Posted on by Mayra Barbosa under Laboratory, Medicare & Medicaid

Key Takeaways

  • CMS and the CDC published proposed rule CMS-3478-P on Oct. 8, 2026. Comments are due Dec. 7, 2026.
  • The rule would let qualified staff review digital lab data and images remotely under the primary lab’s CLIA certificate, a practice CMS calls “virtual access.”
  • Cytology is excluded. Remote cytology review still requires a separate CLIA certificate for each remote location.
  • The rule would also ease laboratory director qualifications, end twice-yearly on-site director visits and require test reports to show the lab’s CLIA number and certificate name.
  • For billing teams, remote work stays tied to the primary lab’s CLIA number, so certificate scope, test reports and claims need to line up.

Remote review of lab data and digital slides would move from temporary CMS guidance into permanent federal regulation under a proposed rule that the Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) published on Oct. 8, 2026. The proposal, CMS-3478-P, reaches nearly every lab specialty. Alongside remote review, it rewrites laboratory director qualifications, updates gynecologic cytology proficiency testing and changes what test reports must show.

Each change affects the CLIA certificates, personnel records and report formats that billing teams rely on to support claims. Today’s Clinical Lab covered the proposal from the lab manager’s side.

What is virtual access under the proposed CLIA rule?

Virtual access is the term CMS proposes for reviewing digital lab data, results, live imaging and digital images from outside the primary lab over a secure connection to its LIS, instruments, EHR or other systems. Under the proposed CLIA rule, pathologists and other qualified personnel would do that work under the primary lab’s CLIA certificate, with no separate certificate needed for a pathologist’s home or other remote site.

The proposal would turn the enforcement discretion CMS has used for remote review since 2020 into regulation, with these conditions:

  • CMS examples include quality control data, real-time microscope viewing in hematology and histopathology, and images from pathology, hematology and clinical cytogenetics.
  • The primary lab director would be responsible for testing and reporting done through virtual access. Remote staff would need to be qualified and listed on Form CMS-209, and the lab would give CMS a list of them on request.
  • Labs would log who performed each remote review, the software version and the device used.
  • Written policies would keep remote work off public networks and in confidential settings.
  • Digital images and digital data would join slides, blocks and tissue on the list of items labs must keep. For cytology and histopathology, labs would keep both the glass slide and, where one exists, its digital image.
  • Virtual access would not apply to provider-performed microscopy (PPM) certificates or to cytology.

Why is cytology excluded from remote review under the proposed CLIA rule?

Cytology is excluded because federal law requires cytology screening to take place on the premises of a CLIA-certified laboratory. The Public Health Service Act sets that requirement, and only Congress can change it, so CMS and the CDC cannot extend virtual access to cytology by regulation.

CMS ended its enforcement discretion for remote review of digital cytology images on March 23, 2026. Since then, any location where staff review cytology slides or images remotely has needed its own CLIA certificate, and the proposed rule keeps that requirement. CMS has also said that remote rapid on-site evaluation (ROSE) requires a separate certificate for the off-site location.

The rule would expand digital cytology in one area: gynecologic cytology proficiency testing could use digital images of glass slides, matching FDA-authorized digital cytology screening systems.

When did CMS start allowing remote pathology review?

CMS has allowed remote review of lab data and images since the COVID-19 public health emergency in 2020 through enforcement discretion, which proposed rule CMS-3478-P would make permanent. Key dates:

Date What happened
March 2020 CMS begins exercising enforcement discretion so pathologists can review slides and images at temporary remote sites (QSO-20-21-CLIA).
May 2023 After the public health emergency, CMS continues remote review of digital materials through enforcement discretion in QSO-23-15-CLIA.
December 28, 2024 Personnel requirements from the 2023 CLIA final rule take effect.
June 23, 2025 QSO-25-21-CLIA eases enforcement of several personnel requirements.
September 23, 2025 CMS revises QSO-23-15-CLIA to end enforcement discretion for remote review of digital cytology images.
March 23, 2026 Remote cytology review requires a separate CLIA certificate for each remote location.
October 8, 2026 CMS and the CDC publish proposed rule CMS-3478-P.
December 7, 2026 Comment period on CMS-3478-P closes.

How would the proposed rule change CLIA lab director qualifications?

The proposed CLIA rule would ease director requirements set by the 2023 CLIA final rule, which took effect Dec. 28, 2024. That rule required many director candidates to have both supervisory experience and 20 continuing education (CE) credit hours. Under the proposal, candidates on the MD/DO, doctoral, master’s and bachelor’s routes could qualify with either one year of supervisory experience or 20 CE hours. Physicians could also qualify with one year of laboratory training during residency or fellowship, and the HHS-approved board certification requirement for doctoral directors would be dropped.

Board-certified dermatologists could qualify as high complexity laboratory directors for Mohs testing in dermatology offices, which house about 20% of all certificate-of-compliance labs, according to the rule. Directors would no longer need to visit the lab on site every six months and would instead need to be accessible as needed, the standard before December 2024.

Qualifying science degrees would be defined by federal Classification of Instructional Programs (CIP) codes, adding fields such as animal science, veterinary medicine, histotechnology and pathologists’ assistant programs.

