340B News & Regulatory Updates — August 2026

The Most Important 340B Developments of August 2026, Summarized in Plain English

Published by 340bprogram.com | August 31, 2026
Sources: HRSA Federal Register, Holland & Knight, National Law Review, AJMC, Becker’s Hospital Review, AHA, Senate HELP Committee, Senator Boozman’s Office, Senator Kaine’s Office, Pharmacy Times, 340B Report

AUGUST 2026 OVERVIEW

August 2026 was the month the 340B program’s reform fight moved from two fronts to three — simultaneously. HRSA’s revised rebate pilot program landed squarely in the middle of the legislative reform fight when, just five days after the Federal Register notice went live, a bipartisan Senate coalition introduced the SUSTAIN 340B Act — a bill specifically designed to stop the rebate pilot in its tracks. At the same moment, two critical comment deadlines — the Cassidy discussion draft and the CMS proposed Medicare reimbursement cut — required covered entities to mount a coordinated advocacy response across three simultaneous regulatory proceedings. Arkansas filed a landmark state enforcement lawsuit against thirteen drug manufacturers. A longtime PhRMA leader announced his departure. The ACA subsidies expired with significant 340B implications. And Novo Nordisk expanded its state exemption list. August 2026 demanded more simultaneous attention from covered entities and contract pharmacies than any prior month in the program’s history. NatLawReview

🚨 TOP STORY #1 — THE SUSTAIN 340B ACT: CONGRESS DIRECTLY CHALLENGES HRSA’S REBATE PILOT

August 5, 2026 — Six Bipartisan Senators Introduce the SUSTAIN 340B Act

The Supporting Underserved and Strengthening Transparency, Accountability and Integrity Now and for the Future of 340B Act — the SUSTAIN 340B Act — was introduced August 5 by Senators Jerry Moran (R-KS), John Boozman (R-AR), Tammy Baldwin (D-WI), Shelley Moore Capito (R-WV), Tim Kaine (D-VA), and John Hickenlooper (D-CO), members of the Senate 340B Bipartisan Working Group, which has existed for more than a decade. AJMC

“The SUSTAIN 340B Act makes comprehensive reforms to the program while preserving its critical benefits that support eligible health care providers and the patients they serve throughout the country,” the senators said. “By continuing to work together in bipartisan fashion, we are committed to strengthening the 340B program and helping make certain it remains accessible to serve patients and communities for years to come.” Senator John Boozman

What the SUSTAIN 340B Act would do — in plain English:

Unlike Chairman Cassidy’s discussion draft, which would let covered entities choose among a discount, a rebate, or a government-operated claims repository, the SUSTAIN 340B Act takes direct aim at HRSA’s regulatory approach. It would preserve the traditional point-of-purchase discount model as the default and sunset HRSA’s Rebate Model Pilot Program within one year of enactment. NatLawReview

This is the most important distinction in the entire August legislative landscape. The Cassidy draft opens the door to rebates as one of several options. The SUSTAIN 340B Act closes that door — killing the HRSA rebate pilot entirely if enacted.

The bill would make several structural changes to the program: It would let covered entities use wholly owned pharmacies alongside contract pharmacies, while requiring entities to cancel contracts with pharmacies that haven’t dispensed 340B drugs to patients in the prior 12 months, with exceptions for ownership changes or service area shifts. Becker’s Hospital Review

The three bills now in play simultaneously:

As of August 2026, Congress has three active 340B proposals on the table simultaneously — giving Congress three active 340B proposals to weigh at once. Becker’s Hospital Review

1. Cassidy Discussion Draft (Senate HELP) — Allows covered entities to choose between discount, rebate, or government repository. Adds new reporting requirements. Comment deadline August 28.

2. SECURE 340B Act (House, H.R. 9599) — Pauses manufacturer rebates, establishes new patient definition, creates new contract pharmacy oversight framework. Introduced July 6.

