McLean HospitalDepartment of Postgraduate and Continuing Education

Grand RoundsSeptember 17, 2009

Visiting Scholar Series: “Conflict of Interest Policies”

Presented by Gretchen Brodnicki, J.D.

Dean for Faculty and Research Integrity, Harvard Medical School

Laura Marhoefer Gamel, J.D. Outside Activities Manager, Partners Compliance and Business Integrity

Mary Mitchell, B.A. Director of Research Compliance, Partners Compliance and Business Integrity

Christopher Clark, Esq. Legal Counsel, P.H.S. Office of General Counsel

9/17/09

Conflicts of Interest

McLean Grand Rounds

September 17, 2009

Conflict of Interest Policy Background

• Pre-1990 - General Policy• 1980s -Increasing Role of Industrial Sponsored

Research• 1990 - Comprehensive Policy Promulgated • 1993 - Amended to Add De Minimis Levels• 1995 - Amended in Response to PHS/NSF Regs

Conflict of Interest Policy Background

• 1998 - Appointment of Faculty Review Committee

• 2000 - Revised to Strengthen Trainee Protections• 2003 – Appointment of Faculty Review

Subcommittees • 2004 - Revised and Clarified• 2005 - Electronic Disclosure Process (through

eCommons)• 2009 – Committee Appointed to Review and

Revise COI Policy

Overview

• Mandatory Disclosure by All Faculty (10,000+)• Categorization of Potential Conflicts by Degree of

Seriousness• Detailed Set of Definitions for Key Terms

Key Provisions

• Clinical Research –Category I (a)– A Faculty Member is not permitted to

Participate in Clinical Research on a Technology owned by or contractually obligated to a Business in which the Faculty Member or a member of his/her Family has a consulting or similar relationship, holds a stock or similar ownership interest, or has any other Financial Interest.

• Basic Science Research Category I (b)– A Faculty Member is not permitted to received

University or Hospital supervised Sponsored Research support (whether in dollars or in kind) for any research from a Business in which he/she or a member of his/her Family holds a stock or similar ownership interest.

Key Provisions

• Equity De Minimis: A Faculty Member in a Category I(a) or I(b) situation may hold up to $30,000 in equity in a widely held publicly traded company. (revised level)– There is no de minimis for equity interests in privately held businesses.

• Consulting and Other Fees De Minimis: A Faculty Member in a Category I(a) situation may receive fees up to $20,000 a year from the company. (revised level)

• Royalty Exception: A Faculty Member may receive post market royalties through institutional royalty sharing agreements (clarification).

Key Definitions

• Definition of “Clinical Research” – The definition defines clinical research broadly. It is

meant to include generally all research which would be approved by an IRB.

– The definition explicitly excludes commercially obtained de-identified human cell lines and human tissue as well as de-identified tissue obtained from institutional tissue banks.

• Definition of “Participate”– The definition is broad and includes study design and

authorship on a paper reporting on the research.

Key Definitions• End of Sponsored Research

– Sponsored research (and the prohibition of equity ownership) is considered to have ended when the term of the sponsored research agreement has ended and publications reporting on the research are completed (or the decision made not to publish). It is the investigator’s responsibility to determine when that time has been reached.

Other Key Provisions• Conflict of Commitment. Full-time members of the Faculty

of Medicine are expected to devote their primary professional loyalty, time, and energy to their teaching, research, administrative responsibilities and, where applicable, patient care at the School and its affiliated Hospitals.

• Member may engage in outside professional work– Activities must serve member and Faculty’s interests– No more than 20% of total professional effort may be

directed to outside work, not to exceed 1 working day per week.

Other Key Provisions

• Disclosure in Publications. When a faculty member presents the results of his/her research via publication or formal presentation, or when he/she provides expert commentary on a subject, they are expected to simultaneously disclose to the journal (in the case of a publication) or the audience (in the case of a presentation) any financial interest they may have in a business which owns a technology being reported or discussed or which sponsors the research being reported or discussed.

Disclosure to HMS

• HMS Office for Research Issues centrally sends out and receives back disclosure forms, and enters information into data base. Starting in 2005, disclosure is made electronically through eCommons.

• All members of the faculty are required to complete and submit a disclosure form on a regular basis.

What to Disclose?

• Everything…there is no de minimus for disclosure• How far back to disclose? Since last cycle.• What’s considered “outside”

– Includes Grand Rounds beyond HMS walls

– Includes CME or other education or speaking engagements. If you know the source, disclose it

• Can we update?– Yes, definitely. Please do!

