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Federal Register / Vol. 68, No.

56 / Monday, March 24, 2003 / Notices 14245

forms the basis for determining the 11, 2000. The applicant claims that the Dated: February 7, 2003.
amount of extension an applicant may investigational device exemption (IDE) Jane A. Axelrad,
receive. required under section 520(g) of the Associate Director for Policy, Center for Drug
A regulatory review period consists of Federal Food, Drug, and Cosmetic Act Evaluation and Research.
two periods of time: A testing phase and (the act) (21 U.S.C. 360j(g)) for human [FR Doc. 03–6892 Filed 3–21–03; 8:45 am]
an approval phase. For medical devices, tests to begin became effective on June BILLING CODE 4160–01–S
the testing phase begins with a clinical 16, 1999. However, FDA records
investigation of the device and runs indicate that the IDE was determined
until the approval phase begins. The substantially complete for clinical DEPARTMENT OF HEALTH AND
approval phase starts with the initial studies to have begun on August 11, HUMAN SERVICES
submission of an application to market 2000, which represents the IDE effective
the device and continues until date. Health Resources and Services
permission to market the device is Administration
2. The date the application was
granted. Although only a portion of a initially submitted with respect to the
regulatory review period may count Notice of Filing of Annual Report of
device under section 515 of the act (21 Federal Advisory Committee
toward the actual amount of extension
U.S.C. 360e): May 29, 2001. The
that the Director of Patents and Notice is hereby given that pursuant
applicant claims April 3, 2001, as the
Trademarks may award (half the testing to section 13 of Public Law 92–463, the
date the premarket approval application
phase must be subtracted as well as any fiscal year 2002 annual report for the
(PMA) for GENESIS
time that may have occurred before the following Health Resources and
NEUROSTIMULATION SYSTEM (PMA
patent was issued), FDA’s determination Services Administration’s Federal
P010032) was initially submitted.
of the length of a regulatory review advisory committee has been filed with
However, FDA records indicate that
period for a medical device will include the Library of Congress: Maternal and
PMA P010032 was submitted on May
all of the testing phase and approval Child Health Research Grants Review
29, 2001.
phase as specified in 35 U.S.C. Committee.
156(g)(3)(B). 3. The date the application was
Copies are available to the public for
FDA recently approved for marketing approved: November 21, 2001. FDA has
inspection at the Library of Congress,
the medical device GENESIS verified the applicant’s claim that PMA
Newspaper and Current Periodical
NEUROSTIMULATION SYSTEM. P010032 was approved on November
Reading Room in the James Madison
GENESIS NEUROSTIMULATION 21, 2001.
Memorial Building, Room LM–133
SYSTEM is indicated as an aid in the This determination of the regulatory (entrance on Independence Avenue,
management of chronic, intractable pain review period establishes the maximum between First and Second Streets, SE.,
of the trunk and/or limbs, including potential length of a patent extension. Washington, DC).
unilateral or bilateral pain associated However, the U.S. Patent and Copies may be obtained from:
with failed back surgery syndrome, Trademark Office applies several Kishena C. Wadhwani, Ph.D., Executive
intractable low back pain, and leg pain. statutory limitations in its calculations Secretary, Maternal and Child Health
Subsequent to this approval, the Patent of the actual period for patent extension. Research Grants Review Committee,
and Trademark Office received a patent In its application for patent extension, Parklawn Building, Room 18A–55, 5600
term restoration application for this applicant seeks 840 days of patent Fishers Lane, Rockville, Maryland
GENESIS NEUROSTIMULATION term extension. 20857, Telephone 301–443–2340.
SYSTEM (U.S. Patent No. 4,793,353)
Anyone with knowledge that any of Dated: March 17, 2003.
from Advanced Neuromodulation
the dates as published are incorrect may Jane M. Harrison,
Systems, and the Patent and Trademark
submit to the Dockets Management
Office requested FDA’s assistance in Director, Division of Policy Review and
Branch (see ADDRESSES) written or Coordination.
determining this patent’s eligibility for
electronic comments and ask for a
patent term restoration. In a letter dated [FR Doc. 03–6858 Filed 3–21–03; 8:45 am]
October 31, 2002, FDA advised the redetermination by May 23, 2003.
BILLING CODE 4165–15–P
Patent and Trademark Office that this Furthermore, any interested person may
medical device had undergone a petition FDA for a determination
regulatory review period and that the regarding whether the applicant for DEPARTMENT OF HEALTH AND
approval of GENESIS extension acted with due diligence HUMAN SERVICES
NEUROSTIMULATION SYSTEM during the regulatory review period by
represented the first permitted September 22, 2003. To meet its burden, Office of Inspector General
commercial marketing or use of the the petition must contain sufficient facts
to merit an FDA investigation. (See H. OIG Compliance Program Guidance for
product. Thereafter, the Patent and
Rept. 857, part 1, 98th Cong., 2d sess., Ambulance Suppliers
Trademark Office requested that FDA
determine the product’s regulatory pp. 41–42, 1984.) Petitions should be in
AGENCY: Office of Inspector General
review period. the format specified in 21 CFR 10.30.
(OIG), HHS.
FDA has determined that the Comments and petitions should be ACTION: Notice.
applicable regulatory review period for submitted to the Dockets Management
GENESIS NEUROSTIMULATION Branch. Three copies of any information SUMMARY: This Federal Register notice
SYSTEM is 469 days. Of this time, 292 are to be submitted, except that sets forth the recently issued
days occurred during the testing phase individuals may submit one copy Compliance Program Guidance for
of the regulatory review period, while identified with the docket number Ambulance Suppliers developed by the
177 days occurred during the approval found in brackets in the heading of this Office of Inspector General (OIG). The
phase. These periods of time were document. Comments and petitions may OIG has previously developed and
derived from the following dates: be seen in the Dockets Management published voluntary compliance
1. The date a clinical investigation Branch between 9 a.m. and 4 p.m., program guidance focused on several
involving this device was begun: August Monday through Friday. different areas of the health care
14246 Federal Register / Vol. 68, No. 56 / Monday, March 24, 2003 / Notices

industry. This voluntary compliance have consulted with the Centers for compliance program and for those that
program guidance should assist Medicare and Medicaid Services (CMS) have already done so and are seeking to
ambulance suppliers and other health and the Department of Justice in analyze, improve or expand existing
care providers in developing their own developing final guidance for programs. As with the OIG’s previous
strategies for complying with federal ambulance suppliers. This final guidance, the guidelines discussed in
health care program requirements. guidance outlines some of the most this CPG are not mandatory, nor is the
FOR FURTHER INFORMATION CONTACT: common and prevalent fraud and abuse CPG an all-inclusive document
Sonya Castro, (202) 619–2078, or Joel risk areas for the ambulance industry containing all the components of a
Schaer, (202) 619–1306, Office of and provides direction on how to: (1) compliance program. Other OIG
Counsel to the Inspector General. Address various risk areas; (2) prevent outreach efforts, as well as other federal
SUPPLEMENTARY INFORMATION:
the occurrence of instances of fraud and agency efforts to promote compliance,
abuse; and (3) develop corrective can and should also be used in
Background actions when those risks or instances of developing a compliance program
The creation of compliance program fraud and abuse are identified. tailored to an entity’s particular
guidances (CPGs) is a major initiative of This CPG is divided into the structure and operations.
the OIG in its effort to engage the private following five separate sections, with an This guidance focuses on compliance
health care community in preventing appendix: measures related to services furnished
the submission of erroneous claims and • Section I is a brief introduction. primarily under the Medicare program
in combating fraudulent and abusive • Section II provides information and, to a limited extent, other federal
conduct. In the past several years, the about the basic elements of a health care programs. (See, e.g., section
OIG has developed and issued CPGs compliance program for ambulance IV for a brief discussion of Medicaid
directed at a variety of segments in the suppliers. ambulance coverage.) Suppliers are free
health care industry. The development • Section III discusses various fraud to address private payor claims and
of these CPGs is based on our belief that and abuse and compliance risks services in their compliance programs.
