Endocrine Insider: June 23, 2016

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Past Issues


Advocacy News

Senate Committee Gives $2 Billion Boost to NIH Funding; Outlook Still Unclear – Take Action Today

Society Building Support for Medicare Coverage of CGM; Urge Your Representative & Senator to Co-Sponsor Legislation

European Commission's Overreaching Decision Fails to Protect Public Health

Clinical News

AMA Approves Society-Supported Policies at Annual Meeting

Society Urges Agencies to Reevaluate Competitive Bidding Program & Uphold Existing Standards

Transforming Clinical Practice Initiative Offers Free Support for Transition to New Payment System

FDA Takes Action on SGLT-2 Inhibitors

Research News

NIH Releases Final Multi-Site IRB Policy

NIGMS Seeks Information on Graduate Education

NICHD Council Discusses Global Health, Zika Virus Response


Advocacy News

Senate Committee Gives $2 Billion Boost to NIH Funding; Outlook Still Unclear – Take Action Today

On June 9, the Senate Appropriations Committee approved the fiscal year (FY) 2017 Labor, Health and Human Services (LHHS) Appropriations bill by a vote of 29-1. Senator James Lankford (R-OK) was the only “no” vote. The bill provides a $2 billion increase for the National Institutes of Health (NIH), bringing the agency's budget to $34.1 billion in FY 2017.

This is a major victory that came about because we advocated for an NIH funding increase. We visited many congressional offices, including during our Centennial Hill Day in April, submitted testimony, and wrote letters and emails to Congress.

The Senate bill would mark the second year in a row that the NIH could receive a $2 billion funding boost. Last year, the agency received its largest budget increase in 12 years. However, the outlook for NIH funding is not certain. We do not yet know if Senate leadership will bring the Appropriations Committee-approved LHHS bill to the Senate floor for a final vote. The House L-HHS Appropriations subcommittee is expected to vote on its version of the funding bill before July 4 but with limited legislative days left in the congressional session before the elections, many expect the Congress will be unable to complete action on funding bills and will instead resort to passing a Continuing Resolution that funds the government at this year’s levels.

Take Action: It is critical that all Members of Congress hear from their constituents about the need to provide a funding increase for NIH. Join the Endocrine Society’s advocacy efforts by participating in our online campaign. All you need to do is visit our online advocacy center at http://www.endocrine.org/advocacy and submit your zip code, and our system will send letters to your Representative and Senators.

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Society Building Support for Medicare Coverage of CGM; Urge Your Representative & Senator to Co-Sponsor Legislation

The Endocrine Society is a leading advocate for extending Medicare coverage of continuous glucose monitors (CGM). While CGM devices are covered by nearly all private payers, Medicare does not yet provide coverage of this lifesaving technology which is supported by clinical evidence, including the Society’s Clinical Practice Guideline on CGM.

We have been working to gain congressional support for The Medicare CGM Access Act (H.R. 1427/S. 804), which now has 242 co-sponsors in the House of Representatives and 46 in Senate, but needs additional support.

As reported in the appropriations story above, we have also been working on federal appropriations and recommended language to the Senate Appropriations Committee urging Medicare to modernize its policies to cover CGM, which was included by the Committee in its report accompanying its spending bill. Report language does not have the weight of statute, but it does set specific policy directions and holds the agencies accountable. This language will help support our advocacy regarding Medicare coverage.

Take Action: Join our campaign today to ask your Representative and Senators to support of this important legislation.

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European Commission's Overreaching Decision Fails to Protect Public Health

The Endocrine Society expressed disappointment and concern with the European Commission’s July 15 decision on regulatory criteria for endocrine-disrupting chemicals (EDCs), saying it is too strict to effectively protect the public’s health.

More than 1,300 studies have tied EDC exposure to health problems such as infertility, diabetes, obesity, hormone-related cancers and neurological disorders, according to the Endocrine Society’s 2015 Scientific Statement. Because the health effects of exposure can take years or even generations to become apparent, scientists have used a variety of animal and epidemiological studies to document the effects of EDCs.

