A Medical Device Daily

Comparative effectiveness research is all the rage, but the idea extends beyond comparisons of drugs and devices, as a recently announced series of grants by the Agency for Healthcare Research and Quality indicates.

AHRQ published a request for proposals last week that offers a total of $7 million for a variety of purposes, most of which seem geared toward healthcare system tweaks of various kinds. According to the Feb. 12 announcement, the funds for the grants are provided via the American Recovery and Reinvestment Act of 2009 and will fund projects such as those addressing community collaborations for disease prevention, care management, and patient activation.

Other interests expressed by AHRQ include research geared toward developing systematic efforts to reduce hospital readmissions, and programs that encourage patient self-management. However, the agency also would like to see some proposals that deal with traditional insurance issues such as value-based insurance designs, utilization management, and cost-sharing, but any projects that offer a review of techniques for reducing patient waits in outpatient and emergency care are also of interest.

According to the AHRQ statement, proposals should "provide rigorous analysis of the comparative impact of these designs and changes and evaluate their applicability to multiple settings." The proposed studies should also "assess the applicability or adaptability of the selected designs, strategies, and interventions to multiple care settings and diverse patient subgroups," the announcement states, and "particular attention will be paid to the contribution of system improvements to chronic care and care for priority populations."

AHRQ expects to make between six and 10 awards, which will each be limited to three years and an annual cost of $500,000. The program is open to larger awards, but any such applications must be deemed "likely to generate findings that are of great importance to healthcare policy makers and to delivery system leaders, as well as to researchers." The results of any studies that qualify for super-sized awards should "shed light on delivery system designs and change programs with potential for major impacts on care outcomes and with potential for implementation in a wide range of delivery settings."

Applications are due March 18 and studies may commence as early as Aug. 31.

CMS staffs deputy administrator slot

The mystery of the job of administrator at the Centers for Medicare & Medicaid Services continues with the hiring of Marilyn Tavenner as the agency's principal deputy administrator. Tavenner, described as a former hospital CEO who also served as the Secretary of Health and Human Resources for the state of Virginia, will report directly to acting CMS administrator Charlene Frizzera, who has received nothing in the way of a vote of confidence since taking the job when the Obama administration moved into the White House.

Secretary of Health and Human Services Kathleen Sebelius recently commented on the management staffing situation at CMS, noting that the Obama administration has had "an extensive interview process" for the CMS administrator's job (Medical Device Daily, Feb. 2, 2010). Sebelius brushed off the issue, asserting, "We have incredibly good leadership" in the persons of Cindy Mann, CMS's director of state Medicaid operations, and Jonathan Blum, director of the Center for Medicare Management. Sebelius said also that the appointment of CMS's administrator would be made in the "not too distant future."

Tavenner's experience suggests that she might be qualified for the CMS chief's post, given that she oversaw 18,000 employees and a $9 billion annual budget while handling the Virginia HHR post, a job that included oversight of the state's Medicaid program. Her private sector experience includes stints as group president of outpatient services at Hospital Corporation of America (Nashville, Tennessee) and as the CEO of two hospitals, including Chippenham Medical Center (Richmond, Virginia). Both Blum and Mann are expected to report to Tavenner.

Another CMS slot, that of deputy administrator for program integrity, was filled by Peter Budetti, MD, formerly a staffer for Rep. Henry A. Waxman, (D-California). According to The Hill, the program integrity position is "a new center formed to head up the agency's anti-fraud efforts." Budetti's experience is said to include "academic posts dealing with healthcare fraud issues and public health issues." Budetti holds a JD in addition to an MD.

FDA rolls out PREDICT for import safety

Predicting what sort of imported products might prove harmful or even lethal to American consumers and patients is impossible, so FDA won't try to predict that. Not exactly, anyway.

In a Feb. 4 speech to the Center for Strategic and International Studies (Washington) earlier this month, FDA commissioner Margaret Hamburg, MD, outlined the problem with imports. She told an audience that FDA-regulated products "are currently imported from more than 150 countries," and "from more than 300,000 foreign facilities." She also noted that nearly "20 million shipments of food, devices, drugs, and cosmetics will arrive at U.S. ports of entry" this year, a number more than triple the 6 million per year at the beginning of the decade.

Hamburg also noted that as much as 40% of the drugs consumed in the U.S. annually are brought in from abroad and that 80% of the active pharmaceutical ingredients making up those drugs are made in other nations. "Imported medical devices are another rapidly growing area," she remarked.

As has been said before, however, Hamburg remarked, "It is simply not possible for us to inspect our way to safety."

Noting that those 20 million shipments "will be handled by fewer than 500 inspectors," Hamburg asserted that the U.S. government "must move from an approach based on reacting to problems to one that proactively prevents such problems," a change she said amounts to "a simple, yet profound paradigm shift."

The PREDICT (Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting) program, Hamburg said, is part of food safety legislation now in Congress and calls for "better controls at the point of production." This would be abetted in part by greater cooperation from authorities in other nations to check those overseas points of production, but Hamburg indicated she hopes that other governments will get in the habit of publishing information about products that have proved harmful.

Another point of emphasis is that governments must "hold importing companies responsible for their supply chain" at least to the extent that importers "must be able to effectively demonstrate that safety, quality and compliance with international and U.S. standards are built into every component of every product and every step of the production process."

The system is "a sophisticated information technology system ... that will allow us to monitor products at the port of entry more reliably and to target shipments for inspection that pose the greatest risk," Hamburg said. The system went through pilot testing in Los Angeles and is going online in New York. Hamburg added, "Hopefully we will have it up and running around the country by the end of the spring."

With PREDICT, "investigators will still be checking only a small percentage of all import shipments," but will employ a risk-based rubric to rank import shipments according to risk, Hamburg said. However, she said that the benefits of this global approach to product safety "go well beyond our borders, and in fact, they go beyond health." She added that when governments collaborate to boost the compliance regimes of entities making food, drugs, devices, cosmetics and other products, "there are multiple and mutual benefits" enjoyed by citizens of all nations.