In this Issue…

Notes from Joe
· Supporting Partners Across the Community

Alliance Update
· Join us for the New HTC Staff Meeting!

Legal Update
· Really, Truly: Only Eligible Patients Can Receive 340B Drugs

Washington Update

Payer Update
· Know Your Patients and Their Insurance

Notes from the Community
· HTC Considerations for 2023 DSCSA Requirements

Team Alliance Contact Information

Supporting Partners Across the Community
by Joe Pugliese, President and CEO

When we started the Hemophilia Alliance group purchasing organization in 2006, we made a promise to the bleeding disorders community. The promise was to give back to the community. The promise was of course dependent on our being successful. I think you would agree that the Alliance has been successful beyond the expectations of everyone, myself included.

The success has allowed us to live our mission: “The Hemophilia Alliance works to ensure member Hemophilia Treatment Centers have the expertise, resources and public support to sustain their integrated clinical and pharmacy services for individuals with bleeding and clotting disorders.”

We have just over the last two years reinvested about $4 million back into the community – through the Hemophilia Alliance Foundation and direct support to ATHN, National Hemophilia Foundation, the World Federation of Hemophilia, as well as development of DDAVP NS. We also supported the Partners program, as you can read about below.

Earlier this year we got a call from the Partners program in Indianapolis. Partners provides educational programs to health care providers in the bleeding disorders community. They have produced numerous live educational programs. many are available online and are free of charge. Some like the gene therapy modules offer continuing education credits. https://www.partnersprn.org.

They had been working on creating a Physicians Academy to reach hematologists early in their careers. They thought they had lined up funding for the program but had just found out the request had been denied. We immediately saw this as an opportunity. What better way to fulfill our mission then to fund a program designed to ensure HTCs have the expertise to care for the bleeding disorders community.

Chris Roberson provided this synopsis of the program:

“Last week, the IHTC and the Partners in Bleeding Disorders Education program launched the inaugural Partners Physician Academy. The Partners Physician Academy is the first and only US based intensive classical hematology training program for early career physicians in the US Hemophilia Treatment Center Network. The Academy was developed by many of the most respected leaders in the bleeding disorders community and was incredibly well-received by the fourteen, early-career physician participants. One participant’s reflections on the week included noting that, “Hearing how other centers optimize resources to provide the best care for our patient population was so helpful – and this is not something I could learn at any other conference or from a publication.” The Academy sought to address the training gap existing for most physicians upon completion of a hematology-oncology fellowship. Physicians are simply not adequately prepared to embark on a career at an HTC. The Academy also aimed to provide participants with an unparalleled opportunity to network with some of the key opinion leaders in the HTC network. The participants enjoyed a variety of engaging evening activities, including a visit to Newfields (Indianapolis Museum of Art) and Duckpin Bowling.

The Program left both the participants and faculty feeling energized and inspired. Dr. Steve Pipe, a Partners Physician Academy Advisory Board Member and Program Faculty remarked, “This Program has given me a renewed sense of excitement and hope for the future of hemophilia care. We have such an engaged group of young physicians and physician scientists, which is so important for the future success of the HTCs.”

The Partners Physician Academy was made possible with generous financial support from the Hemophilia Alliance and The Alliance Pharmacy. For more information, please visit https://www.partnersphysicianacademy.com.

We have to thank our members for believing we could make this happen and we have to thank our manufacturing partners for supporting our mission. The Alliance and The Alliance Pharmacy look forward to sponsoring next year’s program.

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Join us for the New HTC Staff Meeting!

1. When? October 25-27, 2022
2. Where? Las Vegas, NV
3. Who can attend? A staff member of the Hemophilia Alliance member HTC who was hired after January 1, 2019
4. What does it cost? It is a member benefit. The Hemophilia Alliance will underwrite airfare⁺, accommodations, group meals and ground transportation
   
   ⁺Airfare will be booked by the Hemophilia Alliance who will do its best to make your trip as easy as possible.

Meeting Schedule
Tuesday – October 25th
5:30 pm – Networking session and cocktail hour

Wednesday – October 26th
7:30 am – Networking breakfast
8:30 am – Meeting begins
12:30 pm – Networking lunch
5:30 pm – End of first day meeting
6:30 pm – Group dinner

Thursday – October 27th
7:30 am – Networking breakfast
8:30 am – Meeting begins
12:00 pm – Networking lunch
5:00 pm – End of meeting

The meeting will be underwritten by pharmaceutical manufacturers. We are planning on limiting it to 4 manufacturers. Each manufacturer will present a 45-minute session as part of the meeting. The manufacturers will have table displays in the lobby area outside the meeting room.

