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Active Work Plan Items

This list reflects OIG audits, evaluations, and inspections that are underway or planned. You may search the entire contents of the Active Work Plan Items and corresponding summaries in the search bar. For a summary of a particular Work Plan Item, please click on the title.

Announced or Revised Agency Title Component Report
Number(s)
Expected
Issue Date (FY)
Summary
Announced or Revised Agency Title Component Report Number(s) Expected Issue Date (FY) Summary
October 2017 Office of the Secretary Secretary Price's Use of Chartered Aircraft for Federal Travel Office of Audit Services W-00-17-59431 2018 Federal Travel Regulations provide limited instances in which chartered aircraft can be used for official Government business. OIG is reviewing Secretary Price’s use of chartered aircraft for Federal travel. We will determine compliance with applicable Federal regulations and Department of Health and Human Services policies and procedures.
October 2017 Centers for Medicare & Medicaid Services Specialty Drug Coverage and Reimbursement in Medicaid Office of Evaluation and Inspections OEI-03-17-00430 2019 Medicaid spending on specialty drugs has rapidly increased. There is no standard definition for specialty drugs. They may be expensive; be difficult to handle, monitor or administer; or treat rare, complex or chronic conditions. We will describe States’ definitions of, and payment methodologies for, Medicaid specialty drugs and determine how much States paid for specialty drugs. We will also review strategies that States use to manage specialty drug costs, such as formularies, cost sharing, step therapy, and prior authorization.
October 2017 Food and Drug Administration FDA Oversight of Risk Evaluation and Mitigation Strategies To Address Prescription Opioid Abuse Office of Evaluation and Inspections OEI-01-17-00510 2019 Opioid abuse and overdose deaths are at epidemic levels in the United States. The Food and Drug Administration Amendments Act of 2007 provided the Food and Drug Administration (FDA) with the authority to require pharmaceutical companies to develop Risk Evaluation and Mitigation Strategies (REMS) when FDA determines that the risk of using a drug outweighs its benefit. Through the REMS program, FDA intends to “increase the number of prescribers who receive training on pain management and safe prescribing of opioid drugs in order to decrease inappropriate opioid prescribing.” We will describe how FDA determined the need for opioid REMS and determine the extent to which FDA has held pharmaceutical companies with required opioid REMS accountable for REMS assessments. We will also determine the extent to which FDA has held opioid REMS sponsors accountable for REMS goals to mitigate risks of misuse, abuse, addiction, overdose, and serious complications because of medication errors.
October 2017 Food and Drug Administration Drug Traceability Test Office of Evaluation and Inspections OEI-05-17-00460 2019 Potentially dangerous drugs, including diverted, counterfeit, and imported unapproved drugs, can enter the supply chain and pose a threat to public health and safety. The Drug Supply Chain Security Act (DSCSA) provides the Food and Drug Administration (FDA) and others with new tools to prevent the introduction of harmful drugs into the supply chain and to identify and remove them. DSCSA requires trading partners to exchange drug product tracing information when they take ownership of drugs, resulting in a tracing record that FDA and others can use to investigate suspect and illegitimate drugs. Ensuring that DSCSA’s drug product tracing requirements function as intended will help FDA to respond effectively to potentially harmful drugs in the supply chain. We will determine the extent to which selected drugs can be traced from the dispenser back to the manufacturer. This study—part of OIG’s body of work in this area—builds on our previous examinations of trading partners’ early experiences exchanging drug product tracing information by testing the accuracy of those tracing records.
October 2017 Centers for Medicare & Medicaid Services Review of Medicare Payments for Bariatric Surgeries Office of Audit Services W-00-17-35226 2018 Bariatric surgery is performed to treat comorbid conditions associated with morbid obesity. (A comorbid condition exists simultaneously with another medical condition.) Medicare Parts A and B cover certain bariatric procedures if the beneficiary has (1) a body mass index of 35 or higher, (2) at least one comorbidity related to obesity, and (3) been previously unsuccessful with medical treatment for obesity (CMS, Medicare National Coverage Determinations Manual, Pub. No. 100-03, chapter 1, part 2, § 100.1). Treatments for obesity alone are not covered. The Comprehensive Error Rate Testing program's special study of certain Healthcare Common Procedure Coding System codes for bariatric surgical procedures found that approximately 98 percent of improper payments lacked sufficient documentation to support the procedures (CMS, Medicare Quarterly Provider Compliance Newsletter, "Guidance to Address Billing Errors," volume 4, issue 4, July 2014). We will review supporting documentation to determine whether the bariatric services performed met the conditions for coverage and were supported in accordance with Federal requirements (Social Security Act, §§ 1815(a) and 1833(e)).
October 2017 Centers for Medicare & Medicaid Services Review of Medicare Payments for Telehealth Services Office of Audit Services W-00-16-35790; A-05-16-00058 2018 Medicare Part B covers expenses for telehealth services on the telehealth list when those services are delivered via an interactive telecommunications system, provided certain conditions are met (42 CFR § 410.78(b)). To support rural access to care, Medicare pays for telehealth services provided through live, interactive videoconferencing between a beneficiary located at a rural originating site and a practitioner located at a distant site. An eligible originating site must be the practitioner's office or a specified medical facility, not a beneficiary's home or office. We will review Medicare claims paid for telehealth services provided at distant sites that do not have corresponding claims from originating sites to determine whether those services met Medicare requirements.
October 2017 Administration for Children and Families States' Accuracy of Reporting TANF Spending Information Office of Audit Services W-00-17-25100 2018, 2019 The Temporary Assistance for Needy Families (TANF) program is designed to help needy families achieve self-sufficiency. States receive block grants ($16.5 billion annually) to design and operate programs that accomplish one of the four purposes of the TANF program. States must report expenditures to ACF on a quarterly basis. Effective FY 2015, States will report actual transfers, expenditures, and unliquidated obligations (henceforth referred to as expenditures) made with each open grant year award during a fiscal year on form ACF-196R. Each quarterly report will reflect expenditures cumulative through that quarter for the fiscal year, resulting in a fourth quarter report that reflects actual expenditures made with the grant year award funds for the fiscal year. States will no longer report expenditures cumulative through the current reporting period. We will determine the accuracy of States' reporting of TANF spending information using the new form ACF-196R.
October 2017 Administration for Children and Families Head Start: Review of Single Audit Findings and Recommendations Office of Audit Services W-00-16-20010; various reviews 2018 Effective for awards made on or after December 26, 2014, all non-Federal entities that expend $750,000 or more of Federal awards in a year are required to obtain an annual audit in accordance with the Single Audit Act Amendments of 1996 (prior to December 26, 2014, the single audit threshold was $500,000). We will review the Office of Head Start's audit resolution of findings and recommendations contained in the single audit reports involving Head Start grantees for FYs 2013 to 2015. We will focus on grantees with repeat findings and review what action the Office of Head Start has taken to resolve the findings.
October 2017 Administration for Children and Families Unaccompanied Children Program Grantee Reviews Office of Audit Services W-00-16-25060; various reviews 2018 Under the Homeland Security Act of 2002, § 462, the Office of Refugee Resettlement (ORR) administers the Unaccompanied Children (UC) program. The UC program provides temporary shelter, care, and other related services to unaccompanied children in its custody. Before FY 2012, about 8,000 children were served annually in this program. In FY 2014, the number of children increased to over 57,500. The UC grant program totaled $911 million for FY 2014. We will review whether selected grantees met applicable grant terms and conditions of the program. Specifically, this work will determine whether a grantee met certain safety standards applicable for the care of UC children in its custody and used funding in accordance with Federal requirements.
October 2017 Administration for Children and Families Foster Care: Monitoring the Health and Safety of Children Through the Complaint Resolution and Licensing Process Office of Audit Services W-00-16-25056; various reviews 2018 Under Title IV-E of the SSA, States must establish complaint procedures for handling allegations or referrals of abuse and noncompliance of health and safety requirements for foster care children. We will review whether complaints are recorded, investigated, and resolved in accordance with Federal and State requirements. We will also review States' oversight process to ensure they meet licensing requirements for foster care family homes (SSA Title IV-E § 471(a)(9) and Title IV-E § 472(c)(1)).
October 2017 Centers for Disease Control and Prevention World Trade Center Health Program: Review of Administrative Costs - Mandatory Review Office of Audit Services W-00-14-59040 2018 Pursuant to the legislative requirements, medical services are provided to eligible responders and survivors with health conditions related to the September 11, 2001, terrorist attacks on the World Trade Center through contracted facilities known as Clinical Centers of Excellence. The World Trade Center Health Program (WTCHP) was established in January 2011 and is administered by CDC (James Zadroga 9/11 Health and Compensation Act of 2010 and Public Health Service Act § 3301(d)). Prior Federal audits found that CDC did not reliably estimate costs for monitoring and treating program beneficiaries. We will review WTCHP expenditures to assess whether internal controls have been established in the WTCHP in accordance with OMB Circular A-123, Management's Responsibility for Internal Control. As part of our review, we will determine whether the internal controls are adequate to prevent excessive administrative payments in accordance with Federal contracting requirements.
October 2017 Centers for Disease Control and Prevention Grantee's Use of President's Emergency Plan for AIDS Relief Funds Office of Audit Services W-00-16-57300; various reviews 2018 President's Emergency Plan for AIDS Relief (PEPFAR) funds support international programs for acquired immunodeficiency syndrome (AIDS) prevention, treatment, and care. CDC received PEPFAR funds from the annual HHS appropriation and the Foreign Operations appropriation. In previous audits of foreign PEPFAR grantees, we identified unallowable expenditures and internal control weaknesses. We will review (1) whether CDC effectively accounted for and monitored PEPFAR funds and (2) whether selected foreign grantees managed PEPFAR funds received under the PEPFAR program in accordance with award requirements. In addition, we plan to prepare a report to summarize the findings for all foreign grantee audits and recommendations for CDC to take corrective action.
October 2017 Centers for Medicare & Medicaid Services Security of Certified Electronic Health Record Technology Under Meaningful Use Office of Audit Services W-00-15-42002; various reviews 2018 A core meaningful-use objective for eligible providers and hospitals is to protect electronic health information created or maintained by certified EHR technology by implementing appropriate technical capabilities. To meet and measure this objective, eligible hospitals must conduct a security risk analysis of certified EHR technology as defined in Federal regulations and use the capabilities and standards of certified EHR technology (45 CFR § 164.308(a)(1) and 45 CFR §§ 170.314(d)(1) through (d)(9)). We will perform audits of various covered entities receiving EHR incentive payments from Centers for Medicare & Medicaid Services to determine whether they adequately protect electronic health information created or maintained by certified EHR technology.
October 2017 Centers for Medicare & Medicaid Services States' Collection of Rebates on Physician-Administered Drugs Office of Audit Services W-00-17-31400; various reviews 2018 States are required to collect rebates on covered outpatient drugs administered by physicians in order to be eligible for Federal matching funds (SSA § 1927(a)). Previous OIG work identified concerns with States' collection and submission of data to Centers for Medicare & Medicaid Services, including national drug codes that identify drug manufacturers, thus allowing States to invoice the manufacturers responsible for paying rebates (Deficit Reduction Act of 2005). We will determine whether States have established adequate accountability and internal controls for collecting Medicaid rebates on physician-administered drugs. We will assess States' processes for collecting national drug code information on claims for physician-administered drugs and subsequent processes for billing and collecting rebates.
October 2017 Centers for Medicare & Medicaid Services States' Collection of Rebates for Drugs Dispensed to Medicaid MCO Enrollees Office of Audit Services W-00-17-31483; various reviews 2018, 2019 Medicaid MCOs are required to report enrollees' drug utilization to the State for the purpose of collecting rebates from manufacturers. Section 2501(c) of the Patient Protection and Affordable Care Act expanded the rebate requirement to include drugs dispensed to MCO enrollees. We will determine whether States are collecting prescription drug rebates from pharmaceutical manufacturers for Medicaid MCOs. Drugs dispensed by Medicaid MCOs were excluded from this requirement until March 23, 2010.
October 2017 Centers for Medicare & Medicaid Services Manufacturer Rebates - Federal Share of Rebates Office of Audit Services W-00-17-31450; various reviews 2018 Section 2501 of the Patient Protection and Affordable Care Act increased the Medicaid drug rebates (both single-source and multiple-source drugs) for Medicaid outpatient drugs and required that those additional rebate amounts attributable to the increase be given solely to the Federal Government. We will review States' reporting of the Federal share of Medicaid rebate collections to determine whether States are correctly identifying and reporting the increases in rebate collections.
October 2017 Centers for Medicare & Medicaid Services Adult Day Health Care Services Office of Audit Services W-00-16-31386; various reviews 2018 Adult day health care programs provide health, therapeutic, and social services and activities to program enrollees. Beneficiaries enrolled must meet eligibility requirements, and services must be furnished in accordance with a plan of care. Medicaid allows payments for adult day health care through various authorities, including home- and community-based services waivers (SSA § 1915 and 42 CFR § 440.180). Prior OIG work shows that these payments do not always comply with Federal and State requirements. We will review Medicaid payments by States for adult day health care services to determine whether providers complied with Federal and State requirements.
October 2017 Centers for Medicare & Medicaid Services Oversight of States' Medicaid Information Systems Security Controls Office of Audit Services W-00-17-41015; various reviews 2018 Centers for Medicare & Medicaid Services is responsible for ensuring that appropriate security controls have been implemented over States' Medicaid information systems. Prior OIG audits reported that States lack sufficient security features, potentially exposing Medicaid beneficiary health information to unauthorized access. We will determine whether the States safeguarded Medicaid data and supporting systems in accordance with Federal requirements. We will review general controls and use OIG's automated assessment tools to assess controls for their information system networks, databases, and web-facing applications.
October 2017 Centers for Medicare & Medicaid Services States' MCO Medicaid Drug Claims Office of Audit Services W-00-17-31520 2018, 2019 Under the drug rebate program, Centers for Medicare & Medicaid Services provides States with a quarterly Medicaid drug tape, which, in effect, lists all covered outpatient drugs and indicates a drug's termination date, if applicable. A drug manufacturer must have a rebate agreement with Centers for Medicare & Medicaid Services to have its outpatient drugs covered under Medicaid (SSA § 1927(a)(1)). Centers for Medicare & Medicaid Services guidance instructs the States to use the tape to verify coverage of the drugs for which they claim reimbursement. States contract with MCOs to provide Medicaid services, including covered outpatient drugs to enrollees if the MCO is contractually required to provide such drugs. We will determine whether MCO capitation payments included reimbursement for drugs that are not covered under the Medicaid program. MCOs have some flexibility in maintaining formularies of drugs regardless of whether the manufacturers of those drugs participate in the drug rebate program. State Medicaid agencies can establish requirements regarding MCOs' formularies.
October 2017 Other Audit of HHS Information System Security Controls to Track Prescription Drug Disbursements Office of Audit Services W-00-16-42020 2018 HHS is responsible for implementing appropriate controls in National Institutes of Health and Indian Health Services hospitals to track the disbursement of prescription drugs (including opioids and other Schedule II drugs) in accordance with Federal security requirements. Prior OIG audits reported that HHS lacks sufficient security controls, which potentially impact abuse of prescription drugs. We will determine whether HHS applications that track the disbursement of prescription drugs meet Federal information security standards. We will focus on access and physical controls. For selected National Institutes of Health and Indian Health Services hospitals, we will review application controls and use OIG's automated assessment tools to assess the security of the networks, databases, and web-facing applications.
October 2017 Centers for Medicare & Medicaid Services Incorrect Medical Assistance Days Claimed by Hospitals Office of Audit Services W-00-16-35782 2018 The Medicare program, like the Medicaid program, includes provisions under which Medicare-participating hospitals that serve a disproportionate share of low-income patients may receive disproportionate share hospital payments. In Medicare, disproportionate share hospital payments to providers are based on Medicaid patient days that the hospitals furnish. Providers report these Medicaid patient days on the Medicare cost reports that Medicare administrative contractors review and settle. Because Medicare disproportionate share hospital payments are the result of calculations to which a number of sometimes complex factors and variables contribute, they are at risk of overpayment. We will determine whether, with respect to Medicaid patient days, Medicare administrative contractors properly settled Medicare cost reports for Medicare disproportionate share hospital payments in accordance with Federal requirements.
October 2017 Centers for Medicare & Medicaid Services Intensity-Modulated Radiation Therapy Office of Audit Services W-00-16-35733; various reviews 2018 Intensity-modulated radiation therapy (IMRT) is an advanced mode of high-precision radiotherapy that uses computer-controlled linear accelerators to deliver precise radiation doses to a malignant tumor or specific areas within the tumor. IMRT is provided in two treatment phases: planning and delivery. Certain services should not be billed when they are performed as part of developing an IMRT plan. Prior OIG reviews identified hospitals that incorrectly billed for IMRT services. We will review Medicare outpatient payments for IMRT to determine whether the payments were made in accordance with Federal requirements.
October 2017 Centers for Medicare & Medicaid Services Comparison of Provider-Based and Freestanding Clinics Office of Audit Services W-00-17-30026 2018 Provider-based facilities often receive higher payments for some services than freestanding clinics. The requirements that a facility must meet to be treated as provider-based are at 42 CFR § 413.65(d). We will review and compare Medicare payments for physician office visits in provider-based clinics and freestanding clinics to determine the difference in payments made to the clinics for similar procedures. We will also assess the potential impact on Medicare and beneficiaries of hospitals' claiming provider-based status for such facilities.
October 2017 Centers for Medicare & Medicaid Services Reconciliations of Outlier Payments Office of Audit Services W-00-16-35451; W-00-16-35781; various reviews 2018 Outliers are additional payments that Medicare provides to hospitals for beneficiaries who incur unusually high costs. The original outlier payments are based on the cost-to-charge ratio from the most recently settled cost report. The actual cost-to-charge ratio for the year in which the service was provided is available only at the time of cost report settlement for that year. Centers for Medicare & Medicaid Services performs outlier reconciliations at the time of cost report settlement. Without timely reconciliations and final settlements, the cost reports remain open and funds may not be properly returned to the Medicare Trust Fund (42 CFR § 412.84(i)(4)). We will review Medicare outlier payments to hospitals to determine whether Centers for Medicare & Medicaid Services performed necessary reconciliations in a timely manner to enable Medicare contractors to perform final settlement of the hospitals' associated cost reports. We will also determine whether the Medicare contractors referred all hospitals that meet the criteria for outlier reconciliations to Centers for Medicare & Medicaid Services.
October 2017 Centers for Medicare & Medicaid Services Payment Credits for Replaced Medical Devices That Were Implanted Office of Audit Services W-00-16-35745; various reviews 2018 Certain medical devices are implanted during an inpatient or outpatient procedure. Such devices may require replacement because of defects, recalls, mechanical complication, etc. Federal regulations require reductions in Medicare payments for the replacement of implanted devices that are due to recalls or failures (42 CFR §§ 412.89 and 419.45). Prior OIG reviews have determined that Medicare Administrative Contractors made improper payments to hospitals for inpatient and outpatient claims for replaced medical devices.� We will determine whether Medicare payments for replaced medical devices were made in accordance with Medicare requirements.
October 2017 Centers for Medicare & Medicaid Services Selected Inpatient and Outpatient Billing Requirements Office of Audit Services W-00-16-35538; W-00-17-35538; various reviews 2018 This review is part of a series of hospital compliance reviews that focus on hospitals with claims that may be at risk for overpayments. Prior OIG reviews and investigations have identified areas at risk for noncompliance with Medicare billing requirements. We will review Medicare payments to acute care hospitals to determine hospitals' compliance with selected billing requirements and recommend recovery of overpayments. Our review will focus on those hospitals with claims that may be at risk for overpayments.
October 2017 Centers for Medicare & Medicaid Services Duplicate Graduate Medical Education Payments Office of Audit Services W-00-15-35432; W-00-17-35432; various reviews 2018 Medicare pays teaching hospitals for direct graduate medical education (DGME) and indirect medical education (IME) costs. When payments for DGME and IME costs are being calculated, no intern or resident may be counted by Medicare as more than one full-time equivalent (FTE) employee (42 CFR §§ 413.78(b) and 412.105(f)(1)(iii)). To ensure that this incorrect counting does not occur, Centers for Medicare & Medicaid Services created the Intern and Resident Information System (IRIS). Prior OIG reviews determined that hospitals received duplicate reimbursement for DGME costs. We will review provider data from IRIS to determine whether hospitals received duplicate or excessive DGME payments. We will also assess the effectiveness of IRIS in preventing duplicate payments for DGME costs. If duplicate payments were claimed, we will determine which payment was appropriate.
October 2017 Centers for Medicare & Medicaid Services Payments for Patients Diagnosed with Malnutrition Office of Audit Services W-00-15-35715; W-00-17-35538; various reviews 2018 Kwashiorkor is a form of severe protein malnutrition that generally affects children living in tropical and subtropical parts of the world during periods of famine or insufficient food supply. It is typically not found in the United States. A diagnosis of kwashiorkor on a claim substantially increases the hospitals' reimbursement from Medicare. Prior OIG reviews have identified inappropriate payments to hospitals for claims with a kwashiorkor diagnosis. We will review Medicare payments made to hospitals for claims that include a diagnosis of kwashiorkor to determine whether the diagnosis is adequately supported by documentation in the medical record. We will roll up the results of our audits of Medicare hospital payments for kwashiorkor to provide Centers for Medicare & Medicaid Services with cumulative results and make recommendations for any appropriate changes to the program.
October 2017 Centers for Medicare & Medicaid Services Review of Hospital Wage Data Used to Calculate Medicare Payments Office of Audit Services W-00-16-35452; W-00-17-35725; various reviews 2018 Hospitals report wage data annually to Centers for Medicare & Medicaid Services, which is then used to calculate wage index rates to account for different geographic area labor market costs. Prior OIG wage index work identified hundreds of millions of dollars in incorrectly reported wage data and resulted in policy changes by Centers for Medicare & Medicaid Services with regard to how hospitals reported deferred compensation costs. We will review hospital controls over the reporting of wage data used to calculate wage indexes for Medicare payments (SSA §§ 1886(d)(3) and 1886(d)(3)(E)).
October 2017 Centers for Medicare & Medicaid Services Skilled Nursing Facility Prospective Payment System Requirements Office of Audit Services W-00-16-30014 2018 Medicare requires a beneficiary to be an inpatient of a hospital for at least 3 consecutive days before being discharged from the hospital to be eligible for SNF services (SSA § 1861(i)). If the beneficiary is subsequently admitted to an SNF, the beneficiary is required to be admitted either within 30 days after discharge from the hospital or within such time as it would be medically appropriate to begin an active course of treatment. Prior OIG reviews found that Medicare payments for SNF services were not compliant with the requirement of a 3-day inpatient hospital stay within 30 days of an SNF admission. We will review compliance with the SNF prospective payment system requirement related to a 3-day qualifying inpatient hospital stay.�
October 2017 Centers for Medicare & Medicaid Services Home Health Compliance with Medicare Requirements Office of Audit Services W-00-16-35712; W-00-16-35501; W-00-17-35712; various reviews 2018 The Medicare home health benefit covers intermittent skilled nursing care, physical therapy, speech-language pathology services, continued occupational services, medical social worker services, and home health aide services. For CY 2014, Medicare paid home health agencies (HHAs) about $18 billion for home health services. Centers for Medicare & Medicaid Services's Comprehensive Error Rate Testing (CERT) program determined that the 2014 improper payment error rate for home health claims was 51.4 percent, or about $9.4 billion. Recent OIG reports have similarly disclosed high error rates at individual HHAs. Improper payments identified in these OIG reports consisted primarily of beneficiaries who were not homebound or who did not require skilled services. We will review compliance with various aspects of the home health prospective payment system and include medical review of the documentation required in support of the claims paid by Medicare. We will determine whether home health claims were paid in accordance with Federal requirements.
