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Transparency

As part of the DePuy Synthes Companies' ongoing efforts in the area of compliance, we have developed a Comprehensive Compliance Program that is designed to comply with applicable federal and state laws and industry standards relating to the marketing and promotion of our products.

Please select a company to learn about its Compliance Program.


Transparency

Grants
Grants

 

DePuy Orthopaedics, Inc. is committed to Our Credo, which guides us to provide high quality products and services to health care professionals and patients and to support the communities in which we work and live.

We recognize that medical science evolves rapidly with new information becoming available constantly. As part of the health care system, we also understand the need to support health care professionals in their pursuit of the most current education to provide the best patient care possible. There is further need to support patients, caregivers, and communities to ensure that they have the information and products required to live healthy, quality, and productive lives. As such, we are proud to have the opportunity to support educational programs and community programs through educational grants and charitable contributions, respectively.

We hold ourselves accountable to the highest standards to ensure that we are providing educational grants and charitable contributions in an appropriate manner. There are a number of policies and guidance documents from various external regulatory and policy-making organizations that form the basis for the development of our company's guiding principles used to evaluate grant and charitable request submissions.

Our primary focus is making life-changing, long-term differences in human health and disease management for those who may be helped by the products and services we provide. The purpose of our disclosure of supported educational grants and charitable contributions is to demonstrate our ongoing commitment to this endeavor. It is our hope that this disclosure will help the general public to better understand the nature and volume of programs that we support in the interest of advancing patient care and supporting local communities.

 

Educational Grants Process

DePuy Orthopaedics, Inc. understands the need to comprehend all aspects of disease management and treatment and that both health care professionals and patients benefit from a wide variety of learning formats that employ generally accepted adult learning techniques.

DePuy Orthopaedics, Inc. is proud to be able to provide grants to support educational activities and programs that help health care professionals enhance the care of their patients. We prioritize support in areas of scientific interest to the company that are intended to contribute to improvement in health care provider knowledge.

Our organization follows a defined and specific process to ensure that our procedures for making educational grants are in agreement with appropriate guidelines and policies. The guidance we use to evaluate our support of various educational programs is based on recognized standards.

  • Educational grants may be given to support bona fide educational activities directed toward health care professionals or patients and may include funding for accredited/certified continuing education, fellowships, and patient education.
  • Independent, company-supported educational activities are intended to benefit health care professionals and the patients they serve through the dissemination of information that contributes to the practice of medicine.
  • DePuy Orthopaedics, Inc. does not control or influence the content of programs or the selection of the speakers, authors, or faculty planners. This guideline applies equally to all educational activities involving any health care professional, or customer who is in a position to influence the purchase of DePuy Orthopaedics, Inc. products.

DePuy Orthopaedics, Inc. does not provide "unrestricted educational grants" and grant funds must be used for the purpose defined within the original request. Each grant request is evaluated for completeness based on four basic components:

  1. An assessment documenting why the education is necessary
  2. An agenda or brochure describing the schedule of events
  3. A detailed budget identifying all sources of funding and how grant funds will be used
  4. Evidence of accreditation to provide continuing education credit and/or tax exempt status

Educational grants must be provided in accordance with the policies and procedures of Guidance Documents and with the U.S. Food and Drug Administration's Guidance on Industry-Supported Scientific and Educational Activities. They must also be consistent with the Accreditation Council for Continuing Medical Education Standards for Commercial Support (www.accme.org) ("ACCME Standards"), the American Medical Association Ethical Guidelines for Gifts to Physicians from Industry (www.ama-assn.org) ("AMA Guidelines"), the Pharmaceutical Research and Manufacturers of America Code on Interactions with Health care Professionals (www.phrma.org) ("PhRMA Code"), the AdvaMed Code of Ethics for Interactions with Health Care Professionals (www.advamed.org) ("AdvaMed Code") and/or other relevant industry standards.

DePuy Orthopaedics, Inc.'s Medical Affairs, Scientific Affairs, or other relevant departments have responsibility for the monitoring and recordkeeping of independent educational programs supported by DePuy Orthopaedics, Inc., including budget, staff and interactions with educational providers. In addition, DePuy Orthopaedics, Inc. has:

  • Written policies and procedures relating to the submission, review and approval of grant requests and interactions with educational providers, so as to comply with applicable requirements of the guidelines mentioned above;
  • An internal, multidisciplinary review process for evaluation of educational grant requests which includes our Medical Education, Medical Affairs/Clinical Research, Health Care Compliance, Regulatory Affairs and Law departments, as necessary;
  • Appropriate measures to ensure that support of educational programs are scientifically and clinically justified, and the program is not intended to be promotional in nature. DePuy Orthopaedics, Inc. may consider the following factors:
    • The demonstrated scientific and clinical need for the program;
    • Whether the proposed program is sponsored solely by DePuy Orthopaedics, Inc. or if our funding represents a significant proportion of the program budget;
    • The grant requestor's history, and whether prior educational activities appeared to be conducted in an independent and unbiased manner and not influenced by support from industry sponsors.
       

 

Frequently Asked Questions

1. Why is the grant information being disclosed?

DePuy Orthopaedics, Inc. is proud to have the privilege of providing educational grants to support independent educational activities, which are intended to contribute to better patient care. We believe that being transparent with this information is the appropriate action to demonstrate our commitment to providing the highest quality health care products and services, including support for medical education.

2. What grant information is being disclosed?

Beginning in the first quarter of 2009, DePuy Orthopaedics, Inc. is providing the:

  • Name, city and state of the accrediting organization
  • Co-sponsor to whom the funds were paid, if applicable, and their city and state
  • Title of the educational activity
  • Amount of the payment
  • Date the educational activity will be initiated

3. What types of grants does DePuy Orthopaedics, Inc. support?

  • Accredited Continuing Education: Educational programs for health care providers such as physicians, nurses, and/or pharmacists that provide continuing education credits.
  • Non-Accredited Professional Educational Activities: Educational programs for health care providers such as physicians, nurses, and pharmacists that do not provide continuing education credits. As a condition for funding, to the extent DePuy Orthopaedics, Inc. products are discussed as part of such funded activities, DePuy Orthopaedics, Inc. requires that such discussion be done in a manner consistent with the FDA approved labeling.

4. Who is the "grant requestor(s)"?

This is the organization requesting the independent educational grant from DePuy Orthopaedics, Inc. and is typically an accredited/educational provider or similar organization responsible for designing and conducting an educational activity. The accredited/educational provider is the organization that signs the letter of agreement/contract with DePuy Orthopaedics, Inc. and has ownership of the educational activity, controlling all aspects of the activity/program. Individual health care professionals or private health care professional practices are not eligible to receive grant funding.

5. Who decides the name/title of an educational activity?

The grant requestor and/or accredited continuing education provider is in complete control of all aspects of their educational activity including the title, scope of activity, faculty and audience selection, content, distribution and evaluation of the program. For posting purposes, the title of the education activity is obtained from the information provided with the grant submission.

6. What is a co-sponsor?

To be consistent with accepted industry standards (Accreditation Council for Continuing Medical Education, American Nurses Credentialing Center, and American College of Physician Executives), a continuing education provider may specify a co-sponsor in the letter of agreement. This does not include organizations retained by the provider in a subcontracting relationship that supply administrative or logistical services.

7. How is the total amount of the grant determined and distributed?

The total amount approved for funding is based on the grant request and the grant committee's funding decision. This may be full or partial funding and can be of an equal or lesser amount than requested in the grant application. This amount is specified in the letter of agreement/contract.

The disclosure report posted by DePuy Orthopaedics, Inc. is limited to the funding we provided and does not include or address funding secured by the grant requesting organization from sources other than DePuy Orthopaedics, Inc.. The accredited/educational provider has complete control over the distribution of funds received from DePuy Orthopaedics, Inc. and the choice of co-sponsor(s).

8. What should one be aware of to further understand how the funding amount is being disclosed on our Web site?

Every grant request received undergoes a thorough review, which follows a well-defined process to ensure that appropriate funding is made according to accepted standards (i.e., U.S. Food and Drug Administration, Accreditation Council for Continuing Medical Education, Office of Inspector General, AdvaMed, and Pharmaceutical Research and Manufacturers of America) and company policies. A grant can only be approved for funding after it has undergone a rigorous review. The funding amount may be divided into partial payments that are stated in the letter of agreement/contract between the accredited/educational provider and DePuy Orthopaedics, Inc..

To ensure accurate reporting of funds disbursed, DePuy Orthopaedics, Inc. is disclosing all payments to an accredited/educational provider within a defined fiscal quarter. These financial disclosures may not include grants made by companies recently acquired by DePuy Orthopaedics, Inc. prior to the acquisition. Available records from such companies will be reviewed and evaluated, and applicable grant information will be posted within a reasonable period following acquisition.

9. What types of information are not reflected by the funding amounts we have disclosed?

The payment information posted on this site does not itemize the amount of funds the grant requestor may pay to third parties as "pass-through" expenses associated with building health care provider awareness of the educational activity and conducting the event. Typical pass-through expenses may include: fees (e.g., accreditation/certification, fees CE certificates, sub-contractors, medical societies, etc.), administrative costs (e.g., printing, postage, etc.), logistical support (e.g., room rental, audiovisual equipment rental, etc.), faculty honorarium and travel expenses, and other expenses.

10. Why might some funds appear to have been reported for the same amount across multiple quarters?

All reporting is based on actual payments made, not on total dollar amounts approved for each grant request. There may be certain situations where grant requests are approved with installment payments of equal or similar value spread over time. Usually these will occur when more complicated educational activities with multiple components are approved. Payments are disbursed upon completion of project milestones that demonstrate the activity is proceeding as originally proposed, as defined by the accredited provider/educational sponsor.

11. Are the volume of requests and the number of approvals generally consistent over the course of a calendar year?

The number of grant requests DePuy Orthopaedics, Inc. receives varies throughout the year. The quantity, timing, and nature of requests are determined by the needs of accredited providers/educational sponsors submitting proposals to DePuy Orthopaedics, Inc.. In addition, changes in the availability of DePuy Orthopaedics, Inc. funds affect the volume and dollars available for grants.

12. What is the difference between a charitable contribution and an educational grant?

Educational grants are provided for bona fide educational activities and fall into one of the following categories:

  • Accredited Continuing Education: Educational programs for health care providers such as physicians, nurses, and/or pharmacists that provide continuing education credits.
  • Non-Accredited Professional Educational Activities: Educational programs for health care providers such as physicians, nurses, and pharmacists that do not provide continuing education credits. As a condition for funding, to the extent DePuy Orthopaedics, Inc. products are discussed as part of such funded activities, DePuy Orthopaedics, Inc. requires that such discussion be done in a manner consistent with the FDA approved labeling.

Charitable contributions describe donation requests that are used for purposes other than health care professional education initiatives. Charitable contributions may be cash or product donations.

