News & Analysis as of

Office of the Inspector General Dept. of Health and Human Services

Legislation, Lawsuit Cloud Future of 340B Program Payment Rate Reductions

by Jones Day on

The Situation: A Final Rule published by the Centers for Medicare & Medicaid Services carries a provision that reduces reimbursement for most 340B Program drugs dispensed by disproportionate share hospitals and rural referral...more

OIG: Medicare Program Integrity at the Top of HHS Management Challenges

by Reed Smith on

The OIG’s latest compilation of top HHS management and performance challenges flags vulnerabilities in key HHS health and social services programs, including includes the following: 1. Ensuring Program Integrity in...more

New OIG Project Expands Telemedicine Audits to State Medicaid Programs

by Foley & Lardner LLP on

Following on the heels of its plans to review Medicare payments for telehealth services, the federal Office of Inspector General (OIG) at the Department of Health & Human Services (HHS) just announced a new project to review...more

Hospitals Will Need Psychiatrists And Mental Health Professionals To Satisfy EMTALA

by Cozen O'Connor on

Hospitals that have emergency departments should call upon their “available resources” to screen and stabilize patients with mental health emergencies as required by the Emergency Medical Treatment and Labor Act (“EMTALA”)...more

Six Key Follow-Up Questions Asked by Congress in 340B Hearing

Earlier this month the House Energy and Commerce Committee’s subcommittee on Government Oversight and Investigations held its second hearing on the 340B Drug Discount Program. The hearing followed on the heels of a July 18th...more

OIG Work Plan – October 2017 Update

by Baker Ober Health Law on

The OIG added five new items to its Work Plan with its October 2017 monthly update. This is a decrease from the nine new items added to the Work Plan with the September 2017 update. (For more information on last month's Work...more

Blog: OIG Releases October Work Plan Items; Includes Opioid REMS and Specialty Drug Coverage and Medicare Reimbursement

by Cooley LLP on

As we recently announced, the Office of Inspector General (OIG) is updating its Work Plan monthly rather than its previous twice-yearly publications. The October updates include 5 new Work Plan items...more

OIG Finds Continued Procedural Errors in Hospital Outlier Payment Reconciliations

by Baker Ober Health Law on

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) recently released a report concluding that there are vulnerabilities in the process of reconciling Medicare hospital outlier payments....more

Retail Pharmacy: OIG Signals It’s Okay to Reward Again

by Morgan Lewis on

OIG Advisory Opinion paves the way for expanded retailer reward programs. The US Department of Health and Human Services Office of Inspector General (OIG) issued an advisory opinion on September 7 that provides important...more

HHS-OIG blesses product replacement program

by Dentons on

The federal health care program anti-kickback statute, 42 U.S.C. § 1320a-7b(b) (AKS), in addition to prohibiting payments for patient referrals, prohibits one party (such as a manufacturer) from providing anything of value to...more

In Targeting Outlier Payment Reconciliation, OIG Calls for an Aggressive Reading of CMS Reopening Regulations

by King & Spalding on

The HHS OIG recently published a report detailing CMS’s and Medicare Administrative Contractor’s (“MACs’”) ongoing issues in the outlier payment reconciliation process. A previous 2012 review identified 465 cost reports that...more

OIG Work Plan – September 2017 Update

by Baker Ober Health Law on

Beginning in June 2017, the OIG began making monthly Work Plan updates. These monthly updates create some practical challenges for health care providers and compliance professionals trying to make operational and compliance...more

OIG Advisory Opinion 17-03 Approves Pharmaceutical Manufacturer's Product Spoilage/Replacement Program

by Baker Ober Health Law on

A pharmaceutical manufacturer proposing to offer customers – at no additional cost – replacements for certain spoiled products that can no longer be administered to patients (Replacement Program) has been granted approval by...more

OIG Study Finds States Are Not Using Medicaid Payment Suspensions

by King & Spalding on

A recent HHS OIG review of 2014 data on fraud allegations found that significant challenges were limiting the States’ use of payment suspensions, even in the face of what CMS determined were credible allegations of provider...more

Concierge Medicine – Medicare Compliance Is Still A Consideration

by Farrell Fritz, P.C. on

In our July 10, 2017 post, Concierge Medicine – Is it for you?, we cautioned that Medicare compliance concerns do not fall away when moving to a concierge or direct-pay model. HHS has determined that concierge-style...more

Blog: OIG Releases September Work Plan Items; Includes Part D Sponsor Reporting of Rebates and Price Concessions to Medicare

by Cooley LLP on

As we recently announced, the Office of Inspector General (OIG) is updating its Work Plan monthly rather than its previous twice-yearly publications. The September updates include 9 new Work Plan items: Federal Marketplace...more

OIG Signs Up for Customer Loyalty Program

by BakerHostetler on

In Advisory Opinion 17-05, posted by the U.S. Department of Health and Human Services Office of Inspector General (OIG) on September 7, 2017, the OIG approved a pharmacy’s customer loyalty/discount program (Benefit Program)....more

Inspector General Audit Could Impact Skilled Nursing Facilities

by Ruder Ware on

Skilled nursing facilities (SNF) may see even more scrutiny from the Centers of Medicare and Medicaid Services (CMS) because of a recent audit conducted by the Office of Inspector General of the U.S. Department of Health and...more

OIG Issues Advisory Opinion to Pharmacy

On September 7, 2017, the HHS Office of Inspector General (OIG) issued an Advisory Opinion to the owner of a retail pharmacy chain (Pharmacy) that would allow Federal health care program beneficiaries to participate in a paid...more

Healthcare Law Update: September 2017

by Holland & Knight LLP on

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

OIG Issues Stark Warning to Skilled Nursing Facilities: Potential Abuse or Neglect of Residents Receiving Emergency Room Services...

On August 24, 2017, the Office of Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”) issued an “Early Alert” that disclosed the preliminary results of its ongoing review of abuse of Medicare...more

OIG’s Expanded Interpretation of Warranty Safe Harbor Portends Well for Value-Based Health Care

by Ropes & Gray LLP on

In a new advisory opinion, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) clarified the scope of the Anti-Kickback Statute (“AKS”) warranty safe harbor (the “Warranty Safe Harbor”). In...more

HHS-OIG Issues Favorable Opinion on Pharmaceutical Spoilage Replacement Program

by McGuireWoods LLP on

On Aug. 25, 2017, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published a favorable advisory opinion regarding a pharmaceutical manufacturer’s proposed replacement program for spoiled...more

OIG Makes Monthly Update to Its Work Plan

by King & Spalding on

Last month, the HHS Office of Inspector General (OIG) announced that it would start updating its Work Plan website on a monthly basis instead of only once or twice per year. Consistent with this new initiative, the OIG...more

The Four Things That Surprised Us in the EpiPen False Claims Settlement

On August 17, 2017, the U.S. Department of Justice (DOJ) announced that it had reached a $465 million false claims settlement with Mylan, the manufacturer of EpiPen, over the company’s alleged underpayment of Medicaid Drug...more

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