2019-03459. Agency Information Collection Activities: Submission for OMB Review; Comment Request

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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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 on the collection(s) of information must be received by the OMB desk officer by April 1, 2019.

ADDRESSES:

When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: [phone] OR Email: [e-mail].

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

1. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [e-mail].

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

FOR FURTHER INFORMATION CONTACT:

William Parham at [phone].

SUPPLEMENTARY INFORMATION:

Under the Paperwork Reduction Act of 1995 (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 (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-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 that summarizes the following proposed collection(s) of information for public comment:

1. Type of Information Collection Request: New collection (Request for a new OMB control number); Title of Information Collection: Home Health (HH) National Provider Survey; Use: Section 1890A(a)(6) of the Social Security Act (the Act) requires the Secretary of HHS every three years to assess the quality and efficiency effects of the use of endorsed measures in specific Medicare quality reporting and incentive programs. This request is for review and approval of a survey and qualitative interview guide for the home health setting, which CMS proposes to use to address critical needs regarding the impact of use of quality and efficiency measures in the home health setting, including the burden they impose on home health agencies.

CMS plans to use the findings from surveys and qualitative interviews for multiple purposes. The qualitative interviews and standardized survey will inform CMS about the impact of measures used to assess care in HHAs. The surveys will help CMS understand whether the use of performance measures has been associated with changes in HHA behavior—namely, what QI investments HHAs are making and whether adoption of QI changes is associated with higher performance on the measures. The survey will help CMS identify characteristics associated with high performance, which, if understood, could be used to leverage improvements in care among lower-performing HHAs. The survey and interviews, assuming approval by August 2019, would be fielded from fall 2019 through spring 2020. Form Number: CMS-10688 (OMB control number: 0938-New); Frequency: Yearly; Affected Public: State, Local or Tribal governments; Number of Respondents: 1,040; Total Annual Responses: 1,040; Total Annual Hours: 1,040. (For policy questions regarding this collection contact Noni Bodkin at 410-786-7837.)

2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Notice of Research Exception under the Genetic Information Nondiscrimination Act; Use: Under the Genetic Information Nondiscrimination Act of 2008 (GINA), a plan or issuer may request (but not require) a genetic test in connection with certain research activities so long as such activities comply with specific requirements, including: (i) The research complies with 45 CFR part 46 or equivalent federal regulations and applicable State or local law or regulations for the protection of human subjects in research; (ii) the request for the participant or beneficiary (or in the case of a minor child, the legal guardian of such beneficiary) is made in writing and clearly indicates that compliance with the request is voluntary and that non-compliance will have no effect on eligibility for benefits or premium or contribution amounts; and (iii) no genetic information collected or acquired will be used for underwriting purposes. The Secretary of Labor or the Secretary of Health and Human Services is required to be notified if a group health plan or health insurance issuer intends to claim the research exception permitted under Title I of GINA. Nonfederal governmental group health plans and issuers solely in the individual health insurance market or Medigap market will be required to file with the Centers for Medicare & Medicaid Services (CMS). The Notice of Research Exception under the Genetic Information Nondiscrimination Act is a model notice that can be completed by group health plans and health insurance issuers and filed with either the Department of Labor or CMS to comply with the notification requirement. Form Number: CMS-10286 (OMB control number: 0938-1077); Frequency: Occasionally; Affected Public: Private Sector; State, Local or Tribal governments; Number of Respondents: 2; Total Annual Responses: 2; Total Annual Hours: 0.5. (For policy questions regarding this collection contact Usree Bandyopadhyay at 410-786-6650.)

3. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Data Submission for the Federally-facilitated Exchange User Fee Adjustment; Use: Section 2713 of the Public Health Service Act requires coverage without cost sharing of certain preventive health services, including certain contraceptive services, in non-exempt, non-grandfathered group health plans and health insurance coverage. The final regulations establish rules under which the third party administrator of the plan would provide or arrange for a third party to provide separate contraceptive coverage to plan participants and beneficiaries without cost sharing, premium, fee, or other charge to plan participants or beneficiaries or to the eligible organization or its plan. Eligible organizations are required to self-certify that they are eligible for this accommodation and provide a copy of such self-certification to their third party administrators. The final rules also set forth processes and standards to fund the payments for the contraceptive services that are provided for participants and beneficiaries in self-insured plans of eligible organizations under the accommodation described previously, through an adjustment in the FFE user fee payable by an issuer participating in an FFE.

CMS will use the data collections from participating issuers and third party administrators to verify the total dollar amount for such payments for contraceptive services provided under this accommodation for the purpose of determining a participating issuer's user fee adjustment. The attestation that the payments for contraceptive services were made in compliance with 26 CFR 54.9815-2713A(b)(2) or 29 CFR 2590.715-2713A(b)(2) will help ensure that the user fee adjustment is being utilized to provide contraceptive services for the self-insured plans in accordance with the previously noted accommodation. Form Number: CMS-10492 (OMB control number: 0938-1285); Frequency: Annually; Affected Public: Private sector (Business or other for-profits and Not-for-profit institutions); Number of Respondents: 861; Total Annual Responses: 861; Total Annual Hours: 12,930. (For policy questions regarding this collection contact Alper Ozinal [phone].)

4. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Data Collection to Support QHP Certification and other Financial Management and Exchange Operations; Use: As directed by the rule Establishment of Exchanges and Qualified Health Plans; Exchange Standards for Employers (77 FR 18310) (Exchange rule), each Exchange is responsible for the certification and offering of Qualified Health Plans (QHPs). To offer insurance through an Exchange, a health insurance issuer must have its health plans certified as QHPs by the Exchange. A QHP must meet certain minimum certification standards, such as network adequacy, inclusion of Essential Community Providers (ECPs), and non-discrimination. The Exchange is responsible for ensuring that QHPs meet these minimum certification standards as described in the Exchange rule under 45 CFR 155 and 156, based on the Patient Protection and Affordable Care Act (PPACA), as well as other standards determined by the Exchange. Issuers can offer individual and small group market plans outside of the Exchanges that are not QHPs.

The instruments in this information collection will be used for the 2020 certification process and beyond. Providing these instruments now will give issuers and other stakeholders more opportunity to familiarize themselves with the instruments before releasing the 2020 application. Form Number: CMS-10433 (OMB control number: 0938-1187); Frequency: Annually; Affected Public: State, Local, or Tribal Governments, Private Sector (Business or other for-profits); Number of Respondents: 2,892; Number of Responses: 2,892; Total Annual Hours: 68,666. (For questions regarding this collection contact Joshua Annas at 301-492-4407.)

Dated: February 22, 2019.

William N. Parham, III,

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