Life Science Compliance Update

August 12, 2014

Institute of Medicine Recommends Value-Based Payment System and More Transparency For Graduate Medical Education


"There is a striking absence of transparency and accountability in the GME financing system for producing the types of physicians the nation needs," states the Institute of Medicine's Committee on the Governance and Financing of Graduate Medical Education (GME).

The Committee recently published a report entitled Graduate Medical Education that Meets the Nation's Health Needs and held a corresponding discussion. They recommend significant changes to GME financing and governance with the goal of shifting the program "to a performance-based system," rather than one that directs money to facilities with an accredited training program.


Currently, the vast majority of public financing for GME—totaling $15 billion in 2012—comes from Medicare, which financed an estimated $9.7 billion of graduate medical education that year. In 2012, the Josiah Macy Jr. Foundation asked the Institute of Medicine to conduct an independent review of the governance and financing of the GME system. Eleven other private foundations provided additional support for the study, including the ABIM foundation, Aetna Foundation, Kaiser Permanente, and UnitedHealth Group Foundation as well as the Health Resources and Services Administration (HSRA) and the Department of Veterans Affairs. Eleven U.S. senators, from both sides of the aisle, encouraged the IOM to undertake the study.

Outdated GME Model

Medicare GME payment rules date as far back as 1965, "a time when hospitals were the central, if not exclusive, site for physician training," IOM states. The payment system relies on a class-based reimbursement model, even though Medicare is moving dramatically away from that. Hospitals services remain essential, but "the burden of chronic disease, the need for greater emphasis on preventative care, and modern information technologies…mean that health care increasingly takes place in community settings and relies on non-physicians and integrated care models," the report argues.

In short, IOM states, healthcare is moving towards a value-based system for hospitals and physician reimbursement. The only place not moving in this direction is graduate medical education.

"Newly trained physicians," for example "are not very well equipped for ambulatory care even though that's where most of the care is provided in the United States," stated committee co-chair Gail R. Wilensky of Project Hope at the Public Briefing about the report.

"If we were to continue to recommend funding using Medicare resources, we needed to have it redesigned and repurposed to develop a physician workforce we deemed appropriate for the 21st Century."

Committee Goals

The IOM Committee identifies six goals for an improved GME financing system.

  • (1) Encourage production of a physician work-force better prepared to work in, help lead, and continually improve an evolving health care delivery system that can provide better individual care, better population health, and lower cost.
  • (2) Encourage innovation in the structures, locations, and designs of GME programs to better achieve Goal 1.
  • (3) Provide transparency and accountability of GME programs, with respect to stewardship of public funding and the achievement of GME goals.
  • (4) Clarify and strengthen public policy planning and oversight of GME with respect to the use of public funds and the achievement of goals for the investment of those funds.
  • (5) Ensure rational, efficient, and effective use of public funds for GME in order to maximize the value of the public investment.
  • (6) Mitigate unwanted and unintended negative effected of planned transitions in GME funding methods.

The Committee noted that they "were struck" by the lack of accountability in graduate medical education with regards to examining patient need. "The only mechanism that currently exists is that the program be accredited." There was virtually no oversight into whether a particular GME program "makes sense in terms of the needs of the population."

Committee Recommendations

The Committee provided recommendations to further their goals with a view towards the next decade.

According to the IOM committee, they began their deliberations with a very basic question: "Should the public continue to support GME, and, if so, at what level?" Ultimately, the committee concluded that Medicare GME funding should be maintained at the current level, but that payment methods should be modernized reward performance, ensure accountability, and incentivize innovation in the content and financing of GME. Given the amount of change the healthcare delivery system is undergoing, Medicare funding could provide "key leverage" to help produce meaningful change and lead to efficient care provided at lower cost.

While the Committee wants to keep the same amount of funding, they recommend taking a hard look at where these funds are going.

"IOM committee strongly urges Congress to amend Medicare law and regulation to allow a transition to an accountable, performance-based system," states the report. "Transforming Medicare's role in financing GME will be a complex undertaking and requires careful planning." Thus, the committee recommends "a 10-year transition from the status quo to full implementation of its recommendations, followed by a reassessment of the need for continued Medicare GME funding."

A fundamental aspect of the recommendation is a two-part governance infrastructure for federal GME financing modeled after the Medicare payment advisory commission. "A GME Policy Council in the Office of the Secretary of the Department of Health and Human Services should oversee policy development and decision making," states the report. A GME Center within the Centers for Medicare & Medicaid Services "should function as an operations center with the capacity to administer payment reforms and manage demonstrations of new payment models." A central function of this Council would be to "serve as coordinator between accrediting agencies," noted Wilensky.

