In September, 2015, OCR and HHS issued a press release announcing a Resolution Agreement with the Cancer Care Group, P.C., which included entry into the agreement, the adoption of a robust compliance plan, and the payment of a $750,000 penalty. The settlement arose out of an incident involving the theft of an employee laptop containing
Compliance
Department of Justice Issues Guidance on Corporate Investigations and Executive Accountability
By Michael Cassidy on
Posted in Compliance
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…
CMS Stark Proposals Allow “Holdover” Arrangements and Signature Window
By Michael Cassidy on
Posted in Compliance
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:
- “hold over arrangements” are permitted to satisfy the
…
CMS Limits Scope of Review for MACs
By Michael Cassidy on
Posted in Compliance, Medicare & Reimbursement
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 Clarifies Written Agreement Requirement
By Michael Cassidy on
Posted in Compliance, Medicare & Reimbursement
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…
OIG Issues Fraud Alert to Warn Hospitals and Physicians
By Michael Cassidy on
Posted in Compliance
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;…
Physician Estopped From Alleging FCA Violations in Contract He Previously Approved
By Michael Cassidy on
Posted in Compliance
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,…
District Court Approves Government’s Use of Sampling and Extrapolation to Prove False Claims Act Liability
By Michael Cassidy on
Posted in Compliance, Fraud - Stark
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…
OIG Rejects Specialty Pharmacy Request to Pay “Per-Fill” Payents to Retail Pharmacies
By Michael Cassidy on
Posted in Compliance
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…
Hospital Network Reports Large HIPAA Breach
By Paul Welk on
Posted in Compliance, HIPAA, HIT, and EHR
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