21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking, 54662-54718 [2024-13793]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• Office of the Secretary

[Federal Register Volume 89, Number 126 (Monday, July 1, 2024)]
[Rules and Regulations]
[Pages 54662-54718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13793]



[[Page 54661]]

Vol. 89

Monday,

No. 126

July 1, 2024

Part II





Department of Health and Human Services





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Centers for Medicare and Medicaid Services





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42 CFR Part 414, et al.

45 CFR Part 171





21st Century Cures Act: Establishment of Disincentives for Health Care 
Providers That Have Committed Information Blocking; Final Rule

Federal Register / Vol. 89 , No. 126 / Monday, July 1, 2024 / Rules 
and Regulations

[[Page 54662]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 414, 425, and 495

Office of the Secretary

45 CFR Part 171

RIN 0955-AA05


21st Century Cures Act: Establishment of Disincentives for Health 
Care Providers That Have Committed Information Blocking

AGENCY: Centers for Medicare & Medicaid Services (CMS) and Office of 
the National Coordinator for Health Information Technology (ONC), 
Department of Health and Human Services (HHS).

ACTION: Final rule.

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SUMMARY: This final rule implements the provision of the 21st Century 
Cures Act specifying that a health care provider determined by the HHS 
Inspector General to have committed information blocking shall be 
referred to the appropriate agency to be subject to appropriate 
disincentives set forth through notice and comment rulemaking. This 
rulemaking establishes, for certain health care providers, a set of 
appropriate disincentives using authorities under applicable Federal 
law.

DATES: This rule is effective as of July 31, 2024.

FOR FURTHER INFORMATION CONTACT: 
    Alexander Baker, Office of Policy, Office of the National 
Coordinator for Health Information Technology (ONC), (202) 690-7151, 
for general issues.
    Elizabeth Holland, Centers for Medicare & Medicaid Services (CMS), 
(443) 934-2532, for issues related to the Promoting Interoperability 
Program and the Promoting Interoperability performance category of the 
Merit-Based Incentive Payment System.
    Aryanna Abouzari, Centers for Medicare & Medicaid Services (CMS), 
(415) 744-3668 or [email protected], for issues related 
to the Medicare Shared Savings Program.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary
    A. Purpose of Regulatory Action
    B. Summary of Major Provisions
    C. Costs and Benefits
    D. Severability
II. Background
    A. Statutory Basis
    B. Regulatory History
    1. ONC Cures Act Final Rule
    2. Office of Inspector General (OIG) Civil Money Penalties (CMP) 
Final Rule
    3. Establishment of Disincentives for Health Care Providers That 
Have Committed Information Blocking Proposed Rule
    C. General Comments on the Disincentives Proposed Rule
III. Provisions of the Regulation and Anticipated Approach to 
Investigations and Referrals
    A. Relevant Statutory Terms and Provisions
    1. Appropriate Agency
    2. Authorities Under Applicable Federal Law
    3. Appropriate Disincentives
    B. Approach to Determination of Information Blocking and 
Application of Disincentives
    1. OIG Investigation and Referral
    2. General Provisions for Application of Disincentives
    3. Transparency for Information Blocking Determinations, 
Disincentives, and Penalties
    C. Appropriate Disincentives for Health Care Providers
    1. Background
    2. Medicare Promoting Interoperability Program for Eligible 
Hospitals and Critical Access Hospitals (CAHs)
    3. Promoting Interoperability Performance Category of the 
Medicare Merit-Based Incentive Payment System (MIPS)
    4. Medicare Shared Savings Program
IV. Request for Information
V. Collection of Information Requirements
VI. Regulatory Impact Statement
    A. Executive Order 12866
    B. Regulatory Flexibility Act
    C. Unfunded Mandates Reform Act
    D. Executive Order 13132

I. Executive Summary

A. Purpose of Regulatory Action

    This final rule implements the 21st Century Cures Act (Cures Act) 
provision for referral of a health care provider (individual or 
entity), determined by the HHS Office of Inspector General (OIG) to 
have committed information blocking, ``to the appropriate agency to be 
subject to appropriate disincentives using authorities under applicable 
Federal law, as the Secretary sets forth through notice and comment 
rulemaking'' (section 3022(b)(2)(B) of the Public Health Service Act 
(PHSA) (42 U.S.C. 300jj-52(b)(2)(B)), as added by section 4004 of the 
Cures Act (Pub. L. 114-255, Dec. 13, 2016)). This final rule 
establishes disincentives for certain health care providers (as defined 
in 45 CFR 171.102) that are also Medicare-enrolled providers or 
suppliers.

B. Summary of Major Provisions

    This final rule establishes disincentives applicable to certain 
health care providers (as defined in 45 CFR 171.102), determined by OIG 
to have committed information blocking (as defined in 45 CFR 171.103), 
that also are Medicare-enrolled providers or suppliers. This final rule 
also provides information related to OIG's investigation of claims of 
information blocking and referral of a health care provider to an 
appropriate agency to be subject to appropriate disincentives. Finally, 
this final rule establishes a process by which information will be 
shared with the public about health care providers and other actors 
(health IT developers or other entities offering certified health IT, 
health information exchanges, and health information networks) that OIG 
determines have committed information blocking.
    Although this final rule does not establish disincentives for all 
of the health care providers included in the 45 CFR 171.102 definition, 
the health care providers to whom the disincentives finalized in this 
rule apply furnish a broad array of services to a significant number of 
both Medicare beneficiaries and other patients. Thus, this set of 
disincentives directly advances HHS priorities for deterring 
information blocking, while also advancing appropriate sharing of 
electronic health information (EHI) by health care providers \1\ to 
support safer, more coordinated care for all patients.
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    \1\ Except if noted in reference a particular statutory 
authority or CFR section, we use in this rule ``health care 
provider,'' ``provider,'' and ``provider type'' as inclusive of 
individuals and entities that may be characterized for purposes of 
Medicare enrollment or particular reimbursement policies as 
providers or suppliers--or both across different contexts such as 
specific services furnished in particular settings.
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    We believe it is important to establish appropriate disincentives 
that account for all health care providers that fall within the 
definition of health care provider at 45 CFR 171.102. While effective 
deterrence of information blocking can benefit patients by reducing the 
degree to which health care providers engage in this practice, fewer 
patients will benefit from these deterrent effects if disincentives 
have not been established for all health care providers within the 
definition of health care provider at 45 CFR 171.102. In section IV of 
the 21st Century Cures Act: Establishment of Disincentives for Health 
Care Providers That Have Committed Information Blocking proposed rule 
(Disincentives Proposed Rule), we requested information on how we could 
establish disincentives for other health care providers, particularly 
those health care providers not implicated under the CMS authorities

[[Page 54663]]

we proposed to use to establish disincentives in the proposed rule (88 
FR 74966 and 74967).
    Consistent with PHSA section 3022(b)(2)(B), in section III.C. of 
this final rule, CMS has finalized the following disincentives using 
authorities under applicable Federal law, as follows:
     Under the authority for the Medicare Promoting 
Interoperability Program in the Social Security Act (SSA), at sections 
1886(b)(3)(B)(ix) and 1886(n) for eligible hospitals, and at section 
1814(l)(4) for critical access hospitals (CAHs), CMS has finalized that 
an eligible hospital or CAH is not a meaningful electronic health 
record (EHR) user in an EHR reporting period if OIG refers, during the 
calendar year of the reporting period, a determination that the 
eligible hospital or CAH committed information blocking as defined at 
45 CFR 171.103. As a result, an eligible hospital subject to this 
disincentive will not be able to earn the three quarters of the annual 
market basket increase associated with qualifying as a meaningful EHR 
user, and a CAH subject to this disincentive will have its payment 
reduced to 100 percent of reasonable costs, from the 101 percent of 
reasonable costs it might have otherwise earned, in an applicable year.
     Under the authority in SSA sections 1848(o)(2)(A) and (D) 
and 1848(q)(2)(A)(iv) and (B)(iv), for the Promoting Interoperability 
performance category of the Merit-based Incentive Payment System 
(MIPS), CMS has finalized that a health care provider defined in 45 CFR 
171.102 that is a MIPS eligible clinician (as defined in 42 CFR 
414.1305 and including groups) is not a meaningful EHR user in a 
performance period if OIG refers, during the calendar year of the 
reporting period, a determination that the MIPS eligible clinician 
committed information blocking as defined at 45 CFR 171.103. CMS also 
has finalized that the determination by OIG that a MIPS eligible 
clinician committed information blocking will result in the MIPS 
eligible clinician, if required to report on the Promoting 
Interoperability performance category of MIPS, not earning a score in 
the performance category (a zero score), which is typically a quarter 
of the total final composite performance score (a ``final score'' as 
defined at 42 CFR 414.1305). CMS has codified this proposal under the 
definition of meaningful EHR user for MIPS at 42 CFR 414.1305 and added 
it to the requirements for earning a score for the MIPS Promoting 
Interoperability performance category at 42 CFR 414.1375(b).
     Under the authority in SSA section 1899(b)(2)(G) for the 
Medicare Shared Savings Program (Shared Savings Program), CMS has 
finalized that a health care provider as defined in 45 CFR 171.102 that 
is an accountable care organization (ACO), ACO participant, or ACO 
provider/supplier, if determined by OIG to have committed information 
blocking as defined at 45 CFR 171.103, may be barred from participating 
in the Shared Savings Program for at least 1 year (88 FR 74964 and 
74965). In this final rule, in consideration of the comments received, 
CMS has finalized incorporation of an alternative policy discussed in 
the proposed rule, under which CMS will consider an OIG information 
blocking determination in light of relevant facts and circumstances 
before applying a disincentive under the Shared Savings Program, such 
as denying the addition of an ACO participant to an ACO participant 
list (or an ACO provider/supplier to the ACO provider/supplier list), 
informing an ACO that remedial action should be taken against the ACO 
participant (or ACO provider/supplier), denying an ACO's application to 
participate in the Shared Savings Program if the remedial action is not 
taken, or terminating an ACO's participation agreement with CMS. This 
will result in a health care provider being removed from an ACO or 
prevented from joining an ACO; and in the instance where a health care 
provider is an ACO, this will prevent the ACO's participation in the 
Shared Savings Program. The relevant facts and circumstances include 
the nature of the health care provider's information blocking, the 
health care provider's diligence in identifying and correcting the 
problem, the time since the information blocking occurred, whether the 
provider was previously subject to a disincentive in another program, 
and other factors.

C. Costs and Benefits

    Executive Order 12866 on Regulatory Planning and Review and 
Executive Order 13563 on Improving Regulation and Regulatory Review 
direct agencies to assess all costs and benefits of available 
regulatory alternatives and, if regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety effects, distributive 
impacts, and equity). Section 3(f) of Executive Order 12866, as amended 
by Executive Order 14094, defines a ``significant regulatory action'' 
as an action that is likely to result in a rule that may: (1) have an 
annual effect on the economy of $200 million or more (adjusted every 3 
years by the Administrator of the Office of Information and Regulatory 
Affairs (OIRA) for changes in gross domestic product), or adversely 
affect in a material way the economy, a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local, territorial, or tribal governments or 
communities; (2) create a serious inconsistency or otherwise interfere 
with an action taken or planned by another agency; (3) materially alter 
the budgetary impact of entitlements, grants, user fees, or loan 
programs or the rights and obligations of recipients thereof; or (4) 
raise legal or policy issues for which centralized review would 
meaningfully further the President's priorities or the principles set 
forth in the Executive Order, as specifically authorized in a timely 
manner by the Administrator of OIRA in each case. The Office of 
Management and Budget (OMB) has determined that this final rule is not 
a significant regulatory action, as the potential costs associated with 
this final rule would not be greater than $200 million per year, and it 
does not meet any of the other requirements to be a significant 
regulatory action.

D. Severability

    We are clarifying and emphasizing our intent that if any provision 
of this final rule is held to be invalid or unenforceable by its terms, 
or as applied to any person or circumstance, or stayed pending further 
action, it shall be severable from this final rule, and from rules and 
regulations currently in effect, and not affect the remainder thereof 
or the application of the provision to other persons not similarly 
situated or to other, dissimilar circumstances. If any provision is 
held to be invalid or unenforceable, the remaining provisions which 
could function independently, should take effect and be given the 
maximum effect permitted by law.
    Through this rule, we adopt provisions that are intended to and 
will operate independently of each other, even if each serves the same 
general purpose or policy goal. Where a provision is necessarily 
dependent on another, the context generally makes that clear (such as 
by cross-reference to a particular standard, requirement, condition, or 
pre-requisite). Where a provision that is dependent on one that is 
stayed or held invalid or unenforceable, as described in the preceding 
paragraph, is included in a subparagraph, paragraph, or section within 
part 171 of 45 CFR or part 414, 425, or 495 of 42 CFR, we intend that

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other provisions of such subparagraph(s), paragraph(s), or section(s) 
that operate independently of the provision stayed or held invalid or 
unenforceable would remain in effect.

II. Background

A. Statutory Basis

    The Cures Act was enacted on December 13, 2016, ``[t]o accelerate 
the discovery, development, and delivery of 21st century cures, and for 
other purposes'' (Pub. L. 114-255, December 16, 2016). Section 4004 of 
the Cures Act added section 3022 to the PHSA. Section 3022(a)(1) of the 
PHSA defines information blocking as a practice that, except as 
required by law or specified by the Secretary pursuant to rulemaking, 
is likely to interfere with, prevent, or materially discourage access, 
exchange, or use of electronic health information, and: (1) if the 
practice is conducted by a health information technology developer, 
exchange, or network, such developer, exchange, or network knows, or 
should know, that such practice is likely to interfere with, prevent, 
or materially discourage the access, exchange, or use of electronic 
health information; or (2) if the practice is conducted by a health 
care provider, such health care provider knows that such practice is 
unreasonable and is likely to interfere with, prevent, or materially 
discourage access, exchange, or use of electronic health information. 
Section 3022(a)(3) of the PHSA further provides that the Secretary 
shall, through rulemaking, identify reasonable and necessary activities 
that do not constitute information blocking. Section 3022(a)(4) of the 
PHSA states that the term ``information blocking'' does not include any 
practice or conduct occurring prior to the date that is 30 days after 
December 13, 2016 (the date of the enactment of the Cures Act).\2\ 
Section 3022(a)(2) of the PHSA describes certain practices that may 
constitute information blocking.
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    \2\ As January 12, 2017, was the thirtieth day after December 
13, 2016, conduct occurring on or after January 13, 2017, that 
otherwise meets the PHSA section 3022(a) definition of ``information 
blocking,'' would be included in that definition.
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    Section 3022(b)(1) of the PHSA authorizes OIG to investigate 
information blocking claims. Section 3022(b)(1)(B) of the PHSA 
authorizes OIG to investigate claims that ``a health care provider 
engaged in information blocking.'' Section 3022(b)(2)(B) of the PHSA 
provides that any health care provider OIG determines to have committed 
information blocking shall be referred to the appropriate agency to be 
subject to appropriate disincentives using authorities under applicable 
Federal law, as the Secretary sets forth through notice and comment 
rulemaking. Sections 3022(b)(1)(A) and (C) of the PHSA authorize OIG to 
investigate health information technology (IT) developers of certified 
health IT or other entities offering certified health IT, health 
information exchanges, and health information networks. Section 
3022(b)(2)(A) of the PHSA authorizes the imposition of civil money 
penalties (CMPs) \3\ not to exceed $1 million per violation on those 
individuals and entities set forth in sections 3022(b)(1)(A) and (C) of 
the PHSA.
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    \3\ We use the term ``civil money penalty'' here, rather than 
``civil monetary penalty'' as used in PHSA section 3022(b)(2)(A) for 
consistency with OIG's usage in the OIG CMP Final Rule (88 FR 
42820).
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    PHSA section 3022 also authorizes ONC, the HHS Office for Civil 
Rights (OCR), and OIG to consult, refer, and coordinate to resolve 
claims of information blocking. PHSA section 3022(b)(3)(A) authorizes 
OIG to refer claims of information blocking to OCR if OIG determines a 
consultation regarding the health privacy and security rules 
promulgated under section 264(c) of the Health Insurance Portability 
and Accountability Act of 1996 (HIPAA) (Pub. L. 104-191, Aug. 21, 1996) 
(42 U.S.C. 1320d-2 note) will resolve such claims. PHSA section 
3022(d)(1) specifies that the National Coordinator may serve as a 
technical consultant to OIG and the Federal Trade Commission (FTC) for 
purposes of carrying out section 3022 and may share information related 
to claims or investigations of information blocking with the FTC for 
purposes of such investigations, in addition to requiring the National 
Coordinator to share information with OIG, as required by law.
    PHSA section 3022(d)(4) requires the Secretary, in carrying out 
section 3022 and to the extent possible, to ensure that information 
blocking penalties do not duplicate penalty structures that would 
otherwise apply with respect to information blocking and the type of 
individual or entity involved as of the day before the date of 
enactment of the Cures Act. Section 3022(a)(7) of the PHSA states that, 
in carrying out section 3022, the Secretary shall ensure that health 
care providers are not penalized for the failure of developers of 
health information technology or other entities offering health 
information technology to such providers to ensure that such technology 
meets the requirements to be certified under Title XXX of the PHSA.
    We address the statutory basis for each disincentive in greater 
detail in section III.C. of this final rule.

B. Regulatory History

1. ONC Cures Act Final Rule
    On March 4, 2019, a proposed rule titled 21st Century Cures Act: 
Interoperability, Information Blocking, and the ONC Health IT 
Certification Program (ONC Cures Act Proposed Rule) appeared in the 
Federal Register (84 FR 7424). The rule proposed to implement certain 
provisions of the Cures Act to advance interoperability and support the 
access, exchange, and use of electronic health information. The ONC 
Cures Act Proposed Rule included a request for information regarding 
potential disincentives for health care providers that have committed 
information blocking and asked whether modifying disincentives already 
available under existing Department programs and regulations would 
provide for more effective deterrence (84 FR 7553).
    On May 1, 2020, a final rule titled 21st Century Cures Act: 
Interoperability, Information Blocking, and the ONC Health IT 
Certification Program (ONC Cures Act Final Rule) appeared in the 
Federal Register (85 FR 25642). The final rule identified eight 
reasonable and necessary activities that do not constitute information 
blocking, consistent with the requirement in PHSA section 3022(a)(3). 
Such reasonable and necessary activities are often referred to as 
``exceptions'' to the definition of information blocking, or 
``information blocking exceptions,'' as specified in 45 CFR part 171.
    The ONC Cures Act Final Rule finalized definitions that are 
necessary to implement the statutory information blocking provision in 
PHSA section 3022, including definitions related to the four classes of 
individuals and entities covered by the statutory information blocking 
provision: health care providers, health IT developers, health IT 
networks, and health IT exchanges.
    As the term ``health care provider'' is not explicitly defined in 
section 3022 of the PHSA, as added by section 4004 of the Cures Act, 
the ONC Cures Act Final Rule adopted in 45 CFR 171.102 the definition 
of health care provider in section 3000(3) of the PHSA \4\ for

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purposes of the information blocking regulations in 45 CFR part 171. 
The definitions listed in section 3000 of the PHSA apply ``[i]n this 
title,'' which refers to Title XXX of the PHSA (85 FR 25795). Section 
3022 of the PHSA is included in Title XXX.
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    \4\ As defined in 42 U.S.C. 300-jj, the term ``health care 
provider'' includes a hospital, skilled nursing facility, nursing 
facility, home health entity or other long term care facility, 
health care clinic, community mental health center (as defined in 
section 300x-2(b)(1) of this title), renal dialysis facility, blood 
center, ambulatory surgical center described in section 1395l(i) of 
this title, emergency medical services provider, Federally qualified 
health center, group practice, a pharmacist, a pharmacy, a 
laboratory, a physician (as defined in section 1395x(r) of the 
title), a practitioner (as described in section 1395u(b)(18)(C) of 
the title), a provider operated by, or under contract with, the 
Indian Health Service or by an Indian tribe (as defined in the 
Indian Self-Determination and Education Assistance Act [25 U.S.C. 
5301 et seq.]), tribal organization, or urban Indian organization 
(as defined in section 1603 of title 5), a rural health clinic, a 
covered entity under section 256b of this title, an ambulatory 
surgical center described in section 1395l(i) of this title, a 
therapist (as defined in section 1395w-4(k)(3)(B)(iii) of the 
title), and any other category of health care facility, entity, 
practitioner, or clinician determined appropriate by the Secretary. 
See also this guidance document: https://www.healthit.gov/sites/default/files/page2/2020-08/Health_Care_Provider_Definitions_v3.pdf.
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    The ONC Cures Act Final Rule also established in 45 CFR 171.102 
regulatory definitions for ``health information network or health 
information exchange'' and ``health IT developer of certified health 
IT,'' \5\ among other terms.\6\ The preamble text of the ONC Cures Act 
Final Rule makes clear that an individual or entity could meet both the 
definition of a health care provider and the definition of a health IT 
developer of certified health IT (85 FR 25798 and 25799), or could meet 
both the definition of a health care provider and a health information 
exchange or network (85 FR 25801). We mention these potential scenarios 
so that health care providers are aware that they would not necessarily 
only be subject to the disincentives finalized in this rule, but 
depending on the specific facts and circumstances, they could meet the 
definition of a health information network, health information 
exchange, or health IT developer of certified health IT--and therefore 
be subject to civil money penalties, if found by OIG to have committed 
information blocking.
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    \5\ In the ONC Cures Act Final Rule, ONC defined the term 
``health IT developer of certified health IT'' in 45 CFR 171.102, 
instead of using the term that appears in PHSA 3022(a)(1): ``health 
IT developer.'' ONC explained that, because title XXX of the PHSA 
does not define ``health information technology developer,'' ONC 
interpreted section 3022(a)(1)(B) in light of the specific authority 
provided to OIG in section 3022(b)(1)(A) and (b)(2). ONC noted that 
section 3022(b)(2) discusses developers, networks, and exchanges by 
referencing any individual or entity described in section 
3022(b)(1)(A) or (C). Section 3022(b)(1)(A) states, in relevant 
part, that OIG may investigate any claim that a health information 
technology developer of certified health information technology or 
other entity offering certified health information technology 
engaged in information blocking (85 FR 25795, emphasis added).
    \6\ In January 2024, ONC finalized a definition of what it means 
to ``offer health IT,'' and finalized a corresponding update to the 
``health IT developer of certified health IT'' definition. These 
policies are part of a final rule titled Health Data, Technology, 
and Interoperability: Certification Program Updates, Algorithm 
Transparency, and Information Sharing (89 FR 1354 through 1358) 
(HTI-1 Final Rule).
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    On November 4, 2020, an interim final rule with comment period 
titled Information Blocking and the ONC Health IT Certification 
Program: Extension of Compliance Dates and Timeframes in Response to 
the COVID-19 Public Health Emergency (ONC Cures Act Interim Final Rule) 
appeared in the Federal Register (85 FR 70064). The ONC Cures Act 
Interim Final Rule extended certain compliance dates and timeframes 
adopted in the ONC Cures Act Final Rule to offer the healthcare system 
additional flexibilities in furnishing services to combat the COVID-19 
pandemic, including extending the applicability date for the 
information blocking provisions to April 5, 2021 (85 FR 70068). The ONC 
Cures Act Interim Final Rule also extended from May 2, 2022, to October 
6, 2022, the date on which electronic health information as defined in 
45 CFR 171.102 for purposes of the information blocking definition in 
45 CFR 171.103 would no longer be limited to the subset of EHI that is 
identified by data elements represented in the United States Core Data 
for Interoperability (USCDI) standard adopted in 45 CFR 170.213 (85 FR 
70069).\7\ On and after October 6, 2022, practices likely to interfere 
with access, exchange, or use of any information falling within the 
definition of EHI in 45 CFR 171.102 may constitute information blocking 
as defined in 45 CFR 171.103.
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    \7\ For more information about the USCDI, see: https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi.
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2. Office of Inspector General (OIG) Civil Money Penalties (CMP) Final 
Rule
    On April 24, 2020, a proposed rule titled Grants, Contracts, and 
Other Agreements: Fraud and Abuse; Information Blocking; Revisions to 
the Office of Inspector General's Civil Money Penalty Rules (OIG CMP 
Proposed Rule) appeared in the Federal Register (85 FR 22979). The OIG 
CMP Proposed Rule set forth proposed regulations to incorporate new CMP 
authority for information blocking and related procedures in PHSA 
section 3022 (85 FR 22982). Specific to information blocking, OIG also 
provided information on--but did not propose regulations for--expected 
enforcement priorities, the investigation process, and OIG's experience 
with investigating conduct that includes an intent element (85 FR 
22984).
    A final rule titled Grants, Contracts, and Other Agreements: Fraud 
and Abuse; Information Blocking; Office of Inspector General's Civil 
Money Penalty Rules appeared in the Federal Register on July 3, 2023 
(OIG CMP Final Rule) (88 FR 42820). This rulemaking addressed 
imposition of CMPs for information blocking by health IT developers or 
other entities offering certified health IT, and health information 
exchanges and health information networks (HIEs/HINs). The OIG CMP 
Final Rule did not establish appropriate disincentives for health care 
providers that OIG has determined to have committed information 
blocking.
    In the OIG CMP Final Rule, OIG stated that a health care provider 
that also meets the definition of a health IT developer of certified 
health IT, or HIE/HIN, or both, under 45 CFR 171.102, may be subject to 
information blocking CMPs (88 FR 42829). OIG further stated that as 
part of its assessment of whether a health care provider is a HIN/HIE 
that could be subject to CMPs for information blocking, OIG anticipates 
engaging with the health care provider to better understand its 
functions and to offer the health care provider an opportunity to 
explain why it is not a HIN/HIE (88 FR 42828).
3. Establishment of Disincentives for Health Care Providers That Have 
Committed Information Blocking Proposed Rule
    On November 1, 2023, a proposed rule titled 21st Century Cures Act: 
Establishment of Disincentives for Health Care Providers That Have 
Committed Information Blocking appeared in the Federal Register (88 FR 
74947) (Disincentives Proposed Rule). The Disincentives Proposed Rule 
proposed to establish a set of appropriate disincentives for 
information blocking by health care providers using authorities under 
applicable Federal law, consistent with PHSA section 3022(b)(2)(B). The 
Disincentives Proposed Rule also proposed to define certain statutory 
terms and proposed to establish elements of a process for the 
imposition of appropriate disincentives by an appropriate agency. The 
Disincentives Proposed Rule further proposed to publicly post 
information on ONC's website about health care providers that have been 
determined by OIG to have committed information blocking and 
subsequently referred by OIG to an appropriate agency to be subject to 
appropriate disincentives, as well about health IT developers of 
certified health

