                          UNITED STATES DISTRICT COURT
                          FOR THE DISTRICT OF COLUMBIA
____________________________________
                                      )
UNITED STATES OF AMERICA, et al., )
                                      )
ex rel. TINA D. GROAT,                )
                                      )
              Plaintiffs,             )
                                      )
        v.                            )    Civil Action No. 15-487 (RBW)
                                      )
BOSTON HEART DIAGNOSTICS              )
CORPORATION,                          )
                                      )
              Defendant.              )
____________________________________)

                                         MEMORANDUM OPINION

         The plaintiff/relator, Tina D. Groat, M.D., initiated this qui tam action against the

defendant, Boston Heart Diagnostics Corporation (“Boston Heart”), under the federal False

Claims Act, 31 U.S.C. § 3729 (2012), and various analog state false claims statutes. See

Relator’s Second Amended Complaint Pursuant to the Federal False Claims Act, 31 U.S.C.

§§ 3729 et seq. and Pendent State False Claims Acts (“2d Am. Compl.”) ¶ 1. On June 9, 2017,

the Court granted in part and denied in part Boston Heart’s motion to dismiss the relator’s

complaint. See United States ex rel. Groat v. Boston Heart Diagnostics Corp., 255 F. Supp. 3d

13, 17, 32–33 (D.D.C. 2017) (Walton, J.). Currently before the Court is Boston Heart

Diagnostics Corporation’s Motion for Reconsideration of the Court’s Order on the Motion to

Dismiss (“Def.’s Mot.”). Upon careful consideration of the parties’ submissions, 1 the Court

concludes that it must grant in part and deny in part Boston Heart’s motion for reconsideration.


1
 In addition to the filings already identified, the Court considered the following submissions in reaching its
decision: (1) the Relator’s Substitu[t]ed Oppos[i]tion to Defendant’s Motion for Reconsideration (“Relator’s
                                                                                                     (continued . . . )
                                         I.     BACKGROUND

        The Court discussed the factual background and statutory authority pertinent to this case

in its Memorandum Opinion issued on June 9, 2017, see Groat, 255 F. Supp. 3d at 17–20, and

will not reiterate those facts and authorities again here. In that opinion, the Court declined to

dismiss the relator’s presentment claim under § 3729(a)(1)(A) and false statements claim under

§ 3729(a)(1)(B), as well as her analog presentment and false statements claims under various

state false claims act statutes, but dismissed her “reverse false claims” under § 3729(a)(1)(G) and

the analog state statutes. See id. at 30–33. On June 23, 2017, Boston Heart filed its present

motion, requesting that the Court reconsider its conclusion “that Boston Heart has an obligation

to establish that the tests for which it seeks government reimbursement are medically necessary,”

id. at 25, which “underlies [the Court’s] conclusions with respect to both falsity and knowledge

as to [the r]elator’s presentment . . . [and] false statements allegations,” Def.’s Mot. at 9 (internal

citations omitted).

                                   II.        STANDARD OF REVIEW

        Under Federal Rule of Civil Procedure 54(b), any order or decision that does not

constitute a final judgment “may be revised at any time before the entry of a judgment

adjudicating all the claims and all the parties’ rights and liabilities.” Fed. R. Civ. P. 54(b).

Although “district court[s] ha[ve] ‘broad discretion to hear a motion for reconsideration brought

under Rule 54(b),’” Univ. of Colo. Health at Mem’l Hosp. v. Burwell, 164 F. Supp. 3d 56, 62

(D.D.C. 2016) (quoting Isse v. Am. Univ., 544 F. Supp. 2d 25, 29 (D.D.C. 2008)), district courts



( . . . continued )
Opp’n”); (2) Boston Heart Diagnostics Corporation’s Reply in Support of Its Motion for Reconsideration of the
Court’s Order on the Motion to Dismiss (“Def.’s Reply”); (3) the Brief of Amicus Curiae American Clinical
Laboratory Association (“Amicus Br.”); (4) the Relator’s Response to Brief of Amicus Curiae American Clinical
Laboratory Association (“Relator’s Amicus Resp.”); and (5) the Reply to Relator’s Response to Brief of Amicus
Curiae American Clinical Laboratory Association (“Amicus Reply”).

                                                       2
grant motions for reconsideration of interlocutory orders only “as justice requires,” Capitol

Sprinkler Inspection, Inc. v. Guest Servs., Inc., 630 F.3d 217, 227 (D.C. Cir. 2011) (quoting

Greene v. Union Mut. Life Ins. Co. of Am., 764 F.2d 19, 22–23 (1st Cir. 1985)).

