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Federal Register / Vol. 67, No.

109 / Thursday, June 6, 2002 / Notices 39015

expenses other than local mileage for DEPARTMENT OF HEALTH AND Place: Crowne Plaza Hotel, 14th and K
local participants; (11) organization HUMAN SERVICES Streets, NW., Washington, DC 20005, (202)
dues; (12) honoraria or other payments 682–0111.
Health Resources and Services The meeting is open to the public.
for the purpose of conferring distinction Purpose: The Committee provides advice
or communicating respect, esteem, or Administration
and recommendations to the Secretary of
admiration; (13) patient care; (14) Availability of Funds; Correction Health and Human Services on the following:
alterations or renovations; and (15) Department programs which are directed at
indirect costs. AGENCY: Health Resources and Services reducing infant mortality and improving the
Administration, HHS. health status of pregnant women and infants;
Grant funds may not be used to factors affecting the continuum of care with
provide general support for ACTION: Correction and extension of
respect to maternal and child health care,
international scientific conferences held time for application deadline. including outcomes following childbirth;
outside the United States or Canada. SUMMARY: This notice corrects an factors determining the length of hospital
Grant funds may be awarded to a U.S. Internet address for accessing stay following childbirth; strategies to
component of an international coordinate the variety of Federal, State, and
application materials and extends the local and private programs and efforts that
organization to provide limited support time that applications will be accepted are designed to deal with the health and
for specified segments of an for fiscal year 2002 competitive social problems impacting on infant
international conference held outside Cooperative Agreements for Health mortality; and the implementation of the
the United States or Canada if the Workforce research that was published Healthy Start initiative and infant mortality
conference is compatible with FDA’s in the Federal Register on Thursday, objectives from Healthy People 2010.
mission. An example of such support May 23, 2002 (67 FR 36198) [FR Doc. Agenda: Topics that will be discussed
would be a selected symposium, panel, 02–12928]. That notice announced that include the following: Early Postpartum
applications must be received by mail or Discharge; Low-Birth Weight; Disparities in
or workshop within the conference, Infant Mortality; and the Healthy Start
including the cost of planning and the delivered to the HRSA Grants
Program.
cost of travel for U.S. participants for Application Center by no later than June Anyone requiring information regarding
the specified segment of the scientific 19, 2002. The deadline for applications the Committee should contact Peter C. van
conference. Any Public Health Service has been extended and applications Dyck, M.D., M.P.H., Executive Secretary,
(PHS) foreign travel restrictions that are must be received by mail or delivered to ACIM, Health Resources and Services
in effect at the time of the award must the HRSA Grants Application Center, Administration (HRSA), Room 18–05,
901 Russell Avenue, Suite 450, Parklawn Building, 5600 Fishers Lane,
be followed, including but not limited Rockville, MD 20857, telephone: (301) 443–
Gaithersburg Maryland, 20879, by no
to: 2170.
later than July 8, 2002. Additionally, the
1. Limitations or restrictions on Internet address given in the above Individuals who are interested in attending
countries to which travel will be referenced Federal Register notice for any portion of the meeting or who have
questions regarding the meeting should
supported; or accessing application materials was contact Ms. Kerry P. Nesseler, HRSA,
2. Budgetary or other limitations on incorrect. The correct Internet address Maternal and Child Health Bureau,
availability of funds for foreign travel. for accessing application materials is telephone: (301) 443–2170.
hrsagac@hrsa.gov. Agenda items are subject to change as
The collection of information priorities are further determined.
requested in PHS Form 398 and its FOR FURTHER INFORMATION CONTACT:
instructions have been submitted by Sarah Richards (phone 301–443–5452 or Dated: May 31, 2002.
PHS to the Office of Management and via e-mail at srichards@hrsa.gov) or Jane M. Harrison,
Louis Kuta (phone 301–443–6634 or via Director, Division of Policy Review and
Budget (OMB) and were approved and
e-mail at lkuta@hrsa.gov). Coordination.
assigned OMB control number 0925–
0001. Information collection Dated: May 31, 2002. [FR Doc. 02–14171 Filed 6–5–02; 8:45 am]
requirements requested on PHS Form Jane M. Harrison, BILLING CODE 4165–01–P

5161–1 were approved and issued under Director, Division of Policy Review and
OMB Circular A–102. Coordination.
[FR Doc. 02–14170 Filed 6–5–02; 8:45 am] DEPARTMENT OF HEALTH AND
C. Legend BILLING CODE 4165–15–P HUMAN SERVICES
Unless disclosure is required by the Office of Inspector General
Freedom of Information Act as amended DEPARTMENT OF HEALTH AND
(5 U.S.C. 552) as determined by the Draft OIG Compliance Program
HUMAN SERVICES
freedom of information officials of Guidance for Ambulance Suppliers
DHHS or by a court, data contained in Health Resources and Services AGENCY: Office of Inspector General
the portions of this application that Administration (OIG), HHS.
have been specifically identified by
Advisory Committee; Notice of Meeting ACTION: Notice and comment period.
page number, paragraph, etc., by the
applicant as containing restricted In accordance with section 10(a)(2) of SUMMARY: This Federal Register notice
information shall not be used or the Federal Advisory Committee Act seeks the comments of interested parties
disclosed except for evaluation (Public Law 92–463), announcement is on draft compliance program guidance
purposes. made of the following National (CPG) developed by the Office of
Dated: May 31, 2002. Advisory body scheduled to meet Inspector General (OIG) for the
during the month of July 2002. ambulance industry. Through this
Margaret M. Dotzel,
Name: Advisory Committee on Infant notice, the OIG is setting forth its
Associate Commissioner for Policy.
general views on the value and
Mortality (ACIM).
[FR Doc. 02–14101 Filed 6–4–02; 8:45 am]
Date and Time: July 10, 2002; 9 a.m.–5 fundamental principles of ambulance
BILLING CODE 4160–01–S p.m., July 11, 2002; 8:30 a.m.–3 p.m. industry CPG, and the specific elements
39016 Federal Register / Vol. 67, No. 109 / Thursday, June 6, 2002 / Notices