[[Page 54666]]

IT and HIEs/HINs and that have been determined by OIG to have committed 
information blocking. Finally, the Disincentives Proposed Rule 
requested public comment on establishing disincentives for other health 
care providers included in the definition of health care provider in 45 
CFR 171.102 that are subject to the information blocking regulations, 
but were not implicated by the disincentives proposed in the 
Disincentives Proposed Rule.

C. General Comments on the Disincentives Proposed Rule

    We received a number of general comments on the Disincentives 
Proposed Rule. A discussion of those comments and responses can be 
found below.
    Comments. Several commenters expressed general support for the 
proposed disincentives for health care providers who have been found to 
have committed information blocking. A few commenters stated that the 
disincentives will lead to better patient outcomes, improved 
information sharing, increased transparency, a reduction in systemic 
inefficiency and waste, and improved accountability and compliance. A 
few commenters expressed general support for the establishment of the 
disincentives proposed because the disincentives are necessary and 
appropriate and would discourage information blocking by health care 
providers. Commenters also asserted that the proposed disincentives 
would encourage data exchange and enhance interoperability.
    Response. We thank the commenters for their support.
    Comments. Many commenters recommended that HHS delay implementation 
or enforcement of information blocking disincentives against health 
care providers. Commenters recommended this delay in order for HHS to 
provide education regarding issues such as: what constitutes 
information blocking; the investigation process; the application of 
disincentives; and information about exceptions. Commenters stated that 
a delay was warranted because the information blocking regulations, 
including the disincentives discussed in this final rule, are new and 
complicated, requirements change frequently, and health care providers 
need time to implement information sharing processes and identify best 
practices. Commenter recommendations for how long to delay enforcement 
following the publication of the final rule ranged from 1 to 2 years.
    Response. We disagree with commenters that further delay in 
establishing disincentives for health care providers that commit 
information blocking is necessary. We note that the information 
blocking regulations in the ONC Cures Act Final Rule went into effect 
April 5, 2021 (85 FR 70068), and several years will have already passed 
between the date when these regulations went into effect for health 
care providers and the effective date of this final rule. In addition, 
the disincentives CMS has finalized in this final rule are established 
under authorities for existing programs with which health care 
providers are already familiar. Thus, we do not believe it is necessary 
to further delay establishment of disincentives. We refer readers to 
section III.C. of this final rule, in which CMS describes how each of 
the disincentives it has finalized will be effective upon the effective 
date of this final rule.
    We also note that section III.B.1. of this final rule states that 
OIG will not begin investigating possible information blocking 
committed by health care providers until after the effective date of 
this rule, and that OIG will exercise its enforcement discretion not to 
make any determinations regarding conduct occurring prior to the 
effective date of this rule for information blocking disincentives. As 
OIG will not make a determination on conduct occurring prior to the 
effective date, OIG will not refer any health care providers based on a 
determination of conduct occurring prior to the effective date of this 
rule for information blocking disincentives. This means that no 
disincentives finalized in this final rule will be applied to conduct 
occurring before the effective date of this final rule.
    We appreciate the recommendations regarding offering educational 
opportunities that would be helpful to health care providers and will 
consider these recommendations.
    Comments. A few commenters requested that HHS set a maximum period 
from the date the alleged information blocking complaint was referred, 
after which HHS would not impose any disincentives, such as a 6-year 
period to align with the time period for imposing CMPs for other 
actors. Some commenters expressed concern that the proposed process for 
investigating claims of information blocking and referring findings to 
appropriate agencies for disincentives could cause a long delay between 
the information blocking complaint being filed and the application of a 
disincentive.
    Response. For the disincentives finalized in section III.C. of this 
final rule, CMS did not propose and has not finalized a maximum period 
from the date the alleged information blocking complaint was referred, 
after which CMS would not impose the disincentives it has finalized. 
Because the authorities used to establish disincentives may include 
requirements related to timing around the imposition of disincentives, 
we believe it is more appropriate to allow appropriate agencies to 
establish any such limits instead of setting a uniform limit for any 
disincentive established to deter information blocking by health care 
providers. We note that for the disincentive policy finalized under the 
Shared Savings Program in section III.C.4., CMS will consider relevant 
facts and circumstances before imposing a disincentive under the Shared 
Savings Program, and CMS has stated that one of the relevant factors 
CMS will consider is the time elapsed since a referral of information 
blocking has taken place. For the disincentives finalized for the 
Medicare Promoting Interoperability Program and the MIPS Promoting 
Interoperability performance category in sections III.C.2. and 
III.C.3., respectively, CMS has stated that it will impose the 
applicable disincentive in the EHR reporting period or performance 
period of the calendar year that a referral of a determination of 
information blocking is received from OIG. We further recognize that 
there may be a delay between the initial submission of an information 
blocking claim and the eventual application of a disincentive if OIG 
determines that the practices identified in the claim were information 
blocking and refers the determination to an appropriate agency. 
However, we are unable to estimate the time necessary to complete 
investigations of these practices.
    As commenters mentioned, section 3022(b)(2)(C) of the PHSA, which 
applies to actors subject to the information blocking regulations that 
are not health care providers (health IT developers or other entities 
offering certified health IT, and HINs/HIEs), requires the imposition 
of CMPs to follow the procedures set forth in section 1128A of the 
Social Security Act (SSA). Section 1128A(c)(1) requires that an action 
for CMPs must be initiated within 6 years from the date of the 
occurrence. In the OIG CMP Final Rule, OIG stated that this would be 6 
years from the date of the violation (88 FR 42826).
    Comments. A few commenters recommended the creation of a 
centralized HHS coordinating entity to

[[Page 54667]]

implement and oversee information blocking disincentives, provide a 
main point of contact for health care providers to learn about the 
process and resolve discrepancies, ensure coordination among agencies, 
and minimize confusion and potential errors that could cause burden for 
providers. One commenter stated that supplemental rulemaking would be 
needed to create this centralized HHS coordinating entity and that HHS 
should engage in this supplemental rulemaking before finalizing the 
Disincentives Proposed Rule. A few commenters specifically suggested 
the creation of a clearinghouse process to ensure disincentives applied 
are not duplicative, arbitrary, and unduly punitive.
    Response. We appreciate this recommendation. While we did not 
propose to create an entity as recommended by the commenters, we may 
consider this recommendation in future rulemaking. However, we do not 
believe that establishing such an entity is necessary to finalize the 
policies in this final rule, as many of these issues are addressed 
through existing policies. For instance, regarding coordination between 
agencies, we refer readers to the discussion in section III.B.1.b. of 
this final rule where we discuss the ways ONC, OCR, and OIG will 
consult, refer, and coordinate on information blocking claims as 
permitted by the Cures Act (see also, 88 FR 42823 and 42824). We also 
refer readers to the information provided about OIG's investigation 
process in section III.B.1. of this final rule, which includes a 
discussion of how OIG may engage with health care providers as part of 
its investigation, as necessary, to understand specific facts and 
circumstances related to an information blocking claim. The commenters 
did not provide further information about how such an entity would 
address issues related to ensuring disincentives are not duplicative, 
arbitrary, and unduly punitive.
    Comments. A few commenters recommended that ONC allow for 
`complaint clearinghouses,' where health care providers or payers can 
send their complaints alleging information blocking violations to an 
independent, private sector third party who would aggregate those 
complaints over time and submit them as a group to HHS to ensure 
complaints are unattributed to specific complainants. Commenters 
suggested this approach could mitigate concerns over retaliation, 
retribution, or harm to business relationships associated with alleging 
information blocking violations. A few commenters also recommended ONC, 
OIG, and CMS be more transparent in providing specifics to the public 
on how complaints will be handled to ensure interested parties have 
transparency in knowing the status of their complaints, and when a 
final decision can be expected.
    Response. We thank commenters for their suggestions. As authorized 
under PHSA section 3022(d)(3)(A), ONC has already established a ``a 
standardized process for the public to submit reports on claims'' 
related to information blocking. We refer readers to the discussion of 
the complaint process in the ONC Cures Act Final Rule (85 FR 25899 and 
25900), as well as the Information Blocking Portal on ONC's website for 
more information.\8\ Regarding commenters' concerns around harm 
resulting from attribution of complaints to specific organizations, we 
note that PHSA section 3022(d)(2) prohibits the National Coordinator 
from disclosing ``[a]ny information that is received by the National 
Coordinator in connection with a claim or suggestion of possible 
information blocking and that could reasonably be expected to 
facilitate identification of the source of the information'' except as 
may be necessary to carry out the purpose of PHSA section 3022 (PHSA 
section 3022(d)(2)(A)). As stated in the ONC Cures Act Final Rule, we 
believe the publishing of complaints could lead to the identification 
of the source of the information or reasonably facilitate 
identification of the source; therefore, we do not intend to make 
complaints publicly available (85 FR 25900). While the complaint 
process is not required by statute to be established through 
rulemaking, we will take commenters' input into consideration as we 
continue to receive complaints related to information blocking.
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    \8\ For more information, see: https://inquiry.healthit.gov/support/plugins/servlet/desk/portal/6.
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    Comments. Commenters stated that health care providers are still 
unclear about what practices are prohibited under the information 
blocking regulations. Commenters also recommended that supplemental 
rulemaking or sub-regulatory guidance be provided on certain topics 
prior to implementation or enforcement of health care provider 
information blocking disincentives, including: further describing 
investigative processes and the application of disincentives; the 
establishment of an appeals process; and describing how the 
disincentives implemented under this final rule interact with existing 
quality reporting program rules.
    Response. We appreciate commenters' concerns and recognize that 
many health care providers are still gaining awareness and 
understanding of the information blocking regulations. We encourage 
health care providers to review the resources available on ONC's 
website to learn more about practices that may be information 
blocking.\9\
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    \9\ For more information, see: https://www.healthit.gov/faqs.
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    We appreciate commenters' recommendations for topics HHS should 
consider addressing through notice and comment rulemaking. However, we 
note this final rule addresses many of these issues, including: the OIG 
investigative process (section III.B.1.), application of disincentives 
(section III.B.2.), and appeals processes (section III.B.2.). The 
discussion of the disincentives finalized in sections III.C.2. through 
III.C.4. does not identify any interactions with quality reporting 
program rules. Quality reporting programs are entirely separate 
authorities from those under which we proposed appropriate 
disincentives (which we have finalized in section III.C. of this rule); 
therefore, we are unclear what commenters' concerns are with respect to 
information blocking disincentives and quality reporting programs.
    The discussion of these issues provides additional information 
regarding the policies we have finalized in this rule and further 
notice and comment rulemaking on these topics is not necessary before 
finalizing these policies, due to the completeness of the policies 
described in this final rule.
    Comments. A few commenters recommended that before implementing 
health care provider information blocking disincentives the agencies 
should work to advance EHR adoption and interoperability. Commenters 
recommended that HHS further define and clarify interoperability 
standards, and recognize that not all health care providers utilize 
EHRs.
    Response. We do not agree that the need for further advances with 
respect to EHR adoption and interoperability should delay establishing 
the disincentives for health care providers that have been found to 
commit information blocking that we finalize in this rule. While we 
recognize that additional progress can be made to improve 
interoperability and advance adoption of EHRs, many health care 
providers are using electronic health information today and could 
engage in practices that are considered information blocking under PHSA 
section 3022. Therefore, it is important

[[Page 54668]]

that appropriate disincentives exist to deter information blocking by 
those health care providers that are currently using electronic health 
information. We note that HHS has pursued activities to advance 
interoperability in EHRs and other health IT systems through a variety 
of initiatives, including the ONC Health IT Certification Program. For 
more information about initiatives to advance interoperability, we 
refer readers to resources on ONC's website.\10\
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    \10\ For more information, see: https://www.healthit.gov/topic/interoperability.
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    Comments. Several commenters provided recommendations about 
specific scenarios that should not be considered information blocking, 
including: a delay in the release of sensitive and distressing health 
information and test results, such as for severe or complex diagnoses, 
to allow for provider review; a delay in the release of information in 
the interest of patient safety; a delay in the release of information 
if a patient states that they will harm themselves if they receive a 
diagnosis from their provider; or instances where a provider attempts 
in good faith to comply with an exception or not engage in information 
blocking.
    Response. We thank commenters for their recommendations regarding 
information blocking exceptions, however, we did not propose any 
exceptions to information blocking in the Disincentives Proposed Rule 
and these issues are out of scope for this final rule. In the ONC Cures 
Act Final Rule (85 FR 25820), ONC established exceptions to information 
blocking consistent with PHSA section 3022(a)(3), and subsequently made 
revisions to these exceptions in the HTI-1 Final Rule (89 FR 1373). We 
invite readers to review the information blocking exceptions to better 
understand how various scenarios may be addressed by these 
exceptions.\11\ We may also consider this input for future rulemaking 
related to exceptions to information blocking.
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    \11\ For more information on exceptions to information blocking, 
see ONC's website: https://www.healthit.gov/topic/information-blocking.
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    Comments. A few commenters recommended delaying the implementation 
or enforcement of provider information blocking disincentives until 
issues related to reproductive health data and privacy are resolved. A 
few commenters expressed concern that the proposals described in 
section III.C. of the Disincentives Proposed Rule could negatively 
impact patient-provider relationships, risk patient and provider 
criminalization, and lead to patients delaying seeking healthcare due 
to reproductive health data and privacy issues. A few commenters 
recommended considering the context of the healthcare landscape 
following the overturning of the Federal constitutional right to an 
abortion and subsequent legislation in certain states to criminalize 
people who seek reproductive health care before finalizing the 
proposals in section III.C. of the Disincentives Proposed Rule. 
Commenters expressed concern that because of the financial impact the 
proposed appropriate disincentives may carry, health care providers may 
disclose sensitive health information, including reproductive health 
information, to the detriment of people seeking reproductive care. 
Commenters similarly expressed concern that the Disincentives Proposed 
Rule could result in the disclosure of other forms of sensitive health 
information, including information related to contraceptive access, in 
vitro fertilization (IVF), gender-affirming healthcare, sexually 
transmitted infections (STIs), intimate partner violence, and sexual 
assault. A few commenters recommended providers be exempt from 
information blocking requirements if they do not disclose patient 
information to protect patient privacy related to sexual and 
reproductive health and to protect the patient or themselves from 
criminalization or harassment. The commenter also recommended that a 
new ``good faith'' exception to information blocking should be 
established under which providers acting in ``good faith'' to withhold 
sensitive health information are presumed to be acting reasonably and 
in the best interest of their patients. One commenter recommended that 
implementation of disincentives should not occur until EHRs can ensure 
sensitive health data can be protected, clear concise exceptions are 
created, and consent management software is widely available. 
Commenters stated that EHR vendors cannot currently meet data 
segmentation standards for sensitive health information, such as 
reproductive healthcare data. One commenter recommended delaying 
implementation for 2 years to allow providers to comply with the 
anticipated ``HIPAA Privacy Rule to Support Reproductive Health Care 
Privacy'' final rule \12\ and ONC's ``Health Data, Technology, and 
Interoperability: Certification Program Updates, Algorithm 
Transparency, and Information Sharing'' proposed rule (88 FR 
23746).\13\
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    \12\ Subsequent to receiving this comment, the HIPAA Privacy 
Rule To Support Reproductive Health Care Privacy final rule (89 FR 
32976) appeared in the Federal Register on April 26, 2024.
    \13\ The Health Data, Technology, and Interoperability: 
Certification Program Updates, Algorithm Transparency, and 
Information Sharing final rule (89 FR 1192) appeared in the Federal 
Register on January 9, 2024.
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    Response. We acknowledge the concerns commenters may have regarding 
the sensitivity of health data relating to reproductive health care and 
will take these comments under consideration. We further acknowledge 
commenters' concerns that disincentives could lead to health care 
providers disclosing sensitive health information, including 
reproductive health information, and welcome commenters' 
recommendations regarding an exception to information blocking when a 
health care provider withholds sensitive information to protect the 
patient or themselves from criminalization or harassment. However, we 
did not propose exceptions to information blocking in the Disincentives 
Proposed Rule and believe that such policies are out of scope for this 
final rule. Instead, we will take these comments under consideration 
for other rulemaking activities in which we focus on revising and 
expanding the exceptions to information blocking.
    Section 4004 of the Cures Act, which added section 3022 to the 
PHSA, does not amend existing laws governing the confidentiality, 
privacy, and security of health information, such as HIPAA, its 
implementing regulations at 45 CFR parts 160, and 164, or other 
applicable Federal or state laws or regulations. Health care providers 
are responsible for ensuring their compliance with applicable laws and 
regulations governing confidentiality, privacy, and security of their 
patients' health information.
    Regarding commenters' statement that implementation of 
disincentives should not occur until improvements to technical 
approaches to data segmentation are achieved, we agree that this is an 
important area for advancement. However, we believe that this work can 
continue in parallel with the finalization of this rule and 
establishment of information blocking disincentives for health care 
providers.
    Finally, we acknowledge that health care providers are also focused 
on meeting other regulatory provisions. However, we reiterate that the 
information blocking regulations in 45 CFR part 171 have been effective 
since April 5, 2021, and that this final rule is focused on 
establishing disincentives for practices that are inconsistent with

[[Page 54669]]

the existing regulations defining information blocking. It does not 
create new affirmative obligations for health care providers.
    Comments. One commenter expressed concerns that the changes to the 
information blocking regulations have occurred too frequently, thereby 
creating burden and confusion for health care providers. One commenter 
expressed concern about the impact this new proposed disincentive 
structure will have on health care providers, given that they are also 
navigating other requirements related to EHI, such as surprise billing, 
electronic prescription, and electronic clinical quality measures. The 
commenter recommended that CMS remain cognizant of the many regulations 
that govern the flow of EHI and the differences in health IT use 
between provider types and sites of service.
    Response. We appreciate commenters' concerns. We understand that 
health care providers are continuing to gain experience and 
understanding of the information blocking regulations, and that health 
care providers have numerous compliance obligations with respect to 
Federal laws and regulations. We will continue to collaborate closely 
within the Department to consider other requirements that impact health 
care providers and seek to reduce burden.
    Comments. One commenter requested we provide lessons learned from 
cases of information blocking on the website to help educate actors on 
what does and does not qualify as information blocking. One commenter 
recommended a nation-wide marketing campaign to educate patients about 
information blocking practices and promote awareness of the information 
blocking website.
    Response. We appreciate the commenters' recommendations and will 
take them into consideration as we develop educational materials in the 
future. We note that there are resources available on ONC's website 
\14\ about information blocking, which can help health care providers 
learn about what practices constitute information blocking and how 
health care providers can avoid these practices.
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    \14\ For more information, see: https://www.healthit.gov/topic/information-blocking.
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III. Provisions of the Regulation and Anticipated Approach to 
Investigations and Referrals

