The Final Rule related to the Health and Human Services Office of Inspector General’s (OIG) exclusion authority pursuant to the Social Security Act (the Act), as amended by the Affordable Care Act (ACA) and the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), was released last week. The Proposed Rule was issued previously by the OIG in May 2014. The effective date of the Final Rule is February 13, 2017.
Noteworthy changes made by the Final Rule include the following key items:
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued today its 2017 Work Plan. This annual publication summarizes new and ongoing reviews and activities by the OIG related to various HHS programs. For example:
- There are at least three new areas of review related to each skilled nursing facilities and hospice.
- OIG will conduct a review of Medicare payments for certain clinical diagnostic laboratory tests, as mandated by section 216 of the Protecting Access to Medicare Act of 2014 (PAMA).
- OIG will conduct a review of the data reported to Open Payments under the Physician Payments Sunshine Act. Among other things, OIG intends to determine the volume and total dollar amount for drugs, devices and medical equipment ordered by physicians under Medicare Parts B and D who are contained in the Open Payments reports.
- OIG will conduct an analysis to determine the amount the federal government could potentially collect from pharmaceutical manufacturers if inflation-indexed rebates were required under Medicare Part B. This analysis builds on prior OIG analyses.
- OIG also will conduct an analysis to determine the amount the federal government could potentially save if pharmaceutical manufacturers paid rebates for drugs dispensed through the Medicare Part D program at 340B covered entities and contract pharmacies.
Pharmaceutical and medical device companies, clinical laboratories and other health care entities should carefully review the OIG 2017 Work Plan to determine areas of government focus. The Work Plan often serves as a useful resource for companies planning and prioritizing compliance activities for the upcoming year, including training, auditing and monitoring. Additionally, reports issued by the OIG after a review are a valuable resource regarding the OIG’s current analysis of industry activities.
The Department of Health and Human Services (HHS) Office of Inspector General (OIG) released this week its FY2016 Work Plan (Work Plan). The OIG Work Plan summarizes new and ongoing OIG reviews of various HHS programs and activities, which are selected based on a number of factors such as mandatory OIG review requirements; requests from Congress, HHS management, or the Office of Management and Budget (OMB); and previously identified issues. Some key, new OIG reviews in the FY2016 Work Plan include the following:
The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) issued two reports yesterday calling for the HHS Office of Civil Rights (OCR) to strengthen its Health Insurance Portability and Accountability Act (HIPAA) enforcement efforts. In response to these reports, HHS announced that it will launch HIPAA audits early next year in order to be more proactive in HIPAA enforcement. Continue reading
On Tuesday, the Health and Human Services (HHS) Office of Inspector General (OIG) issued an Advisory Opinion regarding a program to provide a 30-day supply of cancer drugs free of costs to patients who experience an insurance coverage determination delay of at least five business days (the Free Supply Program). The OIG concluded that although the Free Supply Program could potentially generate prohibited remuneration under the federal health care program anti-kickback statute (AKS) (42 U.S.C. 1320a-7b(b), the OIG would not impose administrative sanctions against the two requestors, pharmaceutical companies that co-promote the drug, in connection with this arrangement.
As we discussed here, the government continues to improve its use of data analytics to identify and prevent fraud, waste, and abuse in the health care industry. This week, the Centers for Medicare & Medicaid Services (CMS) announced that its Fraud Prevention System (FPS) has identified and prevented $820 million in improper Medicare payments in its first three years of operation. CMS stated that the FPS “helps to identify questionable billing patterns in real time and can review past patterns that may indicate fraud”, which allows CMS to, among other things, revoke provider payments, withdraw provider enrollment in Medicare, and/or refer appropriate matters to law enforcement for further investigation.
The Office of Inspector General (OIG) recently certified the “positive return on investment” from the FPS and recommended its continued operation, although the OIG determined that it was not feasible at this time to expand the FPS program to Medicaid and the Children’s Health Insurance Program (CHIP). Also last month, several members of Congress asked the Government Accountability Office (GAO) to provide additional information regarding the GAO’s review of the FPS, including expansion of the program to Medicaid and CHIP.