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1 Natinal Assciatin f Criinal DeFense lawyers Septeber/Octber The Rise f EnvirnentaL Crie Prsecutin LAS VEGAS, NV > > > SEE PAGE 4 Oct / NACDl 2i NCDD's 14th AnnuaL DUI Seinar SAVANNAI-i, GA > > > SEE PAGE 27 Nv. 3-5/ NACDl's 2010 FaUSeinar Defendin~ Sexual Assault Cases LAS VEGAS, NV > > > SEE PAGE 45 Nv / NACDl's 3rd Annual Defending Dru~ Cases Seinar ASPEN, CO > > > See PAGE 47 Jan / NACDl's 31St Annual Advanced Criinal law Seinar SAN ANTONIO, TX > > > SEE PAGE 55 Feb / NACDl's 2011 Midwinter Meetin~ 2i Seinar LAS VEGAS, NV > > > SEE PAGE 61 March 25-26/ NACDl 2i CAO's 4th AnnuaL frensic Sdence Seinar ALSO IN THIS ISSUE l-iealthcare Refr FCPA FDA SlV:>IOOn:l3d

2 l-tere Ce the Feds: The Significant Ipact f l-iealthcare Refr n Gvernent Investigatins And Enfrceent Fr the heavily regulated and already ebattled healthcare industry, the recent changes in the healthcare arena by the Fraud Enfrceent and Recvery and the Patient Prtectin and Affrdable Care Act (P.L ) as aended by the Health Care and Educatin Recnciliatin Act f 2010 (tgether, the Healthcare Refr Law) are largely unwelce news. The expansin f ptential liability. and the Departent f Justice's authrity and ability t investigate fraud akes investigatins int and challenges f prviders' practices by bth the gvernent and individual whistleblwers cnsiderably re likely. While healthcare is a highly specialized practice area, all white cllar practitiners culd benefit fr a general understanding f the recent changes in this area and the likely practical effect f these changes. I. Increased Ephasis Upn, and Funding fr, Fraud Investigatins In May 2009, the Fraud Enfrceent and Recvery Act (FERA) allcated significant additinal resurces t varius federal agencies t assist in cbating fraud, including specifically healthcare fraud. FERA allcated $165 illin t the DOJ in fiscal years 2010 and 2011 t hire fraud prsecutrs and 'investigatrs. The law als dedicated $140 illin t the FBI, $50 illin t the U.S. Attrney's Offices, and ver $80 illin t ther federal agencies fr the specific purpse f investigating fraud. In his 2011 budget, President Obaa prpses apprxiately $1.7 billin, and the Healthcare Refr Law sets aside an additinal $250 illin ver the next 10 years, t fund the DOl, the Departent f Health and Huan Services (DHHS), and a nuber f enfrceent agencies tasked with fighting healthcare fraud. In shrt, there is n shrtage f funds fr, r ephasis upn, investigating and prsecuting healthcare fraud. II. FERA and Healthcare Refr Law Make Material Changes t Statutes Ipacting Healthcare Industry The Healthcare Refr Law aends the False Clais Act (FCA), the Stark Law (Stark), the Anti Kickback Statute, and the criinal Healthcare Statute in ways that are likely t negatively ipact investigatins and whistleblwer lawsuits against prviders. A. Significant Changes t the False Clais Act While the False Clais Act (FCA) applies nly in the civil investigatin cntext, white cllar practitiners nnetheless need t be aware f its prvisins. First, 28 w w W. N A C D l. 0 R G BY \-lolly PIERSON T\-IE CI AMPION

3 federal health care investigatins are ften parallel, with bth a civil and criinal investigatin prceeding siultaneusly. As such, the tls avail able t whistleblwers and the gvern ent fr purpses f the civil investiga tin can have a treendus ipact n the criinal investigatin. The recent aendents by FERA and the Healthcare Refr Law t the FCA cbine t draatically expand ptential FCA liability - t a vast and unprecedented degree. Under the FCA as aended, the class f persns wh can serve as whistleblwers and the types f transactins that can be subjected t FCA liability are,;irtually unliited. When this expansin f the FCA is viewed in cbinatin with rapant federal gvernent spending and the current ephasis n recvering funds fr fraud and abuse t pay fr new fed eral entitleent prgras, the healthcare industry faces uncertain and perilus ties ahead. While practitiners in the healthcare arena have been preaching cpliance fr years, the need fr vigi lant, rigrus, up-t-date, and effective cpliance prgras has never been re at the frefrnt r re critical. Befre a rbust cpliance plan can be ipleented, hwever, prviders and suppliers ust under stand the changes t the relevant healthcare laws, including the FCA, and dificatins and adjustents that these new prvisins will require. The purpse f this article is t highlight the key changes ade t the FCA in 2009 and 2010 and their practical ipact n the healthcare industry. 