July 2021 Newsletter


In this Issue…

Notes from Joe
· Washington Update

Legal Update
· Compliance Program Check-Up: OIG’s Seven Elements of Compliance

Payer Update
· Connecting The Dots

Alliance Update
· Update on New Member Meeting

Team Alliance Contact Information

Notes from Joe

Washington Update
by Joe Pugliese

It has been a very active first half of the year in our space and the broader debate over health care policy in Washington. Certainly, the biggest news has been the distribution of COVID vaccines that have allowed many of us to return to a more normal life. Of course, the delta variant and the other variants to follow remain a cause for concern, especially since efforts to vaccinate have slowed noticeably and cases have been rising. If you or a loved one hasn’t gotten vaccinated yet, please do! It’s clear the best thing you can do to protect yourself and everyone else. In terms of policy, there has been a flurry of court cases, requests for information (RFIs) and executive orders.

On the regulatory front, I’m pleased to share that the final rule implementing the Hemophilia SNF Access Act was just released last night. CMS has listened to the comments that the Alliance submitted with NHF and HFA and is adding a few new J Codes to the list of drugs that SNFs will be able to bill separately. We know that everyone is excited for our patients to have better access to SNFs starting in October. Stay tuned for more information about how the law will be implemented and how your HTC can work with SNFs near you to serve your patients.

In last month’s Newsletter, we shared information about the California v. Texas lawsuit about the Affordable Care Act (ACA) and recent litigation related to manufacturers declining to provide 340B drugs if dispensed by contract pharmacies. Despite all of this litigation, I remain very positive about the unwavering support we enjoy form our manufacturing partners and confident that our ability to use contract pharmacies will remain unimpeded.

President Biden has also not been shy about issuing executive orders (EOs), with 52 to date. As a few points of comparison, President Trump averaged 55 per year, FDR is the clear winner with 3,721 EOs, and Presidents Adams, Madison and Monroe are tied for last with just one each. The most recent Biden EO that’s relevant to us is expansive, impacting a dozen federal agencies and many policies and programs with the goal of increasing competition. The EO comments on high prices for prescription drugs and consolidation within the health care industry that increases costs and asks for his agencies to give him policies to lower drug costs and increase competition in the health care space. We’ll provide updates as any of these policies is released.

On the regulatory front, the Alliance recently joined with NHF and HFA to submit comments on an RFI regarding Reporting on Pharmacy Benefits and Prescription Drug Costs, about implementation of a new law enacted last year that will require public reporting from insurers and PBMs about drug prices and financial relationships between them. Our comments focused on copays accumulators and the new and pernicious alternate funding model, and encourage HHS to look at the impact of manufacturer rebates paid to PBMs and health plan on drug costs. We are now reviewing the impact of the 2022 Hospital Outpatient Prospective Payment System (HOPPS) proposed rule, in which CMS proposes to continue the 30% cut to 340B hospitals’ reimbursements. In past years, we have determined that no HTCs have been affected by this reduction and are confirming that will remain true. This policy is also the subject of litigation, which will go before the US Supreme Court next year.

As if that weren’t enough, there’s also been activity in Congress. The PROTECT 340B Act (HR 4390) was recently introduced. It is remarkable in several respects. First, it is bipartisan and second it is trying to address what has been terms “pickpocketing,” where commercial interests want to take some or all of the 340B discount from covered entities. We are encouraged by the proposed legislation put forth by Reps. McKinley and Spanberger and are reviewing and giving input on specific language. Finally, we’re keeping our eyes out for what relevant health policies might be included in the BIF, the Bipartisan Infrastructure Framework and its sibling reconciliation bill. Rumors are that there may be some drug pricing provisions included to help pay for the other elements, and we’re advocating to make sure that there aren’t any harmful provisions for HTCs.

Suffice it to say, the Alliance leadership and Washington Team are hoping for but not really anticipating a quieter half of 2021. We will continue to update you about everything happening in Washington and hope that you will contact us with any questions.

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Legal Update

Compliance Program Check-Up: OIG’s Seven Elements of Compliance
by Elizabeth “Issie” Karan

For decades, the Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) has provided its perspective on the most important elements to consider when developing and implementing an effective compliance program. Hospitals are required to implement these elements, but any health care entity can benefit from considering them as they update and augment their programs. Please keep in mind that these elements apply to general compliance programs. While they may be useful in ensuring 340B Program compliance, they are intended to apply broadly to all potential areas of risk for health care organizations (e.g., billing, fraud, financial relationships with physicians and other healthcare professionals, etc.).

The OIG believes that the following are important components of compliance:

  1. Implementation of written policies, procedures and standards of conduct;
  2. Designation of a compliance officer and compliance committee;
  3. Conducting effective training and education;
  4. Development of effective lines of communication;
  5. Conducting internal monitoring and auditing;
  6. Enforcement of standards through well-publicized disciplinary guidelines; and
  7. Responding promptly to detected offenses and undertaking corrective action.

