On February 17, 2009, President Obama signed into law the American Recovery and Reinvestment Act of 2009 (Public Law 111-5). Leading up to his signing of this bill (hereafter ARRA of 2009), he made it abundantly clear during his Address to Congress that there could be no sustainable economic recovery without controlling the costs of healthcare. To accentuate his point, soon after signing this bill, the U.S. Department of Commerce projected that healthcare costs for 2009 would top $2.5 trillion and consume 17.6% of the entire Gross Domestic Product (GDP). The GDP percentage increase from 16.6% in 2008 to 17.6% in 2009 represented the first time in almost 50 years of tracking that healthcare’s percentage of the GDP had jumped a full point in just one year. Based on current trends and without any changes, the Congressional Budget Office (CBO) has projected that by 2025, the cost of healthcare alone will consume fully 25% of the GDP.

In an effort to alleviate the escalating costs of healthcare, which are crushing both businesses and individuals, while maintaining or improving the quality and safety of care, the ARRA of 2009 has appropriated a total of $1.1 billion to fund what is being termed comparative clinical effectiveness research. Of this $1.1 billion, $300 million will be administered by the Agency for Healthcare Research and Quality (AHRQ), $400 million by the National Institutes for Health (NIH) and $400 million by the Secretary of HHS.

“The Act includes funds for a contract under which the Institute of Medicine (IOM) will make recommendations (to the Congress and Obama Administration by June 30, 2009) for ‘national priorities for comparative effectiveness research’. It establishes a Federal Coordinating Council for Comparative Effectiveness Research, which will be composed of up to 15 federal officials (at least half of whom are physicians or others with clinical expertise) and chaired by the Secretary of Health and Human Services (HHS). The council will be tasked with recommending and coordinating research, but will not be able to ‘mandate coverage, reimbursement, or other policies for any public or private payer’” (Steinbrook, R., Health Care and the American Recovery and Reinvestment Act at: http://content.nejm.org/cgi/content/full/NEJMp0900665).

The Commonwealth Fund Commission on a High Performance Health System, chaired by James Mongan, M.D., CEO of Partners HealthCare, concluded in a recent report that creation of a center for comparative effectiveness could save $634 billion between 2009 and 2020. The $634 billion question, however, is how strictly would the results of these studies need to be followed to achieve these savings? Would the results of these studies establish new standards of care, against which physicians’ actions will be evaluated?

How much will the results of comparative clinical effectiveness research influence physician reimbursement?

Fortunately for physicians, the Senate version of the ARRA of 2009 contained the previously mentioned non-coercive language in it:

The Federal Coordinating Council for Comparative Effectiveness Research will be tasked with recommending and coordinating research, but will not be able to mandate coverage, reimbursement, or other policies for any public or private payer (Cf. Steinbrook and the NEJM web link, above).

The House version of the ARRA of 2009 had no such restriction. The Council has its first public meeting on April 14, 2009 in the D.C. area.

Nevertheless, just how much will this provision prevent either public or private payers from altering their reimbursement policies to “persuade” physicians to follow the recommendations deriving from these studies? The language above merely prevents the Council from mandating coverage, reimbursement or other policies for any public or private payer. That provision could not be read to prevent any public or private payer from using the results of the research to alter its coverage, reimbursement or other policies.

As both public and private payers continue to move toward some type of value-based purchasing reimbursement model, it certainly seems plausible, if not likely, that they will seriously consider various means of persuasion to get physicians to follow the recommendations deriving from the results of these studies. Their methods of persuasion could include:

• Providing something less than previous levels of reimbursement for following a course of action not supported by the results of comparative clinical effectiveness research (e.g. performance of a meniscectomy prior to a full course of physical therapy for a patient with chronic knee problems with or without previously diagnosed torn cartilage)

• Classifying as “non-preferred” or even “non-formulary” those medications being ordered for specific purposes (e.g. antibiotics for first time pediatric ear infections) that are not necessarily supported by clinical effectiveness research results

• Reimbursing at the same level any treatment (e.g. diuretics for hypertension) concluded by the results of studies to be at least as effective for patients with certain levels of high blood pressure as the more expensive treatments which may achieve comparable results

Insurers may influence patients also by using the results of this research to:

• Steer them toward certain treatments by lowering the copayment, coinsurance or deductible amounts associated with those deemed to be of higher value

• Make it more difficult to obtain certain treatments (e.g. knee operations—see above) by making them complete a course of physical therapy before qualifying for the invasive (perhaps, more definitive) procedure

• Reimbursing less of the costs of seeing certain practitioners known (through tracking) to be more likely not to follow the best evidence based practices deriving from the results of these comparative effectiveness studies

Reimbursement issues aside for the moment, what might be the potential liability implications of not following (or, in some cases, even following) these best practices? What defenses could physicians mount for not following them? What types of best practices could be determined to be credible and might even serve as a shield for physicians who follow them?