Difference between revisions of "False Claims Act"

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*[https://www.justice.gov/usao-mdfl/pr/villages-dermatologist-agrees-pay-more-17-million-settle-false-claims-act-liability Upcoding in the form of billing for 14,000-level tissue transfers], which should have been billed as lower-level wound repairs.
*[https://www.justice.gov/usao-mdfl/pr/villages-dermatologist-agrees-pay-more-17-million-settle-false-claims-act-liability Upcoding in the form of billing for 14,000-level tissue transfers], which should have been billed as lower-level wound repairs.
*Making misrepresentations regarding certified cost or pricing data in violation of federal procurement laws and regulations.  See 10 U.S.C. 2306a; 41 U.S.C. Chapter 35; FAR 15.403-4 and 15.403-5.
*Making misrepresentations regarding certified cost or pricing data in violation of federal procurement laws and regulations.  See 10 U.S.C. 2306a; 41 U.S.C. Chapter 35; FAR 15.403-4 and 15.403-5.
=='''Stark Act Violations or Kickbacks Can Violate the False Claims Act'''==
*Both the Stark Act and the Anti-Kickback Act prohibit a health care provider from submitting claims to Medicare based upon referrals from physicians who have a “financial relationship” with the health care entity, unless a statutory or regulatory exception or safe harbor applies. 42 U.S.C. §§ 1395nn(a)(1); 1320a-7b(b).  In particular, the Stark Act prohibits “knowingly and willfully” offering or paying “any remuneration . . . to any person to induce such person . . . to refer an individual to a person 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).  And it prohibits “knowingly and willfully solicit[ing] or receiv[ing]” kickbacks “in return” for such conduct.  Id. § 1320a-7b(b)(1)(A).
*The Stark Act expressly prohibits Medicare from paying claims that do not satisfy each of its requirements, including every element of any applicable exception.  42 U.S.C. §§1395nn(a)(1), (g)(1).
*“Falsely certifying compliance with the Stark or Anti-Kickback Acts in connection with a claim submitted to a federally funded insurance program is actionable under the FCA.”  ''United States  ex rel. Kosenske v. Carlisle HMA, Inc.'', 554 F.3d 88, 95 (3d Cir. 2009) (''citing United States ex rel. Schmidt v. Zimmer, Inc.'', 386 F.3d 235, 243 (3d Cir. 2004) (other citations omitted)).  Typically submission of a claim to Medicare requires the provider to certify compliance with the Anti-Kickback Law on CMS Form 855s, which states in relevant part “I understand that payment of a claim by Medicare is conditioned upon the claim and the underlying transaction complying with [Medicare] laws, regulations, and program instructions (including, but not limited to, the Federal [A]nti-[K]ickback [S]tatute . . . ), and on the supplier’s compliance with all applicable conditions of participation in Medicare.”
*In other words, a claim for payment made pursuant to an illegal kickback is false under the FCA. ''United States ex rel. Quinn v. Omnicare, Inc.'', 382 F.3d 432, 439 (3d Cir. 2004).
*A defendant can avoid liability under the Stark Act by demonstrating that either a statutory or regulatory exception (or safe harbor) applies.  The safe harbor exceptions recognize that financial arrangements between physicians and health care entities may exist for legitimate reasons independent of referrals.
Note that opposing kickbacks or raising concerns about kickbacks is protected conduct under the False Claims Act anti-retaliation provision.  For more information about [https://www.zuckermanlaw.com/false-claims-act-whistleblower-retaliation-lawyer/ False Claims Act whistleblower protection], click [https://www.zuckermanlaw.com/false-claims-act-whistleblower-retaliation-lawyer/ here].
For more information about the False Claims Act, Anti-Kickback Statute, Physician Self-Referral Law, and Exclusion Statute, see the HHS OIG’s [https://oig.hhs.gov/compliance/physician-education/fraud-abuse-laws/ roadmap for physicians about fraud and abuse laws].
=='''Kickback Whistleblower Need Not Prove “but for” Causation'''==
Recently the Third Circuit rejected a provider’s contention that a kickback is actionable under the FCA only where the relator provides that the kickback actually influenced a patient’s or medical professional’s decision to use a particular provider.  In [https://www2.ca3.uscourts.gov/opinarch/171152p.pdf ''Steve Greenfield v. Medco Health Solutions Inc.,''] the Third Circuit held that a kickback qui tam can be proven by showing that a claim was submitted for reimbursement for medical care that was provided in violation of the Anti-Kickback Statute (as a kickback renders a subsequent claim ineligible for payment).  But the court noted that “[a] kickback does not morph into a false claim unless a particular patient is exposed to an illegal recommendation or referral and a provider submits a claim for reimbursement pertaining to that patient.”
In June 2019, Rialto Capital Management LLC (Rialto) and its former affiliate RL BB-IN KRE LLC (RL BB) agreed to pay $3.6 million to resolve allegations that Rialto and the Kentuckiana Medical Center (KMC), an Indiana-based hospital owned by RL BB, violated the Anti-Kickback Statute, the Stark Law, and the False Claims Act by engaging in illegal financial arrangements with two doctors who referred patients to KMC. According to the DOJ’s [https://www.justice.gov/opa/pr/rialto-capital-management-and-current-owner-indiana-hospital-pay-36-million-resolve-false press release], “KMC, under the direction of Rialto, provided personal loans to two referring doctors and then repeatedly forbore from requiring repayment of those loans” and “the hospital’s failure to collect on loans to key referral sources constituted a form of remuneration prohibited by both the AKS and the Stark Law.”


='''Materiality and the False Claims Act'''=
='''Materiality and the False Claims Act'''=