Next-Gen Sequencing Database

Next-Gen Sequencing Database

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 annual Medicare Part B test volumes and allowed payments by test code for each provider (for calendar-year 2022). The database comes in easy-to-use and searchable Excel spreadsheets.

  • The data is in a user-friendly-excel spreadsheet that includes:
    • National Provider Identifier (NPI)
    • Provider Name & Complete Address + Phone
    • Specific Annual Medicare Part B Test Volume for 31 NGS CPT Codes for all Independent Labs, Hospitals,
    • Pathologists and Other Providers (2022)
    • Specific Annual Medicare Part B Allowed Payments for 31 NGS CPT Codes for all Independent Labs, Hospitals,
    • Pathologists and Other Providers (2022)
    • Overall Annual Next-Gen Sequencing Test Volume and Revenue Estimates for each Provider (2023)

 

  • Provide your sales rep with the data they need to succeed!
    • Data for all 50 states and Puerto Rico
    • Find NGS labs, hospitals and pathologists who can become your clients
    • Locate new NGS lab clients to grow your sales
    • Create targeted lists by location or specialty to focus on your best opportunities
    • Identify underserved markets for geographic expansion
    • Save time and money by using accurate, complete and consistent data

Is Alzheimer’s Testing the Next Big Lab Market?

Is Alzheimer’s Testing the Next Big Lab Market?

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) and Biogen (Cambridge, MA), has fallen far short of its goals for patient prescriptions. That’s partly because the current methods for diagnosing Alzheimer’s—ex- pensive brain imaging scans and invasive cerebral spinal fluid (CSF) tests— are acting as bottlenecks. However, new blood tests for Alzheimer’s are
being introduced that could give more patients access to treatment.

An estimated 6.9 million Americans aged 65 and older are currently living with Alzheimer’s disease, according to the Alzheimer’s Association (Chicago, IL). And an estimated 500,000 new cases of Alzheimer’s will be diagnosed this year. The new Alzheimer’s treatment Leqembi has a list price of $26,500 per year.

In addition, the FDA recently cleared Eli Lilly’s Alzheimer’s drug Kisunla (donanemab), which has a list price of $32,000 per year. Both drugs are intravenous infusions that attack a protein (amyloid) that clumps into plaques in the brains of people with Alzheimer’s. Both drugs slow disease progression (e.g., memory loss or other cognitive problems) but do not stop or reverse it. In addition, at least nine pharmaceutical companies have clinical trials underway for new Alzheimer’s drugs. Those in late-stage trials for oral pill treatments include BioVie (NE3107) and AB Science (masitinib).

But these drugs rely on PET scans and CSF tests to identify Alzheimer’s patients for treatment. “The availability of more affordable and minimally invasive diagnostic tools will help support broad access for the management of Alzheimer’s disease,” according to Eisai’s global Alzheimer’s disease officer, Keisuke Naito.

New blood-based immunoassays that identify the proteins associated with Alzheimer’s are likely to become the new standard for screening and monitoring the disease. The potential lab market could reach $500+ million per year. This estimate assumes 4 blood tests to identify and monitor each of the 500,000 new cases of Alzheimer’s each year at an average reimbursement of $260 per test (for two protein markers per test).

At the June 25th Annual CLFS Meeting with CMS to address rate setting for new codes, ACLA requested a Medicare rate of $130 per Alzheimer’s protein marker. Thus, a two-protein test (e.g., pTau181 & Abeta42) would be reimbursed $260. This level of reimbursement would match the Medicare rate of $260 for Fujirebio’s FDA-cleared Lumipulse test. Coding and final rates will be announced by CMS later this year for an effective date of January 1, 2025.

There are currently at least six Alzheimer’s lab tests on the market (see table). In addition, Danaher’s Beckman Coulter is developing a blood test for its immunoassay analyzers. Beckman is expected to release a two-protein test (pTau217 & Abeta42) in RUO format later this year. Clinical data from the RUO test will be used to support an eventual FDA application.

How to Keep Your Existing LDTs on the Market

How to Keep Your Existing LDTs on the Market

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 test menus; 2) switch to an FDA-cleared test kit (if available); or 3) ignore the FDA regs and risk potential enforcement actions and fines. For expert advice on option 1 from regulatory attorney Christine Bump.

