MEDICAL DEVICE PROGRAM MEDICAL DEVICE PROGRAM AT HARVARD-2008AT HARVARD-2008

Jim SheehanNew York Medicaid Inspector GeneralJGS05@OMIG.State.NY.US518 527-1026

USUAL DISCLAIMERSUSUAL DISCLAIMERS

Public information onlyPresumption of innocenceSteal my slidesDisclosures

– Johnson & Johnson shareholder– Former Assistant US Attorney

IDEAS FROM MANY SOURCESIDEAS FROM MANY SOURCES

PROPOGATING GOOD IDEAS IS NOT PLAGIARISM

THE THIRD TIME I HEAR A GOOD IDEA, I OFTEN THINK IT IS MY OWN

NO PEEKING AT NAME BADGES DURING QUESTION TIME

THE 360 DEGREE THE 360 DEGREE COMPLIANCE PROGRAMCOMPLIANCE PROGRAM

EMPLOYEES CONTRACTORS CUSTOMERS USERS THOUGHT LEADERS AND PRODUCT

DEVELOPERS MANDATORY REPORTERS ELECTRONIC RECORDS, PUBLIC

REPORTING

HEADLINE NEWS-KNEES AND HEADLINE NEWS-KNEES AND HIPSHIPS

ZIMMER-$169 million Howmet-$26.9 million Smith & Nephew-$29 million DePuy-$84.7 million Stryker-$0 18 months of independent monitor paid for by

company (except Stryker) The public list of payment recipients on each

company’s website

MONITORSMONITORS

At UMDNJ, within one year of monitor, president, general counsel, compliance officer, and most of board were out

At Bristol-Myers, President forced to resignDOJ deferred prosecution policy will mean

more monitors

PHYSICIAN PAYMENTSPHYSICIAN PAYMENTS

OLD MODEL-CASE OVER, PUT THE FILE AWAY

NEWER MODEL-CORPORATE INTEGRITY AGREEMENT, SOME DISCLOSURES TO OCIG EMPLOYEE.

NEWEST MODEL-SHARE THE NAMES OF ALL PAYMENT RECIPIENTS WITH EVERY ENFORCEMENT,PROGRAM INTEGRITY, MEDIA ORGANIZATION, PARTNER, AND EX-SPOUSE

THE PHYSICIAN RECIPIENTS THE PHYSICIAN RECIPIENTS OF PAYMENTS FROM DEVICE OF PAYMENTS FROM DEVICE

FIRMSFIRMSHow does it look to each audience?How can you treat the physicians fairly?Is more information better?Marketing and disclosureCompliance and disclosure

SMITH & NEPHEWSMITH & NEPHEW

“The Smith & Nephew minimally invasive techniques allow you to make the incision smaller at a pace with which you feel comfortable.” Dr. H., New York quoted in S&N marketing flyer

No disclosure of relationship on flyer 2007--$1.65 million in 2007 from Smith and

Nephew Expert on specially designed knees for women

ZIMMERZIMMER “Patients today are expecting to maintain an active lifestyle after a

total knee replacement,” said Dr.S., New York orthopedic surgeon. “The LPS-Flex Fixed Knee offers a new option for those suffering from osteoarthritis to reclaim aspects of their lives on which they place much value. Many hobbies such as gardening and golfing may require high degrees of flexion, or bending, of the knee. In addition, cultural activities, such as kneeling for prayer, sitting cross-legged and squatting, demand frequent deep flexion.

Dr. S. added. “With early diagnosis, and good preoperative flexibility, the Flex Fixed Knee can allow patients to resume many of the physical activities they have come to enjoy, which is an important part of maintaining a desired quality of life.” May 24 press release from Zimmer.

No disclosure on press release. 2007-$899,000 to Dr. S. from Zimmer

STRYKERSTRYKER

Dr. K., New York, has a significant relationship as a Consultant with Stryker Orthopedics and. may refer to it in his presentation –(AAOS 2004 program).

“Significant relationship”=$1.5 million in 2007.

Designer of Stryker knee navigation system.

