Laboratory Quality:
Financing the Clinical Laboratory Improvement Act (CLIA) Program
HEHS-00-47R: Published: Feb 4, 2000. Publicly Released: Mar 6, 2000.
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Pursuant to a congressional request, GAO reviewed user fees paid to the Health Care Financing Administration (HCFA) for Clinical Laboratory Improvement Act (CLIA) activities, focusing on the: (1) CLIA program budget history, including their rationale for recent fee increases; (2) allocation of increased fees across laboratories and states; and (3) information HCFA provided to states on CLIA program operations and the recent increase in fees.
GAO noted that: (1) when HCFA first implemented the CLIA amendments, the agency overestimated the numbers and types of laboratories in the United States, and set user fees too low to cover all planned program activities; (2) anticipating a shortfall, HCFA officials accelerated billing to meet the program's cash flow needs and curtailed expenditures through efficiencies and deferred program operations; (3) as a result, the funding shortfall did not materialize; (4) however, to avoid long-term loss in CLIA's capacity to ensure laboratory quality, the agency increased laboratory user fees in 1998, and began funding deferred program activities; (5) the largest increases were assessed on the highest-volume laboratories; (6) the following year, fees were increased for approved states, requiring them to pay a greater proportion of CLIA's total administrative costs than had been the case in the past; (7) officials in these states have questioned HCFA's legal authority to impose these fees; (8) in response, HCFA officials maintain that approved states derive benefits from the national program and note that they are required by regulation to pay a prorated share of general administrative costs; and (9) in communicating with state officials regarding CLIA, HCFA was generally responsive to requests for program and budget information, but the agency did not provide timely notification of the amount of the recent fee increase.
Jan 21, 2021
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Rural Hospital Closures:
Affected Residents Had Reduced Access to Health Care ServicesGAO-21-93: Published: Dec 22, 2020. Publicly Released: Jan 21, 2021. -
Health Care Funding:
Federal Obligations to and Funds Received by Certain Organizations Involved in Health-Related Services, 2016 through 2018GAO-21-188R: Published: Dec 21, 2020. Publicly Released: Jan 21, 2021.
Jan 14, 2021
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Medicaid:
Data Completeness and Accuracy Have Improved, Though Not All Standards Have Been MetGAO-21-196: Published: Jan 14, 2021. Publicly Released: Jan 14, 2021.
Jan 4, 2021
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Medicare Severe Wound Care:
Spending Declines May Reflect Site of Care Changes; Limited Information Is Available on QualityGAO-21-92: Published: Jan 4, 2021. Publicly Released: Jan 4, 2021.
Dec 22, 2020
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Defense Health Care:
Efforts to Ensure Beneficiaries Access Specialty Care and Receive Timely and Effective CareGAO-21-143: Published: Dec 22, 2020. Publicly Released: Dec 22, 2020.
Dec 16, 2020
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Medicaid Long-Term Services and Supports:
Access and Quality Problems in Managed Care Demand Improved OversightGAO-21-49: Published: Nov 16, 2020. Publicly Released: Dec 16, 2020.
Dec 14, 2020
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Drug Pricing Program:
HHS Uses Multiple Mechanisms to Help Ensure Compliance with 340B RequirementsGAO-21-107: Published: Dec 14, 2020. Publicly Released: Dec 14, 2020. -
Substance Use Disorder:
Reliable Data Needed for Substance Abuse Prevention and Treatment Block Grant ProgramGAO-21-58: Published: Dec 14, 2020. Publicly Released: Dec 14, 2020.
Dec 10, 2020
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Indian Health Service:
Actions Needed to Improve Oversight of Provider Misconduct and Substandard PerformanceGAO-21-97: Published: Dec 10, 2020. Publicly Released: Dec 10, 2020. -
Clinical Labs:
Studies Suggest Biopsy Specimen Misidentification and Contamination Errors Are InfrequentGAO-21-59: Published: Nov 10, 2020. Publicly Released: Dec 10, 2020.
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