On March 31, 2025, the US District Court for the Eastern District of Texas struck down the US Food and Drug Administration’s (FDA) final rule under which FDA would have started regulating most laboratory-developed tests...more
The Centers for Medicare & Medicaid Services (CMS) issued the final procedural notice on Transitional Coverage for Emerging Technologies (TCET), effective as of August 12, 2024. TCET is a new pathway that uses existing...more
On April 29, 2024, the US Food and Drug Administration (FDA) issued the long-awaited final rule around the regulation of laboratory developed tests (LDTs), which are in vitro diagnostic products (IVDs) that FDA describes as...more
Last week, the Centers for Medicare & Medicaid Services (CMS) announced that it would allow health plans under Medicare Part D (the Medicare prescription drug benefit) to cover Wegovy and other weight-loss medications if they...more
It’s Thanksgiving week, so instead of eating eggs with your regs, you should sit back, relax and reflect on the regs you are thankful for as you eat your turkey legs (or whatever you enjoy on Thanksgiving). Many of the...more
11/21/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Final Rules ,
Healthcare ,
Healthcare Reform ,
Inpatient Prospective Payment System (IPPS) ,
Medicare ,
Mental Health ,
New Legislation ,
New Regulations ,
No Surprises Act (NSA) ,
Outpatient Prospective Payment System (OPPS) ,
Physician Fee Schedule ,
Regulatory Agenda ,
Telehealth
On September 29, 2023, the US Food and Drug Administration (FDA) published a long-awaited proposed rule on laboratory-developed tests (LDTs). If FDA finalizes this rule as proposed, FDA will regulate virtually all LDTs as...more
On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a procedural notice with comment period on Transitional Coverage for Emerging Technologies (TCET), a new pathway that uses existing national coverage...more
Can House Republicans Find Unity?
Last week, 11 members from the Republican Freedom Caucus voted against a rule to proceed to several messaging bills on federal regulations and gas stoves. These 11 members voted against...more
The US Department of Health and Human Services Office of Inspector General (OIG) recently issued Advisory Opinion (AO) 23-03, analyzing a proposed arrangement in which a company that manufactures an at-home colon cancer...more
+Dx Forum 2023 is the premier gathering for the laboratory diagnostics community.
Join us for insightful discussion about the latest regulatory and reimbursement developments....more
2/1/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratories ,
Diagnostic Tests ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
Events ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Reform ,
Laboratory Developed Tests ,
Legislative Agendas ,
Medicare Administrative Contractors (MAC) ,
Prior Authorization ,
Regulatory Agenda ,
Reimbursements
McDermott’s cross-functional team of life sciences professionals present the inaugural Munich Life Sciences Bootcamp focusing on issues and trends important to life sciences companies. This half-day program is designed for...more
11/13/2019
/ Data Protection ,
Digital Health ,
Events ,
Food and Drug Administration (FDA) ,
Germany ,
Health Care Providers ,
Health Technology ,
Healthcare ,
Life Sciences ,
Mobile Apps ,
Pharmaceutical Industry ,
Popular ,
Reimbursements ,
Technology Sector
On November 15, 2017, the FDA announced the clearance of a tumor profiling test under a novel, streamlined FDA premarket review pathway for certain next generation sequencing (NGS)-based tumor profiling tests. The creation of...more
Shortly after the recently enacted, bipartisan 21st Century Cures Act, which revised and expanded the extent to which specific health care economic information (HCEI) may be disseminated to certain stakeholders, and comes...more
On January 13, 2017, the US Food and Drug Administration (FDA) posted a “discussion paper” in which the agency outlines a substantially revised “possible approach” to the oversight of laboratory-developed tests (LDTs). The...more
On August 27, 2015, the U.S. Food and Drug Administration (FDA) released long-awaited and highly anticipated draft guidance regarding the non-proprietary naming of biological products, including biosimilars. The draft...more
9/10/2015
/ Biologics ,
Biosimilars ,
Comment Period ,
Draft Guidance ,
Drug Safety ,
Federal Register ,
Food and Drug Administration (FDA) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Regulation ,
Public Health Service Act ,
World Health Organization
On October 31, 2014, the Centers for Medicare & Medicaid Services (CMS) released its annual final rule (Final Rule) setting the payment rates and coverage policies for items and services reimbursed under the Outpatient...more
Historically, the U.S. Food and Drug Administration (FDA) has exercised enforcement discretion with respect to most laboratory developed tests (LDTs) and has not required laboratories that furnish LDTs to comply with FDA’s...more
On March 31, 2014, the Senate gave final approval to the Protecting Access to Medicare Act of 2014 (the Act), which includes significant reforms to the way Medicare pays for clinical diagnostic laboratory services. The House...more
Through two recently issued regulations, the Centers for Medicare and Medicaid Services have announced their intention to reform and improve Medicare policies addressing clinical diagnostic laboratory services. These...more
On July 8, 2013, the Centers for Medicare & Medicaid Services (CMS) released a pre-publication version of the 2014 Medicare Physician Fee Schedule and the 2014 Medicare Hospital Outpatient Prospective Payment System Notices...more
The Centers for Medicare & Medicaid Services recently issued final regulations and a final payment guidance that address reimbursement for laboratories furnishing molecular pathology services. While the publications answer...more
11/15/2012