Submissions of 1135 Waiver Request Automated Process (CMS-10752)

Forms and Documents

Document Name	Status
Form CMS-10752 1135 Waiver Request Automated Process Form and Instruction	New
CMS-10752 1135 Waiver Web Form Emergency Justification 9-30-20.pdf Supplementary Document	2020-10-08
CMS 10752 Supporting Statement Clean 10-7-20.docx Supporting Statement A	2020-10-08

IC Document Collections

IC ID	Document Title	Status
243968	1135 Waiver Request Automated Process Form and Instruction	New

ICR Details

OMB Control No: 0938-1384	ICR Reference No: 202010-0938-007
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: Submissions of 1135 Waiver Request Automated Process (CMS-10752)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 10/16/2020
OIRA Conclusion Action: Approved with change	Conclusion Date: 10/15/2020
	Date Received in OIRA: 10/09/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2021	4 Months From Approved
Responses	3,000	0	0
Time Burden (Hours)	3,000	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Waivers under Section 1135 of the Social Security Act (the Act) and certain flexibilities allow the CMS to relax certain requirements, known as the Conditions of Participation (CoPs) or Conditions of Coverage to promote the health and safety of beneficiaries. Under Section 1135 of the Act, the Secretary may temporarily waive or modify certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements to ensure that sufficient health care services are available to meet the needs of individuals enrolled in Social Security Act programs in the emergency area and time periods. These waivers ensure that providers who provide such services in good faith can be reimbursed and exempted from sanctions. During emergencies, such as the current COVID-19 public health emergency (PHE), CMS must be able to apply program waivers and flexibilities under section 1135 of the Social Security Act, in a timely manner to respond quickly to unfolding events. In a disaster or emergency, waivers and flexibilities assist health care providers/suppliers in providing timely healthcare and services to people who have been affected and enables states, Federal districts, and U.S. territories to ensure Medicare and/or Medicaid beneficiaries have continued access to care. During disasters and emergencies, it is not uncommon to evacuate Medicare-participating facilities and relocate patients/residents to other provider settings or across state lines, especially, during hurricane and tornado events. CMS must collect relevant information for which a provider is requesting a waiver or flexibility to make proper decisions about approving or denying such requests. Collection of this data aids in the prevention of gaps in access to care and services before, during, and after an emergency. CMS must also respond to inquiries related to a PHE from providers and beneficiaries. CMS is not collecting information from these inquiries; we are merely responding to them.

Emergency Justfication: When the President declares a disaster or emergency under the Stafford Act or National Emergencies Act and the HHS Secretary declares a public health emergency under Section 319 of the Public Health Service Act, the Secretary is authorized to temporarily waive or modify certain Medicare, Medicaid, Children’s Health Insurance Program (CHIP) and Health Insurance Portability and Accountability Act (HIPAA) requirements. This will ensure that sufficient health care services are available to meet the needs of individuals enrolled in Social Security Act programs in the emergency area and time periods, and to reimburse and exempt from sanctions providers who provide such services in good faith. During emergencies, such as the current COVID-19 public health emergency (PHE), CMS must be able to apply program waivers and flexibilities under section 1135 of the Social Security Act, in a timely manner, to respond quickly to unfolding events. When there is a disaster or emergency, waivers and flexibilities assist health care providers to give timely healthcare services to people who have been affected by the emergency event or disaster and enable states, Federal districts, and U.S. territories to ensure Medicare and/or Medicaid beneficiaries have continued access to care. During disasters and emergencies, it is not uncommon to evacuate provider facilities and relocate patients to other provider settings or across state lines, especially, during hurricane and tornado events. The waivers and flexibilities allow the Agency to relax certain Conditions of Participation and Conditions of Coverage to promote the health and safety of Medicare and Medicaid covered persons. The statutory authority that allows for the implementation of waivers and flexibilities are Section 1812(f) of the Social Security Act, Section 1135 of the Social Security Act and Section 319 of the Public Health Service Act.

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Authorizing Statute(s): US Code: 42 USC 1320b-5 Name of Law: Social Security Act
   US Code: 42 USC 1135 Name of Law: Social Security Act
   US Code: 42 USC 1812(f) Name of Law: Social Security Act
  

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

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
1135 Waiver Request Automated Process	CMS-10752	CMS 1135 Waiver/Flexibility Request and Inquiry Form

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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	3,000	0	0	3,000	0	0
Annual Time Burden (Hours)	3,000	0	0	3,000	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.

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Annual Cost to Federal Government: $1,616,528

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? Yes

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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: 10/09/2020

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