Medicare
Advisory Opinions as a Means of Clarifying Program Requirements Gao ID: GAO-05-129 December 8, 2004Health 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.
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.
GAO-05-129, Medicare: Advisory Opinions as a Means of Clarifying Program Requirements
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Report to Congressional Committees:
December 2004:
MEDICARE:
Advisory Opinions as a Means of Clarifying Program Requirements:
[Hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-05-129]:
GAO Highlights:
Highlights of GAO-05-129, a report to congressional committees:
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.
Advisory Opinion User Fees at Four Agencies in Fiscal Year 2004:
Agency: CMS;
User fee: $75 per hour for staff costs, with a $250 nonrefundable
deposit required when the request is made;
Charges per opinion: $250[A].
Agency: EBSA;
User fee: Not applicable;
Charges per opinion: No charge.
Agency: HHS-OIG;
User fee: $86 per hour for staff costs, with a $250 nonrefundable
deposit required when the request is made;
Charges per opinion: Ranged from $301 to $3,784.
Agency: IRS;
User fee: $6,000, based on average cost to agency, with special rate
for qualifying requesters;
Charges per opinion: $6,000[B].
Sources: Interviews with CMS, EBSA, HHS-OIG, and IRS officials.
[A] In fiscal year 2004 CMS issued four advisory opinions for which it
charged $250 for each opinion. CMS anticipates that charges for future
advisory opinions could be higher.
[B] Some taxpayers may be eligible for reduced user fees, depending on
the issues involved and the taxpayers‘ specific circumstances.
[End of table]
www.gao.gov/cgi-bin/getrpt?GAO-05-129.
To view the full product, including the scope and methodology, click on
the link above. For more information, contact Leslie G. Aronovitz at
(312) 220-7600.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
Five Key Factors for Establishing an Advisory Opinion Process:
Medicare Providers Consider Advisory Opinions as a Possible Way to
Improve Guidance:
Concluding Observations:
Agency Comments:
Appendixes:
Appendix I: Medicare Stakeholders Contacted:
Appendix II: Comments from the Department of Health and Human Services:
Appendix III: GAO Contact and Staff Acknowledgments:
Tables:
Table 1: Advisory Opinion Workload and Staffing Levels at EBSA, HHS-
OIG, and IRS in Fiscal Year 2003:
Table 2: Advisory Opinion User Fees at Four Agencies in Fiscal Year
2004:
Abbreviations:
APA: Administrative Procedure Act:
CMS: Centers for Medicare & Medicaid Services:
EBSA: Employee Benefits Security Administration:
ERISA: Employee Retirement Income Security Act of 1974:
FTE: full-time equivalent:
HHS: Department of Health and Human Services:
HHS-OIG: Department of Health and Human Services-Office of Inspector
General:
IRS: Internal Revenue Service:
MAC: Medicare Appeals Council:
Letter December 8, 2004:
The Honorable Charles E. Grassley:
Chairman:
The Honorable Max Baucus:
Ranking Minority Member:
Committee on Finance:
United States Senate:
The Honorable Joe Barton:
Chairman:
The Honorable John D. Dingell:
Ranking Minority Member:
Committee on Energy and Commerce:
House of Representatives:
The Honorable Bill Thomas:
Chairman:
The Honorable Charles B. Rangel:
Ranking Minority Member:
Committee on Ways and Means:
House of Representatives:
The Centers for Medicare & Medicaid Services (CMS), an agency within
the Department of Health and Human Services (HHS), administers
Medicare--the federal health insurance program that serves the nation's
aged and certain disabled individuals. In fiscal year 2003, Medicare
paid over $271 billion for the health care of approximately 41 million
beneficiaries. More than 1 million providers submitted about
950 million claims during that year. As part of its responsibilities,
CMS issues regulations to implement Medicare laws that govern the
participation of beneficiaries, physicians, hospitals, medical
suppliers, and other stakeholders in the Medicare program. Because of
Medicare's size and complexity, its regulations are written to cover a
variety of situations. Although it is critical that stakeholders
understand how the program operates, it may be difficult for them to
interpret Medicare's many regulations and apply them to their own
unique circumstances. CMS--with the assistance of the claims
administration contractors[Footnote 1]--routinely issues various forms
of guidance to beneficiaries and health care providers. CMS and its
contractors also respond to questions from interested parties to
further help them understand program requirements.
In recent years, Medicare providers have become increasingly concerned
about the quality of guidance issued by CMS. For example, they have
criticized CMS for a lack of clarity in regulations and related
guidance on a variety of program issues ranging from the determination
of medical necessity for services covered to the proper use of billing
codes. Providers have also expressed concern that because Medicare
policies and procedures change frequently, program guidance on which
they rely may be obsolete. Consequently, they worry that they may make
billing errors that could trigger a range of possible adverse
consequences.[Footnote 2]
Like other federal agencies, HHS currently issues advisory opinions as
part of its guidance framework. HHS has two separate advisory opinion
processes for specific provisions of Medicare law, but neither process
covers the wide range of regulations that govern the Medicare program.
Advisory opinions are typically written responses to specific questions
that address whether a requester's action or proposed action is in
compliance with applicable laws and regulations. The purpose of
advisory opinions is generally to permit people engaging in complex or
unprecedented transactions to act with some confidence that their
actions will not later be found to have been illegal. In general,
advisory opinions (1) are issued to a requesting party, (2) interpret
or apply law and regulation to a specific set of facts, such as an
ongoing or proposed business arrangement, and (3) are legally binding,
if at all, only with respect to the requesting party, the specific set
of facts described, and the extent set out in the advisory opinion.
