• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Adding Fabrication Capabilities: Additive Manufacturing for Production Parts

    Delivering the Goods: The Evolving World of Combination Products

    Anxious Undertones: The 2019 Year in Review

    From Art to Science: The Changing Face of Extrusion

    Exact Science: A Micromolding Roundtable
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Top News
    FDA OKs Roche's Nasal Swab MRSA Test

    Philips & Paige to Deliver Clinical-Grade AI Applications to Pathology Labs

    Eye Test for Parkinson's Gains Breakthrough Designation

    Biomerics Forms New Business Unit

    J&J's New Monofocal IOL for Cataract Patients with Astigmatism
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Adding Fabrication Capabilities: Additive Manufacturing for Production Parts

    Delivering the Goods: The Evolving World of Combination Products

    Anxious Undertones: The 2019 Year in Review

    From Art to Science: The Changing Face of Extrusion

    Exact Science: A Micromolding Roundtable
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    From Genome Sequencing to the World’s First Portable MRI

    An Update on Digital Health

    ‘If You’re Reading This, You Need to Be at This Meeting’

    Five Steps for Succeeding Globally in Medtech

    Unlocking Market Doors with Real-World Evidence
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Nelson Laboratories LLC

    IQMS

    NN Life Sciences/Paragon Medical

    K-Tube Technologies

    RJG Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Understanding Key Processes for Mixing APIs with Silicone

    How to Minimize Color Variations in Your Medical Device

    Don’t Touch: Gesture Tech Is Reshaping How We Interact with Devices

    Revenue-Based Financing: A New Form of Growth Capital

    Pre-Filled Safety Syringes and the Self-Administration Trend
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    RJG Inc.

    Accumold

    FUTEK Advanced Sensor Technology Inc.

    Halkey-Roberts Corporation

    Lyons
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • Podcasts
    • Resources
    • eBook
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Columns

    Potential Sunshine Act Changes & A 2018 Midterm Elections Update

    Potential Sunshine Act Changes & A 2018 Midterm Elections Update
    Related CONTENT
    • MedTech M&A and Manufacturing Predictions for 2018
    • Cook Group Promotes Executive to Federal and International Government Affairs VP
    • Manufacturing’s Great Opportunity
    • Medical Devices and the Political Climate of 2018: An Update from the Swamp
    • Buyer (and Seller) Beware: Rate-Setting Commissions and the Future of Healthcare Delivery
    Jeffrey J. Kimbell and David C. Rudloff , Jeffrey J. Kimbell & Associates Inc.07.26.18
    Of particular interest to the life sciences industry are a series of recent efforts by the U.S. Congress to expand the scope of the Physician Payments Sunshine Act—a 2010 law that requires transactional transparency between drug and device manufacturers and their customers or providers.

    On June 12, the U.S. Senate Finance Committee voted unanimously to advance the Helping to End Addiction and Lessen Substance Use Disorders (HEAL) Act of 2018. The legislative package contains a measure that would expand Sunshine Act provisions by requiring drug and device manufacturers to publicly disclose the payments they make to nurse practitioners and physician assistants for promotional talks, consulting, and other interactions. The Sunshine Act already requires such transparency for payments made to physicians and academic medical centers.

    Some members of Congress have proposed going even further in expanding the law. Senator Claire McCaskill (D-MO) filed an amendment to the HEAL Act that would greatly expand the scope of the Sunshine Act. McCaskill’s original amendment would have required drug manufacturers to publicly disclose payments made to patient groups and advocacy organizations such as a professional society of healthcare providers or pharmacists; a patient or consumer advocacy organization; a patient education organization; a provider of continuing education; a clinical trial organization; an educational accreditation organization; and a co-pay assistance organization or any organization providing financial assistance to patients. However, during the Senate Finance Committee markup of the HEAL Act on June 12, Senator McCaskill offered, and later withdrew, a modified version of her original amendment. The modified amendment would have required only opioid manufacturers to publicly report payments made to patient groups and advocacy organizations, in the same manner in which they currently report payments to physicians and teaching hospitals under the Sunshine Act. After withdrawing her amendment, McCaskill stated that she is working with Senators Chuck Grassley (R-IA) and Bill Cassidy, M.D., (R-LA) on compromise modifications to her amendment that she is negotiating to be included in the final text of the bill on the Senate floor. In the markup, Senator Cassidy added there should be transparency in what pharmaceutical companies give to patient advocacy groups because of potential conflicts of interest. Senator Cassidy stated that he had received assurances from the Committee that this matter will be discussed in a separate future hearing on drug costs.

