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UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF FLORIDA
TAMPA DIVISION

UNITED STATES OF AMERICA
ex rel . JANE DOE,
Plaintiffs,
v.

CASE NO. 8:03-CV-1813-T-27TGW

ACCULAB LABORATORIES, INC.,
(a Florida Corporation, Dissolved),
ACCULAB LABORATORIES, INC.,
(a Nevada Corporation), JOSEPH T.
DEGREGORIO,

DEMAND FOR JURY TRIAL

/

Defendants.

FIRST AMENDED COMPLAINT
OF THE UNITED STATES OF AMERICA
Comes now the United States of America, through Paul I. Perez, United States
Attorney for the Middle District of Florida, and his undersigned Assistant U. S. Attorney,
and states as follows:
I. INTRODUCTION
1.

On August 22, 2003, Relator Jane Doe, filed a Complaint under seal,

under the qui tam provisions of the False Claims Act, 31 U.S.C. §§ 3729-3733, against
Defendant Acculab Laboratories, Inc.
2.

On July 10, 2006, Plaintiff United States of America filed its Notice of

Intervention.
3.

This is an action for treble damages and civil penalties under the False

Claims Act, and in the alternative, for money damages for common law fraud, unjust
enrichment, and payment by mistake of fact, due as a consequence of those

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Defendants having knowingly participated in a scheme or plan for the submission of
false claims for payment by the United States. The United States also seeks prejudgment and post-judgment remedies pursuant to 28 U.S.C. §§ 3001-3308.
II. JURISDICTION AND VENUE
4.

This action arises under the False Claims Act, as amended, 31 U.S.C.

§§ 3729-3733, and at common law. This Court has subject matter jurisdiction under 28
U.S.C. § 1345 and 31 U.S.C. § 3732(a).
5.

This Court has personal jurisdiction over the Defendants because all of

the Defendants can be found, reside, or transact business or have their principal place
of business in Sarasota, Florida, within the Middle District of Florida, Tampa Division.
6.

This Court has venue under 28 U.S.C. .§ 1391(b) and under 31 U.S.C.

§ 3732(a).
III. THE PARTIES
7.

The Plaintiffs are the United States of America (“Government”) and

Relator Jane Doe. The United States acts on behalf of the Department of Health and
Human Services (“HHS”). The Secretary of HHS administers the Medicare Program
through the Health Care Financing Administration (“HCFA”), now known as the Centers
for Medicare and Medicaid Services (“CMS”), an agency of HHS. At all times relevant
to this First Amended Complaint, HHS, through HCFA, now CMS, administered the
Medicare Part B Program for the processing of claims and reimbursement for clinical
laboratory services through contracts with private insurance companies called “carriers.”
8.

Relator Jane Doe was employed by Defendant Acculab as a

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phlebotomist during the relevant time period of this First Amended Complaint. Ms. Doe
was responsible for drawing patients blood pursuant to physician orders and handling
the requisition forms that were sent to Acculab’s main laboratory and billing office
located in Sarasota, Florida.
9.

Defendant Acculab Laboratories, Inc., a Florida corporation formerly

known as Multi-Tech Laboratories, Inc., was incorporated in Florida on or about July 16,
1996, through on or about January 22, 2002, at which time the corporation was
dissolved by Defendant DeGregorio.
10.

Defendant Acculab Laboratories, Inc., a Nevada corporation, was

incorporated by Defendant DeGregorio in Nevada on or about May 26, 2000.
11.

Defendant Acculab Laboratories, Inc., a Nevada corporation, on or about

January 22, 2002, applied for and received, simultaneous with the dissolution of
Acculab Laboratories, Inc., a Florida corporation, authorization from the state of Florida
to conduct business in Florida as a foreign corporation doing business under the name
Acculab Laboratories, Inc., a Nevada corporation.
12.

At all times relevant to this First Amended Complaint, Acculab

Laboratories, Inc., a Florida corporation, and Acculab Laboratories, Inc., a Nevada
corporation, hereinafter referred to as “Acculab,” conducted business with its principal
office and main laboratory located in Sarasota, Florida.
13.

Acculab has phlebotomy draw stations throughout the state of Florida and

specifically along the west coast of Florida. The blood vials along with the patient
requisition forms are sent from the phlebotomy draw stations to the main office in
Sarasota for the tests to be performed.
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14.

Defendant Acculab sends claims for reimbursement to Medicare under

its Medicare Provider Number L8626. Medicare records show that Acculab applied for
and has been an eligible Medicare provider (“Provider”) from on or about 1996, using
provider number L8626 which was previously issued to Multi-Tech Laboratories, Inc., in
1992. Acculab continued the use of this same Medicare provider number until August
30, 2006, at which time Medicare issued a Notice of Suspension letter.
15.

A HCFA Electronic Data Exchange (“EDI”) Enrollment Form was

submitted by Defendant Acculab and signed by Defendant DeGregorio on or about
June 10, 1997, which allows the provider to submit claims electronically.
16.

