In this Issue…

Notes from Joe
· Isn’t it Strange?

Alliance Update
· Reminder: The 340B Program Recertification Period is Open!
· Save the Date for Alliance Meetings for 2023!

Legal Update
· 340B Compliance Spotlight: The Importance of Self-Audits

Washington Update
· 2023 Washington Outlook

Payer Update
· Prepare for the Medicaid PHE Unwinding and Redetermination Process

Team Alliance Contact Information

Isn’t it Strange?
by Joe Pugliese, President and CEO

Last year we developed a five-year plan for the Alliance activities to meet the needs of our members and the patients they serve. We recently met to review our progress to date and reaffirm that our plans for 2023 targeted the key issues. There was general agreement that we have the right programs in place or under development to address the challenges facing the members of the Hemophilia Alliance and the larger bleeding disorders community.

Regular readers of our newsletter know that the Alliance has steadily grown as a go-to organization for all parts of our community. What started in 1999 as a cooperative effort took root in 2006 and arguably took off in 2010. In 2022 and 2023, we have expanded our support for the community once again. We are adding more resources by adding two new Directors of Member and Community Relations, bringing our community facing number to 8. This is in addition to our administrative staff and our best-in-class consultants for Legal, Advocacy and Payer issues.

As I look towards the near future, there are three interrelated, difficult, and intractable issues that are clearly not in our control but desperately need to be addressed. All three have a direct and obvious impact on access to care.

1. The first of the year has long been a traditional time to raise prices and again this year, we saw price increases basically across the board. While pricing calculations are complicated, it is possible to show the effects of what are individually modest price increases. The Alliance recently modeled what a hypothetical HTC that purchases a representative cross-section of all types of products. This mythical but representative HTC purchased 17,639,354 i.u., mg or mcg in 2022. When you apply the increase in prices on all these purchases, it will cost an additional $2,327,936 to purchase the same products in 2023.
2. As we all remember from high school physics classes, every action has an equal reaction. I believe that ever-increasing prices are responsible in part for the ever-more common payer/PBM program like alternative funding programs, co-pay accumulator adjustor and co-pay maximizer programs, narrow preferred drug lists and formularies, and burdensome prior authorization processes. All of these raise the out-of-pocket costs of individual patients and families, make it harder for people to access the medication that their physician thinks will be most effective for them, and consume countless hours of wasted time for providers and patients.
3. Against this backdrop, last November, the FDA approved the first of many long-awaited gene therapy products for the bleeding disorders community. The community was and is very excited for this new option that has been 25+ years in the making. But the approval was also widely reported by virtually all media outlets. This isn’t because it was the first gene therapy product approved, but because it the most expensive drug ever brought to market . . . to date.

Today, we are already blessed with a broad array of excellent therapies and there are three more gene therapy products and at least three “novel” therapies likely to be approved in the next 12 months. While none of these products represent a cure, all continue a now decades-long trend of continuous improvement.

The challenge going forward will be to ensure that patients have access to these products and to federally-recognized HTCs. We will need vigilant and consistent enforcement of HRSA grant rules that require program income to be reinvested in maintaining and expanding the care for the bleeding disorders community, as well as policies to ensure that HTCs can maintain control of their patients, who are at risk of being poached by other covered entities.

We need to address these issues in the very near term if we want to preserve the clinical services the community needs today and for the foreseeable future.

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• Reminder: The 340B Program Recertification Period is Open!

The 2023 HRSA, OPA 340B Program Recertification period for HRSA Grantees and Indian Health Service will be January 30-February 27, 2023.

Prior to being able to recertify, Authorizing Officials (AOs) and Primary Contacts (PCs) must set up a user account in the 340B Office of Pharmacy Affairs Information System (340B OPAIS). Failure to set up user accounts will result in not being able to view accounts or conduct recertification, thus removal from the 340B Program. AOs and PCs must create individual user accounts, they will not be able to share access. All active 340B IDs associated with an AOs user account must be updated in order for recertification to be completed by the established deadline.

For assistance with the 340B OPAIS, it is strongly encouraged to utilize the online help that is available for your convenience. HRSA also has information and tutorials available on our website at https://www.hrsa.gov/opa/340b-opais/index.html. For further assistance please contact the 340B call center operated by the 340B Prime Vendor Program at apexusanswers@340bpvp.com or 1-888-340-2787 (Monday – Friday, 9 a.m. – 6 p.m. EST).

