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Presented by: Presented by: John R. Kamp, PhD, JDJohn R. Kamp, PhD, JDJudith G. Ribble, PhDJudith G. Ribble, PhD

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Fraud, Funding, and the First Amendment:Fraud, Funding, and the First Amendment:How Did CME Get Caught Up in Washington Health Care How Did CME Get Caught Up in Washington Health Care

Debates?Debates?

2For technical assistance e-mail [email protected]

Fraud, Funding, and the First Amendment:Fraud, Funding, and the First Amendment:How Did CME Get Caught Up in Washington How Did CME Get Caught Up in Washington

Health Care Debates?Health Care Debates?

Presented by: Presented by: John R. Kamp, PhD, JDJohn R. Kamp, PhD, JDJudith G. Ribble, PhDJudith G. Ribble, PhD


““ItIt’’s not about the moneys not about the money””

•• White HouseWhite House•• CongressCongress•• HHSHHS

–– CMSCMS–– FDAFDA–– IG (and DOJ)IG (and DOJ)

•• 50 State Budgets50 State Budgets•• Plaintiff Class Plaintiff Class

ActionsActions


Pharmaceutical Industry Cases Since 2000Pharmaceutical Industry Cases Since 2000

•• Fines: approx. $ 3.1 BillionFines: approx. $ 3.1 Billion

–– TAP TAP -- $ 885 Million$ 885 Million

–– Abbott Abbott -- $ 600 Million $ 600 Million

–– PfizerPfizer -- $ 430 Million$ 430 Million

–– AstraZeneca AstraZeneca -- $ 355 Million$ 355 Million

–– ScheringSchering--PloughPlough -- $ 345 Million$ 345 Million

–– Bayer A.G.Bayer A.G. -- $ 257 Million$ 257 Million

–– GlaxoSmithKlineGlaxoSmithKline -- $ 88 Million$ 88 Million


New CasesNew Cases

•• SeronoSerono ——October 2005October 2005 -- $ 704 Million$ 704 Million•• LillyLilly --December 2005December 2005 -- $ 36 Million$ 36 Million•• 100 100 –– 300 Pending Qui Tam Cases300 Pending Qui Tam Cases•• New State PowersNew State Powers•• Medicare Part DMedicare Part D


HowHow the Government Healththe Government HealthPolicy Makers View CMEPolicy Makers View CME

•• ItIt’’s not really about medical education.s not really about medical education.

•• ItIt’’s about:s about:–– FDA Marketing Rules, esp. FDA Marketing Rules, esp. ““off labeloff label”” promospromos

–– HHS IG Investigations of HHS IG Investigations of ““IllegalIllegal”” inducements for inducements for government paymentsgovernment payments

•• False Claims ActFalse Claims Act

•• AntiAnti--kickback Actskickback Acts

–– Congressional Inquiries on industry ethicsCongressional Inquiries on industry ethics


Who is watching ?Who is watching ?

•• Food and Drug Administration (FDA)Food and Drug Administration (FDA)•• DHHS Office of the Inspector General (HHSDHHS Office of the Inspector General (HHS --OIG)OIG)

–– Department of JusticeDepartment of Justice -- U.S. AttorneysU.S. Attorneys•• State Attorneys GeneralState Attorneys General•• CompetitorsCompetitors•• ConsumersConsumers•• PressPress•• CongressCongress


HHSHHS--OIG, DOJ, OIG, DOJ, US Attorneys General OfficesUS Attorneys General Offices

•• HHSHHS--OIG Fraud Alert Prescription Drug Marketing OIG Fraud Alert Prescription Drug Marketing Schemes Schemes –– August 1994August 1994

•• HHSHHS--OIG Pharma Industry Guidance OIG Pharma Industry Guidance -- 20012001•• False Claims ActFalse Claims Act

–– Qui Tam Actions (Whistle blowers)Qui Tam Actions (Whistle blowers)•• AntiAnti --kickback Lawkickback Law•• FDA ActFDA Act


