Rule2021-26764
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 10, 2021
Effective
December 10, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 235 (Friday, December 10, 2021)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> MA organizations (42 CFR 422.119(f)); or
<bullet> 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: <a href="https://www.cms.gov/about-cms/health-informatics-and-interoperability-group/faqs#122">https://www.cms.gov/about-cms/health-informatics-and-interoperability-group/faqs#122</a>.
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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
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