Questions?

Gretchen Brodnicki

Gretchen_Brodnicki@hms.harvard.edu

617-432-2496

http://www.hms.harvard.edu/integrity/

Partners HealthCare

Laura Marhoefer Gamel, JDOutside Activities Manager

Partners Compliance and Business Integrity

• Conflict of Interest Policy: – Research, purchasing transactions, and a periodic disclosure cycle

• Policy on Consulting and Other Outside Activities– Outside Activities: work that you perform for a “for” or “not for profit”

Outside Entity that: • Draws on your expertise (and you are paid); or• Is with an entity that provides, has provided or is likely to provide

goods/services to Partners; or• Is involved in providing Health Care Related Goods and Services

– Focuses on written agreements when working with with past, present or likely vendors of Partners

– RVL review before commencing work or signing the agreement– Disclosure and Supervisor Review– Special Review Processes: writing editing textbooks, moonlighting, expert

witness, consulting for financial services companies

Partners Policies

Examples of Outside Activities

• Consulting for pharmaceutical or medical device companies, or other vendors of Partners

• Scientific Advisory Board Membership• Medical case reviews for law firms or insurance

companies• Serving on a Board of Trustees for a non-profit or

for-profit organization• Authoring or medical textbooks• Editing for the New England Journal of Medicine• Consulting for a start-up on how to leverage its IT

• On-line, periodic disclosure process (goal is yearly) • Four questions

– Outside Activities– Equity Interests– Family Associations and Equity Interests– Payments for Intellectual Property

• Keep in Mind– No De Minimis for reporting– Goes beyond pharmaceutical and medical device

companies

• Forms are reviewed by Supervisors

The Partners Disclosure Process

Reporting Outside Activities

• Covers “for” and “not for profit” organizations– Professional Association Boards– Governmental organizations

• Time Commitment is reported as days per year

• Private Practices exempt from disclosure

Reporting Equity Interests• Financial holdings that are not a part of a mutual fund, pension, or 401(k)/403(b) fund

• Examples– Stocks or other securities

– Stock options

– Financial interests held through trusts or other personal holding companies

– Ownership interests (shares in a start-up)

Reporting Family Associations and Equity Interests

• Relationships that anyone in your immediate family, or living in your household of which you are aware

• Examples– Brother is a consultant with Deloitte

– Daughter is a major shareholder of her own biotech start-up looking to do business with Partners

Reporting Payments for Intellectual Property

• Money you receive that comes from patents, copyrights, tangible material, such as cell lines, reagents or tissues.

• Examples– Up-Front payments– Milestone payments– Royalties

Partners HealthCare System

Transactional COI Reporting

Mary Mitchell, B.A.

Director of Research CompliancePartners Compliance and Business Integrity

Transactional COI Reporting• New and continuing grant applications and contract

proposals to Federal and not-for-profit sponsors.• COI G&C Reporting Form and instructions on Partners Research

Management web site http://phsresearchintranet.partners.org/PHS_ResearchMgmt/RM_Forms.asp

• Questions– McLean: Pete Paskevich, 617-855-2922, ppaskvech@partners.org – General: Mary Mitchell, 617-954-9597, mmitchell14@partners.org

• Corporate sponsored clinical trial agreements.• Corporate sponsored basic science research agreements.• Human research protocols submitted to IRB for review.

PARTNERS COMMISSION ON INTERACTIONS WITH INDUSTRY

Christopher ClarkOffice of General Counsel

Thanks to Dr. Eugene Braunwald and Dr. David Torchiana,from whose slide decks I borrowed heavily

9/15/09

Source: NEJM, “Doctors and Drug Companies – Scrutinizing Influential Relationships” by Eric G. Campbell, PhD November 1, 2007

Background

Range of Relationships

US Senate Finance Committee

Since 2007, Senator Grassley, the Ranking Republican on the Senate Finance Committee, has written to many universities and hospitals asking for detailed information on the outside income of faculty, especially physicians. His requests have asked for information on all gifts from Rx companies, medical device manufacturers and manufacturers of biologics.

