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-Final.docx Supporting Statement A	2018-10-04

IC Document Collections

IC ID	Document Title	Status
8395	Subpart D-Private Contracts and Supporting Regulations in 42 CFR 405.410 (a)	Modified
217358	Subpart D-Private Contracts and Supporting Regulations in 42 CFR 405.455(a)	Modified
178718	Application to Medicare Choice Contracts 405.455(a)	Modified
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))	Modified
178714	Subpart D-Private Contracts and Supporting Regulations in 42 CFR 405.410(a)	Modified

ICR Details

OMB Control No: 0938-0730	ICR Reference No: 201810-0938-005
Status: Active	Previous ICR Reference No: 201511-0938-005
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-FFS
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: 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: 12/03/2018
	Date Received in OIRA: 10/05/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2021	36 Months From Approved	03/31/2019
Responses	58,222	0	26,430
Time Burden (Hours)	24,057	0	6,307
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): Statute at Large: 42 Stat. 4507 Name of Statute: null
   PL: Pub.L. 105 - 33 4507 Name of Law: Use of Private Medicare Beneficaries
  

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:
	83 FR 33223	07/17/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 50100	10/04/2018
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)
Application to Medicare Choice Contracts 405.455(a)
Subpart D-Private Contracts and Supporting Regulations in 42 CFR 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	58,222	26,430	0	0	31,792	0
Annual Time Burden (Hours)	24,057	6,307	0	0	17,750	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: We updated the burden estimate in section A.12 from the last burden estimate to reflect changes in the number of physicians and practitioners who have opted out and refinements to our methodology for estimating the burden associated with contracts. We have also updated the cost estimate to account for the current BLS wage estimates and to include the estimated costs for Medicare Advantage plans.

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Annual Cost to Federal Government: $0

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 10/05/2018

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