A. Relevant Statutory Terms and Provisions

    In this section, we discuss certain statutory terms and provisions 
in PHSA sections 3022(a) and (b) related to the establishment of 
appropriate disincentives for health care providers as defined in 45 
CFR 171.102. For brevity, we refer to PHSA section 3022(b)(2)(B), which 
states that health care providers that OIG has determined to have 
committed information blocking ``shall be referred to the appropriate 
agency to be subject to appropriate disincentives using authorities 
under applicable Federal law, as the Secretary sets forth through 
notice and comment rulemaking,'' as the ``disincentives provision'' 
throughout this section.
1. Appropriate Agency
    The disincentives provision states that an individual or entity 
that is a health care provider determined by OIG to have committed 
information blocking shall be referred to the ``appropriate agency'' to 
be subject to appropriate disincentives. In the Disincentives Proposed 
Rule, we proposed to define ``appropriate agency'' in 45 CFR 171.102 to 
mean a government agency that has established disincentives for health 
care providers that OIG determines have committed information blocking 
(88 FR 74951). An ``agency'' may be any component of HHS that has 
established a disincentive or disincentives on behalf of the Secretary 
of HHS, including any of the Staff or Operating Divisions of HHS. For 
example, the disincentives finalized in section III.C. of this final 
rule are established using authorities held by CMS, which is an 
Operating Division of HHS. Under the disincentives finalized in this 
final rule, CMS is the ``appropriate agency'' to which OIG will refer a 
health care provider to be subject to disincentives.
    We invited public comments on our proposed definition of 
``appropriate agency.'' The following is a summary of the comments we 
received and our responses.
    Comments. One commenter agreed that CMS would be the appropriate 
agency for OIG referrals for enforcement because of the large 
percentage of health care providers participating in the programs 
discussed in section III.C. of the Disincentives Proposed Rule and the 
fact that CMS administers those programs.
    Response. We thank the commenter for their support. We wish to 
clarify that an appropriate agency could include any of the Staff or 
Operating Divisions of HHS. However, all of the disincentives finalized 
in this rule were established using authorities for programs 
administered by CMS.
    Comments. One commenter contended that the proposed definition of 
``appropriate agency'' is very broad and requested that the specific 
agencies that may receive a referral and assess provider disincentives 
be clarified and listed in the rule.
    Response. We appreciate the comment but decline to change the 
definition of ``appropriate agency'' to list all of the specific 
agencies that may receive a referral and impose disincentives. We note 
that, as of the effective date of this final rule, the only agency that 
has established disincentives for health care providers is CMS. While 
other disincentives could be established under other agencies through 
future notice and comment rulemaking, we cannot preemptively identify 
the agencies that may establish disincentives at this time. Therefore, 
we believe maintaining the broad definition of appropriate agency is 
appropriate as it allows for the potential addition of disincentives 
established under other agencies in the future.
    After consideration of the public comments, we have finalized our 
definition of ``appropriate agency'' in 45 CFR 171.102 as proposed to 
mean a government agency that has established disincentives for health 
care providers that OIG determines have committed information blocking.
2. Authorities Under Applicable Federal Law
    In the Disincentives Proposed Rule we proposed to interpret the 
phrase ``authorities under applicable Federal law'' in the 
disincentives provision to mean that an appropriate agency may only 
subject a health care provider to a disincentive established using 
authorities that could apply to information blocking by a health care 
provider subject to the authority, such as health care providers 
participating in a program supported by the authority (88 FR 74951). In 
section III.C. of this final rule, CMS identifies the authority under 
which each disincentive has been finalized.
    The following is a summary of the comments we received and our 
responses.
    Comments. One commenter expressed concern that the proposed 
interpretation of ``authorities under applicable Federal law'' limits 
the agency's ability to put in place an effective and fair enforcement 
structure for information blocking by limiting the applicable authority 
only to those with already existing penalty structures that exist to 
serve other policy goals. The commenter recommended that HHS revisit 
its interpretation of ``authorities under applicable Federal law'' to 
allow appropriate agencies to promulgate specific disincentives for 
information blocking conduct that: permit

[[Page 54670]]

consideration of mitigation and aggravating factors; allow for a 
broader range of disincentives (including technical assistance and 
corrective action plans); and preserve a health care provider's due 
process rights.
    Response. We appreciate the commenter's recommendations. However, 
we note that PHSA section 3022(b)(2)(B) specifies that disincentives 
must be established ``using authorities under applicable Federal law.'' 
As a result, disincentives established by an appropriate agency must be 
consistent with the authority under which the appropriate agency 
establishes the disincentive through notice and comment rulemaking. 
Furthermore, under the definition of ``disincentive'' that we have 
finalized in 45 CFR 171.102, a disincentive is imposed for the purposes 
of deterring information blocking. By finalizing this definition, we 
intend to limit disincentives to only include the conditions 
established by an appropriate agency that are intended to have a 
deterrent effect on information blocking practices. The disincentives 
provision in PHSA section 3022(b)(2)(B) and the definition of 
disincentive that we have finalized in 45 CFR 171.102 do not limit an 
appropriate agency from proposing, via notice and comment rulemaking, 
to establish other programmatic elements mentioned by the commenters, 
if such elements are within the scope of the appropriate agency's 
authority.
    Comments. One commenter stated that the interpretation of 
``authorities under applicable Federal law'' described in the 
Disincentives Proposed Rule limits HHS to promulgating disincentives 
that are duplicative of existing penalty structures that might 
otherwise apply to information blocking conduct committed by certain 
health care providers. The commenter stated that this may conflict with 
the statutory requirement in PHSA section 3022(d)(4). The commenter 
stated that Congress' intent with the provision in PHSA section 
3022(d)(4) was that HHS, in establishing disincentives, should take all 
measures possible to not use existing authorities that could apply to 
information blocking by a health care provider. The commenter further 
stated that existing authorities under which we proposed to establish 
disincentives in the Disincentives Proposed Rule, such as the Medicare 
Promoting Interoperability Program as well as the Medicare Shared 
Savings Program, exist to serve other policy goals and regulatory 
requirements, and disincentives established under these authorities 
should not qualify as an appropriate enforcement structure to target 
information blocking specifically.
    Response. We disagree that the disincentives CMS has finalized in 
this final rule conflict with the statutory provision in PHSA section 
3022(d)(4). Section 3022(d)(4) of the PHSA requires the Secretary, in 
carrying out section 3022 and to the extent possible, to ensure that 
information blocking penalties do not duplicate penalty structures that 
would otherwise apply with respect to information blocking and the type 
of individual or entity involved as of the day before the date of 
enactment of the Cures Act. However, the disincentives that CMS has 
finalized in section III.C. of this final rule create new policies to 
deter information blocking that are based on a referral of a 
determination by OIG that a health care provider has committed 
information blocking as defined in PHSA section 3022(a).
    After consideration of the public comments, we continue to view the 
disincentives provision in PHSA section 3022(b)(2)(B) to require that 
an appropriate agency may only subject a health care provider to a 
disincentive established using authorities that could apply to 
information blocking by a health care provider subject to the 
authority, such as health care providers participating in a program 
supported by the authority.
3. Appropriate Disincentives
    We stated in the Disincentives Proposed Rule that the Cures Act 
does not specify or provide illustrations for the types of 
disincentives that should be established (88 FR 74951). As such, we 
proposed to define the term ``disincentive'' in 45 CFR 171.102 to mean 
a condition specified in 45 CFR 171.1001(a) that may be imposed by an 
appropriate agency on a health care provider that OIG determines has 
committed information blocking for the purpose of deterring information 
blocking practices. In section III.B.2. of the Disincentives Proposed 
Rule, we proposed to identify in 45 CFR 171.1001(a) those disincentives 
that have been established pursuant to the statute for the express 
purpose of deterring information blocking practices (88 FR 74952 and 
74953).
    We also noted that the term ``appropriate'' for disincentives is 
likewise not defined in PHSA section 3022, nor are illustrations 
provided. In the Disincentives Proposed Rule, we stated that a 
disincentive for a health care provider that OIG has determined to have 
committed information blocking may be any condition, established 
through notice and comment rulemaking, that would, in our estimation, 
deter information blocking practices among health care providers 
subject to the information blocking regulations (88 FR 74951). In 
section III.C. of the Disincentives Proposed Rule, CMS described the 
potential impact that each proposed disincentive would have on a health 
care provider (88 FR 74954 through 74966).
    Finally, in the Disincentives Proposed Rule we noted that the 
disincentives provision does not limit the number of disincentives that 
an appropriate agency can impose on a health care provider (88 FR 
74951). Accordingly, we proposed that a health care provider would be 
subject to each appropriate disincentive that an agency has established 
through notice and comment rulemaking and is applicable to the health 
care provider. We stated that imposing cumulative disincentives, where 
applicable, would further deter health care providers from engaging in 
information blocking.
    We invited public comments on our proposals to establish 
disincentives in section III.C. of the Disincentives Proposed Rule (88 
FR 74954 through 74966). The following is a summary of the comments we 
received and our responses on the definition of the term 
``disincentive'' and related proposals.
    Comments. One commenter agreed that a health care provider should 
be subject to appropriate and applicable disincentives established 
through notice and comment rulemaking. Some commenters agreed that 
subjecting health care providers to cumulative disincentives, where 
applicable, may deter providers from engaging in information blocking.
    Response. We thank the commenters for their support.
    Comments. A few commenters expressed concern that the proposed 
definition of ``appropriate disincentives'' is too broad and unclear. 
The commenters requested that ONC narrow its definition of 
``appropriate disincentives'' so that it is reflective of the 
underlying statute's requirement that disincentives be appropriate. 
Another commenter expressed concern that the definition does not impose 
limits on what may be deemed ``appropriate,'' therefore any 
disincentive proposed by an appropriate agency could theoretically meet 
this broad standard. Commenters expressed that a disincentive structure 
that does not consider the severity of the underlying misconduct cannot 
be considered ``appropriate.''
    Response. We thank the commenters for their input. We note that we 
did not propose to define the term ``appropriate

[[Page 54671]]

disincentives.'' Instead, we proposed to define the term 
``disincentive,'' to mean a condition specified in Sec.  171.1001(a) 
that may be imposed by an appropriate agency on a health care provider 
that OIG determines has committed information blocking for the purpose 
of deterring information blocking practices (88 FR 74951). We have 
finalized this proposed definition at 45 CFR 171.102 with a 
modification to replace the phrase ``may be imposed'' with ``is 
imposed'' to clarify that a disincentive is the completed action by an 
appropriate agency to impose a condition on a health care provider that 
OIG determines has committed information blocking.
    Regarding commenter concerns that we did not propose to impose 
limits on what may be deemed ``appropriate,'' and that a disincentive 
which does not consider the severity of the underlying misconduct 
should not be deemed ``appropriate,'' we reiterate that the term 
``appropriate'' is not defined in PHSA section 3022, nor are 
illustrations provided. We believe that term ``appropriate'' is 
capacious and is best read to give the Secretary significant discretion 
to craft disincentives using existing authorities. As we noted in the 
Disincentives Proposed Rule, the key feature of appropriate 
disincentives is that the agency believes that they will deter 
information blocking (88 FR 74951). We have carefully considered each 
disincentive we have finalized for appropriateness, as it relates to 
deterring information blocking; in section III.C.2.-III.C.4., CMS 
describes the potential impact of each proposed disincentive on a 
health care provider which would result in deterring information 
blocking practices.
    However, we believe the disincentives finalized in section III.C. 
also align with the use of the term ``appropriate'' in PHSA section 
3022 by including certain limits on the impact of each disincentive. 
For instance, under the Medicare Promoting Interoperability Program and 
the MIPS Promoting Interoperability performance category, CMS has 
finalized disincentives that affect otherwise applicable payment 
adjustments based on a health care provider failing to meet the 
requirements of each program by committing information blocking. In 
sections III.C.2.c. and III.C.3.c., CMS has finalized that the 
disincentive under each program would only be applied for the EHR 
reporting period or performance period of the calendar year in which 
OIG refers a determination of information blocking to CMS. Barring a 
subsequent referral of a determination of information blocking, the 
health care provider would be eligible to successfully meet the 
program's requirements in the following calendar year's EHR reporting 
period or performance period. As discussed in section III.C.4., the 
disincentive finalized under the Medicare Shared Savings Program to 
deter information blocking through potential denial of approval to 
participate in or removal from the Shared Savings Program, limits the 
duration of the disincentive to a year to ensure that health care 
providers who have committed information blocking and corrected their 
actions are not permanently barred from participating in the Shared 
Savings Program. By balancing deterrent impact with these limits, CMS 
has finalized disincentives consistent with the general direction in 
PHSA section 3022 to establish disincentives that are ``appropriate.''
    We disagree with the commenter that a disincentive that cannot be 
adjusted to reflect the severity of the underlying misconduct cannot be 
considered ``appropriate.'' To be sure, the agency imposing an 
appropriate disincentive on a health care provider may not have the 
flexibility to determine the value of the disincentive for each 
individual or entity based on their conduct, as authorized for 
developers, networks, and exchanges that engage in information blocking 
under PHSA section 3022(b)(2)(A) (through CMPs). But lingering 
inflexibility is a function of the statute's authorization only to use 
``existing authorities'' to subject health care providers to 
disincentives rather than CMPs.
    Finally, we did not propose to define disincentive in the manner 
commenters have suggested in order to preserve flexibility for agencies 
to establish disincentives for information blocking. Since 
disincentives must be established using authorities under applicable 
Federal law (in accordance with PHSA section 3022(b)(2)(B)), there may 
be a limited set of statutory provisions that could be used to 
establish disincentives. Thus, we proposed and have finalized a 
definition of disincentive that would not unduly limit our ability to 
use available authorities to establish disincentives and have not 
proposed to further limit disincentives through proposing a definition 
for the term ``appropriate.''
    Comments. One commenter recommended that ONC revise its proposed 
definition of ``appropriate disincentives'' to explicitly incorporate 
technical assistance or a corrective action plan. The commenter further 
contended that this adjustment would be more consistent with HHS' 
enforcement of other regulations, such as the HIPAA Privacy and 
Security Rules.
    Response. We appreciate the commenter's recommendation. We note 
that we did not propose to define the term ``appropriate 
disincentives.'' Instead, we proposed to define the term 
``disincentive'' to mean a condition specified in Sec.  171.1001(a) 
that may be imposed by an appropriate agency on a health care provider 
that OIG determines has committed information blocking, for the purpose 
of deterring information blocking practices. Activities such as the 
provision of technical assistance or the provision of a corrective 
action plan may not adequately deter information blocking practices, 
and we decline to include such activities in the definition of a 
disincentive at this time. We further refer readers to resources on 
ONC's website \15\ about information blocking, which can help health 
care providers learn about what practices constitute information 
blocking and how health care providers can avoid these practices.
---------------------------------------------------------------------------

    \15\ For more information, see: https://www.healthit.gov/topic/information-blocking.
---------------------------------------------------------------------------

    Comments. Many commenters did not support our proposal for a health 
care provider to be subject to each appropriate disincentive 
established by an appropriate agency applicable to such health care 
provider, without limit to the number of disincentives, and disagreed 
that this policy would deter providers from engaging in information 
blocking. One commenter contended that unlimited cumulative 
disincentives should not be considered appropriate.
    Several commenters expressed that subjecting health care providers 
to multiple disincentives for the same misconduct, simply based on 
their participation in multiple programs rather than the severity of 
the conduct, is duplicative, overly punitive, and heightens the risk 
for providers who participate in multiple CMS programs. A few 
commenters recommended that HHS establish a clear process to reconcile 
multiple disincentives and ensure fair and non-duplicative or punitive 
enforcement for providers participating in multiple programs. A few 
commenters suggested limiting the number of disincentives that could be 
applied or clarifying under which program the disincentive would be 
applied. A few commenters expressed concern that the allowance of 
cumulative disincentives will create confusion and complexity.
    Response. We thank commenters for their input. We disagree with 
commenters that multiple disincentives will not deter information 
blocking, as

[[Page 54672]]

the increased impact on a health care provider of receiving cumulative 
disincentives is likely to be a stronger deterrent due to potentially 
imposing greater adverse consequences on the health care provider that 
commits information blocking. Moreover, health care providers who 
participate in multiple programs may be larger than health care 
providers who do not participate in multiple programs, or may have a 
greater ability to influence health information exchange than other 
health care providers, and so may need greater disincentive exposure to 
deter information blocking practices.
    Finally, we believe that the possibility of receiving cumulative 
disincentives will have a greater deterrent effect on health care 
providers that are determined to have committed information blocking, 
since individual disincentives are likely to have variable impacts 
depending on the circumstances of a given health care provider, as 
further discussed in section III.C.1. of this final rule. If a health 
care provider expects to only be subject to one disincentive, and the 
health care provider expects the disincentive to have a small impact, 
for instance, through minimal exposure under a certain program, the 
value of that disincentive to deter information blocking practices for 
that health care provider will be minimized. The availability of 
disincentives under more than one authority can mitigate this issue, as 
under our policy a health care provider may expect that they could be 
subject to cumulative disincentives established under different 
authorities, increasing the likelihood that there is an available 
disincentive that will have a meaningful deterrent effect for that 
specific health care provider.
    We also disagree with the commenter that the term ``appropriate'' 
should be interpreted to prohibit applying multiple disincentives on a 
health care provider that has committed information blocking. PHSA 
section 3022(b)(2)(B) specifically contemplates that a health care 
provider may be subject to ``appropriate disincentives''--plural. The 
plain language of the statute therefore suggests that multiple 
``disincentives'' would be ``appropriate.''
    We further disagree that subjecting a health care provider to 
multiple disincentives is unfair and overly punitive. The disincentives 
that CMS has finalized in this final rule are established under 
authorities which provide for specific requirements for programs 
authorized under those authorities. CMS describes in section III.C. how 
information blocking committed by a health care provider would conflict 
with the requirements under each of the programs through which a 
disincentive has been established. Accordingly, we believe it is 
reasonable that a health care provider that has acted in a manner 
inconsistent with these programs by committing information blocking 
could be subject to a disincentive under that authority, regardless of 
whether the health care provider has also been subject to a 
disincentive established under another authority.
    However, we believe it is necessary to provide further 
clarification around our proposed policy with respect to cumulative 
disincentives. Specifically, we believe that our proposed policy may 
not have accounted for scenarios under which an appropriate agency may 
choose to exercise discretion when imposing a disincentive. For 
example, in section III.C.4. of this final rule, CMS has finalized a 
policy under the authority for the Shared Savings Program, which CMS 
originally discussed as an alternative policy in the Disincentives 
Proposed Rule (88 FR 74966). This finalized policy will permit CMS, as 
the appropriate agency, to consider relevant facts and circumstances 
when deciding whether to apply a disincentive to an ACO, ACO 
participant, or ACO provider/supplier in the Shared Savings Program.
    We note that CMS has finalized this alternative policy for the 
Medicare Shared Savings Program only, as this policy is consistent with 
existing practices under the Shared Savings Program for addressing 
program integrity issues among ACOs, ACO participants, or ACO 
providers/suppliers. In addition, this policy addresses scenarios 
specific to imposing a disincentive under the Shared Savings Program, 
for instance, where removal of one entity from participation in an ACO 
could result in the ACO not meeting program requirements such as 
falling below the 5,000 assigned beneficiary threshold required by 42 
CFR 425.110(a)(1), thereby interrupting care coordination benefits of 
beneficiaries receiving care from ACO participants and ACO providers/
suppliers that did not commit information blocking. Under the finalized 
alternative policy, CMS will consider relevant facts and circumstances 
before imposing a disincentive under the Shared Savings Program. The 
relevant facts and circumstances include the nature of the health care 
provider's information blocking, the health care provider's diligence 
in identifying and correcting the problem, the time since the 
information blocking occurred, whether the provider was previously 
subject to a disincentive in another program, and other factors. We 
refer readers to section III.C.4. for a complete discussion of the 
alternative policy finalized under the Shared Savings Program. As 
discussed in sections III.C.2. and III.C.3. of this final rule, the 
Medicare Promoting Interoperability Program and the MIPS Promoting 
Interoperability performance category will impose a disincentive on an 
applicable health care provider following a referral of an information 
blocking determination by OIG.
    Thus, we are revising our proposed policy for consistency with the 
policies finalized in this rule. Where we stated in the proposed rule 
(88 FR 74951) that a health care provider ``would'' be subject to each 
appropriate disincentive that an agency has established through notice 
and comment rulemaking and is applicable to the health care provider, 
in this final rule we clarify that, under the disincentives provision, 
a health care provider ``may'' be subject to each appropriate 
disincentive that an agency has established through notice and comment 
rulemaking and is applicable to the health care provider. Under this 
revised policy, we acknowledge that an appropriate agency could 
establish a policy that allows for discretion in imposing a 
disincentive, consistent with the agency's authority and implementing 
regulations.
    Finally, we disagree with the commenters that a cumulative 
disincentives approach will introduce more confusion and complexity. We 
believe this final rule provides clarity about the disincentives 
established under each of the relevant programs to ensure health care 
providers understand the consequences they may face for committing 
information blocking with respect to the requirements of each program.
    Comments. A few commenters expressed concern about the negative and 
disproportionate impact of potentially imposing cumulative 
disincentives on small and less resourced practices. One commenter 
recommended considering the relative impact of cumulative disincentives 
on the health care provider, such as the size and resources of the 
provider.
    Response. We appreciate the commenters' concerns about the impact 
of cumulative disincentives on small and less resourced practices. 
However, we disagree with commenters that we should revise our policy 
with respect to cumulative disincentives to be based on the size and 
resources of the health care provider subject to the disincentive, as 
we believe this policy should be consistent across health care 
providers,

[[Page 54673]]

regardless of their size, and that any considerations with respect to 
how an appropriate disincentive should impact health care providers 
should be addressed by the appropriate agency establishing the 
disincentive.
    An appropriate agency, in establishing a disincentive and related 
policies, could retain or implement policies based on the type of 
health care provider subject to the disincentive, including small 
practices, consistent with the agency's authority. For instance, CMS 
automatically reweights the MIPS Promoting Interoperability performance 
category to zero percent of a MIPS eligible clinician's final score if 
the MIPS eligible clinician is in a small practice as defined in 42 CFR 
414.1305 and does not submit data for the MIPS Promoting 
Interoperability performance category for the applicable performance 
period (42 CFR 414.1380(c)(2)(i)(C)(9)). In other words, if the MIPS 
eligible clinician meets this criterion for automatic reweighting at 42 
CFR 414.1380(c)(2)(i)(C)(9), the MIPS eligible clinician is not 
required to complete the requirements for earning a score for the 
Promoting Interoperability performance category as set forth in 42 CFR 
414.1375. In such event, CMS does not assign a score for the MIPS 
eligible clinician for the Promoting Interoperability performance 
category and redistributes the weight of the performance category 
(typically 25 percent of the final score) to the remaining performance 
categories on which the MIPS eligible clinician is scored in accordance 
with 42 CFR 414.1380(c)(2)(ii). In section III.C. of the proposed rule 
and section III.C. of this final rule, CMS has neither proposed nor 
finalized any policy that would amend this automatic reweighting policy 
at 42 CFR 414.1380(c)(2)(i)(C)(9) for MIPS eligible clinicians in a 
small practice if such practice were subject to the disincentive being 
finalized as discussed section III.C.3. of this final rule.
    After consideration of the public comments, we have finalized our 
definition of the term ``disincentive'' in 45 CFR 171.102 as proposed 
to mean a condition specified in 45 CFR 171.1001(a) that is imposed by 
an appropriate agency on a health care provider that OIG determines has 
committed information blocking for the purpose of deterring information 
blocking practices. We have also finalized our policy, with 
modification, that a health care provider may be subject to each 
appropriate disincentive that an agency has established through notice 
and comment rulemaking and is applicable to the health care provider.

