2020-25598. 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 January 19, 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.

2. Call the Reports Clearance Office at [phone].

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-10764 Evaluation of Risk Adjustment Data Validation (RADV) Appeals and Health Insurance Exchange Outreach Training Sessions

CMS-10454 Disclosure of State Rating Requirements

CMS-R-71 Quality Improvement Organization (QIO) Assumption of Responsibilities and Supporting Regulations

CMS-370/CMS-377 ASC Forms for Medicare Program Certification

CMS-1572 Home Health Agency Survey and Deficiencies Report

CMS-10332 Disclosure Requirement for the In-Office Ancillary Services Exception

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: New collection (Request for a new OMB control number); Title of Information Collection: Evaluation of Risk Adjustment Data Validation (RADV) Appeals and Health Insurance Exchange Outreach Training Sessions; Use: CMS recognizes that the success of accurately identifying risk-adjustment payments and payment errors is dependent upon the data submitted by Medicare Advantage Organizations (MAOs), and is strongly committed to providing appropriate education and technical outreach to MAOs and third-party administrators (TPAs). In addition, CMS is strongly committed to providing appropriate education and technical outreach to States, issuers, self-insured group health plans and TPAs participating in the Marketplace and/or market stabilization programs mandated by the Affordable Care Act (ACA).

CMS will strengthen outreach and engagement with MAOs and stakeholders in the Marketplace through satisfaction surveys following contract-level (CON) RADV audit and Health Insurance Exchange training events. The survey results will help to determine stakeholders' level of satisfaction with trainings, identify any issues with training and technical assistance delivery, clarify stakeholders' needs and preferences, and define best practices for training and technical assistance. Form Number: CMS-10764 (OMB control number: 0938-NEW); Frequency: Occasionally; Affected Public: Private Sector; Number of Respondents: 4,270; Total Annual Responses: 4,270; Total Annual Hours: 1,068. (For questions regarding this collection contact Melissa Barkai at 410-786-4305.)

2. Type of Information Collection Request: Extension of a currently approved collection; Title of information Collection: Disclosure of State Rating Requirements; Use: The final rule “Patient Protection and Affordable Care Act; Health Insurance Market Rules; Rate Review” implements sections 2701, 2702, and 2703 of the Public Health Service Act (PHS Act), as added and amended by the Affordable Care Act, and sections 1302(e) and 1312(c) of the Affordable Care Act. The rule directs that states submit to CMS certain information about state rating and risk pooling requirements for their individual, small group, and large group markets, as applicable. Specifically, states will inform CMS of age rating ratios that are narrower than 3:1 for adults; tobacco use rating ratios that are narrower than 1.5:1; a state-established uniform age curve; geographic rating areas; whether premiums in the small and large group market are required to be based on average enrollee amounts (also known as composite premiums); and, in states that do not permit any rating variation based on age or tobacco use, uniform family tier structures and corresponding multipliers. In addition, states that elect to merge their individual and small group market risk pools into a combined pool will notify CMS of such election. This information will allow CMS to determine whether state-specific rules apply or Federal default rules apply. It will also support the accuracy of the federal risk adjustment methodology. Form Number: CMS-10454 (OMB control number 0938-1258); Frequency: Occasionally; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 3; Total Annual Responses: 3; Total Annual Hours: 17. (For policy questions regarding this collection contact Russell Tipps at 301-869-3502.)

3. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Quality Improvement Organization (QIO) Assumption of Responsibilities and Supporting Regulations; Use: The Peer Review Improvement Act of 1982 amended Title XI of the Social Security Act to create the Utilization and Quality Control Peer Review Organization (PRO) program which replaces the Professional Standards Review Organization (PSRO) program and streamlines peer review activities. The term PRO has been renamed Quality Improvement Organization (QIO). This information collection describes the review functions to be performed by the QIO. It outlines relationships among QIOs, providers, practitioners, beneficiaries, intermediaries, and carriers. Form Number: CMS-R-71 (OMB control number: 0938-0445); Frequency: Yearly; Affected Public: Business or other for-profit and Not-for-profit institutions; Number of Respondents: 6,939; Total Annual Responses: 972,478; Total Annual Hours: 1,034,655. (For policy questions regarding this collection contact Kimberly Harris at 401-837-1118.)

4. Type of Information Collection Request: Extension of a currently approved collection; Titles of Information Collection: ASC Forms for Medicare Program Certification; Use: The form CMS-370 titled “Health Insurance Benefits Agreement” is used for the purpose of establishing an ASC's eligibility for payment under Title XVIII of the Social Security Act (the “Act”). This agreement, upon acceptance by the Secretary of Health & Human Services, shall be binding on the ASC and the Secretary. The agreement may be terminated by either party in accordance with regulations. In the event of termination of this agreement, payment will not be available for the ASC's services furnished to Medicare beneficiaries on or after the effective date of termination.

The CMS-377 form is used by ASCs to initiate both the initial and renewal survey by the State Survey Agency, which provides the certification required for an ASC to participate in the Medicare program. An ASC must complete the CMS-377 form and send it to the appropriate State Survey Agency prior to their scheduled accreditation renewal date. The CMS-377 form provides the State Survey Agency with information about the ASC facility's characteristics, such as, determining the size and the composition of the survey team on the basis of the number of ORs/procedure rooms and the types of surgical procedures performed in the ASC. Form Numbers: CMS-370 and CMS-377 (OMB control number: 0938-0266); Frequency: Occasionally; Affected Public: Private Sector—Business or other for-profit and Not-for-profit institutions; Number of Respondents: 1,567; Total Annual Responses: 1,567; Total Annual Hours: 1,012. (For policy questions regarding this collection contact Caroline Gallaher at 410-786-8705.)

5. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Home Health Agency Survey and Deficiencies Report; Use: In order to participate in the Medicare Program as a Home Health Agency (HHA) provider, the HHA must meet federal standards. This form is used to record information and patients' health and provider compliance with requirements and to report the information to the federal government. Form Number: CMS-1572 (OMB control number: 0938-0355); Frequency: Yearly; Affected Public: State, Local or Tribal Government; Number of Respondents: 3,833; Total Annual Responses: 3,833; Total Annual Hours: 1,917. (For policy questions regarding this collection contact Tara Lemons at 410-786-3030.)

6. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Disclosure Requirement for the In-Office Ancillary Services Exception; Use: Section 6003 of the Affordable Care Act (ACA) established a new disclosure requirement that a physician must perform for certain imaging services to meet the in-office ancillary services exception to the prohibition of the physician self-referral law. This section of the ACA amended section 1877(b)(2) of the Act by adding a requirement that the referring physician informs the patient, at the time of the referral and in writing, that the patient may receive the imaging service from another supplier.

Physicians who provide certain imaging services (MRI, CT, and PET) under the in-office ancillary services exception to the physician self-referral prohibition are required to provide the disclosure notice as well as the list of other imaging suppliers to the patient. The patient will then be able to use the disclosure notice and list of suppliers in making an informed decision about his or her course of care for the imaging service.

CMS would use the collected information for enforcement purposes. Specifically, if we were investigating the referrals of a physician providing advanced imaging services under the in- office ancillary services exception, we would review the written disclosure in order to determine if it satisfied the requirement. Form Number: CMS-10332 (OMB control number: 0938-1133); Frequency: Occasionally; Affected Public: Private Sector, Business or other for-profits, Not-for-profits institutions; Number of Respondents: 2,239; Total Annual Responses: 989,971; Total Annual Hours: 18,694. (For questions regarding this collection contact Laura Dash at 410-786-8623.)

Dated: November 16, 2020.

William N. Parham, III,

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