Academic journal article American Journal of Law & Medicine

Comparative Effectiveness Research under the Patient Protection and Affordable Care Act: Can New Bottles Accommodate Old Wine?

Academic journal article American Journal of Law & Medicine

Comparative Effectiveness Research under the Patient Protection and Affordable Care Act: Can New Bottles Accommodate Old Wine?

Article excerpt

The Patient Protection and Affordable Care Act (PPACA), as amended by the Health Care and Education Reconciliation Act of 2010, initiated comprehensive health reform for the healthcare sector of the United States. PPACA includes strategies to make the American healthcare sector more efficient and effective. PPACA's comparative effectiveness research initiative and the establishment of the Patient-Centered Outcomes Research Institute are major strategies in this regard. PPACA's comparative effectiveness research initiative is one in a long line of federal initiatives to address the rising costs of healthcare as well as to obtain better value for healthcare expenditures. The key question is whether the governance and design features of the institute that will oversee the initiative will enable it to succeed where other federal efforts have faltered. This Article analyzes the federal government's quest to ensure value for money expended in publically funded healthcare programs and the health sector generally. This Article will also analyze what factors contribute to the possible success or failure of the comparative effectiveness research initiative. Success can be defined as the use of the findings of comparative effectiveness to make medical practice less costly, more efficient and effective, and ultimately, to bend the cost curve.

CONTENTS

I. INTRODUCTION ..................................................................................... 524

II. THE ROAD TO COMPARATIVE EFFECTIVENESS RESEARCH ..................... 524

A. Early Efforts at Technology Assessment ....................................... 525

B. The Ascendency of Health Services Research ............................... 526

C. The Saga of Medicare Coverage Policy ......................................... 533

D. The AHRQ, the NIH, and Comparative Effectiveness Research ....................................................................................... 539

1. Federal Efforts in Comparative Effectiveness Research Under the American Recovery and Reinvestment Act of 2009 ............................................................................ 541

2. The Brouhaha over Comparative Effectiveness Research in 2009 ................................................................................... 544

III. THE PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE ................. 544

A. Key Definitions ............................................................................. 545

B. Purpose of the Institute ................................................................. 545

C. Duties ........................................................................................... 546

1. Identifying Research Priorities and Establishing a Research Project Agenda ........................................................ 546

2. Collecting Data ...................................................................... 548

3. Appointing Expert Advisory Panels ....................................... 548

4. Supporting Patient and Consumer Representatives ................. 549

5. Establishing a Methodology Committee ................................. 549

6. Providing a Peer Review Process for Primary Research ......... 550

7. Releasing Research Findings .................................................. 550

8. Adopting Policy ..................................................................... 551

9. Submitting Annual Reports .................................................... 551

D. Institutional Design, Governance, and Administration .................. 552

1. Administration ....................................................................... 552

2. Board of Governors ................................................................ 552

3. Financial and Governmental Oversight ...... …

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