Medical Device Daily Washington Editor

Members of the House Energy & Commerce health subcommittee are taking another crack at some ideas of long standing, including an attempt to cut the legs out from under the much-maligned sustainable growth rate (SGR) mechanism used to control Medicare Part B spending. The subcommittee also has opted to pass on the markup of the FDA reauthorization bill until next Tuesday, no doubt thanks in part to criticism of the bill by FDA staff and GOP representation (Medical Device Daily, June 13).

Rep. Michael Burgess, MD, (R-Texas) reported a series of three bills designed to bolster physician participation in Medicare and put more doctors into underserved areas and under-populated medical specialties. Dubbed the Physician Workforce Improvement and Incentives Package, the three bills include one that would spell the demise of SGR, which governs the rate of growth of Medicare Part B services, and the other two would create financial incentives to deal with the geographic and specialty issues.

The bill, titled Ensuring the Future Physician Workforce Act of 2007 (H.R. 2583), would replace the SGR with a medical economic index starting in 2010 and would reset the SGR payment level to doctors for Part B services at the amount actually paid in 2007 rather than the amount that would be paid if Congress had not suspended the cuts. This and most of the other provisions have made the rounds on the Hill in the past couple of years, including one that would pay doctors a 3% bonus for implementing healthcare information technology (HIT) in their practices and another that provides safe harbor from anti-kickback statutes so as to allow hospitals to help physician practices get HIT.

The Physician Workforce and Graduate Medical Education Enhancement Act of 2007 (H.R. 2584) is designed to establish interest-free loans for hospitals in rural areas to finance residency training programs for family, internal, and emergency medicine, pediatrics, obstetrics/gynecology, and general surgery. Burgess is recommending an authorization of $25 million over ten years starting in 2008.

The High-Need Physician Workforce Incentives Act of 2007 (H.R. 2585) would set up a scholarship program for physicians in the same specialties to be paid to doctors-to-be who would work in high-need areas. The five-year program would pay out $5 million in scholarships each year starting in 2008. Another five-year program that would also be authorized for $25 million would pay student loans for already-minted MDs who agree to work in high-need areas.

FDA reauthorization to be delayed

Several sources have confirmed that health subcommittee chair Rep. Frank Pallone (D-New Jersey) pulled the plug on today’s markup of the FDA reauthorization after hearing a slew of negative comments from both FDA and industry. Among the concerns brought to light in the June 12 hearing was that the bill included language that would forbid direct-to-consumer advertising for new drugs for up to three years, but the prospects that the courts would uphold such a ban were not seen by all as positive. Committee Republicans also complained about the short notice of the bill’s contents because the two-day turnaround to markup left little time for bipartisan amendment.

Tort reform a Congressional priority

Tort reform is another issue always on the Congressional radar screen, and Rep. Phil Gingrey, MD (R-Georgia), introduced the Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act designed to cut down on malpractice suits.

“Today’s medical tort system is designed for lawyers, not patients,” Gingrey said in a prepared statement, adding that “average awards in medical malpractice cases have risen 76% in recent years.” This drives doctors to practice defensive medicine, adding $126 billion a year to our national healthcare costs, according to a news release.

Gingrey’s bill would limit “pain and suffering” awards to $250,000 and would bar punitive damages unless an economic judgment is rendered, limiting punitive damage award amounts to twice the economic damage award. According to Gingrey’s news release, the bill currently has 57 co-sponsors.

FDA set to reclassify fusion devices

FDA has released its guidance for its reclassification of intervertebral body fusion devices with bone graft materials from Class III, which requires a PMA, to Class II, a 510(k) category with special controls. However, FDA is keeping such devices that contain therapeutic biologics, such as morphogenic proteins, in the Class III bin.

FDA published the draft in February 2006 and took in a dozen comments. Two of those comments were on the subject of device sterilization and testing, which the announcement in the Federal Register says prompted the agency to “update the guidance to clarify its recommendations about these two topics.”

On the topic of sterilization, the guidance recommends that the device “should be sterile with a sterility assurance level (SAL) of 1 x 10-6” that is validated per the Quality Systems Regulation. If the manufacturer intends to ship the device minus sterilization “for subsequent sterilization in a healthcare facility, you should provide clear and adequate instructions for sterilization,” and clearly indicate on the label that the device is not sterile.

As for testing, the agency suggests that “you test constructs comprised of components that are of the worst case (e.g., most likely to fail) final design version” and provide a rationale for selecting that construct. All components, metallic or otherwise, should be tested after sterilization if there is a chance those components would be affected by sterilization. Test reports should include data on tests for static and dynamic torsion testing for cervical fusion devices, static and dynamic axial compression and compression shear testing for both lumbar and cervical devices, and subsidence testing for both types. The agency cautions, however, that it might want to see additional tests for a design that makes use of polymer composites and for some designs and methods of attachment.