Endocrine Insider: January 31, 2017

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Past Issues


Advocacy News

Congress Struggles to Craft a Plan for Repealing Obamacare; Take Action Today to Support Endocrine Society Core Principles in Health Care Reform

Endocrine Society Responds to Trump’s Executive Order on Immigration

Clinical News

Eli Lilly Announces Discount Program to Address Insulin Prices

CMS Offers Additional Resources for Quality Payment Program Implementation

Research News

HHS Releases Final Updated Common Rule

NICHD Issues FOA on Fertility Status and Overall Health

FASEB Seeks Responses to Survey on Shared Research Resources, Nominations for Excellence in Science Award


Advocacy News

Congress Struggles to Craft a Plan for Repealing Obamacare; Take Action Today to Support Endocrine Society Core Principles in Health Care Reform

Within the first 24 hours of assuming office, President Donald Trump took steps to weaken the Patient Protection and Affordable Care Act (ACA) through an executive order that instructs relevant federal agencies to delay or waive the requirements of the health care law and identify ways to repeal it. The week prior, Congress also approved a resolution that allows the Republican majority to begin the process of repealing the ACA and its major provisions. Yet, while the President and Congress have prioritized repeal of the ACA, lawmakers are far from a consensus on how best to replace it.

Last week, the Republicans missed their first deadline for committee development of a health care law repeal measure and they remain muddled over future action on overhauling the requirements for offering individual health insurance coverage and adjusting the health care law’s expansion of the Medicaid program. Republican leaders recalibrated the target timeframe into March for finishing initial action on the health care law.

In the meantime, we continue to monitor relevant pieces of legislation that may be included in the ACA repeal or replacement vehicles. Several members of Congress have put forward plans for consideration, including Speaker of the House Paul Ryan’s “A Better Way to Fix Health Care” and the American Health Reform Act. Several bills have also been introduced to address market-based reforms, health savings accounts, and high deductible plans. We will continue to monitor these bills as they move through the legislative process and will alert our members as the ACA replacement package take shape. The Society is also working to ensure that any package addresses the needs of patients with chronic conditions, like diabetes, and are working with relevant committees to expand the National Diabetes Prevention Program, reauthorize the Special Diabetes Program, secure passage of the National Diabetes Clinical Care Commission Act, and address rising drug costs.

To avoid potential harm to patients, the Endocrine Society has advocated that Congress identify a replacement plan before repealing the ACA. We also are urging Congress and the Trump administration to use our core principles as a guide as they consider a replacement plan, specifically: providing affordable access to health insurance, maintaining preventive health benefits, incorporating coordinated care in new health delivery models, and protecting women’s health.

What you can do: As members of Congress consider replacement options, they need to hear from their constituents. Please help share the Endocrine Society’s message by joining our campaign. Writing to your Congressional delegation is quick and easy when you use our Health Care Reform campaign link. Click to access the campaign, and a pre-written letter will be provided for you. You will only need to either provide your email and member ID, OR enter your address information so that the system will send your message to the correct recipients.

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Endocrine Society Responds to Trump’s Executive Order on Immigration

US President Donald Trump signed an executive order on Friday, January 27, limiting refugees into the US, barring the citizens of seven countries—Iraq, Iran, Syria, Somalia, Sudan, Libya, and Yemen—from entering the US on any visa category, and, consequently, also creating new barriers to the global exchange of scientific information. In recent days, the order has caused confusion and there has been a lack of clarity among various US agencies about its implementation. In the coming days, we expect to see legal challenges to overturn the order both through the judicial and legislative processes, but we do not know whether this order will be allowed to stand.

The Society strongly opposes efforts that create barriers to the exchange of scientific information. We will continue to welcome and support scientists and clinicians from around the globe in our Society and our meetings and activities because science, like disease, has no borders. We are currently working with the broader research and medical community on supporting legal efforts to overturn the order and we are exploring ways to accommodate those colleagues who are prevented from attending ENDO through special online access to sessions.

You can read a copy of the Society’s press release on this issue here.

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Clinical News

Eli Lilly Rolls Announces Discount Program to Address Insulin Prices

Eli Lilly and Company announced that it will offer discounted prices on insulin products purchased through certain online platforms as a step toward addressing increasing insulin prices. Starting January 1, 2017, Lilly’s discounts, offered through a partnership with Express Scripts, will benefit people with diabetes who have no insurance and those who are covered by a high-deductible insurance plan and have not yet met the deductible. Lilly said people who currently buy insulin products at full price may save 40 percent by purchasing the products through Blink Health’s web and mobile platforms.

The Society is concerned rising insulin prices have created a barrier that makes it challenging for people with diabetes who are insulin-dependent to obtain treatments they need. We continue to call on entities throughout the insulin supply chain—including manufacturers, pharmacy benefit managers and insurers—to ensure this life-saving therapy remains accessible to patients who need it. With greater transparency across the supply chain, the Society believes stakeholders can work together to help patients and providers maintain access to affordable, patient-centered therapies.

