Life Science Compliance Update

November 09, 2017

Senators Blumenthal and Grassley Ask CMS to Continue Funding Open Payments

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In a letter to Acting Secretary of the U.S. Department of Health and Human Services (HHS) Eric D. Hargan, United States Senators Richard Blumenthal (D-CT) and Chuck Grassley (R-IA) ask HHS to prioritize funding for the Center for Medicare and Medicaid Services’ Center for Program Integrity (CPI), a program that enhances transparency in transactions between medical providers and pharmaceutical companies.

The CPI’s Open Payments database, created under the bipartisan Physician Payments Sunshine Act, mandates disclosure of billions of dollars in payments from manufacturers to prescribers and hospitals. This is of concern at a time when over-prescribing of opioid medications has exacerbated a public health crisis nationwide.

“As part of your ongoing commitment to the mission of CPI, we encourage you to continue to prioritize funding and administration of the Open Payments database,” wrote the Senators. 

The letter also references “[r]ecent reports [that] have raised concerns about the effect payments to health professionals may have on opioid prescribing practices, which in many ways has exacerbated this ongoing public health epidemic. Pending litigation against a fentanyl manufacturer has revealed instances of regular weekly contact with high-volume prescribers, in addition to a large number of total payments.”

In their letter, the Senators acknowledge often, “relationships between academic medicine and industry are necessary and beneficial,” but express concern that “some financial relationships influence prescribing and drive up costs.”

Blumenthal and Grassley are the lead sponsors of a bill to expand the Physician Payments Sunshine Act disclosure requirements to nurse practitioners and physician assistants, who are currently not mandated to disclose transactions with manufacturers.

The Provider Payment Sunshine Act, S. 308, would require drug companies and medical device makers to publicly disclose their payments to nurse practitioners and physician assistants for promotional talks, consulting and other interactions. The disclosures already apply to doctors, dentists, chiropractors, optometrists and podiatrists under the Physician Payment Sunshine Act, co-authored by Grassley and enacted in 2010 adopted as part of the Affordable Care Act (aka Obamacare). The records that apply to doctors are publicly available in the federal Open Payments database. 

Nurse practitioners and physician assistants write a significant number of prescriptions in Medicare and nationwide, and they were among the top prescribers for some drugs, including narcotic controlled substances, according to a ProPublica analysis. 

Blumenthal and Grassley are often on the same page when it comes to publishing payments from industry to physicians and other prescribers.

“There ought to be a complete record for consumer benefit,” Grassley has said. “The goal of sunshine for payments to doctors is to help the public. It makes sense to apply the sunshine to anyone who prescribes medicine. This bill is meant to continue the transparency that brings accountability in this part of the health care system.”

“It’s absolutely essential that companies disclose gifts and payments made to any health care provider who prescribes medications – not just doctors,” Blumenthal said. “Our bipartisan bill will rein in bad behavior by increasing transparency and accountability across the healthcare industry. Increased access to information is in the public’s best interest, and this legislation will ensure healthcare consumers receive safe, efficient, and cost-effective practices.”

July 03, 2017

CMS Releases 2016 Open Payments Data

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2016 Open Payments Data was released on Friday, June 30, 2017. In 2016, the total dollar amount of payments totaled $8.18 billion. The total amount of general payments made amounted to $2.80 billion; the total amount of research payments amounted to $4.36 billion; and the value of ownership or investment interest totaled $1.02 billion.

Where Did The Money Go?

The $8.18 billion was given to 631,000 clinicians and 1,146 teaching hospitals. Drug and device makers are required to report any “transfer of value” of $10 or more, or transfers of value that add up to more than $100 per year.

Roughly 75% of the $2.8 billion ($2.07 billion) in general payments went to clinicians, including physicians, dentists, optometrists, podiatrists, and chiropractors. Teaching hospitals received $724.51 million in general payments.

Research payments largely went to teaching hospitals: $867.95 million, compared to the $95.21 million that went to physicians. The physician research payment total includes payments where the company making the payment has named a physician as the primary recipient, as well as payments to a research institution or entity where a physician is named as a principal investigator on the research project.

Year to Year Comparisons

The below tables show comparisons of different data points over the past few years.

1

The above table compares the percent change in total payments and records. The percent change in payments and interest from 2015 to 2016 totaled 1.11% ($8.09 billion to $8.18 billion).

2

The above table compares the percent changes in three different payment categories: general payments (4.5%); research payments (-2%); and ownership interest (6.3%).

3

The above table compares the 2014 to 2016 change in number of companies reporting (-8.24%); physicians receiving payments (.96%); and teaching hospitals receiving payments (1.69%).

Medscape joined the “fake news” craze, by stating the increase was 8.8% from last year’s payments. However, the actual rise was less than 1.1%.

Conclusion

Visitors to the CMS Open Payments website can look up individual clinicians and hospitals to see what they have received from drug and device makers and compare their payments to national and specialty averages.

April 28, 2017

ExL Events to Host the 8th Aggregate Spend and Sunshine Act Conference

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Unlock the Value of Transparent and Efficient Data Reporting to Improve the Operation of Your Organization

ExL Events will host the 8th Aggregate Spend and Sunshine Act Conference this June 15-16 at the Sonesta Philadelphia Rittenhouse Square in Philadelphia, PA.

Progressive leaders from pharmaceutical, biotechnology and medical device companies will convene for two days to discuss the value of transparency reporting and exchange tools used to translate aggregate spend data into business improvements that enhance daily efficiency. View the complete agenda and faculty list here.

This annual conference attracts delegates globally. Participants will include representatives from Pfizer, Viscadia, Alkermes, Qiagen, Sun Pharma, Foundation Medicine, Bayer Healthcare, Chiesi, Draeger Medical, Horizon Pharma, Concur, Regeneron Pharmaceuticals and Medtronic.  

Featured speakers include:

  • Michael O’Connor, Senior Director, Global Head Compliance and Ethics Operations, ALEXION PHARMACEUTICALS, INC.
  • Gretchen Reyes Cseplo, Compliance Officer, US, Canada and Global Compliance Operations, CONVATEC
  • Avi Spira, Vice President and Chief Compliance Officer, CANTEL MEDICAL CORP.
  • Ben Yao, Director, Transparency, ASTELLAS
  • Amie Phillips Pablo, Associate Director, Government Reporting, NOVO NORDISK INC.

Conference sponsors and supporting partners include: Concur, MedPro Systems, QuintilesIMS and Alanda Software.

Register now to save $200 off the standard registration rate — early bird pricing expires April 28. Please mention priority code C882PMLSCU when signing up.

ABOUT EXL EVENTS
ExL Events, a division of Questex, LLC, is the industry leader in developing innovative, educational conferences that serve the pharmaceutical and allied healthcare communities in the United States, Europe, Latin America and additional markets. Its experienced team conducts extensive market research and targeted outreach. The results translate into innovative, high-quality events designed to exceed the dynamic informational and networking needs of audiences. ExL Events conference platforms facilitate the exchange of critical information between industry executives and suppliers to support their scientific and commercial goals. www.exlevents.com

CONTACT
For business development and sponsorship opportunities, please contact Alexander Siegel at 917-242-3893 or asiegel@exlevents.com.

For general information, please contact Tyler Lobo, Conference Production Director, at 917-242-3899 or tlobo@exlevents.com. 

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