IRS Guidance on Reimbursement of Over-the-Counter Drugs

Last Friday, the IRS issued Notice 2010-59, which provides guidance on Section 9003 of the Patient Protection and Affordable Care Act, which, effective January 1, 2011, limits the reimbursement of over-the-counter drugs under health FSAs, HRAs, HSAs, and Archer MSAs to only prescribed drugs or insulin. The Notice …

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Just Released: HHS Application Procedure for Annual Dollar Limit Waivers

In an earlier post, we discussed the interim final regulations issued relating to the prohibition of annual dollar limits on essential health benefits. Those regulations also provided that these restricted annual limits could be waived by the Secretary of HHS if compliance with the regulations would result in a …

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CMS Issues Stricter DMEPOS Supplier Qualifications

On Friday, August 27, 2010, the Centers for Medicare & Medicaid Services (CMS) issued new regulations (75 Fed. Reg. 52629) that make qualifying for and retaining Medicare billing privileges more stringent for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) suppliers. The new …

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Approved Early Retiree Applications

If you submitted an application for the Early Retiree Reimbursement Program, you may have recently received notice of your approval from HHS. If you didn’t receive an approval notice and want to see if your plan, or any other plan, has been approved, HHS released the list of the first 2,000 approved applications …

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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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