[Footnote 3] An advisory opinion provides the party who requested it
with assurance that, should the party proceed consistent with the
opinion, the agency will not take adverse action against that party to
the extent set out in the advisory opinion. Because advisory opinions
may be published, other interested parties may readily look to them as
guidance.
The Medicare Prescription Drug, Improvement, and Modernization Act of
2003 directed us to determine the appropriateness and feasibility of
establishing in HHS the authority to provide legally binding
advisory opinions on the appropriate interpretation and application of
regulations to carry out the Medicare program.[Footnote 4] As we
discussed with the committees of jurisdiction, we (1) identified
factors relevant to the establishment of such an advisory opinion
process and (2) assessed the role such a process could play in
clarifying Medicare regulations.
To identify factors relevant to the establishment of an advisory
opinion process, we selected four federal agencies that have such
processes in place and reviewed the policies and procedures each has
instituted to manage the processes. We obtained information on the
workload and staffing levels related to the advisory opinion process at
each agency. In addition, we obtained information on the user fees
charged by these agencies to those requesting advisory opinions. The
information we obtained was the most current available at the time we
performed our work. We also interviewed officials involved with issuing
advisory opinions at all four agencies. In selecting agencies, we chose
the two agencies within HHS--CMS and HHS's Office of Inspector General
(HHS-OIG)--that issue opinions on provisions of Medicare law, and two
other federal agencies--the Internal Revenue Service (IRS) and the
Employee Benefits Security Administration (EBSA) of the Department of
Labor--that administer complex programs governed by numerous laws and
regulations affecting large constituencies. In addition, we met with
two experts on administrative law and two private sector attorneys to
discuss advisory opinion processes and factors relevant to the
establishment of a new process at HHS to interpret Medicare
regulations.
To assess the role an advisory opinion process might play in clarifying
Medicare regulations, we interviewed officials from 15 organizations
representing various Medicare stakeholders, with an emphasis on
organizations representing providers, including one hospital that we
visited. (See app. I.) We conducted our work from May 2004 through
November 2004 in accordance with generally accepted government auditing
standards.
Results in Brief:
We identified five factors that are critical to the establishment and
management of an advisory opinion process. Officials at each of the
four agencies whose processes we examined consistently cited these
factors as critical to their processes. First, all four agencies have
defined the scope of the advisory opinion process by establishing
criteria for submitting advisory opinion requests. For example, none of
the four agencies will provide advisory opinions for requests that are
based on hypothetical situations. In addition, two of these agencies--
IRS and EBSA--have further restricted the scope of their processes by
identifying topics on which they will not provide opinions. Second, all
four agencies use alternative ways of responding to advisory opinion
requests. For example, these agencies may decide that a request
concerning a straightforward question that is already clearly addressed
in other published guidance does not necessitate an advisory opinion.
In such cases, the agencies may opt instead to respond through a letter
or by telephone. Third, addressing the issue of a time frame for
responding to requests was viewed as essential. Statutory requirements
drive such time frames at CMS and HHS-OIG. However, IRS and EBSA have
devised their own approaches. IRS has set its own deadline of
responding to requests within 4 to 6 months. Conversely, EBSA has not
established a deadline. Instead, in determining when to respond to a
requester, it considers the significance of the issue addressed by the
request and also takes into account whether the request involves a
time-critical matter. Fourth, the four agencies had to consider their
anticipated workload, staffing requirements, and appropriate user fees.
An advisory opinion process was viewed as needing an adequate number of
staff with appropriate backgrounds, such as attorneys and individuals
with program expertise. Fifth, the agencies stressed that creating
internal review and external coordination procedures with other federal
agencies that may have a stake in the outcome of any given opinion was
important to their programs.
Overall, most of the representatives of provider organizations we spoke
with agreed that a process for providing legally binding
advisory opinions would partially address their concerns about the
guidance that they currently receive from CMS and its contractors. They
told us that providers often find it difficult to obtain timely and
reliable answers to their questions regarding Medicare from CMS and its
claims administration contractors. Most favored the establishment of an
advisory opinion process to interpret Medicare regulations, in part
because such a process would provide them with accurate, written
responses that could offer providers protection from possible adverse
actions. At the same time, these groups also generally recognized that
a legally binding opinion may not provide an immediate answer. By their
nature, advisory opinion processes are not designed to provide
requesters with answers within a day or a few weeks. As a result, these
groups concurred that, while beneficial, advisory opinions may not
address their need to obtain timely responses to their questions. In
addition, they noted that improving the clarity and accessibility of
other forms of Medicare guidance would remain important to them,
regardless of the availability of legally binding advisory opinions.
In commenting on a draft of this report, HHS stated that an enhanced
and more formal advisory opinion process for Medicare would not be a
successful pursuit at this time. HHS said it would be costly to
implement, 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.
Background:
The process of implementing programs established by federal law often
begins with the issuance of rules to guide those who are subject to the
law's requirements. The requirements for promulgating rules, set out in
the Administrative Procedure Act (APA), usually include the publication
of a proposed rule, an opportunity for public comment, and the
publication of a final rule after taking into consideration the
comments received.[Footnote 5] Final rules, also referred to as
regulations, have the force and effect of law. To explain and clarify
the statutory law and implementing regulations, the APA also permits
agencies to issue orders, which are the result of an adjudication that
resolves a dispute or controversy between the agency and one or more
parties. While orders are typically binding only on the parties
directly involved, agency officials and program participants often use
them for guidance. Because agencies rarely issue regulations or orders
that explain every element of the programs they administer, they also
produce a wide variety of written guidance, which may include
advisory opinions. Although the APA prescribes the process agencies
generally must follow to issue rules and orders, it does not prescribe
a process for producing advisory opinions. In light of this, agencies
generally have discretion in how they can structure their advisory
opinion processes, subject to constraints, if any, in other applicable
statutes.
