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| September 8, 2008 |
 
BNA® News |
Court Holds Beneficiaries Lack Standing to Challenge Regulation of Drug Marketing
Medicare beneficiaries eligible for Part D drug benefits had no
standing to challenge policies regulating private entity marketing of
the Medicare Part D prescription drug benefit, a federal district
court held Aug. 25 (Fox v. Leavitt
, D.D.C.,
No. 1:06-cv-01490-RMC,
8/25/08). From Medicare Drug Watch, Publication date September 2, 2008
Link to Story
FDA Funding, Follow-On Biologics, Patent Reform Top Issues for BIO in 2009
In 2009, the Biotechnology Industry Organization plans to focus on
follow-on biologics, patent reform, and obtaining more funding for the
Food and Drug Administration, Bio President James C. Greenwood said
Sept. 3 during a press briefing. From Pharmaceutical Law & Industry ReportŪ, Publication date September 5, 2008
Link to Story
Sixth Circuit Affirms Dismissal of Suit to Force Approval of Cancer Drug
The U.S. Court of Appeals for the Sixth Circuit Aug. 28 affirmed
the dismissal of a suit seeking to force the Food and Drug
Administration to step up its approval of Provenge, a vaccine against
prostate cancer (CareToLive v. Von Eschenbach,
6th Cir.,
No. 07-4465,
8/28/08). From Health Care Daily Report, Publication date September 2, 2008
Link to Story
"JAMA" Says Medical Center Conflict-of-Interest Policies Seem Effective
Stricter conflict-of-interest policies adopted over the past few
years by academic medical centers appear to be working without any
detriment to staff retention, according to a commentary published in
the Sept. 3 Journal of the American Medical Association. From Medical Research Law & Policy ReportŪ, Publication date September 3, 2008
Link to Story
HHS Rule Would Bar Retaliation if Workers Refuse to Participate in Abortion Services
The Department of Health and Human Services Aug. 21 announced plans
to implement a regulation that would bar discrimination or retaliation
against health care workers who refuse to participate in any
abortion-related services. From Health Law Reporter, Publication date August 28, 2008
Link to Story
Lawmakers Call for More Public Input of Waivers, Cite Concerns With R.I. Proposal
The Centers for Medicare & Medicaid Services must increase the
level of transparency it employs when reviewing proposed changes to
states' Medicaid programs or harmful policies could be implemented,
Senate Finance Committee leaders said Aug. 21, citing a recent
application from Rhode Island as a prime example of their
concerns. From Health Care Policy Report, Publication date August 25, 2008
Link to Story
One-Quarter of Part D Enrollees Reach 'Doughnut Hole,' Kaiser Foundation Says
About one-quarter of Medicare prescription drug benefit enrollees
in 2007 reached the “doughnut hole,” the gap in coverage
after a reimbursement threshold has been reached, and 4 percent spent
enough to receive catastrophic coverage, the Kaiser Family Foundation
said in study released Aug. 21. From Health Plan & Provider Report, Publication date August 27, 2008
Link to Story
WIPO Report Shows Global Patent Filings Dip for Biotech, Medical Tech; Pharma Rises
According to a report released Aug. 4 by the World Intellectual
Property Organization, patent filings worldwide were up almost 5
percent while there was only a modest increase in pharmaceutical
filings and a slight decrease in those for biotechnology and medical
technology. From Life Sciences Law & Industry Report, Publication date August 15, 2008
Link to Story
Stents, Hip Resurfacing Among Topics for Potential Coverage Determinations
The Centers for Medicare & Medicaid Services July 30 released a
list of 19 topics for possible national Medicare coverage
determinations, including hip resurfacing, off-label use of
drug-eluting stents, and minimally invasive methods for bariatric
surgery. From Medical Devices Law & Industry Report, Publication date August 13, 2008
Link to Story
OIG Won't Impose Sanctions on Hospitals, Surgeons Over Cost-Sharing Arrangement
The Department of Health and Human Services Office of Inspector
General will not impose sanctions against a medical center and
surgeons over an arrangement between them to share cost savings from
the surgeons' cost reduction measures for certain procedures, the OIG
said in an advisory opinion (No. 08-09) posted Aug. 7. From Health Care Fraud Report, Publication date August 13, 2008
Link to Story
BNA Audioconference: Implications of a Regulatory Enforcement Surge
BNA is sponsoring an audioconference on Sept. 10 from 1-2:30 p.m.
titled, "Regulatory Enforcement Surge: RACs, MACs, QIOs, ZPICs
and the OIG."
Link to Story
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