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Q: The HRSA audit data request list for Fiscal Year 2021 includes a request (8) for the covered entity to provide Medicaid fee-for-service billing documentation for each covered entity site that carves-in. HRSA expects to receive a copy of one Medicaid fee-for-service claim for each location and each state being billed. What should we do if we have no Medicaid fee-for-service billing for one or more covered entity locations during the audit review period?

 Answered by Jasmine Muniz-Cadorette: Recent communications from HRSA/Bizzell auditors has indicated that if a covered entity location does not have any Medicaid fee-for-service billing during the audit period, the covered entity should provide the Medicaid enrollment form for the respective location.

Q: Can I do anything about manufacturers restricting access to 340B pricing?

 Answered by Jim Moye: A lot of information has come out and changes have happened in the 340B Program over the past year, two of them being the ongoing restriction of distribution or data collection by manufacturers. As we navigate through this time of uncertainty within the 340B Program, we exhort covered entities to implement strategic opportunities which mitigate impact. These could include an assess and wait approach, declining to participate in data collection, modifying prescribing practices or supply chain strategies, expanding overall 340B access, and advocacy. With HRSA finalizing the 340B Administrative Dispute Resolution (ADR), this gives covered entities another pathway to consider. HRSA has put up a website which contains information about the process. ADR petitions were able to be submitted starting January 13, 2021. We are aware of petitions already being filed, but no outcomes as of this being written. Because there is a $25,000 threshold that must be met, assessing the impact is the first step. The SpendMend Pharmacy Optimization team, formerly Elevate340B, can assist with a strategy to ensure your patients are receiving the benefit of 340B to its fullest. If interested, reach out to Jake Thompson at

Tidbit #1: An Auditors Insight: Are there dollars hiding in your data?
by Heidi Larson

Rarely do I perform a 340B audit where I do not find something that could save the covered entity money. It may be part of my previous experience as the person responsible for the drug budget at a large DSH that my mind is looking for opportunities, or just part of my frugal tendencies, but whatever it is I find that many covered entities are leaving dollars on the table. Given the landscape of current health care, who would not want to be more fiscally savvy? My recent audits have uncovered opportunities relating to modifying purchasing practices for sublingual nitroglycerin tablets, billing for waste on a couple of infusion products, and reviewing a contract pharmacy arrangement in which non-covered outpatient drugs were being processed as 340B eligible drugs – resulting in unnecessary transaction charges to the covered entity. We, as your 340B external auditors, often stumble upon financial opportunities as we review your data. Who has the time and resources to find opportunities to save dollars and salvage the budget when we are trying to devise plans for storage and distribution of the COVID vaccines and caring for those with COVID? Thankfully, the SpendMend Pharmacy Optimization team does. I would urge covered entities to consider speaking to our Pharmacy Optimization staff without any obligation. As I see it, there is nothing to lose by hearing/exploring what they have to offer, but there may be a lot to gain.

Tidbit #2 

by Nate Raney

The beginning of the year is a great time to review state Medicaid payer information updates and update Third Party Administrator (TPA) payer exclusion lists for entities that carve-out Medicaid or carve-in Medicaid but choose not to bill out-of-state Medicaid payers for 340B drugs. Unfortunately, updates to Medicaid BIN/PCN/GRP information are not always readily communicated by state Medicaid offices. To ensure you have the most up-to-date billing information, it is helpful to perform a web search for each Fee-For-Service (FFS) and Managed Care Organization (MCO) plan in your state to identify current payer information and associated billing numbers. For example, by entering “Minnesota Medicaid billing BIN and PCN” in a web search, the first result provides a link to Minnesota’s Department of Health Services (DHS) website that lists the individual MCO plans: Sometimes, the list of plans will not be accompanied by the specific billing information so searching for each plan’s Provider Billing Manual can be helpful as well. Remember that, ultimately, the responsibility of preventing duplicate discounts falls on covered entities, so don’t give up and keep searching!

Tidbit #3 Ryan White Re-certification Updates Regarding NOFOs 

by Roxie Nevarez

New for Ryan White (RW) type entities this year, during recertification you will need to enter your Notice of Funding Opportunity (NOFO) number. HRSA recommends contacting your State Program Manager if you are unsure of your NOFO number.
Below are instructions to help to find your NOFO number and a table with some potential NOFO numbers – this table is a reference only! Please reach out to us with any questions or if you have any issues finding your NOFO.