    In the same vein as Senator McCaskill’s modified amendment, on the House side, U.S. Rep. Jan Schakowsky (D-IL), a notable supporter of single-payer healthcare, introduced an amendment to H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act. Like the McCaskill amendment, Schakowsky’s would expand Sunshine Act provisions to require opioid manufacturers to publicly disclose any payments made to patient groups and advocacy organizations. Schakowsky’s amendment was not included in the bill, but serves as a warning sign that members of Congress are considering changes to the Sunshine Act.

    While some of these proposals do not affect the medical device industry directly, it is important to monitor the increased scrutiny Congress is giving to the relationship between manufacturers and advocacy groups. Senator McCaskill and Rep. Schakowsky’s amendments would have created yards of unnecessary red tape and reporting requirements for manufacturers as well as making industry collaboration with stakeholders more difficult. As members of the life sciences community, it is important that we collaborate with groups representing the patients and physicians who use our products. These groups provide important advocacy bridges from the manufacturer to the public and help make our voices heard in an increasingly challenging regulatory environment. Judging by the recent activity with this issue, we will continue to see more criticism of these relationships, especially if Congress changes hands next year.

    2018 Midterm Elections Update
    Much has happened on the campaign trail since our previous update. Over half of the states have held their primary elections, allowing us to get a better glimpse of what the races will look like in November. On May 8, businessman Mike Braun won a heated Republican primary for the Senate race in Indiana. By pegging himself as a true Washington outsider, Braun was able to defeat two sitting U.S. Congressmen, Reps. Luke Messer (R-IN) and Todd Rokita (R-IN) with 41 percent of the total vote. Braun now faces incumbent U.S. Senator Joe Donnelly (D-IN) in a state where President Trump won by 19 percentage points. We expect this race to be competitive, but give Braun the edge given the popularity of the President in ruby-red Indiana.

    In North Dakota, incumbent Senator Heidi Heitkamp (D-ND) faces U.S. Rep. Kevin Cramer (R-ND) in what is seen as one of the bigger pick-up opportunities for Republicans. Heitkamp has voted as a moderate, but it will be hard for her to distance herself from her party in this polarized climate when Trump won North Dakota by over 35 points in 2016. The President has been active on the campaign trail and hosted a large rally in Fargo on June 27 to support Cramer.

    Another competitive race ensues in West Virginia, where incumbent Senator Joe Manchin (D-WV) will take on Republican challenger Patrick Morrissey. Morrissey, the current Attorney General of West Virginia, won a heated three-way primary defeating sitting U.S. Rep. Evan Jenkins (R-WV) and coal baron Don Blankenship in the process. Trump won West Virginia by 42 percentage points, the largest margin of victory for any presidential election in the state’s history; however, Manchin remains popular as a moderate “blue dog” Democrat. This race will be competitive but, perhaps seeing the writing on the wall, Manchin recently stated that he regrets voting for Hillary Clinton and would be open in 2020 to supporting Trump.

    Montana poses another potential blue-to-red pickup for the GOP. On June 5, Montana State Auditor Matt Rosendale won a contested four-way Republican primary to take on sitting Senator Jon Tester (D-MT). Montana is another red state that Trump won by a large margin, but unlike some of his moderate Democratic cohorts, the former rancher Tester has bona fide blue-collar credentials. It is important to note, however, that Tester has never won a race with over 50 percent of the vote. We expect this race to be decided by less than 20,000 votes.

