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CY 2020 OPPS Proposed Rule – HHS Seeks Comments on 340B Payment Reductions and Remedies

This past week, CMS confirmed it will continue the 2018 and 2019 underpayment policy for certain 340B covered entities unless the D.C. Court of Appeals upholds the lower court’s ruling that it is unlawful. In that case, CMS...more

340B In The Spotlight – Key Program Developments

In this issue, Polsinelli’s 340B and Reimbursement teams provide an update on the most recent developments in the ongoing 340B /Part B Payment litigation and also highlight recent Government Accountability Office (“GAO”)...more

340B Litigation Update: Hospitals Must Take Steps to Comply with Final Rule

Significant Medicare Part B reimbursement rate cuts and burdensome claim modifiers apply to certain drugs purchased by hospitals through the 340B drug discount program effective on Jan. 1, 2018 after a federal judge declined...more

FDA Guidance on Software as Medical Devices Represents Broader Deregulation Trend

The FDA recently published two draft guidance documents to clarify which types of medical software, based on their functionality, are no longer considered medical devices as a result of the changes imposed under section 3060...more

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