Endocrine Society Opposes Increase in SBIR/STTR Set-Aside
On May 10, the Endocrine Society joined a coalition of research and professional societies and educational institutions, to oppose a provision in the Commercializing on Small Business Innovation Act of 2016 (H.R. 4783) that would increase the set-aside funding for small business grants at federal agencies such as the National Institutes of Health (NIH).
The NIH is required by law to spend a percentage of its budget each year on Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. H.R. 4783 would increase this set-aside from 3.46 percent in fiscal year 2018 to 4.5 percent in fiscal year 2022. While the sign-on letter expresses support for the SBIR/STTR programs in general, we are concerned that increasing the set-asides will adversely impact funding for research by reducing the funds spent on other worthwhile programs at NIH and other research funding agencies. The SBIR/STTR programs are not underfunded relative to other types of research, and the SBIR/STTR programs increased by 29 percent between fiscal years 2011 and 2016, while the NIH budget as a whole grew by only 4.5 percent. We also urged the House Science Committee to hold hearings to review the outcomes of the previous SBIR/STTR reauthorization and evaluate any change in the set-aside for these programs based on the merits and justification for doing so.
Consensus Statement Supports Endocrine Society Position on EDC Identification Criteria
On May 4, an international group of scientists released a consensus statement on the identification of endocrine disrupting chemicals (EDCs) supporting the Endocrine Society's position that potency "is not relevant" for the identification of a compound as an EDC. The statement is the direct outcome of a meeting organized by the German National Institute for Risk Assessment (BfR) and included 23 international scientists with expertise on the subject of EDCs. Endocrine Society members R. Thomas Zoeller, PhD, and Rémy Slama, PhD, participated in the meeting.
As reported previously in Endocrine Insider, the Endocrine Society has been highly engaged in international efforts to reduce harms due to exposures to EDCs. In the European Union, the Society has consistently advocated for a multi-level categorization for EDCs that does not include potency as a criterion and has supported Option 3 in the European Commission Roadmap. This option is similar to the existing framework for identifying and regulating carcinogens. The Society is encouraged by the new statement and we hope that the Commission will use the consensus statement towards the adoption of Option 3 as the most appropriate approach for establishing criteria to define EDCs.
MACRA Proposed Rule Provides More Clarity Around New Payment Model
The Centers for Medicare and Medicaid Services (CMS) issued a Notice of Proposed Rulemaking on April 27, 2016 to implement key provisions of the Medicare Access and CHIP Reauthorization Act (MACRA). The Proposed Rule provides specifics on how CMS proposes to implement the “Quality Payment Program”, which includes two paths for payment: the Merit-based Incentive Payment System and the Advanced Alternative Payment Models.
1. The Merit-based Incentive Payment System (MIPS): Most Medicare clinicians may choose to initially participate in the Quality Payment Program through MIPS. MIPS allows Medicare clinicians to be paid based on the quality of care provided through four performance categories:
Quality (50 percent of total score in year 1; replaces the Physician Quality Reporting System and the quality component of the Value Modifier Program)
Advancing Care Information (25 percent of total score in year 1; replaces Meaningful Use)
Clinical Practice Improvement Activities (15 percent of total score in year 1)
Resource Use (10 percent of total score in year 1; replaces the cost component of the Value Modifier Program)
Clinicians MIPS scores will be used to compute a positive, negative, or neutral adjustment to their Medicare payments. In the first year, adjustments are calculated so that the negative adjustments can be no more than 4 percent, and positive adjustments are generally up to 4 percent with additional bonuses for the highest performers.
2. Advanced Alternative Payment Models (APMs): Clinicians who take a further step toward care transformation and receive enough of their payments or see enough of their patients through Advanced APMs would be exempt from MIPS reporting requirements and qualify for a 5 percent incentive payment. These models include:
Comprehensive ESRD Care Model (Large Dialysis Organization arrangement)
Comprehensive Primary Care Plus (CPC+)
Medicare Shared Savings Program – Track 2
Medicare Shared Savings Program – Track 3
Next Generation ACO Model
Oncology Care Model Two-Sided Risk Arrangement (available in 2018)
In order to determine if clinicians meet the requirements for the Advanced APM track, all clinicians will report through MIPS in the first year.
