November 2019 Newsletter

In this Issue…

Notes from Joe
· Back to the Future

New Board Member
· Regina Butler

Payer Update
· Patient Data: Who Owns It, How Do You Use It, and Why Should You Care?

Washington Update

Legal Update
· Supporting Patients while Steering Clear of Fraud

Notes from the Community
· Update from the Hemophilia Alliance Foundation

Alliance Update
· Alliance Operations Update
· 2020 Meeting Schedule

Team Alliance Contact Information

Notes from Joe

Back to the Future
By Joe Pugliese

My September article talked about the seven founders whose vision created the Hemophilia Alliance. The Alliance was originally created as a 501(c)(6) trade organization in 1999. The concept as mentioned before was to pool the resources of centers around the country for the good of all the centers. The early organization did great work. The 340B Program was only seven years old. Recombinant factor products had just been introduced in the mid-90s.

The founders did a great job of identifying the opportunity this program created for all treatment centers. They also quickly identified a significant limitation to this type of organizational structure: FUNDING. Trade organizations are required to generate most of their revenue through membership dues. Members generally like lower dues versus higher, just like they generally like more services versus fewer.

The second thing they recognized was there was a significant opportunity to assist HTCs across the country by forming a group purchasing organization (GPO). The GPO was formed in 2005 as an independent 501(c)(3) organization. It launched (probably a strong word) January 1, 2006. The newly formed GPO had a board of seven and no participating members. The first HTC to formally become a participating member if the Alliance was the University of Pennsylvania. This center was quickly joined by CHLA, IHTC, HoG, Stanford, Western PA and 14 other centers. We sent out a request for proposals to all manufacturers in the middle of 2006. We got back thanks but no thanks from every manufacturer. The silver lining was we had it in writing from everyone that they had declined the opportunity. It was not until the middle of 2007 that we got our first contract of note. I always thank CSL Behring for making the Alliance possible, without their contract the Alliance as you know it today would simply not exist.

As it turned out, a 501(c)(3) cannot give money to a 501(c)(6), so in the spring of 2008 the boards of the Hemophilia Alliance and the GPO voted to merge the two organizations, dissolve the original 501(c)(6) and do business as the Hemophilia Alliance.

You will read inside about the announcement of the 2020 grant cycle for the Hemophilia Alliance Foundation. You will also read an update about the ATHN. I’m so pleased that we have been funding data managers through ATHN in support of HTC efforts for the last nine years. We provide significant support for patient advocacy. We have grown from Joe and Sean to a team of 13 employees and consultants and we will be adding additional capabilities in 2020 all in support of our member HTCs and in reality all of the HTCs across the country.

Last month, I talked about how transformative all the new therapies will be to our little community. When I started in this community in 1977, virtually all of the factor replacement products were dispensed out of HTCs across the country. As you think about the coming gene therapy products and the need for ongoing clinical care, I see us going back to the future if we want to maintain a vibrant and capable comprehensive hemophilia treatment center network.

New Board Member

Regina Butler
By Heidi Lane, Vice Chair and Chair of the Nominating Committee and Jennifer Borrillo, Chair

Regina ButlerThe mission of the Hemophilia Alliance is to work “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”. Per the Hemophilia Alliance by-laws, “The Board of Directors should, to the extent feasible, include members representative of the eight (8) regional networks of hemophilia treatment centers, types of programs, expertise, and experience."

We want to sincerely thank all of the recent applicants for their interest in serving on the board of the Hemophilia Alliance. Each applicant possessed experience and expertise that would prove an asset to the board. We thoughtfully reviewed and considered all applicants in the context of our mission and by-laws, in conjunction with the current make-up of the board, seeking to broadly represent our membership, while diversifying our expertise and insight in order to be able to more strategically address the future challenges faced by HTCs.

We are pleased to announce Regina Butler, RN-BC has been elected to serve on the board, beginning January 2020. Regina is the Clinical Manager in the Division of Hematology at the Children's Hospital of Philadelphia, the HTC Nurse Coordinator and the Regional Director of the Mid-Atlantic Region III HTCs. Regina brings to the board practical, clinical knowledge and expertise in collaboration, commitment and leadership, from nursing, HTC and Divisional administration, and from regional and national leadership roles. Examples of committee and leadership roles Regina holds or has held include:

    Director, Mid Atlantic/Region III Federally funded HTCs (2008 – present)

    Co-Chair, U.S. HTC Leadership Committee

    Founding Member and former chair NHF Nursing Committee

    NHPCC Access to Care Committee

    Board of Directors, Delaware Valley Chapter of NHF (former)

    Chair, World Federation of Hemophilia Nursing Committee (former)

    ISTH Nursing Committee

    Chair, NHPCC Needs Assessment Committee (former)

    NHPCC Quality Improvement Committee (former)

    HTRS Membership Committee (former)

Again, we sincerely thank the numerous individuals who applied to serve on the board. We are heartened by the growing interest of our community members in serving on the board and encourage our many qualified applicants to consider reapplying when new openings occur. We may be reaching out to several of you to assist in serving the Alliance in other ways. The next board opening is January 2021. We plan to announce a request for applications during our Fall Member meeting 2020. Finally, Happy Holiday Season to all!