Two days before the European Commission announced its criteria, Endocrine Society members called on the European Commission to adopt science-based policies for regulating endocrine-disrupting chemicals in an opinion piece published in The Lancet Diabetes & Endocrinology.

The European Commission had proposed four options for regulatory criteria identifying endocrine-disrupting chemicals. The Endocrine Society supported option 3, which would create multiple categories based on the amount of scientific evidence that a particular chemical acts as an endocrine disruptor. This option also allows for incorporating new data as more studies are published. Ultimately, however, the Commission selected a restrictive version of option 2.

The European Commission’s overly strict criteria would result in very few EDCs being identified and regulated, at a high cost to the public’s health. Recent studies have found that adverse health effects from EDC exposure cost the European Union more than €163 billion each year in healthcare expenses and lost productivity. Bisphenol A and other EDCs can be found in common products, including food containers, plastics, cosmetics and pesticides.

The European Parliament and member countries still need to approve the regulatory criteria before they take effect. The Society will continue to advocate for changes to ensure the criteria are grounded in scientific evidence.

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Clinical News

AMA Approves Society-Supported Policies at Annual Meeting

The American Medical Association (AMA) recently held its annual meeting of the House of Delegates (HOD), which is the policy-making body of the AMA. The Society’s delegates – Amanda Bell, MD, Daniel Spratt, MD, and Palak Choksi, MD– represented the interests of endocrinologists in the debates surrounding issues that impact the practice of medicine. Discussion of new AMA policy focused on a range of issues relevant to endocrinologists, including care of transgender patients, assignment of gender at birth for patients with ambiguous genitalia, expansion of the National Diabetes Prevention Program, and a reduction in corn subsidies for the production of high fructose corn syrup. The HOD also voted to expand existing policy on gun control to establish that gun violence is a public health crisis. As a result, the AMA will actively lobby Congress to overturn the ban on research on gun violence by the Centers for Disease Control and Prevention.

The Endocrine Society’s delegates also worked closely with the delegates from the American Association of Clinical Endocrinologists, American Society for Reproductive Medicine, and American Association of Endocrine Surgeons during the meeting on issues of importance to endocrinologists, and met with members of the Obesity Caucus to discuss issues related to care of patients with obesity and provider education.

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Society Urges Agencies to Reevaluate Competitive Bidding Program & Uphold Existing Standards

The Endocrine Society submitted a letter to the Senate Finance Committee, the Centers for Medicare and Medicaid Services (CMS), and the U.S. Food and Drug Administration citing concern about access problems for diabetes testing and devices supplies obtained through the CMS Competitive Bidding Program (CBP). The CBP was enacted to reduce costs incurred by both the Medicare program and its beneficiaries; however, its implementation has disrupted access to the supplies needed to manage diabetes. Studies have found that this disruption has led to an increase in mortality, inpatient admissions, and higher inpatient costs. This has also resulted in an abundance of inaccurate, low-cost blood glucose monitoring systems coming onto the market as a result of the FDA’s failure to uphold existing standards following initial submission of these systems to the agency for approval. Finally, the CBP has led to access problems for pump supplies as many suppliers only offer one brand.

The letter urges Congress to review the CBP to ensure that beneficiaries are able to effectively and safely manage their diabetes and urges the FDA to enforce existing standards for blood glucose monitoring systems. We also urge CMS to review the CBP and include a new category specific for external infusion pumps and supplies to ensure that those who provide these products are able to do so. We will continue to work with federal agencies to remedy these issues; we will keep our members informed once we receive a response.

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Transforming Clinical Practice Initiative Offers Free Support for Transition to New Payment System

Physicians, Nurse Practitioners and Physician Assistants in all practice types (primary care, pediatrics, specialty, surgical, etc.) are eligible to be part of a free nationwide initiative to help them prepare for the new payment models and help them reduce the burden of practice. The Transforming Clinical Practice Initiative (TCPI) is designed to help clinicians achieve large-scale health transformation. The initiative will support more than 140,000 clinician practices over the next four years in transitioning from a volume-based payment system to a patient-centered approach, and provide an opportunity for sharing, adapting and further developing their comprehensive quality improvement strategies.

