Senators Grassley and Wyden Expand Their Opioid Investigation to Tax-Exempt Organizations

In 2012 Senators Grassley and Baucus sent letters to the American Pain Society and other pain-related organizations including the Joint Commission and the Federation of State Medical Boards asking for information on their relationships with industry.

This past week, Senate Finance Committee Chairman and Ranking Member sent follow-up letters to ten tax-exempt organizations associated with pain, requesting information about their financial relationships with opioid manufacturers and other medical entities.  This time asking for a significantly greater amount of information than in 2012.

The letter reads, “We write to request information regarding your organization and its financial relationship with opioid manufacturers and other entities that manufacture products to treat pain. As Chairman and Ranking Member of the Senate Finance Committee, we have a responsibility to ensure transparency and accountability in matters that directly affect Federal healthcare programs and tax-exempt organizations. This responsibility includes examining the extent to which pharmaceutical manufacturers fund tax-exempt organizations and how these payments may influence pain treatment practices and policy.”

It continues, stating, “We acknowledge that the answer to the opioid epidemic continues to be anything but simple. However, we believe that it is important to shed light on these financial relationships to ensure transparency and accountability in matters that affect Federal healthcare programs and the patients that participate in them.”

The senators ask for the following information from the organizations:

• All Form 990s that the organization filed with the IRS from 2012 to present, as well as the organization’s complete Schedule Bs;
• A detailed accounting of all payments/transfers received from any drug, device, biologic, or medical supply manufacturer, and from individuals that produce, market, or promote products on the manufacturer’s behalf. Specifically, the senators are looking for the following information on each transfer:
  • Date of payment,
  • Source or entity making the payment,
  • Description of the payment (i.e., general support, project specific, etc.),
  • Amount of payment,
  • Year-end or year-to-date payment total and cumulative total payments for each organization or individual, and
  • The percentage of funding from organizations identified above to total revenue for each year a payment was received;
• A description of any collaborative activity between the organization and the entities identified above from 2012 to the present and the timeframe in which the activity took place;
• A copy of the conflict of interest policy maintained by the organization, if such exists, as well as a description of any additional mechanisms the organization uses to police conflicts of interest and promote transparency of funding sources;
• A detailed list of all funding received from the Federal government since 2012, including the year, amount, and purpose of the funding, in hard copy, PDF, and Excel spreadsheet formats;
• Copies of all comments or other written materials the organization has made to Federal task forces, committees, advisory groups or similar entities from 2012 to present;
• If any activity identified in the two prior questions pertains to information distributed to physicians and patients concerning prescription pain medication, identify any materials developed by organizations identified above and provide copies of those materials;
• A complete list of all instances from 2012 to present in which a board member, executive, staff or affiliated volunteer has served on any Federal task force, committee, advisory group or other entity; and
• Identification of any person employed by the organization who communicated with the entities outlined above regarding the content of materials distributed to patients and physicians pertaining to opioid use and/or prescribing practices from 2012 to present, including their name, position, dates of employment, and job description. This shall also be provided in hard copy, PDF, and Excel spreadsheet formats.

The letters were sent to the: American Chronic Pain Association, American Pain Society, American Society for Pain Management Nursing, American Society of Pain Educators, Center for Practical Bioethics, Federation of State Medical Boards, The Joint Commission, American Academy of Physical Medicine and Rehabilitation, Alliance for Patient Access, and International Association for the Study of Pain.

We will have a full analysis of this investigation and what it could mean to organizations and manufacturers in an upcoming issue of Policy and Medicine Compliance Update.