Payer Update

Patient Data: Who Owns It, How Do You Use It, and Why Should You Care?
By George Oestreich

As is routine for any patient visit, the provider obtains patient-specific information, both demographic and clinical, and preferably saves the patient information in an electronic health record (EHR) system. This information is used to develop plans of care, continue treatment and track the health trends of the patient. The patient owns this collection of protected health information (PHI) while the record itself is owned by the provider or treatment site (the Center). The Center will typically ask the patient to sign a waiver to legally enable sharing the PHI with specified family members and to authorize its use for billing the provider’s products and services. Some providers are reluctant to share patient data, even with another provider. This may stem from a belief that if the data is shared, the patient may take it to another provider. Alternatively, the treating provider may believe that the PHI data belongs to them, not just the record.

It is time to revisit data sharing policies and issues. The review should include the data that is collected, stored, and shared with other parties. The healthcare industry is entering a brave new world that uses alternative payment models (APM). Two APMs being increasingly utilized are value-based reimbursement (VBR) and value-based purchasing (VBP):

Value-based reimbursement (VBR) is the payment model for medical services that is gradually replacing the traditional fee-for-service model for payers and healthcare organizations. The goal is to cut rising healthcare costs by switching from a model based on quantity of units delivered to value-based reimbursement, which is based on quality. The quality can be subjective or in some cases objective depending on the disease state treated (i.e., pay based on the number of diabetics in a physician panel that are at their A1C goal). This attempts to link quality of case to the best performing providers. This also assumed that the level of effort is the same for all chronic disease and if not how you rank the effort and the relative value.

Value-Based Reimbursement (VBP): Linking payments to improved performance or efficacy of drug products. This form of payment holds manufacturers accountable for the cost of their products in the context of the efficacy the products produce in treating a chronic disease in a patient panel. The most prominent example was promoted by the SmartD program and produced the “Netflix” like pricing or aggregate pricing from Hep C drugs to the populations of patients with the disease. Example: the drug cures HepC in 85% of patients, the challenge is making sure the patients take the medication and that they are not reinfected. Also often a problem is defining what “cure” is in the contract.

These program management tools are ever more frequently being utilized by both state and federal payers as well as by the private sector payers. There are 40 states with Medicaid managed care and 28 of them now require VBR. The number of payers using VBP is also growing quickly. All of these program management tools rely upon an interface with the patient’s PHI.

It is imperative to accurately and consistently collect, record, store and share PHI with other healthcare delivery participants for the mutual benefit of all parties. Accurate data is keenly important to properly reflect the clinical information and thus receive adequate reimbursement for provided products and services. The future will rapidly continue to emphasize the use of clinical data interfaces.

It should also be emphasized that this data is still subject to the Health Insurance Portability and Accountability Act (HIPAA) legal requirements. Serious penalties will accrue if violations are found by federal and state regulatory reviews. The vast majority of data that may be used in VBR/VBP is deidentified, but the new HIPAA guidelines may be more stringent than before when considering small populations with special health needs.

Healthcare providers will begin seeing their reimbursement based on patient outcomes established from collected data. The data may be used to produce comparisons between peer providers or simply compare trends for chronic diseases. The efficacy of products is also subject to pricing established from data trending. With the new highly expensive products this form of contracting will only increase.

With the effective use of data and an understanding of the process of VBR, the Center will be prepared for the future APM. Appropriately following your patient’s data will also support the integrated comprehensive care model, increase their positive outcomes and aid in the benefits of monitored transitional care. The data supporting the quality of the Center’s care leading to fewer bleeds, tight assay management, and less tertiary care with overall better outcomes puts the Center in a position to support higher reimbursement.

It’s time to start loving your data, whether it is subjective or objective, clinical notes, or units of a product dispensed by the pharmacy. It is also a good time to scrutinize the data you do collect so you can get the most value for your effort and have it tell a positive story about the Center. Collect, record, and verify the accuracy of your data to increase its benefits and prepare the Center for the future shift around data in healthcare. Remember, if it’s not written down, it’s not really “done”. Without the recorded data you have no story to tell.

Washington Update

By Johanna Gray and Ellen Riker

Drug Pricing
Congress has been working for the last several months to consider comprehensive drug pricing proposals –there are three main versions that have been released by the Senate Health, Education, Labor and Pensions (HELP) Committee, Senate Finance Committee, and House Democrats. The House version (HR 3) has passed out of all three House Committees and was expected to be voted on by the full House earlier this fall, but the timing keeps being pushed back – now to December. On the Senate side, the Finance Committee is working on a new draft of their bill and the staff said in a recent meeting that they are trying to strengthen the bill’s benefits for patients. We will review this new version and will assess its impact on HTCs and the bleeding disorders community.

