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Testimony

Chairwoman Johnson, Representative Stark, distinguished members of the Committee: I thank you for inviting me here today to discuss the new Chronic Care Improvement Program, (CCIP) about which we at CMS are very excited.   As you know, this voluntary program was created by Section 721 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA).  The CCIP could be a major new step in improving the quality of care for chronically ill beneficiaries under Medicare fee-for-service.  I would like to make particular note of the work that Chairwoman Johnson did to champion this new program and let her know that we believe that her work will make a real difference in the lives of hundreds of thousands of Medicare beneficiaries across the country who suffer from chronic ailments.  Today, I would like to address the questions of how the CCIP may help Medicare beneficiaries, and how Phase I will work, including beneficiary selection, payment, and criteria for expanding the program nationwide under Phase II. 

HOW CAN THIS PROGRAM BE HELPFUL?

Medicare beneficiaries living with chronic conditions in the traditional fee-for-service Medicare program face a particularly challenging task in effectively managing their conditions.   The goals of the CCIP are to assist these individuals utilizing the latest in evidence-based care management and information technology, as well as personal interactions with caregivers to ensure better outcomes.  We believe that Medicare may be able to utilize these proven measures not only to improve the fiscal outlook of the program, but also to more adequately assist our beneficiaries in living healthier lives. 

Widespread failings in chronic care management are a major national concern.   Many of these failings stem from systemic problems rather than lack of effort or intent by providers to deliver high quality care.  Medicare beneficiaries are disproportionately affected because they typically have multiple chronic health problems.  Fragmentation of care can lead to poor health outcomes.  In addition, Medicare beneficiaries with five or more chronic conditions represent 20 percent of the Medicare population but 66 percent of program spending.  Most of Medicare expenditures for care of these beneficiaries are for multiple and often preventable hospitalizations. 

Congestive Heart Failure (CHF) and diabetes are among the five most common chronic diseases in the Medicare population.  According to findings from the 2002 Medicare Current Beneficiary Survey, individuals with CHF, and coronary artery disease represent 21.3 percent of non-institutionalized fee-for-service Medicare beneficiaries and account for 36.8 percent of Medicare expenditures, including treatment for all their health problems.  Individuals with diabetes represent 19.4 percent of beneficiaries and 30.4 percent of fee-for-service Medicare expenditures.  Beneficiaries with these diseases tend to have complex self-care regimens and medical care needs, that when neglected, or uncoordinated, can lead to complications and acute care crises.  The health risks of these beneficiaries depend heavily on how effectively they are able to control their conditions in their daily lives and whether or not they receive appropriate medical care and effective coordination of their care.  Efforts to control their conditions successfully may benefit from ongoing guidance and support beyond individual provider settings.

Prevalence rates of diabetes and CHF are even higher among minorities than among all Medicare beneficiaries.  For example, as shown in Figure 1, the Centers for Disease Control and Prevention reports that 23.0 percent of black males and 23.5 percent of Hispanic males ages 65-74 have diabetes compared to 16.4 percent of white males and 15.4 percent of all individuals in that age group.  Black and Hispanic females in that age group have diabetes prevalence rates of 25.4 percent and 23.8 percent, respectively, compared to 12.8 percent for white females and 15.4 percent for all individuals in that age group.  Given these prevalence figures, improving quality and adherence to evidence-based care has the potential to improve outcomes and reduce racial and ethnic health disparities, consistent with HHS’ Healthy People 2010 goals.

Figure 1

The Medicare fee-for-service system is structured and financed to manage acute care episodes, not to manage and support individuals with progressive chronic diseases.  Providers of care are organized and paid for services provided in discrete settings (for example, hospitals, physician offices, home health care, long-term care, or preventive services).  Patient care can be fragmented and poorly coordinated and patient information difficult to integrate among settings.  Providers may lack timely and complete patient clinical information to fully assess their patients’ needs and to help prevent complications.  Ongoing support to beneficiaries for managing their conditions outside their physicians’ offices is rare.

