Transitional Pass through payments related to Drugs, Biologicals, and Radiopharmaceuticals to determine eligibility under the Outpatient Prospective Payment System (CMS-10008)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form CMS-10008 Drug and Biological Pass- Through Application	Form and Instruction	Modified	Available
Form CMS-10008 Transitional Pass through payments related to Drugs, Biologicals, and Radiopharmaceuticals to determine eligibility under the Outpatient Prospective Payment System	Form and Instruction	Modified	Repair queued
CMS-10008 Supporting Statement A_Drug PT 2024.docx	Supporting Statement A	Uploaded 2024-05-24	Repair queued
Drug PT Crosswalk.pdf	Supplementary Document	Uploaded 2024-05-20	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
8584	Transitional Pass through payments related to Drugs, Biologicals, and Radiopharmaceuticals to determine eligibility under the Outpatient Prospective Payment System	Form and Instruction	Modified	Drug and Biological Pass- Through Application
8584	Transitional Pass through payments related to Drugs, Biologicals, and Radiopharmaceuticals to determine eligibility under the Outpatient Prospective Payment System	Form and Instruction	Modified

ICR Details

OMB Control No: 0938-0802	ICR Reference No: 202405-0938-019
Status: Active	Previous ICR Reference No: 202107-0938-007
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-FFS
Title: Transitional Pass through payments related to Drugs, Biologicals, and Radiopharmaceuticals to determine eligibility under the Outpatient Prospective Payment System (CMS-10008)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/17/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 05/24/2024
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2027	36 Months From Approved	01/31/2025
Responses	35	0	30
Time Burden (Hours)	560	0	480
Cost Burden (Dollars)	0	0	0

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Abstract: Section 1833(t)(6) of the Act provides for temporary additional payments or “transitional pass-through payments” for certain drugs and biological agents. As originally enacted by the Balanced Budget Refinement Act (BBRA), this provision required the Secretary to make additional payments to hospitals for current orphan drugs, as designated under section 526 of the Federal Food, Drug, and Cosmetic Act (Pub. L. 107-186); current drugs and biological agents and brachytherapy used for the treatment of cancer; and current radiopharmaceutical drugs and biological products. For those drugs and biological agents referred to as “current,” the transitional pass-through payment began on the first date the hospital OPPS was implemented (before enactment of Benefits Improvement and Protections Act (BIPA) (Pub. L. 106-554), on December 21, 2000). Transitional pass-through payments are also required for certain “new” drugs, devices and biological agents that were not being paid for as a hospital outpatient department (OPD) service as of December 31, 1996, and whose cost is “not insignificant” in relation to the outpatient perspective payment system (OPPS) payment for the procedures or services associated with the new drug, device, or biological. Under the statute, transitional pass- through payments can be made for at least 2 years but not more than 3 years.

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Authorizing Statute(s): Statute at Large: 18 Stat. 1833
  

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:
	89 FR 18411	03/13/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 45898	05/24/2024
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

IC Title	Form No.	Form Name
Transitional Pass through payments related to Drugs, Biologicals, and Radiopharmaceuticals to determine eligibility under the Outpatient Prospective Payment System	CMS-10008	Drug and Biological Pass- Through Application

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ICR Summary of Burden

table that charts list 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	35	30	0	0	5	0
Annual Time Burden (Hours)	560	480	0	0	80	0
Annual Cost Burden (Dollars)	0	0	0	0	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 burden has increased due to the increase in submitted applications from 30 to 35 applications per year. Due to this, the annual burden has increased from 480 hours to 560 hours annually.

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Annual Cost to Federal Government: $105,000

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: 05/24/2024

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