       In deciding whether “justice requires” reversal of a prior interlocutory order, courts

assess circumstances such as “whether the court ‘patently’ misunderstood the parties, made a

decision beyond the adversarial issues presented, made an error in failing to consider controlling

decisions or data, or whether a controlling or significant change in the law has occurred.” In

Defense of Animals v. Nat’l Insts. of Health, 543 F. Supp. 2d 70, 75 (D.D.C. 2008) (quoting

Singh v. George Wash. Univ., 383 F. Supp. 2d 99, 101 (D.D.C. 2005)); see also Davis v. Joseph

J. Magnolia, Inc., 893 F. Supp. 2d 165, 168 (D.D.C. 2012) (“[A] motion for reconsideration is

discretionary and should not be granted unless the movant presents either newly discovered

evidence or errors of law or fact that need correction.”). “The burden is on the moving party to

show that reconsideration is appropriate and that harm or injustice would result if reconsideration

were denied.” United States ex rel. Westrick v. Second Chance Body Armor, Inc., 893 F. Supp.

2d 258, 268 (D.D.C. 2012) (citing Husayn v. Gates, 588 F. Supp. 2d 7, 10 (D.D.C. 2008)). And,

motions for reconsideration are not vehicles for either reasserting arguments previously raised

and rejected by the court or presenting arguments that should have been raised previously with

the court. See Estate of Gaither ex rel. Gaither v. District of Columbia, 771 F. Supp. 2d 5, 10 &

n.4 (D.D.C. 2011).

                                       III.    ANALYSIS

       Boston Heart urges the Court to reconsider its conclusion “that Boston Heart has an

obligation to establish that the tests for which it seeks government reimbursement are medically

necessary,” Groat, 255 F. Supp. 3d at 25, for three reasons, see Def.’s Mot. at 1–2. The Court



                                                 3
agrees that this conclusion warrants correction to clarify that a laboratory may rely on the

ordering physician’s determination of medical necessity in the laboratory’s certification to HHS

on the CMS–1500 form. Nonetheless, the Court concludes that despite its correction of the

medical necessity ruling, its denial of Boston Heart’s motion to dismiss the relator’s federal and

state presentment and false statements claims was proper.

A.     The Court’s Conclusion Regarding Laboratories’ Obligations with Respect to
       Medical Necessity

       1.      HHS Compliance Program Guidance for Clinical Laboratories

       First, Boston Heart argues that the Court’s prior medical necessity conclusion “conflicts

directly with the longstanding position of the Office of the Inspector General for the Department

of Health and Human Services . . . that ‘laboratories do not and cannot treat patients or make

medical necessity determinations.’” Id. at 1 (quoting Publication of OIG Compliance Program

Guidance for Clinical Laboratories (“OIG Guidance”), 63 Fed. Reg. 45,076, 45,079 (Aug. 24,

1998)); see also id. at 3–5 (discussing the OIG guidance). The relator argues in response that the

OIG Guidance “firmly establishes a lab[oratory]’s duty to only submit claims for medically

necessary tests and directly aligns with the CMS Form 1500 requirement for [a] ‘physician or

supplier’ to certify” the medical necessity of each test ordered. Relator’s Opp’n at 6. Although

the Court agrees with the relator that a laboratory has a “legal duty to ensure that it is not

submitting false or incorrect claims to Government . . . payors,” OIG Guidance, 63 Fed. Reg. at

45,077, it concludes for the reasons set forth below that a laboratory cannot and is not required to

determine medical necessity, but rather is permitted to rely on the ordering physician’s

determination that the laboratory tests billed to Medicare are medically necessary.

       The OIG Guidance was issued “to refine and build on the original model guidance plan

for clinical laboratories,” which was published in 1997 as part of an effort “to engage the private

                                                  4
health care community in combating fraud and abuse.” OIG Guidance, 63 Fed. Reg. at 45,076.

This supplemental guidance was “intended to assist clinical laboratories in developing effective

internal controls that promote adherence to applicable . . . law[s,] . . . [and to] advance the

prevention of fraud, abuse, and waste in the clinical laboratory industry.” Id. at 45,077. The

OIG Guidance identifies for laboratories “specific areas of potential fraud,” including, as

relevant to this case, “marketing schemes, [ ] coding issues, . . . and improper claims

submission.” Id. at 45,078.

