October 2018 Newsletter

In this Issue…

Notes from Joe
· Collaboration, Communication and Progress

Washington Update
· Trump Administration Releases New Proposal on Medicare Part B Drug Reimbursement

Payer Update

Legal Update
· Recent HRSA Guidance on 340B Contract Pharmacies

Notes from the Community
· Maintaining Expert Care at Federally Funded Hemophilia Treatment Centers: Regional Core Center Oversight

Team Alliance Contact Information

Notes from Joe

By Joe Pugliese

The Alliance member meeting held September 23rd -25th is well in the rearview mirror. This is a shame because the survey results are in and it was frequently identified as the best Alliance meeting yet. It also set records for attendance both in terms of most attendees and most physicians. The memory lives on in the member’s section of the website, where you can find all of the slide presentations.

We thanked Kathy Stone, Oklahoma University Medical Center for her years of service to the community and the Alliance board. She is retiring (for real this time!) on October 31st. We had the good fortune to have a robust pool of candidates from our last call for new board member, in late 2017. To fill the slot, we decided to draw from that outstanding group of candidates and I am very excited to announce that Stacy Croteau, MD, MMS, Director of the Hemophilia/VWD Program at Boston Children’s Hospital will be joining the board in January 2019.

In early October, the community descended on Orlando for the newly named Bleeding Disorders Conference. It has long been my favorite meeting of the year and I think I have only missed two meetings in the last forty years. Everybody is there – patients, patient organizations, providers, specialty pharmacies, and manufacturers. The Alliance is well represented from the beginning to end of the meeting. From attending the state advocacy meeting on the Wednesday, through sponsoring the chapter luncheon on Thursday, visiting people at our booth in the exhibit hall, and we were well represented on the CCSC panel discussion on Saturday afternoon.

This year we helped sponsor the closing night event. Our banner hung from the ceiling in the ballroom:

I think this simple statement captures the reality of how critical the HTC network is to the larger community. It starts with the MCH grant, and it is supported by the regional core centers and the sub grantees around the country who commit to meeting and typically exceeding a uniform set of standards to earn the right to be recognized as a federally funded center.

We just returned from the 2018 ATHN Data Summit where over 360 physicians, clinical team members from HTCs, and government and private sector partners came together to share ideas, celebrate accomplishments, and collaborate to reach future goals. During the first day of the conference, we were honored to provide attendees with a Hemophilia Alliance Partner update.

“ATHN is grateful to partner with the Hemophilia Alliance to support the efforts of Hemophilia Treatment Centers,” said Crystal Watson, President & CEO, ATHN. “It was an honor to attend the Alliance board meeting last month and we very much appreciated Joe’s willingness to present at the ATHN Data Summit. We look forward to strengthening our partnership and continuing to work together to support data collection and quality at HTCs.” The organization is under new management with the promotion of Crystal Watson to President & CEO. She has great plans to build on the work started by Diane Aschman. You can learn about the 2018 ATHN award winners here.

Inside you will find a great summary of the role of the Regional coordinating centers, authored by Regina Butler, RN.

Next month we will highlight how all of this hard work pays off with an article summarizing the responses to the second national Patient Satisfaction Survey (PSS) disseminated by the US Hemophilia Treatment Center Network (USHTCN). The results will not be surprising.

Washington Update

Trump Administration Releases New Proposal on Medicare Part B Drug Reimbursement
By Ellen Riker

On October 25, 2018, the Trump Administration announced the release of an Advanced Notice of Proposed Rulemaking (ANPRM) on the “International Pricing Index” (IPI) Model. The Model outlined would be for Medicare Part B drugs and is a step in the Administration’s efforts to reduce drug prices. The ANPRM is open for comments until December 31, 2018.

A detailed summary of the Notice prepared by our firm is available here and a chart of the top Part B drugs likely to be included in the model if finalized is available here. No hemophilia treatments are currently included, but this model is in a very preliminary stage and will be released as a proposed rule open to comment in the spring of 2019.

