The 340B Drug Pricing Program is a federal drug discount program established under Section 340B of the Public Health Service Act. It requires drug manufacturers participating in Medicaid to offer eligible safety-net providers deeply discounted drug prices, enabling hospitals, community health centers, and clinics to stretch scarce resources further. For Georgia seniors and families, 340B is the financial engine behind much of the safety-net infrastructure providing cancer care, primary care, and specialty pharmacy services statewide.
What is the 340B Drug Pricing Program?
The 340B Drug Pricing Program is a federal drug discount program established under Section 340B of the Public Health Service Act. It was created by the Veterans Health Care Act of 1992.
340B requires drug manufacturers that participate in the Medicaid Drug Rebate Program (Section 1927 of the Social Security Act) to enter into a separate agreement with the U.S. Department of Health and Human Services (HHS) under which the manufacturer agrees to offer eligible covered entities the right to purchase covered outpatient drugs at or below a statutorily defined ceiling price. The ceiling price is calculated as the Average Manufacturer Price (AMP) minus the Unit Rebate Amount (URA) that the manufacturer would owe under the Medicaid Drug Rebate Program for the same drug.
In plain terms: if a drug manufacturer wants Medicaid to pay for its drugs (and effectively every manufacturer does, given Medicaid's size), the manufacturer must also offer that drug at a deep discount to a defined list of safety-net providers, including hospitals serving high-Medicaid populations, community health centers, HIV/AIDS clinics, hemophilia treatment centers, tuberculosis clinics, family planning clinics, and other entities that disproportionately serve low-income, uninsured, and underinsured patients.
The program is administered by the Health Resources and Services Administration (HRSA) through its Office of Pharmacy Affairs (OPA). HRSA maintains the 340B database of eligible covered entities, publishes ceiling prices, audits compliance, and resolves disputes between manufacturers and covered entities.
340B has been operationally central to American safety-net pharmacy economics for more than three decades. The savings to covered entities are intended to "stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services" (a phrase drawn from the 1992 legislative history that remains the program's purpose statement).
Why 340B matters for Georgia eldercare
For Georgia seniors and their families, 340B is not an abstract pharmacy economics program. It is the financial engine behind a substantial portion of the safety-net infrastructure that serves older adults in Atlanta, Augusta, Savannah, Macon, Albany, and rural Georgia. When a Medicare beneficiary receives chemotherapy at Grady Memorial Hospital's oncology infusion center, walks into a Mercy Care FQHC for a primary care visit, or fills a prescription at a contract pharmacy affiliated with a rural Georgia Critical Access Hospital, 340B economics are at work.
Specifically for Georgia:
- Grady Memorial Hospital, Atlanta's largest safety-net Disproportionate Share Hospital (DSH), is a 340B-eligible covered entity. Grady's 340B savings help fund uncompensated care for low-income Atlanta-area seniors.
- Most Atlanta-area DSH hospitals are 340B-eligible: Emory University Hospital, Emory University Hospital Midtown, Wellstar Kennestone Regional Medical Center, Piedmont Atlanta Hospital, and Northside Hospital Atlanta.
- Georgia FQHCs, including Mercy Care Atlanta, Saint Joseph's Mercy Care, and the statewide Georgia Primary Care Association network, are 340B grantees as Federally Qualified Health Centers.
- Rural Georgia Critical Access Hospitals across the state are 340B-eligible.
- Children's Healthcare of Atlanta is 340B-eligible as a children's hospital.
- Augusta University Georgia Cancer Center is 340B-eligible as a free-standing cancer hospital component.
- Major Georgia oncology programs, including Grady, Wellstar, Piedmont, Northside, Atrium Health Navicent in Macon, Memorial Health in Savannah, and Phoebe Putney Memorial in Albany, leverage 340B drug acquisition for chemotherapy, infusions, and oncology specialty pharmacy.
- 340B contract pharmacy networks extend access beyond the four walls of covered entities, allowing patients to fill 340B-priced prescriptions at retail pharmacies under contract.
The economics matter especially for senior beneficiaries because:
- Many Medicare Part B drugs (chemotherapy infusions, certain biologics, injectables administered in hospital outpatient settings) are acquired by covered entities at 340B prices.
- Dual-eligible seniors served by Georgia FQHCs receive medications dispensed through the FQHC's 340B program.
