Federal Register Extracts

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

SUMMARY: This proposed rule would place new requirements on Medicare Advantage (MA) organizations, state Medicaid fee-for-service (FFS) programs, state Children's Health Insurance Program (CHIP) FFS programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs) to improve the electronic exchange of healthcare data and streamline processes related to prior authorization, while continuing CMS' drive toward interoperability in the healthcare market. This proposed rule would also add a new measure for eligible hospitals and critical access hospitals (CAHs) under the Medicare Promoting Interoperability Program and for Merit-based Incentive Payment System (MIPS) eligible clinicians under the Promoting Interoperability performance category of MIPS. These policies taken together would play a key role in reducing overall payer and provider burden and improving patient access to health information.

DATES:

To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on March 13, 2023.

ADDRESSES: In commenting, please refer to file code CMS-0057-P.

Comments, including mass comment submissions, must be submitted in one of the following three 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 regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-0057-P, P.O. Box 8013, Baltimore, MD 21244-8013.

Please allow sufficient time for mailed comments to be received before the close of the comment period.

3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-0057-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Alexandra Mugge, (410) 786-4457, for general questions related to any of the policies in this proposed rule, or questions related to CMS interoperability initiatives.

Lorraine Doo, (443) 615-1309, for issues related to the prior authorization process policies, or the Prior Authorization Requirements, Documentation, and Decision (PARDD) Application Programming Interface (API).

Shanna Hartman, (410) 786-0092, for issues related to the Payer-to-Payer API, the Electronic Prior Authorization measure for the MIPS Promoting Interoperability performance category and Medicare Promoting Interoperability Program, or any of the API standards and implementation guides (IGs) included in this proposed rule.

David Koppel, (303) 844-2883, for issues related to the Patient Access API policies, or patient privacy.

Scott Weinberg, (410) 786-6017, for issues related to the Provider Access API policies, or the Requests for Information.

Amy Gentile, (410) 786-3499, for issues related to Medicaid managed care.

Kirsten Jensen, (410) 786-8146, for issues related to Medicaid FFS.

Joshua Bougie, (410) 786-8117, for issues related to CHIP.

Natalie Albright, (410) 786-1671, for issues related to MA organizations.

Ariel Novick, (301) 492-4309, for issues related to QHPs.

Elizabeth Holland, (410) 786-1309, for issues related to MIPS and the Medicare Promoting Interoperability Program.

Russell Hendel, (410) 786-0329, for issues related to the Collection of Information and Regulatory Impact Analysis.

SUPPLEMENTARY INFORMATION:

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. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: https://www.regulations.gov. Follow the search instructions on that website to view public comments. CMS will not post on Regulations.gov public comments that make threats to individuals or institutions or suggest that the individual will take actions to harm the individual. CMS continues to encourage individuals not to submit duplicative comments. We will post acceptable comments from multiple unique commenters even if the content is identical or nearly identical to other comments.

Table of Contents

I. Background and Summary of Provisions

A. Purpose and Background

B. Summary of Major Proposals

II. Provisions of the Proposed Rule

A. Patient Access API

B. Provider Access API

C. Payer to Payer Data Exchange on FHIR

D. Improving Prior Authorization Processes

E. Electronic Prior Authorization for the Merit-Based Incentive Payment System (MIPS) Promoting Interoperability Performance Category and the Medicare Promoting Interoperability Program

F. Interoperability Standards for APIs

III. Requests for Information

A. Request for Information: Accelerating the Adoption of Standards Related to Social Risk Factor Data

B. Request for Information: Electronic Exchange of Behavioral Health Information

C. Request for Information: Improving the Electronic Exchange of Information in Medicare Fee-for-Service

D. Request for Information: Advancing Interoperability and Improving Prior Authorization Processes for Maternal Health

E. Request for Information: Advancing the Trusted Exchange Framework and Common Agreement (TEFCA)

IV. Collection of Information Requirements

V. Response to Comments

VI. Regulatory Impact Analysis

Regulations Text

I. Background and Summary of Provisions

A. Purpose and Background In the May 1, 2020, Federal Register, we published a final rule implementing the first phase of CMS interoperability rulemaking in the "Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability and Patient Access for MA Organization and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges, and Health Care Providers" final rule (85 FR 25510) (hereinafter referred to as the "CMS Interoperability and Patient Access final rule").

On December 18, 2020, we published a proposed rule (85 FR 82586) (hereinafter referred to as the "December 2020 CMS Interoperability proposed rule") in which we proposed new requirements for state Medicaid FFS programs, state CHIP FFS programs, Medicaid managed care plans, CHIP managed care entities, and QHP issuers on the FFEs to improve the electronic exchange of healthcare data and streamline processes related to prior authorization, while continuing CMS' drive toward interoperability and reducing burden in the healthcare market. In addition, on behalf of the Department of Health and Human Services (HHS), the Office of the National Coordinator for Health Information Technology (ONC) proposed the adoption of certain specified implementation guides (IGs) needed to support the proposed Application Programming Interface (API) policies in that proposed rule.

We received approximately 251 individual comments on the December 2020 CMS Interoperability proposed rule by the close of the comment period on January 4, 2021. While commenters largely supported the intent of the proposals and the proposals themselves, many noted and emphasized that MA organizations were not included among the impacted payers. The National Association of Medicaid Directors and state Medicaid programs expressed concerns about the implementation timeframes, states' constraints to secure the funding necessary to implement the requirements of the rule in a timely manner, and states' ability to recruit staff with necessary technical expertise. Commenters also raised concerns that the relatively short comment period inhibited more thorough analyses of the proposals and, for membership organizations, the ability to receive input from and gain consensus among their members. The December 2020 CMS Interoperability proposed rule will not be finalized; we considered whether to issue a final rule based on that proposed rule, but considering the concerns raised by the commenters, we have opted not to do so. Instead, we are withdrawing the December 2020 CMS Interoperability proposed rule and issuing this new proposed rule that incorporates the feedback we received from stakeholders on that proposed rule. This approach will allow us to incorporate the feedback we have already received and provide additional time for public comment.

Some of the changes we have incorporated in this proposed rule were influenced by the comments we received on the December 2020 CMS Interoperability proposed rule. For example, unlike in that proposed rule, we now propose to require impacted payers to use those health information technology (IT) standards at 45 CFR 170.215 that are applicable to each set of API requirements proposed in this rule, including the HL7 Fast Healthcare Interoperability Resources (FHIR) standard, the HL7 FHIR US Core Implementation Guide, and the HL7 SMART Application Launch Framework Implementation Guide. Also, in this proposed rule, we include MA organizations as impacted payers and propose that the policies included herein would have a longer implementation timeline.

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

Proposed rule.

CFR Part: "42 CFR Parts 422, 431, 435, 438, 440, and 457"; "45 CFR Part 156"

RIN Number: "RIN 0938-AU87"

Citation: "87 FR 76238"

Document Number: "CMS-0057-P"

Federal Register Page Number: "76238"

"Proposed Rules"