News & Analysis as of

Food and Drug Administration (FDA) Centers for Medicare & Medicaid Services (CMS) Final Rules

Ankura

FDA Will Now Regulate Laboratory Developed Tests

Ankura on

On April 29, 2024, the Food and Drug Administration (FDA) announced a final rule to consider laboratory-developed tests (LDTs) to be medical devices and thus under FDA oversight. LDTs are laboratory tests that are designed,...more

Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

Holland & Knight LLP on

The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more

Holland & Knight LLP

Holland & Knight Health Dose: September 10, 2024

Holland & Knight LLP on

Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | July 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more

McGuireWoods Consulting

Washington Healthcare Update - July 2024 #4

This Week in Washington: HHS announces reorganization of health technology offices; House recesses early because of an inability to pass appropriations bills; Senate Finance Committee chairman introduces legislation to...more

McGuireWoods Consulting

Washington Healthcare Update - July 2024 #3

This Week in Washington: House Rules Committee to consider FY2025 Agriculture-FDA and Related Agencies funding bill amendments; MedPAC releases July 2024 data book on Medicare program spending; National drug shortages fall to...more

McGuireWoods Consulting

Washington Healthcare Update - July 2024 #2

This Week in Washington: House Appropriations Committee marks up FY2025 Labor-HHS-Education and the Agriculture- FDA and Related Agencies funding bills; Senate Appropriations Committee marks up FY2025 Agriculture-FDA and...more

Mintz - Health Care Viewpoints

Five Observations from FDA’s Responses to Comments in the Final Rule on LDTs

Now that the final rule on laboratory developed tests (LDTs) has been available for over a month and the stages of the enforcement discretion phaseout process and the Food and Drug Administration’s (FDA’s) newly proposed...more

McGuireWoods Consulting

Washington Healthcare Update - July 2024

This Week in Washington: House Ways and Means Committee marks up healthcare bills related to new technologies and coverage for weight loss drugs; CMS releases CY2025 Home Health and End-Stage Renal Disease PPS proposed rules;...more

McGuireWoods Consulting

Washington Healthcare Update - June 2024 #3

This Week in Washington: CBO releases analysis of health insurance rates; Senate Finance Committee Chairman releases draft legislation concerning labor and delivery unit closures; House Oversight and Accountability Committee...more

McGuireWoods Consulting

Washington Healthcare Update - June 2024 #2

This Week in Washington: House Energy and Commerce Committee marks up 13 healthcare bills; House Energy and Commerce Committee Subcommittee on Health holds hearing on CMMI; CMS announces it will recalculate MA Star Ratings....more

McGuireWoods Consulting

Washington Healthcare Update - June 2024

This Week in Washington: Senate Finance Committee Chairman sends letters concerning healthcare cybersecurity measures; House Energy and Commerce Committee Oversight and Investigations Subcommittee holds hearing on 340B...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | April 2024 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more

McGuireWoods Consulting

Washington Healthcare Update - May 2024 #4

This Week in Washington: Senate Finance Committee releases draft proposal outline concerning GME program; Senate HELP Committee marks up seven healthcare bills; NIH issues first-of-its-kind policy proposal to promote equal...more

Venable LLP

Summary of LDT Rule: An In-depth Look at the Final Rule Regarding Laboratory-Developed Tests

Venable LLP on

The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for laboratory-developed tests (LDTs) and "correct...more

McGuireWoods Consulting

Washington Healthcare Update - May 2024 #3

This Week in Washington: House appropriators release FY2025 topline appropriations levels; Senate Finance Committee releases white paper on Medicare physician payment reforms; House Energy and Commerce Committee Subcommittee...more

Foley & Lardner LLP

LDTs: FDA Rolls Out a Phased Implementation for New Regulatory Requirements

Foley & Lardner LLP on

On May 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final rule significantly modifying FDA’s approach to oversight of laboratory developed tests (LDTs). The final rule is effective July 5, 2024....more

McGuireWoods Consulting

Washington Healthcare Update - May 2024 #2

This Week in Washington: House Ways and Means Committee marks up telehealth legislation; CMS extends state Medicaid unwinding flexibilities; Senate HELP Committee ranking member releases white paper outlining possible NIH...more

McDermott+

It’s Raining Regs: CMS Releases Major Laboratory-Developed Test Reg in Midst of Massive Reg Storm

McDermott+ on

Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more

McGuireWoods Consulting

Washington Healthcare Update - May 2024

This Week in Washington: Senate Finance Committee releases discussion draft concerning generic drug shortages; FDA releases laboratory-developed tests final rule; Administration extends ACA subsidies for Deferred Action for...more

McDermott+

McDermottPlus Check-Up: May 3, 2024

McDermott+ on

House Energy & Commerce Health Subcommittee Holds Legislative Hearing on Improving Medicaid Access. Daniel Tsai, deputy administrator and director of the Center for Medicaid and CHIP Services (CMCS), testified. Members...more

McGuireWoods Consulting

Washington Healthcare Update - April 2024 #3

This Week in Washington: CMS releases SNF minimum staffing standards final rule; Senate HELP Committee chairman requests information on Ozempic and Wegovy pricing; HHS OCR releases final rule concerning HIPAA reproductive...more

McGuireWoods Consulting

Washington Healthcare Update - April 2024 #2

This Week in Washington: House Energy and Commerce Committee chairmen and ranking members request information on Change Healthcare cyberattack impacts; FDA establishes CDER Center for Clinical Trial Innovation; House Energy...more

McGuireWoods Consulting

Washington Healthcare Update - April 2024

This Week in Washington: Senate HELP Committee Chairman requests comments on Long COVID draft proposal; CMS announces proposed Transforming Episode Accountability Model; CMS releases FY2025 Inpatient and Long-Term Care...more

McGuireWoods Consulting

Washington Healthcare Update - March 2024 #4

This Week in Washington: Congress passes remaining appropriations bills; House Energy and Commerce Committee marks up 17 healthcare bills; CMS announces coverage for some Wegovy prescriptions....more

135 Results
 / 
View per page
Page: of 6

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide