Novartis Pharmaceuticals, a US subsidiary of a Swiss pharmaceutical group Novartis, settled with the US Department of Justice (DOJ) for $420 million for allegations of the off-label promotion of Trileptal, submitting false claims because of the unlawful marketing, and paying kickbacks to health care professionals inducing them to prescribe Trileptal and five other drugs. The […]
On September 28, the Office of Inspector General (OIG) posted Advisory Opinion 10-20 in which it analyzed another pre-authorization arrangement. This is the OIG’s third Advisory Opinion issued this year that favorably reviews the provision of free pre-authorization services to referral sources (please visit our September 9 and May 14 blogs both of which address […]
Pursuant to our September 11, 2010 blog entry, the FTC is to hold a day-long workshop entitled “Workshop Regarding Accountable Care Organizations and Implications Regarding Antitrust, Physician Self-Referral, Anti-Kickback and Civil Monetary Penalty Laws.” According to the workshop’s website, those who are unable to attend the Baltimore workshop may listen in via webcast. Registration is […]
On September 22, 2010, the House passed HR 6130: Strengthening Medicare Anti-Fraud Measures Act of 2010 (the “Bill”), introduced by Reps. Pete Stark (D-CA) and Wally Herger (R-CA). The Bill provides for an expanded “permissive exclusion from participation in Federal health care programs to individuals and entities affiliated with sanctioned entities.” Summaries of the pertinent […]
On September 23, CMS released its Voluntary Self-Referral Disclosure Protocol (“SRDP”) pursuant to Section 6409 of the Affordable Care Act (“ACA”), which “requires the Secretary of HHS to inform providers of services and suppliers of how to disclose an actual or potential violation pursuant to the protocol….” The new statutory deadline for reporting and returning […]
Last week, CMS posted the Preview of the Proposed Rules, which will officially be released in Federal Register format and open for comments on September 23. The proposed rule focuses on implementing the Affordable Care Act (“Act”) that will, in part: • Establish screening procedures for suppliers and providers of services participating in Medicare, Medicaid, […]
On September 15, 2010, the US Department of Health and Human Services Inspector General Daniel Levinson testified before the House Subcommittee on Health of the House Committee on Energy and Commerce regarding Medicare’s coverage of DMEPOS suppliers. Stating that DMEPOS expenditures represented 2% of all Medicare expenditures–$10 billion–in 2009, Levinson notes that there is a […]
On September 8, 2010, the OIG released Advisory Opinion 10-14 regarding an arrangement in which a sleep lab management company (the “Requestor”) provides a Hospital sleep lab with all of the equipment, technology, supplies, and staff necessary to operate a sleep testing laboratory. No physicians have any ownership interest in Requestor and Requestor does not […]
Sleep Solutions, Inc. (“Sleep Solutions”)–a Maryland diagnostic service provider of in-home sleep tests–settled with the United States for $500,000 to settle claims that it violated the False Claims Act by submitting false claims to TRICARE and the Federal Employees Health Benefit Program. The United States contends that from February 2003 through December 2009, Sleep Solutions […]
Dr. Sam Smith Hill, III’s 2008 healthcare fraud conviction was affirmed by the 5th Circuit on August 25, 2010 (US v. Hill, No. 09-40749 (5th Cir. Aug. 25, 2010). Found guilty in five counts of healthcare fraud by a jury, Dr. Hill’s indictment alleged that he fraudulently billed Medicaid from 2001 to 2008. Having founded […]
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