Physician Payments Sunshine Act Delayed

CMS announced that it will delay the implementation of the Physician Payments Sunshine Act and begin collecting data in 2013.  A final rule is expected to be promulgated later this year, despite a request from Senators Kohl and Grassley that the rule be issued before June.

PPACA Community Health Center Grants

HHS announced that $629 million in PPACA grants have been made to 171 existing community health centers to expand their facilities, improve existing services and serve more patients.  Another $99.3 million was made to allow 227 centers to address pressing facility and equipment needs.  The grants complete the $1.5 billion made available under the PPACA for construction projects at existing facilities.

PCIP Incentive Payments End

CMS announced that it is suspending the incentive payments to insurance agents and brokers who have helped direct individuals to enroll in the temporary high-risk insurance pools established under the PPACA Pre-Existing Condition Insurance Plan.  To date the costs for PCIP participants are about 2.5 times higher than expected.

Part D Donut Hole Savings

CMS released information showing that Part D drug plan beneficiaries spent $3.4 billion less on prescription drugs since March 2010 because of the PPACA’s  partial closing of the so-called “donut hole.”  The law is scheduled to fully close the spending gap by 2020.

Medicare Fraud Reduction Efforts

Six Senate Finance Committee members--Baucus, Wyden, Carper, Hatch, Coburn and Grassley--sent a letter to “all interested stakeholders in the health care community” asking for ideas related to Medicare program and payment integrity reform and fraud and abuse enforcement.  The Finance Committee is expected to release a document later this year summarizing the various anti-fraud ideas and best practices supplied.  In related news, HHS and the Justice Department announced the filing of charges against 107 individuals across the country for allegedly participating in Medicare fraud schemes totaling $452 million in false billing.  The agencies Medicare Fraud Strike Force targeted fraud in seven cities.

CMS/FDA Agree on TAVR Coverage

CMS and the FDA issued a decision using a joint agency “coverage with evidence of development” procedure that will provide for Medicare coverage of transcatheter aortic valve replacement (TAVR) under certain conditions for beneficiaries with damaged aortic heart valves.

New Uses for Failed Drugs

NIH Director Francis Collins announced that the NIH National Center for Advancing Translational Sciences has obtained agreement with three drug companies under which the companies will make available dozens of compounds for NIH-funded testing.  Under the agreement, the companies will let NIH commission studies on drugs which proved ineffective for prior uses, but for which new uses might be discovered.  HHS Secretary Kathleen Sebelius said that ‘Americans are eagerly awaiting the next generation of cures and treatments to help them live longer and healthier lives.  To accelerate our nation’s therapeutic development process, it is essential that we forge strong, innovative, and strategic partnerships across government, academia and industry….”

IOM Report on Drug Safety

The Institute of Medicine issued a report which is designed to give the FDA guidance on how to require that drug manufacturers conduct additional post-approval safety trials or alter their labels to account for new data, rather than relying on voluntary action from the companies.  The reports said the FDA should take a “life cycle” approach to drug safety oversight, conducting safety trials both before and after a drug is approved.  The report recommends that the FDA: maintain a single, comprehensive and publicly available record on safety concerns and regulatory alerts for each drug; require post-approval research on drugs whose benefits or risks are particularly uncertain; keep and annually update a list of criteria that are allowed for use in approving new drugs; and revisit safety recommendations that are controversial or particularly difficult.

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