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31 posts from July 2013

July 31, 2013

Physician Payment Sunshine Act: AMA Reminds Members to Update Their Disclosures




The American Medical Association (AMA) is reminding physicians that reporting of financial arrangements with industry stakeholders starts today on August 1, 2013 as the Physician Payments Sunshine Act goes into effect. We have written about this with much frequency on Policy and Medicine.


The AMA states: "As the sole physician organization whose reach and depth extends across the nation, the American Medical Association (AMA) has been actively informing physicians about the Physician Payment Sunshine Act (Sunshine Act), which will require industry to report on their interactions with physicians beginning on Thursday, August 1. As required by law, these interactions will be published by the Centers for Medicare and Medicaid Services (CMS) starting in September 2014.


'The Sunshine Act affects all physicians with a current medical license and the changes are starting now,' said AMA President Ardis Hoven, M.D. 'Physicians should know that pharmaceutical and medical device companies must begin tracking and reporting information on their interactions with physicians beginning August 1, and this information will soon be published online by CMS.'


'We strongly urge physicians to make sure all of their financial and conflict of interest disclosures, as well as their information in the national provider identifier (NPI) database, are current and regularly updated. We also urge physicians to ask industry representatives with whom they interact to provide an opportunity to review and, if necessary, correct all information they will report before it is submitted to the government,' said Dr. Hoven."


The AMA has a Physician Sunshine Act Tool Kit to aid members in complying with the law. The kit includes a Web seminar available to all physicians. The association further urges physicians to ask organizations they have a financial relationship with for the opportunity to review and correct if necessary information that is being reported to CMS.


Starting in January 2014, physicians can register with CMS to receive a report on their activities each June for the prior reporting year. CMS also recently introduced free mobile phone applications to help physicians and businesses track financial relationships.

ACCME Annual Report Data 2012

The Accreditation Council for Continuing Medical Education (ACCME) published its 2012 Annual Report Data which includes data on the size and scope of the continuing medical education (CME) enterprise nationwide.

The report shows that in 2012:

  • CME Economy grew by 5.3%, $124,747,818 to $2,474,328,099 from 2011
  • Commercial support for CME decreased by 10.3%, or $77,659,472, from 2011 marking the sixth year of decline.
  • Commercial support now represents 27.3% of the total CME funding, down from 46% of total funding in 2007.        
  • Physician attendance increased by 4.8%,or 656,584 attendees, to 14,398,205
  • Non Physician attendance increased by 6.7%, or 648,448 attendees, to 10,207,237
  • The majority of CME activities (82%) did not receive commercial support.
  • 37% of physicians attended regularly scheduled events such as grand rounds, followed by 34% received credit for internet enduring materials, 16% for courses, and 9% for Journal CME.
  • Over $60 Million in Revenue from 2011 to 2012 was reallocated from unclassified to various provider categories.
  • The cost per physician participant in CME programs varied widely, from $63.89 for hospital physicians to $1,045.37 for government or military participants

The data shows that there are more than 2,000 accredited CME providers across the country that offered more than 133,600 activities in 2012, almost a 5% increase from 2011. Accredited CME providers report that their 2012 activities educated more than 23 million participants including more than 13 million physicians and more than 9 million non-physician health care professionals. Slide10

In addition, the 2012 Annual Report Data features separate data sets about the CME delivered by ACCME-accredited providers and by state-accredited providers, offering an overview of the CME system at both the national and state levels.

The ACCME directly accredits providers that offer CME primarily to national or international audiences of physicians and other health care professionals. The ACCME also recognizes state and territory medical societies as accreditors for providers that offer CME primarily to learners from their state or contiguous states. All accredited providers within the ACCME accreditation system are held to the same high standards and are required to report information about their programs that the ACCME collects and analyzes in order to produce annual report data.

The 2012 Annual Report Data includes an overview of commercial support received by ACCME-accredited providers. The data shows commercial support distribution by numbers and types of activities, hours of instruction, and participants. The ACCME is able to publish this commercial support overview because of the Program and Activity Reporting System (PARS). Launched in 2010, PARS is a Web-based portal designed to centralize and streamline the collection, management, and analysis of program and activity data from accredited CME providers. The structure of PARS and the CME community's adoption of PARS enable the ACCME to produce new information.

The 2012 Annual Report Data marks the 15th year the ACCME has been collecting, analyzing, and publishing information about accredited providers, and offers more than a decade-long perspective on the evolution of the ACCME accreditation system. .

