Physicians Office of the Inspector General

News & Analysis as of

Watch Out! Recent Government Settlements Implicate Referring Physicians and Laboratories

$48.5 million settlement with Health Diagnostics Laboratory, Inc. and Singulex, Inc. - On April 9, 2015, the U.S. Department of Justice ("DOJ") announced a $48.5 million settlement with two cardiovascular diagnostic...more

Medicare Access and CHIP Reauthorization Act: Paving the Way for Broader Gainsharing Activities

On April 16, 2015, President Obama signed into law H.R.2, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), a critical piece of health care legislation which represents significant movement towards a health...more

SGR Legislation Includes Gainsharing Fix and More Anti-Fraud Measures

The legislation repealing the Medicare sustainable growth rate formula (SGR), signed by President Obama on April 16, 2015, contained several anti-fraud related provisions that affect the health care industry. The provision...more

Blog: Fraud Watch: Laboratory Referrals Under Government Scrutiny

Significant recent regulatory and enforcement activity related to laboratory fees and services continues to demonstrate an increased focus on this industry. Government enforcers are active in cases involving both the...more

SGR Law Brings Changes to CMP Prohibition on Gainsharing

On April 16, President Barack Obama signed into law the “Medicare Access and CHIP Reauthorization Act of 2015,” ending a perennial struggle over the Medicare reimbursement formula for physicians. Although the law is most...more

OIG Nixes Arrangements Involving Free Tests

Labs Attempt to Counter Exclusive Lab Arrangements - With increasing frequency, clinical laboratories have found themselves unable to receive any payments for tests performed for individuals whose third-party insurer...more

OIG Issues Unfavorable Advisory Opinion on Proposal for Exclusive Laboratory Services Arrangements

On March 25, 2015, the U.S. HHS Office of Inspector General (OIG) released an unfavorable Advisory Opinion in which it found that it could potentially impose administrative sanctions and exercise its permissive exclusion...more

OIG Warns Lab “Pull-Through” Arrangements May Be Illegal

In an important advisory opinion, the U.S. Department of Health and Human Services Office of Inspector General (OIG) gave a thumbs-down to a proposed clinical laboratory “pull-through” arrangement even though the patients in...more

OIG: Exclusive laboratory arrangement may violate Antikickback Statute and result in exclusion for excessive charges

On March 25, 2015, the Office of Inspector General (“OIG”) issued Advisory Opinion 15-04, which found that an exclusive arrangement between a laboratory and its referring physician practices could violate the Federal...more

Blog: OIG Releases Advisory Opinion Regarding Laboratory and Physician Practice Agreement

On March 25, 2015, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion No. 15-04. In the opinion, the OIG addresses a laboratory’s proposal to enter into agreements...more

OIG Finds Exclusive Lab Arrangement May Violate Anti-Kickback Statute

Yesterday the Office of Inspector General for the Department of Health and Human Services (the “OIG”) issued Advisory Opinion 15-04 (“Advisory Opinion”) in which it found that an exclusive arrangement between a laboratory...more

OIG Advises that Exclusive Lab Referral Arrangement May be a Kickback

The Department of Health and Human Services Office of Inspector General (OIG) released an advisory opinion (No. 15-04) today that states a proposed arrangement to provide free laboratory tests for certain patients of...more

OIG Examines Appropriateness of Medicare Ophthalmology Claims

The OIG recently assessed the appropriateness of claims submitted by providers for screening for, diagnosing, evaluating, or treating cataracts, wet age related macular degeneration (wet AMD), and glaucoma in 2012....more

Challenges Physicians Can Expect in 2015

Reimbursement for medical services continues to decline. Continuing uncertainty about the Affordable Care Act persists. Government regulations create burdensome paperwork, busywork, and compliance headaches. Technology costs...more

CMS Releases Final Rule That Increases Difficulty of Medicare Enrollment

In early December, CMS released a final rule that implements certain provider (i.e., Hospitals, SNFs, physicians, etc.) and supplier (i.e., DME companies, etc.) enrollment requirements (“Rule”). The goal of CMS’...more

OIG Releases Proposed Gainsharing Regulation

In early October, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) released a proposed rule that included, among other provisions, a proposed gainsharing regulation (“Proposed Rule”),...more

The Game Plan for Health Care Enforcement: Office of Inspector General Releases 2015 Work Plan

The Office of Inspector General (“OIG”) within the federal Department of Health and Human Services (“HHS”) is charged with protecting the integrity of HHS programs by combating fraud, abuse and waste. On Halloween of 2014,...more

Arrangements between Laboratories and Referring Physicians Involving “Registries”

The United States Office of Inspector General (“OIG”) recently issued a “Special Fraud Alert” focusing on two potentially illegal trends that it has detected in arrangements between laboratories and their referring...more

Do You Offer or Accept Copayment Coupons? OIG says YOU are Responsible for Compliance with Federal Law

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...more

Analysis of HHS OIG Proposed Rule to Amend the Anti-Kickback Safe Harbors, CMP Rules on Beneficiary Inducements & Gainsharing...

On October 3, 2014, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) published a major proposed rule that would amend the safe harbors to the Anti-Kickback Statute (AKS) and the Civil...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 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

OIG Proposes New Safe Harbors to the Anti-Kickback Statute and New Exceptions to the Two Civil Monetary Penalty Provisions

On October 3, 2014, the Department of Health and Human Services’ Office of Inspector General (“OIG”) published a proposed rule (“Proposed Rule”) to add new safe harbors to the federal health care program anti-kickback statute...more

Proposed Updates to the Civil Monetary Penalties Law for Health Care Providers

On October 3, 2014, the Office of Inspector General of the Department of Health and Human Services (“OIG”) published a proposed rule and request for comments (“Proposed Rule”) that would amend certain rules under the Civil...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

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