Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

United States ex rel. Riedel v. Boston Heart Diagnostics Corp.

United States District Court, District of Columbia

September 12, 2018

UNITED STATES OF AMERICA ex rel. CHRIS RIEDEL, Plaintiff,
v.
BOSTON HEART DIAGNOSTICS CORPORATION, Defendant.

          MEMORANDUM OPINION

          REGGIE B. WALTON UNITED STATES DISTRICT JUDGE.

         The plaintiff/relator, Chris Riedel, brings this qui tam action on behalf of the United States against the defendant, Boston Heart Diagnostics Corporation (“Boston Heart”), under the False Claims Act, 31 U.S.C. § 3729 (2012). See Relator's Second Amended Complaint for Money Damages and Civil Penalties for Violations of the False Claims Act (“2d Am. Compl.”) ¶¶ 1, 108-21. Currently before the Court is Boston Heart Diagnostics Corporation's Motion to Dismiss Relator's Second Amended Complaint (“Def.'s Mot.”), which seeks dismissal of the relator's claims pursuant to Federal Rules of Civil Procedure 9(b) and 12(b)(6). See Def.'s Mot. at 1. 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 to dismiss.

         I. BACKGROUND

         A. Applicable Statutes

         A brief overview of the Medicare program and the statutes at issue in this case will help elucidate the relator's allegations in his Second Amended Complaint.

         1. The Medicare Program

         Medicare is a federal health insurance program for the elderly and people with disabilities. See 42 U.S.C. § 1395c (2012). Medicare Part B, which provides outpatient coverage for, among other things, diagnostic laboratory tests, see 42 C.F.R. § 410.32 (2017), only covers medical services that are “reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, ” 42 U.S.C. § 1395y(a)(1)(A). “[Laboratory t]ests that are performed in the absence of signs, symptoms, complaints, personal history of disease, or injury are not covered except when there is a statutory provision that explicitly covers tests for screening as described.” Medicare Claims Processing Manual: Chapter 16-Laboratory Services (“Processing Manual”) § 120.1 (2018).[2] “[E]ven 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.” United States ex rel. Groat v. Boston Heart Diagnostics Corp., 296 F.Supp.3d 155, 163 (D.D.C. 2017) (Walton, J.) (Groat II).

         “The Secretary of the Department of Health and Human Services administers the Medicare program through the Centers for Medicare and Medicaid Services, which contracts with Medicare Administrative Contractors [(‘MACs')] to manage enrollment of health care providers and to process payments.” Popkin v. Burwell, 172 F.Supp.3d 161, 164 (D.D.C. 2016). This includes ensuring that claims for payment are “clean claims, ” meaning “claim[s] that ha[ve] no defect or impropriety.” 42 U.S.C. § 1395h(c)(2)(A)-(B).

         “When submitting claims for payment . . ., healthcare service providers . . . use standard billing forms[, ] . . . [which] use numeric codes to describe the medical services for which the provider seeks payment.” Ass'n of N.J. Chiropractors v. Aetna, Inc., No. 09-3761 (JAP), 2012 WL 1638166, at *1 (D.N.J. May 8, 2012). “Federal regulations, specifically 45 C.F.R. § 162.1002(a)(5), (b)(1), designate the American Medical Association's Current Procedural Terminology (‘CPT') and the Centers for Medicare & Medicaid Services Common Procedure Coding System (‘HCPCS') as the standard codes to be used for physician services and other health care services.” Id. “HCPCS codes can define a single test or a panel (a group of tests that are commonly performed together).” Dep't of Health & Human Servs. Office of Inspector Gen., Questionable Billing for Medicare Part B Clinical Laboratory Services at 2 (2014). One “common Medicare fraud scheme[] involving clinical lab services . . . [is] unbundling tab tests.” Id. “Unbundling is the practice of inappropriately reporting each component of a service or procedure instead of reporting the single comprehensive code.” Id. at 2 n.12.

         An entity seeking reimbursement for services provided to Medicare patients must submit a CMS-1500 form to the MAC. See United States ex rel. Hobbs v. MedQuest Assocs., Inc., 711 F.3d 707, 711 (6th Cir. 2013) (“The[ CMS-1500] form[] reflect[s] the treatment or services provided and identif[ies] the [entity that] provided them.”). The CMS-1500 form requires the entity to certify that, among other things, “the services on this form were medically necessary.” Health Insurance Claim Form (“CMS-1500”) at 2, available at https://www.cms.gov/Medicare/ CMS-Forms/CMS-Forms/Downloads/CMS1500.pdf (last visited Sept. 12, 2018).