1. Changes Made t the FCAby FERA The FCA was already a pwerful weapn in the hands f gvernent prsecutrs and cunsel fr whistle blwers, with its treble daages and punitive per-ccurrence penalties. The 2009 aendents t the FCA, ade as part f the Fraud Enfrceent and Recvery Act', vastly expanded FCA liability t include "dwnstrea" clais ade nt just t the gvern ent itself but als t all recipients f federal funds. The aendents als aterially expanded "reverse false clais" liability under the FCA and eliinated the specific intent require ent that se curts had read int the statutry schee, while increasing whistleblwer prtectins and giving the gvernent additinal prcedural advantages. At the end f the day, the 2009 aendents added significant weapns t the whistleblwers' and gvernent's arsenal. clai and the payent f the clai by the gvernent. a. New Definitin f 'Clai' and Eliinatin Of Presentent Clause As aended by FERA, the new defi nitin f clai fr purpses f the FCA is n lnger liited t requests r deands fr ney r prperty ade directly t the gvernent. Instead, clais nw include deands ade t "a cntractr, grantee, r ther recipient [f federal funds]" if the ney r prperty prvid ed t the recipient will be (1) spent r used n the gvernent's behalf r (2) used n behalf f the gvernent t advance a gvernent prgra r inter est, as lng as the gvernent has pr vided r will reiburse the recipient fr any prtin f the ney r prperty requested.' The eliinatin f the pre sentent requireent in the aend ents denstrated that Cngress rejected judicial decisins, such as United States ex rei. Ttten v. Bbardier Crp.,' which had deterined that FCA liability culd nly attach if the clai was pre sented t an fficer r eplyee f the gvernent. In effect, FCA liability after the 2009 aendents can attach t deands fr ney r prperty ade nt just t the gvernent itself, but t any recipient f gvernent funds (i.e., cntractr, grantee, etc.). c. Liability fr Reverse False Clais Befre the 2009 aendents in FERA, the "reverse false clais" prvi sin in the FCA prhibited an individ ual fr "knwingly ak[ing], us[ing], r caus[ing] t be ade r used, a false recrd r stateent t cnceal, avid, r decrease an bligatin t payr trans it ney r prperty t the gvern ent."] As aended by FERA, the reverse false clais prvisin prhibits "knwingly ak[ing], us ling], r caus[ing] t be ade r used, a false recrd r stateent aterial t an bli gatin t payr transit ney r prp erty t the gvernent, r knwingly cncea1[ing] r knwingly and iprper ly avid[ing] r decreas[ing] an bliga tin t payr transit ney r prper ty t the gvernent.'" By adding this sectin t the definitin f reverse false clais, Cngress reved the previus requireent that FCA plaintiffs establish an affirative act (aking/using/causing a false recrd r stateent) fr a defen dant t be subject t FCA liability fr aviding r decreasing an bligatin t pay. Nr des the alleged iscnduct have t invlve a false r fraudulent state ent r recrd; cnscius disregard r recklessly iprper cnduct is nw suffi cient fr FCA liability t attach under the reverse false clais prvisin.' Liability fr reverse false clais was als expanded by the FERA aend ents' new definitin fr the ter bli gatin: "an established duty, whether r nt fixed, arising fr an express r iplied cntractual, grantr-grantee, r licensr-licensee relatinship, fr a fee-based r siilar relatinship, fr statute r regulatin, r fr the reten tin f any verpayent."10 Prir t the cdificatin f this brad definitin f bligatin, several curts had declined t interpret bligatin t include pten tial r cntingent bligatins, requiring instead that the bligatin be fixed at the tie f the allegedly false clai." FERA's definitin f the ter bliga tin seeed t raise re questins than it answered. Prviders and suppliers were left t pnder several questins. What is an bligatin? What is an verpayent? When are they triggered? What duty are prviders and suppliers under t identify verpayents? When is an verpayent fficially identified fr purpses f this statute? In the absence f guidance n these issues, hw are prviders and sup pliers t cnduct theselves? b. Eliinatin f Specific Intent Requireent Prir t the 2009 aendents, FCA liability culd nly attach if a persn "knwingly akes, uses, r causes