In this Issue…

Notes from Joe
· The Light at the End of the Tunnel

Legal Update
· HHS Continues Its “Regulatory Sprint”

Washington Update

Payer Update
· Payer Update: 35 and Growing!

Notes from the Community
· Plasminogen Deficiency Foundation Launched

Alliance Update
· Announcing Our New Board Member
· 2021 Meeting Schedule

Team Alliance Contact Information

The Light at the End of the Tunnel

By Joe Pugliese

The big news has to be the recent announcements by Pfizer, Moderna and Astra Zeneca about their COVID-19 vaccine clinical trials. These positive results highlight the advantages of having a robust pharmaceutical industry. It is also a success for Operation Warp Speed, a federal program to accelerate vaccine development organized by the Department of Health and Human Services. The program started the end of March and we are now seeing the positive results of this unprecedented effort. Apparently lack of options creates clarity of mind. At the same time, it is clear we are not out of the woods yet. Everyone is clearly tired of the pandemic. I completely understand, but please, WEAR A MASK and keep your distance. The goal is to be here for Thanksgiving and Christmas 2021!

The other big news has been the election. Like so many other things in 2020, this election was unlike any other. Both presidential candidates received more popular votes than any other candidate in history and there were millions of first-time voters. We won’t know who controls the Senate until the two Georgia runoffs in January. In the meantime, our advocacy work continues: we are still working to get the skilled nursing facility legislation passed in the current lame duck session. We are also coordinating with other covered entities to try to identify a common set of priorities that would help safety net providers, like HTCs, stretch scarce federal resources and use those funds to maintain and expand clinical care for at risk populations. Some self -proclaimed “experts” suggest that stretching scarce federal dollars as a vague idea. But, the results of the recent Patient satisfaction with US Hemophilia Treatment Center Care, Teams and Services: The First National Survey indicate that the thousands of patients seen at HTCs do not see their medical care funded in large part through the 340B program as some vague idea. They enjoy the benefits of an expert, comprehensive care team and the resulting dramatic reductions in mortality and morbidity.

Earlier this year, we detailed a variety of overreaching policies launched by a number of pharmaceutical companies to create barriers to covered entities accessing 340B priced drugs. I must reiterate that our manufacturing partners have for the most part not been engaged in these activities but rather, have been uniformly supportive of HTC access to 340B. One company did launch an initiative and they were quick to assure us in writing their actions did not apply to HTCs. We thank all of our partners and remind them how critical their support is to allowing HTCs to maintain and expand care for the bleeding disorders community.

The challenge and opportunity as I pointed out in last month’s Newsletter was expanding the market share of HTCs nationwide. One way to do that is to have happy, healthy patients, per the patient satisfaction survey above. Another way is to do is to work closely with patient advocacy organizations. This recent press release from the National Hemophilia Foundation highlights the benefit of using the hemophilia treatment centers as the gold standard of care, not just to save costs but also to provide optimal patient care. Speaking of NHF, I also wanted to share this lovely letter that we got in recognition of our financial contributions. We are only able to make donations to bleeding disorders organizations due to you, so I want to be sure that you get the thanks, as well.

Finally, this edition includes a story very familiar to the bleeding disorders community: Drs. Rebecca and Ryan Bialas find answers to their prayers and a solution to their child’s plasminogen deficiency at – of course – a federally-supported hemophilia treatment center. Next month we will focus on the ways that Alliance is focused on lowering the cost and the aggravation of getting paid for the services you provide.

HHS Continues Its "Regulatory Sprint"
By Elizabeth "Issie" Karan 

As part of the Department of Health and Human Services’ (HHS’) “Regulatory Sprint to Coordinated Care,” the Centers for Medicare & Medicaid Services (CMS) and the HHS Office of the Inspector General (OIG) both released final regulations on Friday, November 20, 2020. The Regulatory Sprint aims to reduce regulatory barriers to care coordination and accelerate the transformation of the health care system into one that better pays for value and promotes care coordination. Most provisions of both regulations take effect January 21, 2020.

AKS and CMP Law Overview and Changes

The anti-kickback statute (AKS)¹ provides for criminal penalties for whoever knowingly and willfully offers, pays, solicits, or receives remuneration to induce or reward, among other things, the referral of business reimbursable under any of the Federal health care programs, including Medicare and Medicaid. Health care providers and others may voluntarily seek to comply with statutory and regulatory safe harbors so that they have the assurance that their business practices will not be subject to sanctions under the AKS. The Beneficiary Inducements provisions of the civil monetary penalties (CMP)² provides for the imposition of CMPs against any person who offers or transfers remuneration to a Medicare or State health care program beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier for the order or receipt of any item or service for which payment may be made, in whole or in part, by Medicare or a State health care program.

