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Top GOP Senators Question CMS Head On Recouping Lost SBM Funds

Republican Sens. Orrin Hatch of Utah, Chuck Grassley of Iowa and John Barrasso of Wyoming on Monday (Aug. 3) showed their displeasure over mismanaged state exchange funds in a letter to acting CMS Administrator Andy Slavitt, saying that millions of dollars in taxpayer money should be recovered by the federal government.

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As FDA considers an application for a biosimilar to treat Crohn's Disease, a survey of gastroenterologists shows that most are willing to prescribe biosimilars despite some concerns, such as FDA's use of extrapolation for indications.

Surgeons and medical professors urged FDA to modify its approach to robotically-assisted surgical devices (RASD) so that assessment of such devices includes more real-world experience, with one physician saying that money provided in the 21st Century Cures Act should be used for developing a database for every operation as well as for tapping into other databases to assist professional societies.

House Energy & Commerce Committee leaders are questioning FDA's policy of not routinely conducting good manufacturing practices inspections at facilities that use drugs solely for research purposes, as lawmakers step up their probe of the recent closure of a section of NIH's Clinical Center Pharmacy Department that manages investigational drugs.

FDA alerted users of Hospira's Symbiq Infusion System that the product has cybersecurity vulnerabilities, and encouraged health care facilities to transition to alternative infusion systems Friday (July 31).

Sen. Robert Casey (D-PA) introduced his own version of legislation to make the FDA pediatric priority review program permanent, as well as modify the definition of “rare pediatric disease” to include any form of sickle cell disease and any pediatric cancers.

As the Senate health committee continues work on its Innovation for Healthier Americans initiative, sources say the upper chamber has not shown much interest in pursuing a mandatory funding stream for the National Institute of Health as was included in the recently passed House 21st Century Cures bill.

CMS on Friday (July 31) issued final pay rules for services in five areas: hospitals, long-term care hospitals, hospice, inpatient rehabilitation facilities and inpatient psychiatric facilities.

Providers, vendors and other health IT stakeholders are asking CMS to quickly finalize its proposed rule adding additional flexibility to the troubled meaningful use program in 2015 through 2017, as providers are quickly running out of time to make the necessary changes the rule would require.