As reported in previous issues of Endocrine Insider, all Medicare payments will be made through one of these paths starting in 2019. As many components of the new system will be based on 2017 performance, offering providers with specific approaches to the new system as soon as possible is vitally important. Members of the Society’s MACRA Task Force will be reviewing the Proposed Rule in more depth and will provide a comprehensive overview in future editions of Endocrine Insider. Members may also visit the CMS website and American Medical Association website for additional information on MACRA implementation.
Society Works with FDA to Expand Access to Diabetes Therapies
The Society has been working with the U.S. Food and Drug Administration (FDA) to expand access to diabetes therapies that are both under review and which have evidence supporting new indications. On May 24 and 25, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will review two new therapies for diabetes: Sanofi’s application for a glargine/lixisenatide injectable and Novo Nordisk’s degludac/liraglitide injectable. The Society submitted testimony to the FDA in support of new treatment options for patients with diabetes given recent scientific advancements. We noted in our testimony that a variety of options can better enable individuals to reach their A1C goals, improve time in range, reduce hypoglycemia, and improve the overall quality of life. The Society will monitor the hearings at the FDA and will provide updates should these therapies be approved.
The Society is also working with the American Diabetes Association and the American Association of Clinical Endocrinologists for a new indication for metformin for people with prediabetes. Our societies submitted a letter requesting a meeting with the FDA to discuss this proposal and are currently working to develop an application in support of this new indication. We expect that a meeting will take place later this summer to discuss this proposal in more depth.
UnitedHealthcare Chooses Medtronic as Preferred Insulin Pump Supplier
UnitedHealthcare has announced that effective July 1, 2016, insurance holders will only be covered for a new insulin pump supplied by Medtronic. After the new policy goes into effect, new patients will be required to use a Medtronic device in order to receive insurance coverage. United will continue to cover pump supplies for patients who currently use a non-Medtronic device, provided that it is still under warranty and functions properly. However, all patients will be required to switch to a Medtronic device when their pump needs to be renewed. While United’s medical policy for covering insulin pumps will not change, this nuance restricts patient access to different types of pump devices. Minors and members of UnitedHealthcare Sierra Health, Life Commercial, or UnitedHealthcare Medicare Advantage are excluded from this policy.
Society Members Discuss Priorities and Opportunities for Collaboration with NICHD Leadership
On Friday, May 6, Endocrine Society members Richard Legro, MD and Carole Mendelson, PhD represented the Society at a meeting with leadership from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), including the Acting Director of the NICHD, Catherine Spong, MD.
During the meeting, Drs. Legro and Mendelson discussed how to maintain support for the next generation of researchers given the challenging fiscal climate. Dr. Spong discussed the results of a review by the Institute of their training programs for graduate students and early career investigators. Moving forward the NICHD will have a greater focus on individual awards to trainees, and will make a concerted effort to increase support for the successful K99/R00 program.
The group also discussed challenges facing the biomedical research enterprise generally, including difficulties in maintaining support for investigator-initiated research projects. NICHD described how they are reviewing their grant portfolio and comparing it to other Institutes to determine what variances exist and how they should be managed. Drs. Legro and Mendelson shared Society concerns about set-asides for special projects and how these might impact support for the pool of R01-supported investigators.
Dr. Spong highlighted the many synergies that exist between the priority areas supported by NICHD and the disease and research interests of Endocrine Society members. She encouraged us to continue to raise the profile of research on women and children’s health and work with the Institute to raise awareness among trainees of the programs at NIH to support their research.
We will continue to work with NICHD to advance endocrine research and explore further opportunities to collaborate. For more information on NICHD priorities and news from the Institute, please see the NICHD website at https://www.nichd.nih.gov/Pages/index.aspx.