June 2019 Newsletter

In this Issue…

Notes from Joe
· Checking in, Halfway Through the Year

Legal Update
· To Contract, or Not to Contract – It Depends

Washington Update
· Update on Alliance Advocacy Activities

Payer Update

Notes from the Community
· Update from the Hemophilia Alliance Foundation
· Reminder about 340B Conference

Team Alliance Contact Information

Notes from Joe

Checking in, Halfway Through the Year
By Joe Pugliese

We are quickly approaching the half-way point of 2019. The Alliance Board, staff and consultants met in January to set the strategic goals for the year and now seems like a great time to update you on how we’re doing. It is also a good time for you to share with us how you think we are doing! The Alliance started with simple premise that by banding together federally-supported HTCs would be able to use their collective purchasing power and expertise to enhance their ability to care for patients in the bleeding disorder community. Initially, staffing and resources were limited. Over the last 20 years, we have gone from a single person to a full-time staff of 5 (soon to be 6), with an additional 6 part-time or contracted people. We effectively have about 7-8 full time equivalents. We break this massive organization up into four units and everyone works cross functionally.

Group Purchasing Organization: We have gone from having a single contract in 2007 to having agreements with every relevant manufacturer in our space. Over the last six months, we have added a lab testing contract and a nursing services agreement, which like all of our other are designed to assist our membership. We have reached out to the Sickle Cell community and are looking for opportunities for those patients to benefit from the comprehensive care model that has served the bleeding disorders community since 1975. Finally, we are having ongoing discussions with the manufacturers in the gene therapy space and assessing what we will have to do to be a good partner in bringing these new therapies to the community.

Payer Activities: Our payer team and activities have grown in recent years. Jeff Blake joined us in 2016 to head up our payer team and we created HANS (Hemophilia Alliance Network Services) in early 2017. HANS is a wholly-owned subsidiary of the Alliance, whose sole purpose is to give us a vehicle for facilitating contracting with payers on behalf of HTCs who are Alliance members. What used to be a trickle of opportunities from payers and brokers has turned into a steady stream of inquiries. They want to use the HTC network and their pharmacy programs to deliver best in class clinical care, produce the best possible outcomes for the patients, and save patients, employers and insurers money. We will be rolling out a preferred provider network before the end of the year to facilitate this process. There will be webinars on July 24th and August 15th at 2pm eastern discussing plans for national implementation (read on for more info).

Advocacy/Legal: Our Washington Bureau provides you with top notch legal and advocacy advice. The legal team provides a timely update on the ins and out of contract pharmacy services later in this issue. Their thoughtful and through explanation regarding what is program income and how you can spend it, is available 24 /7 in the members section of the website. Our advocacy team is on top of all the legislative and regulatory issues that could affect your center’s ability to participate in 340B or affect access to insurance and coverage for your patients. They are also leading the charge on trying to improve access to skilled nursing facilities (SNFs) for our patients on Medicare (read on for more on that).

Marketing/Communications: Sean Singh heads up our marketing and communications group. They have been leading the charge on updating the website to make it easier to use and access. The home page features a number of videos from community members that clearly lays out the case for supporting HTCs. We have just recently got agreement from some of our manufacturing partners to post recordings of their webinars in the members section so they can be accessed 24/7 just like our in-house webinars and member meeting presentations. The operations team is also in the forefront of our initiative to attend chapter meetings across the country.

We have heard from all corners of the community that the new and novel technologies that are here already or coming soon are changing the face of the community. Beyond questions raised by HTCs and patients, we have heard that some specialty pharmacies are less than happy about the economics of providing new therapies. If you are one of those pharmacies, please send the patient to their local HTC. HTCs don’t discriminate against patients based on the economics of providing them the product their physician prescribes. They will always find a way to serve each patient and will gladly take any patient a Specialty Pharmacy doesn’t want to service.

