Wednesday, April 16, 2014

CMS Releases Revised Kidney Care ACO Applications

CMS on Tuesday (April 15) re-opened the End Stage Renal Disease Seamless Care Organization demonstration with a revised Request for Applications following discussions and feedback from the industry, which had previously pushed CMS to reconsider some of the demo's quality measures and performance benchmarks.

Tri-Agency HIT Meeting Aims To Flesh Out Details Of Proposed Framework

FDA, the Office of the National Coordinator for Health Information Technology and the Federal Communications Commission are slated to hold a three-day public meeting next month on a draft proposal for a risk-based health information technology framework -- seeking discussion on the specifics of a proposed multi-agency center and risk stratifications determining when HIT falls under FDA, ONC or is low risk.

FDA Calls For More Regenerative Therapy Standards-Setting Collaboration

FDA is seeking more collaboration among regenerative and cell therapy developers to create baseline standards for manufacturing and clinical development that could help companies meet regulatory requirements and obtain marketing clearance, agency officials said at a recent workshop.

Cost Of Fixing SGR Creeps Up Weeks After Congress Fails To Reform Physician Pay

The cost of freezing Medicare physician pay is creeping back up after the price for a permanent "doc-fix" had been falling for more than a year, according to the most recent estimate by the Congressional Budget Office.

Therapy Lobbyists Turn To MMR Issues, But Hopeful For Permanent Fix

Some therapy lobbyists, who had hoped to get a new outpatient therapy payment system passed alongside now-stalled physician payment reform legislation, are now turning their attention to the manual medical review process, though others remain hopeful that a permanent therapy cap fix is not far off.

AHA Sues HHS Over Two Midnight Hospital Inpatient Admissions Policy

In a move that one lobbyist says should not be a surprise, the American Hospital Association is challenging HHS over the controversial two-midnights inpatient admission policy, arguing in two related lawsuits filed Monday (April 14) that the rule burdens hospitals with unlawful, arbitrary standards and deprives hospitals of proper Medicare payment for caring for patients.

MACPAC Lays Groundwork For Long-Term Care Work In 2015

Congressional Medicaid advisors have begun working on addressing concerns with long-term care and could issue recommendations on how to improve the system in one of its 2015 reports.

BARDA, Former FDA Officials Float Ideas For Universal Flu Vaccine

The lack of details surrounding the concept of a universal influenza vaccine could pose challenges to FDA reviewers and the agency should collaborate with industry to develop criteria to evaluate the effectiveness of the to-be-developed class of flu vaccines, a former FDA official recently said.

HHS Eyes April 17 Release Of Latest Enrollment Numbers

HHS is planning a Thursday (April 17) release of its next exchange enrollment report that covers the entire 2014 open enrollment period that ended March 31 and most of the sign-ups during the new special enrollment period that will wrap up Tuesday (April 15), Inside Health Policy has learned.

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