Pending Legislation:

Physician Payments Sunshine Act(S. 301) Introduced 1/22/09

Introduced by Sen. Grassley (R-IA

Cosponsors: Kennedy (D-MA), Kohl (D-WI), Klobuchar (R-MD), McCaskill (R-MO), Schumer (D-NY),

Bingaman (R-NM), Whitehouse (D-RI)

• Requires industry quarterly “transparency reports” on payments to MDs, including amount, purpose and institution

• Establishes civil monetary penalties for each failure to report

• Requires public availability of transparency reports and an annual report to Congress

Since first introduced in 2007:• Two public hearings have been held.• Grassley has revised the bill to:

– Reduce the civil penalties– Add language pre-empting any state laws so that a

single standard can be in place for manufacturers

Proposal• Gifts. Prohibit all gifts from pharmaceutical and device industries

• Rx samples. No samples provided directly to physicians; permit vouchers for low-income patients

• Rx formularies. Medical professionals with financial relationships with Rx/device companies may not participate on formulary committees

• CME. No manufacturer support to any ACCME-accredited program; unconditional contributions to a central repository allowed

• Funds for MD travel. Only through central grants

• Speakers bureaus and ghostwriting. None

• Consulting and research contracts. Permit with more transparency, explicit contracts and a ban “no strings attached” grants

Health Industry Practices That Create Conflicts of InterestA Policy Proposal for Academic Medical CentersJanuary 25, 2006 By Troyen Brennan, MD, et al

Headlines

• December 12, 2005:HOW A FAMED HOSPITAL INVESTS IN DEVICE IT USES AND PROMOTESFocused on 1,200 patients at Cleveland Clinic who had undergone AtriCure procedure for correcting atrial fibrillation. Cleveland Clinic held 4.1% stake; its chief executive sat on the AtriCure board of directors, invested personally in the fund and was a general partner.

• December 13, 2005CLEVELAND CLINIC STRIPS TOPOL OF POSTTrustees of the Cleveland Clinic ratified the decision to strip a noted cardiologist of his top post at the hospital's medical school; he had criticized certain business relationships involving the clinic's CEO.

• February 9, 2006CLEVELAND CLINIC TO TIGHTEN ITS DISCLOSURE POLICIESCleveland Clinic toughened its policies on research for drug and medical-device makers after an internal review that found 'institutional and individual inattention' to conflicts of interest.

• February 9, 2006 DRUG FIRM, SUBSIDIARY SETTLE SUITS FOR $515m; PRICING SCHEMES, FRAUD ALLEGEDBristol-Myers Squibb has agreed to pay more than $515 million to settle civil suits over fraudulent drug marketing and pricing schemes, including illegally promoting an anti-psychotic drug to children and the elderly.

• November 7, 2007HUB SURGEONS GOT MILLIONS FROM IMPLANT FIRMSTwo Boston orthopedic surgeons each received $6.75 million this year from a maker of joint replacement implants, the largest among those revealed in a $311 million settlement of a suit that alleged five companies paid doctors to use their products.

• October 31, 2007ORTHOPEDICS COMPANIES DISCLOSE CONSULTANT PAYMENTSThe five major makers of orthopedic devices disclosed the millions of dollars in payments they made to consultants, including 47 cases where payments were more than $1 million.

• April 10, 2009PARTNERS CURBS DOCTORS’ DRUG INDUSTRY TIESDoctors at Partners HealthCare may no longer accept gifts and meals from drug and device firms, or travel the country as paid members of company "speakers bureaus," as the state's largest hospital and physician network adopts tougher restrictions to counter industry's influence over the drugs and treatments physicians prescribe.

Other external events

• NIH is reviewing its COI regulations• IOM convened a committee

– Report released spring 2009– Contained general recommendations: disclose payments made by industry to individuals;

eliminate financial conflict of interest in human subjects research; moderate remuneration for outside activities; ban gifts and ghostwriting; limit drug samples to indigent patients; eliminate industry influence on the content of CME

• Massachusetts passed state legislation requiring that the MA Dept of Public Health promulgate regulations to establish a marketing code of conduct for all pharmaceutical and medical device components – regs recently issued

• Other institutions are reviewing their policies– Harvard University and HMS are doing separate but coordinated reviews– Cleveland Clinic, UPenn and Stanford, as part of extensive review/revisions, are

designing websites that disclose the financial interest of physicians associated w/their institutions on public websites – Cleveland Clinic has gone live.

