In this Issue…

Notes from Joe
· Access to the Best Care

Alliance Board Update
· Board Update – Welcome Colleen Druzgal, M.D.

Alliance Update
· Join the Alliance as we Support the NHF United for Bleeding Disorders Walk Challenge

Legal Update
· Genesis Healthcare Inc. v. Becerra: Reevaluating HRSA’s Regulatory Authority for the 340B Program

Washington Update

Payer Update
· Cost of Dispensing Survey: That’s a Wrap!

Team Alliance Contact Information

Access to the Best Care
by Joe Pugliese, President and CEO

The Hemophilia Alliance hosted one of the more extraordinary meetings held in the bleeding disorders community, June 20 and 21st in Chicago. The meeting was extraordinary for several reasons. First, we had sent out an invite to all members, the three national patient organizations, the Regional Directors and Administrators, ATHN, and HRSA, with little notice and asked people to travel on Father’s Day. We had over eighty attendees, which included NHF and the Coalition for Hemophilia B (HFA was planning to attend but had travel difficulties), four regions, representatives from ATHN and 44 HTCs were represented, including twenty-five doctors, nurses, pharmacists, and administrative staff.

The key take away from this multi-stakeholder meeting is that gene therapy in the bleeding disorders community should come through the federally-recognized network of HTCs. It is the best way of assuring the most clinically effective and cost-efficient introduction of the therapy to the community. The meeting focused on how to make sure all centers were prepared to bring gene therapy to the patient community. There are follow-up meetings being scheduled at the upcoming NHF BDC in Houston in August (click here for more information) well as the Alliance member meeting October 2-4th. The Alliance is also developing a moderated blog on our website for members to discuss issues related to gene therapy. You can access it here.

On another note, it has been close to a year since the first batches of DDAVP NS, manufactured by STAQ Pharma Inc, a 503B compound manufacturer, were shipped. It has been a community effort, with NHF, HFA and the Hemophilia Alliance, working together to get the product covered by insurance and into the hands of the patients. Our work together has been as recent as last week, when after multiple contacts, Express Scripts confirmed to NHF that the product was added to the national formulary effective July 1, 2022. They are joined by Optum (who fills scripts by exception), Ingenio and Accredo, who have added it to their national formularies. One would think getting coverage for a product that is far more convenient, is 10 to 20 times less expensive and offers appropriate clinical coverage would be easy. Nevertheless, we know there is still work to do, but I’m heartened by the progress we’ve made together. Finally, you can access a document laying out lots of the billing details that can be helpful to you in negotiating with any payer here.

I’m also pleased to highlight the amazing work of the World Federation of Hemophilia in helping to meet the needs of people with bleeding disorders in Ukraine. You can see an update that WFH shared here and they expect that additional funds will also be sent to the WFH national member organization in Lithuania and to the HTC in Germany, which continues to welcome new patients/families who are emigrating there. We will share more details as we have them. You can also learn more about other WFH and Alliance activities in this article on the Travel Grant recipients at the WFH congress and this article on the IHTC fellowship program.

Finally, as always, please remember that the Alliance works for you. Please contact me with any questions or concerns about these or any other issues that your HTC is facing.

▲ Top

Board Update – Welcome Colleen Druzgal, M.D.
by Eric Gray, Vice Chair

We are delighted to announce that Colleen Druzgal, M.D., has joined the Alliance Board of Directors effective July 1st, 2022. Colleen has done a great job of growing her program at the University of Virginia, where she serves as the medical director. Please read on for her bio:

Colleen Druzgal is an Associate Professor of Pediatric Hematology/Oncology at the University of Virginia and the Director of the Hemophilia and Thrombosis Treatment Center there since 2018. She is originally from Philadelphia and did her medical school training at the University of Pennsylvania and residency and fellowship at the University of Utah. She has worked within the UVA HTC since 2014, and is most proud to have expanded the treatment center to include care of adult patients, outreach clinics to both Northwest and Southeast Virginia, and a pediatric thrombosis service, as well as a multidisciplinary clinic for girls with bleeding and thrombotic disorders to the program. She has served as a physician representative to the Region III executive committee for the last 5 years. She has been in Charlottesville, VA since 2010 and lives with her husband, Jason, and her two children. In her limited free time, she enjoys watching UVA basketball and other sports, skiing, reading and spending time with her family, her dog and two cats.