- Rural seniors at Critical Access Hospital outpatient pharmacies access 340B-priced drugs.
- 340B savings cross-subsidize uncompensated care, which disproportionately benefits low-income elderly patients who fall outside Medicare coverage or who cannot afford Medicare cost-sharing.
- 340B economics interact directly with the Medicare Part B drug payment methodology following the Supreme Court's 2022 decision in American Hospital Association v. Becerra.
- 340B economics interact with episode-based oncology payment under the Enhancing Oncology Model (EOM) and the historical Oncology Care Model (OCM).
Statutory and regulatory foundation
Section 340B of the Public Health Service Act
The core statutory text creates the program. It defines:
- The pricing obligation on participating manufacturers.
- The definition of a "covered outpatient drug" by reference to the Medicaid Drug Rebate Program at Section 1927 of the Social Security Act.
- The list of eligible covered entity categories.
- The duplicate discount prohibition: a covered entity may not request a Medicaid drug rebate on a drug that was also purchased at the 340B ceiling price.
- The diversion prohibition: a covered entity may not resell or transfer 340B-purchased drugs to anyone who is not a "patient" of the covered entity (a term HRSA has interpreted through guidance).
- HRSA's administrative authority, including the authority to audit covered entities and manufacturers, to publish ceiling prices, and to operate a dispute resolution process.
The Veterans Health Care Act of 1992
The Veterans Health Care Act of 1992 added Section 340B to the Public Health Service Act. Although the statute's name reflects its broader subject matter, the 340B provision stands alone as the foundational authority for the drug pricing program.
HRSA 340B implementing guidance
HRSA's Office of Pharmacy Affairs administers the program through a body of sub-regulatory guidance rather than full notice-and-comment regulations for many program elements. Key guidance documents include:
- The 340B Patient Definition Guidance (originally 1996): defines who counts as a "patient" of a covered entity for diversion purposes.
- The 2010 Contract Pharmacy Guidance: expanded the use of contract pharmacies beyond a single-pharmacy limit, allowing covered entities to contract with multiple retail pharmacies to dispense 340B drugs to their patients.
- HRSA program integrity audits: HRSA conducts audits of both covered entities and manufacturers.
- HRSA Administrative Dispute Resolution: formal process for resolving disputes between manufacturers and covered entities (codified at 42 CFR Part 10 Subpart C after the ADR final rule).
The Affordable Care Act expansion
Section 7102 of the Affordable Care Act expanded the list of 340B covered entity categories to include:
- Children's hospitals
- Free-standing cancer hospitals
- Critical Access Hospitals
- Sole Community Hospitals
- Rural Referral Centers
Before this expansion, those provider categories were not 340B-eligible. The ACA expansion dramatically broadened 340B's reach and is a major reason that many of Georgia's safety-net hospitals, including rural Critical Access Hospitals, became 340B-eligible.
Section 1927 of the Social Security Act and the duplicate discount prohibition
Section 1927 of the Social Security Act is the Medicaid Drug Rebate Program statute. It requires manufacturers participating in Medicaid to pay rebates on drugs dispensed to Medicaid beneficiaries. The 340B duplicate discount prohibition exists because the same drug cannot generate both:
- A Medicaid rebate to the state, and
- A 340B ceiling-price discount to the covered entity.
To prevent duplicate discounts, covered entities are required to identify 340B-purchased drugs dispensed to Medicaid beneficiaries (the "Medicaid Exclusion File" mechanism for fee-for-service Medicaid; "carve-in" or "carve-out" decisions for Medicaid managed care). Failure to manage duplicate discounts can result in HRSA enforcement action and manufacturer chargeback disputes.
American Hospital Association v. Becerra (Supreme Court, 2022)
In the Hospital Outpatient Prospective Payment System (OPPS) Final Rule for CY 2018, CMS reduced the Medicare Part B payment rate for separately payable 340B-acquired drugs from the default rate of Average Sales Price (ASP) plus 6% to a significantly reduced rate. CMS extended the policy in subsequent OPPS rules.
Hospital plaintiffs led by the American Hospital Association challenged the cut, arguing that the Medicare statute permits CMS to use survey-based payment differentiation only when CMS has actually surveyed hospital acquisition costs, which CMS had not done. The Supreme Court unanimously ruled in American Hospital Association v. Becerra that CMS's 340B payment cut violated the Medicare statute because CMS had not conducted the required acquisition-cost survey.
