Notes from Joe
by Joe Pugliese
It’s hard to believe that we’re already half-way through February! The dust is starting to settle in DC. There are 62 new Representatives and 9 new Senators, not to mention the people in new roles in the Biden Administration. I think it is safe to assume that these newbies do not have a great understanding of the 340B Program and its importance to communities like ours. I am also certain that every interest group in Washington is making plans to educate these new policymakers.
The term “interest group” generally has a negative connotation, except of course when it is representing your interests. The bleeding disorders has two annual advocacy events – NHF’s Washington Days will be March 1-5th and the Alliance Hill Day is scheduled for May 5th. The goal in both cases is to educate Members of Congress about our interests, which have been and will remain ensuring access to care and treatment and policies to support federally-supported HTCs.
Given the razor thin majorities in both the House and Senate, individual Members of Congress can have a great impact on policymaking. That means that we have to make sure that we have friends on both sides of the aisle. The community and policies we care about have long enjoyed bipartisan support – having a bleeding disorders isn’t a partisan issue after all. It’s also true that we shouldn’t take anything for granted nor assume that all is lost, no matter who is in the White House or controls Congress.
That’s why telling our stories are so important! Some new Members of Congress or appointees may have preconceived notions about the 340B Program, but it is our job to tell them about our experience. For example, President Biden’s nominee to serve as Director of the Office of Management and Budget (OMB – a very powerful and generally unknown office) used to run a think tank in DC that published papers suggesting policies to avoid duplicate discounts that could make it more difficult for covered entities to participate in Medicaid. I want to be optimistic and say that this creates an opportunity to educate not just the new Members of Congress but also new staffers who will have a lot of power when it comes to regulations. But it also means that we should continue doing what we’re doing – telling our story to any policymakers willing to hear it and making sure that we anticipate challenges and take advantage of opportunities wherever they may lie.
State Laws Regulating Pharmacy Reimbursement, ERISA, and the Supreme Court – What Could Rutledge Mean for 340B Covered Entities?
by Elizabeth (Issie) Karan
On December 10, 2020, in Rutledge v. Pharmaceutical Care Management Association, the Supreme Court rejected a challenge to states’ authority to regulate pharmacy benefit managers (PBMs) and pharmacy reimbursements.
In a unanimous decision drafted by Justice Sotomayor, the Court determined that a 2015 Arkansas law was not preempted by the Employee Retirement Income Security Act (ERISA). The state legislature passed Arkansas Act 900 to stem the decline in independent and rural pharmacies operating in the state by requiring PBMs to reimburse pharmacies for the cost of prescription drugs at no less than the pharmacies’ acquisition costs. Prior to Arkansas Act 900, some pharmacies were losing money on certain prescription transactions because of contract terms. The Act sought to address this practice and other situations where the conduct of PBMs could cause harm to pharmacies. PBMs called for Arkansas Act 900 to be struck down arguing that it was preempted by federal rules under ERISA and Medicare. However, in Rutledge, the Court clarified that states may regulate plans’ contractors, and that cost-control regulation is presumptively beyond ERISA’s preemptive scope.
45 states have passed laws to regulate PBMs and Rutledge puts them on much firmer footing. These laws do different things, from banning PBM gag clauses that prevent pharmacies from telling consumers about lower-cost options, to requiring PBMs to disclose their price lists and manufacturer rebates to improve transparency. Importantly for HTCS, certain state laws regulating PBMs prohibit so-called “discriminatory reimbursement” practices where PBMs reimburse less or charge 340B covered entities more because of their participation in the 340B Program. Looking ahead, Rutledge may eliminate at least one challenge facing broader adoption of state laws regulating PBMs.
What’s New in Washington?
by Johanna Gray
As Joe notes above, there are many new policymakers in DC and things are starting to ramp up, both in Congress and in the Biden Administration. Here’s the latest:
- COVID Relief:
Congress is now considering the American Rescue Plan, a new $1.9 trillion COVID relief package. The bill includes provisions to extend unemployment benefits, provide funding to accelerate vaccination distribution, and provide additional financial support to American families, small businesses, nonprofits and many specific industries (restaurants, modes of transportation, etc). The bill also includes several policies to improve access to health insurance, including: a financial incentive for states to extend Medicaid that haven’t; expanding access to and generosity of tax credits for people to purchase insurance on the ACA Marketplaces; and subsidizing coverage for people who have lost their jobs, either through COBRA or on the marketplaces. Congressional leaders are hoping to have the bill enacted into law by mid-March. We will provide updates as the bill progresses.
