LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
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New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
HHS Signals that the End of the PHE Is Near
Last week, CMS announced that it was eliminating certain waivers and regulatory flexibility it provided when the COVID-19 pandemic began.
Labs in Court Weekly Roundup
While labs...
OSHA Releases Scaled-Down Health Care Worker COVID-19 Protection Rule
The kinder, gentler version of the standard removes key controversial elements, such as mandating vaccination for employees.
CMS Delays Start of Radiation Oncology Model
The model, meant to start Jan. 1 of this year, had already been delayed over concerns from key stakeholders, and its start date is now TBD
More Time Needed to Evaluate VALID Act, AMP Urges Congress
Key stakeholders hold a briefing to inform lawmakers of the impact of potential new regulations for laboratory developed testing procedures.
White House: Great Progress in Health Care Coverage, but More Work to Be Done
The White House recently provided on update on agencies’ progress in carrying out EO to boost Medicaid and the Affordable Care Act
Device Makers to FDA: Give Us More Time for ISO 13485 Harmonization
On Feb. 23, the...
Join Us April 27th to Discuss How We Can Improve Our Content
Webinar will give you the chance to learn about recent changes at G2 and ask the editorial team any questions you may have.
Congress Strikes Deal on COVID-19 Response Funding
The good news:...
