2021-04303. Agency Information Collection Activities: Proposed Collection; Comment Request

AGENCY:

Centers for Medicare & Medicaid Services, Health and Human 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 May 3, 2021.

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

FOR FURTHER INFORMATION CONTACT:

William N. Parham at [phone].

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-10054 New Technology Services for Ambulatory Payment Classifications under the Outpatient Prospective Payment System

CMS-10632 Evaluating Coverage to Care in Communities

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: Extension of a currently approved collection; Title of Information Collection: New Technology Services for Ambulatory Payment Classifications under the Outpatient Prospective Payment System; Use: Section 1833(t)(6) of the Social Security Act (the Act) states, “The Secretary shall provide for an additional payment under this paragraph for any of the following that are provided as part of a covered OPD service (or group of services).” In accordance with the Act, CMS needs to keep pace with emerging new technologies and make them accessible to Medicare beneficiaries in a timely manner. It is necessary that we continue to collect appropriate information from interested parties such as hospitals, medical device manufacturers, pharmaceutical companies and others that bring to our attention specific services that they wish us to evaluate for New Technology Ambulatory Payment Classifications (APC) payment.

The information that we seek to continue to collect is necessary to determine whether certain new services are eligible for payment in New Technology APCs, to determine appropriate coding and to set an appropriate payment rate for the new technology service. The intent of these provisions is to ensure timely beneficiary access to new and appropriate technologies.

Both the New Technology APC provision and the transitional pass-through provisions provide ways for ensuring appropriate payment for new technologies for which the use and costs are not adequately represented in the base year claims data on which the outpatient PPS is constructed. Although individual drugs and biologicals and categories of medical devices will receive transitional pass-through payments for 2 to 3 years from the date payment is initiated for the specific item or category, the underlying statutory provision is permanent and provides an on-going mechanism for reflecting the introduction of new items into the payment structure in a timely manner. New Technology APCs are designed to allow appropriate payment for new technology services that are not covered by the transitional pass-through provisions. Form Number: CMS-10054 (OMB control number: 0938-0272); Frequency: Yearly; Affected Public: Private Sector, Business or other for-profits; Number of Respondents: 10; Total Annual Responses: 10; Total Annual Hours: 160. (For policy questions regarding this collection contact Allison Bramlett at 410-786-6556.)

2. Type of Information Collection Request: Reinstatement with change; Title of Information Collection: Evaluating Coverage to Care in Communities; Use: The purpose of this study is to extend our understanding from RAND Corporation's prior study of how C2C materials are used. This will be accomplished by assessing what materials best serve partners in their efforts to activate, engage, and empower consumers and how consumers engage with or respond to C2C materials. These data collection efforts will also serve the goals of informing future consumer messaging and creating a long-term feedback loop for maintaining a relevant, successful, and engaging C2C initiative. Initial survey results will be available in early 2022, which may help to fine-tune the strategy for the 2022 relaunch of C2C and will influence strategies and techniques going forward. Further, this study opens the door for a feedback loop that may include future consumer testing to adjust and improve C2C outreach strategies to meet the changing needs of various targeted populations.

The C2C Logic Model serves as the basis of this package. The goal of C2C is to improve the health of all populations, especially vulnerable and newly insured populations, by helping consumers understand their health insurance coverage and connecting individuals to primary care and preventive services. The urgency of achieving this goal is underscored by the COVID-19 pandemic, which has discouraged patients from seeking preventive care and hampered patients from properly managing chronic conditions at a time when preserving emergency room and hospital bed capacity is paramount.

There are three main paths of information dissemination covered by the C2C Logic Model (see Exhibit 1): (a) A direct path to the consumer, (b) a path to the consumer through a partner, and (c) a role for performance measurement in improving performance (i.e., desired effect and how C2C can improve). The partner and consumer surveys in the present evaluation build upon RAND's earlier study by adapting their questions to the C2C Logic Model and using similar survey methodologies in three to four targeted geographic areas known to have received a high volume of C2C materials and messages. These research questions and sub-questions correspond to the short-term and intermediate-term outcomes on the C2C Logic Model. Thus, the foregoing is a reformulation of questions answered by RAND and a consideration of additional questions. Form Number: CMS-10632 (OMB control number: 0938-1342); Frequency: Yearly; Affected Public: Individuals and Households, Business or other for-profits, Not-for-profits institutions; Number of Respondents: 460; Total Annual Responses: 460; Total Annual Hours: 152. (For policy questions regarding this collection contact Ashley Peddicord-Auston at 410-786-0757.)

Dated: February 25, 2021.

William N. Parham, III,

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