Research & Development
Policy & Regulation
Trends & Finance
AACC criticizes FDA over warning on prenatal genetic tests
NIPTs can determine the risk of a fetus having certain genetic abnormalities, which could result in a child being born with a serious health condition. However, since they are not diagnostic tests, they cannot confirm or rule out a suspected genetic abnormality, the FDA said.
April 21, 2022
CAP calls for action to reduce health disparities
If passed, the Social Determinants Accelerator Act of 2021 (HR 2503) could improve healthcare data collection between federal agencies and establish a federal council to develop plans to address determinants plaguing beneficiaries in the Medicaid program, CAP said. In addition, the legislation will provide grants and assistance to state, tribal, and local governments to deploy strategies addressing these issues in their own communities.
March 30, 2022
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 backs new small business funding bill, advises practices on emergency loans
Funds are now available through the federal Coronavirus Aid, Relief, and Economic Security (CARES) Act, which created more than $350 billion in emergency aid for small businesses during the COVID-19 national emergency and economic downturn. Through CARES, small businesses can apply to the Small Business Administration for the Paycheck Protection Program, which provides loans to cover payroll, rent, mortgage, and utility expenses. If all employees stay on the payroll for eight weeks, the loans are forgiven.
April 7, 2020
VITAL Act steps in on regulation of lab-developed tests
Introduced by Sen. Rand Paul (R-KY), the VITAL Act also proposes ways to modernize CLIA regulations governing LDTs.
March 18, 2020
Coronavirus symptoms take 5 days | VALID Act gets revived | FDA defends coronavirus response
Dear LabPulse Member,
March 9, 2020
Chembio Diagnostics applies for FDA CLIA waiver for HIV, syphilis test
Dr. Fauci invokes Yogi Berra to describe emerging infectious disease challenge
Thermo Fisher Scientific introduces digital PCR liquid-biopsy assays for academic, clinical research
Thermo Fisher Scientific updates Applied Biosystems genetic analyzers to comply with IVDR
Week in Review: Elizabeth Holmes sentenced; good cholesterol worse for some adults; earlier type 2 diabetes diagnosis; and more
Quest Diagnostics completes acquisition of Summa Health outreach lab services business
Revival of VALID Act draws mixed response
The issue of diagnostics regulation has emerged as a political lightning rod, with some faulting the Trump administration's response to the outbreak and others blaming what they claim is a history of federal overregulation of clinical labs.
March 8, 2020
Congress skips surprise billing, passes LAB Act
Per the LAB Act data reporting requirements on payments for lab services associated with the Protecting Access to Medicare Act of 2014 (PAMA) will be delayed for one year. Furthermore, an independent study will be commissioned on data collection and rate setting for lab services.
December 22, 2019
CAP deems surprise billing deal 'unacceptable'
Sen. Lamar Alexander (R-TN), Rep. Frank Pallone (D-NJ), and Rep. Greg Walden (R-OR) unveiled an agreement on December 8 that includes provisions enabling the government to set payment rates and an independent arbitration process for claim amounts over $750. The plan is to attach the proposal to spending legislation, which needs to be passed by December 20.
December 10, 2019
CAP: Action on surprise medical bills may collapse, despite bipartisan support
Surprise billing is at the forefront of issues on CAP's advocacy agenda, said Dr. Donald Karcher, chair of CAP's Council on Government and Professional Affairs. He moderated a panel on timely advocacy topics at the meeting, which is being held at the Gaylord Palms Resort and Convention Center in Kissimmee, FL, near Orlando.
September 22, 2019
Antiopioid law could criminalize sales commissions for clinical lab patient referrals
The legislation, called the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, was originally intended to battle the U.S. opioid crisis when passed in 2018. But the bill also has an all-payor kickback prohibition that applies to laboratories, recovery homes, and clinical treatment facilities. This prohibition applies to all laboratory business arrangements covered by all payors -- not just government but also commercial -- and to all types of testing, not just to labs undertaking opioid-related toxicology testing.
April 17, 2019
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