HRSA Determines Six Pharmaceutical Manufacturers Are In Violation of the 340B Statute

May 19, 2021

The Health Resources and Services Administration (HRSA) Acting Administrator Diana Espinosa sent letters to six pharmaceutical manufacturers stating that HRSA has determined that their policies that place restrictions on 340B Program pricing to covered entities that dispense medications through pharmacies under contract have resulted in overcharges and are in direct violation of the 340B statute.

Beginning in July 2020, these manufacturers began taking specific actions that limited a covered entity’s access to discounted drugs available for purchase under the 340B Program. Some manufacturers stopped providing the 340B ceiling price on their drug products sold to covered entities and dispensed through contract pharmacies, while others limited sales by requiring specific data submissions or selling drug products only after a covered entity has demonstrated 340B compliance. HRSA has conducted a review of these actions and an analysis of complaints received from covered entities, resulting in today’s letters.

The 340B Program Ceiling Price and Civil Monetary Penalties final rule states that any manufacturer participating in the 340B Program that knowingly and intentionally charges a covered entity more than the ceiling price for a covered outpatient drug may be subject to a Civil Monetary Penalty (CMP) not to exceed $5,000 for each instance of overcharging. Assessed CMPs would be in addition to repayment for an instance of overcharging.

“[The drug manufacturer] must immediately begin offering its covered outpatient drugs at the 340B ceiling price to covered entities through their contract pharmacy arrangements…” HRSA Acting Administrator Diana Espinosa wrote in the letters. “[The drug manufacturer] must comply with its 340B statutory obligations and the 340B Program’s CMP final rule and credit or refund all covered entities for overcharges that have resulted from [this] policy. . . . Continued failure to provide the 340B price to covered entities utilizing contract pharmacies, and the resultant charges to covered entities of more than the 340B ceiling price, may result in CMPs as described in the CMP final rule.”

The full text of the letters can be found on the Program Integrity page.

Emergency Medical Services for Children Program Survey

May 19, 2021

The HRSA Federal Office of Rural Health Policy on behalf of HRSAs Emergency Medical Services for Children Program has shared an opportunity to participate in an important assessment from the National Pediatric Readiness Project (NPRP). The purpose of this effort is to ensure that all emergency departments (EDs) are ready to care for children. This is particularly important since the large majority of kids needing emergency care each year will be seen in non-children’s hospitals.

The NPRP Assessment is a national assessment of EDs across the U.S. The assessment determines progress in pediatric readiness, identifies existing gaps, promotes quality improvement efforts in hospital EDs around the country, develops national collaboratives to address common and critical gaps, and establishes best practices.

The assessment launched on May 1, 2021 and remain open through July 31, 2021. Your ED should be receiving official mailed invitations to participate in the assessment. For convenience, you can access the assessment through a secure web-based system by visiting the following website and following the instructions:

www.pedsready.org

This website contains a printable copy of the assessment if you would like to prepare before taking it online. You may also be interested in reviewing the ED Toolkit and checklist at pediatricreadiness.org. Since only one assessment per hospital will be accepted, please review with your ED leadership. The assessment should take about 20-30 minutes to complete and does not have to be finished in one session. Once you submit your responses, you will receive immediate feedback in the form of a gap report with details about the pediatric readiness of your ED as well as access to quality improvement resources.

Your responses will be kept confidential and will be combined with the results of other participating EDs for reporting purposes. If you have any questions about this project, please contact Michael Ely, project manager, at pedsready@hsc.utah.edu or 801-213-3393.

The results will be very helpful in evaluating progress since the first assessment in 2013, and in identifying how we can best support EDs in further improving pediatric readiness. Your time and participation are greatly appreciated in helping us protect our nation’s greatest resource: children!

Rural Minnesota Path to Value Podcast Series

Through the Minnesota Office of Rural Health and Primary Care’s work with rural hospitals, a need has emerged for education directed towards critical access hospital (CAH) staff and mid-level leaders (MLLs) on the ‘why’ and ‘how’ of value-based care and population health.

Explore the Podcast Series:

Mini-Podcasts for Hospital Staff | Three 10-minute Podcasts

The basics of population health and social determinants of health are applicable to everyone that works in a hospital. Use these 10-minute podcasts during departmental/staff meetings.

Podcasts for Mid-Level Leaders | Five 30-minute Podcasts

Learn best practices from experts and CAH mid-level leaders as they address social determinants of health and shift towards population health.

