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Senators Push Breakthrough Pathway For Devices Bill That Mirrors 'Cures' Draft Language

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.

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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.

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).

Sen. Michael Bennet (D-CO) urged FDA to evaluate the effect the agency’s draft framework for laboratory developed tests (LDTs) might have on medical innovation and patient access to in vitro diagnostic services, laying out his concerns in a letter Thursday (April 23).

The IRS shifted around substantial resources and manpower to implement the Affordable Care Act while its overall operations and taxpayer assistance suffered, according to a Republican staff report released by the House Ways and Means committee.

CMS proposed Thursday (April 23) to increase Medicare pay rates 1.7 percent for inpatient rehabilitation facilities, and the agency proposed to publicly report facility performance, although it is suspending the data-validation policy that was scheduled to take effect this fall.

Now that the SGR formula has been repealed, providers are turning their attention to implementing the new pay system, and they're focusing on the merit-pay program and alternative pay models in which providers must participate to avoid an eventual pay freeze in fee-for-service Medicare.

Some Medicare Advantage plans said the Quality Bonus Payment demonstration that ended in 2014 gave plans a chance to improve their star ratings before the full effect of the Affordable Care Act payment cuts kicked in, though one high-performing plan said giving bonus payments to plans with three stars watered down incentives for improvements, according to an evaluation of the demo.