For the 2012 Annual Report, the ACCME changed the name of the organizational type "Not classified" to "Other." The ACCME reviewed ACCME-accredited providers that had previously been categorized as "Not classified" and, when appropriate, reclassified them according to their business model. Eighteen providers remained as “Other,” 12 were reclassified as “Publishing/education companies,” 6 as “Nonprofit
(other),” 1 as an “Insurance/managed-care company,” and 1 as a “School of
medicine.” All state-accredited providers that had been categorized as
"Not classified" remained as "Other

2012 Report

The ACCME recently made changes to the way they reported previous year's data to include information from ACCME accredited and state accredited providers. So earlier versions of our analysis included previously published data from previous year's that is different than the previous year's data published in this year's report. We have subsequently fixed the data to match the ACCME changes.

The total income of the CME industry increased by $124,747,818, or 5.3%, to $2,474,328,099 between 2011 and 2012, the total income has decreased by $210,794,198, or 7.9% since 2007. Commercial support of CME continued to decline, by $77,659,472, this represents a 10.32% reduction from $752,406,638 in 2011 to $674,747,166 in 2012 and a total reduction of a full $574,177,706, or -46% since 2007.

Making up for some of this lost income, however, were increases in Advertising/Exhibits (7.3% in 2012 and 16.7% since 2007) and Other Income (14% in 2012 and 27.4% since 2007).

According to the ACCME, "Other income" represents income other than commercial support and advertising and exhibits income; for instance, participant registration fees, and allocations from a provider's parent organization or other internal departments.   

Commercial support now represents only 27% of the total CME enterprise, a 10.32% decline since 2011 and a 46 % decline since 2007.  Other Income now represents 59% of the total revenue for accredited CME providers.  Advertising and exhibits share has increased over time but not by very much.  

There are wide variations in the changes to CME income by provider type.  Goverment providers increased their income 38.8%. Non profit physician membership income increased 12.9%, and publshers by 12.4%.  Most groups that lost income saw slight decreases in revenue.  As discussed earlier, the Other catagory saw significant decreases due to reclassification of 20 CME providers.


For publishing/medical education companies, total income increased 12.4%, however, total income since 2007 has decreased 27.3%. Commercial support increased 9.5% in 2012 but has declined 54.3% since 2007. Moreover, whereas commercial support was 71.5% of the enterprise in 2007, it was 45% in 2012. The income has increased minimally in advertising and exhibits (3% in 2012) and seen a dramatic increase in other income (52% in 2012).  One contributing factor may be the reclassifcation of 12 providers from unclassified to the publisher catagory.  That probably resulted in millions in revenue moving between catagories and could explain much of the revenue increase.

Medical Schools

For schools of medicine (universities), total income decreased 6.5% in 2012. Commercial support declined 20.3% in 2012 and 34.6% since 2007.


For Nonprofits (physician membership organizations and other nonprofits), total income increased 11.3%, and has increased 7.6% since 2007. Commercial support increased 0.9% in 2012, but has declined 36.1% since 2007.

The number of physician and non-physician participants has continued to increase since 2007, while the hours of instruction and the number of activities has decreased.

Type of Activity

The grand total types of activities supported directly by accredited CME providers are broken down below:

  • Courses: 49,808 activities, with 278,536 hours of instruction and 1,615,570 physician participants
  • Regularly scheduled series: 20,573 activities, with 447,214 hours and 4,353,909 physician participants
  • Internet (enduring materials): 17,681 activities, with 38,965 hours of instruction, and 4,004,372 physician participants
  • Enduring materials (other): 6,310 activities, with 33,471 hours of instruction and 1,131,683 total physician participants
  • Journal CME: 6,523 activities and 1,184,321 physician participants

Activities by Organization

The total numbers of directly sponsored activities based on type of CME provider and the top three formats of CME offered are as follows:

  • Hospital/health care delivery system: 42,708 activities. Courses (24,029); Regularly scheduled series (13,216); internet (enduring materials) (3,063)
  • School of medicine: 16,464 activities. Courses (7,681); Regularly scheduled series (6,401); internet (enduring materials) (1,838)
  • Publishing/education company: 18,020 activities. Courses (6,479); internet (enduring materials) (6,897); enduring materials other (3,912)
  • Nonprofit (physician membership organization): 13,601 activities. Courses (5,260); internet (enduring materials) (3,821); enduring materials (other) (1,183); journal CME (2,660)
  • Government or Military: 3,080 activities. Courses (1,703). Most hours as well for courses (24,029).

