J&J adds 340B claims data requirements amid growing manufacturer restrictions

Johnson & Johnson joined the list of drug manufacturers requiring providers to submit claims data on in-house pharmacy drugs as a condition of receiving discounts in the 340B Drug Pricing Program.

Hospitals and other 340B covered entities have 45 days to submit the data after dispensing a covered drug, according to J&J’s policy, although certain oncology and autoimmune drugs have a 60-day deadline. Providers will receive at least two notices of noncompliance before their 340B pricing is suspended on all products.

The reporting policy takes effect Sept. 15, as do restrictions on discounts for 340B drugs issued through contract pharmacies. Discounts on J&J drugs will be limited to one such pharmacy within a 40-mile radius of the covered entity.

“It is important to further improve 340B Program covered entity and contract pharmacy integrity and compliance to help ensure the 340B Program’s long-term sustainability,” according to a J&J notice.

J&J also said the data-reporting policy was designed “to create no more than a minimal administrative burden on covered entities. The limited, commercially standard claims data requested under this policy must already be maintained in covered entities’ auditable records to demonstrate compliance with 340B program requirements.”

In an August analysis, the American Hospital Association (AHA) said such statements missed the mark when made by manufacturers that have implemented similar policies in 2026.

“For example, data for in-house dispenses are often spread across multiple disparate data systems. Reconciling and aligning those systems would create significant costs for covered entities, requiring them to divert vital dollars away from patient care and toward complying with these new programmatic hurdles,” the AHA wrote.

Manufacturer 340B claims-data obligations continue to expand

Mandates to submit in-house claims data have been rolled out this year by Bristol Myers Squibb, Eli Lilly, Novo Nordisk and several other companies. The manufacturers have said the expanded requirements are necessary to ensure 340B discounts do not duplicate the drug discounts available in Medicare and Medicaid and are not diverted to ineligible patients.

Lilly began enforcing its policy in June, directing wholesalers to cut off 340B pricing for hospitals that the manufacturer said were noncompliant. The company’s action became the subject of at least one lawsuit, Florida Health Sciences Center v. Eli Lilly. Novo Nordisk has said similar penalties loom for entities that have not complied with its policy.

Based on current or pending state legislative protections, Lilly exempted providers in 10 states (Colorado, Maine, Nebraska, North Dakota, Oregon, Rhode Island, South Dakota, Tennessee, Vermont and West Virginia, along with federally qualified health centers in New Mexico) from the requirements. Other manufacturers, among them J&J, do not appear to have made a similar accommodation.

J&J is going further than other manufacturers with respect to contract pharmacy restrictions, including by applying such restrictions to all 340B covered entities, not just disproportionate share hospitals. Grantees such as federally qualified health centers, Ryan White HIV/AIDS clinics, and healthcare facilities operated by the Indian Health Service face the same constraints, albeit with a later effective date of Nov. 3.

Covered entities see a fragmented compliance landscape

Issued before J&J notified providers of its new policy, an analysis by Frier Levitt notes that some 340B covered entities, especially those with fewer resources, may struggle to comply with the various manufacturer requirements. The new policies have “different scopes, timing and state carve-outs, leaving covered entities to track a fragmented and expanding set of manufacturer-specific rules rather than a single uniform standard.”

Covered entities that expect to fall short of meeting the requirements should not just sit around waiting to be penalized.

“A covered entity that engages [with the manufacturer] early and explains, in specific and documented terms, what data it can provide now and what will require additional system work may be able to negotiate a phased submission schedule that preserves 340B pricing while the entity builds out its reporting capability,” according to the analysis.

Another tip applies if a provider is locked out of 340B pricing because of what a manufacturer says is noncompliance with the requirements. In that scenario, the provider “should treat every resulting purchase at a non-340B price as a documented overcharge. That documentation gives the covered entity a factual record it can bring to HRSA to seek enforcement action, including possibly civil monetary penalties, against manufacturers that condition 340B pricing on data submission,” per the analysis.

HRSA has not issued a formal public response to the expanded claims-data requirements.

Federal reporting changes add to 340B pressure

Combined with the Jan. 1 start of the federally organized 340B rebate model, the manufacturer policies ramp up the transparency requirements facing 340B providers.

And as previously noted, a separate federal requirement taking effect Jan. 1 requires providers to report Medicare Part D claims data to a centralized repository. The 2027 proposed rule for the Medicare Physician Fee Schedule included a provision for mandatory reporting to the new data center as a way to test whether such a system can identify 340B units for the purpose of excluding those units from Part D inflation rebate calculations.

In August, CMS published an FAQ with additional information on the repository, including processes for account creation and claims submission. The repository is scheduled to launch Oct. 1 for voluntary use over a three-month period leading up to Jan. 1. Failure to comply once data submission becomes mandatory could become grounds for revocation of Medicare enrollment.