Regulatory Focus™ > News Articles > House Budget Draft Eliminates Comparative Effectiveness Research Agencies

House Budget Draft Eliminates Comparative Effectiveness Research Agencies

Posted 18 July 2012 | By

Two federal agencies charged with controlling costs by conducting non-binding comparative effectiveness research stand to be eliminated under the latest draft of an appropriations bill in the House of Representatives.

AHRQ to be 'Terminated'

The Agency for Healthcare Research and Quality (AHRQ) is, like the US Food and Drug Administration (FDA), contained under the umbrella of the US Department of Health and Human Services, and is run by longtime-Director Carolyn Clancy. Clancy has been director of the agency under both Presidents George W. Bush and Barack Obama-a relative rarity given the desire of presidents to leave a mark on the agencies they take charge of.

The agency is charged with conducting effectiveness research, particularly of medical interventions by healthcare providers in hospital settings. While it largely avoids healthcare products, its work is hugely influential in setting indicators of quality.

Section 227 (a) of the appropriations bill would eliminate the agency in its entirety effective 1 October 2012, with all remaining funding going towards an orderly transition. Other agencies would be banned from assuming the duties currently carried out by AHRQ (Sec. 227 (c)) unless they already have existing statutory authority to do so.

PCORI to Lose All Funding, Gut CER Research

Section 217 of the appropriations bill would eliminate funding for the Patient-Centered Outcomes Research Institute (PCORI). The relatively new agency was formed as a result of the Patient Protection and Affordable Care Act (PPACA) of 2010, and is intended to provide a source of comparative effectiveness research (CER) regarding medicines, healthcare products and other medical interventions. It's recommendations, like those of the US Preventative Services Task Force (US PSTF) are complied with on a voluntary basis, though many insurers adjust reimbursement amounts accordingly.

The legislative language would also prevent any other agency from conducting research that could be construed as patient-centered outcomes research. "Notwithstanding any other provision of law, none of the discretionary funds appropriated by this Act may be used to support any patient-centered outcomes research," explain the draft.

It is unclear whether the provisions could eventually be struck from the bill. The de-funding of PCORI could potentially face trouble in the Democrat-controlled Senate, which has already defended the PPACA from numerous salvos from the Republican-controlled House of Representatives.

FDA's appropriations are not covered by this particular piece of legislation.

Read more:

House Budget Bill (Healthcare Funding Pgs. 76-93).

Regulatory Focus newsletters

All the biggest regulatory news and happenings.