The Centers for Medicare and Medicaid Services (CMS) continues to offer guidance related to the coronavirus (COVID-19) outbreak. On March 10, CMS issued a memo to all Medicare Advantage (MA) organizations and Part D sponsors...more
• The Centers for Medicare & Medicaid Services (CMS) has announced a new Medicare Part D demonstration to address the potential implementation of a recent proposed rule that would exclude from anti-kickback safe harbor...more
4/10/2019
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Manufacturers ,
Medicare ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Proposed Rules ,
Rebates ,
Safe Harbors
The Centers for Medicare and Medicaid Services (CMS) has just announced a significant shift in Medicare Part D formulary design to allow Part D sponsors to customize their formularies based not just on the drug, but also...more
Centers for Medicare and Medicaid Services (CMS) has just issued guidance to address Medicare Part D coverage for newer insulin delivery devices for the treatment of diabetes. Medicare Part D has historically covered “medical...more
OIG Advisory Opinions -
Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized -
On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more
9/6/2017
/ Anti-Kickback Statute ,
Anti-Steering Rules ,
Appeals ,
Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
EMTs ,
Expert Testimony ,
False Claims Act (FCA) ,
False Statements ,
Food and Drug Administration (FDA) ,
FRCP 9(b) ,
Health Care Providers ,
Health Insurance ,
Hip Replacement ,
Hospitals ,
Litigation Strategies ,
Manufacturers ,
Medicaid Reimbursements ,
Medicare ,
Medicare Part D ,
Misrepresentation ,
OIG ,
Patient Safety ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Defects ,
Qui Tam ,
Retaliation ,
Reversal ,
Witness Preparation
Last month, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services released a comprehensive report and data brief detailing its concerns about the ability of Medicare Part D sponsors – as...more
7/22/2015
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Healthcare ,
Healthcare Fraud ,
Medicaid ,
Medicare ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reporting Requirements
- CMS issues final Medicare Advantage and Part D regulatory changes after a controversial proposed rule was announced earlier this year.
- New requirements for the reporting and return of Medicare Advantage and Part D...more
The Medicare Advantage and Part D Final Call Letter announces requirements for the 2015 contract year, including changes to Part C and Part D star ratings and how CMS will evaluate Part D plan structures submitted for the...more
On May 23, 2013, CMS issued its Final Rule on Medical Loss Ratio (MLR) requirements for Medicare Advantage (MA) and Medicare Part D programs. MLR calculates the percentage of revenue used by MA organizations and Part D...more