Latest Resources and Information on the changes to the 340B Program
Since July of 2020, there have been a number of threats to the 340B program that have come in the form of an Executive Order and changes in policy from several large drug manufacturers. To help stay up to speed with this evolving situation, CHAD maintains a 340B distribution list where important 340B updates are shared. Please email Bobbie Will to be added to our distribution list.
How 340B supports health center patients :
By lowering how much they must pay for pharmaceuticals, 340B enables health centers (FQHCs) to:
- Make drugs affordable for their low-income uninsured and underinsured patients; and,
- Support other key services that expand access to their medically vulnerable patients.
Why is 340B so critical to health centers?
As small, community-based organizations, health centers lack the market power to negotiate discounts off the sticker price.
Prior to 340B, most health centers were unable to offer affordable pharmaceuticals to their patients.
How do health centers use the savings generated by 340B?
Health centers invest every penny of 340B savings into activities that expand access to medically-underserved patients. This is required by federal law, federal regulations, and the health center mission.
- Each health center’s patient-run board decides how to best invest its 340B savings.
- They offset losses on drugs for sliding fee patients (e.g., the $50 loss above).
- Remaining savings are used for services that could not otherwise be funded. Common examples include expanded SUD treatment, clinical pharmacy programs, and adult dental services.
What it says:
Requires FQHCs to sell insulin and EpiPens to low-income uninsured patients at the 340B price.
Why is that a problem?
The Executive Order creates a significant administrative burden to solve a problem that doesn’t exist in the Dakotas.
Health centers already provide insulin and Epipens at affordable rates to low-income and uninsured patients.
What are we doing to address it?
The Health Resources and Services Administration (HRSA) accepted comments last year on the proposed rule that would have implemented the Executive Order on EpiPens and Insulin. CHAD submitted comments outlining our concerns, along with the National Association of Community Health Centers (NACHC). See NACHC’s concerns about the EO here.
3 areas of concern:
- Refusal to ship 340B priced drugs to contract pharmacies
- Demands for extensive data
- Move from a discount to a rebate model
Why is it a problem?
- Loss of patient access to prescriptions (Rx) at contract pharmacies.
- Loss of savings from prescriptions (Rx) dispensed at contract pharmacies.
- North Dakota CHCs aren’t able to have in-house pharmacies due to the state’s unique pharmacy ownership law.
- The extensive data collection is burdensome and time consuming. It also raises concerns about legal issues that could arise from collecting and sharing such data.
- The move from a discount model to a rebate model could create serious cash flow issues for pharmacies.
Four drug manufacturers have stopped shipping 340B priced drugs to most contract pharmacies starting in the Fall 2020. The four manufacturers each have slightly different rules around their new restrictions. The chart below summarizes those changes.
What are we doing to address it?
Communicating with Policy Makers
CHAD communicates regularly with our members of Congress on the importance of the 340B program to health centers. We have encouraged them to reach out to the Department of Health and Human Services (HSS) and let them know the impact these changes will have on health care providers in our states.
Senator John Hoeven sent a letter to HSS Alex Azar on Friday, October 9, and raised many of the concerns that health centers are having with changes to the 340B program. You can read a copy of that letter here.
Along with bipartisan colleagues, South Dakota Congressman Dusty Johnson sent a letter to presumptive HSS Secretary Xavier Becerra on Thursday, February 11. The letter urges Becerra to take four actions to protect the 340B Drug Discount Program:
- Penalize manufacturers that are not in compliance with their obligations under the statute;
- Require manufacturers to refund covered entities for unlawful overcharges;
- Halt manufacturers’ attempts to unilaterally overhaul the structure of the 340B program; and,
- Seat the Administrative Dispute Resolution panel to adjudicate disputes within the program.