Congressional staff are hoping to reach agreement on drug pricing so that policies could be included in an end-of-the-year package in December (see below for more details). But it remains unclear if there is enough support for any proposals to pass either chamber, much less consensus on a set of policies that could have enough support to pass both chambers and be signed into law by President Trump.

Congress has not been able to pass full-year funding bills yet, but rather has passed two short-term continuing resolutions (CRs). The current bill to fund the government goes until December 20th. The sticking points have been that the House and Senate can’t agree on the top-line funding levels for each bill (how much is allocated to the Labor-HHS-Education bill vs. the Defense bill) nor how to handle a handful of difficult policy issues, such as the border wall and family planning funding. Congressional leaders are continuing to negotiate and hope to agree on these sticky issues so that they can pass negotiated bills before the end of the year (rather than another CR). These bills would provide funding for the federal hemophilia activities at the CDC, HRSA and NIH for the rest of the year. These bills are also the likeliest vehicle for drug pricing and other policies that Congress wants to enact this year.

CMS Releases Final Hospital Outpatient Payment Rule for 2020 with 340B Cuts
The Medicare Hospital Outpatient Prospective Payment System Final Rule was released on November 1, 2019. Included in the rule is a provision to extend the reduction in payment for 340B drugs at ASP-22.5 percent for 2020, for drugs furnished in hospital outpatient departments and off-campus provider-based departments (non-excepted). Critical access hospitals, rural sole community hospitals, children’s hospitals and PPS-exempt cancer hospitals remain excepted from the payment reduction. Hospitals subject to the payment reduction must continue to use claim-level modifiers when 340B drugs are used.

This policy is currently subject to a lawsuit, which CMS is appealing. CMS decided to continue the payment reduction until the court decision is finalized. The agency plans to survey hospitals on actual acquisition costs for 340B drugs shortly and states that it is relying on this survey to establish an alternative to ASP-22.5 percent or use another option such as ASP+3 percent, depending on the outcome of the court case.

Legal Update

Supporting Patients while Steering Clear of Fraud
By Elizabeth “Issie” Karan

Hemophilia Treatment Centers (HTCs) often want to give their patients things they need to be, and stay, healthy. However, anytime a health care provider gives Medicaid and Medicare beneficiaries something of value, they implicate the Beneficiary Inducement Prohibition of the Civil Monetary Penalties Act (CMP Law). Luckily, the CMP Law contains exceptions. The Hemophilia Alliance tries to make HTCs aware of exceptions which may enable them to assist their patients, as envisioned by the comprehensive care model, without compromising compliance. In this article, we are providing background on the financial need exception to the CMP Law.

Section 1128A(a)(5) of the Social Security Act prohibits providers offering inducements to Medicare and Medicaid beneficiaries which may encourage them to utilize that provider’s services over others. This law provides for imposition of a civil monetary penalty against any person who provides remuneration to a Medicare or Medicaid program beneficiary that the person “knows or should know” is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of any item or service for which payment may be made, in whole or in part, by Medicare or Medicaid. The penalties under this law are steep. The civil monetary penalty for each violation of § 1128A(a)(5) is $10,000, plus treble damages.

Remuneration is defined broadly to include “the waiver of coinsurance and deductible amounts (or any part thereof), and transfers of items or services for free or for other than fair market value.” Thus, because remuneration includes both services and goods, almost anything may be viewed as remuneration. The OIG recognizes that free equipment would be particularly beneficial to those with acute health conditions, but states that chronically ill beneficiaries also generate the most business, thus making it more attractive for providers to offer inducements to those patients.

Inducement includes “any offer of valuable goods and services as part of a marketing or promotional activity.” Marketing or promotional activity includes passive marketing, meaning that even something that is not advertised but becomes known via word of mouth is considered an inducement. The “should know” requirement for inducement does not require specific intent and is met when a provider acts with deliberate ignorance or reckless disregard.

The CMP law contains an exception for the provision of goods or services to financially needy patients under certain circumstances. Section 1128B(A)(i)(6)(H) of the SSA, and related regulations at 42 C.F.R. 1003.110, allows for the provision of items or services for free or less than fair market value if:

  1. The items or services are not advertised or tied to the provision of other items or services reimbursed by the Medicare and Medicaid program;
  2. There is a reasonable connection between the items or services and the medical care of the individual; and
  3. The recipient has been determined to be in financial need.