       The OIG Guidance section devoted to “Medical Necessity” states, among other things,

that

       [l]aboratory compliance programs, to be effective, should communicate to
       physicians that claims submitted for services will only be paid if the service is
       covered, reasonable, and necessary for the beneficiary, given his or her clinical
       condition. Laboratories should take all reasonable steps to ensure that [they are]
       not submitting claims for services that are not covered, reasonable and necessary.
       Upon request, a laboratory should be able to produce or obtain from the treating
       physician . . . the documentation to support the medical necessity of the service the
       laboratory has provided and billed to a Federal . . . health care program. We
       recognize that laboratories do not and cannot treat patients or make medical
       necessity determinations. However, there are steps that such facilities can take to
       assure compliance with the applicable statutes, regulations and the requirements of
       Federal . . . health plans.

Id. at 45,079 (footnote omitted).

       The OIG Guidance recommends various processes a laboratory can implement to ensure

that laboratories do not submit claims for unnecessary tests. For example, the OIG Guidance

encourages a laboratory to

       construct [its] requisition form to capture the correct program information as
       required by Federal . . . health care programs and to promote the conscious ordering
       of tests by physicians . . . . The laboratory should construct the requisition form to
       ensure that the physician . . . has made an independent medical necessity decision
       with regard to each test the laboratory will bill. Laboratories should encourage
       physicians . . . to submit diagnosis information for all tests ordered, as



                                                  5
        documentation of the medical necessity of the service. The form should contain a
        statement indicating that Medicare generally does not cover routine screening tests.

Id. It also states that

        there are steps laboratories can take to determine whether physicians . . . are being
        encouraged to order medically unnecessary tests. More importantly, if the
        laboratory discovers that it has in some way contributed to the ordering of
        unnecessary tests, the OIG believes the laboratory has a duty to modify its practices,
        as well as notify the physician(s) . . . of its concerns and recommend corrective
        action.

Id. at 45,080. Finally, the OIG Guidance notes that

        [l]aboratories cannot alter the physician’s order in any way either increasing or
        decreasing the number of services performed without the express consent of the
        ordering physician . . . . To ensure code accuracy, laboratories should require that
        individuals with technical expertise in laboratory testing review the appropriateness
        of the codes before the claims are submitted. Intentional or knowing upcoding (i.e.,
        the selection of a code to maximize reimbursement when such code is not the most
        appropriate descriptor of the service) could violate the False Claims Act and/or
        other civil laws, and criminal law.

Id.

        Upon review of the OIG Guidance, the Court concludes that it overstated a laboratory’s

“obligation to establish that the tests for which it seeks government reimbursement are medically

necessary.” Groat, 255 F. Supp. 3d at 25. Although it is true that when a laboratory “submits the

CMS–1500 form, it certifies that the tests performed were medically necessary,” id. (emphasis

added), and that it has a role to play to ensure that it does not submit claims for medically

unnecessary tests, see OIG Guidance, 63 Fed. Reg. at 45,077, the Court is now convinced that a

laboratory cannot and is not required to determine medical necessity, but rather is permitted to

rely on the ordering physician’s determination that the laboratory tests billed to Medicare are

medically necessary. The OIG Guidance makes clear that “laboratories do not and cannot treat

patients or make medical necessity determinations,” but “should be able to produce or obtain

from the treating physician . . . the documentation to support the medical necessity of the service

                                                  6
the laboratory has provided.” Id. at 45,079. Moreover, the OIG Guidance, in describing a

laboratory’s duties to ensure that it does not submit claims for medically unnecessary tests, does

not include among those duties a laboratory’s obligation to make an independent determination

of the medical necessity of each test performed and billed. See id. at 45,079–080 (e.g., stating

that laboratories should communicate with physicians, maintain documentation to support

medical necessity, construct requisition forms to promote conscious ordering of tests by

physicians, and review coding). In the Court’s view, the OIG Guidance would have explicitly

included that obligation among its recommended compliance processes if it had intended to

impose such an obligation on laboratories, and to suggest otherwise would entirely contradict

that explicit language of the OIG Guidance. 2

         2.       HHS Regulation on Clinical Laboratory Recordkeeping

         Second, Boston Heart argues that the federal regulation regarding laboratory

recordkeeping “also underscore[s] that physicians, and not laboratories, establish the medical

necessity of patient tests.” Id. at 5; see also id. at 5–7 (discussing the regulation). The Court

considered this regulation in its prior Memorandum Opinion and ultimately concluded that

