In this Issue…

Notes from Joe
· Working Together to Maintain Gold Standard Care

Washington Update

Legal Update
· HHS Rescinds Advisory Opinion after Court Describes 340B Statute as Ambiguous as to Contract Pharmacies

Payer Update
· Hemophilia Treatment Center (HTC) Revenue Cycle Survey Response Reminder
· Cost of Dispensing Survey: We Need Your Help!

Alliance Update
· Update on Alliance Data Portal
· Harmony in Hemophilia Update

Team Alliance Contact Information

Working Together to Maintain Gold Standard Care
by Joe Pugliese

Last month, we focused on the mission of the Alliance and the provided background on the restrictions and requirements for recipients. This month, I want to discuss a few different areas where we can all work together to ensure that our gold standard clinical care can be maintained.

First, HTCs cannot hope to continue to produce the best outcomes if they do not listen to their patients. Accordingly, we’re delighted to promote participation in the Third National HTC Patient Satisfaction Survey (PSS), which you can find at: www.htcsurvey.com. We hope all HTCs and chapters will encourage their patients and members to take advantage of this opportunity to talk to their providers. The deadline for the PSS is August 31, 2021 and the goal is to have more than 5000 patients from more than 90% of HTCs. The deadline is extended to give the largest possible numbers of HTC bleeding disorder patients/caregivers the chance to take the survey. It will also give additional time for our partners to spread the word. The Alliance has been providing financial support for the regional core centers for the last decade, through the annual Hemophilia Alliance Foundation grant funding.

Secondly, we all recognize the urgent need for a sufficient pool of healthcare professionals to maintain and expand patient care. Beyond the day-to-day clinical care, we also need to fund ongoing research for the bleeding disorders community. The Alliance is pleased to have participated in the HTRS research colloquium. The Resource Center for the virtual HTRS Research Colloquium: “Developing a Sustainable Research Career in Hemostasis and Thrombosis,” is now open. The Resource Center includes all full session recordings as well as the Meeting Booklet and we are pleased to be able to share this with Alliance members. To access, please visit: https://na.eventscloud.com/HTRS2021RC/ and use Username: HTRS and Password: HTRS2021.

Additionally, the Alliance has provided funding to ATHN since 2011 in support of the ATHN Data Quality Counts program. This important program provides funding to support data managers at HTCs to expand the amount of data contributed to the ATHNdataset and enhance the quality of data collected. Recently, we turned to ATHN to address a few questions related to our work on a new option for DDAVP intranasal spray. Although the data was helpful, it was clear that it did not represent the full complement of DDAVP related data in our US population. This highlights the fact that we need more participation in the ATHNdataset. Again, we encourage HTCs, chapters and individual patients to actively participate in contributing data to the ATHNdataset. It helps us all make better and more timely decisions about how to ensure we how we allocate the resources we have ensure the best outcomes for the community today and in the future.

Finally, we will have a DDAVP intranasal spray available for patients in at least 30 states by the end of July. Details about how to order the product and what we can do to facilitate reimbursement will be forthcoming. The product was made possible by the Alliance Board investing in funding the start-up costs associated with developing the product.

▲ Top

by Johanna Gray

It’s shaping up to be another busy summer in Washington! Here are a few quick updates about recent issues we’ve been tracking:

• California v. Texas: On June 17th, the United States Supreme Court released its opinion in the California v. Texas lawsuit challenging the constitutionality of the Affordable Care Act (ACA). In a 7-2 opinion, the Court dismissed the lawsuit based on no one having standing to bring the suit; basically, they found that no one could prove harm from the continued existence of the individual mandate since the penalty was zeroed out in the 2017 tax reform law. This is the third time that the Court has upheld the ACA. While there may be additional challenges in the future, the bleeding disorders community can rest easier knowing that the ACA will remain the law of the land.
• Drug Pricing Policy Heats Up: The Congressional debate over drug pricing reform has continued into the summer. We recently met with staff of the House Energy and Commerce Committee (one of the key House committees who will be involved in negotiating a drug pricing policy) to talk about the importance of 340B to covered entities, including HTCs. On the Senate side, Chairman Ron Wyden (D-OR) recently released principles that he will use to draft what he hopes will be bipartisan legislation that the Senate Finance Committee can consider this summer. Senator Wyden is the chair of the Senate Finance Committee, which has jurisdiction over Medicare and Medicaid, and he was also the author (with then-Chair Senator Chuck Grassley (R-IA)) of the only bipartisan drug pricing legislation to be considered last Congress. Any chance for meaningful drug pricing reform this Congress will go through Chairman Wyden’s committee. We are actively monitoring the situation and will closely review any draft legislation to assess its impact on HTCs and the bleeding disorders community.
• Implementation of the Hemophilia SNF Access Act: As you know, the Hemophilia SNF Access Act will be fully implemented in October, when the new skilled nursing facility (SNF) year starts. The Alliance, along with NHF and HFA, submitted comments on the annual SNF proposed rule that will implement the law, among other provisions. We will also work to educate SNFs about the policy change so that they will begin to accept people with bleeding disorders this fall.

▲ Top

HHS Rescinds Advisory Opinion after Court Describes 340B Statute as Ambiguous as to Contract Pharmacies
by Elizabeth “Issie” Karan

Last week saw a new installment in the never-ending saga of legal disputes related to the use of contract pharmacies in the 340B Discount Drug Pricing Program. On June 18, 2021, the Department of Health and Human Services rescinded an HHS Office of General Counsel Advisory Opinion released in December 2020 (“Advisory Opinion”). The Advisory Opinion stated that drug makers have an obligation to provide discounts to covered entities in the 340B Program regardless of the method used to dispense drugs (i.e., contract pharmacies). In the legal filing which rescinded the Advisory Opinion, HHS stated that it was pulling it to “avoid confusion and unnecessary litigation” and claimed that the lawsuit is now moot.

The agency’s actions come after the U.S. District Court for the District of Delaware, on June 16, rejected the Biden administration’s request to dismiss a lawsuit by AstraZeneca challenging the Advisory Opinion. In doing so, the Court stated that the 340B Statute is ambiguous as to the use of contract pharmacies in the program. The Court’s opinion states that “Congress may very well want pharmaceutical manufacturers to deliver 340B drugs to an unlimited number of contract pharmacies as a condition for manufacturers’ participation in the Medicare Part B and Medicaid programs. But that kind of policymaking is for Congress, not this Court. The only issue before the Court is whether Congress has spoken clearly and unambiguously on this arrangement. It has not.”

Neither the Court nor the HHS filing definitively address a series of letters sent to drug makers by the Health Resources and Services Administration (HRSA), including AstraZeneca, in May 2021. These letters stated that the drug companies are in direct violation of the 340B Statute and must immediately being offering outpatient drugs at the 340B ceiling price to covered entities through their contract pharmacy arrangements. HRSA gave the companies until June 1 to respond and indicated that without remedial actions, they could face monetary penalties. These letters do not mention the Advisory Opinion.

However, Eli Lilly, one of the other drug makers warned by HRSA, sued HRSA last month over the letter. Although the Court acknowledged HHS’ interpretation of 340B statute is a reasonable one, the Court’s opinion also caused HHS to rescind its Advisory Opinion. This creates significant uncertainty for the future of contract pharmacy arrangements in the 340B program. We will keep members informed as these legal disputes proceed.

▲ Top

Hemophilia Treatment Center (HTC) Revenue Cycle Survey Response Reminder
by Kimberly Wolverton Lackman

As we continue our focus on expanding our Revenue Cycle Management services, the HTC Revenue Cycle Survey was distributed on Monday, May 24th. The completion of the Survey will allow us to better comprehend and anticipate the needs of our Member Treatment Centers as well as develop HTC Revenue Cycle Management Best Practices along with insights to assist in expanding our current reimbursement and revenue cycle services.

The Survey is broken into categories representing the different steps in the revenue cycle process. The ten sections encompass multiple choice and open-ended questions including Billing, Collections, Contracting, Credentialing, Billing Barriers, and Reflection. The estimated completion time is 30-45 minutes.

