CDC's HICPAC Update: Impact on COVID-19, Pathogen Control, and Immunocompromised Safety in Health Care Settings

The CDC’s HICPAC (Healthcare Infection Control Practices Advisory Committee Committee) on November 3 and 4, 2023, advanced changes in their infection control guidance, which will impact the control of SARS-CoV-2, the virus that causes COVID-19, and other airborne pathogens.

A letter to the CDC¹ was submitted on Oct 24, 2023, supporting the safety of immunocompromised individuals in health care settings. This concern was further underscored by the findings of the INFORM² and EPOCH³ research initiatives. The EPOCH study concluded:

“Immunocompromised populations appear to be at substantial risk of severe COVID-19 outcomes, leading to increased costs and HCRU. Effective prophylactic options are still needed for these high-risk populations as the COVID-19 landscape evolves.”³

The action letter was signed by 11 prominent patient advocacy and professional organizations and 21 patient advocates. This letter stresses that our health care system frequently encounters and treats airborne pathogens, including seasonal influenza, respiratory syncytial virus (RSV), and SARS-CoV-2.

Another group is concerned with HICPAC’s charter. The World Health Network has filed a complaint with the Office of the Inspector General charging Xavier Bacerra, secretary of the Department of Health and Human Services, Dr. Mandy Cohen, director of the CDC, and Dr. Alexander Kallen, the lead for HICPAC, with gross misconduct, according to Forbes.

“Kevin Bell, a retired lawyer and member of the World Health Network, explained that the HICPAC committee violates its charter, which requires 14 members; it only has 9. Also, the Federal Advisory Committee Act requires that committee memberships be ‘fairly balanced in terms of the points of view represented and the functions to be performed.’ The Act adds, 'In balancing committee memberships, agencies are expected to consider a cross-section of those directly affected, interested, and qualified.'”

Bell expressed his concern about the need for more balance in the committee. He found it surprising that the committee no voting members who were an expert in aerosol science. He pointed out that the guidelines needed to give more importance to the aerosol transmission of COVID-19, the primary mode of virus transmission.

The complaint by the World Health Network challenges the legality of HICPAC's formal guidance on "Preventing Transmission of Infectious Agents in Healthcare Settings." It questions the legitimacy of this guidance due to a purported violation of the committee's charter membership requirements. Specifically, the World Health Network argues that HICPAC should include a substantial representation of experts in specialized fields like aerosol science, industrial hygiene, UV and HEPA filtration, ventilation engineering, respiratory protection, and occupational health and safety to comply with the Federal Advisory Committee Act. However, the complaint highlights the absence of such members within the Committee. This void in the representation of these critical fields is the core contention within the complaint, aiming to challenge the credibility and legal standing of the guidance provided by HICPAC.

The current CDC draft guidance⁴ appears to be conflicting and in places in error. For example, some provisions allow for the use of surgical masks when treating patients who have airborne infections (COVID-19 and seasonal influenza). Surgical masks are not designed for or intended to prevent the spread of airborne pathogens.

In a statement to CNN and posted on WSILTV.com, Jane Thomason, the principal industrial hygienist at National Nurses United (NNU), the biggest nursing union in the US, expressed concern that the draft incorrectly classified surgical and medical masks as both personal protective equipment (PPE) and respiratory protection.

“A surgical or medical mask does not provide protection against inhalation of infectious aerosols,” Thomason wrote in a statement to CNN on HICPAC’s draft recommendations. “NNU urges CDC to fully recognize the science on aerosol transmission of infectious diseases and respiratory protection (including N95s, powered air-purifying respirators, and elastomeric respirators) in creating infection prevention guidance,” Thomason wrote.

Patients’ reactions were similar. During one of the public comment periods, a member of the public said, “I am deeply afraid of being in a situation where avoiding health care is not an option,” said Seifer Almasy, who spoke as a member of the public. He said he was recently in that situation when he decided he couldn’t put off getting his updated COVID-19 and influenza vaccines. He said he made 34 phone calls and was on hold for more than four hours to find a provider that would wear an N95 while giving him his vaccines.

“HICPAC must recommend clear, robust, and authoritative precautions against the airborne transmission of pathogens. Anything less is malpractice and will do harm,” Almasy said.
 Negative pressure rooms are not recommended for patients infected with MERS, SARS-CoV-1, SARS-CoV-2, and influenza. United States’ modern health care facilities often prioritize energy efficiency by sequestering indoor air from the outside air. This sequestration allows deadly pathogens to circulate throughout a facility, placing not just immunocompromised individuals but everyone at risk.