a health care provider can use internal associated with ambulance services As in other sectors of the health care
controls to more efficiently monitor covered under the Medicare program. industry, most ambulance suppliers are
adherence to applicable statutes, • Section IV briefly summarizes honest suppliers trying to deliver
regulations, and program requirements. compliance risks related to Medicaid quality services. However, like other
Copies of these CPGs can be found on coverage for transportation services. health care industry sectors, the
the OIG Web site at http://oig.hhs.gov. • Section V discusses various risks ambulance industry has seen its share of
under the anti-kickback statute. fraudulent and abusive practices. The
Developing Compliance Program • The appendix provides relevant OIG has reported and pursued a number
Guidance for Ambulance Suppliers statutory and regulatory citations, as of different fraudulent and abusive
Having experienced a number of well as brief discussions of additional practices in the ambulance transport
instances of ambulance provider and potential risk areas to consider when field. Examples include:
supplier fraud and abuse, the developing a compliance program. • Improper transport of individuals
ambulance industry has expressed Under the Social Security Act (the with other acceptable means of
interest in protecting against such Act), ambulance ‘‘providers’’ are transportation;
Medicare participating institutional • Medically unnecessary trips;
conduct through increased guidance to • Trips claimed but not rendered;
the industry. To date, the OIG has providers that submit claims for
Medicare ambulance services (e.g., • Misrepresentation of the transport
issued several advisory opinions on a destination to make it appear as if the
variety of ambulance-related issues (see hospitals, including critical access
hospitals (CAHs) and skilled nursing transport was covered;
endnote 13 in this compliance program • False documentation;
guidance) and has published final facilities (SNFs); the term ‘‘supplier’’
means an entity that is other than a • Billing for each patient transported
rulemaking concerning a safe harbor for in a group as if he/she was transported
ambulance restocking arrangements (66 provider. For purposes of this
document, we will refer to both separately;
FR 62979; December 4, 2001).
ambulance suppliers and providers as • Upcoding from basic life support to
To provide further guidance, the OIG advanced life support services; and
ambulance ‘‘suppliers.’’
published a Federal Register notice (65 • Payment of kickbacks.
FR 50204; August 17, 2000) that Compliance Program Guidance for To help reduce the incidence and
solicited general comments, Ambulance Suppliers prevalence of fraudulent or abusive
recommendations, and other conduct, an ambulance supplier should
suggestions from concerned parties and I. Introduction consider the recommendations in this
organizations on how best to develop The OIG recognizes that the guidance.
compliance guidance for ambulance ambulance industry is comprised of This final CPG has been modified
suppliers to reduce the potential for entities of enormous variation: some from the draft CPG to take into further
fraud and abuse. On June 6, 2002, the ambulance companies are large, many consideration CMS’s adoption of a new
OIG published a Draft Compliance are small; some are for-profit, many are fee schedule for payment of ambulance
Program Guidance to afford all not-for-profit; some are affiliated with services. The CMS’s ambulance fee
interested parties a further opportunity hospitals, many are independent; and schedule is the product of a negotiated
to provide specific comments in the some are operated by municipalities or rulemaking process and will replace
development of this final CPG (67 FR counties, while others are commercially (over a five-year transition period) the
39015; June 6, 2002). In response to that owned. Consequently, this guidance is retrospective, reasonable cost
notice, the OIG received three public not intended to be a one-size-fits-all reimbursement system for providers,
comments, collectively representing a guide. Rather, like the previous CPGs, and the reasonable charge system for
variety of outside sources. We have this guidance is intended as a helpful suppliers of ambulance services. As the
carefully considered those comments, as tool for those entities that are government and the industry gain more
well as previous OIG publications, and considering establishing a voluntary experience under the new fee schedule,
Federal Register / Vol. 68, No. 56 / Monday, March 24, 2003 / Notices 14247

the OIG may update or supplement this appropriately to detected offenses, process may be simple and
CPG to address newly identified risk including the initiation of appropriate straightforward or it may be fairly
areas, as appropriate. corrective action. An organization’s complex and involved. For example, an
response to detected misconduct will evaluation of whether an ambulance
II. Elements of a Compliance Program
vary based on the facts and supplier’s existing written policies and
for Ambulance Suppliers
circumstances of the offense. However, procedures accurately reflect current
A. Basic Elements of a Compliance the response should always be federal health care program
Program appropriate to resolve and correct the requirements is straightforward.
The following basic components have situation in a timely manner. The However, an evaluation of whether an
become accepted as the building blocks organization’s compliance officer, and ambulance supplier’s actual practices
of an effective compliance program: legal counsel in some circumstances, conform to its policies and procedures
should be involved in situations when may be more complex and require
1. Development of Compliance Policies serious misconduct is identified.
and Procedures several analytical evaluations to
6. Developing Open Lines of determine whether system weaknesses
The ambulance supplier should Communication are present. Even more complex is an
develop and distribute written evaluation of an ambulance supplier’s
standards of conduct, as well as written Ambulance suppliers should create
and maintain a process, such as a practices in light of applicable statutes,
policies and procedures, that reflect the
hotline or other reporting system, to regulations, and other program
ambulance supplier’s commitment to
receive and process complaints and to requirements, when there are no pre-
compliance and address specific areas
of potential fraud or abuse. These ensure effective lines of communication existing written policies and
written policies and procedures should between the compliance officer and all procedures.
be reviewed periodically (e.g., annually) employees. Further, procedures should The evaluation process should furnish
and revised as appropriate to ensure be adopted to protect the anonymity of ambulance suppliers with a snapshot of
they are current and relevant. complainants, where the complainants their strengths and weaknesses and
desire to remain anonymous, and to assist providers in recognizing areas of
2. Designation of a Compliance Officer protect whistleblowers from retaliation. potential risk. We suggest that
The ambulance supplier should 7. Enforcing Disciplinary Standards ambulance suppliers evaluate a variety
designate a compliance officer and other Through Well-Publicized Guidelines of practices and factors, including their
appropriate bodies (e.g., a compliance policies and procedures, employee
committee) charged with the Ambulance suppliers should develop
policies and procedures to ensure that training and education, employee
responsibility for operating and knowledge and understanding, claims
monitoring the organization’s there are appropriate disciplinary
mechanisms and standards that are submission process, coding and billing,
compliance program. The compliance accounts receivable management,
officer should be a high-level individual applied in an appropriate and consistent
manner. These policies and standards documentation practices, management
in the organization who reports directly
should address situations in which structure, employee turnover,
to the organization’s upper
employees or contractors violate, contractual arrangements, changes in
management, such as the chief
executive officer or board of directors. whether intentionally or negligently, reimbursement policies, and payor
The OIG recognizes that an ambulance internal compliance policies, applicable expectations.
supplier may tailor the job functions of statutes, regulations, or other federal
1. Policies and Procedures
the compliance officer position by health care program requirements.
taking into account the size and Developing and implementing a Because policies and procedures
structure of the organization, existing compliance program may require represent the written standard for daily
reporting lines, and other appropriate significant resources and time. An operations, an ambulance supplier’s
factors. individual ambulance supplier is best policies and procedures should describe
situated to tailor compliance measures the normal operations of the ambulance
3. Education and Training Programs to its own organizational structure and supplier and the applicable rules and
A key element of a compliance financial capabilities. In addition, regulations. Further, written policies
program should be regular training and compliance programs should be and procedures should go through a
education of employees and other reviewed periodically to account for
formal approval process within the
appropriate individuals. Training changes in the health care industry,
organization and should be evaluated on
content should be tailored appropriately federal health care statutes and
a routine basis, and updated as needed,
and should be delivered in a way that regulations, relevant payment policies
to reflect current ambulance practices
will maximize the chances that the and procedures, and identified risks.
(assuming these practices are
information will be understood by the B. Evaluation and Risk Analysis appropriate and comport with the
target audience. relevant statutes, regulations, and
It is prudent for ambulance suppliers
4. Internal Monitoring and Reviews conducting a risk analysis to begin by program requirements). In addition,
Appropriate monitoring methods are performing an evaluation of internal and ambulance suppliers should review
essential to detect and identify problems external factors that affect their policies and procedures to ensure that
and to help reduce the future likelihood operations. These may include internal they are representative of actual
of problems. systems and management issues, as well practices. For example, an ambulance
as the federal health care program supplier’s policy for reviewing
5. Responding Appropriately to requirements that govern their business ambulance call reports (ACRs) should
Detected Misconduct operations. In many cases, such not state that it will review 100 percent
Ambulance suppliers should develop evaluation will result in the creation of its ACRs, unless the ambulance
policies and procedures directed at and adoption or revision of written supplier is capable of performing and
ensuring that the organization responds policies and procedures. The evaluation enforcing such comprehensive reviews.
