Medical Device Daily Washington Editor

Proposals for the reform of healthcare routinely make the rounds in and around the Beltway, and it would seem odd if the insurance industry did not chime in with a plan. Hence, America's Health Insurance Plans (AHIP; Washington) went public with its latest offering yesterday.

AHIP has offered other plans but this plan, discussed during a conference call yesterday, would be the first of AHIP's efforts that is purported to make health insurance coverage available to all while addressing spiraling costs.

AHIP's President/CEO, Karen Ignagni, said at the beginning of the call "we have spent a great deal of time to develop a proposal to contribute to this debate" and that the association's members "want to ensure that ... all Americans are covered." Ignagni said that growth in healthcare premiums is "at the lowest rate in 10 years," but nonetheless "cost shifting is mounting substantially."

The five-pronged plan would address the usual suspects, namely comparative effectiveness research, healthcare information technology (HIT), tort reform, value-based purchasing and better disease management and care coordination.

"Only an integrated strategy that addresses quality ... and access" can do the job of making healthcare both affordable and effective, Ignagni said.

The paper published by AHIP in conjunction with the call laid out the rationale and the specifics in substantial detail, but AHIP's calculations indicate that reform of healthcare along these five axes could shave as much as $145 billion off the nation's annual healthcare tab by 2015, even after taking out an up-front investment of about $50 billion. Comparative effectiveness research is credited with only about $5 billion of the total savings and comes in at the low end of the scale. At the high end is disease management and care coordination, which the AHIP analysis says would pull $47 billion a year off the cost of healthcare by 2015.

Between those two extremes are value-based purchasing at $11 billion, HIT at $37 billion, and tort reform at $45 billion. Much of the savings from tort reform, Ignagni said, would derive from the end of the practice of defensive medicine.

The association subjected its plan to an analysis by the auditing and accounting firm Price Waterhouse Coopers (PWC; New York), which sent two representatives to sit in on the call, Jack Rodgers, PhD, formerly with the Congressional Budget Office, and Mike Thompson, a principal at the New York Office of PWC.

Rodgers said that from the data generated by the PWC analysis, "we concluded that the level of savings [projected by AHIP] is reasonable." Rodgers said that among the criteria used to analyze the plan was how those estimates compare with other published studies.

Rodgers pointed out that the AHIP projection pegs the savings from comparative effectiveness studies, which the association said would provide "approximately a .6% reduction in health spending in 2025," was "well within the range" cited by other sources. Among these are a .1% reduction projected by CBO and a 1.3% reduction arrived at by the Commonwealth Fund (New York). Rodgers also said that AHIP's estimate on factor "might be conservative if ... payment policies are tied to effectiveness studies."

Rodgers also said that a full roll-out of HIT could generate cost savings of "about 10% of hospital costs and 5% of physician costs over the next 15 years," pegging the net savings at about 3.6% in the year 2025. However, Rodgers said that the attainment of such savings "would require substantial leadership from the federal government," to encourage widespread adoption and interoperability.

Rodgers indicated that liability reform "would not only reduce malpractice premiums, but also would reduce defensive medicine," which "would reduce total health spending by 1.6% by 2025." He characterized this estimate as "really quite reasonable."

Thompson said "over the next 10 years [value-based purchasing could] reduce both hospitals and physicians [costs] by 1%," or a total of half a percent of total healthcare spending, an estimate he said was "quite conservative." As for disease management and care continuity, Thompson said that dealing effectively with obesity and tobacco use could knock off as much as 2.7% of the national healthcare tab by 2025.

FDA proposes breast cancer ablation registry

With all the emphasis on treatment of breast cancer, keeping track of data generated by all the treatment modalities becomes a large task. As a result, FDA said Wednesday that it will seek input from stakeholders on the question of "whether a registry could facilitate standardization of feasibility trials studying local treatment of small breast cancers with different thermal ablation devices and therapies."

The agency said it is interested in such a registry in connection with several modalities, but is "specifically interested in understanding how breast cancer ablation feasibility trials can be constructed so that there exists standardized evaluation" of tissue biopsy pathology, tumor selection, surgical image guidance and post-ablation imaging and assessment.

"The lack of uniformity among different feasibility study protocols has resulted in various study results that cannot be easily compared," FDA said, and the agency wants to "motivate the breast cancer ablation industry to standardize its feasibility study protocols so that data emerging are comparable in all respects except for the specific ablation modality," which could generate data that "could be used to hypothesize best practices and potentially serve as the basis for larger prospective clinical trials."

Toward that end, "FDA seeks comments on the possible role that a registry of breast cancer treatment using thermal ablation devices could have on advancing the development of thermal ablation devices" with an eye toward the role of such a registry on "imaging, pathological evaluation, and ablation timing protocols."