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26 posts from May 2011

May 31, 2011

Accountable Care Organizations: A Long Way to Go

Desert Road 
One of the keystone provisions contained within the Affordable Care Act (ACA or health care reform) was the idea of Accountable Care Organizations (ACOs).  The provision states that ACOs will begin on January 1, 2012, with each capable of treating at least 5,000 Medicare patients.

Over the past several months, the issue of ACOs has been widely discussed and debated.  ACO’s are a “symbol of the Obama administration’s belief that driving providers to deliver better care will also eliminate large amounts of unnecessary spending.”

Consequently, a recent article from POLITICO noted that ACOs are “in danger of being crushed under its own weight.”


The goal of ACOs is to facilitate coordination and cooperation among providers to improve the quality of care for Medicare beneficiaries and reduce unnecessary costs.  The program is intended to encourage providers of services and suppliers (e.g., physicians, hospitals and others involved in patient care) to create a new type of health care entity, an “Accountable Care Organization” that agrees to be held accountable for improving the health and experience of care for individuals and improving the health of populations while reducing the rate of growth in health care spending.  To participate as an ACO, organizations must:

  • Have a formal legal structure to receive and distribute shared savings
  • Have a sufficient number of primary care professionals for the number of assigned  beneficiaries (to be 5,000 at a minimum)
  • Agree to participate in the program for not less than a 3-year period
  • Have sufficient information regarding participating ACO health care professionals as the Secretary determines necessary to support beneficiary assignment and for the determination of payments for shared savings.
  • Have a leadership and management structure that includes clinical and administrative systems
  • Have defined processes to (a) promote evidenced-based medicine, (b) report the necessary data to evaluate quality and cost measures (this could incorporate requirements of other programs, such as the Physician Quality Reporting Initiative (PQRI), Electronic Prescribing (eRx), and Electronic Health Records (EHR), and (c) coordinate care
  • Demonstrate it meets patient-centeredness criteria, as determined by the Secretary.

As POLITICO noted, the idea of ACOs “is to get different kinds of health care providers to band together to provide coordinated care to a population of patients. The ACA says that if they do it “efficiently and in a way that gives better care to the patients, they’d be able to keep a share of any savings they create.”

Consequently, several weeks ago, the Centers for Medicare and Medicaid (CMS) issued a long-awaited proposed rule for entities interested in becoming ACOs,

“The proposed rule goes a step further than the statute, requiring ACOs to be at risk of losing money if their costs wind up higher than expected. It also imposes a high bar before providers can pocket any savings. The savings have to be big enough that they’re clearly the result of real changes to the delivery of care, not just random variation.”

Proposed Rule

Before the rule came out, “it had been eagerly anticipated for months, with many providers signaling they would enroll as soon as there were details.”

At the time, Health and Human Services Secretary Kathleen Sebelius said the “department had spent months carefully digesting all of the feedback so it could write a rule flexible enough to allow many different kinds of providers to take part.”

However, as POLITICO notes, “now that providers have had time to digest it, even the most likely candidates have rejected it as written.”

Specifically, the article noted that providers “biggest concerns include the provisions that are supposed to keep the ACOs from potentially increasing Medicare spending — costing, rather than saving, money — if savings targets aren’t reached.”  While experts say this is “necessary caution, given the potential scope of the program … if this makes it unworkable for providers, the administration will have choked the goose that is supposed to lay the golden savings.”

Moreover, providers only have the proposed rule.  Whether “the final version of the rule is stricter or looser than the current version is not clear and depends on whether the Obama administration can actually get the savings it wants.”

In other words, if the rule is too restrictive and “nobody participates, you’re not going to get the savings,” which appears to be very likely according to Tevi Troy, deputy secretary of HHS under former President George W. Bush.  But if projected savings are reduced because they “loosen up the rule, … you won’t get the same amount of budget savings.”

In response to this concern, Richard Sorian, HHS assistant secretary of public affairs, said the department was “100 percent confident that Accountable Care Organizations will be established on schedule, improve the quality of care and lower costs.”

