Since CMS’s Center for Medicare and Medicaid Innovation launched three years ago, its staff have been frequently hailed for undertaking an ambitious research agenda.
But a New York Times story this week was eye-catching for a different reason: author Gina Kolata mostly assailed Medicare’s researchers for how they’re choosing to do that research.
“Experts say the center is now squandering a crucial opportunity,” Kolata wrote in a front-page article. “Many researchers and economists are disturbed that [CMMI] is not using randomized clinical trials, the rigorous method that is widely considered the gold standard in medical and social science research.”
But many researchers and economists that I talked to at this week’s Academy Health conference say that’s not the case at all. (And some were disturbed to learn that they were supposed to be disturbed.)
“RCTs are helpful in answering narrowly tailored questions,” Harvard’s Ashish Jha told me. “Something like—does aspirin reduce 30-day mortality rates for heart attack patients.”
“However, for many interventions, RCTs may be either not feasible or practical.”
“While RCTs may be the gold standard for testing some hypotheses, it is not necessarily the most effective or desirable model for testing all hypotheses,” agrees Piper Su, the Advisory Board’s vice president of health policy.
CMMI’s ambitious goals
On its surface, Kolata’s article is built around a reasonable conclusion: RCTs offer plenty of value in health care, and we’d benefit from more of them.
- As Jha alludes to, think of a double-blinded pharmaceutical study where half the participants randomly get a new drug and the other half get a placebo; that’s an RCT.
- The famous RAND study that found having health insurance changes patients’ behavior: An RCT.
- The ongoing Oregon Health Insurance Experiment: Also, an RCT.
And it’s fair to examine how CMMI is pursuing its research, too.
2012 has been a challenging year for me.
On the personal side, my wife had cancer. Together we moved two households, relocated her studio, and closed her gallery. This week my mother broke her hip in Los Angeles and I’m writing from her hospital room as we finalize her discharge and home care plan before I fly back to Boston.
On the business side, the IT community around me has worked hard on Meaningful Use Stage 2, the Massachusetts State Health Information Exchange, improvements in data security, groundbreaking new applications, and complex projects like ICD10 with enormous scope.
We did all this with boundless energy and optimism, knowing that every day we’re creating a foundation that will improve the future for our country, communities, and families.
My personal life has never been better – Kathy’s cancer is in remission, our farm is thriving, and our daughter is maturing into a fine young woman at Tufts University.
My business life has never been better – Meaningful Use Stage 2 provides new rigorous standards for content/vocabulary/transport at a time when EHR use has doubled since 2008, the State HIE goes live in one week, and BIDMC was voted the number #1 IT organization the country.
It’s clear that many have discounted the amazing accomplishments that we’ve all made, overcoming technology and political barriers with questions such as “how can we?” and “why not?” rather than “why is it taking so long?” They would rather pursue their own goals – be they election year politics, academic recognition, or readership traffic on a website.
As many have seen, this letter from the Ways and Means Committee makes comments about standards that clearly have no other purpose than election year politics. These House members are very smart people and I have great respect for their staff. I’m happy to walk them through the Standards and Certification Regulations (MU stage 1 and stage 2) so they understand that the majority of their letter is simply not true – it ignores the work of hundreds of people over thousands of hours to close the standards gaps via open, transparent, and bipartisan harmonization in both the Bush and Obama administrations.