• 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
    MPO's 2023 Medtech Supply Chain Survey

    Exceeding Medical Device Extrusion Expectations

    Medical Device Micromolders Discuss the 'Minor Details'

    Superior Subtractive Solutions for Machining Medtech

    Assembly & Automation Experts Share Thoughts on Medtech Trends
    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
    Dentsply Sirona Names Former NuVasive CEO Lucier as Chairman

    SeaStar Medical Gets Breakthrough Nod for Selective Cytopheretic Device

    ResMed, Nyxoah Team Up to Grow Sleep Apnea Awareness & Therapy in Germany

    Siemens Healthineers’ Magnetom Viato.Mobile Cleared by FDA

    Cardinal Health's Kangaroo OMNI Enteral Feeding Pump Enters U.S. Market
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    MPO's 2023 Medtech Supply Chain Survey

    Exceeding Medical Device Extrusion Expectations

    Medical Device Micromolders Discuss the 'Minor Details'

    Superior Subtractive Solutions for Machining Medtech

    Assembly & Automation Experts Share Thoughts on Medtech Trends
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Back to School for Medical Device Cybersecurity Training

    Driving Clinical Trial Excellence to Help Study Teams Run a Faster Relay Race

    Medtech’s Supply Chain: From Disruption to Opportunity

    Are Medtech’s Mega-Deals Gone For Good?

    Will a Skilling Gap Hinder Organizational Readiness for Medtech’s New Age of AI?
    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
    Providence Enterprise USA Inc.

    Johari Digital Healthcare Ltd.

    Cirtec Medical

    NDH Medical Inc.

    JBC Technologies
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    How Wearables Are Changing the Way We Collect Real-World Data in Clinical Trials

    Could Medtech Ever Stop a Hospital Killer in Their Tracks?

    A One-Stop-Shop, Turnkey Solution Is Paramount for Success

    How Additive and Subtractive Manufacturing Are Revolutionizing the Medical Device Industry

    Medical Device Commercialization: It’s What, Not When, to Transfer to Manufacturing
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Providence Enterprise USA Inc.

    Johari Digital Healthcare Ltd.

    Cirtec Medical

    NDH Medical Inc.

    JBC Technologies
    • 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

    Will Recent Changes in CMS Rules Sink Us?

    As of Jan. 1, CMS started cutting its list of inpatient-only services.

    Will Recent Changes in CMS Rules Sink Us?
    Dawn A. Lissy, Founder & President, Empirical06.02.21
    I love to lose myself in a good read. Ideally, it’s from the pile of fun books I stack next to my bed over the course of a snowy Colorado winter—one filled with memorable characters, lush settings, moving prose, and happy endings. It’s a much needed distraction, an escape from the weightier matters filling my work days.
     
    While I wouldn’t classify the 85,000-plus pages of the Centers for Medicare & Medicaid Services (CMS) Rules and Regulations for 2021 an enjoyable read, I do highly recommend it—at least, the highlights of the 440-page section related to procedures now designated as payable at the outpatient and ambulatory surgical center (ASC) level.
     
    I’ll save you some searching and scrolling; as of Jan. 1, CMS started cutting its list of inpatient-only services. It added 11 operations (including total hip arthroplasty) to the ASC-covered procedures list, with 267 more procedures to be tacked on that list this year.
     
    Between this change in Medicare/Medicaid coverage and the long-term effects of a pandemic, this will likely cause significant shifts in both patient care and the medical device industry.
     
    “Who knows how that will impact procedure volumes post-pandemic,” said Jude Paganelli, founder of Cor Medical Ventures Inc., in Del Mar, Calif. “Will more patients will be willing to have surgeries, will hospitals be able to do more surgery due to increased bed availability? The downstream impact remains to be seen.”
     
    I can envision a post-pandemic world in which patients—particularly seniors—are more reluctant to enter a hospital and perhaps more likely to put off an elective procedure.
     
    Steve Courtney is a spine surgeon and owner of Eminent Spine in Plano, Texas. He also predicts significant, long-term effects from the new rules and COVID-19.
     
    “There is definitely a shift in healthcare,” he said. “[In] the pandemic, the last place you want to be is in a hospital. The hospital, that’s where all the sick people go.”
     
    Courtney said given the excellent, streamlined services people can expect at most ASCs, patients can expect equal or better care outside of a hospital.
     