t be ade r used, a false recrd r stateent t get a false r fraudulent clai paid r apprved by the gvernent."4 Based upn this statutry language, the Supree Curt, in Allisn Engine,s deterined that a plaintiff in an FCA case ust establish that the defendant specifically intended t get the gvern ent itself t pay the clai. Legislatively reversing Allisn Engine, the 2009 aendents reved the "t get" and "by the gvernent" language fr the FCA. The aended statute required nly that a false state ent be "aterial t" a gvernent pay ent f the clai, i.e., that the false clai r stateent had "a natural ten dency t influence" r was "capable f influencing" the payent f the c1ai. 6 In essence, this aendent eliinated any specific intent requireent and relieved FCA plaintiffs fr their prir burden f having t establish a direct cnnectin between the allegedly false SEPT-MBER/OCTOBER -i > r -i n > ~ 20~O -

4 Ll ~ «u I... I d. Expanded Whistleblwer Prtectins Fr Retaliatin Cnsistent with ther changes t the FCA in the FERA aendents, whistleblwer prtectins in the statute were expanded t cver nt nly eplyees, but als cntractrs and agents." Additinally, actins taken by whistleblwers t stp vilatins f the FCA are nw cvered by the retaliatin prtectins. 1l Prir t the 2009 aendents, whistleblwers were prtected nly when (J) the whistleblwer engaged in cnduct that was directly in furtherance f an actual actin under the FCA; (2) the eplyer knew abut the investigatin r actin; and (3) the eplyer retaliated against the whistleblwer as a result.!' The aended retaliatin prvisin expanded bth the ptential pl f whistleblwers wh culd invke prtectin under the FCA and the array f prtected cnduct t which the retaliatin prvisin applies. e. Relatin Back f Gvernent's Cplaint Prir t the 2009 FCA aendents, the state f the law with regard t when the statute f liitatins n FCA cases began t run was unsettled. Defendants argued, and any curts agreed, that the statute f liitatins began t run at the filing f the whistleblwer's cplaint and that the gvernent's cplaint-ininterventin did nt relate back t the date f the relatr's cplaint. FERA aended the FCA t explicitly state that the gvernent's cplaint did relate back t the whistleblwer's cplaint." This explicit change eans that the whistleblwer's cplaint nw serves as a placehlder r backstp that essentially allws the gvernent re leeway t investigate and engage in discvery withut the tie pressure f having t file its wn cplaint-in-interventin. As a result, investigatins are likely t be lengthier and re expensive. f. Civil Investigative Deands Anther iprtant change brught abut by the 2009 aendents was the expansin f the DOl's authrity t use Civil Investigative Deands (CIDs). \Vhile civil and criinal prsecutrs previusly ran parallel investigatins and shared dcuentary infratin btained fr Adinistrative Investigative Deands (AIDs), the CIDs perit the civil prsecutrs t cpel bth dcuents and swrn testiny, and then t share this infratin with criinal prsecutrs and cunsel fr whistleblwers.!6 Befre FERA, CIDs were nt widely used in FCA investigatins because they were required by statute t be issued by the u.s. Attrney General. FERA, hwever, aended the statute t perit the Attrney General t delegate the authrity t issue CIDs, and the Attrney General has delegated this authrity t, inter alia, the individual United States Attrneys.!? As with any new weapn in the prsecutr's arsenal, the delegatin f this authrity t the lcal enfrceent level is certain t result in a significant increase in its utilizatin. The increased authrity thrugh CIDs t gather and share evidence at this early stage in an investigatin will adversely ipact prviders and suppliers bth in fending ff a whistleblwer suit and in atte pting t negtiate the already treacherus waters f a parallel civil and criinal investigatin. 2. Changes Made t the FCA by The Healthcare Refr Law While the healthcare industry was still trying t get its ars arund the iprt and eaning f the 2009 aendents t the FCA, Cngress went back t the well and ade even re significant changes t the law. Like their 2009 predecessrs, the 2010 aendents, enacted as part f the Healthcare Refr Law, further bradened ptential expsure fr prviders and suppliers, increased yet again the ptential pl f whistleblwers and eliinated previusly available defenses t FCA clais. a. Peritting Mre Whistleblwers t Qualify As the Original Surce Under the FCA, a whistleblwer ust be the "riginal surce" f the infratin that frs the basis f the alleged fraud.!s Prir t the 2010 aendents, the FCA defined riginal surce as "an individual wh has direct and independent knwledge f the infratin n which the allegatins are based and has vluntarily prvided the infratin t the gvernent befre filing an actin under this sectin which is based n the infratin."