US · guidance
CMS Pub. 100-18, ch. 14, § 50.13
Executing Business Associate Agreement (BAA) with CMS and Part D Transaction Facilitator
Consistent with the HIPAA Privacy Rule (45 CFR Part 160 and Subparts A and E of Part
164), the CMS Part D Transaction Facilitator will be a business associate of Part D sponsors
for the purpose of performing TrOOP facilitation and COB functions when it receives data
directly from the sponsor. Currently, the facilitator receives data from a sponsor whenever a
beneficiary makes a contract-level enrollment change during the coverage year, and the
automated TrOOP balance transfer process is triggered. In that process, the Transaction
Facilitator receives data from the disenrolling Part D plan as well as from any prior Part D
plan in which the beneficiary was enrolled during that coverage year. Note that the BAA
requirement is applicable not only to sponsors directly reporting the TrOOP accumulators to
the CMS Part D Transaction Facilitator , but also to sponsors using a processor for the
automated TrOOP balance transfer process. Therefore, each Part D sponsor must execute
and submit the CMS-approved D Transaction Facilitator BAA to the CMS Part D
Transaction Facilitator.
45
On January 25, 2013, the Office for Civil Rights (OCR) issued an omnibus fi nal rule (78 FR
5566) that modified the HIPAA Privacy, Security, and Enforcement Rules to implement the
new statutory requirements included in the Health Information Technology for Economic
and Clinical Health Act (HITECH). Among the Privacy Rule changes addressed in the final
rule was the extension of certain HIPAA requirements to business associates. As a result,
the former standard language CMS Part D Transaction Facilitator BAA was revised to
incorporate these changes.
The revised BAA, and implementation form and instructions for the completion and
submission of the documents are available on the Facilitator’s Website. (See Appendix B for
the specific web address.) CMS strongly encourages Part D sponsors to execute the CMS
Part D Transaction Facilitator BAA without modification. Only those modifications
required by state regulations will be permitted.
Note that while PACE plans are not required to participated in the Automated TrOOP
Balance Transfer process, they are required to coordinate be nefits and receive data from
accept Nx transactions. As such all PACE programs are required to have an executed CMS
Part D Transaction Facilitator BAA.
History
(Rev. 18, Issued: 08 -23-13, Effective Date: 06-07-10, Imple mentation Date : 01-01-11)
Provenance
- Source
- cms.gov
- Retrieved
- 2026-09-17
- Edition
- iom-2026-09-17
- Content hash
f57cc9053d339b12e7f2f134bf503c706f53e3944f70fe25822c9486d0679612
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