Defendant Joseph T. DeGregorio (“DeGregorio”) is President and owner

of Acculab, a Florida corporation, formally known as Multi-Tech Laboratories, and
Acculab, a Nevada corporation. At all times relevant to this First Amended Complaint,
Degregorio personally directed the billing and had control over all the Medicare claims
submitted to the Government for reimbursement. DeGregorio’s principal place of
residence is located in Sarasota, Florida.
17.

Blue Cross and Blue Shield, Inc., of Florida (“BC/BS of Florida”), a

contracted carrier, administered the Medicare Part B Program for claims arising in the
state of Florida. In or about 1999, BC/BS of Florida formed a wholly-owned subsidiary,
First Coast Service Options, Inc. (“First Coast”), which thereafter administered the
Medicare Part B Program for claims arising in Florida.
18.

First Coast received, adjudicated, and paid “assigned claims” submitted

by providers in Florida. Assigned claims were claims for which the provider could
obtain payment directly from the carrier instead of the Medicare beneficiary.
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19.

CMS regulates all laboratory testing, except research performed on

humans, through the Clinical Laboratory Improvement Amendments (“CLIA”)
Congress passed the CLIA in 1988, establishing quality standards for all laboratory
testing to ensure the accuracy, reliability and timeliness of patient test results
regardless of where the test was performed. A laboratory is defined as any facility
which performs laboratory testing on specimens derived from humans for the purpose
of providing information for the diagnosis, prevention, treatment of diseases, or
impairment for the assessment of health. Acculab operated its clinical laboratory under
CLIA No. 10D0709020.
20.

CMS separately contracts with private organizations, or Program

Safeguard Contractors (“PSC”), to aid in ensuring the integrity of the Medicare Program
through data analysis, medical reviews, and administrative recovery of funds. During
the relevant time period of this First Amended Complaint, CMS contracted with two
PSC companies to conduct reviews on Medicare providers in the state of Florida,
specifically, TriCenturion, LLC. (“TriCenturion”) and Electronic Data Systems, Inc.
(“EDS”).
IV. STATUTORY AND REGULATORY BACKGROUND
THE MEDICARE PART B PROGRAM
21.

Plaintiff, the United States of America, through HHS, administers the

Supplementary Medical Insurance Program for the Aged and Disabled established in
1965 by Title XVIII, of the Social Security Act under 42 U.S.C. §§ 1395, et seq. HHS
has delegated the administration of the Medicare Program to its component agency,

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HCFA/CMS.
22.

Medicare supplementary medical insurance, or the Medicare Part B

Program, is a one hundred (100) percent federally subsidized health insurance system
for disabled persons or persons who are 65 years of age or older.
23.

Under 42 U.S.C. §1395k(a)(2)(B), the benefits covered by Part B of the

Medicare Program include medical treatment and services when ordered by a
physician. Medicare Part B reimburses 100 percent of the reasonable and customary,
and therefore allowable, charges for most medically necessary services provided by a
clinical laboratory. (Medicare Claims Processing Manual, Chapter 16 - Laboratory
Services, Section 30-2).
24.

Reimbursement for Medicare claims is made by the United States through

HHS. HHS, through HCFA/CMS, assigns the task of Medicare Part B claims from the
Medicare Trust Fund through private insurance “carriers” under 42 U.S.C. § 1395u.
25.

One such carrier is First Coast, a wholly owned subsidiary of Blue Cross

and Blue Shield of Florida, Inc. First Coast began administering the Medicare Part B
program for Florida including clinical laboratory services in 1999. To perform its duties,
First Coast relies upon, in part, a CMS publication known as the Medicare Carriers
Manual, an administrative manual that instructs carriers how to administer the Medicare
Part B Program.
26.

Medical treatment and services are reimbursable under the Medicare

Part B Program only if the services provided are reasonable and medically necessary.
The provider seeking reimbursement, however, must meet certain obligations. These

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obligations are to:

27.

a.

bill Medicare for only reasonable and necessary medical services,
42 U.S.C. § 1395y(a)(1)(a);

b.

not make false statements or misrepresentations of material facts
concerning requests for payment under Medicare. 42 U.S.C.
§§ 1320a-7b(a)(1)(2), 1320a-7, 1320a-7a; 42 C.F.R.
§ 1001.101(a)(1);

c.

provide economical medical services, and then, only where
medically necessary. 42 U.S.C. § 1320c-5(a)(1);

d.

provide evidence that the service given is medically necessary. 42
U.S.C. § 1320c-5(a)(3);

e.

assure that such services are not substantially in excess of the
needs of such patients. 42 U.S.C. § 1320a-7(b)(6)(8);

f.

certify when presenting a claim that the service provided is a
medical necessity. 41 U.S.C. § 1395n(a)(2)(8).

All diagnostic laboratory tests, and other diagnostic tests, must be ordered

by the physician who is treating the beneficiary, that is, the physician who furnishes a
consultation or treats a beneficiary for a specific medical problem. Tests not ordered by
the physician who is treating the beneficiary are not reasonable and necessary. 42
C.F.R. § 410.32(a).
28.

