of physical exercise; and supporting the treatment of all other identified risk factors. The primary focus should be lifestyle changes, and she is a strong advocate of care managers to coach patients.

To meet that objective, LifeMasters uses the Patient Activation Measure, developed by Judith Hibbard of the University of Oregon. Based on the individual score, coaches customize education and support for the individual patient’s level of engagement, Dr. Osmick says.

TREATING COMORBIDITIES

Prevention and treatment of cardiometabolic disorders reads like a child’s primer. Reduce the major risk factors, stop smoking, maintain physical activity, a healthy diet and weight control. The goal is to decrease the risk of heart disease and prevent the onset of type 2 diabetes.

Boston Medical Center’s Dr. Rosenzweig believes that most primary care physicians continue to treat individual factors even though the components are interrelated. He says that proper weight, diet and exercise can reduce the risk of diabetes by 60% to 70%.

“There is not enough prevention in primary care,” he says. “Metabolic syndrome is not seen as a public health issue. It needs to be addressed earlier in a systematic way.”

Dexter Shurney, MD, chair, DMAA’s Obesity with Associated Comorbidities Workgroup, focuses on obesity as the culprit for cardiometabolic disorders, driving elevated lipids and glucose intolerance.

“Most primary care physicians are not trained to deal with obesity, exercise and behavioral lifestyle changes for their patients,” he says. “There has to be emphasis on root causes, not on the byproduct.”

Dr. Shurney points out several studies that indicate a “reversal” in high A1c, levels allowing patients to stop taking medications, due to intense lifestyle changes. Moderate physical activity is of key importance, followed by smoking cessation and weight loss and control.

“It’s remarkable how little we know about the approach to this disease using principles of population-based care management,” says Jaan Sidorov, a consultant in Harrisburg, Penn. “Rather, the approach seems to be one of identifying folks by the risk factor—high blood pressure, abnormal labs or a big belly—and then using that as a hinge to subsequently diagnose and treat metabolic syndrome. The disease management folks would argue that they have programs in place and ready to go for high blood pressure, cholesterol, high sugar or for obesity, and that the elements of those programs include the type of interventions necessary to also treat the concurrent syndrome.”

He recommends identifying patients through claims data with more specificity and through health risk assessments, then marshaling resources to provide dietary and exercise advice. He agrees with the need for physician incentives and a greater role for the primary care physician.

Care is physician-dominated and with short 15-minute office encounters, doctors should look to other providers, such as nurses and dieticians, who can emphasize lifestyle changes, he says.

A study conducted by Hart Research Associates addresses both diet and reimbursement. It shows that an overwhelming majority of primary care physicians believe that nutrition plays a major role in the prevention, treatment and management of chronic disease. A large majority admits that if costs were reimbursed, they would spend more time counseling their patients on nutrition. A lack of time is second on the list of reasons why nutrition may be overlooked.

Paul Handel, MD, chief medical officer of Health Care Services Corp. (HCSC), a Blue Cross and Blue Shield health insurer, says that cardiometabolic disorders are the most prevalent and preventable causes of chronic disease today.

“It could ultimately break Medicare’s bank or for that matter, the nation’s bank,” he says.

In February, HCSC initiated a 10-week cardiometabolic disorders program for its own employees using face-to-face meetings and Web-based education. The program focused on eating habits, hydration, exercise and fitness, stress management and managing emotional and psychological needs. Each of the 200 participating employees was assigned a health coach who monitored progress, weekly dietary intake and exercise as well as improvements in weight, body mass index (BMI), waist circumference, triglycerides, cholesterol, blood glucose and blood pressure. Although the program did not prescribe a diet, it emphasized reduced sugar intake and portion control.

“It is an educational, behavioral change program,” says Dr. Handel, “not a specific diet or exercise regimen. The program’s classroom experience and Web-based program offer continual support to help foster changes.”

If employees attended fewer than eight of the 10 sessions, they reimbursed the company $75; otherwise, the company paid for the program. Dr. Handle says the biometrics are measured after three months and one year. He hopes to follow participants for three to five years.

Kevin Casey, 42, a manager for HCSC in its Chicago headquarters, qualified for the program because he had three of the five components the company had designated as “metabolic syndrome”—being overweight, having diabetes, and as he says, having “large amounts of belly fat.” His blood pressure and cholesterol, however, were within the normal range.

In the 10-week program, he lost 58 pounds.

“I eat only when my body tells me it’s hungry,” Casey says. “I found that I was really only hungry once a day.”

His exercise regimen consisted of walking or riding a stationery bike, and now includes running four miles a day. When Casey started the program, he was taking 5 mg of glipizide and 1,000 mg of metformin twice a day for his diabetes. During the study, he monitored his blood sugar daily, reduced the metformin to 250 mg twice per day and stopped taking glipizide.

