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Unlocking Affordable Medications: Harnessing the Power of the 340B Program in Student-Run Free Clinics

Logan Franck, PharmD, BCACP

Kevin McGuire, MHPTT, MLS(ASCP)^CM

William Hay, MD, FNAP

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Background

Our clinics focus on Interprofessional care by student volunteers, with multidisciplinary practitioner oversight

SHARING (Student Health Alliance Reaching Indigent Needy Groups) is a primary care clinic, which opened in 1997. The clinic has expanded to more disease state specific offerings including:

RESPECT (Responsible Early STI Prevention Education and Community Testing): Sexually transmitted infection testing and treatment; PrEP treatment

GOODLIFE (Greater Omaha Outreach for Diabetes Lifestyles Impacting Fitness and Education): Treatment of diabetes mellitus
VISION: Ophthalmology and diabetic eye screenings

Clinics

Age 18 or older
No health insurance
Annual household income <200% of the Federal Poverty Level
Completion of proof of income application

Eligibility

SHARING: Tuesday evenings except Holidays
RESPECT: Monday evenings Except Holidays

Hours

https://www.unmc.edu/sharing/

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Audience Poll�How do your patient's get medication?

No Prescriptions(Rx)!
Given Rx only, no special assistance
Use formulary of low-cost medications?
Rx + Samples
Purchase bulk medications to dispense
Medications discounted at local pharmacy
Pay for medications w/ or w/o copay

use MAP programs

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Situation

RESPECT Clinic: PrEP Patients

Increase in syphilis cases

DOC: Penicillin G Benzathine

~$500 per dose & 1-3 doses per pt

Pay vs. Refer

Investigate 340B

Roadblocks Along The Way

2019: Unable to get added to 340B hospital/pharmacy contract at partnering institution

Roadblocks Along The Way

2019: Unable to get added to 340B hospital/pharmacy contract at partnering institution

Roadblocks Along The Way

2019: Unable to get added to 340B hospital/pharmacy contract at partnering institution

Roadblocks Along The Way

2019: Unable to get added to 340B hospital/pharmacy contract at partnering institution

Last year, RESPECT Clinic started identifying more patients with syphilis. The treatment of choice for syphilis is a penicillin injection. With more patients being identified for treatment, the clinic could either buy the therapy, for around $500 per treatment, or refer to the county Health Department for treatment. In talking to county health department, they mentioned applying as STI site at state level since we were getting POC HIV tests from state. In talking to the state, they recommended reaching out to the pharmacy at hospital as our clinics are physically located at the Hospital outpatient clinics. The cost of stocking the therapy made it difficult to maintain, and the poor follow up from patients at the Health Department identified a major gap in patient care. SHARING clinics contacted the hospital-based pharmacy to see if we could be added to the 340B benefit instead of looking for our own 340B program.

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Intent of 340B Program

Section 340B of the Public Health Service Act permits eligible safety net providers “to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.”

H.R. Rep. No. 102-384(II), at 12 (1992)

Section 340B of the Public Health Service Act requires pharmaceutical manufacturers participating in Medicaid to sell outpatient drugs at discounted prices to health care organizations that care for many uninsured and low-income patients. Provide more health care services and to reach more patients. The 340B Drug Discount Program was created by section 602 of the Veterans Health Care Act of 1992, also known as Public Law 102-585. House Energy and Commerce Committee Report that explains the 340B Drug Discount Program. The program protects public hospitals and federally-funded clinics from drug price increases. The program's goal is to help covered entities use federal resources to reach more eligible patients and provide more services. The program is a key part of the nation's public health infrastructure. The program allows safety net providers to use drug savings to address barriers to care for their patients.

340B registration

January 1 – 15 April

April 1 – 15 July

July 1 – 15 October

October 1 – 15 January

What is the 340B Prime Vendor Program (PVP)?

Section 340B(a)(8) of the Public Health Service Act requires the creation of a prime vendor program (PVP). The purpose of the PVP is to develop, maintain, and coordinate a program capable of distribution, facilitation, and other activities in support of the 340B Program. The PVP is a voluntary program for 340B covered entities and serves its participants in three primary roles:

Negotiating sub-340B pricing on pharmaceuticals;

Establishing distribution solutions and networks that improve access to affordable medications; and

Providing other value-added products and services.

All covered entities may participate in the PVP, including hospitals that are prohibited from purchasing in a group purchasing arrangement.

Apexus – apexusanswers@apexus.com

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340B Drug Pricing Program

Outpatient drugs at reduced prices

Medication manufacturers that participate in Medicaid are required to participate

Registration and compliance with program requirements

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Eligible Covered Entities

Federally qualified health centers
Federally qualified health center look-alikes
STI Clinics with Section 318 grants
Title X Family Planning grantees
Ryan White Care Act grantees (A,B,C,D,F)
Black lung clinics
Hemophilia treatment centers
Native Hawaiian health center
Urban Indian organizations
Tribal Compacts
TB prevention grantees

Federal Grantees/Designees

Disproportionate share hospitals
Children’s hospitals
Critical access hospitals
Free standing cancer hospitals
Rural referral centers
Sole community hospitals

Hospitals

https://www.hrsa.gov/opa/eligibility-and-registration

There are over 20 different types of organizations eligible for 340B program. Each eligibility is defined in the statute. There are several HRSA grantees but grantees from other Federal agencies and or sub grantees are eligible. Work closely with CDC, HIS, and DHHS to ensure they are eligible. Since affordable care act of 2020, 6 different hospital types have been eligible to participate in program.

Section 318 of the Public Health Service Act authorizes STD funding. Projects under Section 318 are awarded to state and local health departments, academic, and public health organizations.

The U.S. Department of Health and Human Services’ Centers for Disease Control and Prevention (CDC) oversees and funds the prevention of sexually-transmitted diseases (STDs).

Health Center Program Look-Alikes are community-based health care providers that meet the requirements of our Health Center Program, but don't receive Health Center Program funding. They provide primary care services in underserved areas, provide care on a sliding fee scale based on ability to pay, and operate under a governing board that includes patients.

The hospital-based outpatient pharmacy added SHARING clinics to their 340B umbrella, therefore reducing the costs of prescription medications.

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Nebraska Medicine 340B

Disproportionate Share Hospital

Located within Nebraska Medicine

Need-based patients we serve

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Charity Care

Nebraska Medicine Program

340B Savings Passed to Community Benefit

Medications, Vaccines and other aspects of healthcare

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Outcomes

Pre-340B

Post-340B

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Outcomes

Pre-340B

Post-340B

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Outcomes

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Future Directions

Blood Pressure Monitors

Continuous Glucose Monitors

Transportation

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Discussion and Questions?

Big $avings

Able to Replicate

Care for the Community

Expand Care

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Contacts

Logan Franck, PharmD, BCACP

Logan.Franck@unmc.edu

Kevin McGuire, MHPTT, MLS(ASCP)^CM

Kevin.McGuire@unmc.edu

William Hay, MD, FNAP

WHay@unmc.edu

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