CMS Innovation Center: Early Implementation Efforts Suggest Need for Additional Actions to Help Ensure Coordination with Other CMS Offices
Published: 2012-11-15T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: PPACA created the Innovation Center within CMS. The purpose of the Innovation Center is to test new approaches to health care delivery and payment--known as models--for use in Medicare or Medicaid. GAO was asked to review the implementation of the Innovation Center. Specifically, GAO: (1) describes the center's activities, funding, organization, and staffing as of March 31, 2012; (2) describes the center's plans for evaluating its models and its own performance; and (3) examines whether efforts of the center overlap with those of other CMS offices and how the center coordinates with other offices. GAO analyzed budget and staffing data; reviewed available documentation, such as Innovation Center policies and procedures and functional statements for CMS offices; and interviewed officials from the Innovation Center and other CMS offices, such as the Center for Medicare. GAO assessed how the Innovation Center coordinates in the context of federal internal control standards and key practices for collaboration from prior GAO work.
section_title: What GAO Found
paragraphs: From the time it became operational in November 2010, through March 31, 2012, the Center for Medicare and Medicaid Innovation (Innovation Center) has focused on implementing 17 new models to test different approaches for delivering or paying for health care in Medicare and Medicaid. The center is still relatively early in the process of implementing these models. Eleven of the models were selected by the Innovation Center under the provision in the Patient Protection and Affordable Care Act (PPACA) that established the center, while the remaining 6 were specifically required by other PPACA provisions. The Innovation Center projects that a total of $3.7 billion will be required to fund testing and evaluation of the 17 models, with the expected funding for individual models ranging from $30 million to $931 million. As of March 2012, the center's 184 staff were organized into four groups responsible for coordinating the implementation of different models and another five groups responsible for key functions that support model implementation. Officials said that, among other things, the center's initial hiring of staff reflected the need for leadership and for specific types of expertise, such as individuals with a background in evaluation.
The Innovation Center's plans for evaluating individual models include identifying measures related to the cost and quality of care. Officials from the Centers for Medicare & Medicaid Services (CMS) told GAO that the Innovation Center had developed preliminary evaluation plans for the 17 models being implemented that, among other things, identified proposed measures. According to CMS officials, these measures will be finalized by contractors responsible for evaluating, on behalf of CMS, each model's impact on cost and quality. As of August 1, 2012, the Innovation Center had contracted for the evaluation of 10 of the 17 models. The center's plans for evaluating its own performance include aggregating data across models by using a set of core measures it has developed. In addition, the Innovation Center has taken steps to monitor its progress in implementing the 17 models through biweekly reviews of standard milestones and related data, such as the number of applications to participate in a model the center has received.
GAO identified three key examples of overlap between the 17 Innovation Center models and the efforts of other CMS offices, meaning that the efforts share similar goals, engage in similar activities or strategies to achieve these goals, or target similar populations. However, these overlapping efforts also have differences, and CMS officials said the efforts are intended to be complementary to each other. GAO also identified a number of mechanisms the Innovation Center uses to coordinate its work in order to avoid unnecessary duplication between its models and other efforts, such as multi-office meetings at the staff, director, and agency level. Further, through using these mechanisms, the Innovation Center has engaged in key practices for collaboration, including leveraging resources across offices. At the same time, the center is still working on ways to make its coordination more systematic. For example, largely because of questions raised during GAO's review, the Innovation Center initiated a process to ensure that CMS does not pay for the same service under the contracts in one of its models and those in another CMS office. However, officials told GAO that the center is still working on implementing this process and may need to take additional steps to eliminate any unnecessary duplication. GAO is recommending that the Administrator of CMS direct the Innovation Center to expeditiously complete its process to review and eliminate any areas of unnecessary duplication in contracts that have been awarded in one of its models. HHS agreed with this recommendation and described steps it is taking to address unnecessary duplication.
section_title: What GAO Recommends
paragraphs: GAO is recommending that the Administrator of CMS direct the Innovation Center to expeditiously complete its process to review and eliminate any areas of unnecessary duplication in contracts that have been awarded in one of its models. HHS agreed with this recommendation and described steps it is taking to address unnecessary duplication.

section_title: Letter
paragraphs: Spending on health care in the United States reached $2.6 trillion in 2010  and is expected to increase, with federal spending—driven primarily by  expenditures for Medicare and Medicaid—accounting for a growing  percentage of the total. Complicating these trends, recent evidence  suggests that higher levels of health care spending do not always lead to  enhanced quality of care. As a result, policymakers have sought to both  reduce costs and improve quality by researching ways of changing how  health care services are delivered and health care providers are paid. To  identify approaches that work, policymakers need credible information on  the effects of the approaches on cost and quality. In 2010, the Patient  Protection and Affordable Care Act (PPACA) created the Center for  Medicare and Medicaid Innovation (Innovation Center) within the Centers  for Medicare & Medicaid Services (CMS)—the agency within the  Department of Health and Human Services (HHS) that administers  Medicare and Medicaid. The purpose of the Innovation Center is to test  new approaches to health care delivery and payment—known as  models—in order to reduce Medicare and Medicaid expenditures while  preserving or enhancing quality of care for beneficiaries of the programs.  Although CMS conducted similar testing through demonstrations prior to  PPACA, the recent law provides the Innovation Center with additional  authority. For example, unlike for demonstrations CMS has frequently  conducted in the past, models tested under the provision establishing the  Innovation Center can, under certain conditions, be expanded—including  on a nationwide basis—through rulemaking instead of requiring  legislation. In addition, PPACA significantly increased the funding  available to CMS to test new approaches. According to an analysis by the  Medicare Payment Advisory Commission, CMS’s funding for research,  demonstrations, and evaluations has historically been appropriated  annually, and was less than $1 billion for the period of fiscal years 2000  through 2010. In contrast, PPACA provided the Innovation Center with a  dedicated source of funding, appropriating $10 billion for its activities for  the period of fiscal years 2011 through 2019 and $10 billion per decade  beginning in fiscal year 2020.
PPACA required CMS to make the Innovation Center operational by  January 1, 2011, and the center became operational in November 2010.  Since that time, some members of Congress have raised questions about  the extent to which models the Innovation Center has selected for testing  will lead to reduced costs and improved quality in health care, particularly  given the amount appropriated for its work. They have also raised  questions about the potential for overlap between efforts of the Innovation   which, if not  Center and those of existing centers and offices within CMS, effectively coordinated, could result in the inefficient use of federal  resources through unnecessary duplication.the implementation of the Innovation Center. In this report, we:   (1) describe the Innovation Center’s activities, funding, organization, and  staffing; (2) describe the Innovation Center’s plans for evaluating its  models and its own performance; and (3) examine whether efforts of the  Innovation Center overlap with those of other CMS offices and assess  how the center coordinates with other offices.
We were asked to review  To describe the Innovation Center’s activities, funding, organization, and  staffing, we focused our review on information as of March 31, 2012— about 2 years after the enactment of PPACA. We reviewed documents,  including information on models the center was implementing as of this  date, and planning documents, such as organizational charts. We also  reviewed budget and staffing data for the Innovation Center. We  interviewed knowledgeable agency officials about their efforts to ensure  the quality of the data, checked for anomalies, and determined these data  were sufficiently reliable for our purposes. In order to obtain more in- depth information on center activities, we reviewed examples of the types  of documents used in implementing models, such as a model’s Innovation  Center Investment Proposal (ICIP), which is the document developed to  obtain approval for models or initiatives. Finally, we interviewed  Innovation Center officials and officials in CMS’s Office of Financial  Management.