“Boston Heart’s reliance on the Medicare regulation regarding documentation and recordkeeping

requirements [wa]s unavailing because that provision does not address the entity’s certification




2
  In its filings submitted in support of its motion to dismiss, Boston Heart had cited the OIG Guidance in support of
its argument that laboratories are not required to independently verify the medical necessity of tests ordered by
physicians, but only in its reply brief. See Boston Heart Diagnostics Corporation’s Reply in Support of Its Motion
to Dismiss Relator’s Second Amended Complaint at 4 & n.5; see also Memorandum of Law in Support of Boston
Heart Diagnostics Corporation’s Motion to Dismiss Relator’s Second Amended Complaint at iii–vii (not including
the OIG Guidance in its Table of Authorities). Judges in this District have repeatedly held that arguments may not
be raised for the first time in a party’s reply. See, e.g., Akinsinde v. Not-For-Profit Hosp. Corp., 216 F. Supp. 3d 33,
41 (D.D.C. 2016) (“The court has no obligation to entertain arguments raised for the first time in a reply brief and
declines to do so here.”); Wright v. Metro. Life Ins. Co., 618 F. Supp. 2d 43, 47 n.5 (D.D.C. 2009) (Walton, J.)
(“Courts ‘highly disfavor[] parties creating new arguments at the reply stage that were not fully briefed during the
litigation.’” (alteration in original) (quoting Pub. Citizen Health Research Grp. v. Nat’l Insts. of Health, 209 F. Supp.
2d 37, 43 (D.D.C. 2002))).

                                                           7
of medical necessity on the CMS–1500 form.” Groat, 255 F. Supp. 3d at 26 (citing 42 C.F.R.

§ 410.32(d)(2)). The Court stated:

         Although Boston Heart is correct that the provision requires both the doctor
         ordering the service and the entity submitting the claim for payment to maintain
         documentation regarding medical necessity, see [42 C.F.R.] § 410.32(d)(2)(i)–(ii),
         the CMS–1500 form requires the entity submitting the claim, be it a
         “physician or supplier,” to certify the medical necessity, CMS–1500 at 2 (emphasis
         added). The regulation simply does not state that only the ordering physician, and
         not the entity submitting the claim, has the obligation to certify the medical
         necessity of the tests at issue when submitting claims for payment. See 42 C.F.R.
         § 410.32(d)(2)–(3). In sum, the regulation, which concerns recordkeeping, has no
         bearing on the certification of medical necessity on the CMS–1500 form.

Id. However, the Court did not consider the regulation in the context of the negotiated

rulemaking that produced it, 3 and which addressed the tension between Medicare’s statutory

medical necessity requirement, see 42 U.S.C. 1395y(a)(1)(A), and the “special circumstances

related to laboratories,” see Medicare Program; Negotiated Rulemaking: Coverage and

Administrative Policies for Clinical Diagnostic Laboratory Services; Final Rule (“Laboratory

Final Rule”), 66 Fed. Reg. 58,788, 58,801 (Nov. 23, 2001). 4




3
  “Section 4554(b)(1) of the Balanced Budget Act of 1997 . . . mandate[d the] use of a negotiated rulemaking
committee to develop national coverage and administrative policies for clinical diagnostic laboratory services
payable under Medicare Part B . . . [in order] to promote program integrity and national uniformity and simplify
administrative requirements . . . .” Medicare Program; Negotiated Rulemaking: Coverage and Administrative
Policies for Clinical Diagnostic Laboratory Services; Proposed Rule, 65 Fed. Reg. 13,082, 13,083 (Mar. 10, 2000)
(internal quotation marks omitted). Members of the committee included representatives of HHS, the American
Association of Bioanalysts, the American Association for Clinical Chemistry, the American Association of Retired
Persons, the American Clinical Laboratory Association, the American College of Physicians—American Society of
Internal Medicine, the American Health Information Management Association, the American Hospital Association,
the American Medical Association, the American Medical Group Association, the American Society for Clinical
Laboratory Science, the American Society of Clinical Pathologists, the American Society for Microbiology, the
Clinical Laboratory Management Association, the American Society for Clinical Laboratory Science, the College of
American Pathologists, the Health Industry Manufacturers Association, the Medical Group Management
Association, and the National Medical Association. Id. at 13,083–084.
4
 Again, in support of its motion to dismiss, Boston Heart cited the negotiated rulemaking only in its reply brief. See
Boston Heart Diagnostics Corporation’s Reply in Support of Its Motion to Dismiss Relator’s Second Amended
Complaint at 4 n.5, 5 n.9; see also Memorandum of Law in Support of Boston Heart Diagnostics Corporation’s
Motion to Dismiss Relator’s Second Amended Complaint at iii–vii (not including the negotiated rulemaking in its
Table of Authorities).