Although he admits to sneaking a snack now and then since the program ended, he still lost an additional 40 pounds in the 12 weeks following the program.

In another pilot of the program with an HCSC employer group, 53% of the participants showed a significant reversal for risk and lost an average of 15 pounds each during a 10-week period.

DIABETES

Diabetes is a chronic condition in which the body does not produce or properly use insulin to transport sugar from the blood into the cells. As many as 23.6 million people in the United States have diabetes, 90% to 95% with type 2. About 80% of people with type 2 diabetes are overweight, according to HHS. Unfortunately, about 5.7 million have not yet been diagnosed. Insulin resistance and elevated fasting glucose can lead to type 2 diabetes over time, which in conjunction with high blood pressure, low HDL, elevated triglycerides and obesity, increase the chance of cardiovascular disease.

“Many persons with [cardiometabolic disorders] are unaware that they have diabetes because there are no symptoms,” Alere’s Dr. Norman says. “And then it can evolve into a stroke. To stay ahead of that kind of morbid event, you have to attack early on before the syndrome escalates.”

In order to determine whether or not a patient has prediabetes or diabetes, healthcare providers conduct a Fasting Plasma Glucose Test (FPG) or an Oral Glucose Tolerance Test (OGTT). The American Diabetes Assn. recommends the FPG because it is easier, faster, and less expensive to perform.

Diabetes is the fifth most deadly disease in the United States, increasing by 45% since 1987. Based on death certificate data, diabetes contributed to 233,619 deaths in 2005. If trends continue, one-third of Americans born in 2000 will develop diabetes, according to the American Diabetes Assn.

Type 2 diabetes is associated with older age, obesity, family history of diabetes, history of gestational diabetes, impaired glucose metabolism, physical inactivity and race/ethnicity.

The association estimates the total annual economic burden of diabetes in 2007 was $174 billion. Medical expenditures consumed $116 billion of that total, and accounted for 15 million work days absent and 120 million work days with reduced performance. One in 10 healthcare dollars is attributed to the disease.

The main prescription for diabetes, as well as prediabetes, is a healthy diet, regular exercise and proper weight maintenance. Since most people with type 2 diabetes still produce some insulin, these three suggestions may suffice, but in some cases, oral medications may be needed. The American Diabetes Assn. reports that among adults with diagnosed diabetes (type 1 or type 2), 14% take insulin only, 13% take both insulin and oral medication, 57% take oral medication only and 16% do not take either insulin or oral medication.

Prescription insulin is characterized by three features: onset, the time it takes for the insulin to reach the bloodstream and begin lowering blood glucose; peak time, the time during which insulin is at its maximum strength; and duration, how long the insulin continues to lower blood glucose. Adding to the complexity of finding the right insulin for each patient, there are different types of insulin, ranging from rapid-acting to long-acting.

In addition, insulin may be of a human form; an analogue, which is an altered from of insulin not available in nature but capable of glycemic control; and insulin recombinant, which is made through recombinant DNA technology.

“The main goal of insulin therapy is to mimic the body’s natural response to glucose. The trick is to calculate the patient’s food intake and time of meals and use the various products to control the glucose level,” says Ron Alexander, vice president, clinical services for Diplomat Pharmacy in Flint, Mich. “Too much insulin may drop the patient’s blood level too low, and the patient could have serious reactions. The other side of the coin is too little insulin, and other serious reactions can occur. Thus, there is the need to monitor the blood glucose levels and administer insulin or create a need to increase the patient’s glucose level.”

With the spark in the numbers with diabetes, pharmaceutical research and biotechnology companies have risen to the occasion with 133 drugs for type 2 diabetes under development—either in clinical trials or awaiting approval by the U.S. Food and Drug Administration. The rate of new cases has increased by more than 90% among adults, according to a 2008 study by the CDC.

Late last year, the FDA recommended that all new drugs developed to treat type 2 diabetes show that they do not increase the risk of cardiovascular events. The agency is requesting more stringent trials that collect data on cardiovascular end points and studies that include real-world patients likely to be seen in clinical practice. Bristol-Myers Squibb analyzed data for evidence of cardiovascular harm in pooled data from phase II and III studies of its drug, saxagliptin, which was approved by FDA on July 31, 2009. The drug produced lower major adverse cardiovascular events in nearly all high-risk groups compared with controls.

HYPERTENSION

Hypertension is another primary component of cardiometabolic disorders and occurs when the blood moves through the arteries at a higher pressure than normal (120/80 mmHg). ATP III and IDF guidelines consider any reading equal or greater than 130/85 to qualify for “metabolic syndrome,” while the WHO considers equal or greater than 140/90 as a cardiometabolic risk.