October 2017 Centers for Medicare & Medicaid Services Osteogenesis Stimulators - Lump-Sum Purchase Versus Rental Office of Audit Services W-00-17-35747; various reviews 2019 Osteogenesis stimulators, also known as bone-growth stimulators, apply an electric current or ultrasound to the spine or a long bone (e.g., the femur) and are used when a fusion or fracture failed to heal or after a multilevel spinal fusion. Medicare payments for these devices from 2012 to 2014 were approximately $286 million. Because osteogenesis stimulators are categorized as "inexpensive and other routinely purchased items,"" the beneficiary has the option of either purchasing or renting the stimulators. We will determine whether potential savings can be achieved by Medicare and its beneficiaries if osteogenesis stimulators are rented over a 13-month period (the period of consecutive months of rental at which the Medicare payment is capped) rather than acquired through a lump-sum purchase.
October 2017 Centers for Medicare & Medicaid Services Competitive Bidding for Medical Equipment Items and Services - Mandatory Review Office of Audit Services W-00-14-35241; various reviews 2019 Federal law requires OIG to conduct postaward audits to assess Centers for Medicare & Medicaid Services's competitive bidding program. (Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), § 154(a)(1)(E)). We will review the process Centers for Medicare & Medicaid Services used to conduct competitive bidding and to make subsequent pricing determinations for certain medical equipment items and services in selected competitive bidding areas under rounds 1 and 2 of the competitive bidding program.
October 2017 Centers for Medicare & Medicaid Services Chiropractic Services - Part B Payments for Noncovered Services Office of Audit Services W-00-16-35606; various reviews 2018 Part B pays only for a chiropractor's manual manipulation of the spine to correct a subluxation if there is a neuro-musculoskeletal condition for which such manipulation is appropriate treatment (42 CFR § 410.21(b)). Chiropractic maintenance therapy is not considered to be medically reasonable or necessary and is therefore not payable (Centers for Medicare & Medicaid Services's Medicare Benefit Policy Manual, Pub. No. 10002, Ch. 15, § 30.5B). Prior OIG work identified inappropriate payments for chiropractic services. Medicare will not pay for items or services that are not "reasonable and necessary" (SSA § 1862(a)(1)(A)). We will review Medicare Part B payments for chiropractic services to determine whether such payments were claimed in accordance with Medicare requirements.
October 2017 Centers for Medicare & Medicaid Services Chiropractic Services - Portfolio Report on Medicare Part B Payments Office of Audit Services W-00-17-35770; OIG-12-14-03 2018 Previous OIG work identified inappropriate payments for chiropractic services that were medically unnecessary, were not documented in accordance with Medicare requirements, or were fraudulent. We will compile the results of prior OIG audits, evaluations, and investigations of chiropractic services paid by Medicare to identify trends in payment, compliance, and fraud vulnerabilities and offer recommendations to improve detected vulnerabilities. This planned work will offer recommendations to reduce Medicare chiropractic vulnerabilities that were detected in prior OIG work.
October 2017 Centers for Medicare & Medicaid Services Physical Therapists - High Use of Outpatient Physical Therapy Services Office of Audit Services W-00-16-35220; various reviews 2018 Previous OIG work found that claims for therapy services provided by independent physical therapists were not reasonable, were not properly documented, or the therapy services were not medically necessary. Medicare will not pay for items or services that are not "reasonable and necessary" (SSA § 1862(a)(1)(A)). We will review outpatient physical therapy services provided by independent therapists to determine whether they were in compliance with Medicare reimbursement regulations. Our focus is on independent therapists who have a high utilization rate for outpatient physical therapy services. Documentation requirements for therapy services can be found in Centers for Medicare & Medicaid Services's Medicare Benefit Policy Manual, Pub. No. 100-02, Ch. 15, § 220.3.
October 2017 Centers for Medicare & Medicaid Services Portable X-ray Equipment - Supplier Compliance with Transportation and Setup Fee Requirements Office of Audit Services W-00-16-35464 2018 Portable x-ray suppliers provide diagnostic imaging services at patients' locations - most often residences including private homes and group living facilities, such as nursing homes - rather than in a traditional clinical setting, such as a doctor's office or hospital. Medicare generally reimburses for portable x-ray services if the conditions for coverage are met (42 CFR §§ 486.100 486.110). However, previous OIG work found that Medicare may have improperly paid portable x-ray suppliers for return trips to nursing facilities, i.e., multiple trips to a facility in 1 day. We will review Medicare payments for portable x-ray equipment services to determine whether payments were correct and were supported by documentation. We will also assess the qualifications of the technologists who performed the services.
October 2017 Centers for Medicare & Medicaid Services Administrative Costs Claimed by Medicare Contractors Office of Audit Services W-00-17-35005; various reviews 2018 Centers for Medicare & Medicaid Services administers the Medicare program through contractors. Contracts between Centers for Medicare & Medicaid Services and the Medicare contractors define the functions to be performed and provide the reimbursement of allowable administrative costs incurred in the processing of Medicare claims. We will review administrative costs claimed by various contractors for their Medicare activities, focusing on costs claimed by terminated contractors. We will also determine whether the costs claimed were reasonable, allocable, and allowable. We will coordinate with Centers for Medicare & Medicaid Services regarding selection of the contractors that we will review. Criteria include Appendix B of the Medicare contract with Centers for Medicare & Medicaid Services and the Federal Acquisition Regulation (FAR) at 48 CFR Part 31.
October 2017 Centers for Medicare & Medicaid Services Contractor Pension Cost Requirements Office of Audit Services W-00-17-35067; W-00-17-35094; various reviews 2018 Medicare contractors are eligible to be reimbursed a portion of their pension costs and are required to separately account for the Medicare segment pension plan assets based on the requirements of their Medicare contracts and Cost Accounting Standards. We will determine whether Medicare contractors have calculated and claimed reimbursement for Medicare's share of various employee pension costs in accordance with their Medicare contracts and applicable Federal requirements. We will determine whether contractors have fully implemented contract clauses requiring them to determine and separately account for the employee pension assets and liabilities allocable to their contracts with Medicare. We will also review Medicare contractors whose Medicare contracts have been terminated, assess Medicare's share of future pension costs, and determine the amount of excess pension assets as of the closing dates. Applicable requirements are found in the FAR at 48 CFR Subpart 31.2; Cost Accounting Standards 412 and 413; and the Medicare contract, Appendix B, § XVI.
October 2017 Centers for Medicare & Medicaid Services Contractor Postretirement Benefits and Supplemental Employee Retirement Plan Costs Office of Audit Services W-00-17-35095; various reviews 2018 Centers for Medicare & Medicaid Services reimburses a portion of its contractors' postretirement health benefits costs and the supplemental employee retirement plans costs. The reimbursement is determined by the cost reimbursement principles contained in the FAR, Cost Accounting Standards as required by the Medicare contracts. We will review the postretirement health benefit costs and the supplemental employee retirement plans of Medicare contractors to determine the allowability, allocability, and reasonableness of the benefits and plans, as well as the costs charged to Medicare contracts. Criteria are in the FAR at 48 CFR §§ 31.201 through 31.205.
October 2017 Centers for Medicare & Medicaid Services Medicare Contractor Information Systems Security Programs: Annual Report to Congress - Mandatory Review Office of Audit Services W-00-17-41010 2018 Federal law requires independent evaluations of the security programs of Medicare Administrative Contractors and requires OIG to assess such evaluations and report the results of its assessments to Congress (Medicare Prescription Drug, Improvement, and Modernization Act of 2003, § 912). We will review independent evaluations of information systems security programs of Medicare Administrative Contractors. We will report to Congress on our assessment of the scope and sufficiency of the independent evaluations and summarize their results.
October 2017 Centers for Medicare & Medicaid Services Accountable Care Organizations: Beneficiary Assignment and Shared Savings Payments Office of Audit Services W-00-17-35774; various reviews 2018 The Medicare Shared Savings Program (MSSP), established by section 3022 of ACA, introduced accountable care organizations (ACOs) into the Medicare program to promote accountability of hospitals, physicians, and other providers for a patient population, coordinate items and services, and encourage investment in infrastructure and redesigned care processes for high-quality and efficient service delivery. We will review the MSSP to determine whether beneficiary assignment to ACOs and shared savings payments for assigned beneficiaries complied with Federal requirements. Our review will determine whether Centers for Medicare & Medicaid Services properly performed the process of assigning beneficiaries to ACOs in the MSSP. We will also examine Centers for Medicare & Medicaid Services's shared savings payments for beneficiaries who were assigned to ACOs under the MSSP to ensure that there is no duplication of payments for the same beneficiaries by other savings programs or initiatives (42 CFR § 425.402 and 42 CFR § 425.114(c)).
October 2017 Centers for Medicare & Medicaid Services Skilled Nursing Facilities - Unreported Incidents of Potential Abuse and Neglect Office of Audit Services W-00-16-35779 2018 SNFs are institutions that provide skilled nursing care, including rehabilitation and various medical and nursing procedures. Ongoing OIG reviews at other settings indicate the potential for unreported instances of abuse and neglect. We will assess the incidence of abuse and neglect of Medicare beneficiaries receiving treatment in SNFs and determine whether these incidences were properly reported and investigated in accordance with applicable Federal and State requirements. We will also interview State officials to determine if each sampled incident was reported, if required, and whether each reportable incident was investigated and subsequently prosecuted by the State, if appropriate.
October 2017 Other Review of Centers for Medicare & Medicaid Services Action on CERT Data Office of Audit Services W-00-16-35788 2018 Since 2003, Centers for Medicare & Medicaid Services has utilized the Comprehensive Error Rate Testing (CERT) program to establish a national error rate for Medicare Fee-for-Service payments as mandated by the Improper Payments Information Act of 2002. We issued a report in 2010 identifying error-prone providers and recommended that Centers for Medicare & Medicaid Services target these specific providers that contributed significantly to payment errors in the CERT program for provider-based reviews. Improper error rates and payments have not decreased in recent years. The FY 2015 reported national error rate for Medicare Fee-for-Service payments was approximately 12.1 percent, with improper payments estimated at $43.3 billion. We will determine if Centers for Medicare & Medicaid Services took action on our previous recommendation to use CERT data to target error-prone providers and reduce payment errors. Additionally, we will analyze CERT data to identify errors and potential patterns where further interventions could reduce payment errors.
October 2017 Centers for Medicare & Medicaid Services Drug Waste of Single-Use Vial Drugs Office of Audit Services W-00-17-35788 2019 The Food and Drug Administration approves vial sizes for single use submitted by manufacturers but does not control the vial sizes submitted for approval. Savings might be realized if single vial sizes currently available in other countries were available in the United States and if manufacturers were to market these smaller vials at lower prices. The Medicare Claims Processing Manual, Pub. 100-04, Ch. 17, § 40 provides policy on the use of the "JW" modifier for discarded Part B drugs and biologicals to track the amount of reimbursed waste in single-use vials effective January 1, 2017. We will determine the amount of waste for the 20 single-use-vial drugs with the highest amount paid for waste as identified by the JW modifier and provide specific examples of where a different size vial could significantly reduce waste.
October 2017 Centers for Medicare & Medicaid Services Risk Adjustment Data - Sufficiency of Documentation Supporting Diagnoses Office of Audit Services W-00-16-35078; various reviews 2018, 2019 Payments to Medicare Advantage organizations are risk adjusted on the basis of the health status of each beneficiary. Medicare Advantage organizations are required to submit risk adjustment data to Centers for Medicare & Medicaid Services in accordance with Centers for Medicare & Medicaid Services instructions (42 CFR § 422.310(b)), and inaccurate diagnoses may cause Centers for Medicare & Medicaid Services to pay Medicare Advantage organizations improper amounts (SSA §§ 1853(a)(1)(C) and (a)(3)). In general, Medicare Advantage organizations receive higher payments for sicker patients. Centers for Medicare & Medicaid Services estimates that 9.5 percent of payments to Medicare Advantage organizations are improper, mainly due to unsupported diagnoses submitted by Medicare Advantage organizations. Prior OIG reviews have shown that medical record documentation does not always support the diagnoses submitted to Centers for Medicare & Medicaid Services by Medicare Advantage organizations. We will review the medical record documentation to ensure that it supports the diagnoses that Medicare Advantage organizations submitted to Centers for Medicare & Medicaid Services for use in Centers for Medicare & Medicaid Services's risk score calculations and determine whether the diagnoses submitted complied with Federal requirements.
October 2017 Centers for Medicare & Medicaid Services Medicare Part D Eligibility Verification Transactions Office of Audit Services W-00-17-35751 2018 An E1 transaction is a Medicare Eligibility Verification transaction that the pharmacy submits to the Part D transaction facilitator to determine a beneficiary's eligibility to the Part D program and other drug coverage information. The Part D transaction facilitator returns information to the pharmacy that is needed to submit the prescription drug event. E1 transactions are part of the real-time process of the Coordination of Benefits and calculating the True Out-of-Pocket balance (Centers for Medicare & Medicaid Services, Medicare Prescription Drug Benefit Manual, Pub. No. 100-18, Ch. 14, § 30.4). We will review Centers for Medicare & Medicaid Services's oversight of E1 transactions processed by contractors and whether the E1 transactions were created and used for intended purposes. We will also review E1 transactions to assess the validity of the data.
October 2017 Centers for Medicare & Medicaid Services Documentation of Pharmacies' Prescription Drug Event Data Office of Audit Services W-00-17-35411; various reviews 2018, 2019/td> Drug plan sponsors must submit prescription drug event records, which is a summary record of individual drug claim transactions at the pharmacy, for the HHS Secretary to determine payments to the plans (SSA § 1860D-15(f)(1)). We will determine whether Medicare Part D prescription drug event records submitted by the selected pharmacies were adequately supported and complied with applicable Federal requirements. We will also conduct additional reviews of selected retail pharmacies identified in a prior OIG report as having questionable Part D billing.
October 2017 Centers for Medicare & Medicaid Services Quality of Sponsor Data Used in Calculating Coverage-Gap Discounts Office of Audit Services W-00-16-35611; W-00-17-35611; various reviews 2018 HHS is required to establish a Medicare coverage-gap discount program to provide relief to beneficiaries who are responsible for paying all drug costs during their coverage gaps (SSA § 1860D14A, as amended by the Patient Protection and Affordable Care Act § 3301). Sponsors track beneficiary payment information and the drug cost data necessary to calculate eligibility for the program. We will review data submitted by Part D sponsors for use in calculating the coverage gap discount to assess the accuracy of the data and determine whether beneficiary payments are correct and amounts paid to sponsors are supported.
October 2017 Centers for Medicare & Medicaid Services Medicare Part D Rebates Related to Drugs Dispensed by 340B Pharmacies Office of Audit Services W-00-17-35789 2018 Drug manufacturer rebates reduce the cost of the Part D program to beneficiaries and the Government. Manufacturers frequently do not pay rebates for Part D prescriptions filled at 340B covered entities and contract pharmacies since they are already providing a discount on the purchase of the drug. The Medicare Part D program does not share in the purchase discounts. Savings could be realized if requirements similar to those of the Medicaid Drug Rebate Program that require manufacturers to pay rebates were adopted by the Medicare Part D program. We will determine the upper bound of what could be saved if pharmaceutical manufacturers paid rebates for drugs dispensed through the Medicare Part D program at 340B covered entities and contract pharmacies.
October 2017 Centers for Medicare & Medicaid Services Medicare Part C Payments for Service Dates After Individuals' Dates of Death Office of Audit Services W-00-17-35772 2018 Centers for Medicare & Medicaid Services pays Medicare Advantage organizations for Part C benefits prospectively. A prior OIG review of deceased beneficiaries (OEI-04-12-00130) determined that Medicare improperly made $23 million in payments in 2011, of which $20 million was directly related to Medicare Part C payments that were made that year after beneficiaries' deaths. Federal regulations require that Medicare Advantage organizations disenroll a beneficiary from its Medicare Advantage plan on the death of the individual, which is effective the first day of the calendar month following the month of death. We will determine whether prospective payments made after a beneficiaries' date of death were in accordance with Medicare requirements.
October 2017 Centers for Medicare & Medicaid Services Medicare Part D Payments for Service Dates After Individuals' Dates of Death Office of Audit Services W-00-17-35773 2018 Under Medicare Part D, individuals entitled to Medicare benefits under Part A or enrolled in Part B and who live in the service area of a Part D plan may obtain prescription drug coverage. Centers for Medicare & Medicaid Services contracts with private prescription drug plans and Medicare Advantage plans (collectively known as sponsors) to offer prescription drug benefits to eligible individuals. A prior OIG review of deceased beneficiaries (OEI-04-12-00130) determined that Medicare improperly made $23 million in payments in 2011, of which $1 million was directly related to Medicare Part D payments that were made that year after beneficiaries deaths. Centers for Medicare & Medicaid Services pays prescription drug plan organizations for Part D benefits prospectively. A Part D sponsor must disenroll a beneficiary from its prescription drug plan on the death of the individual, which is effective the first day of the calendar month following the month of death. We will determine whether prospective payments made after a beneficiaries' date of death were in accordance with Medicare requirements.
October 2017 Centers for Medicare & Medicaid Services Accuracy of Financial Assistance Payments for Individual Enrollees Office of Audit Services W-00-15-59018 2018 Under the Patient Protection and Affordable Care Act an enrollee may be eligible for a premium tax credit. The tax credit lowers an individual's premiums for insurance purchased on a marketplace. An enrollee can choose to have the marketplace compute an estimated credit that is paid to the insurance company to lower the amount the enrollee pays in monthly premiums (advance payments of the premium tax credit, or APTC). For enrollees who receive APTCs but do not pay their portion of the premium for 3 consecutive months, qualified health plan issuers are responsible for terminating coverage, returning a portion of APTC payments, and reporting this information to Centers for Medicare & Medicaid Services. In addition, cost-sharing reductions (CSRs) assist certain low-income enrollees with their out-of-pocket costs. The Federal Government makes monthly payments to qualified health plan issuers to cover their estimated CSR costs, and these payments are then periodically reconciled to actual CSR amounts that should have been paid to all plans for confirmed enrollees. We will determine whether Centers for Medicare & Medicaid Services's internal controls were effective in ensuring the accuracy of financial assistance payments APTC and CSRs for individual enrollees. We will also conduct work on Centers for Medicare & Medicaid Services's automated policy-based payments system at the Federal Marketplace by potentially looking at the accuracy of the determination of financial assistance payments and the use of enrollment and payment data.
October 2017 Centers for Medicare & Medicaid Services Review of Funding to Establish the Federally Facilitated Marketplace Office of Audit Services W-00-16-55000 2018 HHS operates the Federally Facilitated Marketplace (FFM) in each State that did not establish and does not operate its own State marketplace. Centers for Medicare & Medicaid Services is accountable for the Federal funds involved in establishing the FFM. A previous OIG audit noted that Centers for Medicare & Medicaid Services did not identify all FFM contract costs and did not properly validate the amounts to withhold for defect resolution. We will identify the source and amount of funding used to establish the FFM. We will determine whether HHS had overall visibility and accountability for funds used by Centers for Medicare & Medicaid Services for the FFM; whether there were appropriate budgeting and management of these funds; how funds were tracked by HHS and Centers for Medicare & Medicaid Services; and whether the funds were used in accordance with appropriation law with regard to purpose, time, and amount (31 U.S.C. § 1502 and 31 U.S.C. § 1341(a)(1)). In addition, we will determine whether the amount that HHS and Centers for Medicare & Medicaid Services identified as FFM funding was accurate and complete.
October 2017 Food and Drug Administration Review of Prescription Drug User Fees Office of Audit Services W-00-16-50003 2018 The Prescription Drug User Fee Act of 1992, Pub. L. 102-571, authorized Food and Drug Administration to collect fees from pharmaceutical and biotechnology companies seeking Food and Drug Administration approval of certain human drug and biological products to expedite the review of human drug applications. Food and Drug Administration is expected to use the user fees it collects under the Act to meet its goals for the timely review of human drug applications. We will review Food and Drug Administration policies and procedures and financial records related to prescription drug user fees to determine whether Food and Drug Administration appropriately expended user-fee collections and accurately computed user-fee rates.
October 2017 Food and Drug Administration Food and Drug Administration Response Planning for a Networked Medical Device Compromise Office of Audit Services W-00-17-42020 2018 Networked medical devices, including dialysis machines, pacemakers, radiology systems, and medication dispensing systems, pose a growing threat to the security and privacy of personal health information and the safety of patients. Such networked devices use hardware, software, and networks to monitor a patient's medical status, regulate bodily functions, and transmit and receive related data. The complexity and task performed by networked devices has increased exponentially over time. To meet the new demands within networked device functionality, wireless, Internet, and network connectivity has been introduced along with new cybersecurity vulnerabilities. Food and Drug Administration is responsible for ensuring and monitoring the safety and effectiveness of networked medical devices. We will examine the Food and Drug Administration's plans and processes for timely communicating and addressing a networked medical device cybersecurity compromise.
October 2017 Food and Drug Administration Monitoring of Domestic and Imported Food Recalls Office of Audit Services W-00-15-50004 2018 Food and Drug Administration generally relies on firms to voluntarily cease distribution and recall harmful articles of food. Prior to 2011, Food and Drug Administration did not have the authority to require a firm to recall certain articles of food. However, the Food Safety Modernization Act (FSMA) added section 423 to the Food, Drug and Cosmetic Act, which gives Food and Drug Administration the authority to order a firm to recall certain articles of food after Food and Drug Administration determines that there is a reasonable probability that the food is adulterated or misbranded and that it will cause serious adverse health consequences or death to humans or animals. We will review Food and Drug Administration's monitoring of domestic and imported food recalls. The audit will determine the extent to which Food and Drug Administration has implemented the FSMA requirements related to the recall of food products and whether it has an effective recall process in place to ensure the safety of the Nation's food supply.
October 2017 Health Resources and Services Administration Compliance with Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Requirements Office of Audit Services W-00-15-59000; various reviews 2018 The Maternal, Infant, and Early Childhood Home Visiting (MIECHV) program is designed to strengthen and improve the programs and activities carried out under Title V of the SSA, improve coordination of services for at-risk communities, and identify and provide comprehensive services to improve outcomes for families that reside in at-risk communities. The ACA, § 2951, provided $1.5 billion for States and territories over 5 years, beginning in 2010, to deliver evidence-based home visiting services to eligible families with children prenatal to age 5. Program funding has been extended through 2017. Health Resources and Services Administration administers the MIECHV program in partnership with ACF. We will review compliance by States with terms and conditions of grants received under the MIECHV program. Specifically, we will determine whether States (1) used funding in accordance with Federal requirements, (2) adequately monitored the activities of subrecipients who provided program services, and (3) reported to Health Resources and Services Administration on the activities in accordance with Federal laws and regulations.