  • A cash charitable contribution is a financial donation that is philanthropic in nature and provided to a nonprofit organization to support a specific community-based (or regional/national) program, project, or event (e.g., a cash donation at a fund raising event).
  • A product donation is provided through specific product giving programs to non-government organizations generally responding to disasters, medical relief efforts and basic health care needs in under-served communities.

13. How are programs that are jointly supported by DePuy Orthopaedics, Inc. and another business reported?

As each business is a separate legal entity, the individual company that signs the letter of agreement and provides the funds directly to the requesting organization reports programs.

14. How is the reporting period for funding determined?

All reported funding is based on DePuy Orthopaedics, Inc.'s financial calendar. In general, grants are reported based on financial quarters, which are 13 weeks in length. Although they closely resemble calendar quarters, there may be occasions where the fiscal quarter does not end on the last day of the calendar month. If the financial calendar ends earlier than the end of the month, any activity from the next day forward would be reported with the next quarterly reporting period.

15. Why might one see duplicate payments reported in different quarters on this Web site?

Rarely, there may be a duplicated payment reported in a different time period if the requesting organization reports a lost check.

16. What happens when the grant recipient does not require, or use, all of the funds originally specified for an activity?

An educational provider/sponsor may reconcile their budget following an activity and find that they have unused funds remaining. As established in the written agreement and in accordance with our policy, DePuy Orthopaedics, Inc. requires that unused funds already disbursed to the educational provider/sponsor be returned to our organization. DePuy Orthopaedics, Inc. is also reporting any unused funds received from an accredited provider/educational sponsor as a lump sum in the quarter they are returned.

For the purposes of accuracy, DePuy Orthopaedics, Inc. is reporting the actual funds disbursed to a grant applicant and, if applicable, the educational partners as specified in the written agreement. Should the educational activity not require all of the funds originally specified in the agreement, unused funds would not be disbursed.

 

 

Charitable Contributions Process Statement and FAQs

"We are responsible to the communities in which we live and work and to the world community as well. We must be good citizens - support good works and charities and bear our fair share of taxes. We must encourage civic improvements and better health and education. We must maintain in good order the property we are privileged to use protecting the environment and natural resources."

---Our Credo

A charitable contribution includes cash or product donations. A cash charitable contribution is a financial donation that is philanthropic in nature and provided to a non-profit organization to support a specific community-based (or regional/national) program, project, or event. A product donation is provided through specific product giving programs to non-government organizations generally responding to disasters, medical relief efforts and basic health care needs in under-served communities.

All requests are reviewed by a multidisciplinary committee, which may include Medical Affairs, Health Care Compliance, Public Affairs, Human Resources, and Legal, as necessary. Recipients must be tax-exempt organizations with an appropriate federal tax-exempt status. Requests should include the organization's mission statement, IRS tax status, project/event description, description of how the funds will be used, project budget (if applicable) and annual operating budget (if applicable).

The following types of requests are generally not eligible for charitable contributions:

  • Organizations that do not have a valid federal tax-exempt status
  • Scholarships to individuals
  • Direct contributions to individuals or physician practices
  • Loans
  • Trips or tours
  • Endowments of any kind
  • Sectarian and religious organizations that do not serve the general public on a nondenominational basis
  • Capital requests (building funds, endowments, multi-year commitments)
  • Political, fraternal or athletic groups

Product contributions must be used in the manner defined below:

  • Product contributions will only be placed with licensed medical and health care professionals;
  • Product contributions cannot be transferred in exchange for money, other property or services;
  • Product contributions cannot be used for research, experimental, or demonstration purposes;
  • Product contributions cannot be billed to any third party payor (public or private); and
  • For purposes of disclosure and reporting, product contributions are valued at the Company's list price.
     

 

Charitable Contributions FAQs

1. Why is charitable contribution information being disclosed?

DePuy Orthopaedics, Inc. is proud to have the privilege of providing charitable contributions to various community organizations. We believe that being transparent with this information is the appropriate action to demonstrate our commitment to providing the highest quality health care products and services.

2. What charitable contribution information is being disclosed?

DePuy Orthopaedics, Inc. is providing the name of the requestor, the city/state where the requesting organization resides, the title of the activity, the amount of the contribution, and the type of contribution (cash or product). Payments made by the company on behalf of its employees , such as payroll deductions for donations to the United Way, are generally excluded from the company’s Contributions report.

3. How is the total amount of the charitable contribution determined and distributed?

The amount approved for funding is a result of the charitable contribution review process. Funding amounts may be based on project/event budgets, fair market value, organizational geographic scope, and merits of the request. This may be of an equal or lesser amount than requested in the application. The organization has complete control over the distribution of funds received from DePuy Orthopaedics, Inc. .

4. What is the difference between a charitable contribution and an educational grant?

An Educational Grant falls into one of the following categories:

  • Accredited Continuing Education: Educational programs for health care providers such as physicians, nurses, and/or pharmacists that provide continuing education credits.
  • Non-Accredited Professional Educational Activities: Educational programs for health care providers such as physicians, nurses, and pharmacists that do not provide continuing education credits. As a condition for funding, to the extent DePuy Orthopaedics, Inc. products are discussed as part of such funded activities, DePuy Orthopaedics, Inc. requires that such discussion be done in a manner consistent with the FDA approved labeling.

Charitable contributions describe donation requests that are used for purposes other than health care professional education initiatives. Charitable contributions may be cash or product donations.

  • A cash charitable contribution is a financial donation that is philanthropic in nature and provided to a nonprofit organization to support a specific community-based (or regional/national) program, project, or event. As noted above, employee payroll deductions remitted by the company to a charitable organization are not reported as a contribution by the company.
  • A product donation is provided through specific product giving programs to non-government organizations generally responding to disasters, medical relief efforts and basic health care needs in under-served communities.

5. How does the company handle expenses that are part of a charitable contribution for which DePuy Orthopaedics, Inc. receives some benefit?

DePuy Orthopaedics, Inc. requires organizations to complete an Omnibus Budget Reconciliation Act of 1993 (OBRA) form. This form documents the amount of the contribution that can truly be considered charitable versus a portion of the amount that represents payments for expenses by the organization for which DePuy Orthopaedics, Inc. receives some benefit (i.e., business expenses). Please note that some of these nominal business expenses associated with some charitable contributions may be included in this report.

6. How are programs that are jointly supported by DePuy Orthopaedics, Inc. and another business reported?

As each company is a separate legal entity, the individual company that provides the funds directly to the requesting organization is responsible for reporting the donation.

These financial disclosures may not include grants made by companies recently acquired by DePuy Orthopaedics, Inc. prior to the acquisition. Available records from such companies will be reviewed and evaluated, and applicable grant information will be posted within a reasonable period following acquisition.

7. Are the volume of requests and the number of approvals generally consistent over the course of a calendar year?

The number of contribution requests DePuy Orthopaedics, Inc. receives varies throughout the year. The quantity, timing, and nature of requests are determined by the needs of the organizations submitting proposals to DePuy Orthopaedics, Inc., which is determined by the requestors' needs. In addition, changes in the availability of DePuy Orthopaedics, Inc. funds affect the volume and dollars available for contributions.

8. How is the reporting period for funding determined?

All reported funding is based on DePuy Orthopaedics, Inc. 's financial calendar. In general, grants are reported based on financial quarters. Financial quarters are 13 weeks in length and, although they closely resemble calendar quarters, there may be occasions where the fiscal quarter does not end on the last day of the calendar month. If the financial calendar ends earlier than the end of the month, any activity from the next day forward would be reported with the next quarterly reporting period.

9. Why might one see duplicate payments reported in different quarters on this Web site?

Rarely, there may be a duplicated payment reported in a different time period if the requesting organization reports a lost check.

 

Criteria for Grant Denials

Educational grant requests are reviewed through a rigorous review process. Processes have been designed and implemented so that no single individual may authorize educational grant support alone. In accordance with government guidance, it is inappropriate for individuals responsible for sales and marketing to be involved in educational grant-making decisions. Grant reviewers typically include personnel from Medical Affairs, Medical Education, Regulatory Affairs, Health Care Compliance, and/or Legal departments, as necessary.

Numerous educational grant requests can be received by DePuy Orthopaedics, Inc. each year. Unfortunately, not all educational grants that are submitted for consideration can be funded.

DePuy Orthopaedics, Inc. abides by rules developed by several regulatory and policy-making organizations. These rules provide guidance on several parameters. For example:

  • Grants should not take into account the volume or value of purchases made by, or anticipated from, a potential grant recipient;
  • Accredited educational activities should be independent and without influence from commercial supporters;
  • Educational grants may only be provided to recognized institutions, organizations, or societies; no funding may be provided by industry directly to an individual or medical practice;
  • Presentations must give a balanced view of therapeutic options and not a specific proprietary business interest (product) of a commercial sponsor; and
  • Any gift items provided to participating practitioners must provide educational value to the patient or healthcare professional.

DePuy Orthopaedics, Inc. uses established policies to evaluate each submission on its own merits. Funds are not provided as "unrestricted educational grants," which implies that recipients may use the financial support for a purpose other than what was originally intended. Although DePuy Orthopaedics, Inc. only provides restricted educational grants, it is assumed that program content is developed in an independent manner by the requestor. It is expected that a provider should develop accredited medical education activities without interference, direct or nuanced, from a commercial supporter.

To ensure that the purpose of the educational activity is clearly understood, all grant requests include several key components to be provided within the grant application when submitting a grant request to our organization.

Each grant request submission is evaluated on four common components:

  • The needs assessment documenting why the activity is necessary and how the proposed activity will address the educational need or gap
  • A proposed or final agenda and/or brochure
  • A detailed budget outlining how the funds will be utilized
  • A statement of accreditation and/or tax exempt status

Unfortunately, educational grants may be denied for a variety of reasons. The primary criterion used by reviewers is that there must be a bona fide educational purpose that should result in improved patient care.

Examples of reasons for denial of educational grants may include:

  • Vague or incomplete grant applications
  • Requests that appear to promote a medical practice or office
  • Support for educational activities that are outside the therapeutic scope of legitimate scientific or clinical interests of the manufacturer
  • Funds to offset travel costs of attendees at an educational activity, other than a qualifying resident or fellow in training
  • Grants to specifically promote an individual product
  • Activities that include topics in a non-accredited environment that are designed to encourage unapproved uses of products
  • Events that include a social activity or entertainment that overshadow the educational activity
  • Requests that stipulate support is required in order to maintain access to health facilities, maintaining existing business relationships, or other quid pro quo
  • All or parts of the proposed budget submitted by the requesting organization exceed fair market values (i.e., faculty honoraria, venue costs, or administrative fees)
  • Limited funds available in DePuy Orthopaedics, Inc.'s educational budget
  • Recent funding of similar educational activity

DePuy Orthopaedics, Inc. is proud to assist with the educational needs of health professionals through educational grants. We do so with intent to place the health and welfare of the patient ahead of economic self-interest.