Christine Bump, a regulatory attorney at Penn Avenue Law & Policy (Washington, DC), has been guiding laboratories and test manufacturers through the FDA’s premarket clearance process and post market compliance requirements for 20 years. Below we summarize Bump’s
advice for keeping existing LDTs on the market.

FDA Stage 1 requirements for currently marketed LDTs
Nearly all LDTs, including currently marketed LDTs (prior to May 6, 2024), “unmet need” LDTs performed by “integrated” health systems and NYS CLEP-approved tests, must meet Stage 1 requirements by May 6, 2025.

Stage 1 includes FDA Medical Device Reporting (MDR), which will require laboratories to report adverse events for any LDT that they perform. Under FDA’s regulations, an adverse event is any event that reasonably suggests that a device has or may have caused or contributed to a death or serious injury, or would be likely to cause or contribute to a death or serious injury if the event happens again. An adverse event report would therefore be required for an incorrect test result that has, may, or could cause such consequences. The incorrect test result could be caused by instrument malfunctions as well as mislabeled or contaminated specimens.

An adverse event report must generally be reported to the FDA within 30 days after the lab became aware of the error. The regulations require specific information be included in the report, and labs will also need to file\ a report that describes what corrective action they took, or if they chose to remove that LDT from their test menu.

An adverse event report could prompt the FDA to ask follow-up questions or schedule an on-site inspection.

The FDA is especially sensitive to incorrect test results that delayed patient treatment or caused
unnecessary treatment (or had the potential to do so).

Stage 1 also requires labs to maintain complaint files for each LDT they offer, including the date the complaint was received; the name, address, and phone number of the complainant; the nature and details of the complaint; any corrective action taken, etc. Specific records and reports
must also be maintained and submitted regarding corrections and removals of tests, including for
repairs, adjustments, relabeling, etc.

FDA Stage 2 requirements for currently marketed LDTs
Once again, Stage 2 requirements apply to nearly all LDTs and become effective May 6, 2026.

Stage 2 requires each laboratory to be registered with the FDA and list all of the LDTs they perform.

Stage 2 also requires labs to submit labeling for each LDT they offer. Labeling includes test performance information and a summary of supporting validation. As part of its review of labeling, the FDA plans to look closely at claims of superior performance and whether those claims are adequately substantiated. This includes any test claims made on a lab’s website, brochures or by sales reps.

Labeling information is typically included as a package insert or affixed to test kit box for FDA-cleared or approved IVD tests. However, since LDTs are not distributed in boxed test kits, it is unclear exactly where the label for an LDT will need to be placed. Labels might be required on the LDT test requisition form, but this hasn’t been confirmed yet. We’re waiting for the FDA to issue more guidance on label requirements.

FDA Stage 3 requirements for currently marketed LDTs

By May 6, 2027, currently marketed as well as “unmet need” LDTs developed and used within “integrated” health systems need to be in compliance with the records requirements of the quality system regulation. These records relate to the device master record, the device history record, and the quality system record. (Note: Complaint file record requirements are already covered under Stage 1.)

The device master records must include information about device specifications, production process specifications, quality assurance procedures and specifications, packaging and labeling specifications, and procedures and methods for installation, maintenance, and servicing.

The device history records must include information about the dates and quantity manufactured, the quantity released for distribution, acceptance records, information to identify each production unit and device identifiers.

Labs must have the required information compiled, documented, and in a records system that is accessible and readily available to FDA investigators during inspections.

FDA On-site Inspections
All registered lab facilities performing LDTs are subject to scheduled on-site inspections by the FDA every two years. FDA inspections are completely different than and are independent of CMS CLIA and CAP inspections. FDA inspectors will be focused on reviewing LDT test records and files. However, the reality is that the FDA already lacks the resources to perform regularly scheduled on-site inspections of existing test kit manufacturers. The agency may have difficulty keeping up with the thousands of new lab facilities that fall under its purview as a result of its final rule. 

March 2024 CLIA Database

March 2024 CLIA Database

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, 9,000 hospital labs and all other labs. 

