M+C and FEHBP both represent large health care purchasing programs that contract with HMOs and other types of health care organizations to provide services. NAIC, JCAHO, and NCQA are not purchasers of health care, but they play important roles in establishing certain HMO requirements. M+C is a component of Medicare, the federal entitlement program for adults age 65 and older and some individuals who are disabled or have end- stage renal disease (ESRD). Medicare beneficiaries can choose to receive covered services through the FFS program or through an M+C health plan if one is offered in the area where they live. HMOs and other types of health care organizations contract with CMS to offer M+C health plans. HMOs participating in M+C receive fixed monthly payments for enrolled beneficiaries, regardless of what their enrollees’ care actually costs, in return for providing all Medicare-covered benefits, except hospice care, and complying with all M+C requirements. CMS monitors each HMO and periodically conducts an on-site review to determine whether the HMO is complying with program requirements. The agency also requires HMOs to regularly submit certain information, such as enrollment and other data used to compute HMO payments. In creating M+C, BBA included many requirements from the previous risk- contract program. For example, the M+C requirement that HMOs submit marketing and enrollee communications for agency approval was a requirement of the risk-contract program. BBA also included requirements that were modifications of previous ones and others that were new. For example, BBA included quality assurance requirements— such as those pertaining to the collection, analysis, and reporting of health outcomes and member satisfaction—that were more comprehensive than previous requirements. BBA required that M+C payments to an HMO be adjusted to reflect the relative health status of that HMO’s enrollees beginning in 2000. The law directed the Secretary of HHS to require HMOs to submit data on their enrollees’ use of inpatient hospital services and data on other services as the Secretary deemed necessary. In addition to the inpatient hospital data requirement, the Secretary required HMOs, in 1998, to collect data on the use of physician and hospital outpatient services. BBA also limited, effective January 1, 2002, the number of opportunities beneficiaries had each year to enroll or change enrollment in a M+C health plan. M+C’s requirements have continued to evolve since BBA, partly as a result of subsequent legislation. Some legislative changes addressed HMOs’ concerns about BBA’s initial implementation. For example, BBRA increased the amount of time that HMOs have each year to develop their benefit package proposals by moving the annual submission deadline from May 1 to July 1. To reduce the administrative burden on HMOs that are monitored by both a private accreditation organization and the agency, BBRA increased the number of topical areas where HMOs may fulfill M+C requirements by receiving accreditation from an organization that has standards, as well as a process for ensuring compliance with those standards, which are determined by CMS to meet or exceed M+C requirements. BBA allowed accreditation standards to be applied for quality assurance and confidentiality of records requirements. BBRA expanded this list to include antidiscrimination, access to services, advance directives, and provider participation requirements. Under BIPA, CMS must expedite review of HMO marketing materials that use agency- specified language without modification. BIPA also required HMOs to expand their quality improvement activities to include a separate focus on racial and ethnic minorities. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) made temporary modifications to M+C requirements. It enabled Medicare to reinstate, through 2004, beneficiaries’ opportunities to change enrollment into any M+C health plan accepting new enrollments or switch to the FFS program on a monthly basis. It also moved the annual submission deadline for HMOs’ benefit package proposals to the second Monday in September for benefit years 2003 through 2005. CMS has also modified certain M+C requirements, in some instances to reduce the administrative burden on participating HMOs. In 2001, for example, the agency postponed the date by which HMOs would have to begin submitting data on beneficiaries’ use of physician and hospital outpatient services. In 2002, CMS gave HMOs more flexibility in advertising plan benefits not available in the FFS program. For example, HMOs were allowed to describe their health plans’ pharmacy discounts in the standard summary of benefits distributed to beneficiaries. CMS has also made changes to address shortcomings that agency staff or outside groups identified. The process for reviewing and approving HMOs’ marketing materials was revised, in part, to correct problems we identified in 1999. Since BBA was enacted, CMS has issued Federal Register notices and other written instructions to inform HMOs about program changes. During 2001, CMS began releasing chapters of a new Medicare managed care manual intended to inform HMOs about program requirements. As of July 11, 2002, the agency had released 9 of a planned 20 