- Final Rule “Regulatory Freeze Pending Review” – ADDED January 21, 2021
- NACHC press release addressing Biden Administration freeze on Insulin/EpiPens Regulation – ADDED January 25, 2021
- Summary of Executive Order – ADDED October 12, 2020
- NACHC Concerns and Comments on EO – ADDED October 12, 2020
- NACHC “Pick Pocketing” One pager – ADDED October 12, 2020
- NACHC – How health centers use 340B – ADDED October 12, 2020
- Incorrect 340B Ceiling Price Notification for HRSA Form – ADDED October 22, 2020
- As ceiling prices change quarterly, we encourage you to use this website to check ceiling prices on medications to see if you are still receiving the 340B price. https://www.340bpvp.com/my-dashboard – ADDED October 22, 2020
- Technical Assistance on 340B with Draffin Tucker:
- Slides and Recording from 9/30/20 Presentation with Matt Atkins – ADDED October 12, 2020
- Slides and Recording from 10/19/20 Presentation from Matt Atkins at Draffin Tucker – ADDED October 22, 2020
- If your health center would like help in receiving technical assistance from Draffin Tucker, please contact Carmen Toft
It can be difficult to admit to yourself or your loved ones when using alcohol or substances has been difficult to manage or control. It’s important to know that substance misuse, addiction, and mental illness can happen to anyone, even in the Dakotas. In fact, addiction is a common, chronic disease, just like diabetes or obesity. It’s okay to reach out, to ask for help, or just to get more information.
Health center providers in the Dakotas are doing all they can to address stigma, answer questions, make recommendations, and
provide treatments without judgment. Click here to find your nearest health center and to learn more about their providers and the resources that they offer.
Below is a list of partner organizations for both North Dakota and South Dakota. We will continue to update this list as more information and resources become available.
Treatment Locator (SAMHSA) or find a health center near you.
Strengthening the Heartland (STH) was developed through the collaborative efforts of faculty from South Dakota State University Extension and North Dakota State University Extension. With generous grant support from the National Institute of Food and Agriculture and the Substance Abuse and Mental Health Services Administration, STH is dedicated to providing services that prevent opioid misuse in rural communities across the Dakotas.
Face It TOGETHER provides effective peer coaching to people living with addiction and their loved ones. Coaching is available to any location by secure video. Financial assistance is available to cover the cost of coaching for those impacted by opioid addiction.
South Dakota Opioid Resource Hotline (1-800-920-4343)
The Resource Hotline is available 24 hours a day, 7 days a week, and will be answered by trained crisis workers to assist in finding local resources for you or a loved one.
Opioid Texting Support
Text OPIOID to 898211 to connect with local resources that best fit your needs. Answer a few questions and get help for yourself or a loved one who is struggling.
Helpline Center: Opioid Care Coordination Program
The Helpline Center provides additional one-on-one support for people struggling with opioid misuse or those who have a loved one struggling with opioid misuse. Informational videos explaining the program can be viewed on YouTube.
Better Choices, Better Health SD
Better Choices, Better Health SD offers free educational workshops for adults living with chronic pain. Participants learn skills to safely manage pain and balance life in a supportive group environment.
Register for an event in your area.
South Dakota Addiction Treatment Services
The Division of Behavioral Health accredits and contracts with substance use disorder treatment agencies across the state to provide quality services to both adults and youth. Services include screenings, assessments, early intervention, detoxification, and outpatient and residential treatment services. Funding assistance may be available, contact your local treatment agency for more information.
DSS Behavioral Health Quick Reference Guide
North Dakota Prevention Resource & Media Center
The North Dakota Prevention Resource and Media Center (PRMC) provides effective, innovative, and culturally appropriate substance abuse prevention infrastructure, strategies, and resources to individuals and communities across North Dakota.
North Dakota Substance Abuse Prevention Basics
2-1-1 is a simple, easy-to-remember, free number connecting callers to health and human services information. 2-1-1 callers in North Dakota will be connected to FirstLink 2-1-1 Helpline, which provides confidential listening and support in addition to information and referral.
