WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement today from President and CEO Scott Whitaker following release of air testing data from the Environmental Protection Agency (EPA) that looked at levels of ethylene oxide (EtO) across the country:
WASHINGTON, D.C. – Scott Whitaker, President and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement today on CMS’s release of final CY 2020 Medicare payment rules – including the CY 2020 Medicare Outpatient Prospective Payment System (OPPS) and Ambulatory Surgery Center final rule and the CY 2020 End Stage Renal Disease (ESRD) Prospective Payment System (PPS) final rule – that support patient access to medical technology innovation:
“The final OPPS and ESRD rule are good news for Medicare beneficiaries as they will help ensure America’s seniors have more timely access to breakthrough and new medtech innovations. The final rules make it easier for new breakthrough technologies to qualify for outpatient transitional passthrough payments in the outpatient hospital setting and for dialysis facilities to receive new add-on payments when using new innovative equipment and supplies that offer substantial improvements in care.
“These changes follow a similar provision in the FY 2020 inpatient hospital rule that AdvaMed has long supported. These rules highlight the continued commitment of HHS Secretary Azar, CMS Administrator Verma, and the Administration to spur access to innovative new technologies for the benefit of American patients.
“We look forward to working closely with CMS on implementation of these final rules, and additional ways to facilitate greater efficiencies in the coverage and payment process.”
WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) issued a statement today from President and CEO Scott Whitaker regarding President Trump’s nomination of Dr. Stephen Hahn to serve as FDA Commissioner.
WASHINGTON, DC. – The Advanced Medical Technology Association (AdvaMed) was named one of the most effective trade associations in Washington, DC, according to the latest annual TradeMarks study released by APCO Worldwide, a leading international advocacy and communications consulting firm.
WASHINGTON, DC. – A top FDA official warned that additional closures of ethylene oxide (EtO) sterilization plants could lead to shortages of critical medical devices across the country.
Medela LLC, headquartered in McHenry, Illinois, today wrote to Illinois state house speaker Michael Madigan saying they "respectfully oppose HB 3888 and HB 3885 because their restriction to EO use would lead to the inevitable elimination of EO sterilization in the state and will likely lead to further restrictions in other states. This process is essentially irreplaceable in its effectiveness to combat infection in hospital surgical settings, and is an essential step for Medela to support the most medically fragile in the Neonatal Intensive Care Unit (NICU)."
As leaders of state and regional trade associations representing the medical technology industry across the country, we are deeply concerned with recent legal and legislative actions undertaken in at least two states to shut down medical device sterilization operations. Should the State of Georgia continue in its current efforts to close a sterilization facility in Covington, this action would mark the third facility closure in two states in just over six months.
WASHINGTON, D.C. – AdvaMed released a statement on FDA’s announcement today that the agency is concerned about medical device shortages in light of two recent closures of ethylene oxide sterilization plants and the possibility of future plant closures.
WASHINGTON, D.C. – This week, six leading medical groups sent a letter to FDA urging caution as regulators consider limiting the use of ethylene oxide (EtO) for medical device sterilization. The surgeons warned that without EtO sterilization, many medical devices on the market – including those used in critical emergencies – would become unavailable to the patients who need them.
WASHINGTON, D.C. – Scott Whitaker, president and CEO of AdvaMed, today released a statement on Georgia’s filing of a temporary restraining order against BD’s medical device sterilization plant in Covington, Ga.