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dmprograms.com • Chronic Care Improvement Program • Frequently Asked Questions

Chronic Care Improvement Program

Frequently Asked Questions

This following is from text that originally appeared at the Chronic Care Improvement program Web site, www.cms.hhs.gov/medicarereform/ccip/.

1. Who will be eligible to eligible to apply as a Chronic Care Improvement Program?

Organizations eligible to apply to implement and operate Chronic Care Improvement programs under Phase I 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.

6/17/2004

2. What is the Voluntary Chronic Care Improvement Program?

The Voluntary Chronic Care Improvement program represents a major new initiative to help improve the quality of care for chronically ill beneficiaries under Medicare fee for service. It is an important component of modernizing and strengthening Medicare.

4/20/2004

3. What is the difference between Phase I and Phase II of the Chronic Care Improvement Program?

In Phase I, the pilot phase, there will be approximately 10 regional Chronic Care Improvement programs, collectively serving approximately 150,000 to 300,000 chronically ill beneficiaries, in regions where at least 10% of Medicare beneficiaries reside. The Phase I programs will operate for 3 years and be evaluated through randomized controlled trials.

4/27/2004

4. What will the Chronic Care Improvement Programs do?

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. CMS will test models that use a wide variety of interventions to bring about improvements in clinical quality, satisfaction and reduced costs.

4/20/2004

5. What are your expectations from Phase-I of the Voluntary Chronic Care Improvement Program?

It leads toward a stronger focus on improving health outcomes for prospectively identified targeted populations who are not well served by the fragmented FFS health care delivery system. It creates a new focus on setting measurable performance goals and tracking improvements in clinical quality, provider and beneficiary satisfaction, and cost-effectiveness in a regional, population-based framework.

It develops and tests the concept of tying contractor payment to results in achieving quality and cost targets and satisfaction levels.

It helps modernize Medicare by creating incentives for the private sector to harness advances in information technology and innovation in care management on behalf of FFS Medicare beneficiaries.

It addresses quality failings without changing beneficiary's benefits, providers, or access to care.

It is an approach that is regional, yet potentially replicable nationally.

It is a substantial investment for those beneficiaries who need it most that will help reduce avoidable costs.

Minority populations suffer disproportionately from chronic diseases and will stand to benefit most from the program.

4/20/2004

6. What is meant by Chronic Care Improvement Program payments will be "contingent on improvements in quality"?

The Chronic Care Improvement program embodies the Secretary's vision of creating a new business platform that will encourage private sector innovation in addressing deficiencies in chronic care in the fragmented FFS health care delivery system. The Chronic Care Improvement-I 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 in 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 Chronic Care Improvement initiative is that through performance based contracting, improvements in quality will lead to better financial and satisfaction outcomes.

As a condition of continued participation in Phase I of the Chronic Care Improvement program, 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. 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.

4/20/2004

7. Are providers, home health agencies, or other organizations eligible to apply under the Chronic Care Improvement Program?

Yes. Providers and other organizations are eligible to apply but such groups should keep in mind that they would be responsible for an entire population located within a designated geographic area, not just their local patient base. They may wish to consider forming or joining a consortium to provide Chronic Care Improvement Services within their local area.

4/20/2004

8. How will the geographic areas be selected under Phase I of the Chronic Care Improvement Programs?

Applicants 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. CMS reserves the right to ask applicants to adjust their proposed area to ensure that an appropriate population is served. More detailed information about this process will be available on the CMS Web site and will be discussed at length at the bidders conference.

4/20/2004

9. What is the size of population in each Chronic Care Improvement Program site? How big will each site be?

The statute mandates at least 10,000 beneficiaries will be in each control group. Control groups could be larger than 10,000 Medicare beneficiaries, depending on statistical and evaluation requirements.

4/20/2004

10. Will rural areas be excluded from Chronic Care Improvement Programs?

No. In fact, quite the opposite is true. Given the scale of the Chronic Care Improvement Program, it is highly likely that a regional program could include, for example, an entire state as a geographic area. Furthermore, we believe that Chronic

Care Improvement programs can be well suited to deliver services to large rural areas because their operational models rely in part on technology and centralized staffing.