!' The Healthcare Refr Law expanded that definitin f riginal surce t include individuals wh either (l) vluntarily disclsed t the gvernent the infratin n which allegatins r transactins in a clai are based prir t a public disclsure, r (2) have knwledge that is independent f and aterially adds t the publicly disclsed allegatins r transactins, and wh vluntarily prvided the infratin t the gvernent befre filing an actin under this sectin. 20 This new definitin f "riginal surce" eliinates the requireent fr direct knwledge by the whistleblwer, and allws individuals t still be cnsidered whistleblwers after the public disclsure f allegatins r transactins if the whistleblwer's infratin is independent f and ateriajly adds t the already-disclsed infratin. In shrt, the 2010 aendents t the riginal surce definitin perit individuals wh previusly culd nt have been whistleblwers because they were nt the riginal surce t nw qualify as whistleblwers in se instances. b. Narrwing f Defense Based Upn 'Public Disclsure' Befre the 2010 aendents t the FCA thrugh the Healthcare Refr Law, ne defense that prviders culd raise was a jurisdictinal bar that prevented an FCA suit by a whistleblwer when the allegatins had been publicly disclsed t the news edia r in a criinal, civil, adinistrative r cngressinal investigatin, prceeding, hearing, audi t, r reprt.'! The Healthcare Refr Law eliinates the jurisdictinal nature f the public disclsure prvisin, and instead gives the gvernent the right t ppse disissal even if there has been a public disclosure. The Healthcare Refr Law als specifically liits the public disclsure definitin as applying nly t disclsures in the news edia and in federal, nt state r lcal, prceedings." Lwer curts previusly interpreted the language f the prir versin f the "public disclsure" bar t include disclsures ade in state, lcal, and federal prceedings. Irnically, the Supree Curt clarified n March 30, 2010, in Graha Cunty Sil and Water Cnservatin District v. U.S. ex rei. Wilsn 23 that the defitin f "public disclsure" under the prir versin f the FCA specifically included disclsures ade in state and cunty reprts. In light f the Graha Cunty decisin, the public disclsure prvisin f the FCA fr suits prir t the effective date f the Healthcare Refr Law will bar whistleblwers wh base their clais n infratin in state and lcal reprts, while FCA clais brught n the sae infratin after the effective date will experience n such prhibitin. c. Definitin f Overpayent Where the 2009 aendents ade under FERA left pen the definitin f verpayent, the 2010 aendents t 3 THE CHAMPION

5 the FCA attepted t fill that vid. The Healthcare Refr Law defines the ter verpayent as "any funds that a persn receives r retains [fr a federal payr] t which the persn, after applicable recnciliatin is nt entitled.... "24 The Healthcare Refr Law then prvides that all verpayents ust be reprted and refunded within 60 days after the identificatin f the verpayent r the date any crrespnding reprt is due. Finally, the 2010 aendents clarify that a repayent retained after the deadline fr reprting and repaying it is an "bligatin" fr FCA purpses. 2S \-\'hether this definitin f verpayent prvides any assistance t prviders and suppliers in the cntext f a reverse false clai is up fr debate. Many f the sae questins surrunding the 2009 reverse false clais act aendents are left unreslved, and new levels f unanswered questins are added by these 2010 prvisins. When, fr exaple, is an verpayent "identified" fr purpses f the statute such that the 60-day reprtlrefund windw is triggered? And in the absence f guidance n these types f issues fr the gvernent, hw is a prvider r supplier t gauge hw t gvern itself? In this envirnent, with increased fcus n enfrceen t and unprecedented expansin f ptential FCA liability, the industry shuld err significantly n the side f cautin. III. Expansin f the Anti Kickback Statute The Healthcare Refr Law als changes the Anti-Kickback Statute (AKS). Specifically, it clarifies that a shwing f "specific intent" t vilate the AKS is nt required. 