Fall Members Meeting Edition 2019

In this Issue…

Notes from Joe
· Celebrating 20 Years of the Alliance!

Alliance Update
· Alliance Seeking Board Member Nominations
· Portland Didn’t Disappoint

Legal Update
· Keeping and Getting Back What’s Yours

Washington Update

Payer Update
· 15 Key Points From Your Payer Team

Notes from the Community
· HTC Patients Highly Satisfied with HTC 340B Programs Nationwide

Linda Gammage Social worker conference
· Register for one of the spots for the conference in San Diego February 2020

Team Alliance Contact Information

Notes from Joe

Celebrating 20 Years of the Alliance!
By Joe Pugliese

The fall meeting season seems to have started in August and is picking up steam. Our Member Meeting just concluded in Portland, Oregon last week. The meeting broke all attendance records, with 140 attendees who represented a diverse cross section of all parts of the hemophilia treatment center community. At the meeting, we celebrated the 20th anniversary of the creation of the Alliance. We were lucky enough to have the original seven founders of the Alliance (Trish Dominic, Bob Fox, Bruce King, Judy Primeaux, Derek Robertson, Bill Sparrow and Marisela Trujillo) join us for a delightful Monday night dinner. The evening featured music by White Rhino, whose leader, Kevin Finkle, is a young man with severe hemophilia A. The band was delightful and added just the right festive spirit to a fun evening.

The seven founders all spoke and took turns recalling how they came to the decision in 1999 that the HTCs needed a national member organization to represent the interests of all. They reminded everyone of the importance of having a not-for-profit organization that comprises federally funded hemophilia treatment centers (HTCs) that either have, or are seeking to have, pharmacy programs under Section 340B of the Public Health Service Act. The purpose of “the Alliance” is to promote the common interests of our member HTCs.

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. Nowhere was that more evident than when the Hemophilia Alliance board in a historic step voted to help support the “new independent Alaska Bleeding Disorders Clinic “ with an angel loan to help them get over the hump and help ensure people with bleeding disorders in Alaska have access to the comprehensive hemophilia care only available through our federally-supported network.

Inside this newsletter, you will hear from Judith Baker about the latest patient satisfaction survey, the results of which won’t surprise you. But I am always gratified to hear from patients about the important and high-quality services provided by HTCs. The Hemophilia Alliance team takes great pride and pleasure in being able to assist centers around the country and we are also delighted to be able to support other organizations. Towards that end we will once again supporting the HTRS Research Colloquium. We received this nice note from Wolfgang Bergmeier:

“I am one of the co-chairs of the upcoming HTRS Research Colloquium. In the name of the entire organizing committee, thank you so much to you and the Hemophilia Alliance for your generous support – amazing! Our goal is to make the HTRS colloquium free of charge for all trainees and your generous contributions is a huge step in this direction. The colloquium is a fantastic event for trainees where they can meet mentors, get their questions answered, and hear from senior investigators, NIH and industry on how to navigate career decisions. We would be excited if you and/or other members of your team could join us in Chicago.” We look forward to being in attendance and hope to see you there.

The Hemophilia Alliance was also recognized by the National Hemophilia Foundation as Red Tie Society member for our support of their nationwide advocacy program. Here is a photo of us receiving our award.

Finally – please remember that we all work for you!

Alliance Update

Alliance Seeking Board Nominations
By Heidi Lane, PT, DPT, PCS, Vice Chair, Hemophilia Alliance Board

The Hemophilia Alliance Board Nominating Committee is seeking applicants or suggested nominations to fill one vacancy on the board of directors, with the term beginning January 2020. The interested applicant must support the Hemophilia Alliance mission, vision and programs, be willing to share their knowledge and expertise with the Hemophilia Alliance and be able to participate in bi-monthly board meetings. The Board meets six times per year, three via conference call and three in person. Two of the in person meetings occur at the Hemophilia Alliance membership meetings and one board retreat takes place in January.

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.

Our Vision
Through the work of the Hemophilia Alliance, the clinical and pharmacy programs of the Hemophilia Treatment Centers are integrated, stable and sustainable within a changing healthcare environment. They are trusted and respected as the preferred way to provide people with hemophilia and other bleeding disorders access to the full range of care they need.

Applicants or suggested nominees must be employed by a Hemophilia Treatment Center in good standing with the Hemophilia Alliance. Terms are for a two-year period not to exceed 3 consecutive terms. We seek to broadly represent our membership and are encouraging applicants from all regions and disciplines to apply.

Applicants should submit a letter of interest and resume or CV to Heidi Lane at Heidi.Lane@imail.org by October 30, 2019 for consideration by the nominating committee.

For more information about the Hemophilia Alliance visit our website hemoalliance.org.

What does it cost to be on the board?
There is no cost to be on the board.