North Dakota Behavioral Health Human Services
The Behavioral Health Division provides leadership for the planning, developing, and oversight of the state’s behavioral health system. The division works with partners within the Department of Human Services and the state behavioral health system to improve access to services, address behavioral health workforce needs, develop policies, and ensure quality services are available for those with behavioral health needs.
Contact the NDBHD
North Dakota Behavioral Health Division
- US COVID-19 Vaccine Product Information, including vaccine storage and handling information, EUAs, FAQs and ACIP recommendations for all approved COVID-19 vaccines
- Training and Education to Support Vaccination Efforts
- COVID-19 Vaccine Effectiveness Research
Infection Prevention and Control
- Interim Infection Prevention and Control Recommendations for Health Care Personnel During the COVID-19 Pandemic – UPDATED February 23, 2021
- Interim Infection Prevention and Control Guidance for Dental Settings During the COVID-19 Pandemic – UPDATED December 4, 2020
- Updated Health Care Infection Prevention and Control Recommendations in Response to COVID-19 Vaccination – UPDATED March 10, 2021
- Using Personal Protective Equipment – UPDATED August 19, 2020
- Summary for Health Care Facilities: Strategies for Optimizing the Supply of PPE during Shortages – UPDATED December 29, 2020
- Guidance for Cleaning, Disinfecting and Ventilation in Businesses, Public Spaces, Workplaces, Schools and Homes– UPDATED December 21, 2021
- Guidance for Wearing Masks - UPDATED February 18, 2021
- Health Care Infection Prevention and Control FAQs for COVID-19 – UPDATED March 4, 2021
- Return to Work Criteria for Healthcare Personnel with SARS-CoV-2 Infection (Interim Guidance) - UPDATED February 16, 2021
- Strategies to Mitigate Healthcare Personnel Staffing Shortages – UPDATED March 10, 2021
- Coping with Stress – UPDATED January 22, 2021
Health Care Professional Resources
- Guidance for Healthcare Workers about COVID-19 Testing – UPDATED July 31, 2020
- Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Person for COVID-19 – UPDATED February 26, 2021
- Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease – UPDATED February 16, 2021
- NIH: COVID-19 Treatment Guidelines – Therapeutic Management of Adults with COVID-19 – UPDATED February 11, 2021
- NIH: EUA of Bamlanivimab plus Etesevimab Combination for the Treatment of COVID-19 – UPDATED March 2, 2021
- Interim Guidance on Duration of Isolation and Precautions for Adults with COVID-19 – UPDATED February 13, 2021
- Clinical Questions about COVID-19: Questions and Answers – UPDATED March 4, 2021
- Resources to support People Experiencing Homelessness – REVIEWED April 6, 2021
- Screening Clients at Homeless Shelters – REVIEWED April 6, 2021
- Homelessness and COVID-19 Frequently Asked Questions – UPDATED February 26, 2021
- National Health Care for the Homeless Council: resources and guidance – REVIEWED April 6, 2021
ND Department Of Health
General Resources & Information
SD Department Of Health
General Resources & Information
- South Dakota – Connect with the Office of Public Health Preparedness and Response at 605-773-6188. Find your regional contact here.
- Sign up for South Dakota’s Health Alert Network (SDHAN) here.
- The Department of Health maintains a variety of listservs that you may find useful in receiving current information on COVID-19 including current guidance and scheduled calls.
- Health Alert Network: https://sdhan.sd.gov
- Laboratory Listserv: https://listserv.sd.gov/scripts/wa.exe?SUBED1=SDLABLIST&A=1
- Epi Listserv: https://listserv.sd.gov/scripts/wa.exe?SUBED1=SDEPI&A=1
- Healthcare-associated Infections Listserv: https://listserv.sd.gov/scripts/wa.exe?SUBED1=SDHCASSOCINFECTIONS&A=1
- Office of Licensure and Certification Listserv: https://listserv.sd.gov/scripts/wa.exe?A0=SDOLC
General Resources & Information
- Medicaid Changes in Response to COVID-19
Both North Dakota and South Dakota Medicaid offices have issued guidance for changes to their Medicaid programs as a result of the COVID-19 pandemic and response. One noted change is that both states will be reimbursing telehealth visits from a patient’s home. Please visit the FAQ pages for North Dakota Department of Human Services (NDDHS) for information specific to ND’s changes and the South Dakota Department of Social Services (SDDSS) for information specific to SD’s changes.
