• 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
    Deep (Brain) Thoughts with Medtronic's Neuromodulation President

    Grab and Go: Examining the Thrombectomy Device Market

    Fine Print: A Discourse on Additive Manufacturing

    MPO's 2022 Medtech Industry Year in Review

    Micro Molding for Medtech Is Miniature Magic
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    MICRO's Costa Rica Facility Achieves ISO 13485:2016 Certification

    FDA Clears SafeSource Direct's Nitrile Exam Gloves

    Baxter, Miromatrix Team Up for Bioengineered Liver

    BlackHägen Design Members Named as Contributing Inventors in Bayer Patent

    The Producto Group Appoints Mark C. Rauenzahn as Chief Executive Officer
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Deep (Brain) Thoughts with Medtronic's Neuromodulation President

    Grab and Go: Examining the Thrombectomy Device Market

    Fine Print: A Discourse on Additive Manufacturing

    MPO's 2022 Medtech Industry Year in Review

    Micro Molding for Medtech Is Miniature Magic
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Reflections on 2022 and What’s Ahead for Medtech: MPO Sounding Board

    3 Ways to Prepare for ISO 13485/Part 820 Harmonization

    A New Home for Theranos' Elizabeth Holmes?

    Health Cost Drivers for Large Employers

    Braving Change: Facing Fears in the Midst of Major Transitions
    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
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Fusion Biotec Inc.

    LEMO USA Inc.

    Paragon Medical

    Forefront Medical Technology

    Halkey-Roberts Corporation
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    How Artificial Intelligence Can Combat Key Issues Impacting Healthcare

    Why Advanced Sensors Are Crucial Within Medical Pumps

    How Artificial Intelligence Could Help Prevent 80% of Chronic Diseases

    4 Ways to Use Injection Molding in Medical Device Manufacturing

    Telemedicine and Connectivity to Drive Material Innovation in the Near Future
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Fusion Biotec Inc.

    LEMO USA Inc.

    Paragon Medical

    Forefront Medical Technology

    Halkey-Roberts Corporation
    • 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
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • 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

    An Update on the 2020 Presidential Election and Recent Regulatory Changes

    The 2020 presidential election is heating up as both parties held their national conventions in late August.

    Related CONTENT
    • Kapstone Medical
    • COVID 19: Supply Chain Professionals’ Ultimate Reality Challenge
    • Let’s Build This: Best Practices for Utilizing External Regulatory Expertise
    • Multiple Function Device Products—Mike on Medtech
    • MEDICA and COMPAMED 2020 Go Virtual
    Jeffrey J. Kimbell, Eric P. Juhl, JD and David C. Rudloff, Jeffrey J. Kimbell & Associates Inc.10.01.20
    The summer has come to a close in Washington, D.C., as both the House and Senate took the August recess to return home to their districts. While passing legislation to provide additional relief during the COVID-19 pandemic remains a priority, much attention has now turned to the highly competitive elections on Nov. 3. There are also a number of recent regulatory changes of importance to manufacturers of medical products.

    2020 Presidential Race Update
    The 2020 presidential election is heating up as both parties held their national conventions in late August. National conventions offer an opportunity to garner substantial media attention. Typically, due to the increased attention, national conventions are accompanied by a slight bump in the polls. However, in this current polarized political climate, it appears polling has not been significantly impacted. Former Vice President Joe Biden still leads President Trump by 7.2 percent in national polls, according to RealClearPolitics polling averages. There is some evidence Trump has narrowed Biden’s lead in swing state polls, but not to the point where he is shown to be ahead. Perhaps one silver lining for the Trump campaign is his odds of winning the election have improved slightly from pre-convention numbers, as Biden held a 72 percent chance of victory as of Aug. 17, according to FiveThirtyEight’s statisticians, and now holds a 69 percent chance of victory. The 2020 presidential election is still no sure bet for either campaign, as much could transpire over the course of the next few weeks.

    Democratic National Convention
    On Aug. 17-20, the Democratic Party held its National Convention, where Biden formally accepted the party’s nomination in the 2020 presidential election. The virtual convention featured a lineup of prominent speakers, including former Presidents Barack Obama and Bill Clinton, as well as Hillary Clinton, Michelle Obama, U.S. Senator Elizabeth Warren (D-MA), and House Speaker Nancy Pelosi (D-CA), among others. In her speech, Vice Presidential candidate Senator Kamala Harris (D-CA) criticized President Trump’s leadership and highlighted her diversity, calling to alleviate structural racism and injustice in healthcare.