To describe the Innovation Center’s plans for evaluating its models and  its own performance, we reviewed documents, such as descriptions of the  center’s model evaluation process and internal tracking documents. We  also reviewed examples of more-detailed information, such as documents  discussing evaluation plans for individual models the center was  implementing as of March 31, 2012, and reviewed information on the  center’s progress in evaluating models. In addition, we reviewed the  statement of work for a contractor to evaluate the Innovation Center’s  operations. To supplement this information, we interviewed Innovation  Center officials and officials from CMS’s Office of the Actuary.
To examine whether efforts of the Innovation Center overlap with those of  other CMS offices and assess how the center coordinates with other  offices, we reviewed the key functions of all offices within CMS, using  information that was available on CMS’s website to identify areas of  potential overlap. We then interviewed Innovation Center officials, as well  as officials from other CMS centers and offices, including the Center for  Medicare, the Center for Clinical Standards and Quality (CCSQ), and the  Center for Medicaid and CHIP Services (CMCS), to obtain more-specific  information about the efforts they conduct. On the basis of these  interviews and review of related documentation, such as statements of  work for program contractors, we assessed whether Innovation Center  models being implemented as of March 31, 2012, had similar goals,  engaged in similar activities or strategies to achieve these goals, or  targeted similar beneficiaries as the efforts of other CMS offices. While  efforts identified in this report may not represent the full universe of  overlapping efforts between the Innovation Center and other CMS offices,  we conducted a systematic examination to identify key examples of  where overlap may have occurred. Finally, we interviewed the same  officials to obtain information on how the Innovation Center coordinates  its efforts with other CMS offices, and reviewed corroborating  documentation, such as center policies and procedures, when available.  We assessed how the center coordinates within the context of federal  internal control standards and key practices for collaboration identified in  prior GAO work. According to federal internal control standards, an  entity should, among other things, have the policies and procedures  necessary to provide reasonable assurance of the effectiveness and  efficiency of its operations, including the use of resources, and ensure  that these policies and procedures are appropriately documented.
We conducted our performance audit from February 2012 through  November 2012 in accordance with generally accepted government  auditing standards. Those standards require that we plan and perform the  audit to obtain sufficient, appropriate evidence to provide a reasonable  basis for our findings and conclusions based on our audit objectives. We  believe that the evidence obtained provides a reasonable basis for our  findings and conclusions based on our audit objectives.
subsections: section_title: Background
paragraphs: While PPACA gives CMS discretion in how to implement the Innovation  Center, such as the composition of its staff, the law also established  certain requirements for the center. For example, PPACA requires that, in  carrying out its duties described in the law, the Innovation Center consult  with representatives of relevant federal agencies and clinical and  analytical experts with expertise in medicine or health care management.  It also requires that, of amounts appropriated to the center, the center  make no less than $25 million available for model implementation each  fiscal year starting in 2011. In addition, PPACA requires that the  Innovation Center evaluate each model to measure its effects on  spending and quality of care, and that these evaluations be made public.  Further, PPACA requires the Innovation Center to modify or terminate a  model any time after testing and evaluation has begun unless it  determines that the model either improves quality of care without  increasing spending levels, reduces spending without reducing quality, or  both.
In addition to these requirements, when selecting models, PPACA  requires the Innovation Center to determine that a model addresses a  situation in which deficits in care were leading to poor clinical outcomes or  unnecessary spending. The law also describes types of models that the  Innovation Center could consider in selecting models to test; however the  center is not limited to this list. Examples of model types include changing  the way primary care providers are reimbursed for services and improving  care for patients recently discharged from the hospital. PPACA also  directs that in selecting models, the Innovation Center give preference to  those that improve the coordination, quality, and efficiency of health care  services and lists additional factors for consideration, such as whether the  model uses certain technology to help achieve its goals.
Finally, PPACA also makes certain requirements not applicable to models  tested under the provision establishing the Innovation Center that were  applicable to demonstrations CMS has frequently conducted in the past.  For example, while prior demonstrations generally required legislation in  order to be expanded, PPACA allows CMS to expand Innovation Center  models more broadly into Medicare or Medicaid—including on a  nationwide basis—through the rulemaking process if the following  conditions are met: (1) the agency determines that the expansion is  expected to reduce spending without reducing the quality of care or  improve quality without increasing spending, (2) CMS’s Office of the  Actuary certifies that the expansion will reduce or not increase net  spending, and (3) the agency determines that the expansion would not  deny or limit coverage or benefits for beneficiaries. In addition, PPACA  makes inapplicable certain requirements that have previously been cited  as administrative barriers to the timely completion of demonstrations.  Specifically, PPACA provides the following:
HHS cannot require that an Innovation Center model be budget  neutral, that is, designed so that estimated federal expenditures under  the model are expected to be no more than they would have been  without the model, prior to approving a model for testing.
Certain CMS actions in testing and expanding Innovation Center  models cannot be subject to administrative or judicial review. For  example, the selection of models for testing or expansion is not  subject to review by the agency or the courts.
The Paperwork Reduction Act does not apply to Innovation Center  models. Under the Paperwork Reduction Act, agencies generally are  required to submit all proposed information collections to the Office of  Management and Budget (OMB) for approval and provide a 60-day  period for public comment on collections, among other things, when  they want to collect data on 10 or more individuals.
section_title: The Innovation Center’s Activities, Funding, Organization, and Staffing Focused on Implementing 17 New Models
paragraphs: From the time it became operational in November 2010, through   March 31, 2012, the Innovation Center’s activities and use of funding  focused on implementing 17 new models to test different approaches to  health care delivery and payment in Medicare and Medicaid. During this  period, the Innovation Center hired and organized staff into groups to  implement models and to provide for the key functions that support model  implementation.
subsections: section_title: Innovation Center Activities and Funding Have Focused on Implementing 17 New Models
paragraphs: From the time it became operational in November 2010, through   March 31, 2012, the Innovation Center announced the implementation of  17 new models designed to test different approaches to health care  delivery and payment in Medicare and Medicaid. These models  generally fall into three different types on the basis of the delivery and  payment approaches tested. The center’s “Patient care” models test  approaches that are designed around improving care for clinical groups of  patients such as patients needing heart bypass surgery. “Seamless care”  models test approaches designed to improve coordination of care for a  patient population across care settings, such as the coordination of  inpatient and outpatient care for all of a provider’s Medicare beneficiaries.  “Preventive care” models test approaches designed to improve health,  such as incentive programs to prevent smoking. The 17 models vary by  the program and beneficiaries targeted. For example, some target  Medicare or Medicaid beneficiaries specifically, whereas others are open  to beneficiaries of either program. In addition, three models have been  designed to target individuals who are covered by both Medicare and  Medicaid. The models also vary in terms of the types of participants  involved, ranging, for example, from physician group practices to  Federally Qualified Health Centers, to health plans, to state Medicaid  programs.
Of these 17 models, 11 were selected by the Innovation Center under the  PPACA provision that established the center and, as a result, certain  requirements that have applied to demonstrations CMS has frequently  conducted in the past are not applicable to these models. The Innovation  Center selected the 11 models for implementation by reviewing model  types identified in PPACA and ideas submitted by CMS staff as well as  through a variety of mechanisms designed to obtain ideas from  beneficiaries, providers, payers, state policymakers and others. Selection criteria—which are available to the public on the Innovation  Center’s website—include focusing on health conditions that offer the  greatest opportunity to improve care and reduce costs, and meeting the  needs of the high-admission-rate hospitals most vulnerable populations.