HHS produces written guidance about Medicare in a variety of forms.
For example, it issues "rulings" that, according to the agency, provide
clarification and interpretation of complex or ambiguous provisions of
law or regulations and promote consistency in the interpretation of
policy and adjudication of disputes. Although rulings are not issued in
response to specific requests, they are binding on CMS and Medicare
contractors, among others. In addition, HHS's Medicare Appeals Council
(MAC) issues written decisions in disputes over Medicare eligibility
and specific Medicare claims.[Footnote 6] Although MAC is a component
of HHS, it functions independently and is not bound by guidance, such
as Medicare program instructions or memoranda, issued by CMS. MAC
decisions are binding precedent in subsequent disputes and serve as
another significant source of Medicare guidance. Furthermore, HHS
provides Medicare guidance through reimbursement manuals, program
transmittals, coverage determinations, program instructions, CMS
publications, program memorandums, fraud alerts, press releases, and
other publications.[Footnote 7] In addition, CMS and its claims
administration contractors respond to millions of written and oral
questions from providers and beneficiaries annually.
HHS does not issue advisory opinions on the Medicare program except
where expressly required by statute.[Footnote 8] CMS and HHS-OIG have
processes that generally focus on two provisions of Medicare law
concerning specific types of business arrangements.[Footnote 9]
Specifically, HHS-OIG provides advisory opinions in connection with the
federal health care antikickback statute,[Footnote 10] which imposes
criminal penalties for knowingly giving, offering, soliciting, or
receiving payment for patient referrals, among other things. CMS
provides advisory opinions related to the so-called Stark Law,[Footnote
11] which generally prohibits physicians from referring patients to
heath care facilities in which they have a financial interest. Both
statutory advisory opinion provisions state that these advisory
opinions shall be binding only on the agency and requesting party. The
agencies also advise that other parties are not bound by and cannot
legally rely on these advisory opinions.
IRS and EBSA differ from CMS and HHS-OIG in the scope, management, and
history of their advisory opinion processes. While both CMS and HHS-OIG
have developed their advisory opinion processes within the last decade,
IRS and EBSA have a long history of providing advisory opinions under
their authority to administer federal tax and employee benefits law,
respectively. 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. IRS established its advisory opinion process in 1953 to
answer requests regarding the tax effects of certain acts or
transactions.[Footnote 12] EBSA established its process in 1976 to
answer inquiries regarding the Employee Retirement Income Security Act
of 1974 (ERISA), which is a federal law governing employee benefit
plans.[Footnote 13] Despite these differences, IRS and EBSA also
characterize their advisory opinions as binding on the agency, subject
to the agencies' ability to modify or revoke the opinion, as
appropriate. The two agencies also advise that the opinions do not
apply to other parties and situations.
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. We identified five key
factors related to agency planning efforts and allocation of resources
that each of the four agencies addressed in establishing its 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. For example, none of
these agencies will provide advisory opinions for requests that are
based on hypothetical situations.[Footnote 14] IRS has identified
circumstances under which it will not issue an advisory opinion, such
as those concerning issues that it finds frivolous or those that it
expects will be resolved following the issuance of pending regulations
or anticipated guidance. IRS has also identified circumstances under
which it will not ordinarily respond to requests, such as those that
involve matters already under examination or audit by IRS, or those
that involve pending litigation. Generally, EBSA will not provide
advisory opinions for requests where all parties involved are
insufficiently identified and described, where material facts or
details of the transaction are omitted, or where the requester is
seeking an opinion on alternative courses of action. Further, EBSA
generally only provides advisory opinions for requests on future
actions, rather than actions or transactions that have already
occurred. HHS-OIG and CMS also have defined submission criteria for
their processes. Specifically, they will not provide advisory opinions
for requests dealing with general questions of interpretation, or
activities in which the requester is not and does not plan to be
involved. In addition, HHS-OIG does not issue opinions on matters where
the same, or substantially the same, subject matter is or has been the
subject of a government proceeding, or if an informed opinion cannot be
made, or could be made only after extensive investigation.[Footnote 15]
Two of the four agencies, IRS and EBSA, whose advisory opinion
processes otherwise involve broad areas of law, have identified
substantive issues on which they will not provide advisory opinions.
IRS has developed extensive "no-rule" lists of certain domestic and
international tax law matters on which the agency will not provide
advisory opinions, and EBSA has identified sections of ERISA about
which it will not ordinarily provide advisory opinions. By contrast,
while the statutory requirements for HHS to provide advisory opinions
focusing on specific Medicare provisions set out two substantive
restrictions,[Footnote 16] HHS-OIG and CMS have not identified other
substantive areas that would eliminate an advisory opinion request from
consideration, provided that the subject of the request falls within
the scope authorized by statute.
Developing alternative ways of responding to advisory opinion requests:
To have efficient advisory opinion processes, the agencies do not
automatically provide an advisory opinion for every request received,
and may respond through other means. For example, if an agency decides
that a request concerns matters that are not complex, it may find it
more appropriate to provide a response during a telephone conversation.
Although not legally binding, such a response may provide the requester
with a satisfactory and timely answer, prompting the withdrawal of the
request for an advisory opinion. The agencies told us that they respond
in this manner when requests involve relatively straightforward
questions that may have already been addressed through earlier
guidance. For example, an official at HHS-OIG told us that the agency
may respond orally to a hospital's question on whether a hospital that
restocks supplies for local ambulances violates the federal health care
antikickback statute by providing incentives to the ambulance companies
to direct patients to the hospital. In this case, the HHS-OIG official
said the agency could direct the requester to existing guidance on the
matter. However, should a requester want an advisory opinion after
receiving informal guidance, HHS-OIG will issue an opinion, as
required.
