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Drug Industry Says QHP Specialty Tiers, High OOP Costs Could Threaten Access

Pharmaceutical executives suggest the public needs to be more aware about the larger consequences of insurers' usage of specialty tiers, high out-of pocket costs and other utilization management practices for drugs in the exchanges, because if it migrates more widely to the commercial market and creates access issues it's going to be "very difficult."

CBO Projects Medicare Spending To Decrease As Health Spending Growth Picks Up Speed

Analysts tell Inside Health Policy that the Congressional Budget Office's latest budget estimate is good news for Medicare, but the report also highlights the growing gap between health spending in the private sector and the relatively stable projections for federal program.

FDA Officials: Demographic Subgroup Labeling Could Be Challenging

A suggestion from patient and consumer advocacy groups to require product labeling specify which demographic populations were included in clinical trials could result in "acres" of text that may not be understandable to consumers, FDA officials said recently.

Sebelius: Feds May Cut Medicaid Pay So States Clear Enrollment Backlogs

Outgoing HHS Secretary Kathleen Sebelius has suggested that states that have yet to enroll thousands of Medicaid beneficiaries deemed eligible by healthcare.gov could see reductions in their matching funds if they are unable -- or unwilling -- to quickly clear the logjam.

GPhA: E-Labeling Reg Could Offer Alternative To Generic Drug Rule

Electronic labeling and other technology could be employed to streamline updates to drug labels, the Generic Pharmaceutical Association's top official recently said, posing alternatives to the regulation generic drug firms vehemently oppose.

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.