New Research Report on U.S. Anatomic Pathology Market

New Research Report on U.S. Anatomic Pathology Market

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 affecting the anatomic pathology market.

The report reveals that the U.S. anatomic pathology market represented an estimated $25.8 billion of revenue in 2022 with a long-term annual growth rate of 7-8%. Growth is being driven almost entirely by increased molecular oncology testing.

U.S. Anatomic Pathology Market

The U.S. anatomic pathology market faces unprecedented change, including the introduction of artificial intelligence tools that increase pathologist productivity, greater utilization management by private payers and persistent reimbursement pressure.

“The introduction of new higher-priced molecular oncology tests and next-generation sequencing for tumor mutation profiling should more than offset price and volume pressure on routine pathology tests,” according to Jondavid Klipp, President of Laboratory Economics.

“In addition, the introduction of AI software tools that enhance pathologist productivity has the potential to profoundly change the way pathology is practiced within the next 3-5 years.”

The report includes:

  • More than 150 charts and graphs
  • Pathology market size and growth rates
  • Detailed estimates for market subsets like uropathology,
    dermatopathology, and gastrointestinal pathology
  • In-depth analysis of the molecular oncology testing market size and growth rates
  • Medicare claims data for 60+ key pathology codes covering surgical pathology, molecular oncology, immunohistochemistry and special stains, tumor marker immunoassays, FISH testing and flow cytometry
  • Cervical cancer testing trends and pricing data
  • In-office histology lab trends
  • Detailed analysis of the emerging digital pathology & AI market
  • Results from Laboratory Economics Anatomic Pathology
    and Clinical Lab Trends Surveys from 2015 through 2021

Anatomic pathology companies highlighted include:

  • Ambry Genetics
  • Bako Diagnostics
  • Caris Life Sciences
  • CellNetix Pathology & Laboratories
  • Exact Sciences
  • Foundation Medicine
  • Fulgent Genetics
  • Guardant Health
  • Labcorp
  • Mayo Clinic Laboratories
  • Myriad Genetics
  • NeoGenomics
  • OPKO/BioReference Labs
  • PathAI/Poplar Healthcare
  • PathGroup
  • Quest Diagnostics
  • Sonic Healthcare/Aurora Diagnostics/ProPath Services

The U.S. Anatomic Pathology Market: Forecast & Trends 2022-2024 is published by Laboratory Economics, an independent market research firm focused exclusively on the business of pathology and laboratory medicine.

Quest To Acquire Summa Health’s Outreach Lab Business

Quest To Acquire Summa Health’s Outreach Lab Business

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 price has not been disclosed.

Summa Health operates four hospitals and a multi-specialty medical group with 300 physicians at 100 offices in northeast Ohio. Summa Health will continue to own and operate its hospital labs, which serve inpatient and hospital-based outpatient departments. In addition, Summa will maintain its pathology department and services.

Summa’s LabCare Plus outreach business is based at its flagship Summa Health System—Akron Campus (648 beds). LabCare Plus has 19 patient service centers in the greater Akron area. It generated $1.5 million in Medicare CLFS payments in 2021. Laboratory Economics estimates that the overall outreach business has revenue of $5-10 million per year.

Quest plans to shift the acquired outreach test volumes to its labs in Twinsburg, Ohio (22 miles north of Akron) and Pittsburgh (111 miles southeast).

The transaction is expected to close in the fourth quarter of 2022.

Labcorp Completes Outreach Lab Deal With RWJBarnabas Health

Labcorp Completes Outreach Lab Deal With RWJBarnabas Health

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 academic health system. Financial terms of the transaction were not revealed.

Clinical lab outreach testing from RWJBarnabas Health will be shifted to Labcorp’s regional laboratory in Raritan, New Jersey. Some STAT and same-day testing will be performed at select RWJBarnabas Health hospitals. Anatomic pathology services are not part of the deal and will not be affected.

In addition, any potential future reference testing relationship with RWJBarnabas Health would be independent of this transaction, according to a Labcorp spokesperson.

“This strategic business decision will provide a high-performing, streamlined outreach network to support our community,” according to John Doll, Senior Executive Vice President and Chief Operations Officer of RWJBarnabas Health. The arrangement is also expected to reduce out-of-
pocket lab costs for RWJBarnabas patients.

RWJBarnabas Health’s decision to sell its clinical lab outreach business comes as it struggles with investment losses, rising labor costs and inflation. In the six months ended June 30, 2022, RWJBarnabas Health reported a net loss of $489 million vs. a net gain of $325 million in the same period a year earlier; total revenue was up 14% to $3.651 billion.

Investment losses at RWJBarnabas Health totaled $729 million in the six months ended June 30, 2022. In addition, salaries and employee benefits increased by $264,375 or 18%; physician fees and salaries increased by $79,207 or 22%; and supplies and other expenses increased by $191,781 or 17%.

RWJBarnabas Health collected total Medicare Part B CLFS revenue of $6.3 million in full-year 2021. Laboratory Economics estimates that Medicare Part B CLFS represents 25% of the overall revenue at RWJBarnabas Health’s clinical lab outreach business (total annual revenue estimated at
$25 million).

Monkeypox Cases May Be Vastly Undercounted

Monkeypox Cases May Be Vastly Undercounted

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 official case count is misleading, according to Manoj Gandhi, MD, PhD, Senior Medical Director at Thermo Fisher Scientific. Gandhi thinks the number of unreported cases is bigger — probably much bigger — than the CDC case count suggests. “We’re just seeing the tip of the iceberg,” says Gandhi. The CDC is currently only reporting monkeypox cases on a weekly basis. The next case count will be announced on August 17.