IRS and EBSA have also established forms of written correspondence in
addition to legally binding advisory opinions to respond to individual
requesters. Specifically, both agencies provide information letters,
which are written statements that call attention to a well-established
interpretation or principle of law without applying it to a specific
factual situation. The agencies provide such letters in response to
requests that they determine do not merit an advisory opinion and could
be addressed by supplying the requester with general information. For
example, IRS may decide that an advisory opinion request on a certain
income tax deduction is best answered through an information letter
describing the general requirements for claiming these deductions.
Neither agency publishes all of their information letters.
In addition, one agency responds to some requests for advisory opinions
by publishing guidance with broad applicability. IRS publishes general
guidance, which includes revenue rulings that inform the public about
IRS's position on a particular issue to ensure its uniform application
of guidance. For example, a revenue ruling might conclude that, given a
specific set of facts, taxpayers may be entitled to claim certain
income tax credits. IRS also publishes revenue procedures, which
consist of official statements of internal practices and procedures,
such as filing procedures, which affect the rights and duties of
taxpayers. For example, a revenue procedure might describe filing
procedures that taxpayers must follow to claim certain income tax
deductions and credits. IRS officials said that the agency places a
higher priority on issuing more broadly focused guidance, such as
revenue rulings, than on other, more narrowly focused forms of guidance
such as advisory opinions.
Determining the time frame for issuing advisory opinions: The four
agencies varied on how they addressed the issue of a time frame for
providing advisory opinions. HHS-OIG is required by law to issue
advisory opinions within 60 days.[Footnote 17] CMS's regulations
provide for it to issue opinions within 90 days or, for requests that
it determines involve complex legal issues or complicated fact
patterns, within a reasonable time.[Footnote 18] IRS does not have any
statutory time frame requirements and has its own deadlines. According
to IRS officials, the agency's goal is to complete more than half of
the requests received within 4 months, and about 90 percent of the
requests received within 6 months. EBSA officials estimate that they
typically provide advisory opinions within 7 to 9 months after
receiving requests. However, EBSA has not established any time frames.
The agency prioritizes its responses to requests after considering the
significance of the issue addressed by a request and whether it
involves a time-critical matter, such as a pending financial
transaction.
Agencies have identified concerns associated with establishing time
frames for issuing advisory opinions. EBSA officials told us that their
agency has not developed time frames for issuing advisory opinions
because imposing a deadline creates an artificial requirement that
bears no relationship to the nature of the request. EBSA prefers to
have flexibility because of the uncertainty of the types and number of
requests the agency will receive. Although HHS-OIG is required to
respond to requesters within 60 days, an agency official told us that
it is sometimes difficult to complete all of the research and other
necessary steps within the required time frame because of both the
complexity of the issues and the other responsibilities held by lawyers
issuing the opinions. However, regulations provide for the suspension
of time limits in order to compensate for delays that are not within
HHS-OIG's control, such as those associated with obtaining additional
information from requesters or expert opinions from external third
parties.[Footnote 19]
Considering anticipated workloads, staffing requirements and user fees:
All four agencies addressed staffing issues to make their advisory
opinion processes effective. For example, EBSA officials told us that
EBSA's process needs to be supported by an adequate number of staff
with appropriate backgrounds, such as attorneys and individuals with
program expertise. As shown in table 1, agencies vary in the size of
their workloads and the number of staff they assign to their advisory
opinion processes. In fiscal year 2003, EBSA and HHS-OIG provided 17
and 18 opinions, respectively. In contrast, IRS provided about 3,000
advisory opinions and used about 69 full-time equivalent (FTE) staff to
respond to requests. Agencies also differed in the number of opinions
issued per FTE. At EBSA and HHS-OIG, 1 FTE staff member was required
for every 8 to 9 opinions provided, while IRS needed 1 FTE staff member
to process 42 opinions on average. Agency variation in the number of
advisory opinions generated by an FTE may reflect differences in case
complexity as well as in the proportion of requests that are withdrawn
prior to issuance of an opinion. For example, an HHS-OIG official
estimated that two-thirds of requests submitted to the agency are
withdrawn before an opinion is issued. In some instances, the
requesters terminated the process after HHS-OIG staff had performed all
of the legal research and analysis necessary to issue the opinions.
Table 1: Advisory Opinion Workload and Staffing Levels at EBSA, HHS-
OIG, and IRS in Fiscal Year 2003:
Agency: EBSA;
Number of opinions provided: 17;
Number of FTE staff: 2;
Average number of opinions per FTE: 8.5.
Agency: HHS-OIG;
Number of opinions provided: 18;
Number of FTE staff: 2;
Average number of opinions per FTE: 9.
Agency: IRS;
Number of opinions provided: 2,919;
Number of FTE staff: 69;
Average number of opinions per FTE: 42.
Sources: EBSA, HHS-OIG, and IRS.
Note: We excluded CMS from this analysis because it did not issue any
advisory opinions during fiscal year 2003.
[End of table]
Despite differences in workload and productivity, all three agencies
employ flexible staffing arrangements to process advisory opinions. For
instance, IRS selects staff from a pool of approximately 500 to 600
attorneys who, in addition to processing advisory opinions, also
provide other guidance to individual taxpayers. Similarly, HHS-OIG
draws from a group of staff who are assigned to respond to requests for
advisory opinions in addition to other responsibilities. EBSA staffs
its advisory opinion processes by assigning personnel to work on
opinions on an as needed basis.[Footnote 20]
Three of the four agencies we contacted charge a fee to process their
advisory opinions. These user fees enable the government to recoup some
of its costs. CMS and HHS-OIG charge an initial nonrefundable fee to
accept a request for an advisory opinion and impose hourly fees for the
time staff spend responding to a request for an opinion. IRS has
implemented a fee schedule and charges fees that vary depending on the
type of requester. The fee is $6,000 with a reduced fee for qualifying
requesters.[Footnote 21] Table 2 summarizes the user fees charged by
the four agencies in fiscal year 2004.