One of the biggest signs of disappointment in the proposed rule came a few weeks ago when “10 medical groups participating in a Medicare pilot program that paved the way for the ACO program declared that none would participate if the rule were not substantially modified.”

In a letter they wrote to CMS Administrator Donald Berwick, MD, the 10 groups asserted that they “ALL have serious reservations about the economics and the complexity of the Medicare Shared Savings Program/ACO NPRM.”

They further noted that, “as currently proposed, ACOs have a greater potential for incurring losses … than for generating savings. This risk-reward imbalance makes it difficult, if not impossible, for internal decision makers to accept the financial design.”

While the comment period continues, Gail Wilensky, who oversaw Medicare and Medicaid under President George H.W. Bush, noted that Berwick may not have much authority to change what the final rule looks like.  Specifically, POLITICO noted that sources indicated that “at least two of the provisions most worrisome to providers were included in the proposed rule at the Office of Management and Budgets (OMB’s) insistence, and this may make them hard to change.

OMB has the final word on all regulations and is charged with policing their impact on the economy and the federal budget. David Spahlinger of the University of Michigan Medical School, one of the people who signed the May 12 letter to Berwick, explained to POLITICO that “OMB and the other agencies with jurisdiction have most of the responsibility for the proposed rule’s shortcomings.”


Given these recent developments, the future of ACOs remains uncertain, especially given the recent letter from the leaders who pioneered this idea.  As providers continue to submit comments on the proposed rule, the shortcomings of ACOs and the bureaucratic process behind them will come to the forefront, and it will ultimately be up to the public to voice its concerns about controlling costs.  Since this is a major initiative of the Obama Administration, officials will likely begin addressing this issue soon as election activities draw closer.  President Obama will want measurable to deliver to voters, and failing at ACOs will not bode well for his reelection efforts. 

What these events demonstrate is that the government’s focus on saving money and cost effectiveness clearly does not take into account the ability of providers to meet such “idealistic” proposals as ACO’s.  For example, as noted in their letter, there are a large number of quality measures, especially new quality metrics in several domains,

that go into effect starting year one.  As an example, on average, it costs about $30,000 just to program a single new quality metric. The proposed rule has more than 60 new ones, which equates to nearly $2,000,000 for each organization.  Accordingly, ACOs seem to have a long way to go.   The government will have to add many more incentives for providers in order for ACO’s to get off the ground, it will be interesting to see if they can do it.

May 27, 2011

American Medical Student Association and Their Pharm Free Association with Naturopathy

Recently, the American Medical Students Association (AMSA) held their annual conference.  Interestingly, one of the participants of the conference provided an ongoing commentary of the events and happenings at this year’s conference.


Of particular interest, the commentator noted that AMSA sold the Association of Accredited Naturopathic Medical Colleges a booth at the 2011 convention.  As the author pointed out, AMSA will not take money from pharmaceutical companies, but they have no problem with taking money from “pseudoscience.”  Perhaps a conflict of interest?


Consequently, the author described how he went up to the booth to find out what

naturopathy is.  He was told that they are “primary care physicians” who treat the “whole patient in a holistic way.” In addition, one of the table reps told the author that naturopathy subscribes to the use of homeopathy, herbalism, acupuncture, therapeutic touch, and “all sorts of other nonsense.”  The author also pointed out that their “written materials were more straightforward about their quackishness.”  Ultimately, while AMSA “professes to support evidence-based medicine,” the author was disturbed by the fact that AMSA  would legitimize “quackery of this sort.”


What is problematic about AMSA’s approach of accepting alternative medicine and banning pharmaceutical support is that it creates an inherent bias among the organization.  This bias is detrimental to advancing medicine, science, and medical education, particularly because AMSA is a vocal voice in the medical community.  Such a revelation that AMSA is willing to accept money from “pseudoscience” instead of hard science, should cast many doubts on the positions that the organization maintains on various policies.  Calling for evidence-based practices, while accepting money from alternative medicine—hardly even close to evidence based—should also cast serious concerns about the Soros and Pew funded PharmFree Campaign started by AMSA in 2002.