Legal Update

To Contract or Not to Contract – It Depends
By Mike Glomb

HTCs, like all other 340B covered entities, may contract with an appropriately licensed pharmacy to dispense drugs to the covered entity’s patients. This often is an effective way for an HTC to provide better access to pharmacy services for its patients. Further, in the event that an HTC does not operate its own dispensing pharmacy, contracting with a licensed pharmacy may be the only way for it to participate in the 340B program and generate savings that can be used to promote patient care.

HRSA has published guidelines for covered entities to follow in contracting with a pharmacy to dispense 340B drugs. The guidelines assume that the 340B covered entity and the pharmacy are separate and independent legal entities, both with the legal capacity to enter into a binding contractual relationship. That is not always the case with HTCs that are part of a larger institution.

For example, a hospital/health system that has a grant to operate an HTC may also operate an in-house pharmacy that serves the HTC’s patients. The pharmacy and HTC may operate as separate divisions of the hospital, as separate cost centers, and under entirely different management authority. But, unless either the pharmacy or the HTC are organized as an independent legal entity, such as a corporation or Limited Liability Company (LLC), they do not have the legal capacity to contract with each other. Put another way, from a legal perspective they are one legal entity, and an entity cannot contract with itself.

Why is this important? 340B contract pharmacies typically charge a dispensing/service fee to a 340B covered entity. While these are negotiable, the extent of which depends on the circumstances. The fee, set at fair market value, always will include some element of profit for a commercial pharmacy. In contrast, the federal grant administration regulations do not allow grantees to make a profit on their grant-supported activities. Using the previous example, the hospital would be allowed to cover its pharmacy’s reasonable overhead costs in dispensing to HTC patients, but could not earn a profit.

In the situation where the pharmacy and the HTC are both part of the same legal entity, characterizing the relationship between the HTC and the pharmacy as a “typical” 340B contract pharmacy arrangement, with fees comparable to what a commercial pharmacy might charge, does not change the result. As a matter of law, if there is no separate legal entity with which to contract, there can be no contract. And the applicable grant administration rules apply. For that reason, HRSA does not require a “contract” between a covered entity and a pharmacy when both are part of the same legal entity.

That is not to suggest that an HTC may ignore appropriate oversight of its “sister” pharmacy if it is part of the same legal entity. An HTC should have written policies and procedures, expressed in an MOU or similar document, addressing inventory management, patient eligibility documentation, service/overhead charges, and the like, and have written policies and procedures for overseeing the pharmacy’s handling of 340B drugs dispensed to HTC patients.

For more information, contact Elizabeth “Issie” Karan at ekaran@FTLF.com or Michael Glomb at mglomb@FTLF.com.

Washington Update

Update on Alliance Advocacy Activities
By Johanna Gray

It has been a busy summer so far in Washington! Here is a brief update on a few Alliance advocacy activities:

Senate HELP Committee Health Care Costs Bill: In May, the Senate Health, Education, Labor and Pensions (HELP) Committee released draft legislation with a number of policy ideas to reduce health care costs. The policies seek to reduce drug costs and increase transparency for consumers and include a number of policies of interest to HTC. Interestingly, the draft bill does not include any provisions related to the 340B Program, though we understand that Committee staff are still working on a policy that would require hospitals to report information related to their 340B pharmacy programs, which could be included in the next draft of the bill. The Alliance submitted a letter to the Committee with feedback on the draft bill and met with Committee staff to discuss the proposal. The HELP Committee is expected to release a new version of the bill and potentially hold a markup to begin the legislative process before Congress heads out for its Fourth of July recess. Other Congressional Committees are working on their own proposals to address health care costs, as well. We are closely monitoring all of this activity and will update Alliance members as the process continues.