Table 2: Advisory Opinion User Fees at Four Agencies in Fiscal Year
2004:
Agency: CMS;
User fee: $75 per hour for staff costs, with a $250 nonrefundable
deposit required when the request is made;
Charges per opinion: $250[A].
Agency: EBSA;
User fee: Not applicable;
Charges per opinion: No charge.
Agency: HHS-OIG;
User fee: $86 per hour for staff costs, with a $250 nonrefundable
deposit required when the request is made;
Charges per opinion: Ranged from $301 to $3,784.
Agency: IRS;
User fee: $6,000, based on average cost to agency, with special rate
for qualifying requesters;
Charges per opinion: $6,000[B].
Sources: Interviews with CMS, EBSA, HHS-OIG, and IRS officials.
[A] In fiscal year 2004, CMS issued four advisory opinions for which it
charged $250 for each opinion. CMS anticipates that charges for future
advisory opinions could be higher.
[B] Some taxpayers may be eligible for reduced user fees, depending on
the issues involved and the taxpayers' specific circumstances.
[End of table]
Although three of the four agencies charge user fees, only IRS has
authority to apply those fees to fund its advisory opinion
process.[Footnote 22] However, although CMS and HHS-OIG do not retain
the user fees charged, they may have been able to absorb the costs of
issuing opinions because they receive relatively few requests per year.
According to legal experts we interviewed, the amount of user fees
charged, and an agency's ability to use them to offset costs, could be
critical to the success of a large advisory opinion process.
Creating internal review and external coordination procedures: In
addition to reviewing its response to an advisory opinion request
internally, an agency issuing an advisory opinion may also need to
coordinate its response with other federal agencies. The agencies said
that this is particularly important if those entities have a stake in
the outcome--for example, if the advisory opinion involves laws
affecting another agency. Internal review and external coordination
permit other entities to bring their perspectives to the issue and to
raise matters that may not have been previously considered.
All four agencies have developed internal review and external
coordination procedures for their advisory opinion processes. Both
CMS's and HHS-OIG's internal reviews consist of obtaining comments from
one another as well as from the HHS Office of the Secretary and the HHS
Office of the General Counsel. In addition, their external coordination
includes consultation with the Department of Justice.[Footnote 23] CMS
officials said that, in certain cases, there may need to be additional
coordination because it has overlapping jurisdictions with other
agencies such as HHS's Public Health Service and Indian Health Service,
as well as the Department of Veterans Affairs. EBSA's internal review
consists of coordination between the office drafting the
advisory opinions and the agency's legal counsel. Depending on the
issue and whether it may have relevance to other laws, EBSA may also
coordinate with IRS, the Pension Benefit Guaranty Corporation, and the
Securities and Exchange Commission. In contrast, IRS has a limited
internal review process that usually involves the attorney writing the
opinion, a reviewing attorney, and the branch chief of the office
issuing the opinion. IRS also rarely coordinates with external entities
due to significant limitations in IRS's ability to share taxpayer data.
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. As a result, most of these organizations viewed the
establishment of an advisory opinion process to interpret Medicare
regulations positively, particularly if the opinions were legally
binding. However, representatives for some organizations told us that
an advisory opinion process is only one way to address their concerns;
improving existing CMS and contractors' guidance was also viewed as
important. In addition, some recognized that advisory opinions may not
always be appropriate, given that questions related to Medicare
regulations may sometimes require a quick response--something that an
advisory opinion process may be unable to provide.
Medicare Providers Are Concerned about Unreliable and Untimely Answers
to Their Questions from CMS and its Contractors:
Officials from most provider organizations we contacted[Footnote 24]
told us that providers are concerned that they often do not receive
reliable or timely responses to their questions. They said that
Medicare providers frequently have questions about a variety of issues
related to Medicare regulations, including matters relating to billing,
coverage of services, medical necessity, and beneficiary eligibility,
particularly if a beneficiary is eligible for both Medicare and
Medicaid.[Footnote 25] However, half said that they have difficulty
obtaining the necessary clarification. For example, some told us that
the claims administration contractors--who are generally the first
point of contact for providers with questions--often respond to
identical questions from providers with substantially different
answers. In addition, about half of the provider organizations we
contacted said that providers cannot rely on CMS to respond to their
questions in a timely manner, particularly in writing. For example,
representatives of one provider organization told us that they have
been trying for about a year to obtain guidance from CMS concerning
whether physicians in a state that has reduced its Medicaid benefits
can bill beneficiaries who are eligible for both Medicare and Medicaid,
to compensate for this reduction, without violating federal law.
Similarly, officials at the hospital we visited told us that it took
CMS about 6 months to reply to the hospital's inquiry about the
findings of a recently completed audit by the hospital's claims
administration contractor. The audit determined that procedures that
the hospital had followed for 12 years--at the instruction of its
contractor--were now considered by the contractor to be in violation of
Medicare regulations. The hospital requested CMS to clarify whether it
would be held liable for its past practices and how it should respond
to the contractor's audit findings. We have also recently reported on
shortcomings in the way CMS and its contractors communicate with
providers. Specifically, we identified problems in both the accuracy
and timeliness of CMS's written guidance and in its oral responses to
providers who contact call centers operated by contractors with
billing-related and other types of policy-oriented questions.[Footnote
26]
CMS officials acknowledged that because the agency receives thousands
of inquiries every year, it is sometimes difficult to respond to all of
them in a timely manner. The time it takes the agency to answer can
vary based on the nature of the inquiry and the type of reply that is
necessary. While basic or routine questions may receive a relatively
quick response, more involved and complex questions, such as the one
presented by the hospital, require extensive research and internal
review, which could delay the agency's response. CMS has taken steps in
recent years to improve communications with providers. For example, it
has held town hall meetings on new initiatives and developed provider-
specific Web pages and listservs. In response to our recommendations to
improve the accuracy of information given to providers from call
centers operated by contractors, CMS has agreed to create a process to
routinely screen, triage, and route provider calls to specialty staff
by fiscal year 2005.