         2. The Anti-Kickback Statute

         The Anti-Kickback Statute prohibits payments in exchange for referrals to federal healthcare programs, specifically prohibiting:

knowingly and willfully offer[ing] or pay[ing] any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind to any person to induce such person . . . to refer an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a Federal health care program.

42 U.S.C. § 1320a-7b(b)(2)(A).

         Unfortunately, the occurrence of kickbacks is reportedly common in the context of laboratory tests billed to Medicare. In 1994, the U.S. Department of Health and Human Services, Office of Inspector General (“OIG”), issued a Special Fraud Alert that addressed laboratory practices that violated the Anti-Kickback Statute, including, but not limited to, “routine waiver of Medicare Part B co-payments and deductibles.” Publication of OIG Special Fraud Alerts, 59 Fed. Reg. 65, 372, 65, 373 (Dec. 19, 1994) (“1994 OIG Special Fraud Alert”). And the OIG has made clear that “disguising remuneration for Federal referrals through offers or payments of inflated amounts for non-Federal business or simply by offering or paying remuneration for non-Federal referrals to ‘pull through' the Federal business” “may violate the [A]nti-[K]ickback [S]tatute.” Dep't of Health & Human Servs. Office of Inspector Gen., Advisory Opinion No. 00-8: Spectrum Housing, d/b/a Housing Referrals of Maine at 5 (2000).

         Consequently, in 2005, the OIG issued an Advisory Opinion stating:

Where a laboratory pays a referring physician to perform blood draws, particularly where the amount paid is more than the laboratory receives in Medicare reimbursement, an inference arises that the compensation is paid as an inducement to the physician to refer patients to the laboratory . . . .

         Dep't of Health & Human Servs. Office of Inspector Gen., Advisory Opinion No. 05-08 at 4 (2005) (“2005 OIG Advisory Opinion”). Thereafter, in 2014, the OIG issued a Special Fraud Alert regarding other laboratory payments to referring physicians, stating that it “ha[d] become aware of arrangements under which clinical laboratories are providing remuneration to physicians to collect, process, and package patients' specimens.” Dep't of Health & Human Servs. Office of Inspector Gen., Special Fraud Alert: Laboratory Payments to Referring Physicians at 3 (2014) (“2014 OIG Special Fraud Alert”). The OIG noted that some of these arrangements may implicate the Anti-Kickback Statute, particularly if, inter alia, “[p]ayment exceeds fair market value for services actually rendered by the party receiving the payment, ” id. at 4, or the “[p]ayment is for services for which payment is also made by a third party, such as Medicare, ” id. at 5.

         3. The Stark Law

         The Stark Law prohibits physicians from referring patients to anyone with whom he or she has a financial relationship. Specifically, “if a physician (or an immediate family member of such physician) has a financial relationship with an entity . . . [, ] the physician may not make a referral to the entity for the furnishing of designated health services.” 42 U.S.C. § 1395nn(a)(1)(A). A financial relationship is defined as “an ownership or investment interest in the entity, or . . .a compensation arrangement . . . between the physician (or an immediate family member of such physician) and the entity.” Id. § 1395nn(a)(2)(A)-(B).

         4. The False Claims Act

         “The False Claims Act imposes civil liability on any person who knowingly submits false claims to the government.” United States ex rel. Dig. Healthcare, Inc. v. Affiliated Comput. Servs., Inc., 778 F.Supp.2d 37, 44-45 (D.D.C. 2011) (Walton, J.) (citing 31 U.S.C. §§ 3729- 3733). Its purpose is “to reach all types of fraud, without qualification, that might result in financial loss to the Government, ” and “reaches beyond ‘claims' which might be legally enforced, to all fraudulent attempts to cause the Government to pay out sums of money.” United States v. Neifert-White Co., 390 U.S. 228, 232-33 (1968) (noting that “the Court has consistently refused to accept a rigid, restrictive reading [of the Act]”). “[V]iolations of [the Anti-Kickback] and Stark [statutes] can be pursued under the False Claims Act, since they would influence the government's decision of whether to reimburse Medicare Claims.” United States ex rel. Pogue v. Diabetes Treatment Ctrs. of Am., Inc., 565 F.Supp.2d 153, 159 (D.D.C. 2008) (Pogue II).