14248 Federal Register / Vol. 68, No. 56 / Monday, March 24, 2003 / Notices

2. Training and Education consider seeking, developing, or using selected will comprise the area of focus
Ensuring that a supplier’s employees other innovative training methods. for the review. Once the universe of
and agents receive adequate education Computer or internet modules may be claims has been identified, an
and training is essential to minimizing an effective means of training if acceptable number of claims should be
risk. Employees should clearly employees have access to such randomly selected. Because the universe
understand what is expected of them technology and if a system is developed of claims and the variability of items in
and for what they will be held to allow employees to ask questions. the universe will vary, the OIG cannot
accountable. Suppliers should also The OIG cannot endorse any specify a generally acceptable number of
document and track the training they commercial training product; it is up to claims for purposes of a claims review.
each ambulance supplier to determine if However, the number of claims sampled
provide to employees and others.
An ambulance supplier should the training methods and products are and reviewed should be sufficient to
consider offering two types of effective and appropriate. ensure that the results are representative
Whatever form of training ambulance of the universe of claims from which the
compliance training: compliance
suppliers provide, the OIG also sample was pulled.
program training and job-specific
recommends that employees complete a Ambulance suppliers should not only
training. If an ambulance supplier is
post-compliance training test or monitor identified errors, but also
implementing a formal compliance questionnaire to verify comprehension evaluate the source or cause of the
program, employees should be trained of the material presented. This will errors. For example, an ambulance
on the elements of the program, the allow a supplier to assess the supplier may identify through a review
importance of the program to the effectiveness and quality of its training a certain claims error rate. Upon further
organization, the purpose and goals of materials and techniques. Additionally, evaluation, the ambulance supplier may
the program, what the program means training materials should be updated as determine that the errors were a result
for each individual, and the key appropriate and presented in a manner of inadequate documentation. Further
individuals responsible for ensuring that is understandable by the average evaluation may reveal that the
that the program is operating trainee. Finally, the OIG suggests that documentation deficiencies involve a
successfully. Compliance program the employees’ attendance at, and limited number of individuals who
education should be available to all completion of, training be tracked and work on a specific shift. It is the
employees, even those whose job appropriate documentation maintained. ambulance supplier’s responsibility to
functions are not directly related to identify such weaknesses and to correct
billing or patient care. 3. Assessment of Claims Submission
them promptly. In this example, at a
Ambulance suppliers should also Process
minimum, additional employee training
train employees on specific areas with Ambulance suppliers should conduct should be required and any identified
regard to their particular job positions periodic claims reviews to verify that a overpayment repaid. A detailed and
and responsibilities, whether or not as claim ready for submission, or one that logical analysis will make claims
part of a formal compliance plan. The has been submitted and paid, contains reviews useful tools for identifying
intensity and the nature of the specific the required, accurate, and truthful risks, correcting weaknesses, and
training will vary by employee type. information required by the payor. An preventing future errors.
Training employees on the job functions ambulance claims review should focus, Ambulance suppliers should consider
of other people in the organization may at a minimum, on the information and using a baseline audit to develop a
also be an effective training tool. documentation present in the ACR, the benchmark against which to measure
Appropriate cross-training can improve medical necessity of the transport as performance. This audit will establish a
employees’ overall awareness of determined by payor requirements, the consistent methodology for selecting
compliance and job functions, thereby coding of the claim, the co-payment and examining records in future audits.
increasing the likelihood that an collection process, and the subsequent Comparing audit results from different
individual employee will recognize payor reimbursement. The claims audits will generally yield useful results
non-compliance. Training should be reviews should be conducted by only when the audits analyze the same
provided on a periodic basis to keep individuals with experience in coding or similar information and when
employees current on ambulance and billing and familiar with the matching methodologies are used.
supplier requirements, including, for different payors’ coverage and As part of its compliance efforts, an
example, the latest payor requirements. reimbursement requirements for ambulance supplier should document
Ambulance suppliers should conduct or ambulance services. The reviewers how often audits or reviews are
make available training for employees at should be independent and objective in conducted and the information
least yearly, and more often if needed. their approach. Claims reviewers who reviewed for each audit. The ambulance
Generally, employees who attend analyze claims that they themselves supplier should not only use internal
interactive training better comprehend prepared or supervised often lack benchmarks, but should utilize external
the material presented. Interactive sufficient independence to accurately information, if available, to establish
training offers employees the chance to evaluate the claims submissions process benchmarks (e.g., data from other
ask questions and receive feedback. and the accuracy of individual claims. ambulance suppliers, associations, or
When possible, ambulance suppliers The appearance of a lack of from payors). Additionally, risk areas
should use ‘‘real’’ examples of independence may hinder the may be identified from the results of the
compliance pitfalls provided by effectiveness of a claims review. audits.
personnel with ‘‘real life’’ experience, Depending on the purpose and scope If a material deficiency is identified
such as emergency medical technicians of a claims review, there are a variety of that could be a potential criminal, civil,
and paramedics. ways to conduct the review. The claims or administrative violation, the
The OIG is cognizant that offering review may focus on particular areas of ambulance supplier may disclose the
interactive, live training often requires interest (e.g., coding accuracy), or it may matter to the OIG via the Provider Self-
significant personnel and time include all aspects of the claims Disclosure Protocol. The Provider Self-
commitments. As appropriate, submission and payment process. The Disclosure Protocol was designed to
ambulance suppliers may wish to universe from which the claims are allow providers/suppliers to disclose
Federal Register / Vol. 68, No. 56 / Monday, March 24, 2003 / Notices 14249

voluntarily potential violations in their tracking processes. A weakness or http://oig.hhs.gov and http://
dealings with the federal health care deficiency in any part of the supplier’s www.arnet.gov/epls, respectively, and
programs. In all cases, identified system can lead to improper claims, contain specific instructions for
overpayments should be reported to the undetected overpayments, or failure to searching the exclusion and debarment
appropriate payor. detect system defects. databases.
Each ambulance supplier should have
a. Pre-Billing Review of Claims computer or other system edits to C. Identification of Risks
As a general matter, ambulance ensure that minimum data requirements
suppliers should review claims on a are met. For example, under CMS’s new This ambulance CPG discusses many
pre-billing basis to identify errors before fee schedule, each transport claim that of the areas that the ambulance
claims are submitted. If there is does not have an originating zip code industry, the OIG, or CMS have
insufficient documentation to support listed should be ‘‘flagged’’ by the identified as common risks for many
the claim, the claim should not be system. Other edits should be ambulance suppliers. However, this
submitted. Pre-billing reviews also established to detect potentially CPG does not identify or discuss all
allow suppliers to review the medical improper claims submissions. A risks that an ambulance supplier may
necessity of their claims. If, as a result systems review is especially important itself identify. Moreover, the CPG may
of the pre-billing claims review process, when documentation or billing ascribe more or less risk to a particular
a pattern of claim submission or coding requirements are modified or when an practice area than an ambulance
errors is identified, the ambulance ambulance supplier changes its billing supplier would encounter based on its
supplier should develop a responsive software or claims vendors. As own internal findings and
action plan to ensure that overpayments appropriate, ambulance suppliers circumstances. Because there are many
are identified and repaid. should communicate with their payor different types of risk areas, ambulance
when they are implementing significant suppliers should prioritize their
b. Paid Claims changes to their system to alert the identified risks to ensure that the
In addition to a pre-billing review, a payor to any unexpected delays, or various areas are addressed
review of paid claims may be necessary increases or decreases in claims
appropriately. Apart from the risks
to determine error rates and quantify submissions.
