Notice of Denial of Medical Coverage (NDMC), and the Notice of Denial of Payment (NDP) - 42 CFR 422.568

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Crosswalk -- Changes to NDP-NDMC - 2010-FINAL.docx	Supplementary Document	Uploaded 2010-07-16	Available
NDMC - 2010 - 508--07-21-10-Track Changes.docx	Supplementary Document	Uploaded 2010-07-23	Available
NDP - 2010 - 508--07-21-10-Track Changes.doc	Supplementary Document	Uploaded 2010-07-23	Available
NDMCforminstructionstrackchanges508.docx	Supplementary Document	Uploaded 2010-07-16	Available
NDPforminstructionstrackchanges508.docx	Supplementary Document	Uploaded 2010-07-16	Available
Supporting Statement508 - CMS-10003 - 2010.doc	Supporting Statement A	Uploaded 2010-08-04	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
8626	Notice of Denial of Medical Coverage (NDMC), and the Notice of Denial of Payment (NDP) - 42 CFR 422.568 (CMS-10003)	Instruction	Modified

ICR Details

OMB Control No: 0938-0829	ICR Reference No: 201008-0938-013
Status: Historical Active	Previous ICR Reference No: 200902-0938-005
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Notice of Denial of Medical Coverage (NDMC), and the Notice of Denial of Payment (NDP) - 42 CFR 422.568
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/29/2010
	Date Received in OIRA: 08/19/2010
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2013	36 Months From Approved	10/31/2010
Responses	1,168,368	0	105,138
Time Burden (Hours)	194,728	0	26,285
Cost Burden (Dollars)	0	0	0

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Abstract: Medicare health plans, including Medicare Advantage plans, cost plans, and Health Care Prepayment Plans (HCPPs), are required to issue written notice of denials of payment or services, in whole or in part, to their enrollees. The denial notice must include a statement in understandable language of the reasons for the denial and a description of the applicable reconsideration and appeals processes. The NDP and NDMC were developed to comply with the Section 1852(g)(1)(B) of the Social Security Act. Regulatory authority for the NDMC and NDP are found at 42 CFR 422.568, and 42 CFR 417.600(b). Also, 42 CFR 417.840 applies certain Subpart M notice and appeal rules to cost plans and HCPPs. Additionally, CMS recently published a final rule with comment, "Medicare Program; Medicare Advantage and Prescription Drug Benefit Programs: Negotiated Pricing and Remaining Revisions," which added language to 42 CFR 422.578 and 42 CFR 422.582. This rule permits a physician providing treatment to an enrollee, upon providing notice to the enrollee, to request a standard reconsideration of a pre-service request for reconsideration on the enrollee's behalf.

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Authorizing Statute(s): US Code: 42 USC 1395w-22 Name of Law: Implementation of Medicare Advantage Program
   Statute at Large: 18 Stat. 1852 Name of Statute: null
  

Citations for New Statutory Requirements: None

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 22810	04/30/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 41487	07/16/2010
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

IC Title	Form No.	Form Name
Notice of Denial of Medical Coverage (NDMC), and the Notice of Denial of Payment (NDP) - 42 CFR 422.568 (CMS-10003)	CMS 10003-NDMC, CMS 10003-NDP	Notice of Denial of Payment ,   Notice of Denial of Medical Coverage

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ICR Summary of Burden

table that charts list 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	1,168,368	105,138	0	1,063,230	0	0
Annual Time Burden (Hours)	194,728	26,285	0	168,443	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: The increase in burden is due to the rise in the number of Medicare health plans and enrollees. Since 2005, the number of plans has increased from 454 to 740, and the number of enrollees has risen from 7.3 million to 10.9 million. Additionally, we adjusted our methodology for estimating the total number of denial notices. Also, there was a substantive change to the form and instructions. For additional information, refer to the crosswalk document.

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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

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Common Form ICR:  No

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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: 08/19/2010

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