Subpart D-Private Contracts and Supporting Regulations in 42 CFR 405.410, 405.430, 405.435, 405.440, 405.445, 405.455, 410.61, 415.110, and 424.24 (CMS-R-234)

Forms and Documents

Document Name	Status
CMS-R-234 - Supporting Statement A [rev 11-16-2015 by OSORA PRA].docx Supporting Statement A	2015-11-16

IC Document Collections

IC ID	Document Title	Status
8395	Subpart D-Private Contracts and Supporting Regulations in 42 CFR 405.410 (a)	Unchanged
217358	Application to Medicare+Choice contracts (sec. 405.455(a))	Unchanged
178718	Subpart D-Private Contracts and Supporting Regulations in 42 CFR 405.455(a)	Unchanged
178717	Subpart D-Private Contracts and Supporting Regulations in 42 CFR 405.455(b)(4)	Unchanged
178716	Subpart D-Private Contracts and Supporting Regulations in 42 CFR 405.445(b)(2)	Unchanged
178715	Conditions for properly opting-out of Medicare (sec. 405.410(b))	Unchanged
178714	Subpart D-Private Contracts and Supporting Regulations in 42 CFR 405.410(a)	Unchanged

ICR Details

OMB Control No: 0938-0730	ICR Reference No: 201511-0938-005
Status: Historical Active	Previous ICR Reference No: 201507-0938-002
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Subpart D-Private Contracts and Supporting Regulations in 42 CFR 405.410, 405.430, 405.435, 405.440, 405.445, 405.455, 410.61, 415.110, and 424.24 (CMS-R-234)
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: 03/02/2016
	Date Received in OIRA: 11/16/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2019	36 Months From Approved	07/31/2016
Responses	26,430	0	26,820
Time Burden (Hours)	6,307	0	7,197
Cost Burden (Dollars)	0	0	0

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Abstract: Section 4507 of BBA 1997 amended section 1802 of the Social Security Act to permit certain physicians and practitioners to opt-out of Medicare and to provide through private contracts services that would otherwise be covered by Medicare. Under such contracts the mandatory claims submission and limiting charge rules of section 1848(g) of the Act would not apply. Subpart D and the Supporting Regulations contained in 42 CFR 405.410, 405.430, 405.435, 405.440, 405.445, and 405.455, counters the effect of certain provisions of Medicare law that, absent section 4507 of BBA 1997, preclude physicians and practitioners from contracting privately with Medicare beneficiaries to pay without regard to Medicare limits.

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Authorizing Statute(s): PL: Pub.L. 105 - 33 4507 Name of Law: Use of Private Medicare Beneficaries
   Statute at Large: 42 Stat. 4507 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:
0938-AS40	Final or interim final rulemaking	80 FR 70886	11/16/2015

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 41685	07/15/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 70886	11/16/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Subpart D-Private Contracts and Supporting Regulations in 42 CFR 405.410(a)
Conditions for properly opting-out of Medicare (sec. 405.410(b))
Subpart D-Private Contracts and Supporting Regulations in 42 CFR 405.445(b)(2)
Subpart D-Private Contracts and Supporting Regulations in 42 CFR 405.455(b)(4)
Subpart D-Private Contracts and Supporting Regulations in 42 CFR 405.410 (a)
Subpart D-Private Contracts and Supporting Regulations in 42 CFR 405.455(a)
Application to Medicare+Choice contracts (sec. 405.455(a))

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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	26,430	26,820	0	-390	0	0
Annual Time Burden (Hours)	6,307	7,197	0	-890	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: Changing Regulations

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

Burden Reduction Due to: Changing Regulations

Short Statement: We revised 42 CFR part 405, subpart D governing the submission of opt-out affidavits. The burden will decrease by -900 hr (300 hr - 1,200 hr) when physicians and practitioners no longer need to submit renewal affidavits starting on June 16, 2017. Under §405.445(a), physicians and practitioners that file valid opt-out affidavits on or after June 16, 2015 and do not want to extend their opt-out status at the end of a 2 year opt-out period may cancel by notifying us at least 30 days prior to the start of the next 2 year opt-out period. The burden associated with this new requirement is the time to draft, sign and submit the writing to the MAC.

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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: 11/16/2015

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