The TCPI offers support and education to practices to:

  • help practices collect, improve and submit the “data” they need to show their “value”
  • use this data to enhance patient care
  • learn methods and processes to reduce the burdens in practice
  • improve care coordination

The initiative provides education, tools, and support to aid in the transition (equivalent to having many free consultants plus educational resources tailored to your needs, help with data analytics, practice operations and transformation, registries and much more), and connects participants to other practices to learn how they are addressing similar challenges.

The American College of Physicians (ACP) was awarded a grant by the Centers for Medicare and Medicaid Services to offer guidance to practices as a Support and Alignment Network. Please contact Cheryl Rusten with the ACP (crusten@mail.acponline.org) to receive more information on the initiative as well as match your practice to a Practice Transformation Network (PTN) in your area. Endocrine Society member, Dr. Carol Greenlee MD (cgreenlee@westslopeendo.com) is faculty for the Colorado TCPI PTN and can explain the initiative in more detail.

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FDA Takes Action on SGLT-2 Inhibitors

EMDAC to Review Empagliflozin for Approval
The Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) will review Boehringer Ingelheim's supplemental application for empagliflozin for the proposed additional indication in adult patients with type 2 diabetes mellitus and high cardiovascular risk to reduce the risk of all-cause mortality by reducing the incidence of cardiovascular death and to reduce the risk of cardiovascular death or hospitalization for heart failure. A post-marketing clinical trial, EMPA-REG OUTCOME, showed that empagliflozin resulted in significantly lower death rate due to cardiovascular events compared to placebo.

The Society submitted testimony to the EMDAC in advance of the June 28, 2016 meeting to urge the FDA to give fair consideration of new options in combating diabetes and to expedite the approval process for emerging therapies that, based on safety and efficacy data, have the potential to reduce complications and impact the progression of the disease.

Empagliflozin is a sodium glucose co-transporter-2 (SGLT-2) inhibitor approved for treatment of type 2 diabetes in adults in 2014, which causes sugar in the blood to be excreted by the kidneys and eliminated in urine.

FDA Strengthens Warning Related to Kidney Injury for Two SGLT-2 Inhibitors
The FDA has also issued an alert strengthening an existing warning about the risk of acute kidney injury for canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR), which added recommendations to minimize this risk. From March 2013, when canagliflozin was approved, to October 2015, FDA received reports of 101 confirmable cases of acute kidney injury, some requiring hospitalization and dialysis, with canagliflozin or dapagliflozin use. Health care professionals should consider factors that may predispose patients to acute kidney injury prior to starting them on canagliflozin or dapagliflozin, including: decreased blood volume; chronic kidney insufficiency; congestive heart failure; and taking other medications such as diuretics, blood pressure medicines called angiotensin-converting enzyme inhibitors and angiotensin receptor blockers, and nonsteroidal anti-inflammatory drugs. Physicians should also assess kidney function prior to starting these medications and monitor periodically thereafter. If acute kidney injury occurs, promptly discontinue the drug and treat the kidney impairment.

Patients should seek medical attention immediately if they experience signs and symptoms of acute kidney injury. This is a serious condition in which the kidneys suddenly stop working, causing dangerous levels of wastes to build up in the body. Signs and symptoms of acute kidney injury may include decreased urine or swelling in the legs or feet. Patients should not stop taking their medicine without first talking to their health care professionals.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. Additional information on this safety alert can be found on the FDA's website.