Partners Commission on Interactionswith Industry – Stage 1, Commission and Report – Fall ‘07–Spring ‘09

• Background events led to formation of Partners Commission on Interactions in Industry

• Formed in fall 2007 by Dr. Mongan

• Met 10 times from Dec. 2007 through November 2008

• Final report issued February 2009

• Accepted by Dr. Mongan, endorsed by Partners Board (3/24/09)

MembershipCommission Members

- Daniel K. Podolsky, M.D. – Chair, 11/’07-6/’08 - Joseph Loscalzo, M.D., Ph. D.

- Eugene Braunwald, M.D. – Chair, 7/’8 - End - G. Marshall Moriarty- Dennis Ausiello, M.D. - Robert Norton- W. Gerald Austen, M.D. - Scott Rauch, M.D.- Barbara Bierer, M.D. - Paul Ridker, M.D., M.P.H.- Richard Bringhurst, M.D. - Jerrold Rosenbaum, M.D.- William Crowley, M.D. - Frederick Schoen, M.D.- Gary Gottlieb, M.D. - Charles Serhan, Ph.D.- Daniel Haber, M.D., Ph.D. - Peter Slavin, M.D.- Brent Henry, Esq. - Allen Smith, M.D.- Michael Jellinek, M.D. - Thomas Thornhill, M.D.- Thomas Kupper, M.D. - David Torchiana, M.D.- Edward Lawrence - Andrew Warshaw, M.D.

- Ross Zafonte, D.O.Harvard University and Harvard Medical School Representatives- Margaret Dale (thru 3/’08- Gretchen Brodnicki (from 5/’08)- Isaac Kohlberg, Ph.D.- Richard Mills

Commission orientation

• Academic-industrial relations are essential to Partners charitable missions, especially translating scientific advances into improved health care.

• But they create the potential for introducing bias into, or leading to the perception of bias in, our clinical care, research and educational activities, and for undermining public trust in our institutions.

• Therefore these relationships must be fully disclosed and reviewed, and appropriately managed, to assure our internal and external communities that they do not introduce bias.

• Result of Commission process – a Report that made 17 specific recommendations

– http://www.partners.org/documents/CommissionReport_PartnersHealthCare2009.pdf• Commission recognized that Partners has had good COI policies since its

inception. The Commission recommended revisions and “tightening” consistent with changes in our environment.

– These are recommendations for new policies – they are not the new policies themselves.

Commission approach

• Analyze various types of industry relationships as to how they apply to our various charitable missions (some cut across several):

– Clinical– Education– Research

• Assess benefits and risks

• Assess whether current policies are sufficient and if not what needs to be changed

Recommendations: Clinical

• No gifts to individuals from pharma/med device companies, or to institution for personal use of staff members– Meals

• Physicians can’t receive free drug samples; free drug samples must be distributed through centralized institutional system

• More rigorous process for vendor access

• More rigorous process for reviewing significant purchasing contracts

• Develop policy for managing financial interests in direct clinical care

Recommendations: Education

Industry-supported programs and fellowships

• Need to have mechanisms in place sufficient to ensure that funding doesn’t affect the content– Establishment of an Educational Review Board (ERB) responsible for

approving, monitoring, and reviewing industry-supported educational programs and fellowships.

– In order to approve an educational program or clinical fellowship, the ERB shall require compliance with a number of specific conditions: two funders; review of financial interests; content review; compliance w/ ACCME requirements.

– Creation of central pooled fund, the “President’s Fund for Medical Education,” as alternative mechanism.

Recommendations: Research

• Narrow the definition of clinical research

• More robust system for managing Conflicts in Research– Based upon risk stratification – of research itself, human

subjects participation, financial/relational interest, and other considerations

• Continue to require internal reporting of everything on COI disclosure forms.

Recommendations: Cross-cutting• Institutional officials – higher standards

– BOD/fiduciary positions on biomedical companies and vendors – limit compensation

– All relationships require COI Committee review

• Employee participation on BOD/boards– Full-time staff/employees may not serve on Board of Directors or hold other fiduciary positions in a

biomedical company without COI Committee review/approval.

• Royalties– Can’t keep them, on sales to institution

• Consulting policy in general– Retain current 20% cap on time spent, in accord with HMS policy.

– Tighten process for supervisor review.

• No speakers bureaus or ghostwriting– Partners will prohibit faculty participation in industry speakers bureaus

– Faculty will also be prohibited from being listed as an author on a paper ghostwritten by others.