 

 

Grants
Grants

 

More information about reporting of grants and contributions can be found at www.jnj.com

Transparency

Grants
Grants

 

DePuy Spine, Inc is committed to Our Credo, which guides us to provide high quality products and services to health care professionals and patients and to support the communities in which we work and live.

We recognize that medical science evolves rapidly with new information becoming available constantly. As part of the health care system, we also understand the need to support health care professionals in their pursuit of the most current education to provide the best patient care possible. There is further need to support patients, caregivers, and communities to ensure that they have the information and products required to live healthy, quality, and productive lives. As such, we are proud to have the opportunity to support educational programs and community programs through educational grants and charitable contributions, respectively.

We hold ourselves accountable to the highest standards to ensure that we are providing educational grants and charitable contributions in an appropriate manner. There are a number of policies and guidance documents from various external regulatory and policy-making organizations that form the basis for the development of our company's guiding principles used to evaluate grant and charitable request submissions.

Our primary focus is making life-changing, long-term differences in human health and disease management for those who may be helped by the products and services we provide. The purpose of our disclosure of supported educational grants and charitable contributions is to demonstrate our ongoing commitment to this endeavor. It is our hope that this disclosure will help the general public to better understand the nature and volume of programs that we support in the interest of advancing patient care and supporting local communities.

 

Educational Grants Process

DePuy Spine, Inc understands the need to comprehend all aspects of disease management and treatment and that both health care professionals and patients benefit from a wide variety of learning formats that employ generally accepted adult learning techniques.

DePuy Spine, Inc is proud to be able to provide grants to support educational activities and programs that help health care professionals enhance the care of their patients. We prioritize support in areas of scientific interest to the company that are intended to contribute to improvement in health care provider knowledge.

Our organization follows a defined and specific process to ensure that our procedures for making educational grants are in agreement with appropriate guidelines and policies. The guidance we use to evaluate our support of various educational programs is based on recognized standards.

  • Educational grants may be given to support bona fide educational activities directed toward health care professionals or patients and may include funding for accredited/certified continuing education, fellowships, and patient education.
  • Independent, company-supported educational activities are intended to benefit health care professionals and the patients they serve through the dissemination of information that contributes to the practice of medicine.
  • DePuy Spine, Inc does not control or influence the content of programs or the selection of the speakers, authors, or faculty planners. This guideline applies equally to all educational activities involving any health care professional, or customer who is in a position to influence the purchase of DePuy Spine, Inc products.

DePuy Spine, Inc does not provide "unrestricted educational grants" and grant funds must be used for the purpose defined within the original request. Each grant request is evaluated for completeness based on four basic components:

  1. An assessment documenting why the education is necessary
  2. An agenda or brochure describing the schedule of events
  3. A detailed budget identifying all sources of funding and how grant funds will be used
  4. Evidence of accreditation to provide continuing education credit and/or tax exempt status

Educational grants must be provided in accordance with the policies and procedures of Guidance Documents and with the U.S. Food and Drug Administration's Guidance on Industry-Supported Scientific and Educational Activities. They must also be consistent with the Accreditation Council for Continuing Medical Education Standards for Commercial Support (www.accme.org) ("ACCME Standards"), the American Medical Association Ethical Guidelines for Gifts to Physicians from Industry (www.ama-assn.org) ("AMA Guidelines"), the Pharmaceutical Research and Manufacturers of America Code on Interactions with Health care Professionals (www.phrma.org) ("PhRMA Code"), the AdvaMed Code of Ethics for Interactions with Health Care Professionals (www.advamed.org) ("AdvaMed Code") and/or other relevant industry standards.

DePuy Spine, Inc's Medical Affairs, Scientific Affairs, or other relevant departments have responsibility for the monitoring and recordkeeping of independent educational programs supported by DePuy Spine, Inc, including budget, staff and interactions with educational providers. In addition, DePuy Spine, Inc has:

  • Written policies and procedures relating to the submission, review and approval of grant requests and interactions with educational providers, so as to comply with applicable requirements of the guidelines mentioned above;
  • An internal, multidisciplinary review process for evaluation of educational grant requests which includes our Medical Education, Medical Affairs/Clinical Research, Health Care Compliance, Regulatory Affairs and Law departments, as necessary;
  • Appropriate measures to ensure that support of educational programs are scientifically and clinically justified, and the program is not intended to be promotional in nature. DePuy Spine, Inc may consider the following factors:
    • The demonstrated scientific and clinical need for the program;
    • Whether the proposed program is sponsored solely by DePuy Spine, Inc or if our funding represents a significant proportion of the program budget;
    • The grant requestor's history, and whether prior educational activities appeared to be conducted in an independent and unbiased manner and not influenced by support from industry sponsors.

 

Frequently Asked Questions

1. Why is the grant information being disclosed?

DePuy Spine, Inc is proud to have the privilege of providing educational grants to support independent educational activities, which are intended to contribute to better patient care. We believe that being transparent with this information is the appropriate action to demonstrate our commitment to providing the highest quality health care products and services, including support for medical education.

2. What grant information is being disclosed?

Beginning in the first quarter of 2009, DePuy Spine, Inc is providing the:

  • Name, city and state of the accrediting organization
  • Co-sponsor to whom the funds were paid, if applicable, and their city and state
  • Title of the educational activity
  • Amount of the payment
  • Date the educational activity will be initiated

3. What types of grants does DePuy Spine, Inc support?

  • Accredited Continuing Education: Educational programs for health care providers such as physicians, nurses, and/or pharmacists that provide continuing education credits.
  • Non-Accredited Professional Educational Activities: Educational programs for health care providers such as physicians, nurses, and pharmacists that do not provide continuing education credits. As a condition for funding, to the extent DePuy Spine, Inc products are discussed as part of such funded activities, DePuy Spine, Inc requires that such discussion be done in a manner consistent with the FDA approved labeling.
  • Patient Education: Printed/online educational materials and/or live educational events produced for people living with a particular disease or condition.
  • Fellowships: Support for bona fide fellowship programs at teaching institutions, medical societies and cooperative groups. We may also support travel scholarships for fellows, residents or health care providers in training to attend relevant major medical or scientific conferences for the purpose of education. All support is in agreement with the AMA Council on Ethical and Judicial Affairs Gifts to Physicians from Industry.

4. Who is the "grant requestor(s)"?

This is the organization requesting the independent educational grant from DePuy Spine, Inc and is typically an accredited/educational provider or similar organization responsible for designing and conducting an educational activity. The accredited/educational provider is the organization that signs the letter of agreement/contract with DePuy Spine, Inc and has ownership of the educational activity, controlling all aspects of the activity/program. Individual health care professionals or private health care professional practices are not eligible to receive grant funding.

5. Who decides the name/title of an educational activity?

The grant requestor and/or accredited continuing education provider is in complete control of all aspects of their educational activity including the title, scope of activity, faculty and audience selection, content, distribution and evaluation of the program. For posting purposes, the title of the education activity is obtained from the information provided with the grant submission.

6. What is a co-sponsor?

To be consistent with accepted industry standards (Accreditation Council for Continuing Medical Education, American Nurses Credentialing Center, and American College of Physician Executives), a continuing education provider may specify a co-sponsor in the letter of agreement. This does not include organizations retained by the provider in a subcontracting relationship that supply administrative or logistical services.

7. How is the total amount of the grant determined and distributed?

The total amount approved for funding is based on the grant request and the grant committee's funding decision. This may be full or partial funding and can be of an equal or lesser amount than requested in the grant application. This amount is specified in the letter of agreement/contract.

The disclosure report posted by DePuy Spine, Inc is limited to the funding we provided and does not include or address funding secured by the grant requesting organization from sources other than DePuy Spine, Inc. The accredited/educational provider has complete control over the distribution of funds received from DePuy Spine, Inc and the choice of co-sponsor(s).

8. What should one be aware of to further understand how the funding amount is being disclosed on our Web site?

Every grant request received undergoes a thorough review, which follows a well-defined process to ensure that appropriate funding is made according to accepted standards (i.e., U.S. Food and Drug Administration, Accreditation Council for Continuing Medical Education, Office of Inspector General, AdvaMed, and Pharmaceutical Research and Manufacturers of America) and company policies. A grant can only be approved for funding after it has undergone a rigorous review. The funding amount may be divided into partial payments that are stated in the letter of agreement/contract between the accredited/educational provider and DePuy Spine, Inc.

To ensure accurate reporting of funds disbursed, DePuy Spine, Inc is disclosing all payments to an accredited/educational provider within a defined fiscal quarter. These financial disclosures may not include grants made by companies recently acquired by DePuy Spine, Inc prior to the acquisition. Available records from such companies will be reviewed and evaluated, and applicable grant information will be posted within a reasonable period following acquisition.

9. What types of information are not reflected by the funding amounts we have disclosed?

The payment information posted on this site does not itemize the amount of funds the grant requestor may pay to third parties as "pass-through" expenses associated with building health care provider awareness of the educational activity and conducting the event. Typical pass-through expenses may include: fees (e.g., accreditation/certification, fees CE certificates, sub-contractors, medical societies, etc.), administrative costs (e.g., printing, postage, etc.), logistical support (e.g., room rental, audiovisual equipment rental, etc.), faculty honorarium and travel expenses, and other expenses.

10. Why might some funds appear to have been reported for the same amount across multiple quarters?

All reporting is based on actual payments made, not on total dollar amounts approved for each grant request. There may be certain situations where grant requests are approved with installment payments of equal or similar value spread over time. Usually these will occur when more complicated educational activities with multiple components are approved. Payments are disbursed upon completion of project milestones that demonstrate the activity is proceeding as originally proposed, as defined by the accredited provider/educational sponsor.

11. Are the volume of requests and the number of approvals generally consistent over the course of a calendar year?

The number of grant requests DePuy Spine, Inc receives varies throughout the year. The quantity, timing, and nature of requests are determined by the needs of accredited providers/educational sponsors submitting proposals to DePuy Spine, Inc. In addition, changes in the availability of DePuy Spine, Inc funds affect the volume and dollars available for grants.

12. What is the difference between a charitable contribution and an educational grant?

Educational grants are provided for bona fide educational activities and fall into one of the following categories:

  • Accredited Continuing Education: Educational programs for health care providers such as physicians, nurses, and/or pharmacists that provide continuing education credits.
  • Non-Accredited Professional Educational Activities: Educational programs for health care providers such as physicians, nurses, and pharmacists that do not provide continuing education credits. As a condition for funding, to the extent DePuy Spine, Inc products are discussed as part of such funded activities, DePuy Spine, Inc requires that such discussion be done in a manner consistent with the FDA approved labeling.
  • Patient Education: Printed/online educational materials and/or live educational events produced for people living with a particular disease or condition.
  • Fellowships: Support for bona fide fellowship programs at teaching institutions, medical societies and cooperative groups. We may also support travel scholarships for fellows, residents or health care providers in training to attend relevant major medical or scientific conferences for the purpose of education. All support is in agreement with the AMA Council on Ethical and Judicial Affairs Gifts to Physicians from Industry.

