Government Seeks Input on 1988 Lab Rules Upgrade
Published Date: 7/16/2026
Proposed Rule
Summary
The government wants your thoughts on updating lab testing rules from 1988 to keep up with new technology and safety needs. This affects labs doing medical tests, especially around breath tests, emergency plans, and cybersecurity. Share your ideas by September 14, 2026, so they can decide if and how to improve the rules—no money changes yet, just gathering info!
Analyzed Economic Effects
14 provisions identified: 2 benefits, 0 costs, 12 mixed.
Emergency Preparedness for Independent Labs
Following a 2025 OIG report, CMS and CDC are seeking comments on whether CLIA should require independent laboratories that participate in Medicare to have emergency preparedness plans so Medicare enrollees retain access to diagnostic testing during future public health emergencies. Comments due September 14, 2026.
Laboratory Cybersecurity Practices
CMS and CDC request information on cybersecurity policies labs use to protect patient data and lab operations, including identity/access verification, foreign access, IP/port restrictions, incident response plans, responsible job positions, and training. They seek challenges faced; comments due September 14, 2026.
Breath Testing Under CLIA
CMS and CDC are asking whether breath tests used in clinical care (for examples cited: COVID-19, cancer diagnosis, microbial ID, gastrointestinal disorders) fall under CLIA rules. They want examples of what breath tests, technologies, and facility types perform them and how specimens are collected, transported, and stored. Submit comments by September 14, 2026.
Pathology Block Retention (2-Year Rule)
Current CLIA rule (42 CFR 493.1105(a)(7)(ii)) requires pathology specimen blocks be kept for at least 2 years. CMS and CDC seek input on requests for additional testing on blocks older than 2 years and how often labs receive such requests. Comments are due by September 14, 2026.
Preanalytic Specimen Prep and Staff Qualifications
CMS and CDC request information on what activities count as specimen preparation (e.g., centrifuging, aliquoting, DNA/RNA extraction), and on the education, training, and competency verification of personnel who perform those tasks. They seek details on existing training and how labs ensure ongoing competence; comments due September 14, 2026.
Performance Specs for Non‑FDA Tests
CLIA (Sec. 493.1253) requires verification of FDA‑cleared tests and establishment of performance specs for non‑FDA‑cleared tests or modifications. CMS and CDC seek information on challenges labs face when establishing those specifications, including for methods like toxicology and next‑generation sequencing (NGS). Comments due September 14, 2026.
AI and Software in Test Interpretation
CMS and CDC request input on how laboratories use software algorithms and AI tools in postanalytic interpretation (e.g., NGS, histopathology, pharmacogenomics), how labs verify software performance, and whether CLIA should address cloud analytics, automation, or AI. Comments must be submitted by September 14, 2026.
Data‑Only Facilities and CLIA Coverage
CMS and CDC seek comments on whether facilities that only process analytical data or provide specialized data interpretation (including some medical device software manufacturers) qualify as ‘laboratories’ under CLIA and therefore require CLIA certification. They ask what activities these data‑only facilities perform. Deadline for comments: September 14, 2026.
Biosafety and Biosecurity Protocols
CMS and CDC seek public comments on biosafety and biosecurity protocols, risk assessments, and training for laboratory personnel handling infectious materials, drawing on CDC guidance used during the COVID-19 public health emergency. Respondents should describe challenges, best practices, and training approaches; comments due September 14, 2026.
Updating CLIA Specialties and Subspecialties
CMS and CDC are asking whether existing CLIA specialty and subspecialty categories (examples mentioned: Mohs testing, andrology, molecular testing) should be revised or expanded to reflect current testing practices. They request evidence-based rationale related to safety, complexity, and public health; comments due September 14, 2026.
Cytogenetics, Immunohematology, Microbiology Focus
CMS and CDC seek comments on technical advances and challenges in clinical cytogenetics, immunohematology (including electronic crossmatching and quality assurance), and microbiology (including blood culture contamination monitoring). CLIAC has recommended BCC monitoring be added to quality management considerations. Comments due September 14, 2026.
Handling Suboptimal Specimens
CMS and CDC ask how laboratories handle specimens that arrive in suboptimal condition, including when labs test them, how often, how results are documented and reported, and how labs communicate with ordering providers. They seek practices and challenges; comments due by September 14, 2026.
