Medical Device Daily Washington Editor

The House of Representatives passed a bill last week that tweaks the functions of the Securities and Exchange Commission and two other entities that oversee publicly traded firms, and the bipartisan effort drew a quick note of thanks from the SEC chairman and former congressman Christopher Cox.

According to GovTrack.us, the Securities Act of 2008 cleared the House without a vote on an amendment to suspend the rules for passage, a motion that met with no objections.

Whether H.R. 6513 will find the Senate as welcoming remains to be seen, but the bill made it through the House quickly after its July 16 debut. The Senate's view is unknown, since Christopher Dodd (D-Connecticut) and Richard Shelby (R-Alabama), the chair and ranking member of the Senate Banking Committee – which has jurisdiction – had not returned calls for comment by press time.

According to a Sept. 11 statement posted at the SEC web site, the Securities Act of 2008 would allow SEC to obtain financial penalties from wrongdoers in administrative proceedings without filing a separate civil action in a federal court.

The SEC also would be empowered to bar anyone who has engaged in alleged misconduct from associating with a broker, dealer, investment adviser or transfer agent. The bill also would require the SEC, the Financial Accounting Standards Board, and the Public Company Accounting Oversight Board to provide annual testimony to Congress on their respective efforts to reduce the complexity in financial reports so as to provide investors with more accurate and understandable financial information.

Cox said in the statement that the bill would "provide additional tools for the SEC's enforcement program that already is seen as the gold standard around the world," and he thanked three members of the House "for their outstanding leadership in shepherding this important legislation through Congress on behalf of America's investors." The three were the bill's author, Paul Kanjorski (D-Pennsylvania), and the chairman and ranking member, respectively, of the House Financial Services Committee, Barney Frank (D-Massachusetts) and Spencer Bachus (R-Alabama).

The SEC statement described the bill as "a boon to the SEC enforcement staff," which was said to make up 34% of the SEC workforce, up from 29% in the 1990s. SEC also stated that in the past three years, "the SEC has achieved the greatest number of corporate penalties in any year in SEC history, the second highest-ever number of enforcement actions brought in a single year, and the second highest-ever single-year total for penalties and disgorgements."

The statement also indicated that thanks to the Sarbanes-Oxley Act of 2002, the agency's enforcement actions have "returned more than $4 billion to harmed investors," with "another $1 billion in [similar] distributions expected in the next six months."

Senate Judiciary inks nursing home bill

Not to be outdone in last-minute bills by the House, the Senate Judiciary Committee passed a bill that would negate any contractual requirement that a nursing home resident go through arbitration before suing a nursing home operator in court.

The Fairness in Nursing Home Arbitration Act of 2008 (S. 2383) is built on the companion House bill (H.R. 6126) and would require that any agreement to engage in arbitration be made after nursing home residents and/or their legal representatives sign the resident into the nursing home.

In a Sept. 11 statement, Sen. Herb Kohl (D-Wisconsin), chairman of the Special Senate Committee on Aging, said the objective is to "protect residents and families from being forced to make a critical decision about their legal rights during the stressful and emotional process of admission into a nursing facility." Co-sponsor Mel Martinez (R-Florida) said the bill would "ensure that families will not have to choose between quality of care and forgoing their rights within the judicial system."

According to the Judiciary Committee press statement, arbitration clauses are often "buried within 40- or 50-page admission documents they are asked to sign during the admissions process." The statement said the bill would "ensure that arbitration is a voluntary and not a coerced forum to resolve disputes."

In e-mail correspondence, Sarah Mashburn, spokesperson for the American Association of Homes and Services for the Aging (AAHSA; Washington), told Medical Device Daily that the association "opposes both the House and the Senate versions because both versions suggest that this type of waiver can never be done fairly (knowingly and voluntarily) and that arbitration agreements have a negative impact on quality."

Mashburn said "there is no relationship between the forum where a dispute is resolved and the requirement to provide quality care." She also stated that a "blanket prohibition ... is unnecessary" because "courts are already doing their job of policing these agreements."

AHRQ publishes guides to prevent DVTs

Deep-vein thromboses (DVTs) and other blood clots take a huge toll on the lives of individuals and cost the U.S. economy plenty, and the Agency for Healthcare Research and Quality has published two guides to help patients and doctors ward off this often-deadly event.

The Sept. 15 AHRQ statement noted that DVTs affect "at least 350,000 and possibly as many as 600,000 Americans each year," and AHRQ Director Carolyn Clancy, MD, said "we know how to prevent many of these dangerous blood clots, and these guides will help patients and clinicians put that knowledge to work to improve care."

The booklet for consumers, titled Your Guide to Preventing and Treating Blood Clots, is described as "a 12-page easy-to-read resource that helps both patients and their families identify the causes and symptoms of dangerous blood clots, learn tips on how to prevent them and know what to expect during treatment." The guide for doctors, Preventing Hospital-Acquired Venous Thromboembolism: A Guide for Effective Quality Improvement, is a 60-page guide serving as "a comprehensive tool to help hospitals and clinicians implement processes to prevent dangerous blood clots."

Acting Surgeon General Steven Galson, MD, said the guides are "timely, easy-to-read guides [that] provide valuable information on preventing and treating dangerous blood clots."

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