Regulations and Regulatory Advocacy

This white paper explores the realities facing healthcare delivery, some of the new models being developed and what they could mean for the supply chain.
How to write a constructive, information-rich comment that clearly communicates and supports its claims to have an impact on regulatory decision making.
The final regulations that provide guidance on the excise tax imposed on the sale of certain medical devices, enacted by the Health Care and Education Reconciliation Act of 2010 in conjunction with the Patient Protection and Affordable Care Act.
The FDA UDI ruling has finally arrived - the proposed rule has published. Please see the FDA website (www.fda.gov/udi) for a link to the proposed regulation. Highlights include a 120 day comment period to begin shortly, 6 months later a final ruling that will begin with Class III devices within 2…
The Patient Protection and Affordable Care Act of 2010 (ACA) requires the Secretary of Health and Human Services to establish a VBP program to pay hospitals for their actual performance on quality measures, rather than just the reporting of those measures, beginning in fiscal year (FY) 2013. The…
An overview of the Centers for Medicare & Medicaid Services' three final rules for calendar year 2011 the outpatient prospective payment system and ambulatory surgical center rule, the Medicare Physician Fee Schedule rule and the Home Health PPS rule.