Skip to main content
Subscribe
  • Sign Up Free
  • Login
  • Subscribe
  • News
    • Current News
    • Providers
    • Insurance
    • Government
    • Finance
    • Technology
    • Safety & Quality
    • Digital Health
    • Transformation
    • ESG
    • People
    • Regional News
    • Digital Edition (Web Version)
    • Patients
    • Operations
    • Care Delivery
    • Payment
    • Midwest
    • Northeast
    • South
    • West
  • Blogs
    • AI
    • Deals
    • Layoff Tracker
    • HIMSS 2023
  • Opinion
    • Breaking Bias
    • Commentaries
    • Letters
    • From the Editor
  • Events & Awards
    • Awards
    • Conferences
    • Galas
    • Virtual Briefings
    • Webinars
    • Nominate/Eligibility
    • 100 Most Influential People
    • 50 Most Influential Clinical Executives
    • Best Places to Work in Healthcare
    • Excellence in Governance
    • Health Care Hall of Fame
    • Healthcare Marketing Impact Awards
    • Top 25 Emerging Leaders
    • Top Innovators
    • Diversity in Healthcare
      • - Luminaries
      • - Top 25 Diversity Leaders
      • - Leaders to Watch
    • Women in Healthcare
      • - Luminaries
      • - Top 25 Women Leaders
      • - Women to Watch
    • Digital Health Transformation Summit
    • ESG: The Implementation Imperative Summit
    • Leadership Symposium
    • Social Determinants of Health Symposium
    • Women Leaders in Healthcare Conference
    • Best Places to Work Awards Gala
    • Health Care Hall of Fame Gala
    • Top 25 Diversity Leaders Gala
    • Top 25 Women Leaders Gala
    • - Hospital of the Future
    • - Value Based Care
    • - Hospital at Home
    • - Workplace of the Future
    • - AI and Digital Health
    • - Future of Staffing
    • - Hospital of the Future (Fall)
  • Multimedia
    • Podcast - Beyond the Byline
    • Sponsored Podcast - Healthcare Insider
    • Sponsored Video Series - One on One
    • Sponsored Video Series - Checking In with Dan Peres
  • Data & Insights
    • Data & Insights Home
    • Hospital Financials
    • Staffing & Compensation
    • Quality & Safety
    • Mergers & Acquisitions
    • Data Archive
    • Resource Guide: By the Numbers
    • Surveys
    • Data Points
  • Newsletters
  • MORE+
    • Contact Us
    • Advertise
    • Media Kit
    • Jobs
    • People on the Move
    • Reprints & Licensing
MENU
Breadcrumb
  1. Home
  2. Providers
August 28, 2015 12:00 AM

Stakeholders say new 340B guidance adds red tape

Steven Ross Johnson
  • Tweet
  • Share
  • Share
  • Email
  • More
    Reprints Print
    Getty Images

    Both supporters and critics view the release Thursday of the federal government's long-awaited proposed guidance on the 340B Drug Pricing Program as a much-needed step to help clarify some of the ambiguity many providers feel has been the program's trademark as providers have tried to remain compliant with its rules year after year.

    But an initial review of the 90-page guidance document has worried stakeholders who think the proposed rules could limit patient access to the program while adding an extra administrative and clinical burden for hospitals.

    According to Alyce Katayama, a partner at law firm Quarles and Brady, the draft guidance released by the Health Resources and Services Administration aims to limit the ability of non-covered organizations to prescribe discounted drugs for patients referred to them by providers covered in the program.

    She adds that in some ways the agency has shifted away from previous guidance it provided.

    “Now that we have this insight as to where HRSA might go with the guidance, I think it's just going to put everyone in limbo until it is finalized,” Katayama said. “People will be concerned about what they're doing; people who might have wanted to implement new programs will put those plans on hold because they don't know how this thing will turn out.”

    Other conditions placed on the definition of a 340B-eligible patient include requiring that an employed staff member for a covered entity provide care for the patient. That prohibits physicians or other providers from prescribing drugs under the program if they have an arrangement in which they only have privileges or credentials with a 340B hospital.

    “There definitely are some provisions in the guidance that appear to be restricting hospitals' ability to use the program and potentially in large ways,” said Beth Feldpush, senior vice president of advocacy and policy for America's Essential Hospitals, the leading advocacy organization for safety net providers.

    Another point of concern involves a provision that prohibits hospitals from prescribing 340B discounted drugs to inpatients at discharge, instead requiring patients to make an outpatient appointment before a prescription is eligible under the program.

    Feldpush said such requirements have the potential to add an undue burden for hospitals and will cost time and money to implement.

    “The 340B program is very administratively complex and costly to administer now,” Feldpush said. “For our members that rely on the savings, I could see where if HRSA narrowed the program so much, a hospital could say the costs to run this program may outweigh (the benefit of) participation in it.”

    Debate over the need for 340B program reforms has increased in recent years as the number of organizations involved in the program has grown. Critics, including the Pharmaceutical Research and Manufacturers of America, have accused the program of allowing some providers to participate and benefit from savings despite serving a relatively small proportion of low-income patients.

    The program requires drugmakers to provide discounts of 20% to 50% to hospitals and clinics for certain outpatient drugs as a condition of eligibility for Medicaid reimbursement.