- Reopening of Open Enrollment for Marketplaces:
In response to the millions of Americans who have lost coverage due to the COVID economic crisis, the Biden Administration has just reopened the federally-managed ACA marketplaces for a special enrollment period until May 15th. If you have patients or friends or family members who have lost coverage and need access to insurance, please refer them to www.healthcare.gov. More information about the special enrollment period may be found here.
- Biden ACA Executive Order (EO):
On January 28th, President Biden signed an Executive Order on Strengthening Medicaid and the Affordable Care Act. The EO directs federal agencies to review their policies for elements that might impede access to Medicaid coverage (such as state waivers that allow for work requirements for Medicaid enrollees) or jeopardize coverage under the ACA. As you may remember from past EOs, they typically just set broad policies that then have to be implemented via further regulations in the future. There have been a few quick policy changes in response to the EO, including the reopening of the marketplaces described above. The Department of Justice also said that it was switching its position on the ACA lawsuit currently awaiting a ruling at the US Supreme Court to support implementation of the ACA.
We expect a very busy winter and spring as the new Congress and Biden Administration further ramp up their activities. We will provide regular updates via the Newsletter and Alliance webinar series and always encourage centers to contact us with any questions.
Update on the Disease Management Program
by George Oestreich
Over the last couple years, the Payer Team has been working on a bleeding disorders Disease Management Program (DMP). The goal of the DMP is to develop and implement a payer reimbursement model that supports the integrated comprehensive care Hemophilia Treatment Centers (HTCs) provide to their patients. In addition to receiving reimbursement for the dispensation of bleeding disorder products, HTCs would also receive a DMP fee from the payer for the integrated care and care coordination provided to patients. To effectively roll out a DMP model, we must first capture cost data for pharmacy and clinical services. The DMP model should fit well in Medicaid and with private insurance payers.
To begin our data collection efforts, we have contracted with Mercer, a multinational firm that is very involved in data collection for state Medicaid Agencies and is respected by the Centers for Medicare and Medicaid Services (CMS). The data collection will occur in two (2) phases, which are highlighted below.
- Phase 1 – Cost of Dispensing (COD) Survey:
HTC pharmacies have been involved in traditional COD surveys with their state Medicaid Agencies for several years. Unfortunately, by being included in traditional cost of dispensing surveys HTC pharmacies COD came back as “outliers” and their COD was excluded from the results. The goal of our HTC COD survey is to obtain a statistically valid sample to support a more reasonable COD that represents the true cost of providing bleeding disorder products through an HTC. This will provide us with data to support HTCs’ higher cost of dispensing and we will be able to use that information to support higher Medicaid dispensing fees for our members. In addition, we have strengthened this effort by working with Mercer to also integrate an advisory group of Medicaid pharmacy directors into the project, giving our study even greater viability and support.
We are very close to finalizing the Survey questionnaire to collect the COD data. Our goal is to distribute the survey to our member HTC pharmacies during March and Mercer will be having a webinar explaining the most expedient way to complete the Survey. The Hemophilia Alliance Team will also be available to support your efforts. Please look forward to the announcements of the information and the webinar. This is a great opportunity to support our position with data.
- Phase 2 – Cost Data for Clinical Care & Care Coordination:
This phase of the Survey will gather data on the clinical and care coordination services that HTCs provide that are typically not reimbursed by payers. This data will be analyzed and grouped so we may be able to bill for these imperative but non-dispensing services in the future. As dispensing fees erode and exclude the other adjuvant data that is critical to patient outcomes, we must find a way to support the provision of these services by the HTC. This is important financially, for patient outcomes, and to fulfill our mission of providing comprehensive and coordinated care for our patients that also recognizes the impact of social determinants of care.
We are excited about this opportunity to obtain data to support our dispensing fee and the overall value of the HTC model of care. We are equally excited to identify those other services that HTC do on a regular basis that is often unreimbursed by the payers.
