Notice of Denial of Medicare Prescription Drug Coverage

Forms and Documents

Document Name	Status
Form CMS-10146SP Notice of Denial of Medicare Prescription Drug Coverage (CMS-10146 and 10146SP) Form	Modified
Crosswalk Coverage Denial Notice 04 2008.doc Supplementary Document	2008-08-13
Supporting Statement 10146 Denial Notice - Part A 04 30 08.doc Supporting Statement A	2008-08-13

IC Document Collections

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

ICR Details

OMB Control No: 0938-0976	ICR Reference No: 200809-0938-010
Status: Historical Active	Previous ICR Reference No: 200603-0938-013
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Notice of Denial of Medicare Prescription Drug Coverage
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 10/24/2008
	Date Received in OIRA: 09/05/2008
Terms of Clearance: This ICR is approved per CMS's 10/15/08 memo and revised form. CMS shall ensure that the Spanish-language version is similarly revised before its issuance.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2011	36 Months From Approved	11/30/2008
Responses	290,344	0	1,056,000
Time Burden (Hours)	145,172	0	528,000
Cost Burden (Dollars)	0	0	53,000

---

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 notice must comport with specific requirements.

---

Authorizing Statute(s): Statute at Large: 18 Stat. 1860 Name of Statute: null
   Statute at Large: 18 Stat. 1852 Name of Statute: null
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AN08	Final or interim final rulemaking	70 FR 4194	01/28/2005

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 30105	05/23/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 46301	08/08/2008
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-10146SP, CMS-10146	Aviso de Negaci?n de la Cobertura de Medicare para Recetas M?d ,   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	290,344	1,056,000	0	0	-765,656	0
Annual Time Burden (Hours)	145,172	528,000	0	0	-382,828	0
Annual Cost Burden (Dollars)	0	53,000	0	0	-53,000	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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 09/05/2008

---