After the decision, CMS faced the question of how to remediate years of underpayments to 340B hospitals. CMS issued the CY 2023 OPPS Remedy Rule (finalized as part of the CY 2024 OPPS rulemaking cycle) providing for lump-sum remedy payments to affected 340B hospitals, with offsetting prospective payment adjustments to maintain OPPS budget neutrality.
For Georgia 340B hospitals, including Grady, Emory, Wellstar, Piedmont, Northside, Atrium Navicent, Memorial Health Savannah, and Phoebe Putney, AHA v. Becerra restored Medicare Part B 340B drug payments and ended a multi-year payment cut.
Manufacturer contract pharmacy restrictions and litigation
Beginning in 2020, several major drug manufacturers, including Sanofi, Eli Lilly, AstraZeneca, Novartis, United Therapeutics, Bristol-Myers Squibb, Boehringer Ingelheim, Merck, and others, announced unilateral policies restricting their willingness to ship 340B-priced drugs to contract pharmacies. Manufacturer rationales varied but generally cited concerns about duplicate discounts, diversion, and lack of program integrity at the contract pharmacy layer.
HRSA found these manufacturer restrictions inconsistent with the 340B statute and referred several manufacturers to the HHS Office of Inspector General for civil monetary penalty consideration. Manufacturers sued HRSA. The resulting litigation has produced split appellate court outcomes and the issue may eventually reach the Supreme Court. The Biden administration and the early Trump administration have both maintained HRSA's position that manufacturers must honor 340B contract pharmacy arrangements.
For Georgia covered entities, manufacturer contract pharmacy restrictions have meaningfully reduced 340B savings for specific drugs (insulin products from certain manufacturers, certain oncology agents, certain cardiovascular drugs). The financial impact on Georgia FQHCs and rural CAHs has been particularly acute because these covered entities rely heavily on contract pharmacies for outpatient dispensing.
State 340B Laws: Georgia HB 1018
Several states have enacted 340B-related legislation, generally aimed at prohibiting Pharmacy Benefit Managers (PBMs) and insurers from "discriminating" against 340B covered entities through lower reimbursement rates, restrictive contracting terms, or differential pharmacy network treatment.
Georgia House Bill 1018 is Georgia's 340B nondiscrimination law. It prohibits PBMs, insurers, and other payers from:
- Reimbursing 340B covered entities at lower rates than non-340B pharmacies for the same drug.
- Imposing additional fees on 340B-acquired drugs.
- Restricting a 340B covered entity's ability to participate in pharmacy networks.
- Requiring 340B covered entities to identify 340B-acquired drugs in claims submissions in ways that enable differential treatment.
HB 1018 reflects the Georgia legislature's policy judgment that 340B savings should flow to covered entities (and ultimately to safety-net mission spending) rather than being recaptured by PBMs through reimbursement reductions.
Eligible 340B covered entity categories
The 340B statute defines eligible covered entities. For Georgia eldercare purposes, the most important categories are:
Hospital covered entities
Disproportionate Share Hospitals (DSH): hospitals with a sufficiently high Medicare DSH percentage to qualify under the statutory threshold. Most large urban safety-net hospitals qualify. Georgia DSH 340B covered entities include Grady Memorial, Emory University Hospital, Emory Midtown, Wellstar Kennestone, Piedmont Atlanta, Northside Atlanta, Atrium Health Navicent Macon, Memorial Health Savannah, and Phoebe Putney Memorial Albany.
Critical Access Hospitals (CAH): small rural hospitals with no more than 25 inpatient beds. Georgia has numerous Critical Access Hospitals across the state, many of which are 340B-eligible.
Sole Community Hospitals (SCH): rural or geographically isolated hospitals serving sole-community populations. Several Georgia rural hospitals qualify.
Rural Referral Centers (RRC): larger rural hospitals serving as referral centers for surrounding areas.
Children's Hospitals: exclusively serve children. Children's Healthcare of Atlanta is a 340B children's hospital covered entity.
Free-Standing Cancer Hospitals: hospitals exclusively or principally engaged in cancer treatment. Augusta University Medical Center's cancer hospital component participates.