At all times relevant to this First Amended Complaint, HHS, through

HCFA/CMS, administered the Medicare Part B Program reimbursement for clinical
laboratories in the State of Florida through its “carrier,” BC/BS of Florida, and its
wholly-owned subsidiary, First Coast. First Coast made payment on those claims
submitted, or caused to be submitted, by Defendant DeGregorio through Defendant
Acculab, for Medicare Part B clinical laboratory tests and services. First Coast made
payment on those claims which appeared to be eligible for reimbursement under the
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Medicare Part B Program, utilizing Federal funds.
V. GENERAL ALLEGATIONS OF CONDUCT
29.

Defendant Acculab’s billing office and laboratory is located in Sarasota,

Florida. Acculab has phlebotomy draw stations throughout the state of Florida and
specifically along the west coast of Florida. Acculab employed phlebotomists who were
responsible for drawing patients’ blood pursuant to physician orders and handling the
requisition forms that were sent to the main billing office in Sarasota along with the vials
of blood. Couriers employed by Acculab would pick up and deliver these items on a
daily basis.
30.

Defendant DeGregorio submitted claims (“HCFA 1500") electronically to

the Medicare Part B Program and through his wholly-owned corporation, Defendant
Acculab. DeGregorio agreed in the electronic enrollment form application with
Medicare, among other things, that DeGregorio would be responsible for all Medicare
claims submitted to HCFA/CMS relating to Acculab’s clinical laboratory services,
whether submitted personally by DeGregorio, or by employees or agents of Acculab,
and that DeGregorio would submit claims that were accurate, complete and truthful.
31.

For a HCFA 1500 claim to be paid by the Medicare Part B Program, it

must identify each service rendered to a patient by a corresponding code for such
services listed in an American Medical Association publication called the Current
Procedural Terminology (“CPT”). The CPT was a systematic listing of codes for
procedures and services performed by or at the direction of the physicians. Each
procedure or service was identified by a five-digit code.
32.

The American Medical Association publishes an International
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Classification of Diseases (“ICD-9") coding manual, which identifies every medical
condition and assigns a unique numeric identifier for each medical condition. In order
to receive reimbursement from Medicare, a HCFA 1500 claim form must identify (a) the
CPT code the provider is billing for and (b) the corresponding ICD-9 code that identifies
the patient’s medical condition and the medical necessity for the service rendered.
33.

Jane Doe, the Relator, is a phlebotomist who was employed by Acculab

during the relevant time period of this First Amended Complaint. Almost immediately,
she questioned Acculab’s procedure for recording patient medical information on
requisition forms. Rather than the standard procedure, where the physician diagnosing
a patient determines the medical diagnosis or ICD-9 code for the patient, Acculab
management directed her to enter ICD-9 diagnosis codes on patient requisition forms
when there was no diagnosis code listed, and to change ICD-9 diagnosis codes when
the diagnosis code had been rejected as not payable. The Relator was instructed to do
this without the benefit of any medical records or any knowledge of the patient’s true
diagnosis.
34.

The Relator alleges this practice of changing or creating diagnosis codes

ultimately tampered with and altered the patient’s permanent medical histories. As an
example, the Relator was ordered on many occasions to enter a diagnosis of prostate
cancer in order to cover a prostate specific antigen (“PSA”) test despite the fact the
patient may not have had cancer. The same was true for tests for breast cancer and
ovarian cancer. The diagnosis of actually having cancer was placed on the patient’s
requisition form in order to ensure the test would be paid for.
35.

The Relator alleges that the Acculab phlebotomy draw stations were
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provided with “cheat sheets” that listed all of the various payable ICD-9 diagnosis codes
that the phlebotomist could use to fill in the patient medical history on the requisition
forms instead of contacting the referring doctor.
36.

Unbundling of services occurs when procedures or lab tests involve a

number of related services or tests that are typically performed and reimbursed
together, but have been manipulated in such a way that more lucrative reimbursement
is received for each test separately. Medicare has specific CPT codes that must be
used to obtain reimbursement for multiple laboratory tests performed on the same day
as a whole rather than allowing reimbursement for each of the tests separately.
Defendant DeGregorio and others, through Defendant Acculab, would and did design
and install computer software programs that unbundled CPT codes and changed ICD-9
codes on claims submitted to Medicare in order to maximize reimbursement from the
Medicare Program.
37.

All diagnostic laboratory tests must be ordered by the physician who is

treating the beneficiary for a specific medical problem. The physician uses the results
of these tests in the management of the beneficiary’s specific medical problem. Tests
not ordered by the physician who is treating the beneficiary are not reasonable and
necessary. Defendant DeGregorio and others, through Defendant Acculab,
fraudulently submitted or caused to be submitted, claims for reimbursement to the
Medicare Part B Program for clinical laboratory services and tests that were never
ordered by the physician or that were in excess of what the physician ordered.

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COUNT ONE
False Claims Act Conspiracy
( 31 U.S.C. § 3729 (a)(3))
38.

The United States realleges and incorporates by reference all preceding

paragraphs of this First Amended Complaint as if fully set forth.
39.

