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Worry-Free Medicare Audits

Increased Medicare audits are raising the stakes for compliance in today’s pharmacies, with stricter enforcement than ever before. In fact, the likelihood of receiving a Part B audit request continues to climb amid national efforts to control fraud, waste and abuse.

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Report: FDA won't subject wearables to pre-/post-marketing regulations

Low-risk general wellness products, including wearable fitness monitors and sleep monitors, will not be subject to pre- or post-market regulatory requirements, the Food and Drug Administration reported Thursday, according to a report from the Regulatory Affairs Professional Society. "FDA has kept in line with its previous guidance on other health and wellness products, such as mobile medical applications and exercise equipment, where depending on the product's intended use, it could fall under FDA regulations," RAPS reported. "FDA says manufacturers could say their product is intended 'to promote, track, and/or encourage choice(s), which as part of a healthy lifestyle, may help to reduce the risk of [or may help living well with] certain chronic diseases and conditions.'" (RAPS)