4/20/2004

11. Why were CHF, diabetes and COPD selected as threshold conditions for the Chronic Care Improvement Programs?

Initially, the programs will be focused on beneficiaries who have congestive heart failure (CHF) and complex diabetes, or chronic obstructive pulmonary disease (COPD) because these beneficiaries have heavy self-care burdens and high risks of experiencing poor clinical and financial outcomes. Individuals diagnosed with CHF, complex diabetes, and COPD disproportionately consume health care resources and account for a high prevalence within the Medicare population. Beneficiaries who live with these conditions often have other co-morbidities. Commonly, beneficiaries who live with multiple chronic illnesses interact with the health care system in a fragmented way, which often leads to poor health outcomes, increased cost, and dissatisfaction, despite the best efforts and intentions of providers. There is 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.

4/20/2004

12. How does the Chronic Care Improvement program differ from other disease management initiatives in CMS?

While CMS has tested and is testing various disease management models through its demonstration authority, the scale and complexity of this program is completely new to CMS. This program is not a demonstration. Rather, Phase I of this initiative is a pilot, with a trigger to expand programmatically if successful. We are not testing whether Chronic Care Improvement is a good idea, but how to incorporate these services into traditional fee-for-service Medicare at scale.

4/20/2004

13. Can applicants choose between either CHF or diabetes?

No, there are only two cohorts from which to choose. In one cohort, we will be using CHF and complex diabetes as the threshold conditions. This means some individuals will have CHF, some individuals will have complex diabetes, and some individuals will have both. These individual may also have multiple co-morbidities. The other cohort will be those diagnosed with COPD as a threshold condition. More detailed information about the two cohorts will be posted on our Web site and will also be included in the sample data set we will be making available.

4/23/2004

14. When will selections be made and when will services start under Chronic Care Improvement Programs?

The statute requires that the Secretary enter into the first agreement by December 8, 2004. We fully expect to meet this requirement and complete all agreements within a few months after that date. We also expect our first site to be operational in early 2005, with the remaining sites to be phased in respectively.

4/20/2004

15. Is the Chronic Care Improvement program (CCIP) initiative consistent with the Administration's goal of accelerating health information technology, including electronic health records, at the point of care?

Yes. We are interested in receiving applications that incorporate the use of health information technology including decision support tools, and if possible, electronic health records to facilitate the exchange of information among providers and with CMS and to improve the continuity of chronic care. Applicants may propose to include incentives for adoption of electronic health records and decision support tools.

4/20/2004

16. How many regions or sites will there be under Phase I of the Chronic Care Improvement Programs?

The statute does not define how many awards can be made for Phase I sites and the Secretary has the discretion to decide the ultimate number of sites so long as the program is being offered in areas where 10% of Medicare beneficiaries reside. In Phase I, the pilot phase, it is foreseeable that the entire effort could serve approximately 150,000 to 300,000 or more chronically ill beneficiaries. It is not unreasonable to estimate that there could be at least 10 sites awarded.

4/20/2004

17. How will CMS ensure that organizations under the Chronic Care Improvement Program have the means to guarantee net savings?

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. 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.

4/20/2004

18. How will beneficiaries be enrolled in Phase I of Chronic Care Improvement program?

The beneficiary enrollment process or 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 by section 1807(d)(2) of the Act. The letter will provide a description of the program and give the beneficiary an opportunity to decline to be contacted by the Chronic Care Improvement organization. The letter will detail how the beneficiary can obtain further information about the program.

3. If Beneficiary says 'No'. Awardees would not contact active opt-outs.

4. If 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, CMS will specify a limit on either the number of attempts or the time period during which the awardees are permitted to attempt to reach them.

5. 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 us that they no longer want to be contacted by the awardee.

4/20/2004

19. When will you know if a Chronic Care Improvement program has been successful?

The statute requires that CMS contract with an independent evaluator, who will evaluate performance for each program as measured by clinical, financial, and satisfaction standards. CMS also plans to conduct an ongoing formative evaluation. This will entail monitoring and oversight of the programs with the goal of assessing performance and providing feedback on an ongoing basis. The statute requires the Secretary to expand the Chronic Care Improvement program if, based upon the results from the independent evaluator, the initiative itself, a single program, or component of a single program shows success. Success is defined in the statute as the improvement in clinical quality of care, the improvement in beneficiary satisfaction, the achievement of savings targets as defined by the Secretary.

4/20/2004

20. Is there any possibility that conditions other than Congestive Heart Failure (CHF), complex diabetes, and Chronic Obstructive Pulmonary Disease (COPD) will be considered in Phase I of the Chronic Care Improvement Program?

