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CMS Disease Management Project Underway in Four States

Donna Young

Three health care organizations began this month recruiting up to 30,000 Medicare beneficiaries in Arizona, California, Louisiana, and Texas with congestive heart failure (CHF), coronary artery disease (CAD), and diabetes mellitus to receive disease management services, including a prescription drug benefit.

The program is a three-year demonstration project sponsored by the Centers for Medicare & Medicaid Services (CMS) to examine whether a fee-for-service disease management program with an outpatient drug benefit leads to improved patient outcomes and lower costs to Medicare, said Amy Knight of CMS's Office of Research, Development, and Information.

The randomized controlled study will include an additional 12,000 beneficiaries who will receive the same Medicare benefits they currently havewithout a prescription drug benefit or disease management services.

CMS solicited proposals for the project in February 2002, but the three companies selected to participate—XLHealth of Baltimore, Maryland; CorSolutions of Rosemont, Illinois; and HeartPartners SM, a Santa Ana, California-based collaboration among PacifiCare, QMed Services, Alere Medical, and Prescription Solutions—were not officially announced until November 2003.

The demonstration program was mandated by the Medicare, Medicaid and State Child Health Insurance Program Benefits Improvement and Protection Act of 2000.

CMS is required to present the results of the project in two reports to Congress: an interim report due in fall 2005 and a final report scheduled for spring 2007, Knight said.

The participating companies, she said, are required to report five types of data from their programs on a quarterly basis: prescriptions filled by the program for each enrollee, the date and type of each program contact with treatment group patients, dates and reasons for disenrollment, goods and services the program purchases for patients, and program contacts with physicians.

The data elements collected will be tailored to the selected programs' interventions.

The three participating organizations must also submit clinical quality of care information to support ongoing quality improvement.

The companies have each partnered with a pharmacy benefit management company (PBM) that will oversee the drug benefit portion of the project and process claims, Knight said.

CorSolutions, HeartPartners, and XLHealth will be the primary payers of the drug benefit, even if the patient has a benefit through an employer or other private program, or through a public program, such as Medicaid or the Department of Veterans Affairs, she said.

Prescription Solutions, a subsidiary of PacifiCare, is providing the prescription drug benefit for HeartPartners, and PBM giant ExpressScripts is providing the benefit for CorSolutions.

XLHealth has partnered with PBM Plus, a subsidiary of OmniCare, for its project's benefit, and the company has also teamed with Walgreens for pharmacist-provided medication counseling services.

All three of the disease management programs are using nurses who will provide telephonic patient education and monitoring services.

Pharmacists' participation in the demonstration project varies among each of the three organizations' care models, but XLHealth's project is the only one for which pharmacists are providing face-to-face counseling services.

Paul Serini, executive vice president for XLHealth, said his company joined with Walgreens in 2001 to provide pharmacist medication management services to Texas patients with diabetes.

Walgreens renovated eight of its drug stores to include patient assessment areas where XLHealth nurses assess patients during scheduled visits and pharmacists provide medication counseling services.

"For Walgreens to take shelf space away from a store manager is not an easy task," Serini said.

XLHealth has incorporated its Walgreens program into its demonstration project.

"Medication compliance is a huge part of managing heart failure, cardiovascular disease, and diabetes," Serini said. "What we've found was that using a combination of on-the-ground nurses and pharmacists . . . was extraordinarily effective in increasing all of the medication management compliance."

XLHealth plans to provide services to 10,000 patients in Texas with "clinically complex" diabetespatients with foot and lower-extremity complications and CADand beneficiaries with both diabetes and advanced CHF. The organization plans to also enroll a smaller group of beneficiaries with advanced CHF but no diabetes.

The company is enlisting the help of about 1400 physicians to help enroll patients in the program, Serini said.

"Our model is very physician driven," he said. "What we do first is, we enroll physicians into the program by having them come onboard and explain the program to them. And essentially the physicians in the program, with a lot of administrative support from us, enroll patients in the program."

Physicians who enroll their patients into the XLHealth project are required to sign a "short" three-page participation agreement, Serini said.

As part of the agreement, XLHealth pays physicians a stipend of about $2500 "for their time and effort," he added.

"The physicians don't need a lot of selling on this," Serini maintained. "It's really a matter of getting in front of them. When you explain to a physician that we're going to permit the physician to bring to their chronically ill patients a robust drug benefit that covers drugs related and unrelated to the principal chronic condition, with very modest copays, plus home visits from a nurse, home telemonitoring of signs and symptoms, and report packages and education support to the physician and patient . . . they get it."