Fragmentation of care can be a serious problem for Medicare beneficiaries.  The average Medicare beneficiary sees seven different physicians and fills upwards of 20 prescriptions per year.  In a recent survey, 18 percent of people with chronic conditions reported having duplicate tests or procedures and 17 percent received conflicting information from providers.[1]   Providers reported feeling ill-prepared to manage chronically ill patients and reported that poor coordination of care led to poor outcomes.  Physicians and other practitioners desire to, and often do, provide very high levels of care in this country, but the challenges they face in integrating all of their efforts often frustrate their excellent intentions.  As a practicing internal medicine physician I encountered these same challenges.  I believe that the CCIP will assist currently practicing physicians and health care providers to avoid some of the challenges that I was faced with while actively treating patients.

The gap between accepted standards of appropriate care for patients with chronic diseases and the care they actually receive is significant.   According to findings of a recent national study published in the New England Journal of Medicine, only 56 percent of patients with chronic diseases received recommended care based on well-established guidelines referenced by the researchers.  Among patients in the study sample who had CHF, only 64 percent received recommended care, and among those with diabetes, only 45 percent received recommended care.  Specifically, only 24 percent of diabetes patients in the study received three or more glycosylated hemoglobin tests over a two-year period.  Similarly, in a recent study of practice patterns under Medicare, researchers found that, across all States, an average of 66 percent of Medicare beneficiaries with heart failure received ACE inhibitors and 16 percent with diabetes received a lipid test. 

A concerted effort to coordinate care and enhance patient compliance will result in fewer acute episodes of care, fewer disease complications and will help eliminate redundant services as physicians and other providers repeat tests and evaluations previously performed because they lack the ability to access results of those services.   These changes alone have the potential to generate substantial savings. 

Currently, Medicare fee-for-service payments do not encourage prevention of diseases, good outcomes and performance.   Instead, the payment system provides money for acute events, missing a potential opportunity to prevent these situations which could be beneficial from a cost standpoint, but, more importantly, from a health perspective.  In a sense, payment incentives are the opposite of the way they should be.  The CCIP seeks to address this problem, as well as others described above, by rewarding efforts to prevent acute episodes and improve health.  Under CCIP, awardees will work to increase patient compliance, facilitate communication between patients and providers, and better coordinate care among providers caring for the same individual.  In a much more direct way than ever before under fee-for-service Medicare, economic incentives will be directly lined up with prevention and performance.  We hope to reward high quality care, rather than high volume and high intensity care. 

Our work with CCIP will nicely complement previous efforts to provide consumers with information on quality outcomes in nursing homes, home health agencies, and hospitals, and to line up economic incentives with quality standards.   This shift in payment and emphasis is a demonstration of the Administration’s commitment to a coordinated, patient-centered approach to healthcare. 

CMS is also working to line up physicians’ economic incentives with quality care through such programs as the physician group practice demonstration project that will provide bonus payments for improvements in quality.  We also will be conducting a demonstration under Section 649 of the MMA to encourage physicians to promote continuity of care, use established clinical guidelines and prevent or minimize exacerbations of chronic conditions.  Additionally, beginning in 2006, all Medicare Advantage plans will be required to operate chronic care improvement programs of their own.  These plans will be able to use varying payment methodologies to line up economic incentives with quality care from providers.  The CCIP under Section 721, although important in its own right, is not the only tool CMS will be using to assist Medicare beneficiaries with chronic conditions to effectively manage their care.

CHRONIC CARE IMPROVEMENT POTENTIAL

To date, there has not been a sufficient number of thorough tests of whether chronic care improvement will improve health care quality and reduce costs in Medicare.   However, private companies have been utilizing the techniques called for under CCIP for some time, and have demonstrated some success in improving health outcomes. 