When does the board meet?
Two in person meetings occur at the Hemophilia Alliance membership meetings, one board retreat takes place in January and three conference calls take place on the fourth Thursday of the month at 2pm EST.

What are the qualifications or degrees needed to be on the board?
You must be an employee of the HTC and in good standing with the Hemophilia Alliance. No other qualifications or degrees are needed.

Do I need to hold a particular role in the HTC?

Does my program have to be a large program to be on the board?
Candidates from all types of centers from new startup centers to well established programs are encouraged to apply.

What are some of the things I should include in my letter of interest?
Your role with the factor distribution program.
Things that interest you in serving on the Hemophilia Alliance board and what you feel you will bring as a member of the board.
Include your experience with local, regional, national committees or boards related to hemophilia and related bleeding and clotting disorders.

If you have any additional questions please feel free to contact me at heidi.lane@imail.org.

– – –

Portland Didn’t Disappoint
By Sean Singh

The fall members meeting is behind us and we are already planning the meetings for 2020. The meeting in Portland was our largest and we were excited to have such a great audience. We covered many topics at the meeting and all meeting materials will be posted in the members section of the website. We rely on your feedback and suggestions to plan the meeting and invite speakers and topics. If you attended the meeting and have not yet completed the evaluation, please click here to give us your thoughts on the meeting.

We were asked to pull together a discussion board for pharmacist who work within an HTC. The intent is to get a dialog going between pharmacists to discuss therapy management and share ideas, best practices and be a resource for each other. If you are interested in participating in this group please email sean@hemoalliance.org.

We are working on the 2020 meeting schedule. We will have the Spring members meeting in conjunction with our Hill Day. The meeting will be held at the Marriott Marquis in Washington DC on March 29th to 31st, 2020. Please save the date on your calendar. More information about registration and hotel will be coming out soon.

Legal Update

Keeping and Getting Back What’s Yours
By Elizabeth “Issie” Karan

Hemophilia Treatment Centers (HTCs) located in a larger organization do not always have control over their operational procedures, including when and how bills for factor are paid. HTCs may face challenges when their organizations’ approach to paying drug manufacturers contradicts the HTCs’ best interests. For example, we have heard from several HTCs about payments to manufacturers being made late or using credit cards which means the HTC must forego “prompt pay” and/or “cash pay” discounts on factor purchases. In these circumstances, HTCs are missing an opportunity to reduce expenses. Although these discounts may be marginal, they add up over time and may run afoul of the spirit, if not also certain obligations, of the Uniform Grants Guidance (“UGG”).

The UGG requires that all costs charged to the federal award be “reasonable” and delineates what federal grantees should consider when determining reasonableness. 45 CFR §75.404 states that a cost is reasonable if, in its nature and amount, it does not exceed that which would be incurred by a prudent person under the circumstances prevailing at the time the decision was made to incur the cost. In determining what is prudent, grantees should consider if the decision demonstrates good judgment (as applied to action or conduct) and the degree of care required by the exigencies or circumstances under which it is to be exercised.

The UGG also indicates what should happen to credits applicable to federal programs. Specifically, 45 CFR §75.406 states that “applicable credits” refer to those receipts or reduction-of-expenditure-type transactions that offset or reduce expense items allocable to the Federal award as direct or indirect costs. The UGG includes examples of such transactions, including purchase discounts, rebates or allowances, recoveries or indemnities on losses, insurance refunds or rebates, and adjustments of overpayments or erroneous charges. The UGG instructs that, to the extent that such credits accruing to or received by the grantee relate to allowable costs, they must be credited to the Federal award either as a cost reduction or cash refund, as appropriate.

HTCs which must give up discounts because of institutional policies should keep these rules in mind. Auditors may question the prudence of not taking discounts on bills for factor from manufacturers. If a prudent person would behave differently under the circumstances, the institution’s policies for paying manufacturers may violate the requirements of the UGG. For violating federal grant rules, the HTC and the institution could be forced to pay back funds to the government. Additionally, to the extent that the institution receives credits or bonuses from credit card payments related to the HTC’s expenses, they should be credited back to the HTC program.

If you have questions, please contact us.

Washington Update

Washington Update
By Johanna Gray and Ellen Riker

It was wonderful to see so many familiar and new faces at the meeting in Portland! For people who weren’t there, here is a brief recap of what we shared in our presentation and for those that were, there are a few updates since we spoke last week:

Appropriations: Congress has been unable to pass the twelve annual appropriations bills that fund the government, but did pass a short-term continuing resolution (CR) to fund the government at current levels until mid-November to give them more time. President Trump signed that into law over the weekend, so there will not be a government shutdown this week. The House and Senate versions of their health care spending bills both included level funding for the hemophilia programs and activities at CDC and HRSA, as well as report language indicating their support for activities at both agencies plus bleeding disorders-related research at NIH. We will update members as the debate over federal funding continues this fall.