Finally, the Committee recommended establishing a two-part Medicare GME fund. First would be a GME "Operational Fund" to finance ongoing residency training activities and, second, a smaller "Transformation Fund" to finance development of new programs, infrastructure, performance methods, and other "priority specialty areas and priority geographic areas that have currently been "given short-shrift in the distribution of Medicare Funds," states Wilensky. Currently, the Committee believe 90 percent will be allocated to the Operational Fund, and 10 percent into Transformation Fund. This allocation will shift as time goes on, and will involve moving from a cost-based system to an outcomes-based system.

Towards the end of the decade, IOM recommends an additional assessment should be done to evaluate the results of the changes and whether or not there continues to be a rationale for Federal funding going forward.

Debra Weinstein of Partners Health System summarized the path that lies ahead: "Strategically investing in GME so we can identify the national health outcomes we think our important, clarify what those outcomes are specifically, develop metrics for measuring them, and then tune the payments towards those metrics."


The IOM report's goals demonstrate the current healthcare migration towards low cost, quality-based initiatives. It will be interesting to follow the next steps of the committee in implementing their recommendations.

The Committee's recommendations haven't been popular with some groups. For example, the Association of American Medical Colleges responded by saying:

"[T]he IOM's proposal to radically overhaul graduate medical education (GME) and make major cuts to patient care would threaten the world's best training programs for health professionals and jeopardize patients, particularly those who are the most medically vulnerable. The committee's proposals assume that in the coming decades, our health care workforce would require no expansion of the highly specialized services or physicians equipped to meet the needs of a growing and aging population, with ever greater need for both primary and specialty health care."

August 09, 2013

IOM Review Shows NIH Clinical and Translational Science Awards Program Contributes to Early Stage Advances in Medicine

Recently, The Institute of Medicine (IOM) released its review of the mission and strategic goals of the Clinical and Translational Science Awards (CTSA) Program. The IOM committee found that the CTSA program contributes significantly to advancing clinical and translational research, and recommended a number of revisions that could make the program more efficient and effective and could ensure future successes.

Created in 2006, and currently funded by the National Institutes of Health's (NIH) National Center for Advancing Translational Sciences (NCATS), the Clinical and Translational Science Awards (CTSA) Program aims to facilitate and accelerate the translation of laboratory discoveries into new and better preventive and treatment solutions to improve human health.

Leading the CTSA Program Into the Future

IOM: "the CTSA Program has grown from 12 sites to 61 sites at academic health centers and other institutions across the United States. For the past seven years, the efforts have focused primarily on developing academic homes for clinical and translational research at individual CTSA sites." The next phase of the CTSA Program will be establishing an integrated and collaborative national network that will further catalyze the development of new diagnostics, therapeutics, and preventive interventions. The Program will continue to drive innovation in clinical and translational research methods, processes, tools, and resources and leveraging the capabilities of health informatics tools and other research technologies.

However, the IOM noted: "that an updated mission statement and set of strategic goals will also ensure an increased understanding of the program and provide the groundwork for communicating its value."

Engaging in Beneficial Collaborations

A primary function of the CTSA Program is to initiate and foster collaborations across and among researchers and research networks. According to the IOM: "The committee recommends that CTSA Program establish an innovations fund to promote collaborative pilot studies and other innovative initiatives. The activities supported through this fund should engage a combination of CTSA institutions and a variety of possible entities and stakeholders."

Building on Initial Success in Education

IOM: "The committee urges increased flexibility and the implementation of best practices in training and education to attract and retain scholars and trainees. The CTSAs should also create new benchmarks that place value on team-based science, leadership, community engagement, and entrepreneurship."

Engaging the Community

IOM: "The IOM committee concludes that these partnerships with patients, family members, health care providers, and other community stakeholders need to be preserved, nurtured, and expanded. Because involving community in all of the stages of research may be new to many researchers, NCATS and the CTSA Program must guide this effort and provide clear goals and expectations."

Focus on Child Health

The IOM recommended the current CTSA Consortium Child Health Oversight Committee: "should work with NCATS to identify a small number of CTSAs with established expertise and outstanding efforts in child health research. These CTSAs should be designated as leaders in this area, collaborating with other CTSAs to expand their efforts." Additionally, the IOM suggested efforts continue to promote and increase community engagement specific to child health, and raise awareness of opportunities for children and families to participate in research efforts, clearly conveying all information on the risks and potential benefits.


IOM: "The IOM committee finds that the CTSA Program is contributing significantly to advancing clinical and translational research, and would benefit from a number of revisions to make the program more efficient and effective and to ensure its future success."

June 20, 2013

NIH - NHLBI Discontinues Guidelines Program Passes Work off to Associations

Over the years, we have written about the important role clinical practice guidelines play in physician care and treatment of patients. In fact, many continuing medical education (CME) programs have improved physician adherence to certain guidelines, which has led to better diagnosis and treatment of certain diseases (for example antibiotic guidelines in hospitals and hypertension guidelines).