Charitable contributions describe donation requests that are used for purposes other than health care professional education initiatives. Charitable contributions may be cash or product donations.

  • A cash charitable contribution is a financial donation that is philanthropic in nature and provided to a nonprofit organization to support a specific community-based (or regional/national) program, project, or event (e.g., a cash donation at a fund raising event).
  • A product donation is provided through specific product giving programs to non-government organizations generally responding to disasters, medical relief efforts and basic health care needs in under-served communities.

13. How are programs that are jointly supported by DePuy Spine, Inc and another business reported?

As each business is a separate legal entity, the individual company that signs the letter of agreement and provides the funds directly to the requesting organization reports programs.

14. How is the reporting period for funding determined?

All reported funding is based on DePuy Spine, Inc's financial calendar. In general, grants are reported based on financial quarters, which are 13 weeks in length. Although they closely resemble calendar quarters, there may be occasions where the fiscal quarter does not end on the last day of the calendar month. If the financial calendar ends earlier than the end of the month, any activity from the next day forward would be reported with the next quarterly reporting period.

Why might one see duplicate payments reported in different quarters on this Web site?

Rarely, there may be a duplicated payment reported in a different time period if the requesting organization reports a lost check.

15. What happens when the grant recipient does not require, or use, all of the funds originally specified for an activity?

An educational provider/sponsor may reconcile their budget following an activity and find that they have unused funds remaining. As established in the written agreement and in accordance with our policy, DePuy Spine, Inc requires that unused funds already disbursed to the educational provider/sponsor be returned to our organization. DePuy Spine, Inc is also reporting any unused funds received from an accredited provider/educational sponsor as a lump sum in the quarter they are returned.

For the purposes of accuracy, DePuy Spine, Inc is reporting the actual funds disbursed to a grant applicant and, if applicable, the educational partners as specified in the written agreement. Should the educational activity not require all of the funds originally specified in the agreement, unused funds would not be disbursed.

 

Charitable Contributions Process Statement and FAQs

"We are responsible to the communities in which we live and work and to the world community as well. We must be good citizens - support good works and charities and bear our fair share of taxes. We must encourage civic improvements and better health and education. We must maintain in good order the property we are privileged to use protecting the environment and natural resources."

---Our Credo

A charitable contribution includes cash or product donations. A cash charitable contribution is a financial donation that is philanthropic in nature and provided to a non-profit organization to support a specific community-based (or regional/national) program, project, or event. A product donation is provided through specific product giving programs to non-government organizations generally responding to disasters, medical relief efforts and basic health care needs in under-served communities.

All requests are reviewed by a multidisciplinary committee, which may include Medical Affairs, Health Care Compliance, Public Affairs, Human Resources, and Legal, as necessary. Recipients must be tax-exempt organizations with an appropriate federal tax-exempt status. Requests should include the organization's mission statement, IRS tax status, project/event description, description of how the funds will be used, project budget (if applicable) and annual operating budget (if applicable).

The following types of requests are generally not eligible for charitable contributions:

  • Organizations that do not have a valid federal tax-exempt status
  • Scholarships to individuals
  • Direct contributions to individuals or physician practices
  • Loans
  • Trips or tours
  • Endowments of any kind
  • Sectarian and religious organizations that do not serve the general public on a nondenominational basis
  • Capital requests (building funds, endowments, multi-year commitments)
  • Political, fraternal or athletic groups

Product contributions must be used in the manner defined below:

  • Product contributions will only be placed with licensed medical and health care professionals;
  • Product contributions cannot be transferred in exchange for money, other property or services;
  • Product contributions cannot be used for research, experimental, or demonstration purposes;
  • Product contributions cannot be billed to any third party payor (public or private); and
  • For purposes of disclosure and reporting, product contributions are valued at the Company's list price.

 

Charitable Contributions FAQs

1. Why is charitable contribution information being disclosed?

DePuy Spine, Inc is proud to have the privilege of providing charitable contributions to various community organizations. We believe that being transparent with this information is the appropriate action to demonstrate our commitment to providing the highest quality health care products and services.

2. What charitable contribution information is being disclosed?

DePuy Spine, Inc is providing the name of the requestor, the city/state where the requesting organization resides, the title of the activity, the amount of the contribution, and the type of contribution (cash or product). Payments made by the company on behalf of its employees , such as payroll deductions for donations to the United Way, are generally excluded from the company’s Contributions report.

3. How is the total amount of the charitable contribution determined and distributed?

The amount approved for funding is a result of the charitable contribution review process. Funding amounts may be based on project/event budgets, fair market value, organizational geographic scope, and merits of the request. This may be of an equal or lesser amount than requested in the application. The organization has complete control over the distribution of funds received from DePuy Spine, Inc .

4. What is the difference between a charitable contribution and an educational grant?

An Educational Grant falls into one of the following categories:

  • Accredited Continuing Education: Educational programs for health care providers such as physicians, nurses, and/or pharmacists that provide continuing education credits.
  • Non-Accredited Professional Educational Activities: Educational programs for health care providers such as physicians, nurses, and pharmacists that do not provide continuing education credits. As a condition for funding, to the extent DePuy Spine, Inc products are discussed as part of such funded activities, DePuy Spine, Inc requires that such discussion be done in a manner consistent with the FDA approved labeling.
  • Fellowships: Support for bona fide fellowship programs at teaching institutions, medical societies and cooperative groups. We may also support travel scholarships for fellows, residents or health care providers in training to attend relevant major medical or scientific conferences for the purpose of education. All support is in agreement with the AMA Council on Ethical and Judicial Affairs Gifts to Physicians from Industry.
  • Patient Education: Printed/online educational materials and/or live educational events produced for people living with a particular disease or condition.

Charitable contributions describe donation requests that are used for purposes other than health care professional education initiatives. Charitable contributions may be cash or product donations.

  • A cash charitable contribution is a financial donation that is philanthropic in nature and provided to a nonprofit organization to support a specific community-based (or regional/national) program, project, or event. As noted above, employee payroll deductions remitted by the company to a charitable organization are not reported as a contribution by the company.
  • A product donation is provided through specific product giving programs to non-government organizations generally responding to disasters, medical relief efforts and basic health care needs in under-served communities.

5. How does the company handle expenses that are part of a charitable contribution for which DePuy Spine, Inc receives some benefit?

DePuy Spine, Inc requires organizations to complete an Omnibus Budget Reconciliation Act of 1993 (OBRA) form. This form documents the amount of the contribution that can truly be considered charitable versus a portion of the amount that represents payments for expenses by the organization for which DePuy Spine, Inc receives some benefit (i.e., business expenses). Please note that some of these nominal business expenses associated with some charitable contributions may be included in this report.

6. How are programs that are jointly supported by DePuy Spine, Inc and another business reported?

As each company is a separate legal entity, the individual company that provides the funds directly to the requesting organization is responsible for reporting the donation.

These financial disclosures may not include grants made by companies recently acquired by DePuy Spine, Inc prior to the acquisition. Available records from such companies will be reviewed and evaluated, and applicable grant information will be posted within a reasonable period following acquisition.

7. Are the volume of requests and the number of approvals generally consistent over the course of a calendar year?

The number of contribution requests DePuy Spine, Inc receives varies throughout the year. The quantity, timing, and nature of requests are determined by the needs of the organizations submitting proposals to DePuy Spine, Inc, which is determined by the requestors' needs. In addition, changes in the availability of DePuy Spine, Inc funds affect the volume and dollars available for contributions.

8. How is the reporting period for funding determined?

All reported funding is based on DePuy Spine, Inc 's financial calendar. In general, grants are reported based on financial quarters. Financial quarters are 13 weeks in length and, although they closely resemble calendar quarters, there may be occasions where the fiscal quarter does not end on the last day of the calendar month. If the financial calendar ends earlier than the end of the month, any activity from the next day forward would be reported with the next quarterly reporting period.

9. Why might one see duplicate payments reported in different quarters on this Web site?

Rarely, there may be a duplicated payment reported in a different time period if the requesting organization reports a lost check.

 

Criteria for Grant Denials

Educational grant requests are reviewed through a rigorous review process. Processes have been designed and implemented so that no single individual may authorize educational grant support alone. In accordance with government guidance, it is inappropriate for individuals responsible for sales and marketing to be involved in educational grant-making decisions. Grant reviewers typically include personnel from Medical Affairs, Medical Education, Regulatory Affairs, Health Care Compliance, and/or Legal departments, as necessary.

Numerous educational grant requests can be received by DePuy Spine, Inc each year. Unfortunately, not all educational grants that are submitted for consideration can be funded.

DePuy Spine, Inc abides by rules developed by several regulatory and policy-making organizations. These rules provide guidance on several parameters. For example:

  • Grants should not take into account the volume or value of purchases made by, or anticipated from, a potential grant recipient;
  • Accredited educational activities should be independent and without influence from commercial supporters;
  • Educational grants may only be provided to recognized institutions, organizations, or societies; no funding may be provided by industry directly to an individual or medical practice;
  • Presentations must give a balanced view of therapeutic options and not a specific proprietary business interest (product) of a commercial sponsor; and
  • Any gift items provided to participating practitioners must provide educational value to the patient or healthcare professional.

DePuy Spine, Inc uses established policies to evaluate each submission on its own merits. Funds are not provided as "unrestricted educational grants," which implies that recipients may use the financial support for a purpose other than what was originally intended. Although DePuy Spine, Inc only provides restricted educational grants, it is assumed that program content is developed in an independent manner by the requestor. It is expected that a provider should develop accredited medical education activities without interference, direct or nuanced, from a commercial supporter.

To ensure that the purpose of the educational activity is clearly understood, all grant requests include several key components to be provided within the grant application when submitting a grant request to our organization.

Each grant request submission is evaluated on four common components:

  • The needs assessment documenting why the activity is necessary and how the proposed activity will address the educational need or gap
  • A proposed or final agenda and/or brochure
  • A detailed budget outlining how the funds will be utilized
  • A statement of accreditation and/or tax exempt status

Unfortunately, educational grants may be denied for a variety of reasons. The primary criterion used by reviewers is that there must be a bona fide educational purpose that should result in improved patient care.

Examples of reasons for denial of educational grants may include:

  • Vague or incomplete grant applications
  • Requests that appear to promote a medical practice or office
  • Support for educational activities that are outside the therapeutic scope of legitimate scientific or clinical interests of the manufacturer
  • Funds to offset travel costs of attendees at an educational activity, other than a qualifying resident or fellow in training
  • Grants to specifically promote an individual product
  • Activities that include topics in a non-accredited environment that are designed to encourage unapproved uses of products
  • Events that include a social activity or entertainment that overshadow the educational activity
  • Requests that stipulate support is required in order to maintain access to health facilities, maintaining existing business relationships, or other quid pro quo
  • All or parts of the proposed budget submitted by the requesting organization exceed fair market values (i.e., faculty honoraria, venue costs, or administrative fees)
  • Limited funds available in DePuy Spine, Inc's educational budget
  • Recent funding of similar educational activity

DePuy Spine, Inc is proud to assist with the educational needs of health professionals through educational grants. We do so with intent to place the health and welfare of the patient ahead of economic self-interest.