▲ Top

Join the Alliance as we Support the NHF United for Bleeding Disorders Walk Challenge
by Karen Bowe, Director Community Relations

Join the Hemophilia Alliance as we support the Bleeding Disorders Community through the NHF Unite for Bleeding Disorders Walk Challenge. This is part of the Hemophilia Alliance initiative “HARMONY IN HEMOPHILIA”. Through this collaboration we are encouraging HTCs to work with their Chapters to foster collaboration leading to better patient care.

As a member HTC of the Hemophilia Alliance, all HTC teams that raise $1,000+ for their local Walk program will be recognized by NHF & the Hemophilia Alliance as being a part of our Wall of Walkers. These teams will receive the following:

Recognition during Unite Rally Chapter and Community virtual training
Recognition from the Hemophilia Alliance in newsletter publications and webinars

1. Top HTC Fundraising Teams:  Unite Walk Chapters have been broken up into five respective market groups. The top HTC fundraising team in each group will receive a $1000 scholarship to send a staff person to attend the 2023 Bleeding Disorders Conference. HTC sponsorships do not count toward Team Fundraising.

2. Family team recruitment:  We want to help you not only succeed but be the top HTC fundraiser in your market group.  HTCs are given the opportunity to receive a quantity of promotional magnets to be given to families during their visits.  Click on the link below for instructions from NHF on how to order magnets for your Center.

https://www.surveymonkey.com/r/T7GNSMV

▲ Top

Genesis Healthcare Inc. v. Becerra: Reevaluating HRSA’s Regulatory Authority for the 340B Program
by Elizabeth “Issie” Karan, Legal Counsel

While lawsuits related to the 340B Discount Drug Program have become commonplace, there is a new important court ruling that jeopardizes the longstanding “patient” definition under the 340B Program. HTCs should expect this lawsuit to be a hot topic in 340B Program circles for months to come.

The case, Genesis Healthcare Inc. v. Becerra, stems from a dispute over the removal of Genesis from the 340B Program following an on-site audit that HRSA conducted in June 2017. HRSA issued two findings: 1) that Genesis failed to comply with the statutory requirement of maintaining auditable records; and 2) that Genesis dispensed 340B drugs to ineligible individuals, causing diversion. HRSA issued the diversion finding because Genesis included prescriptions in its 340B program which were written by providers without a relationship to Genesis for patients that later went to Genesis for care. However, within a week of Genesis filing its lawsuit challenging the diversion finding, the parties reached an agreement that permitted it to be provisionally readmitted to the 340B program.

Despite this reinstatement, Genesis Healthcare filed an amended complaint that argued that it was still required to follow unlawful guidance. Genesis alleges that HRSA’s “patient” definition has “never been promulgated by regulation” and, in any event, “contradicts the plain language of the statute” by “improperly focusing on a patient’s prescription, and who wrote it, rather than the existence of a patient relationship with Genesis (or any other covered entity).” As a result, Genesis requested that the court invalidate HRSA guidance on the patient definition from 1996.

While the District Court dismissed the lawsuit as moot, the Fourth Circuit Court of Appeals agreed with Genesis, overruling the lower court decision, and sending the case back for a determination on its merits. This means that Genesis now has the opportunity to challenge the patient definition in federal court and potentially upend over 25 years of its enforcement.

This case comes at a unique time. A recent high-profile Supreme Court decision (West Virginia v. Environmental Protection Agency (2022)) suggests that the judiciary branch is giving less deference to agencies interpreting laws. You may recall that prior cases have limited HRSA’s rulemaking authority related to the 340B Program; in PhRMA v. HHS (2014), the US District Court of DC held that the 340B Program statute itself provides only limited grants of rulemaking authority in the following three areas: (1) the establishment of an administrative dispute resolution process for claims by manufacturers and covered entities; (2) standards and methodology for calculating ceiling prices; and (2) standards for the imposition of civil monetary penalties. These legal precedents enable the court in Genesis Healthcare Inc. v. Becerra to revisit the validity of the patient definition in the 340B Program.