October 2017 Indian Health Services Charge Card Program Review Office of Audit Services W-00-16-51000; various reviews 2018 Pursuant to the Charge Card Act, OIG performed a risk assessment of HHS's charge card program for FY 2013. We will review Indian Health Services's charge card programs (e.g., purchase and travel cards) to determine if the programs comply with Federal requirements. We used the results of the risk assessment to identify high-risk and high-impact areas warranting an audit.
October 2017 National Institutes of Health Superfund Financial Activities for FY 2015 - Mandatory Review Office of Audit Services W-00-16-59050 2018 National Institutes of Health's National Institute of Environmental Health Sciences (NIEHS) provides Superfund Research Program funds for university-based multidisciplinary research on human health and environmental issues related to hazardous substances. Federal law and regulations require that OIG conduct an annual audit of the Institute's Superfund activities (Comprehensive Environmental Response, Compensation, and Liability Act of 1980, 42 U.S.C. § 9611(k)). We will review payments, obligations, reimbursements, and other uses of Superfund money by NIEHS.
October 2017 Other Audits of FYs 2016 and 2017 Consolidated HHS Financial Statements and Financial-Related Reviews - Mandatory Review Office of Audit Services W-00-17-40009; A-17-16-00001; A-17-17-00001 2018, 2019 The HHS financial statement audit determines whether the financial statements present fairly, in all material respects, the financial position of the audited entity for the specified time period. We will retain an independent external auditor and review the independent auditor's work papers to determine whether financial statement audits of HHS and its components were conducted in accordance with Federal requirements. The financial statement audit is required by Chief Financial Officers Act of 1990, as amended by the Government Management Reform Act of 1994, and performed in accordance with Generally Accepted Government Auditing Standards and OMB Bulletin 15-02, "Audit Requirements for Federal Financial Statements. The audited consolidated FYs 2015 and 2016 financial statements for HHS are due to OMB by November 15, 2016 and 2017, respectively. We plan to perform a number of ancillary financial-related reviews pertaining to the audits of the FY 2016 financial statements. The purpose of the financial-related reviews is to fulfill requirements in OMB Bulletin 15-02, §§ 6.1 through 13.
October 2017 Other OIG Reviews of Non-Federal Audits Office of Audit Services W-00-16-40005 2018 In accordance with the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS awards at 45 CFR Part 75, State, local, and Indian tribal governments; colleges and universities; and nonprofit organizations receiving Federal awards are required to have annual organization-wide audits of all Federal funds that they receive. OIG reviews the audits and reports to ensure they meet applicable standards, identifies any follow-up work needed, and identifies issues that may require management attention. OIG also provides upfront technical assistance to non-Federal auditors to ensure they understand Federal audit requirements and to promote effective audit work. We analyze and record electronically the audit findings reported by non-Federal auditors for use by HHS managers. Our reviews inform HHS managers about the management of Federal programs and identify significant areas of internal control weaknesses, noncompliance with laws and regulations, and questioned costs that require formal resolution by Federal officials. We will continue to review the quality of audits conducted by non-Federal auditors, such as public accounting firms and State auditors, in accordance with the uniform grant guidance.
October 2017 Other OIG Reimbursable Audits of Non-HHS Funds Office of Audit Services W-00-17-50012; various reviews 2018 To ensure a coordinated Federal approach to audits of colleges, universities, and States, OMB establishes audit cognizance, that is, it designates which Federal agency has primary responsibility for audit of all Federal funds that the entity receives. HHS OIG has audit cognizance over all State Governments and most major research colleges and universities that receive Federal funds. We enter into agreements with other Federal audit organizations or other Federal agencies to reimburse us as the cognizant audit organization for audits that we perform of non-HHS funds. We will conduct a series of audits as part of HHS's cognizant agency responsibility under the Uniform Grant Guidance, 2 CFR Part 200 that relates to Audits of States, Local Governments, and Nonprofit Organizations.
October 2017 Other Penetration Testing of HHS and Operating Division Networks Office of Audit Services W-00-17-42020; W-00-17-42000; various reviews 2018 Penetration tests are used to identify methods of gaining access to a system by using tools and techniques known to be employed by hackers. Computer hacker groups are increasingly active in attempts to compromise government systems, release sensitive data to the public, or use such data to commit fraud. We will conduct network and web application penetration testing to determine HHS's and its operating divisions' network security posture and determine whether these networks and applications are susceptible to hackers.
October 2017 Other HHS Government Purchase, Travel, and Integrated Charge Card Programs - Mandatory Review Office of Audit Services W-00-16-59041 2018 The Government Charge Card Abuse Prevention Act of 2012 (Charge Card Act) requires Inspectors General (IGs) to conduct periodic risk assessments of their agencies� charge card programs to analyze the risks of illegal, improper, or erroneous purchases. The Charge Card Act requires IGs to use the risk assessments to determine the necessary scope, frequency, and number of IG audits or reviews of the charge card programs. It requires Federal agencies to establish and maintain safeguards and internal controls for purchase cards, convenience checks, travel cards, and integrated cards. OMB has instructed IGs to submit annual status reports on purchase and travel card audit recommendations beginning January 31, 2014, for compilation and transmission to Congress and GAO. We will review HHS�s charge card programs (e.g., purchase, travel, or integrated cards) to assess the risks of illegal, improper, or erroneous purchases. HHS�s charge card programs enable cardholders to pay for commercial goods, services, and travel expenses.
October 2017 Other Public Health Reviews HHS Coordination of Roles and Responsibilities for Ebola Response Efforts Office of Audit Services W-00-16-58301 2018 Since the first cases of Ebola were reported in West Africa in March 2014, the United States has mounted a Government-wide response to contain and eliminate the epidemic at its source while also taking prudent measures to protect the American people. The HHS effort was launched encompassing many divisions, such as the CDC, ASPR, National Institutes of Health, Food and Drug Administration, Office of Global Affairs, and U.S. Public Health Service Commissioned Corps. We will review the extent to which HHS planned and coordinated strategic decisions related to HHS�s Ebola response efforts.� We will also review how HHS�s Ebola response activities were planned and coordinated with other U.S. Government agencies.�
October 2017 Other Public Health Reviews Controls over the Preparation and Receipt of Select Agent Shipments Office of Audit Services W-00-16-52000; various reviews 2018 Pursuant to 42 U.S.C. 262a and 7 U.S.C. 8401, select agents and toxins are a subset of biological agents and toxins that HHS and the U.S. Department of Agriculture have determined to have the potential to pose a severe threat to public health and safety, to animal or plant health, or to animal or plant products. Federal regulations at 42 CFR § 73.16 regulate the transfer of select agents. We will review National Institutes of Health's and Food and Drug Administration�s controls for preparing and receiving select agent shipments. We will review controls in place at National Institutes of Health and Food and Drug Administration that are designed to ensure that shipments are made and received in accordance with regulations at 42 CFR § 73.11(a) covering written security plans and related supporting laboratory guidance or instruction.
September 2017 Centers for Medicare & Medicaid Services Federal Marketplace Enrollment Systems Multiple W-00-00-0000 2018 OIG is developing new work focused on Federal Marketplace enrollment systems, which may include inquiries into operational readiness, internal controls, and IT security for the fifth open enrollment period. This work may build on prior OIG work addressing Marketplace operations.
September 2017 Office of the Assistant Secretary for Administration HHS Incident Response Capability Office of Audit Services A-18-17-04002 2018 FISMA requires Federal agencies to implement policies and procedures for detecting, reporting, and responding to security incidents. Increased threats to critical cyber-based infrastructure systems have created a need for Government agencies to increase their computer security efforts. Incidents involving cyber security and privacy threats, such as malware, malicious user activity, and vulnerabilities associated with highly interconnected technology require a skilled and rapid response to reduce their likelihood and to reduce or mitigate loss or destruction of data, loss of funds, loss of productivity, and damage to the agency's reputation. We will determine whether HHS has sufficiently implemented incident response capabilities to safeguard the Department's information technology systems and data.
September 2017 Centers for Medicare & Medicaid Services Availability of Behavioral Health Services in Medicaid Managed Care Office of Evaluation and Inspections 02-17-00490 2018 Behavioral health services include treatment and support for mental health conditions-such as bipolar disorder-as well as substance abuse disorders, such as opiate dependence. Medicaid is the single largest payer for behavioral health services in the United States, and most States provide these services through Medicaid managed care plans. Existing research on managed care providers in general has found a shortage of those willing to participate in Medicaid networks, raising concerns that the number of providers may not be sufficient to meet the needs of the Medicaid population. This review of five States will determine the extent to which Medicaid managed care plans include behavioral health providers and whether enough providers are available to meet the needs of the Medicaid population.
September 2017 Centers for Medicare & Medicaid Services Medicaid Health Home Services for Beneficiaries with Chronic Conditions Office of Audit Services W-00-17-31524; A-02-17-00000 2019 Section 1945 of the Social Security Act created an optional Medicaid State Plan benefit for States to establish "health homes" to coordinate care for people with Medicaid who have chronic medical conditions. States receive a 90-percent enhanced Federal Medical Assistance Percentage (FMAP) for health home services valid through the first eight quarters of the program. The State option to provide health home services to eligible Medicaid beneficiaries became effective on January 1, 2011. As of May 2017, CMS has approved Medicaid State plan amendments for 21 States and the District of Columbia for health home programs. More than 1 million Medicaid beneficiaries have been enrolled in these programs. We will review Medicaid health home programs for compliance with relevant Federal and State requirements.
September 2017 Centers for Medicare & Medicaid Services Medicaid Nursing Home Life Safety Reviews Office of Audit Services W-00-17-31525; A-02-17-00000 2019 CMS recently updated its health care facilities' life safety and emergency preparedness requirements to improve protections for all Medicare and Medicaid beneficiaries, including those residing in LTC facilities. These updates include requirements that facilities install expanded sprinkler and smoke detector systems to protect residents from the hazards of fire and develop an emergency preparedness plan that facilities must review, test, update, and train residents on annually. The plan must include provisions for sheltering in place and evacuation. OIG is reviewing this area because residents of LTC facilities are particularly vulnerable to the risk of fires, since many of these residents have limited or no mobility. Our objective is to determine if LTC facilities that received Medicare or Medicaid funds complied with new Federal requirements for life safety and emergency preparedness for the period May 4, 2016, through November 15, 2017.
September 2017 Substance Abuse and Mental Health Services Administration SAMHSA Pre-Award Process for Opioid State Targeted Response Grants Office of Audit Services W-00-17-59429; A-03-17-03302 2018 The 21st Century Cures Act, Pub. L. No. 114-255, § 1003, 130 Stat. 1033, 1044 (2016) authorized the Substance Abuse and Mental Health Services Administration (SAMHSA) to award $1 billion in grants to combat opioid addiction. The authorization allows SAMHSA to award $1 billion in funding, half in fiscal year (FY) 2017 and the other half in FY 2018. Grants are to be awarded to give preference to States with an incidence or prevalence of opioid use disorders that is substantially higher relative to other States. We will review the process and criteria for awarding the formula grants to States to determine whether SAMHSA followed Department of Health and Human Services grant regulations and program-specific requirements when awarding Opioid State Targeted Response grants authorized under the 21st Century Cures Act.
September 2017 Administration for Children and Families Review of Child Care and Development Fund Subsidy Payments in New York City Office of Audit Services W-00-17-59428; A-02-17-02010 2018 The Child Care and Development Fund (CCDF) assists low-income families and families receiving temporary public assistance to obtain childcare so that family members can work or get training or education. CCDF is the primary Federal funding source devoted to subsidizing childcare expenses of low-income families. Each State administers the CCDF and must ensure that all State and local agencies comply with program requirements when submitting childcare subsidy claim payments for Federal reimbursement. Any related childcare expenditures that do not comply with Federal and State requirements will be subject to disallowance and repayment. We will determine whether a State agency complied with Federal and State requirements when claiming reimbursement for childcare subsidy program payments.
September 2017 Centers for Medicare & Medicaid Services Part D Sponsors Reporting of Direct and Indirect Remunerations Office of Audit Services W-00-18-35514; A-03-18-xxxxx 2019 Medicare calculates certain payments to sponsors on the basis of amounts actually paid by the Part D sponsors, net of direct and indirect remuneration (DIR). (42 CFR pt. 423, subpart G.) DIR includes all rebates, subsidies, and other price concessions from sources (including, but not limited to, manufacturers and pharmacies) that decrease the costs incurred by Part D sponsors for Part D drugs. CMS requires that Part D sponsors submit DIR reports for use in the payment reconciliation process. We will determine whether Part D sponsors complied with Medicare requirements for reporting DIR.
September 2017 Administration for Children and Families Child Care and Development Fund: State Criminal Background Check Requirements Office of Audit Services W-00-17-59430 2018 Reauthorized in the Child Care and Development Block Grant Act of 2014 (CCDBG Act), the Child Care and Development Fund is the primary source of Federal subsidies of childcare costs of low-income families. All licensed, regulated, and registered childcare providers, as well as all childcare providers eligible to deliver childcare services, are subject to the CCDBG Act's requirements for criminal background checks. The CCDBG Act mandates that a State have policies and procedures in place that meet the criminal background check requirements. We will determine States' progress toward implementation of criminal background check requirements established under the CCDBG Act. This work may identify best practices that States can use in implementing these requirements.
September 2017 Centers for Medicare & Medicaid Services Medicare Payments for Overlapping Part A Inpatient Claims and Part B Claims Office of Audit Services W-00-16-35752, W-00-17-35752 2017 Overlapping claims can happen when a beneficiary is an inpatient of one hospital and then sent to another hospital to obtain outpatient services that are not available at the originating hospital. Certain items, supplies, and services furnished to inpatients are covered under Medicare Part A and should not be billed separately to Medicare Part B (42 CFR §§ 409.10 and 410.3; Medicare Claims Processing Manual, Ch. 3 § 10.4). Durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) claims for beneficiaries who received DMEPOS items while in an inpatient stay in a hospital should not be billed to Medicare separately. The payments associated with these claims are considered overpayments because Medicare does not allow separate payment for DMEPOS when a beneficiary is in a covered inpatient stay (Medicare Claims Processing Manual, Ch. 20 § 01). We will review the CMS Common Working File (CWF) edits that should deny claims for DMEPOS items furnished during an inpatient stay. Prior OIG reviews and investigations have identified this area as at risk for noncompliance with Medicare billing requirements. We will review Medicare payments to certain types of inpatient hospitals to determine whether claims billed to Part B for certain items, supplies, and services provided during inpatient stays were made in accord with Federal requirements.
September 2017 Indian Health Services Services for American Indians and Alaska Natives Administered by a Federally Qualified Health Center Office of Audit Services W-00-17-59052 2018 The Indian Health Service (IHS) provides comprehensive health services to approximately 2 million American Indians and Alaska Natives (AI/AN), either by operating health facilities directly or by funding tribes through contracts or compacts to operate health facilities themselves. In certain cases, tribes may operate a facility known as a Federally Qualified Health Center (FQHC), which is certified by the Centers for Medicare & Medicaid Services to provide outpatient health services to rural areas or underserved populations. In addition to funding from IHS, the tribes may also receive health care funding from the Medicaid or Medicare programs. This work will build on OIG's body of work identifying longstanding challenges, including insufficient oversight and limited access to specialists, that likely impact the quality of health care services provided to AI/ANs. We will review certain tribally operated FQHCs that are funded by IHS to determine whether health services delivered to AI/ANs met applicable Federal requirements.
September 2017 Substance Abuse and Mental Health Services Administration Controls Over Opioid Treatment Programs Office of Audit Services W-00-17-59035; A-02-16-02002 2018 Substance Abuse and Mental Health Services Administration funds State agencies' opioid treatment programs through its Substance Abuse Prevention and Treatment Block Grant program. Opioid abuse is a compelling public health concern, and in the past OIG has recommended better security protocols to reduce thefts of opioids from hospitals and pharmacies. We will determine whether a State agency is effectively monitoring its opioid treatment programs' services and medications in accordance with the federal guidelines for opioid treatment programs established under 42 CFR Part 8. We will also determine whether program expenditures are allowable in accordance with Federal requirements outlined in 45 CFR Part 75, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards.
August 2017 Other Public Health Reviews Review of the Patient Safety Organization Program Office of Evaluation and Inspections OEI-01-17-00420 2019 The Patient Safety Organization (PSO) program established federally recognized PSOs to work with health care providers to improve the safety and quality of patient care. The program also creates the first and only comprehensive, nationwide patient safety reporting and learning system in the United States. The Patient Safety and Quality Improvement Act of 2005 created the PSO program, and in 2008 the Agency for Healthcare Research and Quality (AHRQ) published the final Patient Safety Rule implementing the Act. We will determine the reach and value of the PSO program among hospitals. We will also assess AHRQ�s oversight of the PSO program and identify challenges the program faces.
August 2017 Centers for Medicare & Medicaid Services Duplicate Drug Claims for Hospice Beneficiaries Office of Audit Services W-00-17-35802; A-06-17-xxxxx 2018 Hospice providers are required to render all services necessary for the palliation and management of a beneficiary�s terminal illness and related conditions, including prescription drugs. Medicare Part A pays providers a daily per diem amount for each individual who elects hospice coverage, and part of the per diem rate is designed to cover the cost of drugs related to the terminal illness. Accordingly, Medicare Part D drug plans should not pay for prescription drugs related to a hospice beneficiary�s terminal illness because the drugs are already included in the Part A hospice benefit. Previous OIG work (A-06-10-00059) found that Medicare may have paid twice for prescription drugs for hospice beneficiaries, once under the Part A per diem rate and again under Part D. We will follow up on this work and review the appropriateness of Part D drug claims for individuals who are receiving hospice benefits under Part A. We will also determine whether Part D continues to pay for prescription drugs that should have been covered under the per diem payments made to hospice organizations.
August 2017 Centers for Medicare & Medicaid Services Medicare Part B Payments for Psychotherapy Services Office of Audit Services W-00-17-35801; A-09-17-xxxxx 2018 Medicare Part B covers psychotherapy services. Psychotherapy is the treatment of mental illness and behavioral disturbances in which a physician or other qualified health care professional establishes professional contact with a patient and, through therapeutic communication and techniques, attempts to alleviate emotional disturbances, reverse or change maladaptive patterns of behavior, and encourage personality growth and development. In calendar year 2016, Part B allowed approximately $1.2 billion for psychotherapy services, including individual and group therapy. A prior OIG review found that Medicare allowed $185 million in inappropriate outpatient mental health services, including psychotherapy services. The review found that psychotherapy services were particularly problematic, noting that almost half of the psychotherapy services reviewed were inappropriate. Specifically, Medicare paid for services that were not covered, inadequately documented, or medically unnecessary. We will review Part B payments for psychotherapy services to determine whether they were allowable in accord with Medicare documentation requirements.
August 2017 Centers for Medicare & Medicaid Services Ventilation Devices: Reasonableness of Medicare Payments Compared to Amounts Paid in the Open Market Office of Audit Services W-00-17-35803; A-05-xx-xxxxx 2018 Medicare reimbursement for ventilation devices has risen from $51 million in 2011 to $72 million in 2015. However, unlike similar items for which Medicare has seen reduced costs through competitive bidding, ventilation devices have not been competitively bid. We will determine the reasonableness of the fee schedule prices that Medicare and beneficiaries pay for ventilation devices compared to prices on the open market to identify potential wasteful spending in the Medicare program.
July 2017 Centers for Medicare & Medicaid Services Consumer-Directed Personal Assistance Program Office of Audit Services W-00-16-31035; A-02-16-01026 2018 Medicaid Consumer-Directed Personal Assistance Programs provide an alternative way of receiving home care services in which consumers have more control over who provides their care and how it is provided. Rather than assigning a home care agency that controls selection, training, and scheduling of aides, the �consumer,� or the family member, friend, or guardian directing his or her care, performs all these functions usually done by the agency. Eligible individuals include those eligible for services provided by a certified home health agency, a long-term home health care (waiver) program, AIDS home care program, or personal care (home attendant). Prior OIG work has shown vulnerabilities in personal care programs resulting in ineligible beneficiaries and Medicaid payments that do not comply with Federal and State regulations. We will determine whether selected States made Medicaid payments for consumer-directed personal assistance program claims in accordance with applicable Federal and State regulations.
July 2017 Centers for Medicare & Medicaid Services Health and Safety Standards in Social Services for Adults Office of Audit Services W-00-17-31503; A-05-17-00009, A-05-17-00028, A-05-17-00030 2018 State agencies operate elderly waiver programs under a 1915(c) waiver to their Medicaid State plan. Adult day centers are center-based facilities directly licensed by the State agency. They provide adult day services to functionally impaired adults on a regular basis for periods of fewer than 24 hours during the day in a nonresidential setting. As the licensing agency for adult day care centers, the State agency must ensure that adult day centers follow applicable licensing standards to protect the health and safety of adults receiving services at these facilities. Recent OIG reports have identified numerous instances of noncompliance in regulated child care facilities and family adult foster care homes. We will determine whether regulated adult day centers comply with applicable Federal, State, and local regulations and standards on ensuring the health and safety of adults in their care.
July 2017 Centers for Medicare & Medicaid Services Medicare Part B Payments for Ambulance Services Subject to Part A Skilled Nursing Facility Consolidated Billing Requirements Office of Audit Services W-00-17-35794; A-01-17-00506 2018 Medicare Part A prospective payments to skilled nursing facilities (SNFs) include most of the services that outside suppliers provide to SNF residents. Pursuant to 1862(a)(18) and 1842(b)(6)(E) of the Social Security Act, outside suppliers, including ambulance suppliers, must bill and receive payment from the SNF, not Medicare, for services provided to beneficiaries in SNF stays covered under Medicare Part A. Prior Office of Inspector General reports have identified high error rates and significant overpayments for services subject to SNF consolidated billing. We will determine whether ambulance services paid by Medicare Part B were subject to Part A SNF consolidated billing requirements. We will also assess the effectiveness of edits in CMS�s Common Working File to prevent and detect Part B overpayments for ambulance transportation subject to consolidated billing.
July 2017 Centers for Medicare & Medicaid Services Assertive Community Treatment Program Office of Audit Services W-00-17-31521; A-02-17-01008, A-02-17-01009, A-02-17-01020 2018 The Assertive Community Treatment (ACT) program offers treatment, rehabilitation, and support services using a person-centered, recovery-based approach to individuals who have been diagnosed with severe and persistent mental illness. Individuals receive ACT services�including assertive outreach, mental health treatment, health, vocational, integrated dual disorder treatment, family education, wellness skills, community linkages, and peer support�from a mobile, multidisciplinary team in community settings. Prior OIG work has shown vulnerabilities in States� mental health programs and their rate-setting methodologies, resulting in Medicaid payments that do not comply with Federal and State requirements. We will determine whether (1) Medicaid payments for ACT services complied with Federal and State requirements and (2) the payment rate for ACT services met the Federal requirement that payment for services be consistent with efficiency, economy, and quality of care.
July 2017 Centers for Medicare & Medicaid Services Children's Health Insurance Program Reauthorization Act (CHIPRA) Performance Bonus Payments Received by States Office of Audit Services W-00-17-31314; A-04-17-00000 2018 In the Children�s Health Insurance Program Reauthorization Act of 2009 (CHIPRA), Congress appropriated $3.2 billion for qualifying States to receive performance bonus payments for Federal fiscal years 2009 through 2013 to offset the costs of increased enrollment of children in Medicaid. Errors in calculating enrollment could result in improper payments to States. OIG has issued several reports identifying millions of dollars in unallowable bonus payments made to States. One State miscalculated its current enrollment, and other States included individuals in their current enrollment who should not have been included. We will determine whether the bonus payments received by States were allowable in accordance with Federal requirements.
