Recommendations Tracker

FDA should take steps to ensure appropriate documentation of meetings with sponsors in drug approval administrative files.

We recommend that the Centers for Medicare & Medicaid Services work with its plan sponsors to identify similar instances of noncompliance that occurred during our audit period and determine the impact to the Federal Government, which could have amounted up to an estimated $465,077,908 in Part D total cost, including $245,365,324 for drugs that were administered during enrollees' Part A SNF stays.

We recommend that the Centers for Medicare & Medicaid Services provide plan sponsors with timely and accurate information, such as dates of covered Part A SNF stays, to reduce instances of inappropriate Part D payment for drugs for which payment is available under the Part A SNF benefit.

CMS should work with States to assess whether their Medicaid reimbursement rates for treatment with MOUD are sufficient to recruit and retain enough MOUD providers.

CMS should geographically target efforts to increase the number of MOUD providers that treat Medicaid enrollees in high-need counties.

We recommend that the South Carolina Department of Health and Human Services work with CMS to determine whether the claims for other multiple-source physician-administered drugs, totaling $1,947,035 (Federal share), were eligible for rebates and, if so, determine the rebates due for these drugs and, upon receipt of the rebates, refund the Federal share of the rebates collected.

We recommend that the South Carolina Department of Health and Human Services continue to review and strengthen its internal controls to ensure that, in line with the State agency's existing policies, all physician-administered drugs eligible for rebates are invoiced.

CMS should provide additional technical assistance to States to clarify what to include or exclude from the reported paid amounts to providers for Medicaid managed care drug claims.

We recommend that the Centers for Medicare & Medicaid Services issue finalized guidance regarding multiple-source physician-administered drugs, to clarify and reinforce the requirement that rebates should be collected for all required physician-administered drugs.

We recommend that the California Department of Social Services coordinate with California Department of Health Care Services to modify the existing data sharing agreement to obtain access to Medicaid claim data for all medications prescribed for children under its care and supervision, to the extent allowable under California law.

We recommend that the California Department of Social Services develop and implement procedures for county agency staff to upload the court authorizations for psychotropic medications prescribed for children in foster care into CWS/CMS.

We recommend that the Mississippi Division of Medicaid strengthen internal controls to facilitate the invoicing of all physician-administered drugs for rebate.

CMS should encourage States and work with Federal partners to educate Medicaid and CHIP enrollees about access to medications for opioid use disorder (MOUD).

We recommend that the Alabama Medicaid Agency refund to the Federal Government $43,981 (Federal share) for claims for top-20 multiple-source physician-administered drugs that were ineligible for Federal reimbursement.

We recommend that the Alabama Medicaid Agency complete the process for rebating pharmacy drugs totaling $6,568 ($4,719 Federal share) for single-source and $219,220 ($157,395 Federal share) for multiple-source drugs that it had not previously collected a rebate on or refund the Federal share.

We recommend that the Alabama Medicaid Agency strengthen its internal controls to ensure that all pharmacy and physician-administered drugs eligible for rebates are invoiced.

We recommend that the Kentucky Cabinet for Health and Family Services, Department for Medicaid Services work with CMS to determine whether the other claims for multiple-source physician-administered drugs, totaling $5,967,128 ($4,281,678 Federal share), were eligible for rebates and, if so, determine the rebates due and, upon receipt of the rebates, refund the Federal share of the rebates collected.

We recommend that the Kentucky Cabinet for Health and Family Services, Department for Medicaid Services ensure that all physician-administered drugs eligible for rebates after our audit period are processed for rebates.

We recommend that the Florida Department of Children and Families coordinate with the Florida Agency for Health Care Administration to obtain access to Medicaid claim data for all children under its care and supervision.

CMS should inform providers about buprenorphine use and the low risk of diversion to encourage providers to treat more Part D enrollees who have opioid use disorder.

CMS should follow up on the prescribers with concerning patterns identified in this report.

We recommend that the Georgia Department of Community Health refund to the Federal Government $9,325 (Federal share) for top-20 multiple-source physician-administered drug claims that were ineligible for Federal reimbursement.

We recommend that the Georgia Department of Community Health complete the process for rebating pharmacy drug claims totaling $1,240,894 (Federal share) for single-source and $360,454 (Federal share) for multiple-source drugs that it had not previously sent for invoicing or refund the Federal share.

We recommend that the Georgia Department of Community Health strengthen its internal controls to ensure that all pharmacy and physician-administered drugs eligible for rebates are invoiced.

We recommend that the Florida Agency for Health Care Administration work with CMS to determine whether the other claims for multiple-source physician-administered drugs, totaling $40,635 ($24,772 Federal share), were eligible for rebates and, if so, determine the rebates due and, upon receipt of the rebates, refund the Federal share of the rebates collected.

We recommend that the Michigan Department of Health and Human Services ensure the electronic case records for children who are prescribed psychotropic medications are maintained in accordance with requirements by implementing policies specific to non-emergency situations that require the FC-PMOU to document when consent forms do not need to be obtained; implementing procedures for caseworkers and the FC-PMOU to monitor the Medicaid claim data to ensure consent forms are obtained and documented; and implementing procedures requiring caseworkers and the FC-PMOU to monitor other medications prescribed for children, including opioids, for potential medication interaction and adverse side effects.

We recommend that the North Carolina Department of Health and Human Services, Division of Health Benefits refund to the Federal Government $733,535 (Federal share) for claims for top-20 multiple-source physician-administered drugs that were ineligible for Federal reimbursement.

We recommend that the North Carolina Department of Health and Human Services, Division of Health Benefits work with CMS to determine and refund the unallowable portion of Federal reimbursement for physician-administered drugs that were not invoiced for rebates after December 31, 2019.