| Proposed Regulation* |
Impact on Infection Prevention |
Committee Action and Status |
Which of APIC Strategic Goals does this related to? |
| CMS: FY 2021 Hospital Inpatient and Long-Term Care Hospital Prospective Payment System (IPPS/LTCH PPS) proposed rule |
Update to infection-related provisions in Medicare payment programs for acute care, long-term acute care, and cancer hospitals. |
Comments submitted 7/10/20 |
Data Standardization Patient Safety Advocacy |
| CDC: Tracking SARS-CoV-2 Infections among Healthcare Personnel, information collection request |
Through Emerging Infections Program (EIP) labs, CDC is collecting information on coronavirus infections among Healthcare Personnel. Stakeholders were invited to comment on this project. |
Comments submitted 7/14/20 |
Data Standardization Patient Safety Advocacy |
| CMS: Revisions to Medicare Programs in Response to COVID-19, interim final rule with comment period |
CMS has relaxed, revised, or delayed implementation of several Medicare/Medicaid programs in response to the COVID-19 public health emergency. Because of time sensitivies, this was published as a final rule that took effect 5/8/20, but stakeholders were invited to comment on the CMS revisions. |
Comments submitted 7/7/20 |
Data Standardization Patient Safety Advocacy |
| CDC: NHSN COVID-19 Module information collection project |
Request for comments on the NHSN COVID-19 module for data collection. |
Comments submitted 6/16/20 |
Data Standardization Patient Safety Advocacy |
| EPA: Strategy to Ensure Effectiveness of Hospital-Level Disinfectants |
Request for comments on EPA draft document “Antimicrobial Performance Evaluation Program (APEP): A Draft Risk-Based Strategy to Ensure the Effectiveness of Hospital-Level Disinfectants.” |
Comments submitted 12/31/19 |
Patient Safety Advocacy |
| CDC: Recommendations for Hepatitis C Screening for Adults |
Request for Information on CDC revised screening recommendations for Hepatitis C in adults |
Comments submitted 12/26/19 |
Patient Safety Advocacy |
| Leapfrog: Proposed changes to 2020 Hospital Survey — Section 6D: Hand Hygiene |
Revisions to Leapfrog’s 2020 Hospital Survey section on hand hygiene. |
Comments submitted 12/20/19 |
Patient Safety Advocacy |
| FDA: Veterinary Oversight of OTC Animal Antibiotics |
FDA recommendations for animal drug manufacturers on voluntary veterinary oversight of medically important antimicrogial drugs. |
Comments submitted 12/20/19 |
Patient Safety Advocacy |
| FDA: Preventing Duodenoscope Contamination |
Joint statement from APIC/SHEA/IDSA to the FDA Medical Devices Advisory Committee |
Comments submitted 12/6/19 |
Patient Safety Advocacy |
| CMS: CY 2020 Physician Fee Schedule proposed rule |
Update to infection-related measures in the Medicare Quality Payment Program |
Comments submitted 9/26/19 |
Patient Safety Data Standardization Advocacy |
| CMS: CY 2020 End-Stage Renal Disease (ESRD) Facility Prospective Payment System proposed rule |
Update to infection-related measures in the ESRD quality improvement program |
Comments submitted 9/20/19 |
Patient Safety Data Standardization Advocacy |
| CMS: CY 2020 Home Health Prospective Payment System proposed rule |
Update on infection prevention-related measures for Home Health quality reporting program |
Comments submitted 9/9/19 |
Patient Safety Data Standardization Advocacy |
| CMS: Revisions to Long-Term Care Requirements proposed rule |
Proposed revisions to promote efficiency and transparency in Long-Term Care requirements |
Comments submitted 9/16/19 |
Patient Safety Advocacy |
| CMS: FY 2020 Hospital Inpatient Prospective Payment System and Long-Term Care Hospital Prospective Payment System (IPPS/LTCH) proposed rule |
Update on infection prevention-related measures for acute care hospitals, long-term acute care hospitals, and PPS-exempt cancer hospitals. |
Comments submitted 6/24/2019 Final rule published 8/16/19 |
