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the Health Policy NewsStand .

FDA-Regulated Firms Press High Court To Limit Adverse Event Reporting

As the Supreme Court prepares to examine whether medical product developers and life science firms must disclose all reported adverse events -- not only those situations with a confirmed link to a drug, device or dietary supplement -- to investors, a large swath of FDA-regulated industries are pressing the nation's top justices to reverse a lower court ruling that they say runs counter to a 1995 securities law aimed at reducing litigation.

CMS Tells States To Employ Correct Coding Initiative By Oct. 1 For Medicaid Claims

CMS informed states that the National Correct Coding Initiative is the only system it will allow Medicaid programs to use to curb inappropriate payments to providers, according to an agency letter sent to state Medicaid directors Wednesday (Sept. 1).

Lawmaker, Consumers Concerned With Public Notification Of Egg Recall

A key Democratic lawmaker and some consumer advocates are raising concerns with FDA's communication to the public during the recent salmonella outbreak that prompted a massive egg recall.

FDA-TRACK Expansion Fuels Accountability, Monitoring Of New Authorities

FDA's new agency-wide metrics program has improved accountability and will help track the implementation of new statutory authorities as the publicly accessible performance measurement system continues to aggregate more data, according to a top agency official.

Off-Label Uncertainty Persists As Allergan Settles First Amendment Lawsuit

Drug maker Allergan's decision to settle a years-long investigation into its off-label promotion of the popular medication Botox instead of pursuing its First Amendment lawsuit against FDA extinguished hopes from the pharmaceutical industry that resolution of the case would provide manufacturers with greater clarity on permitted discussions of unapproved uses.

Pawlenty Order Blocking Reform Funds May Violate State Law

HHS Secretary Kathleen Sebelius and members of a Minnesota health reform task force lashed out at GOP Gov. Tim Pawlenty on Tuesday, after hearing that the 2012 presidential hopeful had issued an executive order blocking state agencies from applying for federal funding to help implement the health reform law.

OSHA Interim Whistleblower Rules Offer Pluses For Both Industry, Worker Advocates

Stakeholders say OSHA's new interim final rules on whistleblower protections provide advantages to employers by making burdens of proof more stringent on the complainant, but also offer whistleblowers an easier avenue to take their cases to court.

Researcher: More Premarket CER Would Allow FDA To Focus On Big Therapeutic Advances

Mandating comparative effectiveness studies in premarket drug reviews could reduce the number of new pharmaceutical applications for products that are exhausting limited FDA review resources without providing substantive improvement over what has already been marketed, according to a prominent researcher with a history of provoking the drug industry on both safety and efficacy issues.

Rx Drug

• Stakeholders: HHS Planning Shop's CER Plan May Undermine Health Law's Institute
• FDA-Regulated Firms Press High Court To Limit Adverse Event Reporting
• Off-Label Uncertainty Persists As Allergan Settles First Amendment Lawsuit

Medicare

• Stakeholders: HHS Planning Shop's CER Plan May Undermine Health Law's Institute
• CMS Tells States To Employ Correct Coding Initiative By Oct. 1 For Medicaid Claims
• CMS Refuses To Release Names Of Winning DMEPOS Bidders

Congress

• Stakeholders: HHS Planning Shop's CER Plan May Undermine Health Law's Institute
• Lawmaker, Consumers Concerned With Public Notification Of Egg Recall
• FDA-TRACK Expansion Fuels Accountability, Monitoring Of New Authorities

Food Safety

• Lawmaker, Consumers Concerned With Public Notification Of Egg Recall
• FDA-EMA Pilot Could Mitigate Safety Argument Against Drug Importation
• CSPI Calls For 'Natural' Labeling Oversight, Eyes FDA And State Action

OSHA

• OSHA Interim Whistleblower Rules Offer Pluses For Both Industry, Worker Advocates
• Ruling Could Help Define Quasi-Public Sector Exemptions From OSHA
• Industry-Wide Warning To Grain Facilities Could Bolster Willful Violation Claims