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Dems Optimistic About Common Ground, Talk Need For ACA Improvement

PHILADELPHIA -- Democratic presidential nominee Hillary Clinton’s longtime health advisers and other experts voiced optimism that America will soon move past its bitter divide over the Affordable Care Act, perhaps regardless of who wins the White House, and take steps to improve the law.

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CMS released the overall hospital star ratings on the Hospital Compare site Wednesday (July 27), emphasizing consumer groups' desire for the information and the outreach to hospitals undertaken by the agency following the original delay of the star ratings' publication.

CMS says some drug manufacturers are incorrectly reporting their quarterly “best price” as higher than the Average Manufacturer Price for the product, and in recently released guidance asks companies to verify the accuracy of their best price before submitting that information to the Drug Data Reporting for Medicaid system.

CMS says in recently released guidance that some states are not reporting accurate drug use data to the agency and aren't fixing that data in a timely way.

The American Association for Homecare is surveying its members and other stakeholders about the impact of durable medical equipment competitive bidding pay cuts on suppliers and beneficiary access to equipment, and the trade group plans to use the results of the member survey to lobby for relief from bid prices applied to rural and non-bid areas.

FDA maintained that it gave manufacturers adequate time to label class II medical devices with a Unique Device Identifier, after issuing a draft guidance dated Tuesday (July 26) clarifying the required form and content of the UDI. Class II medical device packages and labels must bear a UDI by Sept. 24 under the 2013 rule.

FDA issued draft guidance outlining how it plans to use real-world data to complement traditional clinical trials and support regulatory decisions for medical devices.

A New Jersey District Court judge dismissed Amgen's court case challenging Sandoz's decision to cut short the patent dance process for its biosimilar of Amgen's Neulasta, leaving both parties waiting to see if the Supreme Court will take up their separate case that touches on whether a biosimilar applicant must provide the reference product sponsor their application and manufacturing information.

Although CMS wants to push more providers into risk-bearing accountable care organizations, Brookings Institution scholars and many providers say the agency could inadvertently do the opposite by making it possible for providers in ACOs that don't accept the risk of penalties to get much larger bonuses than providers in risk-bearing ACOs.