Patient Safety Data Standardization Advocacy |
| CMS: FY 2020 Inpatient Rehabilitation Facility Prospective Payment System (IRF PPS) proposed rule |
Update infection prevention-related measures for inpatient rehab facilities |
Comments submitted 6/7/2019 Final rule published 8/8/19 |
Patient Safety Data Standardization Advocacy |
| CMS: FY 2020 Skilled Nursing Facility Prospective Payment System (SNF PPS) proposed rule |
Update infection prevention-related measures for skilled nursing facilities. |
Comments submitted 6/7/2019 Final rule published 8/7/19 |
Patient Safety Data Standardization Advocacy |
| CDC: Request for Information on NHSN SSI reporting |
CDC request for information on proposed use of ICD-10 and CPT billing codes for NHSN surgical site infection reporting |
Comments submitted 5/30/2019 |
Patient Safety Data Standardization Advocacy |
| NQF: CQMC draft approaches to measure prioritization |
National Quality Forum request for comments on Core Quality Measures Collaborative draft approaches to future core measure set prioritization |
Comments submitted 3/29/2019 |
Patient Safety Data Standardization Advocacy |
| CMS: Request for comment on Hospital Quality Star Ratings |
CMS request for public input on proposed updates to the Hospital Star Rating program methodology. |
Comments submitted 3/29/2019 |
Patient Safety Data Standardization Advocacy |
| CDC: Request for Information on NHSN OPC and BSI Surveillance Protocols |
Response to CDC Request for Information on the National Healthcare Safety Network (NHSN) Outpatient Procedure Component (OPC) Surveillance Protocol and Bloodstream Infection Surveillance Protocol. |
Comments submitted 4/15/2019 |
Patient Safety Data Standardization |
| HHS/PACCARB: APIC president’s comments to PACCARB |
Comments of APIC President Karen Hoffmann to the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB) requesting PACCARB urge CMS to finalize proposed Conditions of Participation that would require antibiotic stewardship programs in hospitals and critical access hospitals. |
Comments delivered 1/30/2019 APIC response to PACCARB request for information 1/7/2019 |
Patient Safety Advocacy |
| HHS/PACCARB: APIC/SHEA joint letters to PACCARB and HHS |
APIC/SHEA joint letters requesting that PACCARB and the Department of Health and Human Services (HHS) urge CMS to finalize proposed requirement for antibiotic stewardship programs in hospitals and critical access hospitals. |
Letter to PACCARB sent 2/15/2019 Letter to HHS sent 3/1/2019 |
Patient Safety Advocacy |
| HHS/ONC: draft Strategy on Reducing Burden Relating to the Use of Health IT and EHRs |
Strategic plan mandated by the 21st Century Cures Act to reduce time burdens and improve functionality of electronic health records. |
Comments submitted 1/28/2019 |
Patient Safety Data Standardization |
| CMS: Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction |
Reform Medicare regulations that are identified as unnecessary, obsolete, or excessively burdensome on healthcare providers and suppliers. |
Comments submitted 11/15/2018 |
Patient Safety Data Standardization Advocacy |
| CMS: CY 2019 Revisions to Payment Policies under the Physician Fee Schedule proposed rule |
Update infection-related measures in Medicare payment systems for physicians |
Comments submitted 9/6/2018 |
Patient Safety Data Standardization Advocacy |
| CMS: CY 2019 Hospital Outpatient Prospective Payment System/Ambulatory Surgical Center Payment System (OPPS/ASC) proposed rule |
Update infection-related measures in the Hospital Outpatient Quality Reporting Program and the Ambulatory Surgical Center Quality Reporting Program |
Comments submitted 9/24/2018 |
Patient Safety Data Standardization Advocacy |
| CMS: CY 2019 End-Stage Renal Disease (ESRD) Prospective Payment System proposed rule |
Update infection-related measures in the ESRD Quality Incentive Program |