In order to simplify the evaluation and to allow comparisons between the sites, we initially plan to limit Phase I to these three conditions where there is the most evidence for programs producing positive outcomes on a large scale. Nevertheless, this does not mean that other conditions are not amenable to Chronic Care Improvement interventions. We may consider expansions in the future as CMS refines its targeting strategy and gains experience in deploying a program at scale.

4/20/2004

21. Will awardees under the Chronic Care Improvement Program be expected to help participants manage their co-morbidities, including those beneficiaries with intensive needs or those with cognitive impairment?

Yes, awardees will be required to assist participants in managing their health holistically, including all co-morbidities, relevant health care services, and pharmaceutical needs. We recognize that many chronically ill Medicare beneficiaries have unique needs or cognitive impairment. We fully expect organizations to have the skill sets necessary to provide services to those who live with these conditions.

4/20/2004

22. What are your projected savings from Phase I of the Chronic Care Improvement Program?

As a condition of payment for Chronic Care Improvement services, we are requiring a guaranteed minimum of 5 percent savings to the Medicare program in Phase I, including all 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 we will receive and accept proposals with more aggressive savings guarantees.

4/20/2004

23. Is the beneficiary enrolled for a certain time period in a Chronic Care Improvement Program?

Participation is always voluntary. Participants can notify the awardee or us at any time that they no longer want to be contacted by the awardee. Otherwise, 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 us that they no longer want to be contacted by the awardee.

4/20/2004

24. Is the Chronic Care Improvement program compliant with HIPAA?

Yes. HIPAA is not a barrier because the program can 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, permissible disclosures. Health care operations includes 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, Chronic Care Improvement organizations would be considered business associates of CMS, and therefore it would be permissible to transmit health information to them.

4/20/2004

25. Can a Chronic Care Improvement Program (CCIP) proposal cover all conditions, that is, to include chronic heart failure (CHF), complex diabetes, and chronic obstructive pulmonary disease (COPD) or must each proposal cover only one condition?

There are two separate cohorts that Awardees can apply for: 1) CHF and/or Diabetes is one cohort, and, 2) COPD is a second cohort. Applicants may submit two separate proposals - one for COPD and one for CHF/Complex Diabetes. Those may not overlap if awarded. The applicant cannot propose to couple a CHF/complex diabetes program with a COPD program. Please note that awardees must help beneficiaries manage all of their conditions, including all co-morbidities.

5/26/2004

26. There is reference to the Chronic Care Improvement Program (CCIP) application being due 90 days after data is received. Does that mean the due date "clock" starts on receipt of data, or is Aug 6th the due date regardless of when data is received?

The solicitation states that applications are due 90 days from the date data were made available, not from the date data were received. Thus proposals are due on August 6th.

5/26/2004

27. Are beneficiaries in skilled nursing facilities (SNFs) or long-term care facilities included in the Chronic Care Improvement Program (CCIP) intervention and control groups?

Yes. Beneficiaries in SNFs or long term care facilities are included in the intervention and control groups.

5/26/04

28. The Request for Proposals (RFP) requires that the applicant complete the Medicare Waiver Demonstration Application as part of the application process. Most of the information requested on the Medicare Waiver Demonstration Application is also requested in the RFP although the questions posed are different in some instances for example in the Problem Statement. Does CMS intend for the applicant to complete the entire Waiver Demonstration Application or just the "Applicant Data Sheet"?

In the event that the waiver application to participate in the Chronic Care Improvement Program (CCIP) conflicts with the information requested in the solicitation, please follow the solicitation.

5/26/04

29. Can organizations serve both as a CCI-Organization and as a support contractor for CCIP?

Generally, we are not permitting contractors to participate as both a CCI (Chronic Care Improvement) Organization awardee and as a support contractor to CMS for any support function of this CCI project. However, if an organization can make a strong case for conducting activities without a conflict of interest and without additional cost to CMS, then we may entertain such proposals on a case-by-case basis.

5/26/04

30. You indicate that you plan to provide monthly or quarterly claims data to Chronic Care Improvement Program (CCIP) awardees. To properly evaluate and impact beneficiaries' behavior, it is important to receive claim information in a timely manner. Could we have this information real-time or on a daily basis?

We recognize the importance of providing clams information in a timely manner. In Phase I, due to the nature of CMS' systems, monthly delivery of claims is the best we can do. We will investigate ways to deliver data quicker as Phase I proceeds and transitions into Phase II.