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• Save the Date for Alliance Meetings for 2023!

by Theresa Parker, Administrator

Hemophilia Alliance has been working diligently to ensure a full schedule of meetings for the upcoming year. After the difficult years of 2020-2022, it is refreshing to get back to “business as normal” and continue the trend of in-person meetings. There is a lot of activity in the hemophilia community, and it’s been an interesting exercise to navigate around these events.

We are excited to announce several new meetings in 2023 to bring together professionals in the blood disorder field to discuss important issues and advancements. These meetings will provide an important platform for attendees to network, learn from industry experts and share their own experiences. We hope to see you at one or more of these exciting events.

Mark your calendars to SAVE THE DATE!

Hemophilia Alliance Meeting Schedule for 2023


February 13-15	Spring Members Meeting	Nashville, TN
April 26-29	Social Worker CE Conference	San Mateo, CA
May 10-12 (tentative)	New HTC Staff Meeting	New York City, NY
June 12-13	Hill Day	Washington, DC
October 8-10 (New Date)	Fall Members Meeting	TBD

In addition to the above meetings, we are working on other meetings that you have requested. Stay tuned. More to come!

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340B Compliance Spotlight: The Importance of Self-Audits
by Issie Karan, Legal Counsel

Hemophilia Treatment Centers (HTCs), which participate in the 340B Discount Drug Pricing Program as Covered Entities, must dedicate resources to appropriate oversight of their program. The hallmarks of 340B compliance include strong policies and procedures, processes, internal controls and a leadership team that ensures they are being followed. As part of this, HTCs should incorporate a robust internal auditing component. This article outlines the components of a strong self-audit program and which key personnel should be kept in the loop on its results.

Self-audits can happen at whatever interval makes sense for the HTC. Here are some recommendations: the government does not strictly delineate how frequently covered entities must conduct internal audits. We recommend reviewing 340B policies and procedures, Office of Pharmacy Affairs (OPA) Information System listings, and 340B eligibility at least annually. The recertification process (described above!) can serve as a trigger to initiate these reviews.

For 340B claims, we recommend auditing more frequently. Ideally, these claim audits would occur monthly, using a sampling that will capture any compliance concerns. Apexus 340B Tools recommend 30 claims from each large chain contract pharmacy and 10 from each small, independent pharmacy. If an HTC also utilizes an in-house pharmacy, 30 claims would be appropriate.

Self-audits of claims should begin by ensuring that the covered entity’s records fully demonstrate compliance with prohibitions on diversion and duplicate discounts. As a reminder, the 340B statute requires that covered entities maintain auditable records, which means that HTCs should ensure that their own records incorporate data from third parties relevant to 340B compliance:

• For diversion, HTCs must ensure that all 340B drugs were provided to “eligible patients.” More specifically, the audit of the claim should confirm that the health record documents that the prescription was written at an eligible location by an eligible provider for a service within the scope of the HTC grant. If the claim utilizes virtual replenishment, HTCs should verify the quantity accumulated correctly and that appropriate quantities were purchased for replenishment and received by the contract pharmacy.
• For duplicate discounts, HTCs should confirm that their contract pharmacies do not utilize 340B drugs for fee-for-service claims. If the HTC carves Medicaid claims into its 340B program, the HTC should ensure that this is listed correctly on its Medicaid Exclusion File. For managed Medicaid claims, the HTC should ensure that 340B drugs are billed in accordance with state rules that vary by jurisdiction.

HTCs should engage their leadership on results of self-audits. If self-audits reveal issues of non-compliance, the HTC will need to analyze if a material breach has occurred and whether self-disclosures to the government and/or manufacturers are necessary. Having team members engaged in 340B compliance at multiple levels in the organization helps this process so we encourage HTCs to think about who at their institution needs to have a basic understanding of 340B compliance.

As a starting place, we recommend reviewing Apexus 340B Tools for more details on conducting self-audits. However, the Alliance team is always available to answer questions or concerns.

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2023 Washington Outlook
by Johanna Gray, Advocacy Consultant

This month has brought a new Congress with new rules and dozens of new members, a change in party control of the House of Representatives, and a new set of opportunities and challenges for HTCs and the bleeding disorders in Washington. Here’s what you need to know:

The 118th Congress is still getting organized. The members of various committees are still getting identified and real legislative work hasn’t started yet, despite the members taking office at the beginning of the month. There are new chairs and ranking members for a number of key committees, who are hiring staff and starting to identify priority issues for 2023. New House Energy and Commerce Committee Chair Rep. Cathy McMorris-Rodgers (R-WA) has indicated an interest in increasing transparency of health care costs. New Senate Health Education Labor and Pensions Chair Sen. Bernie Sanders (I-VT) wants to continue to enact more policies to lower high drug prices and advance his goal of establishing a single-payer health care system.

