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New HRSA Data Requirements Fall 2018 (Clone)

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The Health Resources and Services Administration (HRSA) recently (fall 2018) published new expectations for all Covered Entities (CE) registered with OPA in the 340B Discount Program.  This blog covers those new requirements and provides suggestions on how to comply with them. As always, if you have additional questions, or would like support in this area, contact your Comprehensive Pharmacy Services (CPS) Friendly Neighborhood 340B Consultant!

As to our Curmudgeon Coalition – I can already hear complaints about HRSA adding new requirements for CE’s.  However, as you read on, note these updates improve compliance and CE transparency, and once completed, are a positive for our programs.  More for our Curmudgeons at the end.


In the fall of 2018, HRSA released several new requirements specific to the “Data Request List” – the list of documents requested for a HRSA Audit. 

There are five (5) key areas:

  1. Policy and Procedure Updates/Revisions
  2. Eligibility Documentation
  3. Reports used to review transactions for an audit
  4. Contract Pharmacy ‘Agreement’ language
  5. Medicaid Billing Documentation

Pushing these items to a ‘back-burner-status’ is tempting.  However, it will be too late to do these when HRSA notifies your facility of an impending 340B Audit.  Try to implement these changes as soon as possible.  This document provides support in doing so.

Updates/Revisions to the CE’s Policies and Procedures

  1. Add a section in your 340B P&P to include a description of ‘exclusions’ to the definition of a covered outpatient drug. This is not as complex as it sounds, and we cover this in our Blog “When is a Drug Not a Drug”, which can be found at this [LINK].  This includes;
  • Bundled drugs – any drug charged as part of a procedure, and not ‘broken out’ and charged on its own.
  • Drugs considered ‘Devices’, such as Hyaluronidase, Saline Flushes, etc. Most, if not all drug eluting stents fall into this category.
  • Drugs without a Medicaid Rebate Agreement (Ofirmev is a good example, as are many radiopaque dyes). The formal link for this information is HERE.
  • Other – There may be other ‘non-drug’ products at your facility: work with your CPS 340B Consultant if you are uncertain.

Documenting and accounting for wastage of a drug not administered

Add a section to your P&P that includes how your staff manages waste and 340B. Again, we have a blog that covers this at this LINK. For additional details, but a duller read, try this LINK.  Consider which of the suggestions offered apply to your own waste situations, and update your P&P accordingly.

Hospital Eligibility Documentation

HRSA began asking for crosswalks earlier this year, and now they are making it an expectation.  A crosswalk (in this situation) is grid that shows the following:

This can take several hours to create, but once you have it completed, a quarterly review and update only takes a few minutes.  I know of more than one facility where the pharmacy staff requested this from finance, and their finance team helped crea340B GO-1te it.  Check with your own finance team.

Government Official Contract                                                         

I know of at least six facilities that lost 340B eligibility in the last sixty days because they could not provide this essential document.  ‘Back-in-the-day’, so to speak, CEs were only required to attest to having this document on file.  In many cases, that document now dates back so far that no one can locate it any longer.  There are two different templates. You can download the template for government owned facilities from this LINK.  The template for facilities NOT owned (most) by a governmental agency is at this [LINK].

The big question we hear is “which government official to use”. The answer is any official who can legally bind that agency to an agreement.  We have seen Mayors, County Supervisors, and even a Parrish Judge.  Your legal department can provide the best local direction for this question. 

It is critical that your team keeps this document updated with the official’s email address, as HRSA may email them for confirmation, and a failure to respond to that email may result in HRSA requiring action from your facility. Failing to provide this document and email response results in termination from 340B eligibility.   I kno

w at least six people who consider this extremely important. It is no fun calculating the fiscal impact of the loss, even for just three months, of 340B discounts.

340B GO

Reports Used During a HRSA Audit

While you do not need this report until HRSA notifies you of an impending HRSA audit, it is sufficiently complicated to require you address it beforehand. HRSA now insists on the following data for the submitted transactional data:

  1. The drug/product name/NDC
  2. The acquisition price
  3. The type of account the drug was purchased through, purchase account and the associated 340B ID number
  4. The quantity issued
  5. The patient ID number (this is typically the medical record number or prescription number, but can be any number you assigned that will allow tracking through CE’s system to retrieve all information associated with the order)
  6. The payer (all payers including Medicaid)
  7. The date of the order (mixed-use pharmacy) or date(s) written and filled (in-house/entity-owned or contract pharmacy)
  8. The ordering provider
  9. The location/site 340B drug was administered/ordered (mixed-use pharmacy) or prescribed (in-house or contract pharmacy)
  10. The date the drug was administered, or dispensed

This data must be compiled into two distinct ‘data universes’, (two distinct files) one for your Mixed Use Areas, and one for your Contract Pharmacies.  This means, if you have more than one TPA handling your Contract Pharmacies, that you will need to combine the separate reports provided to you to one single report with all the transactions from all of your different TPA’s. 

Frankly, this is the one new request that I feel may prove most problematic, unless you engage your IT team to help you convert and combine files.  Consider that any time someone manipulates data there is a chance for an error, so be very careful in how this is accomplished.

Revisions to Existing Contract Pharmacy Agreements

HRSA now requires that your current contract pharmacy agreements specify which Covered Entity and Child Sites are covered under that agreement.  As always, check with your facility’s legal counsel as to the appropriate wording.  If you spell out the specific CE and child sites, you may be adding contract addendums every time you add/remove a child site, so consider revising your agreement with the following statement identifying which CE and child sites are covered: XXXXXXX Hospital, registered with the 340B program as DSH123456, and all registered child sites are included in this agreement.

Medicaid Billing Documentation

About two years ago HRSA began demanding NPI numbers be on file for all CEs ‘Carving-In’ Medicaid.  The potential issue in that some facilities use different NPI numbers for different states.  Not all of those NPI numbers are listed in the MEF and on the OPA website, which leads to duplicate discount findings.

Check with your finance team.  Be certain that all NPI numbers used for 340B billing are listed on the OPA website.  I know of one facility that had eleven NPI numbers, one for their home state, and one for each of the ten other states they billed, using 340B discounts (they were in a vacation locale, and had many visitors from across the country).  Avoid a duplicate discount finding!

And in Closing, for Our Esteemed Curmudgeon Coalition

During a discussion about these requirements, one of our Founding Fathers of our Curmudgeon Coalition complained about HRSA delays in imposing rules on PhRMA while adding a large number of rules onto Covered Entities.  To this, there is but one response: “It is what it is. . .” 

I see these changes as positive for our industry, as they will help covered entities succeed in a higher percentage of ‘perfect’ or “No Findings” HRSA audits, and fewer findings of diversion, duplicate discount, and database errors. 

Making time now to implement these changes will improve your chances of a perfect 340B, and decrease the stress you might feel when your facility is audited.

Please reach out to your Comprehensive Pharmacy Services 340B Consultant for support on these or any other 340B topic.


Posted: Wednesday, April 15, 2020

Tags: Press Releases