5/26/04

31. Will CMS perform any stratification of the Chronic Care Improvement Program (CCIP) intervention group?

No. CMS will identify eligible beneficiaries and assign the intervention group to an awardee (see inclusion criteria in the data dictionary). The awardee is then responsible for any stratification or predictive modeling it deems necessary for operation of the program.

5/26/04

32. Would you include at least two years of historical Medicare claims data on the Chronic Care Improvement Program (CCIP) intervention group?

We intend on providing between one and three years of historical Medicare claims data on the intervention group. Two years of data seems to be reasonable, and we will work with you to meet your need for historical information.

5/26/04

33. Will there be an appeal process, or other opportunity for proposal revision, should a proposal to participate in the Chronic Care Improvement Program be returned without a contract offer?

No. The technical review panel may indicate a need for additional information to clarify issues found in the original proposal. CMS would follow-up on the technical review panel's request; however, there isn't an opportunity for proposal revision.

5/26/04

34. What evaluation methodology will CMS use to compare the control group to the intervention group?

We are still developing the evaluation design at this time. Once we procure the independent evaluator we will further flesh out the details of the evaluation design.

5/26/04

35. Can a bidder submit a proposal that covers more than one geographic area or should each proposal cover only one specific geographic area?

Technically, yes. If multiple geographies are a part of your proposal, then present a cohesive plan in one proposal. However, if you are proposing different programs in different geographies then it might be best to separate them out.

5/26/04

36. Will your calculation of cost savings be adjusted for inflation, technology and pharmaceutical cost changes?

Calculations of savings will be made in comparison to the control group, therefore trends that will exist in the intervention group, such as inflation, etc. can be expected to exist in the control group.

6/01/04

37. What is the intent of the language in the solicitation requiring organizations to make their software and algorithms available to CMS?

The intent of the language in the solicitation is to protect awardees. We are indicating that we do not seek to own proprietary algorithms and software, however we do want to see how a program worked and why.

6/01/04

38. When can awardees contact the beneficiaries that confirm participation?

Immediately after beneficiaries confirm participation.

6/01/04

39. How do I get a copy of the measure and code appendices information which was referred to during the Bidder's Conference?

We will be posting more detailed information about the measures on our Web site shortly.

6/01/04

40. Can proposals be hand delivered?

Due to heightened security measures at the CMS Baltimore facility, we recommend that proposals be delivered by a nationally recognized carrier and would discourage hand delivered materials.

6/01/04

41. Regarding the Clinical Quality Indicators listed in the grid on page 59, is the expectation that the awardee cite the number of tests done or is it necessary to report specifically on the values?

Some metrics measure frequency of tests and some measure values. For the proposals, applicants are expected to project percent improvement over prior year and/or percent improvement compared to the control group for measures where that is possible.

6/01/2004

42. Could CMS provide further clarification on "conflicting" CMS demonstrations listed in the solicitation?

We are still encouraging applicants to contact us about specific states and counties that may contain conflicting areas. We will post more specific information in regards to overlap issues on the Web site. Please visit the Web site frequently.

6/01/2004

43. How will the CCI-I organization need to confirm participation - a verbal or signed consent? The answer to this question need to be precise as possible as it will impact the CCI-I applicant's ability to estimate successful enrollment in the RFP response.

CMS will not require written consent. Instead, CMS will require auditable verbal confirmation of participation. We will expect awardees to track and be able to verify that a beneficiary confirmed participation.

6/01/2004

44. Is CMS including physician notification by CMS in the process and, if so, will it precede patient notification?

Yes, CMS intends to conduct a comprehensive, multidimensional physician engagement process that will precede beneficiary notification. We share the view that this is a critical part of ensuring the success of CCIP.

6/01/2004

45. What expectations exist around cultural competencies and understanding of the impact of culture on how an individual handles chronic illness?

The specific intervention tactics will be determined by the organizations and then assessed by CMS during the application review process. Please note that in the solicitation CMS asked that organizations discuss how the program will ensure that all services provided are tailored to meet the needs of all participants, including those with limited reading skills, with diverse cultural and ethic backgrounds, with sensory/physical/mental disabilities, or primary languages other than English.

6/01/2004

46. Will CMS refresh the population with new eligibles at any time?

We are considering how to refresh data both in terms of the operational or business perspective and from an evaluation perspective. From an operational or business perspective, depending on the attrition rate for the population served, we will determine how often to refresh files. It may be an annual refresh. For evaluation purposes the initial intervention group may have to be large enough to account for attrition.