                                                          8
       The regulation was promulgated to establish “uniform national coverage and

administrative policies for clinical diagnostic laboratory services payable under Medicare Part

B[,] . . . to promote Medicare program integrity and national uniformity[,] and simplify

administrative requirements for clinical diagnostic laboratory services.” Id. at 58,789. The

negotiated rulemaking explained the division of responsibilities between the ordering physician

and the laboratory with respect to documentation and recordkeeping requirements as follows:

       [T]he laboratory is responsible for maintaining information it receives from the
       ordering practitioner, and the practitioner[] is responsible for maintaining the
       information in the medical record. [HHS’s] initial request for information is made
       to the entity submitting the claim. That entity should submit whatever
       documentation it has in support of the claim.

       If the documentation provided by the entity submitting the claim does not
       demonstrate that the service is reasonable and necessary, we will take the following
       action: (1) Provide the ordering physician information sufficient to identify the
       claim being reviewed; (2) request from the ordering physician those parts of a
       beneficiary’s medical record that are relevant to the specific claim(s) being
       reviewed; and (3) if the ordering physician does not supply the documentation
       requested, inform the entity submitting the claim(s) that the documentation has not
       been supplied and deny the claim.

       Since the entity submitting the claim will be the entity to experience a payment
       denial if documentation does not support the medical necessity of the claim, we
       agreed laboratories should not be precluded from requesting additional diagnostic
       or other medical information from the ordering provider. In making requests for
       additional information, laboratories must focus their request for additional
       information on material relevant to medical necessity. In addition, documentation
       requests must take into account applicable laws and regulations related to patient
       confidentiality.

Id. at 58,800. HHS also noted that the regulation

       does not change the current provisions for liability on claims due to lack of
       information supporting medical necessity. Section 1862(a)(1)(A) of the [Social
       Security] Act provides that, notwithstanding any other provision of the Act,
       payment may not be made for services that are not reasonable and necessary for the
       diagnosis or treatment of illness or injury. Presently, all entities that bill the
       Medicare program are held liable when they bill for services and are not able to
       produce documentation of the medical necessity of the service. Although the
       [Negotiated Rulemaking] Committee discussed at length the special circumstances

                                                9
       related to laboratories, which frequently do not have direct contact with the patient,
       the Committee recognized that the law does not provide the authority to exempt
       laboratories from the provision related to medical necessity.

Id. at 58,801 (emphasis added). Finally, HHS stated that it

       do[es] not agree [with some commenters] that the provision related to denial of
       claims for laboratory services when documentation is not provided is unfair.
       Rather, we believe it would be unfair to exempt laboratories from this provision
       while continuing to require it for other providers and suppliers. For example,
       durable medical equipment (DME) suppliers frequently do not have direct contact
       with beneficiaries but are dependent upon physician documentation of medical
       need in order to receive payment.

Id.

       Upon review of HHS’s explanations of the regulation, the Court concludes that HHS’s

view supports the Court’s conclusion that, although laboratories, as the entity submitting a claim

for payment, are required by statute to certify the medical necessity of the tests at issue, see id.

(“[A]ll entities that bill the Medicare program are held liable when they bill for services and are

not able to produce documentation of the medical necessity of the service.”), neither the

Medicare statute nor the regulation regarding laboratories require laboratories to independently

determine the medical necessity of the tests billed. Rather, HHS recognized “the special

circumstances related to laboratories [because they] frequently do not have direct contact with

the patient,” id., and, in the Court’s view, issued the regulation regarding recordkeeping and

documentation in an attempt to balance a laboratory’s statutory requirement to certify medical

necessity with the requirement that the ordering physician determine medical necessity, see id.

