CMS Medicare Part D E-Prescribing Tools in 42 CFR 423.128(d)(1) and 423.160 (CMS-10755)

Forms and Documents

Document Name	Status
CM-10755- Response to Public Comments.docx Supplementary Document	2021-08-27
CMS-10755 - Supporting Statement A (CMS-4189-F version 4).docx Supporting Statement A	2021-08-27

IC Document Collections

IC ID	Document Title	Status
246280	Secure Electronic Prior Authorization for Medicare Part D	Modified

ICR Details

OMB Control No: 0938-1396	ICR Reference No: 202107-0938-008
Status: Received in OIRA	Previous ICR Reference No: 202103-0938-015
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: CMS Medicare Part D E-Prescribing Tools in 42 CFR 423.128(d)(1) and 423.160 (CMS-10755)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 08/27/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	990	0
Time Burden (Hours)	0	0
Cost Burden (Dollars)	11,047,632,750	0

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Abstract: The MMA authorizes CMS to require additional contract terms not inconsistent with the Part D statute. Under this authority, we are proposing to require that Sponsors offer a patient RTBT because we believe that it is appropriate to require that the formulary and benefit information be provided to enrollees in real time. Enrollees should have continuous access to this information, since drug pricing information is so dynamic.

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Authorizing Statute(s): PL: Pub.L. 115 - 271 6062 Name of Law: Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Commu
   PL: Pub.L. 108 - 173 1860D Name of Law: Medicare Prescription Drug, Improvement, and Modernization Act of 2003
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AT94	Final or interim final rulemaking	85 FR 86824	12/31/2020

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 28450	06/19/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 86824	12/31/2020
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Secure Electronic Prior Authorization for Medicare Part D

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ICR Summary of Burden

	Total Request	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	990	0	0	990	0	0
Annual Time Burden (Hours)	0	0	0	0	0	0
Annual Cost Burden (Dollars)	11,047,632,750	0	0	11,047,632,750	0	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:

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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? No

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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: 08/27/2021

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