Michael Rich and colleagues found that a nurse-directed multidisciplinary intervention program reduced net cost of care an average of $153 per patient, per month, for the treatment group versus the control group.  Readmissions in the control group were nearly double that of the treatment group.[2] 

A major U.S. company reported that a disease management program for diabetic patients run out of an on-site clinic realized savings of more than $600,000 in reduced sick time usage in its first year of operation.[3] 

Ronald Aubert and colleagues found significant decreases in fasting glucose levels among patients who were provided with the services of a nurse case manager who was also a certified diabetes educator.  These patients reported perceived improvement in their health status more than twice as often as their control group counterparts.[4]

Researchers at Geisinger Health Plan found that patients who chose to enroll in its diabetes management program had higher scores on diabetes-related HEDIS (Health Plan Employer Data and Information Set) performance measures and lower average monthly claims.  Inpatient days per patient, per year, were lower, though there were more primary care visits.[5]

Another study found that telephonic nurse guidance for CHF patients following initial hospital admission resulted in a 47.8 percent decrease in heart failure readmissions at six months.  The authors reported medical care cost savings net of intervention costs.[6]

In another study, readmissions for heart failure were reduced 56 percent in the first ninety days after discharge for high-risk CHF patients age seventy or older.[7] 

The Diabetes Care Connection program, implemented in 2000 by the Hawaii Medical Service Association (HMSA), targeted all of its 40,000 beneficiaries with diabetes, including more than 6,000 Medicare beneficiaries.  Cap Gemini Ernst and Young found that a much higher percentage of beneficiaries had their blood glucose levels tested during the first year of the program than in the baseline year.  Also, total per capita claims costs were lower for HMSA Medicare beneficiaries with diabetes in 2000 than in 1999, mainly because of reduced hospital costs.[8] 

Despite these proven successes, Medicare beneficiaries who are most likely to benefit from chronic care management services are unlikely to participate in them because they have been unavailable under the fee-for-service program.   Many of the Medicare Advantage health plans have engaged in one form or another of disease management in the past few years.  These programs have assisted beneficiaries enrolled in those plans to reap the benefits of more coordinated and effective care management.   In one such Medicare Advantage disease management program, their CHF program has produced a 70 percent decrease in hospital admissions.  They calculate that for every dollar they invest in their disease management program, they realize a savings of three dollars.  In their diabetes management program, this health plan has seen a 45 percent decrease in amputations made necessary by advanced conditions of the disease.  New cases of retinopathy have declined by 20 percent among participants in the disease management program.  The plan estimates that the 10 year benefit will save $1,500 per patient, or $30 million over that time frame.  Unfortunately, the benefits of a disease management program have been unavailable to beneficiaries in the fee-for-service program until now.  The CCIP will move toward changing this situation.

The programs cited above resulted in patients who were healthier, who spent fewer days in the hospital and who were happier with the care they received.   So what kinds of things do chronic care improvement organizations do to make such a positive impact in people’s lives?

Mrs. Jones, a beneficiary with heart failure, was given the option of using a 1-800 number to call and report her weight on a daily basis, or the equipment that would report automatically.   If her weight increases by more than a certain amount over a week, her physician would be notified immediately.  The weight gain could be an indication that Mrs. Jones is retaining fluid, which could be a reflection of her heart failure flare-up.  With such a timely notification, the physician could adjust Mrs. Jones' medication over the phone, or do a simple, quick checkup in the office before a serious complication occurs, saving Mrs. Jones an unpleasant trip to an emergency room or worse.

Another example might be Mr. Smith, a beneficiary with COPD.   He could receive home health care on a regular basis to help ensure that his home environment does not exacerbate his condition.  Since beneficiaries with COPD often have limited oxygen intake, his home health aid could help ensure that activities such as reaching for a jar from a kitchen cabinet are made easier, that he has air filters in his home, or that he has hypo-allergenic bed sheets, for example.  These are all simple activities that could send Mr. Smith to the emergency room. 

Another example might be Mr. Rodriguez, a beneficiary with diabetes.   He could be in need of transportation services to get to the physician.  He could have a history of failing to seek diabetic wellness visits due to transportation issues.  These could have led to acute exacerbations of his diabetes, where he had to spend time in the hospital.  His nurse case manager could help him obtain transportation so he does not miss critical preventive check-ups.  These preventive check-ups, such as retinal exams, glycosolated hemoglobin tests, blood pressure tests, foot exams, etc. have documented benefits in preventing acute diabetic crises.

