Endocrine Insider: July 21, 2016

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Past Issues


Advocacy News

House Appropriations Committee Passes L-HHS Funding Bill with Increases for NIH, NDPP

School’s Out for Summer: Congress in Recess Until September 6 

Society, Obesity Organizations Hold Briefings at Republican & Democratic Conventions

Clinical News

Medicare Physician Fee Schedule Rule Released; Includes Revisions to Codes, NDPP Expansion

Society Urges FDA to Change Label for CGM to Enable Real Time Treatment Decisions

FDA Approves Syringe for Humulin R U-500 Insulin

Research News

Endocrine Society Encourages Members to Participate in FASEB BioArt Competition

NIH Issues Points to Consider for the Use of Human Genomic Data Under Data Sharing Policy


Advocacy News

House Appropriations Committee Passes L-HHS Funding Bill with Increases for NIH, NDPP

On July 14, the House of Representatives Appropriations Committee approved its version of the fiscal year (FY) 2017 Labor, Health and Human Services (L-HHS), Education and Related Agencies Appropriations spending measure, which includes funding for the National Institutes of Health (NIH) and the National Diabetes Prevention Program (NDPP).

The House L-HHS bill provides an additional $1.25 billion for biomedical research, which would raise the NIH budget to $33.3 billion (a four percent increase) compared to FY 2016. Last month, the Senate passed its version of the L-HHS funding bill with a $2 billion increase prompting House L-HHS Appropriations Subcommittee Chairman Tom Cole (R-OK) to comment, “… I want to be clear I view the mark we set forth today as a floor – not a ceiling – for biomedical research funding and I am hopeful that this number can increase as the process moves forward.”  Within the $1.25 billion increase, the following amounts are included to support specific NIH initiatives:

  • $511.5 million for Clinical and Translational Sciences (CTSA) Awards 
  • $333.3 million for the Institutional Development Awards (IDeA) Program 
  • $350 million increase for Alzheimer's research 
  • $195 million for the Brain Research through Application of Innovative Neuro-technologies (BRAIN) Initiative 
  • $300 million for the Precision Medicine Initiative (PMI) 
  • $12.6 million for pediatric cancer research

The Endocrine Society has been a leading advocate for NIH and NDPP. We testified before the appropriations committees, visited congressional offices, and organized online advocacy campaigns. Thanks to all of you who took action, joined our efforts, and sent emails to your congressional delegations. Your work made a difference and influenced the debate!

Next Steps: The bill is not expected to come before the full House for a vote. Rather, it is expected that the House and Senate will need to pass a stop-gap funding measure known as a Continuing Resolution (CR) by October 1. While a CR will avoid a federal government shut down, it would only fund programs at their current level. When the House and Senate return from recess on September 6, the Endocrine Society will send an action alert to urge Congress to pass a short-term CR. Our hope is that when the Congress returns following the elections for a “lame duck” session, it will pass a real funding measure that would allow increases for the NIH, NDPP, and other federal programs important to Society members.

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School’s Out for Summer: Congress in Recess Until September 6

The House of Representatives and Senate are officially on summer break! Both chambers adjourned July 14 and will not return to Washington until Tuesday, September 6. When Congress comes back to work, legislators are scheduled to be in session for only 17 work days before the November 8 elections. There are no votes scheduled from October 3 through November 11, and the remaining post-election schedule has not been announced yet.

When they return to Washington in September, the top issue on the congressional agenda will be to consider a Continuing Resolution (CR). Although the appropriations committees passed all 12 of the fiscal year 2017 spending bills, few of the measures were approved by the full House and Senate. Given the compressed work schedule prior to the elections, Congress is expected to abandon work on the individual measures and will focus instead on approving a CR to keep federal agencies operating on a temporary basis. Congressional analysts predict a fight over the length of the CR: Republican leaders are said to be in favor of having a CR through March of 2017 in order to gain support from conservatives who indicated they will oppose any attempt to finalize the spending bills after Election Day; appropriators want a shorter CR through early December to force Congress to return to Capitol Hill before Christmas to negotiate an omnibus bill combining all of the appropriations measures into a single package. An omnibus funding bill, rather than a CR, would allow Congress to provide funding increases.

