December 2018 Newsletter

In this Issue…

Notes from Joe
· Happy New Year!

Washington Update
·Texas vs. United States Lawsuit and Washington Year in Review

Legal Update
· Surprise! Trump Administration Finalizes the CMP Rule and Legal Year in Review

Payer Update
· Payer Team Year in Review

Notes from the Community
· THSNA Update
· WFH Acknowledges Hemophilia Alliance Travel Grant

Alliance Update
· Operations Update

Team Alliance Contact Information

Notes from Joe

Happy New Year!
By Joe Pugliese

Amazingly another year has passed, and tradition says you should review the year with an eye towards noting your successes. It is a nice tradition and it was certainly a year full of notable accomplishments. We had 10 new participating members, a significant accomplishment and a great indicator of the value HTCs see in being an Alliance member.

Our payer team has made great headway in reaching out to insurers, brokers, stop loss insurers and others to describe the tremendous value the comprehensive hemophilia treatment center network offers to patients and insurers alike. We have expanded our service offering to include business associate agreements with individual centers, so we can better assist with insurance issues for centers and patients. The group has written multiple individual case agreements that are allowing patients to use their HTCs pharmacy service.

In addition to organizing two member meetings that each set attendance records, the Operations group also hosted 31 webinars. They also spearheaded the effort to get in front of more chapters with an active campaign to attend chapter meetings. Your Alliance representatives are available to attend patient programs with you or in your stead to promote the idea of supporting the HTC network of care.

Finally, our legal and advocacy teams have had a very busy and productive 2018, having advised more than 60 number of member HTCs on legal and compliance questions that came up through the course of the year. They have drafted Alliance responses to 6 different proposed regulations and requests for comment this year, and helped draft letters we cosigned with other covered entities. They have also co-written letters of support for policies critical to the well-being of the patients you serve. Speaking out in support continuing the ban on pre-existing conditions and maintaining the essential health benefits and the ban on annual and lifetime caps.

Glad that is out of the way because 2019 is shaping up to be just as exciting and challenging. The recent court ruling theoretically overturning the Affordable Care Act (read below for a summary of where we are) will likely spark a renewed interest in healthcare reform. This reform could include changes to the 340B Program, which we all know is the lifeblood the comprehensive hemophilia care network. We continue to look for opportunities to get greater clarity and with it better support for the HTC network.

One my hobbies is serving on the board of the World Federation of Hemophilia USA. As you know, WFH has the support of many of our manufacturing partners. This photo of a creative Christmas tree was sent to us from the Philippines as a thank you for the work the great staff at WFH are doing to improve the lives of people with hemophilia around the world.

We at the Alliance wish you all a Merry Christmas, a Happy New Year and health and happiness for you and your family in 2019.

Washington Update

Texas vs. United States Lawsuit and Washington Year in Review
By Johanna Gray and Ellen Riker

At the conclusion of such an active year in Washington, it seems fitting to start with the latest news about a lawsuit challenging the Affordable Care Act (ACA).

Texas vs. United States

On December 14th, a Texas judge ruled in Texas vs. United States, a case challenging the constitutionality of the Affordable Care Act (ACA), that the entirety of the ACA is unconstitutional. To understand what happened last week, we have to go further back to 2014 and 2015 to the first set of cases challenging the constitutionality of the ACA. Then, the question was whether the individual mandate was constitutional since the ACA requires people to purchase health insurance. The Supreme Court ruled then that the individual mandate is constitutional because it imposes a tax penalty on people who don’t comply (the government can’t make you buy health insurance, but they can tax you if you don’t.) Flash forward to the 2017 tax reform law, in which Congress brought the individual mandate penalty down to $0. The theory of the current lawsuit is that reducing the tax penalty to $0 essentially eliminates the individual mandate as a tax, and the entirety of the ACA rests upon that provision – so if the individual mandate has gone away, so, too, must the entire ACA. In last week’s decision, the judge basically agreed with this argument and ruled that the entirety of the ACA is unconstitutional. The case is expected to be appealed immediately and will likely go to the United States Supreme Court for a final ruling in the coming months.

It is critically important to note that this decision does not have any immediate impact. The judge did not issue an injunction that would stop the implementation of the ACA. For now, the ACA will continue – people covered by ACA exchange plans or the Medicaid expansion will continue to be covered and insurers must still follow ACA patient protections, like the ban on pre-existing conditions exclusions and lifetime caps. We will update the community as the case continues and if any further legal proceedings affect access to care. We anticipate that Congress is also likely to act to try to protect the ACA in light of this lawsuit, so there may be opportunities for grassroots advocacy in support of the ACA this winter. We will update you about that, as well.