3. SUSTAIN 340B Act (Senate Bipartisan Working Group) — Preserves upfront discount model as default, sunsets HRSA’s rebate pilot, allows wholly-owned pharmacies. Introduced August 5.

What this means for covered entities and contract pharmacies:

HRSA’s revised rebate pilot program lands squarely in the middle of the legislative reform fight creating a direct collision between executive branch regulatory action and congressional legislative intent. The executive branch — through HRSA — is pushing the rebate model forward. A bipartisan Senate coalition is legislating to stop it. The outcome will be determined by which moves faster — the courts, the legislature, or HRSA’s administrative timeline toward January 1, 2027. NatLawReview

⚠️ Action required: If you have not already submitted comments on the Cassidy discussion draft, the deadline was August 28. Comments were submitted to 340bforpatients@help.senate.gov. Contact your Congressional representative’s office immediately to weigh in on all three proposals.

🚨 TOP STORY #2 — HRSA REBATE PILOT FORMALLY PUBLISHED: WHAT THE AUGUST 3 FEDERAL REGISTER NOTICE ACTUALLY SAYS

August 3, 2026 — HRSA Federal Register Notice: The Details That Matter

The Health Resources and Services Administration on August 3, 2026, published a Federal Register Notice announcing a revised 340B Rebate Model Pilot Program. Holland & Knight

The 2026 Notice was announced approximately one year after HRSA issued its 2025 notice for the first 340B rebate model pilot program, which was subsequently withdrawn following a legal challenge. The Pilot Program is available only for drugs subject to an MFP for initial price applicability years 2026 and 2027 and requires HRSA approval in order to participate. www.hlc.com

How the new rebate model actually works — the operational reality:

The proposed HRSA model would change that entirely. Instead of receiving the 340B discount at the time of sale, covered entities would purchase drugs at Wholesale Acquisition Cost (WAC) — essentially the list price — and then submit detailed data to demonstrate that a given claim is 340B-eligible. Only after that verification process would they receive a rebate equal to the difference between what they paid and the actual 340B price. In other words, covered entities would be required to front the full cost of the drug and wait to be made whole. Pharmacy Times

The double financial hit — why this is particularly dangerous in August 2026:

CMS proposes reducing payment for most 340B-acquired drugs from average sales price plus 6 percent to ASP minus 33.4 percent. Hospitals should consider the Rebate Pilot Program’s operational and financial impacts when formulating their comments on the OPPS proposed rule, which are due by August 31, 2026, as the two initiatives together could compound financial pressures on 340B hospitals, particularly if hospitals must now purchase pilot drugs at WAC upfront while simultaneously facing reduced Medicare outpatient reimbursement rates for those same drugs. Holland & Knight

The timing of the pilot’s January 1, 2027 effective date alongside the CY 2027 OPPS rule creates an environment in which 340B hospitals need a coordinated strategy that addresses both regulatory developments. Holland & Knight

The legal vulnerability — same procedural question:

The 2026 Notice is “effective immediately as published, unless revised by a future notice.” This operative notice approach — implementing the program through a notice rather than full notice-and-comment rulemaking — is the same procedural choice that generated the January 2026 court defeat. Legal challenges from hospital groups are already in preparation. Pharmacy Times

The manufacturer application deadline:

Eligible manufacturers seeking to participate in the 340B Rebate Model Pilot Program must submit plans to 340BPricing@hrsa.gov no later than August 24, 2026, for an effective date of January 1, 2027, for selected drugs for initial price applicability year 2026 and 2027 during their price applicability periods. Federal Register

⚠️ Action required: HRSA was scheduled to announce which manufacturers received approval by September 24, 2026. Watch for that announcement — it will tell you which specific drugs your covered entity must prepare to purchase at WAC beginning January 1, 2027.