    For Democrats, their biggest opportunity to steal a red Senate seat will be Nevada, where incumbent U.S. Senator Dean Heller (R-NV) will face Congresswoman Jacky Rosen (D-NV) in the November Senate election. Nevada is a purple state, but has been trending blue in recent elections. Barack Obama won Nevada in 2008 and 2012, and in 2016 Hillary Clinton won the state by over two percentage points. In the 2012 Senate race, Heller won by a razor thin margin of just 10,000 votes. The challenger Rosen will also be sure to take advantage of the fact that President Trump has a net disapproval rating of negative two in Nevada. Democrats certainly see Nevada as one of their best pickup opportunities and this race will be decided by less than 25,000 votes.

    On the House side, the generic ballot lead for the Democrats has evaporated to just three percentage points, which is within the margin of error. According to the latest June 22 Gallup poll, so has the so-called “enthusiasm gap.” Voter enthusiasm previously favored heavily toward the Democrats, but now the percentage of Democrats and Republicans who are “absolutely certain to vote” in 2018 has evened to around 65 percent for both parties. The party out of power usually has more motivation going into midterm elections, but these recent poll numbers reflect the painstakingly hyper-partisan nature of the current political climate.

    These midterms are especially difficult to predict because analyses by different electoral indicators point to swings in the opposite direction. The economy, by all indications, is doing extraordinary well so far under Trump’s presidency. As expected, the party in power typically gets credit during good economic conditions, which would bode well for the Republicans. Fittingly so, according to FiveThirtyEight’s analysis, if you forecasted the 2018 midterms based on the public’s view of the economy, the GOP would actually gain 55 seats. However other indicators, such as presidential approval, are not favorable for the GOP. President Trump’s approval rating sits around 43 percent which, if forecasted according to FiveThirtyEight’s methodology, would cause the Republicans to lose 68 seats in the elections.

    A third set of indicators are the results of recent special elections. Democrats have over performed by an average of nine points in every federal special election since President Trump took office. A nine-point swing for Democrats would put the 2018 elections on par with the “wave” elections of 1994 and 2010, but the current generic ballot suggests Democrats should not be as optimistic. Of course, you cannot predict elections based on one set of factors since voters have different and, sometimes, contradictory reasons for voting, but these indicators will be especially interesting to watch looking toward November. Democrats need to flip 23 seats to take back the House and Las Vegas has their odds set at 50/50. Today, we anticipate the GOP losing between 12 to 16 seats in the House and picking up a net of plus two seats in the Senate. 


    Jeffrey J. Kimbell, president and founder of Jeffrey J. Kimbell & Associates Inc., represents over 35 clients in the life sciences community seeking legislative and policy remedies in Washington. Founded in 1998, the firm provides strategic solutions to hand-selected clients seeking creation, modification, or proper implementation of public law.

    David C. Rudloff is a manager of government relations at Jeffrey J. Kimbell & Associates Inc. He previously worked as a litigation paralegal at Covington & Burling in Washington, DC. David graduated from Davidson College in 2016 with a B.A. in political science. 
    Related Searches
    • congress
    • manufacturer
    • medical device
    • patient
    Suggested For You
    The Tax Man Cometh for the Healthcare Industry—Again The Tax Man Cometh for the Healthcare Industry—Again
    Industry Applauds House Passage of Device Tax Repeal Bill Industry Applauds House Passage of Device Tax Repeal Bill
    The State of Supply Chain Risk The State of Supply Chain Risk
    Buyer (and Seller) Beware:  Rate-Setting Commissions and the Future of Healthcare Delivery Buyer (and Seller) Beware: Rate-Setting Commissions and the Future of Healthcare Delivery
    Medical Devices and the Political Climate of 2018: An Update from the Swamp Medical Devices and the Political Climate of 2018: An Update from the Swamp
    Manufacturing’s Great Opportunity Manufacturing’s Great Opportunity
    Cook Group Promotes Executive to Federal and International Government Affairs VP Cook Group Promotes Executive to Federal and International Government Affairs VP
    MedTech M&A and Manufacturing Predictions for 2018 MedTech M&A and Manufacturing Predictions for 2018

