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

 

 

 

 

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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