Notes from Joe
by Joe Pugliese
I find myself again sitting down to write Notes from Joe in another tough week. The people in Haiti are dealing with another terrible natural disaster. The recent news out of Afghanistan is heartbreaking. The picture of people clinging to the sides of a jumbo jet as it is taxiing down the runway speaks volumes about desperation and fear. Our thoughts and prayers go out to all of them. We owe the people who allied with us much better than they have gotten to date. Our problems are so nonexistent by comparison.
Even closer to home, the dog days of summer have never been doggier. The days are hotter, the storms are bigger, the fires are bigger and of course the delta variant is ruining our back to normal. I think in a lot of ways last year at this time was easier (not to say it was easy!). There is an old saying that lack of options creates clarity of mind. Last year we had the luxury of limited options. We also had the benefit of looking forward to next year and putting all of 2020 behind us.
We were just warming up to having in person meetings, family vacations, not wearing masks and returning to the office. Now meeting planning is dicey at best. We are maintaining plans for a live new member meeting in November while keeping an eye on the delta variant. Despite the ongoing challenges and rising case rates, it is hard to complain when you see the suffering and death from around the world.
We have a long tradition in the United States of reaching out to help others. Recently the Alliance Board once again affirmed our commitment to the world bleeding disorders community with a grant to support the upcoming WFH Global Summit on Access to Care. See a note from Eric Solte, President of WFH USA with his thanks:
“Greetings Sean & Joe! In speaking with Jennifer recently, she alerted me to the generous support of the Hemophilia Alliance to the WFH Global Summit on Access to Care. I just wanted to add my personal thanks on behalf of the WFH USA and our global hemophilia community for your generous and strong support. Your partnership in such an initiative will help move our vision of Treatment for All forward in significant ways as people around the world in our grass roots become more competently skilled in advocating for the access to CFC’s that are so desperately needed. It also demonstrates the robust support of the partnership that we share. Please pass along my thanks to your Board. Take care.”
As many of you know, last year the Alliance funded the initiative to get the WFH Guidelines for the Management of Hemophilia translated into 6 languages. I had the pleasure of serving on the WFH USA Board, a role now being filled with distinction by my colleague, Sean Singh. Likewise, your Alliance continues to support the bleeding disorders community in the USA through the Hemophilia Alliance Foundation. Jeff Blake is now serving in the role of Alliance liaison and next month they will be announcing this year’s Innovation Award winners (formerly big grant). We are also providing financial support for the 2022 HTRS Trainee Workshops. All of this is in addition to the ongoing support we provide to ATHN, NHF, HFA, and disaster relief.
I know many of you are committed to helping through twinning programs and giving of your time and expertise. We would love to hear from you about ideas to support, maintain and improve patient care here and around the world. We hope you and your families, friends and colleagues are doing well in these difficult times.
Uniform Grants Guidance Procurement Standards: More Than Just Finding a Good Bargain
by Elizabeth “Issie” Karan
When buying goods or materials, Hemophilia Treatment Centers (HTCs) may not first think to check federal regulations for grantees. However, the Uniform Grants Guidance (UGG) contains requirements for procurements conducted by federal grantees. These requirements were changed significantly when the UGG was updated in 2014. After the revised UGG went into effect, the government gave grantees a grace period to implement the new procurement standards. However, that grace period ended. The Hemophilia Alliance recommends reviewing internal policies and procedures related to procurement to ensure they comply with the UGG’s standards. Below we summarize major components of the standards but also are available to answer any questions HTCs might have.
As often is the case with compliance, the UGG focuses on the content, maintenance, and execution of written policies and procedures (P&Ps) for procurement. Generally, any procurement process must provide for full and open competition. The P&Ps must incorporate the procurement methods described in the UGG and outlined below. For every procurement action involving purchases in excess of the simplified acquisition threshold ($250,000), the UGG requires that a cost or price analysis be performed and documented. The UGG requires that federal grantees take necessary affirmative steps to assure that minority businesses, women’s business enterprises, and labor surplus area firms are used when possible. Finally, the organization must maintain written standards of conduct covering internal and external conflicts of interest.