 

Grants
Grants

More information about reporting of grants and contributions can be found at www.jnj.com

 

Transparency

Grants
Grants

 

DePuy Mitek is committed to Our Credo, which guides us to provide high quality products and services to health care professionals and patients and to support the communities in which we work and live.

We recognize that medical science evolves rapidly with new information becoming available constantly. As part of the health care system, we also understand the need to support health care professionals in their pursuit of the most current education to provide the best patient care possible. There is further need to support patients, caregivers, and communities to ensure that they have the information and products required to live healthy, quality, and productive lives. As such, we are proud to have the opportunity to support educational programs and community programs through educational grants and charitable contributions, respectively.

We hold ourselves accountable to the highest standards to ensure that we are providing educational grants and charitable contributions in an appropriate manner. There are a number of policies and guidance documents from various external regulatory and policy-making organizations that form the basis for the development of our company's guiding principles used to evaluate grant and charitable request submissions.

Our primary focus is making life-changing, long-term differences in human health and disease management for those who may be helped by the products and services we provide. The purpose of our disclosure of supported educational grants and charitable contributions is to demonstrate our ongoing commitment to this endeavor. It is our hope that this disclosure will help the general public to better understand the nature and volume of programs that we support in the interest of advancing patient care and supporting local communities.

 

Educational Grants Process

DePuy Mitek understands the need to comprehend all aspects of disease management and treatment and that both health care professionals and patients benefit from a wide variety of learning formats that employ generally accepted adult learning techniques.

DePuy Mitek is proud to be able to provide grants to support educational activities and programs that help health care professionals enhance the care of their patients. We prioritize support in areas of scientific interest to the company that are intended to contribute to improvement in health care provider knowledge.

Our organization follows a defined and specific process to ensure that our procedures for making educational grants are in agreement with appropriate guidelines and policies. The guidance we use to evaluate our support of various educational programs is based on recognized standards.

  • Educational grants may be given to support bona fide educational activities directed toward health care professionals or patients and may include funding for accredited/certified continuing education, fellowships, and patient education.
  • Independent, company-supported educational activities are intended to benefit health care professionals and the patients they serve through the dissemination of information that contributes to the practice of medicine.
  • DePuy Mitek does not control or influence the content of programs or the selection of the speakers, authors, or faculty planners. This guideline applies equally to all educational activities involving any health care professional, or customer who is in a position to influence the purchase of DePuy Mitek products.

DePuy Mitek does not provide "unrestricted educational grants" and grant funds must be used for the purpose defined within the original request. Each grant request is evaluated for completeness based on four basic components:

  1. An assessment documenting why the education is necessary
  2. An agenda or brochure describing the schedule of events
  3. A detailed budget identifying all sources of funding and how grant funds will be used
  4. Evidence of accreditation to provide continuing education credit and/or tax exempt status

Educational grants must be provided in accordance with the policies and procedures of Guidance Documents and with the U.S. Food and Drug Administration's Guidance on Industry-Supported Scientific and Educational Activities. They must also be consistent with the Accreditation Council for Continuing Medical Education Standards for Commercial Support (www.accme.org) ("ACCME Standards"), the American Medical Association Ethical Guidelines for Gifts to Physicians from Industry (www.ama-assn.org) ("AMA Guidelines"), the Pharmaceutical Research and Manufacturers of America Code on Interactions with Health care Professionals (www.phrma.org) ("PhRMA Code"), the AdvaMed Code of Ethics for Interactions with Health Care Professionals (www.advamed.org) ("AdvaMed Code") and/or other relevant industry standards.

DePuy Mitek's Medical Affairs, Scientific Affairs, or other relevant departments have responsibility for the monitoring and recordkeeping of independent educational programs supported by DePuy Mitek, including budget, staff and interactions with educational providers. In addition, DePuy Mitek has:

Written policies and procedures relating to the submission, review and approval of grant requests and interactions with educational providers, so as to comply with applicable requirements of the guidelines mentioned above;

  • An internal, multidisciplinary review process for evaluation of educational grant requests which includes our Medical Education, Medical Affairs/Clinical Research, Health Care Compliance, Regulatory Affairs and Law departments, as necessary;
  • Appropriate measures to ensure that support of educational programs are scientifically and clinically justified, and the program is not intended to be promotional in nature. DePuy Mitek may consider the following factors:
    • The demonstrated scientific and clinical need for the program;
    • Whether the proposed program is sponsored solely by DePuy Mitek or if our funding represents a significant proportion of the program budget;
    • The grant requestor's history, and whether prior educational activities appeared to be conducted in an independent and unbiased manner and not influenced by support from industry sponsors.

 

Frequently Asked Questions

1. Why is the grant information being disclosed?

DePuy Mitek is proud to have the privilege of providing educational grants to support independent educational activities, which are intended to contribute to better patient care. We believe that being transparent with this information is the appropriate action to demonstrate our commitment to providing the highest quality health care products and services, including support for medical education.

2. What grant information is being disclosed?

Beginning in the first quarter of 2009, DePuy Mitek is providing the:

  • Name, city and state of the accrediting organization
  • Co-sponsor to whom the funds were paid, if applicable, and their city and state
  • Title of the educational activity
  • Amount of the payment
  • Date the educational activity will be initiated

3. What types of grants does DePuy Mitek support?

  • Accredited Continuing Education: Educational programs for health care providers such as physicians, nurses, and/or pharmacists that provide continuing education credits.
  • Non-Accredited Professional Educational Activities: Educational programs for health care providers such as physicians, nurses, and pharmacists that do not provide continuing education credits. As a condition for funding, to the extent DePuy Mitek products are discussed as part of such funded activities, DePuy Mitek requires that such discussion be done in a manner consistent with the FDA approved labeling.
  • Patient Education: Printed/online educational materials and/or live educational events produced for people living with a particular disease or condition.
  • Fellowships: Support for bona fide fellowship programs at teaching institutions, medical societies and cooperative groups. We may also support travel scholarships for fellows, residents or health care providers in training to attend relevant major medical or scientific conferences for the purpose of education. All support is in agreement with the AMA Council on Ethical and Judicial Affairs Gifts to Physicians from Industry.

4. Who is the "grant requestor(s)"?

This is the organization requesting the independent educational grant from DePuy Mitek and is typically an accredited/educational provider or similar organization responsible for designing and conducting an educational activity. The accredited/educational provider is the organization that signs the letter of agreement/contract with DePuy Mitek and has ownership of the educational activity, controlling all aspects of the activity/program. Individual health care professionals or private health care professional practices are not eligible to receive grant funding.

5. Who decides the name/title of an educational activity?

The grant requestor and/or accredited continuing education provider is in complete control of all aspects of their educational activity including the title, scope of activity, faculty and audience selection, content, distribution and evaluation of the program. For posting purposes, the title of the education activity is obtained from the information provided with the grant submission.

6. What is a co-sponsor?

To be consistent with accepted industry standards (Accreditation Council for Continuing Medical Education, American Nurses Credentialing Center, and American College of Physician Executives), a continuing education provider may specify a co-sponsor in the letter of agreement. This does not include organizations retained by the provider in a subcontracting relationship that supply administrative or logistical services.

7. How is the total amount of the grant determined and distributed?

The total amount approved for funding is based on the grant request and the grant committee's funding decision. This may be full or partial funding and can be of an equal or lesser amount than requested in the grant application. This amount is specified in the letter of agreement/contract.

The disclosure report posted by DePuy Mitek is limited to the funding we provided and does not include or address funding secured by the grant requesting organization from sources other than DePuy Mitek. The accredited/educational provider has complete control over the distribution of funds received from DePuy Mitek and the choice of co-sponsor(s).

8. What should one be aware of to further understand how the funding amount is being disclosed on our Web site?

Every grant request received undergoes a thorough review, which follows a well-defined process to ensure that appropriate funding is made according to accepted standards (i.e., U.S. Food and Drug Administration, Accreditation Council for Continuing Medical Education, Office of Inspector General, AdvaMed, and Pharmaceutical Research and Manufacturers of America) and company policies. A grant can only be approved for funding after it has undergone a rigorous review. The funding amount may be divided into partial payments that are stated in the letter of agreement/contract between the accredited/educational provider and DePuy Mitek.

To ensure accurate reporting of funds disbursed, DePuy Mitek is disclosing all payments to an accredited/educational provider within a defined fiscal quarter. These financial disclosures may not include grants made by companies recently acquired by DePuy Mitek prior to the acquisition. Available records from such companies will be reviewed and evaluated, and applicable grant information will be posted within a reasonable period following acquisition.

9. What types of information are not reflected by the funding amounts we have disclosed?

The payment information posted on this site does not itemize the amount of funds the grant requestor may pay to third parties as "pass-through" expenses associated with building health care provider awareness of the educational activity and conducting the event. Typical pass-through expenses may include: fees (e.g., accreditation/certification, fees CE certificates, sub-contractors, medical societies, etc.), administrative costs (e.g., printing, postage, etc.), logistical support (e.g., room rental, audiovisual equipment rental, etc.), faculty honorarium and travel expenses, and other expenses.

10. Why might some funds appear to have been reported for the same amount across multiple quarters?

All reporting is based on actual payments made, not on total dollar amounts approved for each grant request. There may be certain situations where grant requests are approved with installment payments of equal or similar value spread over time. Usually these will occur when more complicated educational activities with multiple components are approved. Payments are disbursed upon completion of project milestones that demonstrate the activity is proceeding as originally proposed, as defined by the accredited provider/educational sponsor.

11. Are the volume of requests and the number of approvals generally consistent over the course of a calendar year?

The number of grant requests DePuy Mitek receives varies throughout the year. The quantity, timing, and nature of requests are determined by the needs of accredited providers/educational sponsors submitting proposals to DePuy Mitek. In addition, changes in the availability of DePuy Mitek funds affect the volume and dollars available for grants.

12. What is the difference between a charitable contribution and an educational grant?

Educational grants are provided for bona fide educational activities and fall into one of the following categories:

  • Accredited Continuing Education: Educational programs for health care providers such as physicians, nurses, and/or pharmacists that provide continuing education credits.
  • Non-Accredited Professional Educational Activities: Educational programs for health care providers such as physicians, nurses, and pharmacists that do not provide continuing education credits. As a condition for funding, to the extent DePuy Mitek products are discussed as part of such funded activities, DePuy Mitek requires that such discussion be done in a manner consistent with the FDA approved labeling.
  • Patient Education: Printed/online educational materials and/or live educational events produced for people living with a particular disease or condition.
  • Fellowships: Support for bona fide fellowship programs at teaching institutions, medical societies and cooperative groups. We may also support travel scholarships for fellows, residents or health care providers in training to attend relevant major medical or scientific conferences for the purpose of education. All support is in agreement with the AMA Council on Ethical and Judicial Affairs Gifts to Physicians from Industry.