Federal grantee covered entities
Federally Qualified Health Centers (FQHC): community health centers funded under Section 330 of the Public Health Service Act. Georgia FQHCs, including Mercy Care Atlanta, Saint Joseph's Mercy Care, and the statewide network represented by the Georgia Primary Care Association, are 340B covered entities.
FQHC Look-Alikes: clinics meeting FQHC standards but not receiving Section 330 grants.
Ryan White HIV/AIDS Program Grantees: Title II, III, IV, and Part C/D grantees. Georgia's AID Atlanta, Grady IDP, and other Ryan White grantees are 340B-eligible.
Tuberculosis Treatment Grantees under Section 317A of the PHS Act.
Black Lung Clinics funded under the Black Lung Benefits Act.
Comprehensive Hemophilia Treatment Centers.
Title X Family Planning Grantees.
STD/Sexually Transmitted Infection Grantees.
Native Hawaiian Health Centers and Urban Indian Health Programs.
Ceiling price methodology
The 340B ceiling price is computed as:
Ceiling Price = AMP (Average Manufacturer Price) minus URA (Unit Rebate Amount)
Where:
- AMP is the average price paid by wholesalers for drugs distributed to retail community pharmacies, as defined by the Medicaid Drug Rebate Program statute.
- URA is the unit rebate amount the manufacturer would owe under the Medicaid Drug Rebate Program, including any inflation adjustment when AMP has risen faster than CPI-U.
For most brand drugs, the ceiling price reflects a meaningful discount off AMP. For drugs with significant inflation since launch, the inflation adjustment can drive the ceiling price even lower.
HRSA publishes ceiling prices to covered entities through the 340B OPAIS (Office of Pharmacy Affairs Information System) database. Covered entities can verify ceiling prices and detect overcharges.
Contract pharmacy arrangements
Originally, HRSA guidance limited covered entities to a single contract pharmacy arrangement. The 2010 HRSA Contract Pharmacy Guidance removed the single-pharmacy limit, allowing covered entities to contract with multiple pharmacies, including national chain pharmacies, to dispense 340B drugs to their patients.
In a typical contract pharmacy arrangement:
- The covered entity identifies a prescription written by a covered entity provider for a covered entity patient.
- The contract pharmacy fills the prescription using inventory replenished from the covered entity's 340B account.
- The covered entity reimburses the contract pharmacy a dispensing fee.
- The covered entity retains the spread between the patient's insurer reimbursement and the 340B acquisition cost.
Contract pharmacies have been transformative for FQHCs and rural CAHs, which often lack the infrastructure to operate their own in-house dispensing pharmacies.
The manufacturer restrictions discussed above directly target this contract pharmacy model. The litigation is ongoing.
Medicare Part B 340B Payment: Before, During, and After AHA v. Becerra
Default Medicare Part B drug payment
For most physician-administered drugs covered under Medicare Part B, CMS pays Average Sales Price (ASP) plus 6%. ASP is reported quarterly by manufacturers and reflects actual market transaction prices.
The 2018-2022 340B payment cut
In the CY 2018 OPPS Final Rule, CMS reduced the Medicare Part B payment rate for separately payable 340B-acquired drugs furnished in the hospital outpatient setting to a significantly lower rate than the default ASP plus 6%. CMS rationale: 340B hospitals acquire these drugs at deeply discounted prices, so paying them the default rate creates a windfall that does not reflect their actual acquisition cost.
The cut applied to 340B DSH hospitals, rural referral centers, and SCH (in the OPPS setting). It did NOT apply to children's hospitals, cancer hospitals, or rural sole community hospitals. Critical Access Hospitals are paid under a different methodology and were not affected.
Supreme Court Decision
In American Hospital Association v. Becerra, the Supreme Court unanimously held that CMS's payment cut exceeded its statutory authority. The Court explained that the Medicare statute permits CMS to set differential payment rates for groups of hospitals only if CMS has conducted a survey of hospital acquisition costs. CMS had not surveyed acquisition costs for the 340B drugs at issue, so the cut was unlawful.
CY 2023 Remedy Rule
After the Supreme Court decision, CMS issued the CY 2023 OPPS 340B Remedy Rule providing:
- Lump-sum remedy payments to affected 340B hospitals reflecting underpayments from 2018 through the end of CY 2022.
- Offsetting prospective payment adjustments for non-drug services in the OPPS to maintain statutory budget neutrality.
- Restored ASP plus 6% payment for 340B drugs going forward.