Another example might be Mrs. Johnson, a beneficiary with CHF and depression.   She could have had severe problems with medication compliance and general wellness stemming from her depression.  A nurse in an IPA could reach out to her on a regular basis, provide self-care support for diet and exercise, and ensure medication compliance.  The physician’s office could also bring her in for group therapy and schedule preventive check-ups with the physician.  The IPA could use an electronic health record to track Mrs. Johnson’s progress and communicate with her other physicians.

We expect many CCIPs to rely on innovative uses of IT equipment, including electronic monitoring, records, prescribing and alerts, to help them carry out their programs.   These tools, when properly utilized, are tremendously powerful in aiding physicians, pharmacists and other caregivers to provide the best possible care.  Individual physicians, nurses, home health agencies and other health providers may utilize electronic records or prescribing systems within their own practices, but it is often a challenge to integrate these systems so that information gleaned by one provider can be available to others who serve the same beneficiary.  Part of the CCIP concept is that awardee organizations will work with the beneficiary and through their own innovative IT systems to ensure effective communication between the beneficiary’s providers.  That sort of overarching view of things is expected to greatly assist these providers in their effort to overcome the fragmented state of care often encountered today.  Additionally, we expect that when these individuals see the benefits of this technology they may be more apt to integrate it more fully into their broader practice.

To put it in human terms, patients served by one of these organizations have said the following:

• “[The program] is the best thing that ever happened to me.   Thank God for you. Keep up the good work.”  E.A. 60 yrs. Lake City
• “Please keep this program.   It helps in many ways.  Keeps you on top of your health, and helps you understand what’s happening when things do go wrong.  Good Program.”  P.D. 51 yrs. Titusville
• “I am very pleased to have someone help me to take better care of myself and my self esteem is stronger knowing others care about me.   This program should extend to everyone.”  M.M. 58 yrs Palm Coast
• “The help I have received through your staff and educational material has helped keep me out of the hospital.   Thanks a million.  I also appreciate your personal phone calls. They are a great help.”  D.B. 57 yrs. Pounce de Leon
• “[The program] nurses have been a great help to me. I feel that with their help I have been able to control my CHF and the notes to the doctor have really helped getting the doctor to pay more attention to my problems and get to me faster when needed.”   C.W. 51 yrs. Ocala
• “My nurse is fantastic. She is very informative and cares about your condition and helps you to get better or take care of yourself as best that you can. She is the best. Thank you for assigning her to me. I feel blessed to know her.”   L.G. 35 yrs. Jacksonville

These outcomes represent the kinds of results we hope to accomplish through the CCIP.

HOW THE PROGRAM WILL WORK

On April 23, 2004, CMS published in the Federal Register a notice informing chronic care improvement organizations of the possibility of working with CMS in providing services to Medicare beneficiaries under the new program established by Section 721 of the MMA.

In Phase I, the Secretary will enter into agreements with qualified organizations to run large-scale regional CCIPs for 3 years, for prospectively identified beneficiaries with CHF, complex diabetes, and chronic obstructive pulmonary disease (COPD).   There is some evidence that self-care support, education, and other tools targeted at beneficiaries with these conditions are particularly effective at improving clinical outcomes, reducing overall cost, and improving beneficiary and provider satisfaction.  The CCIPs are to be implemented in approximately ten regions where at least 10 percent of the Medicare population resides.  We expect the CCIPs will collectively serve between 150,000 and 300,000 chronically ill fee-for-service Medicare beneficiaries.  These programs will be evaluated through randomized, controlled trials, with at least 10,000 beneficiaries in the control group for each program.  The evaluations will be conducted by an independent entity.

Each program will offer self-care guidance and support to chronically ill beneficiaries to help them manage their health, adhere to their physicians’ plans of care, and ensure that they seek (or obtain) medical care that they need to reduce their health risks.   The programs will include collaboration with participants’ providers to enhance communication of relevant clinical information.  The programs are intended to help increase adherence to evidence-based care, reduce unnecessary hospital stays and emergency room visits, and help participants avoid costly and debilitating complications.  CCIPs will be required to assist participants in managing their health holistically, including all co-morbidities, relevant health care services, and pharmaceutical needs.  CMS will test models that use a wide variety of interventions to bring about improvements in clinical quality, satisfaction and reduced costs. 

