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Summer 2025 Edition
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LAByrinth
Billing, Operational, and Staffing News for Laboratories
Presented by ADSRCM and ADS, leading providers of outsourced or in-house revenue cycle management, finance, and operations for every type of laboratory
Message From Jim:
If you’re a regular reader/subscriber, you know my monthly message is usually related to laboratory management or an interesting piece of industry news.
This month I was reflecting on meeting with so many laboratorians at the recent War College Conference and how my teammates and I were asked about what approach would be best. Should a particular laboratory outsource its laboratory billing and staffing, or use in-laboratory automation?
Our answer has always been and will always be the same: we don’t know, but we can find out! Sometimes it’s outsourcing, sometimes it’s using your own in-laboratory system. The good news is that ADSRCM and ADS can help with both. ADSRCM utilizes the MedicsPremier financial and management system, which is the same system available from ADS as an in-laboratory platform.
So, while this space has always been about the industry, this month it’s unabashedly about us and how we can help in ways that work best for you!
If you’re attending the 2025 AMP Conference in Boston, please see us at booth 946. Or, don’t wait until November! Contact us for a no-spin, unbiased assessment because we can help with both. 800-899-4237, Ext. 2264 or info@adsc.com.
And now…the news!
Updated: Complaint Procedures for Laboratories
If you thought the first four chapters of the State Operations Manual (SOM) were exciting, then Chapter 5 may push you over the top, because it’s been revised by CMS.
The major bullet points include:
- subsections are now included for “laboratories with Certificates of Compliance, Certificates of Registration, and temporary testing sites”
- state agencies and CMS now have 10 business days to send labs Form CMS-2567 and three business days to look into IJ complaints; three business days are allowed for State Agencies and CMS to “send Form CMS-2567 to laboratories with immediate jeopardy findings” and perform “an on-site revisit survey before imposing principal sanctions”
- instructions for looking into transfusion-related fatalities (TRF) are now included.
Speaking of SOM, their Appendix C also Updated
CMS has also announced updates to the State Operations Manual (SOM), Appendix C – Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services (Clinical Laboratory Improvement Amendments (CLIA).
Major revisions include:
- Chapter 6 surgery procedures have been omitted.
- Guidelines and “new and revised D-tags for the regulations finalized in the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing – Analytes and Acceptable Performance Final Rule (CMS-3355-F) and Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees, Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories Final Rule (CMS-3326-F)” are included.
- Details are included from past QSOs and memos.
- The addition of “approved HHS training program for neuromuscular pathology.”
- Comments from stakeholders were considered and included.
- Omitting certain guidelines from the Appendix C advance copy.
- “Correcting clerical errors” from the Appendix C advance copy.
Note that these are expired: Memos: S&C: 17-11-CLIA, S&C: 16-02-CLIA, and S&C: 15-17-CLIA.
The Wide World of Labs, or the CAP’s LAP
Many laboratories worldwide still face barriers to delivering consistent, high-quality results.
Enter the hero in the form of the College of American Pathologists (CAP), which is working with hospitals to improve lab performance through its Laboratory Accreditation Program (LAP). Dare we say it’s the CAP’s LAP?
In any case, CAP partners with laboratories in developing countries to increase quality and safety by helping those laboratories to meet internationally recognized standards, ensuring that test results are accurate, consistent, and useful for making the right medical decisions.
Essentially, through training, grants, and educational access, the CAP Foundation puts tools in the hands of pathologists in under-resourced regions of the world to strengthen diagnostics and support better outcomes, all by way of CAP’s grant and awards programs and webinars.
Prior Authorizations and Insurers’ Commitments for Reform
In response to commitments by insurers to reform prior authorizations (PAs), the American Society for Radiation Oncology has issued a letter to CMS reminding that solid actions need to be taken beyond just speaking the words that everyone wants to hear.
At the very least, PAs are on the correct agencies’ radars. Hopefully action will be taken to actually make improvements.
(Until that happens, ADSRCM’s automated option makes it easy to get PAs. It might even be needed after any reforms are put into place.)
The CDC’s and ACIP’s Joint Statement on Immunizations
The Centers for Disease Control and the Advisory Committee on Immunizations Practices have issued a joint statement on some key decisions made at their end-of-June meeting:
- ACIP voted in favor of (5-2), a single dose of clesrevumab to protect infants from respiratory syncytial virus (RSV).
