Medical Device Daily National Editor

"Quality." Hard to determine when choosing a radial tire or a new fridge — or anything involving modern technology, such as the intricacies of med-tech and modern healthcare in general.

So what does quality mean for the provision of healthcare: a shift to better providers, or simply more puffery in your local hospital's advertising?

The Federal Trade Commission (FTC) this week unveiled plans to hold two public workshops and roundtables to examine the impact of quality and competition in healthcare, the dates and agendas not yet determined.

The meetings, it said, will look at emerging issues in "healthcare competition and consumer protection" in two broad areas: the development of an abbreviated regulatory pathway for "follow-on" biologic drugs, and a consideration of how quality information may impact competition among healthcare providers and influence consumers.

Michael Wroblewski, an attorney in the FTC's bureau of competition, told Medical Device Daily that a key focus by the commission will be "the competitive significance of quality information — can it move the market?"

The ability of quality information to move healthcare from just the provision of any care to those providers offering better care has been one of the major concerns of payers and regulators in the Bush administration's watch. But many would argue that there has been no evidence that, for instance, payments by the Centers for Medicare & Medicaid Services to those providing quality service has created any major market movements or significantly better, or less, expensive care.

Wroblewski noted another obvious concern by the FTC: that "you want to make sure that quality information that's there isn't false and misleading, so that consumers don't make the wrong quality decisions."

Wrobleski told MDD that the meetings likely will be held at the end of October, "but we're still playing with the dates."

He said that he expected more interest and participation in the workshops from industry rather than consumers, while noting that the "consumer" category should be considered as including physicians, hospitals and other buyers of healthcare services, not just patients.

(See sidebar below for a list of questions the commission wants to consider concerning decision-making on the demand side, based on quality information.)

FTC questions: Does 'quality' impact healthcare purchasing?

Following are some of the demand-side issues to be explored at the FTC's fall workshops on quality in healthcare:

What decisions do quality information help different types of purchasers make?

What are the relevant times at which purchasers make healthcare decisions? What quality information about healthcare services and providers should be presented at these critical junctures?

What quality information is the most competitively significant for different types of purchasers? Are different types of data (e.g., licensing information, compliance with process measures, customer satisfaction, outcomes, outcomes per dollar spent) appropriate for different purchasers and purchaser decisions? How should any differences in measurement of the same provider or service (over the same time frame) be reconciled?

Does healthcare quality vary based by medical condition, provider, and patient? Does it vary over time? If so, how should quality measures be adjusted to take these differences into account?

What information is needed to measure the efficiency of a provider? What is the proper weighting of quality and resource use in an efficiency measure?

How broad a range of differences among healthcare providers and services is needed to motivate purchasers to switch service providers?

How should regional variations be accounted for in showing the results of quality measures? Should local, state, regional, or national benchmarks be used to show differences among service providers? Why or why not?

How does the framing of quality information affect the purchasers' decisions? Do symbols and summaries affect purchaser understanding of healthcare quality information?

What has been learned from public and private quality reporting initiatives that can aid the competitive process?

What are the tradeoffs between quality-based competition and the availability of healthcare?

The need for the workshops, the FTC said, stems from questions raised by a joint 2004 report by the commission and the Department of Justice. That report, Improving Health Care: A Dose of Competition, it said, identified the significant increase in competitive issues as related to consumer protection, thus playing into the FTC's roles in these areas.

The meetings also will build on the commission's Workshop on Innovations in Health Care Delivery held earlier this year, focused, it said, on "healthcare price and quality transparency," including "forms of transparency that may be anticompetitive," such as disclosure of payer/provider contract rates that could foster "coordinated pricing."

The FTC said it will consider whether providers delivering high-quality services "are rewarded with more business (and/or greater revenue) and whether those failing to do so either improve or are penalized with less business (and/or lower revenue)."

The commission said it also will look at "the extent to which there is demand is for high-quality healthcare, the attributes of quality information that motivate purchasers to select high-quality providers, and the ramifications of quality-based competition on the availability of healthcare."

On the biologics side, the fall meetings primarily will be concerned with those drugs "sufficiently similar to an approved or referenced biologic product to permit the follow-on applicant to rely on existing scientific knowledge about the safety and effectiveness of the referenced biologic product to obtain approval of the follow-on product."

The commission said that among the key issues in this case is whether an abbreviated regulatory approval pathway for these products will be the need to strike the right balance between "regulatory exclusivity periods and competition to spur the development of new, improved, and follow-on biologic drug products" in other words, whether the same protections and incentives covering the development of generic pharmaceuticals should be adopted for follow-on biologics.

The FTC is asking for comments on these issues to be sent by Sept. 30, with additional comments accepted for 30 days following the workshops.