January 2024
Volume 1, Issue 1
Inside this issue
Biogen Update
Takeda Update
Gilead Update
Manufacturer Restrictions & their Implications
Hiring Update
Special points of interest
Bipartisan RFI to focus on stability and oversight of 340B
Manufacturer updates (Biogen, Takeda, & Gilead)
Difficulties with the manufacturer restrictions & ESP
Starting 2024 Off Right!
As we begin to embark on a new year, we are excited to announce that we will provide informative monthly newsletters to our partnered covered entities and any who wishes to subscribe.
At ACI, our ACE Certified Account Managers are working diligently to stay
informed on the goings on within our continuously changing 340B landscape. These letters will be posted monthly, allowing for viewing on our website, and an email subscription.
If there are specific topics of interest, please reach out to us via the contact
tab on the ACI website.
Legislation Update: Senator RFI
Since August 2020, the 340B Program has been under pressure due to
manufacturer restrictions limiting contract pharmacy relationships. The contract pharmacy programs that have built relationships between covered entities and their local pharmacies have allowed the program to provide non-taxpayer
benefits to eligible rural health providers to expand and stretch care resources within their local communities, as well as providing discounted drugs to
underinsured/indigent patients.
As we start the new year, we are up to 29 manufacturers with various
restrictions. In a recent update, there is a bipartisan group of six U.S. Senators taking a proactive step by asking for ideas to ensure the program’s stability. These supports of the 340B include Sens. John Thune (R-S.D.), Debbie Stabenow (D-Mich.), Shelley Moore Capito (R-W.Va.), Tammy Baldwin (D-Wis.), Jerry Moran (R-Kan.), and Ben Cardin (D-Md.).
The move came as a request for information (RFI) . The feedback promoted through this RFI could form the basis of legislation that would help amend 340B. The feedback has come from 340B hospitals and other covered entities and
proposals by the pharmaceutical industry and its allies.
What to Come From It?
While a timeline has been set for the close to the RFI, this could lead to many different hearings, congressional letters, or proposed legislation. Hopefully, these ideas will find their way to Capitol Hill and Congress and be signed into law by President Biden.
Biogen Distribution Policy Update
On December 1, Biogen sent a policy update letter adding a new drug to their restriction guidelines.
Their previous update from February 1, 2023, added AVONEX© and PLEGRIDY©. Effective
December 1, they added ZURZUVAE™ to this list. By adding ZURZUVAE™ to their list of
restricted drugs through their limited pharmacy network, it can only be purchased at the 340B price by hospital covered entities exclusively to locations registered as a 340B covered entity or a child site location.
Per Biogen, “any 340B hospital covered entity that does not have an in-house pharmacy may designate a single contract pharmacy location to receive 340B purchases of AVONEX© and
PLEGRIDY©.” As for the additional drug, ZURZUVAE™, any 340B hospital covered entity that does not have an in-house pharmacy capable of dispensing the medication may designate a single contract pharmacy location within the ZURZUVAE™ limited distribution pharmacy
network to receive 340B purchases.
Pharmacies wholly owned by a 340B hospital or have common ownership with a 340B-eligible health system will remain eligible to receive 340B replenishment through their Bill-To / Ship-To 340B orders.
Exception: Covered entities that are federal grantees are not subject to this policy and will
remain able to receive 340B replenishment through their Bill-To / Ship-To 340B orders.
Takeda Distribution Policy Update
On December 15, 2023, Takeda became the 29th manufacturer to send out information
regarding their new restrictions that would take effect on January 22nd, 2024, which will affect the following products: Entyvio Pen, Entyvio IV, Trintellix, Motegrity, Mydayis,
Dexilant, Adderall XR, Pentasa, & Vyvanse.
The following restrictions include;
· Any covered entity that does not have an in-house pharmacy capable of dispensing products purchased at the 340B price to its patients may designate one independent contract pharmacy location.
