Life Science Compliance Update

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17 posts from January 2018

January 19, 2018

Male Doctors Make More in Industry Payments Than Females


A new gender wage gap has been found. A recent study suggests that male physicians in the United States took in more money from the biopharmaceutical industry in 2015 than their female peers, across almost every specialty.

Researchers analyzed the general industry payments, including research grants, consulting fees, and food and beverage expenses, earned by 933,925 physicians.

Two-thirds of the doctors in the study were male. Across all specialties, men received a higher per-physician value of general payments versus women, with a median difference of $1,470. The discrepancy in neurosurgery was particularly wide, with the largest per-physician value of general payments for male neurosurgeons at $15,821, compared with $3,970 for their female colleagues.

Female doctors with children may work fewer hours than their male counterparts, although not every woman physician is a mother, and not every female doctor who is a mother has reduced her hours, noted Hegewisch in an email. “But this is not really a full explanation: why is it that women take so much more responsibility for their kids and for family care overall? Discrimination, access to the highest paying opportunities, and systemic bias in the way funding and patenting systems are set up are also likely to contribute,” she said.

The study also found that male physicians held 93% of the value received from ownership interests, including stock options and partnership shares, and received a higher per-physician value across most specialties, with the largest difference among radiologists. However, women physicians in certain fields such as obstetrics, gynecology, psychiatry and urology, had comparatively higher values of ownership interest.

“Perhaps industries purposely target men more than women, presuming they may have greater influence on market share or sales . . . data shows that women hold fewer patents than their male counterparts, which may be explained by fewer initial connections to the marketplace or exclusion of their name from the patent itself after idea generation,” said study coauthor Kathryn Tringale of the University of California, San Diego.

Dr. Jane Orient, executive director of the Association of American Physicians and Surgeons, suggested what she called another “obvious explanation.” Perhaps “women do less of the work that earns the type of payments being studied,” she said in an email.

The study findings were drawn from the Centers for Medicare & Medicaid Services National Plan & Provider Enumeration System and from 2015 Open Payment reports of industry payments to U.S. doctors.

In a subset of 63,466 licensed California practitioners, after taking years in practice into account, male physicians were still more likely than female physicians to receive general payments and hold ownership interests, and the men received more - and higher-value - general payments, Tringale and her coauthor Dr. Jona Hattangadi-Gluth wrote in JAMA Internal Medicine. “We need to further investigate how interactions with industry influence physician behavior and impact patient care, which we cannot conclude from these results,” said Tringale.

“At first glance, this finding can be interpreted as merely another example of gender disparities in the workplace, which we have seen before with gender gaps in physician salaries and research funding,” said Tringale.

“These data are depressingly familiar,” said Ariane Hegewisch, program director of employment and earnings at the Washington, DC-based Institute for Women’s Policy Research, who was not involved in the study.

Christmas Comes Early - The FCPA Pilot Program Made Permanent


When we first introduced the FCPA Pilot Program in the June 2016 issue, we noted the uncertainties of outcomes for companies who voluntarily self-disclose potential violations. On November 29, 2017, Deputy Attorney General Rod Rosenstein announced that the US Department of Justice (DOJ) had made the FCPA Pilot Program permanent. This article will review some of the key highlights outlined by the DOJ and some considerations for compliance professionals.

The heat is on life science companies. Since 2013, there have been 25 Foreign Corruption Practices Act (“FCPA”) matters involving life science companies, 13 of which occurred in the last two years. Although life science companies have not been immune to FCPA investigations in the past, the statement of Acting Chief of the U.S. Department of Justice (“DOJ”) Fraud Section, Sandra Moser in August was loud and clear - the DOJ would be increasing its enforcement efforts of healthcare related companies.

We reviewed the outcomes of the FCPA Pilot Program (“Pilot Program”) in the September 2017 issue of the Update, examining the benefits of self-disclosure under the program. Now, a year since its inception, the DOJ has announced that the Pilot Program will now be permanent.

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January 18, 2018

Study Highlights Physician QPP Preparedness


Fewer than one in four physicians feel they are prepared to meet requirements under the CMS’ Quality Payment Program (QPP), a new American Medical Association and KPMG survey shows. Out of 1,000 physicians involved in practicing decision-making related to the QPP, only 8% said they were “deeply knowledgeable” about MACRA and QPP. In contrast, almost 92% said they were “somewhat knowledgeable” or not knowledgeable. All of this spells danger for the new program as CMS struggles to inform physicians about the new requirements even as a performance year has almost already been completed.

Study Results

According to the study, 7 in 10 respondents had in fact begun preparing to meet the requirements of the QPP for 2017. Nearly 9 in 10 feel somewhat prepared or well prepared to meet the low-bar requirements set forth by CMS in the first year. Of those participating in the MIPS track of QPP, only 65% felt prepared to meet the requirements, indicating that alternative payment model members have a higher likelihood of feeling prepared. Additionally, of those participating in MIPS, 90% felt the requirements are slightly or very burdensome, with over half responding they were at the higher level of burden.

Respondents to the survey indicated the reporting time required to comply is the most significant challenge and suggest it will be one in future years. Respondents also struggled to understand requirements like MIPS scoring and the cost of reporting.

Previous programs like PQRS and the VBPM contributed to the level of readiness for QPP. The legacy programs set up physicians to be more successful than those with no experience with them. Only 25% of physicians with prior reporting experience felt well prepared for the QPP, however.

An interesting finding in the study is that even among those who feel prepared, they do not fully understand the total impact of the QPP. While they may be prepared to check boxes and complete forms, they lack “long-term strategic financial vision to success in 2018 and beyond.” Only 8% of respondents feel they are very prepared for long-term success with 26% feel not prepared at all.

Findings Support Number of Assumptions About QPP

According to the study, its results confirm assumptions that are widely held regarding physician knowledge and preparedness for QPP requirements:

  • Some challenges are universal regardless of practice size, specialty, or previous value-based payment experience, particularly the time required and the complexity of reporting.
  • Physicians, especially in small practices, need more help to prepare.
  • Physicians want more alternative payment models available to them.
  • Physicians with value-based payment reporting experience are more confident about their preparedness regarding performance under MIPS.
  • Physicians remain deeply concerned about the long-term financial ramifications of the QPP.


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