Policy and Medicine

AMSA Expanding Anti-Industry Scorecard to 400 Teaching Hospitals

We recently reported on a survey of 1,610 first- and third-year medical students and 739 residents regarding conflict of interest (COI) policies and their interactions with industry.  In our story, we noted that almost every year, the American Medical Students Association (AMSA) publishes a yearly “PharmFree Scorecard” that evaluates the COI policies at American medical schools.  Here is a little background and history on AMSA.

The PharmFree Scorecard is funded through the Consumer and Prescriber Education grant program, which resulted from the Neurontin settlement back in 2004.

It is because of organizations like PharmFree that frame all physician-industry collaboration as negative or unethical, that patients, physicians and biopharmaceutical professionals need a voice in the “conflict of interest mania,” such as the recently launched Partners for a Health Dialogue.  

Interestingly, while we cited to the 2012 results, AMSA just released its 2013 Scorecard, the sixth iteration of the scorecard.  The release comes as AMSA hosts its National PharmFree Week April 8-12, 2013.  The annual event “highlights the importance of putting patients first by addressing conflicts of interest and encouraging evidence rather than marketing-based education.”  Below is a summary of this year’s findings as well as additional information about AMSA activities. 

Interestingly, AMSA and Pew announced with this year’s data that they were also charged through a grant from the Oregon State Attorney General’s office to update the AMSA PharmFree Scorecard and expand it to 400 teaching hospitals.  Alongside Dr. Joseph Ross of Yale Medical School who served as a Methodology Consultant, AMSA and Pew developed the new AMSA PharmFree Scorecard set for release in 2014.  Given that payments to teaching hospitals must be reported under the Physician Payment Sunshine Act, the new scoring of teaching hospitals will bring increased scrutiny to physician-industry interactions at such hospitals.  

There will be two versions of the new Scorecard - one for medical schools and another for teaching hospitals.  The number of domains for the Scorecard has also expanded with 16 domains common to both versions and 2 additional domains for “Samples” and “Purchasing and Formulary Committees” specific to the teaching hospital version.  Other revisions to the Scorecard will include a new formula for assessing academic medical centers as well as revisions in the framework for grading schools.

 

2013 Findings

 

“Conflict of interest policies discourage inappropriate relationships and allow transparent and positive industry-physician collaborations to thrive,” said Daniel Carlat, director of the Pew Charitable Trusts’ prescription project, which supports AMSA’s work. “The 2013 scorecard shows medical schools are moving toward stronger conflict-of-interest standards.”

 

As of April 9, 2013, 153 out of 158 medical institutions considered eligible for grading have participated in the Scorecard, a 97% participation rate.  Of these 158 US medical schools, 40 receive “A”s (25%), 75 “B”s (47%), 14 “C”s (9%), and 13 “D”s (8%).  Thus, 115 of 158 medical schools (73%) now receive a grade of A or B for their COI policies, compared with 102 last year.  Approximately 8% of U.S. medical schools improved their COI policies since the 2011-2012 Scorecard.

 

Policies that apply only to medical students and/or residents, but not faculty, and (2) Policies that are only guidelines, without formal requirements, may only achieve a maximum grade of C.

 

13 schools (8%) receive a grade of F.  This includes 3 schools that submitted policies graded as F, two schools that stated they had no COI policy in place, and five schools that did not respond to repeated attempts at follow-up in 2008, 2009, 2010, 2011-12 and 2012-2013.  Three additional schools received an F as they did not submit new policies or demonstrate a continuing policy development process after remaining In Process for one year.  Three schools (2%) received a grade of In Process.  Here are some highlights from this year’s report:

 

• Roughly 80% of medical schools have perfect or close to perfect policies for on-campus CME.
• Only 4 medical schools – Univ. of South Dakota Sanford School of Medicine, Florida State Univ. College of Medicine, Stony Brook Univ. School of Medicine, and the Commonwealth Medical College -- completely ban sales representatives from campus.

• Only 41 schools (26%) have model policy in terms of disclosure, requiring personnel to disclose past and present financial ties with industry (e.g., consulting and speaking agreements, research grants) on a publicly-available website and disclosing these relationships to patients.
• All 8 of the Texas medical schools scored at least a B.  The University of Texas Medical Branch at Galveston, however, remains the lone A in the Lone Star state. All three of the Maryland medical schools scored at least a B, with both Johns Hopkins and University of Maryland Schools of Medicine receiving an A.
• Schools with model policies on speaking arrangements have grown tremendously; 44 schools ban or severely restrict participation in speaker bureaus.

 

Specifically, 18 schools have banned participation by their faculty on speakers’ bureaus: Harvard Medical School, NYU School of Medicine, Duke Univ. School of Medicine, Columbia Univ. College of Physicians and Surgeons, Univ. of Arkansas School of Medicine, Univ. of Maryland School of Medicine, Georgia Health Sciences Univ., Univ. of South Carolina School of Medicine, Univ. of Hawai’i John A Burns School of Medicine, Creighton Univ. School of Medicine, Wake Forest Univ. School of Medicine, Univ. of Massachusetts Medical School, Emory Univ. School of Medicine, Stanford Univ. School of Medicine, Albert Einstein College of Medicine, Univ. of Alabama Birmingham, Univ. of Florida and Jefferson Medical College.

 

The following is a list of domains and the number of perfect scores in each in 2013:

 

• 28 Schools have perfect scores for “On-campus continuing medical education;” improved from 20 in 2011-2, 15 in 2010, 3 in 2009 and 5 in 2008.  On-site education means within the medical school or hospital campus.  To gain a perfect score, “Industry is not permitted to provide direct financial support for educational activities, including CME, directly or through a subsidiary agency.  (However, companies may contribute unrestricted funds to a central fund or oversight body at the AMC, which, in turn, would pool and disburse funds for programs that are independent of any industry input or control.)”

 

• 98 medical schools have “Less stringent limitations to ensure independence of educational content (e.g., standards to establish freedom from industry influence of content, such as review and approval of presentations; language that prevents industry from selecting the speaker; a requirement that programs adhere to ACCME standards; or language such as: industry funding may be allocated for a particular topic, but must be provided directly to the department, not to individuals).  Despite trying to discredit the ACCME as a “non-governmental” organization, CMS recently recognized the critical importance of the ACCME Standards for Commercial Support in the final Sunshine Act rule, and non-compliance with such standards can result in loss of accreditation. 

 

• Off-campus continuing medical education –  102; improved from 88 in 2011-2, 75 in 2010, 49 in 2009 and 23 in 2008.  Off-site education is at outside facilities, including professional conferences.  AMSA measures this category based on how schools regulate compensation for travel or attendance at off-site lectures and meetings.  To gain a perfect score, “Personnel may not accept payment, gifts or financial support from industry to attend lectures and meetings. (An exception may be made for modest meals, if part of a larger program.)  Travel support may only be accepted if it is subject to institutional approval or industry is prevented from selecting (“earmarking”) the recipients.”  It is unclear, however, whether this category captures accredited CME or simply all off-campus educational events.

 

• Scholarships & Funds for Trainees – 123; improved from 108 in 2011-2, 94 in 2010, 66 in 2009 and 29 in 2008.  To gain a perfect score, “The policy must either prevent industry from earmarking or awarding funds to support the training of particular individuals (recipients must be chosen by the school or department), or the policy must mandate institutional review of the giving of funds. (This does not preclude grants that fund a specific research project.)”

 

• Gifts & Meals – 93; improved from 81 in 2011-2, 66 in 2010, 44 in 2009 and 19 in 2008.  To gain a perfect score in Gifts & meals, “All gifts and on-site meals funded by industry are prohibited, regardless of nature or value.”  Less stringent include limitations such as prohibitions above $50 per year, or gifts prohibited but meals allowed.

 

• Disclosure – 41; improved from 29 in 2011-2, 20 in 2010,  5 in 2009 and 1 in 2008.  To gain a perfect score, “Personnel are required to disclose past and present financial ties with industry (e.g., consulting and speaking agreements, research grants) on a publicly-available website and/or disclose such relationships to patients when such a relationship might represent an apparent conflict of interest.”

 

• Curriculum – 79; improved from 69 in 2011-2, 48 in 2010, 28 in 2009, and 12 in 2008.  To gain a perfect score, “Students are trained to understand institutional conflict-of-interest policies and recognize how industry promotion can influence clinical judgment.”

 

• Consulting (excluding scientific research and speaking) – 71, improved from 64 in 2011-2, 49 in 2010, 27 in 2009, and 12 in 2008.  To gain a perfect score, consulting relationships “must be subjected to institutional review or approval. Additionally, they must either be described in a formal contract, or payment for services must be commensurate to the task.” 

 

• Sales representatives – 4; improved from both 2 in 2011-2 and 2010, and both 1 in 2009 and 2008.  To gain a perfect score, “Pharmaceutical and device representatives are not allowed to meet with faculty regardless of location, or are not permitted to market their products anywhere inside the medical center and associated clinics and offices. (Exceptions may be made for non-marketing purposes, such as training on devices or equipment.)”

 

• Purchasing & Formularies – 83; improved from 70 in 2011-2, 66 in 2010, 47 in 2009, and 22 in 2008.  To gain a perfect score, “Formulary committees and committees overseeing purchases of medical devices should exclude those who have financial relationships with drug or device manufacturers.  Exclusion may be specific to participation in particular decisions for which the staff member has a conflict of interest.  This policy does not prevent expert clinicians from advising a committee, provided that potential conflicts are disclosed.  (Note: this standard is not intended to prohibit indirect financial interests, such as investments in mutual funds that may own pharmaceutical company shares).”  

 

• Samples – 42, improved from 31 in 2011-2, 26 in 2010, 20 in 2009, and 12 in 2008.  To gain a perfect score, “Industry samples are prohibited, except under certain narrow circumstances approved by the institution that protect the interests of patients and prevent the use of samples as a marketing tool (e.g., policies that allow samples under limited circumstances with the approval of the Pharmacy and Therapeutics (P&T) Committee or policies that incorporate samples into a larger program designed to ensure the availability of brand-name and generic medications to under-insured patients; if the circumstances of the specific program are not defined, the policy should define the approvals process). Where there is a specific program in place, the policy must prevent samples from being given directly to physicians by pharmaceutical sales representatives.”

 

• Industry-funded speaking – 44; improved from 31 in 2011-2, 19 in 2010, 10 in 2009, and 4 in 2008.  To gain a perfect score, “Speaking relationships are prevented from functioning as de facto gifts or marketing.  An effective policy must not implicitly permit (a) long-term speaking agreements or (b) industry to have a role in determining presentation content.  (Some effective policies may explicitly prohibit participation in a speakers bureau.  Other effective policies contain elements such as limits on compensation and reimbursement and a requirement to ensure the scientific integrity of information presented.)”

 

Similar to the results of the past, the areas that garnered the greatest number of perfect scores were those addressing industry support of scholarships, off-campus “CME,” faculty participation in industry-speaking relationships, purchasing and formulary committees, and gifts.  Industry support of scholarships experienced the largest net growth in achieving perfect scores in this domain (15 additional medical schools).  New areas being addressed by schools include samples as well as purchasing and formula committees.  AMSA says that “on-campus CME” remains a challenging area.

 

Regional Trends

Californian medical schools continued to excel with 7 of their 10 schools receiving an A grade.  This is in part due to the strong system-wide University of California (UC) COI policy, which when graded on its own receives an A grade.  However, some of the UC schools go even further by supplementing the system-wide policy with their own regulations.  Texan schools continue to show significant improvement.  All eight Texan medical schools score at least a B.  University of Texas Medical Branch at Galveston, however, remains the lone A in the Lone Star state.

 

Another major training ground, Massachusetts, continues to show case schools with model policies. This year, University of Massachusetts Medical School and Boston University both received a B grade while Harvard Medical School and Tufts University School of Medicine both received an A grade.

 

The nine Pennsylvania medical schools have strong policies and in Maryland, all three schools (Johns Hopkins University, University of Maryland, and Uniformed Services of the Health University) received a B grade or higher.  Finally, the state of Florida continues to perform well.

 

Methods

 

The PharmFree Scorecard methodology was developed jointly by AMSA and the Pew Prescription Project, an initiative of the Pew Health Group.  Assessed domains are broadly consistent with those identified in recent literature – primarily Brennan et al. Health Industry Practices that Create Conflicts of Interest:  A Policy Proposal for Academic Medical Centers.  JAMA 2006; 295(4): 429-433.

 

The Scorecard assesses policies related to: (1) acceptance of gifts and meals from industry; (2) consulting relationships; (3) speaking relationships; (4) disclosure of financial conflicts; (5) pharmaceutical samples; (6) individuals with financial conflicts participating in university purchasing decisions; (7) financial support for educational events (on- and off-campus); (8) industry support for scholarships and trainee funds; (9) access of industry sales personnel to medical school or hospital personnel; and (10) inclusion of education about conflict of interest within the academic curriculum. Additionally, the presence of oversight and sanctions is examined, but not included in grade calculation.

 

AMSA maintains that “Two blinded assessors independently score each set of policies in the eleven areas included in the scorecard.”  How can such assessors be blinded if they are working for AMSA/Pew, and are clearly anti-industry and biased towards any kind of industry interactions or collaboration?

 

Other AMSA Initiatives

 

Of particular interest is a new initiative known as the “2^nd Slide Campaign,” which is based off the standard practice in graduate and continuing medical education (CME) to disclose conflicts of interest on the 2^nd slide of one’s presentation.  “The premise of this campaign is simple: medical students should receive the same types of disclosures that educators provide in other types of medication.”  AMSA notes that “most medical schools lack clear guidelines to help faculty members disclose conflicts of interest to students.”

 

AMSA provides a sample disclosure slides and other information for medical students to bring about change in their medical schools. AMSA provides three scenarios for when a lecturer should disclose interests to students, and tailors their example disclosure slides to such scenarios:

 

-          Lecturer has conflicts of interest but they are not relevant

-          The lecturer has no conflicts of interest

-          The lecturer has relevant conflicts of interest to disclose to the students 

AMSA said that such disclosures matter because it is “vital” that medical students and “know where information comes from.”  AMSA calls for such disclosure because “research shows that financial conflicts of interest can impact (even subconsciously!)the presentation and interpretation of data.”  AMSA also has resourcs for a PharmFree Curriculum and “Best Practice Policies,” such as for gifts, meals, and samples.  

Given the already hurried schedules of physicians and medical students, will there really be enough time for medical professors to address and discuss potential conflicts with students?  Will such disclosures even matter to students?  It seems more appropriate that this subject be clearly addressed in a standard medical ethics course over the course of medical school, not during each lecture given, particularly in light of the Sunshine Act, which will allow medical students to do their own research on professors, if they desire.   

One interesting new program that AMSA appears to have started is the “National Opt Out Day.”  Specifically, AMSA “asked graduating fourth year members to tell the American Medical Association (AMA) that they are opting out of the AMA Physician Masterfile!”  “As physicians who strive to practice evidence-based medicine, we do not want our personal and prescribing information sold to the pharmaceutical and medical device industries.”  The AMA Physician Masterfile was established by the AMA in 1906 as a record keeping device supporting membership and mailing activities. The Physician Masterfile includes current and historical data for more than 1.4 million physicians, residents and medical students in the United States. 

AMSA also hosted a webinar with the University of Miami Miller School of Medicine to discuss how the school improved their conflict of interest policies as well as the barriers both current and past to implementing change.  Executive Dean of Education and Policy Dr. Laurence Gardner will be presenting. 

AMSA noted that in addition to Pew, it has joined forces with the National Physicians Alliance (NPA) and Community Catalyst to create both external and internal pressure for medical schools and academic medical centers to adopt strong COI policies, through a new initiative- the Partnership to Advance Conflict-Free Medical Education (PACME).  They noted how NPA’s Unbranded Doctor campaign provides resources for conflict-free medical practice including an archive of past events including bimonthly Conflict-Free Leadership Calls and National Grand Rounds. 