overpayments and/or underpayments. Ambulance suppliers should ensure identified in this CPG, ambulance
The post-payment review may help that their electronic or computer billing suppliers of all types (e.g., small, large,
ambulance suppliers in identifying systems do not automatically insert rural, emergency, non-emergency)
billing or coding software system information that is not supported by the should evaluate whether they have any
problems. Any overpayments identified documentation of the medical or trip unique risks attendant to their business
from the review should be promptly sheets. For example, billing systems relationships or processes. For example,
returned to the appropriate payor in targeting optimum efficiency may be set a small, rural not-for-profit ambulance
accordance with payor policies. with defaults to indicate that a supplier may identify risk areas
physician’s signature was obtained different from those of a large, for-profit
c. Claims Denials following an emergency room transport. ambulance chain that serves a primarily
Ambulance suppliers should review If information is automatically inserted urban area. To stay abreast of risks
their claims denials periodically to onto a claim submitted for affecting the ambulance and other
determine if denial patterns exist. If a reimbursement, and that information is health care industries, the OIG
pattern of claims denials is detected, the false, the ambulance supplier’s claims recommends that ambulance suppliers
pattern should be evaluated to will be false. If a required field on a review OIG publications regarding
determine the cause and appropriate claim form is missing information, the ambulance services, including OIG
course of action. Employee education system should flag the claim prior to its advisory opinions, OIG fraud alerts and
regarding proper documentation, submission. bulletins, Office of Evaluation and
coding, or medical necessity may be
5. Sanctioned Suppliers Inspections (OEI) reports, and Office of
appropriate. If an ambulance supplier
Federal law prohibits Medicare Audit Services reports, all located on
believes its payor is not adequately
explaining the basis for its denials, the payment for services furnished by an the OIG’s Web site at http://oig.hhs.gov.
ambulance supplier should seek excluded individual, such as an A review of industry-specific trade
clarification in writing. excluded ambulance crew member. publications will also help ambulance
Accordingly, ambulance suppliers suppliers remain current on industry
4. System Reviews and Safeguards should query the OIG and General changes.
Periodic review and testing of a Services Administration (GSA)
D. Response to Identified Risks
supplier’s coding and billing systems exclusion and debarments lists before
are also essential to detect system they employ or contract with new An ambulance supplier should
weaknesses. One reliable systems employees or new contractors. develop a reasonable response to
review method is to analyze in detail Additionally, ambulance suppliers address identified risk areas, including
the entire process by which a claim is should periodically (at least yearly) written protocols and reasonable time
generated, including how a transport is check the OIG and GSA web sites to frames for specific situations.
documented and by whom; how that ensure that they are not employing or Developing timely and appropriate
information is entered into the contracting with individuals or entities
responsive actions demonstrates the
supplier’s automated system (if any); that have been recently convicted of a
supplier’s commitment to address
coding and medical necessity criminal offense related to health care or
determination protocols; billing system who are listed as debarred, suspended, problems and concerns. Determining
processes and controls, including any excluded, or otherwise ineligible for whether identified problems respond to
edits or data entry limitations; and participation in federal health care corrective actions may require continual
finally the claims generation, programs. The OIG and GSA Web sites oversight.
submission, and subsequent payment are listed at
14250 Federal Register / Vol. 68, No. 56 / Monday, March 24, 2003 / Notices

III. Specific Fraud and Abuse Risks from BLS to ALS related to both 3. Scheduled and Unscheduled
Associated With Medicare Ambulance emergency and non-emergency Transports
Coverage and Reimbursement transports. In 1999, for example, an OIG
Requirements investigation determined that an Because of the potential for abuse in
the area of non-emergency transports,
Ambulance suppliers should review ambulance supplier was not only billing
Medicare has criteria for the coverage of
and understand applicable ambulance for ALS services when BLS services
non-emergency scheduled and
coverage requirements. Ambulance were provided, but the ambulance
unscheduled ambulance transports. For
suppliers that are not complying with supplier did not employ an ALS- example, physician certification
applicable requirements should take certified individual to perform the statements (PCS) should be obtained by
appropriate, prompt corrective action to necessary ALS services. This supplier an ambulance supplier to verify that the
follow the relevant requirements. The paid civil penalties and signed a five- transport was medically necessary. The
new fee schedule covers seven levels of year corporate integrity agreement PCSs should provide adequate
service, including Basic Life Support (CIA). information on the transport provided
(BLS), Advanced Life Support, Level 1 for each individual beneficiary, and
(ALS1), Advanced Life Support, Level 2 2. Non-Emergency Transports
each PCS must be signed by an
(ALS2), Specialty Care Transport, There have also been a number of appropriate physician or other
Paramedic ALS Intercept, Fixed Wing Medicare fraud cases involving non- appropriate health care professional.
Air Ambulance, and Rotary Wing Air Except for pre-signed PCSs for
emergency transports (i) to non-covered
Ambulance. Generally, Medicare Part B scheduled, repetitive ambulance
destinations and (ii) that were not
covers ambulance transports if transports, which can be valid for up to
medically necessary. An OIG OEI report,
applicable vehicle and staff 60 days of transport service, pre-signed
requirements, medical necessity issued in December 1998, found that a
high number of non-emergency and/or mass produced PCSs are not
requirements, billing and reporting acceptable because they increase the
requirements, and origin and transports for which Medicare claims
were submitted were medically opportunity for abuse.
destination requirements are met.
Medicare Part B will not pay for unnecessary as defined by Medicare’s Medicare does not cover transports for
ambulance services if Part A has paid criteria. Medicare’s ambulance fee routine doctor and dialysis
directly or indirectly for the same schedule identifies non-emergency appointments when beneficiaries do not
services. transport as appropriate if (i) the meet the Medicare medical necessity
beneficiary is bed-confined and his or requirements. Similarly, ambulance
A. Medical Necessity her medical condition is such that other services that are rendered for
Medically unnecessary transports methods of transportation are convenience or because other methods
have formed the basis for a number of contraindicated, or (ii) the beneficiary’s of more appropriate transportation are
Medicare and Medicaid fraud cases. not available do not meet Medicare’s
medical condition, regardless of bed-
Consequently, medical necessity is a medical necessity requirements and
confinement, is such that transportation
risk area that should be addressed in an claims for such services should not be
by ambulance is medically required.
ambulance supplier’s compliance submitted to Medicare for payment. For
The beneficiary’s medical condition and example, an ambulance supplier was
program. Medicare Part B covers the necessity for ambulance
ambulance services only if the required to pay over $1 million to the
transportation must be documented. In federal government and enter into a CIA
beneficiary’s medical condition determining whether a beneficiary is
contraindicates another means of with the OIG for billing for medically
bed-confined, the following criteria unnecessary ambulance trips and for
transportation. The medical necessity
must be met: (i) The beneficiary must be non-covered ambulance trips to doctors’
requirements vary depending on the
unable to get up from bed without offices.
status of the ambulance transport (i.e.,
emergency transport vs. non-emergency assistance; (ii) the beneficiary must be
unable to ambulate; and (iii) the B. Documentation, Billing, and
transport). If the medical necessity Reporting Risks
requirement is met, Medicare Part B beneficiary must be unable to sit in a
covers ambulance services when a chair or wheelchair (42 CFR 410.40 (d)). Currently, the HCFA 1491 or 1500
beneficiary is transported: The fact that other modes of forms are the approved forms for
• To a hospital, a critical access transportation may not be as readily requesting Medicare payment for
hospital (CAH), or a skilled nursing available or as convenient does not ambulance services. Inadequate or
facility (SNF), from anywhere, including justify coverage for ambulance transport faulty documentation is a key risk area
another acute care facility, or SNF; for a beneficiary who does not meet for ambulance suppliers. The
• To his or her home from a hospital, Medicare’s medical necessity compilation of correct and accurate
CAH, or SNF; requirements. documentation (whether electronic or
• Round trip from a hospital, CAH, or Under no circumstances should hard copy) is generally the
SNF to an outside supplier to receive ambulance suppliers mischaracterize responsibility of all the ambulance
medically necessary therapeutic or personnel, including the dispatcher who
the condition of the patient at the time
diagnostic services; or receives a request for transportation, the
of transport in an effort to claim that the
• To the nearest appropriate renal transport was medically necessary
personnel transporting the patient, and
dialysis facility from his or her home. the coders and billers submitting claims
under Medicare coverage requirements. for reimbursement. When documenting
1. Upcoding If it is unclear whether the service will a service, ambulance personnel should
Ambulance suppliers should be be covered by Medicare, the ambulance not make assumptions or inferences to
careful to bill at the appropriate level for supplier should nonetheless compensate for a lack of information or
services actually provided. The federal appropriately document the condition contradictory information on a trip
government has prosecuted a number of of the patient and maintain records of sheet, ACR, or other medical source
ambulance cases involving upcoding the transport. documents.