6/01/2004

47. How will CMS compare the control group with the intervention group? Total cost to Medicare or cost per day served?

CMS or its independent evaluator will compare the control group with the intervention group by assessing total cost to Medicare, along with improvements in clinical quality and beneficiary and provider satisfaction.

6/01/2004

48. Will the control and intervention groups be adjusted for beneficiaries who do and do not select a drug benefit in 2006?

Yes. The independent formal evaluation will adjust for differences in uptake of the voluntary Medicare drug benefit that will be offered in 2006 between the intervention and control groups. Yes. The independent formal evaluation will adjust for differences in uptake of the voluntary Medicare drug benefit that will be offered in 2006 between the intervention and control groups.

6/01/2004

49. In 2006 the Medicare Drug Benefit will commence. How can the CCI Organization address drug costs without a previous basis of cost?

CCI-Organizations will be measured against outcomes in the randomized control groups. Thus, despite many of the unknowns at this time, including baseline drug costs, CCI-Organizations should be able to demonstrate measurable reductions in overall costs compared to the control group.

6/01/2004

50. What assumption should we use for claims lag?, meaning how long in weeks/months is the delay between the claims event and the transmission of claims data to the vendor?

The delay from the time a claim is submitted to a FI or carrier and when you receive that claim is 21-45 days. A claim that is sent to a FI or Carrier is processed within two weeks before going to our claims repository for us to extract. That information will be extracted in batch at the end of the month. Thus, depending on when the data arrives at the claims repository, it will be 7 to 30 days before you see the claim. The period of time prior to submission of a claim for payment varies by provider.

6/01/2004

51. Will the CCI-I organizations be allowed to initiate its program on a case by case basis during the outreach program as soon as confirmation is received or is it necessary to wait until the outreach program is complete before starting any intervention?

Yes. CCI-I Organizations will be allowed to initiate program services during the outreach period to confirmed participants.

6/01/2004

52. How will the "snowbirds" (elders who reside in more than one geographical area within a year) continuity of care be handled; will the same DM vendor care for them even if they relocate to another state for a portion of the year?

Organizations will be responsible for the outcomes of their entire assigned population, regardless of whether they move while in the program.

6/01/2004

53. How will CCI-I programs include and emphasize the role of the physician in its implementation and evaluation processes?

As intended by Congress, CMS will seek to partner with awardees whose CCI programs 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 and/or strategies to engage beneficiaries' physicians and other providers. CMS has made physician/provider relationships a key discretionary goal of the CCIP. CMS will provide significant weight to applications that seem most likely to implement programs that enhance the patient-provider relationships.

6/01/2004

54. What is the expected timeline between awards and implementation?

We expect to award the first program in December 2004, with the remainder following shortly thereafter. We expect all sites to be operational by the first half of 2005.

6/01/2004

55. Have you considered the challenges of applicants making projections for this program?

We recognize that this program may be breaking new ground for many organizations. We expect organizations to make reasonable projections based on whatever experience is available to them.

6/01/2004

56. Will CMS supply a list of beneficiaries to Awardees only after removing those who are identified as ineligible?

Yes. CMS will remove ineligible beneficiaries from the initial list given to awardees.

6/01/2004

57. Will CCI-I requirements encourage grant awardees and various guideline committees to develop algorithms and management strategies to fully address patients with multiple (i.e. three or more) co-morbidities?

Yes, CCI-I requirements encourage awardees to develop algorithms and management strategies to fully address patients with multiple co-morbidities. Awardees will be required to assist participants in managing their health holistically, including all co-morbidities, relevant health care services, and pharmaceutical needs. We fully expect organizations to have the skill sets necessary to provide services to those who live with multiple conditions.

6/01/2004

58. Is the financial reconciliation only done after the 3 years, with adequate run out for control and intervention groups, or is it done at other points, also?

We will be conducting interim reconciliations, but the final reconciliation will be done after the three year period, with appropriate run-out.

6/01/2004

59. What are the specific disease diagnoses codes that will be used in the beneficiary identification process by CMS?

The specific diagnosis codes used to identify eligible beneficiaries are listed in the data dictionary, available on our Web site and on the sample dataset CD-ROM.

6/01/2004

60. Will patients who are developmentally disabled, cognitively impaired or institutionalized be expected to participate/enroll in the CCI program?

