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OCR Settlement Lessons – Failing to Perform an Electronic Access Risk Analysis Before an Unauthorized Access Occurs

Posted on May 3, 2017 by

Failure to conduct a risk assessment before a hacking incident occurred resulted in a $400,000 settlement between the Office of Civil Rights (OCR) and a Federally Qualified Health Clinic (FQHC).  The FQHC filed a breach report upon learning its employee emails had been hacked and the hacker had access to electronic health information of over […]

Suggested Questions for the Compliance Officer

Posted on April 19, 2017 by

In a previous blog post, I promised to release a list of questions a Board of Directors (Board) might ask its compliance officer.  This post is intended to fulfill that promise.  My intent is to help Board members exercise their oversight responsibility, assess the compliance officer, and further their understanding of the compliance program and […]

Exercising Board Oversight of the Compliance Function

Posted on April 19, 2017 by

How the Board can Enhance Compliance Effectiveness The Board of Directors (Board) of an organization has oversight responsibilities over the compliance program.  Board members are often unsure of the nature and scope of their responsibilities over compliance.  The roll of many Boards is limited to receiving occasional updates from the compliance officer.  Compliance is then […]

Self-Disclosure Has Become a Normal Part of the Compliance Process

Posted on April 12, 2017 by

As the Office of the Inspector General and Centers for Medicare & Medicaid Services make self-disclosure easier for providers, we have noticed an increase in the rate of cases that are being filed.  Assisting providers in making decisions whether to self-disclose, conducting internal investigations, and guiding the self-disclosure process when appropriate has become a large […]

Ambulatory Surgery Center (ASC) Case Demonstrates Differential Value Theory of Remuneration

Posted on April 11, 2017 by

A relatively recent case involving buy-in terms in an ambulatory surgery center demonstrates how different valuations for referral sources and non-referral sources can be evidence of remuneration under the Medicare Anti-Kickback Statute (42 U.S.C. § 1320a-7b(a)-(b)).  The case also demonstrates how the initial investment terms that favor referral sources can foreclose reliance on safe harbor […]

Can Overpayments Create Criminal Liability?

Posted on April 11, 2017 by

We hear a lot about potential liability under the False Claims Act (FCA) for the failure to repay overpayments within 60 days of discovery. Focus on the 60-day rule has taken focus away from the potential for criminal charges for retaining known overpayments.  Section 1128B(a)(3) of the Social Security Act (42 U.S.C. § 1320a-7b(a)(3)) makes […]

Legal and Compliance Issues Impacting Medical Practices Using Laser Technology

Posted on April 7, 2017 by

Medical practices that routinely use laser technology are subject to some of the same legal issues as other types of practices. Use of lasers creates additional compliance issues and highlights certain compliance risk areas. Our special coverage issue contains articles on some of the legal issues impacting these practices. • Compliance Program Operation. All medical […]

Disputing Inaccurate Reports Under the Physician Payment Sunshine Act

Posted on April 6, 2017 by

The Affordable Care Act added the Physician Payment Sunshine Act (Sunshine Act) as section 1128G to the Social Security Act. The Sunshine Act requires applicable manufacturers of drugs, devices, biologicals, or medical supplies and certain group purchasing organizations to report annually to the Centers for Medicare & Medicaid Services (CMS) certain payments or items of […]

New Safe Harbor Permits Some Free Transportation to Patients

Posted on April 6, 2017 by

A new safe harbor was recently issued by the Health and Human Services (HHS) Office of Inspector General (OIG) that permits eligible health care providers to offer free or discounted transportation to established patients.  The safe harbor addresses concerns that offering free goods and/or services to patients might be considered payment of illegal “remuneration” in […]

Sally Yates was Already Famous for Changing the Focus of Compliance Investigations – The Yates Memorandum

Posted on April 5, 2017 by

By now the whole world knows about Sally Yates.  We are likely to see a lot more of her as a central figure in Congressional investigations.  For some of us who deal with compliance investigations, Sally Yates was famous long before her refusal to defend the immigration ban.  She was the author of the famous […]