XLHealth's pharmacy and therapeutics committee, he said, was charged with designing a formulary for the disease management project that meets the needs of patients with diabetes, CAD, and CHF, and puts "the most effective drugs on the lower tiers of the formulary so that we can remove all of the economic barriers that the patient might have to taking the drugs that their doctors want them to take."

"What we've heard time and again from physicians in the community is, 'Mrs. Garcia needs to be on six drugs, but I don't write the script for four of them because I know she can't afford them' or 'Mrs. Garcia gets six scripts but only fills two.' Either way, it's the same result," Serini said.

XLHealth's formulary includes on its first tier the prescription cholesterol medications Lipitor (Pfizer) and AstraZeneca Pharmaceutical's Crestor.

Patients enrolled in the program would pay a $5 copay for a 30-day supply of each of those drugs, or a $10 copay for a 90-day supply through the PBM's mail-order service.

"You never see those drugs on tier one," Serini said.

Pharmacist Troy Koch, senior director of pharmacy program development for CorSolutions, said his organization is still discussing copay amounts for patients enrolled in the project.

But, he added, CorSolutions, and its PBM partner ExpressScripts, is planning to use a traditional three-tier prescription drug plan: generic, brand name, and nonpreferred brand name.

CorSolutions' benefit will have an annual cap, said Koch, who helped design his company's disease management program.

"Under consideration is a $4000 cap per recipient," he said.

CorSolutions used an existing model from an ongoing Medicare demonstration project in Texas in which the company is participating, said James O'Leary, senior director of research and analysis. But, he added, the previous model did not include a pharmacy benefit.

CorSolutions will be providing services in "most urban parishes" between New Orleans and Shreveport, Louisiana, to about 5000 Medicare beneficiaries with CHF, CAD, or diabetes or patients with one or more of the conditions.

"We selected Louisiana based on both the higher than national average prevalence of heart failure, CAD, and diabetes, and also the higher than average cost associated with those particular diseases for Medicare beneficiaries," O'Leary said.

Patients enrolled in the program will have the option of using a pharmacy network or ordering medications through ExpressScript's mail-order service, he said.

The disease management services, O'Leary said, are "primarily telephonic" and are provided by registered nurses.

"We have a 24-hour nurse connection line, so, if on any the day of the week, if the beneficiary's having problems and they wish to call us, they can," he noted.

The goal of the project, O'Leary said, is to demonstrate whether the addition of disease management and a pharmacy benefit can keep inpatient expenditures down.

"This particular demonstration is really forcing the vendors to be accountable for the whole dollar amount and coordinate care across all three components" of inpatient, outpatient, and pharmacy care, he said. "So we will be actively pushing to make sure that the beneficiaries who come into the treatment group are compliant on their pharmacy regimen, because to do otherwise may just come back and bite us in the back with an inpatient event."

Another purpose of the program, O'Leary said, is to "assist the physician in knowing what is occurring between office visits and to provide that information to them in a way that will assist their clinical practice."

Nurses who are monitoring the patients will send periodic reports to the patient's physician, he said, adding that physicians may also monitor patient information online through a special CorSolutions Web site designed for the project.

Kathy Cartelli, director of disease management for PacifiCare, said HeartPartners will be providing services in Arizona and California to 15,000 Medicare beneficiaries with CHF and patients with CHF and CAD or diabetes or patients with all three conditions.

However, patients must have CHF as the primary condition to be enrolled in the program.

HeartPartners is using a combination of technology, telephonic, and inperson monitoring, Cartelli said. Patients and nurses will be using Alere's Daylink biometric measurement device to monitor the patient's weight daily.

When a patient steps on the device's platform, which is similar to a bathroom scale, his or her weight is electronically sent through the telephone lines to a HeartPartners nurse's station for monitoring and tracking.

Patients also respond daily to specific questions by pressing 'yes' or 'no' buttons on the device's liquid-crystal display. The system also includes an audio-voice unit for patients with vision problems. Nurses use the information to prioritize follow-up calls to patients, Cartelli said.

"This is really trying to get early intervention when [patients] are starting to get into trouble so that it takes an outpatient visit instead [of inpatient care], or just a change in medication dosages," she said.

HeartPartner's nurses also periodically contact patients by phone and alert physicians when necessary, Cartelli said.

The organization provides patients with educational materials about their condition by mail, she added. The organization's PBM partner, Prescription Solutions, will monitor medications and alert physicians to contraindications and possible drug-drug interactions, Cartelli said.