Thermo Fisher is manufacturing reagents that labs can use to develop their own laboratory-developed Monkeypox tests to run on QuantStudio 12K Flex PCR systems. LDT testing will augment the Monkeypox testing that is being performed by labs with access to CDC-developed kits, which are in limited supply.

Currently, the CDC-developed kits for Monkeypox testing are being used by 78 public health labs and five chosen commercial labs, including Aegis Sciences, Labcorp, Mayo Clinic Labs, Quest Diagnostics and Sonic Healthcare. Total combined capacity for public health and the five commercial labs is more than 60,000 Monkeypox tests per week.

In late July, the American Medical Association (AMA) issued a CPT code (87593) for molecular diagnostic testing that detects the monkeypox virus. A Medicare reimbursement rate has not been established yet for CPT 87593 and it is currently in the MolDx program for pricing, according to Lale White, Executive Chairman and CEO at XIFIN Inc. “Labs need to know Monkeypox tests are reimbursable, so they are encouraged to test,” notes Thermo’s Gandhi.

Test samples for Monkeypox are collected by swab from a patient’s blister. People testing positive can be treated with the prescription drug tecovirimat, also called Tpoxx, which is in short supply. Most importantly, Gandhi says positive cases should isolate to prevent the spread. And family
members and close contacts should get tested.

Monkeypox is usually a self-limited disease with the symptoms lasting from 2 to 4 weeks, according to the World Health Organization. However, severe cases can occur. There have been no reported deaths from Monkeypox to date in the United States.

Mako Medical Labs (Raleigh, NC) is one of the first independent labs to offer an LDT for Monkeypox. Mako went live with Monkeypox testing on July 18 on Thermo’s QuantStudio, according to Matthew Tugwell, Director, Genomics at Mako.

Tugwell says Mako currently has the capacity to perform up to 30,000 Monkeypox tests per day. The majority of Mako’s samples for monkeypox testing are coming from STD clinics. Patients getting tested for sexually transmitted diseases like herpes and syphilis are also being tested for
Monkeypox. Positivity rates are currently averaging about 13%. So far, Tugwell says demand for Monkeypox testing has been low—probably because people are shying away from getting tested because of a perceived
stigma associated with the disease.

So far, nearly all Monkeypox cases in the United States have been among gay and bisexual men. However, Tugwell notes, “We don’t really know where this is going. It has the potential to infect anyone, regardless of gender, skin color or sexual preferences.” 

AMA Announces New Add-On Digital Pathology Codes

AMA Announces New Add-On Digital Pathology Codes

AMA Announces New Add-On Digital Pathology Codes

The American Medical Association (AMA) CPT Editorial Panel has
announced 13 new digital pathology add-on codes effective on January
1, 2023. The new digital pathology Category III CPT codes will be used
to report additional clinical staff work and service requirements associated
with digitizing glass slides for primary diagnosis.

Introduction of the codes will allow CMS to monitor the usage of digital
pathology. However, no relative value units (RVUs) or national payment
rates have been assigned to the new codes.

“It’s an important first step, but widespread use in clinical practice will
need to be demonstrated before the new codes are moved to Category I
and assigned RVUs,” notes Jonathan Myles, MD, Chair of the Council
on Government and Professional Affairs at the College of American
Pathologists (CAP).

The new digital pathology add-on codes are linked with 13 of the most commonly billed pathology procedures, including CPT 88305 (Level IV-Tissue Exam). CAP’s Myles says that the new add-on codes should only be reported when used for clinical diagnosis and not for things like archiving slides, training or validation of AI algorithms, or tumor board conferences. “It’s clear that digital pathology will be a part of the practice of pathology and lab medicine, but it has to be proven to be in widespread clinical use to gain Medicare reimbursement,” says Myles.

Assuming that digital pathology volumes prove to be significant, the very earliest that CMS could  assign RVUs and establish national payment rates for the new add-on codes would be for an effective date of January 1, 2024, notes Laboratory Economics. However, the process is more likely to take at
least a few years. In the meantime, each individual Medicare Administrative Contractor (MAC), as well as private insurers, could establish their own payment rates, but are not required to do so.

Many pathology labs in the United States are experimenting, but very few have gone fully digital, according to Michael Rivers, Vice President and Lifecycle Leader for Digital Pathology, Roche Tissue Diagnostics (Santa Clara, CA). “Digitization is a means to an end. It will allow the application
of innovative AI solutions to pathology images and ultimately integrated multi-modal analysis of patient cases combining anatomic pathology, clinical lab and gene-sequencing data,” says Rivers.

“My prediction is that if the Category III codes are converted to Category I code status, in the future Medicare could potentially reimburse the new add-on codes at roughly 3% to 5% of the global rates for related existing codes,” says Erick Lin, MD, PhD, Senior Director, Medical Affairs, PathAI (Boston, MA). Thus, the add-on code for digitizing one unit of CPT 88305 (current global rate of $72) could be reimbursed at between $2 and $4. The key is for all pathology labs to be aware of the new add-on codes, prepare systems to report, and then begin reporting the new codes effective January 1, 2023. If all clinical utilization is appropriately reported on claims, it can help facilitate Medicare’s establishment of national reimbursement rates, explains Lin.

“Although digital pathology, including usage of AI algorithms, could improve pathologist efficiency, this should not be the sole focus of reimbursement calculations. Digital pathology helps labs and pathologists expand their network of brainpower through greater access to information,
second opinions and subspecialist expertise. This ultimately could lead to optimized diagnostic decision-making and inherently leads to better patient management,” according to Esther Abels, Chief Clinical and Regulatory Officer, Visiopharm Corp. (Westminster, CO) and President of the Digital Pathology Association (Carmel, IN).