Calibration Verification for Factory‑Calibrated Devices
Sec. 493.1255 requires calibration verification for nonwaived testing, and CMS/CDC have received inquiries about factory‑calibrated, non‑adjustable instruments (closed systems/cartridge analyzers). They seek comments on technical and operational challenges laboratories face when performing calibration verification on such devices. Comments due September 14, 2026.
Remote Competency Assessment for Lab Staff
CMS and CDC request evidence and experience on using remote direct observation technology (smartphones, tablets, VR, dedicated video) to assess laboratory personnel competency. CLIAC recommended allowing remote assessment, especially to help rural facilities; comments due September 14, 2026.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-15652, Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2027 and Updates to the IRF Quality Reporting Program
This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2027. As required by statute, this final rule includes the classification and weighting factors for the IRF prospective payment system's (PPS) case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2027. It also finalizes the third and final of the 3-year phaseout of the rural adjustment, which began in FY 2025. This final rule includes a solicitation for public comments on alternative data sources for the IRF PPS wage index; requires all therapy treatments and/or therapy evaluations to begin no later than 36 hours from midnight on the day of admission; finalizes requirements for the initial Interdisciplinary Team meeting to occur on or before 4 days from the date the patient is admitted; and summarizes a request for information on potential future IRF PPS payment reform. Additionally, this final rule includes updates to the IRF Quality Reporting Program and changes to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program.
2026-15686, Medicare Program; FY 2027 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements
This final rule updates the hospice wage index, payment rates, and aggregate cap amount for fiscal year 2027. This final rule also includes an analysis of Medicare non-hospice spending, including details regarding a hospice service and spending variation index, and finalizes the requirement that hospices provide the hospice election statement addendum to all Medicare beneficiaries at the time of hospice election. Additionally, this rule finalizes conforming changes to discharge from hospice care regulations and changes to the face-to-face encounter regulations. This final rule also includes a summary of comments received on our requests for information regarding community- based palliative care; the construction of a hospice specific wage index; and the overlap between hospice and medical aid in dying laws. Finally, this rule finalizes changes to the Hospice Quality Reporting Program.
2026-15562, Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program for Federal Fiscal Year 2027
Starting October 1, 2026, skilled nursing facilities (SNFs) will see updated payment rates and new rules for how Medicare pays them. The Quality Reporting and Value-Based Purchasing programs are also getting tweaks to help improve care. These changes affect SNFs nationwide and could impact how much money they get and how they report quality data.
2026-14897, Medicaid Program; Amending the Indirect Hold Harmless Threshold of Health Care-Related Taxes
Starting October 1, 2026, new rules will change how states handle health care-related taxes under Medicaid. These changes set clear limits on tax amounts based on 2025 levels and will gradually lower those limits in some states by 2027. States and taxpayers should get ready for tighter rules and better oversight that could affect tax collections and Medicaid funding.
2026-14709, Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2027; and Basic Health Program; Correction
This correction fixes some typos and technical mistakes in the 2027 health insurance rules under the Affordable Care Act. It mainly affects people and organizations involved in health coverage plans by clarifying when the rules take effect and restoring some important regulation details. These fixes take effect on July 20, 2026, ensuring smoother and clearer health plan operations next year.
2026-14327, Medicare and Medicaid Programs; CY 2027 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program
Starting in 2027, Medicare and Medicaid are updating how doctors and clinics get paid to better match today’s medical care and laws. This includes new rules for drug price rebates, shared savings programs, and payments for rural and specialty care. These changes affect doctors, patients, and drug makers, aiming to save money and improve care quality.
Previous / Next Documents
Previous: 2026-14341, Modernizing Reactor Licensing, Safety Oversight, and Siting Practices
The Nuclear Regulatory Commission is updating the rules for how nuclear reactors get licensed, checked for safety, and where they can be built. These changes will make the process faster and clearer, helping new clean energy get on the grid sooner. If you want to share your thoughts, you have until August 31, 2026, to comment—this could also save money by cutting red tape!
Next: 2026-14450, Endangered and Threatened Wildlife and Plants; Grizzly Bear Listing on the List of Endangered and Threatened Wildlife With a Revised Section 4(d) Rule; Proposed Revision of the Protective Regulations Under Section 4(d)
The U.S. Fish and Wildlife Service is updating the rules that protect grizzly bears in the lower 48 states and reopening the public comment period until August 17, 2026. These changes focus on how the bears are protected under the Endangered Species Act, with no new changes to the bear’s overall endangered status. This update invites everyone to share their thoughts on the new protection details before final decisions are made.