With the support of the Federal Office of Rural Health Policy and through a grant from the Minnesota Department of Health, Office of Rural Health and Primary Care, this podcast series was developed by the Minnesota Path to Value Project.

NHSC Loan Repayment Application Help

Click here to join Virtual National Health Service Corps (NHSC) Loan Repayment Program (LRP) Q&A Sessions!

  • May 20, 2021, 9AM-5PM ET
  • May 21, 2021, 12PM-8PM ET

Frequently Asked Questions

What are the important dates I should know about?

  • The application deadline is extended to May 27, 2021 at 7:30 p.m. ET.
  • You need to be fully licensed and employed at an NHSC-approved site by July 18, 2021
  • You will be notified of award by September 30, 2021

In the application, what does “Proof of Residency” mean?

  • “Proof of Residency” is for anyone who completes a residency or fellowship program, not to be confused with providing proof of residence as in utility or mortgage bill.

How can I find NHSC-approved sites, or if a site is Health Professions Shortage Area (HPSA) eligible?

What loans are eligible? Are undergraduate loans included?

  • Qualifying educational loans are government and private student loans, which includes the applicant’s undergraduate and graduate education. When you submit your loans, you will be notified which ones are eligible or not.

If the site that I am working at is applying to be NHSC-approved, can I apply to this NHSC LRP cycle? Can I still apply if my site hasn’t been approved yet?

  • If you work at an FQHC or most Indian Health Service, Tribally Operated, or Urban Indian Health Care Facilities (ITUs), you can apply for one of the three open NHSC LRP applications at the same time your site is applying to be NHSC-approved.
  • For all other site types the NHSC new site application review process can typically take 6 – 8 weeks. If your site is not an eligible auto-approved site, you will be eligible for the next open application cycle after your site has been approved. For more information on site types, visit https://nhsc.hrsa.gov/sites/eligibility-requirements.html.

Additional Resources

Webinar: Reimagining Healthcare Engagement

Date: June 8, 2021

Time: 10:00 AM to 4:30 PM CST

Click here to Register for this Event!

An interactive live stream event  providing expertise, motivation and practical skills to strengthen your role as an influencer and advocate. Join us as a watch party or with a colleague to learn together and fast track your post event implementation plan.

RHPTP Eligible Learning Collaborative Series

May 17, 2021

Rural Healthcare Provider Transition Project (RHPTP) Learning Collaborative Series

Click here to register for all or some of the webinars below!

A four-part learning collaborative series has been built to promote the assessment of your organizations’ strengths and weaknesses in preparing for the transition to value-based care (VBC). Through education and group discussion, you will gain a better understanding of a variety of VBC topics that help strengthen your organization’s foundation while becoming effective participants in a health system focused on value.

Topic and Speakers:

LC1: Self-Assessment for Transition Planning: How ready is your organization for value-based care?

  • Speakers: Terry Hill and Rhonda Barcus, The Center
  • Date and Time: Monday, May 24, 2021 @ 12:00/NOON – 1:00 PM CST
  • LC2: Basics of Value-Based Care and Payment
  • Speaker: Jennifer Lundblad, Stratis Health
  • Date and Time: Monday, June 28, 2021 @ 12:00/NOON – 1:00 PM CST
  • LC3: Leadership Commitment to Building Population Health
  • Speaker: Dr. Alana Knudson, NORC Walsh Center for Rural Health Analysis
  • Date and Time: Monday, July 26, 2021 @ 12:00/NOON – 1:00 PM CST
  • LC4: Resiliency
  • Speakers: Dr. Jane Pederson and Betsy Jeppesen, Stratis Health
  • Date and Time: Monday, August 30, 2021 @ 12:00/NOON – 1:00 PM CST

RHPTP Application

May 17, 2021

Click here to begin your Application!

The Rural Healthcare Provider Transition Project (RHPTP) is excited to announce RHPTP applications are now being accepted to participate in the next project year (November 2021 – August 2022). To be considered, your application must be completed in the entirety by 11:59 PM CST on September 10, 2021.

RHPTP is designed to help strengthen value-based care (VBC) for health care organizations by building recipients’ foundation for VBC in efficiency, quality, patient experience, and safety of care.