Through the acts described above and otherwise, the Defendants

knowingly entered into a conspiracy among themselves and with others to defraud the
United States Government by seeking and receiving, or causing to be sought and
received, payment of false and/or fraudulent claims. Defendants and their coconspirators have also conspired to omit disclosing or to actively conceal facts which, if
known, would have reduced government obligations to the Defendants or resulted in
repayments from the Defendants to government programs, and Defendants have taken
substantial steps in furtherance of these conspiracies by, among other things, preparing
or causing to be prepared false records and statements and by submitting or causing to
be submitted such records and statements to the government for payment thereon.
40.

By reason of Defendants’ conspiracy and the acts taken in furtherance

thereof, the United States has been damaged by a significant loss of funds, the exact
amount of which is yet to be fully established.
41.

The manner and means of the Defendants’ conspiracy to defraud the

United States, by deceit, craft, trickery, and dishonest means, is set forth with more
particularity in the following specific overt acts, which Defendants committed in the
Middle District of Florida. As a result of the false and fraudulent claims submitted, or
caused to be submitted, by the Defendants, the United States, through its carriers, paid
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the claims, resulting in damages to the United States. The following outlines the
manner and means of the conspiracy:
(1)

On or about January 1, 1993, Defendant DeGregorio, signed a

Medicare Part B Participating Physician or Supplier Agreement as “authorized
representative of the participating organization” for Medicare Provider No. L8626.
(2)

On or about January 1, 2000 and continuing through August 31,

2006, Defendant DeGregorio, and others, billed or caused to be billed, false and
fraudulent claims to the Medicare Part B Program and were paid the following amounts:

(3)

Year 2000

Amount Paid

$2,021,793.87

Year 2001

Amount Paid

$l,973,016.91

Year 2002

Amount Paid

$2,230,288.78

Year 2003

Amount Paid

$3,189,445.99

Year 2004

Amount Paid

$3,333,360.66

Year 2005

Amount Paid

$2,866,099.73

Year 2006(partial) Amount Paid

$1,573,952.00

Defendant DeGregorio, and others, well knew that the false and

fraudulent claims submitted or caused to be submitted to Medicare by Defendants,
resulting in payment of federal funds in excess of seventeen million dollars
($17,000,000), arose from and related to clinical laboratory services and tests that were
fraudulently unbundled, clinical laboratory services and tests that were never ordered
by the physician or in excess of what the physician ordered, and clinical laboratory
services and tests based on manipulated and fabricated patient CPT and ICD-9
diagnosis codes.
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(4)

On or about June 4, 2003, TriCenturion conducted a statistical sampling

of claims submitted by Defendant Acculab under Medicare Provider No L8626 for the
time period January 1, 2000 through June 30, 2001. The sample consisted of a
medical review for thirty-five (35) Medicare beneficiaries and included a sample for one
clinical laboratory test billed under CPT code 83721 - Lipoprotein, direct measurement;
LDL Cholesterol. The purpose of the review was to determine if the services billed to
Medicare were ordered by a physician, documented as having been performed,
appropriately coded, medically reasonable and necessary for the care and treatment of
the patient, and covered services under the Medicare Part B. Program.
(5)

On or about December 31, 2003, TriCenturion sent a letter to Defendant

Acculab informing the provider that the medical review revealed the services for all
thirty-five (35) Medicare beneficiaries were not supported by the documentation
submitted. Further, the letter states in part, ”Our findings indicate that you did submit
claims for services that were not medically necessary and for services that were not
provided, using improper information to receive payment.” An overpayment of
$298,324.10 was assessed based on the denial of these claims.
(6)

On or about January 19, 2004, Defendant Acculab’s General Counsel,

Roy W. Howard, wrote a letter to TriCenturion stating in part, ”Acculab disputes all of
the findings in the determination of the overpayment request.” Additionally, Mr.
Howard states that the overpayment should not be enforced simply because of
inadequate documentation.
(7)

On or about January 23, 2004, four days later, Defendant Acculab’s

General Counsel, Roy W. Howard, wrote a letter to TriCenturion stating in part, ”As a
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result of your letter, Acculab investigated, discovered and hereby acknowledges it has
an error in its billing computer coding for the time period covered by the 35 sample
beneficiaries. The code for a direct LDL test was inadvertently used not only for direct
LDL’s, but also for calculated LDL’s.”
(8)

On or about February 5, 2004, TriCenturion wrote a letter to Acculab

agreeing to reconsider the medical review and give credit for five (5) of the thirty-five
(35) denied claims. The new adjusted overpayment amount was $241,892.54. For this
medical review the error rate is approximately 88%.
(9)

On or about January 20, 2005, Confidential Witness #4 (“CW4") was

interviewed. CW4 was employed as a phlebotomist and was instructed by
management to enter diagnosis codes and change diagnosis codes on patient lab
requisition forms. Further, on many occasions, blood drawn from patients would sit for
such a long period of time that it would no longer be good for testing. Employees would
contact the patient to come in for a second blood draw and Medicare would be billed for
both tests. According to CW4 this happened approximately 50% of the time.
(10)