As intended by Congress, CMS will seek to partner with awardees whose CCIPs are designed to support and improve the patient-physician relationship, not interfere with it.  CMS is particularly interested in programs that have a track record of success in, or a comprehensive plan for, engaging beneficiaries’ physicians and other providers.

Given the considerable time constraints that today’s physicians face, we anticipate that physicians will appreciate the timely, actionable information that these services could provide.  We also anticipate that physicians will appreciate better-educated patients and better information about what is happening with patients outside their offices.  There is nothing about these programs that will supplant a physician’s autonomy.

Completed proposals from potential awardees are due by August 6, 2004 and we expect to sign the first service agreements by December 8, 2004.  We anticipate that program operations will begin and services will be provided by early 2005.

ELIGIBLE ORGANIZATIONS AND BIDDING

Organizations eligible to apply to implement and operate programs under CCIP include:   (1) disease management organizations; (2) health insurers; (3) integrated delivery systems; (4) physician group practices; (5) a consortium of such entities; or (6) any other legal entity that meets the requirements of the solicitation in the Federal Register, published April 23, 2004.

The bidding process is designed to allow different approaches to be reviewed in a comparable manner.  Applicant organizations will propose the geographic region(s) they wish to serve.  CMS will provide applicants with a de-identified nationally representative sample dataset of the type of beneficiaries who would be included in this pilot, on which applicants will base their bids.  Finalists will be provided with geographic specific data to enable bids to be adjusted, if necessary, for regional variations. 

The beneficiary participation process will be conducted in a way that balances giving beneficiaries the greatest opportunity to participate if they want to, while protecting them if they do not.  It is important to note that participation is completely voluntary.  Beneficiaries who participate may terminate participation at any time.  This program is not a form of managed care, in the sense that it has no gate-keeping function, operating to limit services, or do a pre-service review of appropriateness of care.  Beneficiaries will remain enrolled in the traditional fee-for-service program and have access to the full range of Medicare benefits as they currently stand.  Additionally, beneficiaries who participate in the program will have access to any participating Medicare provider.   The beneficiary participation verification process works as follows:

1.  CMS identifies eligible beneficiaries.  All beneficiaries in a chosen geographic area will be screened for eligibility based on historical claims data.  Those beneficiaries who are deemed eligible will be randomly assigned to one of two groups – the intervention group or the control group.

2.  CMS contacts enrollees by letter.  All beneficiaries in the intervention group will be notified of the opportunity to participate through a letter from the Medicare program including the information specified in the legislation.  The letter will provide a description of the program and give the beneficiary an opportunity to decline to be contacted by the CCIP organization.  The letter will detail how the beneficiary can obtain further information about the program.

3.  If the beneficiary says ‘No,’ awardee would not contact beneficiaries who opt not to be contacted regarding the opportunity.

4.  If the beneficiary is silent - awardee attempts to contact beneficiaries to confirm participation.  CMS will then expect each awardee to contact all intervention group beneficiaries in its area who were silent to describe the program and ask if the beneficiary would like to participate.  CMS will provide a specific protocol that each awardee must use during the initial contact.  With regard to non-responders, we will expect applicants’ proposals to specify detailed descriptions about their outreach protocols, including, for example, frequency and number of outreach attempts, and how the applicant will ensure that outreach efforts are respectful of beneficiaries.  CMS may negotiate limits on the number and/or frequency of outreach attempts during the outreach period, and may specify that awardees will be required to cease further outreach efforts after the outreach period.

5.   If the beneficiary is contacted and says ‘Yes’ or ‘No,’ the awardee will record the beneficiaries’ responses.  Beneficiaries who agree to participate will be considered participants until they either become ineligible (for example, joining a Medicare Advantage plan) or notify the awardee or CMS that they no longer want to be contacted by the awardee.

Again, participation is always voluntary.   Participants can notify the awardee or CMS at any time that they no longer want to be contacted by the awardee. 