B. Approach to Determination of Information Blocking and Application of 
Disincentives

    In this section we provide additional detail about the process by 
which a health care provider that has committed information blocking 
may be subject to appropriate disincentives for information blocking. 
This section begins with a discussion, provided for informational 
purposes and not including any final policies, of an OIG investigation 
of a claim of information blocking and how OIG intends to refer a 
health care provider it determines has committed information blocking 
to an appropriate agency. Next, we discuss finalized proposals related 
to the application of a disincentive by an appropriate agency. Finally, 
we discuss our finalized approach to provide transparency into the 
nationwide health IT infrastructure by making information available to 
the public about health care providers that have been determined by OIG 
to have committed information blocking and have been subject to an 
appropriate disincentive for information blocking, and about health IT 
developers of certified health IT and HIEs/HINs and that have been 
determined by OIG to have committed information blocking.
1. OIG Investigation and Referral
    In the Disincentives Proposed Rule, we provided information 
regarding OIG's anticipated approach to information blocking 
investigations of health care providers (88 FR 74951 and 74952). We 
noted that this information was not a regulatory proposal and was 
provided for information purposes only. Preamble discussion of 
investigation priorities for health care provider information blocking 
claims included in the Disincentives Proposed Rule, and restated below, 
is not binding on OIG and HHS. It does not impose any legal 
restrictions related to OIG's discretion to choose which health care 
provider information blocking complaints to investigate. As the 
discussion in the Disincentives Proposed Rule was not a regulatory 
proposal, we have not included direct responses to comments provided on 
this section (III.B.1.). However, to improve public understanding of 
how OIG anticipates it will approach information blocking 
investigations of health care providers, this section (III.B.1.) of the 
preamble provides an informational statement to supplement the 
discussion set forth in the Disincentives Proposed Rule.
    We clarify here that OIG's investigation will depend on the 
specific facts and circumstances presented in the allegation. OIG will 
evaluate each allegation based on the facts and circumstances presented 
in the allegation. As OIG investigates the allegations, though, the 
scope of the investigation may change, and OIG may change the 
individual(s) or entity(ies) under investigation depending on the 
specific facts and circumstances it has found. Indeed, through 
conducting an investigation, OIG will collect evidence which it will 
use to evaluate the individual(s) or entity(ies) with potential 
information blocking liability and potential information blocking 
conduct. The vast bulk of material and relevant evidence (that is, 
evidence relating to whether the actor committed information blocking) 
will come from the actor whose conduct is at issue.
    As part of OIG's investigation, OIG will need to evaluate whether 
an individual or entity meets the definition of an actor under ONC's 
regulations. OIG has previously stated that it will look to ONC's 
regulations and any related guidance in evaluating whether an 
individual or entity meets a specific actor definition, and OIG will 
continue to do so for health care provider investigations (88 FR 
42828). OIG will look to the regulations in effect at the time the 
conduct occurred. Based on the definitions ONC has finalized for health 
IT developer of certified health IT and HIN/HIE, a health care 
provider, as set forth in 45 CFR 171.102, may meet the definition of a 
health care provider and one of those definitions as well (88 FR 
42829). OIG anticipates being in contact with health care providers as 
part of its investigation, as necessary, to understand the specific 
facts and circumstances. For example, OIG may need to engage with the 
health care provider to understand whether the health care provider is 
a HIN/HIE or a health IT developer of certified health IT. And as 
mentioned above, much of the evidence gathered by OIG will likely come 
from the individual(s) or entity(ties) under investigation.
    As part of an investigation, OIG will evaluate whether information 
blocking has occurred. OIG has previously stated that it will look to 
ONC's regulations and any related guidance in evaluating whether 
conduct constitutes information blocking, and OIG will continue to do 
so with respect to health care providers (88 FR 42827). OIG will look 
to ONC's information blocking regulations in 45 CFR part 171 in effect 
at the time the conduct occurred. Through conducting an investigation, 
OIG will collect evidence, which it will use to evaluate whether 
conduct constitutes information blocking and whether an actor had the 
requisite

[[Page 54674]]

intent. As mentioned above, OIG anticipates engaging with health care 
providers during this process as it learns the facts and circumstances 
of the allegation under investigation.
    Regarding the timing of investigations, OIG will not begin 
investigating health care providers until after the effective date of 
this rule, and will exercise its enforcement discretion not to make any 
determinations regarding conduct occurring prior to the effective date 
of this rule for information blocking disincentives. As OIG will not 
make a determination on conduct occurring prior to the effective date, 
OIG will not refer any health care providers based on a determination 
of conduct occurring prior to the effective date of this rule for 
information blocking disincentives. This means that no disincentives 
finalized in this final rule will be applied to conduct occurring 
before the effective date of this final rule.
a. Anticipated Priorities
    As with other conduct that OIG has authority to investigate, OIG 
has discretion to choose which information blocking complaints to 
investigate. To maximize efficient use of resources, OIG generally 
focuses on selecting cases for investigation that are consistent with 
its enforcement priorities and intends to apply that rationale to its 
approach for selecting information blocking complaints for 
investigation.
    For investigations of health care providers, the Disincentives 
Proposed Rule stated that OIG expects to use four priorities: (i) 
resulted in, are causing, or have the potential to cause patient harm; 
(ii) significantly impacted a provider's ability to care for patients; 
(iii) were of long duration; and (iv) caused financial loss to Federal 
health care programs, or other government or private entities (88 FR 
74951). As mentioned in the above section concerning OIG 
investigations, OIG's expected priorities are informational only and 
are not binding on OIG decision making.
    OIG's priorities for health care provider investigations differ 
from the priorities set out in the OIG CMP Final Rule, due to the 
differences in intent. In the OIG CMP Final Rule, OIG stated that it 
would prioritize actors who had actual knowledge, as actual knowledge 
is more egregious, when a lower intent is required (that is, when the 
standard is ``knows, or should know'') (88 FR 42823). However, under 
PHSA section 3022(a), the intent requirement for health care providers 
is that the health care provider ``knows'' that a practice is 
unreasonable and is likely to interfere with, prevent, or materially 
discourage access, exchange, or use of electronic health information. 
Because the Cures Act only provides a single intent standard 
(``knows''), OIG will not consider actual knowledge as part of its 
priorities for health care provider actors.
    Consistent with the OIG CMP Final Rule (88 FR 42822), OIG's 
enforcement priorities are a tool OIG uses to triage allegations and 
allocate resources. OIG provides information about its enforcement 
priorities so the public and stakeholders have a better understanding 
of how OIG anticipates allocating resources for enforcement. OIG's 
enforcement priorities will inform decisions about which information 
blocking allegations to pursue, but these priorities are not 
dispositive. Each allegation will be assessed to determine whether it 
implicates one or more of the enforcement priorities, or otherwise 
merits further investigation and potential enforcement action. There is 
no specific formula OIG can apply to every allegation that allows OIG 
to effectively evaluate and prioritize which claims merit 
investigation.
    Although OIG's anticipated priorities are framed around individual 
allegations, OIG may evaluate allegations and prioritize investigations 
based in part on the volume of claims relating to the same (or similar) 
practices by the same entity or individual.
b. Coordination With Other Agencies
    This section summarizes the discussion in the OIG CMP Final Rule of 
the ways ONC, OCR, and OIG will consult, refer, and coordinate on 
information blocking claims as permitted by the Cures Act (88 FR 
42823).
    PHSA section 3022(d)(1) states that the National Coordinator may 
serve as a technical consultant to the Inspector General. OIG will 
accordingly consult with ONC throughout the investigative process. 
Additionally, PHSA section 3022(b)(3)(A) provides the option for OIG to 
refer claims of information blocking to OCR when a consultation 
regarding the health privacy and security rules promulgated under 
section 264(c) of HIPAA will resolve such claims. Depending on the 
facts and circumstances of the claim, OIG will exercise this statutory 
discretion as appropriate to refer information blocking claims to OCR 
for resolution. There is no set of facts or circumstances that will 
always be referred to OCR. OIG will work with OCR to determine which 
claims should be referred to OCR under the authority provided in PHSA 
section 3022(b)(3)(A). It is important to note that while section 
3022(b)(3)(A) of the PHSA specifically provides OIG with the authority 
to refer information blocking claims to OCR, OIG's statutory authority 
to refer to OCR allegations of violations of the HIPAA Privacy, 
Security, or Breach Notification Rules \16\ is not solely based on PHSA 
section 3022(b)(3)(A). Thus, OIG's authority to refer to OCR such 
allegations against health care providers is not limited to claims of 
information blocking.
---------------------------------------------------------------------------

    \16\ 45 CFR parts 160 and 164, subparts A, C, D, and E.
---------------------------------------------------------------------------

    Finally, OIG anticipates coordinating with other HHS agencies to 
avoid duplicate penalties as identified in section 3022(d)(4) of the 
PHSA. Depending on the facts and circumstances, OIG may also consult or 
coordinate with a range of other government agencies, including CMS, 
FTC, or others (88 FR 42823 and 42824).
c. Anticipated Approach to Referral
    During an investigation of information blocking by a health care 
provider, but prior to making a referral, OIG will coordinate with the 
appropriate agency to which OIG plans to refer its determination of 
information blocking. This coordination will ensure that the 
appropriate agency is aware of a potential referral and that OIG 
provides the information the agency needs to take appropriate action. 
OIG's referral to the appropriate agency will explain its determination 
that a health care provider committed information blocking, including 
meeting the requirements of the intent element of PHSA section 
3022(a)(1)(B)(ii).
    We note that PHSA section 3022 authorizes OIG to investigate claims 
of information blocking and requires OIG to refer health care providers 
to an appropriate agency when it determines a health care provider has 
committed information blocking, to be subject to appropriate 
disincentives. Once OIG has concluded its investigation and is prepared 
to make a referral, it will send information to the appropriate agency 
indicating that the referral is made pursuant to the statutory 
requirement in PHSA section 3022(b)(2)(B). As part of the referral, OIG 
will provide information to explain its determination, which may 
include: the dates when OIG has determined the information blocking 
violation(s) occurred; analysis to explain how the evidence 
demonstrates the health care provider committed information blocking 
(for instance, that the health care provider's ``practice'' \17\ meets 
each

[[Page 54675]]

element of the information blocking definition); copies of evidence 
collected during the investigation (regardless of whether it was 
collected by subpoena or voluntarily provided to OIG); copies of 
transcripts and video recordings (if applicable) of any witness and 
affected party testimony; and copies of documents OIG relied upon to 
make its determination that information blocking occurred. OIG may 
provide additional information as part of its referral based on 
consultation with the appropriate agency, to the extent permitted by 
applicable law.
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    \17\ ``Practice,'' as defined in 45 CFR 171.102, means an act or 
omission by an actor (health care provider, health IT developer of 
certified health IT, health information network or health 
information exchange).
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2. General Provisions for Application of Disincentives
    Following an investigation through which OIG determines a health 
care provider has committed information blocking, and OIG's referral of 
this determination to an appropriate agency, the health care provider 
may be subject to disincentives that have been established under 
applicable Federal law through notice and comment rulemaking. In this 
section, we include general provisions and information related to the 
application of disincentives. For information on the specific 
disincentives and further discussion about how each disincentive will 
be applied, we refer readers to section III.C. of this final rule.
    In the Disincentives Proposed Rule, we proposed to add a new 
subpart J to 45 CFR part 171, entitled ``Disincentives for Information 
Blocking by Health Care Providers'' (88 FR 74952 and 74953). We 
proposed in 45 CFR 171.1000 that this subpart sets forth disincentives 
that an appropriate agency may impose on a health care provider based 
on a determination of information blocking referred to that agency by 
OIG, and certain procedures related to those disincentives. We proposed 
in 45 CFR 171.1001(a) that health care providers that commit 
information blocking would be subject to the following disincentives 
from an appropriate agency based on a determination of information 
blocking referred by OIG, where applicable. The disincentives proposed 
for inclusion in 45 CFR 171.1001(a)(1) through (3) corresponded to the 
appropriate disincentives proposed in section III.C. of the 
Disincentives Proposed Rule:
     An eligible hospital or CAH as defined in 42 CFR 495.4 is 
not a meaningful EHR user as also defined in that section;
     A MIPS eligible clinician as defined in 42 CFR 414.1305, 
who is also a health care provider as defined in 45 CFR 171.102, is not 
a meaningful EHR user for MIPS as also defined in 42 CFR 414.1305; and
     ACOs who are health care providers as defined in 45 CFR 
171.102, ACO participants, and ACO providers/suppliers will be removed 
from, or denied approval to participate, in the Medicare Shared Savings 
Program as defined in 42 CFR part 425 for at least 1 year.
    We noted that in the future, if we propose to establish additional 
disincentives, we intend to add such disincentives to the disincentives 
listed in 45 CFR 171.1001 (88 FR 74953).
    We did not receive any comments on these proposals. However, we 
have modified the regulation text in several ways to increase clarity. 
First, we have made minor modifications to the language of the proposed 
``scope'' section, in 45 CFR 171.1000, to better reflect language used 
in this final rule. Second, we have replaced the proposed paragraph (a) 
from 45 CFR 171.1001, which was redundant with the proposed ``scope'' 
section (45 CFR 171.1000), and reorganized the section to clearly 
reflect that the disincentives finalized in this final rule, and that a 
health care provider may be subject to, were established by CMS (45 CFR 
171.1001(a) as finalized). If we finalize additional disincentives in 
the future, we will add them to a paragraph under 45 CFR 171.1001 
reflecting the appropriate agency that has established the 
disincentive.
    We have finalized, as proposed, the following disincentives in 45 
CFR 171.1001(a)(1)-(3):
     An eligible hospital or CAH as defined in 42 CFR 495.4 is 
not a meaningful EHR user as also defined in that section;
     A MIPS eligible clinician as defined in 42 CFR 414.1305, 
who is also a health care provider as defined in 45 CFR 171.102, is not 
a meaningful EHR user for MIPS as also defined in 42 CFR 414.1305; and
     ACOs who are health care providers as defined in 45 CFR 
171.102, ACO participants, and ACO providers/supplies will be removed 
from, or denied approval to participate, in the Medicare Shared Savings 
Program as defined in 42 CFR part 425 for at least 1 year.
    In the Disincentives Proposed Rule, we proposed in 45 CFR 
171.1002(a) through (d) that an appropriate agency that imposes a 
disincentive or disincentives in Sec.  171.1001(a) would send a notice 
(using usual methods of communication for the program or payment 
system) to the health care provider subject to the disincentive or 
disincentives (88 FR 74953). We proposed that this notice includes:
     A description of the practice or practices that formed the 
basis for the determination of information blocking referred by OIG;
     The basis for the application of the disincentive or 
disincentives being imposed;
     The effect of each disincentive; and
     Any other information necessary for a health care provider 
to understand how each disincentive will be implemented.
    In the Disincentives Proposed Rule we stated that the information 
in this notice would be based upon the authority used to establish the 
disincentive and policy finalized by the agency establishing the 
disincentive (88 FR 74953). For instance, the notice may contain 
specific information regarding when a disincentive would be imposed, 
which may be contingent on both the authority used to establish the 
disincentive and the specific policy under which the disincentive is 
established. We noted that, where a health care provider that has been 
determined to have committed information blocking is subject to 
multiple disincentives established by an appropriate agency, nothing in 
this proposal would prevent the appropriate agency from combining these 
notices into a single communication.
    Comments. One commenter requested clarification regarding whether 
the proposal to send a notice to the health care provider subject to 
the disincentive implies that all health care providers who have been 
identified as alleged information blockers will receive a disincentive.
    Response. A health care provider would only be subject to a 
disincentive or disincentives and receive the notification described in 
this section after a determination has been made by OIG that the health 
care provider committed information blocking and OIG has referred that 
determination to the appropriate agency, which is CMS for the purposes 
of the disincentives finalized in this rule. A health care provider 
that is merely alleged to have committed information blocking but has 
not been investigated and determined by OIG to have committed 
information blocking, would not receive a notification described in 
this section.
    Comments. One commenter expressed support for the proposed 
notification policies and stated that these policies would improve 
transparency.

[[Page 54676]]

    Response. We thank the commenter for their support.
    Comments. A few commenters recommended adding information or a 
communications channel so that health care providers who have been 
notified of a disincentive can respond to or communicate with OIG and 
the agency issuing the disincentive regarding the finding, possible 
mitigating circumstances, or establish a process to deter further cases 
of information blocking. One commenter observed that this would 
increase transparency, avoid patient confusion, and mitigate potential 
unnecessary reputational damage. One commenter expressed concern that 
the proposed notifications only inform health care providers of a 
disincentive after they have been found to have committed information 
blocking. This commenter expressed concern that a health care provider 
found to have committed information blocking may have additional 
practices being investigated or practices that could lead to another 
finding of information blocking and that these practices would not be 
included in the notification, for example, for them to fix potential 
issues. This commenter recommended creating a form notification that 
would inform health care providers of the information blocking issues 
that have led to the disincentive so they could be fixed.
    Response. We appreciate commenters' concerns and wish to clarify 
that the notifications proposed in this section would be issued by an 
appropriate agency following a referral of a determination of 
information blocking by OIG that leads to the imposition of a 
disincentive. For discussion of when communication between OIG and a 
health care provider about alleged information blocking practices may 
occur as part of an investigation (that is, prior to a determination of 
information blocking), we refer readers to section III.B.1. of this 
final rule.
    After consideration of the public comments, we have finalized our 
proposal with modification. In the Disincentives Proposed Rule, we 
proposed in Sec.  171.1002 that an appropriate agency ``would send a 
notice to the health care provider subject to the disincentive or 
disincentives.'' However, we believe that the use of the affirmative 
``shall,'' which we have finalized in the text of Sec.  171.1002, to 
describe the action of an appropriate agency will provide greater 
clarity to health care providers and better conveys the intent of the 
policy, which is that an appropriate agency will send this notice in 
all cases in which disincentives have been imposed on a health care 
provider. For the finalized text of Sec.  171.1002, we also revise our 
proposed reference to disincentives ``specified in Sec.  171.1001(a)'' 
to refer to disincentives ``specified in Sec.  171.1001'' instead, 
since we have finalized that disincentives may be listed throughout 
Sec.  171.1001 and not only under paragraph (a), which specifically 
lists disincentives established by CMS. Therefore, we have finalized in 
45 CFR 171.1002 that an appropriate agency that imposes a disincentive 
or disincentives in Sec.  171.1001 shall send a notice (using usual 
methods of communication for the program or payment system) to the 
health care provider subject to the disincentive or disincentives. We 
have finalized in 45 CFR 171.1002(a) through (d) the elements of the 
notice as proposed.
    In the Disincentives Proposed Rule, we noted that, following the 
application of a disincentive, a health care provider, as defined in 45 
CFR 171.102, may have the right to appeal administratively a 
disincentive if the authority used to establish the disincentive 
provides for such an appeal (88 FR 74953). We noted that PHSA section 
3022(b)(2)(C) requires that the imposition of CMPs that apply to health 
IT developers of certified health IT, and HINs/HIEs, that have 
committed information blocking, follow the procedures of SSA section 
1128A, which includes procedures for appeals. However, the Cures Act 
did not provide similar instruction regarding administrative appeals of 
disincentives for health care providers established under PHSA section 
3022(b)(2)(B), and we did not propose a specific administrative appeals 
process for health care provider appeals. Therefore, any right to 
appeal administratively a disincentive, if available, would be provided 
under the authorities used by the Secretary to establish the 
disincentive through notice and comment rulemaking.
    To provide additional information on these issues to the public, we 
summarize and respond to comments on our statement regarding appeals.
    Comments. Many commenters expressed concern that there is not a 
clearly defined appeals process that would apply across all provider 
types. Many of these commenters recommended that HHS adopt a single 
appeals process through notice and comment rulemaking. Many commenters 
expressed concern that relying on each program's appeals process 
creates an unfair structure in which providers do not have equal appeal 
rights. Some of these commenters further stated that this could require 
some providers to appeal multiple times and that other providers may 
not be able to appeal at all. Some commenters stated that the differing 
appeals processes could create undue administrative burden, with some 
requesting a single or streamlined process. A few commenters 
recommended that HHS ensure that any future disincentives for other 
provider types also allow for a clear and straightforward appeals 
process.
    Response. As noted in the Disincentives Proposed Rule, PHSA section 
3022(b)(2)(C) requires that the imposition of CMPs that apply to health 
IT developers of certified health IT, and HINs/HIEs, that have 
committed information blocking, follow the procedures of SSA section 
1128A, which includes procedures for administrative appeals (88 FR 
74953). The Cures Act did not provide similar instruction regarding 
administrative appeals of appropriate disincentives for health care 
providers established under PHSA section 3022(b)(2)(B), and we did not 
propose and have not finalized any regulations relating to 
administrative appeals of the imposition of disincentives. Instead, we 
reiterate that any right to appeal administratively a disincentive, if 
available, would be provided under the authority used by the Secretary 
to establish a disincentive.
    Section 3022(b)(2)(B) of the PHSA requires that an OIG 
determination be referred to the appropriate agency to ``be subject to 
appropriate disincentives using authorities under applicable Federal 
law.'' In establishing disincentives using authorities under applicable 
Federal law, any administrative appeals processes required under those 
existing authorities would also apply to the disincentives established 
by an appropriate agency under that authority. We recognize that 
reliance on any administrative appeals processes under the authority 
used to establish a disincentive may result in variability in the 
appeals processes available to health care providers, and that in some 
cases, administrative appeals processes may be limited or unavailable. 
However, we disagree that establishing a new single process for 
administrative appeals would effectively address this variability, as 
such a process may conflict with, or duplicate, administrative review 
or appeals processes available under existing authorities. Accordingly, 
we did not propose such a process in the Disincentives Proposed Rule.
    If we establish additional disincentives in the future, we will 
evaluate any administrative review or appeals process available under 
the