- 1135 waivers:
Section 1135 waivers enable state Medicaid and Children’s Health Insurance Programs (CHIP) to waiver certain Medicaid rules in order to meet health care needs during times of disaster and crisis. Section 1135 waivers require both a declaration of national emergency or disaster by the president under the National Emergencies Act or the Stafford Act and a public health emergency determination by the HHS secretary under Section 319 of the Public Health Service Act. Both of those criteria have been met.
1135 CMS Waiver – North Dakota - UPDATED March 24, 2020
1135 CMS Waiver – South Dakota – UPDATED April 12, 2021
South Dakota Medicaid has requested flexibility from the federal government through an 1135 wavier to implement flexibility for Medicaid providers and recipients during the COVID-19 public health emergency.
- CMS 1135 Waiver Response 3.29.2020
- CMS Approved Blanket Waivers for Health Care Providers
General Resources & Information
- The following health plans in North Dakota and South Dakota programs have announced that they are expanding reimbursement for telehealth visits.
- Here is the North Dakota BCBS Guidance.
- Here is the Wellmark Blue Cross and Blue Shield Guidance.
- Here is Avera Health Plans guidance
- Here is the Sandford Health Plan guidance
- Here is the North Dakota Medicaid Guidance for telehealth. – UPDATED May 6, 2020
- Here is the South Dakota Medicaid Guidance for telehealth. - UPDATED March 21, 2021
- Click here for CMS Medicare Guidance for Telehealth UPDATED February 23, 2021
- Click here for a list of services reimbursable by Medicare telehealth. UPDATED April 7, 2021
- Telehealth Resource Center (TRC) provides information to assist health centers on telehealth and COVID-19 topics
- Great Plains Telehealth Resource Center (ND/SD)
For questions related to telehealth please contact firstname.lastname@example.org or 605-351-0604.
Workforce/Employment Law Resources
General Resources & Information
- Unemployment insurance eligibility notices for North Dakota – UPDATED March 22, 2020
- Unemployment insurance eligibility notices for South Dakota – UPDATE March 17, 2020
- Resource Packet: COVID-19 FQHC Employment Issues/Human Resource Guidance – UPDATED March 26, 2020
- North Dakota Department of Commerce COVID-19 Business and Employer Resource
General Resources & Information
- For information on preserving your PPE supply, click here. - UPDATED March 6, 2020
- All requests for PPE from the South Dakota Department of Health (SDDOH) must be emailed to COVIDResourceRequests@state.sd.us, faxed to 605-773-5942, or called into 605-773-3048 to ensure prioritization and coordination of requests.
- All requests for PPE and other supplies in North Dakota should be done through the ND Health Alert Network (HAN) Asset catalog system at http://hanassets.nd.gov/.
- Businesses that have the capability to help with fit testing.
HRSA BPHC/NACHC Resources
General Resources & Information
- NACHC COVID-19 Resources for Health Centers: This site is updated regularly and includes access to networking groups, past meeting and training recording links, and information about upcoming meetings and trainings.
- HRSA Emergency Preparedness and Recovery Resources for Health Centers
- Health Center Program COVID-19 Frequently Asked Questions
- National Health Service Corps and Nurse Corps: Coronavirus (COVID-19) Frequently Asked Questions
CHC Finance & Operations Resources
General Resources & Information
The North Dakota Insurance Department issued several bulletins to guide insurance coverage for both insurance providers and consumers during the COVID-19 pandemic.
