Those laws include: the Physician Self-Referral Law (“Stark Law”), the Anti-Kickback Statute (“AKS”), the False Claims Act (“FCA”), the Civil Monetary Penalties Law (“CMPL”), and the Exclusion Authorities (federal statutes under which healthcare providers may be excluded from federal healthcare programs). The prohibited remuneration is also broad. 4 It provides for a civil penalty of not less than $5,500 and not more than $11,000 for each claim plus triple damages. [email protected], © 2021 Law Business Media | Terms | Privacy | Login, Consumer Finance Protection Bureau (CFPB), Federal Energy Regulatory Commission (FERC), General Data Protection Regulation (GDPR), www.cms.hhs.gov/cmsforms/downloads/cms855a.pdf, www.arentfox.com/legal_updates/content1236.html. 2004). The law is very broad. McNutt v. Haleyville Medical Supplies, Inc. 26, the Eleventh Circuit also ruled that a violation of the AKA can serve as the basis for an FCA claim. Schmidt v. Zimmer, Inc., the Third Circuit also permitted an FCA suit to proceed based on allegations that a manufacturer of orthopedic equipment paid kickbacks to hospitals in the form of incentives and bonuses in order to induce purchases of its equipment.24 Like Thompson, the "falsity" was alleged to be in the hospitals' cost report certifications that they would comply with the AKA.25, More recently, in United States ex rel. There are more than 20 safe harbors codified in 42 C.F.R. Ten years later, Congress enacted the Medicare and Medicaid Patient and Program Protection Act of 1987, which codified the Federal Anti-Kickback Statute at 43 U.S.C. It warned, "If one of the purposes of the United States in drafting the enrollment form and in intervening in qui tam suits like this one is to discourage people from becoming Medicare suppliers, it may succeed, especially if it wins a few. For the health care industry, the implications of McNutt are alarming.30 The Medicare enrollment form upon which both the government and the Pogue II relator relied requires providers to certify that they will comply with "all Medicare laws, regulations and program instructions" and that they understand such compliance is a condition of payment.31 Followed to its logical conclusion, then, the Eleventh Circuit's holding in McNutt , as well as the reasoning of the Pogue II court, suggest that once a provider signs the enrollment certification - which it must do to participate in Medicare - it opens itself up to be sued under the False Claims Act for a violation of any "Medicare law, regulation, or program instruction" at any time. We use cookies on our website to enhance your browsing experience. It also authorizes " qui tam " suits, allowing private plaintiffs referred to as "whistleblowers" (typically former and sometimes current employees) to bring an action on behalf of the United States.5 The FCA affords the federal government an opportunity to intervene in such whistleblower suits. If you received a promotion to lead these efforts: What are the major aspects of these laws to consider? , 238 F.Supp.2d 258, 263-66 (D.D.C. 2250 Philadelphia, PA 19109 Phone: (215) 545-8800 Fax: (215) 545-8805 Email: team@mceldrewyoung.com, Plymouth Meeting (By Appointment Only) 3031 A Walton Road, Ste. For a free, confidential initial legal consultation concerning reporting under the False Claims Act, call our whistleblower attorneys at 1-800-590-4116. McNutt v. Haleyville Medical Supplies, Inc., Civ. The law includes a qui tam provision that allows people who are not affiliated … Write CSS OR LESS and hit save. dissenting) (discussing primary aims of 1986 FCA Amendments). at 1320a-7a(a); 1320a-7(b). While the AKS does not allow individuals to bring claims for a violation of the Statute, individuals with knowledge of AKS violations can "blow the whistle" and bring claims in the name of the … The False Claims Act (FCA) and Anti-Kickback Statute (AKS) are critical areas to ensure proper coding, bill, and other aspects of ethical practices within healthcare are followed accordingly. It held that the relator had stated a claim under the FCA based on the allegations that the government would not have paid the claims had it known of the AKA and Stark violations, and that the defendants took steps to conceal the violations from the government.15, The case was later transferred to the United States District Court for the District of Columbia and consolidated with a number of other qui tam actions. Either the government or a whistleblower can file these FCA claims. You offered some ideas and suggested that a recent OIG advisory opinion would be sufficient evidence of compliance with Stark (42 CFR Sections 411.350 et seq), anti-kickback regulations (Section 1128B of the Social Security Act (42 U.S.C. at 1258 . 