PharmFree Campaign

The campaign was started for medical students to advocate for evidence-based, rather than marketing-based prescribing practices, the removal of conflicts of interest and global access to essential medicines. AMSA provides toolkits, talks and training institutes to help medical students advance these goals.

To advance these goals, AMSA released its first "PharmFree Scorecard" in 2007. This initial Scorecard graded medical schools on the presence or absence of a policy regulating the interactions between their students and faculty and the pharmaceutical and device industries. In 2008, AMSA worked with The Pew Prescription Project, an initiative of the Pew Health Group, to develop an updated Scorecard, which used a rigorous and transparent methodology to assess the content of policies at medical schools throughout the country. 

This framework was used again in the 2010 AMSA PharmFree Scorecard, published last month. The AMSA PharmFree Scorecard evaluated conflict-of-interest policies at 152 medical colleges and colleges of osteopathic medicine in the United States, with a focus on interaction between students or faculty and the pharmaceutical industry.

Using letter grades to assess schools’ performance in eleven potential areas of conflict, the Scorecard gives a comprehensive look at the current and changing landscape of conflict-of-interest policies across American medical education, as well as more in-depth assessment of individual policies that govern industry interaction. It also examined potential conflicts of interest created by industry marketing at the level of the individual physician and trainee. 


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. These include policies related to acceptance of gifts and meals from industry; consulting relationships; speaking relationships; disclosure of financial conflicts; and pharmaceutical samples.

Two blinded assessors independently score each set of policies in the eleven areas included in the scorecard, and then use a formula to derive a letter grade.   

2010 AMSA Scorecard

As of December 15, 2010, 140 of 152 medical institutions had participated in the Scorecard, a 92% participation rate, improved from 88% in 2009. Of 152 US medical schools:

-       19 receive As (13%)

-       60 Bs (39%)

-       24 Cs (16%)

-       18 Ds (12%), and 

-       26 schools (17%) receive a grade of F.

In 2010, over 50% of medical schools, now have grades of A or B (78 schools). This was a tremendous increase from 45 A and B schools (30%) in 2009 and shows a continued progression from 29 A and B schools in 2008. Additionally, 21 schools improved their scores to a C or above after submitting updated policies for review.

AMSA noted in response to this data that “Conflict of interest has clearly become a central issue in medical administration and education and more schools are recognizing the importance of thorough policies.” Specifically, AMSA recognized the University of South Dakota Sanford School of Medicine, Tufts University, and Des Moines College of Osteopathic Medicine for “submitting dramatically improved policies which increased their scores from Ds to As.”

The 2010 Scorecards also recognized 9 other schools that improved at least 2 letter grades: Wake Forest University, New York Medical College, Virginia Commonwealth University, University of Minnesota-Twin Cities, Temple University, Case Western Reserve University, University of Illinois, and University of New England College of Osteopathic Medicine.

The report also noted that medical schools in California, Pennsylvania, New York, Texas, Florida and Massachusetts continued to excel, with a majority of medical schools in each state earning strong grades on the Scorecard. In addition, between 2008 and 2010, the number of perfect scores increased in every domain graded by the Scorecard. 

For example, in 2010, three times as many schools received perfect scores for addressing industry support of scholarships, off-campus continuing medical education, purchasing, and gifts compared to 2008. Notably, the number of institutions with model curriculum on conflict of interest quadrupled between 2008 and 2010.

Nearly one-third of schools now teach medical students to understand institutional conflict of interest policies, to recognize how industry promotion and marketing can influence clinical judgment, and to consider the ethics around conflict of interest. The areas with fewest perfect scores were on-campus continuing medical education (CME) and the access of sales representatives.


