March 2020 Newsletter

In this Issue…

Notes from Joe
· Coronavirus Update

Alliance Update
· Webinars on COVID 19 and Changes in Healthcare
· Alliance Meeting for New HTC Personnel is Postponed
· Contract Data Reporting
· 2020 Meeting Schedule

Legal Update
· Why and How HTCs Can Use Referral Arrangements in the 340B Program

Washington Update
· Policymakers Respond to COVID-19
· Virtual Hill Day Details

Payer Update

Notes from the Community
· Hemophilia Alliance Foundation Announces New “Large” Grant

Team Alliance Contact Information

Notes from Joe

Coronavirus Update
By Joe Pugliese

Dear Community, Like all of you, we are stunned by the recent events that have and will change our world forever. It is impossible not concerned about our own well-being and that of all people here and around the world. Like all of you we are wondering how this will play out over the coming weeks and months. The last few weeks have been unlike any we have ever seen.

At the Alliance, we are focusing on assisting all of our members in setting up systems to ensure patient access to care is maintained. We reached out to the HRSA Office of Pharmacy Affairs seeking their assistance and guidance in setting up a pharmacy network with redundancies to protect our patient community. Admiral Krista Pedley PharmD, MS RADM, USPHS responded to our request for expedited acceptance of additional contract pharmacy options within 24 hours of our request. HTCs across the country are evaluating their current disaster preparedness plan and assessing what steps they need to take to enhance their ability to respond to potential disruption in service.

We also reached out to all of our manufacturing partners to get a real time assessment of their supply chain integrity. All manufacturers report good supplies of the life-saving products. They are also constantly reviewing their supply chains and their manufacturing capacity with an eye towards enhancing redundancies throughout their operations.

We have reached out to NHF, HFA and regional leaders to try to coordinate responses and identify opportunities to eliminate barriers to maintaining seamless patient care. I’m proud that the Hemophilia Alliance Board has approved an additional $500,000 in emergency patient assistance funding to be made available through the Hemophilia Alliance Foundation in partnership with chapters across the country. Details will be forthcoming over the next week, but it will likely be the same grant process the Foundation has used in the past. We need to thank Alliance member HTCs and our manufacturing partners for making this possible. Speaking of the Alliance Foundation, the checks for recipients of the regular 2020 grant cycle will be coming out over the next week. The Foundation board approved $701,000 in grants this year. The emergency funding is in addition to these grants.

Finally, unrelated to COVID19, the Hemophilia Alliance Foundation is announcing the first ever BIG GRANT award opportunity. My thanks to Brenda Riske, Susan Karp, Amy Marquez and Stephanie Raymond. There is an article with more details later on in the newsletter. This is a perfect opportunity to test your skills at collaborating while working remotely, managing home schooling, looking out for loved ones and for all the healthcare professionals, trying to take care of the rest of us at the same time.

We are going to get through this. It will not be easy. It will require all of us to work together. No matter how often you find yourself still awake at 3 am or waking up at 3am, we will get through it. Be safe!

Alliance Update

Webinars on COVID 19 and Changes in Healthcare

Cancelling the spring meeting in Washington DC, scheduled for March 29th to 31st was a difficult decision a few weeks ago. We know it was the right decision. We have added a weekly webinar to help you stay informed of changes in our space and share some of the information we were going to discuss at the member’s meeting. The webinar will be held each week on Thursday at 1 pm ET. We will be asking for topics that you would like to hear about as we know there is more information coming out daily. While we are all respectful of the social distancing, we hope you join virtually for these informative sessions. We will send out the registration for the webinar each week to make sure you have the most current links. The Hemophilia Alliance Team looks forward to sharing some screen time with you.

We will continue to have our manufacturing partners present information pertinent to the changes in our space via webinars. They are anxious to present information that is important to you now. Please contact Sean Singh by email at sean@hemoalliance.org with topics you would like to get information on. Some topics we are looking at include patient assistance programs, hemophilia support programs and more.

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Alliance Meeting for New HTC Personnel is Postponed

The May 2020 meeting for new HTC staffers has been postponed to the fall in light of the evolving COVID-19 situation. More details will be released as the new location is confirmed. We have tentatively rescheduled for the first week of November in Minneapolis. We give a big shout out to the Marriott there for working with us.

