Laboratory Economics Blog
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Next-Gen Sequencing Database
Laboratory Economics is offering a database of all 149 independent labs, 181 hospitals and 8 pathologists and other providers that perform Next-Gen Sequencing for 31 CPT and PLA procedure codes (e.g., 81432, 81433, 81435, 81437, 81450, etc.). The database includes...
Is Alzheimer’s Testing the Next Big Lab Market?
The FDA cleared the Alzheimer’s drug Leqembi (lecanemab) in July 2023. The drug marked the first treatment for slowing Alzheimer’s progression and cognitive decline to make it through the agency’s traditional pathway. But Leqembi, which was developed by Eisai (Tokyo)...
How to Keep Your Existing LDTs on the Market
Labs have some tough decisions to make now that the FDA has issued a final rule giving it authority to regulate LDTs. Labs offering LDTs prior to publication of the final rule on May 6 have three choices: 1) comply with the new FDA regs and keep their LDTs on inhouse...
March 2024 CLIA Database
Laboratory Economics is offering a database of over 318,000 Clinical Lab Improvement Amendments (CLIA) certified laboratory facilities. The database is freshly updated as of March 31, 2024 and includes more than 8,000 independent labs, 122,000 physician-office labs,...
FDA Finalizes LDT Regulation; Partial “Grandfather” Exemptions for Existing LDTs
Although less severe than the FDA’s initial proposed regulations, the Final Rule (published May 6) will add a new complex layer of bureaucracy for labs offering laboratory-developed tests (LDTs). LDTs on the market prior to May 6 will not have to go through the full...
Google Releases AI Tool for Pathology
Google has released a free cloud-based tool (“Path Foundation”) that transforms digitized slide images into numerical data that researchers can use to create AI tools for pathology. “This is a landmark for us,” says David Steiner, MD, PhD, Clinical Research Scientist...
FDA Final LDT Rule Could be Published Soon
On March 1, the FDA submitted its final rule for LDT regulation to the White House’s Office of Information and Regulatory Affairs (OIRA). This is a perfunctory last step before the final rule is publishedin the Federal Register. This could occur as soon as April 1....
New Market Research Report on U.S. Clinical Laboratory Market
Laboratory Economics has just released The U.S. Clinical Laboratory Industry Forecast & Trends 2023-2025. With this special report, you can tap into 100+ pages of proprietary market research that reveals critical data and information about key business trends...
FDA Won’t Extend Comment Period on LDT Regs
The FDA has announced that its standard 60-day comment period for its proposed regulation of laboratory-developed test (LDTs) will not be extended past December 4. Several trade groups, including CAP and ACLA, had requested to stretch the comment period to 120 days....
Pathologist Job Openings Remain Near Record-High
The biggest online job board for pathologists, PathologyOutlines.com, currently has 705 pathologist jobs listed. That’s near the site’s all-time record of 706 pathologist job ads reached in February 2022. Prior to 2020, the average number of job openings was between...
Walgreens to Pay $44 Million to Theranos Customers
Walgreens Boots Alliance (Deerfield, IL) has agreed to a $44 million settlement to resolve class-action claims related to its partnership with Theranos. The proposed settlement, which needs court approval, will provide consumers who participated in the lawsuit with...
Labcorp to Buy Tufts Outreach Lab Assets
Tufts Medicine (Boston, MA) is selling its clinical lab outreach business to Labcorp for an undisclosed amount. The transaction, whichdoes not involve anatomic pathology services, is expected to formallyclose in October. Tufts says the sale is the first step towards a...
CAP Has “Serious Concerns” with UnitedHealthcare’s Z-Code Rollout
The College of American Pathologists (CAP) has sent a letter to Optum requesting a meeting to discuss its partnership with Palmetto GBA and UnitedHealthcare’s new Z-code requirement. CAP and Optum are in the process of scheduling the meeting, says Jonathan Myles,...
Hospital Labs Expanding PCR-Based Test Menus
PCR-based testing for gastrointestinal profiles, gonorrhea/ chlamydia, bacterial vaginosis panels, and herpes simplex virus (HSV) are the tests that most hospital labs plan to add to their test menus within the next 12 months, according to LE’s Hospital Laboratory...
MACs Back Off Proposed Toxicology Cuts
Six Medicare Administrative Contractors (MACs) have retired proposed Local Coverage Determinations (LCDs) that would have limited reimbursement for definitive drug testing to no more than 14 drug classes. The proposed LCDs would have resulted in effective Medicare...
Versant Diagnostics and In-Office Pathology Team Up
Versant Diagnostics (Grapevine, TX) has signed an agreement with In-Office Pathology LLC (Nantucket, MA). Versant will offer professional pathology services to IOP’s network of in-office labs, and IOP will build histology labs at select Versant Diagnostics specialty...