For Georgia 340B DSH hospitals, the Remedy Rule restored payments and provided lump-sum amounts to compensate for the 2018-2022 underpayments.
Best practices for Georgia covered entities (and the patients they serve)
Maintain rigorous patient definition discipline. A 340B drug may only be dispensed to a person who meets HRSA's definition of a "patient" of the covered entity. The patient must have an established relationship with the covered entity, must be receiving health care services from the covered entity, and the prescription must arise from those services. Failure to maintain this discipline leads to diversion findings.
Operate a robust duplicate discount prevention program. Identify 340B-purchased drugs dispensed to Medicaid beneficiaries. Use HRSA's Medicaid Exclusion File for fee-for-service Medicaid. Make documented carve-in or carve-out decisions for Medicaid managed care, and adhere consistently to those decisions.
Audit your 340B program regularly. Internal audits should verify ceiling-price accuracy, patient eligibility, duplicate discount management, and contract pharmacy compliance. HRSA audits findings can result in repayment obligations and reputational harm.
Verify ceiling prices through OPAIS. Manufacturers occasionally overcharge through pricing errors. Covered entities should monitor ceiling prices and seek refunds when overcharges occur.
Manage manufacturer contract pharmacy restrictions strategically. Where manufacturers have restricted contract pharmacy shipments, covered entities should evaluate whether to designate alternative dispensing channels (in-house pharmacy expansion, single-designated contract pharmacy designation under restricted manufacturer policies, etc.).
Coordinate 340B with Medicare Part B oncology economics. With AHA v. Becerra resolved and the CY 2023 Remedy Rule in effect, ASP plus 6% payment is restored for 340B drugs. Oncology covered entities should ensure billing systems capture restored payments accurately.
Document patient services for FQHCs. FQHC covered entities should document the patient encounter that establishes 340B eligibility for each prescription dispensed through 340B channels.
Track contract pharmacy performance. Contract pharmacies should report dispensing volume, replenishment, and any rejected claims associated with manufacturer restrictions.
Reinvest 340B savings in mission-aligned programs. Although the statute does not impose a specific reinvestment requirement, transparency about how 340B savings fund uncompensated care, expand access, or strengthen safety-net services is a critical defense against ongoing political pressure on the program.
Engage Georgia HB 1018 protections. If a PBM or insurer attempts to impose discriminatory reimbursement on 340B covered entities, leverage HB 1018 enforcement mechanisms.
Educate staff annually. All staff involved in prescribing, dispensing, billing, and inventory management should receive annual 340B compliance training. HRSA audits routinely examine training records.
Maintain HRSA registration accuracy. Covered entities must keep their HRSA 340B registration current, including site listings, contract pharmacy arrangements, and authorizing officials.
Use the HRSA dispute resolution process when needed. If a manufacturer overcharges or refuses to honor 340B pricing, covered entities can file an Administrative Dispute Resolution complaint.
Coordinate 340B with Part D and Medicare Advantage payer policies. Part D plans and MA-PD plans have their own 340B-related billing and reporting requirements. Coordinate carefully to avoid billing errors.
Common issues and how to avoid them
Diversion findings. Dispensing 340B drugs to non-patients (community walk-ins, employees not meeting patient criteria, family members of patients) triggers HRSA enforcement and repayment obligations. Prevention: rigorous patient eligibility checks at the point of dispensing.
Duplicate discounts. Allowing 340B-purchased drugs dispensed to Medicaid beneficiaries to also generate Medicaid rebates is a serious compliance failure. Prevention: maintain accurate Medicaid Exclusion File and consistent managed care carve decisions.
Inaccurate Medicare Part B 340B modifier reporting. Hospital outpatient claims must accurately identify 340B-acquired drugs using the appropriate modifier. Errors create overpayments or underpayments. Prevention: accurate inventory tracking and modifier coding.
Manufacturer contract pharmacy restriction surprise. Covered entities have been surprised when manufacturers refused to ship 340B drugs to certain contract pharmacies. Prevention: monitor manufacturer policy announcements, maintain alternative dispensing capacity.
HRSA audit findings. HRSA audits identify diversion, duplicate discounts, patient definition violations, and other compliance failures. Prevention: internal audits using the same methodology HRSA uses.
