Two new federal bills have been introduced in Congress related to manufacturer transparency. Senate Bill 2891 (S. 2891), the Fighting the Opioid Epidemic with Sunshine Act of 2018, was recently introduced by Senators Grassley, Brown and Blumenthal. S. 2891 would amend the current Open Payments law to require annual reporting of payments and transfers of value provided to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse-midwives.

Similarly, the recently introduced Patient Advocacy Transparency Act also would amend the Open Payments law to:

  • Define “grant” to include education grants and capacity building grants;
  • Add to the list of payments or transfers of value that must be reported annually: (i) fundraising event sponsorship; (ii) meeting or conference expenses not already reportable; and (iii) funding of marketing, public relations activities, placement on television programs or internet websites, or social media support; and
  • Expand the definition of “covered entity” to include (i) professional society of health care providers or pharmacists; (ii) patient advocacy organization, consumer advocacy organization, voluntary health agency, or a coalition of such organizations, including a disease-specific advocacy organization; (iii) patient education organization; (iv) continuing education providers, including a medical education or
    communications company; (v) clinical trial organization; (vi) education accreditation organization; (vii) co-pay assistance organization or other organization providing financial assistance to patients; and (viii) foundation established by one of these entities.

These bills include bipartisan support for a trending area within federal and state legislatures to increase transparency related to manufacturer activities, including payments and transfers of value to third parties and product pricing. We will continue to monitor these laws and update the blog accordingly.

Posted by Cooley