PathAI Announces 13 Lab Contracts for Its AI Tools
ePathAI (Boston, MA) has won contracts with 13 lab organizations that will be using its FDA-cleared AISight digital pathology image management and viewer analysis system. These new clients will also be using PathAI’s software algorithm AIM-PD-L1 NSCLC RUO, which...
Aegis Sciences Leads In Toxicology Testing
Aegis Sciences Corp. operates the nation’s largest toxicology lab as measured by Medicare Part B carrier allowed payments for calendar year 2020 (the latest available data). Aegis received Medicare payments totaling $32.4 million for 214,348 test services for five key...
Spotlight Interview with Proscia’s Nathan Buchbinder
Proscia Inc. (Philadelphia, PA) markets a digital pathology software platform (Concentriq) that helps upload, organize into patient cases, annotate, and store whole slide images. Concentriq is currently being used by more than 6,000 scientists and pathologists at 300+...
Quest To Buy Outreach Lab In Maine
Quest Diagnostics has agreed to acquire certain outreach lab assets fromNorthern Light Health (Brewer, ME), an integrated healthcare system,in an all-cash transaction. In addition, Quest will manage nine of NorthernLight Health’s inpatient hospital labs, along with...
Did Digital Pathology Utilization Increase During The Pandemic?
The conventional wisdom says that digital pathology use surged as a result of the pandemic. However, Medicare data for CPT 88361 (computer-assisted IHC for breast cancer) tells a different story. The volume of Medicare Part B allowed claims for 88361 declined by 16%...
New Research Report on U.S. Anatomic Pathology Market
Laboratory Economics has just released The U.S. Anatomic Pathology Market: Forecast & Trends 2022-2024. With this special report, you can tap into 150 pages of proprietary market research that reveals critical data and information about key business trends...
Quest To Acquire Summa Health’s Outreach Lab Business
Quest Diagnostics (Secaucus, NJ) has agreed to acquire select assets of Summa Health’s (Akron, OH) clinical lab outreach business, which does business as LabCare Plus, in an all-cash transaction. Summa picked Quest as a buyer after a competitive bid. The purchase...
Labcorp Completes Outreach Lab Deal With RWJBarnabas Health
Labcorp has completed its acquisition of RWJBarnabas Health’s outreach laboratory business and select related assets (see LE, August 2022). RWJBarnabas Health (West Orange, NJ), which has 12 acute-care hospitals with 4,357 staffed beds, is New Jersey’s largest...
Monkeypox Cases May Be Vastly Undercounted
Based on CDC case counts, the current monkeypox outbreak in the U.S. doesn’t look that bad. As of August 10, the CDC reports a total of 11,177 Monkeypox cases had been recorded since the initial case was identified in Massachusetts on May 18, 2022. However, the...
AMA Announces New Add-On Digital Pathology Codes
The American Medical Association (AMA) CPT Editorial Panel hasannounced 13 new digital pathology add-on codes effective on January1, 2023. The new digital pathology Category III CPT codes will be usedto report additional clinical staff work and service requirements...
California Lab Owners Indicted For $214 Million Medicare Test Fraud
The U.S. Department of Justice has indicted Imran Shams and Lourdes Navarro, both 63 and owners of Matias Clinical Laboratory (Baldwin Park, CA), for their alleged roles in a $214 million Medicare billing fraud scheme. The DOJ says that the married couple arranged for...
MT Salaries Skyrocket As Labs Struggle To Find MTs
Today, laboratories are offering salaries and sign-on bonuses to medical technologists (MTs) that have never been seen before. In the San Francisco Bay Area and San Diego, lab clients are paying salaries as high as $150,000 and $180,000 to attract staff MTs with...
Castle Biosciences To Buy AltheaDx For Up To $140 Million
Castle Biosciences (Friendswood, TX) has agreed to acquire AltheaDx (San Diego, CA) for $65 million in initial consideration consisting of $32.5 million in cash plus $32.5 million in stock. In addition, Castle could pay up to $75 million more in cash and stock if...
Biopsy Client Database for Pathologists
Laboratory Economics is offering a database of 50,000+ specialty physicians and ambulatory surgery centers that perform biopsies that lead to pathology referrals. The database includes annual Medicare Part B biopsy volumes for 2019 plus estimated overall biopsy...
Quest Diagnostics Pays $85 Million For Labtech
The latest 10K annual report from Quest Diagnostics revealed that the company paid $85 million for its acquisition of Labtech Diagnostics (Anderson, SC). The deal, which closed on December 13, 2021, included cash consideration of $80 million and contingent...