  1. Search TAGGS with your Grant Number (this can be found on OPAIS) to locate the CFDA number.
  2. Search with your CFDA to find your NOFO
Grant CFDA 2020 2019 2018 2017 Notes
RW-A 93.914 HRSA-21-055 HRSA-20-063 HRSA-19-033 HRSA-18-066  
RW-B 93.917 HRSA-21-067 HRSA-20-065 HRSA-19-027 HRSA-18-058  
RW-C 93.918 HRSA-21-058 HRSA-20-067 HRSA-19-031 HRSA-18-051 Capacity Development
RW-C 93.918 2017-2018: HRSA-18-005, HRSA-18-004, HRSA-18-001 Early Intervention Existing Program
RW-D 93.153   HRSA-20-068, HRSA-19-026, HRSA-18-044  
STD 93.977     PS19-1901 PS18-801, PS18-802  
TB 93.116   PS20-2001      
FP 93.217 None listed on OPAIS in most recent registrations – unclear if required  

*CFDAs are consistent from year to year

By Rob Nahoopii

Up until now, Sanofi has only allowed 340B pricing in contract pharmacy accounts if a CE signed up for the 340B ESP program and commits to send data every 2 weeks. Sanofi has provided an update that they are now allowing a covered entity one contract pharmacy IF the covered entity does not have an in-house retail pharmacy. You can see a copy of the Sanofi update here.  It does require signing up for the 340B ESP account, but it does not require you to send any data in. In the ESP account is where you will designate your contract pharmacy account. The deadline is February 22nd for a March 1st pricing allowance. After this date, there will be a 10-day delay before pricing is added back.

340B and Fee-For-Service Medicaid AAC Requirements

By Rob Nahoopii

A topic we have covered in our client newsletter in the past, but is long overdue for a full discussion is 340B actual acquisition cost (AAC) requirements for fee-for-service (FFS) Medicaid billing in many states. In 340B audits we perform for clients, we review the AAC requirement and note if there is any risk. However, it is not something specifically looked at by HRSA, since the covered entity (CE) billing AAC does not impact if a Duplicate Discount occurred. To be clear, we are not talking about Duplicate Discount risk here, we are just talking about whether a CE billed an FFS Medicaid plan correctly.

You may be thinking, “if it is not a significant HRSA audit risk, then what is the big deal?” The short answer, is, Government Dollars. We don’t talk about it much, but the 340B program savings isn’t government dollars, it’s manufacturer discounts. Therefore, the legal and financial risks are smaller. When it comes to government dollars, there is the potential for a financial penalty and even legal penalties. Inappropriate billing of Medicaid and Medicare can raise Fraud, Waste, and Abuse concerns. Although this normally refers to egregious acts of commission, such as billing for services you did not actually provide, it is possible that accidental over billing could be considered a form of abuse. Typical fines are 1.5 times the issue/amount in question (e.g., overbilling in the case of charging incorrectly).

Back to 340B, we now have this interesting intersection of 340B and government dollars. This occurs when an FFS Medicaid plan requires a CE to bill at AAC. Many state’s FFS Medicaid plans require this today, and one of the more engaged (that is about the most positive term I can use) states is California. In the past year, California has been sending out self-audit letters for CEs to self-audit their AAC billing. This occurs primarily with the retail side of 340B; however, they have also sent self-audit letters to CEs for hospitals/clinic administered drugs. So far, we have not heard of penalties on top of the payback request, but it is possible. The time period they are using is December 2016 to current. California is using December 2016 because that is when the federal court’s temporary ban on the California AAC law was lifted. If you are in California, we strongly encourage you to plan on receiving a letter at some point in the near future.

Although most of the AAC enforcement is in California, it is likely that states are seeing what California is doing, and noting the positive financial result. As such, more states might try to enforce AAC billing as well. Your assignment for the month is to check your state requirements and confirm you are billing correctly, and remember to check any other states you bill. Don’t just check to make sure you are billing the right dollar amount, also make sure you are billing with the correct NPI or Medicaid provider numbers, and modifiers if needed. If you are a Turnkey (SpendMend) client, ask us for help on identifying your state’s requirements if needed.    

Our own Cam Au lives in beautiful Hawai’i and he wonders:
How do you celebrate an audit?
Steak and garlic fries work every time!