Contract pharmacy oversight gaps. Contract pharmacies operate at distance from the covered entity. Without strong oversight, errors propagate. Prevention: regular dispensing reports, replenishment audits, and contract performance reviews.
Medicare ASP plus 6% billing errors post-Remedy Rule. With ASP plus 6% restored, hospitals must reverse the reduced-rate billing logic embedded since 2018. Prevention: validate billing system updates against CY 2023+ OPPS rates.
PBM reimbursement discrimination. PBMs may attempt to impose lower reimbursement on 340B claims. Prevention: monitor reimbursement patterns, leverage Georgia HB 1018.
Patient definition narrowing for telehealth. Telehealth-only relationships may or may not meet the 340B patient definition depending on facts. Prevention: review HRSA guidance carefully for telehealth-only encounters.
Inventory replenishment errors. Mixed-use environments where 340B and non-340B inventory commingle can produce replenishment errors. Prevention: dedicated 340B inventory accounting or robust virtual inventory tools.
Authorizing official changes not updated in HRSA registration. When the covered entity's authorizing official changes (CEO, CFO, pharmacy director), HRSA registration must be updated.
Child site eligibility errors. Covered entity child sites must independently meet eligibility criteria. Adding a non-eligible site as a child site creates compliance exposure.
Loss of DSH eligibility after Medicaid expansion changes. A hospital's DSH percentage can fluctuate. If it drops below the statutory threshold, the hospital may lose 340B eligibility. Prevention: monitor DSH percentage annually.
Manufacturer dispute resolution complexity. Filing an ADR complaint against a manufacturer is a substantial process. Prevention: maintain meticulous documentation of overcharges and communications.
Worked examples
Example 1: Fulton County, 70-Year-Old Grady Oncology Infusion Patient
Mrs. Williams is a 70-year-old retired Atlanta Public Schools teacher diagnosed with stage III colorectal cancer. She is enrolled in Original Medicare with a Medigap Plan G policy. Her oncologist at Grady Memorial Hospital's Cancer Center prescribes a chemotherapy regimen including a Part B-covered biologic infused in the outpatient infusion clinic every two weeks.
Grady, as an Atlanta DSH hospital with a high DSH percentage, is a 340B covered entity. Grady acquires the biologic at the 340B ceiling price, substantially below the drug's Average Sales Price. When Mrs. Williams receives her infusion, Medicare Part B pays Grady at ASP plus 6% (post-AHA v. Becerra, post-CY 2023 Remedy Rule). The spread between Grady's 340B acquisition cost and the Medicare payment is meaningful and helps fund Grady's broader safety-net mission, including uncompensated care for patients without insurance.
For Mrs. Williams personally, the 340B program does not change her Medicare Part B 20% coinsurance (Medigap covers it). But the program economics make Grady's oncology infrastructure financially viable, which is why Grady can continue serving uninsured and underinsured cancer patients alongside Mrs. Williams.
Example 2: DeKalb County, 75-Year-Old Mercy Care DeKalb FQHC Patient
Mr. Johnson is 75 and dual-eligible for Medicare and Georgia Medicaid. He receives primary care at Mercy Care DeKalb, an FQHC site. His primary care provider prescribes a maintenance medication for hypertension and a statin for hyperlipidemia.
Mercy Care, as an FQHC, is a 340B covered entity. Mr. Johnson's prescriptions are filled through Mercy Care's contract pharmacy network. The contract pharmacy fills the prescription using replenishment from Mercy Care's 340B account. The 340B savings help fund Mercy Care's sliding-fee primary care services, behavioral health integration, and care management for dual-eligible patients like Mr. Johnson.
Because Mr. Johnson is dual-eligible, Mercy Care must carefully manage the duplicate discount prohibition. Mercy Care has carved Medicaid managed care out of its 340B program, meaning the medication is billed to Medicaid Part D (Mr. Johnson's Medicare Part D plan) and Mercy Care uses 340B pricing without triggering a Medicaid rebate.
Example 3: Cobb County, 68-Year-Old Wellstar Kennestone Chemotherapy Patient
Mrs. Rodriguez is a 68-year-old retired engineer with non-Hodgkin lymphoma. She receives chemotherapy at Wellstar Kennestone Regional Medical Center, an Atlanta-area DSH hospital and 340B covered entity. Her regimen includes rituximab, a high-cost biologic, administered in Wellstar's outpatient infusion center.
