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  • 22 Jan 2021 9:26 AM | Anonymous member (Administrator)

    Released: January 22, 2021

    CDMRP Research Funding for 2021

    The Fiscal Year 2021 Department of Defense Appropriations Act provides research funding for the following peer reviewed programs managed by the Department of Defense office of Congressionally Directed Medical Research Programs (CDMRP):

    • Alcohol and Substance Abuse Disorders Research Program - $4.0 million
    • Amyotrophic Lateral Sclerosis Research Program - $40.0 million
    • Autism Research Program - $15.0 million
    • Bone Marrow Failure Disease Research Program - $7.5 million
    • Breast Cancer Research Program - $150.0 million
    • Chronic Pain Management Research Program - $15.0 million
    • Combat Readiness Medical Research Program - $10.0 million
    • Duchenne Muscular Dystrophy Research Program - $10.0 million
    • Epilepsy Research Program - $12.0 million
    • Gulf War Illness Research Program - $22.0 million
    • Hearing Restoration Research Program – $10.0 million
    • Joint Warfighter Medical Research Program - $40.0 million
    • Kidney Cancer Research Program - $50.0 million
    • Lung Cancer Research Program – $20.0 million
    • Lupus Research Program - $10.0 million
    • Melanoma Research Program - $30.0 million
    • Military Burn Research Program - $10.0 million
    • Multiple Sclerosis Research Program - $20.0 million
    • Neurofibromatosis Research Program - $20.0 million
    • Neurotoxin Exposure Treatment Parkinson’s Research Program - $16.0 million
    • Orthotics and Prosthetics Outcomes Research Program - $15.0 million
    • Ovarian Cancer Research Program - $35.0 million
    • Pancreatic Cancer Research Program - $15.0 million  
    • Peer Reviewed Alzheimer's Research Program – $15.0 million
    • Peer Reviewed Cancer Research Program (20 Topics) - $115.0 million
    • Peer Reviewed Medical Research Program (42 Topics) - $370.0 million
    • Peer Reviewed Orthopaedic Research Program - $30.0 million
    • Prostate Cancer Research Program - $110 million
    • Rare Cancers Research Program - $17.5 million  
    • Reconstructive Transplant Research Program - $12.0 million
    • Scleroderma Research Program - $5.0 million 
    • Spinal Cord Injury Research Program - $40.0 million
    • Tick-Borne Disease Research Program - $7.0 million
    • Traumatic Brain Injury and Psychological Health Research Program - $175.0 million
    • Tuberous Sclerosis Complex Research Program - $8.0 million
    • Vision Research Program - $20.0 million

    Pre-announcements and comprehensive Program Announcements will be forthcoming. The pre-announcements will provide a general overview of the anticipated funding mechanisms. The Program Announcements will include detailed descriptions of funding mechanisms, evaluation criteria, submission requirements, and deadlines. Each Program Announcement may be downloaded from CDMRP https://cdmrp.army.mil, Grants.gov https://www.grants.gov, or eBRAP https://eBRAP.org upon its release. For email notification when pre-announcements and Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage.

    For more information about the CDMRP, our research programs, previous awardees, as well as research highlights please visit the website at https://cdmrp.army.mil.

    Point of Contact:

    CDMRP Public Affairs
    301-619-7783
    usarmy.detrick.medcom-cdmrp.mbx.cdmrp-public-affairs@mail.mil


  • 5 Jan 2021 12:18 PM | Anonymous member (Administrator)

    Greetings and Happy New Year!  I hope everyone had the chance to relax and spend some quality time with loved ones.  Let’s get energized for a productive and prosperous 2021!  Here are 6 items of interest to start the new year:

    1. NPPO Annual Report to Congress.  The newest version has been added to the VA Annual Report section of the website.
    2. SCRS White Paper.  Attached is the most recent white paper from SCRS, “Patient Centricity and Virtualizing Technologies in a COVID-19 World”.
    1. NIH GPS Reminder.  Remember that the NIH Grants Policy Statement, which serves as the terms and conditions of all NIH awards, requires each institution to make its FCOI policy publicly available on a pubic website.  See NIH GPS Section 4.1.10 for more information.
    1. Legislative Update.
    1. Appropriations.  The FY2021 Appropriations contains $815 million for VA Medical and Prosthetic Research, a 1.9% increase over FY20.  In other federal medical research appropriations, the omnibus includes increases over the prior year of over $1 billion for NIH, $200 million for the National Science Foundation, and $42 million for the FDA.  The Agency for Healthcare Research and Quality was flat-funded.  The COVID-19 relief bill includes COVID-19 related emergency funding for NIH, CDC, and FDA.
    1. COVID-19 Relief.
    •                                                                i.      Paycheck Protection Program (PPP): Several changes to the PPP program were included, such as allowing qualifying entities to be eligible for a second loan (called “PPP Second Draw”) of up to $2 million. To be eligible, qualifying entities must:

    ·        Employ no more than 300 workers;

    ·        Have used or will use the full amount of their first PPP loan; and

    ·        Demonstrate at least a 25% reduction in gross receipts during the same quarter in 2020 versus 2019.

