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Department of Health & Human Services OIG

Use of States' Immunization Information Systems To Monitor COVID-19 Vaccinations

Immunization Information Systems (IISs) play an integral role in monitoring vaccine uptake in the population and meeting vaccination goals. While the Centers for Disease Control and Prevention (CDC) and other stakeholders have long invested significant efforts to establish plans and standards to guide improvements in IISs, State, and local jurisdictions have often struggled to make these improvements. CDC's work to collect and share data on COVID-19 vaccinations relies heavily on State and local IISs working with Federal systems, but the preexisting limitations of these systems pose challenges for CDC's goal of comprehensive immunization data being made available for clinical and public health uses. This study will examine State and Federal experiences using these systems to collect, share, and monitor data on COVID-19 vaccinations, and identify lessons learned that can improve vaccination data and monitoring for future mass vaccination campaigns as well as routine vaccination programs.

Department of Health & Human Services OIG

Audit of Health Resources and Services Administration's COVID-19 Supplemental Grant Funding for Health Centers

The Health Resources and Services Administration (HRSA) awarded nearly $2 billion in supplemental grant funding to 1,387 health centers nationwide in fiscal year (FY) 2020 to respond to the COVID-19 public health emergency. The funding was intended to support the health centers' activities related to the detection, prevention, diagnosis, and treatment of COVID-19, including maintaining or increasing health center capacity and staffing levels during the pandemic, and expanding COVID-19 testing. The performance period for each of these one-time supplemental grant awards, which HRSA began awarding in March 2020, is 12 months. Health centers were permitted to charge to their awards pre-award costs in order to support expenses related to the COVID-19 public health emergency dating back to January 20, 2020. We will determine whether health centers used their HRSA COVID-19 supplemental grant funding in accordance with Federal requirements and grant terms.

Department of Health & Human Services OIG

Audit of Indian Health Service's COVID-19 Vaccine Policies and Procedures for COVID-19 Vaccines Distributed to Tribal Health Programs

The COVID-19 pandemic has disproportionately affected American Indian and Alaska Native (AI/AN) populations nationwide.  We will focus on IHS's coordination of the distribution, allocation, and administration of the vaccine to Tribal Health Programs. The objective of this audit is to determine whether IHS followed the Memorandum of Agreement for the CDC COVID-19 Federal Agency Vaccination Program and the IHS COVID-19 Pandemic Vaccine Plan to coordinate the distribution, allocation, and administration of the vaccines to Tribal Health Programs to protect AI/AN beneficiaries. 

Department of Health & Human Services OIG

Yearend Review of Opioid Use in Medicare Part D in 2020

Identifying patients who are at-risk of overdose or abuse is key to addressing this crisis. The COVID-19 pandemic has made this need even more pressing. The National Institutes of Health recently warned that individuals with opioiduse disorder could be particularly hard hit by COVID-19, which is a respiratory virus that attacks the lungs. Respiratory disease is known to increase mortality risks among people taking opioids. This data brief would provide information on opioid utilization among beneficiaries enrolled in Medicare Part D in 2020. 

Department of Health & Human Services OIG

Awardee Challenges in Implementing COVID_19 Vaccination Program

CDC Immunization and Vaccines for Children Cooperative Agreement awardees, which are typically State and large metropolitan area public health departments, plan for and oversee the vaccine distribution and administration process. Stakeholders have acknowledged challenges early in Phase 1 distribution and dispensing, and note that these challenges will likely span all three phases identified in the CDC's COVID-19 Vaccine Playbook. We will interview all awardees to identify the reported challenges they are facing while distributing and dispensing vaccines. We will also ask awardees about effective strategies to mitigate those challenges, new challenges they anticipate, and how HHS can best support them in distributing and dispensing COVID-19 vaccines. In doing so, this review will provide HHS with timely and actionable information to address challenges associated with the COVID-19 vaccination efforts.

Department of Health & Human Services OIG

Audits of Medicare Part B Laboratory Services During the COVID-19 Pandemic

Our preliminary analysis has shown that the number of non-COVID-19 tests billed for Medicare Part B beneficiaries during the COVID-19 pandemic has decreased compared with the 6-month period before the pandemic, and many independent laboratories have encountered challenges in providing COVID-19 testing. We will conduct a series of audits on Medicare Part B laboratory services during the pandemic that will initially focus on the effect of the pandemic on non-COVID-19 testing. The series of audits will also focus on aberrant billing of COVID-19 testing during the pandemic.

Department of Health & Human Services OIG

Audit of HHS Sole Source Contracts Awarded for COVID-19 Testing

HHS established contracts under the Public Health and Social Services Emergency Fund to prevent, prepare for, and respond to the COVID-­19 pandemic. The contracts cover more than 600 COVID-19 testing sites in 48 states and the District of Columbia. The contracts utilize a Federal bundled payment program paid directly to retailers that receive a flat fee for each test administered, with participating retailers responsible for coordinating the full, end-to-end testing. The contracts that HHS awarded to contractors were sole source contracts totaling approximately $1 billion for COVID-19 testing. We will review the awarding and management of contracts for COVID-19 testing to determine compliance with applicable Federal statutes, regulations, HHS policies and procedures, contract terms and conditions, and the allowability of claimed costs.

Department of Health & Human Services OIG

Health Resources and Services Administration's Monitoring of High-Risk COVID-19 Grantees

The Health Resources and Services Administration (HRSA) is the primary Federal agency for improving health care to people who are geographically isolated and economically or medically vulnerable. HRSA should identify and mitigate risks related to awarding grants to health centers to minimize the potential misuse or loss of Federal funds. In spring 2020, HRSA awarded through three programs nearly $2 billion to approximately 1,380 health centers in response to the COVID-19 pandemic. To expedite distribution of this funding, HRSA did not require that health centers apply for grants. Instead, it made funds immediately available to health centers. Health centers had 30 days from the award release date to submit the information that is usually submitted, reviewed, and approved during the grant application process prior to a grantee receiving funding. We will determine whether HRSA had an effective process for identifying and monitoring high-risk health centers that received COVID-19 grants.

Department of Health & Human Services OIG

Home Health Agencies' Challenges and Strategies in Responding to the COVID-19 Pandemic

Home health agencies (HHAs) have faced unprecedented challenges to providing care during the COVID-19 pandemic. Reported challenges include, but are not limited to, procuring necessary equipment and supplies, implementing telehealth to treat patients remotely, and addressing staffing shortages. However, the full spectrum of these challenges, including how challenges have evolved over time, is unknown. HHAs have used strategies to address these challenges, but the array of strategies and the extent to which HHAs found them helpful are also unknown. This nationwide study will provide insights into the strategies HHAs have used to address the challenges presented by COVID-19, including how well their emergency preparedness plans served them during the COVID-19 pandemic.

Department of Health & Human Services OIG

Audits of Medicare Part B Telehealth Services During the COVID-19 Public Health Emergency

Telehealth is playing an important role during the public health emergency (PHE), and CMS is exploring how telehealth services can be expanded beyond the PHE to provide care for Medicare beneficiaries. Because of telehealth's changing role, we will conduct a series of audits of Medicare Part B telehealth services in two phases. Phase one audits will focus on making an early assessment of whether services such as evaluation and management, opioid use order, end-stage renal disease, and psychotherapy (Work Plan number W-00-21-35801) meet Medicare requirements. Phase two audits will include additional audits of Medicare Part B telehealth services related to distant and originating site locations, virtual check-in services, electronic visits, remote patient monitoring, use of telehealth technology, and annual wellness visits to determine whether Medicare requirements are met.