Federal Register / Vol. 68, No. 56 / Monday, March 24, 2003 / Notices 14251

To ensure that adequate and requests a transport to a facility other medically necessary services for eligible
appropriate information is documented, than the nearest appropriate facility, the Medicaid recipients. Each state
an ambulance supplier should gather ambulance supplier should inform the establishes its own Medicaid
and record, at a minimum, the patient that he or she may be regulations, which vary depending on
following: responsible for payment of the the state plan. However, two federal
• Dispatch instructions, if any; additional mileage incurred. regulations form the basis for all
• Reasons why transportation by Medicaid reimbursement for
3. Multiple Payors—Coordination of
other means was contraindicated; transportation services and ensure a
• Reasons for selecting the level of Benefits
minimum level of coverage for
service; Ambulance suppliers should make transportation services. First, all states
• Information on the status of the every attempt to determine whether that receive federal Medicaid funds are
individual; Medicare, Medicaid, or other federal required to assure transportation for
• Who ordered the trip; health care programs should be billed as Medicaid recipients to and from
• Time spent on the trip; the primary or as the secondary insurer. medical appointments (42 CFR 431.53).
• Dispatch, arrival at scene, and Claims for payment should not be Second, federal regulations further
destination times; submitted to more than one payor, define medical transportation and
• Mileage traveled; except for purposes of coordinating describe costs that can be reimbursed
• Pickup and destination codes; benefits (e.g., Medicare as secondary with Medicaid funds (42 CFR
• Appropriate zip codes; and payor). Section 1862(b)(6) of the Act (42 440.170(a)).
• Services provided, including drugs U.S.C. 1395y(b)(6)) states that an entity In short, Medicaid often covers
or supplies. that knowingly, willfully, and transports that are not typically covered
1. Healthcare Common Procedure repeatedly fails to provide accurate by Medicare, such as transports in
Coding System (HCPCS) information relating to the availability wheelchair vans, cabs, and ambulettes.
of other health benefit plans shall be However, the transports are subject to
The appropriate HCPCS codes should subject to a civil money penalty (CMP). strict coverage and payment rules. The
be used when submitting claims for The OIG recognizes that there are state Medicaid Fraud Control Units and
reimbursement. The HCPCS codes instances when the secondary payor is federal law enforcement have pursued
reported on the ambulance trip sheets or not known or cannot be determined many fraud cases related to
claim forms should be selected to before the ambulance transportation transportation services billed to
describe most accurately the type of claim is submitted. This may be Medicaid programs. Ambulance
transport provided based on the particularly true for ambulance suppliers should review the Medicaid
patient’s illness, injury, signs, or suppliers that have incomplete regulations governing their state or
symptoms at the time of the ambulance insurance information from a service territories to ensure that any
transport. HCPCS codes should not be transported patient. In such situations, billed services meet applicable
selected based on information relating if an ambulance supplier receives an Medicaid requirements.
to the patient’s past medical history or inappropriate or duplicate payment, the
prior conditions, unless such payment should be refunded to the V. Kickbacks and Inducements
information also specifically relates to appropriate payor in a timely manner. A. What Is the Anti-Kickback Statute?
the patient’s condition at the time of Accordingly, ambulance suppliers
transport. Ambulance suppliers should should develop a system to track and The anti-kickback statute prohibits
use caution not to submit incorrect quantify credit balances to return the purposeful payment of anything of
HCPCS codes on trip sheets or claims to overpayments when they occur. value (i.e., remuneration) in order to
justify reimbursement. induce or reward referrals of federal
C. Medicare Part A Payment for ‘‘Under health care program business, including
2. Origin/Destination Requirements— Arrangements’’ Services Medicare and Medicaid business.12 (See
Loaded Miles section 1128B(b) of the Act (42 U.S.C.
In certain instances, SNFs, hospitals,
Medicare only covers transports for or CAHs, may provide ambulance 1320a–7b).) It is a criminal prohibition
the time that the patient is physically in services ‘‘under arrangements’’ with an that subjects violators to possible
the ambulance. Effective January 1, ambulance supplier. In such cases, the imprisonment and criminal fines. In
2001, ambulance suppliers must furnish SNF, hospital, or CAH is the entity addition, violations of the anti-kickback
the ‘‘point of pickup’’ zip code on each furnishing the transport. Accordingly, statute may give rise to CMPs and
ambulance claim form. Under the new Medicare pays the SNF, hospital, or exclusion from the federal health care
Medicare ambulance fee schedule, the CAH for the service. The SNF, hospital, programs. Both parties to an
point of pickup will determine the or CAH pays the ambulance supplier a impermissible kickback transaction may
mileage payment rate. The ambulance contractually agreed amount. be liable: the party offering or paying
supplier should document the address Ambulance suppliers that provide such the kickback, as well as the party
of the point of pickup to verify that the transports ‘‘under arrangements’’ with a soliciting or receiving it. The key
zip code is accurate. SNF, hospital, or CAH should not bill inquiry under the statute is whether the
The ambulance crew should Medicare for these transports. All such parties intend to pay, or be paid, for
accurately report the mileage traveled arrangements should be carefully referrals. Paying for referrals need not be
from the point of pickup to the reviewed to ensure that there is no the only or primary purpose of a
destination. Medicare covers ambulance violation of the anti-kickback statute, as payment; as courts have found, if any
transports to the nearest available more fully described in section V. one purpose of the payment is to induce
treatment facility. If the nearest facility or reward referrals, the statute is
is not appropriate (e.g., because of traffic IV. Medicaid Ambulance Coverage violated. (See, e.g., United States v.
patterns or an inability to address the The Medicaid program, a joint federal Kats, 871 F.2d 105 (9th Cir. 1989);
patient’s condition), the beneficiary and state health insurance program, United States v. Greber, 760 F.2d 68 (3d
should be taken to the next closest provides funds for health care providers Cir.), cert. denied, 474 U.S. 988 (1985).)
appropriate facility. If a beneficiary and suppliers that perform or deliver In short, an ambulance supplier should
14252 Federal Register / Vol. 68, No. 56 / Monday, March 24, 2003 / Notices

neither make nor accept payments E. For Whom Are Ambulance Suppliers purchasers’ obligations to report the
intended, in whole or in part, to Sources of Referrals? discounts to the federal programs.
generate federal health care program In some circumstances, ambulance Accurate and complete records should
business. suppliers furnishing ambulance services be kept of all discount arrangements.
may be sources of referrals (i.e., Ambulance suppliers should exercise
B. What Are ‘‘Safe Harbors’? caution when selling services to
patients) for hospitals, other receiving
The department has promulgated facilities, and second responders. purchasers who are also in a position to
‘‘safe harbor’’ regulations that describe Ambulance suppliers that furnish other generate federal health care program
payment practices that do not violate types of transportation, such as business for ambulance suppliers (e.g.,
the anti-kickback statute, provided the ambulette or van transportation, also SNFs or hospitals that purchase
payment practice fits squarely within a may be sources of referrals for other ambulance services for private pay and
safe harbor. The safe harbor regulations providers of federal heath care program Part A patients, but refer Part B and
can be found at 42 CFR 1001.952 and on services, such as physician offices, Medicaid patients to ambulance
the OIG Web page at http://oig.hhs.gov/ diagnostic facilities, and certain senior suppliers). Any link or connection,
fraud/safeharborregulations.html#1. centers. In general, ambulance whether explicit or implicit, between
suppliers—particularly those furnishing the price offered for business paid out
Compliance with the safe harbor
emergency services—have relatively of the purchaser’s pocket and referrals
regulations is voluntary. Thus, failure to
limited abilities to generate business for of federal program business billable by
comply with a safe harbor does not
other providers or to inappropriately the ambulance supplier will implicate
mean that an arrangement is illegal.
steer patients to particular emergency the anti-kickback statute.
