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Title: Policy on Interactions with Pharmaceutical and Medical Device
Companies
Department: Office of General Counsel
Applies to: Interactions between Partners HealthCare System, Inc., its affiliates and their employees and medical staff members, and pharmaceutical and medical device companies and their employees and representatives Approved by: Partners Chief Medical Officers Committee; Partners Operating Heads
Approval Date: 3/28/2005
Revision Date: 10/1/2009
Effective Date: 10/1/2009
Keywords:
vendor, vendors; device manufacturer; device manufacturers, device company.
POLICY:
Note that significant provisions of this policy are superseded by the Partners Interim Policy
Statement on Interactions with Industry.
This Policy on Interactions with Pharmaceutical and Medical Device Companies establishes ethical principles of conduct for interactions between Partners HealthCare System, Inc., its affiliates (Partners Health Care System, Inc. and its affiliates shall be referred to herein as "Partners"), and their employees and medical staff members ("Individuals") on the one hand, and pharmaceutical and medical device companies ("P/D Companies") and their employees and representatives ("Representatives") on the other. This policy intends to codify in a single document the principles of conduct that are applicable to Partners, Individuals, P/D Companies and Representatives under existing laws, codes and policies, including (without limitation) the American Medical Association Guidelines on Gifts to Physicians from Industry, the PhRMA Code on Interactions with Healthcare Professionals, the AdvaMed Code of Ethics on Interactions with Health Care Professionals, and the Partners HealthCare System Code of
Conduct.
1 A
PPLICATION:
1 References to such existing laws, codes and policies are included throughout this policy in parentheses to indicate
the sources upon which the standards set forth in this policy are based. Existing Partners policies are referenced by
use of an abbreviation of the name of the Partners institution (e.g., "PHS" for Partners HealthCare System, or "BWH"
for Brigham and Women"s Hospital). Abbreviations for other sources are listed in Section V (References) below.
Except as provided below, Partners" and Individuals" interactions with P/D Companies and their Representatives must be in compliance with this policy and all applicable laws and regulations (see References at end), and should be conducted in a manner that protects Partners" decision makers from undue influence. This policy shall not be binding upon medical staff members who are not Partners employees when they are in their individual private practice offices. However, this policy shall be binding upon medical staff members who are not Partners employees when they are at a Partners facility or in situations where they are identified as affiliated with a Partners entity. This policy shall serve as suggested guidelines for such Individuals at all other times. Notwithstanding the foregoing, each Partners entity shall have the discretion to apply this policy to a broader set of individuals (e.g., by requiring that certain non-employed Individuals who may be construed as Partners" agents comply with this Policy at all times). S
TANDARDS:
Federal law prohibits offering, soliciting, paying or receiving remuneration to induce or reward referrals for goods or services paid for under Medicare or Medicaid. This prohibition applies to the drugs and devices purchased by Partners entities since both pharmaceuticals and medical devices are components of Medicare and Medicaid charges. Federal law also makes it illegal for providers to sell drug samples to their patients or to bill free samples to state, federal or commercial third-party payors. Finally, federal law restricts the use and disclosure of protected health information by covered entities such as hospitals and physicians. This restriction limits the ability of P/D Company Representatives to be present during patient treatment or at meetings where a patient"s treatment is being discussed. Outlined below are system-wide standards applicable throughout Partners, including its affiliates and their employees and medical staff members. Each Partners entity is encouraged to develop additional specific standards and procedures as necessary to fully address those areas in which the sales and marketing efforts of P/D Companies may cause concern.
A. Access; Drug Detailing; Samples
1. Appointments
. Representatives may have access to Partners sites and Individuals on an appointment only basis. Drop-in visits by Representatives are not permitted. Representatives are required to make an appointment to visit Partners sites and/or Individual(s) in advance of the appointment. (BWH; FH; MGH; NWH; NSMC; SKRH)
2. Registration and Identification.
Upon arrival at a Partners site, Representatives are required to register with a central department designated by the Partners site. Representatives must wear a Partners-issued identification badge at all times. (BWH; FH; MGH; McLH; NWH;
NSMC; SKRH)