         Three provisions of the False Claims Act are at issue in this case. Section 3729(a)(1)(A) creates liability for “any person who . . . knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval.” 31 U.S.C. § 3729(a)(1)(A). Section 3729(a)(1)(B) creates liability for “any person who . . . knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim.” Id. § 3729(a)(1)(B). And § 3729(a)(1)(G), known as the “reverse false claims” provision, creates liability for “any person who . . . knowingly makes, uses, or causes to be made or used, a false record or statement material to an obligation to pay or transmit money or property to the Government, or knowingly conceals or knowingly and improperly avoids or decreases an obligation to . . . the Government.” Id. § 3729(a)(1)(G).

         B. Factual Background and Procedural History

         The relator is a retired individual who previously “had a long career in the commercial reference laboratory business, ” 2d Am. Compl. ¶ 20, and was a member of the Board of Directors of Boston Heart “from 2007 until majority control of the Company was acquired by Bain Capital Venture Fund in late 2010, ” id. ¶ 101. “Boston Heart is a medical laboratory that specializes in advanced lipid testing.” Id. ¶ 22.

         The relator filed his original Complaint under seal on August 28, 2012. See Relator's Complaint for Money Damages and Civil Penalties for Violations of the False Claims Act, 31 U.S.C. § 3730(b)(2) (Aug. 28, 2012), ECF No. 1. On August 19, 2016, the United States declined to intervene in this case, see Notice of Election to Decline Intervention (Aug. 19, 2016), ECF No. 24, and the Court therefore unsealed the case, see Order at 1 (Aug. 24, 2016), ECF No. 25. On February 18, 2016, the relator filed his First Amended Complaint. See Amended Complaint for Money Damages and Civil Penalties for Violations of the False Claims Act (Feb. 18, 2016), ECF No. 19. On September 20, 2017, the Court denied Boston Heart's motion to dismiss the relator's First Amended Complaint without prejudice and granted the relator's request for leave to file a Second Amended Complaint, see Order at 7 (Sept. 20, 2017), ECF No. 39, which he did on October 4, 2017, see 2d Am. Compl. at 1.

         The Second Amended Complaint contains three causes of action: (1) a violation of the “false presentment” provision of the False Claims Act, see 2d Am. Compl. ¶¶ 108-12; see also 31 U.S.C. § 3729(a)(1)(A); (2) a violation of the “false statements” provision of the False Claims Act, see 2d Am. Compl. ¶¶ 113-17; see also 31 U.S.C. § 3729(a)(1)(B); and (3) a violation of the “reverse false claims” provision of the False Claims Act, see 2d Am. Compl. ¶¶ 118-21; see also 31 U.S.C. § 3729(a)(1)(G).

         The relator asserts five theories of liability against Boston Heart that form the basis of his three causes of action: four alleged kickback schemes and one other purported violation of Medicare requirements. See id. ¶ 1 (“[Boston Heart] provides at least four forms of illegal kickbacks to doctors and clinics in order to induce those doctors and clinics to refer Medicare business to them, and bills Medicare for redundant and unnecessary testing.”). The four alleged illegal kickback schemes are: (1) “waiving co-payments or patient deductible payments from doctors' privately-insured patients, ” for physicians who “send all of their lipid-related business, including Medicare business, ” to Boston Heart, id. ¶ 2; (2) paying physicians inflated packaging fees, in excess of the actual cost of packaging and shipping specimens to Boston Heart, to induce physicians to refer their Medicare business to Boston Heart, see id. ¶ 4; (3) performing and billing the government for laboratory tests ordered by physicians who are Boston Heart shareholders in violation of the Stark Law, see id. ¶ 6; and (4) paying “outrageous consulting fees to referring physicians, ” id. ¶ 7. According to the relator:

Each of these practices constitute[s] an illegal kickback scheme, no more legal than if [Boston Heart] handed doctors envelopes of cash in exchange for Medicare referrals. [Boston Heart] violated the False Claims Act by charging Medicare and other federally funded healthcare programs for lab tests that were referred to [ ] Boston Heart by providers because of kickbacks offered to those providers by [Boston Heart].