2018 Advocacy Year in Review

Turning to a 2018 advocacy year in review, we have to start with 340B Reform. Congress was very active in considering possible reforms to the 340B program, with members of Congress and Congressional committees writing letters, holding hearings, and eventually releasing more than 15 bills relating to 340B policy this summer. While the bills were aimed at changing rules for hospitals and not grantees or HTCs in particular, the Alliance team closely monitored all of this activity to ensure that HTCs would not be harmed. What’s most interesting is that none of this activity turned into any concrete action – no bills were seriously considered in House or Senate committees nor came up for votes on the floor. We believe that our collective advocacy and education efforts with Congress — including another Hill Day involving HTCs, patients advocates, and manufacturers — has helped to ensure that detrimental legislation has not been enacted.

In 2018, the Trump Administration was more successful in achieving its health policy goals related to new drug pricing policies and weakening the Affordable Care Act. The Administration released a Blueprint outlining a broad drug pricing agenda in the spring and released more concrete policy ideas to change drug coverage and pricing in Medicare this fall. Related to ACA, a number of new rules and policies were released in 2019 to give states and plans more flexibility to set rules and to promote “skinnier” insurance plans that don’t have to meet ACA requirements. In just the last couple of months, the Administration has released about a dozen new regulations affecting drug pricing and/or insurance policies in Medicare, Medicaid and private insurance. The Alliance team is evaluating each of these proposals and will be responding to those that would directly affect HTCs and the bleeding disorders community.

2018 has been a very busy year for us in Washington and all signs suggest that the priority issues for our community, including 340B reform, drug pricing, and ACA insurance issues, are likely to be part of Congressional and Trump Administration agendas in 2019. We will continue to update the community as policies are released and advocate to protect our community as much as possible. To achieve this, we need you! We hope that we will see many of you at the Alliance Hill Day in April to begin to educate new Members of Congress and their staffs about our community and what policies matter to us.

Legal Update

Surprise! Trump Administration Finalizes the CMP Rule and Legal Year in Review
By Elizabeth “Issie” Karan

Like my colleagues in the advocacy team, before I provide a review of our legal activities this year, there is a more pressing update first:

CMP Rule

Covered entities are getting a surprise from the Trump Administration this holiday season in the form of implementation of the long-awaited rule on penny pricing and civil monetary penalties for drug manufacturers on January 1, 2019.

On November 29, 2018, the Trump Administration announced that it would finalize the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation (“CMP Rule”) with an effective date of January 1, 2019. The Trump Administration delayed the effective date of the CMP Rule five times, and several groups sued over the two-year delay. In deciding to finalize the 2017 version, the Trump Administration stated the CMP Rule had been “subject to extensive public comment” and that “HHS has considered the full range of comments on the substantive issues.” Therefore, the Trump Administration no longer felt a delay was necessary.

The CMP Rule governs calculation of the maximum prices that manufacturers may charge covered entities in the 340B program (i.e. ceiling prices), and the imposition of civil monetary penalties if a manufacturer “knowingly and intentionally” charges a covered entity more than ceiling prices. Importantly, the CMP Rule affirms the practice of charging covered entities $.01 when the 340B ceiling price calculations result in a ceiling price equal or less than zero (i.e. penny pricing). With regard to civil monetary penalties, in the preamble to the CMP Rule, the Trump Administration provides examples of circumstances that would meet the “knowingly and intentionally” threshold but declined to provide further definition stating that “it is [not] appropriate to incorporate additional language over and above the statutory language.”

The Trump Administration’s delay in finalizing the CMP Rule contributed to postponement of the long-anticipated ceiling price website by the Office of Pharmacy Affairs (OPA). Following the change in effective date of the CMP Rule, OPA announced that it expects to publish 340B ceiling prices on April 1, 2019 on the 340B Office of Pharmacy Affairs Information System. Authorizing Officials and Primary Contacts will be able to create usernames and passwords to view pricing data, and confirm manufacturers are not overcharging covered entities.

Legal Year In Review

The regulation above is proof that 2018 was another eventful year for the Hemophilia Alliance legal team. We have been hard at work providing technical assistance to members and supporting other Alliance activities.

The legal team provided numerous hours of technical assistance to Hemophilia Alliance members on a variety of topics (some of which have been featured in this newsletter throughout the year). The legal team provided guidance to members on compliance with the Uniform Grants Guidance, including allowable program income expenditures and reasonable overhead charges; fraud and abuse laws; and the 340B Drug Program Requirements.