Awardee organizations will be responsible for serving an entire population assigned to them by CMS.  They will be held accountable for improving clinical, satisfaction, and financial outcomes over the entire assigned population.  Because of this fact, the program is considered to be “population based.”  Awardees are held responsible for beneficiaries who choose to participate in the program, as well as those who choose to not participate.  A valid comparison between beneficiaries offered the opportunity to participate in the intervention group and beneficiaries in the control group requires that awardees performance measures include data from intervention group beneficiaries who choose not to participate, since we would have no way of knowing the rate at which beneficiaries in the control group might similarly participate or not. 

The CCIP will be set up so that its activities, including contacting physicians with beneficiary health information, are health care operations of Medicare fee-for-service, and therefore, entail permissible disclosures under the Health Insurance Portability and Accountability Act (HIPAA).   Health care operations, allowed under the HIPAA privacy rule, include population-based activities relating to improving health or reducing health care costs, case management and care coordination, contacting of health care providers and patients with information about treatment alternatives, and other related functions.  Furthermore, CCIP organizations would be considered business associates of CMS, and therefore it would be permissible to transmit health information to them. 

PAYMENT

The CCIP contracting model is flexible enough to accommodate a wide range of program models, but payment methods in all instances will be performance-based.   Fees paid to awardees will be at risk for performance improvements in clinical quality, beneficiary and provider satisfaction, and reduced costs across their assigned target populations compared to their regional control groups.   The statute purposely links payment and quality.  The underlying premise of the CCIP initiative is that through performance-based contracting, improvements in quality will lead to better financial, health, and satisfaction outcomes.

As a condition of continued participation in the CCIP, organizations will be required to demonstrate improvements in quality of care for beneficiaries in the intervention group.   Prior to award, the specific measures for improved quality and satisfaction will be negotiated with the organizations based upon the quality parameters listed in the solicitation as a minimum.  CMS reserves the right to reduce or withhold payments should the mutually agreed upon quality targets not be achieved.  The specific guidelines for such action will be negotiated with each organization prior to award.

The goal of the CCIP is to reduce Medicare costs in traditional fee-for-service, while simultaneously improving beneficiary outcomes.   CMS is requiring a guaranteed minimum of 5 percent savings to the Medicare program, including all CCIP fees for the assigned population compared to the control group’s experience.  The exact amount of savings is contingent upon a number of unknown variables such as the total number of sites and beneficiaries who will be served across the program and whether CMS will receive and accept proposals with more aggressive savings guarantees. 

As part of the application process, all organizations will be required to show proof of their financial solvency and ability to assume financial risk up to 100 percent of their monthly fees, up to the 5 percent net savings guarantee.  The agreements between CMS and the awardees will specify the exact mechanism for guaranteeing performance and security.  Their ability to achieve proposed Medicare savings targets will be evaluated on an individual basis based upon their proposed program designs, the results of site visits, and evidence of prior achievements.  CMS plans to hold a bidders conference on May 13 for organizations interested in providing CCIP services under this new program.  The conference will provide participants an opportunity to gain knowledge of issues associated with applying to implement and operate a chronic care improvement program as part of Phase I of CCIP.  CMS has already enrolled as many potential bidders as it can to attend the conference.  

EXPANSION OF THE PROGRAM

Phase II, the potential expansion phase of CCIP, depends on the success of Phase I.  The statute provides for the Secretary to expand successful CCIPs or program components, possibly nationally.  The Secretary may begin Phase II expansion not earlier than 2 years, and no later than 3½ years, after implementing Phase I.  Quality and satisfaction measures will continue to be a key part of contracts with CCIP awardees through Phase II.

CONCLUSION

We at CMS fully expect this program to improve beneficiary health outcomes, increase their satisfaction with the services they receive through Medicare, better the partnership between caregivers and patients, and save the Medicare program money.  It is an innovative model for care delivery, focusing on preventing problems, rather than allowing them to develop in the first place.  We appreciate the Congress’ support in providing the means for this program to take place and look forward to sharing the results with you as it progresses.  Thank you for your time and I would be glad to answer any questions.