In what passes for neon lights in the regulatory world, CMS said Medicare Advantage (MA) plans must follow the two-midnight rule, its case-by-case exception and the inpatient-only (IPO) list, according to the final 2024 rule...more
In a climate of shrinking margins, diminishing reimbursement, and frequent denials, healthcare organizations may make efforts to increase the volume of services they provide, especially those that are more profitable. Of...more
A recent decision by the U.S. District Court for the District of Columbia has clarified that a Medicare beneficiary may challenge a Medicare Local Coverage Determination (LCD) without first having to exhaust the lengthy...more
The year 2021 marks the 10th anniversary of the Bradley False Claims Act Year in Review. In that decade, much has remained the same in FCA enforcement. To start with the obvious: It continues to result in billions of dollars...more
On November 12, 2021, the Centers for Medicare and Medicaid Services (CMS) announced that it is rescinding the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” (MCIT/R&N) final rule,...more
On January 27, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued a national coverage determination (“NCD”) that authorizes Medicare coverage of next-generation sequencing (“NGS”) as a diagnostic laboratory...more
A few days before Thanksgiving, the news media published an internal memo by the Office of General Counsel (OGC) at the US Department of Health and Human Services (Department) to officials at the Centers for Medicare and...more
On October 31, 2019, the Office of General Counsel for the U.S. Department of Health and Human Services (HHS) issued an important memo from Kelly M. Cleary, CMS Chief Legal Officer, and Brenna E. Jenny, Deputy General...more
On October 29, 2019, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed decision memo with a national coverage determination (“NCD”) that would allow for Medicare coverage of next-generation sequencing...more
The Department of Justice (DOJ) recently announced a $1.99 million False Claims Act (FCA) settlement with GenomeDx Biosciences Corp. (“GenomeDx”), a laboratory headquartered in Vancouver, British Columbia with operations in...more
In October 2018, the Centers for Medicare & Medicaid Services (“CMS”) announced that it made significant changes to the process by which local coverage determinations (“LCDs”) are developed and issued. These changes were...more
On Oct. 3, 2018, the Centers for Medicare & Medicaid Services released a Fact Sheet summarizing key revisions to Chapter 13 of the Medicare Program Integrity Manual. These revisions, issued in response to the 21st Century...more
The Tenth Circuit Court of Appeals has issued a significant decision, finding that a physician’s medical judgment about the medical necessity of heart procedures can be “false or fraudulent” under the federal False Claims Act...more
On January 25, 2018, the U.S. Department of Justice (DOJ) issued a memorandum limiting the use of agency guidance documents in affirmative civil enforcement (ACE) cases. Stating that “[g]uidance documents cannot create...more
On July 11, 2016, Reps. Lynn Jenkins (R-Kan.) and Ron Kind (D-Wis.) introduced the Local Coverage Determination Clarification Act (H.R. 5721), with the goal of modifying the LCD process performed by Medicare Administrative...more