    Related Columns

    • Diagnostics
      From Genome Sequencing to the World’s First Portable MRI

      From Genome Sequencing to the World’s First Portable MRI

      Dr. Jonathan Rothberg has risen about as high as a scientist can, save for the Nobel Prize.
      Sam Brusco, Associate Editor 11.04.19

    • Digital Health
      An Update on Digital Health

      An Update on Digital Health

      Sure, most are startups—but not all. There were some brilliant ideas presented at The MedTech Conference (AdvaMed’s annual meeting) on Sept. 23-25 in Boston and the Connected Health Conference, also in Boston, put on by Partners Health…
      Maria Shepherd, President and Founder, Medi-Vantage 11.04.19

    • ‘If You’re Reading This, You Need to Be at This Meeting’

      ‘If You’re Reading This, You Need to Be at This Meeting’

      The AAOS/FDA/Industry Townhall is taking place March 24, 2020, at the AAOS annual meeting in Orlando.
      Dawn A. Lissy, President & Founder, Empirical 11.04.19


    • Five Steps for Succeeding Globally in Medtech

      Five Steps for Succeeding Globally in Medtech

      World views can differ considerably, so it is important to understand, appreciate, and respect cultural realities and differences.
      Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 11.04.19

    • Software & IT
      Unlocking Market Doors with Real-World Evidence

      Unlocking Market Doors with Real-World Evidence

      Real-world evidence is becoming increasingly important for manufacturers to demonstrate value beyond efficacy and safety standards.
      Seth Goldenberg, Ph.D., Vice President, Vault Medical Device & Diagnostics, Veeva Systems 11.04.19

    • Contract Manufacturing
      Sales Tips for Contract Manufacturers of Finished Devices

      Sales Tips for Contract Manufacturers of Finished Devices

      Evolving trends in the supply chain may require companies to consider a strategy of selling devices of their own design.
      Tony Freeman, President, A.S. Freeman Advisors LLC 11.04.19


    • Impeachment, Executive Orders, and Must-Pass Congressional Legislation: A Fall Update

      Impeachment, Executive Orders, and Must-Pass Congressional Legislation: A Fall Update

      The final quarter of 2019 has begun, which means Congress and the Trump Administration are hard at work finalizing healthcare initiatives before year's end.
      Jeffrey J. Kimbell, David C. Rudloff and Caroline P. Tucker, Jeffrey J. Kimbell & Associates Inc. 11.04.19

    • R&D & Design
      Perfecting Drug Delivery Device Design

      Perfecting Drug Delivery Device Design

      Unlike medical products that just need to work, drug delivery devices must also consider intuitiveness, usability, and how it makes the user feel when operated.
      Bryce G. Rutter, Ph.D., Founder & CEO, Metaphase Design Group Inc. 11.04.19

    • Diagnostics
      Elizabeth Holmes: The Making of a Pop Culture Icon

      Elizabeth Holmes: The Making of a Pop Culture Icon

      Despite keeping a relatively low profile this year (not by choice), Elizabeth Holmes’ celebrity status has continued to grow.
      Michael Barbella, Managing Editor 10.08.19


    • A Look at Physician/Surgeon Salary and Employment Statistics

      A Look at Physician/Surgeon Salary and Employment Statistics

      No more call for physicians? Not really, but schedule predictability is in for physicians.
      Maria Shepherd, President and Founder, Medi-Vantage 10.08.19

    • Bridging Generation Gaps to Build Better Teams and Business

      Bridging Generation Gaps to Build Better Teams and Business

      I’ve learned the hard way that building teams of motivated, productive employees is equal parts science and art.
      Dawn A. Lissy, President & Founder, Empirical 10.08.19

    • Testing
      Managing Risks for Medical Devices:  A Guide to Understanding ISO 14971

      Managing Risks for Medical Devices: A Guide to Understanding ISO 14971

      The intent of ISO 14971 is to provide a general “bird’s-eye view” approach to designing and implementing a risk management plan for medical devices.
      Helin Räägel, Ph.D., Biocompatibility Expert, Nelson Labs 10.08.19

    • Testing
      Preparing for MDR: Test In-House or Outsource?