🚨 TOP STORY #3 — CMS COMMENT DEADLINE PASSES: AUGUST 31, 2026

The Proposed 39.4% Medicare Reimbursement Reduction — Comment Period Closes

The August 31 deadline for comments on CMS’s proposed rule cutting Medicare Part B reimbursement for 340B-acquired drugs from ASP plus 6% to ASP minus 33.4% passed on August 31, 2026. The AHA, 340B Health, NACHC, and hundreds of individual covered entities submitted formal comments opposing the proposed cut.

The key arguments made in opposition by covered entity groups:

The ASP minus 28% alternative. CMS disclosed that the 340B ceiling price is in aggregate only 28% below mean ASP — meaning the proposed 33.4% reduction would force some covered entities to receive Medicare payment below their actual statutory acquisition cost. Commenters urged CMS to adopt the ASP minus 28% alternative rate identified in its own proposed rule.

Safety-net patient impact. 340B savings fund services for the country’s most vulnerable patients. A 39.4% swing in Medicare reimbursement — from ASP plus 6% to ASP minus 33.4% — directly reduces the financial capacity that funds those services. Commenters documented specific patient programs that would be cut or eliminated under the proposed rule.

The legal vulnerability. While CMS this time conducted the drug acquisition cost survey the Supreme Court said was required in Becerra, commenters argued the proposed payment rate still has legal vulnerabilities — particularly because the proposed cut exceeds the survey’s own findings on actual 340B acquisition costs.

What happens next: CMS is expected to issue a final rule in October or November 2026, with the new payment rate potentially taking effect January 1, 2027. Watch for the final rule — and for any litigation filed by hospital groups challenging it.

⚖️ COURT DECISIONS — AUGUST 2026

August 2026 — Arkansas Attorney General Sues Thirteen Drug Manufacturers

Arkansas Attorney General Tim Griffin sued multiple major drugmakers alleging they undermined healthcare providers’ access to a federal drug discount program. UALR Public Radio

Griffin said the defendant drug companies have put rules in place that are “so burdensome and so prohibitive” that the 340B drug discount program can’t function as intended. UALR Public Radio

This lawsuit is significant for several reasons. Arkansas has the most battle-tested 340B contract pharmacy protection law in the country — it survived PhRMA’s challenge all the way to the Supreme Court, which declined to hear the appeal in December 2024. Having survived the preemption challenge, manufacturers then implemented data requirements and operational restrictions so burdensome that the Arkansas AG concluded they effectively circumvent the law without technically violating it.

Drug companies illegally limited how many contract pharmacies covered entities could use. The lawsuit names thirteen manufacturers and seeks to enforce Arkansas’ contract pharmacy access law through state attorney general enforcement action — a new and potentially powerful enforcement mechanism that other state AGs may follow. UALR Public Radio

Why this matters nationally: If Arkansas successfully uses state AG enforcement to compel manufacturer compliance with contract pharmacy access laws, it creates a template for other states with enacted laws — particularly Minnesota, Mississippi, Louisiana, Tennessee, and Illinois — to pursue similar enforcement actions rather than waiting for private litigation to resolve.

August 2026 — Ninth Circuit False Claims Act Whistleblower Case Advances

The 9th Circuit whistleblower lawsuit against AbbVie, AstraZeneca, Novartis, and Sanofi alleging 340B overcharges under the False Claims Act continued to advance through the appellate process in August 2026. This case — which was revived by the 9th Circuit earlier in 2026 — adds another potential federal enforcement mechanism against manufacturer 340B pricing conduct.

August 2026 — State Litigation Roundup

Active litigation in more than 50 340B state contract pharmacy cases continued through August 2026. Key developments:

Missouri — 8th Circuit ruling pending. Oral arguments were held in July 2026. A ruling from the 8th Circuit is expected in September or October 2026. The outcome is critical — the 8th Circuit previously upheld Arkansas’ law, and a similar ruling for Missouri would significantly strengthen the legal foundation for all Midwest state contract pharmacy protection laws.

