Notice of Denial of Medicare Prescription Drug Coverage

Forms and Documents

Document	Type	Status	Availability
Form CMS-10146(SP) Notice of Denial of Medicare Prescription Drug Coverage (CMS-10146 and 10146SP)	Form and Instruction	Modified	Available
Justification for Nonmaterial Change.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2013-12-16	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
37928	Notice of Denial of Medicare Prescription Drug Coverage (CMS-10146 and 10146SP)	Form and Instruction	Modified

ICR Details

OMB Control No: 0938-0976	ICR Reference No: 201312-0938-013
Status: Historical Active	Previous ICR Reference No: 201307-0938-022
Agency/Subagency: HHS/CMS	Agency Tracking No: 21129
Title: Notice of Denial of Medicare Prescription Drug Coverage
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/12/2014
	Date Received in OIRA: 12/20/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2016	11/30/2016	11/30/2016
Responses	1,497,929	0	1,497,929
Time Burden (Hours)	374,527	0	374,527
Cost Burden (Dollars)	0	0	0

---

Abstract: Pursuant to 42 CFR 423.568(c) and (d), if a Part D plan denies drug coverage it must give the enrollee written notice of the adverse coverage determination. The form and content of the written denial notice must comport with specific requirements, including a description of the appeals process. Pursuant to a 2009 change in regulations at 423.580 and 423.582, a prescriber may now request a standard redetermination (plan level appeal) on behalf of an enrollee. It is necessary to incorporate this change in the description of the appeals process contained on the Notice of Denial of Medicare Prescription Drug Coverage.

---

Authorizing Statute(s): Statute at Large: 18 Stat. 1860 Name of Statute: null
   Statute at Large: 18 Stat. 1852 Name of Statute: null
   US Code: 42 USC 1395w-104 Name of Law: null
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Notice of Denial of Medicare Prescription Drug Coverage (CMS-10146 and 10146SP)	CMS-10146(SP)	Notice of Denial of Medicare Prescription Drug Coverage

---

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	1,497,929	1,497,929	0	0	0	0
Annual Time Burden (Hours)	374,527	374,527	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

---

Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

---

Common Form ICR:  No

---

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 12/20/2013

---