1. It is a clone of the UK National Institute for Clinical Excellence (NICE) NICE is independent and does not mandate coverage, guidelines or reimbursement. SImilarly CERA does not mandate coverage, reimbursement, or other
policies for any public or private payer. States that none of the reports or research
findings shall be construed as mandates, guidelines, or policy recommendations.
But NICE winds up being the de fault position for National Health Service in the UK. In fact, after NICE was instituted, the NHS made acceptance of their evaluations a requirement for reimbursement. Nothing in the bill stops CMS or a private insurer from imposing that requirement on patients and doctors. But it will happen.
2. NICE completely ignores the development of metrics and measures to capture patient variation at the genetic and biological level in assessing value and outcomes.
So doe CERA. For all Baucus' observation that the age of personalized medicine and genetic engineering will
provide even more choices for patients and their physicians there is nothing -- absolutely nothing in the bill that would stimulate the development of measures and studies that reflect such advances. How can patients make choices among treatment options developed from personalized medicine with evaluation techniques that ignore such variation?
3. The bias towards large randomized trials, review of old and small studies and sponsors that benefit from it are grandfathered into CERA. The bill directs the Institute to "give preference to federal agencies and instrumentalities
with experience in conducting comparative effectiveness research, such as the
Agency for Healthcare Research and Quality (ARHQ), when entering into
contracts for the management and conduct of research according to the research
project agenda. "
Guess who ARHQ relies on for such research? Entities funded by HMOs and other payers with a goal towards cost containment. And it defers to the NIH which has given us CATIE, ALLHAT and the clarity-inducing results of the ACCORD study on the effect of reducing insulin below existing target levels on stroke and other diabetes related illness. Yes, money well spent. And it defers to CMS as well with it's well documented effort to develop patient-centered approaches to anemia drug dosing instead of a one size fits all approach...
Moreover, CERA "allows the Institute to alternatively enter into contracts with appropriate private sector research or study-conducting entities for the conduct of research according to the research project agenda."
Here's a hint, it's not Phrma or BIO or any of the study conducting entities they support. Of course neither. Not that either would be a better or less self-serving job.
4. CERA presumes that comparative effectiveness research does improve outcomes or improve better quality evidence concerning the best treatment, prevention, and management of the health conditions. It assumes that comparative effectiveness research helps patients, providers, and payers of health care to make more informed decisions.
Is there any evidence that these two assumptions are true?
How about a study to determine whether comparative effectiveness research is, compared to other types of research, actually achieves these goals? At least a meta-analysis or review to examine just how well-designed or comparatively effective comparative effectiveness research is...
And what if CERA becomes a de facto guideline for reimbursement and coverage. Doesn't it become another obstacle to access, just like in the UK, CMS and health plans that try to deny cancer patients coverage to innovative uses of new medicines?
How about a study about that?
All the "stakeholders" in DC and beyond are acting like this is a fait accompli. Hardly. By the time this bill gets through hearings and proper vetting, it will not stand in it's current form or at all.