that ambulance providers/suppliers abuse; and (3) develop corrective • Section III of this document
should consider when developing a CPG actions when those risks or instances of discusses various fraud and abuse and
initiative. fraud and abuse are identified. compliance risks associated with
DATES: To ensure consideration, ambulance services covered under the
Public Input and Comment in
comments must be delivered to the Medicare program;
Developing Final CPG • Section IV briefly summarizes
address provided below by no later than
5 p.m. on July 22, 2002. In response to our earlier solicitation compliance risks related to Medicaid
notice, the OIG received 37 comments coverage for transportation services; and
ADDRESSES: Please mail or deliver
from various organizations and • Section V discusses various risks
written comments to the following the ambulance industry faces under the
address: Office of Inspector General, associations. In developing this notice
for formal public comment, we have anti-kickback statute. The Appendix
Department of Health and Human provides relevant statutory and
Services, Attention: OIG–415–CPG, considered those specific comments as
well as previous OIG issuances, such as regulatory citations as well as brief
Room 5246, Cohen Building, 330 discussions of additional potential risk
Independence Avenue, SW., OIG-issued Advisory Opinions, and
have consulted with the Centers for areas to consider when developing a
Washington, DC 20201. compliance program.
We do not accept comments by Medicare and Medicaid Services and
the Department of Justice. The OIG is especially interested in the
facsimile (FAX) transmission. In comments and suggestions the
commenting, please refer to file code To ensure that all parties have an
opportunity to provide input, we are ambulance industry and affiliated
OIG–415–CPG. Comments received providers may have regarding this draft
timely will be available for public publishing this CPG in draft form, and
welcome specific comments from all CPG. The OIG recognizes that the
inspection as they are received, ambulance industry is made up of
generally beginning approximately 2 interested parties. The OIG will
consider all comments that are received entities of enormous variation: Some
weeks after publication of a document, ambulance companies are large, many
in Room 5541 of the Office of Inspector within the above-cited time frame,
incorporate any specific are small; some are for-profit, many are
General at 330 Independence Avenue, not-for-profit; some are affiliated with
SW., Washington, DC 20201 on Monday recommendations, as appropriate, and
prepare a final version of the CPG hospitals, many are independent; and
through Friday of each week from 8 a.m. some are operated by municipalities or
to 4:30 p.m. thereafter for publication in the Federal
Register. counties, while others are commercially
FOR FURTHER INFORMATION CONTACT: owned. Consequently, this guidance is
Sonya Castro (202) 619–2078 or Joel Draft Compliance Program Guidance not intended to be a one-size-fits-all
Schaer (202) 619–1306, Office of for Ambulance Suppliers (May 2002) guide on ambulance supplier
Counsel to the Inspector General. compliance programs. Rather, like the
I. Introduction
SUPPLEMENTARY INFORMATION: previous OIG CPGs, this guidance is
In keeping with the previous efforts of intended as a helpful tool for those
Background the Office of Inspector General (OIG) to entities that are considering establishing
The ambulance industry has provide guidance to various health care a voluntary compliance program, or for
experienced a number of instances of industry sectors on sound compliance those that have already done so and are
ambulance provider and supplier fraud program measures, the OIG is seeking to analyze, improve or expand
and abuse and has expressed interest in publishing this draft compliance existing programs.3 As with the OIG’s
increasing the awareness of the industry program guidance (CPG) 1 for the previous guidance, the guidelines
to assist in protecting against such ambulance industry and other parties discussed in this CPG are not
conduct. In response to the industry’s that are affected by the services mandatory. Nor do they represent an all-
concerns, the OIG has, to date, written provided by ambulance suppliers.2 This inclusive document containing all the
several Advisory Opinions on a variety CPG is divided into five separate components of a compliance program.
of ambulance-related issues 1 and has sections with an appendix: Other OIG outreach efforts, as well as
published final rulemaking concerning a • Section I is a brief introduction other Federal agency efforts to promote
safe harbor for ambulance restocking about this CPG; compliance, can also be used in
arrangements.2 • Section II provides information developing a compliance guidance.
In an effort to provide further about the basic elements of a
guidance, the OIG published a Federal A. Scope of the Compliance Program
compliance program for ambulance
Register notice on August 17, 2000 (65 Guidance
suppliers;
FR 50204) that solicited comments, This guidance focuses on compliance
recommendations and other suggestions 1 In its solicitation of information and measures related to services furnished
from concerned parties and recommendations for developing guidance for the primarily to the Medicare program, and
organizations on how best to develop ambulance industry (published in the Federal to a limited extent, other Federal health
Register on August 17, 2000 (65 FR 50204), the OIG
compliance guidance for ambulance indicated that it expected to refer to the ambulance
care programs. (See, e.g., section IV for
suppliers to reduce the potential for compliance guidance as a ‘‘compliance risk a brief discussion of Medicaid
fraud and abuse. The OIG expects that guidance.’’ After additional input and to remain
final guidance will outline the most consistent with the name and format of prior OIG 3 To date, the OIG has issued compliance program
compliance guidances, the OIG has decided to call guidance for the following nine industry sectors: (1)
common and prevalent fraud and abuse this document a compliance program guidance. Hospitals; (2) clinical laboratories; (3) home health
risk areas for the ambulance industry, 2 Ambulance providers are all Medicare- agencies; (4) durable medical equipment suppliers;
and provide direction on how to (1) participating institutional providers that submit (5) third-party medical billing companies; (6)
address various risk areas; (2) prevent claims for Medicare ambulance services (hospitals, hospices; (7) Medicare+Choice organizations
including critical access hospitals; skilled nursing offering coordinated care plans; (8) nursing
the occurrence of instances of fraud and facilities; and home health agencies). The term facilities; and (9) individual and small group
supplier means an entity that is other than a physician practices. The guidances listed here and
1 See footnote 23 in section V.F. of the draft
provider. For purposes of this document, we will referenced in this document are available on the
compliance program guidance. refer to both ambulance suppliers and providers as OIG website at www.oig.hhs.gov in the Fraud
2 See 66 FR 62979; December 4, 2001. ambulance suppliers. Prevention and Detection section.
Federal Register / Vol. 67, No. 109 / Thursday, June 6, 2002 / Notices 39017

ambulance coverage.) Issues related to 3. Education and Training Programs statutes, regulations, or other Federal
private payor claims and services Compliance programs must include as health care program requirements.4
covered by private payors may also be Developing and implementing a
a key element the regular training and
covered by an ambulance supplier compliance program may require
education of employees and other
compliance program if the supplier so significant resources and time. An
appropriate individuals. Training
desires. individual ambulance supplier is best
content should be tailored appropriately
situated to tailor compliance measures
B. Basic Elements of a Compliance and should be delivered in a way that
to its own organizational structure and
Program will maximize the chances that the
financial capabilities. In addition,
information will be understood by the compliance programs should be
While information and guidance target audience. This CPG discusses
furnished in this CPG may form the reviewed periodically to account for
training in more detail in section II.A.2. changes in the health care industry,
basic framework for developing a
compliance program, this guidance is 4. Internal Monitoring and Reviews Federal health care statutes and
not by itself a compliance program. The regulations, relevant payment policies
Ambulance suppliers should develop
basic components that have become and procedures, and identified risks.
and use appropriate monitoring Accordingly, the OIG has attempted to
accepted as the building blocks of an methods to detect and identify
effective compliance program are: (1) take into consideration the Centers for
problems, and to help reduce the future Medicare and Medicaid Services’ (CMS)
Developing compliance policies and likelihood of problems. Claims and
procedures; (2) designating a recent adoption of the fee schedule for
system reviews are a common internal payment of ambulance services. The
compliance officer or contact person(s); monitoring method and are discussed in
(3) conducting appropriate training and CMS’s ambulance fee schedule is the
greater detail in section II.A.3 of this product of a negotiated rulemaking
education; (4) conducting internal CPG.
monitoring and reviews; (5) responding process and will replace the current
appropriately to detected offenses and 5. Responding Appropriately to retrospective, reasonable cost
developing corrective actions; (6) Detected Misconduct reimbursement system for providers and
the reasonable charge system for
developing open lines of Ambulance suppliers should develop suppliers of ambulance services.5 As
communication; and (7) enforcing policies and procedures directed at appropriate, the OIG may update or
disciplinary standards through well- ensuring that the organization responds supplement this CPG to address new
publicized guidelines. The components appropriately to detected offenses, identified risk areas following the
of a compliance program are briefly including the initiation of appropriate implementation of the ambulance fee
discussed below with a more in-depth corrective action. An organization’s schedule.
discussion in section II of this CPG. response to detected misconduct will
vary based on the facts and II. Elements of a Compliance Program
1. Development of Compliance Policies
circumstances of the offense. However, for Ambulance Suppliers
and Procedures
the response should always be Like other sectors of the health care
The ambulance supplier should appropriate to resolve and correct the industry, most ambulance suppliers are
develop and distribute written situation in a timely manner. The honest suppliers trying to deliver
standards of conduct, as well as written organization’s compliance officer, and quality ambulance transportation
policies and procedures, which promote legal counsel in some circumstances, services. However, like other health care
the ambulance supplier’s commitment should be involved in situations when industry sectors, the ambulance
to compliance and address specific serious misconduct is identified. industry has seen its share of fraudulent
areas of potential fraud or abuse. These and abusive practices. The OIG has
written policies and procedures should 6. Developing Open Lines of
Communication reported and pursued a number of
be reviewed periodically (e.g., annually) different fraudulent practices in the
and revised as appropriate to ensure Ambulance suppliers should create ambulance transport field involving,
they are current and relevant. (See and maintain a process, such as a among others:
section II.A.1 of this CPG for a more in- hotline or other reporting system, to • Situations when individuals had
depth discussion of the development of receive and process complaints and to other acceptable means of
policies and procedures.) ensure effective lines of communication transportation;
between the compliance officer and all • Medically unnecessary trips;
2. Designation of a Compliance Officer
employees. Further, procedures should
The ambulance supplier should be adopted to protect the anonymity of 4 The term ‘‘Federal health care programs’’ is

designate a compliance officer and other complainants, where the complainant applied in this CPG as defined in 42 U.S.C. 1320a–
7b(f), which includes any plan or program that
appropriate bodies (e.g., a compliance desires to remain anonymous, and to provides health benefits, whether directly, through
committee) charged with the protect whistleblowers from retaliation. insurance, or otherwise, which is funded directly,
responsibility for operating and 7. Enforcing Disciplinary Standards
in whole or in part, by the United States
monitoring the organization’s Government (i.e., through programs such as
Through Well-Publicized Guidelines Medicare, Federal Employees’ Compensation Act,
compliance program. The compliance Black Lung, or the Longshore and Harbor Workers’
officer should be a high-level individual Ambulance suppliers should develop Compensation Act) and any State health plan (e.g.,
in the organization who reports directly policies and procedures to ensure that Medicaid, or a program receiving funds from block
to upper management, such as the chief there are appropriate disciplinary grants for social services or child health services).
mechanisms and standards that are Also, for purposes of this CPG, the term ‘‘Federal
executive officer or Board of Directors. health care program requirements’’ refers to
The OIG recognizes that an ambulance applied in an appropriate and consistent statutes, regulations, rules, requirements, directives,
supplier may tailor the job functions of manner. These policies and standards and instructions governing the Medicare and other
a compliance officer position by taking should address situations in which Federal health care programs.
5 The CMS’s final ambulance fee schedule was
into account the size and structure of employees or contractors violate,
published in the Federal Register on February 27,
the organization, existing reporting whether intentionally or negligently, 2002 (67 FR 9100) and went into effect on April 1,
lines, and other appropriate factors. internal compliance policies, applicable 2002.
39018 Federal Register / Vol. 67, No. 109 / Thursday, June 6, 2002 / Notices