Charitable contributions describe donation requests that are used for purposes other than health care professional education initiatives. Charitable contributions may be cash or product donations.

  • A cash charitable contribution is a financial donation that is philanthropic in nature and provided to a nonprofit organization to support a specific community-based (or regional/national) program, project, or event (e.g., a cash donation at a fund raising event).
  • A product donation is provided through specific product giving programs to non-government organizations generally responding to disasters, medical relief efforts and basic health care needs in under-served communities.

How are programs that are jointly supported by DePuy Mitek and another business reported?

As each business is a separate legal entity, the individual company that signs the letter of agreement and provides the funds directly to the requesting organization reports programs.

How is the reporting period for funding determined?

All reported funding is based on DePuy Mitek's financial calendar. In general, grants are reported based on financial quarters, which are 13 weeks in length. Although they closely resemble calendar quarters, there may be occasions where the fiscal quarter does not end on the last day of the calendar month. If the financial calendar ends earlier than the end of the month, any activity from the next day forward would be reported with the next quarterly reporting period.

Why might one see duplicate payments reported in different quarters on this Web site?

Rarely, there may be a duplicated payment reported in a different time period if the requesting organization reports a lost check.

What happens when the grant recipient does not require, or use, all of the funds originally specified for an activity?

An educational provider/sponsor may reconcile their budget following an activity and find that they have unused funds remaining. As established in the written agreement and in accordance with our policy, DePuy Mitek requires that unused funds already disbursed to the educational provider/sponsor be returned to our organization. DePuy Mitek is also reporting any unused funds received from an accredited provider/educational sponsor as a lump sum in the quarter they are returned.

For the purposes of accuracy, DePuy Mitek is reporting the actual funds disbursed to a grant applicant and, if applicable, the educational partners as specified in the written agreement. Should the educational activity not require all of the funds originally specified in the agreement, unused funds would not be disbursed.

 

Charitable Contributions Process Statement and FAQs

"We are responsible to the communities in which we live and work and to the world community as well. We must be good citizens - support good works and charities and bear our fair share of taxes. We must encourage civic improvements and better health and education. We must maintain in good order the property we are privileged to use protecting the environment and natural resources."

---Our Credo

A charitable contribution includes cash or product donations. A cash charitable contribution is a financial donation that is philanthropic in nature and provided to a non-profit organization to support a specific community-based (or regional/national) program, project, or event. A product donation is provided through specific product giving programs to non-government organizations generally responding to disasters, medical relief efforts and basic health care needs in under-served communities.

All requests are reviewed by a multidisciplinary committee, which may include Medical Affairs, Health Care Compliance, Public Affairs, Human Resources, and Legal, as necessary. Recipients must be tax-exempt organizations with an appropriate federal tax-exempt status. Requests should include the organization's mission statement, IRS tax status, project/event description, description of how the funds will be used, project budget (if applicable) and annual operating budget (if applicable).

The following types of requests are generally not eligible for charitable contributions:

  • Organizations that do not have a valid federal tax-exempt status
  • Scholarships to individuals
  • Direct contributions to individuals or physician practices
  • Loans
  • Trips or tours
  • Endowments of any kind
  • Sectarian and religious organizations that do not serve the general public on a nondenominational basis
  • Capital requests (building funds, endowments, multi-year commitments)
  • Political, fraternal or athletic groups

Product contributions must be used in the manner defined below:

  • Product contributions will only be placed with licensed medical and health care professionals;
  • Product contributions cannot be transferred in exchange for money, other property or services;
  • Product contributions cannot be used for research, experimental, or demonstration purposes;
  • Product contributions cannot be billed to any third party payor (public or private); and
  • For purposes of disclosure and reporting, product contributions are valued at the Company's list price.

 


Charitable Contributions FAQs

1. Why is charitable contribution information being disclosed?

DePuy Mitek is proud to have the privilege of providing charitable contributions to various community organizations. We believe that being transparent with this information is the appropriate action to demonstrate our commitment to providing the highest quality health care products and services.

2. What charitable contribution information is being disclosed?

DePuy Mitek is providing the name of the requestor, the city/state where the requesting organization resides, the title of the activity, the amount of the contribution, and the type of contribution (cash or product). Payments made by the company on behalf of its employees , such as payroll deductions for donations to the United Way, are generally excluded from the company’s Contributions report.

3. How is the total amount of the charitable contribution determined and distributed?

The amount approved for funding is a result of the charitable contribution review process. Funding amounts may be based on project/event budgets, fair market value, organizational geographic scope, and merits of the request. This may be of an equal or lesser amount than requested in the application. The organization has complete control over the distribution of funds received from DePuy Mitek .

4. What is the difference between a charitable contribution and an educational grant?

An Educational Grant falls into one of the following categories:

  • Accredited Continuing Education: Educational programs for health care providers such as physicians, nurses, and/or pharmacists that provide continuing education credits.
  • Non-Accredited Professional Educational Activities: Educational programs for health care providers such as physicians, nurses, and pharmacists that do not provide continuing education credits. As a condition for funding, to the extent DePuy Mitek products are discussed as part of such funded activities, DePuy Mitek requires that such discussion be done in a manner consistent with the FDA approved labeling.
  • Fellowships: Support for bona fide fellowship programs at teaching institutions, medical societies and cooperative groups. We may also support travel scholarships for fellows, residents or health care providers in training to attend relevant major medical or scientific conferences for the purpose of education. All support is in agreement with the AMA Council on Ethical and Judicial Affairs Gifts to Physicians from Industry.
  • Patient Education: Printed/online educational materials and/or live educational events produced for people living with a particular disease or condition.

Charitable contributions describe donation requests that are used for purposes other than health care professional education initiatives. Charitable contributions may be cash or product donations.

  • A cash charitable contribution is a financial donation that is philanthropic in nature and provided to a nonprofit organization to support a specific community-based (or regional/national) program, project, or event. As noted above, employee payroll deductions remitted by the company to a charitable organization are not reported as a contribution by the company.
  • A product donation is provided through specific product giving programs to non-government organizations generally responding to disasters, medical relief efforts and basic health care needs in under-served communities.

5. How does the company handle expenses that are part of a charitable contribution for which DePuy Mitek receives some benefit?

DePuy Mitek requires organizations to complete an Omnibus Budget Reconciliation Act of 1993 (OBRA) form. This form documents the amount of the contribution that can truly be considered charitable versus a portion of the amount that represents payments for expenses by the organization for which DePuy Mitek receives some benefit (i.e., business expenses). Please note that some of these nominal business expenses associated with some charitable contributions may be included in this report.

6. How are programs that are jointly supported by DePuy Mitek and another business reported?

As each company is a separate legal entity, the individual company that provides the funds directly to the requesting organization is responsible for reporting the donation.

These financial disclosures may not include grants made by companies recently acquired by DePuy Mitek prior to the acquisition. Available records from such companies will be reviewed and evaluated, and applicable grant information will be posted within a reasonable period following acquisition.

7. Are the volume of requests and the number of approvals generally consistent over the course of a calendar year?

The number of contribution requests DePuy Mitek receives varies throughout the year. The quantity, timing, and nature of requests are determined by the needs of the organizations submitting proposals to DePuy Mitek, which is determined by the requestors' needs. In addition, changes in the availability of DePuy Mitek funds affect the volume and dollars available for contributions.

8. How is the reporting period for funding determined?

All reported funding is based on DePuy Mitek 's financial calendar. In general, grants are reported based on financial quarters. Financial quarters are 13 weeks in length and, although they closely resemble calendar quarters, there may be occasions where the fiscal quarter does not end on the last day of the calendar month. If the financial calendar ends earlier than the end of the month, any activity from the next day forward would be reported with the next quarterly reporting period.

9. Why might one see duplicate payments reported in different quarters on this Web site?

Rarely, there may be a duplicated payment reported in a different time period if the requesting organization reports a lost check.

 

Criteria for Grant Denials

Educational grant requests are reviewed through a rigorous review process. Processes have been designed and implemented so that no single individual may authorize educational grant support alone. In accordance with government guidance, it is inappropriate for individuals responsible for sales and marketing to be involved in educational grant-making decisions. Grant reviewers typically include personnel from Medical Affairs, Medical Education, Regulatory Affairs, Health Care Compliance, and/or Legal departments, as necessary.

Numerous educational grant requests can be received by DePuy Mitek each year. Unfortunately, not all educational grants that are submitted for consideration can be funded.

DePuy Mitek abides by rules developed by several regulatory and policy-making organizations. These rules provide guidance on several parameters. For example:

  • Grants should not take into account the volume or value of purchases made by, or anticipated from, a potential grant recipient;
  • Accredited educational activities should be independent and without influence from commercial supporters;
  • Educational grants may only be provided to recognized institutions, organizations, or societies; no funding may be provided by industry directly to an individual or medical practice;
  • Presentations must give a balanced view of therapeutic options and not a specific proprietary business interest (product) of a commercial sponsor; and
  • Any gift items provided to participating practitioners must provide educational value to the patient or healthcare professional.

DePuy Mitek uses established policies to evaluate each submission on its own merits. Funds are not provided as "unrestricted educational grants," which implies that recipients may use the financial support for a purpose other than what was originally intended. Although DePuy Mitek only provides restricted educational grants, it is assumed that program content is developed in an independent manner by the requestor. It is expected that a provider should develop accredited medical education activities without interference, direct or nuanced, from a commercial supporter.

To ensure that the purpose of the educational activity is clearly understood, all grant requests include several key components to be provided within the grant application when submitting a grant request to our organization.

Each grant request submission is evaluated on four common components:

  • The needs assessment documenting why the activity is necessary and how the proposed activity will address the educational need or gap
  • A proposed or final agenda and/or brochure
  • A detailed budget outlining how the funds will be utilized
  • A statement of accreditation and/or tax exempt status

Unfortunately, educational grants may be denied for a variety of reasons. The primary criterion used by reviewers is that there must be a bona fide educational purpose that should result in improved patient care.

