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340B and HRSA Changes From COVID-19

COVID-19 brings with it changes from 340B and HRSA. Join us for a look at general flexibilities, changes due to social distancing, and more.

Covid-19 Effects on 340B: HRSA’s response

By: Butch David, Senior Consultant – 340B Solutions

HRSA’s response to Covid-19 is timely and dynamic, with information sent out as rapidly as it is approved. This may result in an incomplete understanding about what a Covered Entity (CE) may or may not do in this Pandemic time.

To help address this, here is a summary of some of the changes that are permitted by HRSA during this health crisis.  We note ‘some’, as these are the changes as of mid-April 2020, and there may be additional changes following this publish date.

As you read through the changes, note a theme that HRSA is willing to review individual circumstances.  If you find one of these flexibilities is close to, but not exactly what your organization needs to help cope with Covid-19, contact HRSA as explained below to present your case.

General Flexibilities

  1. Abbreviated Health Record: During this time, an abbreviated health record may be adequate for purposes of the 340B Program. The record should identify the patient, record the medical evaluation (including any testing, diagnosis or clinical impressions) and the treatment provided or prescribed. For purposes of 340B Program eligibility, the record may be a single form or note page. It is the recorded information that creates a record. For example, under these circumstances the patient may be without insurance cards or identity papers and providers may not have access to documented medical histories. In the current public health emergency, HRSA believes that self-reporting of identity, condition, and history are adequate for purposes of 340B recordkeeping requirements.
  2. Temporary Providers: In addition, in a situation where volunteer health professionals are providing health care, emergency documentation should be generated to make the relationship between the provider and the covered entity clear and to make clear the covered entity’s responsibility for providing care. This documentation should recognize the emergency nature of the situation, the name and address of the volunteer, and his/her relationship to the clinic, and should be kept on file by the covered entity.
  3. Temporary Expansion of Services: The increase in patients may require an Entity to temporarily expand services to a previously non-340B Eligible clinic. HRSA will review these on a case-by-case basis.  You may contact HRSA to review your own case via this Apexus Link.
  4. Temporary Exception to Reporting: HRSA allows the use of GPO discounts for outpatients in a few distinct situations (FAQ 1242 – here): During the Covid-19 Crisis, an Entity may use GPO pricing as described in FAQ 1242, but HRSA will not require the entity to report, but instead just document the action. Note HRSA expects you to add a section to your P&P to cover your facility’s actions during this time.
  5. Tele-Health: We addressed this in a previous blog.  You can read about it here.
  6. Immediate Enrollment in 340B: Noted in news updates today, HRSA is allowing immediate enrollment (no Calendar Quarter Delay) into 340B. If your facility is now enrolling, or planning to do so, check this link for more information. You may be able to enroll 90 days earlier than planned.


Changes Due to Social Distancing

HRSA responded rapidly to the CDC’s guidelines for Social Distancing and implemented Tele-Auditing.  The process mimics the traditional on-site audit Data Request List, but additional screen shots are needed to verify eligibility for any off-line portions of the audit. 

  • Option #1 allows for a half-day Web Meeting, followed up with the CE staff completing the transaction reviews. These are validated for eligibility by including screenshots of the Medical Record pages or prescription scans that would normally be viewed during on-site audits.  The local staff has five working days to complete the reviews and submit them.
  • Option #2 allows for a full-day web meeting where all aspects of the CE’s 340B program are reviewed, including web meeting-facilitated viewing of all appropriate medical records and charts. In this option, the CE is finished with the audit at the end of the Web Meeting, although additional information may be requested to be uploaded by the auditor throughout the course of the review.


What's Next?

As of this writing, Covid-19 is leveling off in some areas, still peaking in others.  HRSA will likely continue being responsive to public comments and suggestions.  Keep watching this blog, and the HRSA 340B web page to stay up to date.


What Should MY TEAM Do?

Apologies in advance to the Director of Pharmacy who did not want to hear about updating his/her policy and procedure again.

It is important that your CE document your actions, if they vary from the norm, during this time of Covid-19.  This means:

  1. Updating your Policy and Procedure to include any changes required by the Covid-19 crisis
  2. Document any exception to a normal HRSA policy as outlined above and retain this documentation as required by your policies
  3. As priorities allow, present your Covid-19 changes to your Oversight Committee for review and possible further action.

Not every 340B team will need to use all options available.  But your team may need portions.  One of the more popular questions we’ve seen relates to 340B and tele-health encounters.  HRSA addressed that rapidly, and you can read more information at our blog here.



As always, if you have any questions, or need 340B support, please reach out to your Comprehensive Pharmacy Services 340B Solutions team at


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Posted: Thursday, June 4, 2020

Tags: 340B, Blog