The Impact of Comparative Effectiveness Research
on Interventional Pain Management: Evolution
from Medicare Modernization Act to Patient
Protection and Affordable Care Act and the
Patient-Centered Outcomes Research Institute
Authors: Manchikanti Laxmaiah 
Published: March 2021

The Patient-Centered Outcomes Research Institute (PCORI) was established by the Affordable Care Act
of 2010 to promote comparative effectiveness research (CER) to assist patients, clinicians, purchasers,
and policy-makers in making informed health decisions by advancing the quality and relevance of
evidence concerning the manner in which diseases, disorders, and other health conditions can
effectively and appropriately be prevented, diagnosed, treated, monitored, and managed through
research and evidence synthesis.
The development of PCORI is vested in the Medicare Modernization Act (MMA) and the American
Recovery and Reinvestment Act (ARRA). The framework of CER and PCORI describes multiple elements
which are vested in all 3 regulations including stakeholder involvement, public participation, and
open transparent decision-making process. Overall, PCORI is much more elaborate with significant
involvement of stakeholders, transparency, public participation, and open decision-making. However,
there are multiple issues concerning the operation of such agencies in the United States including the
predecessor of Agency for Healthcare Research and Quality (AHRQ), the Agency for Healthcare Policy
and Research (AHCPR), AHRQ Effectiveness Health Care programs, and others.
The CER in the United States may be described at cross-roads or at the beginnings of a scientific era
of CER and evidence-based medicine (EBM). However the United States suffers as other countries,
including the United Kingdom with its National Health Services (NHS) and National Institute for Health
and Clinical Excellence (NICE), with major misunderstandings of methodology, an inordinate focus
on methodological assessment, lack of understanding of the study design (placebo versus active
control), lack of involvement of clinicians, and misinterpretation of the evidence which continues to
be disseminated.
Consequently, PCORI and CER have been described as government-driven solutions without
following the principles of EBM with an extensive focus on costs rather than quality. It also has been
stated that the central planning which has been described for PCORI and CER, a term devised to be
acceptable, will be used by third party payors to override the physician’s best medical judgement and
patient’s best interest. Further, stakeholders in PCORI are not scientists, are not balanced, and will set
an agenda with an ultimate problem of comparative effectiveness and PCORI that it is not based on
medical science, but rather on political science and not even under congressional authority, leading
to unprecedented negative changes to health care. Thus, PCORI is operating in an ad hoc manner
that is incompatible with the principles of evidence-based practice.
This manuscript describes the framework of PCORI, and the role of CER and its impact on
interventional pain management.
Key words: Patient-Centered Outcomes Research Institute (PCORI), comparative effectiveness
research (CER), National Institute for Health and Clinical Excellence (NICE), Patient Protection
and Affordable Care Act (ACA), Medicare Modernization Act (MMA), American Recovery and
Reinvestment Act (ARRA), interventional pain management, interventional techniques, evidencebased medicine, systematic reviews.