Id. ¶ 8. Boston Heart's other purported Medicare violation is performing and billing the government for medically unnecessary tests ordered through its own test panels. See id. ¶¶ 11- 13. Each alleged theory of liability asserted in the Second Amended Complaint is now described in further detail below.

         1. Waiving Co-Payments and Deductibles Theory of Liability

         The relator alleges that from 2011 through 2016, id. ¶¶ 1, 98-99, 103, Boston Heart waived patients' co-payments and deductibles, in violation of the Anti-Kickback Statute, “as an incentive for physicians to refer business to Boston Heart, ” id. ¶ 39. According to the relator, private health insurance companies typically “require that a patient ordering a laboratory test make a co-payment of approximately 20% of allowable charges to the laboratory.” Id. ¶ 40. And, “[p]rivate insurance companies also require their patients to make a deductible payment to the laboratory until the patient has met his [or] her deductible amount for the year.” Id. The relator alleges that “Boston Heart's most common panel of tests is the Complete One panel, which costs $614.29.” Id. ¶ 42. Therefore, a 20% co-payment for the Complete One panel “would be approximately $122, ” if it were charged. Id. The relator alleges that Boston Heart's waiver of co-payments and deductibles were thus a “great benefit to the doctors, who [we]re able to attract and retain the business of patients by promising no co-payments or patient deductible amounts, ” and that “[k]nowing this, [Boston Heart] promise[d] physicians that it w[ould] waive the co[-]payment[s], as long as the physicians send all of their lipid-related business-including Medicare business-to [Boston Heart].” Id. ¶ 42; see also id. ¶¶ 43-44 (alleging the same waiver scheme and benefits for patients' deductibles). The relator further alleges that this scheme encouraged medically unnecessary tests because, “[b]y waiving patient deductible[s] and co-payments, the physician [wa]s no longer subject to any restraint on whether tests [we]re medically necessary because they [we]re free for patients, ” and “by removing the patient's financial stake in the transaction, [Boston Heart] ha[d] neutralized one of the market's inherent checks on frivolous treatment-individual monetary responsibility for the cost of care.” Id. ¶ 46. According to the relator, Boston Heart “more than ma[d]e[] up” the amount of money it lost on the waived co-payments and deductibles “with the profits it earn[ed] on the Medicare referrals.” Id. ¶ 45.

         To support this allegation, the relator submitted with his Second Amended Complaint a copy of an Explanation of Benefits (“EOB”) for a patient who received Boston Heart tests. See id., Exhibit (“Ex.”) 3 (EOB (Jan. 25, 2017)). According to the relator, the EOB shows that $4, 000 in costs were not covered by the patient's insurance, but that “the patient was never charged for the tests.” Id. ¶ 43; see also id. ¶ 81 (“For the 2017 EOB . . ., the insurer declined all charges, which amounted to over $4, 000, but the patient never received an invoice for any amount.”).

         The relator alleges that Boston Heart continued its waiver practice until 2016, even though in 2014, the Department of Justice pursued enforcement actions against three different laboratories based on their “alleged failure to invoice patients for deductibles and co-payments.” Id. ¶ 47 (alleging that the Department of Justice intervened in one false claims act action against one laboratory and settled with two others). According to the relator, in 2016, Boston Heart, “knowing the co-pay[ment] waivers violated the False Claims Act, ” id. ¶ 48, “tweaked its fraud, ” and instead of waiving co-payments and deductibles entirely, instead began “to charge patients a ‘special fee' named a ‘Know It Now [Fee], '” id. ¶ 3; see also id. ¶ 48 (alleging that Boston Heart replaced its co-payment and deductible waiver scheme “with a new form of inducement for patient invoices”); id., Ex. 2 (Know It Now Fee Schedule).