Medicare/SNF Issue: We have been working to identify Congressional champions to introduce legislation that would improve access to skilled nursing facilities for people with bleeding disorders on Medicare. We have had some very encouraging discussions since the Portland meeting and hope that we will have some exciting news to report very soon. We will need your help to add additional co-sponsors once bills are introduced. More to come!

Drug Pricing: More than 60 bills related to drug pricing have been introduced into Congress so far this year, including a few comprehensive bills being worked on by relevant Committees. The latest version from House Democrats would allow for negotiation of up to 250 of the highest drug prices by the government, with a ceiling set based on the much lower prices paid in other countries. While it remains unclear whether the House, Senate and President Trump will be able to agree on the details for one proposal to become law, we will continue our advocacy on behalf of HTCs and the bleeding disorders community.

Affordable Care Act: The biggest concern relates to the Texas vs United States lawsuit challenging the constitutionality of the ACA. The United States Court of Appeals for the Fifth Circuit is expected to release its ruling on the case this fall, and then the case is likely to move to the US Supreme Court next year. We expect that the law would continue to stand as appeals happen but it is obviously cause for concern and you may hear from your patients who are worried about press accounts.

Accumulator Adjusters: Earlier this year, HHS released a rule that said that insurance plans and PBMs must allow manufacturer co-pay assistance (and count it towards the deductible) for drugs with no generic alternatives. In August, HHS released a new FAQ that walks this back because the IRS says that this rule may conflict with its policies related to high-deductible health plans (HDHPs) and health savings accounts (HSAs). The two departments are working together to resolve the policy dispute but in the meantime, HHS has said that it will not enforce their rule for the rest of 2019 – which means that accumulators can come back for clotting factor assistance programs. We will see more information from HHS on this in a rule that will be released later this fall, but in the meantime, please contact the Alliance if you have a patient facing an accumulator.

Payer Update

Payer Relations Update

15 Key Points From Your Payer Team

The Hemophilia Alliance Fall meeting in Portland was a huge success. We had a record number of member attendees and a wide array of timely topics were discussed. The Payer Team’s five members have each summarized their presentations into 3 key points to remember as we continue to seek access to payer networks and expand your business.

Jeff Blake, Senior VP of Payer Relations:

  1. The HANS PPO Agreement is a contract between the HTC and HANS that allows the Hemophilia Alliance Team to negotiate regional and national payer contracts on behalf of HTCs.
  2. One of the goals of the PPO Agreement is to work together with HTCs to solve insurance issues so more patients can use the HTC pharmacy programs and grow your business.
  3. There is no additional cost to participate in the PPO Agreement. This service is included in your annual membership dues.

Roland Lamy, VP of Payer Relations:

  1. Anthem’s new PBM, Ingenio Rx, will transition all business served by ESI/Accredo by 1/1/20.
  2. IngenioRx is supported in the "back office functions" by CVS/Caremark, but Ingenio is calling all the shots on decisions, including those with respect to the network
  3. IngenioRx has told us there is no intention to move patients away from HTCs. But member communication could be messy if HTC patients currently receive other medications from Accredo, since they will be told those other prescriptions must transition. That fact should not impact an HTC’s ability to continue to dispense clotting factor under its prevailing Anthem agreement.

George Oestreich, Pharm D, MPA, Senior Medicaid Consultant:

  1. Each Medicaid agency in each state is different. It is important to know the differences and how they affect your practice. It is also important to maintain a relationship with your state Medicaid agency.
  2. You can impact reimbursement for products and services separately. It is important to separate the products and clinical services to increase your reimbursement and to assure that patients are well supported in caring for their disease.
  3. Managed care is continuing to grow as a delivery system. You may work with your state to assure your reimbursement has a “floor” set and may not be reduced below the state direct reimbursement. You may also negotiate your MCO contract. It is not a “take-it-or-leave-it” opportunity.

Jeff Amond, Director, Payer Relations, Midwestern States:
SUCCESS – Based on the last few years of experience, the Payer Team has found a successful approach to winning back the clotting factor business to your HTC. The approach consists of 3 parts:

  1. Establish a relationship with your Hemophilia Alliance Payer Team and complete the insurance questionnaire and clotting factor utilization spreadsheet.
  2. Get a Business Associates Agreement signed between the HTC and the Hemophilia Alliance. Once this is signed, an in-person meeting is arranged. The in-person meeting will focus on using the clotting factor utilization spreadsheet and insurance questionnaire to develop the strategic plan to win back the clotting factor business.
  3. Identify the key people at your HTC and/or hospital that will be needed when a clotting factor opportunity is brought to you. Then work with them to develop a process to be ready for any opportunity that comes your way. For example, figure out who are the decision makers for pricing and who has signatory authority for signing a Letter of Agreement. Having a well-defined process is essential since the window of opportunity for clotting factor opportunities is about 3 weeks. If a decision is not made within that time, the opportunity is lost, and the broker moves on to other business.