    ·        Organizations primarily engaged in political or lobbying activities, including public policy advocacy organizations and think tanks, are ineligible for the loan.

    The bill also simplifies the loan forgiveness process for loans of $150,000 or less. 

    •                                                              ii.      Changes to the Charitable Contribution Deduction:
    • Extends until 2021 the above-the-line temporary charitable deduction that was included in the CARES Act. Non-itemizer individuals in tax year 2021 can deduct $300 for cash contributions to qualifying public charities, and non-itemizer couples filing jointly qualify for $600. Donations to donor advised funds and supporting organizations are not eligible for this deduction.
    • Extends for one year the increased limit from the CARES Act on deductible charitable contributions for corporations and taxpayers who itemize. The limits for 2021 will be 100 percent of AGI for individuals and 25 percent of taxable income for corporations.
    •                                                            iii.      Paid Sick Leave: Extends the refundable payroll tax credits for paid sick and family leave that were established in the Families First Coronavirus Response Act, through March 31, 2021.
    •                                                             iv.      Changes to the Charitable Contribution Deduction:
    • Extends until 2021 the above-the-line temporary charitable deduction that was included in the CARES Act. Non-itemizer individuals in tax year 2021 can deduct $300 for cash contributions to qualifying public charities, and non-itemizer couples filing jointly qualify for $600. Donations to donor advised funds and supporting organizations are not eligible for this deduction.
    • Extends for one year the increased limit from the CARES Act on deductible charitable contributions for corporations and taxpayers who itemize. The limits for 2021 will be 100 percent of AGI for individuals and 25 percent of taxable income for corporations.
    1. Calendar Highlights

    JAN 7               Non-Profit Oversight Board (NPOB) Quarterly Meeting

    JAN 13             NAVREF Webinar:  “Adapt, Survive, and Thrive: How the Clinical Research Workforce Rebuilds” presented by Medix Staffing Solutions

    JAN 19             SCRS Webinar: “Engaging Physicians in a Healthcare Setting to Increase Research Activity”  Register Here

  • 16 Dec 2020 10:40 AM | Anonymous member (Administrator)

    (Washington, D.C.) - The Board of Directors of the National Association of Veterans' Research and Education Foundations announces the appointments of Genet D’Arcy, M.D. and Rebecca Rosales, MBA, to the NAVREF Board as Directors.  Dr. D’Arcy serves as the Associate Chief of Staff for Education at the VA Eastern Colorado Health Care System in Denver, CO.  Ms. Rosales serves as the Executive Director of the Northern California Institute for Research and Education affiliated with the San Francisco VA Health Care System in San Francisco, CA. 

    “We are thrilled to have these stellar leaders join our board,” said Board Chair Ron Hakes.  “Their experience, expertise, and passion for supporting veterans will be tremendous assets to the board and the 75 VA-affiliated nonprofit research and education foundations that comprise our membership.” 

    Dr. D’Arcy earned her undergraduate degree from Colorado College and her medical degree from the University of Colorado Health Sciences Center.  She began working at the Department of Veterans Affairs as a Neurologist in 1992.  Ms. Rosales earned her Master of Business Administration from St. Mary’s College of California.  She is a Certified Research Administrator and has been a member of the Society of Research Administrators International since 2004.  Ms. Rosales joined NCIRE in 2017. 


  • 9 Dec 2020 12:10 PM | Anonymous member (Administrator)

    The Fiscal Year 2021 (FY21) Defense Appropriations Bill has not been signed into law.  Although FY21 funds have not been appropriated for the Department of Defense Ovarian Cancer Research Program (OCRP), the OCRP is providing the information in this pre-announcement to allow investigators time to plan and develop ideas for submission to the anticipated FY21 funding opportunities. This pre-announcement should not be construed as an obligation by the Government.

    The FY21 Defense Appropriations Act is anticipated to provide funding to the Department of Defense OCRP to support patient-centered research to prevent, detect, treat, and cure ovarian cancer to enhance the health and well-being of Service members, Veterans, retirees, their family members, and all women impacted by this disease.  As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency J9, Research and Development Directorate manages the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation.  The managing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and Development Command (USAMRDC).