AMSA's national president, Dr. Brian Hurley, noted that “AMSA's Scorecard is meant to be not only a yardstick for measuring U.S. medical school conflict-of-interest policies, but also a guide for medical schools working toward adopting stronger and more practical policies.”

Robert Restuccia, executive director of The Prescription Project asserted that "The schools that earned 'A' and 'B' scores are to be commended for setting a high bar and aggressively moving forward to ensure medical education, training and patient care is free of commercial bias.”

Heather Pierce, JD, senior director of science policy and regulatory counsel at the Association of American Medical Colleges (AAMC) asserted that “The positive changes reflected in this assessment highlight the active engagement of the academic medical community in addressing industry interactions, both through policies and the education of its faculty and students.”

However, the Association of Clinical Researchers and Educators (ACRE), which supports relationships with drug companies, called AMSA misguided for its lack of understanding about how such partnerships can benefit students and patients. ACRE noted in its statement that “AMSA has devoted their time and resources rating medical schools on biased, meaningless subjects which reflect little on their actual education."

Additionally, one physician stated that he was proud that the academic medical center he worked at, Western University, received an F from AMSA Scorecard. Specifically, Jeff Unger, MD, associate director of metabolic studies at Catalina Research Institute in Chino, asserted that the AMSA Scorecard and Pew Prescription Project are an “obscure group of liberals who have nothing better to do than criticize those of us in the private sector trying to improve the lives of our patients.

Dr. Unger’s editorial offered AMSA and Pew a historical lesson about the pharmaceutical industry in hopes that they might spend their time on something better than “releasing results of such useless surveys.” He pointed out how the discovery of insulin in 1922, which was mass-produced by pharmaceutical companies such as Eli Lilly, changed the landscape of medical science and proved that chronic disease could be treated effectively with a specific medication. Since 1945, the pharmaceutical companies have spent billions of dollars developing new classes of drugs to treat diabetes.

As a result, he asserted that “None of these accomplishments would be possible without pharmaceutical company innovation, education and support.” Morever, Dr. Unger recognized that “pharmaceutical companies are not the enemy, and that all increasing government interference with companies has done is drive up research and development costs.

Dr. Unger further acknowledged that the role of industry is important because pharmaceutical companies “provide educational opportunities to physicians, physician assistants, nurses, nurse practitioners and certified diabetic educators about disease state awareness and treatment guidelines.” As he noted, “these programs are tightly regulated by the FDA and providers who attend these programs overwhelmingly approve of the educational format and the professionalism of the presentations.” 

With respect to other policies graded by the scorecard, Dr. Unger explained that “Patients should thank physicians who see pharma reps because they enable physicians to provide patients free samples for medications they are unable to afford because their insurance will not cover them. These samples are extremely important for diabetes patients because the medications used to manage diabetes “are often safer and more effective than those available on standard third-payer formularies.

He also pointed out that with the assistance of pharmaceutical representatives, physicians can help patients in applying for company programs that help patients pay for drugs they cannot afford.

One important observation about the important role of industry that Dr. Unger offered was a recent experience he had while lecturing. He explained that the speakersbefore him, who were from Ivy League schools that did not allow visits from pharmaceutical reps, gave the audience incorrect information regarding a particular diabetes drug.” As a result, he had to “correct the audience by explaining the latest FDA approvals regarding the particular drug, which a pharmaceutical representative had explained to him three days prior to this national meeting.” 


Ultimately, the impact of the AMSA Scorecard remains questionable, especially given the new revelation that AMSA accepts money from alternative medicine, but not industry. Where does the actual quality of teaching or patient care get ranked in their system? Does ‘improved’ score equate to anything other than less media attention of non-issue? While it is important that academic medical centers continue to implement policies for interacting with industry, until evidence shows that less industry-academia collaboration improves patient care and outcomes, these Scorecards will continue to hinder collaboration and innovation, and AMSA and the Pews will continue to be “thorns in the side of medical progress.”