July 2017 Centers for Medicare & Medicaid Services High-Risk, Error-Prone HHA Providers Using HHA Historical Data Office of Audit Services W-00-17-35800; A-05-17-00035 2018 For Calendar Year 2016, Medicare paid home health agencies (HHAs) about $18.2 billion for home health services. CMS�s Comprehensive Error Rate Testing (CERT) program determined that the 2016 improper payment error rate for home health claims was 42 percent, or about $7.7 billion. Using data from the CERT program, we will identify the common characteristics of �at risk� HHA providers that could be used to target pre- and post-payment review of claims.
July 2017 Centers for Medicare & Medicaid Services Recovery of Federal Funds Through Judgments/Settlements Office of Audit Services W-00-17-31522; A-05-17-00000 2018 Any State action taken as a result of harm to a State�s Medicaid program must seek to recover damages sustained by the Medicaid program as a whole, including both Federal and State shares. On October 28, 2008, CMS issued a letter (SHO #08-004) to State health officials that clarified language from Section 1903(d) of the Social Security Act, stating that the Federal Government is entitled to the Federal Medical Assistance Percentages (FMAP) � proportionate share of a State�s entire settlement or final judgment amount. We will determine whether selected States reported and returned the applicable FMAP share of the settlement and judgment amounts to the Federal Government.
July 2017 Centers for Medicare & Medicaid Services Nationwide Medicare Electronic Health Record Incentive Payments to Hospitals Office of Audit Services W-00-17-35795; A-09-17-03020 2018 Medicare incentive payments were authorized over a 5-year period to hospitals that adopted electronic health record (EHR) technology (Recovery Act, � 4102). From January 1, 2011, through December 31, 2016, the Centers for Medicare & Medicaid Services (CMS) made Medicare EHR incentive payments to hospitals totaling $14.6 billion. The Government Accountability Office identified improper incentive payments as the primary risk to the Medicare EHR incentive program. A Department of Health and Human Services, Office of Inspector General (OIG), report describes the obstacles that CMS faces in overseeing the Medicare EHR incentive program. In addition, previous OIG reviews of Medicaid EHR incentive payments found that State agencies overpaid hospitals by $66.7 million and would in the future overpay these hospitals an additional $13.2 million. These overpayments resulted from inaccuracies in the hospitals� calculations of total incentive payments. We will review the hospitals� incentive payment calculations to identify potential overpayments that the hospitals would have received as a result of the inaccuracies.
July 2017 Centers for Medicare & Medicaid Services Review of Medicare Payments for Nonphysician Outpatient Services Provided Under the Inpatient Prospective Payment System Office of Audit Services W-00-17-35799; A-01-17-00508 2018

Under the Medicare Part A inpatient prospective payment system (IPPS), hospitals are paid a predetermined amount per discharge for inpatient hospital services furnished to Medicare beneficiaries, as long as the beneficiary has at least one benefit day at the time of admission. The prospective payment amount represents the total Medicare payment for the inpatient operating costs associated with a beneficiary�s hospital stay. Inpatient operating costs include routine services, ancillary services (e.g., radiology and laboratory services), special care unit costs, malpractice insurance costs, and preadmission services. Accordingly, hospitals generally receive no additional payments for nonphysician outpatient services furnished shortly before and during inpatient stays. Medicare makes a duplicate payment if it makes a separate Part B payment to providers for such nonphysician outpatient services.

Prior Office of Inspector General reviews identified significant overpayments to hospital outpatient providers for nonphysician services furnished shortly before or during inpatient stays. Our recent work indicated that providers are still billing inappropriately and contractors continue to make inappropriate payments for these nonphysician outpatient services. Additionally, Medicare payment system controls are not preventing or detecting overpayments for incorrectly billed services. Our objective is to determine whether nationwide Medicare payments to hospital outpatient providers were correct for nonphysician outpatient services provided within 3 days prior to the date of admission, on the date of admission, or during IPPS stays (excluding date of discharge).

July 2017 Centers for Medicare & Medicaid Services Medicaid Claims for Opioid Treatment Program Services Office of Audit Services W-00-17-31523; A-02-17-01021 2018 Medicaid is a significant source of coverage and funding for behavioral health treatment services, including treatment of substance abuse. Some Medicaid State agencies provide payment for Opioid Treatment Program (OTP) services. Services can be provided at freestanding and hospital-based OTPs. We will determine whether selected State agencies complied with certain Federal and State requirements when claiming Medicaid reimbursement for OTP services.
July 2017 Centers for Medicare & Medicaid Services Medicaid Targeted Case Management Office of Audit Services W-00-17-31082; A-07-17-03219 2018 The Social Security Act, § 1915(g)(2), defines case management services as those assisting individuals eligible under the State plan in gaining access to needed medical, social, educational, and other services. Case management services do not include the direct delivery of an underlying medical, educational, social, or other service for which an eligible individual has been referred. Payments for case management services may not duplicate payments made to public agencies under other program authorities for the same service. Prior OIG work in one State identified 18 percent of such claims as unallowable, with an additional 20 percent as potentially unallowable. We will determine whether Medicaid payments for targeted case management services in selected States were made in accord with Federal requirements.
July 2017 Centers for Medicare & Medicaid Services Medicare Payments for Unallowable Overlapping Home Health Claims and Part B Claims Office of Audit Services W-00-17-35796; A-09-17-03022 2018 According to Section 1842 (b)(6)(F) of the Social Security Act, consolidated billing for all home health services is required while the beneficiary is under a home health plan of care authorized by a physician. The Act established a Medicare prospective payment system that pays home health agencies (HHA) for home services and covers all of their costs for furnishing services to Medicare beneficiaries. Pursuant to the home health consolidated billing requirements, the HHA that establishes a beneficiary�s home health plan of care has Medicare billing responsibility for services furnished to the beneficiary. Payment is made to the HHA whether or not the item or service was furnished by the HHA or by others by arrangement. We will review Medicare Part A payments to HHAs to determine whether claims billed to Medicare Part B for items and services were allowable and in accord with Federal regulations. Generally, certain items, supplies, and services furnished to inpatients are covered under Part A and should not be separately billable to Part B. Prior OIG audits, investigations, and inspections have identified this area for noncompliance with Medicare billing requirements.
July 2017 Centers for Medicare & Medicaid Services Medicare Payments for Unallowable Overlapping Hospice Claims and Part B Claims Office of Audit Services W-00-17-35797; A-09-17-03021 2018 According to 42 CFR 418.24(d), a hospice beneficiary waives all rights to Medicare payments for any services that are related to the treatment of the terminal condition for which hospice care was elected or treatment of a related condition or treatment that is equivalent to hospice care. Excepted are those services provided by another hospice under arrangement or by an independent attending physician. The hospice agency assumes responsibility for medical care related to the beneficiary�s terminal illness and related conditions. When a service that is related to the hospice patient�s terminal illness is furnished by an outside provider, other than an independent attending physician, the provider must look to the hospice for payment. Medicare should not make a separate payment to the outside provider. Prior OIG audits, investigations, and inspections have identified this area for noncompliance with Medicare billing requirements. We will review Medicare Part A payments to hospices to determine whether claims billed to Medicare Part B for items and services were allowable and in accord with Federal regulations. Generally, certain items, supplies, and services furnished to inpatients are covered under Part A and should not be separately billable to Part B.
June 2017 Centers for Medicare & Medicaid Services Review of Quality Measures Data Reported by Accountable Care Organizations in the Medicare Shared Savings Program Office of Audit Services W-00-17-35798; A-09-17-03023 2018 2018 The Medicare Shared Savings Program (MSSP) was established by section 3022 of the Patient Protection and Affordable Care Act to facilitate coordination and cooperation among providers, improve quality of care for Medicare fee-for-service beneficiaries, and reduce unnecessary costs. Eligible providers and suppliers may voluntarily participate in the MSSP by creating or joining an Accountable Care Organization (ACO). ACOs that lower health care costs and meet quality performance standards for their beneficiary populations are eligible to share in any savings that the ACOs generate for the Medicare program (earned shared savings). To demonstrate that they are providing appropriate, high-quality care while reducing costs, ACOs are required to report complete and accurate data on quality measures and to satisfy minimum levels of certain quality measures as set by CMS. CMS assesses an ACO�s overall quality performance by calculating a single quality performance score across all quality measures reported by the ACO. This score is used in part to calculate the ACO�s earned shared savings. We will review MSSP ACOs that received earned shared savings payments to determine whether they reported quality measures data in accordance with Federal requirements. Our review is part of several OIG reviews that will examine various aspects of the ACOs under the MSSP.
June 2017 Centers for Medicare & Medicaid Services Data Brief: Excessive Use of Opioids in Medicare Part D Office of Evaluation and Inspections OEI-02-17-00250 2017 Opioid abuse and overdose deaths are at epidemic levels in the United States. In 2015, the number of opioid-related deaths was higher than any previous year, exceeding 33,000 for the first time. Although opioids can be appropriate for some beneficiaries, OIG shares in concerns about opioid misuse, fraud, and abuse in Medicare Part D. Previous OIG work called attention to increased Part D spending for commonly abused opioids. OIG has also highlighted the problem of drug diversion�the redirection of prescription drugs for an illegal purpose, such as recreational use or resale. This data brief builds on OIG�s previous work and includes in-depth analysis of opioid utilization among Medicare Part D beneficiaries. It provides baseline data on the extent to which beneficiaries are receiving extreme amounts of opioids and appear to be doctor shopping. It also identifies prescribers who have questionable opioid prescribing patterns.
June 2017 Substance Abuse and Mental Health Services Administration Access to Buprenorphine-Waivered Providers for the Treatment of Opioid Use Disorder Office of Evaluation and Inspections OEI-12-17-00249 2018 SAMHSA estimates that 2.5 million people have an opioid use disorder related to prescription pain relievers and/or heroin. Medication-Assisted Treatment (MAT), including buprenorphine, is a significant component of the treatment protocols for opioid use disorder and plays a large role in combating the opioid epidemic in the United States. Congress has taken sustained action to support MAT services through broadened prescribing authorities, increased Federal funding, and insurance protections. However, a treatment gap continues to exist where less than 1 percent of the people in the United States who need treatment for substance use disorder receive it. OIG will examine access to MAT treatment through SAMHSA�s buprenorphine waiver program, which permits providers to prescribe buprenorphine to patients in office settings, rather than traditional opioid treatment facilities. We will examine the number, location, and patient capacity of providers who have obtained buprenorphine waivers from SAMHSA. We will also determine the extent to which waivered providers are located in areas with the greatest need for MAT services, the number of patients they report treating with buprenorphine, and the factors that may either facilitate or hinder the provision of buprenorphine in an office setting.
June 2017 Centers for Medicare & Medicaid Services Including Non-Covered Versions When Setting Payment Amounts for Part B Drugs Office of Evaluation and Inspections OEI-12-17-00260 2017 With certain exceptions, self-administered drugs are typically not covered under Medicare Part B. However, preliminary analysis shows that Part B payment amounts for a small number of drugs are being based, in part, on the average sales prices of non-covered, self-administered versions. We will examine how the Centers for Medicare & Medicaid Services determines which versions of drugs are included in Part B payment amount calculations, and the cost to Medicare and its beneficiaries of including non-covered, self-administered versions when calculating Part B payment amounts.
June 2017 Centers for Medicare & Medicaid Services Followup: CMS's Management of the Quality Payment Program Office of Evaluation and Inspections OEI-12-17-00350 FY We will assess the Centers for Medicare & Medicaid Services�s (CMS) progress in addressing key challenges to implementing the Quality Payment Program (QPP), a new initiative intended to shift Medicare from a volume-based payment system to one that rewards value. In December 2016, OIG found that two aspects of QPP implementation require particular focus: 1) providing sufficient guidance and technical assistance to ensure that clinicians are ready to participate in the QPP, and 2) developing backend information technology (IT) systems to support key QPP functions, such as data reporting and validation. If these issues are not fully addressed, QPP implementation may be delayed, fewer clinicians may participate, and the program may fail to achieve its goals. We will review CMS�s clinician outreach and training efforts and determine the status of IT system development, including the extent to which CMS has conducted security and functionality testing.
June 2017 Centers for Medicare & Medicaid Services Trends in Hospice Deficiencies and Complaints Office of Evaluation and Inspections OEI-02-17-00020 2018 The Medicare hospice program is an important benefit for beneficiaries and their families at the end of life. Surveys and complaint investigations are critical oversight mechanisms that address the care provided to beneficiaries by hospices. The Centers for Medicare & Medicaid Services (CMS) contracts with State survey agencies to conduct onsite surveys of hospices for certification and in response to complaints. National accreditation organizations, approved by CMS, may also conduct onsite surveys. These surveys assess the extent to which hospices meet Federal health and safety standards and require that surveyors cite hospices with deficiencies if they fail to meet the standards. Previous OIG reports identified numerous vulnerabilities and raised concerns about the limited enforcement actions against poorly performing hospices. As part of OIG�s ongoing commitment to address quality of care, we will determine the extent and nature of hospice deficiencies and complaints and identify trends.
June 2017 Centers for Medicare & Medicaid Services Medicare Drug Integrity Contractor's Activities Office of Evaluation and Inspections OEI-03-17-00310 2018 As required by the Comprehensive Addiction and Recovery Act of 2016, this study will fulfill OIG�s mandate to review the effectiveness of the Medicare Drug Integrity Contractor (MEDIC) in identifying, combating, and preventing fraud under the Medicare program, including how the MEDIC assists in determining beneficiaries at risk for drug abuse. Since 2013, there have been policy, regulatory, and statutory changes that affect the way the MEDIC accesses data needed to perform its required benefit integrity activities. This study will focus on the results of the MEDIC�s benefit integrity activities in Medicare Part C and Part D. It also will describe how the MEDIC assists plan sponsors in identifying potential at-risk beneficiaries. Finally, it will identify any barriers and challenges the MEDIC has experienced while performing its benefit integrity activities.
June 2017 Centers for Medicare & Medicaid Services Invalid Prescriber Identifiers on Medicare Part D Drug Claims in 2016 Office of Evaluation and Inspections OEI-03-17-00040 2018 Section 1860D-4(c) of the Social Security Act, as amended by Section 507 of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), requires that, starting in plan year 2016, claims for a covered Part D drug must contain a valid prescriber National Provider Identifier (NPI). (P.L. 114-10 (April 6, 2015) � 507.) MACRA Section 507 requires the Secretary of Health and Human Services to establish procedures for determining the validity of the Part D prescriber NPIs. MACRA also requires OIG to submit to Congress a report on the effectiveness of these procedures no later than January 1, 2018. We will determine the extent to which invalid NPIs were used as prescriber identifiers on Part D prescription drug event records in 2016 and identify the procedures the Centers for Medicaid & Medicare Services has used to determine the validity of prescribers� NPIs.
June 2017 Centers for Medicare & Medicaid Services FDA Approval Status of Drugs in the Medicaid Drug Rebate Program Office of Evaluation and Inspections OEI-03-17-00120 2018 The Food and Drug Administration (FDA) is responsible for ensuring that new drugs are safe and effective before they can be approved for marketing in the United States. With certain exceptions, drugs generally must be FDA-approved for safety and effectiveness to qualify for Federal payments under Medicaid. Under the Medicaid Drug Rebate Program, a drug manufacturer must provide the Centers for Medicare & Medicaid Services (CMS) with its FDA-assigned labeler code and a complete list of drugs marketed by the company. Drug manufacturers are also generally required to enter into rebate agreements with the Secretary of Health and Human Services and pay quarterly rebates to States to qualify for Federal payments under Medicaid. At the request of Congress, we will review the FDA approval status of drugs covered under the Medicaid Drug Rebate Program. We will also determine what steps CMS takes to review the FDA approval status of drugs and prevent inappropriate payments for unapproved drugs under the Medicaid Drug Rebate Program.
June 2017 Centers for Medicare & Medicaid Services Accuracy of Drug Classification Data Used to Collect Medicaid Rebates Office of Evaluation and Inspections OEI-03-17-00100 2017 For Federal payments to be available for covered outpatient drugs provided under Medicaid, drug manufacturers are generally required to enter into rebate agreements with the Secretary of Health and Human Services and pay quarterly rebates to States. Under the Medicaid Drug Rebate Program, drug manufacturers must provide the Centers for Medicare & Medicaid Services (CMS) with the average manufacturer price (AMP) and, if applicable, best price for each of their covered outpatient drugs. The rebate amount for a drug is based in part on whether the drug manufacturer classifies it as an innovator, i.e., a single-source or an innovator, multiple-source product, or a non-innovator, multiple-source product. We will review CMS�s Medicaid drug rebate classification data and evaluate the accuracy of innovator and non-innovator classifications for drugs. We will also review the procedures CMS has in place to ensure that manufacturers are in compliance with the requirements of the Medicaid Drug Rebate Program.
June 2017 Centers for Medicare & Medicaid Services Reasonable Assumptions in Manufacturer AMP Reporting Office of Evaluation and Inspections OEI-12-17-00130 2018 For Federal payments to be available for covered outpatient drugs provided under Medicaid, drug manufacturers are generally required to enter into rebate agreements with the Secretary of HHS and pay quarterly rebates to States. Under the Medicaid Drug Rebate Program, drug manufacturers must provide the Centers for Medicare & Medicaid Services (CMS) with the average manufacturer price (AMP) and, if applicable, best price (BP) for each of their covered outpatient drugs. The complexities of industry practices and the absence of specific guidance can present difficulties for manufacturers when calculating AMPs and BPs. CMS�s recent Medicaid covered outpatient drugs final rule offers substantial guidance to manufacturers, but it likely does not provide complete clarity for every situation. As outlined in the rebate agreement, CMS permits manufacturers to make �reasonable assumptions� under certain circumstances when calculating AMPs and BPs. Manufacturers must document their assumptions, but they are not required to submit them to CMS. In response to a Congressional request, we will estimate how many manufacturers make such assumptions and identify the major issues for which assumptions are being made. We will also examine CMS�s oversight of the reasonable-assumptions process and explore whether manufacturers believe that CMS�s recent final rule clarified issues for which manufacturers previously made assumptions.
June 2017 Centers for Medicare & Medicaid Services Monitoring Children Enrolled in Medicaid and Diagnosed with Attention Deficit Hyperactivity Disorder Office of Evaluation and Inspections OEI-07-17-00170 2018 The Children�s Health Insurance Program (CHIP) Reauthorization Act of 2009 (CHIPRA), Section 401: Child Health Quality Improvement Activities for Children enrolled in Medicaid or CHIP, requires the development of an initial core set of health care quality measures. The Centers for Medicare & Medicaid Services (CMS) has issued a core set of children�s health care quality measures referred to as the Child Core Set that includes two behavioral health care measures related to followup care for children with attention deficit hyperactivity disorder (ADHD). Prior OIG work found that children enrolled in Medicaid who are prescribed psychotropic medications are not consistently or regularly monitored. We will evaluate the extent to which children diagnosed with ADHD and enrolled in Medicaid received followup care and psychosocial intervention.
June 2017 Centers for Disease Control and Prevention CDC's Global Health Security Agenda Office of Audit Services W-00-17-59427; A-04-17-02004 2018 The Global Health Security Agenda (GHSA) was launched in February 2014 to help create a world safe and secure from the threat of all infectious disease and elevate global health security as a national and global priority.�The Centers for Disease Control and Prevention (CDC) received $597 million, to remain available through FY 2019, from the Consolidated and Further Continuing Appropriations Act, 2015 (P.L. 113-235), which CDC is using to implement the GHSA by providing grants to both foreign organizations and U.S.-based organizations (domestic recipients) working abroad.�� We will determine whether CDC domestic recipients managed and expended funds to implement the GHSA in accordance with Federal requirements.
June 2017 Food and Drug Administration Review of the Food and Drug Administration's Contract Closeout Actions Office of Audit Services A-03-17-03001 2018 As one of the largest contracting agencies in the Federal Government, HHS performed contracting actions (awards and modifications) totaling almost $24 billion in fiscal year 2016. Prior OIG work identified issues regarding contract closeout, which is required once the contracting officer receives evidence of receipt of property and final payment, or evidence of physical completion of the contract. The closeout process is generally the last chance to detect and recover improper contract payments, and delayed closeout poses a financial risk to agency funds. Also, the closeout process (1) ensures that goods and services were provided as intended, (2) validates final costs and payments, and (3) frees up excess funds for possible use elsewhere. We will determine whether the Food and Drug Administration (FDA) closed contracts in accordance with the Federal Acquisition Regulation and departmental guidance. We will also determine whether the FDA identified when contracts are eligible for closeout.
June 2017 Health Resources and Services Administration HRSA's Award Process for Zika Response and Preparedness Funds Office of Audit Services A-04-17-02003 2018 The Zika Response and Preparedness Appropriations Act, 2016 (P.L. 114-223, Division B, September 29, 2016), provided to HRSA $66 million in funding to remain available until September 30, 2017. The funding was to be directed at efforts in Puerto Rico and other territories to (1) expand the delivery of primary health care services; (2) support public health departments and entities, with the goal of ensuring access to recommended services for pregnant women, infants, and children; and (3) make loan repayment awards to National Health Service Corps members providing primary health services. We will determine whether HRSA awarded these funds during fiscal year 2017 in compliance with Federal regulations and HHS grant policies.
June 2017 Indian Health Services Case Study: Closure of the Rosebud Hospital Emergency Department Office of Evaluation and Inspections OEI-06-17-00270 2018 The Indian Health Service (IHS) provides comprehensive health services for approximately 2.2 million American Indians and Alaska Natives (AI/ANs). Ensuring that these services are both safe and accessible is critical to the well-being of AI/ANs. During a 7-month period, IHS discontinued emergency services at its Rosebud Hospital location. The closure of the Rosebud emergency department (ED) followed a notice of intent by the Centers for Medicare & Medicaid Services (CMS) to terminate Rosebud Hospital from the Medicare program. Representatives of the Rosebud Sioux Tribe raised concerns to OIG about the Rosebud ED closure and linked that closure to several patient deaths that occurred during ambulance transports to other facilities when emergency care was unavailable locally. In response to these concerns, we will examine factors considered and procedures involved in IHS�s decisions to close and later reopen the Rosebud ED. We will also assess IHS�s management, coordination, and communication related to the closure and will identify lessons learned that IHS could apply to similar situations in the future.
June 2017 Other HHS Resolution of Audit Recommendations Office of Audit Services W-00-17-25102 2018 HHS is responsible for resolving Federal and non-Federal audit report recommendations related to its activities, grantees, and contractors within 6 months after formal receipt of the audit report. OIG prepares and forwards to HHS agencies monthly stewardship reports showing the status of these audit recommendations. An October 2016 Senate report found that 72 different Inspector General (IG) offices reported that Federal departments and agencies were wasting a total of $87 billion by failing to implement more than 15,000 IG recommendations. Of the 72 Federal departments and agencies mentioned in the report, HHS had the second highest number of open and unimplemented IG recommendations and the fifth highest in potential cost savings, $23 billion, if recommendations had been implemented. We will determine whether each agency has resolved audit recommendations in a timely manner during fiscal years 2015 and 2016. We will also identify all unresolved audit recommendations that were due for resolution as of September 30, 2016.
