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Dem Lawmakers To FDA: Finalize Proposed Generic Labeling Rule As Is

A group of 47 Democratic lawmakers from the House and Senate is urging FDA to finalize a proposed rule that effectively would require generic drug makers update safety information on their labels before the agency makes a final determination instead of adopting an industry alternative.

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House and Senate lawmakers from both parties are again urging CMS to give states at least a year to implement Medicaid drug reimbursement changes required by the Affordable Care Act after the agency finalizes a long-awaited Medicaid drug rule and the final Federal Upper Limit amounts.

Many of the points laid out in Republican blueprints to revamp the Affordable Care Act are echoed in a new report issued last week by the nonpartisan business-led Committee for Economic Development -- a group that includes the pharmaceutical trade lobby's top official and other former drug and insurance industry leaders.

CMS plans to post rate data for qualified health plans and non-QHPs on Oct. 30, just two days prior to the Nov. 1 launch of the open enrollment period, the agency reveals in a document listing key dates and deadlines related to the federally-facilitated exchange's 2016 QHP certification process, rate review and risk and reinsurance policies.

Both the House Ways & Means and Senate Finance committees retained Medicare sequester pay cuts to help pay for trade legislation despite providers' efforts to strip the offset during markups this week.

Senator appropriators had much more on their minds than the Affordable Care Act as they questioned HHS Secretary Sylvia Burwell Thursday (April 23) in a budget hearing with little of the typical bickering over health insurance.

The chairmen of the House Republican Study Committee and Senate Steering Committee on Thursday (April 23) became the latest lawmakers to ask Congress to use narrow reconciliation language to repeal the Affordable Care Act as part of the fiscal 2016 budget.

Inpatient psychiatric facilities would receive an estimated 1.6 percent, or $80 million, increase in Medicare pay for fiscal 2016 under a proposed pay rule released Friday (April 24).

Sens. Richard Burr (R-NC), Michael Bennet (D-CO) and Orrin Hatch (R-UT) introduced bipartisan legislation Thursday (April 23) that would create a breakthrough designation pathway for expedited FDA approval of medical devices -- a plan closely mirroring language in the House Energy and Commerce Committee's 21st Century Cures draft bill released in January.