Community Catalyst is in the process of developing a series of toolkits to help institutions improve their policies with examples of language from other model institutions and provides technical assistance to schools via regional roundtable and individual consultation.

 

 

Partners for Healthy Dialogues: Offers Prescription for Healthy Physician-Industry Interactions

When it comes to our health, “collaboration between physicians and biopharmaceutical professionals is essential to improving the care we receive and developing new medicines.  Whether it is collaborating on research for new medicines or learning about the latest treatment options, interactions between physicians and biopharmaceutical professionals lead to better health and better medicine.” 

This simple motto underlies a critical new initiative launched by a wide range of organizations, known as the “Partners for Healthy Dialogues.”  The partnership is a collaboration between health care provider organizations and biopharmaceutical organizations to demonstrate the value of interactions between physicians and biopharmaceutical companies, from better patient care to advancing medical innovation.  The Partners include: 

-          American Association of Neurological Surgeons (AANS)

-          American College of Preventive Medicine (ACPM)

-          American Osteopathic Association (AOA)

-          American Urological Association (AUA)

-          The Congress of Neurological Surgeons (CNS)

-          National Council of Asian Pacific Islander Physicians (NCAPIP)

-          The Pharmaceutical Research and Manufacturers of America (PhRMA)

-          The Society of Pharmaceutical and Biotech Trainers (SPBT) 

The initiative was launched largely in response to the Physician Payment Sunshine Act—Section 6002 of the Patient Protection and Affordable Care Act (PPACA), and the finalized regulations issued by the Centers for Medicare & Medicaid Services on February 1, 2013.  The Sunshine Act will increase transparency when a new public database will outline the specifics of these interactions.   

Ethical interactions between biopharmaceutical companies and health care professionals and increased transparency are essential to strengthening patient trust in our health care system.  The Partnership is working closely with CMS to ensure that the database and information will provide simple, clear, and unbiased information so that patients and other stakeholders can better understand how these interactions improve their health and well-being.  

Partners for Healthy Dialogues support transparency and the principles of the Sunshine Act, and is committed to providing meaningful background about ways in which physicians and the biopharmaceutical industry collaborate for patients.  The Partnership noted that while efforts like ProPublica’s Dollars for Docs could help raise awareness for these collaborations, the limited information runs the risk of not fully conveying how and why these interactions occur. 

With proper context, the Sunshine Act has the potential to help patients understand how their physicians work with biopharmaceutical professionals and how these interactions benefit their health and, more broadly, medical innovation.  Partners for Healthy Dialogues was created to provide details about these collaborations and help the public understand why these interactions are essential to lifesaving medical breakthroughs, the development of new medicines, and improvements in the care we all receive.”   

As the Sunshine Act is implemented, the mission of the Partnership is to provide clear, helpful information to three core groups: (1) patients; (2) health care professionals; and (3) biopharmaceutical professionals.  Below is a summary of information that the Partnerships provides for each stakeholder.  

Patients  

Collaboration between physicians and biopharmaceutical professionals can improve patient health and advance medical innovation.  A biopharmaceutical company may compensate doctors for a number of reasons all of which are rooted in patient care and/or medical innovation.  What does this collaboration mean for patients and how does it happen?  

Over the past few decades, the lives of physicians have become increasingly complex.  From significant amounts of paperwork to evolving administrative duties and increasing patient needs, physicians are busier than ever, particularly with the advent of health information technology (HIT) and electronic health records (EHRs).  Despite this increasing workload, physicians must remain current on the latest medical knowledge and practice standards, including research on new treatments and medicines.  

In 2005, however, researchers found that a primary care physician would have to read 341 relevant medical journals and 7,287 monthly articles, equaling more than 627 reading hours per month, to stay up-to-date on all medical literature.  Here is a breakdown of how physicians spend their day: 

• 55% – Face-to-face patient care describes any time spent interacting directly with patients in a clinical setting 
• 14.5% – Visit-specific work outside of the exam room
  • Reviewing the medical record
  • Writing notes and completing patient encounter forms
  • Arranging for tests or consultations and writing prescription
• 23% – Work related to patients not currently being seen
  • Reviewing medical records and lab results/writing notes
  • Making telephone calls or receiving them from patients
  • Fielding patient-related questions from staff
  • Interacting with insurance companies
  • Looking up medical information
• 7.5% – Administrative and academic activities and patient care in other settings
  • Hospital rounds and teaching
  • Office management
  • Research and reading the latest medical information
  • Home visits 

Patients should understand that their physicians are concerned about their caseloads.  In a recent survey, more than 75% of physicians said their practices are either at “full capacity” or that they are “overextended and overworked.”  Making matters worse, physicians will become even busier over the next several years as we continue to see declining number of primary care physicians, which accounts for more than a third of all practicing physicians in the United States.  In fact, American Medical Association (AMA) President Jeremy A. Lazarus recently recognized that the U.S. “will face a shortage of 130,000 physicians across all specialties by 2025” and that this “shortage will be exacerbated by the increased demand on our health care delivery system as more seniors enroll in Medicare and newly insured Americans seek access to care. 

Physicians turn to multiple sources of information to make decisions about prescriptions and care, including 1) their clinical knowledge and experience, 2) their patients’ responses to particular medicines, 3) each patient’s particular situation, which might include drug interactions, side effects and contraindications, 4) clinical practice guidelines, 5) discussions with colleagues/peers, and 6) articles in peer-reviewed journals.   

For example, a recent survey showed that physician’s best means for learning about new medications and treatments is industry-supported continuing medical education (CME) programs (52%), followed by medical journals (51%), followed by industry (17%), colleagues (14%), and internet (including social media) content (13%).  66% of respondents said they trust the information they get from industry.  Physicians weigh all of this information when making the best prescribing decisions for you.   

However, a 2011 survey showed that more than four in 10 physicians find it difficult to stay informed about new medicines, but 79 percent said meetings and discussions with biopharmaceutical professionals are help ensure that they stay current on medical information while balancing heavy workloads to address these concerns.  As physicians’ time becomes more and more limited, sometimes the only available time to meet with a biopharmaceutical professional to catch up on the latest developments related to medicines is over a brief lunch break, which is typically modest in nature, such as a sandwich or salad. 

Biopharmaceutical professionals spend this time keeping physicians abreast of emerging safety, benefit, and risk information; new studies and the latest clinical information and trial results; appropriate dosing; new FDA approved drugs and treatments; and new indications, as appropriate.  Such information is critical to physicians because it could affect their decisions about appropriate patient care.  For example, many medicines require post-approval research to ensure that medicines are being used safely and appropriately.  By meeting with physicians to convey such information, such as a safety concern, companies ensure that patients using that product are provided with alternatives to avoid a treatment gap.

Such professionals also engage with physicians to discuss the ways their patients respond to the company’s medicines beyond a controlled clinical trial setting and to discuss disease challenges more broadly.  These in-person meetings provide a level of detail that a physician cannot get through literature alone.  In addition, physicians can ask questions specific to a medicine that the biopharmaceutical professional has deep expertise and knowledge about or the professional can refer the physician to the company’s medical liaison for even more specialized information. 

These conversations enable physicians to share real-world feedback on how well the medicines are working, how patients react to prescribed medicines, patient compliance, and any side effects.  This information helps companies make improvements and advancements for patient care and can prompt biopharmaceutical professionals to conduct additional research that could translate into a product change or new treatment protocols that can benefit patients.  

Physician meetings with biopharmaceutical professionals are also critical because physicians learn about company-sponsored programs that offer free or discounted treatments from their doctors to patients who do not have prescription drug coverage.  This helps ensure that patients can actually take their medicines as prescribed, which can benefit their health, and reduce the need for hospitalizations and other expensive medical care.  Such meetings also ensure, in compliance with federal and state law, that physicians can give samples to patients to help start treatment early or to determine proper dosing or any unwanted side effects. 

Ultimately, patients should understand that your physician collaborates with biopharmaceutical professionals to get the information they need to make the best health care decisions for you.  Moreover, federal law strictly prohibits companies from compensating physicians for prescribing a particular medicine or course of treatment.  Instead, doctors rely on the information noted above in making their prescribing decisions and make such choices on a case-by-case basis and in the best interest of each patient.  Further, over 75% of prescriptions in the U.S. are for generic drugs.  

Patients – Research 

Before medicines are approved for patient use, they must be tested extensively through clinical trials.  The discovery of new and improved medicines is dependent on research collaborations between physicians and biopharmaceutical companies.  In fact, new medications cannot be sold in the United States until they have been tested through clinical trials.  Clinical trials sponsored by biopharmaceutical companies have led to life-saving breakthroughs for people suffering from cancer and other life-threatening diseases.  These include the first ever vaccine to protect against cervical cancer, a breakthrough treatment for Cystic Fibrosis, and a therapy that helps adults suffering from multiple sclerosis. 

Patients should understand that physicians play an integral role in the success of clinical trials, as they carry out research, track patient progress, report the research in peer-reviewed journals, and complete patient evaluation forms, among other responsibilities.  Physicians are compensated appropriately for the time all this work requires, and never based on the outcome of the trial results (click here for the Sunshine Regs on research payments).  Physicians who participate in clinical trials are likely to have a better understanding of research outcomes and to interpret the data objectively.  Moreover, biopharmaceutical companies respect the independence of physicians and entities involved in clinical research to exercise their judgment to ensure that results are interpreted fairly. 

Patients should also be aware that biopharmaceutical companies, the federal government, academic medical centers and hospitals sponsor clinical trials.  In fact, 70% of funding for clinical trials in the U.S. comes from the biopharmaceutical industry. In a recent survey of physicians, 94 percent felt that it is useful for biopharmaceutical companies to sponsor clinical trials to research new medicines and treatments.  

Clinical trials occur across the country, with over 2,000 in Massachusetts in state clinical research centers, university medical schools and hospitals, who are working together with biopharmaceutical companies to target the nation’s six most debilitating and chronic diseases.  As the health care environment continues to rapidly evolve, these collaborations will remain crucial to the discovery of new and improved medicines and to address unmet medical needs worldwide and harness the full potential of new scientific discoveries. 

Patients should also be aware that companies work with physicians to conduct research throughout the entire lifetime of a medicine, long after FDA-approval.  In fact, many biopharmaceutical companies invest more than a third of their research budget on post-approval studies related to safety to ensure that physicians continue to use such drugs safely, appropriately and effectively with patients. 

Regulations for the conduct of clinical research are enforced by the FDA, but many different entities and individuals contribute to the safe and appropriate conduct of clinical research, including investigative site staff and medical professionals who serve as clinical investigators; hospitals and other institutions where research is conducted; and institutional review boards and ethics committees.  The public or private entity that conducts the trial is responsible for the ethical conduct of the study and for ensuring that rigorous scientific standards are upheld.  The American Medical Association has established guidelines for physician participation in clinical trials and all research collaborations between physicians and biopharmaceutical professionals are upheld with the highest professional standards, and by those set by their respective associations: 

• AOA – Code of Medial Ethics on Interactions
• American Association of Neurological Surgeons – Code on Interactions
• American Urological Association – Code of Ethics
• American College of Preventive Medicine – Code of Ethics
• PhRMA – Code on Interactions with Healthcare Professionals
• AMA – Code of Medical Ethics on Interactions
• AMA – Information on the Sunshine Act 

Patients – Company Sponsored Education 

In addition to the meetings that biopharmaceutical professionals have with physicians or group practices, biopharmaceutical companies sponsor speaker programs.  Company-sponsored education programs are one of the most useful ways for physicians to gain knowledge and skills that help their patients.  According to a 2011 physician survey, more than half of attendees at peer speaker events say they often gain knowledge or skills that are helpful to their practice. 

Physicians who attend and present at these events do so to 1) expand and improve their clinical knowledge; 2) learn about potential side effects of medicines; 3) learn about new uses for medicines; 4) learn about the latest clinical data; and 5) learn about the range of treatment options and emerging safety and risk information.  Many of these programs could not take place without the sponsorship of biopharmaceutical companies.  

Company-sponsored education programs also fill an educational gap and are especially important to for primary care and rural physicians charged with treating everything from lung conditions to migraines.  Moreover, physicians in rural communities have limited peer interactions and access to professional conferences.  A biopharmaceutical-sponsored event, led by a well-qualified physician, may be their most convenient opportunity to learn the latest information on treatments.  In fact, a 2011 survey showed that 86 percent of rural physicians attend company-sponsored education programs. 

Physician education programs allow physicians to interact face-to-face and learn about some of the most complex disease states and treatments available.  While medical technology evolves and becomes increasingly complex, face-to-face interactions among physicians provide a level of detail that is hard to capture in literature, including peer-reviewed journals.  In person education allows for an open discussion about advancements made in patient health and medical innovation.  This kind of interaction helps their peers gain a better understanding of specific therapies and also provides a forum for those who might have questions about treatment options. 

To help ensure that the scientific information presented is accurate and up to date, biopharmaceutical companies sponsoring these educational events comply with both federal requirements and stringent self-imposed standards.  For example, the FDA holds companies accountable for the presentations of their speakers; materials presented at these events must include all FDA-approved product information, and must be truthful, accurate and consistent with product labeling approved by the FDA. 

The PhRMA Code also contains detailed provisions specific to the conduct and training of speakers.  Under the PhRMA Code, company decisions regarding the selection of physicians are based on defined criteria such as medical expertise, reputation, knowledge and experiences in a particular therapeutic area, and communication skills.  Companies take active steps to ensure that qualified speakers are carefully vetted and meet the highest ethical standards whenever they present at company-sponsored educational events. 

Biopharmaceutical companies pay physician experts to speak at these seminars and educational programs because physicians are uniquely qualified to educate their peers about the medicines and treatments they prescribe and new innovations in an effort to foster improved patient care on a larger level.  Physicians receive reasonable compensation for their time to prepare and deliver the presentations, as is customary with most speaker programs.  Physicians who attend such programs may also receive compensation in the form of travel, lodging, meals, or educational items and materials such as slides or handouts.  Any compensation or reimbursement is based on fair market value, per PhRMA’s Code.   

Patients – Independently Accredited Education With Commercial Support 

By necessity, physicians are lifelong learners who must stay up-to-date on the evolving science of medicine.  However, for busy physicians, pouring over stacks of journal articles on the latest treatments may be unrealistic.  To address this concern, almost every state in the U.S. requires that physicians receive continuing medical education (CME) every year to maintain their license to practice.  CME offers a convenient opportunity to learn about new medicines that could prove safer and/or more effective for patients (click here for Sunshine Regs on CME).   

Consequently, some biopharmaceutical companies also provide financial support for CME.  The Accreditation Council for Continuing Medical Education (ACCME) sets the specific standards for such support, as well as the biopharmaceutical sector’s voluntary guidelines.  Biopharmaceutical companies sponsor CME programs to enable physicians to improve their clinical knowledge, learn about new uses for medicines, and present their own research findings about the impact of medicines and treatments for their patients.  These educational events are also designed to help raise awareness of innovative treatments—treatments that some doctors might not know exist—that can help improve the health of patients suffering from life-threatening and life-debilitating diseases such as cancer, heart disease, and diabetes.  

Sharing their experiences, knowledge and expertise with other physicians is a crucial part of the learning process and he exchange of such information improves patient care.  In fact, CME has been proven to improve patient outcomes in areas such as multiple sclerosis, hypertension, COPD, ICU patients, improved taking of family history by physician assistants, Sepsis, healthcare-associated infections, reduction in CT scans, and several other areas.   

HEALTH CARE PROFESSIONALS 

The page for health care professionals includes general information about the Sunshine Act regulations and requirements.  It informs physicians that transparency in the various activities noted above “can help maintain trust in the health care system.”  The page informs physicians that they, their patients, media, and other stakeholders may have questions about publicly disclosed payments.  Accordingly, this page provides resources to physicians to help answer those inquiries and other questions that may arise.  The page also provides resources to help physicians explain to your patients and the public the importance of collaboration.  In light of the upcoming deadline for companies to begin reporting—August 1, 2013—this page recommends that physicians: 

• Get details on the financial reporting requirements that biopharmaceutical professionals must follow in documenting interactions with physicians.
• Equip yourself with information and tools to share with patients how physician-biopharmaceutical professional collaboration helps them and furthers medical innovation.
• Download materials you can share with patients and peers, including FAQs, fact sheets, and a brochure. 