June 2017 National Institutes of Health NIH Compliance with Federal Requirements for Indirect Cost Rate Setting Office of Audit Services W-00-17-59422; A-04-17-04059 2018 In fiscal year 2016, HHS awarded contracts to commercial organizations totaling over $5.9 billion. Indirect costs make up a significant portion of award costs. The National Institutes of Health (NIH) Division of Financial Advisory Services (DFAS) is the cognizant Federal agency responsible for negotiating and establishing indirect cost rates for commercial organizations that receive the preponderance of their Federal contract awards from HHS. We will determine whether DFAS established indirect cost rates for applicable commercial organizations in accordance with Federal requirements.
November 2016 Administration for Children and Families Recommendation Follow-Up: Office of Refugee Resettlement's Post-Placement Activities for Unaccompanied Children Office of Evaluation and Inspections OEI-09-16-00260 2017 Under the Homeland Security Act of 2002, § 462, HHS�s Office of Refugee Resettlement (ORR) administers the Unaccompanied Children program. ORR provides temporary shelter, care, and other related services to unaccompanied children in its custody before releasing them to a parent, relative, or other adult sponsor. In a 2008 report, OIG found a lack of clarity between HHS and the Department of Homeland Security regarding their roles and responsibilities related to unaccompanied children. OIG also found that at the time, neither Department checked on children�s safety and well-being after their release from Federal custody. OIG recommended that the Departments delineate their roles and responsibilities in a formal agreement. This recommendation has not been fully implemented; therefore, we will follow up on ORR�s progress toward addressing the recommendation, and examine ORR�s efforts to promote the safety and well-being of children after their release from ORR�s custody.
November 2016 Administration for Children and Families States' Implementation of Guardian Ad Litem Requirements Office of Evaluation and Inspections OEI-12-16-00120 2018 Section 8 of the Child Abuse Prevention and Treatment Act requires that, as a condition of receiving Child Abuse Prevention and Treatment Act grant funding, States must ensure that every child involved in an abuse or neglect judicial proceeding is appointed an advocate, or guardian ad litem. The purpose of the guardian ad litem requirement is to ensure that the best interests of these vulnerable children are represented in the court by an individual who has a clear understanding of the situation and the child�s needs. We will assess selected States� compliance with guardian ad litem requirements. We will also determine whether States ensure that guardians ad litem receive the required training appropriate to their role. We will further describe how children receive guardians ad litem representation in each State, including the number of times guardians ad litem met with children outside the court.
November 2016 Administration for Children and Families Foster Care: States' Protocols for the Use and Monitoring of Psychotropic Medications for Children in Foster Care Office of Evaluation and Inspections OEI-07-15-00380 2018 Psychotropic medications are used to treat mental health disorders such as schizophrenia, depression, bipolar disorder, anxiety disorders, and attention deficit/hyperactivity disorder. Pursuant to section 422(b)(15)(A) of the SSA, each State must develop a plan for ongoing oversight and coordination of health services for children in foster care, including oversight of prescription medicines, e.g., appropriate use and monitoring of psychotropic medications.� We will describe States� protocols for the appropriate use and monitoring of psychotropic medications for children in foster care. �For selected States, we will determine whether a sample of children in foster care enrolled in Medicaid received psychotropic medications in accordance with their State's protocols.� Because ACF is responsible for the oversight of States� foster care programs, we will determine the extent to which the Agency ensures that children in foster care receive psychotropic drugs in accordance with States� protocols.
November 2016 Administration for Children and Families States' Payment Rates for the Child Care and Development Fund Program Office of Evaluation and Inspections OEI-03-15-00170 2018 Reauthorized in the Child Care and Development Block Grant Act of 2014, the Child Care and Development Fund (CCDF) is the primary Federal funding source devoted to subsidizing the childcare expenses of low-income families. Each State sets payment rates for childcare providers, and the Administration for Children and Families (ACF) oversees payment rates. States must certify that payment rates �are sufficient to ensure equal access, for eligible families in the area served by the [State], to childcare services comparable to those provided to families not eligible� for CCDF subsidies (45 CFR � 98.45a). We will compare CCDF payment rates to the prices charged by childcare centers and family childcare homes. We will review States� processes for determining their payment rates as well as ACF�s methods for determining whether States� CCDF payment rates are sufficient to ensure equal access to childcare services.
November 2016 Administration for Community Living Senior Medicare Patrol Projects' Performance Data - Annual Review Office of Evaluation and Inspections OEI-00-00-00000 2017 In 1997, Senior Medicare Patrol (SMP) projects were established to recruit and train retired professionals and other senior citizens to prevent, recognize, and report health care fraud, errors, and abuse. The initiative stemmed from recommendations in a congressional committee report accompanying the Omnibus Consolidated Appropriations Act of 1997. OIG reports these performance data annually. We will review performance data and documentation relating to Medicare and Medicaid recoveries, savings, and cost avoidance for SMP projects. ACL requested this information, which will support its efforts to evaluate and improve the performance of its projects.
November 2016 Centers for Disease Control and Prevention Oversight of the Select Agent Program Office of Evaluation and Inspections OEI-04-15-00431; OEI-04-15-00432 2018 The Federal Select Agent Program oversees the possession, use, and transfer of biological select agents and toxins, which, if handled improperly, have the potential to pose a severe threat to public health. Entities registered with the program must conduct annual internal inspections to ensure compliance with regulatory requirements (42 CFR � 73.9(a)(6)), and the Centers for Disease Control and Prevention (CDC) conducts periodic inspections of entities to oversee the program. We are conducting a three-evaluation series on CDC�s oversight of the Federal Select Agent Program. The first report (OEI-04-15-00430) found that CDC generally met its inspection goals for the Federal Select Agent Program, but opportunities exist to strengthen oversight. The second report will examine reporting of theft, loss, or releases (TLRs) to CDC within a sample of entities, as well as describe sampled entities� experiences and perspectives on reporting TLR events. Our third report will examine the extent to which CDC ensures that sampled entities comply with annual internal inspection requirements and correct observations identified during these inspections. This third report will also identify any differences and/or similarities between observations identified in CDC�s and sampled entities� inspections.
November 2016 Centers for Disease Control and Prevention Oversight of Security of the Strategic National Stockpiles of Pharmaceuticals Office of Audit Services W-00-16-58310 2017 The Strategic National Stockpile program, for which CDC and the Department of Homeland Security (DHS) share management responsibility, is designed to supplement and restock State and local public health agency pharmaceutical supplies in the event of a biological or chemical incident in the United States or its territories. The stockpiles are stored at strategic locations for the most rapid distribution possible. CDC is responsible for ensuring that the materials in these facilities are adequately protected and stored. We will review CDC�s efforts to ensure that pharmaceutical stockpiles are secure from theft, tampering, or other loss. We will use guidelines established in DHS�s Physical Security Manual to assess security risks at selected stockpiles.
November 2016 Centers for Medicare & Medicaid Services Medicare Incentive Payments for Adopting Electronic Health Records Office of Audit Services W-00-14-31352 2017 Medicare incentive payments are authorized over a 5-year period to physicians and hospitals that demonstrate meaningful use of certified EHR technology (Recovery Act, §§�4101 and 4102). Incentive payments were scheduled to begin in 2011 and continue through 2016, with payment reductions to health care professionals who fail to become meaningful users of EHRs beginning in 2015 (§�4101(b)). As of July 2015, Medicare EHR incentive payments totaled more than $20 billion. �We will review Medicare incentive payments to eligible health care professionals and hospitals for adopting EHRs and Centers for Medicare & Medicaid Services safeguards to prevent erroneous incentive payments. We will review Medicare incentive payment data to identify payments to providers that should not have received incentive payments (e.g., those not meeting selected meaningful-use criteria). �We will also assess Centers for Medicare & Medicaid Services�s plans to oversee incentive payments for the duration of the program and corrective actions taken regarding erroneous incentive payments.
November 2016 Centers for Medicare & Medicaid Services Physician-Administered Drugs for Dual Eligible Enrollees Office of Audit Services W-00-16-31512 2017 The term "dual eligible" is used to describe individuals who are enrolled in both Medicare and Medicaid. States are required to collect rebates on physician-administered drugs.� To collect these rebates, State agencies must submit to the manufacturers the National Drug Codes for all single-source drugs and for the top 20 multiple-source physician-administered drugs.� For dual-eligible enrollees, covered Medicare Part B prescription drugs received in a hospital outpatient setting (which include physician-administered drugs) require a copayment, which Medicaid is generally responsible for paying.� If a State agency paid any portion of a drug claim to the provider, the State agency must then invoice the eligible drugs for rebate and the manufacturer would thus be liable for payment of the rebate. We will determine whether Medicare requirements for processing physician-administered drug claims impact State Medicaid agencies� ability to correctly invoice Medicaid drug rebates for dual-eligible enrollees.�
November 2016 Centers for Medicare & Medicaid Services Specialty Drug Pricing and Reimbursement in Medicaid Office of Evaluation and Inspections OEI-00-00-00000 2018 Specialty pharmacies dispense prescription drugs that often require special handling or administration.� These specialty drugs are often expensive and are used to treat complex conditions, such as Hepatitis C, HIV, and certain cancers. States use Centers for Medicare & Medicaid Services�s national average drug acquisition cost to set Medicaid pharmacy reimbursement amounts. However, this average does not include the cost of drugs sold at specialty pharmacies. Therefore, States that use the national average drug acquisition cost data to assist in setting Medicaid pharmacy reimbursement amounts may have difficulty determining Medicaid pharmacy reimbursement amounts for specialty drugs.� We will determine how State Medicaid agencies (States) define specialty drugs, how much States paid for specialty drugs, how States determine payment methodologies for specialty drugs, and the differences in reimbursement amounts for these drugs among the States.
November 2016 Centers for Medicare & Medicaid Services States' Actions Based on Medicaid Drug Utilization Reviews Office of Evaluation and Inspections OEI-05-13-00550 2017 States are required to establish drug utilization review (DUR) programs to receive the Federal share of Medicaid payments (42 CFR �456.703). DUR programs must involve ongoing and periodic retrospective examination of claims data to identify patterns of fraud, abuse, gross overuse, or medically unnecessary care. (42 CFR �456.709). We will review the actions that States have taken on the basis of information generated by their DUR programs related to inappropriate dispensing and potential abuse of prescription drugs, including opiates.
November 2016 Centers for Medicare & Medicaid Services Treatment of Authorized Generic Drugs Office of Audit Services W-00-17-31499 2017 An authorized generic drug is one that the manufacturer holding the title to the original new drug application permits another manufacturer to sell under a different national drug code.� Provisions in 42 CFR § 447.506(b) provide that the manufacturer holding title to the original new drug application of the authorized generic drug must include the sales of this drug in its average manufacturer price (AMP) only when such drugs are being sold by the manufacturer directly to a wholesaler. �Manufacturers that also include the sales of an authorized generic to a secondary manufacturer could lower the AMP and, consequently, a lower rebate would be paid to the State. �We will review drug manufacturers� treatment of sales of authorized generics in their calculation of AMP for the Medicaid drug rebate program.� We will determine whether manufacturers included sales of authorized generics to secondary manufacturers in their AMP calculations.
November 2016 Centers for Medicare & Medicaid Services Medicaid Payments for Multiuse Vials of Herceptin Office of Audit Services W-00-17-31476; various reviews 2017 Previous OIG audits of Herceptin, a drug used to treat breast cancer, have shown provider noncompliance with Medicare billing requirements. Similar issues may occur in Medicaid.� We will review States� claims for the Federal share of Medicaid payments for Herceptin to determine whether providers properly billed the States for the drug.� We will determine whether providers� claims to States were complete and accurate and were billed in accordance with the regulations of the selected States.
November 2016 Centers for Medicare & Medicaid Services Oversight and Effectiveness of Medicaid Waivers Office of Audit Services W-00-17-31513 2018 More States are using waivers to alter their Medicaid program in significant ways.� Oversight of State waiver programs present challenges to ensure that payments made under the waivers are consistent with regards to efficiency, economy, and quality of care and do not inflate Federal costs.� We will determine the extent to which selected States made use of Medicaid waivers and if costs associated with the waivers are efficient, economic, and do not inflate Federal costs.� We will also look at Centers for Medicare & Medicaid Services�s oversight of State Medicaid waivers.�
November 2016 Centers for Medicare & Medicaid Services Transportation Services - Compliance with Federal and State Requirements Office of Audit Services W-00-17-31121; various reviews 2018 Federal regulations�require States to ensure necessary transportation for Medicaid beneficiaries to and from providers (42�CFR §�431.53). Each State may have different Medicaid coverage criteria, reimbursement rates, rules governing covered services, and beneficiary eligibility for services. We will determine the appropriateness of Medicaid payments by States to providers for transportation services.
November 2016 Centers for Medicare & Medicaid Services Health-Care-Acquired Conditions - Prohibition on Federal Reimbursements Office of Audit Services W-00-17-31452; various reviews 2018 As of July 1, 2011, Federal payments to States are�prohibited for any amounts expended for providing medical assistance for health-care-acquired conditions (SSA §�1903 and Patient Protection and Affordable Care Act §�2702). Federal regulations prohibit Medicaid payments by States for services related to health-care-acquired conditions and for provider preventable conditions as defined by Centers for Medicare & Medicaid Services or included in the Medicaid State Plan (42�CFR�§�447.26). We will determine whether selected States made Medicaid payments for hospital care associated with health-care-acquired conditions and provider preventable conditions and quantify the amount of Medicaid payments for such�conditions.
November 2016 Centers for Medicare & Medicaid Services Dental Services for Children - Inappropriate Billing Office of Audit Services W-00-17-31135 2018 Dental services are required for most Medicaid-eligible individuals under age 21 as a component of the Early and Periodic Screening, Diagnostic, and Treatment services benefit (SSA §§�1905(a)(4)(B) and 1905(r)). Federal regulations define �dental services� as diagnostic, preventative, or corrective procedures provided by or under the supervision of a dentist (42 CFR §�440.100). Services include the treatment of teeth and the associated structure of the oral cavity and disease, injury, or impairment that may affect the oral cavity or general health of the recipient. Previous OIG work indicated that some dental providers may be inappropriately billing for services. We will review Medicaid payments by States for dental services to determine whether States have properly claimed Federal reimbursement.
November 2016 Centers for Medicare & Medicaid Services Community First Choice State Plan Option Under the Affordable Care Act Office of Audit Services W-00-17-31495 2018 Section 2401 of the Patient Protection and Affordable Care Act added section 1915(k) to the SSA, a new Medicaid State plan option that allows States to provide statewide home and community-based attendant services and support to individuals who would otherwise require an institutional level of care. States taking up the option will receive a 6-percent increase in their FMAP for Community First Choice (CFC) services. To be eligible for CFC services, beneficiaries must otherwise require an institutional level of care and meet financial eligibility criteria. We will review CFC payments to determine whether the payments are proper and allowable.
November 2016 Centers for Medicare & Medicaid Services Payments to States Under the Balancing Incentive Program Office of Audit Services W-00-17-31482; various reviews 2018 Under the Balancing Incentive Program (BIP), eligible States can receive either a 2-percent or 5-percent increase in their FMAP for eligible Medicaid long-term services and support (LTSS) expenditures. Funding to States under the BIP cannot exceed $3 billion over the program�s 4-year period (i.e., October 1, 2011, through September 30, 2015). To receive payments, participating States agree to make structural changes to increase access to noninstitutional LTSS. The States must also use the additional Federal funding for the purposes of providing new or expanded offerings of noninstitutional LTSS. We will review expenditures that States claimed under the BIP to ensure that they were for eligible Medicaid LTSS and determine whether the States used the additional enhanced Federal match in accordance with § 10202 of the ACA.
November 2016 Centers for Medicare & Medicaid Services State Agency Verification of Deficiency Corrections Office of Audit Services W-00-17-31502; various reviews 2018 Federal regulations require nursing homes to submit correction plans to the State survey agency or Centers for Medicare & Medicaid Services for deficiencies identified during surveys (42 CFR § 488.402(d)). Centers for Medicare & Medicaid Services requires State survey agencies to verify the correction of identified deficiencies through on-site reviews or by obtaining other evidence of correction (State Operations Manual, Pub. No. 100-07, § 7300.3). A previous OIG review found that one State survey agency did not always verify that nursing homes corrected deficiencies identified during surveys in accordance with Federal requirements. We will determine whether State survey agencies verified correction plans for deficiencies identified during nursing home recertification surveys.
November 2016 Centers for Medicare & Medicaid Services Medicaid Beneficiary Transfers from Group Homes and Nursing Facilities to Hospital Emergency Rooms Office of Audit Services W-00-16-31040; various reviews 2018 High occurrences of emergency transfers could indicate poor quality of care. Previous OIG work examined transfers to hospital emergency departments, raising concerns about the quality of care provided in some nursing facilities. We will review the rate of and reasons for transfer from group homes or nursing facilities to hospital emergency departments.
November 2016 Centers for Medicare & Medicaid Services State Use of Provider Taxes to Generate Federal Funding Office of Audit Services W-00-17-31455; various reviews 2018 Many�States finance a portion of their Medicaid spending by imposing taxes on health care providers. Federal regulations define and set forth the standard for permissible health-care-related taxes (42�CFR §§�433.55 and 433.68). Previous OIG work raised concerns about States� use of health-care-related taxes.� We will review State health-care-related taxes imposed on various Medicaid providers to determine whether the taxes comply with applicable Federal requirements. Our work will focus on the mechanism States use to raise revenue through provider taxes and determine the amount of Federal funding generated.
November 2016 Centers for Medicare & Medicaid Services State Compliance with Federal Certified Public Expenditures Regulations Office of Audit Services W-00-17-31110; various reviews 2018 Public entities (e.g., public hospitals) may certify that they spent funds on Medicaid items or services that are eligible for Federal matching funds.��These funds are referred to as certified public expenditures (CPEs) and may be claimed as the State�s share of Medicaid expenditures as long as the CPEs comply with Federal regulations and are being used for the required purposes (42 CFR §�433.51 and 45 CFR §�95.13.) We will determine whether States comply with Federal regulations for claiming CPEs, which are normally generated by local governments as part of their contribution to the coverage of Medicaid services.
November 2016 Centers for Medicare & Medicaid Services State Cost Allocations That Deviate from Acceptable Practices Office of Audit Services W-00-17-31467; various reviews 2018 Previous OIG reviews of school- and community-based administrative claims found significant unallowable payments that were based on random moment sampling systems. Such systems must be documented to support the propriety of the costs assigned to Federal awards (OMB Circular A87, Cost Principles for State, Local, and Indian Tribal Governments, Attachment A, § C.1.j). A�State must claim Federal financial participation for costs associated with a program only in accordance with its approved cost allocation plan. (45 CFR §�95.517(a).) We will review public assistance cost allocation plans and processes for selected States to determine whether the States claimed Medicaid costs that were supported and allocated on the basis of random moment sampling systems that deviated from acceptable statistical sampling practices.
November 2016 Centers for Medicare & Medicaid Services Enhanced Federal Medical Assistance Percentage Office of Audit Services W-00-17-31480; various reviews 2018 The ACA, § 2001, authorized the use of an FMAP of 100 percent for individuals who are newly eligible because of Medicaid expansion. In addition, the ACA, § 1202, required that Medicaid payments to primary care providers be at least those of the Medicare rates in effect for CYs 2013 and 2014. States can claim 100 percent FMAP for the difference between the Medicare rate and the States� Medicaid rate. We will review States� Medicaid claims to determine whether the States correctly applied enhanced FMAP payment provisions of the ACA.�
November 2016 Centers for Medicare & Medicaid Services Medicaid Payment Suspensions for Credible Allegations of Fraud Office of Audit Services and Office of Evaluation and Inspections OEI-09-14-00020 2017 Federal financial participation in Medicaid is not available for items or services furnished by an individual or entity when there is a credible allegation of fraud, unless �good cause� exists not to suspend payment (SSA � 1903(i)(2), as amended by the ACA � 6402(h)(2)). When a State Medicaid agency determines that a credible allegation of fraud exists, the agency must suspend all or part of the Medicaid payments to the provider, while law enforcement investigates and potentially prosecutes the provider, unless good cause exists not to suspend payment (42 CFR � 455.23(a)). The State Medicaid agency must also refer the credible allegation of fraud for investigation to the State�s MFCU or to other appropriate law enforcement agencies in States with no certified MFCUs (42 CFR � 455.23(d)). We will review States� use of payment suspensions as a program integrity tool.
November 2016 Centers for Medicare & Medicaid Services State Medicaid Fraud Control Unit FY 2017 Annual Report Office of Evaluation and Inspections OEI-00-00-00000 2017 OIG provides guidance to the MFCUs, assesses compliance with Federal regulations and policy, and evaluates adherence to published performance standards. This annual report will analyze the statistical information that was reported by the MFCUs for FY 2016, describing in the aggregate the outcomes of MFCU criminal and civil cases. This report will also identify trends in MFCU case results and will report on significant developments for the MFCUs over the course of the year.
November 2016 Centers for Medicare & Medicaid Services OIG Oversight for State Medicaid Fraud Control Unit Office of Evaluation and Inspections OEI-00-00-00000; various reviews 2017 The 50 State MFCUs, located in 49 States and the District of Columbia, investigate and prosecute Medicaid provider fraud as well as complaints of patient abuse or neglect in Medicaid-funded facilities and board and care facilities. OIG provides oversight for the MFCUs and administers a Federal grant award that provides 75 percent of each MFCU�s funding. As part of OIG�s oversight, we provide guidance to the MFCUs; assess their adherence to Federal regulations, policy, and performance standards; and collect and analyze performance data. We also provide technical assistance and training and identify effective practices in MFCU management and operations. We will perform on-site reviews of a sample of MFCUs.
November 2016 Centers for Medicare & Medicaid Services State Medicaid Agency Breach Protections and Responses Office of Evaluation and Inspections OEI-09-16-00210 2018 Breaches of unsecured protected health information (PHI), including data held by State Medicaid agencies and their contractors, are a major concern for health care providers and consumers. The Breach Notification Rule (BNR) outlines requirements for health information safeguards and for notifications after the discovery of a breach of unsecured PHI (45 CFR §§ 164.400�414). Beyond the BNR requirements, State Medicaid agencies may establish other requirements that govern their responses to breaches. We will examine the efforts of State Medicaid agencies in conducting oversight and in responding to breaches.
November 2016 Centers for Medicare & Medicaid Services Duplicate Payments for Beneficiaries with Multiple Medicaid Identification Numbers Office of Audit Services W-00-17-31374; various reviews 2018 During a preliminary data match, OIG identified a significant number of individuals who were assigned more than one Medicaid identification number and for whom multiple Medicaid payments were made for the same period.� We will review duplicate payments made by States on behalf of Medicaid beneficiaries with multiple Medicaid identification numbers and identify States� procedures or other controls for preventing such payments. �
November 2016 Centers for Medicare & Medicaid Services Completeness of Data in Transformed Medicaid Statistical Information System: Early Implementation Office of Evaluation and Inspections OEI-05-15-00050 2017 The Transformed Medicaid Statistical Information System (T-MSIS) is designed to be a detailed national database of Medicaid and CHIP information to cover a broad range of user needs, including program integrity. It is a continuation of Centers for Medicare & Medicaid Services�s past attempts to improve nationally available Medicaid data after OIG and others found that the data were not complete, accurate, or timely. We will determine to what extent States� plans for submitting T-MSIS data will result in a complete national database.