Wellstar acquires rituximab at the 340B ceiling price. Medicare Part B pays ASP plus 6% (post-Remedy Rule). The 340B economics meaningfully improve Wellstar's oncology service line margin, which supports continued investment in Wellstar's regional cancer center infrastructure.
In 2021, before the AHA v. Becerra decision, Mrs. Rodriguez's rituximab payments to Wellstar were at the reduced rate CMS had imposed. After the Supreme Court decision and the CY 2023 Remedy Rule, Wellstar was made financially whole for those underpayments and is now paid at the restored ASP plus 6% rate.
Example 4: Worth County, 72-Year-Old Phoebe Putney Oncology Patient
Mr. Davis is 72 and lives in Worth County in rural southwest Georgia. He has prostate cancer and receives quarterly leuprolide injections (a Part B-covered oncology hormone therapy) at Phoebe Putney Memorial Hospital in Albany, the regional safety-net hospital serving a 40-county service area. Phoebe Putney is a 340B DSH covered entity.
Phoebe Putney acquires leuprolide at the 340B ceiling price. Medicare Part B pays Phoebe Putney at ASP plus 6%. The spread supports Phoebe Putney's rural oncology infrastructure, including its ability to maintain an oncology service in southwest Georgia despite the region's high uninsured rate and challenging payer mix. For Mr. Davis, the practical effect is that he can receive oncology care close to home rather than traveling to Atlanta.
Example 5: Bibb County, 80-Year-Old Atrium Navicent Cancer Drug Recipient
Mrs. Thompson is 80 and lives in Macon. She has multiple myeloma and receives bortezomib infusions every two weeks at Atrium Health Navicent, the central Georgia regional medical center serving Bibb County. Atrium Navicent is a 340B DSH covered entity.
Atrium Navicent acquires bortezomib at the 340B ceiling price. The 340B economics support Atrium Navicent's regional oncology service line and its participation in episode-based oncology payment under the Enhancing Oncology Model (EOM) where applicable. Mrs. Thompson's Medicare Part B and Medicare Advantage Part C coverage handles cost-sharing.
For Atrium Navicent, the coordination of 340B economics with EOM is operationally complex. EOM Monthly Enhanced Oncology Services (MEOS) payments coexist with 340B drug acquisition, and the practice must allocate savings appropriately across both programs.
Example 6: Hall County, 67-Year-Old NGMC 340B Patient
Mr. Patel is 67 and recently retired in Gainesville, Hall County. He has chronic kidney disease and receives erythropoiesis-stimulating agent injections at Northeast Georgia Medical Center (NGMC). NGMC is a 340B DSH covered entity serving northeast Georgia.
NGMC acquires the ESA at the 340B ceiling price. Medicare Part B pays ASP plus 6% (post-Remedy Rule). The 340B economics support NGMC's broader nephrology service line, including dialysis program coordination and CKD care management for Hall County and surrounding counties' senior population.
For Mr. Patel, 340B is invisible at the point of care, but it is part of why NGMC can sustainably operate a comprehensive nephrology program close to his home.
Frequently Asked Questions
Frequently Asked Questions
A federal program (Section 340B of the Public Health Service Act) that requires drug manufacturers participating in Medicaid to sell outpatient drugs to eligible safety-net providers at deeply discounted ceiling prices.
The Veterans Health Care Act of 1992 added Section 340B to the Public Health Service Act.
The Health Resources and Services Administration (HRSA), specifically its Office of Pharmacy Affairs (OPA).
Average Manufacturer Price (AMP) minus the Unit Rebate Amount (URA) the manufacturer would owe under the Medicaid Drug Rebate Program. Ceiling prices are substantially below market list prices for most brand drugs.
Disproportionate Share Hospitals, Critical Access Hospitals, Sole Community Hospitals, Rural Referral Centers, Children's Hospitals, Free-Standing Cancer Hospitals, FQHCs, FQHC look-alikes, Ryan White grantees, hemophilia treatment centers, family planning grantees, tuberculosis clinics, STD clinics, Black Lung clinics, Native Hawaiian Health Centers, and Urban Indian Health Programs.
Yes. Grady is an Atlanta DSH hospital and a major 340B covered entity.
Yes. FQHCs are 340B-eligible by virtue of their Section 330 grant status. Mercy Care, Saint Joseph's Mercy Care, and other Georgia FQHCs participate.