Participant Polling Question #1:Participant Polling Question #1:HowHow the Government Health Policy Makers the Government Health Policy Makers

View CME: Rules & RegsView CME: Rules & Regs

"The organization whose rules and regulations most "The organization whose rules and regulations most concern me is:concern me is: ””

a. FDA (Food & Drug Administration)a. FDA (Food & Drug Administration)

b.b. HHSHHS--OIG (Inspector GeneralOIG (Inspector General’’s Office of thes Office of the

Department of Health & Human Services)Department of Health & Human Services)

c. CMS (Centers for Medicare & Medicaid Services)c. CMS (Centers for Medicare & Medicaid Services)

d. ACCME (Accreditation Council for Continuing Medical d. ACCME (Accreditation Council for Continuing Medical

EducationEducation

e. Senate Finance Committeee. Senate Finance Committee


The Landmark Case: ParkeThe Landmark Case: Parke --Davis (Pfizer)Davis (Pfizer)

•• Example of cases involving CME and Example of cases involving CME and the role of whistleblowersthe role of whistleblowers

•• What interested the government in What interested the government in ParkeParke --Davis (Pfizer)Davis (Pfizer)

•• The Legal PathwayThe Legal Pathway•• Lessons learnedLessons learned


Qui Tam ActionQui Tam Action• 1986 - False Claims Act Amendments became Law

• Qui Tam provisions enable persons with evidence of fraudulent wrong doing to sue for recovery of ill-gotten gains and to retain a share of the proceeds

• Since 2000, over $3.1 billion was recovered from drug companies due to Qui Tam actions

• Whistleblowers averaged about 18% share

• In pharmaceutical cases, $ 330 Million was paid to whistleblowers for reporting fraud by five companies


Parke-Davis [Pfizer] Case

•• False Claims Act prohibits the filing of a false cl aim False Claims Act prohibits the filing of a false cl aim [not FDA approved][not FDA approved]

•• Medicaid will not pay Medicaid will not pay for prescription drugs unless for prescription drugs unless the use of the drug is in labeling or is listed in specific the use of the drug is in labeling or is listed in specific compendiacompendia

•• The majority of prescriptions for Neurontin were fo r The majority of prescriptions for Neurontin were fo r offoff --label uses.label uses.


ParkeParke --DavisDavis

•• United States of America and David Franklin, United States of America and David Franklin, Relator v. ParkeRelator v. Parke --DavisDavis

•• Alleges that ParkeAlleges that Parke --Davis Davis ““ engaged in engaged in fraudulent fraudulent scheme scheme to promote sale of Rx drugs for offto promote sale of Rx drugs for off --label label usesuses

•• Illegal marketing campaign Illegal marketing campaign causedcaused submission of submission of false claimsfalse claims to the VA and to the Federal to the VA and to the Federal government for Medicaid benefitsgovernment for Medicaid benefits


Allegations in ParkeAllegations in Parke --DavisDavis

•• DOJ press release June 7, 2004DOJ press release June 7, 2004

–– ““ WarnerWarner --Lambert promoted Neurontin even when Lambert promoted Neurontin even when scientific studies had shown it was not effectivescientific studies had shown it was not effective ””

•• FDA rejected monotherapy useFDA rejected monotherapy use•• Bipolar studies showed no difference from placeboBipolar studies showed no difference from placebo

–– Funded Funded ““ independent medical educationindependent medical education ””with with ““ extensive input from Warnerextensive input from Warner --Lambert Lambert regarding topics, speakers, content and regarding topics, speakers, content and participants.participants. ””


The PathwayThe Pathway

ParkeParke --Davis markets Neurontin to Davis markets Neurontin to doctors,doctors,��who prescribe it for their who prescribe it for their

patients,patients,��who take the prescriptions to who take the prescriptions to

their pharmacists,their pharmacists,��who file claims for who file claims for

Medicaid reimbursementMedicaid reimbursement


The IssueThe Issue•• The Court said: The Court said:

–– ““ the only issue is whether Parkethe only issue is whether Parke --Davis Davis ‘‘caused to be presentedcaused to be presented ’’ a false claima false claim

–– §§ 3729 does not require that the 3729 does not require that the ““ causecause ”” be be fraudulent or otherwise independently fraudulent or otherwise independently unlawful.unlawful.