    Biden spoke about the need to bring people across the country together and criticized the Trump administration’s response to the COVID-19 pandemic. He emphasized the need to protect people with pre-existing conditions and expand coverage under the Affordable Care Act, a plan Biden claimed would lower premiums, deductibles, and drug prices. Biden ended his remarks with a national call for unity and return to normalcy.

    Biden’s healthcare platform calls for creating a public option to give all Americans the ability to buy into Medicare, allowing premium-free access to the public options for individuals in states that have not expanded Medicaid, and lowering the Medicare age to 60. With regard to drug pricing, Biden would allow direct negotiation of drug prices in Medicare and establish an independent review board within the U.S. Department of Health and Human Services (HHS) to recommend a reasonable price that Medicare and the public option would pay for new specialty drugs without competition. He would also limit price increases for all brand, biotech, and “abusively priced” generic drugs to inflation and allow consumers to buy and import drugs from other nations.

    Republican National Convention 
    On Aug. 24-27, the Republican Party held its National Convention in Charlotte, N.C., with most events taking place virtually. Notable speakers included South Carolina Gov. Nikki Haley, Senator Tim Scott (R-SC), Secretary of State Mike Pompeo, House Minority Leader Kevin McCarthy (R-CA), and Senate Majority Leader Mitch McConnell (R-KY), among others. The fourth night of the convention culminated with the re-nomination of President Donald Trump and Vice President Mike Pence.

    In his speech, President Trump laid out the case for his re-election, citing his administration’s response to the pandemic and economic recovery. Trump assured the nation of the development of a COVID-19 vaccine by the end of the year and stated the use of convalescent plasma would be helpful in treating the virus. Trump also stated he would further reduce the cost of prescription drugs and health insurance premiums as well as end surprise medical billing and highlighted his recent Executive Orders on drug pricing. Trump closed his speech by criticizing Biden and calling for law and order.

    During the convention, the Trump campaign released a bullet-point agenda for his potential next term. The agenda called attention to several healthcare issues including lowering the price of prescription drugs, putting patients and doctors back in charge of the healthcare system, lowering premiums, ending surprise medical billing, covering all pre-existing conditions, protecting Social Security and Medicare, and providing veterans with world-class healthcare and services.

    Recent Regulatory Changes
    After devoting much of its focus during the first half of 2020 on a response to the COVID-19 Public Health Emergency (PHE), the HHS and Centers for Medicare and Medicaid Services (CMS) turned their attention to issuing a number of proposed rules that update the Medicare program.

    In late August, CMS released a proposed rule that would provide faster access to new, innovative medical devices that have been designated as “breakthrough” by the U.S. Food and Drug Administration (FDA) and have also received market authorization. The Medicare Coverage of Innovative Technology (MCIT) proposed rule would begin national Medicare coverage for eligible devices on the date of FDA market authorization. The national coverage determination would continue for four years. In the proposed rule, CMS states the “coverage pathway delivers on the Administration’s commitment to give Medicare beneficiaries access to the newest innovations on the market…”

    CMS acknowledged the concerns it has heard from a variety of stakeholders about the variation in coverage between Medicare jurisdictions and the length of time it takes from FDA approval to a Medicare coverage determination. Under the current structure, coverage determinations can take, on average, nine to 12 months, which CMS states leads to coverage uncertainty between the period of FDA market authorization and any Medicare coverage determination. Such uncertainty hampers beneficiary access to innovative medical devices and could delay treatment.

    As CMS notes in the proposed rule, so far, 16 breakthrough devices have received market authorization, so the immediate impact of the proposed rule may be limited. However, the number of designated breakthrough devices under the FDA pathway has grown to almost 300 devices. As more of these devices gain market authorization, the impact of the proposed rule grows. Since it is hard to predict how many devices might gain FDA market authorization, and therefore would be covered under the MCIT pathway, CMS estimates the program could cost anywhere between $66 million and $2 billion over the next four years. Interested stakeholders wishing to comment on the proposed rule have until Nov. 2 to make their submissions on regulations.gov.

    In addition to the MCIT proposed rule, CMS also released several proposed rules that update payment rates and policies in the Medicare program. In late July, CMS issued both the CY 2021 Hospital Outpatient Prospective Payment System (OPPS) Proposed Rule and CY 2021 Medicare Physician Fee Schedule (MPFS) and Quality Payment Program (QPP) Proposed Rules.

    The OPPS Proposed Rule provides updated payment rates and policy changes for the OPPS and Ambulatory Surgical Center Payment System. CMS is proposing to update the OPPS rates by 2.6 percent for 2021 and estimates overall payments to OPPS providers would be $83.9 billion, approximately $7.5 billion higher than estimated CY 2020 OPPS payments.