    Subject to the FY21 Congressional appropriation for OCRP funding, FY21 OCRP Program Announcements and General Application Instructions for the following award mechanisms will be posted on the Grants.gov website.  Pre-application and application deadlines will be available when the Program Announcements are released. 

    https://cdmrp.army.mil/pubs/press/2021/21ocrppreann

    Investigator-Initiated Research Award

    Must be at or above the level of Assistant Professor (or equivalent).

    Partnering PI Option: 
    Up to two investigators may collaborate on a single application, each of whom will be recognized as a Principal Investigator (PI) and receive a separate award. 

    ·      Supports meritorious basic and clinically oriented research in ovarian cancer.

    ·      Impact is an important review criterion.

    ·      Preliminary data are required.

    ·      Clinical trials are not allowed. 

    Pre-application is required; application submission is by invitation only.

    ·       Maximum funding of $600,000 for direct costs (plus indirect costs).

    • Maximum funding of $800,000 for direct costs (plus indirect costs) for Partnering PI Option.
    • Maximum period of performance is 4 years.

    Ovarian Cancer Academy Award – Early-Career Investigator

    NEW!  Must be within 5 years of their last postdoctoral research position (Ph.D.) or clinical fellowship (M.D.), or equivalent as of the full application submission deadline.  A letter attesting to eligibility is required.

    ·      Supports the addition of new Early-Career Investigators (ECIs) to the unique, interactive virtual academy that provides intensive mentoring, national networking, collaborations, and a peer group for junior faculty.

    ·      ECIs whose ability to commit to conducting ovarian cancer research is limited by lack of resources or other overwhelming obstacles are encouraged to apply.

    ·      A Designated Mentor who is an experienced ovarian cancer researcher with ovarian cancer funding is required.

    ·      A Designated Mentor may only mentor one ECI.

    ·      The Designated Mentor is not required to be at the same institution as the ECI.

    ·      Preliminary data are required.

    ·      Clinical trials are allowed.

    ·      Pre-application is required; application submission is by invitation only.

    ·      Maximum funding of $725,000 for direct costs (plus indirect costs).

    ·      Maximum period of performance is years.

    Pilot Award

    Investigators at or above the postdoctoral level (or equivalent).

    ·      Supports innovative, high-risk/high-reward research that could ultimately lead to critical discoveries or major advancements that will drive the field of ovarian cancer research forward.

    ·      Innovation and Impact are important review criteria.

    ·      Goal is to develop preliminary data; thus, preliminary data are not required, but are allowed.

    ·      Clinical trials are not allowed.

    ·      Pre-application is required and blinded; application submission is by invitation only.

    ·      Maximum funding of $250,000 for direct costs (plus indirect costs).

    ·      Maximum period of performance is 2 years.

    Clinical Translational Research Award

    Must be at or above the level of Assistant Professor (or equivalent).

    ·      Supports translational research addressing high-impact or unmet needs in ovarian cancer.

    ·      Supports research projects related to or associated with planned, ongoing, or completed clinical trials supported by other funding sources. 

    ·      Emphasis on the utilization of precision medicine and computational approaches that identify individual tumor characteristics and predictive biomarkers across diverse groups to optimize patient care and outcomes.

    ·      Preliminary data are required.

    ·      Clinical trials are not allowed.

    ·      Pre-application is required; application submission is by invitation only.

    • Maximum funding of $450,000 for direct costs (plus indirect costs).
    • Maximum period of performance is 3 years.

    Teal Expansion Award

    Investigators of the following awards:

    • OCRP FY14-FY17 Ovarian Cancer Academy – Early Career Investigator Award
    • OCRP FY15-FY17 Investigator-Initiated Research Award
    • OCRP FY15-FY18 Pilot Award

    ·      Supports the expansion of the initial research idea or the generation of a new idea based on the original research project.

    ·      Impact is an important review criterion.

    ·      Preliminary data are required.

    ·      Outcomes Statement is required.

    ·      Clinical trials are allowed.

    ·      Pre-application is required; application submission is by invitation only.

    • Maximum funding of $450,000 in direct costs (plus indirect costs)
    • Maximum period of performance is 3 years.

    Proteogenomics Research Award

    Must be at or above the level of postdoctoral fellow or clinical fellow (or equivalent).

    ·      Supports the genomic and/or transcriptomic and/or proteomic analysis of currently available clinical specimens with a focus on answering biologic and pathophysiologic questions of clinical relevance in ovarian cancer.

    ·      Innovation and impact are important review criteria.

    ·      Analysis of clinical trial-derived specimens and/or large patient specimen cohorts is encouraged.

    ·      Clinical trials are not allowed.

    ·      Preliminary data are not required but are allowed.

    ·      Submission of a Letter of Intent is required prior to full application submission.