ROLE OF ADVAMED AND ROLE OF ADVAMED AND OTHER VOLUNTARY OTHER VOLUNTARY

INDUSTRY CODES OF ETHICS INDUSTRY CODES OF ETHICS IN INVESTIGATION AND IN INVESTIGATION AND

ENFORCEMENT DECISIONS ENFORCEMENT DECISIONS

Advamed Code-September 3, 2003New FAQs-April 15, 2005Advamed Code of Ethics Logo Program-

6/19/06

ISSUES VOLUNTARY CODES ISSUES VOLUNTARY CODES ARE TO ADDRESSARE TO ADDRESS

Guidance for members and employees Guidance for industry partners and customers Level playing field-working with inventors,

opinion leaders Preventing illegal conduct Demonstrating senior management, board

commitment to compliance program Shortening investigations Evidence of effective compliance program

CRIMINAL, CIVIL EXPOSURE CRIMINAL, CIVIL EXPOSURE

FRAUD ON THE FDA-HOW DID THE PRODUCT GET APPROVED?(ROLE OF CONSULTANTS AND INVESTIGATORS)

FRAUD ON THE FDA-HOW DID THE COMPANY RETAIN APPROVAL?(MANDATORY REPORTING COMPLIANCE)

PATIENT RISK OF HARM FAILURE OF MANDATORY REPORTING

CRIMINAL, CIVIL EXPOSURECRIMINAL, CIVIL EXPOSURE

FRAUD ON PAYOR PROGRAMS-BUT FOR (FALSE OR MISLEADING) PROMOTION OR ENDORSEMENTS, PHYSICIANS WOULD NOT HAVE USED THIS PRODUCT WITH OUR PATIENTS

FRAUD ON PAYOR PROGRAMS-FALSE OR MISLEADING INFORMATION TO PUBLISHED JOURNALS, PHYSICIANS, PATIENTS (GHOST WRITERS, FAILURES TO DISCLOSE FINANCIAL RELATIONSHIPS)

CRIMINAL, CIVIL CRIMINAL, CIVIL EXPOSUREEXPOSURE

KICKBACKS TO PHYSICIANS OR OTHER REFERRAL SOURCES FOR MEDICARE, MEDICAID, OTHER GOVERNMENT PROGRAM PATIENTS

KICKBACKS IN CONNECTION WITH HEALTH PLANS WITH A FEDERAL CONTRACT

UNREPORTED HOSPITAL REBATES (OIG WORK PLAN 2007)

FRAUD ON THE FDA-HOW DID FRAUD ON THE FDA-HOW DID THE PRODUCT GET THE PRODUCT GET

APPROVED? APPROVED?

FALSE STATEMENTS ABOUT CLINICAL TRIALS– Results (efficacy, adverse events)– Compliance with protocol (patient selection, end

points)– Participant protections

FRAUD ON THE FDA-HOW DID FRAUD ON THE FDA-HOW DID THE PRODUCT RETAIN THE PRODUCT RETAIN

APPROVAL?APPROVAL?

Endovascular Technologies-failure to report serious adverse events

In Re Grand Jury Subpoena 220 F.R.D. 130 (D. Mass. 2004) –if you knew the product was likely to fail more frequently than disclosed in your labeling, and you do not disclose to FDA, product is misbranded

United States v. Caputo 374 F. Supp. 2d 632 (N.D. Ill. 2005)-evidence allowed that “defendant intentionally avoided information about potential safety hazards.”

February 7, 2008-one company makes over 300 adverse event and product reports

READING THE MEDWATCH READING THE MEDWATCH REPORTS REPORTS

The Medical Device Reporting (MDR) regulation, 21 CFR Part 803

Manufacturers of medical devices must notify FDA when they become aware of a death or serious injury that may have been caused or contributed to by one of their marketed devices

Must also notify FDA when they become aware of malfunction of one of their devices which, if it were to recur, would be likely to cause or contribute to a death or serious injury

READING THE MEDWATCH READING THE MEDWATCH REPORTSREPORTS

Manufacturers are responsible for making sure their employees know how to recognize what may be reportable. Manufacturers should also emphasize that any employee may learn of an adverse event during a phone call, a sales visit, a professional conference, from correspondence received or from service/warranty orders. FDA QSR Manual

READING THE MEDWATCH READING THE MEDWATCH REPORTSREPORTS

The 5-day report (803.53) is for MDR reportable event(s) that require a remedial action to prevent an unreasonable risk of substantial harm to the public health . This situation may be identified by the manufacturer or FDA.

The 5-day period of reporting starts the day after any employee, who is a person with management or supervisory responsibilities over persons with regulatory, scientific, or technical responsibilities, or a person whose duties relate to the collection and reporting of adverse events, becomes aware that a reportable MDR event or events, from any information, including any analysis, necessitate remedial action to prevent an unreasonable risk of substantial harm to the public health.QSR Manual

FDA DRAFT GUIDANCE ON FDA DRAFT GUIDANCE ON OFF-LABEL-2/15/08OFF-LABEL-2/15/08

Allowed Documents:

Scientific or Medical Articles

- Documents published by an organization with an editorial board that uses qualified and objective experts who are independent of the organization to review. - Peer-reviewed, and not in the form of a supplement or publication that has been funded in whole or in part by one or more of the manufacturers (whose product is being discussed).