Although hypertension usually has no symptoms, it damages blood vessels, which in turn can raise the risk of stroke, kidney failure, heart disease and heart attacks. It is important for members to have their blood pressure checked regularly to identify risk early. Like the other cardiometabolic disorder components, hypertension can be addressed through healthy lifestyle choices and medications.

Hypertension occurs in about one in every three adults in the United States, according to NHLBI, with an estimated price tag in 2006 of $63.5 billion.

Antihypertensives lower blood pressure by opening and widening the blood vessels, which prevents them from tightening and reduces the load on the heart. These drugs, however, do not cure hypertension and may lose their effectiveness over time, making it necessary to change medications or add another drug to leverage both drugs’ actions. Most physicians start patients with high blood pressure at a relatively low dose and assess the effectiveness over the course of several weeks. If the blood pressure remains elevated, the dose of the medication is gradually increased.

There are many classes of drugs that treat high blood pressure, and finding the one that works best with limited side effects may be an exercise of trial and error. Since most people with hypertension do not feel any symptoms, it also may be difficult to determine how well a drug is working.

Diuretics—Often taken in conjunction with other antihypertensives, these “water pills” promote the development of urine in the kidneys, causing the body to flush out fluid and minerals, such as sodium. The result is a reduction in fluid volume and sodium level, which opens bloods vessels wider. Side effects include frequency of urination and increased urinary excretion of potassium.

Beta Blockers—These medications reduce nerve impulses to the heart and blood vessels, making the heart beat more slowly and with less force. They may slow heart rate excessively.

Vasodilators—They directly open blood vessels by relaxing the muscle in the vessel walls, allowing the blood to flow more freely and the heart pump more efficiently. Vasodilators include angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs) and calcium channel blockers.

ACE inhibitors block the formation of the hormone angiotensin II, which tightens blood vessels. About 10% of patients develop a chronic cough.

Producing the same effects as ACE inhibitors, ARBs inhibit the action of angiotensin II by blocking it from entering angiotensin receptors in the body. Angiotensin receptor blockers (also known as angiotensin II receptor antagonists) are generally well tolerated by most people, and serious side effects are rare. Some reported side effects include dizziness, headaches, runny nose and muscle cramps.

Calcium channel blockers prevent calcium from entering the muscle cells of the heart and blood vessels, thus, causing the vessels to relax. These medications may exacerbate pulmonary arterial hypertension as well as headaches, swelling of the ankles and feet and congestive heart failure symptoms.

HYPERLIPIDEMIA

Hyperlipidemia—increased fats in the blood including cholesterol and triglycerides—is easily diagnosed through standard lipid blood tests, which include a measurement of total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL) and triglycerides. Like hypertension, hyperlipidemia has no recognizable symptoms.

Although a total cholesterol level of 200 mg/dl is considered desirable and a value of more than 240 is high, most readings are recorded by looking at both LDL and HDL, the former a more important indicator of risk for heart disease. None of the three organizations producing guidelines even include a measurement of LDL cholesterol in their identification of metabolic disorders; however, both the APT III and the IDF agree that an HDL (“good” cholesterol) reading of less than 40 mg/dl for men and 50 mg/dl for women is a risk factor, while the WHO is stricter—less than 35 mg/dl for men and less than 39 mg/dl for women. All three organizations identify those with triglycerides equal to or greater than 150 mg/dl as at high risk for heart disease and type 2 diabetes.

According to the AHA, approximately 102.3 million American adults have total blood cholesterol values of 200 mg/dl and higher, and of these, about 41.3 million American adults have levels of 240 or above.

The cost of a first time heart attack or stroke occurring in people who failed to reduce their cholesterol was more than $13 billion in terms of both lost wages and hospitalization. For recurring heart attacks or fatal strokes the cost continues at $13 billion per year. Other indirect costs bring that total up to $53.6 billion per year according to theJournal of the American Heart Association.

HMG-CoA reductase inhibitors—statins—are a class of drugs that lower the level of cholesterol in the blood by reducing the production of cholesterol by the liver. Statins block the enzyme in the liver that is responsible for making cholesterol.

Although cholesterol is critical to the normal function of every cell in the body, it also contributes to the development of atherosclerosis, in which cholesterol-containing plaques form within arteries, block them and reduce the flow of blood to the tissues that the arteries supply. In addition to lowering cholesterol levels, statins also reduce inflammation, which often affects those at high risk for cardiometabolic disorders.

In general, for every doubling of the dose of a statin, LDL levels fall by approximately 6%, according to the Third Report of the National Cholesterol Expert Panel on ATP III.

While statins have amassed a worthy track record, they are not without side effects, primarily affecting liver function and damage to muscle tissues, which can be exacerbated by combining statins with other cholesterol-lowering drugs.

The most serious side effect of statins, though rare, is rhabdomyolysis, which begins with muscle pain and may progress to loss of muscle cells and kidney failure.