• Submission of excessive claims; reimbursement policies, and payor regard to their particular job positions
• Trips were claimed but not expectations. and responsibilities, whether or not as
rendered; 1. Policies and Procedures part of a formal compliance plan. The
• Misrepresentation of the transport intensity and the nature of the specific
destination to make it appear as if the Because policies and procedures training will vary by employee type.
transport was covered; represent the written standard for daily Training employees on the job functions
• False documentation; operations, an ambulance supplier’s
of other people in the organization may
• Billing for each patient transported policies and procedures should describe
also be an effective training tool. Such
in a group as if he/she was transported the normal operations of an ambulance
supplier and the applicable rules and appropriate cross-training improves
separately; and employees’ overall awareness of
regulations. Further, written policies
• Upcoding from basic life support to compliance and job functions, thereby
and procedures should go through a
advanced life support services. increasing the likelihood that an
formal approval process within the
To help reduce the incidence and individual employee will recognize
organization and should be evaluated on
prevalence of fraudulent or abusive a routine basis, and updated as needed, non-compliance. Training should be
conduct, an ambulance supplier should to reflect current ambulance practices provided on a periodic basis to keep
consider the following guidance and (assuming these practices are employees current on ambulance
adapt the OIG’s suggestions to conform appropriate and comport with the supplier requirements, including, for
with any unique ambulance supplier relevant statutes, regulations, and example, the latest payor requirements.
elements. program requirements). In addition, Ambulance suppliers should conduct or
A. Evaluation and Risk Analysis ambulance suppliers should review make available training for employees at
policies and procedures to ensure that least yearly and more often as needed.
It is prudent for ambulance suppliers they are representative of actual
conducting a risk analysis to begin by Generally, employees who attend
practices. For example, an ambulance
performing an evaluation of internal supplier’s policy for reviewing interactive training better comprehend
operations as well as factors that affect ambulance call reports (ACR) should the material presented. Interactive
such operations (e.g., Federal health not state that it will review 100 percent training offers employees the chance to
care program requirements). In many of its ACRs, unless the ambulance ask questions and receive feedback.
cases, such evaluation will result either supplier is capable of performing and When possible, ambulance suppliers
in the creation and adoption of written enforcing such comprehensive reviews. should use ‘‘real’’ examples of
policies and procedures or the revision If certain policies and practices become compliance pitfalls provided by
thereof. The evaluation process may be genuinely impractical, we recommend personnel with ‘‘real life’’ experience,
simple and straightforward or it may be that such policies and procedures be such as emergency medical technicians
fairly complex and involved. For updated to reflect alternative, acceptable and paramedics.
example, an evaluation of whether an practices that conform to legal and
ambulance supplier’s existing written The OIG is cognizant that offering
regulatory requirements. interactive, live training often requires
policies and procedures accurately
reflect current Federal health care 2. Training and Education significant personnel and time
program requirements is Ensuring that a supplier’s employees commitments. As appropriate,
straightforward. However, an evaluation and agents receive adequate education ambulance suppliers may wish to
of whether an ambulance supplier’s and training is essential to minimizing consider seeking, developing, or using
actual practices conform to its policies risk. Employees should clearly other innovative training methods.
and procedures may be more complex understand what is expected of them, Computer or internet modules may be
and require several analytical and for what they will be held an effective means of training if
evaluations to determine whether accountable. Suppliers should also employees have access to such
system weaknesses are present. Even document and track the training they technology and if a system is developed
more complex is an evaluation of an provide to employees and pertinent to allow employees to ask questions.
ambulance supplier’s practices when personnel. The OIG cannot endorse any
there are no pre-existing written policies An ambulance supplier should commercial training product—it is up to
and procedures and the subsequent consider offering two types of each ambulance supplier to determine if
analysis of whether the particular compliance training: compliance the training methods and products are
supplier’s practices comply with program training and job-specific effective and appropriate.
applicable statutes, regulations, and training. If an ambulance supplier is
other program requirements. Whatever form of training ambulance
implementing a formal compliance
The evaluation process should furnish suppliers provide, the OIG also
program, employees should be trained
ambulance suppliers with a snapshot of recommends that employees complete a
on the elements of the program, the
their strengths and weaknesses and thus importance of the program to the post compliance training test or
assist providers in recognizing areas of organization, the purpose and goals of questionnaire to verify comprehension
potential risk. We suggest that the program, what the program means of the material presented. This will
ambulance suppliers evaluate a variety for each individual, and the key allow a supplier to assess the
of practices and factors, including their individuals responsible for ensuring effectiveness and quality of its training
policies and procedures, employee that the program is operating materials and techniques. Additionally,
training and education, employee successfully. Compliance program training materials should be updated as
knowledge and understanding, claims education should be available to all appropriate and presented in a manner
submission process, coding and billing, employees, even those whose job that is understandable by the average
accounts receivable management, functions are not directly related to trainee. Finally, the OIG suggests that
documentation practices, management billing or patient care. the employees’ attendance at, and
structure, employee turnover, Ambulance suppliers should also completion of, training be tracked and
contractual arrangements, changes in train employees on specific areas with appropriate documentation maintained.
Federal Register / Vol. 67, No. 109 / Thursday, June 6, 2002 / Notices 39019

3. Assessment of Claims Submission of inadequate documentation. Further Protocol.7 The Provider Self-Disclosure
Process evaluation may reveal that the Protocol was designed to allow
Ambulance suppliers should conduct documentation deficiencies involve a providers/suppliers to disclose
periodic claims reviews to verify that a limited number of individuals who voluntarily potential violations in their
claim ready for submission, or one that work on a specific shift. It is the dealings with the Federal health care
has been submitted and paid, contains ambulance supplier’s responsibility to programs.
the required, accurate, and truthful identify such weaknesses and to a. Pre-Billing Review of Claims
information required by the payor. An promptly correct them. In this example,
at a minimum, additional employee As a general matter, ambulance
ambulance claims review should focus, suppliers should review claims on a
at a minimum, on the documentation training would be required along with
pre-billing basis to identify errors before
present in the ACR, the medical the repayment of any identified
claims are submitted. If there is
necessity of the transport as determined overpayment. Such a detailed and
insufficient documentation to support
by payor requirements, the coding of the logical process of analysis will make
the claim, the claim should not be
claim, the co-payment collection claims reviews useful tools for submitted for payment until it is
process, and the subsequent payor identifying risks, correcting weaknesses, determined by a responsible person
reimbursement. The claims reviews and preventing future occurrences of within the organization that the
should be conducted by individuals errors. appropriate, adequate documentation
with experience in coding and billing Ambulance suppliers should also exists to support the claim. Pre-billing
and they should be familiar with the consider using a baseline audit to reviews also allow suppliers to review
different payors’ coverage and develop a benchmark from which to the medical necessity of their claims
reimbursement requirements for measure performance. This audit will before they are submitted for
ambulance services. The reviewers establish a consistent methodology for reimbursement. If, as a result of the pre-
should be independent and objective in selecting and examining records in billing claims review process, a pattern
their approach. Claims reviewers who future audits. It is helpful to chart and of claim submission or coding errors is
analyze claims that they themselves track the results of each of the audits to identified, the ambulance supplier
prepared or supervised often lack document progress. The results of each should develop a responsive action plan
sufficient independence to accurately (see section II.C), which would include
subsequent audit will indicate whether
evaluate the claims submissions process a plan to ensure that overpayments are
further actions are appropriate.
and the accuracy of individual claims. identified and repaid.
Comparing audit results from different
Additionally, the appearance of a lack of
audits will generally yield useful results b. Paid Claims
independence may also hinder the
only when the audits analyze the same In addition to a pre-billing review, a
effectiveness of a claims review.
Depending on the purpose and scope or similar information and when review of paid claims may be necessary
of a claims review, there are a variety of matching methodologies are used. For to determine error rates and quantify
ways to conduct the review. The claims example, results of audits of a supplier’s overpayments and/or underpayments.
review may focus on particular areas of compliance with the physician The post-payment review may help
interest (i.e., coding accuracy) or it may certification statement requirements for ambulance suppliers in identifying
include all aspects of the claims non-emergency transports and a billing or coding software system
submission and payment process. The supplier’s compliance with ambulance problems. Any overpayments identified
universe 6 from which the claims are and vehicle licensure cannot be readily from the review should be promptly
selected will comprise the area of focus compared. The trending information returned to the appropriate payor in
for the review. Once the universe of may need to be broken out and accordance with payor policies.
claims has been identified, an separately analyzed to track compliance.
c. Claims Denials
acceptable number of claims should be As part of its compliance efforts, an
randomly selected. Because the universe ambulance supplier should document Ambulance suppliers periodically
of claims will vary as will the variability (i) how often audits or reviews are should review their claims denials from
of items in the universe, the OIG cannot payors to determine if denial patterns
conducted and (ii) the information
specify a generally acceptable number of exist. If a pattern of claims denials is
reviewed for each audit. In addition, the
claims for purposes of a claims review. detected, the patterns should be
results of such reviews should be
However, the number of claims sampled evaluated to determine the cause and
compared to previous findings to
and reviewed should sufficiently ensure appropriate course of action. Employee
determine if a problem persists or if the education regarding proper
that the results are representative of the supplier’s corrective actions are
universe of claims from which the working. The ambulance supplier 7 The OIG encourages that providers/suppliers
sample was pulled. should not only use internal police themselves, correct underlying problems,
Ambulance suppliers should not only benchmarks, but should utilize external and work with the Government to resolve any
monitor identified errors, but also information, if available, to establish problematic practices. The OIG’s Provider Self-
evaluate the source or cause of the Disclosure Protocol, published in the Federal
benchmarks (e.g., data from other Register on October 30, 1998 (63 FR 58399), sets
errors. For example, an ambulance ambulance suppliers, associations, or forth the steps, including a detailed audit
supplier may identify through a review from carriers). Additionally, risk areas methodology, that may be undertaken if suppliers
a certain claims error rate. Upon further may be identified from the results of the wish to work openly and cooperatively with the
evaluation, the ambulance supplier may OIG. The Provider Self-Disclosure Protocol is open
audits. to all health care providers and other entities and
determine that the errors were a result is intended to facilitate the resolution of matters
If, as a result of the audit, a material that, in the provider’s reasonable assessment, may
6 The term ‘‘universe’’ is referred to in this CPG deficiency is identified that could be a potentially violate Federal criminal, civil, or
to mean the generally accepted definition used potential criminal, civil, or administrative laws. The Provider Self-Disclosure
when performing a statistical analysis. Specifically, administrative violation, the ambulance Protocol is not intended to resolve simple mistakes
the term ‘‘universe’’ means the total number of or overpayment problems. The OIG’s Self-
sampling units from which the sample was
supplier may disclose the matter to the Disclosure Protocol can be found on the OIG web
selected. OIG via the Provider Self-Disclosure site at www.oig.hhs.gov.
39020 Federal Register / Vol. 67, No. 109 / Thursday, June 6, 2002 / Notices

