August 5, 2010 – A provision in the new health care reform law calling for more research and disclosure on the pros and cons of medical interventions could drastically change how payers pick which medicines to favor, how providers pick which ones to prescribe and how manufacturers pick which ones to develop and promote.
A section buried deep within the Affordable Care Act’s (ACA) thousand-plus pages established the Patient-Centered Outcomes Research Institute, which is charged with evaluating the costs and benefits of pharmaceuticals and other therapies—a field better known as comparative effectiveness research. A 21-member board chosen by the U.S. Comptroller General will run the institute. One of its first jobs will be to conduct an inventory of existing research, building on work already begun under last year’s federal economic stimulus bill.
Searching for “What Works”
Health care stakeholders have been hunting with greater urgency for “what works” in medicine since the Institute of Medicine released its pivotal 1999 white paper, “To Err is Human: Building a Safer Health System.” That study concluded that every year up to 98,000 Americans die due to preventable medical errors. It inspired dozens of public and private health care quality improvement efforts, including the Health Resources and Services Administration’s Patient Safety and Clinical Pharmacy Services Collaborative and the Institute for Healthcare Improvement’s 100,000 Lives Campaign, the latter founded by Dr. Donald Berwick, the new head of the Centers for Medicare and Medicaid Services.
Berwick’s close association with comparative effectiveness research has made him a frequent target of criticism for those who believe that the field is setting the stage for health care rationing and “death panels.” Comparative effectiveness research, however, is far less toxic within the health care profession. Many in it think the research holds substantial promise of improving patients’ qualify of life while holding down health care costs.
One of them is Mark Gibson, director of the Center for Evidence-based Policy (CEbP) at Oregon Health Sciences University. The field, he says, “offers many potential benefits, including better informed consumers, improved clinical decision making by providers and decreased medical costs.”
The key word is “potential.” No one knows, for example, whether patients will become “educated consumers” in large enough numbers to leverage big changes in medical practice or whether pressure from payers will trump marketing by manufacturers in influencing physicians’ prescription decisions.
The new federal institute will have little if any direct power to force anyone or anything to change what it does. The ACA bars it from “mandat[ing] coverage, reimbursement, or other policies for any public or private payer.” Large institutional direct purchasers as well as insurers and other payers, however, would be free to use the institute’s findings to make coverage and reimbursement decisions. For example, it is already common for pharmacy and therapeutic committees to rely on comparative effectiveness research when creating preferred drugs lists for state Medicaid plans and formularies for pharmacies and health plans.
Manufacturers’ Concerns
Drug manufacturers are understandably concerned about concentrating power to sway markets in the hands of a government-appointed panel of experts.
“Pharmaceutical companies support comparative effectiveness research because of its potential to improve medical treatment and patient health,” says Michael McCaughan, a founding member of the biopharma policy analysis firm Prevision Policy. “The industry wants to avoid a system, though, in which the government is the sole voice or decision maker on what drugs are eligible for reimbursement or where cost is the only focus and therapeutic effectiveness is ignored.”
As previously mentioned, some politicians and commentators suggest the new research institute will ultimately lead to denial of care for those deemed least able to benefit. In response to such fears, the ACA forbade federal health officials from using comparative effectiveness research findings to make coverage, reimbursement, or incentive decisions that value care for an individual who is young, non-disabled or not terminally ill over someone who is elderly, disabled, or terminally ill.
Getting Patients to Buy in
Perhaps no one’s buy-in matters more than patients. A recent report in the policy journal HealthAffairs revealed many patients are hesitant about their physicians using comparative effective research to make treatment decisions. A large percentage of patients believe that newer or more costly care is better care.
Gibson of the Center for Evidence-based Policy notes that “one key to realizing the potential benefits of comparative effectiveness research is disseminating information in a form that clinicians will trust and can easily use to support their decision making.” But, he observes, “little work has been done to determine what are the most effective ways to incorporate research findings into clinical decision support systems.”
To help fill that void, CEbP, Safety Net Hospitals for Pharmaceutical Access (SNHPA) and other organizations are jointly seeking funding from the Consumer and Prescriber Grant Education Program to develop implementation standards and prototypes to improve prescribing practices. They expect a decision on their grant application by November.