As Dr. Unger recognized, academic medical centers “should continue to welcome pharmaceutical reps and pharma companies onto the campus and their medical students should learn the value that these liaisons share in changing the lives of individuals afflicted with acute and chronic diseases.” Moving forward, Dr. Unger noted that instead of listening to AMSA and Pew, “the voices of patients who suffer from chronic diseases are the only ones that should count in the finally tally.” 

May 26, 2011

CME Shown To Produce Positive Clinical Outcomes - Findings From Study Published In International Journal of COPD


Physicians who participated in live half-day, case-based, multi-format Continuing Medical Education (CME) workshop were 50% more likely to provide evidence-based care for chronic obstructive pulmonary disease (COPD) than those who did not participate, according to a study conducted by the Potomac Center for Medical Education (PCME), a Rockpointe company, and CE Outcomes, LLC. These findings, which point to the positive impact of CME on physician practice, were published in the International Journal of COPD on May 25, 2011.

Previously, the positive outcomes from this CME program were presented at Chest 2010, the annual meeting of the American College of Chest Physicians, which was held October 30-November 4 in Vancouver, BC, Canada.

In addition to being more likely to provide evidence-based care, participants were more likely than non-participants to correctly recognize COPD in a patient presenting with dyspnea (94% vs 74%; P=0.007); recognize that women may have a greater susceptibility than men to the toxic effects of smoking (90% vs 54%; P<0.001); and identify the mechanisms of action of emerging therapies (65% vs 33%; P=0.003). Each of these areas had been identified as gaps in current COPD clinical practices; thus, these findings show that continuing medical education can help narrow these gaps.

The series of live symposia were CME-certified by accredited provider PCME and supported by an unrestricted educational grant from Novartis. Attendees listened to comprehensive presentations from nationally recognized faculty thought-leaders and participated in interactive hands-on workshops, where they conducted spirometry tests and treated “virtual” patients through case studies.


Chronic obstructive pulmonary disease (COPD) is a major cause of mortality and morbidity worldwide.  Approximately 16 million Americans are currently diagnosed with COPD, while another 14 million may be affected but remain undiagnosed.  Each year, COPD is responsible for more than eight million physician office and hospital outpatientvisits, 1.5 million emergency department visits, and 726,000 hospitalizations.  COPD is the fourth leading cause of death in the US, and is projected to become third by the year 2020 if drastic changes in diagnosis and management are not implemented.

Despite these striking statistics, COPD remains poorly managed in the primary care setting.  One major barrier to better patient outcomes is the underdiagnosis of COPD, which delays treatment and leaves symptoms unmanaged.

Consequently, a recent study published in the International Journal of COPD found that participants in a series of live, regional CME programs were 50% more likely than non-participants to provide evidence based care.  The results from these CME programs were previously presented at the American College of Chest Physicians annual meeting Chest 2010 in Vancouver, British Columbia

COPD in the Primary Care Setting

COPD is highly prevalent in primary care; approximately one in four adults aged 40 years or older with known risk factors for COPD, including tobacco use and self-reported symptoms of chronic bronchitis, have airway obstruction consistent with a diagnosis of COPD.  Yet primary care physicians will less commonly consider and pursue the diagnosis of COPD than other diagnoses with fewer symptoms, such as hypertension and diabetes.  Moreover, only one in four primary care physicians adhere to guideline-recommended spirometry and medication use more than 90% of the time.

According to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, COPD is both a preventable and treatable disease, and increased focus on accurate diagnosis, staging, and management may reduce the overall burden of the disease.  Continuing medical education (CME) programs that address the inadequacies of COPD care may improve physician competency in providing guideline directed

COPD care. The American College of Chest Physicians has called for more research on the effectiveness of CME initiatives in improving physician competency and performance toward evidence-based care. 