documentation, coding, or medical Conversely, if information is than an ambulance supplier would


necessity may be appropriate. If an automatically inserted onto a claim encounter based on its own internal
ambulance supplier believes its carrier submitted for reimbursement, and that findings and circumstances. Because
or payor is not adequately explaining information is false, the ambulance there are many different types of risk
the basis for its denials, the ambulance supplier’s claims will be false. If a areas, ambulance suppliers should
supplier should seek clarification in required field on a claim form is missing prioritize their identified risks to ensure
writing. information, the system should flag that the various areas are addressed
such a claim prior to its submission. appropriately.
4. System Reviews and Safeguards To stay abreast of risks affecting the
Periodic review and testing of a 5. Sanctioned Suppliers ambulance and other health care
supplier’s coding and billing systems Federal law prohibits Medicare industries, the OIG recommends that
are also essential to detect system payment for services furnished by an ambulance suppliers review OIG
weaknesses. One reliable systems excluded individual, such as an publications regarding ambulance
review method is to analyze in detail excluded ambulance crew-member. services, including OIG Advisory
the entire process by which a claim is Accordingly, with respect to its existing Opinions, OIG Fraud Alerts, Office of
generated, including how a transport is employees and contractors, ambulance Evaluations and Inspections (OEI)
documented and by whom, how that suppliers should periodically (at least reports, and Office of Audit Services
information is entered into the yearly) check the OIG’s and General (OAS) reports, all located on the OIG’s
supplier’s automated system (if any), Services Administration’s (GSA) web web site at www.oig.hhs.gov. A review
coding and medical necessity sites to ensure that they do not employ of industry specific trade publications
determination protocols, billing system or contract with individuals or entities will also help ambulance suppliers stay
processes and controls, including any that have been recently convicted of a current on the industry changes.
edits or data entry limitations, and criminal offense related to health care or Ambulance suppliers, like others in the
finally the claims generation, who are listed as debarred, excluded or health care industry, should devote the
submission, and subsequent payment otherwise ineligible for participation in necessary resources to ensure
tracking processes. A weakness or Federal health care programs. compliance with relevant requirements.
deficiency in any part of the supplier’s Additionally, ambulance suppliers Effective internal controls will help to
system can lead to improper claims, should query the OIG and GSA prevent or reduce instances of mistakes,
undetected overpayments, or failure to exclusion and debarments lists before errors, fraud and/or abuse.
detect system defects. they employ or contract with new
Each ambulance supplier should have C. Response to Identified Risks
employees and new contractors. The
computer or other system edits to OIG and GSA websites are listed at Following an ambulance supplier’s
ensure that minimum data requirements process of evaluation and identification
www.oig.hhs.gov and www.arnet.gov/
are met. For example, documentation of of its risks, a reasonable response
epls respectively, and contain specific
ambulance transports must now should be developed to address
instructions for searching the exclusion
indicate the point of pick-up of the appropriately identified risk areas.
and debarment databases.8
beneficiary. Under CMS’s new fee Determining how identified problems
B. Identification of Risks
schedule for ambulance services, each respond to corrective actions may
This ambulance CPG discusses many
transport claim that does not have an require continual oversight. However,
of the areas that the ambulance
originating zip code listed should be developing timely and appropriate
industry, the OIG, and CMS have
‘‘flagged’’ by the system. Other edits responsive actions demonstrates to an
identified as common risks for many
should be established to detect ambulance supplier’s employees and
improper claims, such as emergency ambulance suppliers. Apart from the
risks identified in this CPG, ambulance other interested parties (e.g., payors, the
codes used when the destination is OIG, etc.) its level of commitment to
something other than an emergency suppliers of all types (e.g., small, large,
rural, emergency, non-emergency) address problems and concerns.
room. A systems review is especially Ambulance suppliers should develop
important when documentation or should identify if they have any unique
protocols and reasonable timeframes for
billing requirements are modified or risks attendant to their business
responding to identified problems.
when an ambulance supplier changes its relationships or processes. An
Ambulance suppliers can identify in
billing software or claims vendors. As ambulance supplier may have certain
advance and through a written protocol
appropriate, ambulance suppliers unique characteristics that will affect its
how certain situations will be
should communicate with their carrier risk areas. For example, small, rural not-
addressed, including the internal
when they are implementing significant for-profit ambulance suppliers may
reporting obligations and involvement,
changes to their system to alert the identify risk areas different from those
if appropriate, of legal counsel. Such
carrier to any unexpected delays, or of a large, for-profit ambulance chain
response protocols should include a
increases or decreases in claims that competes with multiple other
monitoring process by which the issue
submissions. ambulance suppliers. This CPG may not
will be revisited on an as needed basis.
Ambulance suppliers have the identify or discuss all risks that an
responsibility of ensuring that their ambulance supplier may itself identify. III. Specific Fraud and Abuse Risks
electronic or computer billing systems Moreover, the CPG may ascribe more or Associated with Medicare Ambulance
are not automatically inserting less risk to a particular practice area Coverage and Reimbursement
information that is not supported by the Requirements
8 Ambulance suppliers should read the OIG’s
documentation of the medical or trip September 1999 Special Advisory Bulletin, entitled
Ambulance suppliers should, at a
sheets (e.g., whether physician signature ‘‘The Effect of Exclusion From Participation in the minimum, review and understand
was obtained). Billing systems targeting Federal Health Care Programs,’’ published in the applicable ambulance coverage
optimum efficiency may be set with Federal Register on October 7,1999 (64 FR 58851) requirements. Ambulance suppliers that
and is located at www.oig.hhs.gov/frdalrt, for more
defaults to indicate, for example, that a information regarding excluded individuals and
are not complying with applicable
physician’s signature was obtained entities and the effect of employing such requirements should take appropriate
following an emergency room transport. individuals or entities. prompt corrective action to follow the
Federal Register / Vol. 67, No. 109 / Thursday, June 6, 2002 / Notices 39021

