Correspondence issued by the Government Accountability Office with an abstract that begins "In 2009, Medicare--a federal health insurance program that serves about 46.3 million beneficiaries--spent approximately $8.1 billion on durable medical equipment (DME), prosthetics, orthotics, and related supplies for 10.6 million beneficiaries. DME includes items such as wheelchairs, hospital beds, and walkers. Medicare beneficiaries typically obtain DME items from suppliers, who submit claims for payment for these items to Medicare on behalf of beneficiaries. The Centers for Medicare & Medicaid Services (CMS), an agency within the Department of Health and Human Services (HHS), has responsibility for administering the Medicare program. Both we and HHS's Office of Inspector General (OIG) have reported that Medicare and its beneficiaries--through their out-of-pocket costs--have sometimes paid higher than market rates for various medical equipment and supplies. To achieve Medicare savings for DME and to address DME fraud concerns, Congress, through the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), required CMS to phase in a competitive bidding program (CBP) for DME suppliers in selected competitive bidding areas (CBA). In CBP, suppliers submit bid prices in the amounts they are willing to accept as payment to provide DME items to Medicare beneficiaries. CMS then …

A letter report issued by the Government Accountability Office with an abstract that begins "In 2007, Congress reauthorized two laws, the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA). PREA requires that sponsors conduct pediatric studies for certain products unless the Department of Health and Human Services' (HHS) Food and Drug Administration (FDA) grants a waiver or deferral. Sponsors submit studies to FDA in applications for review. BPCA is voluntary for sponsors. The FDA Amendments Act of 2007 required that GAO describe the effect of these laws since the 2007 reauthorization. GAO (1) examined how many and what types of products have been studied; (2) described the number and type of labeling changes and FDA's review periods; and (3) described challenges identified by stakeholders to conducting studies. GAO examined data on the studies from the 2007 reauthorization through June 2010, reviewed statutory requirements, and interviewed stakeholders and agency officials."