Examples of reasons for denial of educational grants may include:

  • Vague or incomplete grant applications
  • Requests that appear to promote a medical practice or office
  • Support for educational activities that are outside the therapeutic scope of legitimate scientific or clinical interests of the manufacturer
  • Funds to offset travel costs of attendees at an educational activity, other than a qualifying resident or fellow in training
  • Grants to specifically promote an individual product
  • Activities that include topics in a non-accredited environment that are designed to encourage unapproved uses of products
  • Events that include a social activity or entertainment that overshadow the educational activity
  • Requests that stipulate support is required in order to maintain access to health facilities, maintaining existing business relationships, or other quid pro quo
  • All or parts of the proposed budget submitted by the requesting organization exceed fair market values (i.e., faculty honoraria, venue costs, or administrative fees)
  • Limited funds available in DePuy Mitek's educational budget
  • Recent funding of similar educational activity

DePuy Mitek is proud to assist with the educational needs of health professionals through educational grants. We do so with intent to place the health and welfare of the patient ahead of economic self-interest.

 

Grants
Grants

More information about reporting of grants and contributions can be found at www.jnj.com.

Transparency

Grants
Grants

 

Codman is committed to Our Credo, which guides us to provide high quality products and services to health care professionals and patients and to support the communities in which we work and live.

We recognize that medical science evolves rapidly with new information becoming available constantly. As part of the health care system, we also understand the need to support health care professionals in their pursuit of the most current education to provide the best patient care possible. There is further need to support patients, caregivers, and communities to ensure that they have the information and products required to live healthy, quality, and productive lives. As such, we are proud to have the opportunity to support educational programs and community programs through educational grants and charitable contributions, respectively.

We hold ourselves accountable to the highest standards to ensure that we are providing educational grants and charitable contributions in an appropriate manner. There are a number of policies and guidance documents from various external regulatory and policy-making organizations that form the basis for the development of our company's guiding principles used to evaluate grant and charitable request submissions.

Our primary focus is making life-changing, long-term differences in human health and disease management for those who may be helped by the products and services we provide. The purpose of our disclosure of supported educational grants and charitable contributions is to demonstrate our ongoing commitment to this endeavor. It is our hope that this disclosure will help the general public to better understand the nature and volume of programs that we support in the interest of advancing patient care and supporting local communities.

 

Educational Grants Process

Codman understands the need to comprehend all aspects of disease management and treatment and that both health care professionals and patients benefit from a wide variety of learning formats that employ generally accepted adult learning techniques.

Codman is proud to be able to provide grants to support educational activities and programs that help health care professionals enhance the care of their patients. We prioritize support in areas of scientific interest to the company that are intended to contribute to improvement in health care provider knowledge.

Our organization follows a defined and specific process to ensure that our procedures for making educational grants are in agreement with appropriate guidelines and policies. The guidance we use to evaluate our support of various educational programs is based on recognized standards.

  • Educational grants may be given to support bona fide educational activities directed toward health care professionals or patients and may include funding for accredited/certified continuing education, fellowships, and patient education.
  • Independent, company-supported educational activities are intended to benefit health care professionals and the patients they serve through the dissemination of information that contributes to the practice of medicine.
  • Codman does not control or influence the content of programs or the selection of the speakers, authors, or faculty planners. This guideline applies equally to all educational activities involving any health care professional, or customer who is in a position to influence the purchase of Codman products.

Codman does not provide "unrestricted educational grants" and grant funds must be used for the purpose defined within the original request. Each grant request is evaluated for completeness based on four basic components:

  1. An assessment documenting why the education is necessary
  2. An agenda or brochure describing the schedule of events
  3. A detailed budget identifying all sources of funding and how grant funds will be used
  4. Evidence of accreditation to provide continuing education credit and/or tax exempt status

Educational grants must be provided in accordance with the policies and procedures of Guidance Documents and with the U.S. Food and Drug Administration's Guidance on Industry-Supported Scientific and Educational Activities. They must also be consistent with the Accreditation Council for Continuing Medical Education Standards for Commercial Support (www.accme.org) ("ACCME Standards"), the American Medical Association Ethical Guidelines for Gifts to Physicians from Industry (www.ama-assn.org) ("AMA Guidelines"), the Pharmaceutical Research and Manufacturers of America Code on Interactions with Health care Professionals (www.phrma.org) ("PhRMA Code"), the AdvaMed Code of Ethics for Interactions with Health Care Professionals (www.advamed.org) ("AdvaMed Code") and/or other relevant industry standards.

Codman's Medical Affairs, Scientific Affairs, or other relevant departments have responsibility for the monitoring and recordkeeping of independent educational programs supported by Codman, including budget, staff and interactions with educational providers. In addition, Codman has:

  • Written policies and procedures relating to the submission, review and approval of grant requests and interactions with educational providers, so as to comply with applicable requirements of the guidelines mentioned above;
  • An internal, multidisciplinary review process for evaluation of educational grant requests which includes our Medical Education, Medical Affairs/Clinical Research, Health Care Compliance, Regulatory Affairs and Law departments, as necessary;
  • Appropriate measures to ensure that support of educational programs are scientifically and clinically justified, and the program is not intended to be promotional in nature. Codman may consider the following factors:
  • The demonstrated scientific and clinical need for the program;
    • Whether the proposed program is sponsored solely by Codman or if our funding represents a significant proportion of the program budget;
    • The grant requestor's history, and whether prior educational activities appeared to be conducted in an independent and unbiased manner and not influenced by support from industry sponsors.

 

Frequently Asked Questions

1. Why is the grant information being disclosed?

Codman is proud to have the privilege of providing educational grants to support independent educational activities, which are intended to contribute to better patient care. We believe that being transparent with this information is the appropriate action to demonstrate our commitment to providing the highest quality health care products and services, including support for medical education.

2. What grant information is being disclosed?

Beginning in the first quarter of 2009, Codman is providing the:

  • Name, city and state of the accrediting organization
  • Co-sponsor to whom the funds were paid, if applicable, and their city and state
  • Title of the educational activity
  • Amount of the payment
  • Date the educational activity will be initiated

3. What types of grants does Codman support?

  • Accredited Continuing Education: Educational programs for health care providers such as physicians, nurses, and/or pharmacists that provide continuing education credits.
  • Non-Accredited Professional Educational Activities: Educational programs for health care providers such as physicians, nurses, and pharmacists that do not provide continuing education credits. As a condition for funding, to the extent Codman products are discussed as part of such funded activities, Codman requires that such discussion be done in a manner consistent with the FDA approved labeling.
  • Patient Education: Printed/online educational materials and/or live educational events produced for people living with a particular disease or condition.
  • Fellowships: Support for bona fide fellowship programs at teaching institutions, medical societies and cooperative groups. We may also support travel scholarships for fellows, residents or health care providers in training to attend relevant major medical or scientific conferences for the purpose of education. All support is in agreement with the AMA Council on Ethical and Judicial Affairs Gifts to Physicians from Industry.

4. Who is the "grant requestor(s)"?

This is the organization requesting the independent educational grant from Codman and is typically an accredited/educational provider or similar organization responsible for designing and conducting an educational activity. The accredited/educational provider is the organization that signs the letter of agreement/contract with Codman and has ownership of the educational activity, controlling all aspects of the activity/program. Individual health care professionals or private health care professional practices are not eligible to receive grant funding.

5. Who decides the name/title of an educational activity?

The grant requestor and/or accredited continuing education provider is in complete control of all aspects of their educational activity including the title, scope of activity, faculty and audience selection, content, distribution and evaluation of the program. For posting purposes, the title of the education activity is obtained from the information provided with the grant submission.

6. What is a co-sponsor?

To be consistent with accepted industry standards (Accreditation Council for Continuing Medical Education, American Nurses Credentialing Center, and American College of Physician Executives), a continuing education provider may specify a co-sponsor in the letter of agreement. This does not include organizations retained by the provider in a subcontracting relationship that supply administrative or logistical services.

7. How is the total amount of the grant determined and distributed?

The total amount approved for funding is based on the grant request and the grant committee's funding decision. This may be full or partial funding and can be of an equal or lesser amount than requested in the grant application. This amount is specified in the letter of agreement/contract.

The disclosure report posted by Codman is limited to the funding we provided and does not include or address funding secured by the grant requesting organization from sources other than Codman. The accredited/educational provider has complete control over the distribution of funds received from Codman and the choice of co-sponsor(s).

8. What should one be aware of to further understand how the funding amount is being disclosed on our Web site?

Every grant request received undergoes a thorough review, which follows a well-defined process to ensure that appropriate funding is made according to accepted standards (i.e., U.S. Food and Drug Administration, Accreditation Council for Continuing Medical Education, Office of Inspector General, AdvaMed, and Pharmaceutical Research and Manufacturers of America) and company policies. A grant can only be approved for funding after it has undergone a rigorous review. The funding amount may be divided into partial payments that are stated in the letter of agreement/contract between the accredited/educational provider and Codman.

To ensure accurate reporting of funds disbursed, Codman is disclosing all payments to an accredited/educational provider within a defined fiscal quarter. These financial disclosures may not include grants made by companies recently acquired by Codman prior to the acquisition. Available records from such companies will be reviewed and evaluated, and applicable grant information will be posted within a reasonable period following acquisition.

9. What types of information are not reflected by the funding amounts we have disclosed?

The payment information posted on this site does not itemize the amount of funds the grant requestor may pay to third parties as "pass-through" expenses associated with building health care provider awareness of the educational activity and conducting the event. Typical pass-through expenses may include: fees (e.g., accreditation/certification, fees CE certificates, sub-contractors, medical societies, etc.), administrative costs (e.g., printing, postage, etc.), logistical support (e.g., room rental, audiovisual equipment rental, etc.), faculty honorarium and travel expenses, and other expenses.

10. Why might some funds appear to have been reported for the same amount across multiple quarters?

All reporting is based on actual payments made, not on total dollar amounts approved for each grant request. There may be certain situations where grant requests are approved with installment payments of equal or similar value spread over time. Usually these will occur when more complicated educational activities with multiple components are approved. Payments are disbursed upon completion of project milestones that demonstrate the activity is proceeding as originally proposed, as defined by the accredited provider/educational sponsor.

11. Are the volume of requests and the number of approvals generally consistent over the course of a calendar year?

The number of grant requests Codman receives varies throughout the year. The quantity, timing, and nature of requests are determined by the needs of accredited providers/educational sponsors submitting proposals to Codman. In addition, changes in the availability of Codman funds affect the volume and dollars available for grants.

12. What is the difference between a charitable contribution and an educational grant?

Educational grants are provided for bona fide educational activities and fall into one of the following categories:

  • Accredited Continuing Education: Educational programs for health care providers such as physicians, nurses, and/or pharmacists that provide continuing education credits.
  • Non-Accredited Professional Educational Activities: Educational programs for health care providers such as physicians, nurses, and pharmacists that do not provide continuing education credits. As a condition for funding, to the extent Codman products are discussed as part of such funded activities, Codman requires that such discussion be done in a manner consistent with the FDA approved labeling.
  • Patient Education: Printed/online educational materials and/or live educational events produced for people living with a particular disease or condition.
  • Fellowships: Support for bona fide fellowship programs at teaching institutions, medical societies and cooperative groups. We may also support travel scholarships for fellows, residents or health care providers in training to attend relevant major medical or scientific conferences for the purpose of education. All support is in agreement with the AMA Council on Ethical and Judicial Affairs Gifts to Physicians from Industry.