Below is a brief summary of the potential components of an IPI model, based on HHS documents (more details in the links above):

  • Medicare will set Part B payments at a “Target Price” based on the discounts manufacturers offer in other countries – this is estimated to result in “roughly a 30% savings in total spending” for selected Part B drugs in the model
  • The model will be phased in over 5 years. It will launch in 50% of the country, with the “opportunity to scale up over time”
  • Provider payment would change from the current ASP add-on payment to a “set payment amount for storing and handling drugs that would not be tied to drug prices”
  • IPI Model participants would include physician practices and hospital outpatient departments (HOPDs) that furnish the model’s included drugs in the selected model geographic areas. Participation would be mandatory for these participants.
  • CMS is considering whether to also include durable medical equipment (DME) suppliers, Ambulatory Surgical Centers (ASCs), or other Part B providers and suppliers that furnish the included drugs in the model.
  • The IPI model proposes to initially focus on single source drugs and biologicals, and the model will include drugs that HHS “identifies from international pricing data.” HHS notes that the model “could over time include multiple source drugs and Part B drugs provided in other settings.”
  • CMS intends to use a “number of private sector vendors” to supply the drugs, take on the financial risk of acquiring drugs, and bill for the drugs. Medicare will pay vendors based on the Target Price, and vendors would have “flexibility to offer innovative delivery mechanisms,” such as electronic ordering
  • CMS will be considering stakeholder comments on these and other issues as it considers a proposed rule on the IPI model in Spring 2019

Payer Update

Payer Team Update
By Jeff Blake

The Payer Team has been very busy promoting Hemophilia Alliance Network Services (HANS) and our member HTCs with the payer community. The team provided several updates at the Fall Member Meeting related to Medicaid, our collaborative efforts with NHF and payer activities to support member HTCs. Below is a summary of the payer items presented at the meeting.

Jeff Blake presented the Medicaid update which focused on the development of a hemophilia disease management program (DMP). With the reduction of clotting factor reimbursement by Medicaid, the Team has focused attention on creating alternative payment methods for HTC integrated clinical care. The DMP model would provide HTCs to bill Medicaid either a per member per month fee or a capitated rate for integrated clinical care – physician, nursing, social work, physical therapy, care coordination and other related services. This fee would be over and above any clotting factor reimbursement. The program design is in its final stages and we are ready to pilot the program with interested HTCs and Medicaid Agencies.

Jeff Blake and Michelle Rice provided and update on the Hemophilia Alliance and NHF’s collaborative efforts with the payer community and HTCs. This collaboration brings together HANS (Hemophilia Alliance Payer Contracting wholly owned subsidiary) and the NHF CCSC Program (Comprehensive Care Sustainability Collaborative Program). Jointly, the Hemophilia Alliance and NHF have been meeting with payers to promote HTCs, the integrated clinical and pharmacy services, quality care and cost savings. We have submitted proposals to large national self-insured health plans and pharmacy benefit managers (PBMs). The proposals combine our national network of HTCs and their pharmacy programs through HANS and NHF’s CCSC data reporting elements by HTCs and payers to highlight the integrated care value and cost savings.

Jeff Amond and Mark Plencner presented our Payer Team update as it relates to working with HTCs and payers. They discussed the importance of the HTCs providing payer data by completing the Insurance Questionnaire and the Patient Clotting Factor Utilization Spreadsheet. The data provided by HTCs with these two tools helps create a strategy to work with key payers and bring more patients back to your pharmacy program. We encourage all members to work with Payer Team to complete Questionnaire and Spreadsheet. Jeff and Mark also highlighted our process of working with HTCs, payers and our successes to date solving insurance/payer issues to bring patients back to the HTC pharmacy programs.

If you would like to learn more about the Payer Team efforts and how we can work together on our payer relations and contracting efforts, please contact a member of the Hemophilia Alliance Team. Remember, WE WORK FOR YOU!

Legal Update

Recent HRSA Guidance on 340B Contract Pharmacies
By Michael Glomb

HRSA’s Office of Pharmacy Affairs (OPA), which oversees the 340B Drug Pricing Program, recently posted two items of note for HTCs that use, or are considering using, a contract pharmacy to serve their patients.