HRSA Funding Opportunities

May 17, 2021

HRSA Expanding Community-Based Workforce for COVID-19 Vaccine Outreach

As part of the large federal investment in local-level response to the coronavirus pandemic, the Health Resources and Services Administration (HRSA) will make approximately 10 awards with total funding of $125 million. The funding will support outreach, education and assistance related to the COVID-19 vaccine and go to public and/or private nonprofit organizations with demonstrated experience in public health programs across a broad geographic area. Applicants are expected to have partnerships with health and social service organizations that can directly hire community outreach workers from vulnerable, medically-underserved communities. This is the first of two funding opportunities for community-based vaccine outreach. The second funding opportunity will be released in mid-May and will focus on smaller community-based organizations. Applications due May 18

Nurse Corps Scholarship Program

This program provides financial support to students enrolled in nursing degree programs in exchange for a commitment to serve in high-need areas across the country. HRSA has received a historic increase in funding this year under the American Rescue Plan. With this additional funding, Nurse Corps anticipates making significantly more awards to including:

Up to 20 percent of total awards to nurse practitioners (NP) specializing in psychiatric mental health

  • Up to $5 million to women’s health NPs and certified nurse midwife advanced practice nurses and registered nurses (RNs) who wish to pursue a career in women’s health
  • Up to $2 million dollars to support unlicensed assistive personnel such as Certified Nursing Assistants, Home Health Aides, Medical Assistants, as well as those in entry level nursing careers, such as Licensed Practical (Vocational) Nurses to pursue an Associate’s Degree in Nursing or Bachelor’s in Science of Nursing.

Application cycle has now been extended through May 26.

National Health Service Corps (NHSC) Loan Repayment Programs

HRSA extended the deadline for each of three loan repayment programs: the NHSC Loan Repayment Program, the NHSC Substance Use Disorder Workforce Loan Repayment Program, and the NHSC Rural Community Loan Repayment Program. A record number of new awards for eligible clinicians is being supported by an $800 million increase in funding. Extended to May 27 (from May 6).

Rural Maternity and Obstetrics Management Strategies (RMOMS) Program

HRSA will make three awards, each $1 million per year for a four-year project. Recipients will be networks that have already been established by three or more separately-owned entities and include at least two rural hospitals, among other requirements. The goal of the program is to test models for improved access to care in areas that are underserved. Applications due June 4.

Coming Soon – New HHS funding for Rural Health Clinics to strengthen COVID-19 testing and mitigation and increase vaccine confidence

May 14, 2021

The Health Resources and Services Administration’s (HRSA) Federal Office of Rural Health Policy (FORHP) will be making new U.S. Department of Health and Human Services (HHS) funding available for Rural Health Clinics (RHCs) to strengthen COVID-19 testing and mitigation and increase vaccine confidence.

Rural Health Clinic Vaccine Confidence (RHCVC) ProgramComing Soon!

Interested RHCs should watch for the upcoming funding opportunity and start the process to register to apply for a HRSA grant. HRSA will fund all eligible RHCs that have a complete and acceptable application. RHCs may use this funding to increase vaccine confidence, improve health care in rural areas, and reinforce key messages about prevention and treatment of COVID-19 and other infectious diseases.

For additional information please register in advance and join the National Association of Rural Health Clinic’s (NARHC) RHC COVID Initiatives webinar on Wednesday May 19th, at 12 PM ET. Please join the RHC Vaccine Confidence Program mailing list for additional program announcements and updates by clicking here. For additional questions: RHCVaxConfidence@hrsa.gov.

Rural Health Clinic COVID-19 Testing and Mitigation ProgramComing Soon!

RHCs that have met the requirements for the RHC COVID-19 Testing Program will receive a one-time allocation of up to $100,000 per clinic site automatically deposited in the bank account of the corresponding TIN organization in June 2021. RHCs will not have to apply for payments for this program. Ineligible RHCs that are not current with reporting of testing data on rhccovid19reporting.com will have the opportunity to catch up for future program consideration, dependent on the availability of funds. Please join the RHC COVID-19 Testing Program mailing list for additional program announcements and updates by clicking here. For additional questions: RHCCOVID-19Testing@hrsa.gov.

Elks Report Announcement

May 13, 2021

The Missouri Office of Dental Health (ODH) is proud to announce the completion of The Elks Report: Information on the Oral Health of Individuals with Intellectual/Developmental Disabilities. The report is taken from data gathered in 2019 & 2020 during the Basic Screening Survey on individuals when they were seen in the Elks Mobile Dental van.

View the report here.