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Earlier this week, the Office of Inspector General OIG issued a Special Fraud Alert (Alert) on speaker programs by pharmaceutical and medical device companies in connection with the Federal Anti-Kickback Statute. In the Alert, the “speaker programs” are defined as company-sponsored events at which a health care professional makes a speech or presentation to other health care professionals about a … Continue Reading

On October 2, 2020, Health and Human Services (HHS) Secretary, Alex M. Azar II, announced the renewal of the public health emergency declaration due to the continued consequences of the COVID-19 pandemic. The 90-day renewal is effective October 23, 2020, and extends until January 20, 2021.

The renewal impacts a number of regulatory flexibilities and temporary rules applicable to health … Continue Reading

New guidance issued by the U.S. Department of Justice (DOJ) highlights the importance of updating corporate compliance programs to satisfy regulatory requirements.  The 2020 updates pick up where the 2019 guidance left off in addressing the evaluation metrics for compliance.  The key takeaway for 2020 is that companies are encouraged to update and improve compliance programs with the latest in … Continue Reading

On October 24, 2018, Congress enacted a new anti-kickback law that applies to many commercial health insurance plans, as well as Medicare and Medicaid.  The law, known as the “Eliminating Kickbacks in Recovery Act of 2018” (the “Law”), was passed as part of the SUPPORT for Patients and Communities Act, which generally targets the national opioid crisis.

PillsMoneyThe Law makes … Continue Reading

The Office of Inspector General (“OIG”) of the Department of Health and Human Services, generally, would have concerns about a potential or existing referral source receiving free goods or services, since these free goods and services could be used to provide unlawful payments for the referral of Federal health care program business.  However, under Advisory Opinion 16-09, the OIG … Continue Reading

In a recent Advisory Opinion (No. 16-02), the OIG concluded that it would not seek sanctions against a state-run hospital (the “Hospital”) under the federal anti-kickback statute or the civil monetary penalty law for two arrangements under which the Hospital provides transportation aid and short-term lodging to pregnant women covered by federal health care programs.  Although the OIG stressed that … Continue Reading

The Office of Inspector General (OIG) of the Department of Health and Human Services posted an Advisory Opinion today addressing a hospital system’s proposal to lease administrative employees and to provide operational and management services to a related psychiatric hospital for an amount equal to the hospital system’s fully loaded costs (i.e., salary plus benefits and overhead expense) plus a … Continue Reading

This week the Office of Inspector General published an interesting Advisory Opinion (AO 12-22) dealing with a cardiology co-management agreement between a hospital and a private cardiology group practice.

Under the arrangement, the hospital would compensate the physicians for certain management, oversight, strategic planning and medical direction services in connection with the hospital’s four catheterization labs.

The Compensation payable to … Continue Reading

Now that the new year is upon us, today’s post will look at the Department of Health and Human Services’ Office of Inspector General (OIG), in particular, OIG’s priorities for 2013.   According to OIG’s Fiscal Year 2013 Work Plan, it will be focusing upon a number of topics of interest – including some items not addressed last … Continue Reading

This week the Office of Inspector General of the Department of Health and Human Services published Advisory Opinion 12-15 in which it blessed an on-call compensation arrangement between a hospital and specialist physicians on its staff.  In finding that it would not prosecute the arrangement, the OIG pointed to several "safeguards" which it felt would adequately protect against a violation of … Continue Reading