Aggregate Spend

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Aggregate Spend is the process to aggregate and monitor total amount spent by healthcare manufacturers (Pharmaceutical, Biotechnology and, in some states, Medical Device organizations) on individual Healthcare Professionals and Organizations (HCP/O) through payments, gifts, honoraria, travel and other means.[1]

Aggregate Spend compliance has been affected by individual state law compliance, which requires Healthcare Manufacturers to address and collect distinct spend types to comply with disclosure requirements at the HCP/O aggregate level. Minnesota, Maine, West Virginia, Vermont, California, Nevada, and Washington D.C. all have some type of gift-giving limit or disclosure law. Starting July 2009 Massachusetts and Vermont Gift ban law became active with bans of $5,000 and $10,000 per violation respectively. Other states are evaluating similar options as well.[2]

As opposed to the individual state legislation, On September 6, 2007, Senator Chuck Grassley introduced the Physician Payments Sunshine Act of 2007 (S. 2029). In March 2008, Rep. Peter DeFazio (D-Oregon) and Rep. Pete Stark (D-California) introduced a slightly different companion bill in the House of Representatives. (The House bill is referred to as H.R. 5605). These bills were reintroduced in 111th Congress as the Physician Payments Sunshine Act of 2009 (S. 301 and H.R. 3138) again by Senator Chuck Grassley and in the House of Representatives by Rep. Baron Hill (D-Indiana). The bill would amend the Social Security Act "to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP." The bill proposed that each quarter after January 1, 2008, companies or their agents that manufacture drugs, medical devices, or medical supplies would be required to disclose all payments of over than $25 in value made to "to a physician, or to an entity that a physician is employed by, has tenure with, or has an ownership interest in."

The bill would also require to provide details on the date, value and nature of the payment, such as whether it was for "food, entertainment, or gifts", "trips or travel", "a product or other item provided for less than market value", "participation in a medical conference, continuing medical education, or other educational or informational program or seminar, provision of materials related to such a conference or educational or informational program or seminar, or remuneration for promoting or participating in such a conference or educational or informational program or seminar", "product rebates or discounts", "consulting fees or honoraria" or "any other economic benefit."

The bill would also require each company to submit a summary report in electronic format. The proposed penalties for breaches were "not less than $10,000, but not more than $100,000, for each such failure.[3][4]

The revised version of the Physicians Payments Sunshine Act would require drugmakers to disclose gifts, payments, travel expenses and other financial donations to docs and would undermine a stronger Vermont law if passed, according to state officials and advocacy groups. But the reporting threshold under the proposed federal law is $500 - much higher than the $25 threshold found in a similar Vermont law passed five years ago. If passed, the federal bill would preempt the state law.

According to Ashley Glacel, the press secretary for the Senate Aging Committee, whose chairman, Herb Kohl, co-sponsored the bill, the Senate bill is more expansive because it also include Medical Device makers.[5]

In May 2008, the Pharmaceutical Research and Manufacturers of America stated that they supported a revised version of the bill but only on condition of "the continued inclusion of the provision that preempts state law". In a media statement, PhRMA President Billy Tauzin stated that "PhRMA believes that preempting local and state marketing reporting or disclosure laws that have been enacted or are pending avoids a confusing myriad of local, state and federal requirements that confuse patients accessing the information and are overly burdensome and costly for those required to report."[6]

References

  1. http://www.healthleadersmedia.com/content/215072/topic/WS_HLM2_PHY/Certification-of-Compliance-Among-Biggest-Changes-to-PhRMA-Code.html
  2. http://www.hcpro.com/content/213998.cfm
  3. http://www.sourcewatch.org/index.php?title=Physician_Payments_Sunshine_Act_of_2007#_note-1
  4. http://www.govtrack.us/congress/bill.xpd?bill=h110-5605
  5. http://www.pharmalot.com/2008/05/vermont-irked-by-revised-senate-disclosure-bill/
  6. http://www.phrma.org/news_room/press_releases/phrma_statement_on_the_senate_sunshine_act/


External links

Further reading

  • "Sales & Marketing Compliance: Keeping up with Global and Local Challenges" PharmaVOICE January 2007
  • "Pharmaceutical Company Payments to Physicians: Early Experiences With Disclosure Laws in Vermont and Minnesota" JAMA, Vol. 297 No. 11, March 21, 2007
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