Comments of the Healthcare Supply Chain Association (HSCA) on FDA Request for Comments on Ethylene Oxide Sterilization of Medical Devices
On behalf of the Healthcare Supply Chain Association (HSCA), we appreciate the opportunity to provide comments to the U.S. Food and Drug Administration (FDA) regarding the use of Ethylene Oxide (EtO) to sterilize medical devices.
HSCA represents the nation’s leading healthcare group purchasing organizations (GPOs), the sourcing and purchasing partners to virtually all of America’s 7,000+ hospitals, as well as the vast majority of the 68,000+ long-term care facilities, surgery centers, clinics, and other healthcare providers. GPOs work with healthcare providers to support a safe and reliable supply of healthcare products. We help ensure quality medical products at the best value for patients, hospitals, payers, Medicare and Medicaid, and taxpayers. The value that GPOs deliver allows healthcare providers and physicians to focus on their core mission: providing first-class patient care.
HSCA and its member GPOs have a unique line of sight over the entire healthcare supply chain – from raw materials to the manufacturing process for drugs and medical devices to their delivery to patients. Even seemingly minor disruptions to the healthcare supply chain could have significant consequences for patients. In that vein, we appreciate the Agency’s efforts to seek feedback and input on this critical matter.
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HSCA Submits Comments to ANSI on Healthcare Supply Chain Data Standards to Help Improve Accuracy, Efficiency, and Patient Safety
Washington, DC (November 26, 2019) – The Healthcare Supply Chain Association (HSCA) Committee for Healthcare eStandards (CHeS) today submitted comments to the American National Standards Institute’s (ANSI) Accredited Standards Committee (ASC) X12 supporting the Committee’s recommendation to include medical device identifiers in the healthcare electronic claim form.
The vast majority of healthcare insurance claims are communicated electronically, using electronic data interchange (EDI) standards that are promulgated and maintained by the ASC X12 Committee. The ANSI ASC X12 Committee is currently proposing a number of changes to the electronic healthcare claim form, including adding medical device identifiers to the form to enable providers and payers to exchange product information.
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Dear Senator Collins and Senator Smith,
The undersigned organizations are writing in support of S.2723 – The Mitigating Emergency Drug Shortages (MEDS) Act. Drug shortages have been on the rise for several years, with an estimated 210 drugs currently at risk or not readily available for U.S. hospitals, according to the national database maintained by the American Society of Health System Pharmacists (ASHP). The Food and Drug Administration (FDA) also states that drug shortages have grown more persistent since 2014 with many shortages lasting multiple years.
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HSCA Applauds Senators Collins and Smith for Bipartisan Legislation to Prevent and Mitigate Drug Shortages
Washington, DC (October 30, 2019) – Healthcare Supply Chain Association (HSCA) President and CEO Khatereh Calleja today released the following statement applauding Senator Susan Collins (R-ME) and Senator Tina Smith (D-MN) and announcing HSCA’s support for The Mitigating Emergency Drug Shortages (MEDS) Act:
“HSCA and its member group purchasing organizations (GPOs) applaud Senators Collins and Smith for their bipartisan leadership in addressing drug shortages, reducing healthcare costs, and improving patient outcomes for Americans across the country. HSCA strongly supports the MEDS Act, which builds upon the important steps Congress has taken to provide additional authority to the FDA to help mitigate drug shortages and develop market-based incentives to ensure a stable supply of medications critical for patient care.
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Washington, DC (October 29, 2019) – Healthcare Supply Chain Association (HSCA) President and CEO Khatereh Calleja today released the following statement regarding the recent report by the Food and Drug Administration (FDA) Drug Shortages Task Force on drug shortages:
“Ongoing critical prescription drug shortages jeopardize patient access to essential medications. As FDA has noted, the causes of drug shortages are complex and multifactorial, requiring an all-hands-on-deck, multi-stakeholder solution. HSCA and its member group purchasing organizations (GPOs) are on the front lines of helping providers prevent and mitigate drug shortages, working collaboratively with hospitals, physicians, manufacturers, distributors, and government agencies to ensure that providers and patients have access to the life-saving drugs they need.
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Comments of the Healthcare Supply Chain Association (HSCA) on Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2020
On behalf of the Healthcare Supply Chain Association (HSCA), we appreciate the opportunity to provide comments on the U.S. Drug Enforcement Administration’s (DEA or Agency) proposed aggregate production quotas for Schedule I and II controlled substances. HSCA supports DEA’s efforts to support interagency collaboration around controlling opioid diversion. We are concerned, however, that absent differentiation of injectable opioids from solid dosage form for purposes of the rule, these changes to aggregate production quotas could lead to injectable narcotic shortages that threaten patient care.
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Washington, DC (September 23, 2019) – The Healthcare Supply Chain Association (HSCA), the association representing the nation’s leading healthcare group purchasing organizations (GPOs), today announced HSCA President and CEO Khatereh Calleja will moderate a panel on “Chasing Value: Understanding How to Work with GPOs to Introduce New Health Care Innovation in the Supply Chain” at AdvaMed’s MedTech Conference on Monday, September 23rd at the Boston Convention and Exhibition Center in Boston, Massachusetts.
The panel will feature healthcare leaders from Vizient, Premier, Intalere, 410 Medical, and Access Scientific. Panelists will discuss successful partnerships, best practices and how they have successfully worked together and launched new innovations.
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