    CMS is estimating total pass-through payment for medical devices will be $309.8 million in CY 2021. When combined with drugs and biologicals receiving pass-through, total pass-through payments will be approximately $783.2 million, or about 2 percent of total projected OPPS CY 2021 spending. CMS is also proposing a clarification; for a device to be eligible to apply for pass-through payment through an alternative pathway, the device must receive marketing authorization for the indication covered by the Breakthrough Devices Program. This clarification aligns with the coverage determination requirements proposed in the MCIT rule.

    In the MPFS and QPP rules, CMS is proposing a 10 percent reduction in the payment calculation that is used to establish rates for many specialty services included in the physician fee schedule. The impact of the proposed payment cuts varies between provider types, with some experiencing double-digit cuts and others seeing an increase. The impact even varies within a specialty category based on the types of services provided. For example, CMS estimates the proposed change would result in a 6 percent overall estimated reduction for ophthalmology providers. However, ophthalmologists who focus their practice on cataract surgeries are likely to see something closer to a 10 percent cut in payments for CY 2021. Several specialty societies have already voiced strong opposition to the proposed cuts, and it can be expected the opposition will grow louder as the comment period comes to a close in early October. CMS is also contemplating the creation of a temporary new category for telehealth services to reflect additions made to the list of allowable telehealth services during the PHE. Under this proposal, Category Three telehealth services would be temporarily allowed through the calendar year in which the PHE ends. 


    Jeffrey J. Kimbell, president and founder of Jeffrey J. Kimbell & Associates Inc., represents 45 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.

    Eric P. Juhl is a senior director of health policy and reimbursement strategy at Jeffrey J. Kimbell & Associates Inc.

    David C. Rudloff is a senior manager of government affairs at Jeffrey J. Kimbell & Associates Inc. 
    Suggested For You
    Kapstone Medical Kapstone Medical
    COVID 19: Supply Chain Professionals’ Ultimate Reality Challenge COVID 19: Supply Chain Professionals’ Ultimate Reality Challenge
    Let’s Build This: Best Practices for Utilizing External Regulatory Expertise Let’s Build This: Best Practices for Utilizing External Regulatory Expertise
    Multiple Function Device Products—Mike on Medtech Multiple Function Device Products—Mike on Medtech
    MEDICA and COMPAMED 2020 Go Virtual MEDICA and COMPAMED 2020 Go Virtual
    Beaufort CRO Names Senior VP of Regulatory and Quality Beaufort CRO Names Senior VP of Regulatory and Quality
    Breakthrough Designation Program Update—Mike on Medtech Breakthrough Designation Program Update—Mike on Medtech
    Dynamic Organizational Changes to Succeed in the New Normal Dynamic Organizational Changes to Succeed in the New Normal
    Recent Regulatory Changes and a 2020 Election Update Recent Regulatory Changes and a 2020 Election Update
    Combination Products Update—Mike on Medtech Combination Products Update—Mike on Medtech
    Medica 2020 Highlights Start-Ups Medica 2020 Highlights Start-Ups
    Binding vs. Nonbinding FDA Feedback—Mike on Medtech Binding vs. Nonbinding FDA Feedback—Mike on Medtech
    Real World Evidence Revisited—Mike on Medtech Real World Evidence Revisited—Mike on Medtech
    BGI Expands EUA Label for SARS-CoV-2 RT-PCR Test BGI Expands EUA Label for SARS-CoV-2 RT-PCR Test
    FDA Pre-Sub Best Practices—Mike on Medtech FDA Pre-Sub Best Practices—Mike on Medtech

    Related Buyers Guide Companies

    • Kapstone Medical

      ...
      Justin Rowland, Director of Business Development 11.13.20

    • COVID 19: Supply Chain Professionals’ Ultimate Reality Challenge

      COVID 19: Supply Chain Professionals’ Ultimate Reality Challenge

      Having been a part of the medtech supply chain for 40 years, I can say there has never been a more difficult time for supply chain professionals.
      Chris Oleksy, Founder and CEO, Oleksy Enterprises and Next Life Medical; CEO, Emergent Respiratory 11.04.20

    • Let’s Build This: Best Practices for Utilizing External Regulatory Expertise

      Let’s Build This: Best Practices for Utilizing External Regulatory Expertise

      Building a regulatory submission is much like building a house and requires recognition of the order of steps that need to take place.
      Michael C. Morton, Principal, Michael C. Morton Regulatory Affairs Consulting LLC 09.25.20