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. Their reasons included
that such a process would establish a central place to submit questions
and that they would feel more confident about the accuracy of responses
received because an advisory opinion process would, presumably, involve
extensive legal research. In addition, written documentation that such
a process would provide could later help to protect them from adverse
actions if it is subsequently determined that they billed incorrectly
or are otherwise found to be noncompliant with program rules. However,
representatives recognized that while an advisory opinion process
guarantees a response to an inquiry, it may not address providers' need
for quick answers. Some said that providers generally seek relatively
rapid responses to their questions on Medicare regulations--for
example, they told us that for billing questions, providers often need
responses within 24 hours. However, CMS officials said that short time
frames may be unrealistic because of the extensive research necessary
to prepare an advisory opinion.
Providers' representatives also noted additional benefits that can be
associated with the advisory opinion process. For example, even though
these opinions may only be binding to the requesters, if published,
they could also provide instructive guidance to the provider community
at large. However, 8 of the 12 provider organizations we contacted
suggested that, to maximize the usefulness of an advisory opinion
process, the process should be structured to also permit an advisory
opinion to be applied to similarly situated parties with similar
questions, instead of just a single requester. One added that, unlike
HHS-OIG's process, which often requires requesters to provide
proprietary information that could alert their competitors to their
business plans, advisory opinion requests on Medicare regulations are
more likely to involve day-to-day activities that are common to many
providers. Along the same lines, three organizations suggested that an
advisory opinion process also be open to entities representing
providers, so that they could submit questions on behalf of larger
constituencies. Even though it might not be possible for more broadly
applicable advisory opinions to be legally binding, representatives of
some provider organizations indicated that such an approach would make
the process more efficient and responsive to those participating in
Medicare.
Representatives of provider organizations told us that an advisory
opinion process should not be used in place of, or precede other
efforts, to improve the communication of guidance. They stressed that
clarifying existing guidance to address common provider questions is
important. They also told us that receipt of reliable and timely
written responses to their questions would go far to reduce their
interest in an advisory opinion process. While such responses may not
carry as much weight as advisory opinions, these representatives said
that they would help providers better understand regulations.
Representatives from one provider organization we contacted were
opposed to instituting an advisory opinion process because they said
such a process might disrupt the effective dialogue that the
organization has established with CMS in recent years. Specifically,
they were concerned that an advisory opinion process may prevent them
from obtaining more informal and timely guidance from the agency on an
as needed basis. In addition, officials from a beneficiary advocacy
organization expressed concern that an advisory opinion process could
negatively affect beneficiaries. Anticipating that providers would be
the primary users of an advisory opinion process, this organization was
concerned that beneficiaries' interests would not be fully represented.
Concluding Observations:
The Medicare program and its implementing regulations are inherently
complex. It is critical that Medicare providers receive correct and
complete answers to their questions about program rules. An advisory
opinion process to interpret Medicare regulations could provide an
avenue for providers to receive this information in the form of legally
binding answers to complicated questions about their unique
circumstances. Although providers have expressed concern about the lack
of timeliness of CMS's responses to their questions, it would be
unreasonable to expect that advisory opinions could be issued in a
matter of a few days or even a few weeks, given the complexity of the
questions and the significance of obtaining legally binding responses.
However, it is important that the establishment of such a process not
preclude CMS or its contractors from responding promptly to providers
with relatively straightforward questions that do not necessitate an
advisory opinion. If established, an advisory opinion process to
interpret Medicare regulations should not serve as a substitute for
enhancing existing forms of CMS guidance. 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. Specifically,
HHS said such an effort would be costly to implement and noted that
fees collected for its advisory opinions are not paid to or retained by
HHS, and thus do not offset the costs of the staff time allocated to
this work. 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. HHS also provided us with technical comments, which we
incorporated as appropriate. We have reprinted HHS's letter in
appendix II.
We also provided excerpts of the draft to EBSA and IRS. The excerpt
that each agency received consisted only of statements pertaining to
its respective advisory opinion processes. We received technical
comments from both agencies, which we incorporated as appropriate.
We are sending copies of this report to the Secretary of Health and
Human Services, the Administrator of CMS, and other interested parties.
We will also make copies available to others upon request. In addition,
this report will be available at no charge on GAO's Web site at
[Hyperlink, http://www.gao.gov].
If you or your staffs have any questions about this report, please call
me at (312) 220-7600. An additional GAO contact and other staff members
who made major contributions to this report are listed in appendix III.
Signed by:
Leslie G. Aronovitz:
Director, Health Care--Program Administration and Integrity Issues:
[End of section]
Appendixes:
Appendix I: Medicare Stakeholders Contacted:
American Ambulance Association:
American Association of Family Physicians:
American Association of Home Care:
American College of Physicians--American Society of Internal Medicine:
American Health Information Management Association:
American Hospital Association:
American Medical Association:
Center for Medicare Advocacy:
HCPro:
Health Care Billing Managers Association:
Medical Group Management Association:
Medicare Rights Center:
National Association of Home Care:
National Association of State Medicaid Directors:
Northwestern Memorial Hospital:
[End of section]
Appendix II: Comments from the Department of Health and Human Services:
Department of Health & Human Services:
Office of Inspector General:
NOV 22 2004:
Ms. Leslie G. Aronovitz:
Director, Health Care-Program Administration and Integrity Issues:
United States Government Accountability Office:
Washington, D.C. 20548:
Dear Ms. Aronovitz:
Enclosed are the Department's comments on your draft report entitled,
"Medicare-Advisory Opinions As A Means of Clarifying Program
Requirements" (GAO-05-129). The comments represent the tentative
position of the Department and are subject to reevaluation when the
final version of this report is received.
