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###### Department of Health and Human Services

###### Centers for Medicare & Medicaid Services

          - [Document Identifier: CMS-10137 and CMS-10237]

# AGENCY:

Centers for Medicare & Medicaid Services, HHS.

# ACTION:

Notice.

# SUMMARY:

                        The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the                         **Federal Register**                         concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.                    

# DATES:

Comments must be received by October 26, 2018.

# ADDRESSES:

When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:

                        1.                         *Electronically.*                         You may send your comments electronically to                         *http://www.regulations.gov*. Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments.                    

                        2.                         *By regular mail.*                         You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number ___, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.                    

To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:

                        1. Access CMS' website address at                         *https://www.cms.gov/​Regulations-and-Guidance/​Legislation/​PaperworkReductionActof1995/​PRA-Listing.html*.                    

                        2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to                         *Paperwork@cms.hhs.gov*.                    

3. Call the Reports Clearance Office at (410) 786-1326.

# FOR FURTHER INFORMATION CONTACT:

William Parham at (410) 786-1326.

# SUPPLEMENTARY INFORMATION:

## Contents

                    This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see                     **ADDRESSES**                    ).                

CMS-10137 Solicitation for Applications for Medicare Prescription Drug Plan 2020 Contracts

CMS-10237 Medicare Advantage Application—Part C and 1876 Cost Plan Expansion Application Regulations under 42 CFR 422 (Subpart K) & 417.400

                    Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the                     **Federal Register**                     concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.                

## Information Collection

                    1.                     *Type of Information Collection Request:*                     Revision of a currently approved collection;                     *Title of Information Collection:*                     Solicitation for Applications for Medicare Prescription Drug Plan 2020 Contracts;                     *Use:*                     Coverage for the prescription drug benefit is provided through contracted prescription drug plans (PDPs) or through Medicare Advantage (MA) plans that offer integrated prescription drug and health care coverage (MA-PD plans). Cost Plans that are regulated under Section 1876 of the Social Security Act, and Employer Group Waiver Plans (EGWP) may also provide a Part D benefit. Organizations wishing to provide services under the Prescription Drug Benefit Program must complete an application, negotiate rates, and receive final approval from CMS. Existing Part D Sponsors may also expand their contracted service area by completing the Service Area Expansion (SAE) application.                

                    Collection of this information is mandated in Part D of the Medicare Prescription Drug, Improvement, and                           ( print page 43690)                        Modernization Act of 2003 (MMA) in Subpart 3. The application requirements are codified in Subpart K of 42 CFR 423 entitled “Application Procedures and Contracts with PDP Sponsors.” The information will be collected under the solicitation of proposals from PDP, MA-PD, Cost Plan, Program of All Inclusive Care for the Elderly (PACE), and EGWP applicants. The collected information will be used by CMS to: (1) Ensure that applicants meet CMS requirements for offering Part D plans (including network adequacy, contracting requirements, and compliance program requirements, as described in the application), (2) support the determination of contract awards.                     *Form Number:*                     CMS-10137 (OMB control number: 0938-0936);                     *Frequency:*                     Annually;                     *Affected Public:*                     Private Sector (Business or other for-profits, Not-for-Profit Institutions);                     *Number of Respondents:*                     243;                     *Total Annual Responses:*                     256;                     *Total Annual Hours:*                     2,351.08. (For policy questions regarding this collection contact Arianne Spaccarelli, at 410-786-5715.)                

                    2.                     *Type of Information Collection Request:*                     Revision of a currently approved collection;                     *Title of Information Collection:*                     Medicare Advantage Application—Part C and 1876 Cost Plan Expansion Application Regulations under 42 CFR 422 (Subpart K) & 417.400;                     *Use:*                     The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) Public Law 108-173 established the Medicare Prescription Drug Benefit Program (Part D) and made revisions to the provisions of Medicare Part C, governing what is now called the Medicare Advantage (MA) program (formerly Medicare+Choice). The MMA directed that important aspects of the new Medicare Prescription Drug Benefit Program under Part D be similar to and coordinated with regulations for the MA program. The MMA changes made managed care more accessible, efficient, and attractive to beneficiaries seeking options to meet their needs.                

                    This information collection includes the process for organizations wishing to provide healthcare services under MA plans. These organizations must complete an application annually (if required), file a bid, and receive final approval from CMS. The MA application process has two options for applicants that include (1) request for new MA product or (2) request for expanding the service area of an existing product. CMS utilizes the application process as the means to review, assess and determine if applicants are compliant with the current requirements for participation in the MA program and to make a decision related to contract award. This collection process is the only mechanism for organizations to complete the required MA application process. CMS will collect and review information under the solicitation of Part C applications for the various health plan product types described in the Background section above. CMS will use the information to determine whether the applicants meet the requirements to become an MA organization and are qualified to provide a particular type of MA plan. The application process is open to all health plans that want to participate in the MA program. The application is distinct and separate from the bid process, and CMS issues a determination on the application prior to bid submissions, or before the first Monday in June.                     *Form Number:*                     CMS-10137 (OMB control number: 0938-0935);                     *Frequency:*                     Annually;                     *Affected Public:*                     Private Sector (Business or other for-profits, Not-for-Profit Institutions);                     *Number of Respondents:*                     380;                     *Total Annual Responses:*                     400;                     *Total Annual Hours:*                     6,106. (For policy questions regarding this collection contact Keith Penn-Jones, at 410-786-3104.)                

Dated: August 22, 2018.

William N. Parham, III,

Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.

[FR Doc. 2018-18523 Filed 8-24-18; 8:45 am]

BILLING CODE 4120-01-P