The remaining six new models the Innovation Center is implementing  were specifically required by other PPACA provisions. For example, the  center is implementing a model required by PPACA that tests whether  partnerships between and community-based organizations can improve  transition care services for Medicare beneficiaries. The degree of  flexibility that the Innovation Center has in implementing these six models  varies by each model’s specific statutory authority.
These mechanisms included the Innovation Center’s online web program and “listening  session” meetings held across the country in 2010.
The Innovation Center projects that the total funding required to test and  evaluate these 17 models will be $3.7 billion over their lifetime, including  $2.7 billion for the 11 models selected by the Innovation Center and   $1.0 billion for the 6 models specifically required by other provisions of  PPACA. The expected funding for individual models ranges from   $30 million to $931 million, depending on model scope and design.  Officials said that the period required to test and evaluate an individual  model typically ranges from 3 to 5 years. With regard to the Innovation  Center’s annual expenditures, as of March 31, 2012, the Innovation  Center forecast that most of its fiscal year 2012 budget—or   76.8 percent—would be spent implementing the 11 models that were  selected for implementation by the Innovation Center. Table 1 provides  funding information on the 17 Innovation Center models, including total  funding for models over their lifetime, by model type. Appendix I provides  additional information about individual models.
As of August 1, 2012, the Innovation Center was still relatively early in the  process of implementing the 17 models. CMS officials explained that this  process includes a series of steps to develop and prepare the model for  testing followed by a testing and evaluation period that is typically 3 to   5 years in which, among other things, participants and CMS put specified  changes to health care delivery or payment into effect. (See sidebar.)  While the Innovation Center had started testing 12 of the 17 models as of  August 1, 2012, nearly all of these tests had started within the prior   12 months, and 5 had started within the prior 6 months. Thus, the  models still have a significant portion of their testing and evaluation period  remaining. In addition, for the 5 models that had not yet started testing,  the Innovation Center was still completing the steps necessary to start  testing. Appendix II provides additional information about the general  process used to implement models.
In addition to the 17 models, the Innovation Center also assumed  responsibility for 20 demonstrations that were initiated prior to the  Innovation Center’s formation. Responsibility for the demonstrations was  moved to the Innovation Center in March 2011, when the demonstration  and research and evaluation groups of CMS’s former Office for Research,  Development and Information (ORDI) were brought into the Innovation  Center through reorganization. As of August 1, 2012, testing of 9 of  these 20 demonstrations had ended, although evaluation activities were  still ongoing for 4 of them. The demonstrations were initiated under the  Medicare Health Care Quality Demonstration Program which enables  CMS to select which demonstrations to conduct, or because they were  specifically required by various pre-PPACA statutes. Like the Innovation  Center’s models, the demonstrations test a range of delivery and  payment approaches; for example, one demonstration tests the use of  care management—a particular approach to coordinating and managing  health services—for high-cost Medicare beneficiaries while another tests  approaches for preventing and treating cancer among minorities in  Medicare.
section_title: The Innovation Center’s Organization and Staffing Reflect Its Focus on the 17 Models and Other Key Functions That Support Model Implementation
paragraphs: As of March 31, 2012, the Innovation Center’s 184 staff were organized  into nine groups and the Office of the Director. Four of the nine groups  are generally responsible for coordinating the implementation of models.  Three of these four groups—the Patient Care Models, Seamless Care  Models, and Preventive Care Models Groups—focus on models selected  by the Innovation Center under the PPACA provision that established the   The Medicare Demonstrations group is generally responsible for  center.implementing models specifically required by other PPACA provisions as  well as the CMS demonstrations that existed prior to the establishment of  the Innovation Center. Staff in these four groups coordinate planning,  develop model designs, and obtain approval for their models from CMS  and HHS. Once a model is approved, staff in these groups coordinate the  remaining implementation steps, including soliciting and selecting  participants and overseeing the model during the testing and evaluation  period.
The remaining five groups have primary responsibility for key functions  that support model implementation. The Policy and Programs Group  reviews ideas submitted for consideration as possible models and seeks  to ensure a balanced portfolio of different types of models. The Rapid  Cycle Evaluation Group is responsible for evaluation of models, including  collecting data on and providing feedback to model participants about  their performance. The Learning and Diffusion Group facilitates learning  within models and disseminates the lessons learned across models so  that participants can benefit from the experiences of other models. The  Stakeholder Engagement Group conducts outreach to potential  stakeholders to gain support and solicit ideas for innovative models, as  well as outreach to potential participants—such as physician groups and  hospitals—to inform them of the opportunity to participate in models. The  Business Services Group coordinates with other CMS centers and offices  to provide administrative and business support to the Innovation Center in  areas such as budgeting, contracting, and project management.
CMS officials explained that the 184 staff hired between the time the  Innovation Center became operational in November 2010, and   March 31, 2012, were distributed across the Office of the Director and the  nine groups in part because of an initial need for expertise with certain  model types and certain key functions. For example, because most of the  models that the Innovation Center selected for implementation were  Patient Care and Seamless Care Models, more staff were hired in those   Similarly, the Rapid  groups than in the Preventive Care Models Group.Cycle Evaluation Group and the Business Services Group were among  the largest groups by staff size because of (1) the Innovation Center’s  need for evaluation expertise when selecting which models to test as well  as its responsibility for evaluating existing demonstrations and (2) the  need for staff to carry out key administrative activities right away,  including contract solicitation, budget development, and hiring. Because  the Innovation Center assumed responsibility for prior CMS  demonstrations, staff from ORDI, which was responsible for implementing  the demonstrations, were reassigned to the Innovation Center to form the  Medicare Demonstrations Group and part of the Rapid Cycle Evaluation  Group. Table 2 provides information on the staff size for each group in the  Innovation Center as of March 31, 2012.
CMS officials explained that initial hiring of staff also reflected other needs  such as the need for rapid recruitment, the need to balance the number of  staff with expertise in CMS policies and procedures with staff who had  experience in the private sector, and the need for leadership to guide the  development of the new center’s activities.
Rapid recruitment: Approximately 40 percent of the staff working in the  Innovation Center as of March 31, 2012, was brought on board within the  first 5 months from when it became operational in November 2010. In  order to help the center get started quickly, CMS gave the Innovation  Center authority to hire staff directly until March 31, 2011, after which it  followed standard hiring procedures. Of the 184 staff in CMMI as of  March 31, 2012, 64 had been hired through the Innovation Center’s  direct-hire authority.
Balancing the need for CMS expertise with expertise in the private sector:  CMS officials said the Innovation Center sought a balance of staff who  had expertise with CMS policies and procedures and staff from outside of  the agency in the private sector. Of the staff on board as of March 31,  2012, about 54 percent were reassignments from within CMS, while  about 46 percent were new hires from outside of the agency, and officials  explained that most of these were from the private sector.
Leadership: During its first year, CMS officials said the center sought to  build its leadership. When compared with data for CMS as a whole for  2011, the distribution of the center’s staff as of March 31, 2012, shows a  higher percentage of Innovation Center staff at the General Schedule  (GS)-15 employment level, which is one of the higher management  levels. Specifically, 23.4 percent of the Innovation Center’s staff were in  the GS-15 level, compared with 11.5 percent for CMS as a whole. At the  same time, the proportion of staff at other upper levels, including the  Senior Executive Service level, in the Innovation Center was similar to  that of CMS as a whole. Table 3 provides information about Innovation  Center staff by employment level as of March 31, 2012.