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Really, Truly: Only Eligible Patients Can Receive 340B Drugs
by Elizabeth “Issie” Karan, Legal Counsel

The 340B Discount Drug Program grants eligibility to many types of federal grantees and specially designated hospitals, along with Hemophilia Treatment Centers (HTCs). Sometimes these entities may be part of the same health system and/or corporate structure. However, regardless of close relationships or even shared ownership among different 340B covered entities, products purchased under the 340B Program can only be transferred to eligible patients. As a result, the government takes the position that transfer among different covered entities of products purchased under the 340B Program constitutes diversion. Apexus provides the following FAQ on this issue on their website:

FAQ ID: 1349
Last Modified: 08/02/2022
Q: Can a 340B covered entity transfer 340B drugs to another 340B covered entity site, if both are part of the same healthcare system?
A: No. A 340B covered entity is prohibited from transferring 340B drugs to anyone other than a patient of that covered entity. Accordingly, one 340B covered entity cannot transfer a 340B drug to patients of a different covered entity. Under the statute, health care delivery systems to which an eligible 340B covered entity may belong are not included in the statute as eligible entities. For more information, please review OPA Accountable Care Organizations Policy Release, 2012-02, available at: https://www.hrsa.gov/sites/default/files/hrsa/opa/accountable-care-05-23-2012.pdf

Most commonly this question comes up in the context of expiring product. If HTCs are in this situation, we recommend contacting the manufacturers to determine if options for buy-backs, exchange, or transfer exist. If you have additional question, please reach out to the Hemophilia Alliance team!

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by Johanna Gray and Ellen Riker, Advocacy Consultants

We’re excited to provide a quick update on two timely opportunities for HTCs to participate in and help Alliance advocacy:

Webinar on Medicare SNF Policy Scheduled for October 18 at 2 pm: We have just finalized plans for a webinar on the new Medicare SNF policy. We have worked closely with the staff and consultants for the American Health Care Association (AHCA) and NHF, as well as several HTC social workers and administrators on this webinar. The webinar is geared to assist HTCs in placing their Medicare patients with bleeding disorders in Skilled Nursing Facilities (SNFs) following a Medicare approved hospital admission and to provide guidance on how best to provide and bill for needed treatments. The webinar will cover some basics about SNFs, including the services that are provided and the personnel available to patients. There will be a full explanation of the law change in 2021 that allows for bleeding disorder treatments to be billed separately, outside the SNF bundled payment, under Medicare Part B. Several models for delivering services will be shared to inform HTCs of options on how provide and bill for treatments for bleeding disorder patients. Stay tuned for an email so you can register to participate in the webinar.

Alternative Funding Model Advocacy: We recently reconvened our Alliance/NHF/HFA work group working on the Alternative Funding problem and have identified a few new advocacy strategies to address the issue. While we are continuing to develop potential legislation to prohibit the practice, we are also pursuing strategies to determine ways that alternative funding schemes could violate existing law. To that end: we are looking for examples of plan language describing how hemophilia treatments are no longer covered. If you have any patients that have experienced this issue, and if they are willing to share information with us, please let us know. We will continue to update Alliance members as these strategies progress. Please contact us with any questions or concerns!

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Know Your Patients and Their Insurance
by Jeff Amond, Director Payer Relations

Health Insurance Open Enrollment season has begun. Now is a great time to begin preparing and contacting your patients about their 2023 health insurance to determine if there will be changes that may impact the clinical and pharmacy services you provide.

Tuesday November 1st kicks off the open enrollment period for the ACA marketplace plans, which goes until January 15th in most states (it can be as early as December 15th in some states that run their own exchanges). While there remains a lot of uncertainty in the health insurance market, Congress has enacted some important policies during the last few years that will lower premium and out-of-pocket costs for many people seeking insurance on the ACA marketplaces. For many patients, it will pay to shop around. Given the time frame to enroll and the premium changes, we encourage you to contact your patients enrolled on ACA plans to be sure that they reenroll in coverage before the deadline in your state.

Some additional items to consider about the ACA for your patients:

1. Even though the ACA Open Enrollment Period is over for 2022, your patient can still enroll in or change a Health Insurance Marketplace plan if they have a life event that qualifies them for a Special Enrollment Period or if their household income is below 150% of the federal poverty level (FPL). Please see Healthcare.gov for complete details.
2. If your patient qualifies for Medicaid or the Children’s Health Insurance Program (CHIP), they can apply anytime.

Some additional items to consider for your HTC include:

1. Do you have a solid process in place to track your patients’ insurance?
2. Do you know if their insurance is a fully insured or self-insured plan?
3. Do you know if your Pharmacy Program can dispense clotting factor?
4. Do you need the support and assistance from the Hemophilia Alliance to enhance your Pharmacy Program and Insurance Contracting efforts?

The Alliance Team is here to help. We have developed a Patient Insurance Tracking Spreadsheet and Insurance Questionnaire to assist in your efforts. Please contact one of the Alliance Team Members to discuss how we can assist you in your Payer Relations and Insurance Contracting efforts and always remember We Work for You!