The Department provided several technical comments directly to your
staff.
The Department appreciates the opportunity to comment on this draft
report before its publication.
Sincerely,
Signed by:
Daniel R. Levinson:
Acting Inspector General:
Enclosure:
The Office of Inspector General (OIG) is transmitting the Department's
response to this draft report in our capacity as the Department's
designated focal point and coordinator for Government Accountability
Office reports. OIG has not conducted an independent assessment of
these comments and therefore expresses no opinion on them.
COMMENTS BY THE DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) ON THE
U.S. GOVERNMENT ACCOUNTABILITY OFFICE'S (GAO) DRAFT REPORT ENTITLED
"MEDICARE: ADVISORY OPINIONS AS A MEANS OF CLARIFYING PROGRAM
REQUIREMENTS (GAO-05-129):
The HHS appreciates the opportunity to review and comment on GAO's
draft report. We appreciate GAO's efforts to assess the role that a
broader advisory opinion process might play in clarifying Medicare
regulations.
In its concluding observations on page 21, the draft observes that the
Medicare program and its implementing regulations are "inherently
complex," and we agree. We do currently engage in numerous efforts to
assist stakeholders' understanding of the program's complexities, the
most important of which are described below. Included among these
efforts are targeted advisory opinion processes conducted by our Office
of Inspector General (OIG) and also within our Office of General
Counsel. As the draft also acknowledges, however, advisory opinion
processes are limited in their ability to provide quick answers to
pressing problems. We agree.
We believe that an enhanced and more formal process of developing
advisory opinions would not be a successful pursuit at this time. We
believe such a process would be costly and just as slow as the current
processes, which have been streamlined to the extent possible, given
the large volume of pertinent guidance, which is constantly (and
necessarily) in flux. Given the complexity and broad scope of the
Medicare program, an enhanced effort to provide advisory opinions would
require a far larger professional staff than is available under current
resource constraints. It is also important to note that current HHS
opinions specifically state that they are limited in scope to the
specific arrangement described in the request and have "no
applicability to other arrangements, even those which appear similar in
nature or scope" and "may not be introduced into evidence in any matter
involving an entity or individual that is not a requestor of this
opinion." We believe that the usefulness of a broader set of opinions
would be similarly constrained.
Additionally, the GAO draft states that the presence of user fees is
among the critical factors in making currently operational advisory-
opinion processes effective. It is important to note that fees
collected for our advisory opinions are not paid to or retained by HHS,
and thus do not offset the costs of the staff time allocated to this
work.
We cite the following as important existing sources of the guidance
needed by Medicare stakeholders:
The Center for Medicare and Medicaid Services (CMS)'s customized
provider web pages allow physicians, hospitals, ambulances, and other
providers quick access to relevant Medicare information. These web
pages, found on www.cms.hhs.gov/providers, have associated Listservs
that ensure providers will get new information as it becomes available.
CMS has a Medicare Coverage Database on the CMS website,
www.cms.hhs.gov, that contains all I national and local coverage policy
and articles produced by contractors that provide additional coverage
guidance. CMS has also implemented a new web page, allowing for easier
provider and public access to recent Administrator decisions regarding
the Provider Reimbursement Review Board and issued by the Office of the
Attorney Advisor.
CMS publishes a Quarterly Provider Update on the first business day of
each quarter on the CMS web site to inform the public about regulations
and major policies currently under development during this quarter;
regulations and major policies completed or cancelled; and new/revised
manual instructions. This Update, makes it easier for providers,
suppliers, and the general public to be aware of impending program
changes.
In fiscal year 2004, CMS implemented an On-Line Manual System, located
at www.cms.hhs.gov/manuals, to consolidate and update its manuals,
policy and billing instructions, eliminate duplicate policy across
manuals, and establish a single source to obtain information on the
Medicare and Medicaid programs. Additionally, a related Monthly
Bulletin is communicated to Medicare Contractors via email and is
posted on the CMS On-Line Manual System.
In 2001, CMS began an initiative to improve provider communications
when the agency required contractors to institute toll-free phone
service to answer inquiries from providers who bill for services under
fee-for-service Medicare. CMS also now issues nationally consistent
provider education materials to accompany contractor instructions that
implement new or revised policy. "Medlearn Matters ... Information for
Medicare Providers" contains educational articles, written in
consultation with clinicians, billing experts, and other medical
professionals, and tailored in content and language to the specific
provider types who are affected by the program change. These articles
explain in plain English content of the program instructions, and, more
importantly, the specific impact that the change has on the affected
providers. The articles are housed in one central, easily accessible
location (www.cms.hhs.gov/medlearn/matters).
CMS has held fourteen individual Open Door Forums and town hall
meetings for physicians to discuss new initiatives. CMS has also
established a provider partnership network with provider associations
and organizations, whereby providers give input on products and CMS
information tools, and assist in the dissemination of CMS information.
[End of section]
Appendix III: GAO Contact and Staff Acknowledgments:
GAO Contact:
Geraldine Redican-Bigott (312) 220-7678:
Acknowledgments:
Pauline Seretakis, Richard Lipinski, Janet Rosenblad, and Craig Winslow
made key contributions to this report.