(comparing laboratories to durable medical equipment suppliers, which “are dependent upon

physician documentation of medical need in order to receive payment” (emphasis added)); see

also 42 C.F.R. 410.32(a) (noting that “[t]ests not ordered by the physician who is treating the




                                                  10
beneficiary are not reasonable and necessary”). 5 Therefore, although it is true that “[t]he

regulation simply does not state that only the ordering physician, and not the entity submitting

the claim, has the obligation to certify the medical necessity of the tests at issue when submitting

claims for payment,” Groat, 255 F. Supp. 3d at 26 (emphasis added), upon review of HHS’s

explanation at the time it promulgated the regulation, the Court must clarify that even though the

Medicare statute requires the laboratory to certify the medical necessity of any test for which it

makes a claim for payment, the laboratory is not required to make an independent determination

of medical necessity, but rather may rely on the ordering physician’s determination. 6

        3.       Cases Cited by the Court

        Third, Boston Heart argues that the cases the Court cited in support of its conclusion

regarding the medical necessity determination do not “support[] the proposition that a laboratory

must independently establish the medical necessity of tests it performs on a physician’s request.”

Def.’s Mot. at 9; see also id. at 7–9 (discussing cases). Upon further review of these cases, the

Court agrees. In its Memorandum Opinion, the Court directly quoted a decision issued by the

United States District Court for the Central District of California in support of its statement that

“the regulatory scheme ‘places the burden of establishing the medical necessity of diagnostic

tests on the entity submitting the claim.’” Groat, 255 F. Supp. 3d at 26 (quoting Garcia v.



5
  This view is supported by HHS’s decision to allow laboratories to request additional information relevant to
medical necessity from the ordering physician. In other words, although a laboratory cannot make a medical
necessity determination, it is permitted to ask the ordering physician for additional information supporting the
medical necessity determination. See Laboratory Final Rule, 66 Fed. Reg. at 58,800 (“Since the entity submitting
the claim will be the entity to experience a payment denial if documentation does not support the medical necessity
of the claim, we agreed laboratories should not be precluded from requesting additional diagnostic or other medical
information from the ordering provider.”).

6
 The relator argues that Boston Heart fails to meet the standard for reconsideration under Rule 54(b). See Relator’s
Opp’n at 1–4. Because the Court concludes that it must clarify that a laboratory may rely on the ordering
physician’s determination of medical necessity in the laboratory’s certification to HHS on the CMS–1500 form, see
supra Part III.A, it also concludes that “justice requires” the Court to amend its prior memorandum opinion, see
Capitol Sprinkler Inspection, 630 F.3d at 227.

                                                        11
Sebelius, No. CV 10-8820 PA (RZx), 2011 WL 5434426, at *7 (C.D. Cal. Nov. 8, 2011)). That

case concerned a medical doctor’s Administrative Procedure Act challenge of HHS’s decision

“to recoup what the Secretary determined were overpayments billed under [the doctor’s]

Medicare provider number.” Garcia, 2011 WL 5434426, at *1. In Garcia, the entity submitting

the claim was the physician himself, not a clinical laboratory, see id. at *3, and therefore, the

Garcia court’s statement regarding “the burden of establishing the medical necessity of

diagnostic tests” did not address the issue of whether a laboratory must independently determine

medical necessity or is permitted to rely on the ordering physician’s determination in its

certification to HHS.

       This Court also cited to Nephropathology Associates, PLC v. Sebelius, No.

4:12CV00233JLH, 2013 WL 3285685, at *4 (E.D. Ark. June 27, 2013), for the proposition that

“the burden remains on the entity submitting the claim to demonstrate that the services at issue

were reasonable and necessary.” Groat, 255 F. Supp. 3d at 26 (quoting Nephropathology

Assocs., 2013 WL 3285685, at *4). In that case, a clinical laboratory appealed HHS’s denial of

payment for renal pathology services. See Nephropathology Assocs., 2013 WL 3285685, at *1.

The Nephropathology court’s statement that “the burden remains on the entity submitting the

claim to demonstrate that the services at issue were reasonable and necessary” was in response to

the laboratory’s interpretation of 42 C.F.R. § 410.32(d) “to mean that [it] does not have to submit

documentation of a physician’s order unless and until [CMS] requests such documentation,” id.

at *4, and therefore, like Garcia, does not speak directly to the issue of whether a laboratory must

independently determine medical necessity or is permitted to rely on the ordering physician’s

determination in its certification to HHS.