3. Location of Meetings.
Meetings with Representatives shall be held only in department or physician offices, or conference rooms. Meetings with Representatives may not be held in patient care areas, in clinical or waiting areas, in lounges or corridors, or in any other area where the meeting could disrupt patient care, research or education. (BWH; FH; NWH;
NSMC; SKRH)
4. Access to Patient Information. Any access by Representatives to patient information
(including by a Representative"s presence during a patient"s treatment) must comply with all Health Insurance Portability and Accountability Act ("HIPAA") requirements and confidentiality-related policies. (HIPAA; PHS; BWH; FH; MGH; NWH)
5. Contact with Patients.
Representatives are not permitted to be present during patient treatment or otherwise have contact with patients (including through preceptorship arrangements) except as approved by the appropriate Department Chief (or his or her designee) or in accordance with applicable policies of the Partners entity (e.g., a policy on medical device representatives" presence in the operating room). In addition, prior to permitting a Representative to be present for a patient"s treatment, the patient"s consent must be obtained and documented in accordance with HIPAA requirements, and the Representative must acknowledge his or her agreement to adhere to applicable policies in a signed document. (HIPAA; BWH; FH; MGH; NWH)
6. Preceptorships.
Preceptorship arrangements (arrangements in which P/D Company representatives are present during patient office visits or surgical procedures for the educational or other benefit of the P/D Company representative) are not permitted except when approved by the appropriate Department Chief based upon a determination that the preceptorship is in the best interest of Partners and patient care, and complies with all applicable laws.
7. Attendance at Rounds, Lectures or other Meetings.
Representatives may not attend
rounds, lectures or other meetings at Partners sites (including, without limitation, programs sponsored by the Representative"s company) except when invited or approved by the appropriate Department Chief (or his or her designee). Representatives may not use their presence at rounds, lectures or other meetings to market products or discuss industry- specific issues with Individuals. Representatives may not participate in rounds, lectures or other meetings where specific patients will be named or discussed. (BWH; FH; MGH; NSMC)
8. Non-Formulary Drugs.
P/D Companies and their Representatives should be discouraged from promoting drugs that are not on the approved formulary. (FH; NSMC; SKRH)
9. Informational Presentations by Representatives. Informational presentations, including any
complimentary meals provided in connection with such presentations, must be approved by the appropriate Department Chief (or his or her designee) and must be for the legitimate purpose of improving patient care by educating providers. (BWH) (a) The cost of a complimentary meal in connection with a presentation by a Representative must be modest and reasonable according to local standards. (OIG; AMA; PhRMA;
AdvaMed; SRH)
(b) If the presentation does not take place at a Partners site, the presentation must take place at a location conducive to learning and the exchange of information. (OIG; PhRMA;
AdvaMed)
10. Promotional Materials
. P/D Company displays or other written promotional materials are not permitted anywhere at a Partners site unless approved by the pharmacy department or another department designated by the applicable Partners entity. (FH; NWH; NSMC; SKRH)
11. Detailing of Health Care Professionals.
Representatives may not detail health care
professionals (other than Medical Staff Members) while they are working at a Partners site. (BWH; FH; NSMC; SKRH)
12. Samples.
Individuals may not accept drug samples (including for their own or their family"s use) except as part of an approved policy or program and in approved locations. Partners and Individuals may not sell drug samples to patients or bill free samples to state, federal or commercial third-party payors. (OIG; PDMA; BWH; FH; McLH; NSMC; SKRH)
B. Educational Conferences; Educational Grants
1. Support for Educational Programs and Other Educational Gifts. Subject to the exceptions
