News & Analysis as of

HHS to Audit Hospital Reporting of GPO Payments: GAO Report Suggests Further Scrutiny of GPO Shareback with Hospitals

On November 24, 2014, the Government Accountability Office (“GAO”) published a report examining the contracting practices and funding structures of health care group purchasing organizations (“GPOs”) and their potential...more

OIG Again Approves Medicap Insurer's Contract with Preferred Hospital Network

On October 21, 2014, the Department of Health and Human Services, Office of Inspector General (OIG) issued Advisory Opinion 14-10, approving a Medigap insurer’s proposed contract with a preferred hospital network. Similar to...more

Health Law Pulse - October 2014 # 2

In This Issue: - OIG Releases Proposed Rule Revising the Anti-Kickback Statute Safe Harbors and Civil Monetary Penalty Rules ..AKS Safe Harbors ..Revisions to the Civil Monetary Penalty...more

Health Law Alert: OIG Releases Proposed Revisions to Anti-Kickback Safe Harbors and Civil Monetary Penalty Rules

The Department of Health and Human Services Office of Inspector General (OIG) recently released a proposed rule that revises safe harbors under the Anti-Kickback Statute (AKS) and Civil Monetary Penalty (CMP) rules regarding...more

OIG Announces Proposed AKS and CMP Regulations

On October 3, 2014, the Office of the Inspector General (“OIG”) issued a proposed rule codifying into regulation several statutory changes to the Antikickback Statute (“AKS”) and the Civil Monetary Penalty (“CMP”) Law. Nearly...more

OIG Proposed Anti-Kickback Safe Harbors and CMP Regulations: The End of Frustration or Just the Beginning?

On October 3, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published an unexpected, yet long-awaited, set of proposed rules that would add new anti-kickback law safe harbors,...more

OIG Releases New Proposals on Anti-kickback Statute Safe Harbors, Exceptions to the CMP Law and the Gainsharing Prohibition

On October 3, 2014, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a long-awaited proposed rule for implementing amendments to safe harbors under the Anti-kickback Statute and...more

OIG Releases Proposed Rule Adding New Safe Harbors to the Anti-Kickback Statute

Last week, the HHS OIG released a proposed rule published in the October 3 Federal Register that would add new safe harbors to the Anti-Kickback Statute and expand the list of conduct exempt from civil monetary penalties...more

Whistleblower Goes It Alone to Secure $5 Million Settlement under False Claims Act

The potential success of a whistleblower lawsuit filed under the False Claims Act (FCA) is significantly reduced when the government fails to intervene because such cases are often assumed to lack merit. However, a plaintiff...more

OIG Offers Greater Protections for Health Care Providers in New Proposed Rule

On October 3, 2014, the U.S. Department of Health and Human Services of the Office of Inspector General (OIG) issued a Proposed Rule amending both the safe harbors to the anti-kickback statute and the civil monetary penalty...more

Sometimes the Government is Here to Help: OIG Proposes More Flexibility in Rules Governing Local Transportation, Beneficiary...

The U.S. Department of Health & Human Services, Office of Inspector General ("OIG") just released a proposed rule (“Proposed Rule”) that provides long awaited guidance on patient transportation services, relaxes the...more

Blog: OIG Releases Proposed Rule re: Beneficiary Inducements and Gainsharing Revisions

The Health and Human Services Office of Inspector General (OIG) released today a proposed rule titled, Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors under the Anti-Kickback Statute, and...more

Department of Justice Files First False Claims Act Lawsuit Against Physician-Owned Distributorship

On Sept. 8, 2014, the United States Department of Justice (DOJ) filed a 98-page civil complaint alleging that investment returns, paid to a Michigan spinal surgeon and other physicians by a spinal implant company partially...more

OIG Warns Pharma Its Copayment Coupons May Aid Crime

Brand name drugs cost a lot. So to make them more attractive, drug manufacturers issue coupons for discounts on the copayment portion of the price. They work the same as the dollar-off coupons offered by cereal manufacturers....more

OIG Issues Special Advisory Bulletin Covering Manufacturer Copay Coupons and Medicare Part D

For years, many drug manufacturers have issued coupons to help cover some or all of the cost of copayments (commonly referred to as a “copay”) for prescription medications. While the Department of Health and Human Services...more

OIG Advisory Opinion Approves Medigap Insurer’s Plan to Use Preferred Hospital Network

On August 25, 2014, the OIG released an advisory opinion declining to impose civil monetary penalties on a Medicare Supplemental Health Insurance – or Medigap – insurer that planned to discount inpatient hospital deductibles...more

Whistleblower Receives More Than $17 Million in Omnicare Case

A decision has been made in the case against Omnicare, Inc. that will net a former Omnicare pharmacist more than $17.2 million in the ensuing settlement. The settlement with the Department of Justice orders Omnicare,...more

Lessons From Omnicare Settlement In 'Swapping' Cases

On June 25, the U.S. Department of Justice announced that it had settled with Omnicare Inc. in two matters alleging that kickbacks resulted from below-cost discounts offered to skilled nursing homes as an inducement to select...more

New OIG Special Fraud Alert Focuses on Suspect Practices of Labs and Referring Physicians - Certain Payment Arrangements May Be a...

The U.S. Department of Health and Human Services' Office of Inspector General (OIG) issued a new Special Fraud Alert on June 25, 2014, that focuses on certain compensation arrangements between laboratories and referring...more

Do Subsidized Health Care Plans Purchased Under the Affordable Care Act Trigger the Anti-Kickback Statute?

The advent of federally subsidized private pay health insurance under the Affordable Care Act has the potential to expand the application of the federal anti-kickback statute beyond just Medicare, Medicaid, and Tricare. The...more

Jury Verdict Against Millennium Provides Insight on Definition of Remuneration

Ameritox won the latest volley of an ongoing legal battle with Millennium when a federal jury in Florida awarded it $14.75 million on June 16, 2014. Ameritox persuaded the jury that Millennium’s free point of care test (POCT)...more

Healthcare Legal News - July 2014 • Volume 4, Number 2

In This Issue: - DO SUBSIDIZED HEALTH CARE PLANS PURCHASED UNDER THE AFFORDABLE CARE ACT TRIGGER THE ANTI-KICKBACK STATUTE? The advent of federally subsidized private pay health insurance under the Affordable...more

Drug Distributor and Pharmacies Obtain Partial Dismissal of State and Federal FCA Claims

On June 10, 2014, a New York federal court dismissed, in part, state and federal False Claims Act (FCA) claims brought against Novartis Pharmaceuticals Corporation and pharmacies to which it distributed (CVS Caremark Corp.,...more

Commission-Based Sales Agreements for Medical Supplies and Equipment: More Whistleblower Activity on the Horizon? - A Wide Range...

The common industry practice of compensating independent contractor sales representatives on a "percentage of sales" commission basis may be creating an enhanced risk of False Claims Act liability for illegal kickbacks in...more

OIG Supplemental Special Advisory Bulletin Raises New Concerns About Independent Charity Patient Assistance Programs

In an effort to address new concerns about the independence of charity patient assistance programs (PAPs), the Office of Inspector General (OIG) released its Supplemental Special Advisory Bulletin: Independent Charity Patient...more

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