We look forward to working with you on this program.
- Introducing our New Board Member
by Heidi Lane, Chair, Hemophilia Alliance Board
The 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 applicants for their interest in serving on the board. We thoughtfully reviewed and considered all applicants in the context of the Mission and by-laws, seeking to most broadly represent our membership as well as diversify our expertise and insight to most strategically address challenges to further our mission.
We are pleased to announce Becky Burns has been elected to serve on the Board, with her term beginning January 2021. Becky is the COO/CFO of the Bleeding and Clotting Disorders Institute (BCDI) in Peoria, Illinois and directly oversees their 340B pharmacy program. Prior to being promoted to COO/CFO, Becky served as Finance Director and Executive Director at BCDI. Becky brings to the board expertise in insurance/payer relations as well as experience in running an independent center. Becky also serves as faculty on NHF’s Comprehensive Care Sustainability Collaborative (CCSC) and participates in various subcommittees. Becky states one of the more rewarding aspects of her position at BCDI is the opportunity to advocate for patients both on a local and national level and looks forward to serving on the Board to continue her efforts.
Again, we can’t thank enough the individuals who applied to serve on the board. We may be reaching out to you to assist in serving the Alliance in other ways.
- Harmony in Hemophilia Update
by Karen Bowe
In collaboration with NHF, the Hemophilia Alliance has created the ‘HTC Wall of Walkers Challenge’, aimed at increasing HTC participation in NHFs 2021 Unite for Bleeding Disorders National Walk program. This initiative will build upon the primary goal of Harmony in Hemophilia which is to enhance or build relationships between HTCs and Chapters. We will be sharing more details with HTCs as part of our Hemophilia Alliance Winter Webinar series on February 18th. We will do the same for Chapters and Community Members during our next Harmony in Hemophilia webinar, to be held on March 23rd at 7:00 PM EST. Also, on the agenda for the Harmony in Hemophilia webinar will be a discussion on the 340B pharmacy program and why it is important to HTCs and the community, as well as share some successful collaboration stories between Chapters and HTCs. Invitations for the Harmony in Hemophilia webinar will be sent in the near future.
- Membership Dues and Benefits
by Theresa Parker
Membership invoices for 2021 were sent out via email at the beginning of February. If you have questions about your invoice please contact Theresa Parker, firstname.lastname@example.org. As a member of the Alliance you are entitled to certain benefits. A copy of your membership benefits can be found here.
Please help us keep an updated list of your center’s contacts. An email was sent out to the primary contact at your HTC requesting an update of your center’s contact information for 2021. You can also update your contact information throughout the year on our website here.
Meeting Schedule for 2021
Winter/Spring Webinar Series
April – 22nd
May – 20th
Spring Members Meeting
(Members must login before registering)
March – 18th & 19th
Harmony in Hemophilia
March – 23rd
May – 5th (Virtual)
Summer Webinar Series
June – 17th
July – 29th
August – 26th
Fall Members Meeting
September – 12th to 14th (In-person tentative)
New HTC Staff Meeting
October – 10th to 12th (In-person tentative)
Notes from the Community
Reminder About The Patient Notification System
The Patient Notification System (PNS) was established in 1998 to provide a free, confidential, direct-to-registrant system offering information on withdrawals and recalls for plasma-derived and recombinant therapies; as well as other therapies used in the treatment of bleeding disorders.
The PNS recently expanded the notification system to include alerts via text message, which supplement other notification options (email, phone, fax, and first-class USPS mail). The immediacy of text messages and emails ensures registrants receive information about withdrawals and recalls no matter where they might be, further enhancing patient safety. The PNS no longer provides notifications via overnight UPS mailings.
We are very excited to offer PNS alerts via text message and are hopeful many current registrants as well as new enrollees will choose to make text or email their primary notification method.
Please visit www.patientnotificationsystem.org or call 1-888-UPDATE-U to register for the PNS or to change your primary notification method to text messaging. We encourage all HTCs to promote enrollment in PNS to their patients.
Team Alliance Contact Information
We work for you! Please don’t hesitate to contact any of us with any questions or concerns: