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

332 F. Supp. 3d 48
CourtCourt of Appeals for the D.C. Circuit
DecidedSeptember 12, 2018
DocketCivil Action No. 12-1423 (RBW)
StatusPublished
Cited by15 cases

This text of 332 F. Supp. 3d 48 (United States ex rel. Riedel v. Bos. Heart Diagnostics Corp.) is published on Counsel Stack Legal Research, covering Court of Appeals for the D.C. Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States ex rel. Riedel v. Bos. Heart Diagnostics Corp., 332 F. Supp. 3d 48 (D.C. Cir. 2018).

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 *57the 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.

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Cite This Page — Counsel Stack

Bluebook (online)
332 F. Supp. 3d 48, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-ex-rel-riedel-v-bos-heart-diagnostics-corp-cadc-2018.