chapters. No release dates have been announced for the remaining chapters. FEHBP is the largest employer-sponsored group health insurance program in the United States. In 2002, FEHBP covers approximately 8.28 million individuals, consisting of 2.19 million federal employees, 1.86 million federal retirees, and 4.23 million dependents. Like most Medicare beneficiaries, FEHBP beneficiaries may select from among available health plans during an annual open enrollment period. OPM contracts with HMOs and other types of health care organizations to offer health plans to FEHBP beneficiaries. The number of HMOs participating in FEHBP has declined in recent years, from 476 HMOs in 1996 to about 200 HMOs in 2002. In 2002, about 2.42 million FEHBP beneficiaries (29 percent) are enrolled in HMOs. The remaining 5.86 million beneficiaries (71 percent) are enrolled in other types of health plans, such as PPOs. NAIC is a nonprofit association of the insurance regulators of the 50 states, the District of Columbia, and 4 United States territories. Its mission includes promoting consistent health insurance regulations. To help achieve this objective, NAIC prepares model requirements that any state may adopt, in whole or in part, to regulate HMOs operating in the state. NAIC’s model requirements are largely written in general terms to provide a framework that states can tailor to meet local needs. According to NAIC, approximately 30 states have passed legislation based on the requirements in NAIC’s Model HMO Act, which provides a legal framework for the organization and functioning of HMOs and a regulatory framework for state oversight. JCAHO and NCQA provide accreditation programs for HMOs and other health care entities that contract with public and private employers to serve their employees and retirees, with state governments to serve Medicaid beneficiaries, or with the federal government to serve Medicare beneficiaries. JCAHO’s and NCQA’s accreditation standards focus on the HMO operations that affect the quality of care delivered and interactions with members, rather than on all the requirements that a purchaser would typically specify for an HMO, such as the benefits offered and the cost of providing those benefits. HMOs may seek accreditation from a nationally recognized organization, such as JCAHO or NCQA, to signal their commitment to quality and to help attract business. Some potential purchasers consider an HMO’s accreditation status when deciding whether to contract with the HMO. An HMO’s accreditation status may also be an important consideration for some potential enrollees. For that reason, OPM lists the accreditation status of participating HMOs in the annual guide made available to FEHBP beneficiaries. In addition, HMOs with M+C health plans that have received full accreditation from JCAHO or NCQA, and have been determined by one of those organizations to have met certain additional standards, are considered by CMS to have met the M+C quality requirements discussed in this report. An HMO that contracts to serve Medicare beneficiaries must meet M+C program requirements specified by CMS regarding benefit package proposals, the beneficiary enrollment process, marketing and enrollee communications, and quality improvement. Requirements pertaining to benefit package proposals specify the information that HMOs must annually submit to CMS and set coverage parameters, such as limits on beneficiary cost sharing. Beneficiary enrollment process requirements establish how HMOs must collect and process applications, conduct beneficiary eligibility checks, transmit information to CMS, and reconcile data discrepancies. Communication requirements, which cover both general advertising and specific communications to enrollees, set standards for the information that HMOs distribute to beneficiaries and establish CMS’s review and approval process for these materials. Requirements for quality improvement specify that HMOs have the capacity to undertake projects designed to improve the quality of health care and annually measure their clinical and administrative performance and the satisfaction of current and former enrollees. For each M+C health plan that it intends to offer, an HMO must annually submit a benefit package proposal for CMS review and approval. BBRA specified that proposals are due at the beginning of July—6 months before the start of the benefit year. The Bioterrorism Act temporarily changes the benefit package proposal submission deadline to the second Monday in September for 2002 through 2004. The proposals, formally known as adjusted community rate proposals (ACRP), specify the health plan’s covered benefits, beneficiary cost sharing, and beneficiary premiums. An HMO must cover all services available in the FFS program except hospice. An HMO may also offer additional services, such as outpatient prescription drugs, and charge beneficiaries for these services. If Medicare’s payments to an HMO are expected to exceed its cost of providing Medicare-covered services plus the amount of profit or additional revenue that the HMO would normally earn on non-Medicare contracts, the HMO must use the additional money to cover additional items or services, reduce beneficiary cost sharing, or contribute to a benefit stabilization