▲ Top

by Johanna Gray, Advocacy Consultant

All eyes in Washington are turning towards the Senate, which is likely to consider drug pricing reforms as part of a reconciliation package later this month. Whether the final bill comes together remains up in the air – but as of this writing, all 50 Democratic Senators, including Senator Joe Manchin, support the policy. The draft legislation that has been released by the Senate Finance Committee has a few main policies as detailed below, but the upshot is that the policy is not likely to affect HTCs or treatments for bleeding disorders. We are continuing to monitor progress of the bill and the potential for any harmful policies for covered entities in general, or HTCs specifically. Please let us know if you have any questions!

Part 1 – Lowering prices through drug price negotiation

The legislation calls for a Drug Price Negotiation Program, which gives the HHS Secretary authority to negotiate prices for certain drugs under Medicare Part B and Part D. Beginning in 2026, s/he will select and publish a list of 10 drugs that will be subject to price negotiation; in 2027 and 2028, 15 drugs; in 2029, 20 drugs. The eligible drugs will be limited to single source drugs and will be chosen from a list of the drugs with highest total expenditures under Part D for 2026 and 2027, and Part D and Part B beginning in 2028 and subsequent years.

There are a number of exceptions, including for small biotech drugs, vaccines, and new formulations of existing drugs. Exclusions will also exist for certain orphan drugs, low spend Medicare drugs, and plasma-derived products (biological product derived from human whole blood or plasma). Specifically, for orphan drugs, the exclusions will apply to drugs designated for only one rare disease or condition and for which the only approved indication (or indications) is for such disease or condition.

The Secretary cannot choose the same drug twice and the drugs must have been on the market for several years (drugs must have been approved at least 7 years prior; biologics must have been approved at least 11 years prior). All Part D drug plans would have to cover Part D drugs with prices negotiated under this proposal. The agreement is in effect until drug is no longer a selected drug.

The legislation contains specific text related to the 340B ceiling price. If a drug is chosen, the manufacturer will not be required to provide access to the maximum fair price under the 340B program (if the ceiling price is lower than the maximum fair price for this particular drug) but if the maximum fair price is below the ceiling price amount, then the maximum fair price must be offered.

The legislation outlines specific factors to be taken into account when negotiating the price including manufacture specific information and information on alternative treatments. For example, the Secretary will consider the extent to which drugs address unmet needs for a condition for which treatment or diagnosis is not address adequately by available therapy. There are also specific criteria for when a drug is eligible for renegotiation, including when there is an addition of a new indication.

PART 2 – Prescription Drug Inflation Rebates

This section requires rebates to be paid by drug manufacturers of Part B and Part D drugs if the price of the drug grows faster than inflation.

PART 3 – Part D Improvements and Maximum out-of-pocket cap for Medicare Beneficiaries

Beginning in 2024, beneficiaries will pay nothing in the catastrophic phase, and beginning in 2025, there will be a cap of $2,000 for out-of-pocket spending under Medicare Part D. This cap will remain in subsequent years but will be adjusted based on the rate of increase in per capita Part D costs. Also beginning in 2025, enrollees will have the option to pay cost-sharing in monthly capped amounts.

Part 4 – Repeal of Prescription Drug Rebate Rule

Prohibits implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates.

Part 5 – Miscellaneous

Part 5 of the legislative text calls for cost-sharing and deductibles for adult vaccines covered under Part D to be consistent with those covered under Part B, meaning vaccines under Part D will be free.

This section also includes provisions related to payment for biosimilar biological products; expanding eligibility for low-income subsidies under Part D; and, improving access to adult vaccines under Medicaid and CHIP.

▲ Top

Cost of Dispensing Survey: That’s a Wrap!
by George L. Oestreich, PharmD, MPA, Government Payer Consultant

The payer team has been working with Mercer on the Cost of Dispensing (COD) Survey project for over a year. The project had two phases – Phase 1: Cost of Dispensing Survey to have national and regional HTC pharmacy cost of dispensing; and Phase 2: Cost of providing clinical services to create a disease management/care management add on fee. Phase 1 of the project has been completed and below is a summary of the project and the report.