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Contract Data Reporting

We are very excited to announce the new changes in our data reporting portal. We have added a way for you to input data on a daily basis. This feature adds all your entries up to give you a monthly total and a quarterly total. This is another feature we are hoping will help you manage your pharmacy business better to optimize savings based on the manufacturer contracts you participate in through us. If you are not already entering your data monthly, we encourage you to do so. It is an easy process and we are able to help you tackle any challenges. If you do not have a login for the portal please contact Theresa Parker at theresa@hemoalliance.org.

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2020 Meeting Schedule

  • Spring Members Meeting: Cancelled
  • Hill Day: More information to be announced
  • Fall Members Meeting: October 4th to 6th
  • New member meeting rescheduled November 2020

Legal Update

Why and How HTCs Can Use Referral Arrangements in the 340B Program
By Elizabeth Karan

In a specialty area with constantly changing forms of treatment, hemophilia treatment centers (HTCs) may need to prepare for limited distribution networks from product manufacturers. In short, limited distribution networks mean that the manufacturer only will ship certain products to particular providers with which they contract. For HTCs not within these networks, this may mean that patients must go somewhere else to receive their preferred treatment. However, this does not necessarily mean that the HTC’s 340B Program cannot continue to serve the patient.

The patient definition in the 340B Program states that an individual must receive health care services from a health care professional who is either employed by the covered entity or provides health care under contractual or other arrangements such that responsibility for the care provided remains with the covered entity (61 Fed. Reg. 55156 (October 24, 1996). Therefore, if an HTC can document that it retained responsibility for the health care services provided to the referred individual, then that individual may be eligible to receive 340B drugs from the HTC. Importantly, HTCs’ written policies and procedures should address referrals under the 340B Program. Additionally, the use of 340B-purchased products still is limited to outpatient settings only.

In the context of a limited distribution network, an HTC wishing to retain a patient in their 340B Program, who goes to another entity for treatment, must enter into an arrangement with that entity. Such an arrangement must ensure that the HTC receives documentation of the care the patient received at the outside entity, which then is incorporated into the HTC’s records.

If both the HTC and the outside entity are eligible to participate in the 340B Program, only one may claim 340B eligibility on a specific product for a particular patient. As such, we recommend working together in advance of the care to resolve any issues specific to claiming 340B eligibility for a patient. Additionally, covered entities that utilize a replenishment model must have systems in place that ensure that the product provided was not already purchased under 340B and maintain auditable records that demonstrate compliance.

If you have questions regarding referrals in the 340B Program, please contact Elizabeth Karan at elizabeth@karanlegalgroup.com.

Washington Update

Policymakers Respond to COVID-19
By Johanna Gray and Ellen Riker

On March 13th, President Trump declared the COVID-19 epidemic a national emergency, which allows a number of policy changes to be possible. For example, CMS may waive certain requirements under Medicare, Medicaid and CHIP. Since then, a number of press statements and guidances have been released and we anticipate that more changes to Medicare and Medicaid are likely as federal and state governments respond to provider challenges in caring for patients in this extremely difficult time. Here are a few highlights:

  • On March 17, CMS expanded telehealth benefits for Medicare beneficiaries during the COVID-19 outbreak to allow individuals to receive a wider range of healthcare services without having to travel to a healthcare facility. Clinicians can bill immediately for dates of service starting March 6, 2020 for patients affected by COVID-19 and other conditions. Telehealth services are paid under the Physician Fee Schedule at the same amount as in-person services. More info about the telehealth policies may be found here: Medicare Telehealth Fact Sheet and Medicare Frequently Asked Questions.
     
  • State Medicaid programs can apply for Section 1135 waivers to temporarily change their policies in response to the crisis. They are allowed to enact policies such as: to suspend prior authorization requirements; extend existing authorizations for services where beneficiary previously received prior authorization through the end of the public health emergency; and waive requirements that physicians and other health care professionals be licensed in the state in which they are providing services, so long as they have equivalent licensing in another state, among other changes. As of this writing, 35 states have had 1135 waivers approved. This website has more details.
     
  • Separately, a group called GovPredict has created a dashboard to track state legislation related to COVID-19 across multiple topics including general aid, education, workers compensation, telemedicine, emergency measures, among other topics. Click here to see the dashboard.

