News & Analysis as of

Office of the Inspector General Hospitals Medical Devices

Arnall Golden Gregory LLP

OIG Determines That Providing Free Hearing Aids to Bimodal-Hearing Candidates Implicates the Anti-Kickback Statute and Beneficiary...

On October 20, 2023, the Office of Inspector General of the Department of Health and Human Services (“OIG”) issued an unfavorable Advisory Opinion No. 23-08 to a supplier of cochlear implants coupled with external sound...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | May 2022 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights notable enforcement activity between April 21 and May 20, 2022, including a telemedicine case involving $64 million in false and fraudulent claims. We also...more

Rivkin Radler LLP

OIG: Hospitals Need To Improve Oversight Of Cybersecurity For Networked Medical Devices

Rivkin Radler LLP on

On June 23, the Department of Health and Human Services Office of Inspector General (OIG) posted on its website an Issue Brief entitled “Medicare Lacks Consistent Oversight of Cybersecurity for Networked Medical Devices in...more

ArentFox Schiff

New Safe Harbors Offer Opportunities for Innovative Arrangements, Including Digital Health

ArentFox Schiff on

Recent updates to the federal Anti-Kickback Statute give providers additional flexibility to enter into innovative arrangements, but before doing so, providers must ensure they understand the safe harbor requirements...more

Health Care Compliance Association (HCCA)

Hospitals Were Overpaid $33M Over Device Credits; Policy May Change

Report on Medicare Compliance 29, no. 42 (November 23, 2020) - Medicare administrative contractors (MACs) will be coming to 911 hospitals for overpayments caused by unreported manufacturer credits for recalled or...more

Dorsey & Whitney LLP

OIG Skeptical of Medical Device and Pharmaceutical Speaker Programs

Dorsey & Whitney LLP on

The Department of Health and Human Services Office of Inspector General (“OIG”) has issued a Special Fraud Alert to highlight what it views as inherent risks associated with speaker programs that pharmaceutical and medical...more

Baker Donelson

OIG Approves Warranty Program for Surgical Devices and Wound Care Products in Advisory Opinion 18-10

Baker Donelson on

In Advisory Opinion 18-10, issued September 10, 2018, the OIG permitted a manufacturer of surgical devices and wound care products to implement a warranty program under which the manufacturer's hospital customers could...more

Mintz - Health Care Viewpoints

OIG Opinion Illustrates the Need for New AKS Safe Harbors

The Department of Health and Human Services Office of the Inspector General (OIG) has issued Advisory Opinion No. 18-10 (Opinion) in response to a proposal by a surgical device and wound care product manufacturer...more

Robinson+Cole Health Law Diagnosis

OIG Advisory Opinion Approves Surgical Device Warranty Program Intended to Reduce Readmissions

On September 17, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services published a favorable Advisory Opinion allowing a manufacturer of surgical devices and wound care products to offer a...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2017

Bass, Berry & Sims PLC on

A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more

Mintz - Health Care Viewpoints

Pharmaceutical Manufacturers and Healthcare Leaders cite Fraud and Abuse Laws as Obstacle to Value-Based Arrangements

As the healthcare industry moves towards value-based purchasing, pay-for-performance, and other payment reform models, industry leaders have identified federal fraud and abuse laws as a barrier to full implementation of such...more

Dorsey & Whitney LLP

OIG Releases 2017 Work Plan

Dorsey & Whitney LLP on

Executive Summary - The United States Department of Health and Human Services Office of the Inspector General (“OIG”) published its Fiscal Year 2017 Work Plan (“2017 Plan”) on November 10, 2016. The work plan is...more

Hinshaw & Culbertson LLP

Significant Hospital Related Mid-Year Updated OIG Review Activities

This is the second of three alerts discussing the mid-year update to the Fiscal Year 2016 Work Plan issued by the Office of Inspector General (OIG). In the first alert we discussed the top management performance challenges...more

Alston & Bird

Health Care Advisory: Highlights of the OIG’s 2016 Work Plan

Alston & Bird on

On November 2, 2015, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) issued its Work Plan for Fiscal Year 2016 (“2016 Work Plan”).1 The 2016 Work Plan outlines the areas of...more

King & Spalding

OIG Releases FY 2016 Work Plan

King & Spalding on

On November 2, HHS OIG released its FY 2016 Work Plan. The Work Plan summarizes new and ongoing OIG reviews with respect to HHS programs and operations, providing an advance notice to the industry, policymakers, and the...more

Baker Donelson

OIG Hospital Compliance Audits: Is Your Number Up? Are You Ready?

Baker Donelson on

In its Work Plan for Fiscal Year 2012, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) announced it would begin reviews of Medicare payments to hospitals to determine compliance...more

Mintz - ML Strategies

Health Care Update - July 2015

Mintz - ML Strategies on

In This Issue: - Medicare Releases Set of Payment Rules, Physician Fee Schedule on Deck - Implementation of the Affordable Care Act - Federal Regulatory Initiatives - Congressional Initiatives - Other...more

King & Spalding

OIG Releases Mid-Year Update to its Work Plan

King & Spalding on

On May 28, 2015, the OIG published a revised version of its Work Plan for Fiscal Year (FY) 2015. As previously reported, the original version of the FY 2015 Work Plan was published in October and summarized the OIG's ongoing...more

Cozen O'Connor

CMS Releases Final Rule That Increases Difficulty of Medicare Enrollment

Cozen O'Connor on

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

Baker Donelson

OIG's 2015 Work Plan Highlights Departmental Priorities

Baker Donelson on

Each year the Department of Health and Human Services, Office of the Inspector General (OIG) issues its Work Plan to identify for the provider community the key fraud and abuse issues on which it will focus on in the coming...more

Parker Poe Adams & Bernstein LLP

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

Cooley LLP

Blog: HHS OIG Hands Out 2015 Work Plan For Halloween

Cooley LLP on

On Friday October 31, 2014, the U.S. Department of Health & Human Services (HHS) Office of Inspector General (OIG) released its annual “Work Plan” for fiscal year 2015. The Work Plan is a compilation of the OIG’s plans for...more

The Volkov Law Group

The Healthcare Industry And Chief Compliance Officers

The Volkov Law Group on

The healthcare industry has been an innovative leader in developing compliance tools and strategies. They have come by it honestly – prosecutors and HHS-OIG have been pounding on pharmaceutical companies, medical device...more

Baker Donelson

OIG Report Concludes that Physician-owned Distributors Increase Utilization

Baker Donelson on

In response to the U.S. Senate Committee on Finance’s continued questioning of physician-owned distributorships (PODs), the U.S. Department Health and Human Services Office of the Inspector General issued its long-awaited...more

Baker Donelson

OIG Calls PODs "Inherently Suspect"

Baker Donelson on

Making its most strongly worded statement to date, the Department of Health and Human Services Office of Inspector General (OIG) issued a Special Fraud Alert on Physician-Owned Entities on March 26, 2013, calling...more

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