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:
0938-1483
ICR Reference No:
202503-0938-001
Status:
Active
Previous ICR Reference No:
Agency/Subagency:
HHS/CMS
Agency Tracking No:
CM
Title:
Medicare Transaction Facilitator for 2026 and 2027 under Sections 11001 and 11002 of the Inflation Reduction Act (IRA) (CMS-10912)
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:
05/09/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
04/01/2025
Terms of Clearance:
Prior to the submission of the information collection request (ICR) “Medicare Transaction Facilitator for 2026 and 2027 under Sections 11001 and 11002 of the Inflation Reduction Act (IRA),” CMS will provide analysis of the MTF data submissions from manufacturers and dispending entities including the Maximum Fair Price (MFP) effectuation plans and the complaints and disputes form. Also, for the 2028 ICR submission, CMS will address how it made improvements, simplified, and reduced burden on manufacturers and dispending entities.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2027
36 Months From Approved
Responses
93,375
0
0
Time Burden (Hours)
877,960
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
Under the authority in sections 11001 and 11002 of the Inflation Reduction Act of 2022 (P.L. 117-169), the Centers for Medicare & Medicaid Services (CMS) is implementing the Medicare Drug Price Negotiation Program (“the Negotiation Program”), codified in sections 1191 through 1198 of the Social Security Act (“the Act”). The Act establishes the Negotiation Program to negotiate a maximum fair price (“MFP”), defined at section 1191(c)(3) of the Act, for certain high expenditure, single source drugs covered under Medicare Part B and Part D (“selected drugs”). In accordance with section 1193(a) of the Act, any Primary Manufacturer of a selected drug that continues to participate in the Negotiation Program and reaches agreement upon an MFP must provide access to the MFP to MFP-eligible individuals, defined in section 1191(c)(2)(A) of the Act, and to pharmacies, mail order services, other dispensing entities, providers and suppliers with respect to such MFP-eligible individuals who are dispensed that selected drug during a price applicability period. The purpose of this information collection request (ICR) is for CMS to collect information from manufacturers of drugs covered under Part D selected for negotiation under the Inflation Reduction Act for the initial price applicability years 2026 and 2027 and the dispensing entities that dispense the selected drugs to MFP-eligible individuals. To facilitate the effectuation of the MFP, CMS will engage a Medicare Transaction Facilitator (“MTF”). The MTF system will be comprised of two modules: the MTF Data Module (MTF DM), and the MTF Payment Module (MTF PM). Primary Manufacturers participating in the Negotiation Program are required to participate in the MTF DM.
Authorizing Statute(s):
PL:
Pub.L. 117 - 169 11001 and 11002
Name of Law: Inflation Reduction Act of 2022
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
89 FR 85538
10/25/2024
30-day Notice:
Federal Register Citation:
Citation Date:
90 FR 14373
04/01/2025
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
5
IC Title
Form No.
Form Name
Dispensing Entity to Complete Drug Price Negotiation Program MTF DM Dispensing Entity and Third-Party Support Entity Enrollment Form
CMS-10912
CMS-10912.MTF_ICR_DispensingEntityEnrollmentForm_clean
Non-MTF User to Complete Drug Price Negotiation Program MTF DM Complaint Intake Form
CMS-10912
CMS-10912. 2025.05.08_MTF_ICR_Complaints&DisputesForm_clean
Primary Manufacturer and/or Dispensing Entity to Complete Drug Price Negotiation Program Complaint and Dispute Intake Form
CMS-10912
CMS-10912. 2025.05.08_MTF_ICR_Complaints&DisputesForm_clean
Primary Manufacturer to Complete Drug Price Negotiation Program MTF DM Payment Elements Form
CMS-10912
CMS-10912.MTF_ICR_ManufacturerPaymentElementsForm_clean
Primary Manufacturer to Complete Drug Price Negotiation Program MTF DM Primary Manufacturer MFP Effectuation Plan Form
CMS-10912
CMS-10912.MTF_ICR_ MFPEffectuationPlanForm_clean
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
93,375
0
0
93,375
0
0
Annual Time Burden (Hours)
877,960
0
0
877,960
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:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
This is a new information collection request.
Annual Cost to Federal Government:
$281,472
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:
Stephan McKenzie 410 786-1943 stephan.mckenzie@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:
04/01/2025
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