                                                 12
       Finally, the Court also cited to four other federal circuit and district court cases for the

proposition that (1) laboratories may challenge HHS’s denial of payment to them for testing

services rendered based upon the determination that such tests were not medically necessary, see

Groat, 255 F. Supp. 3d at 26 (first citing KGV Easy Leasing Corp. v. Sebelius, No. 09-56393,

2011 WL 490990, at *1 (9th Cir. Feb. 14, 2011); then citing Strand Analytical Labs., LLC v.

Burwell, No. 1:13-cv-00645-LJM-DKL, 2015 WL 4603258, at *1 (S.D. Ind. July 30, 2015)); and

(2) laboratories may be sued under the False Claims Act “for allegedly submitting claims for

medically unnecessary tests,” Groat, 255 F. Supp. 3d at 26 (first citing United States ex rel.

Merena v. SmithKline Beecham Corp., 205 F.3d 97, 98 (3d Cir. 2000); then citing United States

ex rel. Lutz v. Berkeley Heartlab, Inc., 225 F. Supp. 3d 487, 495–97, 513–14 (D.S.C. 2016)).

Again, the CMS–1500 form requires laboratories, as the entity submitting the claim for payment,

to certify medical necessity, see Health Insurance Claim Form (“CMS–1500”) at 2, available

at https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS1500.pdf (last

visited December 6, 2017), and laboratories are allowed to challenge payment denials, but they

are not prohibited from relying on the ordering physician’s determination of medical necessity.

Moreover, as will be discussed in further detail below, see infra Part III.B, laboratories may be

held liable under the False Claims Act. However, like Garcia and Nephropathology, none of

these four cases specifically states whether a laboratory must independently determine medical

necessity or is permitted to rely on the ordering physician’s determination in its certification to

HHS.

B.     The Relator’s Allegations Regarding Boston Heart’s Falsity and Knowledge

       In its Memorandum Opinion, the Court concluded that the relator’s Second Amended

Complaint sufficiently alleged that Boston Heart submitted claims that were expressly legally



                                                 13
false. See Groat, 255 F. Supp. 3d at 23 (“The Second Amended Complaint makes clear that the

relator is alleging that Boston Heart’s claims were ‘legally false’ because, according to the

relator, Boston Heart certified that the tests it performed were medically necessary even though

they were not medically necessary for certain populations.”). The Court stated:

       An express false certification occurs when a claimant explicitly represents that he
       or she has complied with a contractual condition, but in fact has not
       complied. . . . Under [ ] an express . . . false certification claim, the plaintiff must
       plead that the defendant knowingly violated a requirement that the defendant knows
       is material to the Government’s payment decision.

Id. (internal citations and quotation marks omitted). The Court also stated that “the knowledge

element of a false claim or false statement action [ ] requires a defendant to have ‘actual

knowledge of the information’ or to ‘act[ ] in deliberate ignorance . . . [or] reckless disregard of

the truth or falsity of the information.’” Id. at 29 (quoting 31 U.S.C. § 3729(b)(1)(A)).

       According to Boston Heart, if the Court agrees that laboratories are not obligated to

independently determine a test’s medical necessity, the relator has failed to sufficiently allege

facts demonstrating the falsity and knowledge elements of her federal and state presentment and

false statements claims, and these claims must be dismissed. See Def.’s Mot. at 9–10; see also

Def.’s Reply at 5. The Court disagrees.

       Boston Heart does not dispute the Court’s summary of the relator’s allegations regarding

Boston Heart, namely

       that “Boston Heart encourages providers to order [ ] medically unnecessary
       tests” through marketing materials and test panels on pre-printed test requisition
       forms, and that “General Practitioners and other non-cardiology physicians are
       Boston Heart’s primary target” for its allegedly false marketing statements
       regarding the medical necessity of its tests, and their ability “to predict cardiac
       risk.” Ultimately, the relator met with Boston Heart’s CEO and its Vice President
       of Payer Innovation and Strategy on August 15, 2014, and told them “that their test
       panels included many unnecessary tests.”

Groat, 255 F. Supp. 3d at 19–20 (internal citations omitted).

                                                 14
       Even though the Court now clarifies that Boston Heart is not required to independently

determine the medical necessity of tests ordered by physicians, see supra Part III.A, accepting

the relator’s allegations as true, as it must, see Trudeau v. Fed. Trade Comm’n, 456 F.3d 178,

193 (D.C. Cir. 2006), her allegation that Boston Heart engaged in a scheme to encourage

non-cardiology physicians to order medically unnecessary tests through a false marketing

campaign and pre-printed test requisition forms would constitute a knowing violation of its

“legal duty to ensure that it is not submitting false or incorrect claims to Government . . .