[[Page 54677]]

authority used to establish the disincentive and how a disincentive 
would be treated under such a process. However, we decline to limit 
future disincentives to those which provide for administrative appeals 
processes meeting certain standards, as we must balance these 
considerations with our goal of identifying disincentives for all 
health care providers subject to the information blocking regulations, 
as defined in 45 CFR 171.102.
    Comments. Many commenters provided recommendations for elements 
that should be incorporated into an appeals process. Commenters 
recommended that all health care providers should have the ability to 
appeal an information blocking determination by OIG before referral or 
application of a disincentive, as well as the ability to appeal the 
application and calculation of the disincentive. Other commenters 
recommended that HHS include evaluation criteria and definitions of 
intent within the appeals process to ensure transparency. A few 
commenters suggested that health care providers have the ability to 
provide further information that may impact a determination. Some 
commenters recommended entities that the commenters asserted would be 
appropriate to handle the appeals; the specific entities that 
commenters recommended were OIG, CMS, ONC, HHS, an Administrative Law 
Judge, or an impartial agency not involved in the finding or 
disincentive. Some commenters recommended that HHS ensure that the 
entity reviewing appeals have sufficient technical expertise to review 
the OIG finding.
    Some commenters recommended potential models for the appeals 
process, including the process described for ACOs in the Disincentives 
Proposed Rule, the process established for health IT developers of 
certified health IT, HINs/HIEs, Medicare programs, and the process for 
appealing enforcement of the rules promulgated under the Administrative 
Simplification provisions of HIPAA. Some commenters recommended that 
HHS clearly define the timelines for the appeals process and build 
these into the timeline for applying disincentives.
    Response. We appreciate commenters' recommendations regarding 
elements that should be included in an administrative appeals process, 
as well as recommendations regarding existing appeals processes that 
would be an appropriate model for review and appeal of disincentives. 
However, we did not propose to establish a single process for the 
administrative appeal of either a determination by OIG of information 
blocking or a disincentive imposed by an appropriate agency based on a 
referral of a determination of information blocking. Instead, the 
ability of a health care provider subject to a disincentive to appeal 
administratively the specific items identified by commenters, including 
the information blocking determination by OIG, the determination that 
information blocking conduct met the required intent standard, the 
application of a disincentive, and the calculation of the disincentive, 
would be based on the scope of any administrative appeal rights 
provided under the authority used to establish an appropriate 
disincentive. Likewise, any timelines for an administrative appeals 
process may depend upon timelines already established related to 
administrative appeal rights under the authority used to establish a 
disincentive.
    We appreciate the comment regarding technical expertise in review 
of any administrative appeals of a disincentive. While the 
responsibility for reviewing an appeal administratively would be 
determined by the authority under which the disincentive has been 
established and could vary across disincentives, we expect that other 
agencies, such as ONC, could potentially provide technical assistance 
to an appropriate agency as part of any administrative appeals process 
that is available and exercised by a health care provider. We encourage 
readers to review the information in section III.C. of this final rule 
where CMS provides further discussion of relevant policies related to 
administrative appeal, review, and reconsideration under authorities 
used to establish disincentives.
    Comments. One commenter requested clarification about the impact an 
appeal would have on the application of a disincentive and the proposed 
posting of information on the ONC website.
    Response. Regarding the impact an appeal would have on the 
application of a disincentive, we reiterate that any right to appeal 
administratively a disincentive, if available, would be provided under 
the authorities used by the Secretary to establish the disincentive. 
Therefore, the impact of any appeal rights provided for by a specific 
authority would depend on that authority. We encourage readers to 
review the information in section III.C. of this final rule where CMS 
provides further discussion of relevant policies related to appeal, 
review, and reconsideration under authorities used to establish 
disincentives.
    As discussed further in section III.B.3. of this final rule 
regarding our proposal for posting of information on ONC's website, we 
have finalized our proposal regarding information that will be publicly 
posted on ONC's website about actors that have been determined by OIG 
to have committed information blocking (specifically, where the actor 
is a health care provider, the health care provider's name, business 
address (to ensure accurate provider identification), the practice 
found to have been information blocking, including when the practice 
occurred, the disincentive(s) applied, and where to find additional 
information, where available, about the determination of information 
blocking that is publicly available via HHS or another part of the U.S. 
Government). Further, we have finalized at 45 CFR 171.1101(a)(2) that 
the information specified in 45 CFR 171.1101(a)(1) will not be posted 
prior to a disincentive being imposed and will not include information 
about a disincentive that has not been applied. As noted in section 
III.B.3., we have modified our finalized policy to provide further 
clarification that posting of information about a disincentive will not 
occur until after any available administrative appeals process has been 
completed.
    Comments. One commenter recommended not applying disincentives in 
any program that does not have an appeals process that would allow 
health care providers to appeal the finding and the disincentive.
    Response. We appreciate the commenter's recommendation. However, we 
decline to limit the establishment of disincentives to those 
disincentives which can be established using authorities that provide 
for administrative appeal rights meeting certain standards. Since we 
must establish disincentives using authorities under applicable Federal 
law as required under PHSA section 3022(b)(2)(B), we must balance our 
interest in providing for administrative appeal rights with a limited 
set of available authorities which can be used to establish appropriate 
disincentives. We believe that focusing only on those authorities which 
provide for a specific set of administrative appeal rights would limit 
our ability to meet our goal of establishing appropriate disincentives 
for the health care providers subject to the information blocking 
regulations, as defined in 45 CFR 171.102.
    We did not propose to establish a single administrative appeals 
process for health care providers to appeal the application of 
disincentives being finalized in this rule. We reiterate that any right 
to appeal administratively a disincentive, if available, would be 
provided under the authorities used by

[[Page 54678]]

the Secretary to establish the disincentive.
3. Transparency for Information Blocking Determinations, Disincentives, 
and Penalties
    In the Disincentives Proposed Rule, we stated that it is important 
to promote transparency about how and where information blocking is 
impacting the nationwide health information technology infrastructure 
(88 FR 74953). We further stated that publicly releasing information, 
including applicable public settlements, penalties, and disincentives, 
about actors that have been determined by OIG to have committed 
information blocking can inform the public about how and where 
information blocking is occurring within the broader health information 
technology infrastructure.
    PHSA section 3001(c)(4) (42 U.S.C. 300jj-11(c)(4)) requires that 
the National Coordinator maintain an internet website ``to ensure 
transparency in promotion of a nationwide health information technology 
infrastructure.'' We believe this provision provides the National 
Coordinator with the authority to post information on ONC's website if 
that information has an impact on issues relating to transparency in 
the promotion of a nationwide health information technology 
infrastructure. In the Disincentives Proposed Rule, we proposed to add 
a new subpart K to 45 CFR part 171, entitled ``Transparency for 
Information Blocking Determinations, Disincentives, and Penalties'' (88 
FR 74953). As proposed in 45 CFR 171.1100, this subpart would set forth 
the information that would be publicly posted on ONC's website about 
actors that have been determined by OIG to have committed information 
blocking.
    We proposed in 45 CFR 171.1101 that, in order to provide insight 
into how and where information blocking conduct is impacting the 
broader nationwide health information technology infrastructure, ONC 
would post on its public website information about actors that have 
been determined by OIG to have committed information blocking (88 FR 
74953). For health care providers that are subject to a disincentive, 
we proposed in 45 CFR 171.1101(a)(1) that the following information 
would be posted: health care provider's name, business address (to 
ensure accurate provider identification), the practice found to have 
been information blocking, the disincentive(s) applied, and where to 
find additional information, where available, about the determination 
of information blocking that is publicly available via HHS or another 
part of the U.S. Government. We proposed in 45 CFR 171.1101(a)(2) that 
the information specified in 45 CFR 171.1101(a)(1) would not be posted 
prior to a disincentive being imposed and would not include information 
about a disincentive that has not been applied.
    We recognized that under the authorities used to establish the 
disincentives proposed in section III.C. of the Disincentives Proposed 
Rule, an appropriate agency may have other obligations related to the 
release of information about a participant that is a health care 
provider (as defined in 45 CFR 171.102) in programs under that 
authority (88 FR 74953 and 74954). For instance, under SSA section 
1848(q)(9)(C), MIPS eligible clinicians have a right to review 
information about their performance in MIPS prior to having this 
information publicly posted on the Compare Tool in accordance with 42 
CFR 414.1395. Therefore, we proposed in 45 CFR 171.1101(a)(3) that 
posting of the information about health care providers that have been 
determined to have committed information blocking and have been subject 
to a disincentive would be conducted in accordance with existing rights 
to review information that may be associated with a disincentive 
specified in 45 CFR 171.1001. For instance, where a health care 
provider, as defined in 45 CFR 171.102, has a statutory right to review 
performance information, this existing right would be exercised prior 
to public posting of information regarding information blocking on the 
website described above.
    In order to provide insight into how and where information blocking 
conduct is impacting the broader nationwide health information 
technology infrastructure, we also proposed in 45 CFR 171.1101(b)(1) to 
post on ONC's public website information specified in 45 CFR 
171.1101(b)(1) about health IT developers of certified health IT and 
HINs/HIEs that have been determined by OIG to have committed 
information blocking and have either resolved their CMP liability with 
OIG or had a CMP imposed by OIG for information blocking under subpart 
N of 42 CFR part 1003 (88 FR 74954). To ensure accurate identification 
of actors, we proposed in 45 CFR 171.1101(b)(1) to post the type of 
actor (for example, HINs/HIEs or health IT developers of certified 
health IT) and the actor's legal name, including any alternative or 
additional trade name(s) under which the actor operates.
    The last information we proposed to post on our public website, for 
all actors, would be the two types of information mentioned above 
regarding health care providers (88 FR 74954). First, in 45 CFR 
171.1101(a)(1)(iii) and (b)(1)(iii), we proposed to post a description 
of the practice, as the term is defined in 45 CFR 171.102 and 
referenced in 45 CFR 171.103, found to have been information blocking. 
In the case of a resolved CMP liability, we would post the practice 
alleged to be information blocking. This information will help provide 
transparency into how information blocking conduct is impacting the 
nationwide health information technology infrastructure, and in 
particular, specific practices that are impacting the infrastructure. 
Second, in 45 CFR 171.1101(a)(1)(v) and (b)(1)(iv), we proposed to post 
where to find additional information about the determination (or 
resolution of CMP liability) of information blocking that is publicly 
available via HHS or, where applicable, another part of the U.S. 
Government. This information could include hyperlinks and other 
information, to help interested persons find any additional information 
about the determination, settlement, penalty, or disincentive that has 
been made publicly available by the U.S. Government. Such publicly 
available information would include any summaries or media releases 
that may be posted by OIG, or another part of HHS, on their internet 
website(s). It could also include additional information that may be 
made publicly available about the determination by or other parts of 
the U.S. Government. For example, if an actor who has exhausted 
applicable administrative appeal procedures and brought action in a 
Federal court for review of the decision that has become final, we 
could post information on our website about the existence of the court 
action and where or how to access information about the determination, 
or resulting court action, that has been made publicly available by the 
court. This information would provide additional context for how 
information blocking conduct is impacting the nationwide health 
information technology infrastructure.
    In the Disincentives Proposed Rule, we stated that publicly posting 
information about actors that have been determined by OIG to have 
committed information blocking is important for providing transparency 
into how and where information blocking conduct is occurring within and 
impacting the broader nationwide health information technology 
infrastructure (88 FR 74954). Between April 5, 2021, and September 30, 
2023, we received over 800 claims of information blocking through the

[[Page 54679]]

Report Information Blocking Portal.\18\ We publicly post information 
about these claims, which we update monthly. Beyond posting the number 
of claims, the posted information includes claim counts by type of 
claimant and claim counts by potential actor.\19\ While OIG has not 
necessarily evaluated whether these claims qualify as information 
blocking, this information provides transparency about how participants 
in the nationwide health IT infrastructure perceive actions by actors 
that are part of the same infrastructure, which is intended to support 
the access, exchange, and use of EHI. A natural progression of the 
posting of such information is the posting of information about actual 
information blocking determinations by OIG, including any disincentives 
applied to health care providers. This information can help the public 
understand how the information blocking regulations, which seek to 
prevent and address practices that unreasonably or unnecessarily 
interfere with lawful access, exchange, or use of EHI through the 
nationwide health IT infrastructure, are being enforced. It would also 
provide clarity regarding how and where actors are engaging in 
information blocking practices within the nationwide health IT 
infrastructure. Based on this information, participants in the 
nationwide health IT infrastructure, as well as members of the general 
public, can confirm or dispel perceptions of information blocking 
within that infrastructure. Additionally, the combined transparency 
into the processes Congress authorized and instructed HHS to implement 
(that is, ONC implementing a claims reporting process, disincentives 
for applicable actors found to have committed information blocking by 
OIG) would foster public confidence in the information blocking 
enforcement framework and potentially encourage public participation in 
that framework, whether by submitting a claim of information blocking 
or participating in an OIG information blocking investigation. We 
invited public comments on these proposals, including comments on 
whether we should publicly post additional information (and why) about 
health care providers, health IT developers of certified health IT, or 
HINs/HIEs that have been determined by OIG to have committed 
information blocking.
---------------------------------------------------------------------------

    \18\ For more information, see: ``Information Blocking Claims: 
By the Numbers,'' https://www.healthit.gov/data/quickstats/information-blocking-claims-numbers.
    \19\ Ibid.
---------------------------------------------------------------------------

    The following is a summary of the comments we received and our 
responses.
    Comments. Many commenters supported the proposal to publicly post 
information about actors that have been determined to have committed 
information blocking. Several commenters expressed that the proposal 
would increase transparency by: providing a better understanding for 
the healthcare community, including patients, about information 
blocking practices and how they are assessed by HHS; providing greater 
visibility to regulators and other health system stakeholders on the 
gaps and barriers to information sharing; showing the degree to which 
healthcare data is currently being blocked; supporting patients in 
making informed decisions about future care; and providing health care 
providers with information about health IT developers of certified 
health IT and HINs/HIEs. Several commenters expressed that public 
posting will further help prevent information blocking violations, 
enhance accountability, and drive improvements.
    Response. We thank commenters for the support of our proposal to 
publicly post information about actors that have been determined to 
have committed information blocking and, in the case of health care 
providers, have been subject to a disincentive.
    Comments. A few commenters supported the proposal, in 45 CFR 
171.1101(a)(3), that posting of the information specified in 45 CFR 
1101(a)(1) about health care providers that have been determined to 
have committed information blocking and have been subject to a 
disincentive would be conducted in accordance with existing rights to 
review information that may be associated with the applied 
disincentive. Other commenters expressed concern over not having the 
ability to review what information is posted prior to the information 
being publicly posted and recommended being able to review the 
information for accuracy before posting. One commenter expressed 
concern that health care provider information could be erroneously 
posted and the burden to correct any inaccurate postings would fall 
upon the provider after the fact.
    Response. We thank commenters for their comments. We did not 
propose a unique process by which health care providers would be 
provided an opportunity to review information prior to posting on ONC's 
website. The information that would be posted is basic information 
about the health care provider and the information blocking 
determination (for example, provider name and address, practice found 
to be information blocking, disincentive(s) applied, and where to find 
additional information about the determination of information blocking 
that is publicly available via HHS or, where applicable, another part 
of the U.S. Government) that would be derived and confirmed through the 
OIG investigation and referral to CMS. HHS will work with healthcare 
providers to correct any clerical errors in these information elements 
to be posted prior to the information being posted on ONC's website or 
to correct such information after posting.
    Further, in the Disincentives Proposed Rule, we recognized that an 
appropriate agency may have other program obligations related to 
release of information about a participant that is a health care 
provider (as defined in 45 CFR 171.102) in such programs (88 FR 74953 
and 74954). On this basis, we proposed at 45 CFR 171.1101(a)(3) that 
posting of the information about health care providers that have been 
determined to have committed information blocking and have been subject 
to a disincentive would be conducted in accordance with existing rights 
to review information that may be associated with a disincentive 
specified in 45 CFR 171.1001. For instance, where a health care 
provider, as defined in 45 CFR 171.102, has a statutory right to review 
performance information, this existing right would be exercised prior 
to public posting of information regarding information blocking on the 
website described above. We believe that establishing an additional 
review process could potentially conflict with or duplicate these 
existing statutory review rights, such as review rights provided under 
MIPS at SSA section 1848(q)(9)(C).
    Comments. Many comments recommended against public posting until 
after a health care provider has completed an appeals process. Many 
commenters also recommended not publicly posting information on the ONC 
website if the actor(s) are conducting or have completed educational or 
corrective steps, including providing a period of one or more years for 
actors to complete corrective actions or come into compliance before 
public posting.
    Response. We did not propose a single administrative appeals 
process for information blocking disincentives. Instead, as described 
in section III.B.2. of this final rule, any right to appeal 
administratively a disincentive, if available, would be provided under 
the authorities used by the Secretary to establish a disincentive 
through notice

[[Page 54680]]

and comment rulemaking. In proposing at 45 CFR 171.1101(a)(2) that 
information will not be posted prior to a disincentive being imposed 
and will not include information about a disincentive that has not been 
applied, we intended to capture scenarios where a health care provider 
may have a right to administratively appeal under the authority used to 
establish the disincentive. Our intent was to be consistent with our 
proposal for health IT developers of certified health IT and HIN/HIEs 
in 45 CFR 171.1101(b)(2), which states that information will not be 
posted on ONC's website until a CMP has become final consistent with 
the procedures in subpart O of 42 CFR part 1003, which include 
procedures for an appeal of a CMP. However, we believe that additional 
clarity regarding the issue of appeals highlighted by the commenters is 
necessary to ensure the language reflects our intended policy. 
Therefore, we have finalized a modification to the provision in 45 CFR 
171.1101(a)(2) to add that information will not be posted prior to the 
completion of any administrative appeals process pursued by the health 
care provider, for example, an appeals process provided for under the 
authority used to establish the disincentive.
    For health care providers, we note that we did not propose, and 
have not finalized, corrective action options for those health care 
providers that OIG has determined to have committed information 
blocking, including remedial actions, to avoid public posting. 
Regarding corrective action plans for health IT developers of certified 
health IT or HINs/HIEs, we refer readers to the discussion in the OIG 
CMP Final Rule, in which OIG states that it does not anticipate using 
alternatives to CMPs such as corrective action plans at the time of the 
final rule but may consider such approaches in the future (88 FR 
42824).
    Comments. One commenter stated that public posting should not be 
implemented until all health care providers are equally disincentivized 
for information blocking. Another commenter urged ONC to delay the 
launch of this website until regulated health care providers and the 
relevant Federal agencies have had experience with investigations and 
referrals for disincentives and actors have received clearer guidance.
    Response. We acknowledge commenters' concerns that this final rule 
does not finalize disincentives that apply to all the types of health 
care providers included in the health care provider definition at 45 
CFR 171.102. However, it is important to begin providing transparency 
about those health care providers to whom the disincentive(s) finalized 
in this rule are applied in order to begin providing the public with 
transparency about how and where information blocking is impacting the 
nationwide health information technology infrastructure.
    PHSA section 3001(c)(4) requires that the National Coordinator 
maintain an internet website ``to ensure transparency in promotion of a 
nationwide health information technology infrastructure.'' The website 
where the information would appear is not a new website but rather the 
current ONC website.\20\ We disagree that posting on the website should 
be delayed until regulated health care providers and Federal agencies 
have had experience with investigations and referrals for 
disincentives. Federal agencies have experience with investigations and 
referrals, and health care provider information already appears on 
several websites throughout the Federal government. We also provide 
data on the ONC website about claims or suggestions of possible 
information blocking collected through the Report Information Blocking 
Portal \21\ and education resources and guidance on the information 
blocking regulations on the ONC website.\22\
---------------------------------------------------------------------------

    \20\ For more information, see: https://www.healthit.gov/.
    \21\ For more information, see: https://www.healthit.gov/data/quickstats/information-blocking-claims-numbers.
    \22\ For more information, see: https://www.healthit.gov/topic/information-blocking.
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    Comments. Some commenters stated that posting health care provider 
information is a second penalty on top of the monetary disincentive. 
One commenter asked if public posting is considered a disincentive and 
recommended it be classified as such. Several commenters expressed 
concerns about the proposal to list the names of actors determined to 
have engaged in information blocking on ONC's website, stating that 
this provision will do little to advance transparency regarding the 
impact of information blocking on the nationwide health information 
technology infrastructure but will result in public shaming of actors 
who have already been penalized for their conduct.
    Response. We do not agree with commenters that publicly posting 
health care provider names constitutes a disincentive. We also disagree 
with commenters that the posting of health care provider names would be 
sufficient to deter information blocking, consistent with our 
discussion of appropriate disincentives in section III.A.3. of this 
final rule. We note that the disincentives CMS proposed and has 
finalized in this final rule would each potentially result in a 
consequence for a health care provider that has been determined by OIG 
to have committed information blocking, which CMS has stated would 
deter information blocking practices. The posting of information about 
health care providers that have committed blocking and been subject to 
a disincentive does not reflect a consequence commensurate with an OIG 
determination that the health care provider committed information 
blocking or the disincentives CMS has finalized.
    Last, we disagree that the posting of health care provider names 
following the imposition of a disincentive as part of the information 
publicly posted on ONC's website will not advance transparency about 
information blocking practices. As we have stated, the purpose of 
posting health care provider names is to ensure transparency in 
promotion of a nationwide health information technology infrastructure, 
as we explain elsewhere in this final rule.
    Comments. A few commenters did not support public posting due to 
the delay from when the information blocking practice may have occurred 
and when the information would be publicly posted, stating that public 
posting after an actor has completed corrective action would unfairly 
label them information blockers and impose reputational harm after they 
have already come into compliance. One commenter specifically expressed 
concern with the delay in timing from when the information blocking act 
may have occurred to when the information would be publicly posted, 
because it may result in current health care providers operating under 
an organizational TIN being punished for conduct committed by persons 
who no longer operate under that TIN and that this could steer patients 
away from these health care providers to the patient's detriment. A few 
commenters expressed concern that a group of health care providers 
could suffer reputational harm from public posting based on a single 
actor, for instance, commenters expressed concerns about potential harm 
from public posting information about health care providers who are not 
involved in the information blocking or commit inadvertent acts.
    Response. We appreciate commenters' concerns regarding the period 
of time which may exist between the occurrence of the information 
blocking conduct and the posting of information following the 
imposition of a disincentive. We note that we did not

