Research & Development
Policy & Regulation
Trends & Finance
Payor Coverage: Page 3
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
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
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
U.S. government provides $225M for rural COVID-19 testing
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
States ready to conduct more than 12.9M coronavirus tests in May
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
CMS suspends emergency loan program
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
Genetic causes identified for three rare diseases
Researchers in study validate test to identify newborns with homocystinuria, a rare inherited disease
SARS-CoV-2 infection weakens immune-cell response to vaccination, study suggests
Duke University researchers discover biomarkers may identify early pancreatic cancer risk
Werfen completes $2B acquisition of Immucor, expands presence in specialized diagnostics
Chembio CEO urges stockholders to tender remaining shares as deadline is extended for acquisition
AACC responds to reports of bad blood tests for coronavirus
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
CMS issues guidance on coverage for COVID-19 tests
The move is an effort to mitigate financial barriers Americans may face to receiving COVID-19 testing and health services, CMS said.
April 12, 2020
Waiver allows pathologists to work remotely during pandemic
Through a waiver, pathologists have regulatory flexibility in terms of where they work, with temporary relief from the CLIA regulations, which require pathologists to perform diagnostic tests at certified facilities.
March 26, 2020
CAP suspends facility accreditation inspections
The U.S. suspension was approved by the U.S. Centers for Medicare and Medicaid Services (CMS) and took effect March 17. It applies to all inspections aside from immediate jeopardy complaint visits and follow-ups, CAP explained to members.
March 17, 2020
CMS starts COVID-19 pricing at $36 per test
The release of payment rates complements the agency's release of codes for COVID-19 testing in March and February and will enable healthcare providers and clinical labs to bill for the diagnostic tests. CMS is instructing labs to use Healthcare Common Procedure Coding System (HCPCS) code U0001 for tests developed by the U.S. Centers for Disease Control and Prevention and code U0002 for tests developed by other entities.
March 12, 2020
Blue Cross waives costs for COVID-19 testing
Blue Cross said it encourages anyone showing symptoms of COVID-19 to contact their health provider before they visit an office or emergency room. The provider can evaluate their symptoms before determining if diagnostic testing is appropriate.
March 8, 2020
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