Knowledge Center

EtO Quality Advisory Overview: The AHA and AHRMM have released a Quality Advisory on ethylene oxide sterilization of medical devices. The AHA and AHRMM will continue to update members on this issue.       Read Advisory

GUDID Release 2.2 was successfully deployed. The enhancements will allow for additional functionality as noted below.

Executive Summary Today’s healthcare environment is rapidly changing. Hospitals and healthcare systems are being bombarded by myriad challenges, including the fluctuating economy, cuts in Medicare reimbursements, and new procedural, financial, and reporting requirements of the Affordable Care Act (ACA). All of these factors are pressuring healthcare organizations to reduce costs and improve patient outcomes without sacrificing the quality of care.

Background: In many locations across the country, cold weather or desert climates create dry environmental conditions.  In order to achieve the higher levels of humidity required by regulatory agencies, hospitals and ambulatory surgery centers have to add humidity into the building air, an activity that is expensive and creates its own unique set of challenges.

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.

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 VBP program will apply to all acute-care prospective payment system (PPS) hospitals. Read a summary of key provisions of the proposed rule.

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 years, possibly sooner. Below is the FDA press release:

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.

Quality advisory in response to the Centers for Medicare & Medicaid Services (CMS) announcement that it has suspended plans to add data on hospital-acquired conditions (HAC) to Hospital Compare, citing an error in the agency's data file used to calculate the HAC measures.

This document provides interim guidance for infection control for healthcare facilities (e.g., hospitals, long-term care and outpatient facilities, and other settings where healthcare is provided).

AHRMM Member Advisory: Medical Device Tax Next Steps Background: The medical device excise tax is a feature of the Affordable Care Act. It was implemented by the IRS as of January 1, 2013. The 2.3 percent tax is expected to provide an estimated $20 billion in tax revenues over 10 years to help defray the cost of providing health insurance coverage to some 32 million Americans. 

An overview of Fiscal Year (FY) 2015 Hospital Value-Based Purchasing (VBP) Program.

This Issue

This special fraud alert addresses physician-owned entities, frequently referred to as physician-owned distributorships or 'PODs,' that derive revenue from selling, or arranging for the sale of, implantable medical devices ordered by their physician-owners for use in procedures the physician-owners perform on their own patients at hospitals or ambulatory surgical centers (ASCs).

AHRMM’s Issues & Legislative Committee issued the following Statement on Pricing Transparency approved by AHRMM Board of Directors:

The Food and Drug Administration (FDA) UDI system is being phased in over several years. The first sunrise date (certain Class III devices) occurred 09/24/14. Recognizing UDI implementation will take time, healthcare supply chain and risk management professionals should be aware of already-implemented changes in the FDA’s adverse event reporting methodology. One of the changes required immediately is the use of the UDI in adverse event reporting.