In this Issue…

Notes from Joe
· AC/DC

Legal Update
· 340B Program Flexibilities During COVID-19 Pandemic

Washington Update
· CMS Releases a Second Rule to Provide Flexibility During COVID Emergency
· CMS Releases Rule Reopening Door for Accumulator Adjustor Programs

Payer Update
· HANS Announces New Payer Agreement

Alliance Update
· 2020 Meeting Schedule

Notes from the Community
· All About the WAAPS-Hemo System

Team Alliance Contact Information

AC/DC
By Joe Pugliese

In a typical year, we would just be finishing up with a busy Spring meeting season and everyone would be hoping that the coming summer would slow things down a bit. Now, I am not sure when we will find a new typical. While virtual meetings are an excellent stop gap measure, it will be difficult to replace the personal, face-to-face contact with our friends in the bleeding disorders community.

If you or a loved one has not been directly affected by COVID-19 and you’re lucky to work from home, it sometimes seems like a problem on the other side of the world. However, if you or a family member has been diagnosed or if you have lost a loved one, it is too real. It is also very real for the millions of people who suddenly, unexpectedly find themselves out of work. If you are an essential provider, like healthcare workers, grocery and drug store employees, delivery drivers, and don’t forget the trash guys, you just put your head down and keep going. We are all depending on you to do your job. We cannot thank all of you enough.

Bleeding disorders healthcare providers have adapted to the current reality and have found many ways to support their patients and their families. The manufacturers of these critical life-saving products have kept the supply channels adequately stocked and the distribution network has delivered not just these treatments, but nearly every item you can think of with a minimum of disruption and confusion.

Alliance activities, including our well-attended weekly webinar series, have focused on AC/DC (After COVID-19 and During COVID-19):

• In the AC category, on a recent webinar, Michael Tarantino did a wonderful update on expanding his clinical practice into treating ITP. Meanwhile, the Alliance payer team has identified a way forward for all members with the Preferred Provider Organization that is working to assure that centers remain in network and able to fund the comprehensive care that the bleeding disorders community needs. Additionally, the regions have sent out a survey to all HTCs to gain a better understanding of their capabilities and interest in gene therapy, with the goal of assisting all centers in being prepared for this exciting new treatment. I encourage you to complete the survey at your earliest convenience.
   
• In the DC category, the Hemophilia Alliance Foundation and the HFA Helping Hands program have made excellent use of the funding from the Alliance, providing support for patient assistance programs at 42 chapters across the country and grants for 146 families, respectively. The funding is only possible because of the member organizations of the Hemophilia Alliance. We have also been providing regular updates (including in articles below) regarding COVID-19 related policy changes that can help your center respond to the epidemic and continue to provide excellent care.

It seems certain that during COVID-19 will be with us longer than we had hoped, but there will be an after COVID19. We will continue to push ahead with initiatives designed to ensure the long-term financial security of the HTC network. In the meantime, please stay well and please let me know if there is anything else the Alliance can do to support you.

340B Program Flexibilities During COVID-19 Pandemic
By Elizabeth 'Issie' Karan

Hemophilia Treatment Centers (HTCs) may benefit from relaxation of 340B Drug Pricing Program policies during the COVID-19 pandemic. The Office of Pharmacy Affairs (OPA) which oversees the 340B Program developed a website with resources and frequently asked questions (OPA FAQs) related to the COVID-19 pandemic. Below we highlight two important developments. Additionally, the Hemophilia Alliance also has been working with OPA to ensure that hemophilia treatment centers (HTCs) can register contract pharmacies outside of the registration period to ensure adequate supplies of products.

The OPA FAQs identify important flexibilities for covered entities. First, regarding telemedicine, OPA acknowledges that this is simply a mode of delivery which does not alter 340B patient eligibility. However, OPA recommends that covered entities address these modalities in their policies and procedures and continue to ensure auditable records are maintained for each eligible patient dispensed a 340B drug. We recommend adding language to your 340B policies and procedures, which explicitly incorporates telemedicine into your patient definition, and ensuring that providers continue best practices in recordkeeping. Second, the OPA FAQs also announce that 340B audits will continue to be conducted during the pandemic but will be done virtually for the next several months. Although OPA is not cancelling audits, covered entities may be able to request delays in commencing audits if COVID-19 is impacting resources or operations.

If your HTC is having any difficulties with 340B Program compliance or operations, please reach out to us to ensure you are maximizing your options during this unprecedented time.