    • Maximum funding of $250,000 for direct costs (plus indirect costs).
    • Maximum period of performance is 2 years.

    Omics Consortium Award

    Must be an independent investigator at or above the level of Assistant Professor (or equivalent).

    ·      Supports a multi-institutional research effort conducted by leading cancer researchers and advocates that focuses on the compilation of new and/or use of existing large datasets to study the origin of ovarian cancer, with an emphasis on early detection and screening.

    Two options are available:

    Omics Development Award Option:

    ·      Funds support assembling consortium members and laying the groundwork for the research project, including proof of concept.

    ·      Ovarian cancer advocate(s) are required on the research team.

    ·      Funded applicants will be eligible to compete for the consortium award, which will support the execution of the full research project and is anticipated to be offered in FY23, pending availability of funds.

    Omics Consortium Award Option:

    ·      The research effort will provide immediate benefits for ovarian cancer patients in initial diagnosis and therapy and the end result will lead to improvements in early detection and screening detection of ovarian cancer. 

    ·      Consortium should maximize the use of resources and minimize unnecessary duplication among consortium members by sharing resources among all consortium members.

    ·      Ovarian cancer advocate(s) are required on the research team.

    ·      Submission of a Letter of Intent is required prior to full application submission.

    Omics Development Award Option:

    • Maximum funding of $400,000 for direct costs (plus indirect costs).
    • Maximum period of performance is 2 years.

    Omics Consortium Award Option:

    • Maximum funding of $2.5 million for direct costs (plus indirect costs) from FY21 and future appropriations.
    • Maximum period of performance is 4 years.

    A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline.  All applications must conform to the final Program Announcements and General Application Instructions that will be available for electronic downloading from the Grants.gov website.  The application package containing the required forms for each award mechanism will also be found on Grants.gov.  A listing of all CDMRP and other USAMRDC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420. 

    Submission deadlines are not available until the Program Announcements are released.  For email notification when Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org.  For more information about the OCRP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.army.mil).

    Point of Contact:

    CDMRP Public Affairs
    301-619-9783
    usarmy.detrick.medcom-cdmrp.mbx.cdmrp-public-affairs@mail.mil


  • 1 Dec 2020 10:10 AM | Anonymous member (Administrator)
    1. Legislative:  Congress gets back to work this week.  First order of business—funding the federal government beyond the Continuing Resolution which expires on December 11th.  Other possible legislation before the end of the year includes a pandemic supplemental and a veterans package.
    1. Research Information Security Toolkit:  The OIT Research Support Division (RSD) reached out to the Office of Research Protections, Policy, and Education (ORPP&E) to collaboratively publish a toolkit on Information Security Reviews.  Click here to access this and other ORPP&E toolkits: https://www.research.va.gov/programs/ orppe/education/tools.cfm
    2. Donations:  the CARES Act included some lesser known provisions that increase the tax deductibility of donations.  Read more here: https://www.501c3.org/the-cares-act-increases-donation-tax-deductibility/
    3. Newsletter:  we are seeking NPC success stories to include in the NAVREF Newsletter to be published on Dec 22nd.  Please contact us to share any successes you have achieved in 2020, no matter how small!
    4. Calendar Items: 
    Dec 10, 1pm ET           NAVREF Webinar:       Understanding your HR Options, presented by TriNet (https://attendee.gotowebinar.com/register/209415594360924688)


  • 24 Nov 2020 11:32 AM | Anonymous member (Administrator)

    We have 6 items of interest for you this week:

    1. Despite the short week, we will still be hosting our NPC Discussion Groups on Tuesday from 3-4pm ET and on Wednesday from 1:30-2:30pm ET and 3-4pm ET.  You can attend any of the three at https://www.gotomeet.me/NAVREF/navref-video-conference-room
    1. Indirect cost rates and the direct cost distribution base are about to become publicly available (effective FY2022).  OMB issued a memo on Nov 12 (attached) about how this will occur:

    "On August 13, 2020,4 0MB published an update to the Guidance for Grants and Agreements in Title 2 of the Code of Federal Regulations (2 CFR) which requires the publication of the federally negotiated indirect rate, distribution base, and rate type for a non-Federal entity on an OMB-designated Federal website. This memorandum designates USASpending.gov as the official Federal website to display the federally negotiated indirect rate, distribution base, and rate type for a non-Federal entity receiving federal Financial Assistance awards.  Effective FY2022, cognizant agencies must report this information by non-Federal entity to a central location for display on USASpending.gov recipient profiles. Additionally, agencies must begin reporting indirect cost by total dollar amount by award with their Federal Assistance Broker Submission (F ABS) data to the DATA Act broker. Within fifteen days of issuance of this memorandum, 0MB, in accordance with Section 6 of the GREAT Act and in partnership with the Grants Standards setting agency, will convene a working group to provide recommendations on a set of common standard data elements for award agreements, otherwise known as notice of awards (NOA), and information related to grant awards and indirect costs. The Grants Data Standards Element Working Group will further inform what data elements are needed to link this information to recipient data in SAM. 8 Pub. L. No. 116-103 § 6(b). indirect cost rates."