Comments submitted 9/6/2018 Final rule published 11/14/2018 |
Patient Safety Data Standardization Advocacy |
| CMS: CY 2019 Home Health Prospective Payment System proposed rule |
Updates infection-related Home Health Quality Reporting and Value-Based Purchasing model measures |
Comments submitted 8/30/2018 Final rule published 11/13/2018 |
Patient Safety Data Standardization Advocacy |
| CMS: FY 2019 Inpatient Prospective Payment System/ Long-Term Care Hospital Payment System (IPPS/LTCH) proposed rule. |
Updates infection-related measures in the Hospital Inpatient Quality Reporting Program, Hospital Value-Based Purchasing Program, Hospital-Acquired Condition (HAC) Reduction Program, Long-Term Care Hospital Quality Reporting Program, and PPS-exempt Cancer Hospital Quality Reporting Program |
Comments submitted 6/25/2018 Summary of comments Final rule published 8/17/2018 |
Patient Safety Data Standardization Advocacy |
| CMS: FY 2019 Inpatient Rehabilitation Facility (IRF) Prospective Payment System proposed rule. |
Updates infection-related measures in the Inpatient Rehabilitation Facility Quality Reporting Program. |
Comments submitted 6/25/2018 Summary of comments Final rule published 8/6/2018 |
Patient Safety Data Standardization Advocacy |
| CMS: FY 2019 Hospital Inpatient Psychiatric Facility (IPF) Prospective Payment System proposed rule. |
Updates infection-related measures in the Inpatient Psychiatric Facility Quality Reporting Program |
Comments submitted 6/25/2018 Summary of comments Final rule published 8/6/2018 |
Patient Safety Data Standardization Advocacy |
| CMS: Draft quality measures to satisfy the Improving Medicare Post-Acute Care Transformation (IMPACT) Act of 2014 domain of Transfer of Health Information and Care Preferences When an Individual Transitions — Medication Profile Transferred to Provider/ Medication Profile Transferred to Patient. |
To comply with requirements of the IMPACT Act, CMS is developing new measures to ensure patient safety during care transitions. These proposed measures are intended to provide patient medication profiles to accompany patients when transitioning to new settings or to home. |
Comments submitted 5/1/2018 |
Patient Safety |
| HHS: Phase Four of the National Action Plan to Prevent Healthcare-Associated Infections: Road Map to Elimination; Coordination Among Federal Partners to Leverage HAI Prevention and Antibiotic Stewardship |
This new phase of the HAI Action Plan highlights the importance of antibiotic stewardship to prevent HAIs, and enhances the goals of the National Action Plan on Combatting Antibiotic Resistant Bacteria (CARB) to coordinate activities among government agencies and other stakeholders to prevent the spread of antibiotic resistant infections. |
Comments submitted 12/21/17 |
Patient Safety |
| CDC: Request for Information on water management programs |
CDC is seeking information of effective methods for achieving implementation of water management programs (WMPs) intended to reduce Legionella growth and transmission in buildings at inceased risk. |
APIC members are encouraged to provide information on behalf of their facilities Deadline: 10/17/17 APIC comments submitted 10/11/17 |
Patient Safety |
| CMS: CY 2018 Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems proposed rule |
Updates infection-related provisions in the Hospital Outpatient Quality Reporting Program and the Ambulatory Surgical Canter Quality Reporting Program |
Comments submitted 9/11/17 Final rule published 11/10/17 |
Patient Safety Data Standardization Advocacy |
| CMS: CY 2018 End-Stage Renal Disease Prospective Payment System annual update proposed rule |
Updates infection-related provisions in the ESRD Quality Incentive Program (QIP). |
Comments submitted 8/28/17 Final rule published 11/1/17 |
Patient Safety Data Standardization Advocacy |
| CMS: FY 2018 Hospital Inpatient Prospective Payment System and Long-Term Care Payment System annual update |