The first, entitled Best Practices for Covered Entities: Resolving Contract Pharmacy Related Non-Compliance, addresses situations in which an HTC could be responsible for repaying a manufacturer such as when the contract pharmacy dispenses a 340B-priced product to an person who is not an HTC patient or otherwise is ineligible for 340B drugs, or when the pharmacy has billed Medicaid in a manner that causes a manufacturer to be subject to a “duplicate discount.”

According to HRSA, these situations sometimes are resolved by the contract pharmacy and/or a third party administrator making direct payments to the manufacturers without alerting the covered entity to the problem or engaging the covered entity in the process. HRSA expressed concern about this practice because repayment could be made in ways that do not comply with HRSA policy, because the process may not be transparent to 340B stakeholders, and because HRSA believes that it is inconsistent with the requirement that a covered entity retain full responsibility for its vendors’ compliance activities. HRSA listed the following “best practices” to resolve non-compliance in the contract pharmacy setting:

  • In the event that a covered entity determines that 340B drugs have been dispensed to an ineligible person or that that a duplicate discount has occurred, it should work in good faith to resolve the issues directly with the manufacturer, including providing any necessary documentation as requested by the manufacturer. Material compliance breaches should be reported to HRSA.
  • If a covered entity wishes to reclassify a contract pharmacy transaction from 340B to non-340B, it should first notify the affected manufacturer and ensure that all processes are fully transparent and have a clear audit trail. However, drug transactions may be credited and rebilled through wholesalers according to standard business practices.
  • A covered entity should have written procedures for identifying eligible patients and meeting other 340B program requirements at a contract pharmacy and for resolving noncompliance, and the process should be spelled out in the pharmacy contract.

HRSA reiterated that a covered entity contracting with a third party, be it a pharmacy or a third party administrator, remains fully responsible for 340B compliance. Accordingly, while the “best practices” fall short of a requirement, HTCs are well advised to review their contract pharmacy agreements and operations for actual or potential compliance problems.

HTCs that are considering contracting with a pharmacy to dispense 340B product should pay particular attention to a posting entitled Program Integrity Analysis for Contract Pharmacy Registrations.

According to long standing HRSA policy, contract pharmacies, including all locations where 340B drugs may be dispensed, must first be registered on the HRSA Office of Pharmacy Affairs Information System (OPAIS). Further, a covered entity must have a written and signed pharmacy agreement in place prior to registering that pharmacy. Since contract pharmacies may be registered only during a two week window in each calendar quarter, and often are registered at the last minute, HRSA has found that registrations sometimes precede execution of the underlying contractual agreement.

To address this, HRSA has begun to request copies of the written contracts from some covered entities when a new pharmacy is registered. HRSA will review the contracts to confirm that the contract:

  • Is dated prior to the close of the registration period;
  • Lists all covered entity locations (which may include a blanket statement that the contract covers all registered covered entity locations) served by the contract pharmacy and all contract pharmacy locations, which should be an identical match to the registered addresses; and
  • Is signed by a covered entity official and a pharmacy official.

If any of these are missing, HRSA will request additional documentation through the 340B OPAIS and, if is not timely produced, the registration will be pushed to the next registration period, delaying the commencement of operations for an additional three months.

HTCs should regularly monitor the HRSA OPA website www.hrsa.gov/opa/updates for policy announcements such as these as well as their OPAIS dashboard and emails for other communications from HRSA/OPA.

Notes from the Community

Maintaining Expert Care at Federally Funded Hemophilia Treatment Centers: Regional Core Center Oversight
By Regina B. Butler, RN-BC, Director, Mid-Atlantic/Region III HTCs, Clinical Manager, Division of Hematology and HTC Nurse Coordinator, CHOP

The United States Hemophilia Treatment Center Network (USHTCN) was established in 1976 through federal grants from the Maternal and Child Health Bureau (MCHB) to provide comprehensive, family-centered care to individuals with hemophilia. Currently, MCHB awards funding to eight regional core centers (RCCs) with over 135 HTCs as sub awardees in the network. Outcomes for individuals receiving care within this network have been shown to be significantly better than for those cared for outside of the USHTCN.

In the over four decades since its inception, significant challenges have been faced, patient populations served have expanded, and treatment options and outcomes have undergone transformation. These challenges and advances in care have required that HTC staff continue to acquire new skills and maintain expertise, to provide current care using best practices, communicate regularly with collaborators at the national and regional levels, and engage in ongoing dialogue with patients and families to develop appropriate plans of care to promote optimal outcomes.

