Payor Coverage: Page 3

AACC: LDTs play crucial role in patient care
By Rebekah Moan
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
2020 02 13 23 04 0191 Lab Scientists 400
Clinical labs face interruptions, staffing shortages
By Rebekah Moan
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
2020 02 25 23 24 4831 Lab Microscope Woman 400
HHS: FDA review not needed for coronavirus LDTs
By Brian Casey
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
2020 01 27 21 38 4451 Lab 2019 Coronavirus Test 400
U.S. nursing homes gear up for coronavirus antigen testing at point of care
By Emily Hayes
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
2020 07 16 20 58 2559 Seal Hhs 400
Telemedicine association asks U.S. Congress for permanent reform
By LabPulse.com staff writers
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
2020 03 19 18 44 4053 Washington Dc Capitol 400
AACC to Senate: 4 steps to prepare for next pandemic
By LabPulse.com staff writers
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
2019 08 05 17 59 6641 Aacc 2019 400
CAP publishes new checklists for lab accreditation
By LabPulse.com staff writers
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
2019 07 29 21 36 3339 Survey Checklist 400
Kaiser members get another reprieve on out-of-pocket COVID-19 fees
By LabPulse.com staff writers
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
2019 06 19 18 57 9352 Money Dollar Bandaid 400
U.S. government provides $225M for rural COVID-19 testing
By LabPulse.com staff writers
The funding will provide nearly $50,000 to more than 4,500 rural health clinics. The funding was specifically allotted for rural clinics through the Paycheck Protection Program and Health Care Enhancement Act, the $484 billion law that provides emergency aid to address the ongoing novel coronavirus pandemic.
May 20, 2020
2020 05 21 21 35 7504 Rural 400
States ready to conduct more than 12.9M coronavirus tests in May
By Emily Hayes
Through funding provided in the Coronavirus Aid, Relief, and Economic Security (CARES) Act, the federal government is delivering $11 billion for the sole support of testing to states. To date, more than 9 million coronavirus tests have been conducted in the country. Associations of lab medicine professionals have cited the lack of supplies for testing as a barrier to the ramp-up of testing to allow reopening of the economy.
May 10, 2020
2020 05 11 23 50 9621 Lab 2019 Coronavirus Test 400
CMS suspends emergency loan program
By LabPulse.com staff writers
The programs provide temporary loans during emergencies to cover claims processing and other expenses. The CMS had expanded them in light of the COVID-19 pandemic and since March 28 paid out $59.6 billion to Part A providers, which include hospitals, and $40.4 billion to Part B suppliers include doctors, nonphysician practitioners, and medical equipment suppliers.
April 26, 2020
2020 04 27 21 46 0426 Money Belt Tighten 400
AACC responds to reports of bad blood tests for coronavirus
By LabPulse.com staff writers
In a statement on April 14, AACC President Carmen Wiley, PhD, noted that there have been "worrying reports" of a small number of unreputable diagnostic companies taking advantage of the relaxation of U.S. Food and Drug Administration (FDA) rules during the coronavirus pandemic. Initially, the FDA required all entities to secure an emergency use authorization (EUA) on tests for SARS-CoV-2/COVID-19. The restrictions were controversial. But in mid-March the agency relaxed regulations for vendors and also labs developing their own tests to permit marketing without an EUA.
April 13, 2020
2020 04 14 18 47 7275 Lab Blood Tubes 400
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