News
Podcast: Talking the cure
11 April 2024
Our team is always thinking about how to foresee and conquer the most significant industry issues facing our clients. In 2020, we launched the podcast "Talking the Cure" where we cover...
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Insights and Analysis
Senate proposes greater FDA oversight of Lab Developed Tests
31 May 2022
On May 17, the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee published a discussion draft of their FDA user fee program reauthorization package, the “Food and...
News
HHS again permits FDA review of LDTs, updates EUA policy for laboratory developed tests
22 November 2021
On November 15, the U.S. Department of Health and Human Services (HHS) withdrew a controversial Trump-era HHS Policy Change that effectively prevented the Food and Drug Administration (FDA) ...
News
HHS ends EUA requirement for Laboratory Developed Tests; FDA may continue to assert authority
23 August 2020
On August 19, 2020, the U.S. Department of Health and Human Services (HHS) announced the rescission of guidances and other Food and Drug Administration (FDA) issuances concerning premarket...
News
Expanded access to telehealth services during the COVID-19 pandemic
02 April 2020
In response to the COVID-19 pandemic, the U.S. Congress, the Centers for Medicare and Medicaid Services (CMS), many state legislatures and state Medicaid programs, and private payers have...
News
The Coronavirus Aid, Relief, and Economic Security Act: Notable changes affecting Medicare and Medicaid
31 March 2020
On March 27, 2020, Congress enacted into law the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), an unprecedented $2 trillion stimulus package intended to provide emergency...
News
COVID-19 threat prompts Florida’s Health Officials to expand telehealth under Emergency Order
17 March 2020
On Monday, March 16, 2020, Florida’s Surgeon General issued a rare Emergency Order (the Order) that allows certain out-of-state health care professionals to temporarily provide...
Insights and Analysis
CMS expands national coverage of Next Generation Sequencing tests for breast, ovarian cancer patients Health Alert
31 January 2020
On Monday, 27 January, the Centers for Medicare & Medicaid Services (CMS) finalized its proposal to expand national coverage of FDA-approved or -cleared laboratory tests using next...
News
CMS proposes to expand coverage for Next Generation Sequencing tests for certain cancer patients
01 November 2019
On Tuesday, October 29, CMS issued a "Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer" (Proposed Decision Memo) that...