Yes. We recognize that many chronically ill Medicare beneficiaries have unique needs or cognitive impairment. We fully expect organizations to have the skill sets necessary to provide services to those who live with these conditions.

6/01/2004

61. Will a stand alone COPD proposal be allowed to overlap the geographic areas served by a CHF/complex diabetes only program?

No. A stand-alone COPD program cannot operate in the same geographic area as a CHF/complex diabetes program.

6/01/2004

62. Can an applicant propose to couple a CHF/complex diabetes program with a COPD program?

No. However applicants may submit two separate proposals - one for COPD and one for CHF/Complex Diabetes. These may not overlap if awarded.

6/01/2004

63. Please describe the proposal review process. What will be the make up of the review group and the professional expertise of the reviewers?

We will be convening an independent, unbiased panel of internal and external experts who represent a diverse skill mix, including but not limited to, clinical, financial, operations, contracts, chronic care management, information management systems, and other expertise.

6/01/2004

64. Will any dually eligible (Medicare/Medicaid) beneficiaries be included under the Chronic Care Improvement Program?

Yes. Dually eligible beneficiaries will be included if they meet CCIP eligibility criteria (e.g., not ESRD).

6/16/2004

65. Is there room in the bid to specify less than 100% fee risk under the Chronic Care Improvement Program?

Yes. Applicants that guarantee more than 5% net savings may propose less than 100% fee risk on savings above 5%.

6/16/2004

66. When will the data and measurement specifications, file structure and data exchange protocols be available under the Chronic Care Improvement Program?

We are in the process of designing the performance monitoring and information systems. Awardees will be able to give input into the design. Specifications will be included in the CCI-I agreements between CMS and awardees.

6/16/2004

67. How will changes in eligibility and participation be tracked under the Chronic Care Improvement Program?

They will be tracked in the Group Health Plan System. The system will track and create monthly reports on changes in eligibility (e.g., ESRD, hospice, enrollment in a Medicare Advantage plan). Awardees will be expected to submit disenrollment data to the system.

6/16/2004

68. Are there any restrictions on size or location of proposed regions under the Chronic Care Improvement Program?

No restrictions apply, but applicants should justify their proposed regions. CMS may adjust regions in making awards.

6/16/2004

69. The solicitation indicated that proposals would be due 90 days after the data were made available. Are proposals still due August 6, 2004 under the Chronic Care Improvement Program?

Yes. Proposals are due August 6, 2004.

6/16/2004

70. Will awardees receive physician information at the beneficiary level to assist bidders under the Chronic Care Improvement Program?

Physician identifier information will appear on claims data, but it is not always accurate in terms of the individual physician or practice location. We plan to work with regional carriers to get more detailed physician information.

6/16/2004

71. Can Chronic Care Improvement Organizations provide incentives to providers to participate?

Yes. Applicants have flexibility to craft a variety of arrangements to improve beneficiary outcomes, so long as those incentives are allowed under existing laws and regulations.

6/16/2004

72. Can Chronic Care Improvement Organizations opt out of performance risk if their population sizes diminish greatly?

No. We will plan for attrition in determining initial cohort sizes. In addition, we may add more beneficiaries over time.

6/16/2004

73. Is the 6-month duration of the outreach period firm under the Chronic Care Improvement Program?

Proposals are to be based on the assumption of a 6-month outreach period. The actual outreach period may be longer or shorter based upon mutual agreement between CMS and the awardee.

6/16/2004

74. When will possible refunds to CMS occur under the Chronic Care Improvement Program?

Unless serious performance problems arise, refunds (if any) are expected to occur following final reconciliation.

6/16/2004

75. Can Chronic Care Improvement Organizations work through beneficiaries' physicians to contact eligible beneficiaries?

Yes. Applicants are encouraged to consider ways to collaborate with beneficiaries' physicians.

6/16/2004

76. Can Chronic Care Improvement Organizations solicit business from beneficiaries?

No. CCI-Os may not charge beneficiaries for services or solicit business from them. CCI-Os are not intended to be marketing vehicles.

6/16/2004

77. When will site visits occur under the Chronic Care Improvement Program?

Site visits are likely to occur in late September.

6/16/2004

78. How can we get a list of attendees at the bidders' conference for the Chronic Care Improvement Program?

You can e-mail ccip@cms.hhs.gov to request a list.

6/16/2004

79. Who will Chronic Care Improvement Organizations be paid for during the outreach period and how will the CCI-Os be paid during this period?

