Author Archives: Heather E. Baird

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

CMS Final Rule on Moratoria for the Enrollment of New Home Health Agencies and Ambulance Suppliers and Providers

On February 4, 2014, the Centers for Medicare and Medicaid Services (CMS) issued in the Federal Register a notice of temporary moratoria on enrollment of new home health agencies (HHA) and ambulance suppliers and providers in certain geographic locations across the U.S. The moratoria were effective on January 30, 2014. CMS also extended existing moratoria noticed on July 31, 2013. Continue reading

OIG Releases 2014 Work Plan

The OIG recently made available its 2014 Work Plan. The Plan identifies OIG focus areas and priority projects for the coming year. This post provides a brief summary of many of the new OIG projects for fiscal year 2014 to assist providers in keeping abreast of the latest developments in health care fraud and abuse, compliance, reimbursement, and enforcement activities. Only a small part of the Plan is summarized here. For the entire document, please follow the link below. 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

Long Term Care Facilities Should Anticipate Increased Scrutiny on Nursing Home Trust Fund Oversight

USA Today recently published a report about theft from nursing home resident trust funds by facility employees. According to USA Today’s analysis of data from the Centers for Medicare and Medicaid Services (“CMS”), more than 1,500 nursing homes have been cited since 2010 for mismanaging trust funds—of the more than 100 thefts identified, at least 10 exceeded $100,000. The report warns about inadequate oversight, at both the nursing home and state surveyor level, to effectively protect the integrity of resident funds from employee theft. Continue reading

New CMS Guidance Encourages Facility Buyers to Accept Automatic Assignment of Medicare Provider Agreements

Earlier this month, the Centers for Medicare and Medicaid Services (“CMS”) released a policy memorandum announcing stricter Medicare certification practices for buyers of Medicare-participating providers opting to reject the automatic assignment of the seller’s Medicare provider contracts. When a purchaser is considering opting out of automatic assignment, it must carefully weigh the risk of reimbursement gaps with the benefit of reduced liability exposure.   Continue reading