fund—an escrow-like account that can be drawn upon in future years to help maintain benefit levels—or a combination of these. The HMO’s benefit package proposal describes the extent to which these options will be used. CMS reviews HMOs’ benefit package proposals and approves them if they comply with M+C requirements. For example, an HMO may set beneficiary cost-sharing requirements on individual services that differ from those in the FFS program, but the sum of the actuarial value of its cost-sharing requirements—the total amount that the average beneficiary would be expected to pay in deductibles, coinsurance, and copayments—and the health plan premium may not exceed the actuarial value of cost sharing in the FFS program. The agency has generally approved the proposals before the start of Medicare’s annual enrollment period in November. BIPA requires the agency’s Chief Actuary to review all benefit package proposals submitted on or after May 1, 2001, to determine whether the data values and underlying assumptions in the proposals are reasonable. According to CMS officials, actuary reviews will begin with benefit package proposals submitted in 2002. BBA requires CMS each year to audit the benefit package proposals from at least one-third of the participating M+C HMOs. CMS uses a risk-based approach to select some of the HMOs to audit, but the majority of audited HMOs are randomly selected. HMOs are required to play a major role in the beneficiary enrollment process. A beneficiary who wants to enroll in a health plan submits an application to the HMO, which then must make a preliminary determination about whether the beneficiary lives in the geographic area served by the health plan and is otherwise eligible to enroll. The HMO then forwards the beneficiary’s information to CMS. After CMS confirms enrollment eligibility, the HMO must determine the date that coverage will begin and notify the beneficiary. Through December 31, 2004, beneficiaries are allowed to join or leave health plans each month. After that date, beneficiaries will have fewer opportunities each year to make health plan changes. HMOs must provide accurate and complete information to prospective beneficiaries and current enrollees. CMS’s requirements cover the advertising and marketing materials that HMOs distribute to prospective beneficiaries and the communications between HMOs and their enrollees, such as explanations of benefits or coverage denials. For some materials, such as the summary document that each HMO must produce to describe its health plan’s benefits, CMS requires HMOs to use templates with standardized language and formats. Prior to distribution, HMOs must submit all of their marketing and most of their enrollee communication materials to CMS for review and approval. HMOs must meet M+C requirements designed to improve the quality of care and services they deliver. Every year, an HMO must begin a multiyear quality improvement project that focuses on a topic specified by CMS (the national quality improvement project). For example, in 2002, CMS requires HMOs to participate in the national quality improvement project designed to improve breast cancer screening rates. An HMO must also demonstrate that its previous quality improvement projects have resulted in demonstrable performance improvements and sustain those improvements for at least 1 year. HMOs must participate in annual CMS-sponsored standardized satisfaction surveys of current enrollees and recent disenrollees and provide clinical and administrative data to CMS. Recently, CMS determined that AAAHC’s, JCAHO’s, and NCQA’s standards, and their processes for ensuring compliance with those standards, meet or exceed M+C requirements for quality improvement. As a result, an HMO that has received full accreditation from AAAHC, JCAHO, or NCQA may now choose to have the accreditation organization, instead of CMS, monitor its compliance with M+C quality improvement requirements. FEHBP has requirements for HMOs in all four areas we examined: benefit package proposals, the beneficiary enrollment process, marketing materials and enrollee communications, and quality improvement. Although FEHBP and Medicare both function as purchasers and are broadly similar in terms of offering a choice of plans to beneficiaries, there are key differences in how the two programs operate, which may account for some of the variation in requirements. For example, market forces determine HMO payment rates in FEHBP. In contrast, a statutory formula specifies HMO payment rates in M+C. The difference in rate-setting methodologies affects the type of information that OPM and CMS require HMOs to include in their benefit package proposals. The programs also differ in size and beneficiary characteristics. FEHBP covers about one-fifth as many individuals as Medicare does. Moreover, FEHBP beneficiaries tend to be younger and to use fewer health care services than Medicare beneficiaries. HMOs that intend to participate in FEHBP must annually submit benefit package proposals to OPM for each health plan they offer. The proposals are due in May, at least 7 months before the start of the benefit year. In general, the FEHBP benefit package that an HMO offers in a geographic area provides the same coverage