November 2016 Centers for Medicare & Medicaid Services Medical Loss Ratio - Recoveries of MCO Remittances from Profit-Limiting Arrangements Office of Audit Services W-00-17-31508 2018 When a State recovers a prior expenditure, it must refund the Federal share by reporting the recovery to Centers for Medicare & Medicaid Services at the FMAP used to calculate the amount it had originally received (SSA §�1903(d)(2); Centers for Medicare & Medicaid Services State Medicaid Manual, §�2500.6(B)). In its final rule (81 Fed. Reg. 27498 (May 6, 2016)), Centers for Medicare & Medicaid Services encouraged States to adopt provisions in contracts with managed care plans that would require remittances from the MCOs if a minimum medical loss ratio is not met. A medical loss ratio is a tool that can help ensure that the majority of capitated payments are used to deliver services to beneficiaries. Prior OIG reviews found that some States have adopted such remittance provisions. We will review States and managed care plans with contract provisions that require remittances from managed care plans if a minimum percentage of total costs to be expended for medical services (medical loss ratio) is not met. We will determine whether the Federal share of recoveries of MCO payments that States received through profit-limiting methodologies is returned to the Federal Government. Centers for Medicare & Medicaid Services reimburses each State at the FMAP for the quarter in which the expenditure was made (SSA §�1903(a)(1)).
November 2016 Centers for Medicare & Medicaid Services Review of States' Methodologies for Assigning Managed Care Organization Payments to Different Medicaid FMAPs Office of Audit Services W-00-17-31509 2018 The Federal Government pays its share of a State�s medical assistance expenditures under Medicaid on the basis of the FMAP, which varies depending on the State�s relative per capita income (SSA §�1905(b)). Additionally, certain Medicaid services receive a higher FMAP, including family planning services (90 percent) and services provided through an Indian Health Services facility (100 percent). The FMAPs under the Medicaid program are varied, and the actual services provided are less transparent under a managed care model. Therefore, the burden is on States to create accurate and reasonable methodologies to assign managed care payments to those FMAPs. We will review methodologies for assigning MCO payments to different Medicaid FMAPs, e.g., the regular FMAP, the family planning FMAP, and the Indian Health Services FMAP among others.
November 2016 Centers for Medicare & Medicaid Services Managed Long-Term-Care Reimbursements Office of Audit Services W-00-17-31510 2018 Medicaid managed care plans are subject to Federal requirements (42 CFR Part 438). Some States contract with MCOs to provide long-term services. We will review States� reimbursements made to managed long-term-care plans to determine whether those reimbursements complied with certain Federal and State requirements.
November 2016 Centers for Medicare & Medicaid Services Medicaid Managed Care Reimbursement Office of Audit Services W-00-17-31471; various reviews 2018 States contract with MCOs to provide coverage for specific services to enrolled Medicaid beneficiaries. In return for covering those services, MCOs are paid a set monthly capitation payment. Previous work by GAO found that Centers for Medicare & Medicaid Services�s oversight of States� rate-setting required improvement and that States may not audit or independently verify the MCO-reported data used to set rates (GAO-10-810). We will review States� managed care plan reimbursements to determine whether MCOs are appropriately and correctly reimbursed for services provided. We will ensure that the data used to set rates are reliable and include only costs for services covered under the State plan or costs of services authorized by Centers for Medicare & Medicaid Services (42 CFR §�438.6(e)). We will also verify that payments made under a risk-sharing mechanism and incentive payments made to MCOs are within the limits set forth in Federal regulations (42 CFR §�438.6(c)(5)(ii) and 42 CFR §�438.6(c)(5)(iii) and (iv)).mary
November 2016 Centers for Medicare & Medicaid Services MCO Payments for Services After Beneficiaries' Deaths Office of Audit Services W-00-17-31497 2018 Previous OIG reports found that Medicare paid for services that purportedly started or continued after beneficiaries� dates of death. We will identify Medicaid managed care payments made on behalf of deceased beneficiaries. We will also identify trends in Medicaid claims with service dates after beneficiaries� dates of death.
November 2016 Centers for Medicare & Medicaid Services Medicaid Managed Care Entities' Identification of Fraud and Abuse Office of Evaluation and Inspections OEI-02-15-00260 2018 All MCOs are required to have processes to detect, correct, and prevent fraud, waste, and abuse. However, the Federal requirements surrounding these activities are general in nature (42�CFR�§438.608), and MCOs vary widely in how they deter fraud, waste, and abuse. A previous OIG report revealed that over a quarter of the MCOs surveyed did not report a single case of suspected fraud and abuse to their State Medicaid agencies in 2009. The report also found that MCOs and States are taking steps to address fraud and abuse in managed care, and they remain concerned about their prevalence. We will determine whether Medicaid MCOs identified and addressed incidents of potential fraud�and abuse. We will also describe how States oversee MCOs� efforts to identify and address fraud and abuse.
November 2016 Centers for Medicare & Medicaid Services Medicaid Overpayment Reporting and Collections Office of Audit Services W-00-17-31399; A-05-17-00000 2018 Prior OIG audits identified Medicaid overpayments in various States and included recommendations for the collection of those overpayments. If a Federal audit indicates that a State has failed to identify an overpayment, Centers for Medicare & Medicaid Services considers the overpayment as discovered on the date that the Federal official first notifies the State in writing of the overpayment and specifies a dollar amount subject to recovery (42 CFR § 433.316(e)). Federal regulations require that States report overpayments to Centers for Medicare & Medicaid Services. For OIG audits in which Centers for Medicare & Medicaid Services concurred with recommendations to collect overpayments, we will determine whether the overpayments have been recouped and properly reported to Centers for Medicare & Medicaid Services.
November 2016 Centers for Medicare & Medicaid Services Third-Party Liability Payment Collections in Medicaid Office of Audit Services W-00-17-31517; A-05-17-00000 2018 Medicaid beneficiaries may have additional health insurance through third-party sources. Previous OIG work described problems that State Medicaid agencies had in identifying and collecting third-party payments. States are to take all reasonable measures to ascertain the legal liabilities of third parties with respect to health care items and services (SSA § 1902(a)(25)). Medicaid is the payer of last resort and providers are to identify and refund overpayments received. We will determine if States have taken action to ensure that Medicaid is the payer of last resort by identifying whether a third-party payer exists and if the State correctly reports the third-party liability to Centers for Medicare & Medicaid Services.
November 2016 Centers for Medicare & Medicaid Services Accountable Care in Medicaid Office of Audit Services W-00-17-31518; various reviews 2018 The Medicaid program is experiencing a shift toward new models that promote accountability for the cost and quality of care delivered to patients and focus on better, more efficient coordination of care. Several delivery system reform initiatives in Medicaid, including, for example, medical homes and accountable care organizations, focus on accountable care and include elements such as implementing value-based payment structures, measuring quality improvement, and collecting and analyzing data.� We will review selected accountable care models in Medicaid for compliance with relevant State and Federal requirements.
November 2016 Centers for Medicare & Medicaid Services Delivery System Reform Incentive Payments Office of Audit Services W-00-17-31516; various reviews 2018 Delivery System Reform Incentive Payments are incentive payments made under Section 1115 waivers to hospitals and other providers that develop programs or strategies to enhance access to health care, increase the quality and cost-effectiveness of care, and increase the health of patients and families served. States must be able to demonstrate outcomes and ensure accountability for allocated funding. These incentive payments have significantly increased funding to providers for their efforts related to the quality of services. For example, one State made incentive payments totaling more than $6 billion in a 5-year period. We will ensure that select States adhered to applicable Federal and State requirements when they made incentive payments to providers.
November 2016 Centers for Medicare & Medicaid Services Health-care-related Taxes: Medicaid MCO Compliance with Hold-Harmless Requirement Office of Audit Services W-00-17-31515 2018 Many States finance a portion of their Medicaid spending by imposing taxes on health care providers. A health-care-related tax is permissible if the tax, among other standards, avoids hold-harmless arrangements which return collected taxes directly or indirectly to taxpayers. OIG currently is reviewing State tax programs for hospitals and nursing homes to test for compliance with the hold-harmless requirement. We will determine if health-care-related tax programs for MCOs meet Federal hold-harmless requirements in 42 CFR § 433.68 by examining the tax programs in large States that tax MCOs.
November 2016 Centers for Medicare & Medicaid Services Health-Care-Acquired Conditions - Medicaid Managed Care Organizations Office of Audit Services W-00-17-31519; various reviews 2018 Previous OIG reviews found that some States continued to make Fee-for-Service Medicaid payments for hospital care associated with health-care-acquired conditions and provider preventable conditions. Provider preventable conditions are certain reasonably preventable conditions caused by medical accidents or errors in the health care setting. The ACA, § 2702, and implementing regulations at 42 CFR, § 447.26, prohibit Federal payments for provider preventable conditions. Because we found problems with States making fee-for-service payments associated with provider preventable conditions, we are expanding to managed care arrangements. We will also determine whether Medicaid MCOs have continued to make payments to providers for inpatient hospital services related to treating certain provider preventable conditions.
November 2016 Centers for Medicare & Medicaid Services Comparing HHA Survey Documents to Medicare Claims Data Office of Evaluation and Inspections OEI-05-16-00510 2018 Through the survey and certification process, the Centers for Medicare & Medicaid Services and State agencies may identify potentially unqualified or fraudulent providers because of their direct contact with these providers. Home Health Agencies (HHAs) supply patient information (e.g., rosters/censuses, admission/discharge lists to surveyors during the recertification survey process. Surveyors rely on this information to select patients for review, but cannot verify that the information is complete. Therefore, fraudulent HHAs�or HHAs with serious quality problems� might intentionally omit certain patients from information supplied to surveyors to avoid scrutiny. Previous OIG work has shown that the home health program is prone to fraud, waste, and abuse. We will explore this potential vulnerability, and look for evidence of patients omitted from HHA-supplied patient information from select recertification surveys using Medicare claims data.
November 2016 Centers for Medicare & Medicaid Services States' Enrollment Safeguards for Select Medicaid-only Provider Types Office of Evaluation and Inspections OEI-05-16-00460 2018 Federal rules require enhanced screening for providers and suppliers seeking initial enrollment, reenrollment, or revalidation in Medicare, Medicaid, and CHIP according to risk. In 2016, OIG found opportunities for improvement with enhanced provider screenings in Medicare and Medicaid. When only Medicaid recognizes a provider type (e.g., personal care services and nonemergency medical transportation services), States are responsible for assessing the provider types risk for fraud, waste, and abuse according to the risk the provider poses (42 CFR 455.450; 76 Fed. Reg. 5862 (February 2, 2011)). We will review States enrollment screening activities for select Medicaid-only providers types and any challenges States face in screening Medicaid-only provider types.
November 2016 Centers for Medicare & Medicaid Services Hyperbaric Oxygen Therapy (HBO) Services - Provider Reimbursement in Compliance with Federal Regulations Office of Audit Services W-00-16-35780; various reviews 2018 Hyperbaric oxygen (HBO) therapy involves giving a beneficiary high concentrations of oxygen within a pressurized chamber in which the beneficiary intermittently breathes 100 percent oxygen. HBO therapy is primarily an adjunctive treatment for the management of select nonhealing wounds. In accordance with Centers for Medicare & Medicaid Services Publication 100-03, National Coverage Determinations Manual, Ch. 20, § 20.29(A), a beneficiary must meet 1 of 15 covered conditions for providers to receive HBO reimbursement. Prior OIG reviews expressed concerns that: (1) beneficiaries received treatments for noncovered conditions, (2) medical documentation did not adequately support HBO treatments, and (3) beneficiaries received more treatments than were considered medically necessary. We will determine whether Medicare payments related to HBO outpatient claims were reimbursed in accordance with Federal requirements.
November 2016 Centers for Medicare & Medicaid Services Inpatient Psychiatric Facility Outlier Payments Office of Audit Services W-00-16-35778 2018 Inpatient Psychiatric Facilities, either freestanding hospitals or specialized hospital-based units, provide active psychiatric treatment to meet the urgent needs of those experiencing an acute mental health crisis, which may involve mental illnesses or alcohol- or drug-related problems. From FY 2014 to FY 2015, the number of claims with outlier payments increased by 28 percent, and total Medicare payments for stays that resulted in outlier payments increased from $450.2 million to $534.6 million (19 percent). We will determine whether Inpatient Psychiatric Facilities nationwide complied with Medicare documentation, coverage, and coding requirements for stays that resulted in outlier payments.
November 2016 Centers for Medicare & Medicaid Services Denials and Appeals in Medicare Part C and Part D Office of Evaluation and Inspections OEI-09-16-00410 2018 Capitated payment models are based on a payment per person rather than a payment per service provided. A central concern about the capitated payment models used in Medicare Part C and Part D is the incentive to inappropriately deny access to services or prescription drugs in an attempt to keep health care costs low. We will examine national trends and oversight by the Centers for Medicare & Medicaid Services (CMS) of denied care within Part C and Part D. We will determine the extent to which services and prescription drugs were denied, and the extent to which the denials were appealed and overturned in Part C and Part D from 2014 to 2016. We will also compare rates of denials, appeals, and overturns across Part C and Part D contracts, and evaluate CMS's efforts to monitor and address inappropriate denial of care. Future work in this area may include medical record reviews to examine whether denials are appropriate.
November 2016 Centers for Medicare & Medicaid Services Medicare Market Share of Mail-Order Diabetic Testing Strips: October-December 2016 - Mandatory Review Office of Evaluation and Inspections OEI-04-16-00473 2017 OIG is required to report the market share of diabetic testing strips (DTS) before each subsequent round of the competitive bidding program pursuant to section 1847(b)(I0)(B) of the SSA. This first data brief (OEI-04-16-00470), part of a series of three reports, determined the market share of DTS for the 3-month period immediately preceding the implementation of the National Mail Order Recompete on July 1, 2016 (i.e., April through June 2016). The second report (OEI-04-16-00471) was for the 3-month period immediately after implementation (i.e., July through September 2016). The third report will be for a similar time frame 6 months after implementation (October through December 2016). These data will help Centers for Medicare & Medicaid Services determine how the National Mail Order Recompete may impact shifts in the market. This is the second time we will conduct this series of three DTS market share reports.
November 2016 Centers for Medicare & Medicaid Services Part B Services During Non-Part A Nursing Home Stays: Durable Medical Equipment Office of Evaluation and Inspections OEI-06-16-003800 2018 If a beneficiary continues to reside in a SNF after 100 days, Medicare Part B may provide coverage for certain therapy and supplies (non-Part A stay). A July�2009 OIG report found that Medicare Part B allowed inappropriate payments of $30�million in 2006 for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) provided during non-Part A stays in SNFs. This study will determine the extent of inappropriate Medicare Part B payments for DMEPOS provided to nursing home residents during non-Part A stays in 2015. We will also determine whether Centers for Medicare & Medicaid Services has a system in place to identify inappropriate payments for DMEPOS and recoup payments from suppliers.
November 2016 Centers for Medicare & Medicaid Services Positive Airway Pressure Device Supplies - Supplier Compliance with Documentation Requirements for Frequency and Medical Necessity Office of Audit Services W-00-16-35240; W-00-17-35787 2018 Beneficiaries receiving continuous positive airway pressure or respiratory assist device therapy (PAP) require replacement of the device�s supplies (e.g. mask, tubing, headgear, and filters) when they wear out or are exhausted. Medicare payments for these supplies in 2014 and 2015 were approximately $953 million. Prior OIG work found that suppliers automatically shipped PAP device supplies when no physician orders for refills were in effect. For supplies and accessories used periodically, orders or certificates of medical necessity must specify the type of supplies needed and the frequency with which they must be replaced, used, or consumed (Centers for Medicare & Medicaid Services�s Medicare Program Integrity Manual, Pub. 100-08, Ch. 5, §§ 5.2.3 and 5.9). Beneficiaries or their caregivers must specifically request refills of repetitive services and/or supplies before suppliers dispense them (Centers for Medicare & Medicaid Services�s Medicare Claims Processing Manual, Pub. 100-04, Ch. 20, § 200). We will review claims for frequently replaced PAP device supplies to determine whether documentation requirements for medical necessity, frequency of replacement, and other Medicare requirements are met.
November 2016 Centers for Medicare & Medicaid Services Data Brief on Fraud in Medicaid Personal Care Services Office of Evaluation and Inspections OEI-12-16-00500 2017 OIG has conducted numerous audits, evaluations, and investigative work involving PCS. Much of this work is summarized in a November 2012 portfolio report to Centers for Medicare & Medicaid Services entitled �Personal Care Services: Trends, Vulnerabilities, and Recommendations for Improvement� (OIG-12-12-01). The portfolio report summarized the observations and findings of previous OIG evaluation and audit reports on Medicaid PCS and offered recommendations for improving program oversight. We will issue a data brief that provides, through data collected from the 50 State Medicaid Fraud Control Units (MFCUs, or Units) and OIG�s Office of Investigations, an overview of PCS statistical data collected since the portfolio was issued in 2012. The data brief will provide information on State and Federal investigations, indictments, convictions, and recoveries involving fraud and patient abuse or neglect in Medicaid PCS. The data presented in this brief are intended to illustrate the prevalence and magnitude of fraud and patient abuse or neglect involving PCS. This data will be especially important for OIG�s future work with Centers for Medicare & Medicaid Services to combat these issues.
November 2016 Centers for Medicare & Medicaid Services Power Mobility Devices Equipment - Portfolio Report on Medicare Part B Payments Office of Audit Services OAS-00-17-35791 2018 Previous OIG work identified inappropriate payments for power mobility devices (PMDs) that were medically unnecessary, were not documented in accordance with Medicare requirements, cheaper to rent instead of purchase, or were fraudulent. We will compile the results of prior OIG audits, evaluations, and investigations of PMD equipment paid by Medicare to identify trends in payment, compliance, and fraud vulnerabilities and offer recommendations to improve detected vulnerabilities. This planned work will offer recommendations to reduce Medicare PMD vulnerabilities that were detected in prior OIG work.
November 2016 Centers for Medicare & Medicaid Services Nursing Home Complaint Investigation Data Brief Office of Evaluation and Inspections OEI-01-16-00330 2017 All nursing home complaints categorized as immediate jeopardy and actual harm must be investigated within a 2- and 10-day timeframe, respectively. A 2006 OIG report found that State agencies did not investigate some of the most serious complaints within these required timeframes. We will determine to what extent State agencies investigate the most serious nursing home complaints within the required timeframes. This work will provide an update from our previous review.
November 2016 Centers for Medicare & Medicaid Services Centers for Medicare & Medicaid Services Monitoring Activities for Consumer Operated and Oriented Plan Loan Program Office of Audit Services W-00-16-59019 2017 The ACA, § 1322, directs the HHS Secretary to establish the Consumer Operated and Oriented Plan (CO-OP) program by providing loans to assist the awardees with startup costs and State solvency requirements; 45 CFR Part 156 implements section 1322. We will follow up on prior OIG work that examined the loan award selection process, financial condition, and other factors that could impair the effectiveness of the CO-OP loan program. We will reassess the CO-OPs financial condition to determine whether any improvements were made in 2015 and 2016 and monitor actions by Centers for Medicare & Medicaid Services to address underperforming CO-OPs.
November 2016 Centers for Medicare & Medicaid Services Medicaid Eligibility Determinations in Selected States Office of Audit Services W-00-17-31140; OEI-06-14-00330; various reviews 2018 The ACA, § 2001, required significant changes affecting State processes for Medicaid enrollment, modified criteria for Medicaid eligibility, and authorized the use of an enhanced FMAP of 100 percent for newly eligible individuals. We will determine the extent to which selected States made inaccurate Medicaid eligibility determinations. We will examine eligibility inaccuracy for Medicaid beneficiaries in selected States that expanded their Medicaid programs pursuant to the Patient Protection and Affordable Care Act and in States that did not. We will also assess whether and how the selected States addressed issues that contributed to inaccurate determinations. For some States, we will calculate a Medicaid eligibility error rate and determine the amount of payments associated with beneficiaries who received incorrect eligibility determinations.
November 2016 Centers for Medicare & Medicaid Services Potential Savings from Inflation-Based Rebates in Medicare Part B Office of Evaluation and Inspections OEI-12-17-00180 2017 Each year, statutorily mandated rebates enable Medicaid to recoup a substantial portion of the billions spent by the program on prescription drugs. In contrast, Medicare Part B also spends billions annually on prescription drugs; however, no similar rebate authority exists for Part B to reduce the costs of drugs to the program. OIG will examine the amount the Federal Government could potentially collect from pharmaceutical manufacturers if inflation-indexed rebates were required under Medicare Part B, which builds upon earlier OIG work examining existing inflation-based rebates in Medicaid and potential rebates in Medicare Part B. The study will select a sample of 50�100 Part B drugs. We will calculate the amount covering the difference between the existing rebate policy in 2015 and a scenario where an inflation-based rebate methodology similar to Medicaid had been in place for drugs covered under Medicare Part B and in absence of industry adjustments to such rebate agreement.
November 2016 Centers for Medicare & Medicaid Services Outpatient Outlier Payments for Short-Stay Claims Office of Audit Services W-00-16-35775; A-06-16-01002 2018 CMS makes an additional payment (an outlier payment) for hospital outpatient services when a hospital�s charges, adjusted to cost, exceed a fixed multiple of the normal Medicare payment (Social Security Act (SSA) § 1833(t)(5)). The purpose of the outlier payment is to ensure beneficiary access to services by having Medicare share in the financial loss incurred by a provider associated with extraordinarily expensive individual cases. Prior OIG reports have concluded that hospitals� high charges, unrelated to cost, lead to excessive inpatient outlier payments. We will determine the extent of potential Medicare savings if hospital outpatient short stays (same day or over one midnight) were ineligible for an outlier payments. Prior to a nationwide review, we plan to perform several reviews at one or more hospitals to determine whether outpatient outlier payments to hospitals are associated with extraordinarily expensive individual cases.
November 2016 Centers for Medicare & Medicaid Services Medicare Costs Associated with Defective Medical Devices Office of Audit Services W-00-15-35516; various reviews 2017 According to the Food and Drug Administration, recalls of medical devices nearly doubled from 2003 through 2012. Centers for Medicare & Medicaid Services has expressed concerns about the impact of the cost of replacement devices, including ancillary cost, on Medicare payments for inpatient and outpatient services. We will review Medicare claims to identify the costs to Medicare resulting from additional use of medical services associated with defective or recalled medical devices.
November 2016 Centers for Medicare & Medicaid Services Long-Term-Care Hospitals - Adverse Events in Postacute Care for Medicare Beneficiaries Office of Evaluation and Inspections OEI-06-14-00530 2018 Long-term-care hospitals (LTCHs) are inpatient hospitals that provide long-term care to clinically complex patients, such as those with multiple acute or chronic conditions. Medicare beneficiaries typically enter LTCHs following an acute-care hospital stay to receive intensive rehabilitation and medical care. LTCHs are the third most common type of postacute care facility after SNFs and inpatient rehabilitation facilities. LTCHs account for nearly 11 percent of Medicare costs for postacute care ($5.4 billion in FY 2011). We will estimate the national incidence of adverse and temporary harm events for Medicare beneficiaries receiving care in LTCHs. We will also identify factors contributing to these events and determine the extent to which the events were preventable.
