Medical Device Daily Washington Editor

WASHINGTON – The Agency for Healthcare Research and Quality (AHRQ; Washington) is getting under way with a new quality initiative that could have an impact on the medical device sector.

One of the agency’s newest endeavors – called “What Works in Healthcare” – was partly mandated through the Medicare Modernization Act of 2003 (MMA). A total of $15 million was allocated in the federal budget for fiscal year 2005 to conduct research focusing on outcomes, comparative clinical effectiveness and appropriateness of healthcare items and services, including devices, drugs and various therapies, on a list of different diseases and conditions.

At first, the project will focus on Medicare patients, but researchers know the impact information gathered will go beyond that community.

“The statute ties the work we do to the need of CMS, but I think this program has relevance beyond CMS [Centers for Medicare & Medicaid Services],” Jean Slutsky, director of AHRQ’s center for outcomes and evidence, told Medical Device Daily. “As we all know, their [Medicare patients] needs are not dissimilar to anyone in the healthcare system. But whether you’re a patient, you, me, the manufacturer of a device, or an employee benefit manager, all of us have the need for this information.”

The priority conditions identified for this part of the study are:

  • Arthritis and non-traumatic joint disorders
  • Cancer
  • Chronic obstructive pulmonary disease/asthma
  • Dementia, including Alzheimer’s disease
  • Depression and other mood disorders
  • Diabetes mellitus
  • Ischemic heart disease
  • Pneumonia
  • Peptic ulcer/dyspepsia
  • Stroke, including control of hypertension

In the beginning, the research will take the form of systematic reviews of current scientific literature, published outcomes evidence, and information on comparative clinical effectiveness. Officials at CMS offered input on questions they’d like to see answered by the research. Public comment also was taken into consideration.

“This is a very user-driven program and CMS is certainly one of the drivers because they have a large beneficiary base, but clearly we are asking people in the private sector to provide input as well,” Slutsky said.

She said comparisons may compare the outcomes of drug or device therapies to clinical results from a patient’s behavioral changes. Slutsky emphasized that the research was not intended to single out or name an individual device or drug in particular, though research may evaluate the impact of a class of device on the treatment of a disease.

“The nice thing I like about this program – and of particular interest to your audience – is that this program is not designed to say a device doesn’t work and it is not designed to shut off avenues to innovation,” she explained. “That is not the intent of the program. The intent of the program is to provide the best available evidence for decisions, and find out where we need to fill research gaps.”

She added: “It is not like Coke vs. Pepsi.”

The results of the studies will be made available to Medicare and Medicaid, in addition to health plans, prescription drug plans, other healthcare providers and the public. Slutsky said that additional information will be posted for comment as the agency moves forward with the research, but that they were still working out most of the details.

She said research would be creative and explore new methodologies, but that the information passed along to different audiences would be tailored to suit the individual needs of the audience.

No matter who the audience is, Slutsky said, the emphasis of the research would be “real-world and practical,” and published “in plain language.”

“Our common goals are to ensure that beneficiaries and their clinicians have the best possible information to inform treatment choices based on the scientific evidence that will be gathered and produced in this research effort,” said AHRQ Director Carolyn Clancy, MD. “The findings also will support private-sector initiatives to provide high-quality, safe healthcare that represents the best value.”

The White House’s budget for fiscal year 2006 includes a request for an additional $15 million to keep the program afloat longer.

“But we’ll all have to wait and see what happens there,” Slutsky said.

AHRQ is one of the smallest agencies within the U.S. Department of Health and Human Services.