    1. Clinical Repurposing Funding Opportunity. The global nonprofit Cures Within Reach recently launched the Clinical Repurposing for Veterans Initiative.  The program’s goal is to identify new medical treatments for already approved medications and devices to impact high-priority health concerns for veterans and active military. Cures Within Reach is launching its Clinical Repurposing for Veterans Initiative with a Request for Proposals (RFP) specifically for repurposing research in any disease area that will benefit veterans. Investigator-initiated proposals can come from any US-based institution, and at least one project will be selected to receive a $50,000 grant from Cures Within Reach and its funding partner, the Kahlert Foundation for a clinical repurposing trial. Additional details are in the attached press release or at cureswithinreach.org.  
    2. The U.S. Department of Veterans Affairs’ (VA) announced VA Chief Research and Development Officer, Rachel Ramoni, Ph.D., has been selected as the first recipient of the Above and Beyond Award from the Women in Science Forum of the Prostate Cancer Foundation (PCF).
    • Ramoni received the award for advancing biomedical research and clinical trials for veterans with prostate cancer and contributing to the fight against COVID-19.  To support better prostate cancer care for veterans, the department established the VA Precision Oncology Program for Cancer of the Prostate (POPCaP) in partnership with the PCF. The program aims to deliver precision cancer care to all veterans, including those who live in remote rural areas. There are currently 12 hubs in the POPCaP network distributed across the U.S.  Under Ramoni's stewardship, the VA Office of Research and Development has implemented policies that have streamlined research efforts, especially for multi-site clinical trials. In some cases, this has reduced the start-up time for clinical trials from several months to a matter of weeks.  In addition to advancing precision oncology research, Ramoni promotes diversity within the VA research enterprise and has been instrumental in mentoring women researchers in VA. See full press release at https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5572
    1. SCRS Offers Upcoming Webinar:  Key Strategies for Effective Oncology Clinical Trial Budgeting
    • December 3, 2020 @ 12:00 PM ET  -  Join Kathleen Hurtado, R.Ph., Director, Office of Research Administration, Cancer Treatment Centers of America, for a session that will dive into the policies and business rules that must be in place to support optimal budget development. Kathleen will review strategies for effective budget negotiations, determination of cost and necessary reimbursements, and working with transparency and how FMV comes into play.  Register here: https://customer28911c419.portal.membersuite.com/events/ViewEvent.aspx?contextID=fbf07b1c-0078-cc91-d848-634f9347538a
    1. Calendar Items: 


  • 3 Nov 2020 10:44 AM | Anonymous member (Administrator)

    Our NAVREF partnership with the Association of Clinical Research Professionals (ACRP) is in its fourth year and currently offers over 25 online training modules to our members. These courses come at no cost to our members. To get started, NPCs just need to sign up their personnel by sending NAVREF an email with their information.

    One of the courses offered by ACRP is the Informed Consent Simulation. Don't let this be a missed opportunity! The general research community is practically kicking down ACRP's door to take this course....and they have to pay $239 per person to take the class! NAVREF members with access will get to take this course for free!

    Contact the NAVREF office for more information or questions about the ACRP partnership. 

  • 28 Oct 2020 8:42 AM | Anonymous member (Administrator)

    Billing and reimbursement of services provided by VAMCs to externally sponsored research grants

    NAVREF prepared this analysis to advise members regarding (1) the recent memo from VA ORD (attached) that specifies rates for billing VAMC services on research awards at the Medicare rate less 10%, as well as (2) questions from the field regarding such billings. We considered situations that might occur at NPCs, taking into account the ORD memo, the VHA Handbook, the OMB Uniform Guidance and the new FASB pronouncement on contributed services.

    We deal with the following questions:

    ·       Can a NPC reimburse a VAMC for clinical services provided to patients on NPC-administered research grants?

    Yes.

    Per Handbook 1200.17: (b)(2) “Reimbursement. NPCs may reimburse VA for salaries and other costs incurred by VA in the conduct of VA-approved research projects or education activities.”

    ·       Which services can be billed, and which cannot?

    MRIs and similar tests and studies provided to research grants can be billed but not certain other medical services.

