Other OIG Developments

On December 23, 2015, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) published its annual notice soliciting recommendations for new or modified, safe harbor provisions under the federal anti-kickback statute. The notice also invites suggestions for new OIG Special Fraud Alerts.  The OIG will accept proposals until February

The Department of Justice’s “Yates Memo” sets forth regulatory principles, applicable to both civil and criminal investigations, to ensure that individuals are held accountable for corporate wrongdoing. While several U.S. Attorney Offices had been applying many of these principles already, the Yates Memo now establishes the principles expected to be followed by all U.S. Attorney

On June 18, 2015, HHS Secretary Sylvia M. Burwell and Attorney General Loretta E. Lynch announced that a nationwide Medicare Fraud Strike Force sweep resulted in health fraud charges against 243 individuals involving approximately $712 million in false billings – the largest number of defendants and dollar amount in Strike Force history. Charges in the

On June 9, 2015, the Office of the Inspector General of the Department of Health and Human Services (OIG) released a fraud alert warning physicians to scrutinize carefully the conditions and terms of any medical director or other compensation arrangement they enter into with potential recipients of Federal health care program business. The risks associated with these arrangements under the anti-kickback statute are not new. However, the fraud alert signals  the OIG’s current focus on physicians, which reportedly has also included hiring additional attorneys to handle investigative and enforcement activity involving physicians. Moreover, the government now has access to unprecedented amounts of data regarding financial arrangements between physicians and drug and device manufacturers.

The fraud alert follows on the heels of a dozen recent settlements between the OIG and individual physicians who allegedly received kickbacks disguised as medical directorships and other office staff arrangements. In those settlements, the OIG determined the physicians played an integral role in the schemes and specifically alleged that the agreements:Continue Reading An Apple a Day Keeps the OIG Away: Practical Guidelines for Structuring Physician Compensation Arrangements to Avoid Kickback Allegations

According to a recent OIG report, "Incorrect Place-of-Service Coding Resulted in Potential Medicare Overpayments Costing Millions,” physicians did not always correctly code the place of service on Part B claims.  This resulted in potential overpayments of approximately $33.4 million for services provided from January 2010 through September 2012. The OIG explains that physicians performed

In a recent report, the HHS OIG concludes that FDA has made progress in improving oversight of generic drug manufacturers, including greater parity in inspections of foreign and domestic generic drug manufacturers. A summary of the report, FDA Has Made Progress on Oversight and Inspections of Manufacturers of Generic Drugs, is available on our Life

On April 20, 2015, the Office of the Inspector General of the Department of Health and Human Services (“OIG”) released educational guidance designed to assist governing boards of health care organizations (“Boards”) in their compliance oversight functions. This guidance, entitled “Practical Guidance for Health Care Governing Boards on Compliance Oversight” (the “Guidance”), was developed in a collaborative effort among the OIG, the Association of Healthcare Internal Auditors (“AHIA”), the American Health Lawyers Association (“AHLA”), and the Health Care Compliance Association (“HCCA”). The Guidance updates previous guidance issued by OIG and AHLA, and incorporates insight from the AHIA and HCCA to help assist the internal auditors, compliance officers, and lawyers that report to the Boards. The document addresses four key issues relating to a Board’s oversight and review of compliance program functions: (1) the roles and relationships among an organization’s audit, compliance, and legal departments; (2) the mechanisms and processes for reporting to the Board; (3) identifying and auditing regulatory risk; and (4) methods to encourage organization-wide accountability for achieving compliance goals and objectives.
Continue Reading OIG Partners with Industry Associations by Issuing Practical Guidance for Health Care Governing Boards on Compliance Oversight

The OIG has released its Medicaid Fraud Control Units (MFCU) Fiscal Year 2014 Annual Report, which highlights statistical achievements of the 50 MFCUs nationwide, along with related OIG oversight activities. With regard to criminal cases, the report notes:

  • MFCUs reported 1,318 criminal convictions, most frequently involving home health care aides, certified nursing aides, and other medical

The OIG has released its March 2015 “Compendium of Unimplemented Recommendations,” which highlights the OIG’s top 25 recommendations for cost savings and/or quality improvements in HHS programs, along with other significant unimplemented recommendations. High-priority recommendations address the following areas, among others:

  • Payment Policies and Practices: Expand the DRG window to include additional days prior to

The HHS Office of Inspector General (OIG) has released detailed statistical data on MFCU enforcement actions, recoveries, and expenditures for fiscal year 2014. Overall, state MFCUs reported more than $2 billion in criminal and civil recoveries (settlements, judgments, or prefiling settlements) in FY 2014, more than $1.7 billion of which were civil recoveries. The