· Any covered entity with an in-house pharmacy capable of dispensing products purchased at the 340B price to its patients may also designate its wholly owned contract pharmacy(ies).
· Any designated single-contract pharmacy location or wholly owned contract pharmacy must be within 40 miles of the covered entity parent site, except as described below for Entyvio Pen.
· For Entyvio Pen, only pharmacies in Takeda’s limited distribution network may be designated, so the requirement of the 40-mile radius is waived.
· The covered entity must also provide claims data through 340B ESP™.
Exception: Federal grantees remain eligible for Bill-To / Ship-To arrangements for all Takeda products at the 340B discounted price and do not have to submit data.
Gilead Distribution Policy Update
January 1, 2024, Gilead started the year by updating their previous March 2022
Contract Pharmacy Integrity Initiative, which was to help improve transparency and
address specific program integrity concerns, such as duplicate discounting and diversion through contract pharmacy relationships.
Where previously, Gilead required that data be supplied on those select Branded HCV Products (Epclusa, Harvoni, Savaldi, and Vosevi), and with the data submission to 340B ESP™ covered entities were allowed to continue 340B purchasing through all registered contract pharmacies.
Effective January 30, 2024, Gilead will require covered entities to submit claims-level data for Gilead’s Branded HCV products purchased at the 340B price and dispensed through contract pharmacies that are wholly-owned by the covered entity.
Covered entities that do not have an in-house pharmacy will continue to be able to
designate a single contract pharmacy location. In these instances, the covered entities may designate a wholly-owned contract pharmacy to service as its single contract pharmacy option.
Covered entities may voluntarily submit claims level data purchased at the 340B price and
dispensed through their in-house pharmacies or designated single contract pharmacy location.
Manufacturer Restrictions and their Implications
Written by McKaylin Felton, Sr. Account Manager
In working with different covered entity types, ACI has seen significant implications due to the restrictions placed on 340B by 29 different drug manufacturers. The 340B Program is intended to use non-taxpayer dollars to help stretch scare resources to underserved populations. Since late 2020, when the first three manufacturer restrictions hit the 340B community, we have seen a severe decline in these savings. While it depends on the geographical makeup of the area, the decline ranges from a low of 20% to as high as 86% in others.
In small rural communities with covered entities with two to three contract pharmacies, there are other implications outside of the loss in benefit. There is a political component to their decision when forced to choose one pharmacy over the other. Pharmacies have been accustomed to increased revenue with the contract pharmacy component, and covered entities hate to cause hardship for their local independent pharmacies.
As this prolonged stint of manufacturer restrictions continues, we have seen hospitals at risk of closing their doors, and even some pharmacies closing or selling their business to retail chains or even selling directly to the hospitals in their area.
Each manufacturer has their own restrictions guidelines; single contract pharmacy designation, 40-mile radius for designations, claims data requirements, and even those that add another layer to the data submission that claims are to be submitted within 45 days. For those covered entities that are qualifying referrals, we are seeing some manufacturers eliminating 340B pricing if the claims data doesn’t matter the purchase history. The trouble is not the data submission itself but the 45-day time constraint. Some referral companies are reviewing claims that are already 30 days old; by the time the claims are qualified, they are already older than 45 days.
At ACI, we are continue working towards solutions to help with these implications as best we can. We highly recommend working with your Senators to speak on the importance of the 340B Program to help get some legislation in the works to protect the program.
Inside Story Headline
Takeda makes the 29th drug manufacturer to restrict the 340B Program contract pharmacy side. The struggle to work through the restrictions can be a significant burden to not only the covered entities but also the community pharmacies that covered entities have been working within the counties they serve. Many of these restrictions are being handled through the 340B ESP portal, where designations and data submissions are handled. Covered entities have to ensure timely submissions and ensure the proper designations are made time efficiently, or they will lose the 340B pricing, resulting in lost opportunity for their Program and the pharmacies involved.