Category Archives: OIG Reports

Supplemental Special Advisory Bulletin Clarifies OIG Positions on Independent Charity Patient Assistance Programs

Introduction

The OIG has released a Supplemental Special Advisory Bulletin that “reiterates and amplifies” previous OIG Special Advisory Bulletin guidance from 2005. Pharmaceutical manufacturers and Patient Assistance Programs that provide independent, charitable support for patients’ drug expenses (PAPs) should be aware of this supplemental guidance, as the OIG notes that it may modify some previously-issued favorable advisory opinions. Specifically, in this bulletin the OIG expands on its previous guidance regarding disease funds, eligible recipients, and the conduct of donors.

Background

PAPs provide cost-sharing assistance for patients who cannot afford their prescription medications. Continue reading

OIG Issues Report on Limited Compliance with Medicare’s Face-to-Face Requirement for Home Health Services

On April 9, 2014, the US Department of Health and Human Services Office of the Inspector General’s (OIG) Office of Evaluation and Inspections (OEI) issued a report (OEI-01-12-00390) entitled “Limited Compliance With Medicare’s Home Health Face to Face Documentation Requirements.”

The Center for Medicare and Medicaid Services (“CMS”) requires physicians to physically see and evaluate patients for home health services. The Patient Protection and Affordable Care Act requires the physicians to document this face-to-face visit as a condition of payment. The face-to-face requirement was implemented to help prevent fraud in home health. The idea is that requiring physicians to document the specifics of a face-to-face visit with a Medicare beneficiary will help prevent fraud by ensuring the physician actually saw and assessed the beneficiary before certifying the patient as eligible for home health services. Continue reading

HIPAA Security Rule Enforcement Not Yet Meeting Federal Requirements

A recent Office of the Inspector General (OIG) Report reviews progress made by the Office for Civil Rights (OCR) toward enforcement of the Health Insurance Portability and Accountability Act (HIPAA) Security Rule following the 2009 Health Information Technology for Economic and Clinical Health Act (HITECH) amendments. The OIG found OCR enforcement to be meeting Federal HIPAA requirements in some key areas, but to be wanting in others.

OCR enforcement activities meeting Federal requirements include, (1) making available guidance promoting compliance with the Security Rule; (2) the investigation process for responding to reported Security Rule violations; and (3) proper application of penalties for covered entities found in violation of the Security Rule. Continue reading

Office of Inspector General Issues Strategic Plan

The Office of the Inspector General (“OIG”) issued a 2014-2018 strategic plan including outlining the visions, goals, and priorities of that office for the upcoming several years. The plan sets forth four goals: 1. Fight fraud, waste and abuse; 2. Promote quality, safety, and value; 3. Secure the future; and 4. Advance excellence and innovation. Each goals is identified with several priority areas that support the stated goal. The report can be found at the OIG’s website http://go.us.gov/WdbV