Labcorp Completes Acquisition of PGDx
Labcorp completed its previously announced (see LE, January 2022) acquisition of Personal Genome Diagnostics Inc. (PGDx-Baltimore, MD) on February 18. PGDx markets an FDA-cleared comprehensive tumor profiling test, PGDx ELIO tissue complete, that is covered by...
PathGroup Acquires Pathology Consultants in South Carolina
PathGroup (Brentwood, TN) acquired Pathology Consultants Inc. (PCI-Greenville, SC) for an undisclosed sum in January. PCI operates a CAP-accredited pathology lab in Greenville, South Carolina. It has approximately 100 employees, including 31 pathologists. PCI’s...
BioReference Labs Goes Live With Digital Pathology Plus AI
OPKO’s BioReference Labs (Elmwood Park, NJ) went live in December with new whole-slide imaging scanners from Leica Biosciences (Buffalo Grove, IL). The scanners have been integrated with a digital pathology solution, PathFlow, made by Gestalt Diagnostics (Spokane,...
CDx Diagnostics Leads In Digital Pathology
CDx Diagnostics (Suffern, NY), which specializes in oral, esophageal, and laryngeal cancer testing, is by far the biggest digital pathology lab as measured by volume of Part B claims for CPT 88361. CDx was paid for 55,082 Part B tests for CPT 88361 (including combined...
Exact Sciences Acquires PreventionGenetics For $190 Million
Exact Sciences (Madison, WI) paid $190 million, including 50% in Exact common stock and 50% in cash, for PreventionGenetics (Marshfield, WI) in early January. PreventionGenetics operates a CLIA-certified lab that performs proprietary next-gen sequencing tests,...
Labcorp To Buy PGDx For $575 Million
Labcorp (Burlington, NC) has agreed to acquire Personal Genome Diagnostics Inc. (PGDx-Baltimore, MD) for $450 million in cash at closing plus up to an additional $125 million based on future performance milestones. The transaction is expected to close in the first...
Progenity Sells Lab Business To Northwest Pathology
Progenity Inc. (San Diego, CA) has sold its lab business, Avero Diagnostics (Irving, TX), to Northwest Pathology (Bellingham, WA) for $10.9 million in cash. The sale of Avero Diagnostics is expected to reduce Progenity’s annual operating expenses by approximately $28...
Sonic Buys ProPath
Sonic Healthcare (Sonic) acquired 100% of ProPath Services (Dallas, TX) for an undisclosed price on December 17, 2021. ProPath had been one of the largest pathologist-owned anatomic pathology labs in the nation. ProPath’s annual revenue is approximately $110 million....
Toxicology Labs Average $475 Per Medicare Patient
.The top 25 independent toxicology lab companies received an average of $475 of revenue per Medicare patient they served in 2019, according to data analyzed by Laboratory Economics from the Medicare Part B program. The biggest toxicology lab in the country is Aegis...
Arkansas Lab Owner Indicted in $100 Million Billing Fraud
A federal grand jury in the Western District of Arkansas has indicted Billy Joe Taylor, age 42, for an alleged scheme that billed Medicare for over $100 million dollars in fraudulent lab test claims between February 2017 and May 2021. Taylor is the owner of several...
MD Labs To Pay Up To $16 Million To Resolve Fraudulent Billing Allegations
Nevada-based MD Spine Solutions (doing business as MD Labs) and its two owners have agreed to pay up to $16 million to settle allegations that MD Labs submitted false claims to Medicare and Medicaid, according to the U.S. Department of Justice. The co-owners, Denis...
Enzo Biochem Hires New CEO; Investors Push For More Change
Hamid Erfanian, age 52, has become Chief Executive Officer Enzo Biochem (New York City) effective November 8. Erfanian was most recently Chief Commercial Officer of Euroimmun, an IVD manufacturer owned by PerkinElmer (Waltham, MA). Former CEO Elazar Rabbani, PhD, age...
ARUP And Quest Raise Minimum Hourly Wage To $15
ARUP Laboratories (Salt Lake City, UT) says that it will increase its minimum hourly wage to $15 effective November 27. All new hires and approximately 600 employees who currently earn less than the new minimum will be paid $15 per hour or more. In addition, about...
Khani To Step Down As ACLA President
The American Clinical Laboratory Assn. (Washington, DC) has announced that Julie Khani is resigning as President effective November 26. Khani, who has been ACLA President since January 1, 2017, has accepted a position as Vice President of Government Affairs at Hologic...