26 This change results in an easier standard fr the gvernent t shw there is a vilatin f the AKS. The Healthcare Refr Law als akes expl icit what several federal curts had already deterined - that clais resulting fr kickback arrangeents cnstitute "false r fraudulent clais" under the FCA. One ptentially psitive change fr prviders is the Healthcare Refr Law's aendent t the definitin f reuneratin in the beneficiary induceent prvisins f the Civil Mnetary Penalties. Reuneratin, which is the key t the applicatin f the AKS, nw excludes fr its definitin any reuneratin that bth prtes access t care and des nt pse a significant risk f har t patients r the federal payrs. Many prvider activities wuld stensibly fall within this seeingly brad exclusin. IV. Changes t the Healthcare Criinal Fraud Statute Anther iprtant change under the Healthcare Refr Law is the lwering f the intent requireent cntained in the healthcare fraud criinal statute, 18 U.s.c Prf f actual knwledge f the healthcare fraud statute r f specific intent t vilate the statute is n lnger required. The definitin f healthcare ffense under 18 U.s.c. 24(a) was als aended t include vilatins f the AKS and the Fd, Drug, and Csetic Act. Cnclusin Fr a healthcare prvider and practitiner perspective, the recent changes are nt gd news. The increased funding fr fraud investigatins and the significant lsening f the whistleblwer lawsuit cnstraints virtuaby ensure that the current high level f scrutiny n prviders will increase. White cllar practitiners are re likely than ever t be called upn t navigate the perilus waters f the healthcare regulatry arena, and they shuld nt delve t deeply int these substantive waters withut bringing in a healthcare specialist. A basic understanding f the eaningful way this landscape has changed, hwever, is a valuable tl fr a]] white c]]ar practitiners. Hlly Piersn, All rights reserved. Ntes 1. P.L U.s.C 3729(b)(2) (2009) F.3d 488,490 (D.C. Cir. 2004) U.S.c. 3729(a)(2) (1986) (ephasis added) S. Ct. at U.S.c. 3729(a)(1)(B) and (b)(4) (2009) U.S.C 3729(a)(7) (2006) U.s.c. 3729(a)(7) (2009) (ephasis added) U.S.c. 3729(b)(1) (2009) (defining "knwingly" as actual knwledge, deliberate ignrance, r reckless disregard) U.S.c. 3729(b)(3) (2009). 11. See, e.g,. United States ex rei. Marcy v. Rwan Cpanies, Inc., 520 F.3d 384, 391 (5th Cir. 2008); United States ex rei. Bain v. Gergia Gulf Crp., 386 F.3d 648, 657 (5th Cir. 2004); United States v. Burseau, 531 F.3d 1159, (9th Cir. 2008) U.s.c. 3730(h)(1) (2009). 13.ld U.S.c. 3730(h)(1) (2006) U.s.C 3131 (c) (2009) U.S.C 3133(a)(1) (2009) U.S.C 3133(a)(1) (2009) U.S.c. 3730(e)(4) (2009) U.S.c. 3730(e)(4)(B) (2009) (ephasis added) U.S.c. 3730(e)(4)(B) (2010) U.S.c. 3730(e)(4)(A) (2009) U.s.c. 3730(e)(4)(A) (2010) S.Ct (2010) U.s.c. 1320a-7k (2010). 25.ld. 26. Prir t this clarificatin, several curts required the gvernent t denstrate a heightened knwledge requireent t satisfy the eleents f the Anti-Kickback Statute. In Hanlester Netwrk v. Shalala, 51 F.3d 1390, 1400 (9th Cir. 1995), the curt deterined that the "knwingly and willfully" language in the Anti-Kickback Statute required that the defendant (1) knw that the statute prhibits ffering r paying reuneratin t induce referrals, and (2) engage in prhibited cnduct with the specific intent t disbey the law. The Fifth, Eighth, and Eleventh Circuits declined t g as far as the Ninth Circuit in Hanlester, but nnetheless ipsed a heightened knwledge requireent that the defendant knw his cnduct was wrngful but nt necessarily that it vilated a legal duty. See United States v. Davis, 132 F.3d 1092, 1094 (5th Cir. 1998); United States v. Jain, 93 F.3d 436,441 (8th Cir. 1996); United States v. Starks, 157 F.3d 883 (11th Cir. 1998). Abut the Authr Hlly Piersn is Of Cunsel at Mrris Manning & Martin LLP in the fir's Healthcare, Fraud & Abuse Defense, and Cercial Litigatin Practices. She cncentrates n internal investigatins, white cllar defense and special litigatin, including healthcare fraud, whistleblwer actins, identity theft, rtgage and banking fraud, envirnental issues, and public crruptin. lilly Piersn Mrris, Manning & Martin LLP 1600 Atlanta Financial Center 3343 Peachtree Rad NE Atlanta, GA Fax M!- hpiersn@law.c "71 SEPTEMBER/OCTOBER 20~O 3 1