Regulatory

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TOPICS:

  • Medicare Reimbursement & Coverage
  • Drugs & Devices
  • Health Information Technology (HIT)/ Quality Initiatives
  • Compliance and Professional Affairs
  • Comanagement Guidelines

FDA Reform

“Food & Drug Administration Safety and Innovation Act”(FDASIA)

Summary of the FDA Innovation Act

Joint Guideline on Femtosecond Laser

Joint ASCRS/AAO Guidelines on Femtosecond Laser

CMS Launches Sunshine Act Website

 

CMS has launched a new website that will publish payments made to physicians and teaching hospitals by drug and device manufacturers by September 30, 2014.  Applicable manufacturers and applicable GPOs will report the data for August through December of 2013 to CMS by March 31, 2014, and CMS will release the data publicly by September 30, 2014.  Beginning in 2014, they will be required to register on a CMS website and will submit data using templates.

FDA Issues UPDATED Alert: Recall of All Clinical Specialties Compounding Pharmacy Products—Including Avastin Unit Dose Syringes; Lack of Sterility Assurance

On March 21, the FDA issued an updated alert for an expanded recall of all lots of ALL sterile products repackaged and distributed by Clinical Specialties due to lack of sterility assurance. The recall of all sterile products is conducted in follow-up to concerns regarding practices at the site that cannot assure the sterility of the products.

CMS Posts 2013 Relative Value Unit (RVU) Files

 

Last week, CMS posted the CY 2013 Medicare physician fee schedule addenda, including the 2013 RVU values, which can be found in Addenda B. The Medicare physician fee schedule sets Medicare payment rates for 2013.

Centers for Medicare and Medicaid Services (CMS) Releases ICD-10 Checklists and Timelines

CMS recently released new checklists and timelines for small, medium, and large provider practices that provide a high-level understanding of what the ICD-10 transition requires and recommended timeframes.

Representatives Request Halt to Proposed Medicare Cut for Multiple Procedures Performed on the Same Day

October 17, 2012 - ASCRS teamed with other medical specialty groups to urge Representatives to join a Congressional Sign-on letter requesting the Centers for Medicare and Medicate Services (CMS) halt a proposed cut to Medicare for multiple procedures performed on the same day. 

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