standards set forth. The new Medicare ambulance cases involving upcoding care and liability reasons, ambulance
ambulance fee schedule covers seven from BLS to ALS related to both suppliers often transport patients who
levels of service including Basic Life emergency and non-emergency do not appear to meet Medicare’s non-
Support (BLS), Advanced Life Support, transports. In 1999, for example, an OIG emergency medical necessity
Level 1 (ALS1), Advanced Life Support, investigation determined that an requirements. If an ambulance supplier
Level 2 (ALS2), Specialty Care ambulance supplier was not only billing determines that a transport is not
Transport, Paramedic ALS Intercept, for ALS services when BLS services covered by Medicare, the ambulance
Fixed Wing Air Ambulance, and Rotary were provided, but the ambulance supplier should attempt to obtain a
Wing Air Ambulance.9 Generally, supplier did not employ an ALS signed Advanced Beneficiary Notice
Medicare Part B covers ambulance certified individual to perform the (ABN) from the Medicare beneficiary.
transports if applicable vehicle and staff necessary ALS services. This supplier As part of the ABN process, the
requirements, medical necessity paid civil penalties and signed a 5-year ambulance supplier should explain to
requirements, billing and reporting Corporate Integrity Agreement (CIA). the beneficiary that the service may not
requirements, and origin and be covered by Medicare, in which case
2. Non-Emergency Transports
destination requirements are met. the patient will be responsible for
Medicare Part B will not pay for There have also been a number of payment of the transport and other non-
ambulance services if Part A has paid Medicare fraud cases involving (i) non- covered services.
directly or indirectly for the same emergency transports to non-covered Under no circumstances should
services (e.g., a transport from a skilled destinations and (ii) transports that were ambulance suppliers intentionally
nursing facility to a hospital). not medically necessary. An OIG OEI mischaracterize the condition of the
report 11 issued in December 1998 found patient at the time of transport in an
A. Medical Necessity that a high number of non-emergency effort to claim inappropriately that the
There have been a number of transports for which Medicare claims transport was medically necessary
transportation fraud cases against the were submitted were medically under Medicare coverage requirements.
Medicare and Medicaid programs unnecessary as defined by Medicare’s In instances where it is not clear
involving medically unnecessary criteria.12 The report indicated, for whether the service will be covered by
transport. Consequently, medical example, that certain surveyed patients Medicare, the ambulance provider
necessity is a risk area that should be had been sitting unaided in a chair the should nonetheless appropriately
addressed in an ambulance supplier’s day of and the day after the ambulance document the condition of the patient
compliance program. Medicare Part B transport. Another patient was found and maintain records of the transport.
covers ambulance services only if the sitting in a wheelchair when the
beneficiary’s medical condition ambulance arrived and refused Scheduled and Unscheduled Transports
contraindicates another means of assistance to get back to bed. These Because of the potential for abuse in
transportation. The medical necessity patients did not meet the Medicare the area of non-emergency transports,
requirements vary depending on the coverage criteria for non-emergency Medicare has criteria for the coverage of
status of the ambulance transport (i.e., transports and could have been non-emergency scheduled and
emergency transport vs. non-emergency transported by means other than by unscheduled ambulance transports. For
transport). If the medical necessity ambulance. example, physician certification
requirement is met, Medicare Part B In addition, an August 2001 report 13 statements (PCS) should be obtained by
covers ambulance services when a conducted by the OIG’s OAS at the an ambulance supplier to verify that the
beneficiary is transported: request of a Medicare Part B carrier, transport was medically necessary.14
• To a hospital, a critical access determined that an ambulance supplier The PCSs should provide adequate
hospital (CAH), or a skilled nursing received significant overpayments. For information on the transport provided
facility (SNF) from anywhere, including example, of the 100 trip sheets reviewed for each individual beneficiary and each
another acute care facility or SNF; by the OIG, 99 of the trip sheets did not PCS must be signed by an appropriate
• To his or her home from a hospital, indicate whether the beneficiary was physician or other appropriate health
CAH, or SNF; or bed-confined. care professional.15 Pre-signed and/or
• Round trip from a hospital, CAH, or There are instances when an mass produced PCSs are not acceptable
SNF to an outside supplier to receive ambulance supplier receives a call for because they increase the opportunity
medically necessary therapeutic or assistance or transport of a patient who for abuse.
diagnostic services. does not meet the medical necessity Medicare does not cover transports for
requirements. Due to various patient routine doctor and dialysis
1. Upcoding
appointments when beneficiaries do not
Notwithstanding local or state 11 OIG Report, OEI–09–95–00412 is available on
meet the Medicare medical necessity
ordinance requirements regarding the OIG’s web site at www.oig.hhs.gov/oei.
12 Medicare’s ambulance fee schedule identifies
requirements. For example, Medicare
ambulance staffing and all-ALS does not normally pay for non-
non-emergency transport as appropriate if the
mandated services,10 ambulance beneficiary is bed confined and it is documented emergency scheduled or unscheduled
suppliers should use caution to bill, at that the beneficiary’s medical condition is such that ambulance transportation to a
the appropriate level, for services other methods of transportation are contraindicated, physician’s office from a personal
actually provided. The Federal or if his or her medical condition, regardless of bed-
confinement, is such that transportation by residence or nursing facility when a
Government has prosecuted a number of ambulance is medically required. In determining
whether a beneficiary is bed-confined, the following 14 CMS (formerly the Health Care Financing
9 The Negotiated Rulemaking Committee on the criterial must be met: (1) The beneficiary is unable Administration (HCFA)) Program Memorandum B–
Medicare Ambulance Services Fee Schedule used to get up from bed without assistance; (2) the 00–09 describes different options for ambulance
the National EMS Education and Practice Blueprint beneficiary is unable to ambulate; and (3) the suppliers having difficulty obtaining PCSs. See 42
as the basis for defining the levels of ambulance beneficiary is unable to sit in a chair or wheelchair. CFR 410.40(d)(3)(iii), (iv). For beneficiaries not
service. 42 CFR 410.40(d). under the direct care of a physician, whether they
10 Payment for ALS transports provided at the 13 August 20, 2001, OIG Report, A–03–01–00001 reside at home or in a facility, a PCS is not required.
BLS level will be phased in over CMS’s ambulance is available on the OIG’s web site at Id. § 410.40(d)(3)(ii).
fee schedule transition period. www.oig.hhs.gov/oas. 15 42 CFR 410.40(d).
39022 Federal Register / Vol. 67, No. 109 / Thursday, June 6, 2002 / Notices

patient is able to ambulate. Similarly, • Mileage traveled; a rural adjustment factor will be applied
ambulance services that are rendered for • Pick up and destination codes; to the base rate. The ambulance supplier
convenience or because other methods • Appropriate zip codes; and should document the address of the
of more appropriate transportation are • Services provided, including drugs point of pick-up to verify that the zip
not available, do not meet Medicare’s or supplies. code is accurate.
medical necessity requirements and 1. HCPCS and Diagnosis Code Selection The ambulance crew should
claims for such services should not be accurately report the mileage traveled
submitted to Medicare for payment. For The appropriate diagnosis and from the point of pick-up to the
example, an ambulance provider was procedure codes (e.g., ICD–9, HCPCS/ destination. Medicare covers ambulance
required to pay over $1 million dollars CPT) should be used when submitting transports to the nearest available
to the Federal Government and enter claims for reimbursement. The codes treatment facility. If the nearest facility
into a CIA with the OIG for billing for reported on the ambulance trip sheets or is not appropriate (e.g., because of traffic
medically unnecessary ambulance trips claim forms should be selected to patterns or lack of equipment), the
and for non-covered ambulance trips to describe most accurately the illness, beneficiary should be taken to the next
doctors’ offices. injury, signs or symptoms associated closest and appropriate facility. If a
with the patient and transport. Although beneficiary requests a transport to a
B. Documentation, Billing, and ICD–9 codes are universally known as facility other than the nearest
Reporting Risks diagnosis codes, coders use them to appropriate facility, the ambulance
Currently, the HCFA 1491 or 1500 describe signs and symptoms.17 Coders supplier should inform the patient that
forms are the approved forms for are taught that the patient’s condition he or she may be responsible for
requesting Medicare payment for should be coded to the highest level of payment of the additional mileage
ambulance services. Inadequate or certainty and specificity. Diagnostic incurred.
faulty documentation is a key risk area code information should not be based
3. Multiple Payors—Coordination of
for ambulance suppliers. The on past medical history or prior
Benefits
compilation of correct and accurate conditions, unless such information also
documentation (whether electronic or specifically relates to the patient’s Ambulance suppliers should make
hard copy) is generally the condition at the time of transport. every attempt to determine whether
responsibility of all the ambulance False or uncertain diagnoses should Medicare, Medicaid, or other Federal
personnel, including the dispatcher who never be added to the trip sheets or health care programs should be billed as
receives a request for transportation, the claims to justify reimbursement. If there the primary or as the secondary
personnel transporting the patient, and is a question on the proper code to use insurance. Claims for payment should
the coders and billers submitting claims when coding from the trip sheet or not be submitted to more than one
for reimbursement. When documenting preparing a bill that cannot be payor, except for purposes of
a service, ambulance personnel should appropriately resolved within the coordinating benefits (e.g., Medicare as
not make assumptions or inferences to organization’s proper chain of secondary payer). Section 1862(b)(6) of
compensate for a lack of information or command, the ambulance supplier the Social Security Act (42 U.S.C.
contradictory information on a trip should seek guidance, in writing, from 1395y(b)(6)) states that an entity that
sheet, ACR, or other medical source its local carrier. In addition to obtaining knowingly, willfully, and repeatedly
documents.16 written guidance, ambulance suppliers fails to provide accurate information
To ensure that adequate and should maintain documentation of relating to the availability of other
appropriate information is documented, communication with its carrier. If the health benefit plans shall be subject to
an ambulance supplier should gather ambulance supplier experiences a civil monetary penalty (CMP).
and record, at a minimum, the difficulty in obtaining clarification, it The OIG recognizes, particularly for
following: should submit with the claim a ambulance suppliers that may have
• Dispatch instructions, if any; narrative explaining the issue and the incomplete insurance information from
• Reasons why transportation by basis for the selected choice. Copies of a transported patient, that there are
other means was contraindicated; any carrier correspondence should be instances when the secondary payor is
• Reasons for selecting the level of appropriately maintained by the not known or cannot be determined
service; ambulance supplier. before the ambulance transportation
• Information on the bed-confined claim is submitted. In such situations, if
status of the individual; 2. Origin/Destination Requirements— it is determined that an inappropriate or
• Who ordered the trip; Loaded Miles 18 duplicate payment is received, the
• Time spent on the trip; Medicare only covers transports for payment should be refunded to the
• Dispatch, arrival at scene, and the time that the patient is physically in appropriate payor in a timely manner.
destination times; the ambulance. Effective January 1, Accordingly, ambulance suppliers
2001, ambulance suppliers must furnish should develop a system to track and
16 On December 28, 2000, the Department of
the ‘‘point of pick-up’’ zip code on each quantify credit balances to return
Health and Human Services (HHS) released its final
rule implementing the privacy provisions of the ambulance claim form.19 Under the new overpayments when they occur.
Health Insurance Portability and Accountability Act Medicare ambulance fee schedule, the C. Medicare Part A Payment for ‘‘Under
of 1996. The rule became effective in April 2001, point of pick-up will determine the Arrangements’’ Services
and regulates access, use, and disclosure of mileage payment rate as well as whether
personally identifiable health information by In certain instances, including
covered entities (health providers, plans, and
clearinghouses). Guidance on an ambulance
17 Only licensed physicians and certain other transports for patients of a SNF, hospital
supplier’s compliance with the HHS Privacy licensed practitioners can make determinations on or CAH, Medicare Part A covers
Regulations is beyond the scope of this CPG; a patient’s diagnosis. ambulance transports. Ambulance
18 Loaded miles refers to the number of miles that
however, it will be the responsibility of ambulance suppliers that provide such inpatient
suppliers to comply. Most health plans and the patient is physically on board the emergency
providers must comply with the rule by April 14, vehicle. transports ‘‘under arrangements’’ should
2003. In the meantime, many organizations are 19 HCFA Program Memorandum Transmittal AB– not bill Medicare for these transports.
considering and analyzing the privacy issues. 00–118, issued on November 30, 2000. Medicare reimburses the facility under
Federal Register / Vol. 67, No. 109 / Thursday, June 6, 2002 / Notices 39023