CMS Releases a Second Rule to Provide Flexibility During COVID Emergency
By Ellen Riker

On April 30, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a second Interim Final Rule providing significant flexibility in Medicare coverage and payment for hospital and physician services and waivers on other Medicare and Medicaid requirements during the COVID emergency. Most of the changes in the rule are retroactively effective for services provided as of March 1, 2020 and will continue through the government declared public health emergency or December 31, 2020. A summary of the rule can be found here and a one-pager with details on the telemedicine changes made by both rules may be found here.

While coverage for telephone only services (CPT Codes 99441-99443) was included in the Medicare Interim Final Rule released on March 30, 2020, in this rule the reimbursement rates are being increased to mirror the level 2 – 4 office/outpatient evaluation and management services for established patients. See the summary for more information.

The Alliance submitted a comment letter to CMS on the first Interim Final Rule, published on March 30, 2020 and summarized in earlier Newsletter articles. The letter supports the expansion of telemedicine coverage and the proposal for the home health benefit, which would support bleeding disorders patients who need assistance in self-administering their treatments in their homes.

For more information, please contact me at eriker@artemispolicygroup.com.

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CMS Releases Rule Reopening Door for Accumulator Adjustor Programs
By Johanna Gray

On May 7th, the Centers for Medicare and Medicaid Services (CMS) released the final 2021 Notice of Benefit and Payment Parameters Rule (NBPP), an annual rule that sets policies for private insurance plans. In recent years, CMS has released conflicting information about whether and when accumulator adjustor programs are permitted in private insurance plans (where insurers or PBMs say that manufacturer co-pay assistance does not count towards a person’s out-of-pocket maximum) and unfortunately, the final rule for 2021 reopens the door for these programs.

First, a bit of history: when accumulator adjustor programs first popped up in 2015, several groups started an advocacy campaign to ask CMS to prohibit these harmful programs. After years of education and advocacy, in the 2020 NBPP, CMS indicated that plans could implement accumulator adjustor programs only for brand name drugs when there is a generic alternative. This was very exciting – and welcome! – news for our community. Since there are no generic versions of bleeding disorders treatments, this rule essentially prohibited accumulator adjustor programs for our patients. Then, last summer, CMS released a reinterpretation of the policy, due to a potential conflict with IRS rules surrounding high-deductible health plans and health savings accounts and said that it would clarify the policy in its rule this year.

Unfortunately, in the 2021 rule, CMS says that accumulator adjustor programs are allowed for all drugs, even if there is not a generic equivalent. The Agency does not require plans to implement these programs but provides insurers with discretion over whether to allow co-pay assistance to count towards the out-of-pocket max or not. CMS also urges insurers to be transparent about whether they have implemented an accumulator adjustor program, which would at least help mitigate the surprise.

I hate to be the bearer of bad news from DC but note one positive fact: as we consider additional federal advocacy strategies, advocates are continuing state-level efforts, since states can prohibit accumulator programs for insurance plans they regulate. Several states have done so (based on advocacy from the bleeding disorders community) and others are considering making this change. In the meantime, please do let us know if you have any patients experiencing this issue. We work closely with NHF, a national leader on this issue, and together we have been able to assist many families.

HANS Announces New Payer Agreement
By Jeff Blake

For each patient, WAPPS-Hemo provides an interactive report estimating:

• terminal half-life
• time to desired concentration
• predicted factor concentration at hourly intervals

The built-in clinical calculator function, when used with the patient’s individual PK profile, will help you to build an optimized treatment regimen. Using two of: dose, target trough, or interval, the calculator will provide an interactive graph and calculate the weekly dose, peak, and trough tailored to the patient.

Using this PK-tailored regimen, you may then choose to activate the companion patient mobile app, myWAPPS.

myWAPPS enables hemophilia patients to record infusions and view real-time estimates of their factor level at any time, based on their individual PK study and WAPPS-Hemo generated regimen. For patients using myWAPPS, the infusions recorded in the app appear for your review as treatment logs in their patient profile on WAPPS-Hemo.

For more information about WAPPS-Hemo please visit: www.wapps-hemo.org For additional myWAPPS information: www.mywapps.org

McMaster University is offering training and assistance to HTCs interested in using or learning more about WAPPS-Hemo. This is available to HTCs new to WAPPS and to those already using the system. Please contact Sydney MacLeod for more information: maclesd@mcmaster.ca or 905-525-9140 x25214.