The legal team worked with the advocacy team to understand congressional and administrative proposals for reform and oversight reports on the 340B Program. The legal team’s activities included assisting the advocacy team with writing letters to different agencies within the Administration, preparing and attending meetings with government officials, and assisting with requests from Congress. The topics of these projects ranged from implementation of the Civil Monetary Penalties for manufacturers in 340B, to issues related to 340B reform proposals, to requests for information on contract pharmacy arrangements.

Payer Update

2018 Year in Review
By Jeff Blake

The Payer Team was very busy during 2018 providing support for our members in payer contracting and payer relations. Below is a summary of the Payer Team’s key activities for 2018.

  • The Team continued to expand our marketing efforts of Hemophilia Alliance Network Services (HANS) within the payer community. We met with numerous payers and provided several webinars to regional and national payer organizations. This has increased the awareness of the HTC model of care, including integrated HTC pharmacy services, with many payers.
  • We continued to enhance our payer marketing efforts with insurance companies, insurance brokers/consultants, self-insured employers, pharmacy benefit managers (PBMs), third party claims administrators (TPAs) and stop loss/reinsurance carriers. We’ve expanded the number of insurance organizations we work with and we will continue this expansion in 2019. These efforts have brought numerous opportunities to HTC to increase the number of patients the HTC pharmacies are serving and accounted for over 8,000,000 units of clotting factor for the HTC pharmacies. Single case agreements have opened doors with brokers to look at broader agreements with large national employers
  • The Team continues the development of the Hemophilia Disease Management program to offer payers. An update was provided at our Fall Members Meeting in Las Vegas. We are in discussions with consultants, Medicaid Agencies and private insurance payers about the feasibility and implementation of the program. We are hopeful to roll-out a Disease Management Pilot Program during 2019.
  • The Team continued to work with HTCs, Medicaid Agencies and Medicaid Managed Care Organizations on several items including, clotting factor and Hemlibra reimbursement and remaining or becoming an in-network provider for clinical and pharmacy services.
  • We attended 12 regional and national payer conferences during 2018, and at two of these we also presented the HTC model of care and HANS. We attend conferences as part of our marketing efforts to increase awareness of our HTC members and HANS. We have developed some excellent payer relationship through our attendance.
  • The Team presented two webinars to members. In the late spring we presented Clotting Factor Pricing – Current market conditions and trends and in December we had one of our members present Medicare Best Practices – Documentation for billing success.
  • We worked with several HTCs to complete our HTC Insurance Questionnaire and the Patient Insurance and Clotting Factor Utilization Spreadsheet. These two tools help HTCs organize their patient insurance information and provide the Payer Team the information to help solve payer contracting and payer relations issues. We have also updated our Payer PowerPoint Presentation Template for HTCs to use in their payer discussions.
  • During 2018 we continued our efforts to meet with our HTC members, attend their staff meetings through conference calls or in-person and assist with operational items and payer items.
  • We have continued our efforts to expand our collaborative efforts with NHF. We participate in the NHF Comprehensive Care Sustainability Collaborative (CCSC), co-presented at a payer conference, and several regional and chapter events. We have also jointly responded to a large self-insured employer request for proposal (RFP) to keep HTCs and their pharmacy programs “In-Network” so you can continue to serve their insurance members that are your patients.

2018 was a very exciting and busy year. We continue to expand our payer efforts and we look forward to working with you in 2019. As you know, we work for you, and we encourage you to reach out to your regional payer team liaison with any questions or concerns.

Notes from the Community

THSNA Update
By Salley Pels, MD, Co-Medical Director, Yale Hemostasis Center, Alliance Board Member, and Alliance Designee to the Thrombosis Hemostasis Societies of North America Board

THSNA (Thrombosis Hemostasis Societies of North America) held their most recent board meeting as well as an Industry Meet and Greet during ASH this year in San Diego. Included on the board meeting agenda was planning for the THSNA 2020 Summit. The Biennial Summit of THSNA is a collaboration of fifteen leading organizations in the fields of hemostasis and thrombosis and provides a forum for those with an interest in those disorders to network, learn and share across disciplines and disease states. The meeting will be held at the Sheraton Grand Chicago, April 22-25, 2020. More information available here.

