Federal Reports

The CSB received an unmodified opinion on its fiscal years 2020 and 2019 financial statements.

Manufacturer Credits and Payment Reductions for Medical DevicesFederal regulations and guidance specify how hospitals must report the replacement of a beneficiary’s implanted device if a hospital receives a full or partial credit from the manufacturer for a medical device that is covered under warranty or replaced because of a defect or recall. Medicare does not cover items or services for which neither the beneficiary, nor anyone on his or her behalf, has an obligation to pay (Social Security Act (the Act) § 1862(a)(2)). Federal regulations generally require reductions in both IPPS and OPPS payments for the replacement of certain implanted devices if: (1) the device is replaced without cost to the hospital, (2) the hospital receives full credit for the device cost, or (3) the hospital receives a credit equal to 50 percent or more of the device cost (42 CFR §§ 412.89 and 419.45). Cardiac Medical DevicesCommon cardiac medical devices used to treat beneficiaries include defibrillators, pacemakers, and their associated electrical leads. These devices are implanted during either an inpatient or outpatient procedure. Occasionally, devices may require replacement because of defects, recalls, battery depletions, or mechanical complications, which may be covered under the device manufacturer’s warranty. Generally, cardiac medical device manufacturers provide warranties for defects in materials or workmanship that happen at any time during the life of the product. Such defects may result in recalls or premature failures. When a hospital follows a manufacturer’s warranty process for its cardiac medical device, the manufacturer may issue a full or partial credit to the hospital to cover the cost of the failed or recalled device or provide a replacement without charge.

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In accordance with the Reports Consolidation Act of 2000, the Federal Election Commission (i.e., the “FEC” or “Commission”) Office of Inspector General (OIG) identifies the most serious management and performance challenges facing the Commission and provides a brief assessment of the Commission’s progress in addressing those challenges. By statute this report is required to be included in the FEC’s Agency Financial Report.

Following the 2008 ash spill at Kingston Fossil Plant, TVA’s Office of Inspector General, in conjunction with Marshall Miller & Associates (engineering consultant), performed an inspection that determined there was poor maintenance of coal combustion residual storage facilities, such as not addressing erosion, standing water, and piping issues. Additionally, the inspection found there was no formalized training for personnel who inspected the dikes. Due to past issues identified related to maintenance of coal combustion residual (CCR) storage facilities, we performed an evaluation of required maintenance at TVA’s CCR storage facilities. The objective of the evaluation was to determine if TVA performed required maintenance of CCR storage facilities. The scope of the evaluation was maintenance needs identified during required inspections in fiscal years 2018 and 2019 at Bull Run, John Sevier, and Paradise Fossil Plants. We determined, in general, TVA performed required inspections and completed maintenance to address issues identified during the inspections. However, we determined some inspection reports had incorrect or missing information. We also identified opportunities for improvement related to policies for maintenance and inspection of coal CCR storage facilities, inspection plan requirements, and training requirements.

EAC OIG, through the independent public accounting firm of Brown & Company CPAs, PLLC, audited EAC’s financial statements for the fiscal years ended September 30, 2020, and September 30, 2019.