Maine and Rhode Island — First Circuit ruling pending. Oral arguments were held in May 2026. A First Circuit ruling is expected in September or October 2026. The First Circuit previously blocked HRSA’s rebate pilot — its position on state contract pharmacy laws is not yet established.

Hawaii — Ongoing. AstraZeneca, PhRMA, and AbbVie consolidated challenges to Hawaii’s contract pharmacy law continue. The law remains in effect pending resolution.

Washington — Three simultaneous lawsuits. AbbVie, Novartis, and PhRMA each have separate active lawsuits challenging Washington’s S.B. 5981. The law remains in effect while all three challenges proceed.

Illinois — No manufacturer lawsuits filed as of August 31. Illinois’ newly signed contract pharmacy access bill has not yet faced a manufacturer legal challenge as of the end of August 2026.

🔬 MANUFACTURER POLICY CHANGES — AUGUST 2026

August 24, 2026 — Manufacturer Rebate Pilot Application Deadline

The deadline for manufacturers to submit applications to participate in HRSA’s revised rebate model pilot passed August 24. HRSA was scheduled to announce approved participants by September 24, 2026. The identity of participating manufacturers will determine which specific drugs your covered entity must prepare to purchase at WAC starting January 1, 2027.

What to watch: Manufacturers with IRA-negotiated drugs for 2026 and 2027 are the only eligible participants. The known eligible drug list includes products from several major manufacturers. Whether those manufacturers choose to participate — or are deterred by the SUSTAIN 340B Act’s threat to sunset the program — will become clear by September 24.

August 2026 — Novo Nordisk Exempts Additional States From In-House Data Requirements

Novo Nordisk expanded its list of states exempt from its in-house pharmacy claims data submission requirements — Novo Nordisk exempts 10 states from in-house claims data requirements. Covered entities in newly exempted states should verify their current exemption status directly with Novo Nordisk and through the 340B ESP platform at 340besp.com. 340B Report

Additionally, Merck exempted Washington from contract pharmacy restrictions, then reimplemented them in three states. This pattern of manufacturers selectively adjusting state-by-state exemption lists — sometimes adding states, sometimes removing them — requires covered entities to monitor manufacturer policies continuously rather than assuming their status from prior months remains unchanged. 340B Report

August 2026 — Longtime PhRMA Leader and 340B Critic to Step Down at End of 2026

A longtime PhRMA leader and 340B critic announced plans to step down at the end of 2026. The departure of a key architect of the pharmaceutical industry’s 340B restriction strategy could signal a shift in approach — either toward more aggressive litigation under new leadership, or potentially toward a more negotiated resolution of the contract pharmacy dispute. Monitor PhRMA’s leadership transition and any shift in its 340B litigation and advocacy strategy in Q4 2026. 340B Report

📊 REGULATORY & PROGRAM UPDATES — AUGUST 2026

August 2026 — ACA Subsidies Expire: Significant 340B Implications

Affordable Care Act subsidies expired, which is projected to reduce the number of people with insurance and drug coverage, decreasing available 340B savings. 340B Report

The ACA subsidy expiration — which occurred because Congress did not extend enhanced premium tax credits — means that millions of Americans who obtained insurance through the ACA marketplace may lose coverage or become underinsured. For 340B covered entities, this creates two simultaneous pressures:

More eligible patients. As people lose insurance coverage, they may qualify for care at FQHCs and safety-net hospitals — expanding the patient populations covered entities serve and increasing the clinical need for 340B savings.

Less revenue to fund services. At the same time, uninsured patients generate less reimbursable revenue than insured patients. The combination of more patients needing services and less revenue to fund them increases the financial pressure on covered entities precisely when the 340B program’s financial value is already under threat from the CMS reimbursement cut proposal.