CMS officials said that the Innovation Center plans to hire additional staff  with an emphasis on hiring into the three groups—the Seamless Care,  Patient Care, and Preventive Care Models groups—that focus on models  selected by the Innovation Center. Officials told us that the center’s goal  is to have a total of 338 staff and noted that, compared to initial hiring,  which focused on staff at leadership levels, future hiring will emphasize  lower GS levels.
section_title: The Innovation Center’s Evaluation Plans Include Identifying Measures, Hiring Contractors, and Aggregating Data across Models
paragraphs: The Innovation Center’s plans for evaluating its models include identifying  measures related to the cost and quality of care and hiring contractors to  evaluate the models. The Innovation Center’s plans for evaluating its own  performance include aggregating data on cost and quality measures to  determine the overall impact of the center and monitoring its progress  implementing models.
subsections: section_title: The Innovation Center’s Plans for Evaluating Models Include Identifying Measures Related to the Cost and Quality of Care and Hiring Contractors
paragraphs: As part of its evaluation of individual models, the Innovation Center plans  to identify measures related to the cost and quality of care. CMS officials  said that, as of August 1, 2012, the Innovation Center had developed  preliminary evaluation plans for each of the 17 models being  implemented. In these plans, the center has identified preliminary cost  and quality measures to be used to evaluate the 17 models. According  to CMS officials, in identifying the preliminary measures, they generally  selected cost and quality measures that were well accepted in the health  care industry, including those developed or endorsed by national  organizations, such as the National Quality Forum and the Agency for  Healthcare Research and Quality.measures for which data sources were readily available, such as claims  data and standard patient surveys conducted by providers.
Officials said that they also identified  The preliminary cost and quality measures the Innovation Center  identified vary for different models. For example, preliminary cost  measures include the average total cost of care per Medicare beneficiary  per year and the cost per hospitalization and related outpatient care and  subsequent hospitalizations for certain types of conditions. In the case of  quality, preliminary measures identified by the Innovation Center vary by  the type of care involved, such as the percentage of patients whose blood  pressure exceeds a certain level (primary care); newborn birth-weight  (prenatal care); and the number of adverse events, such as hospital- acquired infections (hospital care). See table 4 for examples of  preliminary measures identified by the Innovation Center and intended for  use for different types of care.
Preliminary measures the Innovation Center identifies will be finalized  with contractors responsible for evaluating models on behalf of CMS.  According to CMS officials, the Innovation Center plans on hiring  contractors to evaluate its models. The Innovation Center uses its  preliminary evaluation plans as the basis for developing solicitations for  and selecting contractors, who will be asked to propose specific  evaluation approaches. Officials said that after contracts are awarded, the  Innovation Center goes through a “design phase” with the contractor  where they reach agreement on the final evaluation plan, including the  measures of cost and quality of care that will be used. As of August 1,  2012, the Innovation Center had contracted with evaluators for 10 of the  17 models and had finalized measures for 2 models.anticipated awarding contracts for 6 of the remaining models by the end  of fiscal year 2012 and for the other remaining model—the Strong Start  for Mothers and Newborns model—by March 2013.
Officials told us that comparison groups will be matched to model participants along a  variety of measurable dimensions, such as provider and market-specific characteristics,  and that particular care will be taken to identify the impact of each reform in the context of  other models or interventions. Officials also told us that in certain cases, it may not be  possible to develop comparison groups for models. In these cases, the center will  compare cost and quality outcomes for model participants before and after the start of the  model. or that it has increased costs and should be discontinued. Alternatively,  there may also be cases where the results at the end of the testing and  evaluation period show that a model saves money but not at the threshold  of statistical significance set by the Innovation Center. CMS officials told  us that impact assessments will be ongoing, but will not begin until a  model has been under way for the amount of time expected for the  change in health care delivery or payment to start producing results.Officials said that they received data for their first impact assessment on  August 31, 2012, although they emphasized that early impact  assessments may not show clear results.
As a complement to assessing the impact of models on the cost and  quality of care, evaluation contractors will be asked to conduct site visits  and interviews to obtain qualitative information about the different  strategies participants may use to deliver care under each model. For  example, for models that seek to incentivize better coordination of care,  participants may implement different strategies to support care  coordination, such as increasing staffing or investing in technology.  Contractors will analyze whether different strategies are associated with  particular cost and quality outcomes.
Innovation Center officials told us that information collected by contractors  will also be shared on a regular basis with model participants. The  purpose of what the center refers to as “rapid cycle” feedback is to  provide timely information so that participants can make improvements  during the testing period of the model. For example, CMS officials  explained that under the Federally Qualified Health Center Advanced  Primary Care Practice model, participating health centers will be provided  with feedback reports on a quarterly basis. According to officials, these  reports will describe how each participant is performing relative to others  with respect to the model’s measures. The reports, officials say, will also  include information on differences among participants in how they are  delivering care under the model in order to encourage the adoption of  more-successful strategies. Officials told us that rapid cycle feedback will  generally begin within the first year after testing of a model has started.  As of August 1, 2012, the Innovation Center had started rapid cycle  feedback for 1 of the 17 models—the Partnership for Patients model.
section_title: The Innovation Center’s Plans for Evaluating Its Own Performance Include Aggregating Data across Models and Monitoring Implementation of Models
paragraphs: The Innovation Center’s plans for evaluating its own performance include  aggregating data on cost and quality measures to determine the overall  impact of the center. To do this, the Innovation Center will use a set of  core measures. The center has identified about 70 core measures,  including some of the preliminary cost and quality measures related to the  17 models it was implementing as of March 31, 2012. Because not all  core measures will apply to all models, data will be aggregated for groups  of models. To conduct this aggregation, the Innovation Center will use  statistical techniques, such as meta-analysis. Aggregation will not occur  until individual models have been evaluated, but officials said that the  Innovation Center has started asking evaluation contractors to consider  using the 70 measures when possible.
The Innovation Center’s plans for evaluating its performance also include  monitoring its progress in implementing models. The Innovation Center  has established a project management approach for its models that  includes standard milestones—such as “completion of OMB clearance”  and “issuance of participant solicitation and application”—that it uses to  track the progress of models against target deadlines. In addition, certain  data are monitored for each model against specified targets, such as the  number of applications submitted and the number of participants  selected. Individual milestones and data are summarized across all of the  Innovation Center models every 2 weeks. The intended purpose is to  allow the center’s management to monitor progress across models and to  identify and promptly address potential delays. According to CMS  officials, the Innovation Center was monitoring the progress of each of the  17 models it was implementing as of March 31, 2012.
Finally, in order to help evaluate its performance, in June 2012, the  Innovation Center contracted with a firm to review the Innovation Center’s  internal operations and how the center operates within the context of  CMS’s programs overall. The statement of work for this contract identified  a number of objectives, including recommending ways to improve the  center’s organizational structure, revising the center’s management  policies and procedures, and identifying additional ways to evaluate the  Innovation Center’s performance on an ongoing basis. To support these  objectives, the contract requires the firm to, for example, identify best  practices for expanding innovative models of care into ongoing programs  such as Medicare and Medicaid. The contract also requires the firm to  identify policies and procedures that are missing within the Innovation  Center that would improve its performance. The evaluation under this  contract is expected to be completed in November 2012.
section_title: The Innovation Center Uses a Number of Mechanisms to Coordinate Efforts That Overlap with Other Offices, but Is Still Working on Ways to Make Coordination More Systematic
paragraphs: In our review of models the Innovation Center was implementing as of  March 31, 2012, we identified three key examples of overlap with efforts  of other CMS offices. While the center uses a number of mechanisms to  coordinate with other CMS offices, it is still working on ways to make  coordination more systematic.
