November 21,2009

The Patient Protection and Affordable Care Act: Fact vs. Fiction on Health Care Research

The Patient Protection and Affordable Care Act would create an independent, non-profit research institute called the Patient-Centered Outcomes Research Institute.  This Institute would be charged with providing for research on what treatments work best for which patients and filling gaps in medical evidence, so doctors have the information they need to deliver the best possible care to their patients.  But, unfortunately, there has been misinformation about this Institute, so the document below separates fact from fiction on this research.

Fiction:     Research that compares the effectiveness of treatments would dictate new government policies, be considered new medical guidelines or make insurance coverage determinations.

Fact:          Today, medical guidelines and coverage decisions are based on science and a methodical review of the evidence – there is nothing in the legislation that would change that process.  The bill clearly states that research findings shall “not be construed as mandates for practice guidelines, coverage recommendations, payment, or policy recommendations.”

Fiction:     Comparative effectiveness research would lead to rationing care, particularly for older Americans.

Fact: The bill prohibits research comparing the effectiveness of different treatments from being used to ration care and includes more patient protections than exist in current law to ensure that it never will be.  Under the legislation, “the Secretary shall not use evidence or findings from comparative clinical effectiveness determining coverage, reimbursement, or incentive programs…in a manner that treats extending the life of an elderly, disabled, or terminally ill individual as of lower value than extending the life of an individual who is younger, nondisabled, or not terminally ill.” That prohibition means this research can never be used in Medicare, Medicaid, CHIP and other health benefit programs to deny people care simply because of age, disability or health status.

Fiction: Research that compares the effectiveness of treatments would be the only evidence that Medicare could use to make coverage determinations.

Fact: Under this legislation, Medicare would be able to use all scientific research to make coverage decisions – just as they do today.  If they wanted to use the findings of the independent research Institute created in the bill, Medicare would be required to take the additional step to first conduct an iterative and transparent review, including a public comment period.

Fiction: Comparative effectiveness research will lead to standardized medicine and practices that treat every patient with the same illness the same way.

Fact: Research that compares different treatments is a tool for doctors in the practice of medicine.  It will empower physicians with more information to help them make the best decision for each patient; it will improve the practice of personalized health care. 

Fiction:Doctors don’t use research comparing the effectiveness of different treatments today.

Fact: Comparative effectiveness research is used all the time in scientific discovery, but much of this research is funded by pharmaceutical companies and device manufacturers whose goal is to sell more of their products.  This research created under this bill will give doctors an independent and impartial source.

Fiction:Comparative effectiveness research is intended to find ways to limit care in the system.

Fact: Research comparing the effectiveness of different treatments has already saved millions of lives.  A good example is breast cancer research.  Years ago, the primary treatment for breast cancer was a bone marrow transplant, but research that compared the effectiveness of different treatments found that bone marrow transplants could be harmful and chemotherapy produced better patient outcomes, and, as a result, that’s the leading treatment used today.  This bill makes an investment in more of this life-saving research.

Fiction:New guidelines, like those recently released by the U.S. Preventive Services Task Force regarding mammograms, could be used to ration care under the bill.

Fact: Under current law, coverage decisions are not made based on recommendations; in Medicare they are made by the Secretary of Health and Human Services and Medicare officials in consultation with medical experts based on all available evidence.  This bill does not change that process. 

Fiction:The Research Institute in this bill will function like the National Institute of Clinical Excellence (NICE) in the U.K. and ration access to health care services based on cost-effectiveness limits. 

Fact: The Research Institute created in this legislation does not have the same charge or mission as NICE.  The Research Institute in this bill will provide for research on clinical outcomes and is strictly prohibited from making any recommendations on coverage, guidelines or reimbursement – and NICE does not have those restrictions.  Further, this research Institute is expressly banned from developing and using cost-effectiveness limits of any kind, and that is also not a policy held by NICE.

Fiction: The new Institute will be more big government getting in between the doctor-patient relationship.

Fact:The Institute is specifically designed not to be a government entity.  It is a private, non-profit entity governed by a multi-stakeholder board appointed by the nonpartisan U.S. Comptroller General.  Six representatives will be from patient and provider groups.  The Institute will have no regulatory authority or governmental functions.  Its purpose is to produce information for patients and providers throughout the health system.

Fiction:Opponents of comparative effectiveness research are looking out for patients’ best interests.

Fact:Rejecting this research is a defense of the status quo in which Medicare is going broke, affordable health care is further and further out of reach for too many families and Americans are getting less from our health care system.  This type of research generates advancements like new generic drugs that benefit many patients and save them money.  Limiting comparative effectiveness research leaves doctors in the dark and could cause medicine to overlook countless new treatments that save lives.