Additionally, there is an upcoming deadline for the next round of applications for the THSNA Travel-To-A-Mentor Award on January 7th, 2019. The THSNA Travel-To-A-Mentor Award provides financial support (up to $2500 per award) for one mentee to train for one week with a pre-selected research mentor at their facility anywhere in the US, Canada, or Mexico. Awardees from many disciplines are encouraged to apply. Applications can come from Nursing, Laboratory technologist/specialist, Pharmacist, PhD researcher, Physician investigator, clinical, translational, or basic Patient advocacy. Applicants must be from one of the 15 THSNA member organizations, which includes the Hemophilia Alliance membership. See link for further details: http://www.thsna.org/web/mentor.php

WFH Acknowledges Hemophlia Alliance Travel Grant Program
By Roddy Doucet

World Federation of Hemophilia (WFH) Dental Committee member Rebecca Schaffer’s achievements are impressive. Hailing from Arizona, U.S.A, a friend living with Von Willebrand’s disease and working with HIV/AIDS patients inspired her to support our community. She has lectured at the international level on bleeding disorders, on various topics related to special care dentistry and on methods to improve communication and collaboration across dental and medical specialties. She has served as vice chair of the liaison committee for the Council of Dentistry for People with Disabilities for the Special Care Dentistry Association. She has also co-authored a chapter on Quality Management and Improvement for Health Care Centers for the National Network for Oral Health Access. Schaffer has also acted as a critical summary writer for the American Dental Association (ADA) Evidence Based Dentistry (EBD) website. All these facts—and many more—make her a praiseworthy recipient of a 2018 Hemophilia Alliance Travel Grant.

The Hemophilia Alliance Travel Fund allows U.S.A.-based WFH multidisciplinary committee members to attend WFH international meetings and conferences. Schaffer’s grant allowed her to be part of the 2018 WFH World Congress in Glasgow. In her estimation, it was a rousing success, as the Dental Committee was able to achieve many of its goals during the session, including sharing the progress and challenges experienced with healthcare professionals, and, most importantly, making progress in helping colleagues understand the importance of oral health and the role it plays in overall health for those living with a bleeding disorder.

Schaffer’s level of professional achievement and personal engagement is typical of many volunteer members serving on WFH committees. The relationship the WFH has with members goes both ways, as the WFH also has a responsibility to invest in their personal and professional growth. The Hemophilia Alliance shares this belief and recognizes the rewards our community reaps thanks to our committee members’ continued development.

REBECCA SCHAFFER – DENTIST, COMMITTEE MEMBER AND 2018 TRAVEL GRANT RECIPIENT
“Bleeding disorders affect every aspect of a person’s life. It is vital that every member of the healthcare team be involved in treatment, collaboration and mutual understanding, as well as keeping up with new treatment modalities, research and political issues. Keep up the great work, and thank you to the Hemophilia Alliance for the opportunity to contribute to improving the lives of people with bleeding disorders.”

The World Federation of Hemophilia is proud to acknowledge The Hemophilia Alliance’s generosity and commitment to advancing progress in the bleeding disorders community.

Alliance Update

Operations Update
By Sean Singh

We continue to work on educating our members on how to run a pharmacy business. This has been well received and we plan to continue to visit centers in 2019 to help with the process of looking at the 340B pharmacy program as a business within a clinical center. This effort has generated some very good conversation and has been helping your Alliance Team better understand the needs and differences of each center.

As Joe noted the webinar series continues to be a value to our members. The topics have ranged from the basics of Hemophilia through contact pharmacy arrangements and onto factor product specific content. We want to tailor the series to our member needs and ask that you please let us know if there is a topic you would like to get information about.

Finally, we have finalized the dates for the Spring member’s meeting and Hill Day for April 28-30 and hope to see you there!

  • Sunday April 28th: Networking reception
  • Monday April 29th: Member General meeting from 7:30 am to 5 pm, and Hill Day prep and dinner will be from 6-8 pm.
  • Tuesday April 30th : Hill Visits to members of Congress

The recent webinar titled “Medicare best practices for billing success” has been added to the library located in the members section. To view the video of the webinar please click here. A list of our recorded webinars is available here.


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
Johanna Gray, MPA jgray@dc-crd.com 202-484-1100
Elizabeth Karan ekaran@feldsmantucker.com 202-466-8960
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@dc-crd.com 202-484-1100
Mark Plencner mark@hemoalliance.org 701-318-2910
Michael B. Glomb MGlomb@ftlf.com 202-466-8960
Theresa Parker theresa@hemoalliance.org
Karen Bowe
Joel Bellucci webmaster@hemoalliance.org 727-504-0491