Federal Register Extracts

Agency: "Internal Revenue Service, Department of the Treasury; Employee Benefits Security Administration, Department of Labor; Centers for Medicare & Medicaid Services, Department of Health and Human Services."

SUMMARY: This document is a request for information (RFI) regarding the application of the preventive services requirements under section 2713 of the Public Health Service Act (PHS Act) to over-the-counter (OTC) preventive items and services available without a prescription by a health care provider. The Department of the Treasury, the Department of Labor, and the Department of Health and Human Services (the Departments) are issuing this RFI to gather input from the public regarding the potential benefits and costs of requiring non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage to cover OTC preventive items and services without cost sharing and without a prescription by a health care provider; seek comment on any potential challenges associated with providing such coverage; understand whether and how providing such coverage would benefit consumers; and assess any potential burden that plans and issuers would face if required to provide such coverage.

DATES:

To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. ET on December 4, 2023.

ADDRESSES: Written comments may be submitted to the address specified below. Any comment that is submitted will be shared with the Department of the Treasury, Internal Revenue Service, and the Department of Health and Human Services (HHS). Commenters should not submit duplicates.

Comments will be made available to the public. Warning: Do not include any personally identifiable information (such as name, address, or other contact information) or confidential business information that you do not want publicly disclosed. All comments are posted on the internet exactly as received and can be retrieved by most internet search engines. No deletions, modifications, or redactions will be made to the comments received, as they are public records. Comments may be submitted anonymously.

In commenting, please refer to file code 1210-ZA31.

Comments must be submitted in one of the following two ways (please choose only one of the ways listed):

1. Electronically. You may submit electronic comments on this regulation to https://www.regulations.gov. Follow the "Submit a comment" instructions.

2. By mail. You may mail written comments to the following address ONLY: Office of Health Plan Standards and Compliance Assistance, Employee Benefits Security Administration, Room N-5653, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210, Attention: 1210-ZA31.

Always allow sufficient time for mailed comments to be received before the close of the comment period. Because of staff and resource limitations, the Departments cannot accept comments by facsimile (FAX) transmission.

Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. The comments are posted on the following website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to view public comments.

FOR FURTHER INFORMATION CONTACT:

Jason Sandoval, Internal Revenue Service, Department of the Treasury, at (202) 317-5500.

Matthew Meidell or Rebecca Miller, Employee Benefits Security Administration, Department of Labor, at (202) 693-8335.

Kei Helm, Centers for Medicare & Medicaid Services, Department of Health and Human Services, at (667) 290-9656.

Customer Service Information:

Individuals interested in obtaining information from the Department of Labor (DOL) concerning employment-based health coverage laws may call the Employee Benefits Security Administration (EBSA) Toll-Free Hotline at 1-866-444-EBSA (3272) or visit the DOL's website (www.dol.gov/ebsa). In addition, information from HHS on private health insurance coverage and on nonfederal governmental plans can be found on the Centers for Medicare & Medicaid Services (CMS) website (www.cms.gov/cciio), and information on health care reform can be found at www.HealthCare.gov.

SUPPLEMENTARY INFORMATION:

I. Background

A. Coverage of Preventive Services Under the Affordable Care Act and Implementing Regulations The Patient Protection and Affordable Care Act (Pub. L. 111-148) was enacted on March 23, 2010. The Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) was enacted on March 30, 2010. These statutes are collectively known as the Affordable Care Act (ACA). The ACA reorganized, amended, and added to the provisions of part A of title XXVII of the PHS Act relating to group health plans and health insurance issuers in the group and individual markets. The ACA added section 715(a)(1) to the Employee Retirement Income Security Act of 1974 (ERISA) and section 9815(a)(1) to the Internal Revenue Code (Code) to incorporate the provisions of part A of title XXVII of the PHS Act into ERISA and the Code, and to make them applicable to group health plans and health insurance issuers providing health insurance coverage in connection with group health plans. The sections of the PHS Act incorporated into ERISA and the Code are sections 2701 through 2728.

Section 2713 of the PHS Act, as added by section 1001 of the ACA and incorporated into ERISA and the Code, and its implementing regulations require that non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage provide coverage without imposing any cost-sharing requirements for the following items and services:

* Evidence-based items or services that have in effect a rating of "A" or "B" in the current recommendations of the United States Preventive Services Task Force (USPSTF) with respect to the individual involved, except for the recommendations of the USPSTF regarding breast cancer screening, mammography, and prevention issued in or around November 2009. /1/

FOOTNOTE 1 The USPSTF published updated breast cancer screening recommendations in January 2016. However, section 223 of title II of Division H of the Consolidated Appropriations Act, 2023 (Pub. L. 117-328) requires that for purposes of PHS Act section 2713, USPSTF recommendations relating to breast cancer screening, mammography, and prevention issued before 2009 remain in effect until January 1, 2025. END FOOTNOTE

* Immunizations for routine use in children, adolescents, and adults that have in effect a recommendation from the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) with respect to the individual involved.

* With respect to infants, children, and adolescents, evidence-informed preventive care and screenings provided for in comprehensive guidelines supported by the Health Resources and Services Administration (HRSA).

* With respect to women, such additional preventive care and screenings not described in the USPSTF recommendations in PHS Act section 2713(a)(1), as provided for in comprehensive guidelines supported by HRSA.

The Departments' regulations under section 2713 of the PHS Act at 26 CFR 54.9815-2713, 29 CFR 2590.715-2713, and 45 CFR 147.130 require that plans and issuers provide coverage of recommended preventive services generally for plan years (in the individual market, policy years) that begin on or after September 23, 2010, or, if later, for plan years (in the individual market, policy years) that begin on or after the date that is one year after the date the recommendation or guideline is issued. In addition, the regulations allow plans and issuers to impose reasonable medical management techniques to determine the frequency, method, treatment, or setting for coverage of a recommended preventive health item or service, to the extent not specified in the applicable recommendation or guideline. /2/ Moreover, if a plan or issuer has a provider in its network that can provide a recommended preventive service, the plan or issuer is not required to provide coverage or waive cost sharing for the item or service when furnished by an out-of-network provider. /3/

FOOTNOTE 2 26 CFR 54.9815-2713(a)(4), 29 CFR 2590.715-2713(a)(4), and 45 CFR 147.130(a)(4). END FOOTNOTE

FOOTNOTE 3 26 CFR 54.9815-2713(a)(3), 29 CFR 2590.715-2713(a)(3), and 45 CFR 147.130(a)(3). END FOOTNOTE

--This is a summary of a Federal Register article originally published on the page number listed below--

Request for information.

CFR Part: "26 CFR Part 54"; "29 CFR Part 2590"; "45 CFR Part 147"

RIN Number: "RIN 1210-ZA31"; "RIN 0938-ZB81"

Citation: "88 FR 68519"

Document Number: "CMS-9891-NC"

Federal Register Page Number: "68519"

"Proposed Rules"