[[Page 54681]]

propose to establish a corrective action plan or other process to allow 
any health care provider to demonstrate compliance with the information 
blocking regulations following a determination by OIG that a practice 
is information blocking. We also remind readers that the definition of 
information blocking for health care providers requires that the health 
care provider ``knows'' that a practice is unreasonable and is likely 
to interfere with, prevent, or materially discourage access, exchange, 
or use of electronic health information. This means there would not be 
posting of unintentional, inadvertent acts of health care providers. 
While a health care provider may subsequently pursue efforts to cease 
the information blocking practice which resulted in the imposition of a 
disincentive, it is still beneficial for the public to be able to 
understand how and where information blocking is impacting the 
nationwide health information technology infrastructure, including what 
aspects of that infrastructure are being impacted by health care 
providers.
    Regarding health care providers operating under or employed by a 
larger entity, we note that under the regulations we have finalized, 
the information posted on ONC's website will be specific to the health 
care provider that OIG has determined has committed information 
blocking and that has been subject to a disincentive. If OIG determines 
that a health care provider who is an individual has committed 
information blocking and refers that individual to an appropriate 
agency, and the individual is subject to a disincentive, ONC would post 
only information regarding the individual, not any other entities with 
which the individual is associated. If OIG determines that a health 
care provider that is an entity, such as a group practice, has 
committed information blocking, and the entity is subject to a 
disincentive, ONC would post information about the entity.
    Comments. Some commenters recommended ONC use certain criteria or 
thresholds in order to decide whether to publicly post information 
about a health care provider for information blocking. Commenters 
recommended that ONC consider the following factors before determining 
whether to publicly post information, including: whether there is 
frequent, repeat, or significant information blocking, as opposed to 
minor conduct undertaken in good faith; whether the public would 
benefit from the information; whether the actor has corrected the 
information blocking; and time since the information blocking occurred. 
Other commenters recommended drawing greater attention to repeat 
offenders and actors who continue to perform the same type of 
information blocking for an extended period of time over actors who had 
a single violation that they remediated quickly.
    Response. We appreciate commenters' suggestions, but we did not 
propose to utilize criteria to determine whether to publicly post 
information about a health care provider and decline to adopt them in 
this final rule. We believe it is important to provide transparency 
with respect to any determination of information blocking that has 
resulted in a health care provider being subject to a disincentive in 
order to increase understanding about how and where information 
blocking is impacting the nationwide health information technology 
infrastructure, including the scope of information blocking practices 
that have resulted in disincentives.
    Regarding the suggested factor which referenced ``minor conduct 
undertaken in good faith,'' we remind readers, as we did in a prior 
response, that information blocking has an element of intent. For 
health care providers, that intent is that the health care provider 
knows that a practice is unreasonable and is likely to interfere with, 
prevent, or materially discourage access, exchange, or use of 
electronic health information.
    We also remind readers that, as discussed in III.B.1.a. of this 
final rule, OIG expects to use four priorities to inform decisions 
about which information blocking allegations to pursue: (i) resulted 
in, are causing, or have the potential to cause patient harm; (ii) 
significantly impacted a provider's ability to care for patients; (iii) 
were of long duration; and (iv) caused financial loss to Federal health 
care programs, or other government or private entities. However, these 
priorities are not dispositive. OIG will assess each allegation to 
determine whether it implicates one or more of the enforcement 
priorities, or otherwise merits further investigation and potential 
enforcement action, and OIG may evaluate allegations and prioritize 
investigations based in part on the volume of claims relating to the 
same (or similar) practices by the same entity or individual.
    Comments. A few commenters recommended that only deidentified actor 
information be posted, at least initially. One commenter did not 
support public posting of obstetrician-gynecologists' names, practice 
information and information blocking determination, expressing concern 
about criminalization and scrutiny of reproductive healthcare data. One 
commenter recommended that rather than listing the details of 
information blockers, ONC list all health care providers who are 
successfully exchanging information.
    Response. We disagree with the commenter that only deidentified 
actor information should be publicly posted. The identification of 
health care providers that have committed information blocking is 
important for the public to be aware of the particular circumstances in 
which information blocking is occurring and, therefore, to understand 
which aspects of the nationwide health information technology 
infrastructure are being impacted. We also disagree with the commenter 
that we should not publicly post information regarding obstetrician-
gynecologists. If a health care provider has been determined by OIG to 
have committed information blocking and is subject to a disincentive, 
we will post information regardless of their specialty or practice. To 
promote transparency, we believe it is important to release information 
about actors that have been determined by OIG to have committed 
information blocking to inform the public about how and where 
information blocking is occurring within the broader health information 
technology infrastructure. For more information about concerns 
regarding withholding electronic health information related to 
reproductive health care, we refer readers to a May 13, 2024, blog post 
on ONC's website \23\ that explains how the ``HIPAA Privacy Rule to 
Support Reproductive Health Care Privacy'' final rule (89 FR 32976), 
which appeared in the Federal Register on April 26, 2024, and the 
information blocking regulations work together to protect the privacy 
of such health information.
---------------------------------------------------------------------------

    \23\ See: https://www.healthit.gov/buzz-blog/information-blocking/supporting-information-privacy-for-patients-now-and-always-four-reminders-of-how-hhs-information-blocking-regulations-recognize-privacy-rules.
---------------------------------------------------------------------------

    Regarding the recommendation to post information about those health 
care providers that are successfully exchanging information, we note 
that we did not propose to do so in the Disincentives Proposed Rule and 
decline to finalize such a policy in this final rule. We also note that 
some of this type of information may be made available through existing 
mechanisms. For instance, the Medicare Promoting Interoperability 
Program and MIPS Promoting Interoperability performance category 
involve public reporting components about health care provider 
performance in these programs, which

[[Page 54682]]

can reflect successful performance on measures of health information 
exchange that contribute to performance under these programs.
    Comments. A few commenters recommended posting the year or 
timeframe in which the information blocking violation occurred. Several 
commenters recommended establishing a time limit on posting the 
information to the website by which to remove health care providers 
from the information blocking list on the website.
    Response. We thank commenters for the recommendation to include the 
timeframe during which the information blocking occurred as part of the 
information we are publicly posting. We stated in the Disincentive 
Proposed Rule that we sought to help the public understand ``how'' and 
``where'' information blocking is occurring within the broader health 
information technology infrastructure (88 FR 74953). We agree that 
information about when information blocking occurred is a critical 
piece of information and that this concept is implicit in our interest 
in providing transparency regarding ``how'' and ``where'' information 
blocking occurred to support understanding of the scope of information 
blocking practices over time that impact the nationwide health 
information technology infrastructure. To this point, knowing when 
information blocking occurred is part of knowing how it occurred. 
Without this information, the public, including other health care 
providers, would not know whether a particular practice determined to 
be information blocking was a recent occurrence that may have 
implications for their own recent or current interactions with the 
health care provider that was found to have committed information 
blocking; or whether the practice occurred at a time when such health 
care providers had no interactions with the health care provider found 
to have committed information blocking. Therefore, we agree with 
commenters that it would be appropriate to explicitly identify the 
timeframe as part of the ``description of the [information blocking] 
practice'' that we proposed to include in the information for posting 
in 45 CFR 171.1101(a)(1)(iii) for health care providers and 45 CFR 
171.1101(b)(1)(iii) (88 FR 74954). Accordingly, we have modified the 
language in 45 CFR 171.1101(a)(1)(iii) and 45 CFR 171.1101(b)(1)(iii) 
to clarify that the description of the practice includes when the 
practice occurred.
    We did not propose to put a time limit on how long the information 
would be posted on ONC's website, and we are not adopting the 
commenter's recommendation. We may consider this recommendation in 
future rulemaking.
    Comments. One commenter expressed concern that HHS could further 
use the posted information to apply additional disincentives or bar a 
physician from participation in other programs and that additional 
rulemaking would be needed for such uses.
    Response. We appreciate the commenter's concern; however, we note 
that the imposition of a disincentive would be based on a referral from 
OIG of its determination that a health care provider committed 
information blocking, rather than the public posting of information on 
ONC's website. Moreover, we note that we have finalized that the 
disincentives established for health care providers pursuant to PHSA 
section 3022(b)(2)(B) are listed in 45 CFR 171.1001. Other actions not 
listed in 45 CFR 171.1001 taken by Federal programs based on the 
information publicly posted on ONC's website would not be a 
disincentive and are outside the scope of this final rule.
    Comments. One commenter stated that public posting of information 
would lead to unintended consequences such as distrust or an 
adversarial relationship between actors subject to the information 
blocking regulations and HHS. Another commenter expressed concern that 
public posting, combined with the potential for significant 
disincentives, would deter information blocking complaints. The 
commenter stated that the health data interoperability community is 
dependent upon good working relationships between individuals and 
organizations that operate in the space and that a complainant may 
refrain from submitting information blocking claims in order to 
maintain a good relationship with the individual or entity alleged to 
have committed information blocking.
    Response. We appreciate commenters' input but believe that the 
value of publicly posting this information outweighs any concerns about 
increasing distrust between health care providers and HHS or between 
health care providers and other entities supporting health information 
exchange. We note that information blocking negatively impacts health 
care providers by limiting access to electronic health information that 
may be necessary for effective care delivery and suggest that all 
parties committed to increasing the exchange of electronic health 
information should support the public availability of information about 
how and where information blocking is impacting the nationwide health 
information technology infrastructure.
    After consideration of the public comments, we have finalized these 
proposals with the modifications discussed above.

C. Appropriate Disincentives for Health Care Providers

    In the Disincentives Proposed Rule, we proposed to establish a set 
of disincentives for health care providers that have committed 
information blocking (88 FR 74954 through 74966). We noted that each of 
the proposed disincentives would be imposed by CMS following a referral 
of a determination of information blocking by OIG. We stated that each 
of the disincentives was being proposed using authorities under 
applicable Federal law, consistent with PHSA section 3022(b)(2)(B).
1. Background
a. Impacted Health Care Providers
    In the Disincentives Proposed Rule, we stated that the proposed 
disincentives would apply to a subset of the individuals and entities 
meeting the information blocking regulations' definition of health care 
provider at 45 CFR 171.102 (88 FR 74954 and 74955). As discussed 
hereafter, this rule establishes disincentives for health care 
providers (as defined in 45 CFR 171.102) that are also eligible to 
participate in certain Federal programs: the Medicare Promoting 
Interoperability Program and the MIPS Promoting Interoperability 
performance category (previously the EHR Incentive Programs); and the 
Medicare Shared Savings Program.
    In the Disincentives Proposed Rule, we recognized that the 
disincentives proposed would only apply to certain health care 
providers and that the information blocking regulations are also 
applicable to health care providers that are not eligible to 
participate in these programs (88 FR 74955). However, the policies we 
have finalized in this rule are a first step that focuses on 
authorities that pertain to certain health care providers that furnish 
a broad array of healthcare services to large numbers of Medicare 
beneficiaries and other patients. We believe optimal deterrence of 
information blocking calls for imposing appropriate disincentives on 
all health care providers (as defined at 45 CFR 171.102) determined by 
OIG to have committed information blocking. In section IV. of this 
final rule, we acknowledge public comments received in response to a 
request for information on establishing disincentives, using applicable 
Federal law, that could be

[[Page 54683]]

imposed on a broader range of health care providers.
b. Impact of Disincentives
    In the Disincentives Proposed Rule, we stated that we believe the 
proposed disincentives would deter information blocking by health care 
providers. However, we recognized that the actual monetary impact 
resulting from the application of the disincentives may vary across 
health care providers subject to the disincentive (88 FR 74955). For 
example, the disincentive proposed in section III.C.3. of the 
Disincentives Proposed Rule, for the MIPS Promoting Interoperability 
performance category, would result in an adjustment to payments under 
Medicare Part B to MIPS eligible clinicians (as defined in 42 CFR 
414.1305). This disincentive would reduce to zero the Promoting 
Interoperability performance category score of any MIPS eligible 
clinician that has been determined by OIG to have committed information 
blocking (as defined at 45 CFR 171.103) during the calendar year (CY) 
of the referral of a determination from OIG. However, the actual 
financial impact experienced by a health care provider because of this 
proposed disincentive being applied in MIPS would vary. For example, 
Part B payments to the MIPS eligible clinician are subject to a MIPS 
payment adjustment factor, which CMS determines based on the MIPS 
eligible clinician's final score. We noted that, in determining each 
MIPS eligible clinician's final score, CMS considers the assigned 
weight of, and the MIPS eligible clinician's performance in, the four 
MIPS performance categories, including the Promoting Interoperability 
performance category. The MIPS eligible clinician's final score then 
determines whether the eligible clinician earns a negative, neutral, or 
positive payment adjustment factor that will be applied to the amounts 
otherwise paid to the MIPS eligible clinician under Medicare Part B for 
covered professional services during the applicable MIPS payment year 
(88 FR 74955).
    In the interest of addressing this variability, we discussed in the 
Disincentives Proposed Rule that we had considered whether we could 
propose an alternative approach under which we would tailor the 
monetary impact of a disincentive imposed on a health care provider to 
the severity of the conduct in which the health care provider engaged 
(88 FR 74955). However, we stated that we did not believe it would be 
feasible to develop such an approach for the disincentives proposed for 
health care providers. We noted that, because disincentives must be 
established using authorities under applicable Federal law, the statute 
under which a disincentive is being established would need to 
specifically authorize or provide sufficient discretion for an 
appropriate agency to be able to adjust the monetary impact of the 
disincentive to fit the gravity or severity of the information blocking 
the health care provider has been determined to have committed. We 
noted that, based on our review of potential authorities under which to 
establish disincentives, we believed many authorities do not provide 
discretion to adjust the monetary impact of a potential disincentive in 
this fashion. For instance, in the Disincentives Proposed Rule, CMS 
proposed to establish a disincentive through the Medicare Promoting 
Interoperability Program utilizing authority in SSA section 1886 (88 FR 
74955). Under this authority, CMS, as specified in section 
1886(b)(3)(B)(ix)(I) of the SSA, adjusts payments for eligible 
hospitals by a fixed proportion, based on whether or not an eligible 
hospital (as defined in section 1886(n)(6)(B) of the SSA) is a 
meaningful EHR user.
    We did not make any proposals in this section of the Disincentives 
Proposed Rule; however, we summarize and respond below to general 
comments that we received on this discussion.
    Comments. Some commenters expressed support for disincentives for 
health care providers who have been found to have committed information 
blocking. These commenters expressed that these disincentives will lead 
to better patient outcomes, improved information sharing, increased 
transparency, a reduction in systemic inefficiency and waste, and 
improved accountability and compliance. Some commenters agreed that the 
three programs described in the Disincentives Proposed Rule (that is, 
the Medicare Promoting Interoperability Program for eligible hospitals 
and CAHs, the Promoting Interoperability performance category of MIPS, 
and the Medicare Shared Savings Program) are appropriate programs under 
which to establish disincentives.
    Response. We thank commenters for their support of the proposed 
disincentives.
    Comments. One commenter expressed that the proposed disincentives 
impose substantial punishments on health care providers found to have 
engaged in information blocking and thereby exceed the regulatory 
authorities delegated to HHS agencies by Congress. The commenter stated 
that the term ``disincentivize'' means the act of creating a 
disincentive or withdrawing a previously existing incentive. However, 
the commenter stated that the Disincentives Proposed Rule proposed 
penalties that would impose significant punishments on health care 
providers found to have engaged in information blocking. The commenter 
cited West Virginia v. EPA,\24\ to suggest that the rule ``may'' have 
the type of significant impact that requires Congress explicitly to 
grant regulatory power to the agency.
---------------------------------------------------------------------------

    \24\ 597 U.S. 697 (2022).
---------------------------------------------------------------------------

    Response. We disagree that the disincentives that CMS has finalized 
in section III.C. of this final rule exceed the regulatory authority 
Congress granted to the Secretary in the Cures Act. Section 4004 of the 
Cures Act amended the PHSA to create section 3022(b)(2)(B), which 
states that a health care provider ``shall be referred to the 
appropriate agency to be subject to appropriate disincentives using 
authorities under applicable Federal law, as the Secretary sets forth 
through notice and comment rulemaking.'' The commenter does not dispute 
that each of the disincentives CMS proposed and has finalized in this 
section (III.C.) use authorities under applicable Federal law, and we 
are adopting each disincentive through this notice-and-comment 
rulemaking. The agency is applying existing authorities to individuals 
and entities that are already subject to them, to disincentivize one 
set of prohibited behaviors. This is not one of the ``extraordinary 
cases'' in which the ``history and the breadth of the authority that 
the agency has asserted, and the economic and political significance of 
that assertion'' merits increased scrutiny.\25\ Even if it did, the 
statute has specifically delegated responsibility for establishing 
appropriate disincentives to the Secretary of HHS, through notice and 
comment rulemaking, and so provides all express authorization that 
might be needed.
---------------------------------------------------------------------------

    \25\ West Virginia v. EPA, 597 U.S. 697, 721 (2022).
---------------------------------------------------------------------------

    The commenter reads the term ``disincentive'' to exclude penalties 
or punishment. We agree that we should account for statute's use of the 
term ``disincentives.'' We do so by adopting a definition of 
``disincentive'' in 45 CFR 171.102 that includes conditions imposed by 
an appropriate agency on a health care provider that OIG determines has 
committed information blocking, for the purpose of deterring 
information blocking. A disincentive could be any condition that would 
have a deterrent effect on information blocking, as explained in 
section III.A.3. of this final rule. But we reject the commenter's 
effort to draw a strict line between deterrence and punishment.

[[Page 54684]]

Those two concepts are often interrelated.\26\
---------------------------------------------------------------------------

    \26\ See Exxon Shipping Co. v. Baker, 554 U.S. 471, 493 (2008), 
(noting one ``aim'' of ``punishment'' is ``deterrence''); Hudson v. 
United States, 522 U.S. 93, 102 (1997), (``[A]ll civil penalties 
have some deterrent effect.'').
---------------------------------------------------------------------------

    Finally, CMS has finalized disincentives that are designed to deter 
information blocking; they are not impermissibly punitive. As discussed 
in section III.C.2. of this final rule, a reduction of three quarters 
of the annual market basket update deters eligible hospitals from 
engaging in information blocking because it would reduce the inpatient 
prospective payment system (IPPS) payment that an eligible hospital 
could have earned had it met other requirements under the Medicare 
Promoting Interoperability Program. For CAHs, receiving 100 percent of 
reasonable costs instead of the 101 percent of reasonable costs that a 
CAH may have earned for successful participation in the Medicare 
Promoting Interoperability Program deters information blocking by CAHs 
because it reduces the reimbursement a CAH could have received had it 
met other requirements under the Medicare Promoting Interoperability 
Program. For MIPS eligible clinicians, the disincentive under the MIPS 
Promoting Interoperability performance category deters information 
blocking by other MIPS eligible clinicians because a MIPS eligible 
clinician who receives a score of zero in the MIPS Promoting 
Interoperability performance category under the disincentive cannot 
earn a positive MIPS payment adjustment factor that they otherwise 
could have earned for their performance in MIPS (88 FR 74960). Finally, 
the disincentive CMS has finalized under the Shared Savings Program 
deters information blocking by potentially withholding revenue which an 
ACO or participant in an ACO might otherwise have earned through 
participation in the Shared Savings Program.
    Comments. Many commenters expressed concern that the proposed 
disincentives will have a differential impact, are variable and 
confusing, and are not equitable across programs, circumstances of 
individual health care providers, and years. A few commenters expressed 
concern that there would be a much greater burden for clinicians in the 
Shared Savings Program compared to clinicians who are only subject to 
disincentives under the MIPS Promoting Interoperability performance 
category, because the monetary disincentive would be much greater for 
Shared Savings Program clinicians and would potentially interrupt care 
coordination and harm Medicare beneficiaries' care. Others stated that 
hospitals could be disproportionately impacted, citing concerns about 
the high variability of disincentive amounts that could be imposed on 
hospitals based on the market basket increase in a given year and the 
proportion of Medicare patients served. Commenters also noted that 
hospitals face unique financial and operational challenges, such as 
narrow operating margins and minimal reserves. Several commenters 
expressed concern that disincentives would lead to a larger burden and 
impact for health care providers with a larger proportion of Medicare 
claims, patients, and reimbursement. Several commenters expressed 
concern that disincentives would vary from year to year based on the 
value of the market basket adjustment and certain performance 
incentives in a given year. A few commenters specifically expressed 
concern that variation in disincentives between referral years could be 
based on how quickly OIG processes the case and refers it to CMS for 
action.
    Response. We understand commenters' concerns about the potential 
for the disincentives CMS has finalized in this rule to vary based on 
factors related to the circumstances of the health care provider, such 
as the amount of Medicare reimbursement received. However, under PHSA 
section 3022(b)(2)(B), we must establish disincentives ``using 
authorities under applicable Federal law.'' As discussed in section 
III.A.2. of this final rule, we may therefore only establish, through 
notice and comment rulemaking, a disincentive for health care providers 
using an authority Congress has previously granted to an appropriate 
agency. Where these authorities result in differential treatment of a 
health care provider based on the health care provider's circumstances 
or based on changes to the regulations promulgated under that authority 
over time, these elements will ultimately impact the value of the 
disincentive established under that authority. We acknowledged this 
variability, providing a specific example with respect to the MIPS 
Promoting Interoperability performance category, in the Disincentives 
Proposed Rule (88 FR 74955).
    However, we disagree that this variability is a compelling reason 
to not establish a certain disincentive. Such variability already 
exists as part of these programs. For instance, the monetary impact on 
an eligible hospital that is not a meaningful EHR user because it fails 
to meet the objectives and measures associated with the Medicare 
Promoting Interoperability Program will be higher for an eligible 
hospital that receives a greater volume of Medicare payment than an 
eligible hospital that receives a lower volume of Medicare payment. 
Under section 1886(b)(3)(B)(ix) of the SSA, if an eligible hospital 
does not demonstrate that it has met the requirements to be a 
meaningful EHR user under section 1886(n)(3)(A), CMS reduces the 
eligible hospital's payment by three quarters of the applicable 
percentage increase in the market basket update or rate-of-increase for 
hospitals. Under SSA 1886(b)(3)(B), the market basket update is a 
percentage applied to a hospital's base operating cost, meaning that 
the monetary value of the market basket update depends on the 
hospitals' base operating cost. This variability is integrated into the 
authority Congress established for the program, and Congress has 
required the Secretary to establish appropriate disincentives using 
authorities under Federal law.
    We further disagree with the commenters that ensuring equitable 
treatment across programs is necessary to finalize the disincentives we 
are establishing in this final rule. The authorities under which we 
have finalized disincentives require health care providers to satisfy 
certain requirements in order to participate in a program that may 
provide incentives or other benefits. In the case of the MIPS Promoting 
Interoperability performance category and the Medicare Promoting 
Interoperability Program, eligible clinicians, and eligible hospitals 
and CAHs, have the opportunity earn positive Medicare payment 
adjustments as specified under each authority. Under the Shared Savings 
Program, ACOs, ACO providers/suppliers, and participants have the 
opportunity to earn additional revenue through participation in an ACO 
if the ACO meets the requirements to earn shared savings payments.
    As discussed in section III.C., by committing information blocking, 
a health care provider is engaging in behavior that conflicts with core 
requirements of each of these programs. Health care providers that 
participate in CMS programs offering opportunities to receive positive 
payment adjustments or additional revenue take on increased 
responsibilities associated with these programs. To deter information 
blocking, we believe that where a health care provider commits 
information blocking, it should not receive these benefits, consistent 
with the increased responsibilities that these programs impose. Thus, 
as discussed by CMS under each part of this section (III.C.) in which 
it has finalized a disincentive,

