340B Audit Results
340B SUMMARY OF TYPICAL FINDINGS
340B AUDIT - 2015
The following represents a summary of typical findings during a 2015 340B Audit that resulted in sanctions being placed on the covered entities.
· 340B Drugs dispensed to non-patient at the contract pharmacy;
· No evidence of a closed loop referral for specialists;
· Incorrect 340B database record for the authorizing official;
· Covered entity was billing the Medicaid Program when it was excluded from doing so;
· Incorrect office location and contact information;
· Drugs dispensed to ineligible patient;
· Incorrect name listed in OPA database;
· Pharmacy listed as child site;
· Pharmacy listed as child site;
· Prescription written at ineligible site;
· Contract pharmacy arrangement did not include provision to prevent duplicate discounts;
· 340B drugs shipped to pharmacy not listed on OPA database;
· NPI numbers missing;
· Ineligible providers prescribing drugs;
· Incorrect codes;
· Missing modifiers; and
· Incorrect provider numbers.
340B ENTITIES WHERE AUDITS
RESULTED IN SANCTIONS
Program Integrity | |||
Fiscal Year 2015 | |||
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Type of Entity | Audits Performed | Audits with Sanctions | % |
Aids Grantee | 3 | 2 | 66.67% |
Children's Hospitals | 2 | 2 | 100.00% |
Consolidated Health Center | 4 | 3 | 75.00% |
Critical Access Hospital | 29 | 12 | 41.38% |
Disproportionate Share | 108 | 77 | 71.30% |
Family Planning | 5 | 4 | 80.00% |
Health Centers | 21 | 17 | 80.95% |
Homeless Program | 2 | 0 | 0.00% |
Ryan White Grantee | 1 | 0 | 0.00% |
Sexually Trans Disease | 7 | 1 | 14.29% |
Sole Community Hospital | 7 | 3 | 42.86% |
Tuberculosis | 1 | 0 | 0.00% |
190 | 121 | 63.68% |
340B AUDIT FINDINGS BY TYPE OF ENTITY
2015
Download 340B Audit Findings by Type of Entity 2015
340B SUMMARY OF TYPICAL FINDINGS
340B AUDIT - 2016
The following represents a summary of typical findings during a 2016 340B Audit that resulted in sanctions being placed on the covered entities. The audits of these 152 covered entities resulted in 205 findings and 186 sanctions. 12 contract pharmacies were terminated from the program with the majority due to a lack of oversight and the absence of a signed contract by the covered entity. In addition, 5 outpatient sites were also terminated from the program for a variety of reasons. Many the sanctions could have been avoided if the covered entity would have exercised a limited degree of proactive review of compliance with program guidelines that have been published since the start of the program.
# Find | | Finding Description | # | Sanction |
3 | 1.14% | Billing Medicaid inconsistent with Exclusion File | 3 | Repayment |
3 | 1.14% | Closed O/P site listed on database | 3 | None |
2 | 0.76% | Contract Pharmacy Listed as Child Site | 1 | Repayment |
1 | None | |||
4 | 1.52% | Contract Pharmacy Oversight not provided | 3 | Termination of Pharmacy |
1 | None | |||
1 | 0.38% | Contract Pharmacy used before listed on database | 1 | None |
12 | 4.55% | Contract Pharmacy without contract | 9 | Termination of Pharmacy |
3 | Repayment | |||
3 | 1.14% | Controls not in place to prevent diversion | 3 | Repayment |
1 | 0.38% | Controls not in place to prevent duplicate discounts | 1 | Repayment |
7 | 2.65% | Covered outpatient drugs obtained through a GPO | 6 | Repayment |
1 | Termination of Offsite Facility | |||
12 | 4.55% | Drug dispensed not supported in medical record | 12 | Repayment |
16 | 6.06% | Drugs dispensed to inpatients. | 16 | Repayment |
11 | 4.17% | Drugs were not properly accumulated | 11 | Repayment |
2 | 0.76% | Duplicate entry for Offsite facility | 2 | Repayment |
1 | 0.38% | Failure to keep auditable records | 1 | Termination of Offsite Facility |
34 | 12.88% | Inaccurate or incomplete information in Exclusion file | 32 | Repayment |
2 | None | |||
1 | 0.38% | Incorrect Contract Pharmacy Address | 1 | None |
1 | 0.38% | Incorrect entry for Authorizing Official. | 1 | Repayment |
1 | 0.38% | Incorrect entry for Primary contact. | 1 | Repayment |
2 | 0.76% | Incorrect grant number | 2 | None |
1 | 0.38% | Incorrect listing of Authorizing Officer | 1 | Termination of Offsite Facility |
2 | 0.76% | Incorrect names used for O/P facility | 2 | Repayment |
5 | 1.89% | Incorrect O/P address | 3 | Repayment |
2 | None | |||
1 | 0.38% | Incorrect Contract Pharmacy Address | 1 | Repayment |
1 | 0.38% | Incorrect Primary Contact | 1 | Repayment |
1 | 0.38% | Incorrect Shipping address | 1 | Repayment |
4 | 1.52% | Ineligible site registered | 4 | Repayment |
47 | 17.80% | Ineligible sites, Drugs written at | 47 | Repayment |
2 | 0.76% | Medicaid was being billed without notifying HRSA | 2 | Repayment |
59 | 22.35% | No Findings | 59 | None |
24 | 9.09% | Offsite Facility not listed on database | 15 | Repayment |
2 | Termination of Offsite Facility | |||
| | 7 | None | |
264 | 100.00% |
340B ENTITIES WHERE AUDITS
RESULTED IN SANCTIONS
Program Integrity | |||
Type of Entity | |||
Fiscal Year 2016 | |||
Type of Entity | Audits Performed | Audits with Sanctions | % |
Aids | 3 | 0 | 0.00% |
Black Lung Clinic | 1 | 1 | 100.00% |
Children's Hospitals | 5 | 3 | 60.00% |
Consolidated Health Center | 3 | 1 | 33.33% |
Critical Access Hospital | 17 | 6 | 35.29% |
Disproportionate Share | 84 | 57 | 67.86% |
Family Planning | 6 | 2 | 33.33% |
FQHC Look Alike | 1 | 1 | 100.00% |
Health Centers | 20 | 12 | 60.00% |
Rural Referral Center | 6 | 4 | 66.67% |
Ryan White Grantee | 1 | 0 | 0.00% |
Sexually Trans Disease | 1 | 1 | 100.00% |
Sole Community Hospital | 6 | 1 | 16.67% |
Tuberculosis | 1 | 1 | 100.00% |
155 | 85 | 54.84% | |
NOTE: 152 entities were audited and several had multiple entity types. |
340B AUDIT FINDINGS BY TYPE OF ENTITY
2016
Download 340B Audit Findings by Type of Entity 2016
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