that the HMO offers to most enrollees in the same area. Each proposal includes the proposed health plan premium, which must be based on the lowest community-rated premium that the HMO charges to commercial customers for a similar number of covered lives. OPM actuaries evaluate an HMO’s supporting documentation for the proposed premium. The benefits to be covered by a health plan and its cost to the government and to enrollees may be affected by subsequent discussions between OPM and the HMO. For example, OPM may question specific cost estimates submitted by an HMO if they are much higher than other HMOs’ estimates. In such a situation, according to OPM, the agency will not agree to a rate unless these higher costs are adequately justified. Negotiations are generally concluded in August, at least 2 months before the start of FEHBP’s annual enrollment period in November. FEHBP HMOs are subject to audits by OPM’s Office of Inspector General (OIG). If an HMO is found to have overcharged the government, the HMO must repay the amount of the overcharge plus interest. The OPM OIG has a goal of auditing every HMO at least once every 7 years. However, its audit strategy is risk based and concentrates resources on HMOs where problems are thought most likely to be found. While FEHBP has some enrollment process requirements for HMOs, they are limited because OPM and agencies that employ federal workers are responsible for most enrollment activities. FEHBP HMOs’ primary enrollment responsibility is to confirm that applicants live in, or in some cases work in, the geographic area served by their health plan. HMOs must also quarterly reconcile enrollments with agencies. Beneficiaries who are active workers enroll through the federal agencies that employ them, either in writing or through an automated telephone system or a dedicated Web site. The agencies determine eligibility and coverage start dates. Retirees enroll through an automated telephone system or a dedicated Web site. Agencies conduct tentative eligibility determinations for retirees that OPM then confirms. In general, FEHBP allows beneficiaries to switch health plans once a year, during the annual open season. FEHBP requires HMOs to produce annual brochures in a standard format using standard language. The brochure must completely describe the covered benefits, limitations, and exclusions. According to OPM officials, the brochures represent a contractual document between HMOs and OPM. OPM must approve HMOs’ brochures before they can be distributed. HMOs must conform to OPM and NAIC guidelines in preparing materials that supplement the brochure and marketing materials, such as descriptive circulars and leaflets. According to OPM representatives, the agency focuses its review efforts on the annual brochures, but may selectively review other marketing materials distributed by HMOs. HMOs must meet performance standards specified in their FEHBP contracts. These standards cover such areas as timeliness of telephone responses and wait times for appointments. FEHBP HMOs must annually conduct a standardized enrollee satisfaction survey and provide clinical and administrative performance data to OPM. FEHBP HMOs currently do not have to conduct quality improvement projects. However, in 2001, HMOs had to submit their business plans and timelines for attaining accreditation from an approved external accreditation organization; OPM currently recognizes JCAHO, NCQA, and URAC/American Accreditation HealthCare Commission. To achieve accreditation from such an organization, HMOs have to undertake quality improvement projects. NAIC, JCAHO, and NCQA have established standards for HMOs in two of the areas we examined: 1) marketing and enrollee communication materials and 2) quality improvement. NAIC, JCAHO, and NCQA have not set standards for either benefit package proposals or beneficiary enrollment—two areas that health care purchasers must address. The three entities tend to establish standards that are less specific than parallel M+C requirements and that may be modified or interpreted to fit local circumstances. NAIC’s model requirements for marketing materials specify that an HMO must produce advertising that is clear, complete, and does not mislead beneficiaries. HMOs may be required to annually certify that their marketing materials comply with a state’s insurance laws and regulations or to submit their marketing materials to a state insurance commissioner prior to distribution. NAIC’s model requirements for enrollee communications focus on HMO contract documents and specify that state insurance commissioners can require HMOs to file these documents for approval by the state prior to issuance. NAIC’s model requirements pertain to the general contents of contract documents, but not the use of standardized formats or language. JCAHO’s and NCQA’s accreditation standards require HMOs to provide complete information to their enrollees. NCQA’s accreditation standards also apply to marketing materials intended for prospective members. Both organizations have general content requirements and review marketing materials during their on-site accreditation visits. NCQA requires that HMOs have a systematic and ongoing process for assessing how clearly new enrollees understand HMO