OIG Okays Charitable Contribution Program To Encourage Physicians to Meet with Drug and Device Manufacturers

In a new twist on pay to play, the Office of Inspector General of the Department of Health and Human Services (“OIG”) has concluded that a charitable contribution program designed to encourage physicians and other health care providers to meet with drug and device manufacturer representatives does not violate …

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CDRH Seeks to Assure Device Makers, But Holds Ground

In an August 31, 2010 webinar, representatives from FDA's Center for Devices and Radiologic Health (CDRH) fielded questions concerning the reports with preliminary recommendations issued earlier this month by the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making. …

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Time Period to Submit Medicare Claims Is Shortened to Twelve Months

The proposed Medicare Physician Fee Schedule for 2011 (PFS) includes a proposal that Medicare fee-for- services claims for services furnished on or after January 1, 2010, must be filed within one calendar year after the date of services. This proposal by CMS is aimed at implementing Section 6404 of the Affordable …

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Just Released: Model Claims Notices and External Review Guidance

The DOL has released three model notices in connection with the recent rules on internal claims and appeals and external review processes.  The notices cover internal benefit determinations and external review decisions: Model Notice of Adverse Benefit Determination Model Notice of Final Internal Adverse …

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Proposed CMS Rule Would Require Group Practices to Notify Medicare Beneficiaries of Alternative Advanced Imaging Suppliers

Section 6003 of the Patient Protection and Affordable Care Act (PPACA) amended the Stark Law in-office ancillary service exception as applied to physician practices furnishing MRI, CT, PET, and potentially other diagnostic imaging services. The Stark Law prohibits a physician from making a referral for certain …

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Eighth Circuit Issues Decision on Bundling and Exclusive Dealing

The Eighth Circuit has issued a significant antitrust decision addressing bundled rebates and the law surrounding exclusionary contracts. In Southeast Missouri Hospital v. C.R. Bard, Inc. (No. 09-3325, Aug. 17, 2010), the Eighth Circuit affirmed the district court's grant of summary judgment dismissing a …

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