Information Collection Requirement for Mid-Year Formulary Change Reporting and Notice Requirement (CMS-10696)

Forms and Documents

Document Name	Status
Form CMS-10696 Drug Formulary Changes Template Form and Instruction	New
CMS-10696 - Supporting Statement (NPRM).docx Supporting Statement A	2019-04-08

IC Document Collections

IC ID	Document Title	Status
235621	Drug Formulary Changes Template Form and Instruction	New

ICR Details

OMB Control No: 0938-1365	ICR Reference No: 201904-0938-005
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No: CCIIO
Title: Information Collection Requirement for Mid-Year Formulary Change Reporting and Notice Requirement (CMS-10696)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule	Conclusion Date: 07/10/2019
	Date Received in OIRA: 04/09/2019
Terms of Clearance: Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: At §147.106(e)(5), we propose for plan years beginning on or after January 1, 2020, a health insurance issuer may make mid-year formulary changes by notifying the plan enrollees of changes a minimum 60 days prior to initiating a change that removes the brand name drug from the formulary when a generic equivalent becomes available; or adds a generic equivalent drug to the formulary and moves the brand drug to a higher formulary drug tier. As a subset of this notice requirement, at §156.122(d)(3) we propose that QHP issuers in the FFEs would be required to notify HHS annually in an HHS-specified format of any mid-year formulary changes made in the prior plan year consistent with the policy proposed at §147.106(e) that would allow an issuer to make mid-year drug formulary changes. QHP issuers in the FFEs would be required to report the name of the drug being removed from the formulary, dosage, name of the generic equivalent, the Rx Norm Concept Unique Identifier (RxCUI) associated with the brand and generic drug, if the brand drug was moved to a higher cost sharing tier or removed from the formulary. Issuers would be required to submit the formulary changes in a template as specified by HHS.

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Authorizing Statute(s): US Code: 45 USC 156.102(d)(3) Name of Law: ACA - Guaranteed Renewability of Coverage
   US Code: 45 USC 147.106(e)(5) Name of Law: ACA - Health Insurance Reform Requirements for the Group and Individual Health Ins
  

Citations for New Statutory Requirements: US Code: 45 USC 147.106(e)(5) Name of Law: Health Insurance Reform Requirements for the Group and Individual Health Ins
US Code: 45 USC 156.102(d)(3) Name of Law: Guaranteed Renewability of Coverage

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AT37	Proposed rulemaking	84 FR 331	01/24/2019

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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
Drug Formulary Changes Template	CMS-10696	Drug Formulary Change Template

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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 of information.

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Annual Cost to Federal Government:

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]? Yes

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? Uncollected

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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: 04/09/2019

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