Please keep an eye out for a new advocacy campaign from us in September urging the Senate and House to work towards an omnibus funding bill. It is critical that the Congress hear from constituents in order to have any chance of seeing an increase for National Institutes of Health (NIH), the National Diabetes Prevention Program (NDPP), and other programs we care about.

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Society, Obesity Organizations Hold Briefings at Republican & Democratic Conventions

The Society and members of the Obesity Care Action Network will conduct an educational briefing at both the Republican and Democratic Conventions to educate policymakers about obesity, change mindset, and increase support for access to evidence-based obesity care. Through this effort, we hope that more members of Congress will become aware of and support the Treat and Reduce Obesity Act which would enable specialists to provide intensive behavioral counseling for obesity and would provide Part D coverage for weight loss drugs. At the briefing, the Society also will highlight our policy priorities for the coming year, which include diabetes prevention and coverage issues, the need for increased NIH funding, and opportunities to educate the public about endocrine-disrupting chemicals. We look forward to continuing to stress the importance of a comprehensive approach to addressing chronic diseases with policymakers and we plan to host a congressional briefing in September on how obesity has impacted children in America.

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Clinical News

Medicare Physician Fee Schedule Rule Released; Includes Revisions to Codes, NDPP Expansion

The Centers for Medicare and Medicaid Services (CMS) released the Proposed Rule for the 2017 Medicare Physician Fee Schedule, which sets payment policy for the Medicare program for the upcoming year. CMS is proposing a number of new policies that will improve Medicare payment for those services provided for patients with multiple chronic conditions, improve payment accuracy for cognitive services, and expand the National Diabetes Prevention Program.

CMS is proposing several revisions to the PFS billing code set to more accurately recognize the work of primary care and other cognitive specialties to accommodate the changing needs of the Medicare patient population. Historically, care management and cognitive work has been “bundled” into the evaluation and management (E&M) visit codes used by all specialties. This has meant that payment for these services has been distributed equally among all specialties that report the visit codes, instead of being targeted toward practitioners who manage care and/or primarily provide cognitive services. CMS’ efforts to address this inaccuracy have included the creation of new codes that separately pay for chronic care management and transitional care management services. Proposals for 2017 include:

  • Making separate payments for certain existing Current Procedural Terminology (CPT) codes describing non-face-to-face prolonged evaluation and management services.
  • Revaluing existing CPT codes describing face-to-face prolonged services.
  • Making separate payments for codes describing chronic care management for patients with greater complexity.
  • Making several changes to reduce administrative burden associated with the chronic care management codes to remove potential barriers to furnishing and billing for these important services.

The Endocrine Society has been working with a coalition of cognitive specialty organizations to urge CMS to revalue the E&M codes to account for the changing role of the cognitive specialist in management of patients with complex conditions. We are pleased that CMS has proposed these policy changes in the Proposed Rule and believe they will lead towards more equitable payment for cognitive services by our members.

The Rule also proposes to expand the duration and scope of the National Diabetes Prevention Program (NDPP) pilot, and refer to the new program as the Medicare Diabetes Prevention Program (MDPP). The proposed rule provides a basic framework for the MDPP, and CMS notes that if finalized, they will engage in additional rulemaking within the next year to establish specific MDPP requirements. CMS proposes MDPP will be a 12-month program using the Centers for Disease Control (CDC)-approved DPP curriculum. CMS’ overview of the MDPP program includes the following proposals:

  • A program with 16 core sessions over 16-26 weeks, and the option for monthly core maintenance sessions over six months thereafter if beneficiaries achieve and maintain a minimum weight loss.
  • Any organization recognized by the CDC to provide DPP services would be eligible to apply for enrollment in Medicare beginning on January 1, 2017. 
  • Full implementation of the MDPP expansion would begin on January 1, 2018.  
  • Payment for MDPP services would be tied to the number of sessions attended and achievement of a minimum weight loss of five percent of baseline weight. 
  • MDPP suppliers would be required to attest to beneficiary session attendance and weight loss at the time claims are submitted to Medicare. 
  • MDPP is available to Medicare beneficiaries who:  1) are enrolled in Medicare Part B; 2) have a body mass index of at least 25 or at least 23 if self-identified as Asian; and 3) have within 12-months prior to attending the first core session a hemoglobin A1c test with a value between 5.7 and 6.4, or a fasting plasma glucose of 110-125 mg/dL, or a 2-hour post-glucose challenge of 140-199 mg/dL.  
  • Providers could deliver DPP services in-person or via remote technologies.