August 2026 — Drug Price Reductions Affect WAC-Based Rebate Calculations

Many manufacturers, those included in the Medicare Drug Price Negotiation Program, announced dramatic drug list price reductions ranging from 40% to 70%. 340B Report

This development creates a complex interaction with the rebate model pilot. Under the traditional upfront discount model, the 340B ceiling price is calculated as a percentage below WAC. If WAC drops by 40 to 70%, the 340B ceiling price drops proportionally — but the dollar value of the 340B savings may also compress. Under the rebate model, covered entities would pay WAC and receive a rebate back to the ceiling price. If WAC has already been dramatically reduced, the rebate amount and the cash flow burden are both different than expected when the pilot was designed.

HRSA has not yet issued guidance on how dramatically reduced WAC prices interact with the rebate model pilot calculation methodology. Watch for guidance before January 1, 2027.

August 28, 2026 — Cassidy Discussion Draft Comment Deadline Passes

The August 28 comment deadline for Senator Cassidy’s 340B Drug Pricing Integrity and Affordability for Patients Act discussion draft passed. The AHA, 340B Health, NACHC, America’s Essential Hospitals, and individual covered entities submitted formal comments. The broad themes of the provider community’s response:

Opposition to mandatory reporting requirements. Covered entities objected to new federal reporting requirements as administratively burdensome and duplicative of existing oversight mechanisms.

Support for contract pharmacy access codification. Providers strongly supported the provision that would codify contract pharmacy access in federal statute — potentially providing definitive legal resolution to years of manufacturer litigation.

Opposition to rebate model provisions. Even covered entities that supported other aspects of the Cassidy draft objected to provisions that would permit or facilitate a rebate model delivery system.

Support for improved dispute resolution. The provision allowing covered entities to request adjudication at government or manufacturer expense received broad support from covered entity commenters.

🗺️ STATE LEGISLATIVE UPDATES — AUGUST 2026

August 2026 — State Scorecard

Full protection — law in effect with no active injunction:
Arkansas, Louisiana (5th Circuit appeal pending), Mississippi, Minnesota, Tennessee, Missouri (8th Circuit ruling pending), Washington, Illinois, Colorado (10th Circuit appeal pending), Hawaii (manufacturer challenges pending), Idaho, South Dakota, Rhode Island (1st Circuit pending), Maine (1st Circuit pending), Vermont (appeal pending), Nebraska (appeal pending), Oregon (appeal pending), Oklahoma (10th Circuit appeal pending)

Law blocked or expired:
West Virginia (4th Circuit blocked), North Dakota (permanently enjoined), Oklahoma (law blocked before taking effect — AG appealing), Maryland (4th Circuit vacated), Kansas (expired June 30)

No law enacted:
California, Texas, Georgia, Ohio, Pennsylvania, Indiana, New York (bill advancing)

August 2026 — New York Still Advancing

The New York Senate Finance Committee’s unanimous advancement of S.1913, the “340B Prescription Drug Anti-Discrimination Act,” continued toward a potential full Senate floor vote. No vote had occurred as of August 31, 2026. If New York enacts a contract pharmacy access law, it becomes the largest state in the country with such protection — a significant development given New York’s large safety-net hospital sector.

🏛️ INDUSTRY DEVELOPMENTS — AUGUST 2026

August 2026 — HOPA Annual Conference: Pharmacists Urged to Advocate

At the 2026 Hematology/Oncology Pharmacy Association Annual Conference, pharmacists were told: “340B’s future will be shaped by the people who understand it best and are willing to advocate for it. Pharmacists, as both stewards of the program’s integrity and witnesses to its patient impact, have both the credibility and the responsibility to be active voices in that effort — whether at the state capitol, in response to a federal RFI, or at the bedside.” Pharmacy Times

This call to action at a major pharmacy conference signals a broader mobilization of the pharmacy profession in the 340B advocacy space — moving beyond hospital administrators and covered entity executives to include the front-line pharmacists who understand the program’s patient impact most directly.

