Clinical Practice Guidelines We Can Trust: A User’s Perspective Lewis G. Sandy MD Senior VP,...

Clinical Practice Guidelines We Can Trust: A User’s Perspective

Lewis G. Sandy MDSenior VP, Clinical Advancement

UnitedHealth Group

Institute of Medicine Implementation WorkshopMay 10, 2011

Special Thanks: Richard A. Justman MD

2Confidential Property of UnitedHealth Group. Do not distribute or reproduce without express permission of UnitedHealth Group.

What medical policy is all about

• UnitedHealth Group is a science-based company that translates best clinical evidence into policies, services and products that optimize the health, well-being, and affordability of healthcare for our customers

• Medical policy is manifested in the following activities:– Medical technology assessment– The determination of "proven vs. unproven" services for benefit design,

interpretation, administration and appeals– Reimbursement policies that determine how physicians and hospitals

are paid– Clinical appeals – Clinical quality improvement and performance assessment– Consumer engagement, decision support coaching, and care

management– Clinical operations—e.g., notification, clinical coverage review,

predetermination, concurrent review, case management and disease management, and medical claim review

– Pharmacy programs and drug policies


UnitedHealthcare hierarchy of evidence

– Statistically robust, well-designed randomized controlled trials– Statistically robust, well-designed cohort studies– Large, multi-site observational studies– Single-site observational studies– In the absence of incontrovertible scientific evidence, medical

policies may be based upon national consensus statements by recognized authorities. The following stratification describes the hierarchy of use of medical policies and clinical guidelines within UnitedHealthcare:

• Centers for Medicare and Medicaid Services (CMS) National Coverage Decisions (NCDs) (Medicare population)

• Milliman Care® guidelines (commercial population)• National guidelines and consensus statements, e.g. United States Preventive

Services Task Force (USPSTF), National Institutes of Health (NIH) clinical statements, Agency for Health Care Research and Quality (AHRQ) clinical statements.

• Clinical position papers of professional specialty societies, e.g. American College of Physicians (ACP), American College of Cardiology (ACC), American College of Chest Physicians (ACCP), when their statements are based upon referenced clinical evidence.

– Expert opinion


Clinical review of a procedure, device or drug

• Does it work? How strong is the evidence?

• What population of persons would benefit from a proposed treatment?

• How would a procedure, device or drug affect health outcomes?

• What are the advantages, harms & alternatives to the proposed treatment?

• What is the clinical evidence of safety and efficacy of the proposed treatment?


Medical Technology Assessment Committee

• Physicians in multiple medical and surgical specialties and sub-specialties

• Reviews externally developed technology assessments– Hayes Inc– ECRI– Blue Cross TEC

• Reviews primary source literature• Does not review unpublished data, professional society abstracts

or meeting proceedings• Defines and Communicates Medical Policies Openly and

Transparently• Continually Open to Feedback, Comments, and New Evidence


www.unitedhealthcareonline.com >Tools and Resources >Policies and Protocols > Medical and Drug Policies

http://www.unitedhealthcareonline.com/


Themes From Our Committee’s Work:

• Scientific evidence may vary from patterns of practice

• Some technologies work, but are useful for a very small population

• Some treatments work for some diseases but not for others

• Some technologies work, but their utility is undefined

• Some treatments work for conditions where previously no effective treatment was available

• Some treatments are no better than established treatments, but have substantially greater cost


What’s wrong with the current state?

• Methodological rigor in guideline development variable

– Systematic evidence review vs. consensus vs. expert opinion

• Bias, conflict of interest not clearly addressed

– Bias may be unintended

– Many subject matter experts have consulting agreements with device manufacturers, pharmaceutical companies

• Some topics may have multiple guidelines

– 64 different guidelines identified that address asthma

• Buy-in on use of existing guidelines is variable

– Metrics frequently not available


How to optimize success from clinical practice guidelines

• From Knowing What Works in Health Care: A Roadmap for the Nation:– Groups developing clinical guidelines or

recommendations should use the Program’s standards, document their adherence to the standards, and make this documentation publicly available.

– To minimize bias due to conflicts of interest, panels should include a balance of competing interests and diverse stakeholders, publish conflict of interest disclosures, and prohibit voting by members with material conflicts.

– Providers, public and private payers, purchasers, accrediting organizations, performance measurement groups, patients, consumers and others should preferentially use clinical recommendations developed according to the Program standards.


How the New CPG Standards Can (Potentially) Help:

• Addressing Conflicts of Interest• Making Reasoning More Explicit• Ratings of Evidence and Strength of Recommendation• Improved Articulation of Recommendations• Stronger Guidelines That Can Form the Basis of Medical

Policies• Possible Side Effects:• Excluding Conflicted Experts Could Weaken Guidelines• Standards Could Reduce the Scope of Guidelines• Standards Could Increase Administrative Burden

Let’s Try Them and See!...


Thank You!

Clinical Practice Guidelines We Can Trust: A User’s Perspective Lewis G. Sandy MD Senior VP,...

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