•• What it means is: What it means is: –– Even the dissemination of Even the dissemination of ““ validvalid ”” offoff --label label

information can make you liable under the information can make you liable under the Federal Food Drug & CosmeticFederal Food Drug & Cosmetic ActAct (FCA).(FCA).


The ResultThe Result

•• Pfizer pled guilty to two criminal Pfizer pled guilty to two criminal counts of violating the counts of violating the FCA:FCA:

–– for misbranding the drug for misbranding the drug –– for for introducing an introducing an

unapproved drug into unapproved drug into interstate commerceinterstate commerce


The ResultThe Result$240 Million Criminal Fine$240 Million Criminal Fine

““second largest criminal fine ever second largest criminal fine ever imposed in a health care fraud imposed in a health care fraud prosecutionprosecution””

–– $83.6 Million + interest for federal $83.6 Million + interest for federal civil civil False Claims ActFalse Claims Act liabilitiesliabilities

–– $68.4 Million + interest for civil $68.4 Million + interest for civil liabilities for state Medicaid liabilities for state Medicaid programs to 50 states and DCprograms to 50 states and DC

–– $38 Million + Interest remediation $38 Million + Interest remediation program for harm caused to program for harm caused to consumersconsumers

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Other IssuesOther Issues

For technical assistance e-mail [email protected]

•• FDA always concerned itself with the content of FDA always concerned itself with the content of communications with communications with HCPsHCPs

•• Other enforcement agencies are looking at business Other enforcement agencies are looking at business and personal relationships as well as contentand personal relationships as well as content

•• Usually look at Usually look at totality of relationshiptotality of relationship , not just , not just specific eventspecific event

•• CME is not usually the starting pointCME is not usually the starting point

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InvestigationInvestigation


•• HHSHHS--OIG U.S. Attorneys OIG U.S. Attorneys (Boston and Philadelphia in the lead)(Boston and Philadelphia in the lead)

•• Looking for paper trails regarding Looking for paper trails regarding proactive campaigns for offproactive campaigns for off --label uselabel use–– Position descriptionsPosition descriptions–– Performance evaluationsPerformance evaluations–– Email andEmail and voice mail directivesvoice mail directives–– Where drug marketing practices cross the Where drug marketing practices cross the

lineline


Investigations of FCA CasesInvestigations of FCA Cases

•• Financial incentives for offFinancial incentives for off --label uselabel use•• Examination of company funding for CME Examination of company funding for CME

programs about the offprograms about the off --label uselabel use•• Danger to Public HealthDanger to Public Health•• Increasing use for Increasing use for ““ off off

labellabel ”” purposespurposes•• May be used to open May be used to open

the door to broader the door to broader marketing marketing investigationinvestigation


Federal AntiFederal Anti --Kickback LawKickback Law

•• The knowing and willful The knowing and willful act of:act of:–– Offering or paying cash or Offering or paying cash or

any inany in --kind remuneration to kind remuneration to providers to induce the providers to induce the ordering or purchasing of ordering or purchasing of products covered by and products covered by and ultimately paid for under ultimately paid for under Federal health care Federal health care programsprograms


AntiAnti --Kickback LawKickback Law•• Prohibits in the health care industry some practice s Prohibits in the health care industry some practice s

that are common in other business sectors.that are common in other business sectors.

•• Criminal prohibition against payments in any form Criminal prohibition against payments in any form made purposefully to induce or reward the referral or made purposefully to induce or reward the referral or generation of Federal health care business.generation of Federal health care business.