The site allows physicians to receive Sunshine updates, news and to be alerted when the new database goes live.  

Biopharmaceutical Professional 

This page explains to professionals that “implementation of the Sunshine Act begins now, and it’s important for you to understand what it means and how it impacts you and the physicians you work with.”  The page provides resources on the Sunshine Act and tips to help professionals talk about the various ways in which collaboration between biopharmaceutical professionals and physicians leads to better patient care and future medical innovations.  The page also allows professionals to sign up to receive information and updates as it becomes available.  In the meantime, the Partnership recommends that professionals: 

• Equip yourself with information and tools to share with physicians about how physician-biopharmaceutical collaboration helps them and furthers medical innovation.
• Share downloadable materials with your physician contacts to help them encourage a dialogue with their patients and peers, including FAQs, fact sheets, and a brochure.  

Finally, this page emphasizes the importance of biopharmaceutical professionals maintaining ethical and transparent relationships with all health care professionals, which is crucial to building trust in our health care system.  It also emphasizes the PhRMA Code on Interactions with Healthcare Professionals, which sets industry-wide standards for these interactions to ensure that they are professional, ethical, informational exchanges designed to benefit patients and to enhance the practice of medicine.

OIG Special Fraud Alert – Physician Owned Distributors

OIG recently published a Special Fraud Alert on physician-owned entities that derive revenue from selling, or arranging for the sale of, implantable medical devices ordered by their physician-owners for use in procedures the physician-owners perform on their own patients at hospitals or ambulatory surgical centers (ASCs). These entities frequently are referred to as physician-owned distributorships, or “PODs.” 

As noted by the FDA Law Blog, “This is not the first time the OIG has focused on PODS.  In a 2006 public letter, the OIG noted “an apparent proliferation of physician investments in medical device and distribution entities, including group purchasing organizations,” and stated that OIG guidance on joint ventures (which includes a safe harbor regulation on investment interests) would apply to such entities.”  The 2006 letter noted “the strong potential for improper inducements between and among the physician investors, the entities, device vendors, and device purchasers” and stated that such ventures “should be closely scrutinized under the fraud and abuse laws.”   

Accordingly, the Special Fraud Alert focuses on the specific attributes and practices of PODs that OIG believes produce substantial fraud and abuse risk and pose dangers to patient safety.  OIG reiterated its concern about the proliferation of PODs and OIG’s longstanding position that the opportunity for a referring physician to earn a profit, including through an investment in an entity for which he or she generates business, could constitute illegal remuneration under the anti-kickback statute.  Thus, OIG concluded that it will view PODs as inherently suspect under the anti-kickback statute.   

“We recognize that this valuable model bears a risk of abuse,” Steinmann, who also represents the industry trade group American Association of Surgeon Distributors, said in a phone interview with Bloomberg News.  “We’re happy that the OIG is creating clarity in defining the characteristics of distributorships that violate the public trust.”  Steinmann said that to his knowledge, neither his company nor any other associated with the trade group are under investigation by the inspector general. 

A recent legal analysis by Morgan Lewis describing the risks inherent in PODs can be obtained here.  The Advanced Medical Technology Association (AdvaMed) applauded OIG’s action “in recognizing the inherent conflict-of-interest risks posed by physician-owned distributors (PODs).  AdvaMed agreed with OIG PODs “produce substantial fraud and abuse risk and pose dangers to patient safety.” 

“PODs are controversial business arrangements in which physician-investors form companies that purchase medical devices from third-party manufacturers and sell them to hospitals, often to the hospitals at which the POD physician-investors practice,” AdvaMed wrote. 

“Transparent, ethical interactions between health care professionals and medical technology companies are critical to innovation and improved patient care. However, the emergence of companies with equity investments by physicians, who are also major revenue generators for the companies, raises important legal and policy issues relating to the potential effect on clinical decisions by physicians.” 

The Special Fraud Alert also comes “after the minority staff of the Senate Finance Committee issued a report on PODS, followed the same month by a letter to the OIG from the Committee expressing concern about potential federal health care program abuse by PODs and requesting the OIG to conduct an inquiry into these organizations,” noted the FDA Law Blog.   While “OIG’s FY 2012 and 2013 Work Plans refer to such a report in preparation, but none has been forthcoming yet,” the post noted. 

Interestingly, while applying to PODs, OIG clarified that the principles set forth in the Fraud Alert “would apply when evaluating arrangements involving other types of physician-owned entities.”  This is particularly interesting given the recent final rule issued by the Centers for Medicare & Medicaid Services (CMS) to implement the physician payment transparency (“sunshine”) provisions of the Affordable Care Act.  The Sunshine Act applies to group purchasing organizations” (GPOs), which will be required to report their physician ownership and investment interests, as well as the payments they distribute to their physician owners and investors.   

As the FDA Law Blog notes, “PODs that meet the rule’s definition of applicable GPOs will have to meet these reporting requirements.”  The post notes that “CMS takes the questionable position in the preamble that distributors who take title to federally reimbursable medical products are “applicable manufacturers” subject to sunshine reporting requirements.”  Under this interpretation, the authors write, “even PODs that are not GPOs will be required to report their physician ownership and investment interests as well as the payments they distribute to their physician owners and investors.”  

Highlighting the affect of this Special Fraud Alert and its potential implications for the Sunshine Act, OIG maintained that it does “not believe that disclosure to a patient of the physician’s financial interest in a POD is sufficient to address these concerns.”  As OIG noted in the preamble to the final regulation for the safe harbor relating to ASCs:  

…disclosure in and of itself does not provide sufficient assurance against fraud  and abuse…[because] disclosure of financial interest is often part of a testimonial,  i.e., a reason why the patient should patronize that facility.  Thus, often patients are not put on guard against the potential conflict of interest, i.e., the possible effect of financial considerations on the physician’s medical judgment. 

This reference raises problematic concerns given the nature of the Sunshine Act and the transparency website it requires for the posting of physician payments.  Moving forward, will it be OIG’s position that a physician who discloses their financial interest to a patient for speaking at an educational or promotional event or conducting clinical trials or research, is not sufficient, and therefore may raise medical necessity or other concerns? 

Will OIG now look at teaching hospitals and physician groups where individuals have certain thresholds of payments (e.g., over $50,000) and begin investigating the medical necessity or clinical appropriateness of their decisions because even if the physician/hospital made such disclosures to their patients, it would not be sufficient?   

For example, it was recently reported in Oregon that a physician is being sued by the State under state consumer protection laws, for the physician’s failure to make financial disclosures to the patients. How far reaching is OIG’s position on the insufficiency of financial disclosure?  Could this reach continuing medical education (CME) disclosures by faculty and speakers? 

If this is OIG’s position, physicians will likely continue to reject, prohibit or discontinue relationships and collaboration with industry, which may have harmful effects on medical progress that may ultimately delay treatment for patients.  Accordingly, it will be incumbent upon all stakeholders affected by the Sunshine Act to seek clarification from OIG and CMS on these issues, and how and whether OIG will use the Sunshine database for such purposes. 

“Anytime a few bad actors determine the treatment and care of patients, as this warning makes clear, patient safety is put at risk and millions of dollars are lost to fraud,” Senator Orrin Hatch of Utah, the senior Republican on the Senate Finance Committee who has been tracking the use of PODs, said in an e- mail to Bloomberg News.  “I will continue to scrutinize these high-risk structures and demand answers from HHS.”

PODs, or an actual or potential physician-owner, that have questions about the structure of a particular POD arrangement, may request an OIG Advisory Opinion. 

Background: Anti-kickback Statute 

 One purpose of the anti-kickback statute is to protect patients from inappropriate medical referrals or recommendations by health care professionals who may be unduly influenced by financial incentives.  Section 1128B(b) of the Social Security Act (the Act) makes it a criminal offense to knowingly and willfully offer, pay, solicit, or receive any remuneration to induce, or in return for, referrals of items or services reimbursable by a Federal health care program.  When remuneration is paid purposefully to induce or reward referrals of items or services payable by a Federal health care program, the anti-kickback statute is violated.  

By its terms, the statute ascribes criminal liability to parties on both sides of an impermissible “kickback” transaction.  Violation of the statute constitutes a felony punishable by a maximum fine of $25,000, imprisonment up to 5 years, or both. Conviction will also lead to exclusion from Federal health care programs, including Medicare and Medicaid.  

Longstanding OIG guidance makes clear that the opportunity for a referring physician to earn a profit, including through an investment in an entity for which he or she generates business, could constitute illegal remuneration under the anti-kickback statute. The anti-kickback statute is violated if even one purpose of the remuneration is to induce such referrals.  

OIG has repeatedly expressed concerns about arrangements that exhibit questionable features with regard to the selection and retention of investors, the solicitation of capital contributions, and the distribution of profits. Such questionable features may include, but are not limited to:  

(1)  selecting investors because they are in a position to generate substantial business for the entity,

(2)  requiring investors who cease practicing in the service area to divest their ownership interests, and

(3)  distributing extraordinary returns on investment compared to the level of risk involved.  

“PODs that exhibit any of these or other questionable features potentially raise four major concerns typically associated with kickbacks— 

• corruption of medical judgment,
• overutilization,
• increased costs to the Federal health care programs and beneficiaries, and
• unfair competition.”  

This is because the financial incentives PODs offer to their physician-owners may induce the physicians both to perform more procedures (or more extensive procedures) than are medically necessary and to use the devices the PODs sell in lieu of other, potentially more clinically appropriate, devices.  OIG is “particularly concerned about the presence of such financial incentives in the implantable medical device context because such devices typically are “physician preference items,” meaning that both the choice of brand and the type of device may be made or strongly influenced by the physician, rather than being controlled by the hospital or ASC where the procedure is performed.  

The lawfulness of any particular POD under the anti-kickback statute depends on the intent of the parties. Such intent may be evidenced by a POD’s characteristics, including the details of its legal structure; its operational safeguards; and the actual conduct of its investors, management entities, suppliers, and customers during the implementation phase and ongoing operations.  Nonetheless, OIG reiterated its belief that PODs are inherently suspect under the anti-kickback statute, and noted its particularl concern when PODs, or their physician-owners, exhibit any of the following suspect characteristics:  

• The size of the investment offered to each physician varies with the expected or actual volume or value of devices used by the physician.
• Distributions are not made in proportion to ownership interest, or physician-owners pay different prices for their ownership interests, because of the expected or actual volume or value of devices used by the physicians.
• Physician-owners condition their referrals to hospitals or ASCs on their purchase of the POD’s devices through coercion or promises, for example, by stating or implying they will perform surgeries or refer patients elsewhere if a hospital or an ASC does not purchase devices from the POD, by promising or implying they will move surgeries to the hospital or ASC if it purchases devices from the POD, or by requiring a hospital or an ASC to enter into an exclusive purchase arrangement with the POD.
• Physician-owners are required, pressured, or actively encouraged to refer, recommend, or arrange for the purchase of the devices sold by the POD or, conversely, are threatened with, or experience, negative repercussions (e.g., decreased distributions, required divestiture) for failing to use the POD’s devices for their patients.
• The POD retains the right to repurchase a physician-owner’s interest for the physician’s failure or inability (through relocation, retirement, or otherwise) to refer, recommend, or arrange for the purchase of the POD’s devices.
• The POD is a shell entity that does not conduct appropriate product evaluations, maintain or manage sufficient inventory in its own facility, or employ or otherwise contract with personnel necessary for operations.
• The POD does not maintain continuous oversight of all distribution functions.
• When a hospital or an ASC requires physicians to disclose conflicts of interest, the POD’s physician-owners either fail to inform the hospital or ASC of, or actively conceal through misrepresentations, their ownership interest in the POD.  

OIG clarified that these criteria are not intended to serve as a blueprint for how to structure a lawful POD, as an arrangement may not exhibit any of the above suspect characteristics and yet still be found to be unlawful. Other characteristics not listed above may increase the risk of fraud and abuse associated with a particular POD or provide evidence of unlawful intent.  For example, a POD that exclusively serves its physician-owners’ patient base poses a higher risk of fraud and abuse than a POD that sells to hospitals and ASCs on the basis of referrals from nonowner physicians.  

OIG also noted that PODs that generate disproportionately high rates of return for physician-owners may trigger heightened scrutiny.  Because the investment risk associated with PODs is often minimal, a high rate of return increases both the likelihood that one purpose of the arrangement is to enable the physician-owners to profit from their ability to dictate the implantable devices to be purchased for their patients and the potential that the physician-owner’s medical judgment will be distorted by financial incentives.  

OIGs concerns are magnified in cases when the physician-owners: (1) are few in number, such that the volume or value of a particular physician-owner’s recommendations or referrals closely correlates to that physician-owner’s return on investment, or (2) alter their medical practice after or shortly before investing in the POD (for example, by performing more surgeries, or more extensive surgeries, or by switching to using their PODs’ devices on an exclusive, or nearly exclusive basis).  

In concluding, OIG noted that it did not want to discourage innovation for PODs that purport to design or manufacture their own devices.  However, claims—particularly unsubstantiated claims—by physician-owners regarding the superiority of devices designed or manufactured by their PODs do not disprove unlawful intent.  OIG maintained that “the risk of fraud and abuse is particularly high in circumstances when such physicians-owners are the sole (or nearly the sole) users of the devices sold or manufactured by their PODs.” 

Finally, because the anti-kickback statute ascribes criminal liability to parties on both sides of an impermissible “kickback” transaction, hospitals and ASCs that enter into arrangements with PODs also may be at risk under the statute.  In evaluating these arrangements, OIG will consider whether one purpose underlying a hospital’s or an ASC’s decision to purchase devices from a POD is to maintain or secure referrals from the POD’s physician-owners.

 

HHS OIG Report on Medicare COI Finds Potential for Conflict But No Actual Conflict

Federal law and regulations require Medicare Part D Pharmacy and Therapeutics (P&T) committees to make prescription drug coverage decisions based on scientific evidence and standards of practice.  Formulary decisions affect beneficiaries’ access to specific prescription drugs and the cost of drugs to beneficiaries and the Federal Government.   

To comply with the law, sponsors’ P&T committees must prevent conflicts of interest (COI) from influencing members to give preference to certain drugs.  In addition, sponsors’ P&T committees must comply with Federal law and regulations that specifically address conflicts on P&T committees by requiring that at least one physician and at least one pharmacist on each committee be independent and free of conflict relative to the sponsor and pharmaceutical manufacturers.  However, such laws, regulations and guidance from the Centers for Medicare & Medicaid Services (CMS) “provide limited direction on how P&T committees should handle” COIs or how to define what constitutes a conflict with sponsors, Part D plans, and pharmaceutical manufacturers. 

Consequently, a recent report by the Office of the Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS), revealed that of sponsors’ P&T committees, conducted “have limited oversight of committee members’ conflicts of interest, compromising sponsors’ ability to prevent financial interests from influencing coverage decisions.”  OIG found that “the majority of sponsors’ P&T committees have limited definitions of conflicts of interest, which could prevent them from identifying conflicts.”   

According to an article on the report by the New York Times, “A separate study by university researchers found similar problems in many state Medicaid programs.  The study, published in the journal JAMA Internal Medicine, described “inadequate management of conflicts of interest” among the panels that recommend drugs for coverage under Medicaid.” 

Interestingly, OIG acknowledged in a podcast released with the report, that OIG focused on the oversight mechanisms being used to protect Medicare.  OIG did not “attempt to uncover actual conflicts of interest.  In fact, it would be proved difficult to detect actual conflicts without some insider information.”  The podcast also recognized that “Limited oversight does not necessarily indicate that financial interests are influencing coverage decisions. But, it sure does expose the program to that possibility.” 

