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

ICR 202002-0938-001

OMB: 0938-1374

Federal Form Document

IC Document Collections
ICR Details
0938-1374 202002-0938-001
Historical Active
HHS/CMS OEDA
Hospital Survey for Specified Covered Outpatient Drugs (SCODs) (CMS-10709)
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 04/23/2020
Retrieve Notice of Action (NOA) 02/11/2020
Approved consistent with the understanding that CMS will prepare a report providing a nonresponse bias and standard error analytical results and share with OMB prior to utilization of data for future publications, including rulemaking. The agency will clearly describe the scope and characteristics of the responding hospitals, as well as any limitations in the generalizability of the information collected, in any publications and documents utilizing this data. This action is approved for a period of eighteen months, during which time the agency will request approval to extend or revise the collection, if CMS seeks to continue the information collection activity beyond the period approved under this action.
  Inventory as of this Action Requested Previously Approved
10/31/2021 36 Months From Approved
1,408 0 0
67,584 0 0
0 0 0

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.

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)
  
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)

Not associated with rulemaking

  84 FR 51590 09/30/2019
85 FR 7306 02/07/2020
Yes

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

  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 0 1,408 0 0 0
Annual Time Burden (Hours) 67,584 0 67,584 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
This is a new collection.

$48,384
No
    No
    No
No
No
No
Uncollected
Stephan McKenzie 410 786-1943 [email protected]

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
02/11/2020


© 2024 OMB.report | Privacy Policy