Fees will be paid for all eligible beneficiaries except those that opted out when originally contacted by CMS. Awardees will be paid a fixed fee per eligible beneficiary per month during the outreach period. After the outreach period, awardees will be paid monthly fees only for eligible beneficiaries who affirm willingness to participate.

6/16/2004

80. Can Chronic Care Improvement Organizations provide non-covered services to beneficiaries?

Yes. CCI-Os may propose to provide services essential to accomplishing programmatic objectives, but may not charge beneficiaries for services or solicit business from them.

6/16/2004

81. Will a COPD program have to encompass 30,000 eligible beneficiaries under the Chronic Care Improvement Program?

Applicants should bid on populations of 20,000 eligible beneficiaries, but some adjustment may be possible. We need to have large enough cohorts to yield statistically significant results.

6/16/2004

82. Will eligible beneficiaries who opt out remain in the intervention group under the Chronic Care Improvement Program?

Yes. Applicants who opt out will be in the intervention groups.

6/16/2004

83. How will we get lab data under the Chronic Care Improvement Program?

CMS does not receive lab data. Applicants should describe their sources of participant data.

6/16/2004

84. How will data be collected on intervention group members who opt out under the Chronic Care Improvement Program?

CMS will have claims data. We are examining options for collecting other data from beneficiaries who opt out.

6/16/2004

85. Will Chronic Care Improvement Organizations receive data on their control groups periodically?

Yes, we plan to provide de-identified control group data to awardees periodically, with claims run-off data.

6/16/2004

86. Will awardees be allowed to modify their interventions and standards of care during Phase I of the Chronic Care Improvement Program?

Yes. Awardees will be expected to adjust interventions to reflect changes in standards of care and lessons learned about effectiveness and efficiency in serving the assigned target populations.

6/16/2004

87. Will CMS consider a cost + percent of savings fee arrangement under the Chronic Care Improvement Program?

No. We will pay per beneficiary per month fees, which will be agreed in advance and specified in CCI-I agreements.

6/16/2004

88. Who will randomize the eligible beneficiaries under the Chronic Care Improvement Program?

The independent evaluation contractor will design the randomization protocol. CMS' data contractor will randomize eligible beneficiaries according to that protocol.

6/16/2004

89. How will the evaluation be done if the probability of cross-contamination of the control group is high under the Chronic Care Improvement Program?

We may consider alternatives, such as randomization by physician, but data constraints make such a design difficult to execute. Applicants who anticipate significant cross-contamination to result from their interventions should propose how to overcome the data constraints.

6/16/2004

90. Can proposals for the Chronic Care Improvement Program be stapled or put in 3-ring binders?

Proposals can be put in 3-ring binders. Stapling is less desirable.

6/16/2004

91. Are beneficiary phone numbers available from other federal databases to assist bidders under the Chronic Care Improvement Program?

We are investigating the possibility of getting telephone numbers from the Social Security Administration, but the plans are not yet definitive. We will keep you posted on our plans.

6/16/2004

92. How will CMS and Chronic Care Improvement Organizations exchange data?

We plan to develop web-based data exchange capabilities, but will also be able to accommodate other means of data exchange.

6/16/2004

93. Will beneficiaries who become ineligible be excluded from performance measurement under the Chronic Care Improvement Program?

Beneficiaries will be included in performance data for the months during which they were eligible, but not thereafter.

6/16/2004

94. Is randomization of eligible beneficiaries the only approach to evaluation that CMS will accept under the Chronic Care Improvement Program?

The statute requires that randomized controlled trials be conducted.

6/16/2004

95. Can a region have some non-contiguous or carved-out areas?

Yes. Carve-outs and non-contiguous areas are permissible if they make sense programmatically.

6/16/2004

96. Can applicants propose changes to the target population under the Chronic Care Improvement Program?

No. The target populations for Phase I have been determined and CMS will identify eligible beneficiaries in each region.

6/16/2004

97. In the "CCIP solicitation.pdf" posted on the CMS Web site, page 42 states, "The applications must not exceed 40 double-spaced pages, exclusive of the cover letter, executive summary forms and appendices." Pages 43 through 67 (Sections 4. through 9.) detailing the Phase 1 requirements are 25 pages in length, inclusively. Are in-depth responses to many of the requirements from these 6 sections permitted to be placed in the Appendices (Supplemental Materials), Section 10?

