View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0938-1396
ICR Reference No:
202107-0938-008
Status:
Active
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
OIRA Conclusion Action:
Approved with change
Conclusion Date:
08/03/2022
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/27/2021
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2025
36 Months From Approved
Responses
774
0
0
Time Burden (Hours)
0
0
0
Cost Burden (Dollars)
2,308,346
0
0
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.
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
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0938-AT94
Final or interim final rulemaking
85 FR 86824
12/31/2020
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
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Secure Electronic Prior Authorization for Medicare Part D
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
774
0
0
774
0
0
Annual Time Burden (Hours)
0
0
0
0
0
0
Annual Cost Burden (Dollars)
2,308,346
0
0
2,308,346
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:
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
Agency Contact:
Mitch Bryman 410 786-5258 Mitch.Bryman@cms.hhs.gov
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:
08/27/2021
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