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Feb
16

Comparative effectiveness – what’s left after the sausage-making process

For we policy types, one of the most important provisions in the stimulus bill, aka the American Recovery and Reinvestment Act, addressed comparative effectiveness research.
Alas, the $1.1 billion+ invested in transforming medicine from art to science has been fed through the sausage grinder, and what has come out doesn’t look terribly appetizing. But after you chew on it for a while, it does taste better than it looks.
Merrill Goozner sees the end result as a partial victory noting “The House conferees also insisted on keeping the phrase “comparative effectiveness” throughout the authorizing language, removing the Senate’s insertion of the word “clinical.” However, the report language did note its removal was “without prejudice.”
But he also cites this language from the conference report itself:
The conferees do not intend for the comparative effectiveness research funding included in the conference agreement to be used to mandate coverage, reimbursement, or other policies for any public or private payer [emphasis added]. The funding in the conference agreement shall be used to conduct or support research to evaluate and compare the clinical outcomes, effectiveness, risk, and benefits of two or more medical treatments and services that address a particular medical condition.
A quick read is disheartening as the language seems to make the whole thing rather irrelevant. But parsing the words makes it less concerning. Note the use of the words “do not intend…to mandate coverage, reimbursement or other policies…” The key here is”mandate”, the meaning and intent of which is likely to gladden the hearts of many an attorney.
The definition of the term is “An official or authoritative command; an order or injunction; a commission; a judicial precept.” But there’s a good bit of flexibility left here. It may well be that creative bureaucrats (that term is not used pejoratively) will be able to use the results to encourage certain types of treatment while discouraging others; to require physicians requesting approval for procedures lacking justification provide support for their request to use those procedures, while approving procedures immediately that comply with research recommendations.
The findings of research conducted by the three agencies that will disburse the funding (Agency for Healthcare Quality and Research (AHRQ), the Center for Medicare and Medicaid Services (CMS), and the National Institutes of Health) may be used by payers as part of the criteria set used to select providers that use certain treatment methods and de-select those docs that don’t.
As I noted, the use of the term mandate will undoubtedly drive up litigation and associated expense. Although the legislative process is far from perfect, at least we’re heading in the right general direction. As the Gooz said;
“Based on the experience of the past few weeks, it’s clear the U.S. is still many years away from having a rational discussion about limiting access to technologies that have been priced far beyond a societally-agreed upon benchmark for what constitutes affordable care.”
Why would we ever want government to ensure that it spends taxpayer dollars wisely?


Joe Paduda is the principal of Health Strategy Associates

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