November 2016 Centers for Medicare & Medicaid Services Hospital Preparedness and Response to Emerging Infectious Diseases Office of Evaluation and Inspections OEI-06-15-00230 2018 Several HHS agencies, including Centers for Medicare & Medicaid Services, CDC, and Office of the Assistant Secretary for Preparedness and Response (ASPR) provide resources, i.e., guidance and support, for hospitals as they prepare for emerging infectious disease threats. Prior OIG work identified shortcomings in such areas as community preparedness for a pandemic (2009) and hospital preparedness for a natural disaster (i.e., Superstorm Sandy, 2013). �We will describe hospitals� efforts to prepare for the possibility of public health emergencies resulting from emerging infectious disease threats. Additionally, we will determine hospitals� use of HHS resources and identify lessons and challenges faced by hospitals as they prepare to respond to emerging infectious disease threats, such as Ebola.�
November 2016 Centers for Medicare & Medicaid Services Potentially Avoidable Hospitalizations of Medicare- and Medicaid-Eligible Nursing Facility Residents Office of Audit Services W-00-17-35792 2018 High occurrences of patient transfers from nursing facilities to hospitals for potentially preventable conditions could indicate poor quality of care. Prior OIG work identified a nursing facility with a high rate of Medicaid recipient transfers to hospitals for a urinary tract infection (UTI), a condition that is often preventable and treatable in the nursing facility setting without requiring hospitalization. The audit disclosed that the nursing facility often did not provide UTI prevention and detection services in accordance with its residents� care plans, increasing the residents� risk for infection and hospitalization. We will review nursing homes with high rates of patient transfers to hospitals for potentially preventable conditions and determine whether the nursing homes provided services to residents in accordance with their care plans (42 CFR §�483.25(d)).
November 2016 Centers for Medicare & Medicaid Services National Background Checks for Long-Term-Care Employees - Mandatory Review Office of Evaluation and Inspections OEI-07-16-00160 2018 The Patient Protection and Affordable Care Act provides grants to States, through Centers for Medicare & Medicaid Services, to implement background check programs of prospective long-term-care employees and providers. The Patient Protection and Affordable Care Act requires that OIG conduct an evaluation of this grant program, known as the National Background Check Program, after its completion (ACA § 6201). For States that closed their grants in the preceding year, we will review the procedures States implemented for long-term-care facilities and providers to conduct background checks on prospective employees who would have direct access to patients.� We will determine the outcomes of the States� programs and whether the checks led to any unintended consequences.
November 2016 Centers for Medicare & Medicaid Services Orthotic Braces - Reasonableness of Medicare Payments Compared to Amounts Paid by Other Payers Office of Audit Services W-00-17-35756; various reviews 2018 Since 2009, Medicare payments for orthotic braces, including back and knee, have more than doubled and almost tripled for certain types of knee braces. We will determine the reasonableness of Medicare fee schedule amounts for orthotic braces. We will compare Medicare payments made for orthotic braces to amounts paid by non-Medicare payers, such as private insurance companies, to identify potentially wasteful spending. We will estimate the financial impact on Medicare and on beneficiaries of aligning the fee schedule for orthotic braces with those of non-Medicare payers.
November 2016 Centers for Medicare & Medicaid Services Orthotic Braces - Supplier Compliance with Payment Requirements Office of Audit Services W-00-17-35749 2018 Medicare requires that suppliers� claims for DMEPOS be "reasonable and necessary" (SSA § 1862(a)(1)(A)).� Further, local coverage determinations issued by the four Medicare contractors that process DMEPOS claims include utilization guidelines and documentation requirements for orthotic braces.� Prior OIG work indicated that some DMEPOS suppliers were billing for services that were medically unnecessary (e.g., beneficiaries receiving multiple braces and referring physician did not see the beneficiary) or were not documented in accordance with Medicare requirements.� We will review Medicare Part B payments for orthotic braces to determine whether they were medically necessary and were supported in accordance with Medicare requirements.
November 2016 Centers for Medicare & Medicaid Services Nebulizer Machines and Related Drugs - Supplier Compliance with Payment Requirements Office of Audit Services W-00-15-35465 2018 A nebulizer machine changes medication from a liquid to a mist so that it can be more easily inhaled into the lungs. For CY 2014, Medicare paid approximately $632.8 million for inhalation drugs.� Medicare requires that claims for nebulizer machines and related drugs be "reasonable and necessary"�(SSA § 1862(a)(1)(A)).� Further, the local coverage determinations issued by the four Medicare contractors that process medical equipment and supply claims include utilization guidelines and documentation requirements.� A preliminary OIG review identified that at least 50 percent of claims reviewed were not paid in accordance with Medicare requirements. We will review Medicare Part B payments for nebulizer machines and related drugs to determine whether medical equipment suppliers� claims for nebulizers and related drugs are medically necessary and are supported in accordance with Medicare requirements.
November 2016 Centers for Medicare & Medicaid Services Access to Durable Medical Equipment in Competitive Bidding Areas Office of Evaluation and Inspections OEI-01-15-00040; OEI-01-15-00041; OEI-01-15-00042 2017, 2018 In an effort to reduce waste, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 updated Medicare�s payment system for certain DMEPOS from a fee schedule to a competitive bidding program. Under this program, DMEPOS suppliers compete on price to supply particular geographic areas. Anecdotal reports allege that competitive bidding has led to reduced access to DMEPOS and, in turn, compromised the quality of care that beneficiaries receive. We will determine the effects of the competitive bidding program on Medicare beneficiaries' access to certain types of DMEPOS subject to competitive bidding.�
November 2016 Centers for Medicare & Medicaid Services Monitoring Medicare Payments for Clinical Diagnostic Laboratory Tests - Mandatory Review Office of Evaluation and Inspections OEI-09-17-00050; OEI-09-17-00140 2017 Section 216 of the Protecting Access to Medicare Act of 2014 (PAMA) requires Centers for Medicare & Medicaid Services to replace its current system of determining payment rates for Medicare Part B clinical diagnostic laboratory tests with a new market-based system that will use rates paid to laboratories by private payers.� Pursuant to PAMA, OIG is required to conduct an annual analysis of the top 25 laboratory tests by Medicare payments and analyze the implementation and effect of the new payment system.� We will analyze Medicare payments for clinical diagnostic laboratory tests performed in 2016 and monitor Centers for Medicare & Medicaid Services�s implementation of the new Medicare payment system for these tests.� This work will build upon our previous analyses of Medicare Part B laboratory test payments in 2014 and 2015 and our review of Centers for Medicare & Medicaid Services�s progress toward implementing the new Medicare payment system.
November 2016 Centers for Medicare & Medicaid Services Inpatient Rehabilitation Facility Payment System Requirements Office of Audit Services W-00-15-35730 2018 Inpatient rehabilitation facilities (IRFs) provide rehabilitation for patients recovering from illness and surgery who require an inpatient hospital-based interdisciplinary rehabilitation program, supervised by a rehabilitation physician.� Effective for discharges on or after January 1, 2010, specific medical record documentation, at the time of IRF admission, must support a reasonable expectation�that the patient needs multiple intensive therapies, one of which must be physical or occupational therapy; is able to actively participate and demonstrate measurable improvement; and requires supervision by a rehabilitation physician to assess and modify the course of treatment as needed to maximize the benefit from the rehabilitation process. Our prior reviews of individual IRFs have identified substantial Medicare overpayments. We will determine whether IRFs nationwide billed claims in compliance with Medicare documentation�and coverage requirements.
November 2016 Centers for Medicare & Medicaid Services Histocompatibility Laboratories - Supplier Compliance with Payment Requirements Office of Audit Services W-00-16-35742 2018 Histocompatibility laboratories typically provide testing required for bone marrow and solid organ transplantation services. Cost information for these laboratories must be accurate and in sufficient detail to support payments made for services provided (42 CFR § 413.24(a) and (c)).� Costs claimed in the cost report must be related to the care of beneficiaries; reasonable, necessary, and proper; and allowable under Medicare regulations (42 CFR § 413.9(a), (b), and (c)(3)).� From March 31, 2013, through September 30, 2014, histocompatibility laboratories reported $131 million in reimbursable costs on their most recent cost reports.� We will determine whether payments to histocompatibility laboratories were made in accordance with Medicare requirements.
November 2016 Centers for Medicare & Medicaid Services Ambulatory Surgical Centers - Quality Oversight Office of Evaluation and Inspections OEI-01-15-00400 2018 Medicare sets minimum health and safety requirements for ambulatory surgical centers (ASCs) through the conditions for coverage (SSA �1832(a)(2)(F)(i)). Centers for Medicare & Medicaid Services requires that ASCs become Medicare certified to show they meet these conditions (SSA � 1865 and 42 CFR Part 416). Previous OIG work found problems with Medicares oversight system, including finding spans of 5 or more years between certification surveys for some ASCs, poor Centers for Medicare & Medicaid Services oversight of State survey agencies, and little public information on the quality of ASCs. We will review the frequency and deficiency findings of Medicares certification surveys for ASCs.
November 2016 Centers for Medicare & Medicaid Services Payments for Medicare Services, Supplies, and DMEPOS Referred or Ordered by Physicians Compliance Office of Audit Services W-00-17-35748 2018 Centers for Medicare & Medicaid Services requires that physicians and nonphysician practitioners who order certain services, supplies, and/or DMEPOS be Medicare-enrolled physicians or nonphysician practitioners and be legally eligible to refer and order services, supplies, and DMEPOS (ACA §�6405).� If the referring or ordering physician or nonphysician practitioner is not eligible to order or refer, then Medicare claims should not be paid.� We will review select Medicare services, supplies, and DMEPOS referred or ordered by physicians and nonphysician practitioners to determine whether the payments were made in accordance with Medicare requirements.�
November 2016 Centers for Medicare & Medicaid Services Anesthesia Services - Noncovered Services Office of Audit Services W-00-17-35753 2018 Medicare Part B covers anesthesia services provided by a hospital for an outpatient or by a freestanding ambulatory surgical center for a patient. We will review Medicare Part B claims for anesthesia services to determine whether they were supported in accordance with Medicare requirements.� Specifically, we will review anesthesia services to determine whether the beneficiary had a related Medicare service.
November 2016 Centers for Medicare & Medicaid Services Physician Home Visits - Reasonableness of Services Office of Audit Services W-00-17-35754 2018 A home visit is when a physician provides evaluation and management (E/M) services in a beneficiary�s home. From January 2013 through December 2015, Medicare provided $718 million in payments for physician home visits.� Physicians are required to document the medical necessity of a home visit in lieu of an office or outpatient visit.� Medicare will not pay for items or services that are not "reasonable and necessary� (SSA § 1862(a)(1)(A)).� We will determine whether Medicare payments to physicians for E/M home visits were reasonable and made in accordance with Medicare requirements.
November 2016 Centers for Medicare & Medicaid Services Prolonged Services - Reasonableness of Services Office of Audit Services W-00-17-35755 2018 Prolonged services are for additional care provided to a beneficiary after an evaluation and management (E/M) service has been performed.� Physicians submit claims for prolonged services when they spend additional time beyond the time spent with a beneficiary for a usual companion E/M service. The necessity of prolonged services are considered to be rare and unusual. The Medicare Claims Processing Manual includes requirements that must be met in order to bill for a prolonged E/M service code (Medicare Claims Processing Manual, Pub. 100-04, Ch. 12, §�30.6.15.1). We will determine whether Medicare payments to physicians for prolonged E/M services were reasonable and made in accordance with Medicare requirements.�
November 2016 Centers for Medicare & Medicaid Services Ambulance Services - Supplier Compliance with Payment Requirements Office of Audit Services W-00-17-35574; various reviews 2018 Medicare pays for emergency and nonemergency ambulance services when a beneficiary�s medical condition at the time of transport is such that other means of transportation would endanger the beneficiary (SSA §�1861(s)(7)).� Medicare pays for different levels of ambulance service, including basic life support, advanced life support, and specialty care transport (42 CFR §�410.40(b)).� Prior OIG work found that Medicare made inappropriate payments for advanced life support emergency transports. We will determine whether Medicare payments for ambulance services were made in accordance with Medicare requirements.�
November 2016 Centers for Medicare & Medicaid Services Anesthesia Services - Payments for Personally Performed Services Office of Audit Services W-00-17-35706; various reviews 2018 Physicians must report the appropriate anesthesia modifier code to denote whether the service was personally performed or medically directed (Centers for Medicare & Medicaid Services, Medicare Claims Processing Manual, Pub. No. 10004, Ch. 12, §�50). Reporting an incorrect service code modifier on the claim as if services were personally performed by an anesthesiologist when they were not will result in Medicare paying a higher amount. The service code �AA� modifier is used for anesthesia services personally performed by an anesthesiologist, whereas, the �QK� modifier limits payment to 50 percent of the Medicare allowed amount for personally performed services claimed with the AA�modifier. Payments to any service provider are precluded unless the provider has furnished the information necessary to determine the amounts due (SSA §�1833(e)). We will review Medicare Part�B claims for personally performed anesthesia services to determine whether they were supported in accordance with Medicare requirements. We will also determine whether Medicare payments for anesthesia services reported on a claim with the AA service code modifier met Medicare requirements.
November 2016 Centers for Medicare & Medicaid Services Selected Independent Clinical Laboratory Billing Requirements Office of Audit Services W-00-17-35726; various reviews 2018 An independent clinical laboratory is one that is independent both of an attending or consulting physician�s office and of a hospital. Previous OIG audits, investigations, and inspections have identified independent clinical laboratory areas at risk for noncompliance with Medicare billing requirements. Payments to service providers are precluded unless the provider has and furnishes upon request the information necessary to determine the amounts due (SSA § 1833(e)). We will review Medicare payments to independent clinical laboratories to determine laboratories� compliance with selected billing requirements. We will focus on independent clinical laboratories with claims that may be at risk for overpayments. We will use the results of these reviews to identify clinical laboratories that routinely submit improper claims, and we will recommend recovery of overpayments.
November 2016 Centers for Medicare & Medicaid Services Sleep Disorder Clinics - High Use of Sleep-Testing Procedures Office of Audit Services W-00-17-35521; various reviews 2018 An OIG analysis of CY 2010 Medicare payments for Current Procedural Terminology[1] codes 95810 and 95811, which totaled approximately $415 million, showed high utilization associated with these sleep-testing procedures. To the extent that repeated diagnostic testing is performed on the same beneficiary and the prior test results are still pertinent, repeated tests may not be reasonable and necessary. Medicare will not pay for items or services that are not �reasonable and necessary� (SSA §�1862(a)(1)(A)).� We will examine Medicare payments to physicians, hospital outpatient departments, and independent diagnostic testing facilities for sleep-testing procedures to assess payment appropriateness and whether they were in accordance with other Medicare requirements. Requirements for coverage of sleep tests under Part�B are located in Centers for Medicare & Medicaid Services�s Medicare Benefit Policy Manual, Pub. No. 100-02, Ch. 15, §�70.
November 2016 Centers for Medicare & Medicaid Services Payments for Immunosuppressive Drug Claims with "KX" Modifiers Office of Audit Services W-00-15-35707; various reviews 2017 Medicare Part B covers Food and Drug Administration-approved immunosuppressive drugs and drugs used in immunosuppressive therapy when a beneficiary receives an organ transplant for which immunosuppressive therapy is appropriate (SSA § 1861(s)).� Since July 2008, suppliers that furnish an immunosuppressive drug to a Medicare beneficiary annotate the Medicare claim with the �KX� modifier to signify that the supplier retains documentation of the beneficiary�s transplant date and that such transplant date preceded the date of service for furnishing the drug (Centers for Medicare & Medicaid Services�s Medicare Claims Processing Manual, Pub. No. 100 04, Ch. 17, §�80.3).��Prior OIG reports found that Medicare claims for immunosuppressive drugs reported with the �KX� modifier may not always meet documentation requirements for payment under Part B. We will determine whether Part B payments for immunosuppressive drugs that were billed with a service code modifier �KX� met Medicare documentation requirements.
November 2016 Centers for Medicare & Medicaid Services Collection Status of ZPIC and PSC - Identified Medicare Overpayments Office of Evaluation and Inspections OEI-03-13-00630 2017 OIG issued several reports regarding the tracking and collection of overpayments that Medicare�s contractors have made to providers. In response, Centers for Medicare & Medicaid Services stated that it added reporting requirements that would improve overpayment tracking among the claims processors and Zone Program Integrity Contractors (ZPICs) and Program Safeguard Contractors (PSCs). ZPICs and PSCs are required to detect and deter fraud and abuse in Medicare Part A and Part B in their jurisdictions. They conduct investigations, refer cases to law enforcement, and take administrative actions such as referring overpayments to claims processors for collection and return to Medicare. We will determine the total amount of overpayments that ZPICs and PSCs identified and referred to claims processors in 2014 and the amount of these overpayments that claims processors collected. We will also review the procedures for tracking collections of overpayments identified by ZPICs and PSCs.
November 2016 Centers for Medicare & Medicaid Services Accountable Care Organizations: Savings, Quality, and Promising Practices Office of Evaluation and Inspections OEI-02-15-00450 2018 The MSSP, established by section 3022 of ACA, introduced ACOs into the Medicare program to promote accountability of hospitals, physicians, and other providers for a patient population, coordinate items and services, and encourage investment in infrastructure and redesigned care processes for high-quality and efficient service delivery. We will review ACOs that participate in the MSSP and describe their performance on quality measures and cost savings over the first 3 years of the program. In addition, we will describe the characteristics of the ACOs that performed well on measures and achieved savings and analyze their spending and utilization of services over time. We will also identify these ACOs� strategies for and challenges to achieving quality and cost savings. �
November 2016 Centers for Medicare & Medicaid Services Use of Health Information Technology to Support Care Coordination through ACOs Office of Evaluation and Inspections OEI-01-16-00180 2018 The MSSP, established by section 3022 of ACA, introduced ACOs into the Medicare program to promote accountability of hospitals, physicians, and other providers for a patient population, coordinate items and services, and encourage investment in infrastructure and redesigned care processes for high-quality and efficient service delivery. We will review the extent to which ACOs use health information technology to enhance their care coordination goals. We will also identify best practices and possible challenges to the exchange and use of health data for care coordination purposes.
November 2016 Centers for Medicare & Medicaid Services Review of Financial Interests Reported Under the Open Payments Program Office of Evaluation and Inspections OEI-03-15-00220 2018 The Physician Payments Sunshine Act (from the ACA � 6002) requires that manufacturers disclose to Centers for Medicare & Medicaid Services payments made to physicians and teaching hospitals. Manufacturers and group purchasing organizations must also report ownership and investment interests held by physicians. The Open Payments Program provides public transparency about provider-industry relationships. We will determine the extent to which data in the open payments system is missing or inaccurate, the extent to which Centers for Medicare & Medicaid Services oversees manufacturers and group purchasing organizations compliance with data reporting requirements, and whether the required data for physician and teaching hospital payments are valid.
November 2016 Centers for Medicare & Medicaid Services Hospice Home Care - Frequency of Nurse On-Site Visits to Assess Quality of Care and Services Office of Audit Services W-00-16-35777 2018 In 2013, more than 1.3 million Medicare beneficiaries received hospice services from more than 3,900 hospice providers, and Medicare hospice expenditures totaled $15.1 billion. Hospices are required to comply with all Federal, State, and local laws and regulations related to the health and safety of patients (42 CFR § 418.116). Medicare requires that a registered nurse make an on-site visit to the patient's home at least once every 14 days to assess the quality of care and services provided by the hospice aide and to ensure that services ordered by the hospice interdisciplinary group meet the patient�s needs (42 CFR § 418.76(h)(1)(i)). We will determine whether registered nurses made required on-site visits to the homes of Medicare beneficiaries who were in hospice care.
November 2016 Centers for Medicare & Medicaid Services Review of Hospices' Compliance with Medicare Requirements Office of Audit Services W-00-16-35783; various reviews 2018 Hospice provides palliative care for terminally ill beneficiaries and supports family and other caregivers. When a beneficiary elects hospice care, the hospice agency assumes the responsibility for medical care related to the beneficiary�s terminal illness and related conditions. Federal regulations address Medicare conditions of and limitations on payment for hospice services (42 CFR Part 418, Subpart G). We will review hospice medical records and billing documentation to determine whether Medicare payments for hospice services were made in accordance with Medicare requirements.
November 2016 Centers for Medicare & Medicaid Services Skilled Nursing Facility Adverse Event Screening Tool Office of Evaluation and Inspections OEI-06-16-00370 2018 OIG developed the SNF adverse event trigger tool as part of its study, "Adverse Events in Skilled Nursing Facilities: National Incidence Among Medicare Beneficiaries" (OEI-06-11-00370), released in February 2014. The tool was developed with assistance from clinicians at the Institute for Healthcare Improvement (IHI), which also published the tool for industry use. This product will describe the purpose, use, and benefits of the SNF adverse event trigger tool and the guidance document released by IHI, including the methodology for developing the instrument and the instrument's use in developing the February 2014 report findings. The product will also describe the contributions of OIG and IHI. The goal of this product is to disseminate practical information about the tool for use by those involved with the skilled nursing industry.
November 2016 Centers for Medicare & Medicaid Services Skilled Nursing Facility Reimbursement Office of Audit Services W-00-16-35784 2018 Some SNF patients require total assistance with their activities of daily living and have complex nursing and physical, speech, and occupational therapy needs. SNFs are required to periodically assess their patients using a tool called the Minimum Data Set that helps classify each patient into a resource utilization group for payment. Medicare payment for SNF services varies based on the activities of daily living score and the therapy minutes received by the beneficiary and reported on the Minimum Data Set. The more care and therapy the patient requires, the higher the Medicare payment. Previous OIG work found that SNFs are billing for higher levels of therapy than were provided or were reasonable or necessary. We will review the documentation at selected SNFs to determine if it meets the requirements for each particular resource utilization group.
November 2016 Centers for Medicare & Medicaid Services Data Brief on Financial Interests Reported Under the Open Payments Program Office of Evaluation and Inspections OEI-03-16-00420 2017 The Physician Payments Sunshine Act (from the Patient Protection and Affordable Care Act § 6002) requires that manufacturers disclose to Centers for Medicare & Medicaid Services payments made to physicians and teaching hospitals. Manufacturers and group purchasing organizations must also report ownership and investment interests held by physicians. We will analyze 2015 data extracted from the Open Payments website to determine the number and nature of financial interests. We will also determine how much Medicare paid for drugs and DMEPOS ordered by physicians who had financial relationships with manufacturers and group purchasing organizations. We will determine the volume and total dollar amount associated with drugs and DMEPOS ordered by these physicians in Medicare Parts B and D for 2015.
November 2016 Centers for Medicare & Medicaid Services Medicare Payments for Chronic Care Management Office of Audit Services W-00-17-35785 2018 Chronic Care Management (CCM) is defined as the non-face-to-face services provided to Medicare beneficiaries who have multiple (two or more), significant chronic conditions (Alzheimer�s disease, arthritis, cancer, diabetes, etc.) that place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline. These significant chronic conditions are expected to last at least 12 months or until the death of the patient. CCM cannot be billed during the same service period as transitional care management, home health care supervision/hospice care, or certain end-stage renal disease services. Beginning January 1, 2015, Medicare paid separately for CCM under the Medicare Physician Fee Schedule and under the American Medical Association Current Procedural Terminology. We will determine whether payments for CCM services were in accordance with Medicare requirements.
