[Federal Register Volume 89, Number 207 (Friday, October 25, 2024)]
[Rules and Regulations]
[Pages 85070-85071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24801]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 431 and 457

[CMS-0057-F2]
RIN 0938-AU87


Medicare and Medicaid Programs; Patient Protection and Affordable 
Care Act; Advancing Interoperability and Improving Prior Authorization 
Processes for Medicare Advantage Organizations, Medicaid Managed Care 
Plans, State Medicaid Agencies, Children's Health Insurance Program 
(CHIP) Agencies and CHIP Managed Care Entities, Issuers of Qualified 
Health Plans on the Federally- Facilitated Exchanges, Merit-Based 
Incentive Payment System (MIPS) Eligible Clinicians, and Eligible 
Hospitals and Critical Access Hospitals in the Medicare Promoting 
Interoperability Program; Correcting Amendment

AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of 
Health and Human Services (HHS).

ACTION: Final rule; correcting amendment.

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SUMMARY: This document corrects technical errors in the final rule that 
appeared in the February 8, 2024 Federal Register titled ``Medicare and 
Medicaid Programs; Patient Protection and Affordable Care Act; 
Advancing Interoperability and Improving Prior Authorization Processes 
for Medicare Advantage Organizations, Medicaid Managed Care Plans, 
State Medicaid Agencies, Children's Health Insurance Program (CHIP) 
Agencies and CHIP Managed Care Entities, Issuers of Qualified Health 
Plans on the Federally-Facilitated Exchanges, Merit-Based Incentive 
Payment System (MIPS) Eligible Clinicians, and Eligible Hospitals and 
Critical Access Hospitals in the Medicare Promoting Interoperability 
Program''.

DATES: This correcting amendment is effective October 25, 2024.

FOR FURTHER INFORMATION CONTACT: David Koppel (303) 844-2883.

SUPPLEMENTARY INFORMATION:

I. Background

    In FR Doc. 2024-00895 of February 8, 2024 (89 FR 8758), the final 
rule titled ``Medicare and Medicaid Programs; Patient Protection and 
Affordable Care Act; Advancing Interoperability and Improving Prior 
Authorization Processes for Medicare Advantage Organizations, Medicaid 
Managed Care Plans, State Medicaid Agencies, Children's Health 
Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, 
Issuers of Qualified Health Plans on the Federally-Facilitated 
Exchanges, Merit-Based Incentive Payment System (MIPS) Eligible 
Clinicians, and Eligible Hospitals and Critical Access Hospitals in the 
Medicare Promoting Interoperability Program'' (hereinafter referred to 
as ``CMS Interoperability and Prior Authorization final rule''), there 
were technical errors associated with the regulations text that are 
identified and corrected in this correcting amendment.

II. Summary of Errors

    In Sec. Sec.  431.60 and 457.730, we are correcting errors in 
executing the amendatory instructions regarding the removal of 
paragraph (g) (Data availability) and the redesignation of paragraph 
(f) (Beneficiary resources regarding privacy and security) as the new 
paragraph (g).