         The relator alleges that the Know It Now Fee “[wa]s the amount . . . charged to patients in lieu of a standard calculation of their co-pay[ment] or deductible, ” and that this Fee “[wa]s a fraction of the co-payment requirement (usually in excess of $100) based on Boston Heart's charges to insurance companies.” Id. ¶ 3 (alleging that the Fee is $2 or less for 75% of Boston Heart's tests, and is $7 or less for 95% of its tests); id. ¶ 49 (similar). According to the relator, the Know It Now Fee was “billed to patients as the total amount owed if [the patients] ha[d] not yet met their deductible for the year, ” and “where Boston Heart collect[ed] from an insurer for the services, and the only patient responsibility [wa]s for a co-payment, Boston Heart bill[ed] the ‘Know [I]t Now' [Fee] to the patients, rather than the 20% co-payment.” Id. ¶ 49. The relator alleges that “Boston Heart agree[d] with physicians up front that it w[ould] send ‘two invoices' to the patients, but states that they ‘d[id] not send patients to collections, '” id. ¶ 50, and therefore, the Know It Now Fee was “effectively [a] waiver[] of patients' co-payments and deductibles, ” id. ¶ 51. Moreover, the relator alleges that “within months of Boston Heart beginning to invoice patients for deductibles and co-payments, even through use of its below cost, ‘Know [I]t Now' [F]ees, Boston Heart lost 40% of its revenue.” Id. ¶ 70. The relator also names over fifty individual physicians or medical practices who participated in the alleged waiver scheme until 2016. See id. ¶¶ 98-99.

         2. Packaging Fees Theory of Liability

         The relator alleges that Boston Heart, from 2011 through 2016, see id. ¶¶ 1, 69, 103, induced physicians to refer their Medicare business to Boston Heart by paying them packaging fees that are greater than the actual cost of packaging and shipping specimens to Boston Heart for testing, see id. ¶¶ 4, 53. The relator supports his allegation that these fees were inflated by comparing the standard Medicare draw fee of $3 with the amount Boston Heart allegedly paid to cover the physicians' costs associated with both drawing and shipping the specimens to Boston Heart. See id. ¶¶ 55, 57-58, 62. “Medicare allows the person who collects a specimen to bill Medicare for a nominal specimen collection fee in certain circumstances, including times when the person draws a blood sample, ” 2014 OIG Special Fraud Alert at 3, and the standard amount that the Centers for Medicare & Medicaid Services (“CMS”) allows physicians or laboratories to charge in draw fees is $3, id. at 3 n.10; accord 2d Am. Compl. ¶ 55. CMS also reimburses “packaging fees, ” which are the costs of “processing and packaging specimens for transport to a clinical laboratory through a bundled payment.” 2014 OIG Special Fraud Alert at 4.[3]

         According to the relator, Boston Heart paid physicians between $15 and $25 to cover their costs associated with drawing specimens and packaging them for shipping to the laboratory. 2d Am. Compl. ¶¶ 62, 64. The relator alleges that this payment constituted a kickback, and relies on the 2005 OIG Advisory Opinion prohibiting excessive draw fees in support of this assertion. See id. ¶¶ 54-55 (citing 2005 Advisory Opinion). In that Advisory Opinion, the OIG concluded that a laboratory paying a physician a draw fee of $6, plus blood-drawing supplies, would implicate the Anti-Kickback Statute. See 2005 Advisory Opinion at 4. The relator applies this conclusion to Boston Heart's alleged $15 to $25 packaging fee payments to physicians as support for his position that these payments also amounted to kickbacks. See 2d Am. Compl. ¶ 55 (alleging that “[t]he ‘packaging' fees paid by [Boston Heart] to referring providers in this case are no different” than the scenario in the 2005 Advisory Opinion).

         And, the relator alleges that “Boston Heart encourage[d] physicians to break up their testing needs among multiple colluding laboratories in order to receive draw fees from multiple sources rather than have one lab perform all the tests.” Id. ¶ 59. The relator specifically identifies Health Diagnostic Laboratories, Singulex, Liposcience, and Atherotech as other colluding laboratories. Id. According to the relator, this scheme “facilitate[d] multiple ‘packaging' fees per patient, rather than just one fee per patient, regardless of the number of labs to which the tests specimens [we]re sent.” Id.; see also id. ¶ 61 (alleging that Boston Heart “promote[d] this practice by sponsoring seminars that discuss[ed] how profitable splitting up tests between laboratories c[ould] be for physicians.”).

