Source: https://hemoalliance.org/april-2019-newsletter/
Timestamp: 2019-12-12 01:41:56
Document Index: 367848435

Matched Legal Cases: ['art 75', '§ 75', '§ 75', 'art 75', 'art 75', '§ 75']

April 2019 Newsletter - Hemophilia Alliance
· Three Reasons to Support the HTC Network
Roadmap for Compliant Expenditures of Federal Funds: Highway to the Danger Zone!
Hemophilia Treatment Centers (HTCs) often ask the Hemophilia Alliance legal team how they can compliantly expend grant funds and resources. HTCs can do so in numerous ways. However, as a recipient of a Maternal and Child Health Bureau (MCHB) funds, HTCs are responsible for assuring compliance with the terms of their sub-recipient agreement with the prime, regional grantee recipient as well as the MCHB Regional Hemophilia Network program guidelines. HTCs are also subject to the Department of Health & Human Services’ (HHS’) Uniform Grants Guidance at 45 CFR part 75 (UGG), the HHS Grant Policy Statement, and likely the Regional MCHB Grant program guidance (HRSA 17-074). Please note that alarm bells should go off in your head anytime your HTC wants to give anything of value to a patient for less than fair market cost. Such actions could implicate the requirements of the beneficiary inducement prohibition law and the terms of their (or their host institutions’) private agreements with payers. We recommend working with legal counsel on these matters as they are incredibly fact specific and require individualized advice (although we are always happy to explain the context).
In thinking about how to spend program income in compliance with federal grant rules, we recommend analyzing the key questions described below and asking for advice from experts.
(1) Does this expenditure utilize federal funds, including program income?
The UGG defines what revenue constitutes federal funds and provides general rules for its expenditure. The UGG defines program income in 45 CFR § 75.307 as gross income that a grantee or subgrantee receives that is directly generated by a grant supported activity, or “earned as a result” of the award. Program income includes, but is not limited to, “income from fees for services performed, the use or rental of real or personal property acquired under federally-funded projects, the sale of commodities or items fabricated under an award, license fees and royalties on patents and copyrights, and interest on loans made with award funds.” HTCs must add program income to Federal funds and it “must be used for the purposes and under the conditions of the Federal award” under 45 CFR § 75.307(e)(2). MCHB regards any and all revenue that an HTC earns as program income.
(2) Does this expenditure further the purpose of the HTC grant which is to “promote and improve the comprehensive care of individuals with hemophilia and related bleeding disorders or clotting disorders such as thrombophilia”?
HTC program income must be added to federal funds and “must be used for the purposes and under the conditions of the Federal award.” Under the UGG, the HRSA grants office defines eligible activities to include patient health, education, and supportive services necessary to provide comprehensive care to patients served by the HTCs. If an HTC wishes to use its program income on an expenditure that does not meet the standard of eligible activities, the HTC must first seek and obtain approval from the Regional grantee and, ultimately, HRSA. The approval should be sought and received in writing.
(3) Does this expenditure comply with the grant rules, particularly the rules for procurement and the cost principle restrictions?
The UGG contains numerous other requirements for grantees (which include HTCs). To highlight a few, HTCs must: (1) maximize competition in procurement activities in accordance with the requirements of the UGG; (2) comply with the cost principles prohibiting expenditure of funds on such items as alcohol, international travel, and bad debts; and (3) report deviations from budget or project scope or objective and request prior approvals from HHS awarding agencies for budget and program plan revision. HTCs should familiarize themselves with the UGG and consider regularly educating relevant staff on its requirements.
1HHS’ grant administrative regulations are codified at45 CFR Part 75. The Cost Principles are codified in Subpart E of the same Part 75.
2Program Guidance for Regional Grantees, HRSA 17-074, at https://mchb.hrsa.gov/fundingopportunities/?id=b1459a1d-3397-401a-8ba2-bd53829fb76c.
3HRSA Memo to HTC Regional Grantees, dated May 23, 2003, and confirmed in 2011, indicates that all revenue is considered “program income” and must be used for activities that fall within the scope of the HTC program. This is HRSA’s position despite the very limited federal funding and despite legal arguments that only the revenue derived from 340B priced pharmaceuticals should be considered as program income because the 340B eligibility is based upon the subaward and therefore “earned as a result of the grant.”
4See 45 CFR § 75.307(e)(2).
5HRSA Memo to HTC Regional Grantees, dated May 23, 2003
Payer Update – It’s All About the Data!
Why do payers need and want data? And why do I need to agree to an assay management provision in my contract with payers? These are all great questions.
So why is data so important? Payers are concerned about the cost of hemophilia treatment and the pipeline of hemophilia treatment therapies. Payers want to manage and better control the cost of hemophilia treatment and care. This is a great opportunity for HTCs to explain and highlight the value of the HTC integrated comprehensive clinical and pharmacy services model. So how do HTCs do this?
It’s all about the data. HTCs need to have the ability to gather and track key data elements and be prepared to report this data to payers. So, what data are payers interested in seeing? Payers are very interested in assay management; the number of doses patients have on hand when they reorder and the ability to home/self infuse. Why are payers interested in this data?