    • Multiple Function Device Products—Mike on Medtech

      Multiple Function Device Products—Mike on Medtech

      Mike Drues and Sean Fenske discuss what a Multiple Function Device Product is and how the FDA's guidance impacts manufacturers.
      Sean Fenske, Editor-in-Chief 09.17.20

    • MEDICA and COMPAMED 2020 Go Virtual

      MEDICA and COMPAMED 2020 Go Virtual

      Events to be launched as 'virtual.MEDICA' and 'virtual.COMPAMED' with three focal areas.
      Messe Düsseldorf 09.15.20

    Loading, Please Wait..

    Trending
    • The Future Of Biomedical Engineering Advancements
    • Cirtec Medical Corporation Acquires Precision Components Business From QMD
    • Medtronic's Recall Of Mahurkar Catheters Is Class I
    • Coloplast Launches New Catheter In The U.S.
    • FDA Clears LiveMetric's Wearable Blood Pressure Monitoring Tech
    Breaking News
    • MICRO's Costa Rica Facility Achieves ISO 13485:2016 Certification
    • FDA Clears SafeSource Direct's Nitrile Exam Gloves
    • Baxter, Miromatrix Team Up for Bioengineered Liver
    • BlackHägen Design Members Named as Contributing Inventors in Bayer Patent
    • The Producto Group Appoints Mark C. Rauenzahn as Chief Executive Officer
    View Breaking News >
    CURRENT ISSUE

    November 2022

    • MPO's 2022 Year in Review
    • Fine Print: A Discourse on Additive Manufacturing
    • Grab and Go: Examining the Thrombectomy Device Market
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    BAPP Paper Reviews Common Adulteration Practices Which Go Undetected
    CRN Announces Promotions and Welcomes New Staff Member
    Quercetin Ingredient Linked to Improved COVID-19 Recovery: Study
    Coatings World

    Latest Breaking News From Coatings World

    ROSS Offers Heavy-Duty Three Roll Mills for High Viscosity Dispersions
    PPG Achieves ISO 14001 Certification of Environmental Management System
    AmCoat’s Rhino Shield and Floor Shield Break Records in 2022
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Baxter, Miromatrix Team Up for Bioengineered Liver
    BlackHägen Design Members Named as Contributing Inventors in Bayer Patent
    The Producto Group Appoints Mark C. Rauenzahn as Chief Executive Officer
    Contract Pharma

    Latest Breaking News From Contract Pharma

    HPNE Launches New Approach to Single-Use Assembly Production
    Andelyn Biosciences, Odylia Therapeutics Partner to Manufacture Gene Therapy for Vision Loss
    Lonza Breaks Ground on Commercial Drug Product Facility in Stein
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    L’Oréal Group Recognized by Bloomberg Gender-Equality Index 2023
    Unilever Ventures Invests in Aussie Scalp Care Brand Straand
    La Roche-Posay Named the Fastest Growing Skincare Brand of 2022 by NielsenIQ
    Happi

    Latest Breaking News From Happi

    Perfect Corp Partners with Beekman 1802 for New My Skin Biome Tool
    OPI’s Nature Strong Introduces Botanical Base Coat and New Colors
    Inclusive Hair Brand Hairitage Launches New Anti-Dandruff Collection at Walmart
    Ink World

    Latest Breaking News From Ink World

    C3Nano Offers New SuperGrid Flexible Low-Temperature Ink
    ROSS Develops Heavy-Duty Three Roll Mills for High Viscosity Dispersions
    Alexander's Adds Two New HP Indigo 100K Digital Presses to Fleet
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Baker Labels invests in Digicon 3000 for flexible packaging division
    PIM promotes Kristin Pilling-Davis to executive director
    Stratus Packaging embraces automation with Bobst
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    WPT Nonwovens to Add Thermobonding Line in Kentucky
    Superior Felt & Filtration Adds Domestic Injection Molding to its Medical Filtration Capabilities
    Ahlstrom Launches New Generation FluoroFree Technology
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Solid Growth Ahead for Orthopedic Power Tools Market
    Mobi-C Cervical Disc Replacement Procedures Top 200,000
    OPUM, Corflex Global Partner on Knee Assessment Technology
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    C3Nano Launches New SuperGrid Flexible Low-Temperature Ink
    PPG Earns ISO 14001 Certification of Environmental Management
    Johan Hjertonsson Proposed as New Chairman of ASSA ABLOY

    Copyright © 2023 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.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login