    Per “background” in ORD memo:  "VA Research and Education Non-Profit Corporations (“NPCs”) administer clinical research studies sponsored by non-VA entities, including industry. There are currently more than seventy (70) NPCs across the nation, many of which participate in the same clinical trials. These studies often include the use of VA clinical services, such as laboratory tests (e.g. blood counts and urinalyses), radiologic studies (e.g. chest X-rays and CT scans), and other diagnostic tests (e.g. EKGs, echocardiograms, pulmonary function tests). Each VA is to be reimbursed for only those tests that are performed outside of the “customary care” as described in VHA Handbook 1200.17, as authorized by Title 38.”

    Per 38 CFR 17.102: "Except as provided in § 17.101[ [which details types of charges for medical care, not research], charges at the indicated rates shall be made for Department of Veterans Affairs hospital care or medical services . . . as follows...:

    (g)  Furnished for research purposes.  Charges will not be made for medical services, including transportation, furnished as part of an approved Department of Veterans Affairs research project, except that if the services are furnished to a person who is not eligible for the services as a veteran, the medical care appropriation shall be reimbursed from the research appropriation at the same rates used for billings under paragraph (b) of this section."

    Per 38 U.S. Code § 1701 - Definitions: "(6)The term “medical services” includes, in addition to medical examination, treatment, and rehabilitative services, the following:

    (A)  Surgical services.

    (B)  Dental services and appliances as described in sections 1710 and 1712 of this title.

    (C)  ) Optometric and podiatric services.

    (D)  ) Preventive health services.

    1


    (E)  Noninstitutional extended care services, including alternatives to institutional extended care that the Secretary may furnish directly, by contract, or through provision of case management by another provider or payer.

    (F)  ) In the case of a person otherwise receiving care or services under this chapter—

    (i)  wheelchairs, artificial limbs, trusses, and similar appliances;

    (ii)  special clothing made necessary by the wearing of prosthetic appliances; and

    (iii)  other supplies or services as the Secretary determines to be reasonable and necessary.

    (G)  Travel and incidental expenses pursuant to section 111 of this title.

    (H)  Chiropractic services."

    Diagnostic procedures such as MRIs are not covered by that definition and so may be billed to research grants.

    ·       Is the VAMC required to bill for such services?

    No. We are not aware of a law or regulation that would require that investigator effort, or tests and studies like MRIs, must be billed. The memo says only that "Each VA is to be reimbursed for only those tests that are performed outside of the “customary care” as described in VHA Handbook 1200.17, as authorized by Title 38.” This doesn’t say it must be reimbursed.

    The question may be moot in the future. The VA is implementing Cerner electronic health record, and the system may dictate that VAMC’s account for all services by billing or other actions. The Nonprofit Program Office recommends that when your site goes live, you spend time with those individuals entering the data into the Cerner PowerTrials system to avoid being overbilled or underbilled.

    ·       What rates should the VAMC use in such billings?

    Medicare less 10%, once the rates are incorporated into Cerner EHR.

    Per the cover letter on the ORD memo:  "At the December 12, 2019, Nonprofit Program Oversight Board meeting, the board voted to use the Medicare Rate minus 10% for research-related tests performed outside of “customary care” after reviewing the National Pricing Recommendation from the Charge Delineation Work Group. It may take some effort and training of those involved in clinical trials to assure that the billing takes place at the appropriate rate for each test or study.

    ·       If there is a billing, which appropriation should get the credit—research or medical care?

    The appropriation for medical care.

    Per Handbook 1200.17: “A VA medical facility may retain and use funds provided to it by an NPC. Such funds must be credited to the applicable VA appropriation account and available for account purposes without fiscal year limitations as provided for in 38

    U.S.C. 7364(b)(3)."

    Per the cover letter to the recent ORD memo:  2. Accordingly, VA Medical Center’s (VAMC) shall be reimbursed by the Office of Research and Development for only those


    research-related tests, as part of sponsored clinical trials, that are performed outside of the “customary care” as described in VHA Handbook 1200.17, VA Nonprofit Research and Education Corporations Authorized by Title 38 U.S.C. These funds may also be accepted by VAMC’s without fiscal year limitations.”

    ·       Can the NIH and other federal sponsors pay for research services provided by the VAMC?

    Yes. There is no restriction in the NIH Grants Policy Statement on charges for services from federal entities.  NIH and other federal sponsors have not raised objections to NPCs including reimbursement for services provided by VAMCs (purely for research purposes) in their project budgets. Charges for salaries (e.g., an hourly rate for a specialist) are limited by GPS 17.3 and 17.6, however.

    ·       If the research project is administered by a NPC or by an academic affiliate, is the NPC or the affiliate required to reimburse the VAMC service by service in order to bill the sponsor?