Given the recent finalization of the Physician Payment Sunshine Act, it is only a matter of time before OIG reveals that the problem with COIs on P&T committees is likely much larger, as institutions are probably unable to accurately keep track of all COIs for P&T members—something the CMS Sunshine Act database is supposed to offer to the public.  In fact, in its comments to the report, “CMS indicated that the Physician Payment Sunshine Act will result in information that may help sponsors determine conflicts of interest.”  However, OIG noted that “reported data will not contain information about pharmaceutical manufacturer payments to pharmacists and, therefore, will not help sponsors meet the requirement that at least one pharmacist on each P&T committee be free of conflict.” 

OIG also found that many sponsors’ P&T committees allow their members to determine and manage their own conflicts.  Additionally, “CMS does not adequately oversee sponsors’ compliance with the requirement that at least two members on each P&T committee be independent and free of conflict relative to the sponsor and pharmaceutical manufacturers,” OIG found.  As a result of these findings, OIG recommended that CMS: 

1. Define pharmacy benefit managers as entities that could benefit from coverage decisions,
2. Direct sponsors to ensure that safeguards are in place to mitigate improprieties related to employment by the entity managing the P&T committee,
3. Direct sponsors to ensure that an objective process is used to determine COIs,
4. Direct sponsors to ensure that an objective process is used to manage COIs, and
5. Oversee sponsors' compliance with the requirement that at least two committee members be independent and free of conflict.  

CMS did not concur with the first or second recommendations; concurred with part of the third and fourth, and concurred with OIG’s fifth recommendation.   

In sighting their concern for influence or COIs, OIG noted that “research has shown that financial interests between the pharma industry and health professionals are common,” and that “there is evidence of pervasive conflicts of interest among pharmaceutical manufacturers and health care practitioners, researchers, and educators.”   

OIG cited several studies from Eric Cambell to suggest that financial relationships with industry “may improperly influence medical decision making.”  However, as we have previously written, financial COIs or FCOIs for members on FDA’s Advisory Committees had no impact on their voting.  Specifically, an outside contractor for FDA found no statistically significant relationship between conflict rates and voting outcomes (α=0.05) when considering financial ties. 

Background  

Medicare Part D provides optional drug benefits to Medicare beneficiaries.  CMS contracts with private insurance companies, called sponsors, to provide Part D prescription drug coverage to beneficiaries who choose to enroll.  Sponsors offer drug coverage to beneficiaries through Part D prescription drug plans.  As of March 2012, approximately 31 million beneficiaries were enrolled in Part D plans. 

Sponsors can use a variety of methods to control the cost of providing prescription drug coverage through the Part D program.  Sponsors can establish formularies, or lists of covered drugs, to give preference to certain drugs over others that treat the same condition.  Formularies are generally organized into tiers, which have different copayments to drive utilization toward less-expensive drugs.  Drugs in lower tiers are typically the least expensive and have the lowest beneficiary copayment.  Drugs in ascending tiers are more expensive and have increasing beneficiary copayments. 

Sponsors can employ utilization management practices, such as prior authorization, quantity limits, and generic substitution, to restrict the use of certain drugs on their formularies.  For example, sponsors may require a beneficiary to try a less-expensive alternative drug before progressing to a costlier drug.  Sponsors also can negotiate price concessions with pharmaceutical manufacturers to reduce the cost of prescription drugs for sponsors and beneficiaries. 

Sponsors may contract with one or more pharmacy benefit managers (PBM) to help them manage their formularies and other aspects of their prescription drug benefit.  PBMs offer a wide variety of services including managing formularies, processing prescription drug claims, contracting with pharmacies, and negotiating price concessions with pharmaceutical manufacturers for particular drugs.  PBMs can be compensated for these services in a number of ways, one of which is retaining a percentage of price concessions that they negotiate on behalf of sponsors. 

P&T Committees  

Sponsors that use formularies for their Part D plans are required by Federal law to maintain P&T committees.  Sponsors either manage their own formularies and, therefore, maintain the P&T committee; or contract out these functions to a PBM.  Maintaining P&T committees could involve, among other functions, selecting members, appointing an individual to chair the committee, and creating the policies and administrative procedures that govern the committee.  P&T committees vary in size.  In 2010, P&T committees ranged from 3 to 62 members, with an average of 16. 

P&T committees’ role is to make clinical decisions about which drugs are on Part D plan formularies; many of these decisions are binding on the Part D plan. Per Federal regulations, sponsors are required to follow the decisions that P&T committees make regarding which drugs to include on the formulary.  However, sponsors can decide which formulary tier to place these drugs on, based on the recommendation of their P&T committees.  Sponsors also must adhere to the P&T committees’ decisions regarding prescription drug utilization management practices. 

When determining whether to include a drug on a formulary, Federal law requires P&T committees to base clinical decisions on the strength of scientific evidence and standards of practice.  For example, when voting to include a drug, P&T committees must consider whether the addition of that drug has therapeutic advantages in terms of safety and efficacy.  Cost considerations should be secondary to the determination of clinical efficacy and appropriateness of drugs. 

Sponsors and PBMs may compensate their P&T committee members for serving on the committee and for standard expenses incurred while attending committee meetings.  P&T committee members who were not employees of the sponsor or the PBM managing the P&T committee were paid, on average, $2,404 in 2010 for serving on the committee. 

P&T Committee Conflicts of Interest  

Federal law and regulations restrict some P&T committee members from having conflicts of interest with certain entities.  However, they do not explicitly stipulate what constitutes a conflict.  Beyond that, CMS guidance provides some general expectations for the disclosure of conflicts and recusal of P&T committee members with conflicts.  

As the entities that contract with CMS to provide prescription drug coverage to Medicare beneficiaries, sponsors are responsible for ensuring that all Federal laws and regulations pertaining to P&T committee members’ conflicts are followed.  Although sponsors are ultimately responsible, entities that maintain the P&T committees establish the policies and procedures governing the definition, disclosure, determination, and management of P&T committee conflicts.  These policies and procedures are unique to each P&T committee, not to each sponsor. 

While the minimum is two conflict free members of the P&T committee, CMS explained in the preamble to the 2005 Final Rule that this requirement should be viewed “as a floor which we encourage them to exceed.  Regulations expand the law by including pharmaceutical manufacturers as entities from which at least two members must be independent.   

Despite having no clear definition of what constitutes a conflict, in the Medicare Prescription Drug Benefit Manual, CMS states that certain relationships with pharmaceutical manufacturers may still be considered independent and free of conflict.  Specifically, P&T committee members who have nonemployee relationships with pharmaceutical manufacturers that do not constitute “significant sources of income” may still be considered independent.  Such nonemployee relationships with pharmaceutical manufacturers could be advisory or involve consulting or research. 

The law, regulations, and guidance do not address P&T committee members’ financial interests with any other entities involved in implementing the Part D program, such as PBMs.  While CMS suggests in the preamble to the Final Rule that a conflict of interest is “any direct or indirect financial interest in any entity … that would benefit from decisions regarding plan formularies,” the regulations specify only sponsors and pharmaceutical manufacturers; they do not specifically list PBMs. 

Disclosure and Determination: CMS recommends that P&T committee members disclose financial interests by signing and continually updating COI statements to reveal financial or other relationships with entities affected by drug coverage decisions.  CMS explains in the preamble to the Final Rule that it expects P&T committee members to sign COI statements that are consistent with industry standards for conflict-of-interest disclosures.  However, CMS does not specify which industry standards to follow.  CMS also does not provide any guidance on how disclosed financial interests are to be reviewed to determine whether they constitute conflicts of interest. 

Recusal: While at least two members on each P&T committee must be free of conflict with sponsors and pharmaceutical manufacturers, the remaining members can have COI.  In the preamble to the Final Rule, CMS explains that it expects procedures to be established that are consistent with standard industry practice for recusing P&T committee members from discussions or votes if a particular drug presents a conflict of interest.  However, CMS does not specify which industry standards to follow.  CMS does explain that implementing recusal procedures is necessary to ensure that formulary decisions are based on scientific evidence and standards of practice. 

CMS Oversight of P&T Committee Conflicts of Interest  

CMS requires sponsors to attest on their initial Part D applications that the membership of their P&T committees will include at least one practicing physician and at least one practicing pharmacist, both of whom are free of conflict with the sponsor and pharmaceutical manufacturers.  Additionally, sponsors must report membership information for their P&T committees on their initial Part D applications or ensure that their PBM reports this information on their behalf.  This information includes the names of all P&T committee members and the start and end dates of their service on the committee.  It also includes whether each committee member is free of any conflict of interest with the organization or pharmaceutical manufacturer. 

To report conflict-of-interest information to CMS, sponsors or their contracted PBMs obtain information about P&T committee members’ financial interests using conflict-of-interest statements. These statements are not required to be submitted to CMS.  CMS also requires sponsors to report whether they maintain the P&T committee or contract with a PBM to do so. If sponsors contract with a PBM, they also must report the name of the contracted PBM and whether the P&T committee operates under a confidentiality agreement. 

When sponsors and PBMs enter into confidentiality agreements, PBMs report their P&T committee members’ names, service dates, and conflict-of-interest information directly to CMS.  They do not disclose this information to the sponsors.  CMS requires sponsors or their contracted PBMs to report updates relating to their P&T committees at least annually.  Updates can include changes to P&T committee membership, confidentiality agreement status, or the entity that maintains the P&T committee. If a new P&T committee member is added, all of the member’s information that would have been initially reported is included in this update. 

CMS Oversight of Formularies  

CMS reviews and approves the formularies designed by P&T committees.  CMS’s review focuses on ensuring that formularies provide access to a range of Part D drug choices.  CMS checks the formularies to make sure they meet accepted pharmaceutical standards and include drugs from different therapeutic categories.  CMS generally does not review formularies for individual drugs. However, it does review individual drugs identified to treat some specific diseases and drugs in classes of clinical concern (immunosuppressant for transplant rejection; antidepressants; antipsychotic; anticonvulsant; antiretroviral, and antineoplastic). 

CMS’s formulary review also is designed to ensure that it does not substantially discourage any group of beneficiaries from enrolling in the Part D plan.  For example, if formularies place certain types of drugs only on tiers that require expensive beneficiary copayments, some beneficiaries might be discouraged from enrolling in the Part D plan.  CMS generally reviews the formulary to make sure that low-cost drugs are available on low formulary tiers, which typically have the lowest copayments. CMS also checks that only high-cost drugs (over $600) are placed on the specialty tier, which typically has the highest copayments.  

CMS also conducts targeted audits of sponsors to verify that approved formularies are being administered appropriately and that drug coverage decisions are based on scientific evidence.48 During targeted audits, CMS reviews the development of a Part D plan’s formulary by reviewing documents that would show the P&T committee’s decisions regarding which drugs to cover and the scientific evidence used to support those decisions.  CMS also may conduct an interview with the sponsor, asking questions related to whether the P&T committee appropriately developed the formulary.  

CMS also may review P&T committee meeting minutes to determine whether the P&T committe reviewed utilization management practices for clinical appropriateness.  In 2010, CMS did not review P&T committee conflicts of interest as part of its targeted audits.  However, for 2012, CMS added an optional conflict-of-interest review to its audit protocols.  If CMS’s targeted audit findings relate to the role of the P&T committee, then CMS reviews a list of P&T committee members to determine whether at least one practicing physician and at least one practicing pharmacist are independent and free of conflict with the sponsor and pharmaceutical manufacturers. 

Findings 

Most sponsors’ P&T committees had limited definitions of conflicts of interest, which could prevent them from identifying conflicts:  Without an understanding of what constitutes a COI, committees may not be able to identify potential conflicts that could compromise the independence of a P&T committee’s formulary decisions. 

Half of P&T committees’ definitions did not address conflicts prohibited by Federal regulations: 

• 53% of P&T committees reported their definitions did not include any financial interests with either sponsors or pharmaceutical manufacturers as COI. These committees’ COI definitions failed to include at least one of the entities specified by Federal regulation.
• 6% reported their definitions did not include any financial interests with both sponsors and pharma as conflicts, as specified by Federal regulations
• 52% reported that their definitions did not consider any members’ financial interests in sponsors to be conflicts of interest.  Sponsors are defined in both Federal law and regulations as potential sources of conflict.
• 7% of P&T committees’ definitions failed to consider any financial interests in pharmaceutical manufacturers to be conflicts of interest. 

P&T committees’ definitions did not always address relationships with other entities that could benefit from formulary decisions: P&T committees did not always include relationships with PBMs—which could benefit from formulary decisions—in their definitions of conflicts of interest. 

• 33% of P&T committees reported that they did not define any financial interests in PBMs as conflicts
• Of the 22 P&T committees maintained by PBMs, more than two-thirds reported that they did not define any financial interests in PBMs as conflicts. 

More than two-thirds of P&T committees’ definitions did not address employment 

• 68% of P&T committees did not view employment by the entity that maintains the committee as a potential source of conflict or bias.
• 88% of P&T committees had such employees serving as members.
• Percentage of employees serving on P&T committees ranged from 4 to 97%, with a median of 38%. 

Many sponsors’ P&T committees allowed members to determine and manage their own conflicts of interest 

• 59% of sponsors’ P&T committees allowed committee members to determine their own conflicts and manage them through recusal. 

Nearly two-thirds of P&T committees relied on members to determine whether financial interests constituted conflicts 

• 65% of P&T committees relied on committee members to determine whether their financial interests constituted conflicts of interest.
• 8% of P&T committees had a conflict determination process that designated members as the parties responsible for determining whether their own financial interests should be considered conflicts.
• 57%, or 63 committees, did not have a process for reviewing financial interests disclosed on COI statements and determining whether they constitute COI
• 24% of the 63 P&T committees that did not have a process for determining conflicts did not collect any financial interest information from members.  These P&T committees’ disclosure forms did not require members to disclose any financial interest information.  The members were required only to sign a form stating whether they had financial interests or conflicts of interest.  Members on these P&T committees were not asked to describe the nature or value of their financial interests or to submit any supporting information. 

More than three-quarters of P&T committees relied on members to recuse themselves from discussions and votes 

• 79% of P&T committees relied on members to recuse themselves from discussions or votes when they had a COI related to a particular drug.  CMS advises recusal from discussions and votes if P&T members have a COI.
• 56% of P&T committees had recusal policies that designated members as responsible for recusing themselves from discussions or votes.
• 23% of P&T committees did not have recusal policies.  These P&T committees did not have a process to ensure that members with conflicts did not discuss or vote on a particular drug that presented a conflict. 

CMS does not review P&T committee conflict-of-interest information: During 2010, CMS did not have audit protocols to specifically audit P&T committee member conflicts of interest.  Similarly, CMS did not have audit protocols to assess compliance with P&T committee conflict-of-interest requirements as part of its sponsor audits.  In 2012, CMS added an optional review of P&T committee documentation to determine compliance with Federal conflict-of-interest requirements.  As of August 2012, CMS reported that less than 10 percent of its audits included these elements. 

Data discrepancies would prevent CMS from identifying with certainty the members of each P&T committee: OIG’s review of data showed that CMS could not have identified members of P&T committees.  Without identifying the members on each P&T committee, CMS cannot tell whether a minimum of two members are free of conflict.  OIG found discrepancies such as duplicate names, similar names, different suffixes or prefixes, and names listed in different order (e.g., first name/last name and last name/first name).  OIG also found multiple data submissions for the same P&T committee.  In fact, 58 percent of P&T committees with multiple submissions had discrepancies that would make it difficult to ascertain committee membership.

Physician Payment Sunshine: ProPublica Updates Dollars for Doctors Database for 2013

Back in October 2010, an investigative journalist shop with the help of funding from the Pew Charitable Trust known as ProPublica started publishing stories in local news papers around the country as the “Dollars for Docs” campaign.  The campaign itself created a database that aggregated the payments that pharmaceutical companies had made to physicians and voluntarily or under legal obligations, made public.  Concerns about such relationships grew as pharmaceutical manufactures were settling federal lawsuits alleging that they paid kickbacks and encouraged doctors to prescribe medications for unapproved uses.  