Updates HAI measures and infection-related provisions for acute care hospitals, long-term acute care hospitals, PPS-exempt cancer hospitals, and inpatient psychiatric facilities. |
Comments submitted 6/5/17 Final rule published 8/14/17 |
Patient Safety Data Standardization Advocacy |
| FDA: Coordinated development of antimicrobial drugs and antimicrobial susceptibility test devices, draft guidance |
Draft guidance for industry on coordination in development of antimicrobial drugs and antimicrobial susceptibility test devices. |
Comments submitted 11/18/16 |
Patient Safety |
| HHS: Update of Quarantine Regulations for Control of Communicable Diseases |
Amends domestic and foreign quarantine regulations to protect public health. |
Comments submitted 10/14/16 Final rule published 1/19/17 |
Patient Safety Advocacy |
| CMS: CY 2017 End-Stage Renal Disease Prospective Payment System proposed rule |
Updates infection prevention measures in the End-Stage Renal Disease Prospective Payment System. |
Comments submitted 8/22/16 Final rule published 11/4/16 |
Patient Safety Advocacy Data Standardization |
| CMS: CY 2017 Home Health Prospective Payment System proposed rule |
Updates infection prevention measures in the Home Health Prospective Payment System. |
Comments submitted 8/22/16 Final rule published 11/3/16 |
Patient Safety Advocacy Data Standardization |
| CMS: CY 2017 Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (OPPS/ASC) proposed rule |
Updates infection prevention measures in the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center payment system. |
Comments submitted 8/22/16 Final rule published 11/14/16 |
Patient Safety Advocacy Data Standardization |
| CMS: Hospital and Critical Access Hospital Changes to Promote Innovation, Flexibility, and Improvement in Patient Care proposed rule |
Updates Medicare Conditions of Participation (CoPs) for hospitals and crical access hospitals related to infection prevention and antibiotic prescribing. |
Comments submitted 8/15/16 |
Patient Safety Advocacy |
| CMS: Merit-Based Incentive Payment System (MIPS) under the Physician Fee Schedule, proposed rule |
Creates a new program to determine Medicare payment for physicians based on quality rather than volume of care |
Comments submitted 6/22/16 Final rule published 11/4/16 |
Patient Safety Data Standardization Advocacy |
| CMS: FY 2017 Skilled Nursing Facilities Prospective Payment System, Value-Based Purchasing and Quality Reporting programs proposed rule |
Updates infection prevention measures in the Skilled Nursing Facilities Quality Reporting and Value-Based Purchasing programs. |
Comments submitted 6/17/16 Final rule published 8/5/16 |
Patient Safety Data Standardization Advocacy |
| CMS: FY 2017 Hospital Inpatient Prospective Payment System and Long-Term Care Hospital Payment System (IPPS/LTCH) proposed rule |
Updates HAI measures and infection-related provisions for acute care hospitals, long-term acute care hospitals, PPS-exempt cancer hospitals, and inpatient psychiatric facilities. |
Comments submitted 6/17/16 Final rule published 8/22/16 |
Patient Safety Data Standardization Advocacy |
| CMS: FY 2017 Inpatient Rehabilitation Facility Prospective Payment System |
Updates HAI measures in the Inpatient Rehabilitation Facility Quality Reporting Program |
Comments submitted 6/17/16 Final rule published 8/5/16 |
Patient Safety Data Standardization Advocacy |
| FDA: Ban on powdered gloves |
Proposal to ban powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove. |
Comments submitted 6/1/16 Final rule published 12/19/16 |
Patient Safety Advocacy |
| FDA: Donor screeing recommendations to reduce Zika transmissions |
Guidance for industry on donor screening recommendations to reduce the risk of transmission of Zika virus by human cells, tissues, and cellular and tissue-based products – released for immediate implementation. |
