Medical Device Daily Washington Editor

The Supreme Court case of Riegel v. Medtronic had many Democrats on Capitol Hill up in arms last year, and the response in the House of Representatives was the Medical Device Safety Act of 2008 (Medical Device Daily, June 30, 2008), which would have rewritten the Medical Device Amendments of 1976 (MDA) to end federal pre-emption of state liability laws for non-defective PMA devices.

Now that the implicit pre-emption of drugs has been ended by the Supreme Court Case of Wyeth v. Levine, sponsors of the device bill can move forward without having to decide whether to deal with the drug side of the question.

Thus, the Medical Device Safety Act of 2009 (H.R. 1346) has been introduced into the House Energy and Commerce's health subcommittee by chairman Frank Pallone (D-New Jersey), who was the author of the first iteration of this bill. The new version is essentially a duplicate of last year's bill and would modify the MDA with the addition of a passage that states "nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State."

In a March 9 statement, Pallone said the bill "eliminates the blanket immunity that medical device companies currently enjoy thanks to an unfortunate Supreme Court decision last year," adding that he expects "to mov[e] it through my subcommittee quickly." However, device makers argue that defective devices have never enjoyed immunity from torts in state courts.

In a March 6 statement, Sen. Pat Leahy (D-Vermont), chairman of the Senate Judiciary Committee, said the Senate bill is "another important step to correct an erroneous reading by the Court of Congress' intent in enacting the Medical Device Amendments of 1976." Leahy made the case that MDA was "never was intended to, preempt the common law claims of consumers injured by a federally approved medical device." The Senate version (S. 1861) is sponsored by Leahy and Sen. Ted Kennedy (D-Massachusetts), who chairs the upper chamber's Health, Education Labor and Pensions Committee.

The original idea behind providing devices with pre-emptive power under FDA regulation was that innovative devices enjoy a short product life cycle compared to drugs, given the iterative nature of device design. However, recent case law has sparked a furor in the media on the issue. Democrats in Congress also resisted the Bush administration's position expressed via FDA, which was that non-defective drugs and devices be exempt from state liability laws.

In a March 5 statement, Stephen Ubl, president/CEO of the Advanced Medical Technology Association (AdvaMed; Washington), said the legislation would "ultimately lead to a patchwork of inconsistent and confusing guidance on the use of medical treatments for patients and physicians, or limit their availability altogether." Ubl also said that ending pre-emption would "restrict patient access to essential medical technologies, produce a chilling effect on medical innovation, create more lawsuits and ultimately result in higher healthcare costs for all Americans."

2010 budget sees RBMs for imaging

The Medicare Part B imaging controversy continues in the form of a provision found in the Obama administration's proposed budget for fiscal year 2010 which would require that physicians and hospitals work with a radiology benefits manager (RBM) before proceeding with some medical imaging procedures.

However, this development is running parallel with renewed concern over the impact of repeated imaging procedures on patients, thanks to a report by the National Council on Radiation Protection and Measurements (NCRPM; Bethesda, Maryland). According to a March 3 statement posted at the NCRPM web site, "in 2006, Americans were exposed to more than seven times as much ionizing radiation from medical procedures as was the case in the early 1980s."

The idea of requiring pre-authorization for scans has been raised in meetings of the Medicare Payment Advisory Commission (Medical Device Daily, Sept. 9, 2008). Bruce Steinwald, director of healthcare research at the Government Accountability Office said at a MedPAC meeting that in a study conducted by GAO consisting of interviews of private payers, the plans who were interviewed "reported that prior authorization ... was the practice most important to managing physician use of imaging." Steinwald recommended that "CMS consider more front-end approaches, including prior authorization and privileging," but said CMS should "not necessarily [be] limited to those approaches."

One of the criticisms of how the Centers for Medicare & Medicaid Services pays for imaging is that it does not distinguish between state-of-the-art imaging equipment and older machines, which take more time to perform a scan. This issue is seen as important because CMS uses a payment rate that is based in part on the percentage of time during a work week that an imaging facility is performing scans rather than sitting idle. However, MedPAC also had heard testimony that utilization rates are often underreported.

A comment heard during the September MedPAC hearing was that post-claim reviews might suffice to tamp down inappropriate imaging, but it was also noted that the effort to reclaim imaging payments required of a pay-and-chase approach "would create an even bigger political problem" than pre-authorization.

In an undated statement, the American College of Radiology (ACR; Reston, Virginia) argues that "instead of using a for-profit entity, whose only goal is to bring down costs, physicians themselves can be responsible for ensuring that the imaging they order for patients is appropriate." The statement notes that ACR "fought hard for a demonstration program for the use of physician-developed imaging appropriateness criteria in the Medicare Improvement and Patient Protection Act of 2008," which "is a better way to address utilization concerns and ensure that patients receive the most appropriate imaging studies."

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