    No, a service-by-service reimbursement is not required. However, the NPC should be able to demonstrate (i) that a service took place, (ii) that, if billed by the VAMC, the charge was priced at no more than Medicare less 10% rate, and (iii) that money was flowing in and out of an agency account held for the VAMC and not simply accumulating on the NPC’s balance sheet.

    In accordance with applicable rules, regulations and sponsor policy, NPCs should make all reasonable efforts to work with VAMCs to facilitate billing the NPCs for research- related costs on sponsored projects and to establish systems to ensure that the NPCs liability to the VAMCs is captured in a productive and compliant manner. In the event that the VAMCs do not bill the NPCs for research costs incurred on sponsored awards, a recommended practice is for the NPC to create a liability account to be used at the discretion of the VAMC and in accordance with applicable rules, regulations and policies.

    ·       What if the VAMC donates the service to the NPC-administered award? Are such donations appropriate?

    Yes.

    For effort, per VHA Handbook 1200.17:

    "11 PROVIDING AND FUNDING ADMINISTRATIVE AND RESEARCH SERVICES

    b. Reimbursement and Compensation Related to Approved Research Projects or Education Activities.

    (1)  VA Employees. VA employees may be assigned as part of their VA duties to work on VA-approved research projects or education activities for which an NPC is the flexible funding mechanism.


    (2)  Reimbursement. NPCs may reimburse VA for salaries and other costs incurred by VA in the conduct of VA-approved research projects or education activities. A VA medical facility may retain and use funds provided to it by a[n] NPC."

    For services, per VHA Handbook 1200.17

    11. a. “Use of VA Resources or Time to Support Management or Other Operations of an NPC. (5) VA Resources that Incidentally Further NPC Purposes. The NPC may receive any incidental benefits that result from VA employees using VA resources to carry out their official duties to promote VA research and education missions. The VA medical facility also may provide the NPC with space for its activities.”

    So, as noted above, VAMC employees may work on VA-approved NPC projects, and there appears to be no requirement for billing or reimbursement.  The VA may also donate “incidental” services.

    ·       Must the NPC report the contribution of such services on its statement of activities?

    Yes.

    Per FASB (ASU) 2020-07 § 958-605-50-1B "An entity (NFPs and business entities) that receives contributed services shall describe the programs or activities for which those services were used, including the nature and extent of contributed services received for the period and the amount recognized as revenues for the period. Entities are encouraged to disclose the fair value of contributed services received but not recognized as revenues if that is practicable. The nature and extent of contributed services received can be described by nonmonetary information, such as the number and trends of donated hours received or service outputs provided by volunteer efforts, or other monetary information, such as the dollar amount of contributions raised by volunteers. Disclosure of contributed services is required regardless of whether the services received are recognized as revenue in the financial statements.”

    ·       Would that contribution then be recognized as an expense?

    Yes, if it is recognized as a cost by the NPC.

    ·       Could effort or services contributed by the VAMC be charged to a federal sponsor?

    No.

    Per the OMB Uniform Guidance:

    § 200.434 Contributions and donations.

    (a)  Costs of contributions and donations, including cash, property, and services, from the non-Federal entity to other entities, are unallowable.

    (b)  The value of services and property donated to the non- Federal entity may not be charged to the Federal award either as a direct or indirect (F&A) cost.


    ·       Could effort or services contributed by the VAMC be charged to a non-federal sponsor under a CRADA, for example?

    Yes, there is no such requirement in the Uniform Guidance that applies to CRADAs, but as noted above, an NPC might not want to include such charges in the award budget when they had no intention of paying for them.

    ·       How would services contributed by the VAMC be treated in the NPC’s indirect cost proposal?

    If indirect, they would be excluded from the pool, since under Uniform Guidance §

    200.434 (a) and (b) they are unallowable; if direct, under § 200.434 (e), they would be in the base if “material” in value and “significant” to the calculation.

    Per OMB Uniform Guidance § 200.434

    (e)  The following provisions apply to nonprofit organizations. The value of services donated to the nonprofit organization utilized in the performance of a direct cost activity must be considered in the determination of the non-Federal entity’s indirect cost rate(s) and, accordingly, must be allocated a

    proportionate share of applicable indirect costs when the following circumstances exist:

    (1)  The aggregate value of the services is material;

    (2)  The services are supported by a significant amount of the indirect costs incurred by the non-Federal entity.