Maintaining high standards and assuring highly specialized, expert care within the HTCs is the major responsibility of the eight RCCs. National regional leaders from these RCCs, in collaboration with the National Hemophilia Program Coordinating Center (NHPCC) and MCHB, share goals, processes, and tools to carry out this oversight. MCHB grant guidelines and requirements, current literature and consensus from national expert panels, regional standards and policies, as well as MASAC guidelines are applied to each center as benchmarks for progress and adherence to all standards.

As the landscape for diagnosis and treatment of inherited bleeding and clotting disorders has changed so rapidly and the requirements from MCHB expand to meet current national public health goals, the oversight of HTCs has become more rigorous. While each region must adapt to specific diversity in population needs and challenges, RCCs continue to work together to share tools and strategies to maintain diligent oversight of the HTCs within their regions.

In collaboration with the NHPCC and MCHB, the USHTCN has completed a National Patient Needs Assessment, conducts National Patient Satisfaction Surveys biannually with HTC level data reported back to the RCC and the HTCs, collects and analyzes ongoing Patient Experience Surveys for patients 18-22 years, conducts Quality Improvement training, and provides ongoing technical assistance as needed to all HTCs in the network.

A typical approach to the monitoring needed to ensure HTC compliance with increasing requirements and standards encompasses an array of tools and many forms of communication and review by the RCCs.

Each region has the assistance of a Regional Executive Committee (REC), comprised of representatives from each care discipline as well as consumer representation. The RECs help the regions establish and enforce standards of care, minimum patient numbers, required staffing levels, including adhering to MASAC guidelines. REC policies include standards and procedures for adding HTCs to the region. The REC consumer representatives assist the region in eliciting feedback from patients and families to assist in improving care and access to care.

RCCs provide technical assistance and maintain communication with all of the HTCs through regularly scheduled regional conference calls, annual regional meetings, newsletters, web pages, frequent emails and calls, and staff training workshops. HTCs are required to participate in oversight measures by completing national data forms, such as the Hemophilia Thrombosis Data Set, detailed annual regional monitoring surveys and yearly progress reports, and submitting reports about Healthy People 2020 goals and MCHB Performance Measures. In addition, all HTCs have minimum standards for participation in the CDC Community Counts Program through ATHN.

Each RCC conducts regular site visits to the HTCs in their region and provides written reports, with action steps defined as needed with potential for follow up site visits. These visits include chart review, discussion about available treatment options, patient education programs, clinic hours and accessibility, assuring appropriate staffing to meet patient needs, participation in clinical research, meeting goals for Community Counts enrollment, product choice, and evidence of adhering to MASAC guidelines for treatment of patients with inherited bleeding disorders, including prophylaxis and inhibitor screening. Some regions use HTC Progress Reports to identify successes and challenges and chart progress within each HTC in meeting standards and goals.

Provider education is another key component of the role of the RCCs and the USHTCN. Annual Regional Meetings, enrollment in Partners programs, dissemination of information from the CDC, AHN, the NHPCC and MCHB, and new staff training and mentoring are examples of such support for providers to enhance their expertise.

MCHB requires that RCCs maintain fiduciary responsibility for oversight of Program Income from distribution of factor replacement products. RCCs collaborate with the Hemophilia Alliance in monitoring and supporting HTCs with 340 B programs.

RCCs remain available to support HTC teams in achieving goals and overcoming barriers to optimal care. This includes advocating for the HTC with their local institution and collaborating with consumer groups to assist with outreach or identified barriers to care for patients. An important role of the RCCs is to represent each HTC and all of the patients receiving care in their regions and to advocate for them to collaborators, government agencies, consumer groups, legislators and insurance companies.

As care for patients with bleeding and clotting disorders becomes more complex and as advances are made in the field, it is important to note that no HTC stands alone and that all patients are represented. The USHTCN leadership, in collaboration with MCHB, CDC and ATHN, is committed to set and maintain standards of care to assure that every HTC is providing expert, standard of care and helping their patients and families achieve their health goals with minimal disruption to their lives.

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