US · guidance
CMS Pub. 100-18, ch. 6, § 20.2.2
Part D Sponsor Due Diligence in Prior Authorization of Part A or B Versus Part D Coverage Determination
A drug approved or denied through prior authorization constitutes a coverage determination,
subject to all applicable coverage determination standards, timelines, and requirements.
However, Part D sponsors should rely upon (1) information included by the physician with the
prescription, (2) information communicated by the pharmacist or included with the submitted
claim, such as diagnosis information (e.g., to determine whether the prescription is related to a
Medicare covered transplant), (3) information captured by the plan sponsor previously, such as
diagnosis information from previous PAs, and (4) location of administration (e.g., to determine if
the prescription is being dispensed for a beneficiary in a nursing home) when available to avoid
the need for a separate coverage determination request to obtain the needed information
whenever possible. Assuming the available information is sufficient to correctly assign payment
to Part A or B or Part D, there is no need in such cases to require additional information to be
obtained from the physician.
To the extent that the Part D sponsor requires its contracted pharmacies to report the information
provided on the prescription to assist in the determination of Part A or B versus Part D coverage,
the sponsor should rely on the pharmacist’s report of appropriate information to appropriately
adjudicate the claim under Part D. For example, for cases in which prednisone is prescribed for
a condition other than immunosuppression secondary to a Medicare-covered transplant, and this
is either documented on the prescription, or evident based on the prescriber’s specialty, a known
diagnosis, or concomitant therapies, a sponsor may cover the drug under Part D without seeking
further information from the prescribing physician.
This clarification should not be construed to indicate that a Part D sponsor may not impose prior
authorization or other procedures to ensure appropriate coverage under the Medicare drug
benefit. Part D sponsors may apply prior authorization to establish appropriate payment under
Part A or B or Part D, even if the beneficiary is currently taking the drug. However, CMS
believes that the sponsor will have met appropriate due diligence standards without further
contacting a physician if necessary and sufficient information is available, and the contracted
pharmacy is able to communicate this information to the sponsor in order to make the coverage
determination. Refer to section 30.2.2.3 for additional guidance on the application of PAs. For
more information on Coverage Determination requirements, see Medicare Prescription Drug
Benefit Manual, chapter 18, available at https://www.cms.gov/Medicare/Appeals-and-
Grievances/MedPrescriptDrugApplGriev/Downloads/Chapter18.zip.
History
(Rev. 18, Issued: 01-15-16, Effective: 01-15-16; Implementation: 01-15-16)
Provenance
- Source
- cms.gov
- Retrieved
- 2026-09-17
- Edition
- iom-2026-09-17
- Content hash
f12dde0ed1eb368ca948d447366ce4bacc46718f75567862fa0fb7a82d431268
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