On October 16, 2014, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of the Inspector General (“OIG”) announced the continuation of the Accountable Care Organization (“ACO”) fraud and abuse waivers for an additional year. The Affordable Care Act (“ACA”) authorized creation of the Shared Savings Program to facilitate development of ACOs in

The Office of Inspector General, Department of Health and Human Services, has recently issued guidance for those of its contractors seeking to self-disclose reportable conduct under the Federal Acquisition Regulations (“FAR”). Under federal regulations governing relationships between the federal government and its contractors, any contractors with credible evidence of a potential violation of the False Claims Act or federal criminal law involving fraud, bribery, gratuity, or conflict of interest must make a timely disclosure of such violations to the Office of Inspector General for the agency with which they contract. Failure to timely self-report these potential violations can result in the suspension of contracts or the debarment of the contractor. This requirement applies only to contractors whose contracts are governed by the FAR and which are valued at over $5,000,000.

The guidance details the information required to be included on the disclosure form, including the date the issue was discovered, detailed descriptions of any internal investigation undertaken, and a quantification of the financial harm to the government and any potential overpayments. In addition to the guidance, issued in April of 2014, OIG has provided FAQs for contractors covered by the FAR who may be considering a disclosure.


Continue Reading OIG Issues Self-Disclosure Guidance for Contractors

The Centers for Medicare & Medicaid Services (CMS) identified over $210 million in savings during the second year of implementation of its predictive analytics-based Fraud Prevention System (“FPS”), according to a June 2014 report released last week. CMS claimed that these “identified savings” reflected a return of $5 for every dollar spent on the program, a $2 increase over the program’s first year.

But the Department of Health and Human Services Office of the Inspector General (OIG), based on a new metric called “adjusted savings,” calculated a much lower return on investment—only $1.34 for every dollar spent, or $54.2 million. This “adjusted savings” metric uses historical experience in the Medicare program to determine how much of the “identified savings” CMS will actually recover.

The FPS, established in 2010, was designed to prospectively analyze Medicare fee-for-service claims to identify suspicious transactions. Certain triggering criteria are used to identify a claim or a provider as suspicious. For instance, a claim submitted under an ID number reported as stolen would trigger review, as would a physician who billed 100 patient encounters on a single day (as opposed to an average of 30). Claims and providers identified as suspicious are referred to Zone Program Integrity Contractors (ZPICs) for investigation, which can include prepayment claim review, site visits, and other measures.


Continue Reading CMS, OIG Disagree on Fraud Program Effectiveness

On June 25, 2014, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued a special fraud alert titled Laboratory Payments to Referring Physicians, identifying “specific vulnerabilities with Medicare payments for lab services that need to be addressed to more effectively safeguard the Medicare program.” In 2010, the Centers for

In issuing Advisory Opinion 14-03 (the “New Opinion”) in early April, OIG also took the highly unusual step of rescinding another advisory opinion issued in 2011, Opinion 11-18 (the “2011 Opinion”). Both opinions involve electronic health record (EHR) interfaces that facilitate physician referrals to outside providers and suppliers for ancillary services. As OIG continues to signal its increasing interest in policing EHR-related fraud, this action only serves to reinforce the idea that not only should providers using such systems should be vigilant in ensuring that their systems are compliant with established meaningful use requirements, they should also ensure that vendor relationships that involve EHR coordination comply with federal anti-kickback and Stark law rules as well.

The 2011 Opinion originally examined and found acceptable an arrangement whereby a provider of electronic practice management services (the “First Requestor”) offered a package of EHR software to clients for a discounted monthly subscription fee. The First Requestor charged a small per-transaction fee for the service of facilitating electronic referrals between health professionals and other physicians and ancillary service providers who were not “trading partners,” meaning that they had not enrolled in First Requestor’s service. The total amount of fees that the First Requestor could collect from a provider was capped at the amount of the discount on the overall package. Services provided included the transfer of relevant records, tracking communications between the providers, tracking orders by referring providers, and issuing patient referral reminders. The First Requestor provided trading partners with access to a database of information about providers offering certain services (i.e., labs, pharmacies, DME suppliers, and imaging services) that included both trading partners and non-trading partners.


Continue Reading OIG Terminates Prior Opinion on EHR Exchange Fee Structure

In Advisory Opinion 13-09, the HHS-Office of Inspector General (OIG) determined that a company’s offer of equity to members of its subsidiary group purchasing organization (GPO), partially in exchange for certain commitments to purchase through the GPO, could constitute a violation of the federal anti-kickback statute, 42 U.S.C. § 1320a–7b(b) (the “AKS”). While Advisory Opinion 13-09 is significant for GPOs, it also resonates more broadly, as to the AKS’s discount safe harbor, as well as any instance where the acquisition of equity is connected to items or services reimbursable under a federal health care program.

Background

The opinion’s Requestor was a company providing financial and performance improvement technology-based products and services. The GPO at issue was wholly-owned by the Requestor, and contributed approximately 60 percent of the Requestor’s revenue. On behalf of its members, the largest of which were hospital systems and integrated delivery systems, the GPO negotiated discounts and other contractual terms with vendors.


Continue Reading OIG Issues Unfavorable Opinion on Proposed Offer of Equity Interest to GPO Members