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 07-15-2015 by OSORA PRA].docx Supporting Statement A	2015-07-15

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))	New
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))	Modified
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: 201507-0938-002
Status: Historical Inactive	Previous ICR Reference No: 201306-0938-007
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: Comment filed on proposed rule and continue	Conclusion Date: 10/29/2015
	Date Received in OIRA: 07/15/2015
Terms of Clearance: OMB is withholding approval at this time. Prior to publication of the final rule, the agency should provide a summary of any comments related to the information collection and their response, including any changes made to the ICR as a result of comments. In addition, the agency must enter the correct burden estimates.

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

---

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.

---

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

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AS40	Proposed rulemaking	80 FR 41685	07/15/2015

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

---

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)
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 405.455(a)
Application to Medicare+Choice contracts (sec. 405.455(a))

---

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: Our cost estimate has been adjusted by accounting for the current BLS wage estimates and by factoring in our 100% fringe benefit adjustment. Program changes are associated with a July 15, 2015, NPRM (CMS-1631-P; RIN 0938-AS40). With regard to §405.445(a) and the requirement to notify CMS, the NPRM would add 10 hr (aggregate) to the respondent burden. For Part 405, subpart D the burden would be reduce respondent burden by -900 hr (aggregate) since our currently approved burden estimates 1,200 hr and we now estimate 300 hr since respondents would no longer be required to submit a renewal affidavit.

---

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: 07/15/2015

---