the Part A payment for the patient’s 7b).) It is a criminal prohibition that violated. (See section 1128B of the
entire Part A stay, including any pre- subjects violators to possible Social Security Act (42 U.S.C. 1320a–
discharge ambulance transports. Thus, imprisonment and criminal fines. In 7b).)
ambulance suppliers should not submit addition, violations of the anti-kickback
D. Who Is a Referral Source for
a claim to Medicare Part A or B for a statute may give rise to CMPs and
Ambulance Suppliers?
service that was provided under exclusion from the Federal health care
arrangement with a Part A provider. In programs. Both parties to an Any person or entity in a position to
addition, all such arrangements should impermissible kickback transaction may generate Federal health care program
be carefully reviewed to ensure that be liable: the party offering or paying business for an ambulance supplier is a
there is no violation of the anti-kickback the kickback and the party soliciting or potential referral source. Typically,
statute, as more fully described in receiving it. The key inquiry under the these sources include, but are not
section V of this CPG. statute is whether the parties intend to limited to, governmental ‘‘9–1–1’’ or
pay, or be paid, for referrals. An comparable emergency medical
IV. Medicaid Ambulance Coverage ambulance supplier should neither dispatch systems, private dispatch
The Medicaid program, a joint Federal make nor accept payments intended to systems, first responders, hospitals,
and State health insurance program, generate Federal health care program nursing facilities, assisted living
provides funds for health care providers business. facilities, home health agencies,
and suppliers that perform or deliver physician offices and patients.
B. What Are the ‘‘Safe Harbors’’?
medically necessary services for eligible E. For Whom Are Ambulance Suppliers
Medicaid recipients. Medicaid The Department has promulgated
Sources of Referrals?
regulations, to which ambulance ‘‘safe harbor’’ regulations that describe
suppliers must adhere, vary depending payment practices that do not violate In some circumstances, ambulance
on the applicable State regulations. the anti-kickback statute, provided the suppliers furnishing ambulance services
However, two Federal regulations form payment practice fits squarely within a may be sources of referrals (i.e.,
the basis for all Medicaid safe harbor. The safe harbor regulations patients) for hospitals, other receiving
reimbursement for transportation can be found at 42 CFR 1001.952 and on facilities, and second responders.
services and ensure a minimum level of the OIG web page at http:// Ambulance suppliers that furnish other
coverage for transportation services. All www.dhhs.gov/progorg/oig/ak/ types of transportation, such as
States that receive Federal Medicaid index.htm#. The safe harbor regulations ambulette or van transportation, may
funds are required to assure are voluntary regulations. Thus, failure also be sources of referrals for other
transportation for Medicaid recipients to to comply with a safe harbor does not providers of Federal heath care program
mean that an arrangement is illegal. services, such as physician offices,
and from medical appointments (42 CFR
Rather, arrangements that do not fit diagnostic facilities, and certain senior
431.53). Federal regulations further
must be analyzed under the anti- centers. In general, ambulance
define medical transportation and
kickback statute on a case-by-case basis suppliers, particularly those furnishing
describe costs that can be reimbursed
to determine if there is a violation. To emergency services, have relatively
with Medicaid funds (42 CFR
minimize the risk of a violation, limited abilities to generate business for
440.170(a)).
In short, Medicaid often covers ambulance suppliers should structure other providers or inappropriately steer
ambulance transports that are not arrangements to take advantage of the patients to certain emergency providers.
typically covered by Medicare, such as protection offered by the safe harbors. F. How Can Ambulance Suppliers
coverage of transports in wheelchair Among the safe harbors potentially Avoid Risk Under the Anti-Kickback
vans, cabs and ambulettes. The State relevant to ambulance suppliers are the Statute?
Medicaid Fraud Control Units and safe harbors for space and equipment
Because of the gravity of the penalties
Federal law enforcement have pursued rentals, personal services and
under the anti-kickback statute,
many fraud cases related to management contracts, discounts,
ambulance suppliers are strongly
transportation services billed to employees, price reductions offered to
encouraged to consult with experienced
Medicaid programs. Ambulance health plans, shared risk arrangements,
legal counsel about any financial
suppliers should review the Medicaid and ambulance restocking
relationships with potential referral
regulations governing their State or arrangements.21
sources. In addition, ambulance
service territories to ensure that any C. What Is ‘‘Remuneration’’ for Purposes suppliers should review OIG guidance
billed services meet applicable of the Statute? related to the anti-kickback statute,
Medicaid requirements. including advisory opinions, fraud
Under the anti-kickback statute,
V. Kickbacks and Inducements ‘‘remuneration’’ means virtually alerts and Special Advisory Bulletins.
anything of value. A prohibited Ambulance suppliers concerned about
A. What Is the Anti-Kickback Statute? particular existing or proposed
kickback payment may be in paid cash
The anti-kickback statute prohibits or in-kind, directly or indirectly, arrangements may obtain binding
the purposeful payment of anything of covertly or overtly. Almost anything of advisory opinions from the OIG.22
value (i.e., remuneration) in order to value can be a kickback, including, but Ambulance suppliers should exercise
induce or reward the generation of not limited to, money, goods, services, common sense when evaluating existing
Federal health care program business, free rent, meals, travel, gifts, and
including Medicare and Medicaid investment interests. Paying for referrals
22 The procedures for applying for advisory

business.20 (See section 1128B(b) of the opinions are set forth at 42 CFR part 1008 and on
need not be the only or primary purpose the OIG web page at www.oig.hhs.gov/advopn/
Social Security Act (42 U.S.C. 1320a– of a payment; as courts have found, if index.htm. All OIG advisory opinions are published
any one purpose of the payment is to on the OIG web page. Several published opinions
20 In addition to Medicare and Medicaid, the involve ambulance arrangements and may provide
Federal health care programs include, but are not induce or reward referrals, the statute is useful guidance for ambulance suppliers. These
limited to, TRICARE, Veterans Health Care, Public include OIG Advisory Opinions 97–6, 98–3, 98–7,
Health Service programs, and the Indian Health 21 42 CFR 1001.952 (b), (c), (d), (h), (i), (t), (u) and 98–13, 99–1, 99–2, 99–5, 00–7, 00–9, 00–11, 01–10,
Services. (v). 01–11, 01–12, 01–18, 02–2 and 02–3.
39024 Federal Register / Vol. 67, No. 109 / Thursday, June 6, 2002 / Notices

