The Health Resources and Services Administration ("HRSA") plans to implement a limited pilot program that will allow approved manufacturers to issue post-purchase rebates for 340B covered outpatient drugs rather than upfront...more
8/18/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Insurance ,
Healthcare ,
HRSA ,
Manufacturers ,
Medicare ,
Patient Access ,
Pharmaceutical Industry ,
Pilot Programs ,
Prescription Drugs ,
Rebates ,
Section 340B
New CMS program, WISeR, will leverage third parties to screen prior authorization requests using technologically enhanced processes....more
8/7/2025
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Innovative Technology ,
Machine Learning ,
Medicare ,
Medicare Advantage ,
Prior Authorization ,
Regulatory Requirements ,
Technology-Assisted Review
The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the third of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding drugs,...more
6/13/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Data Collection ,
Data Management ,
Digital Health ,
Drug Pricing ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Life Sciences ,
Medicaid ,
Medical Devices ,
Medicare ,
Patient Access ,
Pharmaceutical Industry ,
Value-Based Care
Following a jury's verdict, a federal court slashed civil penalties under the False Claims Act ("FCA") as violative of the Constitution's 8th Amendment....more
3/28/2025
/ Constitutional Challenges ,
Damages ,
Eighth Amendment ,
Excessive Fines Clause ,
False Billing ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
Healthcare Fraud ,
Medicare ,
Penalties ,
Treble Damages
The Increasing Organ Transplant Access Model ("IOTA Model") introduces mandatory financial incentives and penalties for selected kidney transplant hospitals....more
1/29/2025
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
Healthcare ,
Hospitals ,
Incentives ,
Medicare ,
Organ Transplant Centers ,
Penalties ,
Regulatory Requirements ,
Value-Based Care
The Situation: The False Claims Act ("FCA") imposes treble damages on defendants, as well as mandatory penalties per false claim. Because alleged false claims often involve much smaller amounts—for example, in cases with a...more
8/19/2024
/ Corporate Counsel ,
Due Process ,
Eighth Amendment ,
Excessive Fines Clause ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Medicaid ,
Medicare ,
Treble Damages
In Short -
The Situation: Under 42 U.S.C. § 1320a-7b(g), a claim that "includes items or services resulting from a violation" of the Anti-Kickback Statute ("AKS") is a false claim for purposes of the False Claims Act...more
A defendant who violates the FCA can be liable for treble damages plus a civil penalty of $5,500 to $11,000 (adjusted for inflation) for each false claim. Meanwhile, FCA lawsuits often involve tens of thousands of alleged...more
2/3/2022
/ Civil Monetary Penalty ,
Eighth Amendment ,
Excessive Fines Clause ,
False Claims Act (FCA) ,
False-Certification of Conformance ,
Fines ,
Health Care Providers ,
Medicare ,
Qui Tam ,
Reimbursements ,
Relators ,
Statutory Violations ,
Treble Damages
A recent split decision from the United States Court of Appeals for the Seventh Circuit strengthens an argument many defendants of False Claims Act ("FCA") cases have been advancing for years: the violation of an ambiguous...more
8/23/2021
/ Enforcement Actions ,
False Billing ,
False Claims Act (FCA) ,
Fraud ,
Medicaid ,
Medicare ,
Pharmacies ,
Qui Tam ,
Relators ,
Safeco ,
Statutory Requirements
On June 9, 2017, the U.S. District Court for the District of Columbia denied a motion to dismiss brought by a laboratory in U.S. ex rel. Groat v. Boston Heart Diagnostics Corp., 2017 WL 2533341. Part of the grounds for...more