Notice of Denial of Medicare Prescription Drug Coverage (CMS-10146 and 10146SP)

Form Instructions for the
“Notice of Denial of Medicare Prescription Drug Coverage”
CMS-10146
A Part D plan sponsor must complete and issue this notice whenever it denies a Part D
plan enrollee’s request for prescription drugs. This is not model language. This is a
standard form. Part D plans may not deviate from the content of the form provided. The
notice contains text in curly brackets “{
}” to be inserted as explained in these
instructions. Curly bracketed text shown in italics must be inserted in the notice as
written when it is applicable to the situation. Bracketed text that is not italicized
provides instruction on text to be inserted in the notice.
The Part D Denial Notice is available in English and Spanish. Part D Plan sponsors
should choose the appropriate version of the notice based on the language the
beneficiary best understands. Insertions must be in English when the English language
Denial Notice is used. Similarly, when a Spanish language Denial Notice is used, the
Part D plan sponsor should make insertions on the notice in Spanish, if applicable.
Please note that the OMB number must be displayed in the upper right corner of the
notice.
Heading
Logo - A logo is not required. Part D plans may elect to place their logo in this
space. The name, address, and telephone number of the Part D plan must be
immediately under the logo, if not incorporated within the logo.
Date - Enter the month, day, and year that the notice is issued to the enrollee,
the enrollee’s prescriber, or the enrollee’s representative.
Enrollee’s Name - Enter the enrollee’s full name.
Member Number- Enter the enrollee’s drug plan member identification number.
This number should not include or be the enrollee’s Social Security Number or
Health Insurance Claim (HIC) number.
Section titled: Your request was denied
List the denied prescription drug or drugs requested by the enrollee or prescriber.
Section titled: Why did we deny your request?
The Part D plan must provide a specific and detailed explanation of why the prescription
drug is being denied, including a description of any applicable Medicare coverage rule or
any other applicable Part D plan policy upon which the denial decision was based (e.g.,
a Medicare National Coverage Determination, or a section of the plan’s Evidence of
Coverage). A specific explanation about what information is needed to approve
coverage must be included. If the drug could be approved under the exception rules,
this section must explicitly state the need for a prescriber’s supporting statement and
clearly identify the type of information that should be submitted when requesting a

formulary or tiering exception. Where applicable, the Part D plan sponsor should include
excerpts from the plan’s CMS-approved formulary, including detailed clinical information
related to the plan’s coverage criteria for the requested drug.
Additional Instructions for drugs not covered under Part D when the plan has
determined that the drug is or may be covered under Medicare Part A or Part B:
In addition to the specific denial rationale described above, if the plan has approved
coverage under Medicare Part A or Part B or believes that the drug is covered (or may
be covered) under Medicare Part A or Part B, the plan must include the applicable
bracketed language as described below:
MA-PDs: Where the plan has determined that the requested drug is covered under Part
A or Part B, the plan must insert the following additional text: “This request was denied
under your Medicare Part D benefit; however, coverage/payment for the requested
drug(s) has been approved under Medicare Part A/B (include an explanation of the
conditions of approval in a readable and understandable format). If you think Medicare
Part D should cover this drug for you, you may appeal.”
Standalone PDPs: Where the plan has determined that the requested drug is covered
under Part A or Part B, or does not have sufficient information to make a favorable
determination under Part D, the plan must insert the following additional text: “This
request was denied under your Medicare Part D benefit; however, it may be covered
under Medicare Part A or Part B. For more information, talk to your prescriber or call 1800-MEDICARE.”
Section Titled: What If I Don’t Agree With This Decision?
No information is required to be completed.
Section Titled: Who May Request an Appeal?
In the spaces provided, the Part D plan is required to enter the Part D plan’s
telephone and TTY numbers that enrollees should use to obtain information or
forms on how to name a representative.
Section Titled: There Are Two Kinds of Appeals You Can Request
No information is required to be completed.
Section Titled: What Do I Include with My Appeal?
No information is required to be completed.
Section Titled: How Do I Request an Appeal?
Under the subsection “For an Expedited Appeal” –The Part D plan is required to
enter the telephone, TTY or fax number that the enrollee, prescriber, or the
enrollee’s representative can use to request an expedited (fast) appeal.
Under the subsection “For a Standard Appeal” –The Part D plan must provide the
address where the enrollee, prescriber, or the enrollee’s representative can mail
or hand deliver a standard appeal request. If the Part D plan accepts oral appeal
requests, then it must provide the telephone and TTY numbers that the enrollee,

prescriber, or the enrollee’s representative may use to request a standard
appeal.
Section Titled: What Happens Next?
No information is required to be completed.
Section Titled: Get Help & More Information
In the spaces provided, the plan must insert the plan’s toll free phone and TTY
numbers for the enrollee, physician or representative to call if they need
information or help. The plan must also insert the hours of operation for the call
center and the plan’s appeal website.

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of
information unless it displays a valid OMB control number. The valid OMB control number for this collection
is 0938-0976. The time required to complete this information collection is estimated to average 30 minutes
per response, including the time to review instructions, search existing data resources, and gather the data
needed, and complete and review the information collection. If you have any comments concerning the
accuracy of the time estimate(s) or suggestions for improving this form, please write to CMS, 7500 Security
Boulevard, Attn: PRA Reports Clearance Officer, Baltimore, Maryland 21244-1850.