The Society has advocated for the expansion of the NDPP for many years, and we are pleased that CMS has recognized the important role that the NDPP plays in reducing the progression of pre-diabetes to diabetes.

We will provide comments on the Proposed Rule to CMS. The final rule is expected in early November.

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Society Urges FDA to Change Label for CGM to Enable Real Time Treatment Decisions

Today, the U.S. Food and Drug Administration is considering a label change for Dexcom’s G5 Mobile Continuous Glucose Monitor (CGM) to allow patients to use the CGM as a replacement for their blood glucose meters. This change would enable patients to make treatment decisions based on their real-time readings without a fingerstick verification. Should the FDA approve this application, it would be the first step toward expanding Medicare coverage for CGM, for which the Society has been advocating for a number of years.

Society member Dr. Nicholas Argento testified at the meeting in support of this label change, citing the device’s safety and the need for additional guidance on how to use unverified CGM data effectively. We also initiated a grassroots campaign to advocate for this change garnering scores of letters to the FDA from clinicians, and we worked with DiaTribe to ensure that the FDA heard from a range of voices. We have also continued to advocate for the Medicare CGM Access Act (H.R. 1427/S. 804), which would provide Medicare coverage of CGM. We expect a decision from the FDA in the coming days and will inform our members once this determination has been made.

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FDA Approves Syringe for Humulin R U-500 Insulin

The U.S. Food and Drug Administration has approved a dedicated syringe for the administration of Humulin R U-500 insulin, which is now the only device approved for use with U-500 insulin vial. Approved syringes for use with Humulin R U-500 insulin vials will only be available with a prescription and should be co-prescribed with U-500 insulin. Humulin R U-500 is also available in a prefilled pen device as well as a vial. For patients that do not use the pen, the vial can be used as an alternative. If patients are hospitalized or transitioning care, their dose of Humulin R U-500 should be clearly communicated to hospital staff. Patients who are prescribed Humulin R U-500 insulin should be aware of the following:

  • Only use the U-500 insulin syringe with the U-500 insulin vial.
  • Do not switch between types of syringes because it may increase the risk of dosing errors.
  • Maintain an adequate supply of U-500 insulin syringes. Patients should not attempt to dose with another type of syringe if their supply of U-500 insulin syringes runs out, but instead call their pharmacist or healthcare professional immediately for further instruction.

Additional information can be found on the FDA’s website.

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Research News

Endocrine Society Encourages Members to Participate in FASEB BioArt Competition

Recently, the Federation of American Societies for Experimental Biology (FASEB) announced its fifth annual BioArt Competition. Winners of past competitions have been on display at the National Institutes of Health Visitors Center and featured in exhibits and events. The BioArt Competition “aims to share the beauty and excitement of biological research with the public” through “captivating, high-resolution images and videos representing cutting edge, 21st Century biomedical and life science research.” For the 2016 competition, FASEB will make awards in the following categories:

  • Fluorescence or Electron Microscopy Images
  • All Other Life Science Images
  • Videos
  • Zika Virus or Liquid Biopsy

Take Action: Please consider submitting your compelling images to FASEB for its BioArt competition. Additional instructions, a description of the competition, and the announcement poster are available here. Please note that the entry deadline is August 30.

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NIH Issues Points to Consider for the Use of Human Genomic Data Under Data Sharing Policy

Recently, the National Institutes of Health (NIH) posted a guidance document outlining the responsibilities of institutions and institutional review boards (IRBs) under the NIH Genomic Data Sharing (GDS) Policy. In the document, the NIH reiterates that data from NIH-funded human genomic research be submitted to an NIH-designated data repository. To ensure that patient protections are maintained, the document also advises IRBs and institutions on specific "points to consider" in the development of data sharing plans, including risks associated with the sharing of genomic data; institutional certification, and informed consent.

For more information, please see the full document here.

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