policies and procedures. NAIC’s model requirements specify that HMOs must have a quality improvement program to improve care delivery and health outcomes and to collect and analyze information specific to their enrollees, such as satisfaction with the HMO. However, NAIC does not specify the types of quality improvement projects that HMOs must conduct or require the use of standardized satisfaction surveys or standardized performance measures. Both JCAHO’s and NCQA’s accreditation standards require HMOs to design and conduct quality improvement projects in clinical and administrative areas that achieve meaningful, sustainable performance improvements affecting a significant percentage of their enrollees. JCAHO and NCQA evaluate quality improvement project results during their accreditation site visits. Both organizations also require HMOs to measure enrollee satisfaction and submit administrative and clinical performance data. In written comments on a draft of this report, CMS stated that it generally agreed with our observations and that the tables contained in the appendixes effectively contrast M+C’s, FEHBP’s, and the other entities’ HMO requirements. (App. V contains the full text of CMS’s comments.) CMS suggested that an expanded analysis of the differences between M+C and FEHBP programs, and a more detailed discussion of M+C’s legislative history, could help readers understand why M+C’s HMO requirements may be more stringent. We recognize that there are fundamental differences between Medicare—a large public entitlement program—and FEHBP—an employer-sponsored health insurance program—and that an HMO requirement that is appropriate in one program may not be appropriate in the other. In this report, we provide background information on M+C, FEHBP, and the other entities to help provide context for their HMO requirements. We also understand that behind M+C’s current set of requirements lies a complex legislative history and a series of administrative decisions. The report highlights important Medicare HMO requirement changes introduced by BBA and subsequent actions taken by CMS and the Congress to improve M+C for beneficiaries and encourage participation by HMOs. However, the report’s focus is on the requirements that M+C HMOs face today. By displaying these requirements with the HMO requirements established by other entities, the summary tables may facilitate comparisons and inform discussions about particular M+C requirements and how they contribute to the program’s objectives. We also provided a draft of the report to OPM, NAIC, JCAHO, and NCQA and incorporated the technical comments we received from those organizations and from CMS as appropriate. As agreed with your office, unless you publicly announce the contents of this report earlier, we plan no further distribution of it until 30 days from the date of this report. We will then send copies of this report to the Administrator of CMS, the Director of OPM, NAIC, JCAHO, NCQA, and other interested parties. We will also make copies available to others upon request. In addition, the report will be available at no charge on the GAO Web site at http://www.gao.gov. If you or your staff have questions about this report, please contact me at (202) 512-7119 or James Cosgrove at (202) 512-7029. Other contributors to this report include Jennifer Podulka, Lisa Rogers, and Yorick F. Uzes. M+C and FEHBP have HMO requirements that pertain to benefit package proposals. Our summary of those requirements is organized as follows. Determination of Costs, Benefits, and Government and Beneficiary Contributions Purpose of benefit package proposals Determination of HMO costs or rates Limits on premiums and required cost sharing Submission, Review, and Approval of Benefit Package Proposals Deadline for informing CMS/OPM that existing health plan will not Entities that conduct audits Selection criteria for audits and number of HMOs audited annually Table 1 summarizes selected M+C and FEHBP requirements for HMOs’ benefit package proposals. Figure 1 depicts the 2001 benefit-year timeline for activities associated with the submission, review, and approval of HMOs’ benefit packages. The timing of these activities for M+C will be altered for benefit years 2003 through 2005. Figure 2 depicts the M+C and FEHBP timeline for benefit package proposal activities for those benefit years. M+C and FEHBP have HMO requirements that pertain to beneficiary enrollment. Our summary of those requirements is organized as follows. Transmission of enrollment information to HMOs Reconciliation of data between HMO and administering agency Opportunities to enroll or change enrollment Requirements for health plans to accept new enrollees Determination of effective coverage dates Enrollment and Disenrollment Forms and Notices Notifications for other enrollment-related situations Forms and notifications for voluntary disenrollment Notifications for other disenrollment-related situations Table 2 summarizes selected M+C and FEHBP requirements pertaining to beneficiary enrollment. Table 3 summarizes the annual opportunities for Medicare beneficiaries to enroll in an M+C health plan, change M+C health plans, or switch to FFS under M+C’s enrollment “lock-in” provision. This provision was in effect