Rather, arrangements that do not fit in
providers. An ambulance supplier should not
a safe harbor must be analyzed under
offer or provide gifts, free items or
the anti-kickback statute on a case-by- F. How Can Ambulance Suppliers services, or other incentives of greater
case basis to determine if there is a Avoid Risk Under the Anti-Kickback than nominal value to referral sources,
violation. To minimize the risk under Statute? including patients, and should not
the anti-kickback statute, ambulance accept such gifts and benefits from
suppliers should structure arrangements Because of the gravity of the penalties
under the anti-kickback statute, parties soliciting referrals from the
to take advantage of the protection ambulance supplier. In general, token
offered by the safe harbors whenever ambulance suppliers are strongly
encouraged to consult with experienced gifts used on an occasional basis to
possible. Safe harbors that may be demonstrate good will or appreciation
useful for ambulance suppliers include legal counsel about any financial
relationships involving potential referral (e.g., logo key chains, mugs, or pens)
those for space rentals, equipment will be considered to be nominal in
rentals, personal services and sources. In addition, ambulance
suppliers should review OIG guidance value.
management contracts, discounts,
employees, price reductions offered to related to the anti-kickback statute, G. Are There Particular Arrangements to
health plans, shared risk arrangements, including advisory opinions, fraud Which Ambulance Suppliers Should Be
and ambulance restocking alerts, and special advisory bulletins. Alert?
arrangements. (42 CFR 1001.952(b), (c), Ambulance suppliers concerned about
their existing or proposed arrangements Ambulance suppliers should review
(d), (h), (i), (t), (u), and (v), respectively.) the following arrangements with
may obtain binding advisory opinions
C. What Is ‘‘Remuneration’’ for Purposes from the OIG. particular care. (This section is intended
of the Statute? Ambulance suppliers should exercise to be illustrative, not exhaustive, of
common sense when evaluating existing potential areas of risk under the anti-
Under the anti-kickback statute, or prospective arrangements under the kickback and beneficiary inducement
‘‘remuneration’’ means virtually anti-kickback statute. One good rule of statutes.)
anything of value. A prohibited thumb is that all arrangements for items 1. Arrangements for Emergency Medical
kickback payment may be paid in cash or services should be at fair market Services (EMS)
or in kind, directly or indirectly, value in an arms-length transaction not
covertly or overtly. Almost anything of taking into account the volume or value a. Municipal Contracts
value can be a kickback, including, but of existing or potential referrals. For Contracts with cities or other EMS
not limited to, money, goods, services, each arrangement, an ambulance sponsors for the provision of emergency
free or reduced rent, meals, travel, gifts, supplier should carefully and accurately medical services may raise anti-
and investment interests. document how it has determined fair kickback concerns. Ambulance
D. Who Are Referral Sources for market value. As discussed further in suppliers should not offer anything of
Ambulance Suppliers? appendix A.4, an ambulance supplier value to cities or other EMS sponsors in
may not charge Medicare or Medicaid order to secure an EMS contract. (In
Any person or entity in a position to substantially more than its usual charge general, ambulance suppliers may
generate federal health care program to other payors. provide cities or other municipal
business for an ambulance supplier, Ambulance suppliers should consult entities with free or reduced cost EMS
directly or indirectly, is a potential the safe harbor for discounts (42 CFR for uninsured, indigent patients.) In
referral source. Potential referral sources 1001.952(h)) when entering into addition, arrangements that cover both
include, but are not limited to, arrangements involving discounted EMS and non-EMS ambulance business
governmental ‘‘9–1–1’’ or comparable pricing. In most circumstances, should be carefully scrutinized;
emergency medical dispatch systems, ambulance suppliers who offer conditioning EMS services on obtaining
private dispatch systems, first discounts to purchasers who bill federal non-EMS business potentially
responders, hospitals, nursing facilities, programs must fully and accurately implicates the anti-kickback statute.
assisted living facilities, home health disclose the discounts on the invoice, Absent a state or local law requiring a
agencies, physician offices, staff of any coupon, or statement sent to purchasers tie between EMS and non-EMS
of the foregoing entities, and patients. and inform purchasers of the business, ambulance suppliers
Federal Register / Vol. 68, No. 56 / Monday, March 24, 2003 / Notices 14253

contemplating such arrangements arrangements raise issues with respect Prohibited incentives include, without
should consider obtaining an OIG to proper billing for restocked supplies limitation, free goods and services and
advisory opinion. While cities and other and drugs. Payment and coverage rules copayment waivers. The statute
EMS sponsors may charge ambulance are set by the health care program that contains several narrow exceptions,
suppliers amounts to cover the costs of covers the patient (e.g., Medicare or including financial hardship copayment
services provided to the suppliers, they Medicaid). To determine proper billing waivers and incentives to promote the
should not solicit inflated payments in for restocked supplies or drugs, delivery of preventive care services as
exchange for access to EMS patients, ambulance suppliers should consult the defined in regulations. In addition,
including access to dispatch services relevant program payment rules or items or services of nominal value (less
under ‘‘9–1–1’’ or comparable systems. contact the relevant payment entity. than $10 per item or service or $50 in
A city or other political subdivision of Under the Medicare program, in almost the aggregate annually) and any
a state (e.g., fire district, county, or all circumstances the ambulance payment that fits into an anti-kickback
parish) may not require a contracting supplier—not the hospital—will be the safe harbor are permitted.
ambulance supplier to waive party entitled to bill for the restocked An ambulance supplier should not
copayments for its residents, but it may supplies or drugs used in connection routinely waive federal health care
pay uncollected, out-of-pocket with an ambulance transport, even if program copayments (e.g., no
copayments on behalf of its residents. they are obtained through a restocking ‘‘insurance only’’ billing), although the
Such payments may be made through program. However, under the supplier may waive a patient’s
lump sum or periodic payments, if the ambulance fee schedule, supplies and copayment if it makes a good faith,
aggregate payments reasonably drugs are included in the bill for the individualized assessment of the
approximate the otherwise uncollected base rate and are not separately billable. patient’s financial need.(16) Financial
cost-sharing amounts. However, a city Ambulance suppliers should consult hardship waivers may not be routine or
or other political subdivision that owns with their payor to confirm appropriate advertised. As discussed in section G
and operates its own ambulance service billing during the new ambulance fee above, cities and other political
is permitted to waive cost-sharing schedule transition period. subdivisions are permitted to waive
amounts for its residents under a special copayments for services provided
CMS rule. (See CMS Carrier Manual, 2. Arrangements With Other Responders directly to their residents.
section 2309.4; CMS Intermediary In many situations, it is common Subscription or membership programs
Manual, section 3153.3A; see also, e.g., practice for a paramedic intercept or that offer patients purported coverage
OIG Advisory Opinion No. 01–10 and other first responder to treat a patient in only for the ambulance supplier’s
01–11.) the field, with a second responder services are also problematic because
transporting the patient to the hospital. such programs can be used to disguise
b. Ambulance Restocking the routine waiver of cost-sharing
In some cases, the first responder is in
Another common EMS arrangement a position to influence the selection of amounts. To reduce their risk under the
involves the restocking of supplies and the transporting entity. While fair anti-kickback statute, ambulance
drugs used in connection with patients market value payments for services suppliers offering subscription programs
transported to hospitals or other actually provided by the first responder should carefully review them to ensure
emergency receiving facilities. These are appropriate, inflated payments by that the subscription or membership
arrangements typically do not raise anti- ambulance suppliers to generate fees collected from subscribers or
kickback concerns. However, ambulance business are prohibited, and the members, in the aggregate, reasonably
suppliers participating in such government will scrutinize such approximate—from an actuarial or
arrangements can eliminate risk payments to ensure that they are not historical perspective—the amounts that
altogether by complying with the disguised payments to generate calls to the subscribers or members would
ambulance restocking safe harbor at 42 the transporting entity. expect to spend for cost-sharing
CFR 1001.952(v). In general, the safe amounts over the period covered by the
harbor requires that EMS restocking 3. Arrangements With Hospitals and subscription or membership agreement.
