September 16, 2024 (By Lawrence F Muscarella, PhD) — This article provides links to the proposals, rebuttals, and recommendations by Lawrence F. Muscarella, Ph.D. that were submitted to The Centers for Medicare and Medicaid Services (CMS) in response to “Proposed Rules” the agency published in recent issues of the Federal Register.
Highlighted links:
- Dr. Muscarella’s rebuttal to CMS regarding gastroscope-related infections (2024)
- Dr. Muscarella’s proposal to CMS to use of endoscope-associated infections as a clinical measure of healthcare safety (2024)
- Dr. Muscarella’s response to CMS regarding bronchoscope-related infections (2023)
Note: Dr. Muscarella is accepting new clients seeking guidance in infection prevention, hospital infections, instrument reprocessing, and other related topics.
The primary goals of Dr. Muscarella’s comments to CMS are to prioritize infection prevention, incentivize improvements in patient care, and reduce the risk of hospital-associated infections (“HAIs”), while also reducing U.S. healthcare costs including for Medicare beneficiaries.
Below is a listing of Dr. Muscarella’s comments about flexible endoscopes and the scourge of deadly multidrug-resistant infections that were recently submitted to CMS, in three different reports, for the agency’s consideration:
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Gastroscope-Related Infections (2024): Dr. Muscarella’s comprehensive rebuttal, submitted in August 2024, in response to CMS’s evaluation of a manufacturer’s submitted application to receive Medicare payment status for a sterile, single-use, flexible gastroscope. CMS’s evaluation of this application was published on pages 59316 – 59324 of the July 22, 2024, issue of the Federal Register.
- CMS’s decision: Currently under consideration
- CMS tracking number: m06-t21z-tbaw
- References:
- Muscarella LF. Gastroscopes Have Been Linked to a Cluster of Resistant E. coli Infections — Is the Risk Sufficiently Recognized? Discussions in Infection Control (January 6, 2023)
- Muscarella LF. Contamination of Flexible Endoscopes and Associated Infections: A Comprehensive Review and Analysis of FDA Adverse Event Reports. Discussions in Infection Control (January 28, 2022)
- Muscarella LF. Gastroscopes Now Linked to ‘Superbug’ Infections, Too. Discussions in Infection Control (December 21, 2016)
- Comment: Dr. Muscarella’s rebuttal, along with his commentary and opinions, likely provides the most replete, up-to-date review of the literature and FDA adverse event reports linking gastroscopes to cross-infections of multidrug-resistant organisms including the “CRE” superbug.
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Endoscope-Associated Infections (2024): Dr. Muscarella’s unique proposal submitted in May 2024 in response to CMS’s use of several new electronic clinical quality measures — namely, hospital-acquired conditions including device-related HAIs, such as central-line bloodstream infections (CLABSIs) — to incentivize quality improvements and improve the safety of health care in U.S. acute care hospitals. CMS’s proposal to adopt these new quality measures was published on pages 35934 – 36649 of the May 2, 2024, issue of the Federal Register.
- CMS’s decision: Three months later in the August 28, 2024, issue of the Federal Register (refer to pages 69410 – 11), CMS wrote that it will consider my proposal (along with the comments of others) in future program years.
- CMS tracking number: lws-380d-c56g
- References:
- Muscarella LF. Contamination of Flexible Endoscopes and Associated Infections: A Comprehensive Review and Analysis of FDA Adverse Event Reports. Discussions in Infection Control (January 28, 2022)
- Muscarella LF. Use of ethylene-oxide gas sterilisation to terminate multidrug-resistant bacterial outbreaks linked to duodenoscopes. BMJ Open Gastro 2019;6:e000282.
- U.S. Senate. Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients. [HELP Committee] January 13, 2016.
- Comment: Dr. Muscarella’s proposal to CMS appears to be the first time that infections linked to contaminated, ineffectively reprocessed flexible endoscopes have been suggested to be used by Medicare as a meaningful quality metric to incentivize patient care, improve patient safety, and reduce healthcare costs.
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Bronchoscopes-Related Infections (2023): Dr. Muscarella’s compelling rebuttal submitted in August 2023, in response to CMS’s evaluation of a manufacturer’s submitted application to receive Medicare payment status for a sterile, single-use, flexible bronchoscope. CMS’s comments about this application were published on pages 49639 – 46 of the July 31, 2023, issue of the Federal Register.
- CMS’s decision: Three months after receiving Dr. Muscarella’s rebuttal (along with the comments of others), CMS approved the manufacturer’s application to receive Medicare payment status for this single-use bronchoscope. Refer to pages 81729-81743 of the “Rules and Regulations” in the November 22, 2023, issue of the Federal Register.
- CMS statement: “After consideration of the public comments we received and our review of the device pass-through application, we have determined (that the applicant’s single-use bronchoscope) meets the criteria for device pass-through status. We are approving this application because the documentation (namely the FDA document and additional studies) that were submitted in response to the proposed rule address our concerns and provide evidence of substantial clinical improvement that is required. Therefore, we are approving the (applicant’s single-use bronchoscope) for transitional pass-through payment status beginning January 1, 2024.”
- CMS tracking number: lln-itac-5op2
- References:
- Mehta AC, Muscarella LF. Bronchoscope-Related “Superbug” Infections. Chest 2020 Feb;157(2):454-469.
- Muscarella LF. In Support of Patient Safety, Healthcare Access, and Medicare Payment for a Single-Use Bronchoscope Model. Discussions in Infection Control January 8, 2024.
- Muscarella LF. Can Bronchoscopes Transmit a ‘Superbug’? Discussions in Infection Control (May 14, 2022)
- Comment: Dr. Muscarella’s rebuttal, along with his commentary and opinions, provides a replete, up-to-date review of the literature and FDA adverse event reports linking bronchoscopes to cross-infections of multidrug-resistant organisms including the “CRE” superbug.
- CMS’s decision: Three months after receiving Dr. Muscarella’s rebuttal (along with the comments of others), CMS approved the manufacturer’s application to receive Medicare payment status for this single-use bronchoscope. Refer to pages 81729-81743 of the “Rules and Regulations” in the November 22, 2023, issue of the Federal Register.
Using the CMS tracking numbers above, each of Dr. Muscarella’s comments to CMS may also be downloaded and read from a federal government website at: https://www.regulations.gov/
Forensic Services, Expert Consultations, Root Cause Analyses: LFM-Healthcare Solutions, LLC provides medical expertise and services for healthcare facilities, device manufacturers and the public, specializing in healthcare-associated infections linked to contaminated reusable medical equipment.
Post by: Lawrence F Muscarella, PhD. Copyright (2024). LFM Healthcare Solutions, LLC. All rights reserved. Dr. Muscarella is the president and founder of LFM Healthcare Solutions, LLC, an independent quality improvement company. Click here for a list of his quality improvement healthcare services. E: Larry@LFM-HCS.com. [LFM-ver-1.4]