Skilled Nursing Facilities (SNF) Access for Medicare Beneficiaries with Bleeding Disorders: For the past several months, the Alliance has been working with NHF on an initiative to facilitate access to SNFs for Medicare beneficiaries with bleeding disorders. Since SNFs can’t bill separately for bleeding disorders treatments like other care settings, many HTCs have had problems placing patients in SNFs after surgery. We have been tackling this in several ways: meeting with senior staff at CMS to discuss whether the agency has discretion to change the policy; submitting a comment letter on a recent SNF regulation; and meetings with many Congressional offices to discuss legislation, since we believe that Congress will likely need to act to give CMS authority to make the change. As part of our broader strategy, we have also been working on a survey of HTCs to better understand your experiences with this issue. Please keep an eye out for the survey, which will be sent out by the Alliance and NHF soon.

Payer Update

By Jeff Blake

Over the last two years, the Payer Team has been meeting with a variety of payers (insurance companies, third party administrators, insurance brokers and consultants, pharmacy benefit managers, Medicaid agencies, Medicaid managed care organizations, employer health care coalitions and stop loss/reinsurance carriers). We have been marketing the value of the HTC integrated clinical and pharmacy services model to these payers and we have been successful in bringing pharmacy business back to HTC pharmacy programs. Our goal in 2019 is to be even more successful.

At our 2019 Strategic Planning meeting in January we set a goal to develop and implement a National HTC Centers of Excellence Preferred Provider Network. This network will be managed by Hemophilia Alliance Network Services (HANS), a wholly owned subsidiary of the Hemophilia Alliance. What does this mean for member HTCs?

  1. We will have a “formal” national network of HTCs and their pharmacy programs specifically for clotting factor dispensing. The HTC and HANS will sign a Preferred Provider Network Agreement that will allow HANS to contract with payers that you have not been able to access.
  2. It will allow HANS to respond to payer requests and payer RFPs more quickly and with standardized terms and provisions.
  3. It will bring more pharmacy business back to your program.

Why would a payer want to contract with HANS?

  1. There would be only one contract with HANS and no need to contract with each individual HTC.
  2. There would be common provisions for claims filing, payment, etc.
  3. Better management of bleeding disorder patients with an HTC fully integrated clinical and pharmacy services model of care.

When will HTCs be contacted to learn more about this Preferred Provider Network Agreement?

  1. We have completed a draft of the Agreement and are currently receiving input from our Board Members.
  2. We will be hosting webinars on July 24th and August 15th to provide more details. Look for the email announcing the webinars and registration.
  3. Hemophilia Alliance team members will be contacting our members individually in the late summer and early fall to provide additional information, review the Agreement and sign the Agreement.

We look forward to continuing our efforts to expand the number of patients your pharmacy program can provide service to and working with you on your payer goals.

Notes from the Community

Update from the Hemophilia Alliance Foundation
By Susan Karp, R.N.M.S., Chair

I recently retired after thirty-nine years as the Nurse Coordinator at the University of California, San Francisco, Hemophilia Treatment Center, a large HTC and tertiary care center caring for both children and adults. During my long tenure in the bleeding disorders community, I served in many roles including Chair of the NHF Nursing Committee, camp director and infirmary director at our local summer camp, membership on the local Ryan White HIV Planning Council, board member of our local NHF chapter, and membership on many other local and national committees. In these varied roles I saw the multiple needs of patients and their families, chapters, and treatment centers. I was delighted to be asked to join the Hemophilia Alliance Foundation Board in 2013. The community has many unmet needs and the financial assistance that the Foundation is able to provide is extremely important.

Joe Pugliese, CEO of the Hemophilia Alliance, had a vision to share the Alliance’s discretionary funds with organizations serving the bleeding disorders community. In 2009, a Hemophilia Alliance Grants Board was established and grants totaling $250,000 were awarded to national and regional organizations as well as local consumer organizations and hemophilia treatment centers. In 2013, the Hemophilia Alliance Foundation was incorporated as a nonprofit corporation.