The OIG Final Rule implements seven new safe harbors, modifies four existing safe harbors, and codifies one new exception under the Beneficiary Inducements CMP. It also addresses comments from previous rulemaking, including: describing how medical device manufacturers and durable medical equipment companies may participate in protected care coordination arrangements that involve digital health technology; and lowering the level of “downside” financial risk parties must assume to qualify under the new safe harbor for value-based arrangements with substantial downside financial risk. Additionally, the OIG Final Rule broadens the new safe harbor for cybersecurity technology and services to cover remuneration in the form of cybersecurity-related hardware.

Regarding the local transportation safe harbor, the OIG Final Rule changes to expand mileage limits for rural areas (up to 75 miles) and eliminate mileage limits for transportation to convey patients discharged from the hospital to their place of residence. Additionally, it clarifies that the safe harbor is available for transportation provided through rideshare arrangements.

Stark Law Overview and Changes

The physician self-referral law (or “Stark Law”)³ prohibits a physician from making referrals for certain healthcare services payable by Medicare if the physician (or an immediate family member) has a financial relationship with the entity performing the service. There are statutory and regulatory exceptions. Importantly, the Stark Law is a “strict liability” law meaning that physicians can be held liable for violating its prohibitions regardless of their intent. CMS has regulatory authority over the Stark Law.

In the Stark Final Rule, CMS is establishing a new, permanent exceptions to the physician self-referral law for “value-based” arrangements and definitions for terminology integral to such a system. The Stark Final Rule also includes clarifying provisions and guidance intended to reduce unnecessary regulatory burden on physicians and other health care providers and suppliers, while reinforcing the physician self-referral law’s goal of protecting against program and patient abuse. CMS also is establishing new exceptions for non-abusive arrangements for which there is currently no applicable exception to the physician self-referral law’s referral and billing prohibitions.

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¹ 42 U.S.C. § 1320a-7b(b).
² 42 U.S.C. § 1320a-7a(a)(5).
³ 42 U.S.C. 1395.

By Johanna Gray

It’s been another busy month in Washington! Here are a few quick updates:

• Committee Leaders Seek Input on 340B Modernization: I shared last month that Senate HELP Chairman Lamar Alexander (R-TN) and House Energy and Commerce Committee Ranking Member Greg Walden (R-OR) recently put out a request for information seeking policy ideas from stakeholders about 340B reform. See here for the letter that the Alliance submitted – telling the positive story of how the 340B program enables HTCs to serve their patients and opposing any policies that would impede that.
   
• Trump Administration Regulations: In the last week, the Trump Administration has released several new regulations related to drug pricing for Medicare Parts B and D, and physician anti-kickback rules, and other topics. Issie wrote above about the physician anti-kickback rules, and we are currently analyzing the potential impact of the Most Favored Nation rule, which seeks to limit spending on some Medicare Part B drugs to the much lower prices paid in other countries. Our initial take is that this controversial model (which may not even take effect!) will not have a large effect, since no bleeding disorders treatments will be included in the first year of the model, and since drugs dispensed at home are exempt. We will be able to provide a summary of the rules and their potential impact on December’s webinar. We expect that there will be a number of additional regulations released, as President Trump seeks to tackle various issues before his term ends in January.
   
• ACA Lawsuit: On November 10th, oral argument was heard in the US Supreme Court on the California v. Texas lawsuit concerning the constitutionality of the Affordable Care Act. While it is always tricky to anticipate a final ruling based on the questions asked by Justices during the oral argument (sometimes they ask questions to serve as the Devil’s advocate, for example), there were hopeful signals that the Supreme Court will not find the entire ACA to be unconstitutional if they find that the individual mandate currently is, due to the lack of penalty. Again, we don’t expect a final ruling in the case until the spring or possibly as late as June 2021. We’ll update the community as we learn more.
   
• Federal Funding: Because it was unable to pass the regular federal funding bills before the start of fiscal year 2021 on October 1st, Congress passed, and President Trump signed into law a continuing resolution (or CR) to extend last year’s funding levels until December 11, 2020. Congressional leaders are negotiating this right now, and we are hopeful they will reach agreement before the deadline to prevent a government shutdown. We will provide an update in the December Newsletter.