On or about February 7, 2005, Confidential Witness #5 (“CW5") was

interviewed. CW5 was employed by Acculab as a phlebotomist. CW5 stated that
employees were directed by management to enter payable diagnosis codes on patient
requisition forms and to change diagnosis codes on patient requisition forms without
regard to the accuracy of the codes or the compensability of the procedures. CW5
stated there was a “cheat sheet” that employees were instructed to use to fill in or
change diagnosis codes on Medicare patients.
(11)

On or about February 18, 2005, Confidential Witness #6 (“CW6") was
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interviewed. CW6 was employed at Acculab as a phlebotomist. CW6 was provided a
cheat sheet and instructed by management to change or add diagnosis codes on
patient lab requisition forms without regard to the accuracy of the codes or the
compensability of the procedures. CW6 refused to do so since he/she knew it was
wrong.
(12)

On or about March 8, 2005, Acculab’s General Counsel, Roy W.

Howard, contacted the HHS-OIG in Clearwater, Florida, pursuant to interviews being
conducted with former Acculab employees.
(13)

On or about May 4, 2005, Confidential Witness #2 (“CW2") was

interviewed. CW2 was a former employee of Acculab employed as an office manager.
CW2 advised that Defendant DeGregorio solely handled and administered all of the
Medicare billings and that data entry clerks were employed as a front or cover-up.
DeGregorio would arrive at the business late at night, download the Medicare billing
data, place it on a separate computer and change the billing codes sent to Medicare.
(14)

On or about May 12, 2005, Confidential Witness #7 (“CW7") was

interviewed. CW7 was a former employee of Acculab and stated CW7 was told that if
Medicare billings were rejected that Defendant DeGregorio changed the codes at night.
(15)

On or about March 26, 2006, Confidential Witness #8 (“CW8") was

interviewed. CW8 was employed as a phlebotomist at Acculab. CW8 stated that
Acculab performed lab tests on patients without the required physician’s order. CW8
stated that Acculab employees would provide lab work to patients that would walk in
without a physician’s order. Acculab would fill out the lab requisition forms and bill
Medicare by using the Unique Physician Identifying Number (UPIN) and name of
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another physician in the files that was not the patient’s physician.
(16)

On or about April 25, 2006, at the request of HHS-OIG, EDS conducted

a statistically valid random sample and medical review on claims submitted by Acculab
under Medicare Provider No L8626 for the year 1/1/2003 through 12/31/2003. The
purpose of the review was to determine if the allegations of unbundling, billing for
services not ordered by the physician, changing diagnosis codes and non-rendered and
medically unnecessary services were being submitted to the Medicare Part B Program
were true. The Medical Review Report states that the medical review was performed
on claims for thirty (30) beneficiaries, sixty-two (62) claims and two hundred and thirty
seven (237) services. The report further states that fourteen (14) of the sixty-two (62)
claims reviewed were allowed, forty-six (46) of the sixty-two claims were denied in full,
and two (2) of the sixty-two (62) claims were partially denied. Of the two hundred and
thirty seven (237) services reviewed, two-hundred and seven (207) were denied for an
error rate of approximately 87%.
(17) On or about April 27, 2006, Confidential Witness #1 (“CW1") was
interviewed and provided the following information. CW1 was a former
officer/employee of Acculab and stated that Defendant DeGregorio makes all of his
money committing Medicare fraud. CW1 further testified that DeGregorio developed a
software program “in house” that would find the best paying ICD9 diagnosis codes and
match the codes with CPT procedure codes billed. If the ICD-9 codes that the doctor
wrote on the lab requisition form did not pay as well, the software changed the code
and generated a higher paying ICD-9 code to bill to Medicare. It didn’t matter what the
billing clerks entered into the system because DeGregario would change the Medicare
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billing through the fraudulent software program installed on the computer.
(18)

On or about May 16, 2006, at the request of HHS-OIG, EDS conducted

an additional medical review on claims submitted by Acculab under Medicare Provider
No L8626 during the year 2004. The medical review consisted of seven (7)
beneficiaries, forty-nine (49) claims, and two hundred and five (205) services. The
purpose of the review was to determine if allegations of unbundling, changing diagnosis
codes, performing services different than those ordered by the physician, and billing for
non-rendered services and medically unnecessary services were true. The report
further states that seven (7) of the forty-nine (49) claims reviewed were allowed, thirtytwo (32) of the forty-nine (49) claims were denied and ten (10) of the forty-nine (49)
claims were partially denied. Of the two hundred and five (205) services reviewed, one
hundred and sixty five (165) were denied for an error rate of approximately 80%.
(19)

On or about May 19, 2006, Confidential Witness #3 (“CW3") was

interviewed. CW3 was a former laboratory manager employed at Acculab. CW3 stated
that Defendant DeGregorio had access to the computers from his home and if there
was a problem with the computers at the business, employees would contact
DeGregorio and he would fix the problem from his home.
(20)

On or about June 14, 2006, Special Agents with HHS-OIG, ATF, Postal,

Secret Service, Florida Department of Law Enforcement (FDLE) and the Sarasota
Sheriffs Office executed a search warrant on the business premises of Defendant
Acculab and the residence of Defendant DeGregorio, both located in Sarasota, Florida.
(21)

On or about August 30, 2006, EDS sent a letter to Acculab advising

“Notice of Suspension of Medicare Payments for Provider Number L8626.” The letter
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states in part, ”CMS’s initial decision to suspend your payments is based on reliable
information that you submitted claims for services that were not ordered by a physician,
were unbundled, contained diagnosis codes that did not correlate with those reported
by the ordering physician, and may not have been necessary.”
(22)

On or about September 13, 2006, Acculab’s General Counsel, Roy W.

Howard, responded to EDS in a letter that states in part, ”Acculab has reviewed its
available billing records and has confirmed that an inadvertent computer programming
error in procedure codes being billed separately that should have been billed together
as procedure code 80076 - Heptic function panel. It appears from the available billing
records that this computer programming error was corrected sometime in May 2005.”
COUNT TWO
Substantive Violations of the False Claims Act
(31 U.S.C. §§ 3729 (a)(1) and (a)(2))
2000-2001 MEDICAL REVIEW
42.

The United States realleges and incorporates by reference all preceding

paragraphs of this First Amended Complaint as if fully set forth herein.
43.

This is a claim for treble damages and civil penalties of $11,000.00 for

each violation of the False Claims Act, 31 U.S.C. §§ 3729-3732, as amended.
44.

Through the acts described above, the Defendants and their agents and

employees knowingly presented or caused to be presented to the United States
Government through its Medicare Part B Program, false and fraudulent claims, records,
and statements in order to conceal, avoid or decrease an obligation to the United
States and to obtain reimbursement for false and fraudulent claims for health care
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services provided under the Medicare Program.
45.

The underlying conduct which resulted in these false and fraudulent

claims, records and statements includes but is not limited to the submission of claims
for clinical laboratory tests CPT 83721 (Lipoprotein direct measurement; LDL
Cholesterol) that were never ordered by the physician or in excess of what the
physician ordered, and the false and fraudulent claim, statement or record that the
services and tests were the result of a computer error.
46.

By reason of the false and fraudulent records, statements, claims and

omissions submitted, or caused to be submitted, by the Defendants and others, the
United States has been damaged by a significant loss of funds, the exact amount of
which has yet to be established. The following represents a list of actual examples of
the submission of false and fraudulent claims for clinical laboratory test CPT Code
83721 for the years 2000 and 2001:
Patient

Date of Service

Claim Number

BC

March 24, 2000

1001120075890

KY

June 7, 2001

0202259133010

KO

August 16, 2000

0201281086200

WS

February 24, 2000

1001214016560

AM

March 13, 2000

0200090099040

AT

March 27, 2001

1001102009740

BG

July 13, 2000

0200221120780

BR

January 23, 2001

0201039145170

CJ

November 3, 2000

0200313176390

CR

February 26, 2001

0201068152530

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 Case 8:03-cv-01813-JDW-TGW Document 20 Filed 11/02/06 Page 20 of 30 PageID 37

DC

February 26, 2001

0201058139160

EH

April 30, 2001

1001134005610

EK

November 3, 2000

0200325122410

FM

July 27, 2000

0200221148550

FD

September 1, 2000

0200257107770

HB

September 26, 2000

0200276135990

IS

March 2, 2000

0200070123730

IB

March 8, 2001

0201085110090

JCM

March 29, 2001

1001102016180

JHM

February 1, 2000

0200045134780

LA

January 12, 2000

0200017095550

MB

December 27, 2000

0201015122810

MLB

January 5, 2000

0200017081250

NH

May 4, 2000

0200144108620

RAD

August 7, 2000

0200237128740

RD

June 2, 2000

0200187136990

SB

October 2, 2000

0200283100340

SC

May 2, 2001

1001134010750

ST

October 26, 2000

0200303160380

WB

October 2, 2000

0200283105380

COUNT THREE
Substantive Violations of the False Claims Act
(31 U.S.C. §§ 3729 (a)(1) and (a)(2))
2003 MEDICAL REVIEW
47.

The United States realleges and incorporates by reference all preceding

paragraphs of this First Amended Complaint as if fully set forth herein.
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48.

This is a claim for treble damages and civil penalties of $11,000.00 for

each violation of the False Claims Act, 31 U.S.C. §§ 3729-3732, as amended.
49.

Through the acts described above, the Defendants and their agents and

employees knowingly presented or caused to be presented to the United States
Government through the Medicare program, false and fraudulent claims, records, and
statements in order to obtain reimbursement for health care services provided under
the Medicare program.
50.

The underlying conduct which resulted in these false and fraudulent

claims includes but is not limited to the submission of claims for clinical laboratory tests
that were unbundled, claims that were billed for tests not ordered by a physician or in
excess of the physician’s order, and claims that were billed for non-rendered tests
and/or medically unnecessary tests.
51.