subsections: section_title: Some Innovation Center Models Overlap with Efforts of Other CMS Offices
paragraphs: We identified three key examples of Innovation Center models being  implemented as of March 31, 2012, that overlap with efforts of other CMS  offices, meaning that the efforts share similar goals, engage in similar  activities or strategies to achieve these goals, or target similar  populations. However, these overlapping efforts also have differences,  and CMS officials said they are intended to be complementary to each  other. The three key examples we identified are the following:
The Innovation Center’s Two Accountable Care Organization (ACO)
Models and the Center for Medicare’s Shared Savings Program.  The Innovation Center is implementing two models—the Pioneer ACO  model and the Advance Payment ACO model—that share similar  goals with those of the Shared Savings Program, which is required by  PPACA and administered nationally by CMS through its Center for  Medicare. All three efforts aim to encourage Medicare providers that  participate in ACOs to improve the quality of care among the patients  they serve, while at the same time reducing Medicare expenditures. In  order to achieve these goals, the efforts provide financial incentives  for ACOs that meet specified quality of care and cost savings  thresholds by allowing them to share in a certain amount of the  savings they achieve for the Medicare program. However, the  Innovation Center’s models and the Shared Savings Program each  adopt a different approach to sharing any realized savings. Further,  while the Shared Savings Program is open to all eligible ACOs, the  models target specific subgroups of ACOs. According to CMS  officials, the Innovation Center’s ACO models are intended to be  complementary to the Shared Savings Program, because they allow  CMS to test alternative approaches to the national effort. If these  alternative approaches are proven effective, officials explained, they  could be incorporated into the Shared Savings Program.
The Innovation Center’s Medicaid Models and CMCS’s State  Medicaid Demonstrations. As of March 31, 2012, the Innovation  Center was implementing nine models that share the same broad goal  as the state Medicaid section 1115 demonstrations overseen by  CMCS—testing new ways of delivering and paying for health care in  Medicaid. Despite this similarity, the Innovation Center’s models can  test delivery and payment approaches across geographic areas and  with different types of participants, including directly with providers,  while Medicaid demonstrations under CMCS are agreements between  CMS and state Medicaid agencies to test approaches within a  particular state. According to CMS officials, the Medicaid models and  demonstrations are intended to be complementary: the models allow  CMS to test the effectiveness of approaches it selects, while the  demonstrations are initiated by states on the basis of their own  priorities and needs. Further, officials said that while evaluations of  Innovation Center models may be able to more-rigorously test  effectiveness, state Medicaid demonstrations allow for a larger  number of tests to be conducted—according to CMS, there were  approximately 70 active section 1115 demonstrations as of August  2012—and can point to promising approaches that should be  considered for further testing.
The Innovation Center’s Partnership for Patients Model and CCSQ’s  Quality Improvement Organization (QIO) Program. The goals of the  Innovation Center’s Partnership for Patients model—namely reducing  the rate of preventable hospital-acquired conditions and 30-day  hospital readmissions—are also currently among the many goals of  CCSQ’s QIO program. In order to achieve these goals, both the  Partnership for Patients model and the QIO program contract with  organizations—Hospital Engagement Networks (HEN) and QIOs,  respectively—to disseminate successful patient safety interventions in  hospitals through training and technical assistance. While the two  efforts are very similar in this respect, compared to QIOs, the activities  of HENs target more hospital-acquired conditions and focus on a  broader population that includes non-Medicare patients.officials also told us that the work of HENs and QIOs is intended to be  complementary and that HENs reinforce and expand on work already  being done by QIOs in order to reduce hospital-acquired conditions  and 30-day hospital readmissions at a faster rate. While QIOs may  have established relationships with certain hospitals in their states, as  of September 2012, CMS officials said that HENs had engaged a  much wider network of hospitals in patient safety interventions when  compared with QIOs—about 4,000 versus just over 800 respectively.  Officials said that one reason for this is that HENs focus exclusively  on hospitals whereas QIOs are responsible for implementing  improvement projects across all settings of care. Additionally, officials  said that because hospital system organizations serve as HENs, they  can leverage their member hospitals to encourage these hospitals to  adopt patient safety interventions.
section_title: The Innovation Center Uses a Number of Mechanisms to Coordinate with Other Offices, but Is Still Working on Ways to Make Coordination More Systematic
paragraphs: Over the period of our review, we identified a number of mechanisms the  Innovation Center uses to coordinate its work in order to avoid  unnecessary duplication in models that overlap with efforts of other CMS  offices. In using these mechanisms, the center has engaged in key  practices that we identified in prior work as helping enhance and sustain  collaboration, such as leveraging resources, establishing compatible  policies and procedures, and developing ways to report on results across  offices. The mechanisms the Innovation Center uses are the following:
Committees and boards. The Innovation Center uses a number of  committees and boards to coordinate with other offices. For example,  CMS officials told us that in deciding whether to select a model for  testing, the Innovation Center’s Portfolio Management Committee  considers other efforts within CMS—as well as more broadly across  HHS—that may overlap with the model in order to avoid unnecessary  duplication. Officials said that when overlap is identified, the decision  to continue with the model is made on a case-by-case basis and  involves a determination of whether the model is significantly different  from existing efforts. Additionally, members of the Portfolio  Management Committee are able to help identify staff in other offices  that the Innovation Center might want to invite to work on a model in  order to leverage existing agency expertise. In another example,  CMS’s Enterprise Management Board brings together relevant offices  across the agency, such as the Chief Operating Officer, the Office of  Acquisition and Grants Management, and the Center for Medicare,  early in a model’s implementation to determine what needs to be done  operationally. To avoid unnecessary duplication, the board considers  whether there are existing CMS resources that could be leveraged for  the model’s infrastructure needs or whether a resource being  developed for an Innovation Center model could be shared with other  CMS efforts.
Model approval process. According to CMS officials, the process CMS  uses to approve Innovation Center models for implementation also  allows the center to coordinate with other CMS offices. Officials  explained that as part of this process, all CMS offices must have the  opportunity to review and comment on the ICIP—a document that  contains key information on a proposed model, such as design  parameters and cost estimates—before the model is approved by the  CMS administrator. Officials said that under CMS policy, the  Innovation Center must address these comments. The ICIP contains  sections that specifically address issues related to overlap, such as a  section on “Synergy with Existing or Planned Initiatives” and a section  on “Uniqueness/Innovation.” CMS officials said that, as a result, when  the ICIP is circulated, if the Innovation Center did not sufficiently  coordinate with other CMS centers or offices during the initial  selection of a model, these offices would have the opportunity to raise  any concerns related to unnecessary duplication. After a model is  approved by CMS, HHS and OMB also review and approve the ICIP.
Multi-office meetings at the staff, director, and agency level. First,  CMS officials said that staff from the Innovation Center meet with staff  from other offices to work on efforts that overlap. For example, during  planning for its ACO models, the Innovation Center met with the  Center for Medicare to establish compatible policies and procedures  with the Shared Savings Program, such as developing common  scripts for 1-800-MEDICARE call centers and rules for elevating  beneficiary or provider questions to these centers for additional  review. Additionally, in March 2012, the Innovation Center started  meeting with CCSQ every week to discuss coordination between  HENs and QIOs in order to prevent unnecessary duplication of effort.  Second, CMS officials told us that there is regular coordination  between the director of the Innovation Center and certain other CMS  centers and offices, through meetings that happen on a weekly,  biweekly, or monthly basis. Officials said that, among other things,  these meetings are intended to share the results of ongoing efforts  and address such issues as making sure policies are compatible  across similar efforts. Officials also told us that all CMS offices have  weekly issues meetings with the CMS Administrator that other offices  involved in an issue being discussed are encouraged to attend.  Officials told us that if staff from other CMS offices thought an issue  related to overlapping efforts had not been adequately addressed  through other coordination mechanisms, these meetings serve as an  opportunity for them to raise it.