⚠️ AUGUST 2026 URGENT ACTION CHECKLIST

September 2026 brings several critical deadlines that require immediate preparation:

☐ Monitor September 24, 2026 — HRSA announces which manufacturers are approved for the rebate pilot. Identify which of your drugs will be affected beginning January 1, 2027.

☐ Prepare operationally for January 1, 2027 — If manufacturers participate in the rebate pilot, your covered entity must be ready to purchase affected drugs at WAC and submit claims for rebates. Assess your cash flow capacity to fund upfront WAC purchases.

☐ Monitor Missouri and First Circuit rulings — Both are expected in September or October 2026 and will significantly affect the state law landscape.

☐ Update your Novo Nordisk and Merck exemption status — Both manufacturers changed their state exemption lists in August. Verify your current status at 340besp.com.

☐ Monitor the SUSTAIN 340B Act’s legislative progress — Watch for committee hearings, markup sessions, or floor vote scheduling in September and October.

☐ Contact your Congressional representatives — With three simultaneous 340B bills in play, direct constituent communication from covered entities and contract pharmacies has never been more important.

☐ Verify your OPAIS registration — The October 1–15, 2026 registration window is the final window before January 1, 2027. If any contract pharmacy arrangements have changed, update OPAIS during this window.

💊 HOW THIS AFFECTS YOUR 340B PATIENTS — AND HOW BLISTER CARDS HELP

August 2026 delivered a stark reminder of what the 340B program is actually for. Pharmacists are both stewards of the program’s integrity and witnesses to its patient impact. Pharmacy Times

As three simultaneous legislative proposals, a regulatory rebate pilot, a proposed Medicare reimbursement cut, and manufacturer data requirements all compete for covered entity attention — the patients served by the program are still managing five, ten, and fifteen medications every single day. The advocacy, the litigation, and the regulatory comments are all ultimately in service of those patients’ ability to access affordable medications and the care those savings fund.

Pharmacy-grade blister card packaging is the most practical, most affordable, most evidence-backed tool available to improve medication adherence for your most complex 340B patients. Studies show adherence improves from 61% to 96% with blister card packaging. For the patients you serve — the patients the 340B program was designed to protect — that improvement represents fewer hospitalizations, better disease control, and longer, healthier lives.

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🔗 KEY SOURCES FOR AUGUST 2026

HRSA Federal Register Notice — 340B Rebate Model Pilot Program — federalregister.gov/documents/2026/08/03/2026-15633

Holland & Knight — Rebate Pilot Analysis — hklaw.com

National Law Review — SUSTAIN 340B Act Analysis — natlawreview.com

AJMC — Senate SUSTAIN 340B Act Coverage — ajmc.com

AHA — SUSTAIN 340B Act Statement — aha.org

Senator Boozman Press Release — SUSTAIN 340B Act — boozman.senate.gov

Senator Kaine Press Release — SUSTAIN 340B Act — kaine.senate.gov

Becker’s Hospital Review — Legislative Landscape — beckershospitalreview.com

Pharmacy Times — 340B Updates for Pharmacists — pharmacytimes.com

340B Report — State and Industry Developments — 340breport.com (subscription recommended)

HRSA Official 340B Program Page — hrsa.gov/opa

340B ESP Data Platform — 340besp.com

340B Prime Vendor Program — 340bpvp.com | 1-888-340-2787

Published: August 31, 2026 | [← July 2026] | [September 2026 →] | [Back to 340B News & Updates →]

Information in this update is provided for general educational purposes by 340bprogram.com, published by Medication Packaging Solutions LLC, 2519 N McMullen Booth Road, Clearwater, FL 33761. Sources include HRSA, U.S. federal courts, AHA, Holland & Knight, National Law Review, AJMC, Becker’s Hospital Review, Pharmacy Times, and the 340B Report. This is not legal or compliance advice. For compliance-specific guidance, consult a qualified 340B compliance consultant or healthcare attorney.