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From Health Law Daily, November 3, 2015

OIG has 2016 Work Plan in hand, predicts oversight done right

By Bryant Storm, J.D.

The HHS Office of Inspector General (OIG) issued its Work Plan for Fiscal Year (FY) 2016, which sets out the OIG’s plan for oversight activities in the next year and beyond. The OIG plans to continue and expand upon program integrity efforts related to Medicare, Medicaid, disease, medical devices, and the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148). The OIG efforts are designed to increase program efficiency while combatting fraud and program abuse (OIG Work Plan, November 2, 2015).

Medicare Part A and Part B. In the context of Medicare Part A and Part B, the OIG plans to continue ongoing efforts to reduce improper payments, prevent and deter fraud, and foster economical payment policies. The specific focus for 2016 and beyond will include efforts related to the oversight of hospice care, certification surveys and hospice worker licensure requirements, skilled nursing facilities’ (SNF) compliance with patient admission requirements, and evaluation of CMS’s Fraud Prevention System.

The OIG will pursue new areas of focus, including whether Medicare payments for replaced medical devices were made in accordance with Medicare requirements and whether certain outpatient claims billed to Medicare Part B for services provided during inpatient stays were allowable and in accordance with the inpatient prospective payment system. The OIG plans to evaluate the success of accountable care organization (ACO) participation in the Medicare Shared Savings Program, which was established under section 3022 of the ACA. Another point of emphasis for 2016 will be oversight of the CMS management of the implementation of the 10th version of the International Classification of Diseases (ICD-10) codes in Medicare Parts A and B.

Medicare Part C and Part D. New areas of focus for Medicare Part C and Part D in 2016 include determining whether Medicare advantage (MA) organizations were established in accordance with federal requirements and the degree to which Part D beneficiaries are being prescribed drugs that should not be taken in combination with other drugs they have been prescribed. The OIG also plans to revise its focus on the nature of financial interests reported under the CMS Open Payments Program and scrutinize the CMS oversight of Part D pharmacy enrollment. Another point of emphasis for the Part D program will be "the extent to which pharmacy reimbursement for brand-name drugs under Part D changed between 2010 and 2014."

Medicaid. In light of the expansion of state Medicaid programs under the ACA, the OIG believes that heightened urgency is necessary to protect the Medicaid program from fraud, waste, and abuse. In the Medicaid context, the work plan for 2016 and beyond focuses on issues related to specialty drug pricing and reimbursement, inaccuracies in eligibility determinations due to reliance on eligibility findings made by other programs, state oversight of deficiency corrections, enhanced provider screening, correct coding initiatives, new payment and delivery models, managed care organizations, state financing that focuses on upper payment limits, the issue of drug diversion and abuse, and state programs that restrict beneficiaries to a limited number of pharmacies or prescribers to reduce prescription drug abuse. A future area of focus for the OIG is "beneficiary access to, and program integrity of, mental and behavioral health services."

CDC and FDA. With respect to review of agencies like the Centers for Disease Control and Prevention (CDC) or the FDA, for 2016, the OIG plans to examine the CDC’s oversight of the Select Agent Program (SAP), the security of the nation’s pharmaceutical stockpiles, and the award process for Ebola response and awareness. Regarding the FDA, the OIG plans to continue its oversight of post-marketing studies of approved drugs and high-risk food facilities. However, the OIG intends to add new areas of focus, including an examination of whether the FDA’s oversight of hospitals’ networked medical devices is sufficient to protect associated electronic protected health information (ePHI) and whether tobacco establishments are registering with the FDA and submitting product lists as required under Section 905 of the Family Smoking Prevention and Tobacco Control Act of 2009 (P.L. 111-31).

ACA. The work plan indicates that the OIG is "focused on promoting the economy, efficiency, and effectiveness of ACA programs across HHS." Oversight of health reform planned for 2016 includes analysis of emerging marketplace issues, premium stabilization programs, Medicaid expansion and services, Medicare payment and delivery reform, program integrity, and public health program reform.

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