Recommendations Tracker

We recommend that HRSA develop additional oversight controls and procedures (e.g., deliverable schedules, compliance assessments, and monitoring) to ensure that the OPTN contractor complies with all Federal cybersecurity requirements and implements security controls over the OPTN in an effective and timely manner.

We recommend that WellCare of Florida, Inc. refund to the Federal Government the $3,518,465 of estimated net overpayments.

We recommend that WellCare of Florida, Inc. continue its examination of existing compliance procedures to identify areas where improvements can be made to ensure that diagnosis codes that are at high risk for being miscoded comply with Federal requirements (when submitted to CMS for use in CMS's risk adjustment program) and take the necessary steps to enhance those procedures.

CMS should take appropriate steps to enable a successful transition from current pandemic-related flexibilities to well-considered longterm policies for the use of telehealth for beneficiaries in urban areas and from the beneficiary's home.

CMS should require a modifier to identify all audio-only telehealth services provided in Medicare.

We recommend that the Montana Department of Public Health and Human Services refund to the Federal Government $5,065,966 (Federal share) in overpayments.

We recommend that the Montana Department of Public Health and Human Services require TCM providers to comply with established policies and procedures in order to ensure that case managers who render TCM services to recipients have the experience required by the State plan supplement; TCM providers maintain documentation to support the TCM services rendered; TCM providers maintain documentation to support that case managers are qualified to perform TCM services; the State agency does not pay TCM providers or claim Federal Medicaid reimbursement for services that are not allowable TCM services; and recipients receiving TCM services are eligible to receive those services.

We recommend that the Nevada Department of Health and Human Services ensure that child care providers notify DPBH when a new household member is added or a new employee is hired so that the State may conduct the required criminal background checks.

We recommend that the Nevada Department of Health and Human Services ensure that all required criminal background checks are conducted for all employees who are under the age of 18.

We recommend that the Nevada Department of Health and Human Services add a written requirement and policy to conduct the in-State sex offender registry check, as required by Federal regulations, for all child care staff members.

We recommend that Cigna HealthSpring of Florida, Inc. refund to the Federal Government $39,612 of net overpayments.

We recommend that the National Institutes of Health improve its procedures to ensure that responsible parties of NIH-funded clinical trials comply with requirements to submit results to ClinicalTrials.gov in a timely manner.

We recommend that the National Institutes of Health work with the responsible parties to understand the challenges they face when submitting their results to ClinicalTrials.gov and implement procedures to address the challenges.

Refund to the Federal Government $14,281,626 (Federal share) for claims for single-source physician-administered drugs that were ineligible for Federal reimbursement.

Work with CMS to determine the unallowable portion of $1,328,195 (Federal share) for other claims for multiple-source physician-administered drugs that may have been ineligible for Federal reimbursement, refund that amount, and consider invoicing drug manufacturers for rebates for these drugs if CMS determines that the drug claims are allowable.

Continue to review and strengthen its internal controls to ensure that all physician-administered drugs eligible for rebates are invoiced.

CMS should encourage Part D plans to increase access to and use of the authorized generic versions of Epclusa and Harvoni, within the authorities granted under statute.

We recommend that the Centers for Medicare & Medicaid Services instruct SSAs to follow up with the 28 nursing homes that we have identified with possible infection prevention and control and emergency preparedness deficiencies to verify that they have taken corrective actions.

We recommend that the Centers for Medicare & Medicaid Services provide training to SSAs on the updated phase three interpretive guidance as soon as feasible.

We recommend that the Centers for Medicare & Medicaid Services continue its efforts to recover any collectible portion of the $226 million in uncollected overpayments and inform us of any additional collections related to this amount.

We recommend that the Centers for Medicare & Medicaid Services determine what portion of the $152,510,191 (footnote 25) was collected and recorded in its accounting system based on policies established in response to our recommendation in the previous bullet.

We recommend that the Centers for Medicare & Medicaid Services ensure that employees follow established policies and procedures for verifying that collection information is accurately and consistently recorded.

We recommend that the Centers for Medicare & Medicaid Services revise 42 CFR section 405.980 and corresponding manual instructions related to the reopening period for claims to be consistent with statutory provisions contained in section 1870 of the Social Security Act, which allows Medicare contractors to determine whether overpayments were made and to begin to collect them for 5 years following the year payments were made.

We recommend that the Centers for Medicare & Medicaid Services develop a plan, with milestones, for reconciling cost reports applicable to nine audit reports discussed in Appendix B of this report.

We recommend that Lahey Clinic, Inc. refund to the MAC $6,015 in overpayments for critical care services.

We recommend that Lahey Clinic, Inc. strengthen its policies and procedures to ensure that critical care services billed to Medicare are adequately documented and correctly billed by: providing training to critical care physicians to ensure the services they identify for coding review meet Medicare requirements for critical care services; providing training to coders to ensure they assign the appropriate CPT code for critical care or another E/M service based on their review of the medical record documentation; and developing an internal quality control review process to determine the accuracy of coders who review services identified as critical care services.

We recommend that Cariten Health Plan, Inc. refund to the Federal Government the $9,212,531 of estimated net overpayments.

We recommend that Cariten Health Plan, Inc. examine its existing compliance procedures to identify areas where improvements can be made to ensure that diagnosis codes that are at high risk for being miscoded comply with Federal requirements (when submitted to CMS for use in CMS's risk adjustment program) and take the necessary steps to enhance those procedures.

We recommend that the Centers for Medicare & Medicaid Services work with State survey agencies to require mandatory participation in standardized life safety training for nursing home staff.

We recommend that the Centers for Medicare & Medicaid Services propose regulations requiring carbon monoxide detectors to be installed in accordance with NFPA 72 and 720 for all nursing homes that utilize fuel-burning appliances or have an attached garage.

Refund to the Federal Government the portion of the estimated $140,370,745 for hospice services that did not comply with Medicare requirements and that are within the 4-year claims reopening period.

Strengthen its policies and procedures to ensure that hospice services comply with Medicare requirements.

CDC should expand its efforts both to improve racial and ethnic data associated with COVID-19 and to supplement them with additional data sources.

ACF should work with States to improve compliance with requirements to screen children who return to foster care after going missing to identify whether they are victims of sex trafficking.

ACF should conduct oversight activities to identify States that may not screen all children for sex trafficking when they return to foster care after going missing.

Remediate the vulnerabilities identified on internet-facing systems and implement procedures to ensure compliance with BOD 19-02 requirements.

Implement oversight to ensure corrective actions are performed in accordance with Federal requirements and in the timeframe set forth in CMS policy.

We recommend that the Food and Drug Administration identify and implement additional ways to improve the timeliness of its foreign for-cause drug inspection process.

We recommend that the Food and Drug Administration conduct an analysis of the workloads of individuals responsible for: (1) determining final classification, (2) issuing warning letters, and (3) holding regulatory meetings, and address any potential issues identified by this analysis.

We recommend that the Food and Drug Administration ensure that supervisors review investigators' qualifications and document that they meet applicable training requirements when the investigator training records do not exist.

We recommend that the New Hampshire Department of Health and Human Services refund $7,943,271 to the Federal Government.

We recommend that the New Hampshire Department of Health and Human Services improve communication with providers regarding the State requirements for OUD treatment and provide written confirmation to providers about whether offsite counseling may be included as a required counseling service.