  • 6 Oct 2020 1:04 PM | Anonymous member (Administrator)
    1. NAVREF is proud to announce we are partnering with LIG Solutions, LLC, a subsidiary of Lighthouse Insurance Group, to establish a Partnership Health Member Benefit Program.  A formal announcement and detailed information will be forthcoming, but please block your calendars on October 15, 2-3pm ET for an introductory webinar presentation.
    1. See attached ORD COVID-19 Update from ORD. Please note the webinars highlighted in the “Upcoming Events” portion of this update.
    1. NIH Update - On Sep 30, 2020 Dr. Larry Tabak, Principal Deputy Director of the NIH, participated in a virtual Alliance Member Update with Research America! Key takeaways from the discussion: 
    • Many NIH Institutes and Centers (ICs) are extending application deadlines; most are considering grant extensions and cost supplements triggered by the pandemic on a case-by-case basis; they face tough choices (made all the more so now by the lack of emergency supplemental research funding).
    • In October, NIH will field a survey designed to solicit feedback from extramural scientists and research organizations on the challenges they are facing.
    • Peer review is taking place remotely; this practice may continue beyond the pandemic.
    • NIH will likely initially reduce grant amounts for FY21, as has been common during other Continuing Resolutions.
    1. Legislative Update
    • A.      On Oct. 1, 2020, the president signed H.R. 8337, a continuing resolution to fund the government until Dec. 11, 2020.
    • B.      On Sep 30, 2020, The House Veterans Affairs Committee (HVAC) held a hearing to review the Department of Veterans Affairs’ (VA) intention to go live on October 24 with its new EHR system, from Cerner. VA witnesses emphasized they are fully ready for that date, with employees trained and Cerner support staff in place. VA EHR modernization lead John Windom also told the committee the Department has enough money for its plans throughout the coming fiscal year. The pandemic has delayed the program’s implementation, but the VA expects to still finish within the ten-year timeline.
    1. Upcoming calendar events:                    
    • Oct 6-22                      SCRS Global Site Solutions Summit (virtual)

    • Oct 15, 2-3pm ET        NAVREF Webinar: “Group and Individual Health Coverage Overview,” presented by LIG Solutions

    • Oct 22                          NAVREF Webinar “Fundraising Registration 101: Why, Who, Where and How to Comply with State Laws

    • Oct 28-29                    VHA Innovation Experience (virtual)


  • 29 Sep 2020 1:47 PM | Anonymous member (Administrator)
    1. The NAVREF Annual Conference sessions are still available for all registered attendees.  Please check out those sessions you missed the first time!  Additionally, the survey instruments are still open, please help us gather feedback:
    1. The overall survey on Survey Monkey consists of 10 questions and less than 5 minutes of your time.  Go to: https://www.surveymonkey.com/r/NAVREF2020
    2. The session surveys are on your NAVREF App. Go to the Schedule tab, click on the session you attended, click on “Leave Feedback”, rate the session and the presenter on a 1-to-5 scale and add any additional comments—that’s all!

     

    1. Note that ORD has approved the Sterling IRB as the third commercial IRB that may be used by VA facilities participating in cooperative research activities.
    1. New Requirements for Gifts-in-Kind.  Last week, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2020-07, Not-for-Profit Entities (Topic 958): Presentation and Disclosures by Not-for-Profit Entities for Contributed Financial Assets.  The new standard aims to increase transparency and improve disclosures related to in-kind gifts of nonfinancial assets.  The standard will require that in-kind gifts be presented separately in the revenue section on the Statement of Activities, and will require additional disclosures including:

    •   Disaggregation by type of nonfinancial contribution received;

    • A description of any donor restrictions on the use of the gift;
    • Whether the gift was used or was monetized (converted to cash);
    • If used, a description of the programs or other activities in which the gift was used; and
    • A description of the method used to determine the fair value of the gift, including the principal or most advantageous market used to arrive at the fair value measure.

    The ASU is effective for annual periods beginning after July 15, 2021. The standard is required to be applied on a retrospective basis and early adoption is permitted.

    1. Legislative Update – Last Wednesday, the House unanimously passed S. 785, the Commander John Scott Hannon Veterans Mental Health Care Improvement Act, sending it to the President’s desk to be signed into law. The Senate-crafted bill addresses a wide range of mental health and suicide prevention measures, including opening the care aperture for more veterans.  It also include two provisions supported by NAVREF to solidify the ACT for Veterans initiative:
    • Sec. 704 – to allow sponsored clinical research of VA to use accredited commercial IRBs
    • Sec. 705 – to establish within the VA Office of Information and Technology an Office of Research Reviews to perform centralized security reviews and complete security processes for approved research sponsored outside the VA, with a focus on multi-site clinical trials.

     

    Upcoming calendar events:                         

    • Oct 5, 12-4pm ET                      NAVREF Quarterly Board of Directors Meeting (virtual)
    • Oct 6-22                                     SCRS Global Site Solutions Summit (virtual)
    • Oct 22                                         NAVREF Webinar “Fundraising Registration 101: Why, Who, Where and How to Comply with State Laws
    • Oct 28-29                                VHA Innovation Experience (virtual)

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