New 340B Stewardship Principles

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New 340B Stewardship Principles

This summer’s Congressional 340B hearings drew attention to the need for covered entities to be able to speak to the use of their 340B savings in alignment with program intent. While the documentation and demonstrated use of savings is currently not required by statue for hospitals, many of the grantee covered entity types are already required to demonstrate that all resources generated through the 340B program are used to expand and support services within the scope of their grant. Many covered entities, including hospitals have developed “Use of Savings” documents highlighting the valuable services and programs supported by 340B savings and have shared them with their communities and congressional delegations. The sharing of the importance of the 340B program has gone a long way to build program support.

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American Patients First

A Review of: American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs – May 2018

Is the Trump Administration Blueprint to lower drug costs really about reducing drug prices or reducing drug spending?  According to President Trump, “Prices will come down.” Alex Azar further explains,

“When it comes to the cost of prescription drugs, our healthcare system faces four major challenges:  high list prices for drugs; seniors and government programs overpaying for drugs due to lack of the latest negotiation tools; high and rising out-of- pocket costs for consumers; and foreign governments free-riding off of American investment in innovation.”

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If you do not take the time to tell your story, someone else will!

It was impossible to walk away from this summer’s coalition meeting and not feel compelled to tell your own 340B story. If you read our newsletters, we have not stopped blogging about this!  As you made your way through the many informative sessions at the 340B coalition, you heard the many stories of the positive and often lifesaving impact that 340B has on vulnerable patients. Unfortunately, these stories were told primarily within the confines of the Omni Hotel. After hearing from Sectary Azar, it was even more evident that not enough stories of the good work being done via the 340B program are not reaching the members of our administration.

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Matsui Introduces Legislation in Support of 340B Program

If you are reading this blog, you are probably a big fan of the 340B program, and can witness day after day the benefit it brings to your covered entity and your patients. As we travel the country, our team sees the enormous benefit it brings every day.  If you are like me, you often lie in bed at night and wonder, “what can I do to support the 340B program?”  Here is your chance!

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Your 340B Universe Narrative

When HRSA sends a data request to a covered entity (CE) being audited, the request includes a description of the CE’s 340B universe that includes a narrative, by which the data was gathered, and any limitations or exclusions. Based on our experience supporting HRSA audits, auditors often rely on this narrative to some extent when planning and conducting their onsite audit. Therefore, creating a 340B universe narrative provides you with an excellent opportunity to help facilitate and guide these and other external and internal audits in a manner that promotes efficiency and appropriate focus. Perhaps more importantly, however, creating a narrative is a critical step that you can take to help ensure that you have sufficient oversight of your program. Managing your program should start with being able to accurately describe it in sufficient detail. If you do not understand your program and cannot accurately describe it, you cannot effectively manage it. Drafting a 340B universe narrative forces you to describe your program, and it can be a catalyst for addressing and clarifying confusing or unfamiliar locations and practices, engaging key stakeholders, and developing comprehensive and more detailed documentation.

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A Nerd and Her Calculator

Well it’s my turn to write the blarticle again. I know, I hear your disappointment. I just am not a writer. And I always focus on the politics, nothing personal like the amazing Jen Cook. So it should come as no surprise that again, this blarticle will be political. I wanted to write about the White House Correspondents Dinner but that has little to do with 340B. All I will say is, who caught it? What are your thoughts? Email me! Or text me (‘cause I’m a millennial and any truly verbal way of communication is too aggressive (801-830-5206)).

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The Face of 340B

Life-changing experiences can manifest in many forms.  For me, it was a crooked smile.

A heart in your throat, can’t breathe, “Please, no”, crooked smile of my sweetheart having a stroke at 38.  Four days in the ICU with no answers and a CT scan documenting damage in his brain the size of a peach pit.  Two MRIs, CT scan, two spinal taps, labs, tests, and finally arteriography found Fibromuscular dysplasia (FMD).  FMD is a disease that causes one or more arteries in the body to have abnormal cell development in the artery wall.  He had suffered a stroke caused by a dissection of his carotid artery.

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Creating Your Impact Profile and Why?

With various pending federal legislation bills having “transparency” components, we feel it is prudent that all covered entities should have an Impact Profile. At the 340B Coalition meeting last month, a good definition of the Impact Profile was given as,

“It is a written elevator speech for your 340B program.”

I really like that definition, we should be able to accurately and concisely discuss: Who we serve, What kind of care is being provided, How 340B helps patients, and What would happen if 340B was taken away.
In addition, tell your story. The facts above are good, but what really can impact the person you are trying to educate is the story of actual patients and how they benefit. When I was a pharmacy director at a 340B DSH hospital, I would share the following story:
A young adult male patient in our Endocrinology clinic had an increase in his HgA1C (i.e., a marker for how well a patient’s diabetes is being controlled). A discussion with our pharmacist in the clinic identified that the patient was rationing his insulin toward the end of the month as he could not make his co-payment for his prescription. Because of 340B, we were able to provide this medication to the patient at a significantly reduced price, and he could not believe it, and he teared up as he thanked our staff. Three months later his follow-up visit showed his HgA1C was back inline and he was feeling better. Because of this, we started a 340B Charity Voucher program that provides this benefit to many more patients who needed help with their prescriptions, and as we looked at the data in aggregate, we were able to document a statistically significant decrease in these patient’s HgA1C measurements.