arrangements involving free or reduced Nursing Facilities
price supplies or drugs be conducted in Because hospitals and nursing VI. Conclusion
an open, public, and uniform manner, facilities are key sources of non- This ambulance compliance program
although hospitals may elect to restock emergency ambulance business, guidance is intended as a resource for
only certain categories of ambulance ambulance suppliers need to take ambulance suppliers to decrease the
suppliers (e.g., nonprofits or particular care when entering into incidence of fraud and abuse as well as
volunteers). Restocking must be arrangements with such institutions. errors that might occur due to
accurately documented using trip (See section F above.) inadequate training or inadvertent
sheets, patient care reports, patient noncompliance. We encourage
encounter reports, or other 4. Arrangements With Patients ambulance suppliers to scrutinize their
documentation that records the specific Arrangements that offer patients internal practices to ensure the
type and amount of supplies or drugs incentives to select particular development of a comprehensive
used on the transported EMS patient ambulance suppliers may violate the compliance program.
and subsequently restocked. The anti-kickback statute, as well as the Compliance programs should reflect
documentation must be maintained for CMP law that prohibits giving each ambulance supplier’s individual
5 years. The safe harbor also covers fair inducements to Medicare and Medicaid and unique circumstances. It has been
market value restocking arrangements beneficiaries that the giver knows, or the OIG’s experience that those health
and government-mandated restocking should know, are likely to influence the care providers and suppliers that have
arrangements. The safe harbor beneficiary to choose a particular developed compliance programs not
conditions are set forth with specificity practitioner, provider, or supplier of only better understand applicable
in the regulations. items or services payable by Medicare or federal health care program
Wholly apart from anti-kickback Medicaid. (See section 1128A(a)(5) of requirements, but also their own
concerns, ambulance stocking the Act (42 U.S.C. 1320a-7a(a)(5).) internal operations. We are hopeful that
14254 Federal Register / Vol. 68, No. 56 / Monday, March 24, 2003 / Notices

this guidance will be a valuable tool in 4. Billing Medicare ‘‘Substantially in Excess’’ —HHS department or program being affected
the development and continuation of of Usual Charges by your allegation of fraud, waste, abuse/
ambulance suppliers’ compliance Ambulance suppliers generally may not mismanagement: Centers for Medicare and
charge Medicare or Medicaid patients Medicaid Services (formerly Health Care
programs.
substantially more than they usually charge Financing Administration) Indian Health
Appendix A—Additional Risk Areas everyone else. If they do, they are subject to Service Other (please specify)
exclusion by the OIG. This exclusion —Please provide the following information
1. ‘‘No Transport’’ Calls and Pronouncement (however, if you would like your referral
of Death authority is not implicated unless the
supplier’s charge for Medicare or Medicaid to be submitted anonymously, please
If an ambulance supplier responds to an patients is substantially more than its median indicate such in your correspondence or
emergency call, but a patient is not non-Medicare/Medicaid charge. In other phone call): Your Name
transported due to death, three Medicare words, the supplier need not worry unless it Your Street Address
rules apply. If an individual is pronounced is discounting close to half of its non- Your City/County
dead prior to the time the ambulance was Medicare/Medicaid business. Ambulance Your State
requested, there is no payment. If the suppliers should review charging practices Your Zip Code
individual is pronounced dead after the with respect to Medicare and Medicaid Your E-mail Address
ambulance has been requested, but before billing to ensure that they are not charging —Subject/Person/Business/Department that
any services are rendered, a BLS payment Medicare or Medicaid substantially more allegation is against: Name of Subject
will be made and no mileage will be paid. than they usually charge other customers for Title of Subject
If the individual is pronounced dead after comparable services. It is appropriate for an Subject’s Street Address
being loaded into the ambulance, the same ambulance supplier to determine its usual Subject’s City/County
payment rules apply as if the beneficiary charge with reference to its total charges to Subject’s State
were alive. Ambulance suppliers should non-Medicare/Medicaid customers for an Subject’s Zip Code
accurately represent the time of death and ambulance transport (whether or not the —Please provide a brief summary of your
request payment based on the charges are structured as base rate plus allegation and the relevant facts.
aforementioned criteria. mileage or otherwise) and then to compare Appendix C—Carrier Contact
the resulting ‘‘usual charge’’ to its total Information
2. Multiple Patient Transports charge to Medicare (i.e., base rate plus
On occasion, it may be necessary for an mileage) or Medicaid for comparable 1. Medicare
ambulance to transport multiple patients transport. A complete list of contact information
concurrently. If more than one patient is (address, phone number, e-mail address) for
transported concurrently in one ambulance, Appendix B—OIG/HHS Information
Medicare Part A Fiscal Intermediaries,
the amount billed should be consistent with The OIG’s web site (http://oig.hhs.gov) Medicare Part B Carriers, Regional Home
the multiple transport guidelines established contains various links describing the Health Intermediaries, and Durable Medical
by the payor in that region. Under CMS’s following: (1) Authorities and Federal Equipment Regional Carriers can be found on
new fee schedule rules for multiple Register Notices, (2) Publications, (3) the CMS Web site at http://cms.hhs.gov/
transports, Medicare will pay a percentage of Reports, (4) Hearing Testimony, (5) Fraud contacts/incardir.asp.
the payment allowance for the base rate Prevention and Detection, (6) Reading Room,
applicable to the level of care furnished to (7) OIG Organization and (8) Employment 2. Medicaid
the Medicare beneficiary (e.g., if two patients Opportunities. Such information is Contact information (address, phone
are transported simultaneously, 75 percent of frequently updated and is a useful tool for number, e-mail address) for each state
the applicable base rate will be reimbursed ambulance providers seeking additional OIG Medicaid director can be found on the CMS
for each of the Medicare beneficiaries). resources. Web site at http://cms.hhs.gov/medicaid/
Coinsurance and deductible amounts will Also listed on the OIG’s web site is the OIG mcontact.asp. In addition to a list of state
apply to the prorated amounts. Hotline Number. One method for providers Medicaid directors, the Web site includes
to report potential fraud, waste and abuse is contact information for each state survey
3. Multiple Ambulances Called to Respond agency and the CMS Regional Offices.
to contact the OIG Hotline number. All HHS
to Emergency Call
and contractor employees have a
On occasion, more than one ambulance 3. Ambulance Fee Schedule
responsibility to assist in combating fraud,
supplier responds to an emergency call and waste, and abuse in all departmental Information related to the development of
is present to transport a beneficiary. These programs. As such, providers are encouraged the ambulance fee schedule is located at
are often referred to as ‘‘dual transports.’’ In to report matters involving fraud, waste and http://cms.hhs.gov/suppliers/afs/default.asp.
such cases, only the transporting ambulance mismanagement in any departmental Appendix D—Internet Resources
supplier may bill Medicare for the service program to the OIG. The OIG maintains a
provided. If payment is desired for services hotline that offers a confidential means for 1. Centers for Medicare and Medicaid
provided to a patient, the non-transporting reporting these matters. Services
ambulance company should receive it The CMS Web site (http://cms.hhs.gov/)
directly from the transporting supplier based Contacting the OIG Hotline
includes information on a wide array of
on a negotiated arrangement. These payments By Phone: 1–800–HHS–TIPS (1–800–447– topics, including Medicare’s National
should be fair market value for services 8477). Coverage Database, National Coverage
actually rendered by the non-transporting By Fax: 1–800–223–8164. Policies, Laws and Regulations and State
supplier, and the parties should review these By E-Mail: Htips@oig.hhs.gov. Waiver and Demonstration Programs. In
payment arrangements for compliance with By TTY: 1–800–377–4950. addition, this Web site contains information
the anti-kickback statute. On occasion, when By Mail: Office of Inspector General, related to Medicaid including a General
multiple ambulance crews respond to a call, Department of Health and Human Services, Medicaid Overview, State and Federal Health
a BLS ambulance may provide the transport, Attn: HOTLINE, 330 Independence Ave., Program Contacts, State Medicaid Manual,
but the level of services provided may be at SW., Washington, DC 20201. State Medicaid Plans, State Waivers and
the ALS level. If a BLS supplier is billing at When contacting the hotline, please Demonstration Programs, Letters to State
the ALS level because of services furnished provide the following information to the best Officials, and CMS Publications.
