Compliance Updates

The 2013 Office of Inspector General (OIG) Work Plan has been released by the U.S. Department of Health and Human Services (HHS). The OIG is responsible for detecting and preventing fraud, waste, and abuse among 300+ programs administered by the HHS, as well as maintaining and improving the operations of the programs. 

Investigators receiving payment for their research from any HHS program may be subject to OIG inspections. Some of the major programs under the HHS that fund research programs conducted at Yale include: the National Institutes of Health (NIH); the Centers for Medicare and Medicaid Services (CMS); the Food and Drug Administration (FDA); and the Centers for Disease Control and Prevention (CDC).

The following areas were noted in the 2013 work plan for investigators funded by the NIH and/or CDC:
1. NIH — Equipment Claims by Grantees (NEW): Review whether NIH grantees’ claims for equipment purchases are in compliance with the special terms and conditions set forth by the Recovery Act of 2009 and applicable federal requirements.
2. NIH — Human Subjects Protection Practices of National Cancer Institute Extramural Grantees Collecting Biospecimens (NEW): Determine the extent to which informed consents for biospecimen research studies comply with human subjects protection regulations, and the extent to which PI's and IRB's take measures to address unique risks associated with this type of research.
3. CDC — Oversight of HIV/AIDS Prevention and Research Grants (NEW): Assess whether the CDC’s oversight of HIV/AIDS prevention and research grants was conducted in accordance with federal regulations and HHS policies.
4. NIH — Colleges’ and Universities’ Compliance with Cost Principles: Evaluate colleges’ and universities’ compliance with selected cost principles issued by OMB Circular A-21, “Cost Principles for Educational Institutions.”
5. NIH — Extra Service Compensation Payments Made by Educational Institutions: Assess whether payments for extra compensation charged to federally sponsored grants, contracts, and cooperative agreements by educational institutions complied with Federal regulations.
6. NIH — Use of Data and Safety Monitoring Boards (DSMBS) in Clinical Trials: Determine the extent to which DSMBS monitor data in clinical trials, and how and to what extent the NIH is ensuring that grantees comply with NIH policy for DSMBS in multisite clinical trials.
7. NIH — Inappropriate Salary Draws from Multiple Universities: Evaluate whether faculty members working on NIH grants were inappropriately drawing salaries from multiple universities.
8. NIH – Cost Sharing Claimed by Universities: Determine how universities are meeting cost sharing requirements. Of particular concern is possible misuse of the Cost Accounting Standards (CAS) exemption to directly claim costs that are normally treated as Facilities and Administrative (F&A) costs.

For investigators billing routine care costs or drugs under a clinical trial to Medicare and Medicaid, some of the clinical areas highlighted under the 2013 work plan are:
1. Ophthalmological Services — Questionable Billing (NEW): Review Medicare claims data to identify questionable billing claims for ophthalmological services during 2011.
2. Electrodiagnostic Testing — Questionable Billing (NEW): Review Medicare claims to identify questionable billing for electrodiagnostic testing (including electromyograms and nerve conduction tests)
3. Patient Safety and Quality of Care — Claims for and Use of Atypical Antipsychotic Drugs Prescribed to Children in Medicaid (NEW): Review medical records to determine the extent to which patients 18 years of age or younger had submitted Medicaid claims for atypical antipsychotic drugs during a selected timeframe; and determine the extent to which the drug claims were submitted for off-label uses (when the drug is prescribed for a condition not listed on the product’s label) and for indications not listed in one or more of the approved drug compendia.
4. Evaluation and Management (E/M) Services — Potentially Inappropriate Payments in 2010: Determine the extent to which cms made potentially inappropriate payments for E/M services in 2010 and the consistency of E/M medical review determination. Review multiple E/M services for the same providers and beneficiaries to identify electronic health records (documentation practices associated with potentially improper payments).
5. Diagnostic Radiology — Medical Necessity of High-Cost Tests: Review Medicare payments for high-cost diagnostic radiology tests to determine whether they were medically necessary. Review the extent to which primary care physicians and physician specialists order the same diagnostic tests for the same treatment of a beneficiary.
6. Laboratory Tests — Billing Characteristics and Questionable Billing in 2010: Identify questionable billing for Medicare Part B (outpatient) clinical lab tests in 2010. Medicare pays only for lab tests ordered by a physician or qualified nonphysician practitioner who is treating a beneficiary.
7. Laboratory Tests — Part B Payments for Glycated Hemoglobin A1c tests: Determine the appropriateness of Medicare payments for the glycated hemoglobin test (HgbA1c). Medicare does not consider it reasonable and necessary to perform this test more often than once every 3 months on a controlled diabetic patient, unless documentation supports the medical necessity of testing in excess of national coverage determinations guidelines.
8. Patient Safety and Quality of Care — Off-Label Use of Medicare Part B Drugs: Review off-label and off-compendia use of certain outpatient Medicare (Part B) prescription drugs and determine the extent to which specified compendia provide support for coverage.
9. Drug Payments — Questionable Claims for HIV Drugs: Determine the extent of questionable billing for HIV drugs dispensed in 2010 under Medicare’s outpatient prescription plan (Part D).
10. Sleep Testing — Appropriateness of Medicare Payments for Polysomnography: Identify questionable billing patterns for Medicare sleep services provided in 2009 and 2010.
11. Sleep Disorder Clinics — High Utilization of Sleep Testing Procedures: Examine Medicare payments to physicians, hospital outpatient, and independent diagnostic testing facilities to determine whether they were “reasonable and necessary.” 

Principal investigators (PI's) contacted by an inspector from an hhs program for audit should immediately contact Judy Harris, Medical Billing Compliance Officer, at judy.harris@yale.edu; and Alice Tangredi-Hannon, University Research Compliance Officer for the Office of Research Compliance and Education, at alice.tangredi.hannon@yale.edu. A copy of the entire plan may be viewed at https://oig.hhs.gov/reports-and-publications/workplan/index.asp

.