UHC Announces Laboratory Test Registration Requirement Delayed

  • Jul 9, 2021

United Healthcare (UHC) has once again announced a delay in the implementation of its clinical and pathology Laboratory Test Registry until further notice. COVID-19 and the ongoing public health emergency (PHE) are cited as the driver of the delay. The July 1, 2021 announcement on the UHC provider website, points out that this indefinite delay also applies to the registration of non-genetic...

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Medpac Mandated report released: Assessing the impact of recent changes to Medicare’s clinical laboratory fee schedule payment rates

  • Jul 7, 2021

The Further Consolidated Appropriations Act of 2020 mandated that the Commission examine the methodology CMS used to set private-payer-based payment rates for CLFS services and report on the least burdensome data collection process that would result in a representative and statistically valid data sample of private market rates.  In this chapter, the Commission finds that independent...

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New Liquid Biopsy Data at ASCO Highlights Commercial Push Into Early Cancer Detection

  • Jul 7, 2021

As the clinical applications for liquid biopsy testing begin to widen in the cancer space, biotech companies have started to further invest in DNA fragmentation- and methylation-based platforms to detect a variety of early-stage cancers. At the American Society of Clinical Oncology virtual annual meeting last week, some firms presented data on different techniques to analyze a patient's blood...

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Lawmakers reintroduce diagnostic regulation bill that split the industry

  • Jul 7, 2021

Lawmakers have reintroduced draft legislation for a new regulatory framework for diagnostic tests, marking the third time a form of the proposal has been put to Congress.   The new version of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act hews closely to the draft introduced early in the pandemic. While there have been some changes, the focus is still...

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Biden admin releases first rule banning surprise medical bills

  • Jul 7, 2021

The Biden administration has released an interim final rule that bans surprise billing and certain out-of-network charges, implementing a law passed by Congress late last year. The 411-page interim final rule released Thursday by the departments of Health and Human Services (HHS), Labor and Treasury will go into effect on Jan. 1, 2022, for providers and for insurance plans that begin on or after...

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Supreme Court declines to hear AHA's appeal of site-neutral payments decision

  • Jul 7, 2021

The Supreme Court has declined to hear an appeal of a lower court decision upholding the Department of Health and Human Services’ (HHS') site-neutral payments policy. The appeal was requested by the American Hospital Association (AHA) in February as part of a multiyear legal battle challenging HHS’ authority to bring Medicare payments to off-campus clinics in line with independent...

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HHS Issues Revisions to Provider Relief Fund Reporting Requirements

  • Jul 7, 2021

On June 11, 2021, Health and Human Services (HHS) announced revised reporting requirements and timelines for recipients of Provider Relief Fund (PRF) payments. The update includes expanding the amount of time providers will have to report information and extends key deadlines for spending PRF payments for those who received payments after June 30, 2020.

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Diagnostics Reform Heats Back Up with Introduction of the Verifying Accurate Leading-edge IVCT Development Act of 2021

  • Jul 7, 2021

The Verifying Accurate Leading-edge IVCT Development Act of 2021 (the “VALID Act of 2021,” the “VALID Act” or the “Act”) was introduced in both the House and Senate on June 24, 2021 by U.S. Reps. Diana DeGette (D-CO) and Larry Bucshon (R-IN) and U.S. Sens. Michael Bennet (D-CO) and Richard Burr (R-NC). The bipartisan Act seeks to modernize regulatory oversight of IVDs, including laboratory...

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