Congress has also been extremely busy responding to the COVID-19 emergency. It has enacted three laws to provide additional funding for federal and state public health agencies, health care providers, loans for small businesses and nonprofits, and expanded unemployment insurance and cash payments for individuals. The Coronavirus Aid, Relief, and Economic Security Act or The CARES Act enacted on March 27 also includes health policy changes, such as: to allow for 90-day prescription refills under Medicare Part D (so not for bleeding disorders treatments, but for co-morbidities); ensure no cost-sharing for COVID-19 tests under Medicare Part B; enact significant expansions of telehealth for new patients and provided by home health, hospice, FQHCs, and rural clinics; and allow for Medicaid to cover COVID testing and vaccines for the uninsured without co-pays. While Congress is now in recess until April 20th, we anticipate that there will be a fourth COVID response bill in the coming weeks.

The response from Washington has been evolving as the crisis has. We will send updates to the community as new guidance documents are released. Please be in touch with us with any questions or concerns as you help your centers and patients respond to the virus.

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Virtual Hill Day

While we were not able to hold the Hemophilia Alliance Hill Day this month due to COVID, we still need you to help advocate for the community at home! We are planning to hold a Virtual Hill Day, where we will ask centers to email Congressional offices to seek additional co-sponsors for the Hemophilia SNF Access Act. We will provide you with template emails, contact information for Congressional staff, and will work with you to answer any questions that the staff may have.

While this sort of advocacy will count as lobbying, the good news is that while HTCs are not allowed to spend federal funding on lobbying, if you pursue this activity not during working hours or on a break, no money would be spent on the lobbying activity. We’re hoping to get even more participants than were planning to come to DC, since the time requirements are so much lower.

Look out for an email with more details, including a link to sign up to participate, next week. Please contact us with any questions in the meantime!

Payer Update

By Jeff Blake

During this time of crisis, the Payer Team continues to work with various payers on strengthening our relationships to bring more pharmacy business to our HTC members. We also continue to finalize more HANS PPO Agreements with HTCs. We need to continue to grow our HANS PPO Network to enhance our ongoing payer efforts and continue to grow your pharmacy business. The team is actively working 43 opportunities with payers that represent more than 27,000,000 units of bleeding disorders products. As we finalize more HANS PPO Agreements with members, we are confident we will receive additional payer opportunities.

In addition to our daily payer activities, we have been working with HTCs, payers and National Hemophilia Foundation to address new challenges. These challenges include discussions about relaxing barriers that do not allow HTCs pharmacy to dispense, prior authorizations and appropriate number of doses for patients to have at home. We are also monitoring approved Medicaid Waivers for state Medicaid Programs and any Medicare program changes.

We will continue to provide updates on our activity. If you are encountering issues or new challenges that we can help, please contact a member of the Hemophilia Alliance Team.

Notes from the Community

Hemophilia Alliance Foundation Announces New "Large" Grant

GUIDELINES FOR HEMOPHILIA ALLIANCE FOUNDATION "LARGE" GRANT

The Hemophilia Alliance Foundation has NEW funding for a “large” grant. This funding will allow an organization to fund a larger-scope project than what they are able to do with current smaller grants. This will be a one-time, one-year grant subject to the availability of funds.

Purpose The goal of this grant is similar to the goals for other applicants:

  • To encourage larger scale, creative, and unique projects
  • To serve the community with resources that will improve the lives of patients with blood disorders

These funds may not be used in conjunction with grants from the Hemophilia Alliance.

Requirements

  • A non-profit 501 (c) (3) organization
  • An organization that has a history and documented track record of serving the blood disorders community
  • Completion of the required application
  • The grantee will be responsible for a conference call meeting with HAF board members during and/or after project completion to discuss the process and what could improve the process as well as what worked during the process
  • Grant funds will NOT be awarded for the following costs:
    • Administrative or overhead costs exceeding 8% of budget
    • Basic, laboratory, or clinical research or related equipment
    • Underwriting or sponsorship of fundraising events
    • Recurring costs
  • Collaborative projects between more than one organization are encouraged and given high priority

Timeline

The application period will be April 1 – July 30, 2020 with a project date of September 1, 2020 – August 30, 2021.

Questions

If you have any questions about this grant process, please contact Brenda Riske Brendariske@hemophiliaalliancefoundation.org.


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@artemispolicygroup.com 703-304-8111
Elizabeth Karan ekaran@feldsmantucker.com 612-202-3240
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
Karen Bowe karen@hemoalliance.org 717-571-0266
Joel Bellucci webmaster@hemoalliance.org 727-504-0491