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Likely HRSA and CMS Changes Late 2019

HRSA and CMS Changes

The timing for this blog is consistent with autumn – change is in the air. Two significant potential 340B changes are worth attention. One is from CMS, the other from HRSA.

Apologies up front for TMAs (too many abbreviations).

CMS Intent to Collect Data on 340B Costs.

On September 30, 2019, CMS published CMS-10709. If you want to read the full text of this release, you can find it at this [LINK].   The title is “Hospital Survey for Specified Covered Outpatient Drugs (SCODs)”. Really catchy title and abbreviation.

This report and the data collection to which it refers goes back to the 2018 CMS Payment cuts, and a subsequent District Court ruling.

A part of that ruling reasoned that the HRSA secretary had not collected the necessary data to make payment cuts. To correct this CMS proposes to collect data to help determine payment amounts for drugs acquired under the 340B program.  This links to HRSA’s past stated intent to make the savings and uses of 340B discounts more transparent.

There are no specific data elements identified yet, but they will likely ask for acquisition costs of the drug and costs associated with managing the 340B program. This includes how much it costs for the personnel to administer the program as well as the fees paid for consultants, split billing software, third party administrators, and payments to contract pharmacies.

This may ultimately be the same as the American Hospital Association’s (AHA) “Good Stewardship Principles”. You can read more information at this [LINK]. In addition, AHA plans to release the names of Hospitals that have signed ‘340B Good Stewardship Principles’ on October 18 [LINK]. If your team is already completing the AHA Good Stewardship Principles information, then you may already have the necessary data collection elements ready to go.

There is not a specific start date mentioned for the data collection, if in fact CMS moves forward. As soon as we learn more, we’ll pass it on.

HRSA Alters Corrective Action Plan (CAP) Expectations

HRSA recently updated their expectations for actions required of Covered Entities (CEs). Prior to this change HRSA expected responses to what they termed ‘Areas for Improvement’ (AFIs). They dropped this language to just include Corrective Action Plans. There is no information as to whether HRSA will continue to address AFIs.


We get requests to warm up the Crystal Ball and speculate on future legislative and governmental agency actions related to 340B. Rather than speculate on what they might be, we can recommend actions that address trends.

  1. Develop mechanisms to identify how 340B savings are used at your facility, as well as costs to manage your 340B program, including fees and expenses paid to outside companies supporting your program.
  2. Review your internal audit program. We have a blog at this link if you need a refresher. A sound internal audit program identifies potential issues, allowing you and your team to resolve any issues in a timely manner.
  3. Maintain a Continuous Readiness Program at your facility where your facility stays current on all 340B program changes. Your CPS 340B Consultant can assist in this process.

And in Closing

This blog is slightly shorter than usual because there are more guesses than facts about what might happen to the 340B program. It’s also shorter because we left out references to Aesop and our Friendly Curmudgeon Coalition. Let us know in the comments section if you want to hear more about either of them. . .

If you and your team are anxious about the 340B program and would like additional assistance, please reach out to your Comprehensive Pharmacy Services 340B Consultant.

Posted: Wednesday, August 26, 2020

Tags: Blog