described below, all educational gifts from P/D Companies or Representatives (including, without limitation, gifts to fund broad-based educational activities, gifts to fund specific lectures and seminars, gifts to fund continuing medical education programs, gifts of textbooks and other educational materials, and gifts to provide salary support for health care professionals in training) must be processed through the development office of the applicable Partners entity. The following educational gifts may be processed through the office of the appropriate Department Chief (or his or her designee): (a) food/beverages (or funds to purchase food/beverages) for educational lectures with a value of less than $20 per expected attendee and $5,000 in the aggregate; (b) funds to be used to pay reasonable stipends to and reimburse reasonable travel expenses for speakers at educational lectures sponsored by a Partners entity in an amount less than $5,000 per speaker ($10,000 per speaker for speakers traveling from the West Coast or from abroad); (c) educational materials (or funds to purchase educational materials) with a value of less than $50 per intended recipient and $5,000 in the aggregate. Educational gifts greater than $50,000 must be reviewed and approved by the Partners HealthCare System Education Committee or a designated subcommittee. All educational gifts from P/D Companies must be made solely for the purpose of supporting the charitable educational mission of the Partners entities. Certain Partners entities have adopted additional processing and approval standards for educational gifts that should be consulted. For instance, Individuals at Partners entities that have adopted the Partners Guidelines Regarding Gifts from Industry to Support Educational Programs (which includes the BWH and MGH) should consult that policy for further guidance. (BWH; MGH; NSMC)
2. Sponsored Educational Lectures and Programs. In addition to the processing and approval
requirements in Section III.B.1. above, educational gifts to support educational lectures or continuing education programs at Partners entities may be accepted from P/D Companies or Representatives, subject to the following standards: (a) The terms, conditions and purposes of P/D Company support must be documented in writing. (ACCME) (b) The selection of overall content, educational objectives and methods, specific topics and speakers for educational lectures must be made by the appropriate Department Chief (or his or her designee). It is the responsibility of the Department Chief (or his or her designee) to ensure that balanced, objective and educational information is presented at the lecture or program. (OIG; FDA; AMA; PhRMA; AdvaMed; ACCME; BWH; MGH; McLH; NSMC; SRH) (c) All financial relationships between a P/D Company and an individual with control over the content of the lecture or program must be identified and the conflict of interest resolved prior to the beginning of the lecture or program. (ACCME) (d) Gifts to pay reasonable stipends or travel expenses for visiting speakers must be made to the Partners entity, which will arrange to pay the speaker. (OIG; PhRMA; AdvaMed;
ACCME; BWH; MGH; McLH; NSMC)
(e) The P/D Company"s or Representative"s support must be disclosed in the program materials or, if no program materials are distributed, verbally prior to the beginning of the lecture or program. (FDA; ACCME; BWH; MGH; NSMC; SRH) (f) Speakers must disclose any financial or other relationship that they have with the sponsoring P/D Company or Representative both orally and in any written materials. (FDA;
ACCME; BWH; MGH; NSMC; SRH)
(g) A Representative may attend the lecture or program only when invited by the appropriate Department Chief (or his or her designee) and only when specific patients will not be named or discussed. The Representative may not use his or her presence at the lecture or program to market products or discuss industry-specific issues with Individuals. (BWH;
MGH; NSMC; SRH)
(h) The distribution or presentation of advertising or other promotional materials immediately before, during or immediately after sponsored lectures or programs is prohibited. (FDA;
ACCME; BWH; MGH; NSMC; SRH)
(i) Lectures and programs must be conducted in a manner and location conducive to learning and the exchange of information. (OIG; PhRMA; AdvaMed; ACCME) (j) Accredited Continuing Medical Education programs supported by P/D Companies must be in compliance with the ACCME"s Standards for Commercial Support and must comply with the following standards: (ACCME; BWH; MGH) (i) Any device, product, drug or procedure that is the focus of a program should be widely recognized and accepted as worthwhile for the betterment of human health. TheDepartment Chief (or his or her designee) should review the available evidence to make this determination. FDA approval is generally required. (ii) Any P/D Company associated with the device, product, drug or procedure discussed at the program must be regarded as a legitimate and reputable organization adhering to high ethical standards, as judged by the Department Chief (or his or her designee). (iii) Devices, products or drugs produced by more than one P/D Company should be discussed at the program to prevent the appearance of endorsing a single product. (iv) At times it may be appropriate to require that the P/D Company providing devices, products, drugs, equipment, materials, etc. hold the Partners entity harmless for any damage that may arise from defects in the products, etc. or from misuse by people who have attended the program. Liability issues should be negotiated with the advice of the
Partners Office of the General Counsel.
(v) Participants should pay a reasonable fee for the program. Reduced enrollment fees may be allowed for Partners staff and trainees.
