Over the past two years, federal and state government agencies have moved to regulate the deployment of artificial intelligence (AI) in the healthcare setting, including in the utilization management (UM) and prior...more
11/1/2024
/ Artificial Intelligence ,
Biden Administration ,
Congressional Intent ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Health Care Providers ,
Health Insurance ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hospitals ,
Med Tech ,
Medicare ,
Medicare Advantage ,
Medicare Advantage Organizations (MAOs) ,
New Legislation ,
Physicians ,
Prior Authorization ,
Regulatory Oversight ,
Regulatory Standards ,
Strategic Planning
The goal of value-based care (VBC) is to promote better care for individual patients and improved health outcomes for communities at reduced costs. This is an important and admirable purpose as many VBC stakeholders attempt...more
3/5/2024
/ ACOs ,
Alternative Payment Models (APM) ,
Anti-Kickback Statute ,
Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Compliance ,
Department of Health and Human Services (HHS) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Facilities ,
Industry Consolidation ,
Medicare ,
Medicare Advantage ,
OIG ,
Patient Privacy Rights ,
Regulatory Oversight ,
Rewards Programs ,
Value-Based Care
The Office of Inspector General of the U.S. Department of Health and Human Services (OIG) on Nov. 6, 2023, issued new General Compliance Program Guidance (GCPG) as a reference guide for the healthcare compliance community....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
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