Bridgette Keller on Anti-Kickback Statute

Senate Democrats Pass Long-Awaited Drug Pricing Reforms in Budget Reconciliation Bill

On August 7, 2022, after extensive deliberation, Senate Democrats passed their long-awaited reconciliation bill, the Inflation Reduction Act of 2022 (the Reconciliation Bill). In addition to climate and tax provisions, the...more

8/10/2022 / Anti-Kickback Statute , Biosimilars , Budget Reconciliation , Drug Pricing , Medicare , Medicare Part D , Out-of-Pocket Expenses , Pharmacy Benefit Manager (PBM) , Price Inflation , Transparency

Final Medicare Advantage and Part D Rule will Likely Require Medicare Advantage Plans to Update 2023 Bids under Maximum...

The Centers for Medicare & Medicaid Services (CMS) released its Final Rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (Final Rule) late last...more

5/5/2022 / Anti-Kickback Statute , Centers for Medicare & Medicaid Services (CMS) , Final Rules , Medicaid , Medicare , Medicare Advantage , Medicare Part D , Out-of-Pocket Expenses , Proposed Rules

HHS Finalizes Highly Anticipated Final Rules Amending AKS and Stark Law Regulations, Part IV: Changes to Existing Safe Harbors and...

As you know, we have been parsing through the HHS rules that finalize important changes to the Anti-Kickback Statute (AKS) and Physician Self-Referral Law (Stark Law) regulations. To recap, our team provided an overview of...more

12/11/2020 / Anti-Kickback Statute , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Final Rules , Health Care Providers , OIG , Remuneration , Safe Harbors , Stark Law , Value-Based Care

DOJ Follows Through on a 2018 New Year's Resolution: Rein In Qui Tam Actions

Along with most of us, last January DOJ set its own goals for 2018: new policies related to False Claims Act (“FCA”) enforcement. One such “resolution” for 2018 was the DOJ Civil Fraud section’s instruction to its attorneys...more

12/21/2018 / Anti-Kickback Statute , Department of Justice (DOJ) , Enforcement Actions , False Claims Act (FCA) , Health Care Providers , Healthcare Fraud , Qui Tam , Relators

OIG Says Proposed MCO Incentive Program Protected by AKS Safe Harbor

In its favorable Advisory Opinion 18-11, the OIG explains how a managed care organization’s proposed incentive program to pay network providers to increase the amount of Early and Periodic Screening, Diagnostic, and Treatment...more

11/20/2018 / Advisory Opinions , Anti-Kickback Statute , Beneficiaries , Health Care Providers , Incentives , Managed Care Contracts , MCOs , Medicaid , OIG , Safe Harbors

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: March 2017

Trends & Analysis - ..This issue looks at 18 health care–related qui tam cases that were unsealed in whole or in part in late October through November 2016. ..The cases identified were filed in federal district courts...more

3/20/2017 / Anti-Kickback Statute , False Claims Act (FCA) , Medicaid , Medicare , Personal Care Assistants , Qui Tam , Traumatic Brain Injuries

Government Announces Health Care Fraud “Takedown”

Earlier today, Attorney General Loretta Lynch announced the largest coordinated crackdown in the Medicare Fraud Strike Force’s eight-year history. The government brought charges against 243 individuals for approximately $712...more

6/19/2015 / Anti-Kickback Statute , Health Care Providers , Healthcare Fraud , Home Health Care , Home Healthcare Workers , Medicare , Medicare Fraud Strike Force , Medicare Part D , Nurses , Physicians

Mintz Levin Health Care Qui Tam Update - Recently Unsealed Whistleblower Cases: June 2015

Trends & Analysis: ..We have identified 33 health care–related qui tam cases that have been unsealed in whole or in part since the cases covered in our last Qui Tam Update. In addition, we have also identified one case...more

6/8/2015 / Anti-Kickback Statute , Clinical Trials , False Claims Act (FCA) , Hospitals , Medical Devices , Qui Tam , Whistleblower Protection Policies , Whistleblowers

OIG Special Advisory Bulletin Provides Guidance on Application of Federal Anti-Kickback Statute to Pharmaceutical Manufacturer...

In recent years, copayment coupon programs have become standard promotional practices for both large and small pharmaceutical manufacturers. Copayment coupons are typically offered to commercially insured patients in order to...more

10/21/2014 / Affordable Care Act , Ambulance Providers , Anti-Kickback Statute , CMP Law , Gainsharing , Hospitals , OIG , Pharmacies , Physicians , Proposed Regulation , Safe Harbors

Bridgette Keller

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