- ACIP unanimously voted in favor of (7-0) “the updated Vaccines for Children Program resolution for prevention of RSV.”
- ACIP unanimously voted in favor of (6-0) the annual vaccine for influenza for individuals “aged over six months who do not have contraindications.”
- ACIP voted in favor of (5-1) one dose of seasonal flu vaccines “that are free of thimerosal as a preservative” for those under 18, pregnant women, and all adults.
As of this writing, these items are being reviewed by the CDC. It is presumed that more information will be made available after those reviews.
The CDC’s and ACIP’s Joint Statement on Immunizations
The Centers for Disease Control and the Advisory Committee on Immunizations Practices have issued a joint statement on some key decisions made at their end-of-June meeting:
- ACIP voted in favor of (5-2), a single dose of clesrevumab to protect infants from respiratory syncytial virus (RSV).
- ACIP unanimously voted in favor of (7-0) “the updated Vaccines for Children Program resolution for prevention of RSV.”
- ACIP unanimously voted in favor of (6-0) the annual vaccine for influenza for individuals “aged over six months who do not have contraindications.”
- ACIP voted in favor of (5-1) one dose of seasonal flu vaccines “that are free of thimerosal as a preservative” for those under 18, pregnant women, and all adults.
As of this writing, these items are being reviewed by the CDC. It is presumed that more information will be made available after those reviews.
Laboratory Fraud of the Month
A laboratory owner in Chicago has been sentenced to seven years and was ordered to pay over $14 million in restitution, as well as forfeit almost $7 million in cash and assets.
It stemmed from a COVID-19 scheme in which tests were billed but not performed at all, or not performed correctly. Tests were diluted to save costs, rendering those tests unreliable. It was stated that the laboratory owner also lied to help conceal the fraud.
Laboratory Staffing Issues Continue
According to a recent Harris Poll, 39% of laboratory professionals and stakeholders identified limited staffing as one of their top concerns. The survey revealed that national laboratory vacancy rates range from 7% to 11%, but regionally, they can reach as high as 25%.
Statistics included the number of over 14 billion laboratory tests performed in the US annually, and with 338,000 laboratory professionals working now, it works out to one laboratory professional for every 1,000 persons in the US.
The survey suggests that automation can be leveraged more effectively in several ways to support staffing shortages.
(ADSRCM and our behind-the-scenes outsourced team can help alleviate your laboratory’s administrative and “back of the house” staffing issues by performing time-consuming tasks such as eligibility verifications, denial prevention/management, EOB reconciliations, claim tracking, analytics, patient statements, and with patients calling us when they have statement questions, and more. ADS clients who prefer to use the MedicsPremier platform for in-laboratory automation can benefit administratively as well.)
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Next Up:
August, with new articles and items of interest for laboratories!
If you’re attending November’s AMP Conference in Boston, please see us at booth 946!
With outsourced services from ADSRCM, you can maximize your laboratory's revenue and productivity. If you prefer in-laboratory automation, the MedicsPremier platform from ADS can be deployed! Contact us at 844-599-6881 or email rcminfo@adsc.com for more information, and about the ADSRCM guarantee to increase your revenue in 90 days.
We strive to provide our newsletters with news of the current month, not the previous month. Feedback or comments on our newsletters/content are greatly appreciated. Please opine by emailing marc.klar@adsc.com or by calling me at 973-931-7516. We’d love to hear from you!
Marc E. Klar, Vice President, Marketing, ADSRCM.
Disclaimer: Articles and content about governmental information, such as CMS, Medicare, and Medicaid, are presented according to our best understanding. Please visit www.cms.gov if clarifications are needed. We are not responsible for typographical errors or changes that may have occurred after this newsletter was produced. Visit www.adsc.com to view our most up-to-date information. We don’t endorse any companies or organizations mentioned in our newsletters; you are encouraged to do research and due diligence on any that might interest you.
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Disclaimer: Articles and content about governmental information, such as CMS, Medicare, and Medicaid, are presented according to our best understanding. Please visit www.cms.gov if clarifications are needed. We are not responsible for typographical errors or changes that may have occurred after this newsletter was produced. We don’t endorse any companies or organizations mentioned in our newsletters; you are encouraged to do research and due diligence on any that might interest you.