Unlike CMS and HHS-OIG, the processes in IRS and EBSA  were initiated by the agencies under their authority to administer laws in  these areas rather than in response to specific statutory requirements. Five Key Factors for Establishing an Advisory Opinion Process

The processes at the four agencies we contacted—CMS, HHS-OIG, IRS, and  EBSA—reflect common elements that merit consideration when  establishing an advisory opinion process. These factors are (1) establishing criteria for submitting advisory opinion  requests, (2) developing alternative ways to respond to advisory opinion  requests, (3) determining the time frame for issuing advisory opinions,  (4) considering anticipated workloads, staffing requirements, and user  fees, and (5) creating internal review and external coordination  procedures. The structures of the legally binding advisory opinion  processes at the four agencies, however, reflect differences in their  respective constituencies and responsibilities. Establishing criteria for submitting advisory opinion requests: All  four agencies have defined the scope of their processes by identifying  criteria for submitting advisory opinion requests. Agencies also differed in the number of opinions issued per FTE. In addition, their external coordination includes  consultation with the Department of Justice. Medicare Providers Consider Advisory Opinions as a Possible Way to Improve Guidance

Representatives of most provider organizations we spoke with told us that  providers seeking clarification of Medicare rules and procedures often find  it difficult to obtain reliable or timely written responses to their inquiries. Medicare Providers View Advisory Opinions as One of Several Approaches to Enhance Guidance

Overall, representatives from most of the provider organizations we spoke  with agreed that an advisory opinion process would partially address their  concerns about the guidance that they currently receive from CMS and its  contractors. Specifically, most said that such a process would provide them  with useful answers that they could rely on to appropriately interpret  Medicare regulations. In addition, the  lessons learned by other federal agencies may be useful in structuring a  process for Medicare. Agency Comments

In written comments on a draft of this report, HHS stated that an enhanced  and more formal advisory opinion process for the Medicare program would  not be a successful pursuit at this time. Further, HHS said that  such a process would not provide quick answers to providers’ questions,  and would have limited applicability beyond the parties requesting  advisory opinions. However, HHS acknowledged that the Medicare  program and its implementing regulations are inherently complex and  underscored its efforts to improve stakeholders’ understanding of the  program’s complexities. We are sending copies of this report to the Secretary of Health and Human  Services, the Administrator of CMS, and other interested parties. Medicare Stakeholders Contacted

Comments from the Department of Health and Human Services

GAO Contact and Staff Acknowledgments

	GAO Contact

	Acknowledgments

Pauline Seretakis, Richard Lipinski, Janet Rosenblad, and Craig Winslow  made key contributions to this report.
Why GAO Did This Study

Health care providers are concerned about the quality of Medicare guidance issued by the Centers for Medicare & Medicaid Services (CMS), an agency within the Department of Health and Human Services (HHS). Specifically, they have reported that (1) they receive unclear guidance on program requirements and (2) because policies and procedures change frequently, they may rely on obsolete guidance, resulting in billing errors. Some government agencies issue advisory opinions in response to specific questions from requesters. These opinions permit agencies to apply law and regulation to a particular set of facts and provide requesters with specific guidance. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 directed GAO to determine the appropriateness and feasibility of establishing in the Secretary of Health and Human Services authority to issue legally binding advisory opinions to interpret Medicare regulations. GAO (1) identified factors relevant in establishing an advisory opinion process and (2) assessed the role such a process could play in clarifying program requirements. GAO examined four federal agencies' advisory opinion processes and interviewed officials from organizations representing Medicare stakeholders to learn how such a process might address their concerns.

What GAO Found

GAO identified five common elements in the way four agencies--CMS, the Employee Benefits Security Administration (EBSA) of the Department of Labor, the Internal Revenue Service (IRS), and HHS's Office of Inspector General (HHS-OIG)--set up their advisory opinion processes. While the processes at the four agencies reflected differences in the agencies' respective constituencies and responsibilities, each agency cited five key factors as critical. These were (1) establishing criteria for submitting advisory opinion requests, to define the scope of their processes, (2) developing alternative ways of responding to advisory opinion requests, such as providing other forms of written communication, (3) determining the time frame for issuing advisory opinions, (4) considering anticipated workload, staffing requirements, and user fees as a means of offsetting expenses incurred by the government, and (5) creating internal review and external coordination procedures with other federal agencies with a stake in the outcome of an issued opinion. These five factors and lessons learned from other agencies that issue advisory opinions may be useful in structuring a process for Medicare. Most of the representatives of provider organizations GAO contacted agreed that an advisory opinion process would partially address their concerns, for example, by providing them with reliable, written responses to their Medicare-related questions. However, they recognized that an advisory opinion process would not address all their concerns and that it is one of several approaches that could improve Medicare guidance. For example, refining existing forms of guidance would also be of value. In commenting on a draft of this report, HHS stated that a more formal advisory opinion process for Medicare would be costly to implement, not provide quick answers to providers' questions, and have limited applicability. HHS acknowledged that the Medicare program and its implementing regulations are inherently complex and underscored its efforts to improve stakeholders' understanding of the program's complexities.