    The program has since seen a stark rise in the number of covered organizations. One-third of all hospitals now participate, and the Government Accountability Office has estimated as many as 40% are eligible.

    In a statement released Thursday, Lori Reilly, PhRMA's executive vice president of policy and research, said the organization was “pleased” with HRSA's effort, calling it a “step forward” in providing greater program clarity.

    “PhRMA has long maintained the 340B drug discount program should be targeted to true safety net hospitals and the recipients of federal grants, which rely on the program to serve vulnerable patients,” Reilly said. “PhRMA is pleased the Health Resources and Services Administration is taking a step forward to provide additional clarity on the 340B program.”

    Letter
    to the
    Editor

    Send us a letter

    Have an opinion about this story? Click here to submit a Letter to the Editor, and we may publish it in print.

    Recommended for You
    Rob Allen Intermountain 23
    Intermountain's Graphite Health may be AI 'grounding point,' CEO says
    Nursing home wheelchair
    4,000 Michigan nursing home beds at risk in proposed staffing mandate
    Most Popular
    1
    CMS tries luring providers to revamped Medicare ACOs
    2
    Oregon joins other states in setting ratios for nurse staffing
    3
    Blue Shield CA taps Amazon, Mark Cuban, CVS for new PBM model
    4
    A health innovation hub grows in Lake Nona Medical City
    5
    Hospital-at-home providers push for Medicaid coverage
    Sponsored Content
    Modern Healthcare A.M. Newsletter: Sign up to receive a comprehensive weekday morning newsletter designed for busy healthcare executives who need the latest and most important healthcare news and analysis.
    Get Newsletters

    Sign up for enewsletters and alerts to receive breaking news and in-depth coverage of healthcare events and trends, as they happen, right to your inbox.

    Subscribe Today
    MH Magazine Cover

    MH magazine offers content that sheds light on healthcare leaders’ complex choices and touch points—from strategy, governance, leadership development and finance to operations, clinical care, and marketing.

    Subscribe
    Connect with Us
    • LinkedIn
    • Twitter
    • Facebook
    • RSS

    Our Mission

    Modern Healthcare empowers industry leaders to succeed by providing unbiased reporting of the news, insights, analysis and data.

    Contact Us

    (877) 812-1581

    Email us

     

    Resources
    • Contact Us
    • Help Center
    • Advertise with Us
    • Ad Choices
    • Sitemap
    Editorial Dept
    • Submission Guidelines
    • Code of Ethics
    • Awards
    • About Us
    Legal
    • Terms and Conditions
    • Privacy Policy
    • Privacy Request
    Modern Healthcare
    Copyright © 1996-2023. Crain Communications, Inc. All Rights Reserved.
    • News
      • Current News
      • Providers
      • Insurance
      • Government
      • Finance
      • Technology
      • Safety & Quality
      • Digital Health
      • Transformation
        • Patients
        • Operations
        • Care Delivery
        • Payment
      • ESG
      • People
      • Regional News
        • Midwest
        • Northeast
        • South
        • West
      • Digital Edition (Web Version)
    • Blogs
      • AI
      • Deals
      • Layoff Tracker
      • HIMSS 2023
    • Opinion
      • Breaking Bias
      • Commentaries
      • Letters
      • From the Editor
    • Events & Awards
      • Awards
        • Nominate/Eligibility
        • 100 Most Influential People
        • 50 Most Influential Clinical Executives
        • Best Places to Work in Healthcare
        • Excellence in Governance
        • Health Care Hall of Fame
        • Healthcare Marketing Impact Awards
        • Top 25 Emerging Leaders
        • Top Innovators
        • Diversity in Healthcare
          • - Luminaries
          • - Top 25 Diversity Leaders
          • - Leaders to Watch
        • Women in Healthcare
          • - Luminaries
          • - Top 25 Women Leaders
          • - Women to Watch
      • Conferences
        • Digital Health Transformation Summit
        • ESG: The Implementation Imperative Summit
        • Leadership Symposium
        • Social Determinants of Health Symposium
        • Women Leaders in Healthcare Conference
      • Galas
        • Best Places to Work Awards Gala
        • Health Care Hall of Fame Gala
        • Top 25 Diversity Leaders Gala
        • Top 25 Women Leaders Gala
      • Virtual Briefings
        • - Hospital of the Future
        • - Value Based Care
        • - Hospital at Home
        • - Workplace of the Future
        • - AI and Digital Health
        • - Future of Staffing
        • - Hospital of the Future (Fall)
      • Webinars
    • Multimedia
      • Podcast - Beyond the Byline
      • Sponsored Podcast - Healthcare Insider
      • Sponsored Video Series - One on One
      • Sponsored Video Series - Checking In with Dan Peres
    • Data & Insights
      • Data & Insights Home
      • Hospital Financials
      • Staffing & Compensation
      • Quality & Safety
      • Mergers & Acquisitions
      • Data Archive
      • Resource Guide: By the Numbers
      • Surveys
      • Data Points
    • Newsletters
    • MORE+
      • Contact Us
      • Advertise
      • Media Kit
      • Jobs
      • People on the Move
      • Reprints & Licensing