Bristol Myers Squibb has disclosed its terms of use for the drug claims data that providers must give it in exchange for access to 340B pricing on BMS’s oral oncology drugs Revlimid, Pomalyst, and Thalomid.
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.”
Terms of Use Highlights
BMS fleshed out some of the details in a document tucked away on its vendor 340B ESP’s website. (On the site, scroll down to Bristol Myers Squibb > Designation for iMID Products and click Yes. The terms of use will pop open.)
BMS’s terms of use include:
- 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.
- BMS says it “will maintain in confidence and not disclose to third parties any non-public information it may receive as a result of the submission of claims level data by purchaser, except as may be required by law or these terms of use. BMS may disclose the data received under these terms of use to its contractors performing services to BMS so long as such contractors are under obligations of confidentiality similar to those in these terms of use.”