Importantly, the database includes all 3,470 new CLIA-certified labs that have been formed so far in 2024, including 231 new moderate/high-complexity labs and 3,239 waived testing labs. 

Metro areas showing the greatest number of new lab formations include New York City (202 labs), Seattle (180 labs), Los Angeles (159 labs), Dallas (122 labs), Miami-Ft. Lauderdale (120 labs), Houston (104 labs), Atlanta (74 labs) and Chicago (62 labs). 

A Must-Have for all vendors selling to medical laboratories!

  • Data is available for all 50 states and Puerto Rico
  • Includes all 7,000+ CAP-accredited labs
  • Find new customers to grow your sales
  • Create targeted lists by location or start date to focus on your best opportunities
  • Identify under served markets for geographic expansion
  • Save time and money by using accurate and up-to-date data

New Lab Formations Continue To Boom

New Lab Formations Continue To Boom

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 the second quarter (April 1-June 30, 2021). The all-time high (12,000+ new CLIA labs) occurred in the fourth quarter of 2020. The boom has created a huge demand for lab workers that had already been in short supply before the pandemic. 

Why Were Hospital Labs Excluded From The Initial PAMA Survey?

Why Were Hospital Labs Excluded From The Initial PAMA Survey?

Why Were Hospital Labs Excluded From The Initial PAMA Survey?

A former CMS official involved in drafting the initial Medicare rules that determined which labs must report their private-payer pricing data to CMS for calculating Medicare CLFS rates says that PAMA was specifically designed to exclude hospital labs. This flies in the face of the lab industry’s contention that the PAMA law intended pricing information from all labs, including hospital labs, to be included in the rate calculations.

Speaking at the Annual Meeting for the American Clinical Laboratory Assn. (ACLA), March 4, Marc Hartstein, a Principal with Health Policy Alternatives and former Director of CMS’s Hospital and Ambulatory Policy Group, said, “I provided technical assistance to the Senate Finance Committee, which wrote the statute, and I can tell you the intent was to exclude hospital laboratories. The provision was intended to get savings, and if hospital laboratories were included, that would have raised the payment amounts.”

Hartstein spent 26 years at CMS (1990-2016) and helped develop such major Medicare policies as the misvalued code initiative for the physician fee schedule, the hospital Diagnosis-Related Group system, the hospital two-midnight rule, as well as the regulations for implementing Medicare’s
new CLFS under PAMA.

At this point, the opinions of those involved in drafting the PAMA statute don’t really matter, said Hartstein, who noted that it’s now up to the court to issue a statutory interpretation of the law. “Courts rightly decide issues based on the words of the law, not the opinions of those involved in drafting or enacting the law,” he said. ACLA’s lawsuit challenging the implementation of PAMA (originally filed in December 2017) is now awaiting a ruling from Judge Amy Berman Jackson from the U.S. District Court for the District of Columbia. Judge Jackson initially dismissed the case, but ACLA won an appeal, and the case was sent back to her to make a ruling. All briefs and replies were submitted to Judge Jackson at the end of January, and a decision is expected by year’s end.

“The question is whether the secretary’s definition of ‘laboratory’ is a reasonable definition,” said Hartstein. “If a laboratory is only a laboratory and not its larger organization, the laboratory is going to get 100% of its [Medicare] revenues from the clinical laboratory fee schedule or physician fee schedule. I don’t understand what the majority revenues criterion would be in that circumstance. The majority of revenue criterion must have been drafted to eliminate somebody from this determination.”

Regardless, the second PAMA reporting cycle now requires hospital labs to report their privatepayer data for non-patients to CMS in the first quarter of 2021. The hospital data, along with data from independent labs and POLs, will be used to calculate Medicare CLFS rates for 2022-2024.

Finally, the Medical Payment Advisory Commission (MedPAC) is currently reviewing how CMS has implemented the private-payer-based CLFS under PAMA, giving the lab industry an opportunity to make its case for a different system, said Hartstein. The lab industry wants CMS to analyze the payment data it collects from labs using statistical sampling to ensure that all sectors
of the lab market are accurately represented.