3. Educational Conferences. An Individual serving as a faculty member at an educational
conference may accept a reasonable honorarium and reimbursement for his or her own reasonable travel, lodging and meal expenses, provided that the honorarium and reimbursement are provided by the conference organizer. Individuals not serving as faculty members may not accept financial support or other reimbursement from P/D Companies or Representatives for attendance at an educational conference or meeting, or for travel, lodging or meal expenses associated with such educational conference. (OIG; AMA;
PhRMA; AdvaMed; McLH)
4. P/D Company Training. An Individual may attend P/D Company-sponsored training (i.e.,
training or education provided by a P/D Company for the purpose of training Individuals in the use of its products) only with the approval of his or her Department Chief (or his or her designee). The Department Chief may approve attendance at a P/D Company-sponsored training if there is business and educational value to Partners and the training event takes place in a manner and at a location conducive to learning and the exchange of information. The Individual must provide the Department Chief with sufficient written information (e.g., a course description) for the Department Chief to assess the substantive training content. Any travel and/or lodging provided by the P/D Company (or reimbursement for travel and lodging expenses) must be limited to reasonable travel and modest lodging costs, and may not be provided for guests of the Individual. Meals provided by the P/D Company must be limited to modest meals. (AdvaMed)
5. Educational Materials. In the case of educational gifts made for the purpose of purchasing
educational materials (e.g., textbooks or videotapes), the selection of the educational materials must be made by the appropriate Department Chief (or his or her designee), without input from the P/D Company or Representative making the gift. The Department Chief (or his or her designee) shall be responsible for distributing the selected materials. (BWH; MGH; NSMC)
6. Salary Support for Health Care Professionals. Educational gifts to provide salary support
for health care professionals in training must be processed through the development office of the applicable Partners entity, and may not be made directly to or earmarked specifically for an identified individual. (BWH; MGH)
7. Scholarships for Educational Conferences. Scholarships or other funds donated to permit
health care professionals in training to attend educational conferences must be processed through the development office of the applicable Partners entity, and may not be made directly to or earmarked specifically for an identified individual. (OIG; AMA; PhRMA)
8. Solicitation. P&T Committee members, materials management employees and other
Individuals directly involved in purchasing decisions on behalf of Partners may not solicit grants or donations from P/D Companies or Representatives. (BWH; MGH)
9. Compliance with PhRMA/AdvaMed Guidelines. Partners and Individuals should not accept
any educational grants from pharmaceutical companies or medical device companies that have not formally acknowledged their compliance with the PhRMA or AdvaMed guidelines, respectively. (NSMC) C. Gifts, Gratuities and Other Business Courtesies. Note that significant portions of the highlighted section have been superseded by the Partners
Interim Policy Statement
on Interactions with Industry
1. Anti-Kickback Statute
. Certain benefits that are offered to providers by P/D Companies (e.g., entertainment, recreation, travel) may violate the Federal Anti-Kickback Statute when they involve persons in a position to influence the purchase of prescription drugs, and must therefore be closely scrutinized. (AKS; OIG)
2. Partners Code of Conduct
. Any gifts, are subject to the requirements of the Partners Code of Conduct.
3. Additional Restrictions on Gifts or Gratuities from P/D Companies. In addition to the
requirements imposed by the Partners Code of Conduct, any gift or gratuity from a P/D Company to an Individual must comply with the following standards: (a) A gift or gratuity may be permitted if it is approved by the Individual"s Department Chief (or his or her designee), it has a monetary value of $100 or less, and it primarily serves a patient care or educational purpose (e.g., stethoscopes, pens, notepads). An Individual may accept such a gift or gratuity only occasionally. (Meals provided in connection with informational presentations are addressed in Section III.A.9. above.) (OIG; AMA; PhRMA;
AdvaMed; McLH)
(b) Gifts or gratuities with a monetary value or $100 or greater, or that do not serve a patient care or educational purpose, are prohibited. Gifts that do not primarily serve a patient care or educational purpose include, but are not limited to, payments in cash or cash equivalents (e.g., gift certificates), meals provided in the absence of an informational presentation, golf balls, sports bags, or sports or theater tickets. (OIG; AMA; PhRMA; AdvaMed; McLH) (c) Educational gifts (e.g., textbooks) must be selected and distributed by the Department Chief (or his or her designee). (BWH; MGH; NSMC)
D. Conflicts of Interest
1. Partners Code of Conduct
. All Individuals are required to comply with the Partners HealthCare System Code of Conduct, including its Conflict of Interest Policy, in interactions with P/D Companies and Representatives. (PHS)
2. Pharmacy & Therapeutics Committee
. Each Partners P&T Committee must have a policy specifically addressing potential conflicts of interest of P&T Committee members. Such policy must include, at a minimum, a requirement that members of Partners" P&T Committees declare conflicts of interest and abstain from voting on matters in which they have a conflict of interest in conformance with the Partners Code of Conduct. Partners" P&T Committees should give consideration to the creation of a Partners-wide P&T
Committee.