Payer Update: 35 and Growing!
By Jeff Blake

As many of you know we have been working the last 18 months to develop and implement the Hemophilia Alliance Network Services (HANS) HTC PPO Network. We now have 35 signed PPO agreements with our HTC members, and we are working with several other member HTCs to increase the number of signed PPO agreements. Imagine if all our member HTCs signed the agreement – we could offer the very best network of HTCs to payers.

We now have 4 HANS Agreements with Payers that our members that have signed our HANS PPO agreement can participate in. The agreements are with:

These agreements and individual letters of agreements (LOAs) have brought back millions of units to the participating HTCs pharmacy programs which has strengthened the sustainability of the programs. In addition, we continue to work with insurance brokers/consultants, third party administrators (TPAs), self-insured employers, stop-loss/reinsurance carriers, and other payers. Based on these payer relationships, we now have more than 40 active payer opportunities to bring back more business to our member HTCs.

We have accomplished a lot, but there is so much more that we can do. Below is a summary of the results of bringing business back to HTC pharmacy programs since 2018.

The Hemophilia Alliance Team is excited about our efforts with payers to support our members and we look forward to working with more member HTCs to expand our HANS efforts to help you grow your pharmacy business to support your HTCs operations and programs.

If you have not signed a HANS PPO Agreement, now is the perfect time. Please contact a member of the Hemophilia Alliance Team to learn more about HANS or how we can assist in solving your payer issues.

Plasminogen Deficiency Foundation Launched
By Rebecca Bialas, MD, Board Chair

On behalf of our Board of Directors, I am pleased to announce the official launch of the Plasminogen Deficiency Foundation, a 501(c)(3) nonprofit dedicated to improving the lives of patients with plasminogen deficiency.

Our website is available at plasminogendeficiency.org or PLGD.org, and you can also find us on Instagram (@PLGDFound) and Facebook (facebook.com/PLGDFound). Please feel free to share this information with patients, healthcare providers, researchers, partner organizations, or other organizations working in the rare disease space.

Our mission is to advance the care and treatment of patients with plasminogen deficiency (PLGD) by promoting public awareness of the disease through education and advocacy, creating a community for those affected by PLGD, and supporting research to address the current knowledge gaps and treatment needs in plasminogen deficiency.

My family has personally received the most state-of-the-art medical care and the most comprehensive support from the doctors and staff at the Hemophilia Treatment Center where our children are treated for plasminogen deficiency. As a parent of children with a rare disease, I appreciate how our HTC helps to fit this diagnosis into our life as a whole, with child life specialists, school counselors, pediatric infusion nurses, social workers, and even insurance coordinators on staff to make it easier for families. And that's not to mention the individualized medical care plan developed for my children, both for their daily maintenance dosing, and for management of illness or planned surgical procedures. I don't hesitate to recommend that all patients seek care at Hemophilia Treatment Centers to benefit from their comprehensive, supportive approach to management of this rare disease; there is no place better suited to do so.

We look forward to getting to work on our mission. Please feel free to email me directly at rebecca.bialas@plgd.org with any questions, comments, or ideas for collaboration!

Announcing our New Board Member
By Heidi Lane, Vice Chair and Chair of the Nominating Committee and Jennifer Borrillo, Chair

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 Kimo Stine, MD has been elected to serve on the Board, beginning January 2021. Dr Stine, the Medical Director for the Arkansas Center for Bleeding Disorders, is a Professor of Pediatrics at the University of Arkansas for Medical Sciences, practicing at Arkansas Children’s Hospital in Little Rock, Arkansas. Dr Stine brings to this position over 20 years of leadership at his HTC, which included establishing their 340B program roughly 11 years ago. Dr Stine states their “…program is an example of how the mission and vision of the Alliance can be implemented to allow for growth of a program with the ultimate goal to improve services and care to patients and families with bleeding disorders”.

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. The next board opening(s) will be in Spring 2022. Finally, Happy Holiday Season to all!

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Meeting Schedule for 2021

Spring Members Meeting – Virtual
Hill Day – Virtual
Linda Gammage Social Worker Conference – Fall
New HTC Staff Meeting – Fall
Fall Members Meeting – September 2021

Team Alliance Contact Information

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