A new Congress also means that that all bills need to be reintroduced. We’re working now with a number of Members of Congress on the reintroduction of the HELP Copays Act, the legislation prohibiting copay accumulator adjustor programs that the Alliance and many other organizations supported last year. There were a number of bills addressing the 340B program that were introduced last year and we expect many of them to be reintroduced.

With the very narrow partisan margins for both the House and the Senate and the difference in party control between the two chambers, it is likely to not be an especially productive Congress. It also means that for anything to pass Congress, it will need to be something that can gain support from both parties. There is a growing bipartisan interest in enacting reform of the pharmacy benefit manager (PBM) industry, that we know is responsible for so many practices that make it harder for people with bleeding disorders to access the care they need, and for constructing so many pharmacy networks that exclude HTCs. We are going to be advocating for any policies here to help address our community’s concerns about PBMs – exclusionary networks, copay accumulator and maximizer programs, alternative funding and more. As noted above, there’s also interest in tackling transparency across the health care system – that could create opportunities and challenges for HTCs. Again, we’re keeping a close eye as this all starts to develop.

For its part, the Biden Administration will be even more interested in enacting policies that don’t require Congress to act. We are anticipating regulations relating to improving access to coverage in light of the upcoming Medicaid unwinding (keep reading below!). There will also be new policies to implement the drug pricing negotiation and other provisions of the Inflation Reduction Act enacted last year.

Finally, just a reminder at the start of the year that the Alliance is committed to advancing policies that address the needs of HTCs and their patients. But, we need your help! First, please always feel comfortable to reach out to us about issues that your center is facing so we can assess whether and what policy solutions might help. Second, with a few dozen new Members of Congress, countless new staffers, and the potential that lots of policies important to HTCs could be on the agenda this year, we need you to come to Washington to participate in the Hemophilia Alliance Hill Day this June! Stay tuned for more information about the event, our advocacy goals, and how you can participate.

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Prepare for the Medicaid PHE Unwinding and Redetermination Process
by Jeff Amond, Director Member & Community Relations
and George Oestreich, Government Payer Consultant

As part of the COVID-19 public health emergency (PHE), state Medicaid programs were not allowed to conduct the typical annual re-determination process for beneficiaries (i.e., state Medicaid programs could not remove anyone from their rolls). The Consolidated Appropriations Act, 2023, enacted in December 2022, included a policy ending this continuous enrollment condition on a set date – March 31, 2023 (this process is also known as the “unwinding”).

States can begin their first Medicaid redeterminations as early as February 1, 2023 (with terminations beginning April 1, 2023). States have a year to start renewals for all people and must be complete by May 31, 2024. This process will have a huge impact: the Department of Health and Human Services (HHS) has estimated that as many as 15 million people will be disenrolled, including 6.8 million who will likely still be eligible.

What does this mean for HTCs? It means every single one of your patients who is enrolled in Medicaid will have to go through a process to redetermine their eligibility. To assist with your preparation for this process, we have provided a few suggestions to help make this a smoother transition for you and your patients:

1. Do a deeper dive into your current patient population. Identify each of your current patients that are on Medicaid and proactively contact them about the Medicaid recertification changes. Encourage them to update their contact information with the state Medicaid program and to open and respond to any mail they receive. Try to identify families that may need additional assistance navigating the process.
2. Research what your state’s timeline and process will be. You can check websites like: www.medicaid.gov and the Georgetown Center for Children and Families has a great state tracking document that they are continually updating here. You can also proactively reach out to your state Medicaid office regarding their process/timeline for restarting eligibility recertifications.
3. Provide education to patients about other options, in case they are no longer eligible for Medicaid. For example, assist patients in completing an application for a plan offered on the ACA marketplaces.

**Your work could not be more important as we approach this critical time**

As we get past the February 1st start date for this process, more and more information will be available. The Alliance team and other bleeding disorders organizations, including NHF and HFA, will release more tips, tricks and resources over the coming weeks and months. Please remember that the Hemophilia Alliance and our consultants are here to assist. Reach out to George Oestreich, PharmD, MPA (george@hemoalliance.org) or any of your HA contacts for additional information or assistance. WE WORK FOR YOU!

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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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