In addition to stains, there are other cholesterol-lowering drugs: selective cholesterol absorption inhibitors; resins; fibrates; and Niacin.

OBESITY

Obesity is a medical condition in which excess body fat is enough to cause an adverse effect on health. It is the leading preventable cause of death worldwide. The majority of obesity is most commonly caused by a combination of excessive dietary calories, lack of physical activity and genetic susceptibility. Like the other factors associated with cardiometabolic disorders, obesity can be treated through diet modification and regular physical activity. However, in some instances, medications to reduce appetite or inhibit fat absorption or surgery may be needed.

The risk criteria for qualifying for surgery is one of the biggest issues associated with obesity, Sidorov notes.

“Surgery is a very high price tag for insurers and self-insured employers, who therefore, have a substantial economic incentive to do everything to keep the overweight from getting obese, and to keep the obese from having to go through surgery,” he says.

About 97 million adults in the United States are overweight or obese, according to the NHLBI. A study from the Centers for Disease Control and Prevention estimates 34% of adults over age 20 are obese; however, the obesity prevalence has not measurably increased in the past several years. From 1960 to 2004, the prevalence of overweight increased from 44.8% to 66% in U.S. adults age 20 to 74, according to the National Center for Health Statistics.

In 2008, only one state (Colorado) had a prevalence of obesity less than 20%. Thirty-two states had a prevalence equal to or greater than 25%; six of those states (Alabama, Mississippi, Oklahoma, South Carolina, Tennessee and West Virginia) had a prevalence of obesity equal to or greater than 30%. In 2000, obesity-related healthcare costs totaled an estimated $117 billion, according to the CDC.

While being overweight is closely related to heart disease, diagnosis of metabolic disorders places more emphasis on waist circumference as a predictor of cardiovascular disease. Body fat that accumulates around the stomach area poses a greater health risk than fat stored in the lower half of the body.

The ATP III guidelines for waist circumference are more lenient than those established by the IDF: 102 centimeters for men and 88 centimeters for women, versus 94 and 80 centimeters, respectively, for IDF. Physicians measure waist circumference an inch above the belly button.

In conjunction with waist circumference is body mass index (BMI), which assesses body weight relative to height. Normal values range from 18.5 to 24.9. Those with a BMI of 25.0 to 29.9 are overweight and those with a BMI of 30 or higher are classified as obese.

The WHO outlines guidelines for a waist-to-hip ratio—the circumference of the waist divided by that of the hips—as more than 0.9 for men and more than 0.85 for women. The AHA says that this measurement is less accurate than BMI.

The National Institute of Diabetes and Digestive and Kidney Diseases recommends that prescription weight-loss medications should be used only by patients who are at increased medical risk and not be used for “cosmetic” weight loss. Some of the more common medications to treat obesity—most of which are recommended for short-term use—include sibutramine and phentermine, both appetite suppressants; orlistat, a lipase inhibitor; and bupropion for depression.

Alere’s Dr. Norman says that obesity is a common feature of metabolic syndrome but not necessarily the cause. Nonetheless, he believes there is not enough attention being paid to the epidemic and that few physicians make an attempt to correct the problem.

“There is definitely a moral hazard when patients can take Lipitor and then eat a Big Mac,” he says. “We credit medicine to offset our egregious behavior.”

Alere’s Personal Health Coaching program provides communication tools—e-mail, phone, instant messaging—and access to a health coach for one year. The program is designed to address willingness to change rather than just the specific condition. Coaches, who are registered dieticians, fitness instructors, nurses and others, reach out to members according to results of their health risk assessments and develop behavior change plans.

Besides managing diet, exercise and weight, those with cardiometabolic risks can monitor their own progress to ensure treatment plans are appropriate. Stepping on a scale and self-administered, daily blood sugar tests for those with type 2 diabetes can provide trend data for the patient and the clinician. High blood pressure also can be tracked by the patient with the use of a simple manual or digital monitor.

In addition, patients should visit their providers quarterly for an A1c test. It is recommended that patients with type 2 diabetes who don’t use insulin and maintain blood sugar levels consistently within range have A1c tests twice a year. An A1c level of 6.5% or higher on two separate tests indicates the presence of diabetes. A person who has poor control of blood sugar will typically have an A1c over 7%.

The AHA recommends that everyone over age 20 get a cholesterol test to check total cholesterol, LDL, HDL and triglycerides. Tests are taken after nine to 12 hours of fasting. Normal readings are 200 mg/dl or less for total cholesterol, more than 60 mg/dl for HDL, less than 100 mg/dl for LDL and less than 150 mg/dl for triglycerides.

Considering the recent attention drawn to prevention efforts, cardiometabolic disorders and weight issues deserve further exploration.

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