Life Science Compliance Update

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November 14, 2016

OIG Releases FY 2017 Work Plan

Imgres

The United States Health and Human Services (HHS) Office of Inspector General (OIG) recently released its 2017 Work Plan, which summarizes new and ongoing reviews and activities that OIG plans to pursue with respect to HHS programs and operations during the current fiscal year (and beyond). The Work Plan is updated throughout the year, and this edition describes OIG audits and evaluations that are either currently underway or planned, as well as certain legal and investigative initiatives that are continuing. The Work Plan also notes items that have been completed, postponed, or canceled, and includes new items that have been started or planned since April 2016.

Some of the projects that are described in the Work Plan are statutorily required, such as the audit of the Department’s financial statements (mandated by the Government Management Reform Act).

Additionally, OIG does not provide additional details on jobs to be undertaken or information on the status of jobs contained in its Work Plan. For example, while estimated issue dates are included in the Work Plan, OIG will not provide revised estimates, nor will it provide current status updates.

Open Payments

The Work Plan notes that the Physician Payments Sunshine Act (PPSA) requires that manufacturers disclose payments made to physicians and teaching hospitals to CMS. Manufacturers and group purchasing organizations (GPOs) must also report ownership and investment interests held by physicians. OIG plans to analyze 2015 data extracted from the Open Payments website to determine the number and nature of financial interests.

OIG will also determine how much Medicare paid for drugs and durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) ordered by physicians who had financial relationships with manufacturers and GPOs. OIG plans to determine the volume and total dollar amount associated with drugs and DMEPOS ordered by these physicians in Medicare Parts B and D for 2015. The expected issue date of a “Data Brief on Financial Interests Reported Under the Open Payments Program” is FY 2017.

Skilled Nursing Facility Reimbursements

Another area of focus will be skilled nursing facility (SNF) reimbursements, with a special focus on therapy documentation. According to the report, “Previous OIG work found that SNFs are billing for higher levels of therapy than were provided or were reasonable or necessary. We will review the documentation at selected SNFs to determine if it meets the requirements for each particular resource utilization group.”

OIG also noted it plans to conduct reviews into how state agencies conduct nursing home complaint investigations, whether incidents of abuse and neglect at SNFs were properly reported, and the outcomes of the National Background Check program for long-term care employees.

Protecting Access to Medicare Act of 2014 (PAMA)

In the report, OIG states that it will conduct a review of Medicare payments for certain clinical diagnostic laboratory tests, as mandated under Section 216 of PAMA. OIG will perform the required annual analysis of the top twenty-five laboratory tests by Medicare payments and analyze the implementation and effect of the new payment system. OIG will also analyze Medicare payments for clinical diagnostic laboratory tests performed in 2016 and monitor CMS’ implementation of the new Medicare payment system for these tests.


This work continues to build upon previous analyses performed by CMS of Medicare Part B laboratory test payments in 2014 and 2015 and our review of CMS’ progress toward implementing the new Medicare payment system.

Conclusion

These three topics are just a small sample of what is covered under the OIG 2017 Work Plan. We encourage pharmaceutical and medical device companies, clinical laboratories and other healthcare entities to review the Work Plan in full to determine areas of government focus. The Work Plan can serve as a useful resource for companies planning and prioritizing compliance activities for the upcoming year, including training, auditing, and monitoring. Other reports issued by the OIG after a review can also be a valuable resource regarding the OIG’s current analysis of industry activities.

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