during the first half of 2002 and will be implemented again as of January 1, 2005. Until that date, Medicare beneficiaries may make enrollment changes every month. Table 4 summarizes the annual opportunities for FEHBP beneficiaries to make health plan enrollment changes. Before 2002, a beneficiary in FFS or an M+C health plan could enroll, on a monthly basis, into any M+C health plan accepting new enrollments or switch from an M+C health plan to FFS. BBA included an enrollment lock- in provision, effective January 1, 2002, that limited the number of opportunities, called election periods, for beneficiaries to make such changes (see table 3). Once a beneficiary used an election period to enroll in a health plan, he or she was locked into that health plan until eligible for another election period. All beneficiaries were eligible for at least two election periods per year—one during the annual election period in November and a second during the first 3 months of the benefit year (6 months in 2002). However, the number of election periods each year was higher for beneficiaries with certain characteristics. For example, beneficiaries enrolled in a health plan on their 65th birthday had four election periods during their first 12 months in the program. Institutionalized beneficiaries could change health plans an unlimited number of times throughout the year. On June 12, 2002, the Bioterrorism Act was signed into law. This act temporarily lifted the enrollment lock-in provision that had been implemented as of January 1, 2002; the lock-in provision is scheduled to be reinstated beginning January 1, 2005. Employees and retirees enrolled in FEHBP generally may change health plans one time each year, during the annual open enrollment period. However, FEHBP does permit changes at other times under certain circumstances, such as a change in family status (see table 4). M+C, FEHBP, NAIC, NCQA, and JCAHO have HMO requirements that pertain to marketing and enrollee communication materials. Our summary of those requirements is organized as follows. Types of Materials Subject to Standards Advertising and prospective member materials Materials that explain HMO operations Approach Used to Ensure that Materials Conform to Standards Ongoing assessment of new members’ understanding of HMO Standards for Documents and Information Preenrollment documents related to benefits and coverage Deadline for distributing preenrollment documents Postenrollment documents related to benefits and coverage Deadline for distributing postenrollment documents Producing materials in other languages and formats Telephone numbers References to outpatient prescription drug benefit Items not covered in contract Time frames for standard review Time frames for expedited review Final verification of beneficiary notification materials Annual certification of compliance in preparing marketing materials Table 5 summarizes selected M+C, FEHBP, NAIC, JCAHO, and NCQA requirements for marketing and enrollee communication materials. M+C, FEHBP, NAIC, JCAHO, and NCQA have HMO requirements that pertain to quality improvement (QI). Our summary of those requirements is structured along the following dimensions. Elements of a Quality Improvement Program Administration of Quality Improvement Program Choice of quality measures Minimum performance levels and benchmarks Potential actions based on evaluation How data are externally validated Who pays for external validation When annual data are submitted Member satisfaction survey measures for current enrollees Who pays for survey administration Member satisfaction survey measures for disenrolled members Who participates Who pays for survey administration Member health status survey measures Who pays for survey administration Table 6 summarizes selected M+C, FEHBP, NAIC, JCAHO, and NCQA requirements for QI. 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Summary: Since the early 1980s, health maintenance organizations (HMO) have entered into risk-based contracts with Medicare and offered beneficiaries an alternative to the traditional fee-for-service (FFS) program. By 1997, 5.2 million Medicare beneficiaries were enrolled in an HMO. Although Medicare HMOs were available in most urban areas, they were often unavailable in rural areas. Medicare+Choice (M+C) has HMO requirements pertaining to benefit package proposals, the beneficiary enrollment process, marketing and enrollee communication materials, and quality improvement, among other areas. An HMO must annually submit a benefit package proposal to the Centers for Medicare and Medicaid Services (CMS) for each M+C health plan that the HMO intends to offer. M+C requirements for the beneficiary enrollment process specify the information that an HMO must include in its enrollment application and the checks that it must perform to ensure that beneficiaries who submit applications are eligible to enroll in the HMO's health plan. M+C marketing requirements prohibit HMOs from using inaccurate or misleading language in advertisements or materials distributed to enrollees. M+C requirements for quality improvements specify that HMOs must undertake multiyear projects intended to improve the quality of health care and must routinely gather and report performance data to CMS.