The UGG identifies five methods for procurement depending on the type of project and dollar amount.
||Not to exceed micro-purchase threshold: $0 – $10,000
- Must distribute micro-purchases equitably among qualified suppliers.
- Micro-purchases may be awarded without soliciting competitive quotations if the price is determined to be reasonable.
|Small purchase procedure
||Greater than micro-purchase, not to exceed the simplified acquisition threshold: $10,001 – $250,000
- Price or rate quotes must be obtained from adequate number of sources (at least two)
- Can be informal, e.g., phone call or web search
- All quotes, including phone calls, web searches, etc., must be documented and kept on file
- Price does not need to be deciding factor, but all quotes need to be kept in procurement records
||Greater than the simplified acquisition threshold: $250,001 and greater
- Used when selection of successful bidder can be made principally on the basis of price
- Bids must be solicited from an adequate number of known suppliers, providing sufficient response time
- Invitation for bids must define the items or services in order for bidders to properly respond
- Firm fixed price contract made in writing to the lowest responsive and responsible bidder
- Any or all bids may be rejected if there is a sound documented reason
||Greater than the simplified acquisition threshold: $250,001 and greater
- Must be publicized and identify all evaluation factors and their relative importance
- Must be solicited from an adequate number of qualified sources
- Must have a written method for conducting technical evaluations of the proposals and selecting recipients
- Contracts must be awarded to the responsible firm whose proposal is most advantageous to the program, with price and other factors considered
|Noncompetitive proposal (sole source)
||Greater than micro-purchase threshold: $10,000 and greater
- May be used only when one of the following conditions are met: (1) the item is available only from a single source; (2) the public exigency or emergency will not permit a delay resulting from competitive solicitation; (3) federal awarding agency or pass-through entity expressly authorizes its use in response to a written request; or (4) after solicitation of a number of sources competition is determined inadequate
- All sole source procurements require cost/price justification of the use of noncompetitive proposal which must be documented
Drug Pricing Update
by Johanna Gray
August is typically quiet in Washington as Congress goes on recess and everyone else goes on vacation. Like so much of life these days, this August isn’t normal and has been pretty busy, especially on policies related to drug pricing. Here’s what you need to know:
- Bipartisan Infrastructure Framework: We updated you last month about rumors that the infrastructure package would include drug pricing policies as a way to pay for the investments in the rest of the bill. The bill that ultimately passed the Senate only included two policies, neither of which especially impacts HTCs. The first is a policy that would have manufacturers reimburse the Medicare program for Part B drugs where there is waste because not all of the product in a vial is used. This is aimed at some cancer drugs, so while we don’t anticipate it affecting bleeding disorders treatments, some of our manufacturers do make products that could be affected. The second policy is a delay of a rule that would have instituted new requirements for PBMs. The bill has passed the Senate and has moved over to the House, where it is likely to be paired with a reconciliation bill (see below for more details).
- Most Favored Nation Policy: The Biden Administration released a proposed rule to officially rescind the Most Favored Nation policy implemented by the Trump Administration. This policy would have tied spending for drugs in Medicare to the (much lower) rates paid in other countries. Lawsuits kept the rule from taking effect in January 2020 as scheduled, and the Biden Administration has now rescinded it. Though, the Proposed Rule does note that the Administration is still considering drug pricing policies and so it didn’t close the door on implementing something like the MFN in future years.
- Biden Statement on Drug Pricing: President Biden made a statement and released a factsheet with his priorities for drug pricing reform, which includes allowing Medicare to negotiate drug prices, requiring rebates for drugs whose prices increase too quickly, increase competition and potentially allow for more drugs to be imported from Canada. Much of these policies would require Congress to act, but it does start the negotiation process (pun intended!).
