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340B: Recertification and Dog Days of Summer


The Dog Days of Summer and Changes to 340B Recertification in 2017


Trivia Time

Before I start, the curmudgeons out there (and they know who they are) are already emailing me to complain about relating 340B to an astronomical calendar event. Just hang in there.

The Dog Days of Summer are about the first annual appearance of Sirius, the dog star.  Sirius, and the constellation it’s part of, follows Orion into the night sky, and in the northern hemisphere early morning risers can see Sirius rise just before dawn starting around July 15th (astronomers call this a heliacal rising). Adding complexity, (and complexity relates to 340B) Sirius’ formal astronomical name is Alpha Canis Majoris.  It’s a binary star 2.6 parsecs from Earth. It’s by far the brightest star in the sky, as well as the 7th closest star to earth outside of our sun.  Formal astronomy dog days for the northern Hemisphere are from July 15th to August 15th.

The Greeks connected the Dog Days to heat, drought, lightning, thunder, mad dogs and bad luck. Maybe a little harsh, but if you’re a hospital based 340B covered entity, you should tie it to the annual recertification process. And if you are not ready, you may want to also tie this time of year to bad luck.  The penalty for not recertifying is removal from the 340B program on the first day of the next quarter after the recertification period. (for most it would be October 1st)

And how this relates to 340B?  Well, traditionally this is the same time most of our Covered Entities get the HRSA email that asks them to recertify their 340B program. 

If you need to reach one of our 340B Consultants, use this link.




K. Pedley announced at the 340B Summer Coalition meeting that due to changes in the OPA website, recertification would likely be in October, instead of August this year.

HRSA recommends (read that as you need to do it) that all covered entities update all information and make any needed changes before the recertification process.  Recertification is not the time to make changes.  Be sure your entity’s information is accurate before you recertify.  Note that clicking on hyperlinks (blue and underlined text) within this blog takes you to a web page with more information.


Just like Sirius’s first rising is every August, HRSA sends out the recertification notices every August for most 340B entities (FQHC’s recertified this last January).  There is a deadline to complete the recertification by September 30th, but it’s best to do it as soon as possible after getting the notice.

Since K. Pedley announced the delay to October, HRSA’s not released the exact dates for 2017 yet.  HRSA will email both the Authorizing Official and the Primary Contact of the need to recertify, and this will happen sometime in the next few weeks.  That makes NOW a great time to ensure your facility is ready.  Don't get worried if you don't get an email to recertify in August, but be sure to check not only your regular inbox, but your SPAM filter as well every day.


Preparing for Recertification

The actual recertification process (if you click on this link, it will take you to the guide) does not take long. However, it’s critical that your program information, is accurate when you recertify.  Here are a few checks and verifications:

1. Contacts: check the OPA database and be certain that both the primary contact email and the authorizing official email addresses are correct. Incorrect addresses at this time means your facility will not get the HRSA email alerting you that it’s time to recertify. 

2. Medicaid billing number and NPI number(s): verify with your billing office that the NPI(s) number(s) in use for Medicaid are the same as those posted on the OPA database. Some facilities use a different NPI for each state’s Medicaid, and it is not unusual for Facilities to bill as many as ten or more state Medicaid agencies.

3. Addresses: verify not only the address of the Covered Entity, but the addresses of each child site and all contract pharmacies. HRSA uses the DEA database for this verification.  You can too, but be prepared to pay a hefty sum of $9.00 per look up, or several thousand dollars a year for an unlimited DEA database access. [DEA Database] Just make sure that all addresses are current.

4. Child Sites: review all child sites, and do a quick crosswalk between your posted child sites and your Medicare Cost Report (MCR). Sometimes your finance team makes changes and does not know to alert you to those changes.  One of the facilities we work with did this check, and noted their infusion center across the street was ineligible in the new MCR.  They caught this by accident within a few weeks of the change, allowing a rapid resolution of ineligible drugs.

5. Contract Pharmacies: as with the child sites, verify not only the addresses of your contract pharmacies, but that they are listed in your agreement (usually in an exhibit) with that pharmacy. More than once we’ve heard stories of a new chain pharmacy being added by the TPA but not added to the agreement or the OPA database.  Be sure this does not happen to you!

6. Do a quick review of transactions. A quick pivot table review of payers will let you validate that you are only charging appropriate payers.  One facility did this review and caught an error that, unresolved, could have led to significant ineligible prescriptions and hefty manufacturer paybacks. Their quick action fixed the error quick enough to simply reverse the transactions.

7. Last: Prepare a communications plan between the primary contact and the authorizing official.  Be sure you both understand what each is expected to do, such as immediately alert each other when the email arrives, and then step through a pre-arranged plan to ensure your facility is ready and properly recertified.


Recertification is done at different times of the year based on facility type.  FQHC’s recertified in January, but our hospital based entities will get the notice for October this year instead of the dog day reference to August, as was normal.

Wrapping Up with Dog Days

The Dog Days of summer have an historical perspective that is overwhelmingly negative. Consider the bad to catastrophic consequences the Greeks attributed to them, and even in this century, Finland researchers link the dogs days of summer with increased rates of deep wound infection[1].  The term is so prevalent in literature, that Dickens wrote that Scrooge “Carried his own low temperature around with him to the point he ‘iced his office’ during the dog days of summer.[2] A lot of people see the dogs days as a bad omen.

Avoid having the Dog Days of Summer mean anything other than hot days and follow the advice above.  Get ready now: make any needed changes to the OPA database for your facility, and ensure the process goes smoothly for your Authorizing Official.

And, if you have any 340B question, please contact your Comprehensive Pharmacy Services 340B Consultant.  You can read more about us, or see our webpage and read more about 340B, click on this link.  

[1] Tukiainen, E.; et al. (March 2009), '‘Dog Days’ Surgical Site Infections in a Finnish Trauma Hospital during 2002–2005', Journal of Hospital Infection, Vol. 71, No. 3, pp. 290–291, PMID 19157647doi:10.1016/j.jhin.2008.11.010.

[2] Dickens (1843), p. 2.

Posted: Wednesday, June 13, 2018

Tags: CPS Blog Posts, 340B Recertification, Dog Days of Summer, OPA, HRSA Integrity Audit, CPS