Solid assay management is key in managing the cost of hemophilia. In general, clotting factor prescriptions are written at specific dose +/- 10%. For some patients, the additional 10% of a prescription can be over 50,000 – 100,000 units of clotting factor that would be dispensed. This can increase the cost to a payer by over $100,000. Rumor has it that our competitors, specialty pharmacies and home care companies, tell payers HTCs are very good at clinic care but not very good at assay management. I agree with their clinical care statement but strongly disagree with their assay management statement.
Payers also want to know their members, our patients, are not hoarding clotting factor. You can track this information when a patient reorders their next doses and by not dispensing “bleed” doses when a prophy patient has not reported any “bleeds” since their last order. Payers also often don’t understand dosage and dispense variation among patients. For example, some assume that every patient is the same; a 300 pound man playing community basketball should have the same dosage and product usage as an 8 year old boy that isn't as active. We often have to explain that many variables can explain product usage and explaining certain patient characteristics is part of the telling the story of how we manage patients and subsequently manage product usage.
Payers are very interested in the lowest cost of treatment. Home/self-infusion is by far the lowest cost of treatment. For example, the cost of clotting factor is 2 – 4 times more costly in the hospital than treating at home. Do you track the patients that can treat at home/self-infuse? Do you document the training provided so patients can treat at home?
So, the key takeaways are – track, manage and report assay management, patient doses at home when ordering and home/self-infusion data to payers. More importantly, let the payers you work with know how well you care and manage your patients!!
If you have any questions or would like our assistance in your payer relations efforts, please contact a member of the Hemophilia Alliance Team. We Work For You!
Spring Into our Services
With our member meeting just around the corner we wanted to remind you of a few things.
We have recently moved. Please update our address to:
20 Vine Street, #1227
We realize that things change. We ask that you please take a few minutes to update the contact information for the HTC team members. If your team has changed, please contact Audra as this helps all of us of be more efficient.
Electronic and digital communications continue to be scrutinized by filters and algorithms. Please remember to have hemoalliance.org white listed within your organizations email system to ensure that you receive our emails. Joe and I inform you of current and topical information and we want to make sure you get them. Please check with your IT departments to make sure that joe@hemoalliance.org and Sean@hemoalliance.org are specifically noted as senders you can receive email from.
The membership dues invoice have been emailed to the primary contact at your center. If you have not received your 2019 invoice, please contact Audra at audra@hemoalliance.org. Here is a list of some of the benefits of your membership. If there is something you need help with that is not on this list, please reach out to us as we continue to add to our expertise and services.
Team Alliance Expertise
We give you a national voice in Washington, DC and the expertise of the Alliance consultants which include:
Payer contracting and relations expertise
Advocate in Washington, DC
Updates via Webinars
Access to our website with large libraries of information
Group Purchasing Services discounts
Assistance in setting up a pharmacy program
Participation in Federal Regulatory Process
Bleeding disorder therapies
Nursing and lab services
The Alliance currently has 106 members. Ninety-six of our members are enrolled participating members in the Group Purchasing Organization (GPO). There is no separate fee to be a participating member of the GPO in order to enjoy the benefits and reduced pricing. There is no obligation to purchase products and services under this agreement, but once enrolled you are able to utilize our agreement as you see fit, subject to requirements and restrictions of the individual contracts. In just the past 12 months, GPO participating members have saved in excess of $100,000,000, by taking advantage of the contracts we have available through the GPO. The average savings per participating center was $943,000.
Alliance Benefits the Bleeding Disorders Community
The Alliance gives back to the hemophilia community. The Alliance granted $12,000,000 to the community from 2009-2019. The funding has expanded exponentially since a very modest donation to the National Hemophilia Foundation of $25,000 in 2009. The grants come in three big buckets. First, the Alliance gives a block grant to the Hemophilia Alliance Foundation, an independent nonprofit organization, which granted $731,000 in 2019. Second, the Alliance provides funding to ATHN, which in turn supports ATHN data managers at HTCs across the country. This allows them in their efforts to gather much-needed health data. Finally, the Alliance provides direct funding to national patient organizations. We work closely with National Hemophilia Foundation’s advocacy team and we were pleased to be the inaugural sponsor of the HFA’s (Hemophilia Federation of America) recently-announced Smithsonian initiative that will house the hemophilia history.
We work for YOU our MEMBERS.
HFA Announces Archive Project with Smithsonian Institution
Hemophilia Federation of America (HFA) recently announced they have made an initial donation of historical artifacts related to the history of the bleeding disorders community to the Smithsonian Institute's National Museum of American History in Washington, D.C. The donation materials, which include historical artifacts, personal journals, articles, newsletters, other documents as well as photographs, oral histories, including those of HTC physicians and staff, make up the first step in preserving the history of the bleeding disorders community for future generations.
The Hemophilia Alliance has made a meaningful financial contribution to support the first phase of this effort. The Alliance was recognized for this generous support at HFA’s annual Symposium in San Diego on April 5, 2019. Further personal or organizational financial contributions to the bleeding disorders history project are welcome as additional donations/phases of this project continue. Contributions are accepted at https://give.onecause.com/hfa.
We want you to be a member of the Hemophilia Alliance Team
The Director of Operations and Member Support reports to the Senior Vice President, Marketing and Operations of the Hemophilia Alliance. The position is responsible for the daily operations and interactions with member centers and external partners. The Hemophilia Alliance operations and member support include but are not limited to:
Approximately 40% of time traveling to HTCs, conferences, member HTCs and advocacy events is expected. Must possess a valid driver’s license and be able to travel.