Denial Notice Instruction Track Change

Form Instructions for the
“Notice of Denial of Medicare Part D 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 version of the notice that will be readable and understandable for
the beneficiary.
Please note that the OMB number must be displayed in the lower 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 prescriberprescribing provider, 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) numberMedicare Beneficiary Identifier (MBI).
Section titled: Your request Coverage fofor your drug was denied
List the denied prescription drug or drugs requested by the enrollee or prescribering
provider.
Section titled: Why did we deny your requestwas coverage for this drug denied?
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’sprescribing provider’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, include the applicable bracketed
language as described below:
MA-PDs: Where the plan processes a Part D coverage determination but determines that
the requested drug is covered under Part A or Part B, 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.” If the plan determines that the requested drug is typically covered under
Part B and instead processes a Part C organization determination, the plan must send
the Integrated Denial Notice (CMS-10003) if coverage is denied under Part B (e.g., Part
B drug step therapy requirements have not been met).
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, 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 prescriberprescribing provider or call 1800-MEDICARE.”
Section Titled: What If I Don’t Agree With This DecisionYou have the right to appeal
this decision?
No information is required to be completed.
Section Titled: Who May Requestcan ask for an Aappeal?
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 Two2 Kinds of Appeals: standard or expedited (fast) You
Can Request
No information is required to be completed.
Section Titled: How to ask for an appeal?
Under the section titled “How to ask for an appeal?” the subsection titled “For a
Standard Appeal” gives two options. If the plan accepts verbal requests for standard
appeals, the plan must keep the information after the brackets that states “For plans
that accept verbal standard requests”. If the plan does not accept verbal standard
requests, the plan must only keep the section after the brackets that states “For
plans that do not accept verbal standard requests”. Plans that accept verbal
requests are required to enter the telephone number, TTY number, fax number,
plan website and plan mailing address. physical address that the enrollee,
prescriber, or the enrollee’s representative can use to deliver an appeal request.

Plans that do not accept verbal standard requests are required to enter fax number,
plan website and physical address that the enrollee, prescribing provider’s, or the
enrollee’s representative can use to deliver mail an appeal request.

Section Titled: What Do Ito iInclude with your appeal requestMy Appeal?
No information is required to be completed.
Section Titled: How Do I Request an Appeal?
Under the section titled “How Do I Request an Appeal?” the subsection titled “For a
Standard Appeal” gives two options. If the plan accepts verbal requests for standard
appeals, the plan must keep the information after the brackets that states “For plans
that accept verbal standard requests”. If the plan does not accept verbal standard
requests, the plan must only keep the section after the brackets that states “For
plans that do not accept verbal standard requests”. Plans that accept verbal
requests are required to enter the telephone number, TTY number, fax number,
plan website and physical address that the enrollee, prescriber, or the enrollee’s
representative can use to deliver an appeal request. Plans that do not accept verbal
standard requests are required to enter fax number, plan website and physical
address that the enrollee, prescriber, or the enrollee’s representative can use to
deliver an appeal request.
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, physicianprescribing provider 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 website.

PRA Disclosure Statement 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. 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 information collection is 09380976. This information collection is for the notice Medicare drug plans must provide when a request for a drug is
denied in whole or in part. The time required to complete this information collection is estimated to average less
than 30 minutes per response, including the time to review instructions, search existing data resources, gather
the data needed, to review and complete the information collection. This information collection is mandatory
under Section 1860D-4(g)(h) of the Act and the regulatory authority set in Subpart M of Part 423 at 42 CFR
423.568 and 423.572. If you have 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,
Mail Stop C4-26-05, Baltimore, Maryland 21244-1850.

Form CMS-10146

OMB Approval Number 0938-0976 (Expires: x/xx/202x)