Identifying Medicaid Payment for Physician Administered Drugs (CMS-10215)

Forms and Documents

Document Name	Status
CMS-10215 - Supporting Statement A (2021 version 5).docx Supporting Statement A	2021-07-14
PRA Disclosure Statement Screenshot.png Supplementary Document	2018-07-06

IC Document Collections

IC ID	Document Title	Status
181535	Identifying Medicaid Payment for Physician Administered Drugs	Modified

ICR Details

OMB Control No: 0938-1026	ICR Reference No: 202107-0938-005
Status: Received in OIRA	Previous ICR Reference No: 201802-0938-008
Agency/Subagency: HHS/CMS	Agency Tracking No: CMCS
Title: Identifying Medicaid Payment for Physician Administered Drugs (CMS-10215)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 07/14/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	07/31/2021
Responses	84,589,433	3,910,000
Time Burden (Hours)	351,046	16,227
Cost Burden (Dollars)	0	0

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Abstract: Section 6002 of the Deficit Reduction Act (DRA) of 2005 added provisions under section 1927 of the Social Security Act to require physicians in their offices and hospital outpatient settings or other entities (e.g., non-profit facilities) to collect and submit the drug National Drug Code (NDC) numbers on Medicaid claims to their State in order for Federal Financial Participation to be available for these drugs. We estimate that there are 20,000 physicians in their offices, hospital outpatient settings or other entities (e.g., non-profit facilities) concentrating in the specialties of oncology, rheumatology and urology will be required by their State Medicaid Programs to collect and submit Healthcare Common Procedure Coding System (HCPC) J drug code data match with NDC numbers. CMS released a letter to State Medicaid Directors on July 11, 2006 to explain the requirements of the State collection and submission of the drug NDC numbers on Medicaid claims. This collection is also associated with CMS-2238-FC Medicaid Program: Prescription Drugs published under Volume 72, Number 136, Tuesday, July 17, 2007, Rules and Regulations (RIN 0938-AO20). The requirements for this collection are codified under 42 Code of Federal Regulations section 447.520 Federal Financial Participation: Conditions relating to physician administered drugs.

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Authorizing Statute(s): PL: Pub.L. 109 - 171 6002 Name of Law: Deficit Reduction Act of 2005
  

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:
	86 FR 23729	05/04/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 36281	07/09/2021
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Identifying Medicaid Payment for Physician Administered Drugs

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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	84,589,433	3,910,000	0	80,679,433	0	0
Annual Time Burden (Hours)	351,046	16,227	0	334,819	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: In this 2021 iteration we are not proposing changes to any of our requirements. As indicated in Supporting Statement section 12, there are no reporting instruments. We have, however, revised the title of this collection of information request from, “Physicians and Hospital Outpatient Departments Collecting and Submitting Drug Identifying Information to State Medicaid Programs” to “Identifying Medicaid Payment for Physician Administered Drugs.” The change has no impact on the substance of this collection of information request. As indicated in Supporting Statement section 15, we are also adjusting our total response, total time, and total cost estimates based on FFY 2020 claims data.

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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: 07/14/2021

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