By reason of the false and fraudulent claims, records and statements

submitted, and omissions submitted, or caused to be submitted, by the Defendants and
others, the United States has been damaged by a significant loss of funds, the exact
amount of which is to be established. The following represents a list of actual examples
of the submission of false and fraudulent claims for clinical laboratory tests during the
years 2003.
Patient

Date of Service

Claim Number

AP

March 6, 2003

0203076118430

AP

October 29, 2003

0203314059570

RM

April 24, 2003

0203118150070

BL

March 17, 2003

0203083126560

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BL

July 21, 2003

0203204100990

SG

February 24, 2003

0203058127420

DM

June 18, 2003

0203174074840

DM

June 18, 2003

0203174074842

GH

August 6, 2003

0203224087410

GH

December 30, 2003

0204014078460

SB

June 26, 2003

0203184161250

VA

November 5, 2003

0203314074350

VA

December 3, 2003

0203343065580

JC

April 8, 2003

0203104142070

HS

February 6, 2003

0203059148720

HS

August 13, 2003

0203241126600

MN

May 16, 2003

0203141111692

MN

May 16, 2003

0203141111690

RC

May 13, 2003

0203154211050

RC

August 4, 2003

0203241117420

DP

March 14, 2003

0203083126050

DP

July 2, 2003

0203192086640

SH

October 31, 2003

0203314065820

DK

February 2, 2003

0203059159640

DK

March 26, 2003

0203115121750

DK

July 8, 2003

0203210103190

KZ

April 3, 2003

0203097122570

DD

January 29, 2003

0203041108160

DD

February 17, 2003

0203052168080

OR

March 10, 2003

0203163110050

BS

September 12, 2003

0203274102850

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SB

October 1, 2003

0203289048120

EH

June 5, 2003

0203160116580

EH

September 8, 2003

0203260105420

RC

May 21, 2003

0203142087810

RC

July 15, 2003

0203204094870

PA

January 10, 2003

0203027149080

PA

April 29, 2003

0203121138910

PA

September 24, 2003

0203274132720

DB

March 28, 2003

0203142082950

FH

April 10, 2003

0203104145992

FH

December 30, 2003

0204014079440

FH

April 10, 2003

4704160910617

JC

March 28, 2003

0203093135680

JC

April 15, 2003

0203108107750

JC

August 18, 2003

0203241129310

JC

November 5, 2003

0203314072980

MC

August 13, 2003

0203237081830

COUNT FOUR
Substantive Violations of the False Claims Act
(31 U.S.C. §§ 3729 (a)(1) and (a)(2))
2004 MEDICAL REVIEW
52.

The United States realleges and incorporates by reference all preceding

paragraphs of this First Amended Complaint as though fully set forth herein.
53.

This is a claim for treble damages and civil penalties of $11,000.00 for

each violation of the False Claims Act, 31 U.S.C. §§ 3729-3732, as amended.

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54.

Through the acts described above, Defendants and their agents and

employees knowingly presented or caused to be presented to the United States
Government through its Medicare program, false and fraudulent claims, records, and
statements in order to obtain reimbursement for health care services provided under
Medicare.
55.

The underlying conduct which resulted in these false and fraudulent

claims includes but is not limited to the submission of claims for clinical laboratory tests
that were unbundled, claims that were billed for tests not ordered by a physician or in
excess of the physician’s order, and claims that were billed for non-rendered tests and
or medically unnecessary tests.
56.

By reason of the false and fraudulent claims, records, statements, and

omissions submitted, or caused to be submitted, by the Defendants and others, the
United States has been damaged by a significant loss of funds, the exact amount of
which is to be established. The following represents a list of actual examples of the
submission of false and fraudulent claims for clinical laboratory tests during the year
2004.
Patient

Date of Service

Claim Number

JB

January 26, 2004

0204029067790

JB

October 14, 2004

0204299125880

JB

April 28, 2004

0204127041190

JB

April 1, 2004

0204099037610

JH

September 24, 2004

0204273102330

JH

September 24, 2004

0204285120780

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JH

September 24, 2004

0205091153740

JH

January 26, 2004

0204029067820

MB

October 21, 2004

0204315114140

MB

December 30, 2004

0205004244110

MB

January 5, 2004

0204022131440

MB

February 20, 2004

0204063036770

MB

May 3, 2004

0204127052360

MB

July 6, 2004

0204195110510

MB

August 5, 2004

0205091159010

MB

August 5, 2004

0204230104360

MB

September 13, 2004

0204265089180

MB

December 7, 2004

0204349098860

EH

March 17, 2004

0204089047970

EH

March 13, 2004

0204145021050

EH

November 22, 2004

0204334138970

EH

November 22, 2004

0205272184060

EH

November 22, 2004

0205075135150

EF

January 6, 2004

0204022135490

EF

May 19, 2004

0204145038650

EF

July 8, 2004

0204195121860

EF

September 27,2004

0204285148960

EF

March 1, 2004

0204063054600

EF

May 24, 2004

0204153032390

EF

August 19, 2004

0204239154140

EF

August 19, 2004

0204239154130

BW

December 7, 2004

0204349115490

BW

December 8, 2004

0204349115500

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BW

April 16, 2004

0204114043610

HF

October 20, 2004

0204315148340

HF

November 9, 2004

0205129146190

HF

November 9, 2004

0205286112920

HF

May 19, 2004

0204145038570

HF

February 23, 2004

0204063040350

HF

February 24, 2004

0204063043850

HF

February 25, 2004

0204063044450

HF

September 22, 2004

0204273115610

COUNT FIVE
UNJUST ENRICHMENT

57.