payors,” OIG Guidance, 63 Fed. Reg. at 45,077; see also id. at 45,079–080 (noting that

laboratories should ensure that they do not submit claims for medically unnecessary tests by,

inter alia, communicating with physicians regarding medical necessity, maintaining

documentation of medical necessity, constructing requisition forms to promote conscious

ordering of tests by physicians, and reviewing coding). Therefore, the Court remains convinced

that the relator has sufficiently alleged facts that satisfy the falsity and knowledge elements of

her federal and state presentment and false statements claims, and, once again, declines to

dismiss these claims. See United States ex rel. Schaefer v. Family Med. Ctrs. of South Carolina,

LLC, No. 3:14-382-MBS, 2016 WL 6601017, at *3–4 (D.S.C. Nov. 8, 2016) (denying a motion

to dismiss the United States’ complaint in which it “allege[d] that [the d]efendants created and

utilized custom disease-oriented panels that included more diagnostic tests than typical for

screening or routine testing,” noting that “[t]he United States alleges that [the d]efendants

stressed to the physicians . . . to utilize the laboratory panels designed by [the d]efendants,

regardless of whether all components of the panel were medically necessary”); Berkeley

Heartlab, 225 F. Supp. 3d at 499–500 (declining to dismiss the government’s presentment claim

against a laboratory because “[t]he complaint describes each of the four alleged schemes in



                                                  15
detail,” including one scheme to encourage physicians to order medically unnecessary tests, and

“specifies particular genetic testing that is medically unnecessary for the vast majority of the

population, yet [was] still included in the panels [the d]efendants offered to physicians”); United

States ex rel. Bane v. Breathe Easy Pulmonary Servs., Inc., No. 8:06-CV-40-T-24 MAP, 2007

WL 4885468, at *4, *7 (M.D. Fla. Nov. 30, 2007) (magistrate judge recommendation that

district judge deny a laboratory’s and an oxygen provider’s motion to dismiss the relator’s

complaint alleging a scheme to bill Medicare for additional, unnecessary oxygen testing in

violation of the False Claims Act), adopted in relevant part, 2008 WL 343158 (M.D. Fla. Feb. 5,

2008); United States ex rel. Downy v. Corning, Inc., 118 F. Supp. 2d 1160, 1172 (D.N.M. 2000)

(denying defendant laboratories’ motion to dismiss a complaint in which the relator alleged that

the laboratories, “by using deceptive test order forms and by disseminating deceptive

information concerning the necessity of performing both [of] the . . . tests [at issue], [the

laboratories] induced physicians to order many medically unnecessary tests and then charged the

costs of those tests to the government”), abrogated on other grounds by United States ex rel.

Sikkenga v. Regence BlueCross BlueShield of Utah, 472 F.3d 702 (10th Cir. 2006); see also

United States v. Neifert-White Co., 390 U.S. 228, 232–33 (1968) (“[The False Claims Act is]

intended to reach all types of fraud, without qualification, that might result in financial loss to the

Government. . . . [T]he Act is broadly phrased to reach any person who makes or causes to be

made ‘any claim upon or against’ the United States . . . . [T]he Court has consistently refused to

accept a rigid, restrictive reading [of the Act] . . . . This remedial statute reaches beyond ‘claims’

which might be legally enforced, to all fraudulent attempts to cause the Government to pay out

sums of money.”).




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                                     IV.     CONCLUSION

       In summary, although the Court is persuaded that it overstated the obligations of

laboratories with respect to making medical necessity determinations, it still remains convinced

that laboratories have a legal duty to ensure that they do not submit claims for medically

unnecessary tests. In this case, the relator has sufficiently alleged that Boston Heart submitted

false claims by engaging in a scheme that encouraged non-cardiology physicians to order

medically unnecessary tests, and then billing the Government for those tests. See 2d Am.

Compl.”) ¶¶ 6, 19–22, 52, 94, 127, 132. Accordingly, for the foregoing reasons, the Court grants

in part and denies in part Boston Heart’s motion for reconsideration. Specifically, the Court

amends its June 9, 2017 Memorandum Opinion, United States ex rel. Groat v. Boston Heart

Diagnostics Corp., 255 F. Supp. 3d 13 (D.D.C. 2017) (Walton, J.), to clarify that a laboratory

may rely on the ordering physician’s determination of medical necessity, but denies Boston

Heart’s request to dismiss the remaining claims in this case.

       SO ORDERED this 11th day of December, 2017.

                                                                REGGIE B. WALTON
                                                                United States District Judge




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