We are extending the deadline to complete the survey. If you have not already completed the Survey, we would appreciate your response but no later than July 23rd. If you have any questions, please reach out to Kimberly Wolverton Lackman, Manager, Reimbursement and Payer Marketing via e-mail at kimberly@hemoalliance.org or phone at 813.400.6710.

Cost of Dispensing Survey: We Need Your Help!

As you have heard and read, Hemophilia Alliance (HA) has committed significant resources to fund a national HTC cost of dispensing survey administered through a national consulting firm, Mercer.

• The survey is essential to determine a dispensing fee that is more representative of an HTC so Medicaid and other payers can be assured our cost are higher than traditional pharmacies and we provide a better value both in cost and patient outcomes.
• If we don’t get at least half of our member HTCs to participate then the survey will not be statistically valid and we will not have the necessary data to support a higher dispensing fee with Medicaid and other payers.

While we have been diligent in bringing all the details of the survey to member HTCs, recently some additional questions have been raised:

• The survey information is private and will be treated as proprietary. The information submitted with be deidentified and not shared with anyone including HA at an identifiable level.
• Mercer will sign a Non-Disclosure Agreement (NDA) with any HTC that desires to have one executed. You can see the draft NDA here.
• The survey is detailed and also asks for information on adjuvant services that are provided to hemophilia patients. HTCs may not have well documented data on these additional services and that is perfectly fine. The service data is part of phase two with a goal to target ways you can be reimbursed (these services were often paid from funds generated through dispensing which are no longer available). The payers agree these are valuable and impactful services but don’t not have a mechanism to reimburse for these services, phase two will give them the methodology.
• If the detail is problematic, Mercer will assist the HTC is sorting out the data OR if the HTC wants to share their operating data reports and aggregate expenses, Mercer will sort it out and put it in the most appropriate categories.

We need your help! Please consider how important adequate reimbursement is to your HTC ’s financial wellbeing and the care you provide to your patients. Send in your completed survey as soon as possible but no later than July 30, 2021.

▲ Top

• Update on Alliance Data Portal
  by Theresa Parker

  We’ve just released a new version of the data portal. Entering your data is still the same but the look is more user friendly. There is also a new feature available to you called the Savings Report and it is located in the menu under the Center Purchase Data button (see screenshot below). This savings report will show you what your center’s savings is for the quarter or year selected and will help you keep track of how you are running your business. Currently we are showing 2018 – 2020, however 2016-2017 will be available soon. Here are some quick steps to get to the data portal:

1. Click this link OR go to https://www.hemoalliance.org – Click the Member Log In button and Log In with the username and password YOU selected.
2. Click the Documents/Media tab, then select Data Portal Log In and enter the username and password that I (Theresa Parker) emailed to you.
3. Once you are logged in you can enter all of your center’s factor purchases!

   

As always, feel free to contact me anytime with questions or comments – Theresa Parker, theresa@hemoalliance.org or 727.688.2568

• Harmony in Hemophilia Update
  by Karen Bowe

  The Hemophilia Alliance is collaborating with NHF in support of their 2021 Unite for Bleeding Disorders National Walk campaign. This initiative is meant to build upon the primary goal of Harmony in Hemophilia which is to enhance or build relationships between HTCs and Chapters. The objective of our support is to increase HTC participation in the Walk program. To this end, please find the 2021 Walk schedule here for your convenience. As a reminder, NHF has created Walk magnets (see image to the right) that can be distributed to your patients during routine clinic visits. Although many of our HTCs have already requested magnets, NHF still has some available. If you would like to receive magnets, or replenish your supply, please send an email with your request to karen@hemoalliance.org and I will pass along your information to NHF.
  

  In addition, all HTC participating teams will be acknowledged on the HTC Wall of Walkers located on the Unite Day landing page on NHFs website. The HTC team name along with photos or a logo will be featured in a scrolling fashion and the site will be continuously updated throughout the season. The Hemophilia Alliance thanks everyone for your participation and efforts to benefit your local Chapter.

Happy Walking!!

▲ Top

Team Alliance Contact Information

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