Creation of Model Notices (Plans) (section 423.120(c)(6))

Form Instructions for

Drug Management Program Notices

CMS-10141

These notices must comply with all requirements at 42 CFR §423.153(f) and these instructions.

The language in these notices is not model language. These are standard forms. Part D plan sponsors may not deviate from the content provided. The notices contain italicized text in curly brackets “{ }” to be inserted when applicable to the situation. Bracketed text “[ ]” that is not italicized provides instruction on text to be inserted in the notice.

Please note that the OMB control number must be displayed in the lower left corner of the notice.

Initial Notice (“NOTICE OF INTENT TO LIMIT YOUR ACCESS TO CERTAIN PART D DRUGS”)

When a Part D plan sponsor determines that an enrollee is potentially at risk for prescription drug abuse under 42 CFR §423.153(f) and intends to limit the enrollee’s access to frequently abused drugs under Part D, the plan sponsor must issue this notice to the affected enrollee. Specific instructions on optional language and fillable fields can be found within the notice.

Second Notice (“YOUR ACCESS TO CERTAIN PART D DRUGS IS LIMITED”)

When a Part D plan sponsor determines that an enrollee is at risk for prescription drug abuse under 42 CFR §423.153(f), the plan sponsor must issue this notice to the affected enrollee before or concurrent with implementing a limitation on the enrollee’s access to frequently abused drugs under its drug management program. Specific instructions on optional language and fillable fields can be found within the notice.

Alternate Second Notice

When, after issuing the Initial Notice described above, a Part D plan sponsor determines that an enrollee is NOT at risk for prescription drug abuse under 42 CFR §423.153(f) and will not limit the enrollee’s access to frequently abused drugs under its drug management program, the Part D plan sponsor must issue this notice to the enrollee. Specific instructions on optional language and fillable fields can be found within the notice.

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.

CMS does not discriminate in its programs and activities: To request this form in an accessible format (e.g., Braille, Large Print, Audio CD) contact your Medicare Drug Plan. If you need assistance contacting your plan, call: 1-800-MEDICARE.

Form CMS-10141 OMB Approval No. 0938-0964 (Expires xx/xx/xxxx)