•• Applies if Applies if any one purposeany one purpose of the remuneration may of the remuneration may be to induce or reward the referral or be to induce or reward the referral or recommendation of business recommendation of business payable in whole or part payable in whole or part by a Federalby a Federal health care program.health care program.


Affects Traditional ActivitiesAffects Traditional Activities

•• Providing consulting and auditing services to Providing consulting and auditing services to customerscustomers

•• Use of physician consultants and advisorsUse of physician consultants and advisors

•• Providing trips to conferences and seminarsProviding trips to conferences and seminars

•• ““ Unrestricted educational grantsUnrestricted educational grants ”” to MCOs, medical to MCOs, medical practices, and hospitalspractices, and hospitals


Corporate Integrity AgreementsCorporate Integrity Agreements

•• List of healthcare providers and List of healthcare providers and pharmaspharmas : : http://http:// oig.hhs.gov/fraud/ciaoig.hhs.gov/fraud/cia //

•• HHSHHS--OIG will evaluate policies and practices:OIG will evaluate policies and practices:–– Physicians as speakers, consultants and as members Physicians as speakers, consultants and as members

of advisory boardsof advisory boards–– Funding of meetings, social events, etc. Funding of meetings, social events, etc. –– Educational, clinical and research grantsEducational, clinical and research grants–– GiftsGifts–– SamplesSamples–– Customer assistance programsCustomer assistance programs


HHSHHS--OIG GuidanceOIG Guidance

•• The PhRMA Code The PhRMA Code ““ provides useful and practical provides useful and practical advice for reviewing and structuring these advice for reviewing and structuring these relationshipsrelationships ””

•• ““ Although compliance with the PhRMA Code will not Although compliance with the PhRMA Code will not protect a manufacturer as a matter of law under the protect a manufacturer as a matter of law under the antianti --kickback statute, it will substantially reduce the kickback statute, it will substantially reduce the risk of fraud and abuse and help demonstrate a good risk of fraud and abuse and help demonstrate a good faith effort to comply with the applicable federal faith effort to comply with the applicable federal health care program requirementshealth care program requirements ””


State Attorneys GeneralState Attorneys General•• MultiMulti --state investigationsstate investigations

•• Based on a variety of statutes Based on a variety of statutes prohibiting false claims or unfair or prohibiting false claims or unfair or deceptive marketing practicesdeceptive marketing practices

•• May affect state Medicaid May affect state Medicaid programsprograms

•• Seek money damages and costsSeek money damages and costs


Participant Polling Question # 2:Participant Polling Question # 2:What Does Optimal Compliance Look Like?What Does Optimal Compliance Look Like?

"My organization responded to the increased "My organization responded to the increased scrutiny from regulatory agencies by:"scrutiny from regulatory agencies by:"

a. Increasing CME spending a. Increasing CME spending b. Increasing the Medical Affairs departmentb. Increasing the Medical Affairs departmentc. Naming a Compliance Officerc. Naming a Compliance Officerd. All of the aboved. All of the abovee. None of the abovee. None of the above


Who Else is Watching?Who Else is Watching?

•• Senator Charles Grassley, DSenator Charles Grassley, D --IA, Chairman, Senate IA, Chairman, Senate Finance CommitteeFinance Committee

•• Letters to Big Pharma: January 2006 Letters to Big Pharma: January 2006 RE: Financial support to RE: Financial support to organizations that develop organizations that develop CMECME


Contact InformationContact Information

Judy Ribble Judy Ribble President President

National Commission National Commission for Certificationfor Certification

of CMEof CME Professionals, Inc.Professionals, Inc.(NC(NC--CME)CME)

www.NCCME.orgwww.NCCME.org

505505--281281--11431143jribblejribble @[email protected]

John KampJohn KampExecutive DirectorExecutive Director

Coalition for HealthcareCoalition for HealthcareCommunicationCommunication

www.cohealthcom.orgwww.cohealthcom.org

212212--850850--0708 0708 or 202or 202 --719719--7216 7216

[email protected]@cohealthcom.org

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