No. All critical material must be contained in the 40 pages. Reviewers are not obligated to read more than the 40 pages. However, clear references to relevant appendices are useful for reviewers interested in probing further into certain areas.

6/24/2004

98. The outreach period is for 6 months. When are the first year's metrics assessed? 6 months after the outreach period or 12 months after the outreach period?

Performance monitoring will be ongoing. The first year's metrics will be inclusive of the outreach period.

6/24/2004

99. What, if any, is CMS' position regarding providers who are part of the PACE Elder Services program?

If the organization meets the eligibility criteria to apply, it is welcome to apply. However, the target population will be identified by CMS, and drawn from Medicare FFS beneficiaries. Applicants cannot propose a PACE-eligible target population, so CCIP would be a new line of business for a PACE program serving a new target population.

6/24/2004

100. If an individual wishes to become part of the intervention group after the 6 month outreach period, is that allowed?

The outreach period will last approximately six months, during which time beneficiaries can confirm their participation in the program. CMS and the awardee may negotiate terms under which eligible beneficiaries could also begin to participate after the outreach period.

6/24/2004

101. Will CMS refresh the eligible population at any point during the 3-year pilot? If so, please state the refresh frequency. Will the attrition population be replaced with new eligibles at any time?

We are considering how to refresh data both in terms of the operational or business perspective and from an evaluation perspective. From an operational or business perspective, depending on the attrition rate for the population served, we will determine how often to refresh files. It may be an annual refresh. For evaluation purposes the initial intervention group may have to be large enough to account for attrition.

6/24/04

102. Will be there a different fee for the outreach and the intervention period?

We are expecting applicants to propose their fees, which may include different fees for the outreach and the intervention period.

6/24/04

103. Please provide additional explanation as to what is meant by the phrase, "Applicants must be aware that proposals may be accepted in whole or in part."

CMS reserves the right to negotiate with finalists with regard to program design, geographic location, savings or performance measures guarantees, etc.

6/24/04

104. Can the program work with beneficiary physicians as means to contact (initial and/or future) beneficiaries?

Yes. We recommend that such a proposed strategy be clearly described in the application to provide CMS the confidence that the process is sound, reasonable, and respects both physicians and beneficiaries.

6/24/04

105. Are beneficiary phone numbers available from other federal databases?

We are investigating the possibility of getting telephone numbers from the Social Security Administration, but the plans are not yet definitive. We will keep you posted on our plans.

6/24/04

106. Exactly data information will CMS be providing to the CCI-Os and at what frequency?

On eligible beneficiaries who do not opt out when initially contacted by CMS, we will provide 2 years of historical claims data and claims updates on a monthly basis. In addition, de-identified claims data on the control group and eligible beneficiaries who do not choose to participate will be provided periodically.

6/24/04

107. Will CMS offer the enrollee's primary physician any incentive to buy into the program?

CCI Organizations will have an opportunity to propose incentives to engage primary care physicians. Those incentives must be consistent with Stark and other existing laws and regulations.

6/24/04

108. The outreach period is for 6 months. When are the first year's metrics assessed? 6 months after the outreach period or 12 months after the outreach period?

Performance monitoring will be ongoing. The first year's metrics will be inclusive of the outreach period.

6/24/04

109. Can the quality measures appearing in the tables be made more specific; for example what is the definition of Sodium Intake Counseling; a brief phone call, pointer to a document, on-site training...?

The measures will be negotiated and specified in great detail in the CCI agreements.

6/24/04

110. A consortia, of sorts, is reviewing the solicitation for the CCIP. Is there any requirements that would prohibit a proposal for the dual eligible population only?

Applicants cannot elect to serve dual eligible beneficiaries only. CMS will identify beneficiaries in the target populations in the selected regions, including but not limited to dually eligible beneficiaries that meet the CCIP eligibility criteria.

6/24/04

111. Is more precise information about the conflicting geographic areas available than what is shown in the table.[?]

We are still encouraging applicants to contact us about specific states and counties that may contain conflicting areas. We will post more specific information in regards to overlap issues on the Web site. Please visit the Web site frequently.

6/24/04

112. Will awardees bill directly, monthly or what, or be compensated prospectively or retrospectively by CMS? Also, will the beneficiaries have to pay a co-pay to the awardees for each service encounter, and if so, are awardees expected to collect it?

CMS will pay monthly through the Group Health Plan system. Participation in the CCIP program is free to the beneficiary. No co-pays and deductibles apply.

6/24/04