For example, in 1977, the National Heart, Lung, and Blood Institute (NHLBI) issued the first of a number of clinical practice guidelines that would emerge from the National Blood Pressure Education Program, as well as from other similar efforts like the National Cholesterol Education Program. The NHLBI guidelines have covered a variety of topics, including, but not limited to, cholesterol, blood pressure, asthma, and von Willebrand Disease. "Over the years, these groundbreaking health education initiatives have promoted marked increases in the public's awareness of cardiovascular disease risk factors and contributed to the major reductions in coronary heart disease mortality observed during this period."

The use and creation of guidelines has continued to grow over the years, and more than 2,500 now can be found in the archives of the Agency for Healthcare Research and Quality's (AHRQ) National Guideline Clearinghouse. The last guidelines were published from 1997-2003 with ground breaking reports such as ATP3 and JNC6. In 2007 NHLBI Began the process of convening the panels of experts to revise the guidelines on high blood cholesterol, high blood pressure, and overweight/obesity in adults and develop new reports on cardiovascular risk assessment and lifestyle modification.

However, various concerns were raised about the reliability of certain guidelines and the processes involved in their development.  In response to these concerns, the Institute of Medicine (IOM) issued a new set of standards for clinical practice guidelines in March 2011 intended to enhance the quality of guidelines being produced. 

Consequently, a recent development regarding guidelines creation occurred yesterday, when the NHLBI issued a statement announcing that it will "refocus" its health education agenda to its "core mission of knowledge generation and synthesis by supporting and producing rigorous systematic reviews that can then be used by other collaborating organizations to generate guideline products that serve the public interest."

The NHLBI has decided that "the five integrated cardiovascular guideline products will be published as evidentiary reviews, and that the Institute will subsequently collaborate with other organizations to prepare and issue the related clinical practice guidelines." The decision was made at a public meeting with the NHLBI Advisory Council (NHLBAC).

While the detailed elements of the new NHLBI model remain to be further refined, the Institute said its "overall framework is well aligned with the IOM approach," and outlined "six operating principles" that will govern the new framework:

    1. Before taking on new evidence syntheses, the NHLBI will consult closely with external stakeholders to identify high-priority needs with compelling relevance to the NHLBI mission and the health of the nation.
    2. Once those needs are identified, the NHLBI will work with external stakeholders to determine which critical questions are most crucial for their ability to generate guidelines that are reliable, robust, credible, relatively easy to implement and likely to promote significant improvements in public health.
    3. In supporting and generating evidence syntheses, the NHLBI will pay careful attention to the evolving standards on systematic reviews promulgated by the IOM and other credible sources (citing an IOM report on Standards for Systematic Reviews) (see below for more)

    4. In enabling partner organizations to generate their own guideline products, the NHLBI will continue to abide by the highest standards for developing trustworthy clinical practice guidelines and continue to adapt as best practices and the landscape of stakeholders evolve.(citing an IOM Report on Clinical Practice Guidelines)

    5. The NHLBI will implement a process for internal evaluation and continuous improvement in line with our commitment to results-based accountability and stewardship of public resources.
    6. The syntheses will identify evidence gaps which can guide research investments in areas of importance to public health.

Below is a summary of NHLBI's reasoning for making this decision and some historical background on their previous guideline activities. The Institute noted that while the "time has come for a change in [its] practice of generating clinical guidelines," it will "remain steadfastly committed" to generating "rigorous systematic evidentiary reviews in support of the highest quality clinical practice guidelines worthy of the public trust." They maintained that the "new collaborative partnership model of guideline development will enable the NHLBI to 'recruit knowledge and science in the service of national strength' as envisioned by President Franklin Roosevelt 73 years ago.


For more than sixty-five years, the NHLBI core mission has been, and continues to be, the generation and dissemination of knowledge and science with the goal of securing a healthy nation. On July 26, 1972, Elliot Richardson, the Secretary of the US Department of Health, Education, and Welfare (now HHS), announced the establishment of a "National Hypertension Program." The program planned a four-step approach to include (1) agreement on standards and conditions for treatment, (2) education of health workers, (3) public dissemination of information, and (4) research on the impact of the program on health care delivery.

Richardson appointed two committees: (1), the "Hypertension Information and Education Advisory Committee," which focused on the knowledge of hypertension and the communication of that knowledge, and (2), an "Interagency Working Group" to focus on exchange of information and coordination with the professional community.