In December of last year, we noted that ProPublica had not updated its payment data since 2011.  However, just this week, ProPublica updated its website, and is helping several local news agencies produce articles and stories about payments. 

The database will largely be irrelevant by next year, when the Centers for Medicare & Medicaid Services (CMS) will be posting payments from all applicable manufacturers to physicians and teaching hospitals pursuant to the Physician Payment Sunshine Act—Section 6002 of the Affordable Care Act.  Nevertheless, this recent update from ProPublica should signal to all stakeholders the future of media outlets and local news agencies making use of the public database in ways that may surprise some doctors, and in some cases, incorrectly report such payments.  

Publishing the payments on a large scale is likely to have significant implications for physicians and the pharmaceutical industry.  As a recent article the Newstelegram.com noted, some medical institutions with strict conflict of interest (COI) policies may place restrictions or penalties on physicians found to have violated such policies.  For example, the article noted that since 2008, UMass Memorial Medical Center has prohibited anyone directly or indirectly involved with patient care — from accepting gifts, food, entertainment, travel and honorariums from manufacturers.  “We want to ensure the integrity of all patient care, clinical research and business decisions,” said John T. Randolph, vice president and chief compliance officer at the medical center.

UMass allows consulting work if it doesn't involve marketing. Speaking before nonprofit organizations — for instance, the American Heart Association — is OK as long as no industry is involved in developing the agenda or approving speakers and educational materials.  Speakers' bureaus are considered “a marketing tool of industry,” according to Mr. Randolph, and UMass physicians are prohibited from participating. UMass can't prohibit private appointees to the medical staff or faculty from involving themselves in these talks, but it can — and has, since last year — prohibited them from using their UMass credentials to bolster their credibility. 

New ProPublica Data, Report 

In its newest iteration of data, ProPublica announced that its database now contains more than $2 billion in payments to doctors, other medical providers and health care institutions that have been disclosed by 15 pharmaceutical companies since 2009.  They noted that the combined 15 companies account for prescription drug sales of about 47 percent of the U.S. market in 2011.  However, such reporting is likely incomplete because some companies only recently posted data, others report in only a few categories, and some report in payment ranges, not specific amounts.

ProPublica worked with the Daily News, Los Angeles and the Nashville Business Journal to report on Dr. Jon W. Draud, the medical director of psychiatric and addiction medicine at two Tennessee hospitals.  ProPublica noted that during the last four years, Dr. Draud has earned more than $1 million for delivering promotional talks and consulting for seven drug companies.  ProPublica said this made Dr. Draud the “best-paid speaker” in its database.  He may have more payments because he has separately disclosed ties with at least four additional companies that haven't revealed how much they pay speakers.  

Draud is not the only high earner: 21 other doctors have made more than $500,000 since 2009 giving talks and consulting for pharmaceutical manufactures, the database shows. And half of the top earners are from a single specialty: psychiatry. “It boggles my mind,” said Dr. James H. Scully Jr., chief executive of the American Psychiatric Association, referring to the “big money paid to some psychiatrists for what are billed as educational talks.”  

Scully recognized that paid speaking “is perfectly legal, and if people want to work for drug companies, this is America.”  Unfortunately, ProPublica uses his quote out of context, by maintaining that such payments are only for “marketing,” without acknowledging that a majority of such payments are for research and education—both of which advance patient care and improve patient outcomes—and in some cases is mandated by FDA under a REMS. In fact, ProPublica recognized that while a third of payments went to speakers, roughly half were for research; the rest was for consulting, educational materials, meals and travel. 

Susan Chimonas, a research scholar at the Center on Medicine as a Profession at Columbia University, said many medical centers that regulate interactions between drug companies and their doctors would be “alarmed” by the high tallies in the updated Dollars for Docs.  How do these folks have time to do their real jobs if they’re speaking so much?” Chimonas said.  Hospital administrators, she predicted, would be “concerned not only about the conflict of interest, but also the conflict of commitment.” 

While ProPublica states that “Draud teaches continuing medical education courses, it is unclear from ProPublica’s database whether such CME courses are accredited by CME providers. 

Fellow psychiatrists Rakesh Jain and Vladimir Maletic. Jain, of Lake Jackson, Texas, earned $582,049. Maletic, of Greer, S.C., made $527,850.  Both also speak for other companies that keep their payments private. Jain told ProPublica that “he loves teaching and delivers the same lectures about drugs and medical conditions regardless of whether a drug company is paying him.  “I am not a marketer, I am an educator,” Jain said.  He said he is proud of his collaboration with Draud. 

Changes Since 2010 

In 2010, many universities and teaching hospitals were surprised to find that their faculty members were engaged in promotional speaking.  ProPublica compared the faculty lists of institutions with conflict-of-interest policies barring such speaking with the database and found a number of physicians in violation.  Both the pharmaceutical companies and academia tightened their policies.  

Only a handful of doctors who were among the 20 highest-paid in 2010 have maintained their level of income from speaking, the new data show.  Ten of the doctors dropped from making about $100,000 a year to less than $20,000 in 2012.  Some doctors whose payments declined spoke about drugs the companies are no longer speaking.  Others, like prominent cancer expert David Rizzieri at Duke University School of Medicine, faced new restrictions from their employers.  

Rizzieri had been a speaker for Cephalon, GlaxoSmithKline and Novartis in 2010 and 2011.  But after Duke restricted participation in speakers’ bureaus, his speaking pay dropped markedly in 2012, the new data show.  All told, Rizzieri has received at least $567,300 in speaking and consulting payments since 2009.  Dr. Ross McKinney Jr., director of the Trent Center for Bioethics, Humanities and History of Medicine at Duke, said Duke physicians can deliver paid talks about diseases, but only if they use their own slides and presentation materials.  “The general tone is a little bit more distant and less cozy than it used to be,” he said.  

“I actually enjoy the aspect of educating my counterparts about developments in the field,” said Dr. Gustavo Alva, a California psychiatrist.  Alva has received $663,751 speaking and consulting since 2009 for the companies in Dollars for Docs.  He separately discloses speaking for other companies as well.  

New Drugs, New Dollars  

One thing ProPublica maintained is that payments for speaking is more of a reflection of market realities, not a changing use.  For example, Forest Labs, which is much smaller than companies like Pfizer and Merck, spent $31 million on doctors during the first three quarters of 2012, dwarfing its rivals; nine doctors each made nearly $100,000 from Forest in that time alone, the data show.  Pfizer - whose U.S. sales are five times greater than Forest’s - spent a fifth of Forest's total, paying out $6.2 million to promotional speakers during the same period. AstraZeneca, second to Pfizer in sales, spent $12.2 million. 

Forest spokesman Frank Murdolo said in an email that the company spends more on speakers because it doesn’t use pricey direct-to-consumer TV marketing. It also has more new drugs than its competitors, Murdolo said.  In contrast, GlaxoSmithKline spent $52.8 million on speakers in 2010.  That fell to $24.1 million in 2011 and $7.6 million in the first three quarters of last year.  Glaxo spokeswoman Mary Anne Rhyne wrote in an email that the company’s spending tracks with new drugs or new uses for existing products.  “That activity has been relatively low in the past year, so spending for speaker programs has been lower, too,” she said. 

AstraZeneca's spending on promotional speakers decreased from $31.6 million in 2010 to $17.6 million the following year and $12.2 million in the first three quarters of 2012.

"The decrease in spending is based on a variety of factors, including where our medicines are in their life cycles and brand budgets and strategies," Tony Jewell, a spokesman for AstraZeneca wrote.  

Texas psychiatrist Jain “said he sees real value in the new brands because they give psychiatrists options if their patients are not responding to older drugs.” He said he has recently spoken on behalf of Forest's antidepressant Viibryd, Merck's antipsychotic Saphris, Lilly's ADHD drug Strattera, Pfizer's antipsychotic Geodon and its antidepressant Pristiq.  Speaking for multiple companies should show that physicians’ loyalty cannot be purchased or influenced by one company alone, and that their expertise is sought by many. 

Jain, Draud and Maletic also all serve on the advisory board and steering committee of the U.S. Psychiatric and Mental Health Congress, which will hold its annual convention in Las Vegas in September and October. Maletic is the 2013 program chairman.  The convention receives financial support from several drug companies, and some of its presentations are sponsored by the firms.  The congress is owned by North American Center for Continuing Medical Education, LLC, a for-profit New Jersey company that provides CME courses.   

In response to written questions, Randy P. Robbin, president of the company, said members of the steering committee have “demonstrated experience and expertise in mental health and commitment to providing the highest quality education possible.”

The trio are paid for their work for the congress, but the money does not come from pharmaceutical sponsors, Robbin said.  In CME courses, pharmaceutical companies don’t have a say in the educational content or speaker selection. Jain said in an interview that his talks for the company are reviewed for bias before and after he speaks.  “I cannot present anything at the Psych Congress that hasn't been vetted repeatedly,” he said. “Pharma is not able to influence anything that I do at the Psych Congress."” 

ProPublica and California  

The Pasadena Star-News also collaborated with ProPublica, writing a story outlining the $242 million payments the state of California received between 2009 and 2012, which is the highest in the nation—hardly surprising given it is the largest state and population of prescribers.  California was followed by Florida, Texas, New York, Massachusetts and Pennsylvania.   

Of course the first sentence of the story gives readers no chance to objectively evaluate the article or physician-industry relationships: “Drug money runs deep in the Golden State.”  Once again, the “journalists” at ProPublica and their affiliated news partners violate their own ethical principles of journalism and fail to present a balanced, objective point of view—forcing readers to believe that such relationships are guilty by association.  

“Pharmaceutical companies used to take doctors to dinner, but that was banned years ago,” said Dr. Arthur Chanzel Jeng, an infection control specialist at UCLA-Olive View Medical Center in Sylmar.  “Now they must provide some educational content.”

Jeng was paid $80,500 by Pfizer last year for several speaking engagements.  As an infection control specialist at Olive View, he and others in his field are concerned about drug resistant diseases and the limited number of antibiotics.  Drug companies have little incentive to produce new antibiotics, he said, so if they do, physicians in his field want to know more about the drugs. That’s why he agrees to speak.  

“We (speakers) provide education when a new antibiotic does get released,” he said. “There needs to be education among doctors on how to use this new antibiotic.”  Jeng said Pfizer is never mentioned by name at the events.  Internal monitors attend the engagements to make sure, because of past litigation against the company.  He also said he does not feel pressured to administer medications solely made by Pfizer.

“A lot of the lectures are in university settings. It's part of our job description,” he said. “We don’t take samples.” 

Olive View is part of the Los Angeles County Department Health Services, and has its own policy on pharmaceutical influences, said hospital spokeswoman Azar Kattan.

“The Department of Health Services has a very formal process for selecting the drugs that we prescribe or use for our patients,” Kattan said.  She said a committee establishes a list of drugs that can be used. If a physician wants to recommend a drug that is not on the list, he or she must receive permission from the committee.  

“Part of the reason we have this process is we take potential conflict of interest very seriously, so we try to be very careful in how we select the drugs we use,” Kattan said. “If we identify noncompliance by a physician, we would investigate it and take appropriate action.”  

At UCLA, faculty, staff, and trainees all can continue to be part of “Speakers' Bureaus” or similar programs sponsored by industry, but: “Faculty, staff, and trainees always should strive, however, to ensure that their talks or public presentations are free of any commercial influence,” according to UCLA guidelines.  “In addition, they need to consider whether an industry-sponsored activity creates an appearance of impropriety and strive to avoid any activity that may create the appearance of a conflict of interest. Transparency and disclosure are an essential factor when participating in these programs.” 

One doctor, Donald Tashkin, Medical Director of the Pulmonary Function Laboratory at the David Geffen School of Medicine at UCLA, however, was paid $181,670 last year by companies such as Merck, Novartis, Pfizer, AstraZeneca. But UCLA noted that his payments may be an exception to their guidelines. 

“Dr. Tashkin, as an emeritus faculty member, is not subject to the same set of policies and reporting requirements as is a full-time, active faculty member,” said Dale Tate, spokesman for UCLA Health Sciences.  “His reporting requirements depend on a number of variables including time spent at the David Geffen School of Medicine.” 

“It’s not yet clear what they will report on the website,” said Marjorie Powell, senior assistant general counsel for Pharmaceutical Research and Manufacturers of Americ (PhRMA), in reference to the Sunshine Act database.  “One of the concerns we still have is there will be masses of information and the companies feel it's very important that everybody understand the relationship between pharmaceutical companies and doctors,” she said.  “The only way the companies do the research is to have physicians work on clinical trials.  It's worrisome that things won't translate properly.” 

But while medical schools and teaching hospitals welcome the disclosures, some say the information should be considered carefully by the public.  “One of the most important pieces of disclosure is having context around transparency, which is the only way for true transparency,” said Heather Pierce, senior director of science policy at the Association of American Medical Colleges.  A list of names and dollar amounts does not tell the public the whole story of why a doctor was paid by a pharmaceutical company, she said.  “There is no additional information of where they are speaking, what they are speaking about and who they are speaking to,” Pierce said.  “It’s an important distinction that a financial interest is not necessarily a conflict of interest.” 

Northern Ohio and the News-Herald 

ProPublica also teamed up with the News-Herald in Northern Ohio to show that since 2009 “Ohio physicians received $81.99 million from pharmaceutical companies, seventh highest in the nation.” 

Janice Guhl Hammer, director of media relations and news services at University Hospitals of Cleveland, said UH has had policies in place for several years requiring doctors to report any relationships with companies for more than $5,000.  Since the end of 2011, UH posted online a list of physicians who reported payments of $5,000 or more for speaking or consulting with outside companies, which could include payments from 2010 or 2011. Interestingly, the UH list includes a number of companies not a part of the ProPublica data, such as Bayer Corp. or Anacor Pharmaceuticals. 

UH wanted patients to have as much information as possible so they could begin a “dialogue” with their doctors about any relationships they have with outside companies, said Cheryl Wahl, chief compliance officer for University Hospitals.  “It could potentially bring bias into health care,” Wahl said.  But UH has not had any issues of note with any physicians in recent years about a serious conflict of interests. 

“There’s a lot of checks and balances in place to make sure it doesn't happen,” said Jennifer Elind, director of compliance for University Hospitals and the compliance officer for Case Western Reserve University. This includes an annual disclosure questionnaire that physicians complete.  “From what we've seen, people want to do the right thing,” she said. 

Additionally, while the UH does not forbid physicians from taking speaking engagements from pharmaceutical companies, the doctors do have to justify the engagement beforehand. The opportunity cannot just be for the doctor's own revenue, but it also must establish the physician's expertise in a field of medicine, Elind said.

Wahl said the hospital system has a hotline in place for people to call to report any problems they might have, which include concerns about physicians and outside companies. 

Dr. Martha Sajatovic, who specializes in psychiatry, received the most research money of any UH doctor in the ProPublica data, including $274,800 from Merck and Pfizer for the period of 2010 through 2012.  Elind and Wahl pointed out that the data does not specify how the money is used. While some of the funding likely went into Sajatovic’s salary, the bulk of the money was probably spent on the actual costs of performing the research. 

Another large local hospital system, the Cleveland Clinic, requires staff physicians to regularly disclose and update potential conflicts of interest, according to statements of Integrity and Innovations on the Clinic's website. The potential areas of conflict are formally reviewed by one or more authorities within the Clinic. 

“Cleveland Clinic policies and procedures also govern disclosure of interests to research subjects and the scientific community, as well as consulting, advisory and other financial relationships between staff physicians and healthcare companies,” the statement reads.  A search of the Dollars for Docs database shows 79 disclosures of payments to the Cleveland Clinic from 2009 through 2012, the majority of which were for research. Amounts paid ranged from $400 to more than $3 million.

This effort is part of the "conflict of interest industry "which has been growing the last few years with the goal to discredit modern medicine, encourage the use of generic drugs, and alternative medicine which perhaps could reduce the cost of healthcare. 