         Further, the relator alleges that after the OIG issued its 2014 Special Fraud Alert warning that certain blood-specimen collection, processing, and packaging arrangements could implicate the Anti-Kickback Statute, see id. ¶ 63; see also 2014 OIG Special Fraud Alert at 2-5, “[i]n late 2014 and 2015, ” 2d Am. Compl. ¶ 62, Boston Heart began using third parties, “including, but not limited to LLmobileLab, Biotex, and VeniExpress, ” to funnel the fees to the physicians, id. ¶ 64; see also id. ¶ 63 (“After an OIG ruling in 2014 . . ., rather tha[n] stop the practice of incentivizing physician referrals through cash payments, Boston Heart simply changed its scheme to further conceal it by using third parties to make the payments to physician staff and families, rather than Boston Heart paying physicians directly.”). In other words, the relator alleges that Boston Heart changed its packaging fee payment process in order to avoid detection by the government, see id. ¶¶ 63-66, and, as an example, states that a Boston Heart sales representative, Heidi Ann Mooney, told a California physician that “[the Department of Justice] said we can't pay you [the physician] directly, so we pay [a third party], they take some of the money and they pay you. It's all about perception, ” id. ¶ 66 (alterations in original); see also Id. (alleging that a Biotex representative told the physician that “it didn't even matter if [the payee] was a relative as long as the last names were different” (alteration in original)). The relator alleges that Boston Heart ceased paying packaging fees after October 31, 2016, see id. ¶ 69, and also names over fifty individual physicians or medical practices who participated in the alleged packaging fees scheme, see id. ¶¶ 98-99.

         3. Self-Referrals Theory of Liability

         The relator alleges that, from 2011 through 2015, see id. ¶¶ 1, 99, two physicians who were Boston Heart shareholders referred their patients to Boston Heart for laboratory testing in violation of the Stark Law, id. ¶ 83, 99. To support this allegation, the relator relies on the CMS Voluntary Self-Referral Disclosure Protocol. See id. ¶ 85; see also Ctrs. for Medicare & Medicaid Servs., U.S. Dep't of Health & Human Servs., CMS Voluntary Self-Referral Disclosure Protocol (2010) (“CMS Protocol”). The CMS Protocol states that “conduct that raises liability risks under the physician self-referral law may also raise liability risks under . . . the federal [A]nti-[K]ickback [S]tatute, ” CMS Protocol at 1; see also 2d Am. Compl. ¶ 85, and therefore, the relator claims, “each laboratory test Boston Heart billed to Medicare and performed on a patient referred by a physician with a financial stake in Boston Heart constitute[d] a violation of the [ ] False Claims Act, ” 2d Am. Compl. ¶ 85. The relator names two individual physicians who allegedly were Boston Heart shareholders and referred business to Boston Heart without disclosing their ownership interests to their patients. See id. ¶ 99.

         4. Speaking and Consulting Fees Theory of Liability

         The relator alleges that Boston Heart “paid outrageous consulting fees to referring physicians”; specifically, over $200, 000 in 2012 and 2013 to a nurse practitioner and a physician who “were among the top referral sources to [Boston Heart].” Id. ¶ 7.[4] According to the relator, these

fees were paid primarily for these physicians to solicit physician clients for Boston Heart by speaking at seminars where they explained to physicians how much money they could make by receiving packaging fees and splitting specimens between multiple labs, and how Boston Heart's large panels would have no impact on their patients.

Id. (emphasis removed).

         5. Medically Unnecessary Testing Theory of Liability

         Finally, the relator alleges that, “from at least 2009 to [2017], ” id. ¶ 97, Boston Heart performed and billed for medically unnecessary tests by “encourag[ing] doctors to order their pre-selected panel tests, ” id. ¶ 87, and compares the industry-standard four-test lipid panel to Boston Heart's eight-test panel, id. ¶ 91; see also id., Ex. 1 (Boston Heart Test Panel). The relator relies on a MAC's Future Local Coverage Determination (“Determination”) to support his allegation that these extra tests were medically unnecessary. See id. ¶ 86. That Determination states that “[cardiovascular] risk assessment panels, consisting of various combinations of biochemical, immunologic, hematologic, and molecular tests, is considered screening when performed on an asymptomatic patient, and, as such, are not a Medicare benefit.” 2d Am. Compl., Ex. 4 (Future Local Coverage Determination (LCD): MoIDX: Biomarkers in Cardiovascular Risk Assessment (L36129) (Aug. 20, 2015)) at 2. The relator also relies on purported statements made by Dr. Paul Ziajka, a cardiologist, to support his allegation that Boston Heart's additional tests in its ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.