Category: Fraud and Abuse

The Deadline for Submitting Comments Regarding the Self-Referral Disclosure Protocol Is Fast Approaching

On May 2, 2014, the Centers for Medicare and Medicaid Services (“CMS”)  published a request for comments relating to the Self-Referral Disclosure Protocol (“SRDP”). The SRDP is a voluntary self-disclosure instrument that allows providers of services and suppliers to disclose actual or potential violations of Section 1877 of the Social […]

OIG Issues Proposed Rule Related to Health Care Exclusion Authority

The Health and Human Services Office of Inspector General (OIG) issued a proposed rule related to its authority to exclude individuals and health care entities from participation in federal health care programs, such as Medicare and Medicaid.  The proposed rule codifies changes made by the Affordable Care Act of 2010 (ACA), which […]

FDA Revises Draft Reprint Guidance: Includes New Recommendations for Clinical Practice Guidelines

In today’s Federal Register, the U.S. Food and Drug Administration (“FDA”) announced the availability of a revised draft guidance document titled: “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices” (the “Revised Draft Reprint Guidance”).  This revises the FDA’s 2009 draft guidance document on the subject, which was […]

Government’s Annual Health Care Fraud Results Released: $4.3 Billion Recovered in 2013

The Department of Health and Human Services (DHHS) and The Department of Justice (DOJ) Health Care Fraud and Abuse Control (HCRAC) Program Annual Report for Fiscal Year 2013 (Report) was released this week.  The Report states that the DHHS and DOJ recovered $4.3 billion in health care fraud judgments and settlements in fiscal year 2013.  […]

CMS Proposes Medicare Part D Rule for 2015 Contract Year – Antidepressants and Immunosuppressants Would No Longer Be “Protected Classes”; Antipsychotics May Follow

On January 6, 2014, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule: “Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs” (the “Proposed Rule”).  The Proposed Rule is expected to be published in the Federal Register on […]

Update on HHS “Qualified Health Plans” Determination: Grassley Weighs in…

As we reported earlier this week, the U.S. Department of Health & Human Services (“HHS”) recently issued a letter concluding that HHS “does not consider [Qualified Health Plans (QHPs)], other programs related to the Federally-facilitated Marketplace, and other programs under Title I of the Affordable Care Act to be federal […]

HHS: Qualified Health Plans are NOT “Federal Health Care Programs” – Implications for Anti-Kickback, CMP, and Exclusion Analyses

In an October 30, 2013, letter to Representative Jim McDermott (D-WA), U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius, stated that HHS “does not consider [Qualified Health Plans (QHPs)], other programs related to the Federally-facilitated Marketplace, and other programs under Title I of the Affordable Care Act to […]