[[Page 54685]]

each of these disincentives is warranted under the authorities that CMS 
has used to establish the disincentive.
    Comments. Many commenters expressed concern that the proposed 
disincentives could be extreme or harsh for health care providers. A 
few commenters expressed concern that the burden of health care 
provider information blocking disincentives would be greater for 
smaller, safety net, and less resourced health care providers. One 
commenter expressed concern that the disincentives would create extra 
burden for health care providers or sites of service that lack 
experience with electronic health records.
    Response. We appreciate commenters' concerns regarding the 
potential impact of the proposed disincentives, especially on smaller 
health care providers. However, we remind readers that, as noted in 
section III.A.3. of this final rule, we believe that disincentives 
should have the effect of deterring information blocking practices. We 
also remind readers that, in order for a practice by a health care 
provider to be considered information blocking under PHSA section 
3022(a), the health care provider must know that ``such practice is 
unreasonable and is likely to interfere with, prevent, or materially 
discourage access, exchange, or use of electronic health information.'' 
Therefore, we believe that health care providers can avoid the burden 
of the finalized disincentives by not engaging in information blocking, 
including conduct that the health care provider knows is unreasonable. 
Finally, we note that certain authorities used by CMS to finalize 
disincentives in this final rule include policies which already reflect 
the size of the health care provider, such as payment adjustments which 
reflect the volume of payments received by a health care provider under 
Medicare.
    Regarding the comment that disincentives will create additional 
burden for health care providers that lack experience with electronic 
health records, we understand that commenters are concerned that a 
health care provider could be determined to have committed information 
blocking due to a lack of knowledge or expertise about technology tools 
used to exchange of electronic health information. However, we wish to 
emphasize that for a practice committed by a health care provider to 
meet the definition of information blocking, the health care provider 
must know that such practice is unreasonable, as discussed above.
    Comments. Many commenters expressed concern that the proposed 
disincentive structure does not provide flexibility for HHS to apply 
disincentives that are reasonable, appropriate, and proportional for 
the specific instance of information blocking. Many commenters 
recommended that disincentives should be tailored to the severity or 
frequency of conduct, or the degree to which the conduct resulted in 
patient harm. Other commenters suggested tailoring disincentives based 
on other factors such as: whether the health care provider participates 
in an HIE; whether a health care provider made a good faith attempt to 
not engage in information blocking or comply with an exception; whether 
the health care provider made proactive efforts to promote access to 
information; state-specific circumstances affecting the health care 
provider; and whether the health care provider is engaged in 
complicated medical areas, such as reproductive and gender-affirming 
care. Commenters expressed that tailoring disincentives in this way 
would increase the proposed policy's effectiveness and reduce 
disproportionate impact. Some commenters recommended including a 
maximum disincentive amount to ensure health care providers are not 
unduly penalized. Commenters stated that although the Cures Act 
requires the disincentives to be made ``using authorities under 
applicable Federal law,'' such language could permit different 
disincentive thresholds, scaling, or other ways to establish and 
appropriately calibrate financial penalties. A few commenters 
recommended that the alternative policy discussed in the Disincentives 
Proposed Rule for the Shared Savings Program, in which CMS would review 
other facts and circumstances of the case should be applied for all 
health care provider information blocking disincentives to allow for 
consideration of frequency, severity, and intent and to allow for 
remediation.
    Response. We acknowledge commenters' recommendations to link the 
impact of disincentives to different factors, such as the severity or 
scale of the conduct. As discussed in the Disincentives Proposed Rule, 
we considered whether we could propose an alternative approach under 
which we would tailor the monetary impact of a disincentive imposed on 
a health care provider to the severity of the conduct in which the 
health care provider engaged (88 FR 74955). However, we stated that, 
because disincentives must be established using authorities under 
applicable Federal law, the statute under which a disincentive is being 
established would need to specifically authorize or provide sufficient 
discretion for an appropriate agency to be able to adjust the monetary 
impact of the disincentive to fit the gravity or severity of the 
information blocking the health care provider has been determined to 
have committed. We further noted that, based on our review of potential 
authorities under which to establish disincentives, many authorities do 
not provide discretion to adjust the monetary impact of a potential 
disincentive in this fashion (88 FR 74955). For instance, as discussed 
in the Disincentives Proposed Rule, the authority we used in section 
1886(b)(3)(B)(ix)(I) of the SSA to establish a disincentive under the 
Medicare Promoting Interoperability Program does not allow for such 
discretion (88 FR 74955).
    In the case of the Shared Savings Program, CMS has finalized a 
policy based on an alternative proposal discussed in the Disincentives 
Proposed Rule. This policy will allow the Shared Savings Program to 
exercise discretion about whether or not to impose a disincentive based 
on certain factors, consistent with existing discretion exercised by 
the Shared Savings Program when addressing program integrity issues and 
issues specific to the effects of imposing a disincentive under the 
Shared Savings Program on other individuals and entities that may 
participate in an ACO. CMS states in section III.C.4. that these 
factors include the time since the information blocking conduct 
occurred and whether the ACO or provider/supplier has taken steps to 
mitigate this conduct. However, it is important to note that CMS has 
finalized this as a policy specific to the Shared Savings Program.
    For disincentives established under the Medicare Promoting 
Interoperability Program and the MIPS Promoting Interoperability 
performance category, which have been established under different 
authorities in the SSA, CMS did not propose and has not finalized to 
take such factors into consideration before imposing a disincentive.
    Comments. Many commenters recommended that steps such as initial 
notices or warnings of non-compliance, education, corrective action, 
and technical assistance be utilized before applying a disincentive for 
a health care provider found to have committed information blocking. 
Several commenters recommended that education and technical assistance 
should be provided before applying a disincentive for specific health 
care providers, including health care providers that disproportionately 
serve low-income, minority, underserved, or

[[Page 54686]]

immigrant populations; solo and small practitioners; and other less 
resourced health care providers. Some commenters recommended these 
steps should be used until health care providers gain experience with 
the information blocking requirements or for first time offenders. 
Commenters recommended these steps for a number of reasons, including: 
the information blocking requirements are new and complex and many 
health care providers do not yet fully understand the requirements; 
most information blocking is inadvertent and should not be subject to 
significant penalties as an initial step; such steps could avoid 
potential negative impacts on patient access and Medicare 
participation; and corrective steps before a disincentive would better 
promote information sharing and prevent future information blocking 
violations.
    Many commenters expressed that such approaches would be consistent 
with other HHS and CMS programs and policies that allow for education 
and corrective steps. A few commenters expressed that the terminology 
used in PHSA section 3022(b)(2)(B), ``appropriate disincentives,'' 
allows HHS to establish disincentives other than financial 
disincentives. One commenter stated that the programs HHS is proposing 
to establish disincentives for already have the authority to provide 
health care providers with opportunities for corrective action, 
education, and learning periods before imposing disincentives.
    Response. We appreciate the commenters' recommendations to provide 
for corrective action plans, technical assistance, or other activities 
for health care providers that have been determined by OIG to have 
committed information blocking. We note that we did not propose, and 
have not finalized, that elements such as individualized or corrective 
action would be generally available to any health care provider that 
OIG has determined to have committed information blocking. Nor did we 
propose that activities such as corrective action plans or technical 
assistance would be generally available to certain types of health care 
providers, such as less-resourced providers or first-time offenders. 
Commenters did not identify a separate authority under which to 
establish the general availability of a corrective action plan process 
for any health care provider that has been determined by OIG to have 
committed information blocking. We note that in section III.C.4. of 
this final rule, CMS has finalized that, prior to imposing a 
disincentive under the Shared Savings Program, it will take into 
consideration any evidence that indicated whether conduct that resulted 
in a determination of information blocking had been corrected and 
appropriate safeguards had been put in place to prevent its 
reoccurrence.
    Regarding commenters' suggestions to provide education and 
technical assistance before applying a disincentive for health care 
providers that are smaller, less resourced, or care for specific 
populations, we note that any considerations with respect to how an 
appropriate disincentive should impact health care providers with 
certain attributes would be addressed by the appropriate agency 
establishing the disincentive. In section III.A.1, an appropriate 
agency, in establishing a disincentive, could retain or implement 
policies based on the type of health care provider subject to the 
disincentive, including small practices, consistent with the agency's 
authority. For instance, in section III.A.3. of this final rule we 
discuss existing regulations under the MIPS Promoting Interoperability 
performance category which pertain to small practices.
    Regarding commenters' suggestion to not impose disincentives on 
``first-time offenders'' and instead utilize a corrective action plan, 
we note that such a policy ignores both the intent standard for a 
finding of information blocking by a health care provider and how any 
disincentive may impact a provider's behavior. To engage in information 
blocking, a health provider must know that the practice was 
unreasonable and that the practice was likely to interfere with, 
prevent, or materially discourage the access, exchange, or use of EHI. 
This intent standard supports establishing disincentives that would 
appropriately address and deter such culpable actions by health care 
providers. Further, creating a blanket policy that would give each 
health care provider a ``free offense'' could incentivize providers not 
to refrain from committing information blocking until they are caught. 
We do not believe that is the type of ``disincentive'' required by the 
statute.
    Comments. A few commenters recommended considering whether a health 
care provider has self-disclosed a violation before applying a 
disincentive. Several commenters recommended offering a self-disclosure 
protocol (SDP).
    Response. We appreciate the commenters' recommendations. The Cures 
Act did not require, and we did not propose, to establish a self-
disclosure protocol for health care providers who have committed 
information blocking. We note that OIG stated in the OIG CMP Final Rule 
that it would make a self-disclosure protocol available to those actors 
seeking to resolve their information blocking CMP liability (88 FR 
42824 and 42825). However, we do not believe a self-disclosure protocol 
would be feasible with respect to the finalized disincentives for 
health care providers. An appropriate agency's ability to adjust a 
disincentive to reflect the severity of the underlying information 
blocking conduct is dependent on whether the authority under applicable 
Federal law used to establish the disincentives allows for such an 
adjustment, consistent with section 3022(b)(2)(B) of the PHSA. For 
instance, as discussed previously, we are unable to adjust the amount 
of the reduction in the market basket increase, which is the basis for 
the disincentive finalized under the Medicare Promoting 
Interoperability Program in section III.C.2. of this final rule. With 
respect to this finalized disincentive, a self-disclosure protocol 
would have limited utility as we would be unable to adjust a health 
care provider's ``liability''.
    Comments. One commenter requested clarification of whether the 
proposed disincentive structure allows CMS to determine whether to 
apply a disincentive once it receives a referral from OIG, and if so, 
if CMS can determine to which program or programs a disincentive may 
apply (for example if a physician works in a hospital).
    Response. Under PHSA section 3022(b)(2)(B), as discussed in section 
III.A.2. of this final rule, disincentives must be established using 
authorities under applicable Federal law, as the Secretary sets forth 
through notice and comment rulemaking. As we have finalized in section 
III.A., a health care provider who has committed information blocking 
and is referred by OIG to an appropriate agency could be subject to 
each disincentive established by the appropriate agency that is 
applicable to the health care provider. CMS has finalized in the Shared 
Savings Program a policy in this final rule under which it will 
consider certain factors prior to taking action against an ACO, ACO 
participant, or ACO provider/supplier, consistent with existing 
processes in the Shared Savings Program. CMS did not propose and has 
not finalized a policy to consider additional factors prior to imposing 
the disincentives being finalized under the Medicare Promoting 
Interoperability Program and the MIPS Promoting Interoperability 
performance category.
    Comments. Some commenters expressed concern about the unintended 
consequences of the proposed

[[Page 54687]]

disincentives. Commenters suggested that the proposed disincentives may 
discourage health care providers from participating in the Medicare 
programs, including quality and value-based programs. Additionally, 
commenters expressed that health care providers who receive a greater 
proportion of their payments from Medicare would be exposed to greater 
financial risk under the proposed disincentives and would therefore be 
disincentivized to treat Medicare beneficiaries. Commenters also stated 
that the financial impacts of the proposed disincentives could: cause 
hospitals and health systems to disinvest from health IT; reduce the 
ability to report existing interoperability measures; increase 
financial risk for already precarious health care providers; impact 
access to care; increase documentation burden for health care providers 
to demonstrate they are not information blocking; reduce physician 
morale; and increase burnout. A few commenters recommended that HHS 
design disincentives through collaboration with interested parties. 
Others recommended that if HHS implements the rule as proposed that it 
monitor for potential unintended consequences and impacts of the 
disincentives on deterring information blocking.
    Response. We appreciate the commenters' concerns, but we disagree 
that establishing disincentives will discourage participation in these 
programs. Each of the programs for which CMS has finalized 
disincentives already requires health care providers to meet certain 
requirements, which they have been willing to meet in order to 
potentially earn the incentives or benefits associated with these 
programs. To avoid the disincentives finalized by CMS in this rule, 
health care providers do not need to complete any additional program 
requirements beyond refraining from conduct that meets the definition 
of information blocking in the information blocking regulations, which 
have been effective since April 5, 2021 (85 FR 70066). Due to the lack 
of significant administrative burden associated with disincentives, we 
do not believe finalizing these policies will lead to significant 
numbers of health care providers forgoing the opportunity to earn the 
incentives or benefits available from the programs under which we have 
finalized disincentives.
    Comments. Several commenters recommended other authorities under 
which to propose disincentives, or programs that should serve as models 
for disincentives. These included: the Administrative Simplification 
provisions of HIPAA; CMS Conditions of Coverage and Conditions of 
Participation; electronic prescribing of controlled substances (EPCS) 
disincentives for certain health care provider types; and CMS' Improper 
Payment Measurements Program's Payment Error Rate Measurement's (PERM). 
Commenters identified aspects of these programs that they asserted 
would be desirable as part of the implementation of disincentives, such 
as: education and corrective action plans to allow actors to resolve 
liability; non-punitive methods of resolution; a warning and grace 
period prior to penalties similar to warnings provided for price 
transparency requirements; and a tiered approach depending on the 
severity of the violation, which they stated would result in 
appropriate disincentives and a more just determination.
    Response. We thank commenters for their recommendations and may 
consider them for future rulemaking.
    We did not make any proposals and have not finalized any policies 
in this section.
2. Medicare Promoting Interoperability Program for Eligible Hospitals 
and Critical Access Hospitals (CAHs)
a. Background
    In the Disincentives Proposed Rule, CMS stated that we intended to 
use existing Medicare Promoting Interoperability Program authority 
concerning the meaningful use of certified EHR technology (CEHRT) to 
impose disincentives on eligible hospitals and CAHs that OIG determines 
have committed information blocking (defined in 45 CFR 171.103) and for 
which OIG refers a determination to CMS (88 FR 74955). Under section 
1886(n)(3)(A) of the SSA, an eligible hospital or CAH \27\ is treated 
as a meaningful EHR user for the EHR reporting period for a payment 
year if it demonstrates to the satisfaction of the Secretary, among 
other requirements, that during the EHR reporting period: (1) the 
eligible hospital used CEHRT in a meaningful manner; and (2) the CEHRT 
is connected in a manner that provides, in accordance with law and 
standards applicable to the exchange of information, for the electronic 
exchange of health information. In the Disincentives Proposed Rule, CMS 
stated that the requirements for an eligible hospital or CAH to be a 
meaningful EHR user would be substantially undermined and frustrated if 
the eligible hospital or CAH commits information blocking, such that 
application of an appropriate disincentive is warranted (88 FR 74955).
---------------------------------------------------------------------------

    \27\ Section 1814(l)(3) of the SSA applies to critical access 
hospitals the standard for determining a meaningful EHR user in 
section 1886(n)(3).
---------------------------------------------------------------------------

    Under section 1886(b)(3)(B)(ix) of the SSA, if an eligible hospital 
does not demonstrate that it has met the requirements to be a 
meaningful EHR user under section 1886(n)(3)(A), CMS will reduce the 
eligible hospital's payment by three quarters of the applicable 
percentage increase in the market basket update, or rate-of-increase 
for hospitals. Under section 1814(l)(4) of the SSA, if the Secretary 
determines that a CAH has not been a meaningful EHR user for a given 
EHR reporting period, CMS will pay that CAH 100 percent of its 
reasonable costs, instead of 101 percent of reasonable costs, which is 
the amount that the CAH would have received as a meaningful EHR user 
under the Medicare Promoting Interoperability Program.
    As discussed in the Disincentives Proposed Rule, HHS has authority 
to apply disincentives to both eligible hospitals and CAHs (88 FR 
74955). PHSA section 3022(b)(2)(B) authorizes HHS to apply 
disincentives to health care providers OIG determines have committed 
information blocking. As discussed in section II.B.1 of the 
Disincentives Proposed Rule, HHS has adopted, for purposes of the 
information blocking regulations in 45 CFR part 171, the definition of 
health care provider in section 3000(3) of the PHSA, which includes 
health care providers that are eligible for participation in the 
Medicare Promoting Interoperability Program (88 FR 74949 and 74950). 
The definition of ``health care provider'' in section 3000(3) of the 
PHSA includes ``hospital'' as a health care provider. Section 
1886(n)(6)(B) of the SSA defines the term ``eligible hospital'' for the 
purposes of the Medicare Promoting Interoperability Program (75 FR 
44316 and 44317) as ``a hospital that is a subsection (d) hospital or a 
subsection (d) Puerto Rico hospital.'' Eligible hospitals are in one of 
the fifty States or the District of Columbia (75 FR 44448). Hospitals 
in Puerto Rico became eligible hospitals for the Medicare Promoting 
Interoperability Program with the passage of the Consolidated 
Appropriations Act of 2016 (Pub. L. 114-113, Dec. 18, 2015). A CAH is 
defined in section 1861(mm) of the SSA as ``a facility that has been 
certified as a critical access hospital under section 1820(e).'' 
``Hospital'' is not further defined under the PHSA definition in 
section 3000(3). Therefore, CMS interprets the term ``hospital'' in 
section 3000(3) of the PHSA to include both eligible hospitals and CAHs 
that are

[[Page 54688]]

eligible to participate in the Medicare Promoting Interoperability 
Program.
b. The Medicare Promoting Interoperability Program as an Appropriate 
Disincentive for Information Blocking Under the PHSA
    As discussed in the Disincentives Proposed Rule, the requirements 
under SSA section 1886(n)(3)(A) that an eligible hospital or CAH must 
meet to a be meaningful EHR user, particularly the first two 
requirements under SSA section 1886(n)(3)(A)(i) and (ii), would be 
substantially undermined and frustrated if the eligible hospital or CAH 
commits information blocking, such that application of an appropriate 
disincentive is warranted (88 FR 74956). To be considered a meaningful 
EHR user under section 1886(n)(3)(A) of the SSA, an eligible hospital 
or CAH must, in brief: (1) demonstrate to the satisfaction of the 
Secretary the use of CEHRT in a meaningful manner, (2) demonstrate to 
the satisfaction of the Secretary that their CEHRT is connected in a 
manner that provides for electronic exchange of health information to 
improve the quality of health care, and (3) use CEHRT to submit 
information concerning quality measures and other measures as 
specified. With respect to the electronic exchange of health 
information requirement in SSA section 1886(n)(3)(A)(ii), an eligible 
hospital or CAH must demonstrate to the satisfaction of the Secretary 
that its CEHRT is ``connected in a manner that provides, in accordance 
with law and standards applicable to the exchange of information, for 
the electronic exchange of health information to improve the quality of 
health care, such as promoting care coordination, and . . . 
demonstrates . . . that the hospital has not knowingly and willfully 
taken action (such as to disable functionality) to limit or restrict 
the compatibility or interoperability of the certified EHR 
technology.'' Two examples of the CMS requirements for health 
information exchange include the requirement for eligible hospitals and 
CAHs to report on the Health Information Exchange Objective and the 
Provider to Patient Exchange Objective, both of which are part of the 
requirements for demonstrating the meaningful use of CEHRT, in 
accordance with SSA section 1886(n)(3).
    As discussed in the Disincentives Proposed Rule, by establishing a 
disincentive for information blocking under the Medicare Promoting 
Interoperability Program, CMS is using an authority under applicable 
Federal law as required in section 3022(b)(2)(B) of the PHSA (88 FR 
74956). Eligible hospitals and CAHs that OIG determines to have 
committed information blocking, and for which OIG refers its 
determination to CMS, would be subject to a disincentive under 
applicable law, as they are participating in the Medicare Promoting 
Interoperability Program authorized by that applicable law. In 
addition, the Medicare Promoting Interoperability Program requires 
eligible hospitals and CAHs to engage in practices that encourage the 
access, exchange, and use of electronic health information to avoid a 
downward payment adjustment. The requirements an eligible hospital or 
CAH must meet to be treated as a meaningful EHR user in section 
1886(n)(3)(A)(i) and (ii) of the SSA specify that an eligible hospital 
or CAH must demonstrate that it meets these requirements ``to the 
satisfaction of the Secretary.'' As discussed in the Disincentives 
Proposed Rule, CMS believes these provisions authorize the Secretary to 
interpret these requirements through rulemaking as necessary to ensure 
that an eligible hospital or CAH satisfies the requirements to be a 
meaningful EHR user as defined by the Secretary (88 FR 74956). 
Specifically, CMS believes it is appropriate for the Secretary to 
interpret these requirements through rulemaking to determine that an 
eligible hospital or CAH that has committed information blocking, and 
for which OIG refers its determination of information blocking to CMS, 
has not met the definition of a meaningful EHR user. This proposal is 
consistent with the goals of the Medicare Promoting Interoperability 
Program, which include the advancement of CEHRT utilization, focusing 
on interoperability and data sharing (81 FR 79837); information 
blocking by eligible hospitals and CAHs would frustrate both these 
goals (88 FR 74956).
    In the Disincentives Proposed Rule, CMS also stated that it 
believes the proposed disincentive under the Medicare Promoting 
Interoperability Program would be an appropriate disincentive that 
would deter information blocking by eligible hospitals and CAHs, 
consistent with the discussion in section III.A.3. of the Disincentives 
Proposed Rule (88 FR 74956). While the exact monetary impact of the 
disincentive would vary based on the specific eligible hospital, CMS 
believes a reduction of three quarters of the annual market basket 
update would deter eligible hospitals from engaging in information 
blocking because it would reduce the inpatient prospective payment 
system (IPPS) payment that an eligible hospital could have earned had 
it met other requirements under the Medicare Promoting Interoperability 
Program. Similarly, though the exact dollar amount would vary based on 
the specific CAH, CMS believes that receiving 100 percent of reasonable 
costs instead of the 101 percent of reasonable costs that a CAH may 
have earned for successful participation in the Medicare Promoting 
Interoperability Program would deter information blocking by CAHs 
because it would reduce the reimbursement a CAH could have received had 
it met other requirements under the Medicare Promoting Interoperability 
Program (88 FR 74956).
    In the Disincentives Proposed Rule, HHS analyzed the range of 
potential disincentive amounts an eligible hospital could be subject to 
if the proposed disincentive was imposed, to illustrate the degree to 
which this disincentive could deter eligible hospitals from engaging in 
information blocking. For more information about this analysis, we 
refer readers to the Disincentive Proposed Rule (88 FR 74956 and 
74957).
c. Provisions
    In the Disincentives Proposed Rule, CMS proposed to revise the 
definition of ``Meaningful EHR User'' in 42 CFR 495.4 to state that an 
eligible hospital or CAH is not a meaningful EHR user in a calendar 
year if OIG refers a determination that the eligible hospital or CAH 
committed information blocking, as defined at 45 CFR 171.103, during 
the calendar year of the EHR reporting period (88 FR 74957). As a 
result of the proposal, CMS would apply a downward payment adjustment 
under the Medicare Promoting Interoperability Program to any such 
eligible hospital or CAH because the eligible hospital or CAH would not 
be a meaningful EHR user, as required under SSA sections 
1886(b)(3)(B)(ix) and 1814(l)(4). For eligible hospitals, CMS would 
apply the downward adjustment to the payment adjustment year that 
occurs 2 years after the calendar year when the OIG referral occurs. 
For CAHs, CMS would apply the downward adjustment to the payment 
adjustment year that is the same as the calendar year when the OIG 
referral occurs.
    In the Disincentives Proposed Rule, CMS noted that as a result of 
these proposals, an eligible hospital or CAH that otherwise fulfilled 
the required objectives and measures to demonstrate that it is a 
meaningful EHR user for an EHR reporting period would nevertheless not 
be a meaningful EHR user for that EHR reporting period if

[[Page 54689]]

