• 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
The 340B Drug Pricing Program (340B Program), established by Section 602 of the Veterans Health Care Act of 1992, is administered by the Health Resources and Services Administration (HRSA) of HHS. The 340B Program requires...more
9/29/2015
/ Audits ,
Compliance ,
Covered Entities ,
Dental Practice ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Fee-for-Service ,
Healthcare ,
Hospice ,
Hospitals ,
HRSA ,
MCOs ,
Medicaid ,
Medicaid Reimbursements ,
Medical Reimbursement ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Section 340B ,
Skilled Nursing Facility
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 Massachusetts Board of Pharmacy (BOP) enacted emergency regulations effective November 1, 2012, in response to the deadly fungal meningitis outbreak caused by drug contamination at a Massachusetts compounding pharmacy....more