Finally, another disputed CDC strategy involves Enhanced Barrier Precautions (EBP).^5,6 This strategy is not supported by the predicated data7 upon which it is based and allows patients colonized with candida auris to walk around a facility. This seems contradictory to attempts to prevent outbreaks of this deadly pathogen.⁸

“CDC interim guidance recommends EBP as a strategy in nursing homes to interrupt the spread of “novel or targeted MDROs” (eg carbapenem-resistant organisms or C auris).”

There is also a lack of provisions for air quality standards, such as ASHRAE Standard 241 for the “Control of Infectious Aerosols" and for screening of these pathogens.

The inertia and back peddling of standards is often justified by the imposed “burden” preventive strategies would place on facilities. However, the “burdensome” argument has had little, if any, supportive data regarding the actual impact on an institution. The Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services, considers an intervention cost-effective if the cost is less than 9.6 million dollars per life saved.⁹

During the August 22, 2013, CDC HICPAC meeting, a commentator stated, “The only COVID-19 risks we are forced to take is when seeking out medical care.” As stated in an action letter sent to the CDC, for the immunocompromised, the status quo is unacceptable, and weakening current regulations will result in a “direct threat” (Section 36.208) to their safety and well-being and does not maintain accessible features (Section 36.211) for safe and adequate access to a facility.¹⁰ The conclusion of the action letter emphasizes that the CDC be “mindful of the provisions of the ADA and the impact recommendations will have regarding vulnerable individuals who both work in health care settings or are experiencing reduced access to healthcare because of unsafe healthcare environments.”

References

1. Letter to the Centers for Disease Control and Prevention. Oct. 24, 2023.https://www.healthwatchusa.org/HICPAC-CDC/Downloads/20231024-CDC-HICPAC_ADA-Letter.pdf
   
2. Evans RA, Dube S, Lu Y, et al. Impact of COVID-19 on immunocompromised populations during the Omicron era: insights from the observational population-based INFORM study. The Lancet, Regional Health. Oct. 12, 2023. https://www.thelancet.com/journals/lanepe/article/PIIS2666-7762(23)00166-7/fulltext
    
3. Ketkar A, Willey V, Pollack M, et al. Assessing the risk and costs of COVID-19 in immunocompromised populations in a large United States commercial insurance health plan: the EPOCH-US Study. Curr Med Res Opin. 2023 Aug;39(8):1103-1118. doi: 10.1080/03007995.2023.2233819. Epub 2023 Jul 17. PMID: 37431293. https://www.tandfonline.com/doi/full/10.1080/03007995.2023.2233819
   
4. Lin M, Wright S (Co-Chairs). Isolation Precautions Guideline Workgroup. CDC HICPAC. CDC Slide SetJune 8, 2023 https://www.healthwatchusa.org/HWUSA-Presentations-Community/PDF-Downloads/20230608-CDC-IP_Workgroup_HICPAC-FINAL.pdf
    
5. Consideration for Use of Enhanced Barrier Precautions in Skilled Nursing Facilities. CDC. June 2021. https://www.cdc.gov/hicpac/pdf/EnhancedBarrierPrecautions-H.pdf .
    
6. Frequently Asked Questions (FAQs) Definition and scope of Enhanced Barrier Precautions. CDC. July 22, 2023. https://www.cdc.gov/hai/containment/faqs.html
    
7. Roghmann MC, Johnson JK, Sorkin JD, Langenberg P, Lydecker A, Sorace B, Levy L, Mody L. Transmission of Methicillin-Resistant Staphylococcus aureus (MRSA) to Healthcare Worker Gowns and Gloves During Care of Nursing Home Residents. Infect Control Hosp Epidemiol. 2015 Sep;36(9):1050-7. doi: 10.1017/ice.2015.119. Epub 2015 May 26. Transmission of MRSA to Healthcare Personnel Gowns and Gloves during Care of Nursing Home Residents - PMC (nih.gov)
   
8. Murphy H. Hospital at Center of Deadly Fungus Outbreak. The Messenger. Oct. 28, 2023.https://www.msn.com/en-us/health/other/hospital-at-center-of-deadly-fungus-outbreak/ar-AA1iUuoR
   
9. Guidelines for Regulatory Impact Analysis.DHHS, ASPE. 2016. https://aspe.hhs.gov/sites/default/files/migrated_legacy_files/171981/HHS_RIAGuidance.pdf
   
10. Americans with Disabilities Act (ADA) Title III Regulations. Nondiscrimination on the Basis of Disability by Public Accommodations and in Commercial Facilities. Department of Justice. Mar. 8, 2012. https://www.ada.gov/law-and-regs/title-iii-regulations/
     
11. ASHRAE Standard 241, Control of Infectious Aerosols.https://www.ashrae.org/technical-resources/bookstore/ashrae-standard-241-control-of-infectious-aerosols