The United States realleges and incorporates by reference all preceding

paragraphs of this First Amended Complaint as if fully set forth herein.
58.

This is an action brought by the government under common law against

Defendants DeGregorio and Acculab and others for unjust enrichment.
59.

As a result of engaging in the foregoing conduct described above,

Defendant DeGregorio and Defendant Acculab and others have been unjustly enriched
in an as yet undetermined amount under circumstances where equity requires
defendants to repay plaintiff those amounts of Medicare benefits paid to or on account
of Defendants for services rendered between the years 2000 through 2006, and to
which Defendants were not entitled under applicable law and regulations.

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COUNT SIX
PAYMENT BY MISTAKE OF FACT

60.

The United States realleges and incorporates by reference all preceding

paragraphs of this First Amended Complaint as if fully set forth herein.
61.

As a result of engaging in the foregoing conduct, through the acts

described above and otherwise, Defendant DeGregorio and Defendant Acculab and
others have defrauded the United States Government by seeking and receiving or
causing to be sought and received payment of false or fraudulent claims through the
Medicare Part B Program.
62.

As a result, and by reason of the United States’ payments under the

Medicare contracts, defendants have received money to which they were not entitled
and have thereby been unjustly enriched in an as yet undetermined amount.
COUNT SEVEN
COMMON LAW FRAUD

63.

The United States realleges and incorporates by reference all preceding

paragraphs of this First Amended Complaint as if fully set forth herein.
64.

As a result of engaging in the foregoing conduct, through the acts

described above and otherwise, Defendant Degregorio and Defendant Acculab and
others have engaged in a pattern and practice of fraudulently billing, and or causing to
be billed, false and fraudulent claims to the Medicare program. Defendants knew, or
should have known, that these representations were false and defendants made them

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anyway, intending to induce Medicare to rely on them in paying claims submitted, or
caused to be submitted, by Defendants. Medicare relied upon the Defendants’
materially false representations, and as a result, the United States has been damaged
in an as yet undetermined amount.

COUNT EIGHT
Federal Debt Collection Procedures Act
(28 U.S.C. §§ 3001-3308)
65.

The United States realleges and incorporates by reference all preceding

paragraphs of this First Amended Complaint as though fully set forth herein.
66.

This is a claim for pre-judgment and post-judgment remedies on a debt

and to obtain, before judgment as a debt, certain pre-judgment discovery and remedies
in connection with such claim.
67.

From January of 2000, Defendants have presented and caused to be

presented, claims for payment to the United States knowing such claims were false,
fictitious, or fraudulent, as with reckless disregard or deliberate ignorance of the truth or
falsifying of the claims.
68.

By virtue of the false, fraudulent and fictitious claims submitted by the

Defendants, Plaintiff, United States is entitled to discover the debtor’s financial
condition; pre-judgment remedies such as attachment, receivership, garnishment and
sequestration; post-judgment and liens and garnishments, and the setting aside of
fraudulent transfers.

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PRAYER FOR RELIEF
WHEREFORE, the Government respectfully prays for judgment in its
favor as follows:
1.

On Counts I, II, III, and IV (False Claims Act), against Defendant

DeGregorio and Defendant Acculab and others for civil penalties of not less than
$5,500 and not more than $11,000 for each violation of the False Claims Act, plus triple
the amount of damages which the United States of America sustained because of the
acts of the Defendants, and fees and costs allowable under the False Claims Act, as
amended;
2.

On Count V and VI (Unjust Enrichment and Payment Under Mistake of

Fact) for damages, costs and interest;
3.

On Count VII (Common Law Fraud), for damages, costs and interest;

4.

On Count VIII (Federal Debt Collection Procedures Act), all pre-judgment

and post-judgment remedies provided for in the Federal Debt Collection Procedures
Act, allowed under said law, as applicable, when required, is presented to this Court.
5.

And for all other and further relief as the Court may deem just and proper.
DEMAND FOR JURY TRIAL

The United States hereby demands that this matter be tried before a jury.

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PAUL I. PEREZ
UNITED STATES ATTORNEY

By:

Dated: November 2, 2006

/s/Lacy R. Harwell, Jr.
LACY R. HARWELL, JR.
Assistant United States Attorney
Florida Bar. No. 714623
400 North Tampa Street, Suite 3200
Tampa, Florida 33602
Telephone: 813-274-6350
Facsimile: 813-274-6198
Randy.Harwell@usdoj.gov

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