Comments submitted 3/25/16 |
Patient Safety Advocacy |
| FDA: Medical device reprocessing |
Request for comments concerning the service, maintenance, refurbishment, and alteration of medical devices, including endoscopes, by third-party entities and original equipment manufacturers. |
Comments submitted 5/9/16 |
Patient Safety Advocacy |
| FDA: Reclassification of blood lancets |
Proposal to reclassify single use and single patient blood lancets from class I (requiring general controls) to class II (requiring special controls) |
Comments submitted 5/24/16 |
Patient Safety Advocacy |
| OSHA: PPE information collection request |
Requests extension of current information collection requirements in the Personal Protective Equipment section of the OSHA General Industry Standard. |
Comments submitted 4/18/16 |
Advocacy |
| FDA: Fecal Transplantation |
Draft guidance for industry on enforcement of policy regarding investigational new drug requirements for use of fecal microbiota for transplantation to treat Clostridium difficile infection not responsive to standard therapies. |
Comments submitted 4/1/16 |
Patient Safety Implementation Science |
| CDC/NIOSH: Monitoring and Coordinating PPE in Healthcare to Enhance Domestic Preparedness for Ebola Response |
Proposal to develop an ongoing hospital surveillance system to evaluate and monitor PPE usage and effectiveness in healthcare workers including Ebola protection. |
Comments submitted 3/18/16 |
Advocacy |
| All federal agencies: Revisions to the Common Rule, proposed rule |
Updates the Federal Policy for the Protection of Human Research Subjects, including quality assurance, quality improvement, and public health surveillance activities. |
Comments submitted 12/28/15 Final rule published 1/19/17 |
Patient Safety Advocacy Implementation Science |
| CMS: Revisions to Discharge Planning Requirements for Hospitals, Critical Access Hospitals and Home Health Agencies proposed rule |
Updates discharge planning requirement for Medicare and Medicaid participation to comply with the “Improving Medicare Post-Acute Care Transformation Act of 2014” (IMPACT Act). |
Comments submitted 12/28/15 CMS notice of final rule deadline extension 11/3/18 |
Patient Safety Advocacy |
| AHRQ: Draft Technical Brief |
Critical analysis of evidence for resident safety practices in nursing home settings. |
Comments submitted 11/20/15 |
Patient Safety |
| FDA: Draft Guidance for Industry |
Selection of the appropriate package type terms and recommendations for labeling injectable medical products packaged in multiple-dose, single-dose, and single-patient-use containers for human use. |
Comments submitted 12/17/15 |
Patient Safety |
| NQF: Patient Safety 2015, draft report for comment |
Recommendations from NQF Patient Safety Standing Committee on endorsement or revision of measures, including infection-related measures. |
Comments submitted 9/3/15 |
Patient Safety Data Standardization Implementation Science |
| FDA: Draft Guidance for Industry |
Premarket regulatory requirements and performance testing needed to support liquid barrier claims for gowns intended for use in healthcare settings. |
Comments submitted 8/28/15 |
Patient Safety Advocacy |
| CMS: Reform of Requirements of Long-Term Care Facilities |
Updates requirements for Long-Term Care Facility participation in Medicare, including infection control provisions |
Comments submitted 9/10/15 Final rule published 10/4/2016 |
Patient Safety Advocacy |
| CMS: CY 2016 Physician Fee Schedule proposed rule |
Updates infection-related measures in the Physican Quality Reporting System for Medicare payment determination. |
Comments submitted 8/6/2015 Final rule published 11/16/2015 |
Patient Safety Data Standardization Advocacy |
| CMS: CY 2016 Home Health Prospective Payment System proposed rule |
Updates infection-related Home Health Quality Reporting requirements for Medicare payment determination. |