3. Medical Device Selection and Procurement
. Each Partners entity must have a policy specifically addressing potential conflicts of interest in the selection and procurement of medical devices.
E. Other Arrangements
1. Consulting or Service Arrangements
(a) All Individuals who are Partners employees or who have full- or part-time faculty appointments at Harvard Medical School must comply with the Partners HealthCare System Policy on Consulting and Other Outside Activities in entering into any consulting or other service arrangement with a P/D Company. (PHS) (b) All other Individuals (i.e., medical staff members who are not Partners employees and who do not have full- or part-time faculty appointments at Harvard Medical School) do not need to comply with the Partners HealthCare System Policy on Consulting and Other Outside Activities, but are subject to the following requirements when entering into and engaging in any consulting or other service arrangement with a P/D Company: (i) they may not use the space, facilities, materials or other resources of Partners; and (ii) without the prior written consent of Partners, they may not use the name or logo of any Partners entity in any form other than to identify any position or title the Individual holds at Partners or to identify the Individual as a medical staff member at a Partners hospital in a manner that does not imply endorsement or responsibility for the activity, arrangement or P/D Company involved (or any of the P/D Company"s products) by the Partners entity.
2. Product Conversion ("Switching") Arrangements
. Product conversion or "switching" arrangements involve the offering to physicians or other prescribers cash payments or other benefits each time a patient"s prescription is changed to the manufacturer"s product from a competing product. While such arrangements may be permitted under some managed care arrangements, they may implicate the Federal Anti-Kickback Statute and must be reviewed by the Partners Office of General Counsel. (OIG)
F. Implementation and Enforcement
1. Partners Entities and Individuals
. All Partners entities must establish mechanisms to ensure that this policy is distributed to and reviewed by all Individuals. Individuals who violate this policy shall be disciplined in accordance with the applicable Partners entity"s human resources policies and/or medical staff bylaws.
2. P/D Companies and Representatives
. All P/D Companies who wish to send Representatives to a Partners facility must acknowledge that their Representatives have agreed in writing to comply with the provisions of this policy applicable to P/D Companies and their Representatives. If a Representative violates this policy, the Representative and the P/D Company shall be subject to enforcement action by Partners up to and including barring the Representative and the P/D Company from Partners sites and/or reporting the violation to appropriate regulatory authorities. (FH; MGH; NSMC; NWH)
3. Reporting of Violations
. Violations of this policy should be reported to the Partners
Corporate Compliance Department.
Q
UESTIONS:
Questions concerning this policy may be directed to the Partners Corporate Compliance Department. Answers to a sampling of frequently asked questions are attached. R
EFERENCES:
A. Federal Anti-Kickback Statute, 42 U.S.C. 1320-a7(b) ("AKS") B. Prescription Drug Marketing Act of 1987, 21 U.S.C. 353(c)(1) ("PDMA") C. Health Insurance Portability and Accountability Act of 1996 ("HIPAA") D. OIG, Compliance Program Guidance for Pharmaceutical Manufacturers, http://oig.hhs.gov/fraud/docs/complianceguidance/042803pharmacymfgnonfr.pdf ("OIG") E. FDA, Guidance for Industry: Industry-Supported Scientific and Educational Activities, http://www.fda.gov/cder/guidance/isse.htm ("FDA") F. American Medical Association, Gifts to Physicians from Industry ("AMA") G. PhRMA, Code on Interactions with Healthcare Professionals, http://www.phrma.org/publications/policy//2004-01-19.391.pdf ("PhRMA") H. AdvaMed, Code of Ethics on Interactions with Health Care Professionals, I. Accreditation Council for Continuing Medical Education, Standards for Commercial Support, http://www.accme.org/index.cfm/fa/Policy.home/ Policy.cfm ("ACCME")
J. Partners HealthCare System Code of Conduct
A
TTACHMENT:
Frequently Asked Questions
quotesdbs_dbs17.pdfusesText_23
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