The underlying rationale for CME is that providers who are educated about the latest standards of care will make more informed diagnostic and treatment decisions, resulting in improved patient outcomes.  To date, the CME literature suggests that the most effective strategies contain several design elements, such as a rigorous and accurate assessment of need, use of active and varied learning approaches, and an evidence-based curriculum that focuses on overcoming barriers to change.  Additionally, a change in physician practice is more likely with interventions that are multifaceted, interactive, and consistent with the perceived needs of the learner.


Consequently, to address this gap in care and lack of awareness and knowledge surrounding COPD, the Potomac Center for Medical Education (PCME) held a series of 12 regional, live, half-day meetings between September and December 2009 entitled, “Improving COPD Patient Outcomes: Breaking Down the Barriers to Optimal Care.”  These live regional meetings were supported through an educational grant from Novartis and targeted primary care practices, general practitioners, or primary care providers (PCPs).  The goals of these programs, upon successful completion, were for primary care physicians to be able to: 

  • Describe the demographics of COPD burden and explain the impact of patient comorbid conditions on COPD outcomes and management
  • Obtain reliable office spirometry results through proper patient education and coaching
  • Diagnose, stage, and manage a patient with COPD with a combination of management strategies, including risk reduction and pharmacologic and nonpharmacologic interventions per guideline recommendations
  • List emerging therapies for the management of COPD
  • Implement patient-oriented strategies to optimize adherence and improve outcomes

769 health care providers participated in the educational program, including 699 physicians, 13 nurses, and 57 other practitioners.  Participants reported seeing a total of at least 8459 patients with COPD per week within their clinical practices.

These programs were a mix of proven adult-learning formats, which included a series of short (25-30 min) didactic lectures and a video on the correct use of inhaler devices. The programs also used small-group workshops that went into detailed case discussions, where doctors treated “virtual patients,” and included hands-on demonstrations of the correct use of hand-held spirometers, along with active role-playing of spirometry coaching, reading and interpretation.

To measure whether these programs were successful in meeting these educational objectives and goals, PCME and CE Outcomes, LLC, surveyed a subgroup of participants (n=50) at the end of each program, and demographically matched non-participants (n=50). The survey included detailed case vignettes, a validated tool for measuring physician performance in clinical practice. Case vignettes were designed to assess the consistency of diagnostic and therapeutic choices with clinical evidence. An assessment was then designed to determine: 

  • Whether the diagnostic and therapeutic choices of participants were consistent with the clinical evidence presented during the educational activity
  • Whether practice choices of participants were different from practice choices of non-participants
  • Barriers to the optimal management of COPD

One significant finding from the study showed that participants in the CME program were 50% more likely than non-participants to provide evidence based care. CME program participants were also more likely than non-participants to: 

  • Correctly recognize COPD in a patient presenting with dyspnea (94% vs 74%)
  • Recognize that women may have a greater susceptibility than men to the toxic effects of smoking (90% vs 54%; P<0.001)
  • Identify the mechanisms of action of emerging therapies (65% vs 33%; P=0.003)
  • Report and demonstrate increased familiarity with the GOLD guidelines
  • Correctly determine disease severity (58% vs 44%) based on FEV1
  • Select a strategy for maintenance therapy
  • Demonstrate a greater willingness to use office-based spirometry in initial assessment of suspected COPD (98% vs 90%) and long-term monitoring (86% vs 76%)
  • Report a lower level of familiarity with spirometry measurements


Ultimately, clinicians who participated in this commercially supported CME program demonstrated improved knowledge and competency of the underlying pathophysiology of COPD and in a variety of areas related to the management of COPD, including etiology and risk factors, disease staging, guideline-directed patient management, and emerging treatment options.  Moreover, specific areas of patient care that were most affected by attending the activity included recognizing gender differences in susceptibility to the toxic effects of smoking, using spirometry in the assessment and monitoring of patients with COPD, identifying stage of COPD based on the FEV value, and maintenance therapy.

These findings are significant because each of the areas that saw significant improvement from CME participation had been identified as gaps in current COPD clinical practices. As a result, these findings show that CME can help narrow these gaps.


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