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HTC Considerations for 2023 DSCSA Requirements
by Michael V. Fusaro, PharmD., Compliance Officer – The Alliance Pharmacy

A brief history
The Drug Supply Chain Security Act (DSCSA) became public law in November of 2013. DSCSA created a series of phased requirements to improve visibility across the supply chain. The 10-year timeline was defined by 3 main phases. Lot-level management was the focus of phase 1, and Item serialization was implemented with Phase 2. Many readers will be familiar with phase 2 changes and the unique serial numbers and 2D barcodes (data-matrix) now printed on medication containers. The third phase will bring with it “Serialized Traceability” and enhance the way individual items are tracked across the supply chain.

How are Hemophilia Treatment Centers impacted?
In 2015, the FDA provided draft guidance included definitions of each “Trading Partner” who would be included in the DSCSA’s new requirements³. There are several categories of “Trading Partners”, and while the relationship between Covered Entities and Contract Pharmacies is complex, the general understanding is that a 340B Covered Entity falls under the “Dispenser” entity type. While many of the requirements set forth in the DSCSA fell under the responsibility of manufacturers, repackagers, and wholesale drug distributors, dispensers still have a significant part to play.

What’s up next?
The final phase of the DSCSA is the unit-level traceability requirement by November of 2023. Many vendors already provide lot-level transaction data to customers via an online portal (commonly referred to as “T3”). Phase three will require the addition of unit level serialization data. This will be a significant increase in the amount of information provided.

The FDA is working with GS1, a non-profit organization that designs and maintains global standards for business communications, to establish a universal language for this data. The format that the FDA and GS1 have developed is called “Electronic Product Code Information Services” (EPCIS).

EPCIS is the GS1 standard that is used to generate, capture, and maintain information at specific instances throughout the supply chain. EPCIS is used to track “events” along a product’s lifespan. This includes events such as, receiving, unpacking, dispensing, destroying, and decommissioning. This standard allows all involved parties in the supply chain to capture and store that data, and then to share it with partners in the supply chain. This data will enhance the supply chain’s visibility of where products are at any given time, and the system’s overall ability to recognize counterfeit/illegitimate products. This will be tremendously useful to identify and promptly notify all necessary parties in the case of a drug recall.

How can a dispenser prepare for 2023?

• Start planning how you will maintain EPCIS data.
While upstream partners will be required to both generate and receive EPCIS data, most dispensers will only need to have a means of storing it. Now is a good time to start asking your suppliers what options they have. Many distributors, including The Alliance Pharmacy (TAP), already host your transaction data through their online portals and will be hosting EPCIS data through similar means. By hosting customer data, the customer can satisfy the DSCSA requirements to maintain access to transaction information data in a readily retrievable manner². As we get closer to November of 2023, dispensers should know who is maintaining this data (for every product).
• Confirm your site’s Global Location Number (GLN) or alternative accepted Identifier
As mentioned, EPCIS data defines the fundamental structure of an “event” with data dimensions of what, when, where, and why. The “Where” component will require specific identifiers for each trading partner. These will be in the form of a Global Location Number (GLN)¹. The GLN number is an additional standard developed by GS1. All trading partners will need to have a GLN (or other unique identifier^*) for the EPCIS data to generate correctly. Now is a great time to determine if you already have a GLN and if not, who would be the appropriate person to contact regarding this.
Read GS1’s Quick Start Guide for Pharmaceutical Dispensers and Healthcare Providers (Pharmaceutical Dispenser Global Location Number Quick Start Guide)

As the 2023 deadline approaches, expect to see and hear more conversations around DSCSA. Now is the time to familiarize yourself with applicable requirements and identify any potential opportunities. Discuss company readiness with your compliance and regulatory colleagues. For more information, see the following great resources.

Resources

• GS1 Homepage, with several resources (www.gs1us.org)
• Drug Supply Chain Security Act (DSCSA) | FDA (www.fda.gov)
• Drug Supply Chain Security Act (DSCSA) Resources for Dispensers (dscsa.pharmacy)


<sub>Disclaimer: The information contained in this article is provided for informational purposes. It is not to be considered as medical, legal, or other professional advice. The information contained in this article is provided solely on an “as is” basis, without any representations or warranties, express or implied. No recipients or readers of this article should act or refrain from acting on the basis of any content included in this article. The content of this article contains general information only, and may not reflect the most current standards, legal developments, regulations, or laws.
* Some vendors will accept alternate unique identifiers for customers, such as HIN or DEA. Check with your vendor to confirm.
1 Implementation Guide: Applying GS1 Standards for DSCSA and Traceability, Release 1.2. Retrieved September 18, 2019 from https://www.gs1us.org/industries/healthcare/standards-in-use/pharmaceutical/dscsa-implementation-guideline
2 Title II of the Drug Quality and Security Act Sec.582(d)(1)(B) https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/title-ii-drug-quality-and-security-act
3 https://www.fda.gov/files/drugs/published/Identifying-Trading-Partners-Under-the-Drug-Supply-Chain-Security-Act-Guidance-for-Industry.pdf (493)</sub>


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Team Alliance Contact Information

We work for you! Please don’t hesitate to contact any of us with any questions or concerns:

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