or prospective arrangements under the 1. Arrangements for Emergency Medical areas include, but are not limited to,
anti-kickback statute. One good rule of Services (EMS) routine waivers of copayments, 26
thumb is that all arrangements for items Contracts with cities or other EMS ‘‘insurance programs’’ offering patients
or services between potential referral sponsors for the provision of emergency purported coverage for the ambulance
sources should be fair market value in medical services may raise anti- supplier’s services only, and free goods
an arm’s-length transaction not taking kickback concerns. Ambulance and services. Ambulance suppliers may
into account the volume or value of suppliers should not offer anything of waive copayments based on good faith
existing or potential referrals. For each value to cities or other EMS sponsors in individualized assessments of financial
arrangement, ambulance suppliers order to secure an EMS contract, nor need, so long as the availability of
should carefully and accurately should they condition an EMS contract financial hardship waivers is not
document how fair market value is on obtaining non-EMS ambulance advertised.27
determined (e.g., by market business.24 While cities and other EMS V. Conclusion
comparables, open competitive bidding, sponsors may charge ambulance
cost basis, etc.). Discounts should be This ambulance compliance risk
suppliers amounts to cover the costs of
accurately reflected and appropriately guidance is intended as a resource for
services provided to the suppliers, they
disclosed on all claims and cost reports ambulance suppliers to decrease the
should not solicit inflated payments in
filed with the Federal health care incidence of errors, fraud and abuse that
exchange for access to EMS patients,
programs, and accurate and complete occur due to, among other factors, lack
including access to dispatch services
records should be kept of all discount of knowledge, inadequate training and
under ‘‘9–1–1’’ or comparable systems.
arrangements. Ambulance suppliers inadvertent noncompliance. The
should consult the safe harbor for 2. Arrangements With Other Responders Government has increased its scrutiny
discounts (42 CFR 1001.952(h)) when It many situations, it is common of the health care industry in part in an
entering into discount arrangements. practice for a paramedic intercept or effort to decrease errors and/or
other first responder to treat a patient in fraudulent and abusive practices.
Another good rule of thumb is that Similarly, we encourage ambulance
ambulance suppliers should exercise the field, with a second responder
transporting the patient to the hospital. suppliers to scrutinize their internal
caution when selling services to practices via their compliance efforts.
purchasers who are also in a position to In some cases, the first responder is in
a position to influence the selection of Compliance programs should reflect
generate Federal health care program each ambulance supplier’s individual
business for the ambulance supplier the transporting entity. While fair
market value payments for services and unique circumstances. It has been
(e.g., skilled nursing facilities that the OIG’s experience that those health
purchase ambulance services for private actually provided by the first responder
are appropriate, inflated payments by care providers that have developed
pay and Part A patients, but refer Part compliance programs not only better
B and Medicaid patients to the ambulance suppliers to generate
business are prohibited, and the understand applicable Federal health
ambulance supplier). Any link or care program requirements, but also
connection between the price offered to Government will scrutinize such
payments to ensure that they are not better understand their internal
the seller and referrals of Federal operations. We are hopeful that this
program business will implicate the disguised payments to generate calls to
the transporting entity. guidance will be a valuable tool in the
anti-kickback statute. In other words, development and continuation of
ambulance suppliers should not offer 3. Arrangements With Hospitals and ambulance suppliers’ compliance
purchasers with Federal health care Nursing Facilities programs.
program business a price that is lower Because hospitals and nursing
than the price they would charge a Appendix A—Additional Risk Areas
facilities are key sources of non-
purchaser with a comparable volume of emergency ambulance business, 1. ‘‘No Transport’’ Calls and Pronouncement
business and no Federal health care of Death
ambulance suppliers need to take
program referrals. particular care when entering into If an ambulance supplier responds to an
A third good rule of thumb is that an emergency call, but no transportation of a
arrangements with such institutions. patient is subsequently required due to the
ambulance supplier should not offer or (See, in particular, the second rule of
provide gifts, free items or services, or thumb described above.) incentives to promote the delivery of preventive
other incentives of greater than nominal care services, and health plan differentials in
value to referral sources and should not 4. Arrangements With Patients
copayments. In addition, items or services of
accept such gifts and benefits from Arrangements that offer patients nominal value (less than $10 per item or service or
parties soliciting referrals from the incentives to select particular $50 in the aggregate annually) and any payment
that fits into an anti-kickback safe harbor are
ambulance supplier. In general, token ambulance suppliers may violate the permitted.
gifts used on an occasional basis to anti-kickback statute, as well as the 26 See Special Fraud Alert: Routine Waiver of

demonstrate good will or appreciation CMP law prohibition against giving Copayments or Deductibles Under Medicare Part B,
(e.g., logo key chains, mugs or pens) will inducements to Medicare and Medicaid 59 FR 65372, 65374 (1994) contained on the OIG
web page at http://oig.hhs.gov/frdalrt/index.htm).
be considered to be nominal in value. beneficiaries.25 Potentially prohibited 27 Under a special rule, ambulance suppliers

G. Are There Particular Arrangements to owned and operated by a State or a political


24 In general, ambulance suppliers may offer cities
subdivision of a State, such as a municipality or a
which Ambulance Suppliers Should be or other municipal entities free or reduced cost fire district, may waive Medicare copayments for
Alert? services for uninsured, indigent patients. residents. See CMS Carrier Manual section 2309.4;
25 The CMP law prohibits giving anything of CMS Intermediary Manual section 3153.3A. This
Ambulance suppliers should review value to a Medicare or Medicaid beneficiary that the rule does not apply to private ambulance suppliers
the following arrangements with giver knows, or should know, is likely to influence providing services under contract. However, States
particular care: 23 the beneficiary to choose a particular practitioner, and political subdivisions of States may pay
provider, or supplier of items or services payable uncollected, out-of-pocket copayments on behalf of
by Medicare or Medicaid. (See section 1128A(a)(5) residents. Such payments may be made through
23 This list of arrangements is intended to be of the Social Security Act (42 U.S.C 1320a–7a(a)(5)). lump sum or periodic payments, if the aggregate
illustrative, not exhaustive, of potential areas of risk The statute contains several narrow exceptions, payments reasonably approximate the otherwise
under the anti-kickback statute. including financial hardship copayment waivers, uncollected copayment amounts.
Federal Register / Vol. 67, No. 109 / Thursday, June 6, 2002 / Notices 39025

patient’s death or patient’s refusal to be exclusion by the OIG.29 This exclusion Other (please specify)
transported, there are three Medicare rules authority is not implicated unless the —HHS Department or program being affected
that apply. If an individual is pronounced supplier’s charge for Medicare or Medicaid by your allegation of fraud, waste, abuse/
dead prior to the time the ambulance was patients is substantially more than its median mismanagement:
requested, there is no payment. If the non-Medicare/Medicaid charge. A supplier Centers for Medicare and Medicaid
individual is pronounced dead after the should identify as a risk area its billing Services (formerly Health Care Financing
ambulance has been requested, but before practices if it is discounting close to half of Administration)
any services are rendered, a BLS payment its non-Medicare/Medicaid business. Thus, Indian Health Service
will be made and no mileage will be paid. ambulance suppliers should review charging Other (please specify)
If the individual is pronounced dead after practices with respect to Medicare and —Please provide the following information
being loaded into the ambulance, the same Medicaid billing to ensure that they are not (however, if you would like your referral
payment rules apply as if the beneficiary charging Medicare or Medicaid substantially to be submitted anonymously, please
were alive. Ambulance suppliers should more than they usually charge other indicate such in your correspondence or
accurately represent the time of death and customers. phone call):
request payment based on the Appendix B—OIG–HHS Contact Your Name

aforementioned criteria. Your Street Address

Information
Your City/County

2. Multiple Patient Transports The OIG’s web site (www.oig.hhs.gov) Your State

On occasion, it may be necessary for an contains various links describing the Your Zip Code

ambulance to transport multiple patients following: (1) The OIG’s four different Your E-mail Address