Mark Plencner, Director, Payer Relations, Western States:

  1. Our Specialty Pharmacy competitors at national conferences continue to say that they can manage clotting factor assays better than HTCs and everyone should be able to manage to assays to within 0.5% of the prescribed dose. An assay management best practice model that includes timely and robust reporting capabilities would be a useful addition to our integrated care model.
  2. Bleed log use, management, and reporting is picking up steam as well. There are several mobile apps, such as Audaire and MicroHealth, and some HTCs use home-grown apps. Regardless of which app you use, the data is relevant to excellence in patient care and can prove to be of benefit when seeking access to a payer network.
  3. Payers and PBMs continue to focus on accreditation, though there is variety across the marketplace for what payers require. As payers, PBMs and pharmacies continue to vertically integrate, it may be in the best interest of your HTC pharmacy practice to take a closer look at seeking accreditation.

Notes from the Community

HTC Patients Highly Satisfied with HTC 340B Programs Nationwide
By Judith Baker, DrPH, MHSA; Susan Lattimore, RN; Rick Shearer and Merilee Ashton, Steering Committee

The first-ever nationwide data on patient satisfaction with Hemophilia Treatment Center 340B programs is now available from the 2nd National HTC Patient Satisfaction Survey (PSS). And it’s very positive.

Over 95% of >2500 HTC patients across the US who use a 340B programs at one of 107 HTCs reported being always or usually satisfied with their HTC 340B program. This is the largest nationally uniform assessment of patient satisfaction with 340B programs ever conducted in the US. The one page report is on the 'news' tab of the National HTC Patient Satisfaction Survey (PSS) website: www.htcsurvey.com

Over 4700 people answered the 2nd national survey that was conducted spring-summer 2018. Over 95% reported being ‘always’ or ‘usually’ satisfied with overall HTC care, similar to the first PSS when >5000 patients participated in 2015. Data are also available on satisfaction with HTC core team members, services and care processes. Problems posed by insurance and language are also reported.

One page articles, and posters presented at regional and national conferences, are in the PSS website’s news section as well. If you do use these as part of your education materials or other communiques, please attribute / acknowledge the “National Patient Satisfaction Survey of U.S. Hemophilia Treatment Centers” as the source and give the website address.

We thank all patients who shared their voices and experience with their HTC. We thank all the HTCs, and you, our partners, for promoting the PSS.

Please share this data with your leadership, constituents, and stakeholders. If you have questions, please contact me or HTCSurvey@ucdenver.edu.

23rd Annual Social Worker Conference

Linda Gammage Social Worker Conference

The Hemophilia Alliance is proud to announce the 23rd Annual Linda Gammage Social Worker Conference scheduled for arrival on Wednesday February 26th to Friday February 28th in San Diego, California. This is a clinical conference specifically intended for Social Workers with direct clinical responsibility in the bleeding-disorders field. This two-day event will require a commitment of arrival on Wednesday February 26th and departing after 1 pm on Friday February 28th, 2020. Travel expenses will be paid for by the Hemophilia Alliance. The Hemophilia Alliance will underwrite each participant’s air travel, transfers to and from the hotel, conference hotel accommodations (room and tax) and the group meal expenses. Qualified applicants will be chosen from the pool of applicants*. Information about applying will be sent out at a later date.

This year’s conference will focus on Managing Opioid Addiction and Pain Management in the Bleeding Disorder Patient. Exploring alternative methods without the use of narcotics for managing joint and arthritic pain will be addressed.

Team Alliance Contact Information

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

Name Email Phone
Joe Pugliese joe@hemoalliance.org 215-439-7173
Sean Singh sean@hemoalliance.org 727-388-7326
Jeff Blake jeff@hemoalliance.org 317-657-5913
Jeff Amond amond@hemoalliance.org 608-206-3132
Karen Bowe karen@hemoalliance.org 717-571-0266
Johanna Gray, MPA jgray@artemispolicygroup.com 703-304-8111
Kiet Huynh kiet@hemoalliance.org 917-362-1382
Elizabeth Karan elizabeth@karanlegalgroup.com 612-202-3240
Kimberly W. Lackman kimberly@hemoalliance.org 813-400-6710
Roland P. Lamy, Jr. roland@hemoalliance.org 603-491-0853
Dr. George L. Oestrich, Pharm.D., MPA george@gloetal.com 573-230-7075
Ellen Riker eriker@artemispolicygroup.com 202-257-6670
Mark Plencner mark@hemoalliance.org 701-318-2910
Michael B. Glomb MGlomb@ftlf.com 202-466-8960
Theresa Parker theresa@hemoalliance.org 727-688-2568
Joel Bellucci webmaster@hemoalliance.org 727-504-0491