On September 9, 2015, Sally Quillar Yates, Deputy Attorney General of the Department of Justice (DOJ) issued a memo entitled “Individual Accountability for Corporate Wrongdoing” to address the issue of incentivizing executives, as individuals, to follow appropriate compliance protocols by emphasizing potential individual liability.
The memo stresses the importance and the difficulty of…
In July 2015, CMS released proposals to provide several new Stark Law exceptions and to clarify issues regarding existing exceptions. The full text of these proposal and CMS comments and explanations is available at:
http://www.gpo.gov/fdsys/pkg/FR-2015-07-15/pdf/2015-16875.pdf
Perhaps the most noteworthy of the lesser proposals were clarifications that:
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CMS issued a special edition MLN Matters meant to be effective August 1, 2015. The guidance reflects CMS instructions to Medicare Administrative Contractors (MACs) and Qualified Independent Contractors (QICs) regarding the scope of review for redeterminations and reconsiderations of certain claims.
CMS acknowledges its concern that MACs and QICs were using their discretion to conduct…
CMS has acknowledged that arrangements among providers to satisfy the Stark exceptions need not be created in a single document. Although a single written document memorializing the key facts of an arrangement could provide the surest and most straightforward means of establishing compliance with the applicable exception, there is no requirement under the physician self-referral…
On June 9, 2015, the OIG issued a Fraud Alert entitled “Fraud Alert: Physician Compensation Arrangements May Result in Significant Liability”. This is just a one page letter warning hospitals and physicians by stating the OIG recently reached settlements with 12 individual physicians who entered into questionable medical directorship and office staff arrangements;…
Cooper v. Pottstown Hospital is another case where a dissatisfied party is attempting to use the federal Anti-Kickback Statute or the Stark Law in litigation arising out of the contracts to which they were willing parties at one time. Usually, breaching parties have used this argument as a defense, claiming that the contracts were illegal,…
In United States ex rel. Martin et al. v. Life Care Centers of American, Inc., the Court held that the government could extrapolate from a random sample in order to impose False Claims Act (FCA) liability against Life Care Centers of American Inc. (Life Care) for a substantially larger universe of claims.
In order…
In OIG Advisory Opinion 14-06, the Office of Inspector General (OIG) concluded that payment by a specialty pharmacy to a retail pharmacy on a “per-fill” basis for services provided by the retail pharmacy could violate the Anti Kickback Statute and Civil Money Penalty provisions.
The specialty pharmacy, as the requestor, proposed to pay retail…
Community Health Systems announced today, August 18th, that hackers broke into its computers and stole data on 4.5 million patients. The information included names, Social Security numbers, physical addresses, birthdays and telephone numbers. More information on the breach is available at http://money.cnn.com/2014/08/18/technology/security/hospital-chs-hack/index.html
It is ironic to learn the Office of Inspector General (OIG) believes the Office of the National Coordinator for Health Information Technology (ONC) essentially has an insufficient compliance program to maintain the privacy and security of the protected health information (PHI) hosted by electronic health records (EHR).
In an August 2014 report (A-06-11-00063), OIG concluded…