concurrently. If more than one patient is components (Audit Services, Investigations, —Subject/Person/Business/Department that
transported concurrently in one ambulance, Evaluations and Inspections, Counsel to the allegation is against:
the amount billed should be consistent with IG); (2) External Information such as how to Name of Subject
the multiple transport guidelines established subscribe to the OIG’s mailing list and OIG’s Title of Subject
by the carrier in that region. Under CMS’s Hearing Testimony; (3) Compliance Tools Subject’s Street Address
new ambulance fee schedule rules for that include a list of the OIG’s Compliance Subject’s City/County
multiple transports, Medicare will pay a Guidance, Corporate Integrity Agreements, Subject’s State
percentage of the payment allowance for the and Self-Disclosure Information; (4) Fraud Subject’s Zip Code
base rate applicable to the level of care Detection and Prevention efforts including —Please provide a brief summary of your
furnished to the Medicare beneficiary (e.g., if anti-kickback information, Advisory allegation and the relevant facts.
two patients are transported simultaneously, Opinions, and Fraud Alerts & Bulletins; and
75 percent of the applicable base rate will be (5) Reports and Publications. Such Appendix C—Carrier Contact
reimbursed for each of the Medicare information is frequently updated and is a Information
beneficiaries). Coinsurance and deductible useful tool for ambulance providers seeking
additional OIG resources. 1. Medicare
amounts will apply to the prorated amounts.
Also listed on the OIG’s web site is the OIG A complete list of contact information
3. Multiple Ambulances Called to Respond Hotline Number. One method for providers (address, phone number, e-mail address) for
to Emergency Call to report potential fraud, waste and abuse Medicare Part A Fiscal Intermediaries,
On occasion, more than one ambulance problems is to contact the OIG Hotline Medicare Part B Carriers, Regional Home
supplier responds to an emergency call and number. All HHS and contractor employees Health Intermediaries, and Durable Medical
is present to transport a beneficiary. These have a responsibility to assist in combating Equipment Regional Carriers can be found on
are often referred to as ‘‘dual transports.’’ In fraud, waste, and abuse in all departmental the CMS web site at www.hcfa.gov/medicare/
such cases, only the transporting ambulance programs. As such, providers are encouraged incardir.htm.
supplier may bill Medicare for the service to report matters involving fraud, waste and
mismanagement in any departmental 2. Medicaid
provided. The non-transporting ambulance
company should receive payment directly program to the OIG. The OIG maintains a Contact information (address, phone
from the transporting supplier based on a hotline that offers a confidential means for number, e-mail address) for each State
negotiated arrangement if that company’s reporting these matters. Medicaid director can be found on the CMS
ambulance crew had provided services to the Contacting the OIG Hotline web site at www.hcfa.gov/medicaid/
patient, but had not actually transported the mcontact.htm. In addition to a list of State
By Phone: 1–800–HHS–TIPS (1–800–447– Medicaid directors, the web site includes
patient to a treatment facility.28 On occasion, 8477)
when multiple ambulance crews respond to contact information for each State survey
By Fax: 1–800–223–8164 agency and the CMS Regional Offices.
a call, a BLS ambulance may have provided By E-Mail: Htips@os.dhhs.gov
the transport, but the level of services By TTY: 1–800–377–4950 3. Ambulance Fee Schedule
provided may have been at the ALS level. If By Mail: Office of Inspector General, Information related to the development of
a BLS supplier is billing at the ALS level Department of Health and Human Services, the ambulance fee schedule is located at
because of the services furnished by an Attn: HOTLINE, 330 Independence Ave., www.hcfa.gov/medicare/ambmain.htm.
additional ALS crew member, appropriate SW, Washington, DC 20201
documentation should accompany the claim When contacting the hotline, please Appendix D—Internet Resources
to indicate to the carrier that dual provide the following information to the best
transportation was provided. In any event, 1. Office Of Inspector General
of your ability: (www.oig.hhs.gov)
only one supplier may submit the claim for
—Type of Complaint:
payment. This web site includes a variety of
Medicare Part A
information relating to Federal health care
4. Billing Medicare ‘‘Substantially in Excess’’ Medicare Part B
programs, including the following:
of Usual Charges Indian Health Service
Ambulance suppliers generally may not TRICARE Components
charge Medicare or Medicaid patients • Audit Services
substantially more than they usually charge 29 The OIG may exclude from participation in the
• Investigations
everyone else. If they do, they are subject to Federal health care programs any provider that • Evaluation and Inspections
submits or causes to be submitted bills or requests
for payment (based on charges or costs) under
• Counsel to the IG
28 These payments should be fair market value for Medicare or Medicaid that are substantially in • Management and Policy
services actually rendered by the non-transporting excess of such providers’ usual charges or costs, Compliance Tools
supplier, and the parties should review these unless the Secretary finds good cause for such bills
payment arrangements for compliance with the or requests. See section 1128(b)(6) of the Social • Compliance Guidance
anti-kickback statute. Security Act (42 U.S.C. 1320a–7(b)(6)). • Corporate Integrity Agreements
39026 Federal Register / Vol. 67, No. 109 / Thursday, June 6, 2002 / Notices

• Self-Disclosure Information DEPARTMENT OF HEALTH AND 6,081 respondents in FY 2003, 6081


Press Information HUMAN SERVICES respondents in FY 2004 and 6081
respondents in FY 2005. Estimated
• Subscribe to Mailing List National Institutes of Health Number of Responses per Respondent: 1
• OIG News
in FY 2003, 1 in FY 2004, and 1 in FY
• Hearing Testimony Proposed Collection; Comment 2005. Average Burden Hours Per
Fraud Detection and Prevention Request; Partner and Customer Response: 0.33. Estimated Total Annual
Satisfaction Surveys
• Anti-Kickback Information Burden Hours Requested: 2007 in FY
• Advisory Opinion SUMMARY: In compliance with the 2003, 2007 in FY 2004 and 2007 in FY
• Fraud Alerts and Bulletins requirement of Section 3506(c)(2)(A) of 2005. Costs for time were estimated
Reports and Publications the Paperwork Reduction Act of 1995, using the rate of $38.00 per hour for
for opportunity for public comment on SRG members, SRG chairs, and
• Audit Reports proposed data collection projects, the principal investigators/grant applicants.
• Evaluation Reports Center for Scientific Review (CSR), the The estimated annual cost each year for
• Semi-Annual Reports
National Institutes of Health (NIH) will which the generic clearance is requested
• Orange Book
publish periodic summaries of proposed is $76,266 for FY 2003, $76,266 for FY
• Red Book
projects to be submitted to the Office of 2004 and $76,266 for FY 2005.
• Work Plan
• Regulations and Federal Register Notices
Management and Budget (OMB) for Respondents or recordkeepers should
review and approval. incur no additional costs.
2. Centers for Medicare and Medicaid Proposed Collection: Title: partner
Services (www.hcfa.gov) Request for Comments: Written
and Customer Satisfaction Surveys.
comments and/or suggestions from the
This web site includes information on a Type of Information Collection Request:
public and affected agencies should
wide array of topics, including the following: Revision OMB #0925–0474; expires
address one or more of the following
September 30, 2002. Need and Use of
a. Medicare
Information Collection: The information points: (1) Evaluate whether the
• National Correct Coding Initiative collection in these surveys will be used proposed collection of information is
• Intermediary-Carrier Directory by Center for Scientific Review necessary for the proper performance of
• Payment personnel: (1) To assess the quality of the function of the agency, including
• Program Manuals operations and processes used by CSR whether the information will have
• Program Transmittals and Memorandum to review grant applications; (2) to practical utility; (2) Evaluate the
• Provider Billing/CMS Forms accuracy of the agency’s estimate of the
assess the quality of service provided to
• Statistics and Data burden of the proposed collection of
our partners and customers; (3) to assist
b. Medicaid CMS Regional Offices with the design of modifications of information, including the validity of
these operations, processes and services, the methodology and assumptions used;
• Letters to State Medicaid Directors
• Medicaid Hotline Numbers based on partner and customer input; (3) Enhance the quality, utility, and
• Policy and Program Information (4) to develop new modes of operation clarity of the information to be
• State Medicaid Contacts based on partner and customer need; collected; and (4) Minimize the burden
• State Medicaid Manual and (5) to obtain partner and customer of the collection of information on those
• State Survey Agencies feedback about the efficacy of who are to respond, including the use
• Statistics and Data implemented modifications. These of appropriate automated, electronic,
surveys will almost certainly lead to mechanical, or other technological
3. CMS Medicare Training (www.hcfa.gov/
learning) quality improvement activities that will collection techniques or other forms of
enhance and/or streamline CSR’s information technology.
This web site provides computer-based
operations. The major mechanism by FOR FURTHER INFORMATION CONTACT: To
training on the following topics:
which CSR will request input is through
• CMS 1500 Form request more information on the
• Fraud and Abuse
surveys. The survey for partners is
proposed project or to obtain a copy of
• ICD–9–CM Diagnosis Coding generic and tailored for Scientific
the data collection plans and
• Medicare Secondary Payer Review Group (SRG) past and present
instruments, contact: Karl Malik, Ph.D.,
• Introduction to the World of Medicare members and chairs. The survey for
Office of the Director, Center for
• CMS 1450 (UB92) customers (i.e., grant applicants) will
have slight variations determined by Scientific Review, National Institutes of
4. Government Printing Office which category of scientific review Health, 6701 Rockledge Drive,
(www.access.gpo.gov)
group the researcher/investigator’s grant Rockledge II, Rm. 3016, Bethesda, MD
This web site provides access to Federal application is reviewed. Surveys will be 20892–7814, or call non-toll free: 301–
statutes and regulations pertaining to Federal collected as written documents or via 435–1114, or E-mail your request,
health care programs. the Internet. Information gathered from including your address to:
these surveys will be presented to, and malikk@csr.nih.gov.
5. The U.S. House of Representatives
Internet Library (http://.uscode.house.gov/ used directly by, CSR management to Comments Due Date: Comments
usc.htm) enhance the operations, processes, and regarding this information collection are
This web site provides access to the United services of our organization. Frequency best assured of having their full effect if
States Code, which contains laws pertaining of Response: Yearly. Affected Public: received on or before August 5, 2002.
to Federal health care programs. Universities, not-for-profit institutions, Dated: May 30, 2002.
Dated: May 20, 2002. business or other for-profit, small
businesses and organizations, and John Czajkowski,
Janet Rehnquist,
individuals. Type of Respondents: Adult Acting Executive Officer, Center for Scientific
Inspector General. Review, NIH.
scientific professionals. The annual
[FR Doc. 02–14163 Filed 6–5–02; 8:45 am] reporting burden is as follows: [FR Doc. 02–14118 Filed 6–5–02; 8:45 am]
BILLING CODE 4152–01–P Estimated Number of Respondents: BILLING CODE 4140–01–M