After NHLBI created the initial guidelines noted above, "the landscapes surrounding the management of blood pressure and cholesterol disorders, as well as the landscape of clinical practice guidelines," underwent profound changes. "Many more effective strategies are available for clinicians and patients to choose from, and orders of magnitude more clinical evidence information is available. The advent of the internet and the proliferation of mass media outlets provide the lay public with direct-to-consumer access to a plethora of health information."

Clinical research sophistication has grown, as the "mega-trial" has gone from being the exception to the norm. During this period the number and scope of governmental entities engaged in providing guidance on clinical practice has also changed substantially.

NHLBI also noted that "numerous organizations outside government have developed expertise and experience in developing guidelines. Indeed, a special working group of the NHLBAC has noted that nearly all NIH Institutes and Centers have elected to limit engagement in guideline development to efforts involving close collaboration with professional societies or other external groups. "In recent history, the NHLBI has been the lone exception to this general NIH practice," the statement explains.


Part of the explanation for NHLBI's discontinuation of guideline making is tied to the fact that the number "of available guidelines provided by a variety of sources has literally exploded." However, "serious questions and controversies have arisen about how guidelines should be developed, implemented, and evaluated," and "[c]ritics have aptly noted that it is not a given that clinical practice guidelines benefit patients."

Frequently, guideline "developers have been criticized for failing to adequately control for conflicts of interest, for issuing guidelines of variable quality, and for issuing contradictory guidelines that leave clinicians feeling confused and vulnerable. Despite these allegations, NHLBI correctly maintained that "the development of clinical practice guidelines leads to invaluable benefits for patients and clinicians:

  • improved outcomes due to better deployment of evidence-based strategies,
  • improved consistency of care,
  • empowering information for patients,
  • improved public policy through attention drawn to areas of importance to public health,
  • assistance to clinicians who aim to keep their practices up-to-date,
  • guidance for quality improvement activities; and
  • help researchers and research funders identify important research gaps and set the stage for the iterative process of new knowledge generation and advances in patient care.

NHLBI also noted the "debate about who should be in the driver's seat." (i.e., writing the guidelines. "Primary care generalists, specialists, and government agencies may each have limitations which impede their effectiveness in leading the development of guidelines." These concerns have led many organizations to actively reach out to many stakeholders, as was the case in a cardiovascular guideline on risk assessment that. NHLBI emphasized that multiple stakeholders working together collaboratively should write guidelines, rather than one entity, because "there is a much greater likelihood of high-quality products, products that reflect diverse perspectives, philosophies, and expertise."

NHLBI then went on to cite the two IOM reports (noted above) addressing clinical guidelines and the recommendations and analysis they helped provide in general and to the Institute. The Institute noted IOM's distinction in creating two reports: one on standards for systematic reviews and the other on development of trustworthy guidelines. With respect to the former, NHLBI noted that standards for systematic reviews, which NHLBI will be continuing, include:

  1. assembling expert teams with the capacity to manage bias, conflicts of interest, and stakeholder input;
  2. identifying pressing clinical needs while developing an optimal analytic framework;
  3. developing and following rigorous protocols that cover the search and assessment of evidence, as well as its synthesis; and
  4. preparing structured, user-friendly peer-reviewed final reports

The Institute noted that the "standards on guidelines include a similar focus on transparency, management of conflict of interest, team composition, effective articulation of recommendations, external review, and updating." IOM stated that, "Clinical Practice Guideline developers should use systematic reviews that meet standards, [and should interact with] the systematic review team regarding the scope, approach, and output of both processes."


NHLBI's decision demonstrates an interesting point: even the most cutting edge scientists who are constantly analyzing new scientific and medical information and data are sometimes not able to keep up with the pace or have enough resources to synthesize this kind of information to create new information that physicians can act on to improve patient care. This point is the very heart of why continuing medical education (CME) is so critical for America's healthcare system.

CME provides an additional resource for physicians who do not have the time or resources to learn about clinical practice guidelines, the systematic reviews that helped shape such guidelines, or the reasoning behind the recommendations. Further, CME can help physicians walk through these guidelines in a way they can explain to their patients and if necessary to other colleagues.

Ultimately, with the NHLBI leaving the guideline writing industry, it will be incumbent upon professional medical associations and physician organizations to continue the research, collaboration, and analysis necessary to inform physicians in all fields and specialties about new treatments, discoveries and breakthroughs through clinical practice guidelines. This task, however, may be difficult for some organizations and groups given the tremendous task this amounts to and the incredible financial and resource burden imposed on groups—particularly if they are going to comply with IOM recommendations.

Nevertheless, it is promising to see that NHLBI will continue to focus on creating sound systematic reviews for researchers and groups to use as evidence for guidelines. Hopefully, NHLBI and future guideline writers will include CME stakeholders in this new process because CME may be the ultimate conduit from which physicians learn about such recommendations.


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