On January 31, 2014, the U.S. Department of Health & Human Services Office of Inspector General (OIG) released its “Work Plan for Fiscal Year 2014,” which summarizes OIG’s planned reviews and outlines OIG’s focus areas.

In the Work Plan, OIG explained that in fiscal year 2014 it will conduct (and has already started, in some cases) audits in a number of areas relating to the Electronic Health Record (EHR) Incentive Program.  OIG stated that it planned to review:

  • Medicare and Medicaid EHR incentive payments to health care professionals and hospitals.
  • Medicaid payments for costs associated with a State’s adoption of EHR technology (which receives a 90 percent federal match as an administrative expense).
  • The Centers for Medicare & Medicaid Services’ (CMS) oversight of EHR incentive payments, including whether actions are taken to remedy erroneous payments.

OIG also stated that it planned to audit covered entities receiving EHR incentive payments and their business associates to determine if they were adequately protecting electronic health information, which is a Stage 1 meaningful use objective in the EHR Incentive Program, see 42 C.F.R. § 495.6(d)(15), (f)(14).  OIG mentioned audits of EHR cloud service providers specifically.  It views audits of these particular business associates as “necessary to assure compliance with regulatory requirements and contractual agreements.”

Tags: Office of Inspector General
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Photo of Anna D. Kraus Anna D. Kraus

Anna Durand Kraus advises on issues relating to the complex array of laws governing the health care industry. Her background as Deputy General Counsel to the U.S. Department of Health and Human Services (“HHS”) gives her broad experience with, and valuable insight into…

Anna Durand Kraus advises on issues relating to the complex array of laws governing the health care industry. Her background as Deputy General Counsel to the U.S. Department of Health and Human Services (“HHS”) gives her broad experience with, and valuable insight into, the programs and issues within the purview of HHS, including Medicare, Medicaid, fraud and abuse, and HIPAA privacy and security. Anna is co-chair of the firm’s Health Care Industry practice group.

Anna regularly advises clients on Medicare reimbursement matters, particularly those arising under Part B and the Part D prescription drug benefit. She also has extensive experience with the Medicaid Drug Rebate program. She assists numerous pharmaceutical and device manufacturers, health care providers, pharmacy benefit managers, and other health care industry stakeholders to navigate the challenges and opportunities presented by the Affordable Care Act.

Anna is a trusted adviser on health information privacy, security and breach notification issues, including those arising under the Health Insurance Portability and Accountability Act (“HIPAA”) and the Health Information Technology for Economic and Clinical Health (“HITECH”) Act. Her background in this area dates back to the issuance of the original HIPAA privacy regulations.

Anna’s clients depend on her to guide them through compliance with the Anti-Kickback statute, the Stark regulations, and other laws preventing fraud and abuse in the health care industry. Her deep knowledge of these laws has made her an important component of the firm’s representation of pharmaceutical companies and health care organizations under federal investigation or facing allegations under the False Claims Act. In addition, clients contemplating acquisitions in the health care sector rely on her to guide due diligence efforts.

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