Allowed Distribution:

- In the form of an unabridged reprint, copy of an article, or reference publication. - Cannot be marked, highlighted, or characterized by the manufacturer in any way. - The approved labeling of the drug or medical device must be included.

Summary by America Castro

FDA DRAFT OFF-LABEL FDA DRAFT OFF-LABEL GUIDANCEGUIDANCE

Not Allowed

Scientific or Medical Reference

- Primarily distributed by a drug or device manufacturer. - Written, edited, excerpted or published specifically for, or at the request of, a drug or device manufacturer.

Summary by America Castro

FRAUD ON PAYOR FRAUD ON PAYOR PROGRAMSPROGRAMS

But for fraud on the FDA, our patients would not be using or paying for this product (SERONO)

Information communicated which is inconsistent with the scientific evidence is “false or misleading” and evidence of misbranding. (SERONO)

Knowing false statement about drug efficacy (Dr. Peter Gleason indictment)

Payor relied on labeling and FDA approval as basis for payment.

FRAUD ON PAYOR FRAUD ON PAYOR PROGRAMSPROGRAMS

Payments to physicians, health plans, advisory panels, consultants to advocate for, promote, or write for given product (Poteet complaint, Gleason indictment)

Patrick Chan, MD, Arkansas neurologist pleaded guilty to charges that he had accepted kickbacks from several device companies. He agreed to pay a $1.5 million civil settlement in January, 2008.

FRAUD ON PAYOR FRAUD ON PAYOR PROGRAMSPROGRAMS

But for misleading information to physicians, we would not have claims for this product.

But for misleading off-label promotion of this product, we would not have claims. United States ex rel. Franklin v. Parke-Davis 147 F. Supp. 2d 39 (D. Mass. 2001) See generally Glaxo SmithKline settlement with New York.

But for misleading information to journals or compendia, we would not have paid these claims because they were not for a medically accepted indication.

TRAINING ISSUES-THE TRAINING ISSUES-THE CAROTID STENTCAROTID STENT

Significant advance in treatment of carotid stenosis with related stroke risk

FDA approval of Guidant CAS system CAS system and embolic protection devices

FDA-requires specific training of physicians, delivery only to trained persons

CMS-DECISION MEMO FOR CAROTID ARTERY STENTING(CAG-00085R)– www.cms.hhs.gov/mcd/viewdecisionmemo.asp

THE ZIMMER CASETHE ZIMMER CASE

USA ex rel. Schmidt v. Zimmer 386 F. 2d 235(3d Cir. 2004)– “Conversion incentive” to Premier participants

including price reduction, plus 2% bonus on implant purchases if market share and volume purchase

– Payments to physicians and orthopedic departments from Premier payments if they helped meet goals

– HCFA 2552 certification by hospital were false- Did not disclose Zimmer/Premier rewards Certified compliance with all laws(includes Stark and AKA)

SAFE DEVICE SAFE DEVICE REGULATIONSREGULATIONS

21 C.F.R. Section 803.10(a)(1) (individual adverse events)

21 C.F.R. 803.10(a)(2) (annual reports)“Device user facility” means a hospital,

ambulatory surgical facility, nursing home, or outpatient treatment or diagnostic facility that is not a physicians office.

ROBOTS AS MEDICAL DEVICESROBOTS AS MEDICAL DEVICES

ROBOTS AS MEDICAL DEVICES– Physician robots– Rehab Robots– Pharmacist Robots– Surgeon Robots– Nurse/nurse assistant robots– Complicated interface between professional, device,

and patient- FDA, state licensing, payment rules– Crash/ reboot?

NEXT GENERATION OF DEVICE NEXT GENERATION OF DEVICE ISSUESISSUES

TELEMEDICINE Regulation of devices, software, communications media,

quality control systems, reporting of adverse events Telemedicine training-originating site, distant site Training of “patient presenter” Maintenance,upgrades,repairs Credentialing, peer review, payment rules

Quality of Care/Medical ErrorsQuality of Care/Medical Errors

WHO IS RESPONSIBLE FOR PHYSICIANS WHO ARE NOT CAPABLE OF USING PRODUCTS SAFELY?

IS A WEEKEND OF TRAINING ENOUGH? WHAT IS THAT REP DOING IN THE OR? PATIENT DISCLOSURE/CONSENT NHC Mikes v. Straus, 274 F.3d 687 (2d Cir. 2001)

CONCLUSIONCONCLUSION

New involvement of manufacturers in safety and outcomes

Growth in qui tams focused on marketing and payments to physicians

The Vioxx-Zyprexa allegations- event reports and hiding bad outcomes-model moves to devices

Greater risk in device world