NYSCLA Meeting Highlights:
PAMA, Pandemic Response, Shortages & AI
Following cancellation last year due to the pandemic, the New York State Clinical Laboratory Association (NYSCLA) held this year’s annual meeting in a well-spaced conference room in Albany, October 6-7. Approximately 125 lab directors, managers, pathologists and...
Ibex To Focus On U.S. Market For AI-Assisted Pathology
Ibex Medical Analytics (Tel Aviv, Israel and Boston, MA) has hired Douglas Clark, MD, as its Chief Medical Officer, Americas. Ibex also announced that Joseph Mossel, its co-founder and CEO, is relocating to the United States to lead the company’s expansion in North...
Tips For Negotiating Your Lab’s Next Reference Testing Contract
Reference (aka send-out) testing expenses average between 5% and 10% of the overall budget at most hospital laboratory departments. “Everybody thinks they are getting a good deal, but most have not wrung out the lowest prices available from their reference lab,” notes...
Cancer Diagnoses Declined Sharply During First Year of Pandemic
New diagnoses of eight common cancers (prostate, breast, colorectal, lung, pancreatic, cervical, gastric and esophageal) significantly declined during most of the first 13 months of the pandemic (March 2020-March 2021), according to a study by Quest Diagnostics...
The Pandemic Intensified Chronic Lab Worker Shortage
There are approximately 338,000 clinical laboratory technologist and technician jobs in the U.S., according to the U.S. Bureau of Labor Statistics. Hospitals account for 47% of these jobs; independent labs, 20%; physician offices, 9%; schools and universities, 6%; and...
New Law For Medi-Cal Aimed At Eliminating Retroactive Recoupments
On July 27, California Gov. Gavin Newsom signed a comprehensive health care budget trailer bill (AB 133), which prevents future retroactive reimbursement reductions and recoupments from labs and pathology groups that occur due to “a lack of timeliness in Medi-Cal...
New Lab Formations Continue To Boom
The extraordinary demand for Covid-19 PCR, antigen and antibody testing continues to fuel a record number of new CLIA-certified lab formations, according to the latest CMS data analyzed by Laboratory Economics. More than 7,000 new CLIA lab certificates were issued in...
Medical Technologist Shortages Widespread
Medical technologists (MTs) have been in chronic short supply for at least the past 20 years. In the past, labs have used sign-on bonuses ranging from $2,000 to $5,000 to attract MTs. Last month, Laboratory Economics highlighted Alverno Laboratories (Hammond, IN) use...
Capital Digestive To Open Bigger Pathology Lab
Capital Digestive Care (Silver Spring, MD) has announced plans to relocate and expand its pathology lab to Silver Spring, Maryland. The new lab will be 21,000 square feet and is expected to open in early 2022. In addition, the new lab will become a Roche Diagnostics...
Alverno Labs To Implement Artificial Intelligence For Pathology
Alverno Laboratories (Hammond, IN), which transitioned to digital pathology in 2019 when it implemented Philips IntelliSite Pathology Solution, now says it will add artificial intelligence to aid its pathologists in cancer diagnosis. Alverno will use the Galen AI...
Fulgent Genetics Acquires CSI Laboratories For $50+ Million
Fulgent Genetics Inc. (Temple City, CA) has acquired Cytometry Specialists Inc. (Alpharetta, GA), which does business as CSI Laboratories, for $50 million in cash plus up to $10 million more in potential future milestone payments. CSI Labs was founded by its Chairman...
UnitedHealthcare Delays Lab Test Registry Protocol Indefinitely
After several postponements, UnitedHealthcare (UHC) announced on July 1 that it would delay implementing its planned clinical and pathology Laboratory Test Registry Protocol until further notice. UHC’s Laboratory Test Registry Protocol would have required in-network,...
Spotlight Interview With Paige CEO Leo Grady
Paige (New York, NY) was founded by pathologists and scientists from Memorial Sloan Kettering Cancer Center in 2017. Paige develops artificial intelligence (AI)-based systems that help diagnose cancer. In early 2019, thecompany hired Leo Grady, PhD, as Chief Executive...
XIFIN To Open East Coast Office, Expand Into Radiology Billing
The revenue cycle management firm XIFIN Inc. (San Diego, CA) is opening a new 32,500-square-foot office in Charleston, South Carolina. The new office is slated to open in early August. XIFIN plans to hire over 150 positions in South Carolina over the next two years,...
Alverno Labs Offering Up To $10K Hiring Bonus For MT/MLTs
Alverno Laboratories (Hammond, IN) is offering big sign-on bonuses as it tries to fill hundreds of open jobs. Alverno employs roughly 2,116 people and has about 288 openings, including 29 positions at multiple locations for midnight medical technologist (MT) and...