HTCs should consider whether their compliance programs include these features. For example, is there any open line of communication between all staff and the person in charge of compliance, without interruption from supervisors or other personnel, to enable reporting of any cases of fraud, abuse, or waste? Employees should not be concerned about retaliation for reporting concerns of non-compliance which may necessitate that they can report outside of the managerial chain. Additionally, is the HTC conducting training at regular intervals (likely at least for new employees and annually) to staff and its Board of Directors on potential areas of risk? Training and education demonstrate a proactive approach to compliance and may help avoid problems before they develop.

The Hemophilia Alliance teams stands ready to assist HTCs however possible and answer any questions that you may have regarding high-quality compliance programs.

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Payer Update

Connecting The Dots
by Jeff Amond

As a kid I loved drawing and I especially loved drawing pictures that involved “Connecting the Dots.” Connecting the Dots was a simple, yet enjoyable drawing activity for me as a kid. Today, all grown up and in my payer relations role, work activities can be anything but simple. We deal with complex insurance issues, narrowing pharmacy networks, complicated contracting language, and every issue under the sun regarding 340B. We happily take on these challenges to help our Hemophilia Treatment Center members.

Earlier this year, I had an opportunity to assist with a complex payer relations issue that in the end was resolved by the simple, yet enjoyable activity of Connecting the dots.

This all started in April 2021 when I was contacted by an HTC looking for Payer Relations assistance. The HTC had a family with two boys that had historically used the HTC pharmacy for their factor dispensing. The mom was always able to go to her employer and get an exception for the factor to be billed to the medical side and use the HTC Pharmacy. When they switched to Hemlibra, the employer no longer allowed them to do this exception and were forced to transition to a specialty pharmacy. After mom’s unsuccessful attempt to get the exemption for Hemlibra, she reached out to the HTC for assistance. The HTC team fought and fought to get the exception but the contacts they had for the employer and TPA were either unwilling or unable to make the change for the family.

At this point the HTC started reaching out to others for help. They reached out to our Hemophilia Alliance Payer Team, they reached out to their local foundation, and they reached out to a national foundation. We all took on this challenge to help this family. We hit roadblock after roadblock for months but that all changed after an email conversation our Payer Team had with another HTC. This HTC had a patient with the same employer, the same TPA, the same hemophilia product (Hemlibra) and the same insurance issue. The difference was that they found a person at the TPA that was willing to listen. A few weeks later, they had a meeting with the TPA. The TPA contact not only listened, but they were able to make the benefit changes to allow the HTC Pharmacy to dispense. Great news for this HTC.

Now all that was left for the other HTC was to have someone help them Connect the Dots. Our Payer Team was able to facilitate a conversation with the TPA contact and the other HTC. We Connected the Dots. That simple, yet enjoyable activity of Connecting the Dots was able to bring joy and relief to a family and an HTC. These two HTCs reached out to us with their insurance issues. If it were not for their willingness to reach out to us with their insurance struggles, this would have never happened.

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Alliance Update

Update on New Member Meeting
by Sean Singh

Hi, all! I hope that you received my recent email with information about the upcoming Hemophilia Alliance New Member Meeting! Here are the details as we currently know them. If you haven’t yet, please complete this survey to share your feedback on the meeting.

  • When? November 7-9, 2021
  • Location? TBD
  • Who may attend? Up to two staff members per Alliance member center, who were hired after January 1st 2019. Attendees must commit to attend by September 1, 2021
  • What is the cost? It is a member benefit. The Hemophilia Alliance with support from manufacturing partners will underwrite airfare+, accommodations, food and ground transportation.*

The meeting will be underwritten by pharmaceutical manufacturers. We are planning on limiting it to 4 manufacturers. Each manufacturer will present a 45-minute session as part of the meeting. The manufacturers will also have table displays in the lobby area outside the meeting room.

+Airfare will be booked by the Hemophilia Alliance who will do its best to make your trip as easy as possible.
*Ground transportation will be covered by a $100 prepaid debit card provided to the attendee when they arrive at the meeting.

Meeting Schedule

Sunday November 7th
5:30 pm – Networking session and cocktail hour

Monday November 8th
7:30 am – Breakfast
8:30 am – Meeting begins
12:30 pm – Lunch
5:30 pm – End of first day meetings
6:30 pm – Group dinner

Tuesday November 9th
7:30 am – Breakfast
8:30 am – Meeting begins
12:00 pm – Lunch
4:00 pm – End of meeting

Please contact me at sean@hemoalliance.org with any questions.

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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
Karen Bowe karen@hemoalliance.org 717-571-0266
Johanna Gray, MPA jgray@artemispolicygroup.com 703-304-8111
Kiet Huynh kiet@hemoalliance.org 917-362-1382
Elizabeth Karan elizabeth@karanlegalgroup.com 612-202-3240
Kimberly W. Lackman kimberly@hemoalliance.org 813-400-6710
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

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