      Preparing for MDR: Test In-House or Outsource?

      As the EU MDR deadline draws near, manufacturers are under pressure to bring products into compliance and get submissions in front of regulators ASAP.
      Sandi Schaible, Senior Director, Analytical Chemistry and Regulatory Toxicology, WuXi Medical Device Testing 10.08.19

    • Think Chinese Tariffs Are the Only Industry Job Killers? Think Again

      Think Chinese Tariffs Are the Only Industry Job Killers? Think Again

      One of the latest concerns—arising from an old issue—is the medical device tax, which could return next year without legislative intervention before then.
      Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 10.08.19

    • Contract Manufacturing | Software & IT
      Five Ways Quality 4.0 Is Changing the Face of Medical Device Manufacturing

      Five Ways Quality 4.0 Is Changing the Face of Medical Device Manufacturing

      Industry 4.0 represents the dawn of the digital transformation that began with the third revolution, connecting the physical and natural worlds.
      Scott Reedy, Senior Director of Marketing, Arena Solutions 10.08.19


    Breaking News
    • FDA OKs Roche's Nasal Swab MRSA Test
    • Philips & Paige to Deliver Clinical-Grade AI Applications to Pathology Labs
    • Eye Test for Parkinson's Gains Breakthrough Designation
    • Biomerics Forms New Business Unit
    • J&J's New Monofocal IOL for Cataract Patients with Astigmatism
    View Breaking News >
    CURRENT ISSUE

    November/December 2019

    • Adding Fabrication Capabilities: Additive Manufacturing for Production Parts
    • Delivering the Goods: The Evolving World of Combination Products
    • Anxious Undertones: The 2019 Year in Review
    • View More >
    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    International Scientific Society Calls for Omega-3 Blood Testing in Future Research
    Pharmactive Affron Saffron May Help Relieve Depression Symptoms
    Warmer Temperatures Could Lead to Concerning Levels of Arsenic in Rice
    Coatings World

    Latest Breaking News From Coatings World

    Cristo Rey High School Educator Named 2019 Axalta All-Pro Teacher of the Year
    Michelman Makes United Way of Greater Cincinnati’s List of Top 25 Corporate Campaigns
    BCF: Coatings Industry Reports Record Improvement in Waste, Recycling, Accident Rates
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    FDA OKs Roche's Nasal Swab MRSA Test
    Philips & Paige to Deliver Clinical-Grade AI Applications to Pathology Labs
    Eye Test for Parkinson's Gains Breakthrough Designation
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Almac Awarded $1M BMGF Grant
    Vivera Pharma, Parexel Ink Clinical Services Agreement
    MedPharm Triples Capacity at RTP Site
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    WWP Wins Three NJPEC Awards
    Cat-Themed Beauty Collection to Launch in Japan
    Pantone Names Classic Blue the 2020 Color of the Year
    Happi

    Latest Breaking News From Happi

    Lip Lab Opening in Brooklyn
    Raining Rose Expands Exec Team
    Scott’s Sells Personal Care Production Site
    Ink World

    Latest Breaking News From Ink World

    ePac Flexible Packaging Expands into Asia Pacific Market
    Haney, HP Developing Sustainable Fashion Packaging for Heron Preston
    Addipel Moves to New HQ, Expands Production Facility
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    HP teams with Haney for sustainable packaging
    Tags & Labels Printing adds Heidelberg’s Versafire EP
    Austrian converter installs first Nilpeter press
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Thrace to Relocate U.S. Capacity
    FiltXPO Speaker Line-Up Announced
    Nölken Incorporates Sustainable Wipes Packaging
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Orthofix Appoints New Spine Business Leader
    Viant to Halt EtO Sterilization at Michigan Plant by End of Year
    Synaptive Medical's Modus V Expands Into Spine Market
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    IDTechEx Show! Announces Graphene Award Winner
    OE-A Continues to Bring Future of Printed Electronics to CES 2020
    Avancis, Smit Thermal, HZB, CNRS, Solliace Team for Higher Efficiencies in CIGS

    Copyright © 2019 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.