In the preamble to the rule finalizing this exception, the OIG provided additional guidance on each provision. In particular, the OIG explained that an item must have a reasonable connection to medical care but cannot be contingent on the provision of a particular item or service. For example, although another exception may apply, the provision of diabetes testing strips to a financially needy patient may be appropriate under this exception but not if provided only in conjunction with refills of diabetes medication. Similarly, assistance getting to appointments would not qualify under this exception. In these examples, the discounted supplies and services are only provided if the patient is obtaining other services from the provider.

With regard to being reasonably connected to medical care, the OIG noted that the provision can be interpreted broadly, including the prevention of illness or injury and for safety. The OIG stated that medical professionals are generally in the best position to determine if a reasonable connection exists but cautioned against outlandish interpretations, such as providing tickets to entertainment to a depressed person or sporting equipment to an overweight individual.

HTCs wishing to use this exception should put in place policies and procedures for determining financial need and meeting the other criteria of the exception. Although this exception could be quite useful and flexible, each patients’ specific situation should be evaluated to ensure the exception is being appropriately applied.

As always, if you have questions, please contact HA’s legal team.

Notes from the Community

Update from the Hemophilia Alliance Foundation

A friendly reminder that the Hemophilia Alliance Foundation will be posting its 2020 Grant Guidance online at on December 5, 2019! Since 2009, the Alliance Foundation has awarded over $4 million to help 140+ chapters, treatment centers, and national community organizations build capacity and support and expand their missions. Successful applications for both projects and patient assistance programs should demonstrate clear, measurable outcomes and a strong commitment to the bleeding disorders community. Hear from one of our grant recipients below:

"The Virginia Hemophilia Foundation (VHF) is stronger and well-positioned for future success because of the ongoing support of the Hemophilia Alliance Foundation. With their support, VHF has been able to enhance the education that is offered to constituents, ensure that board members are trained and skilled to lead the organization, guarantee that equipment and supplies are available to increase awareness of inherited bleeding disorders, and provide qualified facilitators to lead strategic planning sessions." – Kelly Waters, Executive Director, Virginia Hemophilia Foundation, 2019

Organizations interested in submitting applications should review the Grant Guidance thoroughly before finalizing their applications as there are several changes to this year’s application. Applications must now be submitted electronically via a SUBMIT button at the bottom of the application. This new system will allow for applicants to immediately receive an automated acknowledgement of receipt of their application. Please note that applications submitted as an attachment to an email will not be considered.

If your organization—or an organization you know—is interested in applying but feels like it does not have the capacity or expertise to do so, please reach out to us at! We can direct you to additional resources that will help you submit a strong application.

Alliance Update

Alliance Operations Update

Data Portal
We have started to roll out the new Data Portal for reporting member purchases. Theresa Parker will be reaching out to centers with information on how to use the portal and input data. We will share a short video and written instructions that show the steps on how to use the system. If you would like to utilize the portal now, please contact Theresa at

Spring Members Meeting and Hill Day
Our 2020 meeting schedule is coming together. We have our Spring meeting and Hill Day set for March 29th to 31st in Washington DC. Information on the meeting including Registering and the link to make hotel reservations is available here.

Member HTC contact information
We try to stay current with any staff changes you have at your center in order to get you pertinent information in a timely manner. We recently received a large batch of “no longer here” responses from an email campaign. Please click here to update the contact details for team members at your center.

Chapter Outreach
The chapters continue to be a great resource for our community and we are always looking for ways to work with and support them. Part of our 2020 vision is working with the chapters to advocate for our community and to help bridge the gap between the HTC and chapter. Recently we partnered with our members in the New England area to attend New England Hemophilia Association’s (NEHA) meeting in Rhode Island on their behalf. This gave the HTCs a voice in a space where they might not have been able to be heard in the past. We attended the Advocacy meeting with the South Carolina Chapter. We will be representing Maine Hemophilia and Thrombosis Center (MHTC) at the Hemophilia Alliance of Maine’s Winterfest in December. Please feel free to reach out to our team members regarding any opportunity our members or chapters feel would be helpful to the community.

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2020 Meeting Schedule

  • Board Retreat: January 12th to 14th
  • Social Worker Conference: February 26th to 28th
  • Spring Members Meeting: March 29th and 30th
  • Hill Day visits: March 31st
  • Fall Members Meeting: To be announced

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 215-439-7173
Sean Singh 727-388-7326
Jeff Blake 317-657-5913
Jeff Amond 608-206-3132
Karen Bowe 717-571-0266
Johanna Gray, MPA 703-304-8111
Kiet Huynh 917-362-1382
Elizabeth Karan 612-202-3240
Kimberly W. Lackman 813-400-6710
Roland P. Lamy, Jr. 603-491-0853
Dr. George L. Oestrich, Pharm.D., MPA 573-230-7075
Ellen Riker 202-257-6670
Mark Plencner 701-318-2910
Michael B. Glomb 202-466-8960
Theresa Parker 727-688-2568
Joel Bellucci 727-504-0491