News: December 12, 2007

Device Manufacturers Should Develop Internal Policies to meet Trial
Registry Requirements. According to the National Institutes of Health
("NIH"), medical device firms should coordinate with the Food and Drug
Administration ("FDA") to establish internal policies to govern how
firms will comply with the new clinical trial registry requirements
imposed by the FDA Amendments Act ("FDAAA"). This suggestion is
intended to address industry confusion over which trials are subject to
the new requirements in the absence of a formal FDA rulemaking or
guidance document. Under FDAAA, device firms must submit descriptive
information about their ongoing clinical trials for products that treat
serious or life-threatening diseases to NIH's www.clinicaltrials.gov
<http://www.clinicaltrials.gov> web site by December 27, 2007. Firms
who begin qualifying trials after that date must submit the required
information within 21 days of enrolling the first patient. Although
there is no bright-line test for determining which clinical trials
qualify for registration, current FDA guidelines establish that the
seriousness of a disease is based on many factors, including the
survival rate, daily functioning, and likelihood that the diseases will
progress to a more serious condition if left untreated. Additional
information is available at www.thegraysheet.com (paid subscription service).

Value-based Purchasing. The Centers for Medicare and Medicaid Services
("CMS") released a report to Congress on November 26, 2007, suggesting
setting aside 2%-5% of hospital inpatient payments for use as a
financial incentive to reward hospitals meeting or showing substantial
improvement on 20 quality measures. The report describes a three-year
phase-in that builds upon the current pay-for-reporting requirements.
The proposed quality measures include process-of-care, outcomes, and
patient satisfaction for treatment of certain diseases. Industry groups
intend to monitor how Congress responds to the report to ensure that
future programs protect patient access to care. Additional information
is available at www.thegraysheet.com (paid subscription service).

Blood Centrifuges Reclassified. FDA reclassified automated blood cell
separator devices that operate by a centrifugal separation principal
when intended for routine collection of blood and blood components from
class III to class II (special controls) on November 30, 2007. This
reclassification becomes effective on December 31, 2007. The agency has
also published an accompanying guidance document providing special
controls for both filtration and centrifugal-based automated blood
separators. The guidance is available at
http://www.fda.gov/cber/gdlns/autobldcell.pdf.
Additional information is available at www.thegraysheet.com (paid subscription service).

Clinical Trial Modernization Initiative. FDA is partnering with Duke
University Medical Center to modernize the way clinical trials are
conducted. This public-private partnership intends to develop new
standards and identify ways to improve patient safety, quality of
information, and the clinical research process. A few key initiatives
include setting national standards for electronic data forums,
contractual agreements to streamline the process, and establishing
accreditation programs for clinical investigators and research sites.
Additional information is available at www.thegraysheet.com (paid subscription service).

Osteoporosis Bill Pending. On November 15, 2007, Shelley Berkley,
D-Nev., introduced a new bill in the House of Representative (H.R. 4206)
to restore Medicare payments for dual energy X-ray absorptiometry to
2006 levels. Reimbursement rates for the procedure at issue received
large cuts in 2007 with the enactment of the Deficit Reduction Act.
Currently, the reimbursement rates for this procedure are expected to
drop from $140 to $50 by 2010. Additional information is available at
www.thegraysheet.com (paid subscription service).