• Miscellaneous– Oversight of all relationships, service agreements, observerships

Recommendation 17: Education, Compliance and Enforcement

• Commitment of resources:– Need to develop the new policies

– Create ERB and COI Committee

– Create new administrative office, reporting directly to Partners CEO or designee, to oversee collaboration between Partners and outside entities

– Staffing

– Electronic database and tracking system

• Commitment to aggressive training/educational initiative– Required training

• Commitment to compliance, auditing, and sanctions for non-compliance

Implementation Task Force: Membership• Chair – Peter Slavin, M.D.• PHS

– Dennis Ausiello, M.D.– Christopher Colecchi .– Thomas Glynn, Ph.D.– Brent Henry– Peter Markell– Eileen McCarthy– Pearl O’Rourke, M.D.– Debra Weinstein, M.D.

• BWH– Barbara Bierer, M.D.– Jonathan Borus, M.D.– Eugene Braunwald, M.D.– James Bryant– Joseph Loscalzo, M.D., Ph.D.– Kate Walsh

• MGH– John Belknap– Robert Birnbaum, M.D.– Richard Bringhurst, M.D.– Alexa Kimball, M.D.– Ann Prestipino– Harry Rubash, M.D.– David Torchiana, M.D.

• Community Hospitals– NSMC – Joseph Jacobson, M.D.– NWH – Frederick Millham, M.D.

• Specialty Hospitals– McLean – Shelly Greenfield, M.D.– Spaulding/PCC – Ross Zafonte, D.O.

• Harvard/HMS– Harvard – David Korn, M.D.– HMS – Gretchen Brodnicki

• Legal/Staff Support– Christopher Clark– Elizabeth (Betsy) Drucker, M.D., J.D. – Robin Jacoby, Ph.D.– Daniel Morash– Joy Rosen

• Resource Attendees– Kaley Klanica– Laura Marhoefer Gamel– Mary Mitchell– Nikki Zapol

Partners Commission – Stage 2, Implementation Planning – Summer ‘09

ImplementationTask Force

Peter Slavin

Policy Frameworkand Formulation

Eugene Braunwald(Chris Clark)

Purchasing and COI Database

Peter Markell(Dan Morash)

Task Force Planning Committee

Peter Slavin

Drug Samples

Kate Walsh(Joy Rosen)

COI Committee

Joseph Loscalzo(Chris Clark)

Educational ReviewBoard

Debra Weinstein(Dan Morash)

Policy Training and Compliance

David Torchiana(Robin Jacoby)

Implementation Task Force: Structure

• At beginning, established 10/1/09 as target date for initial implementation

• Task Force has been very active over the summer, bringing us to …

Partners Commission – Stage 3, First Phase of Implementation – 10/1/09

Infrastructure completed as of 10/1/09• New Committee on Conflicts of Interest created

– Will be responsible for handling day-to-day COI matters and policy.– Co-chaired by Barbara Bierer, MD, SVP for Research, BWH, and Richard Bringhurst, MD, SVP for

Research. MGH.• New Education Review Board created

– Responsible for overseeing industry support of Partners educational activities. – Discussions are underway about the Chair of the ERB.

• New Office of Interactions with Industry created– Consolidates activities currently handled by different offices throughout Partners. – Primary responsibility for overseeing and implementing, in collaboration with Partners affiliated

entities, all policies relating to interactions with industry and outside activities, including centralizing COI disclosure processes.

– Will staff and manage the COI Committee and ERB responsibilities; develop and maintain educational/training programs in collaboration with affiliated entities and other PHS offices; and develop and maintain an audit/compliance system and sanction system in collaboration with affiliated entities and other PHS offices.

• Membership/staffing of Committees and Office still to come • New website

– Dedicated to the Partners Program on Interactions with Industry, will be a centralized source of information about the revised policies and their implementation

First Phase of Implementation – 10/1/09

Substantive Commission Recommendations in effect on 10/1• Ban on certain gifts.

– Gifts from pharmaceutical companies and medical device companies to staff or to the institution for the personal use of staff.

– Includes ban on meals.– Applies to: all full-time “Covered Individuals;” and all other Partners

Individuals while acting in their Partners capacity. • Purchasing Transactions.

– Will implement strengthened oversight processes for significant purchasing transactions.

• Royalties. – Will implement the new requirement to ensure that a Partners entity does not

receive royalties on sales of products made to that entity.• Industry Support of Educational Programs

– As a first step in implementing the Commission recommendations regarding industry support for Partners educational programs, establishment of “President’s Fund for Medical Education” at key hospitals.