Yes. CAHs became 340B-eligible through the Affordable Care Act expansion. Numerous Georgia CAHs are 340B participants.
Yes, as a children's hospital covered entity.
Yes, as a free-standing cancer hospital component.
A covered entity may not allow a drug purchased at the 340B ceiling price to also generate a Medicaid drug rebate. Covered entities must manage this through the Medicaid Exclusion File and managed care carve-in/carve-out decisions.
A retail pharmacy that contracts with a covered entity to dispense 340B-priced drugs to the covered entity's patients. The 2010 HRSA Contract Pharmacy Guidance authorized multiple contract pharmacy relationships.
A unanimous Supreme Court decision holding that CMS's reduction in Medicare Part B 340B drug payments exceeded CMS's statutory authority because CMS had not surveyed acquisition costs.
CMS's remedy for the unlawful 2018-2022 payment cuts: lump-sum remedy payments to affected 340B hospitals with offsetting prospective adjustments to maintain budget neutrality.
Beginning in 2020, manufacturers including Sanofi, Eli Lilly, AstraZeneca, Novartis, and others unilaterally restricted contract pharmacy access, citing duplicate discount and diversion concerns. HRSA disputes the legality of these restrictions; litigation is ongoing.
Georgia's 340B nondiscrimination statute. It prohibits PBMs and insurers from reimbursing 340B covered entities at lower rates than non-340B pharmacies, imposing additional fees on 340B drugs, or restricting 340B covered entity network participation.
Not directly. Medicare Part B coinsurance is calculated based on the Medicare payment rate, not the 340B acquisition cost. 340B savings flow to the covered entity, which uses them to support safety-net services.
Generally no, in the sense that Part D plan benefits and out-of-pocket costs follow the Part D plan's formulary and design, not 340B economics.
Yes. HRSA's 340B OPAIS database (340bopais.hrsa.gov) lists every registered covered entity, child site, and contract pharmacy.
HRSA can require repayment to manufacturers for diversion or duplicate discount findings, remove the covered entity from the program, or refer to OIG for civil monetary penalty consideration.
Yes. The drugs are identical; only the price differs.
Covered entities determine use. Common uses include uncompensated care, expansion of clinic services, care management programs, prescription assistance, and operational sustainability of safety-net services.
For Part B drugs in MA networks, payment is generally aligned with traditional Medicare unless an MA plan negotiates differently. MA plans cannot impose 340B reimbursement discrimination under Georgia HB 1018.
The program faces ongoing scrutiny from manufacturers, some policymakers, and certain conservative critics. Safety-net providers and patient advocates strongly defend it. The program is among the most politically contested federal drug programs.
HRSA Office of Pharmacy Affairs (1-888-340-2787, 340BPVP@hrsa.gov). The 340BOPAIS database. State 340B coalitions, including coalitions of Georgia 340B hospitals.
Call to Action: Georgia 340B-Related Resources
If you, a family member, or someone you care for receives outpatient drugs at a Georgia hospital or community health center, 340B economics may be at work, even if you never see them directly. The contacts below can help with 340B questions, drug cost issues, oncology assistance, and senior benefits navigation.
- Medicare: 1-800-MEDICARE (1-800-633-4227)
- HRSA 340B Office of Pharmacy Affairs: 1-888-340-2787 / 340BPVP@hrsa.gov
- CMS Innovation Center: innovation.cms.gov
- Quality Payment Program Service Center: 1-866-288-8292
- Palmetto GBA (Georgia Medicare Administrative Contractor, Jurisdiction J): 1-866-238-9650
- GeorgiaCares (Georgia SHIP): 1-866-552-4464
- Medicare Rights Center: 1-800-333-4114
- Atlanta Legal Aid: 404-377-0701
- Georgia Legal Services Program: 1-800-498-9469
- 211 Georgia: dial 211
- Eldercare Locator: 1-800-677-1116
- Acentra Health (Georgia Medicare Quality Improvement Organization): 1-844-455-8708
- Social Security Administration: 1-800-772-1213
- American Cancer Society: 1-800-227-2345
- Patient Advocate Foundation: 1-800-532-5274
- NeedyMeds: 1-800-503-6897
- Georgia Primary Care Association: 770-455-0429
Find personalized help understanding 340B benefits and Georgia Medicare options at brevy.com.