(290380):
FOOTNOTES
[1] Among other things, the claims administration contractors assist
CMS by processing and paying claims and by communicating billing
guidance to the provider community and Medicare beneficiaries.
[2] Adverse consequences may include having submitted claims denied or
subjected to additional scrutiny, which could delay payment. In
addition, providers are concerned that even when their billing errors
are inadvertent, they may be subjected to legal action under the False
Claims Act (31 U.S.C. §§ 3729-3733 (2000)), which imposes substantial
financial liability for "knowingly" submitting improper claims. The
statute defines "knowingly" to mean that a person has actual knowledge
of the false claim or acts in deliberate ignorance or reckless
disregard of its truth or falsity; the statute states that no proof of
specific intent to defraud is required.
[3] The extent to which an agency considers itself legally bound by an
advisory opinion it provides may be stated in the advisory opinion
itself. An advisory opinion provided under a statutory requirement for
an agency to provide binding advisory opinions is likely to be accorded
considerable weight by courts, at least with respect to the party who
requested it. Emphasizing facts similar to those at issue in the
advisory opinion, others may argue that the advisory opinion should
govern agency actions involving them as well.
[4] Pub. L. No. 108-173, § 904, 117 Stat. 2066, 2377.
[5] 5 U.S.C. § 553 (2000). This process is referred to as informal
rulemaking. Agencies are not required to use this process when
establishing interpretative rules, general statements of policy, or
rules of agency organization, procedure, or practice. In addition,
agencies may issue rules without notice and comment when they for good
cause find that the process is impracticable, unnecessary, or contrary
to the public interest. Also, statutes sometimes require rules to be
made "on the record" after the opportunity for an agency hearing. This
is referred to as formal rulemaking.
[6] 42 U.S.C. § 1395ff(d)(2) (2000).
[7] Proposed and final rules are published in the Federal Register and
final rules are incorporated into the Code of Federal Regulations.
Other forms of HHS written guidance are, for example, posted on the HHS
Web site, distributed through mailing lists, or provided only upon
request.
[8] Generally, HHS may prescribe statements of policy, interpretative
rules, or rules of agency organization, procedure, or practice
necessary for the Medicare program. 42 U.S.C. § 1395hh (2000). Experts
we consulted, as well as HHS officials, acknowledged that the agency
may issue advisory opinions. In 1998, we addressed the potential use of
advisory opinions in connection with the False Claims Act and a
Medicare rule concerning hospital inpatient costs. We concluded that
advisory opinions did not seem necessary or helpful with respect to the
False Claims Act generally or the particular rule. B-279893, July 22,
1998.
[9] In addition, HHS-OIG is required to provide advisory opinions on
whether an activity or proposed activity could otherwise trigger
certain administrative actions, including civil monetary penalties, as
well as criminal penalties. 42 U.S.C. § 1320A-7d(b)(2)(D) and (E)
(2000).
[10] 42 U.S.C. § 1320a-7d(b) (2000).
[11] 42 U.S.C. § 1395nn(g)(6) (2000).
[12] IRS uses the term letter rulings to describe its
advisory opinions.
[13] 29 U.S.C. §§ 1001 et seq. (2000).
[14] ERISA Procedure 76-1 states that EBSA generally does not issue
advisory opinions for hypothetical situations.
[15] 42 C.F.R. § 1008.15(c) (2003).
[16] The restrictions prohibit HHS from providing advisory opinions on
fair market value or an individual's status as an employee under
federal tax law. 42 U.S.C. §§ 1320a-7d(b)(3) and 1395nn(g)(6)(B)
(2000).
[17] 42 U.S.C. § 1320a-7d(b)(5)(B) (2000).
[18] 42 C.F.R. § 411.380(c)(1) (2003). HHS-OIG and CMS begin counting
these days only after requests have been "formally accepted." 42 C.F.R.
§§ 1008.41(e) and 411.379(b) (2003).
[19] 42 C.F.R. § 1008.43(c)(3) (2003).
[20] EBSA assigns staff with legal backgrounds and at least 3 years of
relevant experience to work on advisory opinions on a part-time basis.
[21] Some taxpayers may be eligible for reduced user fees, depending on
the issues involved and the taxpayers' specific circumstances.
[22] Treasury, Postal Service and General Government Appropriations
Act, 1995, Pub. L. No. 103-329, tit. I, § 3, 108 Stat. 2382, 2388.
Current law provides that no fee may be charged with respect to
requests after December 31, 2004. Act of Oct. 1, 2003, Pub. L. No. 108-
89, sec. 202(a), § 7528(c), 117 Stat. 1131, 1133. In general, agencies
may impose user fees to offset the government's cost of providing a
service. Without specific authorization, however, agencies may not
retain or use fees collected, but must deposit them into the
U.S. Treasury as required by section 3302 of Title 31 of the United
States Code.
[23] With respect to its advisory opinions, HHS-OIG is required to
consult with the Department of Justice. 42 U.S.C. § 1320a-
7d(b)(1) (2000).
[24] We spoke to representatives of organizations representing
providers, suppliers, and billing companies as well as officials from
one hospital. For convenience, we have used the term provider
organizations to refer to these entities collectively.
[25] Medicaid is a jointly funded federal and state program that
provides health care coverage for certain individuals and families who
meet eligibility criteria. 42 U.S.C. §§ 1396 et. seq. (2000). Medicaid
is the largest source of funding for medical and health-related
services for people with limited income.
[26] GAO, Medicare: Communications with Physicians Can Be Improved,
GAO-02-249 (Washington, D.C.: Feb. 27, 2002) and Medicare: Call Centers
Need to Improve Responses to Policy-Oriented Questions from Providers,
GAO-04-669 (Washington, D.C.: July 16, 2004).
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