It is interesting to note that rather than report to the readers of the papers on one year of data, Propublica is adding all the years together to come up with a larger number which may give more interest to reporters but fails to put those payments in context.  This could be described as a journalistic slight of hand.  Big numbers alway impress the readers but do little to encourage innovation.

Strict Conflict of interest Policies at Academic Medical Centers Lead to Prescribing Older Generic Drugs

We have dedicated a large portion of this blog to covering “conflicts of interest” or COIs, and the various claims being made about the potential influence COIs may have on physicians, researchers, and CME providers.  COIs raise concerns because often, the latter group of individuals have relationships with industry—whether consulting, research, advisory, or other—that cause some to believe that those same individuals cannot remain impartial when writing prescriptions or teaching colleagues or even students. 

Consequently, a recent study, published in the British Medical Journal (BMJ) found that doctors who attended medical schools that limited gifts to students from pharmaceutical companies -- sponsored lunches, for example -- may be less open to drug marketing.   

The objective of the study was to “examine the effect of attending a medical school with an active policy on restricting gifts from representatives of pharmaceutical and device industries on subsequent prescribing behavior.” 

Interestingly, the study was funded by the National Institute of Mental Health (NIMH), the National Institute on Aging, the American Federation on Aging, and NIH.   Which we all know means the study is completely unbiased. 

Specifically, the authors looked at the probability that a physician would prescribe a newly marketed medication over existing alternatives of three psychotropic classes: lisdexamfetamine among stimulants, paliperidone among antipsychotics, and desvenlafaxine among antidepressants.  “None of these medications represented radical breakthroughs in their respective classes,” according to the authors. 

For two of the three medications examined, attending a medical school with an active gift restriction policy was associated with reduced prescribing of the newly marketed drug.  Physicians who attended a medical school with an active conflict of interest policy were less likely to prescribe lisdexamfetamine over older stimulants and paliperidone over older antipsychotics.  A significant effect was not observed for desvenlafaxine (1.54, 0.79 to 3.03; P=0.20).  Among cohorts of students who had a longer exposure to the policy or were exposed to more stringent policies, prescribing rates were further reduced. 

Thus, the authors concluded that “Exposure to a gift restriction policy during medical school was associated with reduced prescribing of two out of three newly introduced psychotropic medications.”   

One of the major weaknesses of this study is that the authors used students who have recently graduated from medical school within the last five years.  Thus, their prescribing habits are likely to change significantly over time as they gain more experience, training and knowledge about the diseases they treat and drugs they use.  It may seem obvious that these individuals are hesitant to prescribe these drugs because they have been brainwashed during medical school to think any brand-name medication is evil and if there is marketing on such drug to outright ignore that information—despite the harm this may have to patients about important safety updates. 

In fact, the authors acknowledged that “In instances where the newly introduced medication is a noticeable improvement over alternatives,” such an effect (e.g., not prescribing it) “could slow the diffusion of medical advances.”  However, in instances instances “where the newly introduced medication offers no additional benefit to patients, such an effect may limit the unnecessary use of newer, more expensive brand name medications, potentially slowing the escalation of healthcare costs.” 

Moreover, what is also problematic about this study is that it does not attempt to reconcile patient outcomes with these prescribing patterns.  In other words, we don’t know whether the patients not receiving these prescriptions are doing better, worse or the same.  For all we know, these recent graduates are prescribing drugs that might be harming patients or causing poorer outcomes, leading to higher costs in the future and lower quality of life. 

Additionally, another major weakness of this study--as was pointed out to us by our colleagues--is that the authors attempt to group pharmacetuical and medical device manufacturers and their relationships with AMCs and physicians into the same category.  While AMC policies may lump together pharma and device interactions, that does not mean they are equivalent to one another, something the authors failed to analyze or assess.  Nothing in the article justifies even the slightest mention of the medical device industry and the device industry is vastly different from pharma. 

Often, interactions with medical device manufacturers are required, and indeed necessary in some cases to achieve the proper standard of care to perform a procedure.  Moreover, and most often, the inventor of a particular device or technique must give hands-on training to physicians--either at the manufacturer's office or on-site, to ensure that physicians can implant or use the device in compliance with its FDA clearance.  In fact, many FDA clearance letters for medical devices--particularly for high-risk, Class III devices--mandate that the manufacturer provide specific training and show proof of such training through annual medical device reporting.  The study's failure to acknowledge this is problematic and shows their misunderstanding of the device industry and the importance of their interactions, training and education with physicians.

Another similar study, published in the February Issue of Medical Care, found that “Psychiatrists exposed to conflict-of-interest (COI) policies while completing their residency program are less likely to prescribe brand-name antidepressants after completion of their residency. 

Andrew J. Epstein, Ph.D., of the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, and colleagues used 2009 prescribing data from IMS Health to compare the prescribing behavior of 1,652 psychiatrists from 162 residency programs. The authors sought to determine whether exposure to COI policies during residency affected antidepressant prescribing behavior after training completion. 

About half of the residents graduated in 2001, before COI training guidelines were implemented, and the remaining half graduated in 2008, after COI adoption.  The researchers found that prescription rates for heavily promoted, brand-name, or reformulated antidepressant medications were lower for those graduating in 2008, after COI adoption, but were lowest for those programs with the most restrictive COI policies. 

“In psychiatry, we found that physicians who were exposed to maximally restrictive COI policies during residency training had lower rates of prescribing heavily marketed antidepressants,” the authors write.  “Although physician-industry interactions may serve an important informational function, our results offer one piece of evidence that these COI policies have helped inoculate physicians against the persuasive aspects of pharmaceutical promotion.” 

BMJ Study  

As background for their study, the authors noted that the American Medical Student Association (AMSA) established a PharmFree Campaign to advocate for evidence based, rather than marketing based, prescribing in 2002.  In 2007, AMSA released the first “PharmFree scorecard”, which graded US medical schools on the presence or absence of a policy regulating interactions between students and faculty and representatives of the pharmaceutical and medical device industries.  Since the first PharmFree scorecard was adopted, the number of US medical schools with conflict of interest policies has grown exponentially and most now have policies restricting gifts. 

Studies conducted before the PharmaFree Campaign found that most medical students were exposed to marketing efforts during their medical education.  On average, students either received a gift or attended an industry sponsored event weekly.  “Exposure to marketing efforts by the pharmaceutical industry during medical school has been associated with favorable attitudes towards the pharmaceutical industry.”  

Furthermore, marketing efforts have been shown to reduce the time to new drug adoption and increase the probability that a physician will adopt a new drug.   

Research has found that educational interventions strongly influence students’ attitudes toward pharmaceutical marketing and are associated with increased support for policies banning interactions between representatives of pharmaceutical companies and students.  Similarly, students attending a medical school with restrictive marketing policies tend to have less favorable attitudes about promotional items than their peers who were not exposed to a conflict of interest policy and are less likely to trust the advice they receive from representatives of pharmaceutical companies.  

Although research has found that educational interventions and conflict of interest policies are associated with increased skepticism about pharmaceutical marketing, the effect of medical school gift restriction polices on subsequent prescribing remains unknown.  Accordingly, the authors studied the impact of attending a medical school with a gift restriction policy on the adoption of new drugs.   

Overview and Methodology  

To see whether attending a medical school with a gift restriction policy affected prescribing of new drugs, they used a difference-in-differences design to compare prescribing patterns of physicians who attended a school with a gift restriction policy when the policy was in place with those of physicians who attended the same school before the policy was in place, as well as with the prescriptions written by two matched control groups. 

The authors used prescribing data from IMS health on the three drug classes July 2008 and March 2009.  Using internet searches, as well as information contained in the Institute of Medicine (IOM) as a profession’s conflict of interest database and AMSA’s PharmFree scorecard, one investigator either determined the initial implementation date of the gift restriction policy for medical schools that had a policy or verified that the school did not have a policy in place by the end of the study period.  They also looked for revision dates if policies were changed or updated and verified these as well. 

The authors identified 14 medical schools with a policy that explicitly prohibited or restricted gifts as of 2004.  A restrictive cut-off date of policy implementation by 2004 was necessary to allow for the average time required to complete postgraduate residency training after graduation from medical school for physicians to be eligible to independently prescribe medications by July 2008, the beginning of our prescribing observation period.  Many of the schools that had a policy in place by 2004 had adopted policies as a result of state laws or military restrictions governing gifts.  The policies varied in strength from almost complete bans on gifts to much weaker and ambiguous restrictions.   

Next the authors identified two cohorts of physicians to permit comparisons among those who attended the same medical school before and after implementation of a gift policy.  The first cohort included physicians that graduated two years before the policy was implemented and therefore were not exposed or affected since the policy was enacted after they had graduated.  The second cohort graduated in 2003 or 2004, after implementation of the policy.   

To account for changes in prescribing over time, the authors created a matched control sample composed of physicians who graduated from 20 different medical schools that adopted a policy restricting gifts in 2008.  These physicians were never exposed to the policy since they graduated before implementation.  

To determine the effect of gift restriction policies during medical training on prescribing as physicians, the author examined physicians’ propensity to prescribe newly introduced and marketed psychotropic medications over older medications in the same class.  During the study period, antipsychotics, antidepressants, and stimulants were among the top selling classes of medications, with US sales ranks of 1, 5, and 15, respectively.  Stimulants, antidepressants, and antipsychotics were also among the most promoted classes of medications.  

Given the importance of these three classes of medications to the pharmaceutical industry, the authors identified a newly marketed medication in each class for our study: lisdexamfetamine (Vyvanse; Shire, Wayne, PA) among stimulants, paliperidone (Invega; Janssen Pharmaceuticals, Titusville, NJ) among antipsychotics, and desvenlafaxine (Pristiq; Pfizer, New York, NY) among antidepressants. Lisdexamfetamine was introduced in March of 2007, paliperidone in December of 2006, and desvenlafaxine in February of 2008.  

Although the drugs examined in the study vary in their level of innovation, none represented radical breakthroughs in their class and all relied on mechanisms of action already available on the market.  These medications were the only oral medications within the three classes of data that we had access to that were approved within our study period. 

Results 

In total, 27.8% of prescribers wrote at least one prescription for lisdexamfetamine, 8.7% at least one prescription for paliperidone, and 6.9% at least one prescription for desvenlafaxine.  There were compositional differences between schools that adopted gift restriction policies before 2004 and later adopters, as well as between cohorts, in specialty composition and methods of payment. 

Stimulant Prescribing:  Physicians who were exposed to a gift restriction policy during medical school were significantly less likely than non-exposed physicians to prescribe lisdexamfetamine over older stimulants.  Of prescriptions written by physicians who attended a medical school with an active gift restriction policy, 5.9% were for lisdexamfetamine, in contrast with 7.4% among physicians not exposed to a policy who graduated from the same school before the policy was implemented.   

Among matched controls attending a school that implemented a policy in 2008, 8.3% and 9.1% of prescriptions were for lisdexamfetamine among earlier and later graduates, respectively.  Using a difference-in-differences approach showed that attending a medical school with an active conflict of interest policy significantly reduced the odds that a physician would prescribe lisdexamfetamine, the newly introduced stimulant, over older stimulants.   

In addition, for physicians who attended a medical school in which they would have been exposed to a policy for longer than the group exposed to the policy, the odds of prescribing lisdexamfetamine was further reduced.  Attending a school with a strong active policy also reduced the odds of prescribing lisdexamfetamine. 

Antipsychotic prescribing—paliperidone:  Physicians who were exposed to a gift restriction policy during medical school were significantly less likely than non-exposed physicians to prescribe paliperidone over older antipsychotics.  Of prescriptions written by physicians who attended a medical school with an active gift restriction policy, 0.5% were for paliperidone, in contrast with 1.7% among physicians who were not exposed to the policy and graduated from the same school. 

Among matched controls attending a school that implemented a policy in 2008, 1.2% and 1.4% of prescriptions were for paliperidone among the earlier and later cohorts, respectively.  Using a difference-in-differences approach, attending a medical school with an active conflict of interest policy was associated with a significantly decreased odds of prescribing paliperidone, the newly introduced antipsychotic.   

Antidepressant prescribing—desvenlafaxine:  Exposure to a gift restriction policy during medical school was not associated with differential prescribing of desvenlafaxine.  In all three models using a difference-in-differences approach, attending a medical school with an active gift restriction policy was not associated with significantly decreased odds of prescribing desvenlafaxine, the newly introduced antidepressant.   

In the main model, the odds ratio for students exposed to an active conflict of interest policy was 1.54.  Results were also insignificant in models examining students who were exposed to the policy for a longer duration or were exposed to a stricter policy.  

Discussion 

Implementation of a policy to restrict the receipt of gifts from the pharmaceutical industry at US medical schools was associated with significantly reduced prescribing of two out of three newly marketed psychotropic medications among students once they reached clinical practice. The odds of prescribing a newly marketed stimulant and a newly introduced antipsychotic medication were reduced among physicians who graduated from a medical school that had an active gift restriction policy.  The propensity to prescribe these two newly introduced medications was further reduced if the students were exposed to the policy for a longer duration or if the policy was relatively stringent.  

While these findings may suggest the ability to reduce prescribing of newly marketed pharmaceuticals, it remains yet to be seen whether such findings will result in only lower costs, or also better patient outcomes.  There is a significant chance, particularly given the complex nature of many of these drugs and the diseases they treat, that failing to prescribe new drugs may only further harm patients. 

University COI Policies and Generic Drugs – The Old Becomes New

A recent study from the Perelman School of Medicine at the University of Pennsylvania revealed that psychiatrists who were exposed to conflict of interest (COI) policies during their residency were less likely than peers who lack similar training to prescribe brand-name antidepressants, “which are heavily promoted to psychiatrists and tend to be more expensive,” the study claims.  The study claimed that a “dramatic increase in prescription drug use,” and relationships between pharmaceutical representatives and physicians have “come under extensive scrutiny both within the medical profession and by policy makers.”

“Our study clearly shows that implementation of COI policies have helped shield physicians from the often persuasive aspects of pharmaceutical promotion,” first author Andrew Epstein stated in the press release.  The results will be published in the February issue of Medical Care.  Some have speculated that if the results are correct, we may begin to see an even stronger increase and flurry of COI policies at academic medical centers, although most already have strong policies in place. 

What may change, however, is the emphasis that certain professors or programs place on teaching and training young physicians on COI policies.  This will be troublesome in some cases where the instructor has a negative view of industry and discourages industry relationships or collaboration—which may lead to a generation of physicians who do not work with industry.  We have previously reported that physicians who refuse to see pharmaceutical sales reps were less likely to be aware of important risk information and new clinical data.

The study focused on antidepressants because “they have been among the most heavily marketed drug classes,” Epstein said.  “Data show that antidepressant use increased nearly 400 percent from 1988 to 2008.  The goal for this study was to determine whether exposure to COI policies during residency would influence psychiatrists' antidepressant prescribing patterns after graduation.”

Penn Medicine in 2006 implemented policies placing restrictions on physician interactions with pharmaceutical representatives.  In 2008, the Association of American Medical Colleges (AAMC) developed COI policy guidelines for gifts, free meals, and medication samples provided by pharmaceutical representatives to physicians and trainees.  “The concern was that these interactions could influence clinicians to prescribe brand medications even if they were more expensive or less suitable for patients than generic alternatives.”

To assess the effects of COI policies on physicians’ prescribing patterns after residency, the research team examined 2009 prescribing data from IMS Health for 1,652 psychiatrists from 162 residency programs.  The physicians fell into two categories: about half graduated residency in 2001, before COI training guidelines were implemented, while the other half graduated residency in 2008, after many medical centers adopted COI policies.

Physicians were also categorized based on the restrictiveness of the COI policies adopted by their residency programs' medical centers.  Results of the study show that, although rates of prescribing brand antidepressants, including those that were heavily promoted and brand reformulations, were lower among 2008 graduates than 2001 graduates in general, the rates were lowest for 2008 graduates of residency programs with very restrictive COI policies.  Such results are hardly surprising given the fact that academic medical centers with very restrictive COI policies likely restrict almost all access by industry on their campuses and strictly limit any kind of off-campus interactions with industry—making it almost impossible for the 2008 graduates to ever learn about brand-name drugs. 