First Phase of Implementation – 10/1/09

Substantive Commission Recommendations in effect on 10/1 • Outside Activities of Senior Officials.

– Will implement the restrictions on outside activities of senior institutional officials

• Limits on the amount and type of compensation for BOD/Fiduciary positions in certain companies.

• CCOI review needed for new outside activities.

• Other Outside Board of Director Positions.– Will implement the new requirements that full-time Partners individuals may

not take on BOD/fiduciary position with biomedical companies without CCOI review.

• Speakers Bureaus. – Will implement ban on participation in “speakers bureaus” and certain types of

company promotional events.

– Definitions are key

• Ghostwriting. – Will implement explicit ban on ghost writing.

First Phase of Implementation – 10/1/09

Roll-out plan for 10/1/09 first phase implementation• Coordinating on presentations at various entities, committees, etc.

• Interim Policy document– Captures the Commission recommendations going into effect

• All-User message from Dr. Mongan

• Coordinating with Public Affairs offices on further internal messages, hospital publications, etc.

• Working on coordination with Partners Compliance and entity compliance officers to handle questions while OII is developed.

Subsequent Phases of Implementation• Re-writing of formal Partners policies on interactions with industry

– Consolidating policies into single integrated organized document– Drafting well under way; aim to complete by early 2010.

• Procedures for more rigorous review of research conflicts – Anticipate fully implementing the Commission recommendations regarding a

more rigorous review process of conflicts in the research area as CCOI and OII become operational.

• Procedures and requirements for industry supported educational activities and fellowships – Anticipate fully implementing the Commission recommendations regarding

industry support of educational programs as ERB and OII become operational. • Other Commission Recommendations

– Additional work is on-going to address the other Commission recommendations

– Anticipate that they will be implemented in phases as the CCOI, ERB, and OII become operational.

• Of special note:– Database development– Integration of COI reporting processes– Internal educational/training program (next slide)

Overall Structure of COI Education

Face to face training (200-500)

Online training (7,000+)

W

Webpage

High ProfileGroup

MDs, Ph.Ds, Other SelectedProfessional Staff

Entire Partners Community

Massachusetts Pharmaceutical and Medical Device

Manufacturer Conduct

Laura Marhoefer Gamel, JDOutside Activities Manager

Partners Compliance and Business Integrity

Goals of the law

• Transparency in the relationships between health care and the P/D industry– Payment reporting on public website

• Limit interactions that are designed to affect prescribing patterns

• Account for the productive collaborations between heath care providers and industry

• Target of law is Pharma/Medical Device Company behavior/compliance, not recipients

Who at Partners is affected by the State Disclosure Requirements?

• Health Care Practitioners– Individual providers that are:

• authorized to prescribe, dispense or purchase Rx drugs or medical devices, and are licensed to provide health care in MA

– e.g., MDs, APNs, CNMs, Psychiatric Nurse Specialists, Physician Assistants, Podiatrists

• Partnerships / corporations of individuals meeting the above criteria; and

• Officers, employees, agents or contractors of the above

• Covered Recipients– Hospitals – Nursing Homes– Pharmacists – Health benefit plan administrators

State Pharma/Device Company Payment Disclosure Requirements

• Value, nature, purpose and particular recipient of – fees, payments, subsidies, or other economic benefit

– valued at $50 or more

– in connection with the company’s “Sales and Marketing Activities”

• Advertising, promotion, intended to influence sales/market share

• Influence or evaluate prescribing patterns

• Gauge effectiveness of company sales force

• Includes product training and “seed trials”

• Excludes genuine clinical research, samples for patients, and other charity care items

Examples of payments that will be disclosed:

• Reimbursement for expenses in connection with product training or consulting

• Participation in Speakers Bureau

• Compensation for bona fide services, e.g., consulting agreements

• Donations to Covered Recipients

State Pharma/Device Company Disclosure Requirements

• Data collection starts 7/1/09• First posting by 7/1/10

– First reporting period will cover payments from 7/1/09 – 12/31/09 – CY reports will be due annually thereafter, by 7/1– TBD how recipients will be identified– Public access – www.mass.gov

• Law: http://www.mass.gov/Eeohhs2/docs/dph/quality/healthcare/pharmaceutical_medical_device_conduct_statute.pdf

• Regulations: http://www.mass.gov/Eeohhs2/docs/dph/regs/105cmr970.pdf

Timetable for State Pharma/Device Company Disclosures