Comments submitted 9/3/2015 Final rule published 11/5/2015 |
Patient Safety Data Standardization Advocacy |
| CMS: CY 2016 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center (OPPS/ASC) Payment System proposed rule |
Updates infection-related measures to the Hospital Outpatient Qualitry Reporting Program and ASC Quality Reporting Program for Medicare payment determination. |
Comments submitted 8/10/15 Final rule published 11/13/2015 |
Patient Safety Data Standardization Advocacy |
| CMS: CY 2016 End-Stage Renal Disease Prospective Payment System proposed rule |
Updates infection-related measures to the ESRD Quality Incentives Program for Medicare payment determination. |
Comments submitted 8/24/15 Final rule published 11/6/2015 |
Patient Safety Data Standardization Advocacy |
| FDA: Healthcare Antiseptics proposed rule |
Request for additional data from manufacturers on safety and effectiveness of healthcare antiseptic products. |
Comments submitted 10/26/15 Final rule published 12/20/17 |
Patient Safety |
| NQF: Data for Systematic Improvement: Summarizing an NQF Meeting on the Data Needed for Sustainably Improving Healthcare |
Recommendations from NQF meeting of stakeholders to identify opportunities to improve data and make it more useful for systematic improvement. |
Comments submitted 6/15/15 |
Patient Safety Data Standardization |
| CMS: FY 2016 Hospital Inpatient Prospective Payment System (IPPS/LTCH) Update |
Updates HAI measures in Hospital Inpatient Quality Reporting, Hospital Value-Based Purchasing, HAC Reduction Program, LTCH Quality Reporting programs for Medicare payment determination. |
Comments submitted 6/10/15 Final rule published 8/17/15 |
Patient Safety Data Standardization Advocacy |
| CMS: FY 2016 Inpatient Rehabilitation Facility (IRF) Prospective Payment System update |
Updates the HAI measures in the IRF Quality Reporting Program for Medicare payment determination. |
Comments submitted 6/8/15 Final rule published 8/6/15 |
Patient Safety Data Standardization Advocacy |
| CMS: Meaningful Use Stage 3 |
The Stage 3 proposed rule streamlines the program by reducing the number of clinical quality measures and aligning EHR measures with measures in other CMS quality reporting programs. |
Comments submitted 5/26/15 Final rule published 10/16/2015 |
Data Standardization Patient Safety Advocacy |
| HHS: Health IT Certification Criteria |
Updates and modifies health information technology certification criteria |
Comments submitted 5/26/15 Final rule published 10/16/2015 |
Data Standardization Advocacy |
| FDA: Reprocessing of Duodenoscopes |
Request for comments on reprocessing of duodenoscopes and other endoscopes to the Gastroenterology and Urology Devices Panel of the FDA Medical Devices Advisory Committee |
Comments submitted 4/29/15 |
Patient Safety Advocacy |
| FDA: Draft Guidance for Industry |
Mitigating cross-contamination risk from irrigation accessories for flexible gastrointestinal endoscopes |
Comments submitted 4/16/15 |
Patient Safety |
| CMS: Medicare Conditions for Coverage (CfCs) for End-Stage Renal Disease (ESRD) facilities |
APIC sent CMS suggestions for possible revisions to CfCs for ESRD facilities that would incorporate evidence-based infection prevention practice standards into the CfCs. |
Comments submitted 4/1/2015 |
Patient Safety |
| HHS: Ethical considerations of Ebola Emergency Response |
Request for Comments on the ethical considerations and implications of public health emergency response with a focus on the Ebola epidemic. |
Comments submitted 2/5/2015 Final report published 2/2015 |
Advocacy Patient Safety Implementation Science |
| HHS: Federal Health IT Strategic Plan 2015-2020 |
Strategic plan to expand widespread adoption of health IT and increase interoperability among users to improve healthcare. |
Comments submitted 2/4/2015 Final published 9/21/2015 |
Data Standardization |