Another factor that the study might not have taken into consideration is that a number of the antidepressants likely went off-patent during this time frame so that pharmacies would have had to fill a brand-name prescription with a generic regardless, unless the physician specifically instructed otherwise. 

Additionally, the study did not attempt to measure patient or clinical outcomes.  In other words, there was no discussion or evidence that patients being prescribed brand-name drugs did worse than those on generics or had any more adverse consequences.  Moreover, as the study recognized, there can easily be many other differences and factors between two groups that are 7 years apart—e.g., increased medical literature; advances in research and clinical data; postmarket safety reports; changed, revised or new guidelines, and so on.

Part of the motivation behind the study, as Epstein recognizes, is the high cost of brand-name medications and anti-depressants, particularly because patients must take these pills multiple times a day, for long periods of time—years, even decades.  Accordingly, the study may be seen by some as an argument to help reduce healthcare costs.  Yet Epstein cautioned that lower costs achieved through stringent COI policies may come at a price. 

“Contact with the pharmaceutical industry may have important informational benefits for physicians.  And, by exposing trainees to industry representatives, we may be helping them prepare to navigate these relationships after graduation,” said Epstein. “Nevertheless, while these relationships may be useful in some ways, our study clearly shows that implementation of COI policies have helped shield physicians from the often persuasive aspects of pharmaceutical promotion.” 

Epstein notes that in future research it will be critical to assess whether these policies have similar effects on other drug classes and physician specialties. 

Conclusion

As we have mentioned before, educating young physicians and physicians in training about COI policies and interactions with industry and pharmaceutical sales representatives is a noble goal and one that should be taken seriously.  However, allowing those faculty and medical school staff who are already critical of industry and have their own personal biases about industry to educate impressionable minds is problematic.  There needs to be balance when educating medical students and residents about COI policies and relationships with industry.  There must be an equal voice for industry so that students can understand the critical and crucial relationships that physician-industry collaboration brings to medical innovation and progress.  

If future research is to be conducted on COI policies, such research should evaluate the extent to which such policies adversely affect physician industry relationships, and how such adversity can harm patient care and decrease good patient outcomes.  Moreover, schools with COI policies must ensure that those responsible for training and educating students about COI policies give a fair and balanced presentation of industry relationships. 

 

Medical Students Remain Unfazed by Professors Industry Relationships

Disclosure of potential conflicts of interest (COI) from relationships with the pharmaceutical and device industries is recommended in publishing, research, and education of residents, faculty, and students.  Such disclosures in continuing medical education (CME) are required and are also mandated for federally funded research through the National Institutes of Health (NIH). 

Consequently, the authors of a recent study suggested that, “Disclosure in education may foster critical evaluation of information and assessment for potential bias,” however, they noted that the effect of such disclosure is “unclear.”  To determine the effects of such disclosures, the authors conducted a survey of medical students at a medical school that recently adopted a new COI disclosure policy.  The study, which was published in the Journal of the American Medical Association (JAMA), was  supported by an institutional grant from the Josiah Macy Jr. Foundation

Among other important findings, the authors discovered that “Few [medical] students believed that educational content or quality were influenced by educator relationships with industry.”  The study evaluated a 2010 policy at the Mount Sinai School of Medicine, which mandated conflict of interest (COI) disclosure by lecturers to preclinical students.  In addition, the majority of students (73% to 74%) thought disclosure would lessen the likelihood of presenting biased material, showing support for the argument that transparency can be enough to fight perceived or potential bias despite calls from critics who want complete bans on such relationships.

Nevertheless, when presented with pharmaceutical disclosure information by faculty members prior to lectures, students were more likely to support limiting industry contacts with students, residents, and educators than before disclosure policies were in effect.  “Our findings suggest that a conflict of interest disclosure policy to students is feasible and may influence student attitudes toward industry prescribing but not education,” the authors concluded.

Students saw financial relationships with industry as an influence, with about 70% agreeing that lecturers were more likely to recommend companies' products during class if they had such relationships, and a little over half agreeing that their educators should limit such relationships, reported medpage Today.

However, about three-quarters saw their lecture content as evidence-based and unbiased regardless of what conflicts of interest their lecturers might have.  Just under 60% thought the quality of their own education wasn't influenced by any industry relationships their teachers had.

The authors suggested that this was the first study “to evaluate the association between COI disclosure and preclinical medical students' attitudes.”  Interestingly, they noted that students “were more aware of the potential influence of industry relationships than students in past studies.”  Such an observation is problematic, however, because it suggests that the pool of participants may have been tainted or slanted against industry relationships or collaboration prior to the survey, and thus the results may be unreliable or unrepresentative.

Background

In September 2010, Mount Sinai School of Medicine began mandating COI disclosure by lecturers to preclinical medical students.  Using the natural experiment created by this new policy, the authors studied the association between routine COI disclosure with preclinical medical students and students’ attitudes toward disclosure and industry interactions.  Policy implementation included a brief presentation to students introducing the disclosure policy, routine COI disclosure by faculty during lectures, and continuous student online access to faculty disclosures.  

The authors verified faculty posting of online disclosures but not disclosure during lectures.  Among 188 lecturers to preclinical students, 146 (78.9%) posted disclosures; 130 (89.0%) reported no potential COI.  

The authors then adapted a published survey to assess student attitudes toward COI disclosure and the appropriateness of industry gifts to physicians, industry-sponsored education, and industry-faculty relationships with responses on a 4-point Likert scale (1 = strongly disagree; 2 = disagree; 3 = agree; 4 = strongly agree).  All year 1 and year 2 students were eligible to participate.  Students were surveyed during class meetings at the beginning and end of the 2010-2011 academic year, comparing attitudes (combined agree and strongly agree responses) before and after policy implementation

Findings

Nearly all students (>97.0%) favored disclosure in both surveys .  Attitudes toward academic-industry relationships changed after policy implementation.  After the policy went into effect, more students thought schools should limit industry meetings with:

• Students (72% versus 57%, P=0.004)
• Residents and house staff (53% versus 39%, P=0.01)
• Educators (57% versus 40%, P=0.002)

Students were less likely to think that industry should be involved in funding medical school programs (62% before versus 44% after, P=0.002).  There was also a trend for more students to think that receiving gifts or food from industry has an influence on physician prescribing (70% before versus 79% after, P=0.052).

Attitudes did not change regarding the influence of COI on educators or educational content.  Few students believed that educational content or quality were influenced by educator relationships with industry.

Discussion

Independent of the policy, many favored disclosure by educators and limiting industry interactions, and believed that industry interactions influence prescribing.  Routine COI disclosure was associated with an increase in student desire for limitations in some industry relationships, but not with perceptions of disclosure, the effect of industry relationships on educational content, or instruction by faculty with relevant COI.

“The lack of association may be related to students’ relationships to professors or the rarity of faculty conflict of interest,” the authors wrote.  “The introduction of the policy, rather than disclosure itself, may have influenced the students’ attitudes.”  The authors also recognized several limitations to the study, including the single-site, predisclosure and postdisclosure design, and potential social desirability bias.

Ultimately, the value and results of this survey are unremarkable and mostly counterintuitive.  The study was conducted at a medical school that recently adopted a COI disclosure policy and practically indoctrinated its youngest students with the policy, so it is no surprise that many of them favored such a system—they don’t know any better.  Moreover, the fact that 80% of the professors had no COI disclosures raises two important points. 

First, this is clearly not a medical school that values collaboration with industry; or at the very least, does not encourage such relationships among its faculty; so again, the survey results are unsurprising. 

Second, the faculty and professional staff of the medical school are the ones who adopted and crafted the COI policy and had the motivation to do so.  Therefore, the culture and surroundings at the school make it highly unlikely that students would be non-conforming and support industry-relationships when their superiors and even older students would not dare break rank with persons who control their future livelihood—whether it be grades in medical school, recommendations, residencies, internships, or research positions. 

Ultimately, conducting future research on this area, while interesting, is likely unnecessary.  All medical students should be educated about their institution’s COI disclosure policy, and medical faculty should educate their students about relationships with industry—including their own.  There has been recent discussion about the need to include in the medical school curriculum ethics courses that highlight the nature of COI’s and the history and background of physician-industry collaboration. 

Before we continue to bias the next generation of medical students that industry is “evil” and relationships with industry create potential COI’s, there needs to be an appropriate dialogue with medical schools and stakeholders from all sides to ensure that students are getting objective and balanced information about relationships with industry.  As we have previously written, relationships and collaboration with industry have changed the lives of hundreds of millions of patients. 

With healthcare reform speeding ahead, America is asking our doctors to do more with their time, spending less money, and increasing efficiency.  The advances of drugs, medical devices, and new treatment and care plans may help achieve that goal, however, cutting medical students off from the industries that create such products, or instilling in medical students the notion that such industries are problematic will make realizing those goals more difficult. 

Surgeon Asks: Not Throw the Baby of Innovation Out with the Bathwater of COI Regulations

A recent article discussed “the current polemic against conflict of interest, relationships between physicians and the ‘medical industrial complex;’ a case of overreaction in muddied waters, demonizing good people and inducing consequences those responsible cannot imagine.”

This overreaction, has caused many to throw the “baby out with the bathwater,” and the baby being discarded is a cherished infant indeed–American industry, innovation and of most importance, great medical care. 

When a surgeon sees a patient and uses their position of “undue influence” to recommend an operation for which he or she will be paid, is that not a conflict?  One interest is the patient’s well being, the other is the surgeon’s pocketbook.  This is, of course, an odious example that should offend all of us; physicians are professionals and do what is right for the patient.  When they exploit that privilege they are suitably sanctioned, vilified and sued.  Well-intentioned doctors — the vast majority — have the patient as the sun in their universe; all decisions are made with the individual patient at the core.

The article was written by Dr. Jonathan Mark Sackier, a Visiting Professor Surgery & Medicine at the University of Virginia and a director of Hemoshear and Rex Bionics. Dr. Sackier has consulted to medical technology companies and developed and licensed products to companies such as Valleylab, and Applied Medical and advised others such as the Veterans Administration and the Royal College of Surgeons of England.

“Conflict of interest?”

Recent legislation (the Sunshine Act) and hyperbole decreeing that physicians should have no dialogue with life science companies, should not receive royalties for inventions or fees for running clinical trials or delivering speeches and such activities due to concerns of “conflict of interest” are blatantly absurd – in what other branch of human enterprise is effort not rewarded?

But it goes further than that, some are demanding that such thought-leaders should be discounted from holding leadership positions in academia or on National Institutes of Health advisory panels to prevent potential problems.

“That is truly smart – let’s exclude the best minds from guiding us.”  There is already a good system in place to deal with abuses of power, all we have to do is use it — prosecute to the full extent of the law and not “settle” thereby strongly discouraging others who may follow.  “But to prevent dialogue just in case an abuse might take place is truly ludicrous; the innovation pathway will fragment, corporations implode, exports will decrease, jobs will be lost and of greatest import, patients will suffer. And that is intolerable,” Sackier wrote.

Dr. Sackier, who was born in Britain and educated as a surgeon there, came to America to work and innovate, free of the shackles of “ill-conceived legislation of which we had plenty.”  But his faith was “ill-placed” when he learned of this “conflict of interest mania.”

“Current moves to impose restraints on free exchange of ideas between clinicians and the medical industry are misguided and serve no one well,” he asserted.

How collaboration leads to innovation

Sackier then discussed the importance of industry-academia-physician collaboration.

“You have cancer.”  Three words to change a life. But academic-industry collaboration resulted in the development of Gleevec, enhancing hope.  How did this come about? Scientists at the University of Pennsylvania noted that patients with chronic myeloid leukemia had abnormal chromosomes.

Fast forward to the advent of gene mapping and scientists at the University of Chicago determined that those aberrant genes made a cancer-inducing protein.  Enter Novartis scientists led by Drs. Zimmerman and Buchdunger.  Millions of dollars, 10 years and 400 molecules later we have Gleevec and lives have been saved.  Tommy Thompson, former Secretary of Health and Human Services called it “the wave of the future.”  Dr. Harmon Eyre of the American Cancer Society stated “a huge breakthrough…a great drug, a great new discovery.”  “A collaboration between academics and industry. Job done, lives saved.”

We now have a diabetes epidemic and need to make urgent changes as a society – what we eat, how we exercise and so on.  But at least diabetics can count on insulin to rescue them.  But roll the clock back to 1922 and thank Elizabeth Hughes, daughter of the Secretary of State, a graduate student, young physician, physiologist, biochemist and an astute Indiana corporation—Eli Lilly.

When Hughes was diagnosed with diabetes at age 12, the best option was a starvation diet and early death the likely outcome.  A young Canadian doctor, Frederick Banting had an idea, closed his growing medical practice and collaborated with scientist Charles Best, Professor Macleod and Dr. Collip. The concept? Take pig pancreas and purify what came to be known as Insulin.  The Eli Lilly Company of Indianapolis agreed to help and the rest is history.  “One bright idea from a young man prepared to take a chance. One senior scientist prepared to help, collaboration by others with different skill sets and a company prepared to risk capital and effort. Result? Game changing.”

Other examples? How many do you want? Heart valves, dialysis machines, angioplasty, all the clever procedures now done with minimal invasion, countless diagnostic tests, numerous therapeutic drugs and on and on.  Clinicians spotting an unmet clinical need, scientists who collaborated to solve a problem, financiers who took a chance, companies who invested time, money and resources. And patients who benefited.

“We are going to throw all of this away because, why, exactly? Because certain individuals think certain physicians might use undue influence to pervert medical therapies. Lets ban cars – poor drivers may cause accidents. And here’s one that resonates for Americans, let’s ban guns.”

No exploitation of positions of influence

My contributions have been miniscule in comparison, but my joyous and fulfilling collaboration with Dr. Yulun Wang, formed the foundation for robotically enhanced surgery, dialogue with engineers at one medical technology company brought a device that shaved time off surgical operations and another collaboration saw operating room safety improved.  “I openly disclose my “conflicts” to all and let their good judgment ascertain if I abused my position of influence as a surgeon. I am proud of these – and other – collaborations with industry and have personally seen no examples of exploitation of positions of influence.”

“On the contrary – I have met and interacted with smart, ethical and industrious men and women who have helped make this country great, improving the lives of the patients we all serve. I will be damned if I will stand by and watch them and those of my colleagues who collaborate with industry vilified by ill-advised agents of change.”

Sackier maintained that “Change should be about movement toward something better, not necessarily something new and to effect change, doctors need to be allowed to have free discourse with their industry colleagues, the free speech guaranteed to all in our Constitution.”

Institute of Medicine: Harmonizing Reporting on Potential Conflicts of Interest: A Common Disclosure Process for Health Care and Life Sciences

Almost everyone in the healthcare industry unequivocally recognizes that “patients and the public benefit when physicians and researchers collaborate with pharmaceutical, medical device, and biotechnology companies to develop products that benefit individual and public health.”  However, a growing number of groups and individuals have continued a crusade in making such collaborations or physician-industry relationships more "transparent" due to their concern of the potential for bias or “conflicts of interest.” 

These conflict of interest crusaders argue that relationships with industry may unduly influence professional judgments involving the primary interests and goals of medicine.  As a result, groups like the Institute of Medicine (IOM) have recommended approaches to managing conflicts of interest (COIs), particularly financial relationships, without deterring fruitful scientific collaboration among academics, health care professionals, and industry. 

Managing potential conflicts of interest has been a growing topic over the last several years.  Increasing, physicians and other healthcare providers, are routinely required to provide financial information to a variety of organizations with stewardship responsibilities—academic institutions, funders, journals, continuing medical education (CME) groups, and more.  In addition, physicians must comply with disclosure obligations and regulations through the National Institutes of Health (NIH) and the Food

and Drug Administration (FDA).  Moreover, disclosure of physician-industry relationships is now federal law, as data will be gathered and reported under the Physician Payment Sunshine Act.  