Liaisons. Officials told us that staff members in other CMS offices  serve as liaisons to the Innovation Center, though they are not  formally designated as such. Officials said that these staff members  primarily serve as a central point of contact so that there is a  systematic way to keep track of coordination across offices. For  example, CMCS has a staff member serving as a liaison to the  Innovation Center who, among other things, ensures that the  Innovation Center’s models employ policies and procedures that are  compatible with Medicaid program rules.
Targeted reviews. CMS officials said that as part of selecting  participants for the Innovation Center’s Medicaid models, the  Innovation Center works with CMCS, CMS regional offices, and OMB  to ensure that the models do not duplicate funding for states that are  already being funded to engage in the same activity through a CMCS  demonstration. For example, the application for the Strong Start for  Mothers and Newborns model—which tests, among other things, the  effectiveness of three different approaches to providing enhanced  prenatal care to Medicaid beneficiaries—specified that states that  were already paying for enhanced prenatal services were not allowed  to participate in the model.
While the Innovation Center uses these mechanisms, it is also still  working on ways to make its coordination with other offices more  systematic. Specifically, CMS officials said that while some of the  Innovation Center’s coordination mechanisms are formalized through  documented policies and procedures, the center is considering the extent  to which additional policies and procedures are needed. For example,  officials said that while the Enterprise Management Board, which is  responsible for addressing how models are coordinated with other CMS  efforts operationally, is formally established through a written charter, they  have considered whether a similar group that deals with coordination at  the policy level needs a more formal structure in place. In another  example, the Innovation Center has directed the outside firm that began  an evaluation of Innovation Center operations in June 2012 to consider,  as part of its statement of work, whether there are any gaps in current  center policies and procedures—including those related to coordination  with other offices—and to propose solutions to those gaps.
The Innovation Center is also currently developing a process to ensure  that CMS does not pay for the same service under both HEN and QIO  contracts. Officials said that CMS recognizes there are areas of overlap  between HENs and QIOs and that they made an explicit decision to  include overlapping activities in HEN and QIO statements of work,  because, among other things, the nature of trying to reduce hospital- acquired conditions and readmissions requires multiple entities working  from different perspectives in a reinforcing manner. Although the HEN  and QIO contractors were originally told to work out areas of overlap  locally, largely because of questions asked during our review, officials  recognized the need for a more-formal process to ensure coordination  was working in practice. CMS officials said that a review of the 26 HEN  contracts is under way to identify if any unnecessary duplication of effort  has occurred—that is, whether HENs and QIOs are conducting the same  activities in the same hospital. Officials noted that the review process  has evolved and may continue to evolve over time, in part because of the  size of the review—which includes reviewing HENs’ activities in  approximately 4,000 hospitals—and in part because the Innovation  Center has not conducted this type of review previously. CMS officials  said that they will take steps, including potentially modifying HEN or QIO  contract language, to eliminate any unnecessary duplication of effort that  the review identifies and to document how this duplication was  addressed.
Finally, officials noted that CMS is in the process of developing a  centralized database, which may also help the Innovation Center make its  coordination more systematic. Among other things, officials said that the  database is intended to help prevent duplicative payments to providers  that participate in CMS efforts involving incentive payments for meeting  specified quality of care and cost savings thresholds, such as the  Innovation Center’s ACO models and the Center for Medicare’s Shared  Savings Program. Specifically, officials said that the database is intended  to track which beneficiaries are participating in different efforts across  CMS to help ensure that beneficiaries are not counted twice for the  purposes of calculating incentive payments. While officials reported that  the database initially became operational in June 2012, they also said  that they are currently working on significant system upgrades that are  expected in September 2012.
section_title: Conclusions
paragraphs: The Innovation Center became operational in November 2010 and is still  in the early stages of implementing its first models, with much work— particularly evaluation activities—to be done in coming years. As of   March 31, 2012, the Innovation Center had announced 17 models,  covering a variety of topics, to test new approaches in health care  delivery and payment. In addition, the Innovation Center has developed  preliminary evaluation plans for each of the 17 models, although at the  time of our review, most still needed to be finalized, and it may take as  long as 3-5 years until the evaluations begin to produce results. With  spending on health care in the United States continuing to increase, and  an appropriation of $10 billion every 10 years, it is important that the  Innovation Center continue the testing of its models and conduct  evaluations as planned in order for CMS to determine the extent to which  the new approaches are able to reduce costs and improve quality of care.
At the time of our review, we identified three key examples of Innovation  Center models that overlap with efforts being conducted by other offices  within CMS. As the Innovation Center and other CMS offices work in  similar areas—namely paying for and delivering health care to Medicare  and Medicaid beneficiaries—there likely will be additional efforts that  overlap as the center continues to build its portfolio of models and  initiatives. We encourage these efforts to the extent that they are  complementary, well coordinated, and do not result in unnecessary  duplication. However, our review also suggests that while the Innovation  Center has taken steps to coordinate with other offices, it still has work to  do in making this coordination more systematic. For example, the  Innovation Center is considering whether additional policies and  procedures are needed to coordinate its efforts with other offices, and it  will be important for the center to continue to determine the extent to  which this is necessary, particularly as it considers the results of the  evaluation by an outside firm. In addition, the Innovation Center is still  implementing a process to ensure that CMS does not make payments for  duplicative services under HEN contracts in its Partnership for Patients  model—one of its first and most expensive models to date—and QIO  contracts. Given the significance of the Innovation Center’s work, and the  amount of money involved in its operation, having appropriate and well- documented coordination mechanisms in place will be an important step  going forward to help ensure that resources are used most efficiently and  any overlapping efforts do not become unnecessarily duplicative.
section_title: Recommendations for Executive Action
paragraphs: In order to ensure the efficient use of federal resources, we recommend  that the Administrator of CMS direct the Innovation Center to  expeditiously complete implementation of its process to review and  eliminate any areas of unnecessary duplication in the services being  provided by HENs and QIOs in hospitals.
section_title: Agency Comments and Our Evaluation
paragraphs: We provided a draft of this report to HHS for review and comment. In its  written comments, reproduced in appendix III, HHS agreed with our  recommendation and provided general comments. In addition, on   October 26, 2012, the Innovation Center’s Deputy Director for Operations  provided oral technical comments that were incorporated, as appropriate.
In its written comments, HHS stated that it concurred with our  recommendation to expeditiously complete implementation of its process  to review and eliminate any areas of unnecessary duplication in the  services being provided by HENs and QIOs. HHS described the steps  underway to identify and eliminate any duplication of effort, including   (1) having Contracting Officer Representatives assess whether there are  areas of duplication that require further review and recommend  appropriate actions for each contract and (2) if appropriate, putting in  place acceptable mitigation strategies, issuing technical direction, or  modifying the appropriate contract to eliminate the duplication of effort.  HHS stated that it anticipates completing these steps by December 31,  2012, and has monitoring plans in place to assess future changes in the  work plans of QIOs and HENs to avoid future duplication.
