Regulatory Letters & Comments
SHEA expertise is routinely sought by regulatory and legislative entities. This section showcases regulatory letters and comments.
CMS-3295-P Medicare and Medicaid Programs
SHEA and APIC jointly submitted a letter addressing the CMS-3295-P Medicare and Medicaid Programs; Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care, proposed rule.
FY 2019 Inpatient Prospective Payment System for Inpatient Acute Care and Long-Term Care Hospitals Notice of Proposed Rulemaking – Comments
Abstract: SHEA reviews annually all proposed policy changes associated with IPPS quality reporting requirements and submits comments on all proposed changes that impact reporting requirements measuring healthcare-associated infection rates and outcomes.
Phase Four of the National Action Plan To Prevent Health Care-Associated Infections
Abstract: The Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA) appreciate the opportunity to provide comments on Phase Four of the National Action Plan to Prevent Health Care-Associated Infections: Road Map to Elimination.
Medicare Program; CY 2018 Updates to the Quality Payment Program
SHEA provided comments in response to the proposed rule for the CY 2018 updates to the Quality Payment Program.
Medicare and Medicaid Programs; Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care [CMS-3295-P]
The Society for Healthcare Epidemiology of America provided comments both individually and with The Infectious Diseases Society of America (IDSA) in response to the proposed rule, “Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care,” within the Medicare and Medicaid programs, commonly referred to as the “Conditions of Participation (CoPs).” The individual comments SHEA submitted respond to changes in infection prevention provisions and clarifications needed in the final rule. The joint comments SHEA submitted with IDSA focus on the antibiotic stewardship portion of the proposed rules.
SHEA Comments Addressing Infection Prevention (878 KB)
SHEA & IDSA Joint Comments Addressing Antibiotic Stewardship (432 KB)
CDC Funding Support Congressional Letters
SHEA signed on to both Senate and House letters supporting increased funding for programs within CDC such as the National Healthcare Safety Network (NHSN), Antibiotic Resistance (AR) Solutions Initiative, and the Advanced Molecular Detection (AMD) program.
National Healthcare Safety Network (NHSN) Funding Support Letter – Senate (218 KB)
National Healthcare Safety Network (NHSN) Funding Support Letter – House (217 KB)
APIC & SHEA Endorsed the Preventing Superbugs and Protecting Patients Act
APIC and the SHEA endorsed the Preventing Superbugs and Protecting Patients Act. Senator Patty Murray (D-WA) introduced the legislation and it would establish cleaning instructions and validation data requirements for reusable medical devices, including duodenoscopes. The bill advances recommendations from the “Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients” report released in January 2016 on the multidrug-resistant organism outbreak associated with contaminated duodenoscopes.
SHEA response to Federal Policy for the Protection of Human Subjects
SHEA provided comments in response to Docket ID number HHS–OPHS–2015–0008, specifically the Federal Policy for the Protection of Human Subjects.
SHEA response to The Joint Commission’s Proposed New Standard on Antimicrobial Stewardship
SHEA provided comments on The Joint Commission’s proposed new standard for Antimicrobial Stewardship in healthcare settings.
SHEA response to Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities, Proposed Rule
On October 14, 2015 SHEA submitted comments to the Centers for Medicare & Medicaid Services (CMS) in response to the proposed rule on the Reform of Requirements for Long-Term Care Facilities in the Medicare and Medicaid program.
SHEA response to CMS' Proposed Rule for the Medicare End-Stage Renal Disease Prospective Payment System and Quality Incentive Program
On August 24 SHEA submitted comments to the Centers for Medicare & Medicaid Services (CMS) in response to the proposed rule for the Medicare End-Stage Renal Disease (ESRD) Prospective Payment System and Quality Incentive Program for dialysis centers.
SHEA response to CMS’ Medicare Hospital Inpatient Prospective Payment System (IPPS) proposed changes
On June 16, 2015, SHEA submitted comments to Centers for Medicare & Medicaid Services (CMS) Hospital Inpatient Prospective Payment Systems (IPPS) program for Acute Care Hospitals and Quality Reporting Requirements for Specific Providers.
SHEA Response to Proposed Rule on 2015 Edition Health IT Certification Criteria
The Society for Healthcare Epidemiology of America (SHEA) provided comments in response to the proposed rule for the Office of the National Coordinator’s 2015 Edition Health IT Certification Criteria as published in the March 30, 2015 Federal Register.
SHEA Response to Proposed Rule on Medicare and Medicaid Programs; Electronic Health Record Incentive Program - Stage 3
The Society for Healthcare Epidemiology of America (SHEA) provided comments in response to the proposed rule for Stage 3 of the Electronic Health Record Incentive Program as published in the March 30, 2015 Federal Register.
SHEA Commitments in Response to Proposed White House Summit on Combating Antibiotic Resistant Bacteria
The Society for Healthcare Epidemiology of America (SHEA) provided the CDC and White House with a robust list of commitments on our strategy to alight with national strategy on combating antimicrobial resistant bacteria. The actual summit took place at the White House on June 2, 2015.
Request for Comments on Ethical Considerations and Implications of Public Health Emergency Response with a Focus on the Current Ebola Virus Disease Ep
The Society for Healthcare Epidemiology of America (SHEA) response to a request for comments from the Presidential Commission for the Study of Bioethical Issues on ethical considerations and implications of public health emergency response with a focus on current Ebola Virus Disease (EVD) epidemic, as published in the December 8, 2014 Federal Register.
SHEA Response to Institutions' Implementation of 2010 Guideline for Healthcare Workers Infected with Bloodborne Pathogens
Since the 2010 publication of the "SHEA Guideline for the Management of Healthcare Workers Who Are Infected with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and/or Human Immunodeficiency Virus (HIV)" (1), additional strides have been made in the therapy of these three bloodborne pathogens. Effective treatments offer the promise of sustained virologic control, further reducing the already exceedingly small risk of transmission from an infected healthcare provider to a patient.
SHEA response to CMS' Medicare Hospital Inpatient Prospective Payment System (IPPS) proposed changes for FY 2015
On June 30, 2014, SHEA submitted comments to CMS on the Hospital Inpatient Prospective Payment System (IPPS) proposed rule for FY 2015.
SHEA comments on FDA’s proposal on topical antimicrobial drug products for OTC human use
SHEA submitted comments in response to the FDA proposed rule regarding the safety and effectiveness of consumer antiseptics and topical antimicrobial drug products for over-the-counter human use.
SHEA responds to CMS' Life Safety Code proposal
On June 13, 2014, SHEA submitted comments to CMS in response to the proposed rule for fire safety requirements for certain health care facilities. The Society’s comments address the topics of anesthetizing locations and alcohol based hand rubs.