The Foundation has a volunteer board of directors with eight members from diverse disciplines, geographic areas, and perspectives of the bleeding disorder community. Besides myself, they are: Brenda Riske, MS, MBA, MPA, Denver, CO; Crystal Sallans, LCSW, Houston, TX; Anjali Sharathkumar, MBBS, MD, MS, Iowa City, IA; Michael Craciunoiu, Vice President, Chapter Development, NHF; Stephanie Raymond, Executive Director, Cascade Hemophilia Consortium, Ann Arbor, MI; Amy Marquez, Pharmacy Supervisor, Fairview Pharmacy Services, Minneapolis, MN; and Maria Manahan, formerly Chief Executive Officer, Hemophilia of Georgia, Atlanta, GA. The Foundation also benefits from the donated services of the Alliance’s President, Joe Pugliese, and Vice-President, Sean Singh. Audra Ames and Joel Bellucci provide administrative support and web services, respectively. We are excited that Joyce Strazzabosco, retired Chair of the Foundation, is continuing on as a consultant in 2019.

We are looking for a couple of additional board members in 2019. If you are interested, please see the application available here, which has more details. The deadline is July 15th.

The Foundation receives its funds primarily from the Hemophilia Alliance as well as a generous contribution from The Alliance Pharmacy. In addition, some independent donors have expressed interest in contributing to the Foundation. One of our goals is to determine how to best fund raise in order to continue to provide awards to the needy organizations that apply with the hopes of increasing our grant award dollars in future years.

In 2019, the Foundation awarded grants to 80 organizations totaling $747,000. The organizations range from local chapters and treatment centers to regional and national organizations. These awards serve to strengthen chapters’ infrastructure, fund educational programs and patient and family retreats, allow consumers and providers to attend regional and national meetings, and provide funding to needy individuals and families in the bleeding disorder community through chapter Emergency Assistance Programs. The Foundation has also been able to provide emergency assistance funding to chapters where families have been impacted by natural disasters.

For 2019, chapters and treatment centers are eligible to apply for grants up to $8,000 while national organizations and the eight federally-designated regional hemophilia centers are eligible for grants up to $10,000. Joint projects between treatment centers or between chapters and treatment centers are encouraged, and funding may be awarded to each entity, i.e. a chapter and a treatment center doing a joint project may apply for $16,000. Chapters may apply for funding for projects or for patient assistance funds or a combination of both.

As with any young organization, the Foundation continues to learn and grow. We continue to revise and simplify the application process as well as provide assistance to applicants who request help with the process. We strive to make the process as simple as we can while assuring we receive the information necessary to meet our obligations as trustees and to assure fair and unbiased decisions. The Grant Guidance and application are posted on the Hemophilia Alliance Foundation website each December 1 and applications are due January 31. The award period is April 1 to March 31. People hearing about the Foundation for the first time are encouraged to go to our website and download the Grant Guidance. The Guidance contains information regarding the application process as well as contact information should the applicant have further questions.

I am excited to be Chair of the Foundation and I am so proud of all the work that we do. We are able to provide much needed support to multiple organizations and this support makes a difference in the lives of so many people – both the consumers and the providers serving the bleeding disorder community.

Reminder about the Upcoming 340B Conference

A friendly reminder that the 2019 340B Coalition Summer Conference in Washington is right around the corner. At the conference, you will get up to speed on the latest developments around 340B drug pricing transparency, HRSA 340B audits and other federal oversight activities, explore the latest trends in contract and specialty pharmacy, access the resources and advice you need to run your 340B programs effectively, and hear about some of your peers’ innovative approaches to patient care.

In addition, you will have the opportunity to discuss specific issues faced by hemophilia treatment centers in the hemophilia treatment center breakout session led by Hemophilia Alliance staff. There will also be a track dedicated to Policy and Compliance. The Alliance is also holding a networking dinner at the Stone’s Throw Restaurant in the Wardman Park Marriott at 6 pm on Monday, July 15th. Please RSVP to Joe (joe@hemoalliance.org) if you would like to attend.

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 ekaran@feldsmantucker.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