by an additional ALS crew member, of your ability:
appropriate documentation should —Type of Complaint: Medicare Part A 2. CMS Medicare Training
accompany the claim to indicate to the payor Medicare Part B This CMS Web site (http://
that dual transportation was provided. In any Indian Health Service www.cms.hhs.gov/medlearn/cbts.asp)
event, only one supplier may submit the TRICARE provides computer-based training related to
claim for payment. Other (please specify) CMS’s purpose and history, the three types
Federal Register / Vol. 68, No. 56 / Monday, March 24, 2003 / Notices 14255

of Medicare coverage, the roles agencies and 6. OEI–09–95–00412, available on the Dated: February 14, 2003.
contractors play, and the claims handling OIG’s Web site at http://oig.hhs.gov/oei. Janet Rehnquist,
process. 7. CMS Program Memorandum B–00–09
Inspector General.
describes different options for ambulance
3. Government Printing Office (GPO) suppliers having difficulty obtaining PCSs. [FR Doc. 03–6866 Filed 3–21–03; 8:45 am]
The GPO Web site (http:// (See 42 CFR 410.40(d)(3)(iii) and (iv).) A PCS BILLING CODE 4152–01–P
www.access.gpo.gov) provides access to is not required, for beneficiaries who are not
federal statutes and regulations pertaining to under the direct care of a physician, whether
federal health care programs. the beneficiary resides at home or in a DEPARTMENT OF HEALTH AND
facility. Id. Section 410.40(d)(3)(ii).
4. The U.S. House of Representatives Internet HUMAN SERVICES
8. 42 CFR 410.42(d).
Library 9. On December 28, 2000, the Department
Substance Abuse and Mental Health
The U.S. House of Representatives Internet of Health and Human Services (HHS)
Library Web site (http://.uscode.house.gov/ released its final rule implementing the Services Administration
usc.htm) provides access to the United States privacy provisions of the Health Insurance
Code, which contains laws pertaining to Portability and Accountability Act of 1996. Agency Information Collection
federal health care programs. The rule became effective in April 2001, and Activities: Proposed Collection;
regulates access, use, and disclosure of Comment Request
Endnotes: personally identifiable health information by
1. To date, the OIG has issued compliance covered entities (health providers, plans, and In compliance with section
program guidance for the following nine clearinghouses). Guidance on an ambulance 3506(c)(2)(A) of the Paperwork
industry sectors: (1) Hospitals; (2) clinical supplier’s compliance with the HHS Privacy Reduction Act of 1995 concerning
laboratories; (3) home health agencies; (4) Regulations is beyond the scope of this CPG; opportunity for public comment on
durable medical equipment suppliers; (5) however, it will be the responsibility of proposed collections of information, the
third-party medical billing companies; (6) ambulance suppliers to comply. Most health Substance Abuse and Mental Health
hospices; (7) Medicare+Choice organizations plans and providers must comply with the Services Administration will publish
offering coordinated care plans; (8) nursing rule by April 14, 2003. In the meantime, periodic summaries of proposed
facilities; and (9) individual and small group many organizations are considering and
projects. To request more information
physician practices. The guidances listed analyzing the privacy issues.
here and referenced in this document are 10. Loaded miles refers to the number of on the proposed projects or to obtain a
available on the OIG Web site at http:// miles that the patient is physically on board copy of the information collection
oig.hhs.gov in the Fraud Prevention and the ambulance. plans, call the SAMHSA Reports
Detection section. 11. HCFA Program Memorandum Clearance Officer on (301) 443–7978.
2. The CMS’s final ambulance fee schedule Transmittal AB–00–118, issued on November Comments are invited on: (a) Whether
rule was published in the Federal Register 30, 2000. the proposed collections of information
on February 27, 2002 (67 FR 9100) and went 12. In addition to Medicare and Medicaid, are necessary for the proper
into effect on April 1, 2002. the federal health care programs include, but performance of the functions of the
3. The term ‘‘universe’’ is used in this CPG are not limited to, TRICARE, Veterans Health agency, including whether the
to mean the generally accepted definition of Care, Public Health Service programs, and
the term for purposes of performing a the Indian Health Services.
information shall have practical utility;
statistical analysis. Specifically, the term 13. The procedures for applying for an (b) the accuracy of the agency’s estimate
‘‘universe’’ means the total number of advisory opinion are set forth at 42 CFR part of the burden of the proposed collection
sampling units from which the sample was 1008. and on the OIG Web page at http:// of information; (c) ways to enhance the
selected. www.oig.hhs.gov/fraud/ quality, utility, and clarity of the
4. The OIG encourages that providers/ advisoryopinions.html#3. All OIG advisory information to be collected; and (d)
suppliers police themselves, correct opinions are published on the OIG web page. ways to minimize the burden of the
underlying problems, and work with the A number of published opinions involving collection of information on
government to resolve any problematic ambulance arrangements provide useful respondents, including through the use
practices. The OIG’s Provider Self-Disclosure guidance for ambulance suppliers. These
Protocol, published in the Federal Register include OIG Advisory Opinions Nos. 97–6,
of automated collection techniques or
on October 30, 1998 (63 FR 58399), sets forth 98–3, 98–7, 98–13, 99–1, 99–2, 99–5, 00–7, other forms of information technology.
the steps, including a detailed audit 00–9, 00–11, 01–10, 01–11, 01–12, 01–18, Proposed Project: National Cross-Site
methodology, that may be undertaken if 02–2, 02–3, 02–8, and 02–15. Other advisory Assessment of the Addiction
suppliers wish to work openly and opinions not specifically involving
cooperatively with the OIG. The Provider ambulance arrangements may also provide
Technology Transfer
Self-Disclosure Protocol is open to all health useful guidance. Centers Network—(OMB No. 0930–
care providers and other entities and is 14. See 65 FR 24400; April 26, 2000. 0216, Revision—The Substance Abuse
intended to facilitate the resolution of 15. See Special Advisory Bulletin: Offering and Mental Health Administration’s
matters that, in the provider’s reasonable Gifts and Other Inducement to Beneficiaries, (SAMHSA) Center for Substance Abuse
assessment, may potentially violate federal located on the OIG Web page at http:// Treatment (CSAT) intends to continue
criminal, civil, or administrative laws. The www.oig.hhs.gov/fraud/fraudalerts.html#2.
Provider Self-Disclosure Protocol is not 16. See Special Fraud Alert: Routine
an assessment of its Addiction
intended to resolve simple mistakes or Waiver of Copayments or Deductibles Under Technology Transfer Centers (ATTCs).
overpayment problems. The OIG’s Self- Medicare Part B (59 FR 65372, 65374 (1994)), The data collection instruments are
Disclosure Protocol can be found on the OIG located on the OIG Web page at http:// being modified, and the methodology
Web site at http://oig.hhs.gov. www.oig.hhs.gov/fraud/fraudalerts.html#1. will be updated to comply with CSAT’s
5. Ambulance suppliers should read the 17. The OIG may exclude from new Government Performance and
OIG’s September 1999 Special Advisory participation in the federal health care Results Act (GPRA) requirements. CSAT
Bulletin, entitled ‘‘The Effect of Exclusion programs any provider that submits or causes is requiring all of its programs to use
From Participation in the Federal Health Care to be submitted bills or requests for payment standard GPRA Customer Satisfaction
Programs,’’ published in the Federal Register (based on charges or costs) under Medicare
on October 7, 1999 (64 FR 58851), which is or Medicaid that are substantially in excess
forms for training, technical assistance
located at http://oig.hhs.gov/frdalrt, for more of such providers’ usual charges or costs, and meeting events, approved by OMB
information regarding excluded individuals unless the Secretary finds good cause for under OMB control number 0930–0197.
and entities and the effect of employing or such bills or requests. (See section 1128(b)(6) In response to these new requirements,
contracting with such individuals or entities. of the Act (42 U.S.C. 1320a–7(b)(6)).) the ATTC Network will modify the