The Department of Health and Human Services (HHS) Office of Inspector General (OIG) included several new items in its work plan update in October 2021. The OIG work plan outlines the projects that OIG plans to implement over the foreseeable future. Such projects typically include OIG audits and evaluations. Below are the highlights from the work plan update that providers and suppliers should take notice of.
First, OIG plans to compare the average sales price (ASP) for certain drugs with their corresponding average manufacturer price (AMP) to assess Medicare Part B drug reimbursement. Since Congress established the ASP as the basis for Medicare Part B drug reimbursement, OIG is empowered to monitor market prices to limit excessive Medicare payment amounts. In fact, the Social Security Act requires that OIG compares the ASPs with AMPs, and if the ASP for a drug exceeds the AMP by 5% in the two previous quarters or three previous four quarters, HHS may substitute the reimbursement amount with a lower calculate rate. The memo produced from this investigation will report the number of drugs OIG identified that meet the criteria for substitution of a lower reimbursement amount. Ultimately, providers and suppliers should be aware of the findings in this memo, as they could lead to reduced Medicare Part B reimbursements.
Second, OIG announced their plans for additional oversight of the 50 state Medicaid Fraud Control Units (MFCUs). MFCUs are state agencies that investigate and prosecute Medicaid provider fraud and complaints of patient abuse or neglect in Medicaid-funded facilities, although approximately 75% of MFCU funding comes from the federal government. OIG will conduct on-site reviews of a sample of MFCUs. OIG did not specify which or how many MFCUs they would review. Additionally, OIG will provide guidance regarding Federal regulations, policy and performance through data collection and analysis. Finally, the OIG will provide technical assistance and training to improve MFCU management and operations.
Third, OIG announced plans to further investigate the disparities among hospitalized Medicare patients across the United States. The study will compare patient safety and adverse events across hospitalized Medicare recipients based on race, ethnicity, hospital type, and geographic location. The study will collect data from an ongoing OIG study of adverse effects, which will include detailed information about adverse events experienced by a random sample of 770 hospitalized Medicare patients. The adverse event information will be analyzed alongside demographic information available from medical records and other information found in the CMS claims data. The OIG states that a better understanding of disparities in patient safety will allow researchers to identify and address underlying issues that contribute to inequities in health care delivery.
Fourth, OIG is planning on creating an online toolkit to help health care facilities self-identify adverse events. The toolkit will be built upon guidance and tools established from prior OIG studies and will be available for health care facilities to use. The toolkit’s announcement said that toolkit will provide “standard definitions for most event types, lists of triggers to flag patient harm, suggest guidance for reviewers, and considerations for clinical decision making.” Since Federal regulations require that health care facilities identify harm and to reduce such harmful events, this toolkit will be an excellent resource for health care facilities across the United States.
Finally, OIG will assist the Centers for Disease Control and Prevention (CDC) to evaluate the COVID-19 reporting process for nursing homes. Nursing homes across the United States have been required to report COVID-19 data to the National Healthcare Safety Network (NHSN) since May 2020. Since the announcement of this requirement, there has been a significant increase in nursing home enrollment and reporting to the NHSN. The study will assess CDC oversight and support of nursing home reporting and will attempt to identify NHSN reporting challenges that the nursing homes have experienced. The OIG hopes that the study will inform the CDC’s efforts to support infection tracking, including the collection of infection data and other data related to public health emergencies like COVID-19.
For over 35 years, Wachler & Associates has represented healthcare providers and suppliers nationwide in a variety of health law matters, and our attorneys can assist providers and suppliers in understanding new developments in healthcare law and regulation. If you or your healthcare entity has any questions pertaining to healthcare compliance, please contact an experienced healthcare attorney at 248-544-0888 or wapc@wachler.com