Overall, Courses were the most popular format for offering directly sponsored CME (49,808); followed Regularly scheduled series (20,573); internet (enduring materials) (17,681); enduring materials (other) 6,523; and Journal CME (3,483).

Hours of Instruction

Overall, Regularly scheduled series offered the most total hours of instruction for directly supported CME (447,214), followed by courses (278,536); and internet (enduring materials) 38,965. The breakdown by type of CME provider is as follows:

  • Hospital/health care delivery system: 339,295 hours; most hours are Regularly scheduled series (235,844)
  • School of medicine: 268,848 hours; most hours Regularly scheduled series (193,244)
  • Nonprofit (physician membership organization): 96,827 hours; most hours courses (59,405)
  • Publishing/education company: 53,264 hours; most hours courses (25,181); internet (enduring materials) (8,216); enduring materials (other) (15,265)
  • Government or Military: 21,973 hours; most hours courses (16,296)
  • Non-profit (other) 21,817 – most hours courses (12,455)

Physician Participants

Below is the number of total physician participants attending CME programs based on the provider of the CME.

  • Publishing/education company: 3,946727 participants; most participants: internet (enduring materials) 2,779,017; enduring materials (other) 868,654; courses (110,457)
  • Hospital/health care delivery system: 3,021,772 participants; most participants: Regularly scheduled series (2,212,258); courses (498,884); internet (enduring materials) 176,394
  • School of medicine: 2,421,298 participants; most participants Regularly scheduled series (2,032,658); courses (253,124); internet (enduring materials) 107,532
  • Nonprofit (physician membership organization): 2,818,852 participants; most participants journal CME (998,261); courses (636,724); internet (enduring materials) 794,800

For jointly sponsored events, the total physician participants are as follows:

  • School of medicine : 800,700 participants; most participants internet (enduring materials) (484,615); Regularly scheduled series (148,522); courses (119,074)
  • Publishing/education company: 368,512 participants; most participants journal CME (195,710); internet (enduring materials) 100,780; courses (55,213)
  • Nonprofit (physician membership organization): 283,658 participants; most participants courses (163,497); internet (enduring materials) (65,749); Regularly scheduled series (21,732)
  • Hospital/health care delivery system: 180,234 participants; Regularly scheduled series (87,094); courses (75,067); internet (enduring materials) (12,546)
  • Non-profit (other): 98,318 participants


Overall, publishing/education companies have the most physician participants (4,315,239) followed by:

  • School of medicine – 3,221,998
  • Hospital/health care delivery system – 3,202,006
  • Nonprofit (physician membership organization) – 3,102,510
  • Non-profit (other) – 250,905
  • Insurance company/managed care company – 135,405
  • Government or Military – 92,567
  • Not classified – 77,575

Cost Per Physician Participant

In 2012, the cost per physician participant in CME programs varied widely, from $63.89 for hospital physicians to $1,045.37 for government or military participants.


The CME Economy is finally turning around, which given the current financial circumstances hopefully we have seen the end of years of decline. The trend for the reduction in commercial support by companies fails to take into account that those resources and courses supported by industry may no longer be in existence or available to clinicians. There is a down side potential for physicians not getting the latest information on therapies that could potentially save patients' lives.

With the Physician Payment Sunshine Act final rule recognizing the value of continuing medical education we are encouraged that the state of CME will again become as robust as before.

July 30, 2013

FDA Patient Focused Drug Development

Richard M. Klein, Director of the Patient Liaison Program in FDA's Office of Health and Constituent Affairs, recently wrote at FDA Voice about the agency's efforts in patient-focused drug development. Klein discussed the FDA's Patient-Focused Drug Development initiative, a part of the FDA's commitment under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V).

The FDA states: "In PDUFA V, FDA also committed to a new initiative called Patient-Focused Drug Development with the goal of obtaining the patient perspective on certain disease areas during the five year period of PDUFA V. Assessment of a product's benefits and risks involves an analysis of the severity of the condition treated and the current treatment options available for the given disease. This information is a critical aspect of FDA's decision-making as it establishes the context in which the regulatory decision is made."

Klein writes that the FDA will hold at least 20 public meetings over the next 5 years, each focused on a different disease area. The information discussed will be summarized for consideration by the agency when making regulatory decisions in a therapeutic area.

The FDA's first meeting was with chronic fatigue syndrome and myalgic encephalomyelitis patients on April 25, 2013. The second meeting, on June 14, 2013, discussed HIV-AIDS. At each meeting, the agency learned from patients about their current treatment options. The agency's third meeting was on June 28, 2013 and focused on lung cancer. 13 additional disease areas have been selected for future meetings.


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