Several of these changes, including the director qualification relief, have been in effect through enforcement discretion since June 2025 under memo QSO-25-21-CLIA. The rule would make them permanent.

What else does CMS-3478-P change?

CMS-3478-P would require test reports to show the laboratory’s CLIA number and the name on its CLIA certificate. It would also rescind the mandatory six-month waiting period before a lab can resume testing after proficiency testing failures, citing access problems in rural areas. Today, a lab that fails PT loses Medicare and Medicaid approval or payments, or has its certificate suspended or limited, for at least six months in the failed specialty or analyte. Under the proposal, it could be reinstated as soon as it passes two consecutive PT events and CMS verifies compliance. Obsolete SARS-CoV-2 reporting requirements would be removed.

CMS notes that virtual access could help rural hospitals keep immunohematology testing in-house, where referral delays can affect transfusion care. The agency estimates the rule would cost labs $19.4 million to $40.7 million in the first year, mostly to update policies and procedures, then save them about $2.8 million to $149.8 million a year after that. Most of the savings come from easing lab director requirements, such as board certification, continuing education and on-site visits.

How does the proposed CLIA rule affect lab billing and claims?

Medicare checks the CLIA number on lab claims against the lab’s certificate type and the codes billed (CMS MLN Matters MM13620). Commercial payers such as Arizona Complete Health run similar edits, so the proposed rule’s changes to certificates, personnel and reports carry into the revenue cycle. If the rule is finalized, billing teams should watch five areas:

  1. Remote work bills under the primary lab’s CLIA number. A pathologist reading digital slides from home would work under the primary lab’s certificate, and that certificate must cover the specialties and subspecialties of the remote work. Some payers exempt professional-component-only (-26) claims from CLIA edits, so this matters most for groups that bill global or technical services. Services billed outside the certificate’s scope invite denials.
  2. Remote cytology needs its own certificate. If a pathologist in your group signs out cytology or performs ROSE remotely, confirm which certificate and CLIA number apply before claims go out.
  3. Reports and claims should match. Once test reports must show the lab’s CLIA number and certificate name, auditors can compare reports against claims more easily.
  4. A qualified director protects the certificate. Claims rely on a valid certificate, and the certificate rests on a qualified director. The relaxed requirements may widen the pool of eligible directors for labs that struggled to fill the role after December 2024.
  5. Virtual access records support audits. Access logs, the CMS-209 personnel list and retained digital images document that billed services were performed and reviewed as required. Keep them in your audit file with your quality records and the documentation that supports lab claims.

What should labs do before the CLIA rule is finalized?

CMS-3478-P is still a proposal, but labs that already rely on remote review can prepare now:

  • List every person who reviews data, results or images remotely, and confirm each is on your Form CMS-209.
  • Confirm your CLIA certificate covers every specialty and subspecialty performed remotely.
  • Identify any remote cytology or ROSE work and confirm a separate CLIA certificate is in place for each of those locations.
  • Draft or update policies on secure connections and private work settings for remote staff.
  • Check whether your LIS or digital pathology system can log the reviewer, software version and device for each remote review.
  • Estimate storage for keeping digital slide images alongside glass slides. Current CLIA retention periods are 10 years for histopathology slides and 5 years for cytology slides.
  • Check that your test reports show your CLIA number and certificate name exactly as they appear on claims.
  • Review director qualifications against the proposed requirements, especially if you have had trouble filling the role.

How do you comment on the proposed CLIA rule?

Comments on CMS-3478-P are due Dec. 7, 2026. Submit them at regulations.gov under docket CMS-2026-3235 and reference file code CMS-3478-P. Mail options are listed in the proposed rule. CMS has asked specifically for comments on the virtual access provisions, so labs can point out where the requirements would help their operations and where they would add cost.

Get help preparing your lab billing for CLIA changes

PGM has managed laboratory billing since 1981. If you have questions about how the proposed CLIA changes could affect your certificates, claims or reimbursement, contact the PGM team or learn more about our laboratory billing services.

This post summarizes a proposed rule. Requirements may change before the rule is finalized, and nothing here is legal advice.

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Frequently Asked Questions About the Proposed CLIA Virtual Access Rule

Is the proposed CLIA virtual access rule in effect now?

No. CMS-3478-P is a proposed rule. Its provisions take effect only if CMS publishes a final rule, which would set its own effective date and may differ from the proposal. Until then, labs follow the current CLIA regulations and CMS guidance, including the enforcement discretion in memos QSO-23-15-CLIA and QSO-25-21-CLIA.

Can pathologists review surgical pathology cell blocks remotely without a separate CLIA certificate?

Generally, yes. According to the College of American Pathologists, CMS has indicated that a pathologist may review surgical pathology cell blocks remotely without a separate CLIA certificate when the laboratory director directs it.

Do the proposed personnel changes apply to labs with a Certificate of Waiver?

No. Labs operating under a Certificate of Waiver have no CLIA personnel qualification requirements beyond following manufacturer instructions.

What happens if a lab reviews cytology images remotely without a separate certificate?

CMS guidance holds the primary lab director responsible for all testing under the primary lab’s certificate, including remote work, and cites survey findings and enforcement actions against that certificate. Remote cytology review at a location without its own certificate falls outside what the primary certificate covers, which exposes the primary certificate and the claims billed under it.