Purpose and Background:

We undertook this project to support higher reimbursement rates for HTC pharmacies. Federal regulations (the Covered Outpatient Drug Regulation) required each state develop a professional dispensing fee survey for the pharmacies in their state to cover the actual cost of receiving, processing, and delivering a prescription for a Medicaid recipient. There could be no profit in the calculation nor could services unrelated to dispensing the product be included. By its very nature, this disadvantaged HTC pharmacy programs, but we had further issues because the low volume of prescriptions dispensed by each HTC was used to calculate the per prescription dispensing fee. This resulted in dispensing fees of $1,000 to $2,000 or more, that though accurate, were significantly higher than other specialty pharmacies. These were seen as outliers and were excluded from the state’s COD analysis. This meant that HTCs received the same – lower – dispensing fee as all other pharmacies, even if it did not cover their costs as the regulations intended.

Hemophilia Alliance representatives received guidance from state and federal partners that a separate COD survey would be the best way to universally secure a more reasonable HTC dispensing fee. We knew that even with a higher dispensing fee, HTCs would still be short revenue needed to reimburse for the additional required services for their patients. Therefore, we would enumerate the “other” services required for the comprehensive care model and develop a way for how those might be reimbursed in addition. This would be Phase II of the project that would springboard off the COD survey results.

The Alliance engaged Mercer, a consulting firm that prepared approximately half of all the state COD surveys. Mercer also recruited a Medicaid Advisory Board of state Medicaid pharmacy directors to act as advisors to the project. With this “buy in” from Medicaid pharmacy directors (chosen strategically to ensure a broad-based respected group), we would be in good shape to advocate for a reasonable HTC dispensing fee and ultimately secure additional reimbursement from the states for non-dispensing services provided to patients.

The Alliance and Mercer worked with a group of HTCs to vet the COD survey and modified it using a format modeled from required HTC reports to facilitate participation. HTC participants were assured the information would be held in confidence and not shared at a level that could inadvertently disclose the unique information each respondent would share.

Results and Next Steps:

• Mercer received thirteen (13) COD Surveys from member HTCs. Based on the limited amount of data, the results are not statistically valid and cannot be used on a national or regional basis.
• One of the 13 HTC respondents was able to use their COD survey data to get their Medicaid agency to make a significant change to improve reimbursement while they consider a more thoughtful approach to reimbursing bleeding disorder products.
• The data from the completed COD was compared to a previous survey completed approximately 10 years ago and the results were similar but still not statistically valid.
• The COD Survey report has been shared with the Medicaid Advisory Board and the feedback received was “The Advisory Board believes that state Medicaid programs would not be likely to use the report’s results to make program change to their current reimbursement methods.”

While the results are disappointing there are a few next steps we can take to work together with state Medicaid programs:

• The HTCs that participated in the COD Survey can use their data in discussions with their own Medicaid program.
• To be effective, Medicaid advocacy has to be truly local. To be successful, each HTC has to have a solid working relationship with its state Medicaid agency. We at the Alliance can frame the topics, interpret the regulations, process, and participate in meetings. The primary support must be local.
• With the advent of new treatment paradigms such as Hemlibra and especially gene therapy, there will be even more pressure to control product and services costs separately. That makes now a very good time to meet with your Medicaid agency. We can build a very compelling argument for exclusively using the HTC network to bring gene therapy to the bleeding disorders community.
• Adequate reimbursement for the comprehensive care model and related services is necessary so that HTCs can continue to provide services at their current level of quality and efficiency. The more data you have related to cost of dispensing and cost of providing the clinical services will be very helpful in your discussions with your Medicaid agency.
• Finally, phase 2 of the project – building off of the survey results to develop a way to reimburse for the other services – is still under review. We will update Alliance members if it moves forward.

The Hemophilia Alliance team is here to support you and work with you on your advocacy journey with your state Medicaid agency. We must be unified and targeted in our efforts to secure adequate reimbursement for the services you provide. And last, but not least it is important to know your Medicaid agency personnel and help them know you, your value, and your needs. We work for you!

▲ Top

Team Alliance Contact Information

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

▲ Top