The Fraud and Abuse Control Program, established by the Health Insurance Portability and Accountability Act of 1996(HIPAA), authorized the OIG to provide guidance to the health care industry to prevent fraud and abuse and to promote the highest level of ethical and lawful conduct.
To further these goals, the OIG, on request, renders advisory opinions regarding industry practices or arrangements that potentially implicate the fraud and abuse authorities subject to enforcement by the OIG, to include the Federal Anti-kickback Statute, Social Security Act, Section 1128B(b) (the “Anti-kickback Statute”).
When an advisory opinion opines that a proposed arrangement (the “Proposed Arrangement”) does not constitute prohibited remuneration, directly or indirectly, in cash or in kind to the health care professionals within the meaning of the Anti-kickback Statute the legal effect is to create a safe harbor, to-wit:
The OIG will not impose administrative sanctions against any action that is part of the Proposed Arrangement, taken in good faith reliance upon the advisory opinion, as long as all the material facts have been fully, completely and accurately presented and the Proposed Arrangement in practice comports to the information provided by the entity making the request for an advisory opinion.
Good Works Health, Inc., (“GWH”) is a marketing and research company. It contracts with pharmaceutical companies to provide an interactive web-based program (the “Good Works Health™ marketing platform”) to educate physicians or other health care providers (collectively, “Physicians”), promote Pharma products, and gather information regarding a physician’s diagnosis and treatment of certain illnesses via a survey (the “Program”).
Physicians are encouraged to take part in the Program by offering them the opportunity to designate a public charity(subject to certain disclosures and conditions) to which GWH, using the money of the subject pharmaceutical would make a monetary charitable contribution in the name of the physician completing the Program survey (the “CharitableContribution” or “Proposed Arrangement”).
GWH requested an OIG advisory opinion to determine whether a Physician’s participation in the Program, and the directed Charitable Contribution described above (the Proposed Arrangement), would constitute prohibited“remuneration” to the Physician within the meaning of the Anti-kickback Statute.
On January 29, 2008, based on the facts certified in the Good Works Health, Inc. request for an advisory opinion, the OIG issued its Opinion to Good Works Health, Inc.
The Proposed Arrangement would not generate prohibited remuneration under the anti-kickback statute…3; we discern no actual or expected economic or other actionable benefit that would inure to health care professionals as a result of the[charitable] contribution.4
The OIG will not proceed against Good Works Health, Inc., with respect to any action that is part of the Proposed Arrangement taken in good faith reliance upon this advisory opinion, as long as all the material facts have been fully, completely and accurately presented, and the Proposed Arrangement in practice comports to the information provided (the“Safe Harbor”).5
The above conclusions and Safe Harbor are based on the Program and Proposed Arrangement information certified in the request for an advisory opinion and supplements thereto, and restated in the Opinion.
i. Receives an invitation to a multi-media presentation with a link to an online survey (the Program);
ii. Reviews the presentation and completes the survey questions;
iii. Designates a public charity to receive a charitable contribution funded by the GWH Client (the Proposed Arrangement); and
iv. Certifies that neither the health care professional nor any immediate family member is a board member, is employed by such charity, or has any financial relationship with the designated charity.
The aggregate charitable contribution in the name of any one health care professional to any one charity is Two Thousand Dollars ($2,000) per year.
After reviewing a presentation and submitting answers to the required survey questions, the HCP designates a public charity to receive a charitable contribution.
For every charitable contribution, the website requires the HCP to certify that neither the HCP nor any immediate family member is a board member, is employed by such charity, or has any financial relationship with the designated charity.
The website automatically limits the charitable contribution in the name of any one HCP to any one charity to $2,000 per year, as required by the Advisory Opinion. If the contribution exceeds the $2,000 limit, the website prevents the HCP from making the contribution.
All contributions are reviewed by GWH compliance. The majority of donations are made to major healthcare charities that are featured on the website’s donation page. In addition to the search box that allows the HCP to find any public charity registered with the IRS, the donation page also presents the HCP with five or six major healthcare charities appropriate to the program and also charities popular with HCPs.
For example, the donation page for a cardiology program would typically feature the American Heart Association, the Cardiovascular Research Foundation, and the American College of Cardiology Foundation, along with Doctors Without Borders, The Red Cross, and International Medical Corps.
The website automatically flags for closer scrutiny by GWH compliance all donations to smaller foundations with revenue of $25,000,000 or less; donations to charities whose address is similar to the office address of the HCP; donations to charities where the surname of the HCP matches the surname of the charity’s officers, directors, trustees, key employees, and/or highest compensated employees, and/or independent contractors listed on the charity’s form 990 or website.
A review of a flagged donation either allows or disallows the donation to the charity for that individual HCP. Reviews of a flagged donation include but are not limited to analysis of the charity’s Form 990, the charity’s website and other online information, and contacting the charity and HCP to clarify the relationship between the two. Disallowing a donation results in the website preventing the HCP from being able to select that particular charity for a donation in all future programs.
Among the reasons for GWH compliance disallowing a donation are the HCP being a member of the charity’s board and/or receiving compensation from the charity, the HCP currently paying tuition for himself/herself or an immediate family member to a school designated by the HCP for a contribution, and/or a contribution to a charity that provides office space to the HCP or family member.