- First bulletin addressed coverage for COVID-19 testing. – UPDATED March 11 , 2020
- Third bulletin ordered insurance companies to follow the same telehealth guidance issued by the Centers for Medicare and Medicaid Services. – UPDATED March 24, 2020
- ND Insurance Department information on health insurance and COVID-19.
Blue Cross Blue Shield of North Dakota (BCBSND)
BCBSND is waiving any co-pays, deductibles, and co-insurance for testing and treatment of COVID-19. They also have expanded coverage in areas of telehealth, prescription drug coverage and others. Visit their website for more information.
Sanford Health Plan
offering expanded coverage for members during COVID-19. Office visits, tests, treatment are all covered services. Visit their website for more information.
Avera Health Plans
If COVID-19 testing is ordered by a provider, it will be covered 100%, including related office visits, whether it happens in a physician’s office, urgent care center or emergency department.
Will waive member copays, co-insurance and deductibles for in-network COVID-19 testing and inpatient hospital care.
American Rescue Plan Act
Community Health Center Specific
ARPA includes $7.6 billion in funding for CHC COVID-19 relieve and response. The White House recently announced plans to allocate just over $6 billion directly to CHCs to expand COVID-19 vaccinations, testing, and treatment for vulnerable populations; deliver preventive and primary health care services to people at higher risk for COVID-19; and expand health centers’ operational capacity during the pandemic and beyond, including modifying and improving physical infrastructure and adding mobile units.
Health centers will have 60 days following the upcoming fiscal year 2021 American Rescue Plan Act (H8F) Funding for Health Centers award release to submit information about planned activities and costs to be supported by the funding. Visit the H8F technical assistance page for the award submission guidance, information about upcoming question and answer sessions for recipients, and more.
For detailed information on how this funding is being distributed to health centers, including an interactive map of health centers that will receive funding, please visit the H8F awards page.
Health Resources and Services Administration Bureau of Health Workforce (BHW) received $900 million in new funding in the ARPA to support, recruit, and retain qualified health professionals and students through its National Health Service Corps (NHSC) and Nurse Corps programs. See details here.
CHCs as Employers:
On March 11, 2021, President Joe Biden signed into law the American Rescue Plan Act (ARPA) of 2021 to provide economic relief during the coronavirus pandemic. The $1.9 trillion measure has several provisions that can be found here that directly affect employers.
Provisions That Impact Individuals & Families
A Columbia University study found that the combination of provisions in the ARPA will lift more than 5 million children out of poverty during the law’s first year, and it will cut the child poverty rate in our country by over 50%. Specific provisions include:
- The Child Tax Credit will increase to $3,000 per child (or $3600 for a child under age 6). Learn more with this fact sheet and the2021 Child Tax Credit Calculator.
- Supplemental Nutrition Assistance Program (SNAP) benefits will increase by 15% through September 2021. Learn more with this fact sheet from the U.S. Department of Agriculture.
- WIC Program (Women, Infants, and Children) During the months of June, July, August, and September, WIC participants can receive an extra $35 per month for the purchase of fruits and vegetables.
- Summer Meal Sites for Kids 18 and under
- The UDSA Summer Food Service Program, available in certain communities, will provide free meals to any child 18 and under.
- Visit the Summer Meal Site Finder to find your nearest site (Sites are currently being expanded, so check back for updates), or text “Summer Meals” to 97779 or call (866)-348-6479.
- Local Food Assistance Lists
- North Dakota: Visit the FirstLink website or call 2-1-1. NDSU Extension has also developed county food resource lists for Cass County, Grand Forks County, Rolette County, Ward County, and Williams County.
- South Dakota: Visit the Helpline Center website or call 2-1-1.
Stimulus check of $1,400 check per person, including adults and children for individuals with incomes below $75,000 and joint filers below $150,000 and this includes people experiencing homelessness.