    “[ASCs have] so many things dialed in now as far as post-operative pain control and follow-up, especially for total knee replacements. They have people coming to your home, they have rehab,” he said. “They’ve gotten very good with different types of pain treatment…The patient doesn’t notice a difference.”
     
    This could potentially drive more traffic to ASCs and would lead to more efficient and cost-effective care, said John Shank, a Colorado Springs orthopedic surgeon who prefers to work in an ASC.
     
    Shank and similar orthopedic practices face a new horizon of challenges. Medicare/Medicaid repayment rates—which most of his fees are based on—are decreasing 18-20 percent in Colorado over the next two years. Even as the potential demand could increase with these new rules and the catchup from last year’s delayed elective surgeries, he’s concerned it’s more than the current system can bear.
     
    “I think it will be a disaster,” he said. “The government can’t control medicine effectively. It will be very difficult for a patient to choose and get good care. Providers will leave the state, I think that’s what you’ll see. That’s just Colorado right now, but it’s coming to a state near you soon.”
     
    If other states follow suit with what is essentially a push toward a single payor, Shank said he’s concerned about yet another layer of burden for the provider.
     
    “The overhead of a private practice has increased substantially over the past several years. Medicare has already cut our reimbursements on a nationwide level,” he said. “People are trying to keep up [to offset the decrease]. They’re gonna get burned out.”
     
    To get around the bureaucracy and frustrations of managed care-imposed limitations on his practice, Courtney opened his own small hospital, Eminent Medical Center. He said he opted for a hospital over an ASC in part because reimbursement rates are 30-40 percent higher for hospitals than for surgicenters in Texas.
     
    This new CMS rule will make it even harder for ASCs to be successful, he said. 
     
    “It’s all about how you structure the reimbursement with the insurance companies. It is vital to survive. Implant costs have been going up. The Medicare population has gotten bigger,” Courtney said. “The surgicenters, they need to be attached to a hospital to get a hospital rate. If it’s a free-standing surgicenter, they’re gonna get shut out.”
     
    The issue is much larger than hospital versus ASC, or even patient care overall, Shank said.
     
    “From the medical product side—everything will be affected by this,” he said. “If we’re doing less procedures, patients are having less procedures done, the medical device industry will be directly affected. It will definitely affect the bottom line of the medical device industry.”
     
    Paganelli is hopeful this shift from hospital to ASC will drive advances to offset the initial imbalance that comes with a big change. He wondered about better options to central sterile processing for smaller facilities, if orthopedic procedures can be done with a fully disposable set or instruments, and alternatives to pricey robots that might not be affordable in an outpatient setting.
     
    “Robotics companies might have to not sell the robot but charge on a fee-per-use basis to put them in facilities that can’t afford to purchase them,” Paganelli said. “All kinds of new ideas and products inevitably come out of a shift in the location of surgery.”
     
    I share Courtney’s and Shank’s concerns about the potential negative impacts of these new rules compounded by a year and an economy none of us could have foreseen. But I also share Paganelli’s hope. This is yet another plot twist in the story of the challenges our industry faces and overcomes.
     
    I still prefer easy, mass-market fiction to verbose volumes of government-generated technical reading. But I keep turning the pages on this evolving story. I’m confident the bright minds and good people of our industry will come up with an innovative happy ending.
     

    Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, the Empirical family of companies (Empirical Testing Corp., Empirical Consulting LLC, and Empirical Machine LLC) has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within standards development organization ASTM International and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the U.S. Food and Drug Administration’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio.
    Suggested For You
    JK Medirise-Disposable Medical Device Company JK Medirise-Disposable Medical Device Company
    Providien Providien
    Zeus Zeus
    Nissha Medical Technologies Nissha Medical Technologies
    3DT LLC 3DT LLC
    ECA Medical Instruments ECA Medical Instruments
    Lincotek Medical Lincotek Medical
    DDL Inc. DDL Inc.
    sfm medical devices GmbH sfm medical devices GmbH
    Simbex Simbex
    Hobson & Motzer Inc. Hobson & Motzer Inc.
    IMA Automation North America IMA Automation North America
    WESTPAK Inc. WESTPAK Inc.
    BMP Medical - Delivering Custom Plastics Manufactured Solutions BMP Medical - Delivering Custom Plastics Manufactured Solutions
    High Tech Turning Co. Inc. High Tech Turning Co. Inc.

