BMS acquired the three drugs when it acquired drug manufacturer Celgene in 2019. As described in a six-part 340B Report investigation last year, hospitals complained for years about Celgene’s 2015 limited distribution system for the three drugs and how the system kept them from accessing 340B pricing on the expensive medicines—Revlimid in particular, the most widely used of the three.
In January, BMS announced a major expansion of its tightly controlled limited distribution network for these drugs. It said it would let disproportionate share and children’s hospital and grantee covered entities designate one of the specialty pharmacies in BMS’s network of pharmacies allowed to handle Revlimid, Pomalyst, and Thalomid as a 340B contract pharmacy for 340B bill to / ship to orders.
BMS is not letting critical access hospitals, sole community hospitals, rural referral centers, and free-standing cancer hospitals access 340B pricing on the three drugs under its policy. All three products have orphan designations. Under federal law, these four types of hospitals cannot get 340B pricing on drugs designated for orphan diseases or conditions unless the company chooses to do so voluntarily.
BMS said eligible entities would have to submit claims data for Revlimid, Pomalyst, and Thalomid purchases to BMS directly. It said the data would help it ensure that “customary business practices and program integrity are maintained” and would “support supply chain stability.”
- BMS says it will use the claims data to determine whether contract pharmacy orders comply with BMS’ distribution practices.
- Entities must agree to begin submitting claims level data to BMS 10 to 15 days after the contract pharmacy designation process is finished.
- BMS says it will comply “to the extent applicable” with the Health Insurance Portability and Accountability Act of 1996 and related regulations regarding privacy and security of individually identifiable health information. It said it will not try to re-identify individuals who are the subject of the data elements provided.