III. Waiver of Proposed Rulemaking and Delay in Effective Date

    Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA), 
the agency is required to publish a notice of the proposed rule in the 
Federal Register before the provisions of a rule take effect. 
Specifically, 5 U.S.C. 553 requires the agency to publish a notice of 
the proposed rule in the Federal Register that includes a reference to 
the legal authority under which the rule is proposed, and the terms and 
substance of the proposed rule or a description of the subjects and 
issues involved. Further, 5 U.S.C. 553 requires the agency to give 
interested parties the opportunity to participate in the rulemaking 
through public comment on a proposed rule. Similarly, section 
1871(b)(1) of the Act requires the Secretary to provide for notice of 
the proposed rule in the Federal Register and provide a period of not 
less than 60 days for public comment for rulemaking to carry out the 
administration of the Medicare program under title XVIII of the Act. In 
addition, section 553(d) of the APA, and section 1871(e)(1)(B)(i) of 
the Social Security Act (the Act) mandate a 30-day delay in effective 
date after issuance or publication of a rule. Sections 553(b)(B) and 
553(d)(3) of the APA provide for exceptions from the notice and comment 
and delay in effective date APA requirements. In cases in which these 
exceptions apply, sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the 
Act, also provide exceptions from the notice and 60-day comment period 
and delay in effective date requirements of the Act. Section 553(b)(B) 
of the APA and section 1871(b)(2)(C) of the Act authorize an agency to 
dispense with normal rulemaking requirements for good cause if the 
agency makes a finding that the notice and comment process are 
impracticable, unnecessary, or contrary to the public interest. In 
addition, both section 553(d)(3) of the APA and section 
1871(e)(1)(B)(ii) of the Act allow the agency to avoid the 30-day delay 
in effective date where such delay is contrary to the public interest 
and an agency includes a statement of support.
    We believe that this correcting amendment does not constitute a 
rule that would be subject to the notice and comment or delayed 
effective date requirements of the APA or section 1871 of the Act. This 
correcting amendment corrects technical errors in the regulatory text 
of the final rule but does not make substantive changes to the policies 
that were adopted in the final rule. As a result, this correcting 
amendment is intended to ensure that the regulations at Sec. Sec.  
431.60 and 457.730 accurately reflect the policies adopted in the final 
rule.
    In addition, even if this were a rule to which the notice and 
comment procedures and delayed effective date requirements applied, we 
find that there is good cause to waive such requirements. Undertaking 
further notice and comment procedures to incorporate the regulatory 
text correction in this document into the final rule or delaying the 
effective date would be unnecessary, as we are not altering our 
policies or regulatory changes, but rather, we are simply implementing 
the policies and regulatory changes that we previously proposed, 
requested comment on, and subsequently finalized.
    This final rule correcting amendment is intended solely to ensure 
that the final rule and the Code of Federal Regulations (CFR) 
accurately reflect policies and regulatory changes that have been 
adopted through rulemaking. Furthermore, such notice and comment 
procedures would be contrary to the public interest because it is in 
the public's interest to ensure that the final rule accurately reflects 
our policies and regulatory changes. Therefore, we believe we have good 
cause to waive the notice and comment and effective date requirements.

List of Subjects

42 CFR Part 431

    Grant programs--health, Health facilities, Medicaid, Privacy, 
Reporting

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and recordkeeping requirements, State fair hearings.

42 CFR Part 457

    Administrative practice and procedure, Grant programs--health, 
Health insurance, Reporting and recordkeeping requirements.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services corrects 42 CFR chapter IV by making the following 
correcting amendments:

PART 431--STATE ORGANIZATION AND GENERAL ADMINISTRATION

0
1. The authority citation for part 431 continues to read as follows:

    Authority: 42 U.S.C. 1302.


0
2. Section 431.60 is amended by revising paragraph (g) to read as 
follows:


Sec.  431.60  Beneficiary access to and exchange of data.

* * * * *
    (g) Beneficiary resources regarding privacy and security. The State 
must provide in an easily accessible location on its public website and 
through other appropriate mechanisms through which it ordinarily 
communicates with current and former beneficiaries seeking to access 
their health information held by the State Medicaid agency, educational 
resources in non-technical, simple and easy-to-understand language 
explaining at a minimum--
    (1) General information on steps the individual may consider taking 
to help protect the privacy and security of their health information, 
including factors to consider in selecting an application including 
secondary uses of data, and the importance of understanding the 
security and privacy practices of any application to which they will 
entrust their health information; and
    (2) An overview of which types of organizations or individuals are 
and are not likely to be HIPAA covered entities, the oversight 
responsibilities of the Office for Civil Rights (OCR) and the Federal 
Trade Commission (FTC), and how to submit a complaint to--
    (i) The HHS Office for Civil Rights (OCR); and
    (ii) The Federal Trade Commission (FTC).
* * * * *

PART 457--ALLOTMENTS AND GRANTS TO STATES

0
3. The authority citation for part 457 continues to read as follows:

    Authority: 42 U.S.C. 1302.


0
4. Section 457.730 is amended by revising paragraph (g) to read as 
follows:


Sec.  457.730  Beneficiary access to and exchange of data.

* * * * *
    (g) Beneficiary resources regarding privacy and security. A State 
must provide in an easily accessible location on its public website and 
through other appropriate mechanisms through which it ordinarily 
communicates with current and former beneficiaries seeking to access 
their health information held by the State CHIP agency, educational 
resources in non-technical, simple and easy-to-understand language 
explaining at a minimum--
    (1) General information on steps the individual may consider taking 
to help protect the privacy and security of their health information, 
including factors to consider in selecting an application including 
secondary uses of data, and the importance of understanding the 
security and privacy practices of any application to which they will 
entrust their health information; and
    (2) An overview of which types of organizations or individuals are 
and are not likely to be HIPAA covered entities, the oversight 
responsibilities of OCR and FTC, and how to submit a complaint to--
    (i) The HHS Office for Civil Rights (OCR); and
    (ii) The Federal Trade Commission (FTC).
* * * * *

Elizabeth J. Gramling,
Executive Secretary to the Department, Department of Health and Human 
Services.
[FR Doc. 2024-24801 Filed 10-24-24; 8:45 am]
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