November 2016 Centers for Medicare & Medicaid Services Medicare Payments for Transitional Care Management Office of Audit Services W-00-17-35786 2018 Transitional Care Management (TCM) includes services provided to a patient whose medical and/or psychosocial problems require moderate or high-complexity medical decision-making during transitions in care from an inpatient hospital setting (including acute hospital, rehabilitation hospital, long-term acute care hospital), partial hospital, observation status in a hospital, or skilled nursing facility/nursing facility, to the patient�s community setting (home, domicile, rest home, or assisted living). Beginning January 1, 2013, Medicare covered TCM services and paid for them under the Medicare Physician Fee Schedule. Medicare-covered services, including chronic care management, end-stage renal disease, and prolonged services without direct patient contact, cannot be billed during the same service period as TCM. We will determine whether payments for TCM services were in accordance with Medicare requirements.
November 2016 Centers for Medicare & Medicaid Services Comparison of Average Sales Prices to Average Manufacturer Prices - Mandatory Review Office of Evaluation and Inspections OEI-03-16-00540, OEI-03-17-00360; OEI-00-00-0000 2017 In 2005, Medicare began paying for most Part�B drugs using a new�methodology based on the average sales prices (ASP). The enabling law required that OIG compare ASPs with average manufacturer prices (AMP) (SSA §�1847A(d)(2)(B). Pursuant to the requirement, OIG conducts such reviews and issues quarterly and annual reports of its findings. When OIG finds that the ASP for a drug exceeds the AMP by a certain threshold (5�percent), OIG notifies the HHS Secretary, who may disregard the ASP for the drug when setting reimbursement amounts, e.g., apply a price substitution policy. We will review Medicare Part�B drug prices by comparing ASPs to AMPs and identify drug prices that exceed a designated threshold.
November 2016 Centers for Medicare & Medicaid Services Medicare Hospice Benefit Vulnerabilities and Recommendations for Improvement: A Portfolio Office of Evaluation and Inspections OEI-02-16-00570 2018 The Medicare hospice program is an important benefit for beneficiaries and their families at the end of life. However, OIG and others have identified vulnerabilities in payment, compliance, and oversight as well as quality-of-care concerns, which can have significant consequences both for beneficiaries and for the program. We will summarize OIG evaluations, audits, and investigative work on Medicare hospices and highlight key recommendations for protecting beneficiaries and improving the program.
November 2016 Centers for Medicare & Medicaid Services Integrity of Medicare Advantage Encounter Data Office of Evaluation and Inspections OEI-03-15-00060 2017 In 2012, Centers for Medicare & Medicaid Services began collecting from Medicare Advantage organizations a more comprehensive set of encounter data reflecting the items and services provided to Medicare Advantage plan enrollees. Previous Centers for Medicare & Medicaid Services and OIG audits have indicated vulnerabilities in the accuracy of data reported by Medicare Advantage organizations. Realizing the potential benefits of the Medicare Advantage encounter data for payment and program integrity oversight is contingent upon the data�s completeness, validity, and timeliness. We will review Centers for Medicare & Medicaid Services's oversight of Medicare Advantage encounter data validation and assess the extent to which Centers for Medicare & Medicaid Services�s Integrated Data Repository contains timely, valid, and complete Medicare Advantage encounter data.
November 2016 Centers for Medicare & Medicaid Services Increase in Prices for Brand-Name Drugs Under Part D Office of Evaluation and Inspections OEI-03-15-00080 2018 Prices for the most commonly used brand-name drugs have risen substantially since 2002.� For example, prices for the most commonly used brand-name drugs increased nearly 13 percent in 2013; this increase was 8 times greater than the general inflation rate for the same year.� We will evaluate the extent to which pharmacy reimbursement for brand-name drugs under Medicare Part�D changed between 2011 and 2015 and compare the rate of change in pharmacy reimbursement for brand-name drugs under Medicare Part D to the rate of inflation for the same period.
November 2016 Centers for Medicare & Medicaid Services Part D Pharmacy Enrollment Office of Evaluation and Inspections OEI-02-15-00440 2018 Since the inception of Part D, numerous OIG reports have raised concerns about Centers for Medicare & Medicaid Services�s oversight of or actions to address fraud in the Part D benefit. Recent law enforcement actions have highlighted the role pharmacies can play in prescription drug fraud. When problems occur, Centers for Medicare & Medicaid Services must rely on Part D plan sponsors to follow up and take action against pharmacies.� Currently, Part D pharmacies are not required to enroll in Medicare.� However, they may enroll for other reasons.� For example, pharmacies that bill Medicare for DMEPOS under Medicare Part B must enroll in Medicare Fee-for-Service.� As a result, Centers for Medicare & Medicaid Services screens these pharmacies to ensure that they meet the requirements to be a Medicare provider.� Centers for Medicare & Medicaid Services also has the authority to revoke their enrollment.� We will review Centers for Medicare & Medicaid Services�s ability to oversee pharmacies that bill for Part D drugs and determine the extent to which pharmacies that bill for Part D drugs, especially those identified as high risk, are enrolled in Medicare Fee-for-Service.
November 2016 Centers for Medicare & Medicaid Services Ensuring Dual Eligibles' Access to Drugs Under Part D - Mandatory Review Office of Evaluation and Inspections OEI-05-17-00160 2017 Dual-eligible beneficiaries are enrolled in Medicaid but qualify for prescription drug coverage under Medicare Part D.� As long as Part D plans meet certain limitations outlined in 42 CFR §�423.120, they have discretion to include different Part D drugs and drug utilization tools in their formularies.� We will review the extent to which drug formularies developed by Part D sponsors include drugs commonly used by dual-eligible beneficiaries, as required. The ACA, § 3313, requires OIG to conduct this review annually.
November 2016 Centers for Medicare & Medicaid Services Questionable Billing for Compounded Topical Drugs in Part D Office of Evaluation and Inspections OEI-02-16-00440 2018 Part D spending for compounded topical drugs grew by more than 3,400 percent between 2006 and 2015, reaching $224 million. This growth in spending, combined with an increase in the number of OIG investigative cases involving compounded drugs, suggests the emergence of a fraud risk. This review will describe billing for topical compounded drugs under Part D and identify pharmacies with questionable Part D billing for these drugs and any associated prescribers.
November 2016 Centers for Medicare & Medicaid Services Allowability of Contract Expenditures Office of Audit Services W-00-15-59034 2018 HHS awarded Establishment Grants to certain States to assist the States in setting up State-based marketplaces. HHS award recipients often contract with organizations to provide services necessary to meet the performance requirements of the grant. Contractors that provide services specified in the grant award to beneficiaries are subject to the same requirements and cost principles as the grantee. We will review the allowability of expenditures for contractor services claimed for Federal reimbursement by a State grantee funded under the Establishment Grants.
November 2016 Centers for Medicare & Medicaid Services Review of Affordable Care Act Establishment Grants for State Marketplaces Office of Audit Services W-00-16-59034 2018 The Patient Protection and Affordable Care Act authorized Establishment Grants to States that elected to establish their own marketplaces. We will determine whether seven States complied with Federal requirements related to the development and implementation of a State marketplace in accordance with the terms and conditions of Federal cooperative agreements. For some of the reviews, we will assess whether Federal funds were used as intended and whether the State agencies� procurement process and internal controls for monitoring and oversight were effective. We will also review policies and procedures issued by Centers for Medicare & Medicaid Services to State agencies relating to Establishment Grants for marketplaces.
November 2016 Centers for Medicare & Medicaid Services Centers for Medicare & Medicaid Services Oversight of Eligibility Determinations at State-Based Marketplaces Office of Audit Services W-00-15-42024 2017 Centers for Medicare & Medicaid Services provides general oversight over States that elected to establish their own marketplaces. Prior OIG work identified issues with State-based marketplaces� internal controls involving eligibility and enrollment. Thus, we will assess Centers for Medicare & Medicaid Services�s oversight activities of seven State-based marketplaces (SBMs) to ensure that individuals were determined eligible for qualified health plans and insurance affordability programs according to Federal requirements. As part of this review, we will (1) summarize the results of our reviews of seven SBMs, which determined whether SBM internal controls were effective in ensuring that individuals were enrolled in qualified health plans according to Federal requirements; (2) assess Centers for Medicare & Medicaid Services�s efforts to address the deficiencies identified in our audit reports; (3) assess Centers for Medicare & Medicaid Services�s various review processes of the SBMs; and (4) contact the SBMs to understand how they worked with Centers for Medicare & Medicaid Services to establish internal controls over eligibility determinations.
November 2016 Food and Drug Administration Hospitals' Reliance on Drug Compounding Facilities Office of Audit Services OEI-01-17-00090 2018 Large-scale facilities that compound without a patient-specific prescription are regulated under section 503B of the Food, Drug and Cosmetic Act and referred to as outsourcing facilities. We will determine the extent to which hospitals obtain compounded sterile preparations from compounders, including outsourcing facilities that have registered with the Food and Drug Administration. We will also determine the extent to which compounders that produce compounded sterile preparations without a patient-specific prescription have registered with the Food and Drug Administration.
November 2016 Food and Drug Administration Food and Drug Administration's Review of Networked Medical Device Cybersecurity During the Premarket Process Office of Evaluation and Inspections OEI-09-16-00220 2018 FDA reviews different types of medical devices, such as those that are wireless, Internet, and network-connected (networked medical devices), before they are legally marketed in the United States to assess whether they are safe and effective for their intended use. Networked medical devices, however, are vulnerable to cybersecurity threats that may adversely affect device functionality, disrupt delivery of health care, and/or cause patient harm. We will interview FDA staff and review a purposive sample of premarket files to examine FDA�s approach to reviewing networked medical device cybersecurity during the premarket process.
November 2016 Food and Drug Administration Tobacco Establishment Compliance with the Family Smoking Prevention and Tobacco Control Act Office of Evaluation and Inspections OEI-01-15-00300 2017 The Family Smoking Prevention and Tobacco Control Act of 2009 requires owners and operators of tobacco establishments to register with Food and Drug Administration and submit product lists. A tobacco establishment is a facility that manufactures, prepares, compounds, or processes tobacco products. We will determine how many owners and operators of tobacco establishments have registered and submitted product lists to Food and Drug Administration. This evaluation will also assess the extent to which Food and Drug Administration has inspected and taken action against owners and operators of establishments that do not comply with the Tobacco Control Act.
November 2016 Food and Drug Administration Inspections of Domestic Food Facilities Office of Evaluation and Inspections OEI-02-14-00420 2017 Food and Drug Administration is responsible for safeguarding the Nation�s food supply by ensuring that all food ingredients are safe and that food is free of disease-causing organisms, chemicals, or other harmful substances. To carry out this responsibility, Food and Drug Administration inspects food facilities to ensure food safety and compliance with regulations. Additionally, FSMA established criteria for designating a domestic facility as high risk and mandated frequencies for Food and Drug Administration to complete inspections of domestic facilities designated high risk and non-high risk. We will review Food and Drug Administration�s domestic inspection program and assess whether Food and Drug Administration is on track to meet the -inspection frequencies required by FSMA.
November 2016 Food and Drug Administration Review of Information Exchange in the Drug Supply Chain Office of Evaluation and Inspections OEI-05-14-00640; 05-16-00550 2017, 2018 The drug supply chain is growing increasingly complex, with drugs often passing through numerous companies before ultimately reaching patients. This may make it difficult to track products to their sources in case of a recall and potentially complicate Food and Drug Administrations task of ensuring the integrity of products. We will review drug supply chain trading partners (e.g., wholesale distributors and dispensers) early experiences in exchanging transaction information and transaction history as required by section 202 of the Drug Supply Chain Security Act. Transaction information includes basic information about the drug (the strength and dosage form, the National Drug Code, etc.), and the transaction history includes transaction information for every prior transaction for that drug back to the manufacturer. Together, this information forms the foundation of drug traceability and the security of the drug supply chain. We will interview trading partners about how they have successfully exchanged this information and what, if any, obstacles they have faced.
November 2016 Health Resources and Services Administration Oversight of Vulnerable Health Center Grantees Office of Evaluation and Inspections OEI-05-14-00470 2017 Health centers provide preventive and primary health care to patients regardless of their ability to pay. Approximately 1 in 14 people in the United States relies on a Health Resources and Services Administration-funded health center for medical care.[1] Health Resources and Services Administration collects data on Health Center Program grantees� compliance and financial statuses when evaluating their applications and can take a variety of actions to help them resolve any identified compliance or financial issues.� Having compliance or financial issues does not disqualify health centers from receiving Health Resources and Services Administration grants, but having these types of issues may put health centers at risk for mismanaging their grant funds. We will determine the extent to which Health Resources and Services Administration awarded grant money to Health Center Program grantees that have documented compliance or financial issues.
November 2016 Health Resources and Services Administration Community Health Centers' Compliance with Grant Requirements of the Affordable Care Act Office of Audit Services W-00-15-59028; various reviews 2018 The Patient Protection and Affordable Care Act provided community health centers with $9.5 billion to support ongoing health center operations, create new health center sites, or expand preventive and primary health care services at existing health center sites. We will determine whether community health centers that received funds pursuant to the ACA, § 10503, are complying with Federal laws and regulations. The review is based in part on requirements of the Public Health Service Act, § 330, and Federal regulations.
November 2016 Indian Health Services Purchase Referred Care Program Office of Audit Services W-00-16-51004 2018 Indian Health Services provides Federal health services to 2.2 million American Indians and Alaska Natives in 567 Federally recognized tribes. Indian Health Services can provide health care directly or may fund tribes to independently deliver health care. When an Indian Health Services or tribal facility is not available, or does not provide the required care, patients are referred to the purchased/referred care (PRC) program, which coordinates needed services through private health care providers. PRC program funds grew 17.2 percent from $779.9 million in FY 2011 to $914.1 million in FY 2016. We are initiating this audit because of the significant magnitude and growth of PRC program funds and previous reports by GAO that highlighted problems with the program. This audit will focus on Indian Health Services-administered PRC program services, which totaled $333.7 million in FY 2016. We will determine whether Indian Health Services PRC program services were provided in compliance with the purpose, time, and amount requirements specified in appropriation statutes and Indian Health Services requirements.
November 2016 Indian Health Services Management Review of Indian Health Services Office of Evaluation and Inspections OEI-06-16-00390 2018 Indian Health Services (IHS) directly operates 28 hospitals, 62 health centers, and 25 health stations with dispersed management. We will examine the management of IHS, including assessing the organizational framework of IHS headquarters operations. This will include reviewing the fulfillment of roles and responsibilities, enforcement of policies and procedures, and strategies to address current and future challenges. We will conduct interviews with senior management responsible for policies, practices, and resources that support care delivery in IHS facilities. We will first complete an initial review of key issues facing IHS headquarters management, and follow that review with a more in-depth analysis focused on selected key issues.
November 2016 National Institutes of Health Review of National Institutes of Health Data Controls to Ensure the Privacy and Protection of Volunteers in the Precision Medicine Initiative Office of Audit Services W-00-17-42020 2018 The FY 2016 budget provided $200 million to National Institutes of Health to help develop the Precision Medicine Initiative. The Precision Medicine Initiative plans to have more than 1 million volunteers providing their personal health information to National Institutes of Health so researchers, providers, and patients can work together toward the development of individualized care. Maintaining data security and privacy will be paramount to retaining the volunteers� trust and participation in the Precision Medicine Initiative. We will determine the controls National Institutes of Health has developed to ensure privacy and protection of the volunteers� personal health information.
November 2016 National Institutes of Health Controls over Subcontracting of National Institutes of Health Grant and Contract Work Office of Audit Services W-00-16-51001; various reviews 2018 Cost principles for Educational Institutions at 45 CFR Part 75 are used in determining the allowable costs of work performed by colleges and universities under sponsored agreements. The principles will also be used in determining the costs of work performed by such institutions under subgrants, cost-reimbursement subcontracts, and other awards made to them under sponsored agreements. We will assess colleges� and universities� controls over the subcontracting of National Institutes of Health grant and contract work.� Specifically, we will determine whether colleges and universities effectively monitor the services subcontracted to other organizations and ensure that Federal funds are spent on allowable goods and services in compliance with selected cost principles and the terms and conditions of the grants and subcontracts. �We will conduct reviews at selected organizations based on the dollar value of Federal grants received and on input from National Institutes of Health.
November 2016 National Institutes of Health Colleges' and Universities' Compliance with Cost Principles Office of Audit Services W-00-13-50037 2017 Cost principles for colleges and universities at 45 CFR Part 75 establish guidelines for charges to Federal grants. We will assess colleges� and universities� compliance with selected cost principles. We will conduct reviews at selected colleges and universities on the basis of the dollar value of Federal grants received and input from HHS operating divisions and�the offices of the Assistant Secretary for Financial Resources and the Assistant Secretary for Administration.
November 2016 National Institutes of Health Review of the National Institute of Environmental Health Sciences' Funding for Bisphenol A Safety Research Office of Evaluation and Inspections OEI-01-15-00150 2017 Bisphenol A (BPA) is a chemical primarily used in the production of polycarbonate plastics, but it is also used in food and drink packaging. BPA in packaging may leach into food or drink and be consumed by humans. We will determine the extent to which National Institutes of Health�s National Institute of Environmental Health Sciences (NIEHS ) has conducted and funded research on the safety of BPA since 2000, as well as the roles that other HHS programs and agencies (National Toxicology Program, Food and Drug Administration, and CDC) play in planning, funding, and conducting NIEHS�s BPA research. We will also determine the extent to which NIEHS followed its grant application processes related to peer review when awarding funds for BPA research.
November 2016 Other FYs 2016 and 2017 Centers for Medicare & Medicaid Services' Financial Statements - Mandatory Review Office of Audit Services W-00-17-40008; A-17-16-02016; A-17-17-02017 2017, 2018 The Centers for Medicare & Medicaid Services financial statement audit determines whether the financial statements present fairly, in all material respects, the financial position of the audited entity for the specified time period (Chief Financial Officers Act of 1990, as amended; Government Management Reform Act of 1994; Federal Financial Management Improvement Act of 1996; Generally Accepted Government Auditing Standards; and OMB Bulletin 15-02, "Audit Requirements for Federal Financial Statements�). We will review the independent auditor�s work papers to determine whether the financial statement audit of Centers for Medicare & Medicaid Services was conducted in accordance with Federal requirements.
November 2016 Other Compliance with Reporting Requirements for Improper Payments - Mandatory Review Office of Audit Services W-00-17-40037; A-17-17-52000 2017 The Improper Payments Information Act of 2002 (IPIA), as amended by the Improper Payments Elimination and Recovery Act of 2010 (IPERA) and the Improper Payments Elimination and Recovery Improvement Act of 2012 (IPERIA), requires the head of each Federal agency with programs or activities that may be susceptible to significant improper payments to report certain information to Congress. For any program or activity with estimated improper payments exceeding $10 million and 1.5 percent, or $100 million regardless of the improper payment rate, HHS must report to Congress improper payment estimates, corrective action plans, and reduction targets. Pursuant to IPERA and OMB Circular A-123, Appendix C, �Requirements for Effective Estimation and Remediation of Improper Payments,� OIG will review HHS compliance with IPIA, as amended, as well as how HHS assesses the programs it reports and the accuracy and completeness of the reporting in HHS�s Agency Financial Report. We will make recommendations as needed.
November 2016 Other HHS Agencies� Annual Accounting of Drug-Control Funds - Mandatory Review Office of Audit Services W-00-17-52312; various reviews 2017 The Office of National Drug Control Policy Circular requires that agencies expending funds on National Drug Control Program activities submit an annual accounting of the expenditure of such funds (21 U.S.C. § 1704). The policy also requires that an agency submit with its annual accounting an authentication by the agency�s OIG that expresses a conclusion on the reliability of the agency�s assertions. We will review HHS agencies� compliance with the circular. We will also submit the authentication with respect to HHS�s FY 2016 annual accounting.
November 2016 Other HHS Contract Management Review Office of Audit Services W-00-13-52313 2017 In its July 2011 Anti-deficiency Report to the President, HHS noted that it implemented corrective actions, including adopting quality assurance procedures and conducting procurement management and internal control reviews to validate full compliance with appropriations laws and regulations, to ensure there would be no future violations of the Anti-Deficiency Act (31 U.S.C. § 1341(a)(1)) and Bona Fide Needs Rule (31 U.S.C. § 1502). We will review the controls that the HHS Program Support Center has in place to ensure compliance with requirements specified in appropriation statutes when awarding contracts. We will review HHS�s quality assurance procedures to determine the accuracy and completeness of the internal control reviews to ensure full compliance with appropriations laws.
November 2016 Other HHS Compliance with the Federal Information Security Modernization Act of 2014 - Mandatory Review Office of Audit Services W-00-17-40016; W-00-16-42001; various reviews 2018 The Federal Information Security Modernization Act (FISMA) and OMB Circular A-130, Managing Information as a Strategic Resource, require that agencies and their contractors maintain programs that provide adequate security for all information collected, processed, transmitted, stored, or disseminated in general support systems and major applications. FISMA requires the Inspectors General to conduct an annual independent evaluation to determine the effectiveness of the information security program and practices of its agency. We will review HHS�s and selected HHS operating divisions� compliance with FISMA.
November 2016 Other Compliance with the Digital Accountability and Transparency Act (DATA Act) - Mandatory Review Office of Audit Services W-00-17-41021 2017 or 2018 On May 9, 2014, the President signed the DATA Act of 2014, which mandated the establishment of Government-wide data standards for financial and payment data by May 2015, and agency reporting of consistent, reliable, and searchable financial and payment data by May 2017, to be displayed for taxpayers and policy makers on USASpending.gov. The DATA Act also requires OIG to review a statistically valid sampling of the spending data submitted under this Act by HHS and submit to Congress and make publically available a report assessing the completeness, timeliness, quality, and accuracy of the data sampled and the implementation and use of data standards by HHS. We will use the independent external auditor contracted to audit the annual Centers for Medicare & Medicaid Services and HHS Financial Statement Audits to perform this work.
November 2016 Other Public Health Reviews Review of Office for Human Research Protections Compliance Evaluations to Ensure Human Subject Protection - Mandatory Review Office of Evaluation and Inspections OEI-01-15-00350; OEI-01-15-00351 2017 Section 492 of the Public Health Service Act authorizes the Office of Human Research Protections to establish a compliance oversight process to review violations of HHS regulations protecting human research subjects. We will determine the extent to which the Office of Human Research Protections independently initiates, conducts, and makes determinations about compliance evaluations.
November 2016 Other Public Health Reviews Audits of Superstorm Sandy Disaster Relief Act Office of Audit Services W-00-16-59052; various reviews 2017 The Disaster Relief Appropriations Act of 2013, P.L. No. 113-2 (Disaster Relief Act), provided funding to HHS for use in aiding Hurricane Sandy disaster victims and their communities. After sequestration, HHS received $759.5�million in Disaster Relief Act funding. Of this amount, $733.6 million was allocated to three operating divisions: ACF, National Institutes of Health, and Substance Abuse and Mental Health Services Administration. We plan to perform audits of grantees that have received Disaster Relief Act grant funding through one of the above-mentioned HHS operating divisions. We will review grantees' internal controls related to the oversight of Disaster Relief Act funds. Additionally, we plan to review the allowability of costs claimed and the appropriateness of costs that were budgeted but not yet expended.

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