I don’t think we in health policy really understand how complex our systems are and what manner of challenges – some of which we created – present themselves in clinical care.

It was Dr. Christine Sinsky who enlightened me. She said that just five years ago, a patient with a 143/82 blood pressure, 1.4 creatinine, 128 fasting blood sugar and 189 cholesterol was advised to exercise and lose weight. Today, that same person has hypertension, stage 3 kidney disease, diabetes, hyperlipidemia and is a candidate for four medications and ongoing monitoring.

Citing data from the New England Journal of Medicine, she added that a Medicare patient with diabetes, hypertension and depression with a complaint of headaches is subject to 56 different quality measures.

The complexity of those – and other – clinical situations is something she manages with smart system integration; no doubt you’ve seen her publications on those methods. I can’t help but wonder if CER – not as it is imagined and promised, but as it will be realized – will help or hurt clinicians like her and patients like hers. As a policy maker of longstanding, I have to admit that we generally had the best of intentions, but always created negative unintended effects.

Will we do that again? Have good intentions but negative effects? Only time will tell. Since all of us will soon be walking the territory, I’m offering the beginnings of a map in this blog; a map intended to navigate the territory better. I look forward to the ways others might add to our collective understanding of the landscape. The map is not the territory, as they say, but I believe that the better we explore it now, the better will be the chance that those who traverse it can avoid Donner Pass scenarios.

I currently see 7 components on the CER Map, and each of those has a set of interrelated policy issues. I’m interested if you see the territory differently and if you have components and policy issues that illuminate this endeavor further. As you do, remember Dr. Sinsky and Donner Pass.

The 7 components on the CER map:

1. The types of players who, as stakeholders or vendors, will be involved:

• Public sector; e.g., AHRQ, CMS/QIOs, FDA, NIH, VA/DoD, State Governments
• Private sector, including for-profit groups; e.g., Leapfrog, NBCH, NBGH, NCQA, PBMs, Health plans, insurers, URAC, JACHO, medical centers, producers of products and services (biopharmaceuticals, devices, games), CROs
• Public-Private Joint Groups; e.g., NQF, OHSU Center for Evidence-Based Policy
• Foundations; e.g., RWJ, CHCF
• Academics, professional societies and study groups; e.g., Institute for Clinical and Economic Review (ICER), American College of Physicians (ACP),Drug Effectiveness Review Project (DERP), NY Academy of Medicine Evidence Based Medicine Resource Center, IOM, Rand
• Consumers; e.g., Patient advocates, prescribers, professional societies
• Global Influencers; e.g., NICE.

2. The types of targets that will be deemed important for CER studies:

• Prevention; e.g., primary, secondary, tertiary
• Diagnosis; e.g., pt/caregiver report, lab assessment, imaging
• Condition-related; e.g., all hypertension control methods singly or in combination
• Treatments: e.g., high cost-low volume, high volume-low cost
• Chronic care and maintenance
• Palliative or supportive care; e.g., anti-nausea drugs used with chemotherapy
• Health care delivery system options; e.g., office care vs. telemedicine, physician vs. physician extender.

3. The types of evidence that will be used to conduct studies:

• Economic/claims analyses
• EHR records/data mining
• Clinical guidelines
• Expert opinion
• Registries
• Practical clinical trials
• Predictive modeling.

4. The preferences for types of evidence along the traditional hierarchy:

• Meta-analyses of individual patient data
• Large multi-center RCT
• Meta-analyses of group data
• Small, single-site RTCs
• Prospective cohort studies
• Case control, retrospective cohort or cross-sectional studies
• Poorly controlled studies
• Uncontrolled studies
• Inductive, observational studies.

5. The possible uses of the studies:

• Decision support by clinicians and patients
• Educational for clinicians and patients
• Coverage and payment determinations
• Marketplace entry clearance through product licensure, accreditation or contracting
• Pay for Performance
• Evidence-based clinical guideline updates
• Quality report cards
• Consumer reports.

6. The communication methods by which results will become known:

• Federal agency publications
• Professional society peer-review journals
• Coverage bulletins
• Web-sites
• Lay press.

7. Results implementation and outcome expectations:

• Implementation; e.g., next insurance contract year, first day of next quarter
• Outcome expectations; e.g., price reductions, lower costs of care per episode or course of illness, cost trend decline, patient satisfaction, declines in mortality, improved quality of life

Each of those 7 components has different, but clearly interrelated, policy questions, of which the following are but a sample.

Player-related policy questions:

• Are the players all on equal footing, or are some more important than others?
• Must players who control major segments of the health care market meet different standards of behavior regarding target selection or evidence type because their decisions are more consequential than the role that others might play?
• Are the players who pay for larger shares of the health care budget more important than the players who do not?
• How can the interests of the various stakeholders be accommodated when so many of those are – and will always be – conflicting?
• How will studies account for the reality that stakeholders each defined value in different ways?
• Who will be allowed to conduct useable CER studies? Will credentialing be required of individuals and/or organizations that do CER studies? That is, can anyone with a laptop and data generate a CER, or must they be somehow certified or licensed to do so?
• Can companies do CER studies of their own products in comparison to other modalities (e.g., statin vs. oatmeal)? If so, can these studies be used to change product labels and promotional approaches?
• Can patients opt out of data bases on which CER is conducted? If so, what are the consequences for their care and the validity of the data?
• How will patient outliers be protected? What if patients are harmed by the results? Who is accountable in the chain of those who study, communicate and make decisions based on the results?
• Will there be exceptions or exclusions for rare diseases, and for areas of disease care with considerable unknowns?