340B Questions on Operational Site Visits

Health Center Site Visits Now Include 340B Questions

Health centers preparing for HRSA Operational Site Visits (OSVs) to verify their compliance with the 19 Health Center Program requirements should be aware that those visits now include five questions on the 340B Drug Discount Program.  OSV reviewers are to ask the following but are not expected to review 340B documents/policies or patient records.  The questions are:

1.  Does the health center participate in the 340B drug pricing program? (if NO, the remaining questions are not required)

2.  Does the health center have written 340B policies, procedures, or other related documents? (if NO, proceed to question 4)

3.  If YES to #2, do the policies, procedures or other related documents address the following areas to assure that the individuals provided access to 340B drugs purchased by the health center meet all of the following?

a)  The health center has an established relationship with the individual, as documented by the health center maintaining records of the individual’s health care;

b) The individual receives health care services from a health care professional who is either employed by the health center or under contractual or other arrangements (e.g. referral for consultation) such that responsibility for care provided remains with the health centers; i.e. 340B prescriptions are only made available to those who receive services that are either provided directly by the health center (Form 5A Column I or II) and/or through formal written referral arrangements (Form 5A Column III) consistent with approved scope of project; and

c) The prevention of duplicate discounts for patients covered under Medicaid?

4.  Does the health center dispense 340B drugs to patients through a contract pharmacy services model? If YES, please verify the following:

a)  Does a written contract exist between the health center and contract pharmacy(ies);

b) Does the health center have within its contract or in written policies and procedures how the contract pharmacy will ensure against diversion;

c) Does the health center have, within its contract or in its written policies and procedures, a process that reflects how the contract pharmacy will ensure against duplicate discounts.

5.  Does the health center attest that it provides oversight (e.g. annual audit or other mechanism) of the 340B drugs dispensed by the contract pharmacy(ies)?

While the OSV reviewers are simply to ask the question and record the responses, responses could potentially trigger a 340B audit.  A comprehensive Community Health Center 340B Policy & Procedure Manual can be found online on the 340B University Tool Guide site. For more information, see article on Apexus resources in the March 27 issue.