United States: Health Care Compliance And Enforcement Update - Regulatory And Legislative Developments, Fall 2012

Public-Private Initiative Formed to Prevent Health Care Fraud. On July 26, 2012, HHS and DOJ announced a new collaborative arrangement among the federal government, state officials, private health insurance organizations, and other anti-fraud groups to combat and prevent health care fraud. This new partnership will build on enforcement tools made available by the Affordable Care Act, including increased sentences for those convicted of health care fraud, enhanced screening of Medicare and Medicaid providers and suppliers, and suspended payments to providers and suppliers allegedly engaged in fraudulent activity. The partnership is designed to improve detection and prevent payment of fraudulent claims. One specific goal of the partnership is to facilitate the sharing of information on issues such as fraudulent billing schemes and "fraud hotspots" to prevent losses to both government and private health plans. Eventually, data analytics will be employed to scan industry-wide health care data to supplement fraud detection efforts. Data analytics are a recurring theme in current fraud and abuse enforcement efforts, with the government touting the use of data analytics to increase efficiency in program integrity activities. According to OIG's Spring and Fall 2012 Semi-Annual Reports to Congress, advanced data analytics have already been in use by OIG to conduct risk assessments and pinpoint oversight efforts. Data analytics and other technological advancements in fraud prevention were also a key topic of conversation during the April 4, 2012 Health Care Fraud Prevention Summit hosted by HHS and DOJ. For more, see here.

CMS Delays Implementation of ICD-10. According to a final rule released August 24, 2012, the Centers for Medicare & Medicaid Services ("CMS") has officially delayed the implementation of the International Classification of Diseases, 10th Revision (ICD-10) coding system until October 1, 2014, a full year after the originally scheduled compliance deadline. The one-year delay was granted in direct response to providers' concerns about a lack of resources and ability to adapt their systems in time to meet the original ICD-10 deadline. According to CMS, 26 percent of the providers CMS surveyed in November and December 2011 indicated that they were at risk of not being able to meet an October 1, 2013 compliance date. CMS selected the one-year delay over several other options also on the table to address provider concerns regarding implementation. Such options included foregoing ICD-10 altogether and waiting for implementation of ICD-11, or implementing only the ICD-10 procedure codes in 2013 but delaying implementation of the ICD-10 diagnosis codes. Not all providers were in favor of a delay in implementation. CMS received comments from numerous health plans, large hospitals, physician practices, and IT vendors describing the large investment already made in upgrading systems and personnel, generating a forward momentum that will be disrupted by a delay. CMS acknowledged these concerns but stated that they are outweighed by the potential for a major nationwide disruption in reimbursement resulting from the significant numbers of providers that are reportedly unprepared for implementation. For more, see here.

Senators Urge CMS to "Let the Sunshine In" and Implement the Physician Payments Sunshine Act. At a September 12, 2012, roundtable discussion of the Senate Special Committee on Aging, Senator Chuck Grassley accused CMS of "dragging its feet" on implementation of the Sunshine Act. Nine months have passed since publication of the proposed rule, yet despite numerous requests by the Act's authors, Senators Grassley and Kohl, as well as leading industry groups, CMS has yet to issue the much-anticipated final rule. Senator Grassley stated that efforts to engage CMS "have been met with resistance and silence." While some companies have already invested in development of systems necessary to capture relevant data, the absence of final regulations impedes the full testing and implementation of these systems. Frustrated with CMS's failure to answer for the delay, Senator Grassley cited a "rumor" that CMS has completed the final rule and forwarded it to the Office of Management and Budget ("OMB")â€"yet OMB is delaying its issuance until after the election. Senator Grassley stated that there is a need to "find out what the hold-up is, deal with it, and get the job done." According to the OMB dashboard, the OMB received the final rule on November 27, 2012. For more, see here.

Lawmakers Investigate 340B Drug Discount Program. In May 2012, Senator Grassley asked the University of Alabama Hospital to provide information regarding its policies associated with 340B patients. The request was prompted by a February 2011 presentation in which a Senior Pharmacist at the hospital discussed changing treatment protocol and location in order to maximize saving opportunities associated with the 340B drug discount program. In July, Representatives Joseph R. Pitts and Bill Cassidy, citing oversight problems outlined in a September 2011 Government Accountability Office ("GAO") report, requested that the Health Resources and Services Administration issue an updated definition of "340B patient" in order to curb any misuse of the program. The GAO report identified the risk of improper purchase of 340B drugs since the program is increasingly used in settings that serve both 340B and non- 340B eligible patients. For more, see here and here.

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Theodore T. Chung
Christian Fulda
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