    Related Buyers Guide Companies

    • JK Medirise-Disposable Medical Device Company

      ...
      Ketan Munjani, Marketing Manager 09.28.23

    • Providien

      Providien

      ...
      Bonalyn Boyd, Marketing Manager 11.30.22

    • Zeus

      Zeus

      ...
      Laura Bright, Ad Manager 11.18.22


    • Nissha Medical Technologies

      ...
      Amy Jeary, Market Development Manager 11.18.22

    • 3DT LLC

      ...
      Gaye Kiel, Marketing Manager 11.17.22

    Loading, Please Wait..

    Trending
    • ZOLL Expands Temperature Management Portfolio To Include IQool System
    • Diabetes Innovation: MIT Engineers Unveil Implantable Device With Oxygen Factory
    • Siemens Healthineers Presents Mammomat B.brilliant
    • Danaher Names New Environmental And Applied Solutions Company Veralto
    • A New Approach To Post-Market Surveillance
    Breaking News
    • Dentsply Sirona Names Former NuVasive CEO Lucier as Chairman
    • SeaStar Medical Gets Breakthrough Nod for Selective Cytopheretic Device
    • ResMed, Nyxoah Team Up to Grow Sleep Apnea Awareness & Therapy in Germany
    • Siemens Healthineers’ Magnetom Viato.Mobile Cleared by FDA
    • Cardinal Health's Kangaroo OMNI Enteral Feeding Pump Enters U.S. Market
    View Breaking News >
    CURRENT ISSUE

    October 2023

    • MPO's 2023 Medtech Supply Chain Survey
    • Exceeding Medical Device Extrusion Expectations
    • Medical Device Micromolders Discuss the 'Minor Details'
    • 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

    D2C Supplement Brand Launches Blood Sugar Support Supplement, Gluco-Control
    Natrol Launches First Non-Melatonin Sleep Supplement
    Metagenics Releases Consumer Survey on Menopausal Support Supplement
    Coatings World

    Latest Breaking News From Coatings World

    California Sports Surfaces Celebrates 70 Years
    ROSS Offers Cost-Effective, Expertly Reconditioned Equipment
    AkzoNobel Shares Sustainable Architectural Solutions at Conference
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Dentsply Sirona Names Former NuVasive CEO Lucier as Chairman
    SeaStar Medical Gets Breakthrough Nod for Selective Cytopheretic Device
    ResMed, Nyxoah Team Up to Grow Sleep Apnea Awareness & Therapy in Germany
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Univercells Expands into the U.S. With New Offices in Andover, MA
    Evecxia Therapeutics, Quotient Sciences Complete Clinical Milestone for Depression Treatment
    Ionis, Roche Partner on RNA-targeted Programs for AD and HD
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    YSL Beauty Taps Finn Wolfhard, Lil Yachty & More for Fragrance Campaign
    74% of Makeup Users Open to Affordable ‘Dupes,’ Mintel Says
    Stoelzle Glass Group Names New CEO
    Happi

    Latest Breaking News From Happi

    Christian Siriano Appointed Olay’s First Chief Drop Officer
    The Estée Lauder Companies Launches 2023 Breast Cancer Campaign
    BASF Personal Care Introduces New Cosmetic Ingredient
    Ink World

    Latest Breaking News From Ink World

    Siegwerk’s Climate Targets Validated by SBTi
    ROSS Offering Cost-Effective, Expertly Reconditioned Equipment
    Amcor plc Adds Lucrèce Foufopoulos-De Ridder to Board of Directors
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    SABIC and partners launch bio-based IML solution for food packaging
    tesa completes expansion of Michigan manufacturing facility
    Comexi and Asahi to host 'Effortless Platemaking' event
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Greentech Introduces Air Filter with Advanced Odor Elimination
    Ontex Divests Pakistan Operations to ASAIA Holding
    Goodnites Bedwetting Underwear Recognized by Good Housekeeping
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Lazurite Adds Benchmark Medical as a Distributor for its ArthroFree Wireless Camera System
    ChitogenX Granted New U.S., Canadian ORTHO-R Patent
    Centinel Spine prodisc System Surpasses 2,500-Implant Milestone
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Jabil Posts Fourth Quarter, Fiscal Year 2023 Results
    Ink-Borne ‘Chiplets’ Could Lead to Printable Displays, Electronics and More
    SCHOTT Strengthens Glass Substrate Portfolio

    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