The U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration's (FDA) final rule on March 31, 2025, under which the FDA would have started regulating most laboratory-developed tests (LDTs)...more
4/15/2025
/ Administrative Procedure Act ,
Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Judicial Authority ,
Laboratory Developed Tests ,
Life Sciences ,
Medical Devices ,
Regulatory Requirements ,
Vacated
CMS recently published a proposed rule that would substantially revise the methodology used to pay for clinical laboratory tests that continue to be compensated separately by Medicare. Medicare Program; Medicare Clinical...more
10/20/2015
/ Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratories ,
Clinical Laboratory Testing ,
Medicaid ,
Medicare ,
Medicare Advantage ,
Medicare Part A ,
Medicare Part B ,
Medicare Part C ,
Medicare Part D ,
PAMA ,
Payment Methods ,
Payment Rates ,
Reporting Requirements
In Int’l Rehab. Sci. v. Burwell, No. 08-cv-05442 (W.D. Wash. Feb. 13, 2015), the court found inadequate an advance beneficiary notice (ABN) which stated that “Medicare has not established coverage criteria... or does not...more
In previous Payment Matters articles, we described a policy included in the 2014 hospital outpatient prospective payment system (OPPS) final rule that would “package” certain clinical laboratory tests into OPPS, and CMS...more
In a previous Payment Matters article, we described a new CMS policy under which, effective January 1, 2014, hospitals would no longer be permitted to bill Medicare separately for clinical laboratory tests for hospital...more
Hospitals Lose Right to Bill Separately for Laboratory Tests for Outpatients -
As part of its calendar year 2014 hospital outpatient prospective payment system (OPPS) policy changes, the Centers for Medicare & Medicaid...more
The Centers for Medicare & Medicaid Services (CMS) recently amended Medicare Claims Processing Manual (MCPM) provisions related to payment for anatomic pathology services to specifically address submission of such claims on a...more
District Court Finds That Medical Group’s Failure to Further Investigate Audit Results May Violate Requirement to Return Overpayments -
Background -
Internal audits of third-party payment claims – frequently...more
In our June 12, 2009 Payment Matters, we commented on a recent change in the Medicare Claims Processing Manual (MCPM) that would require claims for physician pathology services to be billed as separate line items if the two...more