In its written comments, HHS also stated that only one of the three key  examples of overlap cited in the report—the HEN and QIO example— poses a risk of duplicative effort. We agree, and the recommendation we  make focuses on this example. The other two key examples we described  in our report are overlapping in that they share similar goals, engage in  similar activities or strategies to achieve these goals, or target similar  populations. We noted that these efforts have important differences and  that CMS officials said the efforts were intended to be complementary to  each other. Because the Innovation Center and other CMS offices work in  similar areas—namely paying for and delivering health care to Medicare  and Medicaid beneficiaries—we observed that there will likely be efforts  that overlap. As we reported, we encourage these efforts to the extent  that they are complementary, well coordinated, and do not result in  unnecessary duplication.
As agreed with your offices, unless you publicly announce the contents of  this report earlier, we plan no further distribution until 30 days from the  report date. At that time, we will send copies to the Secretary of HHS, the  Administrator of CMS, and other interested parties. In addition, the report  will be available at no charge on the GAO website at http://www.gao.gov.
If you or your staffs have any questions about this report, please contact  me at (202) 512-7114 or at kohnl@gao.gov. Contact points for our Offices  of Congressional Relations and Public Affairs may be found on the last  page of this report. GAO staff who made key contributions to this report  are listed in appendix IV.
section_title: Appendix I: Models Initiated by the Innovation Center as of March 31, 2012, in Order of Start Date
subsections: section_title: Title and description
paragraphs: Estimated number   and type of  beneficiaries affected Type of participants  State Demonstrations to Integrate Care for Medicare-Medicaid Beneficiaries—Supports state Medicaid programs in designing  new approaches to service delivery and financing in order to integrate care for Medicare-Medicaid beneficiaries. This program will  enable states to participate in the Financial Alignment Model (see below), which will enroll beneficiaries in 2013.
Total funding in  millions of dollars     (lifetime of model)
Incentives for Prevention of Chronic Diseases in Medicaid—Tests the impact of providing incentives to Medicaid beneficiaries to  participate in prevention programs such as those that address tobacco cessation, controlling or reducing weight, lowering cholesterol,  lowering blood pressure, and avoiding the onset of diabetes.
Not available at the time  of our review  Federally Qualified Health Center Advanced Primary Care Practice—Tests the effect of the advanced primary care practice  model—commonly referred to as the patient-centered medical home—in improving care, promoting health, and reducing the cost of  care provided to Medicare beneficiaries by Federally Qualified Health Centers. Federally Qualified Health Centers are health centers  that have received a “Federally Qualified Health Center” designation from the Centers for Medicare & Medicaid Services (CMS) and  provide comprehensive community-based primary and preventive care services in medically underserved areas or to medically  underserved populations.
Partnership for Patients: Community Based Care Transitions—Tests approaches to reduce unnecessary hospital readmissions  by improving the transition of Medicare beneficiaries from the inpatient hospital setting to home or other care settings.
Hospitals with high  readmission rates that partner  with community-based  organizations that provide  care transition services  Partnership for Patients: Hospital Engagement Networks and Other Strategies—Tests the effectiveness of multiple strategies to  reduce preventable hospital-acquired conditions—conditions that a patient acquires while an inpatient in the hospital, such as  catheter-associated urinary tract infections or injuries from falls—and 30-day hospital readmissions. One example of a strategy used  by the Partnership for Patients is contracting with Hospital Engagement Networks—which are state, regional, and national hospital  system organizations—to disseminate successful patient safety interventions in hospitals through training and technical assistance.
section_title: Title and description
paragraphs: Total funding in  millions of dollars     Type of participants  (lifetime of model) Pioneer Accountable Care Organization (ACO) Model—Tests the effectiveness of allowing experienced ACOs to take on financial  risk in improving quality and lowering costs for all of their Medicare patients. An ACO refers to a group of providers and suppliers of  services, such as hospitals and physicians, that work together to coordinate care for the patients they serve.
ACOs with at least 15,000  Medicare fee-for-service  beneficiaries (or at least  5,000 Medicare beneficiaries  in the case of rural areas)  Treatment of Certain Complex Diagnostic Laboratory Tests—Tests the effect of making separate payments for certain complex  diagnostic laboratory tests on access to care, quality of care, health outcomes, and expenditures.
Strong Start for Mothers and Newborns—Tests two strategies to improve outcomes for newborns and pregnant women: (1) shared  learning and diffusion activities to reduce the rate of early elective deliveries among pregnant women and (2) enhanced prenatal care  to reduce preterm births (less than 37 weeks) in women covered by Medicaid. Each of these strategies addresses three different  approaches to achieving these goals.
Strategy 1:   This model targets all  patients receiving  related services  Strategy 2:   90,000 Medicaid  beneficiaries  2 years;  Strategy 2:   4 years  Advance Payment ACO Model—Tests the effect of prepayment of shared savings to support ACO infrastructure development and  care coordination on quality and costs of care for Medicare beneficiaries.
Small physician-led or rural  organizations participating in  the Medicare Shared Savings  Program  Independence at Home Demonstration—Tests the effectiveness of delivering an expanded scope of primary care services in a  home setting on improving care for Medicare beneficiaries with multiple chronic conditions.
Physician practices with at  least 200 high-need  beneficiaries  Health Care Innovation Awards—Tests a variety of innovative approaches to paying for and delivering care that have a focus on  those that will train and deploy the health care workforce to support these innovations.
Not available at the time  of our review  Medicaid Emergency Psychiatric Demonstration—Tests whether Medicaid can support higher quality care at lower cost by  reimbursing private psychiatric hospitals for certain services for which Medicaid reimbursement has historically been unavailable.
section_title: Title and description
paragraphs: Type of participants  Graduate Nurse Education Demonstration—Tests the effect of offsetting the costs of clinical training for Advanced Practice  Registered Nurses on the availability of graduate nursing students enrolled in APRN training programs. (lifetime of model)
Hospitals, schools of nursing,  and non-hospital-based  community-based care  settings  Comprehensive Primary Care Initiative—Tests the impact of enhanced primary care services, including care coordination,  prevention, and 24-hour access for Medicare and Medicaid beneficiaries.
Up to 315,000 Medicare  and 16,000 Medicaid  beneficiaries  Initiative to Reduce Avoidable Hospitalizations Among Nursing Facility Residents—Tests partnerships between independent  organizations and long-stay nursing facilities to enhance on-site services to reduce inpatient hospitalizations for Medicare-Medicaid  beneficiaries.
Organizations that partner  with states and nursing  facilities to provide enhanced  care coordination  Bundled Payment for Care Improvement—Tests the effect of different payment approaches that link payments for multiple services  received by patients during an episode of care, including hospitalization and posthospital services, on the coordination of patient care.  Four different models of bundling will be tested, but information on models 2 through 4 was not available at the time of our review.
Not available at the time  of our review  Providers such as hospitals,  physician group practices,  and health systems  Financial Alignment Initiative—Tests two approaches to integrating the service delivery and financing of the Medicare and Medicaid  programs to better coordinate care for Medicare-Medicaid beneficiaries: a capitated approach where a state, CMS, and a health plan  enter into a three-way contract to provide comprehensive coordinated care; and a managed fee-for-service approach where a state  and CMS enter into an agreement where the state would be eligible to benefit from savings resulting from its initiatives designed to  improve quality and reduce costs.
Model 1: 389,000  Medicare fee-for-service  beneficiaries  Up to 2 million  Medicare-Medicaid  beneficiaries  73  eligibility requirement for Medicaid. For this report we use the term “Medicaid” to include both  Medicaid and the State Children’s Health Insurance Program.  Section 4108 requires the award of grants to states to test approaches that may encourage behavior  modification and determine scalable solutions by providing incentives to Medicaid beneficiaries.   § 4108, 124 Stat. at 561-564 (codified at 42 U.S.C. §1396a note).  Section 4108 appropriated $100 million for a 5-year period beginning on January 1, 2011. The  amount appropriated is to remain available until expended.  Section 3026 requires the implementation of a model that tests whether partnerships between high- admission-rate hospitals and community-based service organizations can improve transition care  services for high-risk Medicare beneficiaries § 3026, 124 Stat. at 413 - 415 (codified at 42 U.S.C. §  1395b-1 note).  Section 3026 requires the transfer of $500 million from Medicare trust funds for the period of fiscal  years 2011 through 2015. The amount transferred is to remain available until expended.  Section 3113 requires CMS to develop appropriate payment rates for the tests included in this  demonstration. § 3113, 124 Stat. at 422-423 (codified at 42 U.S.C. § 1395I note).  ISection 3113 requires the transfer of $5 million from the Medicare Part B trust fund for administering  the demonstration. The amount transferred is to remain available until expended. Payments under the  demonstration are to be made from Medicare Part B funds and may not exceed $100 million.  Section 3024 requires CMS to conduct a demonstration to test a payment and service-delivery model  that utilizes physician- and nurse practitioner–directed home-based primary care teams for reducing  expenditures and improving the health outcomes of certain Medicare beneficiaries. §§ 3204,  10308(b)(2). 124 Stat. at 404-408, 942 (codified at 42 U.S.C. § 1395cc-5).  Section 3024 requires the transfer of $5 million from Medicare trust funds for each of fiscal years  2010 through 2015. The amounts transferred are to remain available until expended.  Section 2707 requires CMS to select states to participate in the demonstration project on a  competitive basis. §2707, 124 Stat. at 326-328 (codified at 42 U.S.C. § 1396a note).  Section 2707 appropriated $75 million for fiscal year 2011. The amount appropriated is to remain  available through December 31, 2015.  Section 5509 requires CMS to conduct a demonstration under which eligible hospitals receive  payment for their reasonable costs for the provision of qualified clinical training to advanced practice  nurses. § 5509, 124 Stat. at 674-676 (codified at 42 U.S.C § 1395ww note).
Section 5509 appropriated $50 million for each of fiscal years 2012 through 2015. The amount  appropriated is to remain available until expended.
section_title: Appendix II: Innovation Center: Steps in Process for Implementing Models
paragraphs: The Center for Medicare and Medicaid Innovation (Innovation Center) solicits and  receives ideas for different payment and care delivery approaches through  “Listening Sessions” and through its web-based idea-submission tool. The Innovation Center reviews ideas that have been submitted and evaluates  them with respect to their potential to meet its primary goals of better health care,  better health, and reduced costs. It reviews ideas against “Portfolio Criteria” that  were created to guide the Innovation Center in developing a portfolio of models  that address a range of populations, issues, problems, and solutions.
Examples of these criteria include: having the greatest potential impact on  Medicare and Medicaid beneficiaries and improving how care is delivered  nationally; focusing on health conditions that offer the greatest opportunity to  improve care and reduce costs; and meeting the needs of the most  vulnerable and addressing disparities in care.
Develop an Innovation Center Investment  Proposal (ICIP)
As part of this selection process, the Innovation Center reviews model types  suggested in the Patient Protection and Affordable Care Act (PPACA) provision  that established the center, and seeks input from across the Centers for Medicare  & Medicaid Services (CMS), the Department of Health and Human Services  (HHS), and other federal partners and from an array of external stakeholders.
Once the Innovation Center identifies a payment and care delivery model that  shows promise, it develops an ICIP, which typically includes  a proposed design for the model including the size and scope of testing, the  population and programs involved, and duration;  a summary of prior evidence and supporting research;  a preliminary evaluation plan including research questions, proposed  measures related to cost and quality, and discussion of the model’s expected  impact; and  an implementation plan, including the application and selection process, an  analysis of whether the model overlaps or complements other initiatives, and  an analysis of the potential for expansion of the model.
The Innovation Center prepares separate documents for approval that are related  to funding requests and solicitations associated with the model.  The Innovation Center seeks approval for the model. This includes separate  approval processes for the ICIP, for model funding, and for any solicitations that  would be issued to potential participants.  The approval process includes a sequence of reviews within CMS, within HHS,  and finally with OMB. During these reviews, modifications may be made on the  basis of input from individuals in other CMS centers and offices, in other related  HHS programs, and from OMB.
Once the ICIP is approved, the Innovation Center issues an announcement and  other information about the model to the public.
The Innovation Center issues information about how to apply for participation in  the model, including information about which types of providers or organizations  are eligible to participate, the process for submitting applications, and the  selection process. The Innovation Center may also organize webinars or learning  sessions open to the public and interested participants to share information and  answer questions.
Innovation Center models vary by the type of participant that is involved—for  example, physician group practices, health plans, and state Medicaid  programs.
Models also vary in terms of the type of agreement that is established with  participants, for example, whether it is a grant, a cooperative agreement, a  contract, or a provider agreement.  The selection process for participants is generally competitive. The criteria  used in the selection process may vary by model. For example, selection  criteria may include such factors as organizational capabilities and plans for  ensuring quality of care. In other cases, eligible participants may be selected  in order to achieve a mix and balance of certain characteristics for evaluation  purposes, for example geographic location (urban, rural) and whether the  participant uses electronic health records.
The Innovation Center solicits and hires contractors to evaluate the model.  Applicants are asked to propose specific evaluation approaches to the preliminary  evaluation plans that the Innovation Center has identified. Contractors are  selected through a competitive process. Once a contractor is selected, it works  with the Innovation Center to complete a design phase and reach agreement on  the final evaluation plan for the model.  The Innovation Center also engages contractors for other purposes that are part  of implementation, such as data collection and provider recruitment.
subsections: section_title: Testing and evaluation Conduct test of model
paragraphs: The changes that the model is testing—for example, changes to health care  delivery or payment—are put into effect by CMS and by participants.  The testing period for Innovation Center models is typically set for 3 to 5 years.  However, evaluation monitoring may indicate that the model should be modified,  terminated, or expanded before this period ends (see below). The Innovation  Center may choose to shorten the test period for a model for such reasons.
Conduct evaluation of model to assess its  impact on cost and quality
Data are collected for cost and quality measures. Using a variety of statistical  techniques, these data are generally compared to data for a comparison group  representing patients or providers that are not participating in the model to  determine the model’s impact on cost and quality. When comparison groups are  not possible, data for model participants are compared to “baseline” data that  represent a period prior to the test period. Qualitative information on the different  strategies participants may use to deliver care under each model is also collected  and analyzed.
During the testing period information collected is shared on a regular basis with  participants. The purpose of this “rapid cycle” feedback is to provide timely  information so that participants can make improvements during the testing period.
The Innovation Center plans to regularly review each model’s impact on the  quality and cost of care to determine whether the payment or delivery approach is  successful and should be recommended for expansion into the Medicare or  Medicaid program.  If the Innovation Center seeks to expand a program, the CMS Office of the  Actuary must certify that the model would either (1) result in cost savings or   (2) not result in any increase in costs if implemented on a broader scale within  Medicare or Medicaid, or both.
The Innovation Center’s criteria can be found at: http://www.innovations.cms.gov/about/our-portfolio- criteria/index.html (accessed Sept. 13, 2012).
section_title: Appendix III: Comments from the Department of Health and Human Services
section_title: Appendix IV: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: In addition to the contact named above, Kristi Peterson, Assistant  Director; Krister Friday; Mary Giffin; Samantha Poppe; Rachel Svoboda;  and Jennifer Whitworth made key contributions to this report.