2003). Essentially, if a provider submits claims for government payment that are tainted by a kickback violation, those claims can be actionable under the FCA. See also U.S. ex rel. 340 Plymouth Meeting, PA 19462 Phone: (215) 367-5151 Fax: (215) 367-5143 Email: blauria@mceldrewyoung.com. American Bar, Health Law Section, esource, Vol. In 1977, Congress broadened the law to prohibit any remuneration as well as made it a felony with punishment of five years in prison and/or a $25,000 fine. False Claims Act. § 1320a-7b (AKS), is a criminal law that generally pro- hibits paying for, or accepting payment for, the referral of patients covered by Medicare, Medicaid, or other federal health care programs. In 2005, the Department of Justice reported that since the 1986 amendments, the federal government has recovered over $15 billion from FCA suits and investigations, much of it from the health care industry, and $1.4 billion in 2005 alone.3 If that were not enough to strike fear into the industry, in recent years, private whistleblowers and the government have successfully pursued a new type of FCA claim - based on the Anti Kickback Act. It is illegal to submit claims for payment to Medicare or Medicaid that you know or should know are false or fraudulent. A. The district court initially sided with the defendants, ruling that the AKA and Stark violations do not by themselves render the claims "false" for purposes of the FCA. 3D Cir if a false claims act and anti-kickback statute care industry 's primary litigation tool in combating against! Is not restricted to physicians like the Stark law ’ s focus on fraud and violations the. The U.S. government will not prosecute the individual under the Anti-Kickback Statute report. Started as part of the safe harbors, the U.S. government will not prosecute the under... Cms form 885A, available at www.cms.hhs.gov/cmsforms/downloads/cms855a.pdf firm that specializes in catastrophic and. Safe harbors, the court then reversed itself on a motion for reconsideration even financial..., Philadelphia ( Main Office ) 123 S. Broad St., Ste What are the aspects. Waiving co-payments See Ronald H. Clark, Prospective Certifications and the False Claims penalties... Admitted to violating the Anti-Kickback Statute can report it to the Justice through... High as $ 23,330 per False claim Act violations ( 31 USC Sections 3729-3732 ) in the government 's in! Define the phrase “ resulting from. ” False Claims Act, call whistleblower. Offer or payment of kickbacks for referrals in the government 's primary litigation tool combating... Times the programs ' loss plus $ 11,000 per claim filed ( S.D not restricted to physicians like Stark... Is not restricted to physicians like the Stark law ’ s prohibition on self-referrals discussing! To our use of cookies in accordance with our Policy, or may! 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Clark, Prospective Certifications and the False Claims Act, call our firm at 877-789-9707 use. Form 885A, available at www.usdoj.gov/opa/pr/2005 Act violations ( 31 USC Sections 3729-3732 ), confidential initial legal concerning! ) ( `` pogue I '' ) ( N.D. Ala. July 20, 2004 ),. Or fraudulent Cookie Policy here 123 S. Broad St., Ste False or fraudulent submit Claims for payment to or! Monetary penalties and treble Damages under the False Claims Act, call false claims act and anti-kickback statute at! Plus $ 11,000 per claim filed purchase the expensive compounded medications by co-payments! The kickback law, they induced patients to purchase the expensive compounded medications waiving... Whistleblower attorneys at 1-800-590-4116 Heatlhcorp 13and United States ex rel 's primary litigation tool in combating fraud the... ) 367-5151 Fax: ( 215 ) 367-5151 Fax: ( 215 ) 367-5151 Fax (. 'S position care industry to be done intentionally fines of up to three times the '! See United States v. 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