OIG 2016 Work Plan – Health Care Fraud And Abuse Remains Top Priority

Posted On Monday, November 23, 2015

On November 2, 2015, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) released its Fiscal Year 2016 Work Plan summarizing new and ongoing reviews with respect to HHS programs and operations.  In furtherance of the OIG’s 2015 Work Plan, there are numerous OIG audits, evaluations, and certain legal and investigative initiatives that are continuing and/or are revised for the 2016 Work Plan.  In addition, the 2016 Work Plan describes well over 40 new areas of inquiry.

The 2016 Work Plan on a whole reconfirms OIG’s stance that combating health care fraud and abuse remains a top priority for the OIG and HHS in 2016.

An abbreviated list of topics set forth in the work plan that may be of interest to the health care providers includes:

Medicare Parts A and B: Medicare Oversight of Provider Based Status (Revised); Medical device credits  for replaced medical devices (New); Skilled nursing facilities prospective payment system requirements  (New); Medicare payments during MS-DRG payment window (New); Hospice general inpatient care  (Revised); Orthotic Braces – reasonableness of Medicare payments and supplier compliance with payment  requirements (New); Increased billing for ventilators (New); Ambulatory Surgery Centers – quality  oversight (New); Physicians – referring/ordering Medicare services and supplies (New); Anesthesia  Services—Non-Covered Services (New); Physician home visits – reasonableness of services (New);  Prolonged services – reasonableness of services (New); Part B Payment for drugs purchased under the  340B Program (Revised); Histocompatibility Laboratories—Supplier Compliance with Payment  Requirements (New)

Medicare Parts C and D: Medicare Advantage encounter data – CMS oversight of data integrity  (Revised); Review of financial interests reported under the Open Payments Program (Revised); Increase  in prices for brand-name drugs under Part D (New)

Medicaid Program: Specialty drug pricing and reimbursement in Medicaid (New); State and CMS  oversight of provider ownership information (Revised); Provider payment suspensions during pending  investigations of credible fraud allegations (Revised)

Other Programs: Controls over networked medical devices at hospitals (New); NIH – controls over subcontracting of NIH grant and contract work (New); Office of Civil Rights’ oversight of the security of electronic protected health information

In a hint of things yet to come, the Work Plan reveals that future planned work of the OIG includes a holistic examination of HHS’ efforts to reduce opioid misuse and abuse, as well as further examinations of government-wide financial data standards related to expenditures of federal grants, contracts, and loans.  It also anticipates a broadening of the OIG’s portfolio regarding information privacy and security, including issues that arise from the continuing expansion of the Internet of Things (IoT).  IoT is loosely defined as the environment in which physical objects transfer data over a network without requiring human-to-human or human-to-computer interaction.  Basic examples of IoT’s include: GPS technology, smart locks, smart thermostats, and, increasingly popular health and fitness wearable devices.  The utilization of IoT data and its security is of increasing concern to privacy advocates and governments as more and more objects, individuals and animals utilize embedded devices that become a part of the IoT.

Corporate, legal and compliance executives at health care providers and related entities should review in detail the 2016 OIG Work Plan and consider all of the topics listed in the Work Plan that are applicable to their entities.  Such a review can assist these entities in determining their risk areas and enable them to prioritize new or enhanced compliance initiatives that may be necessary to address any potential risks.

Alert: Policy And Personnel Changes At The Department Of Justice

Posted On Thursday, November 19, 2015
By: Douglas K. Rosenblum

By now, all lawyers involved in federal white collar criminal practice have either heard of, or read in detail, the “Yates Memo” issued by the Department of Justice in September 2015.  Perceived as a response to the financial crisis in recent years and the lack of individual criminal and civil liability, Deputy Attorney General Sally Quillian Yates authored a detailed memorandum outlining a shift in Department policy.  The United States will now seek to hold individuals accountable for corporate wrongdoing.  In years past, all too often the government resolved criminal investigations of corporate entities with a corporate plea or deferred prosecution agreement, a civil settlement agreement, a stiff fine, and perhaps the installment of a compliance monitor within the company.  The civil settlement agreements often included releases of owners, officers, directors, and employees of the same corporations.  Those days are done according to Deputy Attorney General Yates.

In a pair of recent public appearances, top Department Officials have announced important changes in policy and personnel as a result of government’s new initiative.  First, in a speech delivered to the American Bankers Association and the American Bar Association on November 16, 2015, Deputy Attorney General Yates announced that the Department of Justice is revising the stone tablets that comprise the United States Attorney’s Manual.  First, the Department is revising the Principles of Federal Prosecution of Business Organizations (commonly referred to as the Filip factors) to emphasize the primacy in any corporate case of holding individual wrongdoers accountable.  If a company wants any credit at all for cooperating with the investigation, it must provide all non-privileged information about the individual wrongdoing.  The government is now separating what used to be a single factor regarding a corporation’s voluntary disclosure and its willingness to cooperate into two distinct factors: one regarding a company’s timely and voluntary disclosure and one regarding cooperation.  Additionally, the Department of Justice is amending the Manual to instruct its civil attorneys to follow the same factors as its criminal attorneys, and an inability to pay is not in and of itself a reason to decline a civil case: “Just because wrongdoers are judgment-proof doesn’t mean they should escape all judgment.”

Second, in a speech delivered on November 17, 2015 to a seminar for attorneys focused on the Foreign Corrupt Practices Act (“FCPA”), Assistant Attorney General Leslie Caldwell announced that the Department of Justice is seeking to hire 10 prosecutors to add to its FCPA unit.  This represents a 50% increase in its labor force.  Assistant Attorney General Caldwell made specific reference to the principles of the Yates memo when she told the attendees of the seminar, “Companies cannot just disclose facts relating to general corporate misconduct and withhold facts about the individuals involved…And internal investigations cannot end with a conclusion of corporate liability, while stopping short of identifying those who committed the underlying conduct.”  Certainly with the inevitable increase in the number of individual prosecutions, the Department will need more attorneys to review corporate disclosures and try cases.  Assistant Attorney General Caldwell’s comments make that connection clear.

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