Payor Coverage: Page 2

PGDx receives updated Medicare rate for Elio test
The Centers for Medicare & Medicaid Services finalized a national reimbursement rate of $2,919.60 for the proprietary laboratory analyses code (0250U) that PGDx obtained for the test, the company reported in a release.
January 27, 2022
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COVID-19 tests drove increase in Medicare spending in 2020
The HHS Office of Inspector General (OIG) found that total Medicare Part B spending has increased each year for the past five years. COVID-19 tests accounted for approximately 19% of total Medicare Part B spending on lab tests, while utilization of non-COVID-19 tests as a group decreased 15.9% from 2019. Spending on lab tests other than for COVID-19 in 2020 was the lowest it had been in the past five years (no other year prior to the pandemic had a decrease).
January 3, 2022
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LabPulse.com Microbiology Insider
Diagnostic testing is key to controlling the COVID-19 pandemic, and the earlier that SARS-CoV-2 infection can be detected, the better. Researchers from Hong Kong believe they may have found an assay that detects SARS-CoV-2 at a much earlier stage of infection.
October 25, 2020
Report: LDT market to exceed $17B
The findings come from LabPulse.com sister company and IVD research firm Kalorama Information in a new report, "The Market for Clinical LDT Services and LDT Supplies." Kalorama noted that the LDT market is driven by relaxed regulatory activity and the need for improved cancer tests.
October 19, 2020
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AACC: LDTs play crucial role in patient care
Furthermore, adding regulation by the U.S. Food and Drug Administration (FDA) would be duplicative, burdensome, and could stymie the ability of labs to respond quickly to new diseases like COVID-19.
October 15, 2020
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Clinical labs face interruptions, staffing shortages
The 100-question survey assessed several aspects of testing SARS-CoV-2: sample types, patient populations, methodologies, validation, performance, supply chain, public health reporting, laboratory workforce, and reimbursement. The survey responses came from 113 representatives affiliated with U.S.-based academic medical centers, commercial reference laboratories, public health laboratories, and community hospitals.
October 8, 2020
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Most Popular
Quest Diagnostics Q4 revenues down 15% on COVID testing but base business grew
In pilot study, liquid biopsy test differentiates between localized and metastatic cancer to inform tailored treatment
SD Biosensor, SJL Partners complete acquisition of Meridian Bioscience
Roche reports flat diagnostics revenue growth for 2022
French point-of-care testing firm Biosynex to acquire Chembio Diagnostics for $17.2M
OIG report outlines challenges with CDC-supported COVID-19 vaccination programs
HHS: FDA review not needed for coronavirus LDTs
In the guidance, the HHS said that the FDA will not require labs to go through premarket review of LDTs for COVID-19 before they can be used on patients. Labs can choose to seek emergency use authorization (EUA) from the FDA if they wish, and the agency will adjudicate these submissions.
August 19, 2020
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U.S. nursing homes gear up for coronavirus antigen testing at point of care
The U.S. Department of Health and Human Services (HHS) on July 14 announced plans for a one-time procurement of point-of-care antigen testing equipment, which will be distributed to long-term care facilities to enable onsite assessment. In a statement about the plan, the HHS noted that the equipment will be cleared by the U.S. Food and Drug Administration. Currently, two antigen testing products have an emergency use authorization -- Becton Dickinson's Veritor system and Quidel's Sofia 2 unit.
July 16, 2020
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Telemedicine association asks U.S. Congress for permanent reform
U.S. Congress expanded access to telehealth services during the COVID-19 pandemic by giving the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) the authority to waive restrictions on Medicare telehealth services.
June 30, 2020
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AACC to Senate: 4 steps to prepare for next pandemic
The Senate Health, Education, Labor, and Pensions Committee recently released a white paper, "Preparing for the Next Pandemic," with recommendations for addressing future pandemics based on lessons learned from COVID-19. The white paper is intended to guide legislation to tackle critical gaps in the U.S. pandemic response, and the Senate health committee seeks public input on the white paper before finalizing it. The four steps recommended by the AACC are:
June 25, 2020
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CAP publishes new checklists for lab accreditation
The checklists, which have approximately 3,000 requirements, are used during CAP inspections to ensure that laboratories comply with U.S. Centers for Medicare and Medicaid Services regulations and achieve accreditation.
June 3, 2020
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Kaiser members get another reprieve on out-of-pocket COVID-19 fees
The waiver went into effect on April 1 and was originally set to expire on May 31 but will continue through the rest of the year. The waiver is intended to alleviate the cost burden and stress of paying for care, Kaiser Permanente said.
May 31, 2020
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