- Reconciliation Bill: Finally, Democrats in the House and Senate are working on a reconciliation bill to accompany the infrastructure bill. The Senate passed a budget resolution with reconciliation instructions that direct a number of Committees to develop policies hitting certain budget goals, which will total $3.5T. Health care policies on the table include more significant drug pricing reforms (perhaps in line with what President Biden has outlined?), as well as potential expansions to Medicare to cover dental, vision and hearing aids, potentially lowering the Medicare eligibility age, expansions to Medicaid, and/or creating paid family and medical leave. This memo from the Senate Democrats has an outline of what they are considering. There are still many steps and there will be much political posturing before anything could become law. We will continue to monitor, advocate and update Alliance members as the debate progresses.
Working with the Payer Team and Hemophilia Alliance Network Services (HANS) a 2021 Case Study
by Jeff Blake
Many of us have been involved in this situation – at the beginning of 2021, one of our member HTCs could no longer provide pharmacy services to one of their patients because the patient’s self-insured employer health plan changed claims administrators from United Healthcare to a third-party claims administrator named Centivo. Effective with this transition, the employer decided to require the HTC’s patient to receive their bleeding disorders medication from a commercial specialty pharmacy. The HTC sent the prescription to the commercial specialty pharmacy and in early January the patient received their first dispensation from the pharmacy.
In early February, I received an email from one of our stop loss carrier relationships asking if we could help them with a large claim for a hemophilia member. The stop loss carrier told me the January 2021 dispense from the commercial specialty pharmacy was almost 18% higher than the last dispense from the previous pharmacy. They wanted to know if the cost of the medication had increased that much, which it had not. I explained if we could receive the necessary de-identified information we could determine if our HANS and HTC solution could help. The stop loss carrier did not have all the information we needed so we had an introductory meeting with the third-party claims administrator, Centivo. Centivo provided me the additional information so we could complete our analysis.
The de-identified data provided by Centivo included the prescribing provider and we determined the provider was at one of our member HTCs. I contacted our primary contact at the HTC and they recalled losing this patient because of this change. The HTC was willing to bill their same rate from 2020 with a minor increase because their acquisition cost increased. We presented this information to Centivo, the employer that provided the health insurance and the employer’s insurance broker. All parties agreed this was an excellent solution and an individual Letter of Agreement (LOA) was signed. The HTC began dispensing to the patient again in March.
The Centivo team was impressed with our solution – expert medical care at an HTC and integrated pharmacy services. Centivo has clients throughout the United States and they wanted to know if our solution could be managed on a national basis. We presented our HANS Payer Contract and the agreement will be finalized within the next 30 – 60 days. Centivo is excited to have a national solution for their members that have bleeding disorder claims and we are excited to have another HANS Payer Contract!
If you would like to learn more and discuss how the Hemophilia Alliance can assist you with your payer challenges and issues, please contact a member of the Hemophilia Alliance Team.
- Harmony in Hemophilia – HTC Wall of Walkers Unite Walk Challenge Update
by Karen Bowe
Our initiative to enhance relationships between HTCs and Chapters and to increase HTC participation in NHFs Unite Walk program is working! So far, we have 17 HTC teams registered. Of walks scheduled in July and August, HTCs teams participated in 5 of the 6 total walks. And of the 20 walks scheduled in September, we currently have 10 HTC teams registered. As the walk season gets into full swing in September and October, we anticipate registrations will continue to increase.
As a reminder, all HTC participating teams will be acknowledged on the HTC Wall of Walkers located on the Unite Day landing page on NHFs website. The HTC team name along with photos or a logo will be featured in a scrolling fashion and the site will be continuously updated throughout the season. In addition, the 5 highest fundraising teams will receive a $1000 travel scholarship to the 2022 NHF Bleeding Disorders Conference to be held in Houston, TX Aug 25th – 27th. The Hemophilia Alliance thanks everyone for your participation and efforts to benefit your local Chapter.
- 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.
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 email@example.com with any questions.
Team Alliance Contact Information
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