Charitable contributions describe donation requests that are used for purposes other than health care professional education initiatives. Charitable contributions may be cash or product donations.

  • A cash charitable contribution is a financial donation that is philanthropic in nature and provided to a nonprofit organization to support a specific community-based (or regional/national) program, project, or event (e.g., a cash donation at a fund raising event).
  • A product donation is provided through specific product giving programs to non-government organizations generally responding to disasters, medical relief efforts and basic health care needs in under-served communities.

13 .How are programs that are jointly supported by Codman and another business reported?

As each business is a separate legal entity, the individual company that signs the letter of agreement and provides the funds directly to the requesting organization reports programs.

14. How is the reporting period for funding determined?

All reported funding is based on Codman's financial calendar. In general, grants are reported based on financial quarters, which are 13 weeks in length. Although they closely resemble calendar quarters, there may be occasions where the fiscal quarter does not end on the last day of the calendar month. If the financial calendar ends earlier than the end of the month, any activity from the next day forward would be reported with the next quarterly reporting period.

15. Why might one see duplicate payments reported in different quarters on this Web site?

Rarely, there may be a duplicated payment reported in a different time period if the requesting organization reports a lost check.

16. What happens when the grant recipient does not require, or use, all of the funds originally specified for an activity?

An educational provider/sponsor may reconcile their budget following an activity and find that they have unused funds remaining. As established in the written agreement and in accordance with our policy, Codman requires that unused funds already disbursed to the educational provider/sponsor be returned to our organization. Codman is also reporting any unused funds received from an accredited provider/educational sponsor as a lump sum in the quarter they are returned.

For the purposes of accuracy, Codman is reporting the actual funds disbursed to a grant applicant and, if applicable, the educational partners as specified in the written agreement. Should the educational activity not require all of the funds originally specified in the agreement, unused funds would not be disbursed.

 

Charitable Contributions Process Statement and FAQs 

"We are responsible to the communities in which we live and work and to the world community as well. We must be good citizens - support good works and charities and bear our fair share of taxes. We must encourage civic improvements and better health and education. We must maintain in good order the property we are privileged to use protecting the environment and natural resources."

---Our Credo

A charitable contribution includes cash or product donations. A cash charitable contribution is a financial donation that is philanthropic in nature and provided to a non-profit organization to support a specific community-based (or regional/national) program, project, or event. A product donation is provided through specific product giving programs to non-government organizations generally responding to disasters, medical relief efforts and basic health care needs in under-served communities.

All requests are reviewed by a multidisciplinary committee, which may include Medical Affairs, Health Care Compliance, Public Affairs, Human Resources, and Legal, as necessary. Recipients must be tax-exempt organizations with an appropriate federal tax-exempt status. Requests should include the organization's mission statement, IRS tax status, project/event description, description of how the funds will be used, project budget (if applicable) and annual operating budget (if applicable).

The following types of requests are generally not eligible for charitable contributions:

  • Organizations that do not have a valid federal tax-exempt status
  • Scholarships to individuals
  • Direct contributions to individuals or physician practices
  • Loans
  • Trips or tours
  • Endowments of any kind
  • Sectarian and religious organizations that do not serve the general public on a nondenominational basis
  • Capital requests (building funds, endowments, multi-year commitments)
  • Political, fraternal or athletic groups

Product contributions must be used in the manner defined below:

  • Product contributions will only be placed with licensed medical and health care professionals;
  • Product contributions cannot be transferred in exchange for money, other property or services;
  • Product contributions cannot be used for research, experimental, or demonstration purposes;
  • Product contributions cannot be billed to any third party payor (public or private); and
  • For purposes of disclosure and reporting, product contributions are valued at the Company's list price.

 

Charitable Contributions FAQs

1. Why is charitable contribution information being disclosed?

Codman is proud to have the privilege of providing charitable contributions to various community organizations. We believe that being transparent with this information is the appropriate action to demonstrate our commitment to providing the highest quality health care products and services.

2. What charitable contribution information is being disclosed?

Codman is providing the name of the requestor, the city/state where the requesting organization resides, the title of the activity, the amount of the contribution, and the type of contribution (cash or product). Payments made by the company on behalf of its employees , such as payroll deductions for donations to the United Way, are generally excluded from the company’s Contributions report.

3. How is the total amount of the charitable contribution determined and distributed?

The amount approved for funding is a result of the charitable contribution review process. Funding amounts may be based on project/event budgets, fair market value, organizational geographic scope, and merits of the request. This may be of an equal or lesser amount than requested in the application. The organization has complete control over the distribution of funds received from Codman .

4. What is the difference between a charitable contribution and an educational grant?

An Educational Grant falls into one of the following categories:

  • Accredited Continuing Education: Educational programs for health care providers such as physicians, nurses, and/or pharmacists that provide continuing education credits.
  • Non-Accredited Professional Educational Activities: Educational programs for health care providers such as physicians, nurses, and pharmacists that do not provide continuing education credits. As a condition for funding, to the extent Codman products are discussed as part of such funded activities, Codman requires that such discussion be done in a manner consistent with the FDA approved labeling.
  • Fellowships: Support for bona fide fellowship programs at teaching institutions, medical societies and cooperative groups. We may also support travel scholarships for fellows, residents or health care providers in training to attend relevant major medical or scientific conferences for the purpose of education. All support is in agreement with the AMA Council on Ethical and Judicial Affairs Gifts to Physicians from Industry.
  • Patient Education: Printed/online educational materials and/or live educational events produced for people living with a particular disease or condition.

Charitable contributions describe donation requests that are used for purposes other than health care professional education initiatives. Charitable contributions may be cash or product donations.

  • A cash charitable contribution is a financial donation that is philanthropic in nature and provided to a nonprofit organization to support a specific community-based (or regional/national) program, project, or event. As noted above, employee payroll deductions remitted by the company to a charitable organization are not reported as a contribution by the company.
  • A product donation is provided through specific product giving programs to non-government organizations generally responding to disasters, medical relief efforts and basic health care needs in under-served communities.

5. How does the company handle expenses that are part of a charitable contribution for which Codman receives some benefit?

Codman requires organizations to complete an Omnibus Budget Reconciliation Act of 1993 (OBRA) form. This form documents the amount of the contribution that can truly be considered charitable versus a portion of the amount that represents payments for expenses by the organization for which Codman receives some benefit (i.e., business expenses). Please note that some of these nominal business expenses associated with some charitable contributions may be included in this report.

6. How are programs that are jointly supported by Codman and another business reported?

As each company is a separate legal entity, the individual company that provides the funds directly to the requesting organization is responsible for reporting the donation.

These financial disclosures may not include grants made by companies recently acquired by Codman prior to the acquisition. Available records from such companies will be reviewed and evaluated, and applicable grant information will be posted within a reasonable period following acquisition.

7. Are the volume of requests and the number of approvals generally consistent over the course of a calendar year?

The number of contribution requests Codman receives varies throughout the year. The quantity, timing, and nature of requests are determined by the needs of the organizations submitting proposals to Codman, which is determined by the requestors' needs. In addition, changes in the availability of Codman funds affect the volume and dollars available for contributions.

8. How is the reporting period for funding determined?

All reported funding is based on Codman 's financial calendar. In general, grants are reported based on financial quarters. Financial quarters are 13 weeks in length and, although they closely resemble calendar quarters, there may be occasions where the fiscal quarter does not end on the last day of the calendar month. If the financial calendar ends earlier than the end of the month, any activity from the next day forward would be reported with the next quarterly reporting period.

9. Why might one see duplicate payments reported in different quarters on this Web site?

Rarely, there may be a duplicated payment reported in a different time period if the requesting organization reports a lost check.

 

Criteria for Grant Denials

Educational grant requests are reviewed through a rigorous review process. Processes have been designed and implemented so that no single individual may authorize educational grant support alone. In accordance with government guidance, it is inappropriate for individuals responsible for sales and marketing to be involved in educational grant-making decisions. Grant reviewers typically include personnel from Medical Affairs, Medical Education, Regulatory Affairs, Health Care Compliance, and/or Legal departments, as necessary.

Numerous educational grant requests can be received by Codman each year. Unfortunately, not all educational grants that are submitted for consideration can be funded.

Codman abides by rules developed by several regulatory and policy-making organizations. These rules provide guidance on several parameters. For example:

  • Grants should not take into account the volume or value of purchases made by, or anticipated from, a potential grant recipient;
  • Accredited educational activities should be independent and without influence from commercial supporters;
  • Educational grants may only be provided to recognized institutions, organizations, or societies; no funding may be provided by industry directly to an individual or medical practice;
  • Presentations must give a balanced view of therapeutic options and not a specific proprietary business interest (product) of a commercial sponsor; and
  • Any gift items provided to participating practitioners must provide educational value to the patient or healthcare professional.

Codman uses established policies to evaluate each submission on its own merits. Funds are not provided as "unrestricted educational grants," which implies that recipients may use the financial support for a purpose other than what was originally intended. Although Codman only provides restricted educational grants, it is assumed that program content is developed in an independent manner by the requestor. It is expected that a provider should develop accredited medical education activities without interference, direct or nuanced, from a commercial supporter.

To ensure that the purpose of the educational activity is clearly understood, all grant requests include several key components to be provided within the grant application when submitting a grant request to our organization.

Each grant request submission is evaluated on four common components:

  • The needs assessment documenting why the activity is necessary and how the proposed activity will address the educational need or gap
  • A proposed or final agenda and/or brochure
  • A detailed budget outlining how the funds will be utilized
  • A statement of accreditation and/or tax exempt status

Unfortunately, educational grants may be denied for a variety of reasons. The primary criterion used by reviewers is that there must be a bona fide educational purpose that should result in improved patient care.

Examples of reasons for denial of educational grants may include:

  • Vague or incomplete grant applications
  • Requests that appear to promote a medical practice or office
  • Support for educational activities that are outside the therapeutic scope of legitimate scientific or clinical interests of the manufacturer
  • Funds to offset travel costs of attendees at an educational activity, other than a qualifying resident or fellow in training
  • Grants to specifically promote an individual product
  • Activities that include topics in a non-accredited environment that are designed to encourage unapproved uses of products
  • Events that include a social activity or entertainment that overshadow the educational activity
  • Requests that stipulate support is required in order to maintain access to health facilities, maintaining existing business relationships, or other quid pro quo
  • All or parts of the proposed budget submitted by the requesting organization exceed fair market values (i.e., faculty honoraria, venue costs, or administrative fees)
  • Limited funds available in Codman's educational budget
  • Recent funding of similar educational activity

Codman is proud to assist with the educational needs of health professionals through educational grants. We do so with intent to place the health and welfare of the patient ahead of economic self-interest.

 

Grants
Grants

More information about reporting of grants and contributions can be found at www.jnj.com.


 

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