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Research News

NIH Releases Final Multi-Site IRB Policy

On Tuesday, June 21, the National Institutes of Health (NIH) issued a final policy establishing that a single Institutional Review Board (sIRB) of record be used for multi-site clinical studies in the United States. The Endocrine Society has consistently advocated for the use of single IRBs for multi-site studies in an effort to increase efficiencies and reduce administrative burdens while maintaining high standards for the protection of human research subjects. We are encouraged that the final NIH policy is in alignment with our longstanding position.

The final policy is scheduled to go into effect on May 25, 2017. For more information on the policy, including an overview of comments received in response to the draft notice, please see the final notice and associated guidance on the allocation of direct and indirect costs.

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NIGMS Seeks Information on Graduate Education

As part of its strategic plan, the National Institute of General Medical Sciences (NIGMS) provides support for the development a highly skilled and diverse biomedical research workforce. On June 8, the National Institute of General Medical Sciences (NIGMS) issued a Request for Information (RFI) on Strategies for Modernizing Biomedical Graduate Education. The Institute is inviting comments on the following topics:

  • Current strengths, weaknesses and challenges in graduate biomedical education.
  • Changes that could enhance graduate education to ensure that scientists of tomorrow have the skills, abilities and knowledge they need to advance biomedical research as efficiently and effectively as possible.
  • The major barriers to achieving these changes and potential strategies to overcome those barriers.
  • The key skills that graduate students should develop in order to become outstanding biomedical scientists, and the best approaches for developing those skills. These could include but not be limited to: a) essential skills applicable to all fields that ensure ability to design meaningful experiments and critically analyze data, b) ability to adapt new and emerging technologies or approaches and c) other skills such as team science
  • Potential approaches to modernizing graduate education through the existing NIGMS institutional predoctoral training grants program to ensure that trainees have the skills and knowledge they need to be prepared to enter the biomedical research workforce.
  • Anything else you feel is important for us to consider.

Take Action: The Endocrine Society encourages members to provide input on the RFI to help NIGMS develop new programs and initiatives for biomedical research trainees. To provide comments, please see the instructions and web form at the following link: https://www.research.net/r/Graduate_Education. Please note that responses to the RFI are due on or before August 5, 2016.

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NICHD Council Discusses Global Health, Zika Virus Response

On June 9, the Endocrine Society participated in the 160th meeting of the National Advisory Child Health and Human Development Council. During the open session of the meeting, Dr. Vesna Kutlesic, the Director of the NICHD Office of Global Health joined the council to provide an overview of NICHD programs to advance global maternal and child health. NICHD’s total international funding related to global health research includes 286 funded projects in 138 countries totaling over $115 million. Dr. Kutlesic described several recent advances from these projects, including a study in South Africa on the evolution of antibiotic resistance in Mycobacterium tuberculosis, and also a study in Denmark on the determinants and health implications of diabetes in pregnancy on women and their children.

Building on the global health presentation, Dr. Nahida Chakhtoura joined the council to deliver a presentation on the Zika virus and NICHD research efforts against Zika. Dr. Chakhtoura gave an overview of the history of the Zika virus and the recent outbreak, including modes of transmission and adverse outcomes. Importantly, it was noted that adverse outcomes are not limited to the widely-reported cases of microcephaly, but include a spectrum of effects such as miscarriage and eye abnormalities. Additionally, the risk of serious effects may span the first through third trimester of pregnancy.

As part of NICHD efforts to advance the science related to preventing and treating patients infected with the Zika virus, the Institute is participating in the R21 funding opportunity “Rapid Assessment of Zika Virus (ZKV) Complications.” The NICHD, along with the other participating institutes, will be accepting applications on a rolling basis given the urgent need to learn more about the Zika virus and prevent further harm to pregnant women and their children. Additionally, a multi-site, multi-country prospective observational cohort study including 10,000 women is currently in the planning phases. The objective of the study will be to “determine the risks of Zika infection during pregnancy on maternal and fetal outcomes while controlling for potential confounders.” In addition to NICHD, the study is supported by the National Institute of Allergy and Infectious Diseases and the National Institute of Environmental Health Studies, and the Fundacao Oswaldo Cruz-Fiocruz.

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