In 2009, the IOM recognized in a report entitled Conflict of Interest in Medical Research, Education, and Practice, the tremendous burden these reporting obligations were placing on health care professionals and biomedical researchers by repetitive, overlapping but non-identical, time-consuming procedures and forms required by different organizations for reporting relationships for evaluation of possible COIs. 

For example, the Federal Demonstration Partnership, a group dedicated to reducing the administrative burdens associated with research grants and contracts, estimates that “42% of an American scientist’s time is spent on administrative tasks.  Much of that burden comes from redundant reporting and assurance requirements that vary.”  “Considering this waste, and anticipating the growing requirements for disclosure by reporting individuals, the need for a harmonized system becomes urgent and compelling,” IOM recently wrote in a new paper entitled “Harmonizing Reporting on Potential Conflicts of Interest: A Common Disclosure Process for Health Care and Life Sciences.”   

IOM explained that while accurate reporting can identify circumstances, in which there exists the possibility of inappropriate influence over patient care, education, or research, requirements are increasing for individual clinicians and researchers to report their relationships.  As a result, the IOM recognized that “The current process of disclosure is fragmented and burdensome for clinicians, researchers, students, trainees, and others who are required to report relationships (reporting individuals).”   

The report was developed by individual participants in a joint activity of the IOM’s Board on Health Sciences Policy and the Best Practices Innovation Collaborative of the IOM Roundtable on Value & Science-Driven Health Care.  Unfortunately, however, the committee that developed this working paper consisted of many individuals who have dedicated their careers to writing and researching about potential conflicts of interest from an anti-industry perspective.  Moreover, the committee did not consist of representatives from industry, clinical trialists, commercial CME providers, or clinical research organizations.  

What is also problematic about this report are some of the definitions IOM uses.  For example, IOM defines “faculty or speaker fee” to include compensation for “continuing education.”  As we have written numerous times over the past year in reference to comments submitted by the CME industry regarding the Sunshine Act, payments from accredited CME providers, in which commercial support is provided, must not be attributed to physicians who serve as faculty members or physicians who attend the CME program.  Such reporting would be contrary to the Accreditation Council for Continuing Medical Education’s (ACCME) Standards for Commercial Support.  IOM’s definition of “honoraria” is also problematic for the same reason.   

In addition, IOM uses a broad definition of “manuscript fee” and “review activity fee,” which may present challenges to physicians or researchers who contribute to the content of CME programs.   

Although the final Sunshine regulations have not been published yet, IOM should clarify that its definitions for (1) faculty or speaker fee; (2) honoraria; (3) manuscript fee; and (4) review activity fee are not applicable to payments made by accredited CME providers, and should exempt such payments from their uniform disclosure system and template.  To the extent that CMS includes accredited CME payments, IOM must work closely with the ACCME to ensure that such reporting is not contrary to ACCME’s standards. 

The proposal is also problematic in that it came out before the final Sunshine Act regulations; thus, only more work, time, money and resources will be spent on this, and companies will still have overlapping responsibilities under this system.  It makes more sense for the Sunshine Act to be implemented for several years, and for IOM to revisit this issue after CMS has worked with the data it collects, and IOM serve as an independent review of how to improve the reporting process.  

An editorial published in the Journal of the American Medical Association (JAMA), noted that while a “single uniform disclosure form is impractical, given that agencies such as NIH and FDA and many state governments have varying disclosure requirements determined by rules that cannot be easily modified …  “Substantial improvements can be made in the disclosure system by creating a centralized data repository that is governed in a manner that ensures data security while reducing the burden of disclosure for individuals and meeting the needs of all stakeholders.” 

GOAL 1: COMMON DISCLOSURE ELEMENTS AND FORMAT  

The Field Definitions Working Group was tasked with identifying a set of common elements to accommodate most current and anticipated requirements for disclosure of relationships for evaluation of possible COI.  The group reviewed 23 sample disclosure forms made available by participants from across health care sectors (federal agencies, academic institutions, journals, CME providers, and professional organizations).  The survey of current requirements revealed substantial differences, including varied directions to reporting individuals, incompletely aligned data elements, differences in response format (e.g., open-ended vs. closed questions), and a range of requirements for inclusion of family members’ relationships with industry.   

Harmonization of definitions and requirements, to the extent possible under current regulations and policies, “will simplify data collection, storage, maintenance, and retrieval.”  Harmonization may also improve the accuracy of data and reduce the need for clarification and revision.  To this end, IOM suggested common elements intended to meet the needs of many organizations’ current policies on COI.  

Relationships to Be Reported  

The 2009 IOM report defined COI broadly as “circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest.”  Primary interests are those related to conducting research, taking care of patients, and providing medical education.  Secondary interests are those that relate to an individual’s gain—e.g., financial, professional, political, or interpersonal.  

The committee recognized that although other relationships might compromise objectivity, financial relationships may be the easiest to measure and track. As a result, IOM proposed that to meet many current regulatory and organizational requirements, a harmonized system should instruct reporting individuals to disclose relationships, activities, or interactions that may influence—or that give the appearance of potentially influencing—professional judgments or actions. 

Although manufacturers will be required to report these extended relationships to CMS, reporting individuals also will need to track these relationships to ensure accuracy.  To meet the requirements of all organizations requesting disclosure statements from reporting individuals (requesting organizations), a harmonized system will need to accommodate reporting for as many different family members as are currently required by organizations.  

IOM noted that current requirements for inclusion of extended family members’ data creates a significant and likely unnecessary burden, on reporting individuals and does not necessarily fulfill the intent of limiting COI.  As a result, IOM suggested the following general principles to guide decisions on when, and at what level, to require reporting of family members’ relationships.  

First, IOM suggested that reporting individuals should disclose others’ financial relationships if there exists the possibility that the financial relationship will benefit the reporting individual, including if the reporting individual has benefitted in the past. Second, to help ease the burden of disclosure, IOM also recommended that requesting organizations consider whether the individual reporters can verify the accuracy of others’ relationships—for example, by requiring only those that are a matter of public record. 

One way to accomplish these two goals would be simply to require disclosure of relationships of the reporting individual’s spouse or domestic partner and dependent children, with expanded disclosure of family financial relationships that may influence professional judgment, and with accommodation for unusual cases, such as with special government employees (SGEs) who advise FDA and are required under federal law (18 U.S.C. 208) to report certain financial interests of individuals and institutions, whose interests are imputed to them regardless of the magnitude of the interest. 

Based on IOM’s survey of requirements and disclosure forms, they proposed the following general features for a harmonized set of data elements:  

• Data elements should be non-duplicative and discrete (non-overlapping).
• Fields should allow the option other, with specification of further details.
• Data elements should be easily and immediately updatable.
• Data elements requested of individuals should be only those that are applicable.  

Definitions of common data elements are listed below and referenced to categories contained in the Sunshine Act.  The definitions include the overarching categories and data elements common to many requesting organizations and does not attempt to harmonize the determination of when a relationship is significant or constitutes a significant COI.  It is important to note that many requesting organizations will require reporting for only a subset of the fields listed.  Accordingly, IOM reported that individuals will need to fill out only those data fields relevant to their personal roles and relationships.  

IOM listed several other parameters to govern the data fields within the harmonized system.  First, data elements should be reported separately for each relationship. Second, in conjunction with the anticipated Sunshine Act rules, when a relationship involves a covered drug, device, or biological or medical supply, the name of that product should be recorded.  Third, the value of each applicable data element should be recorded.  With the variation in standards among organizations regarding monetary thresholds, IOM proposed that a harmonized reporting system prompt reporting individuals to disclose monetary value with sufficient granularity to allow interpretation in accordance with organizational policies.   

Fourth, to accommodate requests for disclosure over various time frames, each relationship should include a start date and an end date, and archived elements should be easily available.  Finally, in the case that a requesting organization is obliged, legally or otherwise, to obtain information in a more detailed or otherwise uniquely categorized manner than is used by the majority of requesting organizations, the harmonized system will accommodate presentation of additional data fields for completion by reporting individuals. 

Framing Principles  

To frame exploration of the options, the working group developed the following core principles for data storage and access.  

1)    Data in the harmonized system are owned by the reporting individual, who fully controls access to and distribution of those data at the time of entry and indefinitely into the future.  Note: Once data are reported by individuals to organizations, those re-ported data are subject to the privacy/confidentiality policies of the organization.

2)    Security of deposited data is paramount.

3)    The data storage mechanism should allow the reporting individual to access, update, and save data at any time.

4)    The data repository or system should include a function to indicate when data are up-dated and allow for “reminder” prompts for updates.

5)    Reporting individuals should be able to input data in multiple ways: via a Web-based portal, computer programs, apps, etc.

6)    The harmonized system should be designed to work with other existing systems, and those not yet developed, to “cross-populate” data among databases, when authorized by individual reporters.

7)    Requesting organizations should be able to obtain data elements as authorized by reporting individuals.  

Data Entry  

IOM recommended that individual reporters be presented only with data elements applicable to them, rather than every possible field of entry. To tailor the elements to the reporting individual, data entry should begin with a “mapping” process in which a set of questions determines exactly which data elements the reporting individual needs to provide to comply fully with the re-quirements of each organization.  The mapping process should include at least two steps: 

1)    Identification of positions or roles held by the reporting individual at a particular organization for which reporting is required (e.g., appointment at Duke University, author for the New England Journal of Medicine, board member of the American Society of Clinical Oncology), and

2)    Determination of whether relationships exist that must be disclosed, per the requirements of those organizations.

The system should allow for updating positions and relationships at any time to accommodate, for example, annual reporting as required by many institutions, as well as periodic reporting such as at the time of publication.  The process described will both maximize the efficiency of data entry and help prevent inadvertent omissions.  If a reporting individual has no relation-ships that may constitute a COI under the requirements of his or her positions, the number of data elements to be filled out should be minimal.

Data Retrieval

After data are entered into the system, two approaches are possible for providing the data to requesting organizations: a “push” or a “pull” mechanism.  With a “push” mechanism, the reporting individual initiates a data transfer to a requesting organization.  The “pull” mechanism allows requesting organizations to query the data repository to retrieve a predefined and preapproved dataset.  With appropriate permission structures, the end result of either mechanism is the same—data are shared with requesting organizations with the express permission of the reporting individual.  Since data security is of paramount importance, IOM believes that the optimal system is one in which the individual reporter “pushes” his or her data to requesting institutions.  IOM then proposed the following structure and support for the system:

1. Data repository: centralized.  A centralized database holds the greatest potential for efficiency and cost savings.  Many organizations currently invest in the maintenance of complex data and human systems which require expensive upkeep.  While a harmonized system will not eliminate the need for organizations to maintain a database to receive and filter information from the harmonized system, IOM anticipates that the remaining intra-organizational database will be significantly smaller and less resource-intensive to maintain.  The “push” will be the default position for data sharing from the repository, with “pull” permission granted selectively and specifically by a reporting individual to certain institutions, if satisfaction of security safeguards can be assured.  

2. Business model: not-for-profit.  To streamline discussions of financial considerations in these early stages, IOM suggests that the harmonized system be established as a not-for-profit model at the outset.  

3. Revenue generation: subscription or membership.  Anticipating that the activity will offset to some extent organizations’ current costs, IOM proposes a subscription or membership model—tiered based on size, utilization patterns, or other parameters of participating individuals and organizations—for revenue generation.  

4. Housing structures: operations and governance.  Housing the operations within an existing organization may maximize resources; however, collective establishment of a new organization is a viable alternative if institutions with experience and resources in managing similar data systems are willing to contribute these to the new organization.  

IOM said it will establish a steering group comprised of equal representation from requesting and reporting organizations, as well as those with technical expertise necessary for carrying out design and implementation of the harmonized system.  Key tasks of the steering group will include evaluating existing organization, support, and governance options, establishing a secretariat, and moving forward with implementation.  IOM has agreed to organize and host the initial gatherings of the steering group. 

Definitions 

The IOM reported included a proposed Table of Data Elements for the Harmonized System and Sunshine Act Reporting.  The table uses specific terms, and as a result, the IOM group provided several definitions, which are drawn from documents developed by the NIH, FDA, CMS, ICMJE, various universities, and English-language dictionaries.   Below is a list of some of the relevant terms:

• Award: A prize or other symbol of recognition given for an achievement or based on merit.
• Consulting fee: Payment received for the provision of personal services, not as an employee, that require advanced knowledge and expertise in a field of science or learning, including the rendering of advice or consultation.  Includes fees for services provided as a member of a scientific advisory board, an agent of a company (e.g., someone who receives a commission or finder’s fee).
• Expert witness fee: Payment for serving as an individual qualified to speak authoritatively by virtue of his or her special education, training, knowledge, skill, or experience/familiarity, or payment for providing expert advice related to a scientific, technical, or professional matter. Expert witness services include providing a written report, appearing for a deposition, or otherwise providing information, including testifying under oath.
• Faculty or speaker fee: Compensation for speaking to others to impart knowledge or skills in health care and life sciences, including, for example, continuing education, board review, seminars, lectures, teaching engagements, speakers bureau or other fees. [Note: the Sunshine Act proposes to define “direct compensation for serving as faculty or as a speaker for a medical education program” as “all instances in which applicable manufacturers pay physicians to serve as speakers, and not just those situations involving ‘medical education programs.’” As noted, comments were invited in this area and clarification is expected in the final rule. Of note, the proposed rule does not provide guidance about where other faculty fees (such as curriculum development or online courses) should be recorded.]
• Gifts: A transfer of tangible or intangible value for which the recipient does not provide equal or greater consideration in return. [Note: Final definitions should follow those in the Sunshine Act final rule (e.g., food gifts).]
• Grant: A financial transfer of money, property, or both to an entity to carry out an approved project or activity.
• Honoraria: Payments to a professional person for services for which fees are not legally or traditionally required (e.g, an appearance, speech, article). [Note: the Sunshine Act proposed rule requests comments on the distinction between honoraria and direct com-pensation for serving as a CME faculty or speaker. The definition of these two items should correspond to the final rule.]
• Manuscript fee: Compensation received for authorship, editing, reviewing, or other ser-vices associated with preparing of materials for publication.
• Review activity fee: Compensation received for professional review of scientific activities, including participation on a data-monitoring board, statistical analysis, etc.  

The table presents the broad categories of data elements expected to be included in the harmonized system.  The table attempts to make clear the intended one-to-one correspondence with anticipated categories required by the Sunshine Act.  The table will be updated upon enactment of the final rule by CMS and updated periodically as indicated by future legislation and rule making.  IOM noted that the harmonized reporting system must be able to identify and highlight those relationships among reporting individuals and manufacturers that are applicable.  The Sunshine Act applies only to a subset of manufacturers and products. 

IOM also said that “it will be incumbent upon the operators of the harmonized system of disclosure to maintain the capacity within the system to identify and flag relationships and covered drugs, devices, biologicals, or medical supplies that fall under CMS regulation and may be subject to review and appeal.” 

Date of payment.  If an arrangement involves payment over time, the manufacturer will elect whether to report a single line-item payment on the first day of payment or report each payment separately.  IOM recommended that manufacturers relay their accounting plan to reporting individuals.  Alternatively, the reporting individual should record each payment separately and the harmonized system should have the capacity to filter and aggregate these payments.  

Conclusion  

If this central system were ever implemented it would create a bonanza for trial attorneys and media to discredit doctors who have no idea of the “value” of non cash items that will be reported in the physician payment sunshine act but they might  not report in to this big brother database.     The concept of a uniform form is one thing but a central database tracking doctors every move is quite something else. 

These recommendations coupled with the Physician Payment Sunshine Act encompass the prospect of the greatest invasion of personal privacy on doctors in the history of our nation.     

Fortunately, this report has a much chance of being implemented as any of our readers winning the Powerball lottery.  I like those odds.