[Federal Register Volume 86, Number 235 (Friday, December 10, 2021)]
[Rules and Regulations]
[Pages 70412-70413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26764]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 422, 431, 435, 438, 440, and 457

[CMS-9115-N2]


Medicare and Medicaid Programs; Patient Protection and Affordable 
Care Act; Interoperability and Patient Access for Medicare Advantage 
Organizations 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

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

ACTION: Notification of enforcement discretion.

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SUMMARY: This notification is to inform the public that CMS is 
exercising its discretion in how it enforces the payer-to-payer data 
exchange provisions. As a matter of enforcement discretion, CMS does 
not expect to take action to enforce compliance with these specific 
provisions until we are able to address certain implementation 
challenges.

DATES: The notification of enforcement discretion is effective on 
December 10, 2021.

FOR FURTHER INFORMATION CONTACT: Alexandra Mugge, (410) 786-4457; or 
Lorraine Doo, (443) 615-1309.

SUPPLEMENTARY INFORMATION: On May 1, 2020, we published the CMS 
Interoperability and Patient Access final rule (85 FR 25510) to 
establish policies that advance interoperability and patient access to 
health information. The rule required Medicare Advantage (MA) 
organizations, Medicaid managed care plans, Children's Health Insurance 
Program (CHIP) managed care entities, and Qualified Health Plan (QHP) 
issuers on the Federally-facilitated Exchanges (FFEs) (collectively 
referred to as ``impacted payers''), to facilitate enhanced data 
sharing by exchanging data with other payers at the patient's request, 
starting January 1, 2022, for:
     MA organizations (42 CFR 422.119(f)); or
     Medicaid managed care plans (42 CFR 438.62(b)(1)(vi)); and 
CHIP managed care entities (42 CFR 457.1216).
    For plan or policy years beginning on or after January 1, 2022, for 
QHP issuers on the FFEs (45 CFR 156.221(f)), as applicable. We also 
required these impacted payers to incorporate and maintain the data 
they receive through this payer-to-payer data exchange into the 
enrollee's record, with the goal of increasing transparency for 
patients, promoting better coordinated care, reducing administrative 
burden, and enabling patients to establish a collective patient health 
care record as they move throughout the health care system (see 
applicable regulations at (Sec.  422.119(f) for MA organizations; Sec.  
438.62(b)(1)(vi) for Medicaid managed care plans (and by extension 
under existing rules at Sec.  457.1216, to CHIP managed care entities); 
and Sec.  156.221(f)(i) through (iii) for QHP issuers on the FFEs). 
These policies are collectively referred to as the payer-to-payer data 
exchange requirement.
    To provide payers with flexibility to support timely adoption and 
rapid implementation, CMS did not require an application programming 
interface (API) or any a specific mechanism for the payer-to-payer data 
exchange. Rather, we required impacted payers to receive data in 
whatever format it was sent and to send data in the form and format it 
was received, which ultimately complicated implementation by requiring 
payers to accept data in different formats.
    Since the rule was finalized in May 2020, multiple impacted payers 
have indicated to CMS that the absence of a required standard or 
specification for the payer-to-payer data exchange requirement is 
creating challenges for implementation and may lead to differences in 
implementation across industry, poor data quality, operational 
challenges, and increased administrative burden. For example, payers 
expressed concerns about receiving volumes of portable document format 
(pdf) documents and files from other payers using a variety of 
technical approaches--from file transfer protocols (FTP), to email, to 
Fast Healthcare Interoperability Resources (FHIR). Payers explained 
that differences in implementation approaches may create gaps in 
patient health information that conflict directly with the intended 
goal of an interoperable payer-to-payer data exchange.
    After listening to stakeholder concerns about implementing the 
payer-to-payer data exchange requirement and considering the potential 
for negative outcomes that impede, rather than support, interoperable 
payer-to-payer data exchange, CMS published three frequently asked 
questions (FAQs) on the CMS and HHS Good Guidance websites \1\ to 
announce that it would be exercising enforcement discretion for the 
payer-to-payer data exchange requirement. In one of the FAQs, CMS 
encouraged payers that have already developed FHIR-based application 
API

[[Page 70413]]

solutions to support the payer-to-payer data exchange to continue to 
move forward with implementation. The FAQ noted that for those impacted 
payers that are not capable of making the data available in a FHIR-
based format, we believed that this policy of exercising enforcement 
discretion would alleviate industry tension regarding implementation; 
avoid the risk of discordant, non-standard data flowing between payers; 
provide time for data standards to mature further; and allow payers 
additional time to implement the more sophisticated payer-to-payer data 
exchange solutions. We are now announcing that we expect to extend this 
exercise of enforcement discretion of the payer-to-payer data exchange 
requirement until we are able to address the identified implementation 
challenges through future rulemaking. We anticipate providing an update 
on any evaluation of this enforcement discretion notification and 
related actions during calendar year 2022. We continue to encourage 
impacted payers that have already developed FHIR-based API solutions to 
support payer-to-payer data exchange to continue to move forward with 
implementation and make this functionality available on January 1, 
2022, or for plan or policy years beginning on or after January 1, 
2022, in accordance with the CMS Interoperability and Patient Access 
final rule policies. However, for those impacted payers that are not 
capable of making the data available in a FHIR-based API format, we 
believe this exercise of enforcement discretion will alleviate issues 
regarding implementation; avoid the risk of discordant, non-standard 
data flowing between payers; provide time for data standards to further 
mature through constant development, testing, and reference 
implementations; and allow payers additional time to implement more 
sophisticated payer-to-payer data exchange solutions.
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    \1\ Link to CMS website with FAQs for interoperability rule, and 
enforcement discretion: https://www.cms.gov/about-cms/health-informatics-and-interoperability-group/faqs#122.
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    While the policy in this notification may result in temporary delay 
of some enrollees' ability to bring their data with them from one payer 
to the next, we believe this decision could ultimately lead to more 
standardization and cohesion of data about enrollees as CMS provides 
additional implementation guidance through future rulemaking.
    Finally, our decision to exercise enforcement discretion for the 
payer-to-payer policy until future rulemaking is finalized does not 
affect any other existing regulatory requirements and implementation 
timelines finalized in the CMS Interoperability and Patient Access rule 
finalized on May 1, 2020.
    Chiquita Brooks-LaSure, Administrator of the Centers for Medicare & 
Medicaid Services, approved this document on October 15, 2021.

    Dated: December 7, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-26764 Filed 12-8-21; 11:15 am]
BILLING CODE 4120-01-P