Take Action: While this plan will not help all patients, we encourage physicians to share this information with patients who use Eli Lilly insulin products and may be eligible.

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CMS Offers Additional Resources for Quality Payment Program Implementation

The Centers for Medicare & Medicaid Services (CMS) recently posted new resources to the Quality Payment Program (QPP) website to help eligible clinicians successfully prepare to participate in the program. New resources for clinicians include:

These resources and others are also available on the Society's MACRA website.

The Center for Medicare & Medicaid Innovation (CMMI) will also host a webinar to discuss various aspects of the Advancing Care Coordination through Episode Payment Models (EPMs) final rule on Thursday, February 9, 2017, from 12:00 PM–1:00 PM (EST). Those interested in participating can register here.

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Research News

HHS Releases Final Updated Common Rule

On January 18, the Department of Health and Human Services (HHS) announced long-awaited updates to the set of ethical rules that broadly apply to Federal Agencies that conduct human subjects research, otherwise known as the Common Rule. The Endocrine Society submitted comments during the development process, outlining several important issues that should be addressed in the final rule. Many of our recommendations were addressed in the final rule, for example:

  • The final rule does not adopt the proposal to require that research involving non-identified biospecimens be subject to the Common Rule, and it does not require that consent be obtained in order to conduct such research. In general, researchers can continue to use such biospecimens in the way they are currently using them.
  • The final rule removes the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects.
  • The final rule provides guidance on public posting of consent forms and the appropriate level of detail to allow patients to rapidly understand the most important information in the form.

The rule also addresses many Society priorities not explicitly referenced in our letter such as:

  • The rule includes a requirement to use a single IRB for multi-site studies in most cases.
  • The rule establishes exemptions based on categories of research based on the level of risk they pose to participants.
  • There are a series of provisions that streamline or reduce burden for IRBs or institutions including: (1) requiring consultation among the Common Rule agencies for the purpose of harmonizing guidance (to the extent appropriate); (2) eliminating an administrative requirement for reporting IRB membership; (3) removing the requirement that IRBs must review and approve grant applications; (4) eliminating, under certain circumstances, continuing review; (5) mandating the use of a single IRB for multi-institutional studies; and (6) holding IRBs not operated by an FWA-holding institution directly responsible for compliance when appropriate.
  • The rule clarifies and makes more flexible the conditions under which broad consent may used by researchers and participants.

Most provisions in the rule are scheduled to go into effect in January 2018; Endocrine Society staff will closely monitor the implementation timeline and report on any adjustments or changes.

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NICHD Issues FOA on Fertility Status and Overall Health

In December, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) in partnership with the Office of Disease Prevention (ODP) issued a Funding Opportunity Announcement (FOA) on Fertility Status and Overall Health. The purpose of the FOA is to “support research that explores the premise that fertility status can be a marker for overall health.” The Endocrine Society submitted comments to NICHD during the development of the FOA, and we are pleased that the specific areas of research interest identified by the FOA are in alignment with many of the Society’s recommendations.

The Endocrine Society considers fertility status to be a critical readout of overall health and we support the NICHD’s efforts to address research gaps in this area. For more information, including additional application instructions, please see the full announcement.

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FASEB Seeks Responses to Survey on Shared Research Resources, Nominations for Excellence in Science Award

Participate in FASEB Survey on Shared Research Resources

In January, the Federation of American Societies for Experimental Biology (FASEB) released a survey to collect data on research resources from both the perspective of users and resource managers located in the United States. FASEB will use the results of this survey to establish baseline data and inform FASEB’s policy discussions and future activities pertaining to shared research resources.

This survey should take approximately 10-15 minutes to complete. The questions focus on the following topics: (1) resource utilization and unmet needs; (2) the role of facilities in providing access to resources; (3) sources of funding and support for resources; (4) careers in resource provision and development as well as training on best practices. Basic demographic information will also be collected.

Take Action: We encourage researchers to participate in the survey, please access the survey here and feel free to share with your colleagues.

Nominate a Colleague for FASEB Excellence in Science Award

The FASEB Excellence in Science Award recognizes “outstanding achievement by women in biological science who have accomplished scientific work of lasting impact and have contributed substantially to training the next generation of scientists.” FASEB seeks nominations for its 2018 Excellence in Science Award. Women who are members of one or more FASEB Member Societies are eligible for nomination; the Endocrine Society is a member of FASEB.

Take Action: We encourage members of the Endocrine Society to submit nominations for deserving candidates for the Excellence in Science award. Please read all nomination instructions and criteria before submitting. Nomination forms must be submitted by 11:59 (EST) on March 1, 2017.

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