Hospital Survey for Specified Covered Outpatient Drugs (SCODs) (CMS-10709)

Forms and Documents

Document Name	Status
Form CMS-10709 Hospital Survey for Specified Covered Outpatient Drugs (SCODs) Form	Unchanged
CMS-10709. Nonsub Change Justification - Final (8-11-20).docx Justification for No Material/Nonsubstantive Change	2020-08-11
CMS-10709. 340B Survey Characteristics Non-Response Bias Report.pdf Supplementary Document	2020-08-10
340B Survey 30 day Comment Response Clean (4-23-20).docx Supplementary Document	2020-04-22
CMS-10709.Supporting Statement Part A Clean (4-23-20).docx Supporting Statement A	2020-04-22
PRA Survey Proposal Crosswalk_02072020_Final.xlsx Supplementary Document	2020-02-10
CMS-10709.Supporting Statement Part B Clean (4-23-20).docx Supporting Statement B	2020-04-22
CMS Response to 340B Survey Comments_1292020_Clean.pdf Supplementary Document	2020-02-07

IC Document Collections

IC ID	Document Title	Status
239876	Hospital Survey for Specified Covered Outpatient Drugs (SCODs) Form	Unchanged

ICR Details

OMB Control No: 0938-1374	ICR Reference No: 202008-0938-005
Status: Active	Previous ICR Reference No: 202002-0938-001
Agency/Subagency: HHS/CMS	Agency Tracking No: CM
Title: Hospital Survey for Specified Covered Outpatient Drugs (SCODs) (CMS-10709)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/13/2020
	Date Received in OIRA: 08/10/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2021	10/31/2021	10/31/2021
Responses	1,408	0	1,408
Time Burden (Hours)	67,584	0	67,584
Cost Burden (Dollars)	0	0	0

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Abstract: The 340B program sets a ceiling on the price that covered entities pay for outpatient drugs. On December 27, 2018, the U.S. District Court for the District of Columbia ruled that the HHS Secretary did not have statutory authority to change Medicare Payment rates for 340B Drugs. The Courts asserted in part that the Secretary had not collected the necessary data to set payment rates based on acquisition costs. As a result of this ruling, CMS believes that it is important to begin obtaining acquisition costs for specified covered outpatient drugs to set future payment rates based on cost for certain 340B Hospitals. This survey will be used to help determine payment amounts for each drug acquired through the 340B Prime Vendor Program. We want to ensure that the Medicare program pays for specified covered outpatient drugs, purchased under the 340B Drug Pricing Program, at a reasonable payment amount to ensure access to care is maintained, prudent payers of taxpayer dollars, and ensure that Medicare beneficiaries can also stretch their scarce resources. MedPAC has consistently stated that Medicare should institute policies that improve the program’s value to beneficiaries and taxpayers. We believe that utilizing the authority granted under Section 1833(t)(14)(D)(ii) is a step forward in increasing value to the program while being cognizant of the constraints to the program. In the March 2019 Report to The Congress MedPAC noted in part that outpatient payments increased in part due to rapid growth in Part B drug spending.

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Authorizing Statute(s): PL: Pub.L. 108 - 173 1833(t)(14)(D)(ii) Name of Law: The Medicare Modernization Act of 2003, section 603(a)
   PL: Pub.L. 108 - 173 1833(t)(14)(D)(i) Name of Law: The Medicare Modernization Act of 2003, section 603(a)
  

Citations for New Statutory Requirements: PL: Pub.L. 108 - 173 1833(t)(14)(D)(i) Name of Law: The Medicare Modernization Act of 2003, section 603(a)
PL: Pub.L. 108 - 173 1833(t)(14)(D)(ii) Name of Law: The Medicare Modernization Act of 2003, section 603(a)

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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:
	84 FR 51590	09/30/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 7306	02/07/2020
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
Hospital Survey for Specified Covered Outpatient Drugs (SCODs)	CMS-10709, CMS-10709	Drug Survey ,   Instruction Sheet for Collecting Acquisition Costs

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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	1,408	1,408	0	0	0	0
Annual Time Burden (Hours)	67,584	67,584	0	0	0	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: This is a new collection.

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Annual Cost to Federal Government: $48,384

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: 08/10/2020

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