- People experiencing homelessness are eligible for the stimulus
- A practitioner’s guide to helping people facing homelessness access stimulus payments.
- The bill seeks to help families and individuals who are recovering from or at risk of homelessness by providing emergency aid to cover back rent. In addition, the bill provides assistance to help struggling homeowners catch up with their mortgage payments and utility costs through the Homeowners Assistance Fund. Learn more here.
- Expanded rental assistance now available. Housing providers and renters interested in learning more about the expanded program will find information online, http://www.nd.gov/dhs/info/covid-19/rent-help.html.
Current unemployment insurance benefits and eligibility have been extended to September 6. It will provide a $300 per week supplement over and above each state’s usual unemployment payment. For local unemployment questions:
2021 Special Enrollment Period (SEP) Extended to August 15 on HealthCare.gov
As of April 1, consumers can enroll or re-evaluate their Marketplace health coverage through August 15 due to the coronavirus disease 2019 (COVID-19) emergency. More people than ever before qualify for help paying for health coverage, even those who weren’t eligible in the past. Learn more about new, lower costs. This SEP doesn’t require a qualifying event like the birth of a child, move, or marriage to enroll in a Marketplace plan. Current enrollees whose state uses HealthCare.gov can chose to change their plan during the SEP, however it’s important to consider any out-of-pocket costs already paid. Changing plans or adding a new household member will likely trigger the start of a new deductible.
Extended Access Opportunity to Enroll in More Affordable Coverage Through HealthCare.gov
- People up to 150% FPL will be able to get silver plans for zero premium with vastly reduced deductibles, through the end of 2022.
- For the first time, premium tax credits will be available for persons with incomes over 400% FPL. Through the end of 2022, these persons will be required to contribute no more than 8.5% of household income toward the benchmark plan.
- For current Marketplace enrollees, subsidies are retroactive to the beginning of this calendar year. However, if current enrollees don’t update their enrollments during 2021, they will be reimbursed for the value of the premium subsidies when they file their 2021 Federal taxes.
- People who paid too little for their Marketplace coverage in 2020 will not be required to repay the difference to the IRS. Health coverage tax tool
Current unemployment insurance benefits have been extended to September 6, saving 11 million Americans from losing benefits. It will provide a $300 per week supplement over and above each state’s usual unemployment payment. People who receive unemployment insurance at any time in 2021 will be eligible for a zero-premium benchmark silver plan with comprehensive cost sharing subsidies this year (but not in 2022).
Learn more about COBRA continuation coverage and the Marketplace. Persons who lost their jobs due to the pandemic and have not yet found new jobs that offer health insurance, can get 100% of their COBRA costs covered for the period April 1, 2021 through September 30, 2021.
Technical stakeholder guidance includes a toolkit that includes prepared communication guides, tools and frequently asked questions.
ARPA Impact on North Dakota and South Dakota
The American Rescue Plan: Impacts on North Dakota and South Dakota
On May 10, the US Department of the Treasury announced the launch of the COVID-19 state and local fiscal recovery funds in the amount of $350 billion, established by the American Rescue Plan Act. Local governments will receive the first portion in May and the remaining 50% balance 12 months later. The funds can be used for the negative economic impact caused by the pandemic, replace lost public sector revenue, provide pay for essential workers, invest in water, sewer, and broadband infrastructure, and support public health response.
The Treasury has posted the portal link for states to request fiscal recovery funds of $1.7 billion for North Dakota and $974 million for South Dakota. This site provides fact sheets, answers to frequently asked questions, and reference guides on how to utilize the funds.
ARPA requires state Medicaid programs and the Children’s Health Insurance Program (CHIP) to provide coverage, without cost-sharing, for treatment or prevention of COVID-19 for one year after the end of the public health emergency (PHE), while raising the federal medical assistance percentage (FMAP) to 100% for payments to states for administering vaccines for the same period. ARPA changes to Medicaid can be found here.