To help you create your Impact Profile, 340B Health has provided a really good resource.  Once you have created your Impact Profile, and maybe even have a story to share, then here comes the Why! 340B is under attack, and PhRMA is leveraging as many legislators and presidential contacts they have to either reduce or kill the 340B program. That is their goal! We need every covered entity to reach out to their federal senators and representative to share what 340B means to the people in their communities they represent. Please go to the 340B Health legislation page to see the anti-340B bills and ask your senators and representatives to oppose them. In addition, ask them for 5 minutes so you can share what 340B means to patients in your community. Then be ready to share your Impact Profile and your 2-minute Elevator Speech and remind them that this program costs taxpayers very little, but the impact on patient care is significant.

We can save 340B, but only if we all do our part. We can’t hope that 340B Health and other organizations will do it for us, we all need to carry the water!


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A Glimpse Back at 2017 HRSA Audits

The Bizzell Group, began performing all HRSA 340B audits in fiscal year 2017 and as with most changes, there was concern about how audits might change. One difference from previous HRSA auditors is that the Bizzell Group hired pharmacists and 340B staff with hands-on 340B experience to perform and support 340B audits. We have noticed that having audit staff with hands-on 340B experience has helped the audits run a little smoother. The auditors have a better understanding of how the covered entities work.

The selection process for entities to be audited remains the same:

  • Risk-based audits which factor in the complexity of the covered entity’s 340B program such as the number of outpatient facilities, number of contract pharmacies and volume of purchases.
  • Targeted audits triggered by reported violations or allegations from manufacturers or the public. HRSA may also do a targeted audit to follow-up on previously audited entities to ensure corrective action plans have been fully implemented.
  • Random selections.

The type of audit findings posted for 2017 are similar to the 2016 audit findings; however, the number of findings appear to be decreasing. There have been 146 audit results posted of the expected 200 audits performed last fiscal year, roughly the same number as fiscal year 2016. Of the audits published, 46% resulted in repayments to the drug manufacturer. Covered entities in 35 states were audited. California led the way with 20 audits followed by Illinois and Texas with 10 each.

 

Diversion

The top finding posted across covered entities is diversion, specifically, “340B drug dispensed to a patient at entity for a prescription written at an ineligible site.” The covered entity must be able to link a prescription back to a qualified visit at a 340B eligible location showing that the covered entity had responsibility for the patient’s care surrounding the prescription in order for 340B purchased drugs to be used. Keep in mind that every prescription filled with 340B purchased drugs must meet the following criteria:

  • The covered entity must have established a relationship with the individual such that it maintained their health care records; and,
  • The individual must have received health care services from a health care professional employed or under a contract or other arrangement (e.g., referral) with the covered entity; and,
  • The covered entity remains responsible for the individuals care with respect to the drug.

 

Duplicate Discounts

Additionally, the duplicate discount finding that appears most often continues to be, “incorrect or incomplete billing information on the 340B Medicaid Exclusion File.” If a covered entity decides to carve-in Medicaid, (billing Medicaid for drugs purchased at a 340B price), they must list their National Provider Identifier (NPI) and any Medicaid billing number on the 340B Medicaid Exclusion File. This should be the NPI and any Medicaid billing number that the billing office is adding to the claim to bill Medicaid.

 

Database Errors

There also continues to be a high number of 340B database errors. The top two incorrect 340B database findings in 2017 were, “offsite outpatient facilities were not listed on the 340B database” and “registered contract pharmacy without written contract in place.” Surprisingly, there are still findings for incorrect entry of Authorizing Official, Primary Contact and facility address. Covered entities should assign someone to check the HRSA database quarterly to ensure the entity’s information is correct. HRSA updates the database quarterly and mistakes happen. Keep agreements with contract pharmacies where they are easily accessible. Don’t rely on the contract pharmacy to keep up with the contract. Ensure the contract pharmacy registration date on the HRSA database is after the date on the contract pharmacy agreement or contract.

HRSA makes it clear that the covered entity is ultimately responsible for ensuring 340B program compliance. Covered entities should be monitoring their 340B compliance and always be audit ready. Reviewing HRSA’s audit results can help covered entities understand where to examine their 340B program to ensure audit readiness.


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New Year’s Resolution- 340B Style

The arrival of a “New Year” seems like a natural time to make important changes. But how quickly do those New Year’s resolutions lose traction? Instead of focusing on ourselves and all the clichés that could be your New Year’s resolution, let us instead vow to make a resolution for another! Can you think of a better way to help others than our 340B program? If we all take a moment to look at our own 340B programs, we are making a New Year’s resolution to protect it!

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