OIG refers a determination of information blocking to CMS during the 
calendar year in which the EHR reporting period falls (88 FR 74957). 
CMS considered applying this proposed disincentive based on the date 
that the eligible hospital or CAH committed the information blocking as 
determined by OIG, instead of the date OIG refers its determination to 
CMS. However, a significant amount of time could pass between the date 
when the eligible hospital or CAH is determined to have committed 
information blocking, and the date when OIG makes a referral to CMS, 
due to the time required for OIG to fully investigate a claim of 
information blocking. Such delay between the date the information 
blocking occurred, and OIG's referral could complicate the application 
of the disincentive and would likely necessitate reprocessing of a 
significant number of claims. Therefore, CMS proposed to use the date 
of the OIG referral instead of the date of the information blocking 
occurrence to apply the proposed disincentive. Accordingly, CMS would 
apply the proposed disincentive to the payment adjustment year 
associated with the calendar year in which the OIG referred its 
determination to CMS (88 FR 74957).
    CMS further noted in the Disincentives Proposed Rule that if an 
eligible hospital or CAH received the applicable downward payment 
adjustment because CMS had already determined the eligible hospital or 
CAH had otherwise not been a meaningful EHR user during the applicable 
EHR reporting period due to its performance in the Medicare Promoting 
Interoperability Program, imposition of the proposed disincentive would 
result in no additional impact on the eligible hospital or CAH during 
that payment adjustment year (88 FR 74957). Finally, even if multiple 
information blocking violations were identified as part of OIG's 
determination (including over multiple years) and referred to CMS, each 
referral of an information blocking determination by OIG would only 
affect an eligible hospital's or CAH's status as a meaningful EHR user 
in a single EHR reporting period during the calendar year when the 
determination of information blocking was referred to CMS by OIG. 
Unless OIG makes an additional referral of an information blocking 
determination in the subsequent calendar year, an eligible hospital or 
CAH would again be able to qualify as a meaningful EHR user starting in 
the subsequent EHR reporting period (88 FR 74957).
    CMS invited public comment on these proposals, particularly on its 
approach to the application of a disincentive for OIG determinations 
that found that information blocking occurred in multiple years and 
whether there should be multiple disincentives for such instances (for 
example, disincentives in multiple calendar years/reporting periods 
compared to only the calendar year/reporting period in which OIG made 
the referral). The following is a summary of the comments we received 
and our responses.
    Comments. One commenter supported our proposal to apply 
disincentives to eligible hospitals and CAHs, referred by OIG to CMS, 
for information blocking. The commenter stated that the approach would 
not involve additional services or requirements for patients, and that 
this structure incentivizes the use of health IT and exchange of 
electronic health information.
    Response. We thank this commenter for their support and agree that 
using an existing program and its existing structure to establish a 
disincentive, without including additional requirements for eligible 
hospitals and CAHs, does incentivize the meaningful use of CEHRT. We 
also agree that this approach continues to promote the interoperable 
exchange of health information for patients, eligible hospitals, and 
CAHs.
    Comments. One commenter supported the underlying goal of 
encouraging information exchange but strongly opposed the proposed 
disincentive. They stated that these disincentives could damage 
essential eligible hospitals and CAHs and undermine HHS goals by 
decreasing resources available to otherwise make appropriate 
investments in their IT infrastructure. Several commenters opposed the 
disincentive stating that it is excessive, potentially harmful to 
already fragile eligible hospitals and CAHs, and has the potential to 
eliminate annual payment updates for offenders. Several commenters 
stated that this disincentive is unsustainable financially.
    Response. We thank commenters for sharing this feedback and 
expressing their concerns. We disagree that this disincentive is 
unsustainable, excessive, and potentially harmful. This disincentive 
utilizes the existing payment adjustments that are currently applied 
under the Medicare Promoting Interoperability Program (previously the 
Medicare EHR Incentive Program) and were authorized as part of the 
American Recovery and Reinvestment Act of 2009, and we have chosen to 
use that authority for these payment adjustments to establish a 
disincentive for information blocking determinations by OIG. As 
described, we consider eligible hospitals and CAHs that commit 
information blocking as not demonstrating the meaningful use of CEHRT. 
We are aligning the disincentive we are finalizing with the existing 
process for those who do not meet the minimum requirements for 
demonstrating the meaningful use of CEHRT.
    In addition, there are eligible hospitals and CAHs that receive the 
same payment adjustment as would apply under this disincentive due to 
their failure to participate, or through unsuccessfully demonstrating 
meaningful use by not meeting the minimum program requirements in the 
EHR reporting period for a payment adjustment year. These hospitals 
would not experience an additional impact if OIG refers a determination 
that they committed information blocking, if such eligible hospitals or 
CAHs also fail to participate or unsuccessfully demonstrate meaningful 
use by not meeting the minimum program requirements in a given EHR 
reporting period. Foundationally, being considered a meaningful user of 
CEHRT in the Medicare Promoting Interoperability Program reflects that 
an eligible hospital or CAH is meaningfully using health IT and sharing 
health information. If an eligible hospital or CAH is not meaningfully 
using CEHRT, including by engaging in information blocking conduct, 
they would be subject to the same payment adjustment as would an 
eligible hospital or CAH that fails to meet our other program 
requirements.
    Comments. Many commenters supported our proposed disincentive 
policy but have asked for an extension in various forms. Some 
commenters asked that disincentives start 2 years after the effective 
date of this final rule, to give eligible hospitals and CAHs two 
additional years of support and education to understand what is 
considered information blocking, and to ensure adequate training for 
their staff. Several commenters asked for an undefined grace period to 
educate staff and utilize support services from OIG, ONC, and CMS, to 
fully understand these policies before the disincentives are 
implemented. A few commenters suggested that we delay the disincentives 
policy, and instead start with a non-enforcement period before punitive 
penalties begin. Lastly, some commenters asked that we delay the 
disincentives policy, and instead start with a corrective action plan, 
followed by punitive penalties in the future.

[[Page 54690]]

    Response. We thank commenters for their feedback. We appreciate the 
suggestions asking for additional support and education and may 
consider this feedback. However, we do not agree that the disincentive 
policy should be delayed for a minimum of 2 years after the release of 
this final rule. As discussed above, the payment adjustment structure 
for not meeting the definition of being a meaningful user of CEHRT 
under the Medicare Promoting Interoperability Program is not new or 
unique to information blocking. Eligible hospitals and CAHs are already 
subject to payment adjustments under the Medicare Promoting 
Interoperability Program if they fail to meet the requirements of being 
a meaningful user of CEHRT based on not meeting minimum program 
requirements (sections 1886(b)(3)(B) and 1814(l) of the Act). We have 
finalized our proposal to update the definition of meaningful EHR user 
in 42 CFR 495.4 to exclude from that definition eligible hospitals and 
CAHs that OIG refers to CMS based on a determination of information 
blocking. Therefore, the only additional requirement for eligible 
hospitals and CAHs is that OIG did not refer a determination that the 
eligible hospital or CAH committed information blocking as defined at 
45 CFR 171.103 during the calendar year of the EHR reporting period. We 
further note that the information blocking regulations in the ONC Cures 
Act Final Rule went into effect April 5, 2021 (85 FR 70068), and 
several years will have already passed between the date when these 
regulations went into effect for health care providers and the 
effective date of this final rule.
    We refer readers to section III.B.1. of this final rule which 
states that OIG will not begin investigating health care providers 
until after the effective date of this rule, and that OIG will exercise 
its enforcement discretion not to make any determinations regarding 
conduct occurring prior to the effective date of this rule for 
information blocking disincentives. As OIG will not make a 
determination on conduct occurring prior to the effective date, OIG 
will not refer any health care providers based on a determination of 
conduct occurring prior to the effective date of this rule for 
information blocking disincentives (see also, 88 FR 42823 and 42824). 
This means that no disincentives finalized in this final rule will be 
applied to conduct occurring before the effective date of this final 
rule, which is 30 days after the final rule appears in the Federal 
Register.
    We appreciate the recommendations regarding offering educational 
opportunities that would be helpful to health care providers and will 
consider these recommendations.
    Comments. Many commenters asked that CMS reconsider the 
disincentives policy to reflect a tiered approach, proportional to 
severity and frequency, suggesting that as proposed, a singular 
disincentive conflates egregious claims with minor claims, and one-time 
offenders with repeat offenders. Several commenters suggested that CMS 
consider applying a disincentive only to egregious claims rather than 
all claims.
    Response. We thank commenters for this feedback. As discussed 
previously, the definition of meaningful EHR user is central to the 
Medicare Promoting Interoperability Program and this policy. While we 
acknowledge there may be varying levels of severity, frequency, and 
potential patient harm encompassed in different OIG determinations of 
information blocking, we will receive all determinations of information 
blocking that are referred to CMS by OIG. As we have finalized our 
proposal to revise the definition of ``Meaningful EHR User,'' the 
disincentive associated with not being a meaningful EHR user would be 
applying the existing downward adjustment under the Medicare Promoting 
Interoperability Program. This downward adjustment was established in 
the American Recovery and Reinvestment Act of 2009, and CMS does not 
have the flexibility to adjust the level of the downward adjustment 
utilizing a tiered approach. For instance, as discussed in the 
Disincentives Proposed Rule (88 FR 74955), under section 
1886(b)(3)(B)(ix)(I) of the SSA, CMS adjusts payments for eligible 
hospitals by a fixed proportion, based on whether an eligible hospital 
(as defined in section 1886(n)(6)(B) of the SSA) is a meaningful EHR 
user.
    We note that while our proposed policy states that each referral of 
an information blocking determination by OIG would only affect an 
eligible hospital's or CAH's status as a meaningful EHR user in a 
single EHR reporting period during the calendar year when the 
determination of information blocking was referred by OIG, it is 
possible that repeated subsequent determinations could be referred by 
OIG in future years. We will address all determinations referred by OIG 
applicable to eligible hospitals and CAHs within the existing payment 
adjustment under the Medicare Promoting Interoperability Program, as 
finalized in this final rule.
    As for commenters' concerns that a single disincentive conflates 
egregious claims with minor claims, we remind readers that prior to the 
application of the disincentive OIG will investigate an allegation and 
determine if information blocking has occurred. As discussed in 
III.B.1. of this final rule, OIG's enforcement priorities inform 
decisions about which information blocking allegations to pursue, but 
they are not dispositive. Indeed, OIG will assess each allegation to 
determine whether it implicates one or more of the enforcement 
priorities, or otherwise merits further investigation and potential 
enforcement action, and OIG may evaluate allegations and prioritize 
investigations based in part on the volume of claims relating to the 
same (or similar) practices by the same entity or individual. 
Additionally, we take this opportunity to remind readers that CMS's 
application of a disincentive will be based on the referral of OIG's 
determination that information blocking has occurred. Information 
blocking includes an element of intent, which for health care providers 
is that the health care provider knows that a practice is unreasonable 
and is likely to interfere with, prevent, or materially discourage 
access, exchange, or use of EHI.
    Comments. A few commenters raised concerns regarding the timing 
between OIG receiving a referral, the claim being referred to CMS, and 
the timing of the disincentive. Commenters asked that disincentives be 
the same for all cases of information blocking, rather than based on 
hospital size, annual market basket updates, or reasonable costs. Under 
the proposal, if a large eligible hospital and a CAH are each referred 
to OIG with a claim of information blocking, the penalties vary based 
on EHR reporting period, size, and hospital type.
    Response. We thank commenters for sharing this feedback. We 
understand that some commenters believe that the disincentive should be 
based on the date that the information blocking occurred, but doing so 
would be administratively difficult, and therefore impractical, to 
implement because it would likely involve reprocessing past claims. 
Since we expect the time it takes OIG to fully investigate an 
information blocking claim and refer a determination to CMS will vary, 
we decided not to use the date that OIG determines information blocking 
conduct occurred to determine the application of the payment 
adjustment. Instead, CMS will use the date of the OIG referral to CMS 
and specify that the eligible hospital or CAH is not a meaningful user 
of CEHRT for the EHR reporting period in that calendar year. The 
payment adjustment will apply to the payment adjustment year 2 years

[[Page 54691]]

later. We agree that with the existing payment adjustment under the 
Medicare Promoting Interoperability Program, there is variation in the 
annual market basket updates for eligible hospitals and in reasonable 
costs for CAHs. As a result of that variability, there would be 
variability in the amount of any disincentives imposed under the 
Medicare Promoting Interoperability Program as a result of an OIG 
referral of a determination of information blocking. While CMS did 
consider alternative approaches (88 FR 74957), we have finalized our 
proposal to revise the definition of meaningful EHR user in 42 CFR 
495.4, and therefore the requirements to be considered a meaningful EHR 
user. While we are mindful there is variation in the monetary impact of 
payment adjustments under the Medicare Promoting Interoperability 
Program based on size, hospital type, and timing of receiving the 
referral of an OIG determination of information blocking, we 
respectfully disagree with commenters that the monetary impact of the 
disincentive should be the same for all eligible hospitals or CAHs, as 
this could disproportionately impact hospitals with lower Medicare 
claims volumes.
    After consideration of the public comments, CMS has finalized our 
proposal to revise the definition of ``Meaningful EHR User'' in 42 CFR 
495.4 to state that an eligible hospital or CAH is not a meaningful EHR 
user in a calendar year if OIG refers a determination that the eligible 
hospital or CAH committed information blocking, as defined at 45 CFR 
171.103, during the calendar year of the EHR reporting period.
    For eligible hospitals, CMS will apply a downward payment 
adjustment to the payment year that occurs 2 years after the calendar 
year when an OIG referral occurs. This is a reduction of three quarters 
of the annual market basket update that an eligible hospital could have 
earned.
    For CAHs, CMS will apply a downward payment adjustment to the 
payment year that is the same as the calendar year when the OIG 
referral occurs. This reduction results in a payment of 100 percent of 
reasonable costs instead of the 101 percent of reasonable costs that a 
CAH could have earned.
    Lastly, CMS has finalized our proposal that if multiple information 
blocking violations are identified as part of OIG's determination 
(including over multiple years) and referred to CMS, each referral of 
an information blocking determination by OIG will only affect an 
eligible hospital's or CAH's status as a meaningful EHR user in a 
single EHR reporting period during the calendar year when the 
determination of information blocking was referred to CMS by OIG.
d. Notification and Application of the Disincentive
    In the Disincentives Proposed Rule, CMS stated that after OIG has 
determined that a health care provider has committed information 
blocking and referred that health care provider to CMS, CMS would 
notify the eligible hospital or CAH that OIG determined that the 
eligible hospital or CAH committed information blocking as defined 
under 45 CFR 171.103, and thus the eligible hospital or CAH was not a 
meaningful EHR user for the EHR reporting period in the calendar year 
when OIG referred its information blocking determination to CMS. This 
notice would be issued in accordance with the notice requirements 
proposed at 45 CFR 171.1002, as discussed in section III.B.2. of the 
proposed rule.
    As a result of our proposal to modify the definition of meaningful 
EHR user in 42 CFR 495.4, the application of the disincentive would 
result in a downward payment adjustment for eligible hospitals 2 years 
after the OIG referral of a determination of information blocking to 
CMS. Based upon the existing regulation at 42 CFR 495.4, the downward 
payment adjustment would apply 2 years after the year of the referral 
and the EHR reporting period in which the eligible hospital was not a 
meaningful EHR user. For CAHs, the downward payment adjustment would 
apply to the payment adjustment year in which the OIG referral was 
made.
    CMS invited public comment on these proposals. The following is a 
summary of the comments we received and our responses.
    Comments. Commenters asked for ample notification from CMS that a 
determination has been referred from OIG to CMS regarding information 
blocking.
    Response. We thank commenters for their support on this proposal 
and agree that ample notification and communication is necessary.
    After consideration of the public comments, CMS has finalized our 
proposal that we will notify an eligible hospital or CAH that OIG has 
determined that the eligible hospital or CAH committed information 
blocking as defined under 45 CFR 171.103, and, as a result, that the 
eligible hospital or CAH was not a meaningful EHR user for EHR 
reporting period in the calendar year when OIG referred its information 
blocking determination to CMS.
3. Promoting Interoperability Performance Category of the Medicare 
Merit-Based Incentive Payment System (MIPS)
a. Background
    MIPS requires that MIPS eligible clinicians use CEHRT, as defined 
at SSA section 1848(o)(4) and 42 CFR 414.1305,\28\ in a meaningful 
manner, in accordance with SSA sections 1848(q)(2)(A)(iv) and (B)(iv) 
and 1848(o)(2) and 42 CFR 414.1375, to earn a score for the MIPS 
Promoting Interoperability performance category. In the Disincentives 
Proposed Rule, CMS stated that we intend to use this existing 
authority, requiring the meaningful use of CEHRT, to impose 
disincentives on MIPS eligible clinicians that OIG determines to have 
committed information blocking as defined at 45 CFR 171.103 (88 FR 
74957 and 74958).
---------------------------------------------------------------------------

    \28\ For MIPS, SSA section 1848(o)(4) defines CEHRT as a 
qualified electronic health record (as defined in PHSA section 
3000(13)) that is certified by ONC pursuant to PHSA section 
3001(c)(5) as meeting standards adopted under PHSA section 3004 that 
are applicable to the type of record involved, as determined by the 
Secretary. CMS has codified the definition of CEHRT, including 
additional criteria it must be certified as meeting, that MIPS 
eligible clinicians must use at 42 CFR 414.1305.
---------------------------------------------------------------------------

(1) MIPS Overview--Scoring and Payment Calculations
    As authorized by the Medicare Access and CHIP Reauthorization Act 
of 2015 (MACRA) (Pub. L. 114-10, April 16, 2015), the Quality Payment 
Program is a value-based payment program,\29\ by which the Medicare 
program rewards MIPS eligible clinicians who provide high-value, high-
quality services in a cost-efficient manner. The Quality Payment 
Program includes two participation tracks for clinicians providing 
services under the Medicare program: MIPS and Advanced Alternative 
Payment Models (APMs). The statutory requirements for MIPS are set 
forth in SSA sections 1848(q) and (r).
---------------------------------------------------------------------------

    \29\ In the Disincentives Proposed Rule, we referred to the 
Quality Payment Program as a payment incentive program (88 FR 
74958). Within the Quality Payment Program, MIPS is more 
appropriately described as a value-based payment system, and we have 
revised this statement for clarity and precision.
---------------------------------------------------------------------------

    For the MIPS participation track, MIPS eligible clinicians are 
subject to a MIPS payment adjustment (positive, negative, or neutral) 
based on their performance in four performance categories (cost, 
quality, improvement activities, and Promoting Interoperability) 
compared to the

[[Page 54692]]

established performance threshold for that performance period/MIPS 
payment year. CMS assesses each MIPS eligible clinician's total 
performance according to established performance standards with respect 
to the applicable measures and activities specified in each of these 
four performance categories during a performance period to compute a 
final composite performance score (a ``final score'' as defined at 42 
CFR 414.1305) in accordance with our policies set forth in 42 CFR 
414.1380.
    In calculating the final score, CMS must apply different weights 
for the four performance categories, subject to certain exceptions, as 
set forth in SSA section 1848(q)(5) and at 42 CFR 414.1380. Unless CMS 
assigns a different scoring weight pursuant to these exceptions, for 
the CY 2024 performance period/2026 MIPS payment year and subsequent 
performance periods/MIPS payment years,\30\ the scoring weights are as 
follows: 30 percent for the quality performance category; 30 percent 
for the cost performance category; 15 percent for the improvement 
activities performance category; and 25 percent for the Promoting 
Interoperability performance category (SSA section 1848(q)(5)(E); 42 
CFR 414.1380(c)(1)).
---------------------------------------------------------------------------

    \30\ In the Disincentives Proposed Rule, we only noted that 
these scoring weights apply to the CY 2024 performance period/2026 
MIPS payment year (88 FR 74958). However, as set forth in SSA 
section 1848(q)(5)(E), these scoring weights applied beginning 6 
years after MIPS began applying to Medicare Part B payments (CY 2017 
performance period/2019 MIPS payment year) and continue to apply for 
each subsequent year thereafter. Accordingly, we amended this 
description in this final rule for clarity and accuracy to note that 
these scoring weights continue to apply, provided CMS does not 
assign a different scoring weight pursuant to applicable exceptions.
---------------------------------------------------------------------------

    To calculate the payment adjustment factor that will be applied to 
the amounts otherwise paid to MIPS eligible clinicians under Medicare 
Part B for covered professional services during the applicable MIPS 
payment year, CMS then compares the final score to the performance 
threshold CMS has established for that performance period/MIPS payment 
year at 42 CFR 414.1405(b). The MIPS payment adjustment factors 
specified for a year must result in differential payments such that 
MIPS eligible clinicians with final scores above the performance 
threshold receive a positive MIPS payment adjustment factor, those with 
final scores at the performance threshold receive a neutral MIPS 
payment adjustment factor, and those with final scores below the 
performance threshold receive a negative MIPS payment adjustment 
factor. As further specified in SSA section 1848(q)(6)(F) and 42 CFR 
414.1405, CMS also applies a scaling factor to determine the MIPS 
payment adjustment factor for each MIPS eligible clinician, and CMS 
must ensure that the estimated aggregate increases and decreases in 
payments to all MIPS eligible clinicians as a result of MIPS payment 
adjustment factors are budget neutral for that MIPS payment year. As 
provided in SSA sections 1848(q)(6)(A) and (B)(iv) and 42 CFR 
414.1405(c), the positive MIPS payment adjustment factor may be up to 9 
percent for a final score of 100 and the negative MIPS payment 
adjustment factor may be up to negative 9 percent for a final score of 
zero.
(2) MIPS Promoting Interoperability Performance Category
    For MIPS eligible clinicians, SSA section 1848(q)(2)(A)(iv) 
includes the meaningful use of CEHRT as one of the four performance 
categories by which a MIPS eligible clinician is assessed to determine 
a MIPS payment adjustment factor, as discussed previously. CMS refers 
to this performance category as the Promoting Interoperability 
performance category. SSA section 1848(q)(2)(B)(iv) provides that the 
requirements set forth in SSA section 1848(o)(2) for determining 
whether a MIPS eligible clinician is a meaningful user of CEHRT also 
apply to CMS's assessment of MIPS eligible clinicians' performance on 
measures and activities with respect to the MIPS Promoting 
Interoperability performance category. Also, SSA section 1848(o)(2)(D) 
generally provides that the requirements for being a meaningful EHR 
user under section 1848(o)(2) continue to apply for purposes of MIPS.
    A MIPS eligible clinician that is not a meaningful user of CEHRT in 
accordance with SSA section 1848(o)(2)(A) cannot satisfy the 
requirements of the MIPS Promoting Interoperability performance 
category and, therefore, would earn a score of zero for this 
performance category. Applying the weights for the performance 
categories under 42 CFR 414.1380(c)(1), a score of zero for the 
Promoting Interoperability performance category would mean that the 
maximum final score a MIPS eligible clinician could achieve, if they 
performed perfectly in the remaining performance categories, would be 
75 points.
    To be a meaningful EHR user under SSA section 1848(o)(2)(A) (and 
therefore meet the requirements of the MIPS Promoting Interoperability 
performance category under SSA section 1848(q)(2)(B)(iv)), a MIPS 
eligible clinician must meet three requirements related to the 
meaningful use of CEHRT during a performance period for a MIPS payment 
year. In brief, the MIPS eligible clinician must: (1) demonstrate to 
the satisfaction of the Secretary the use of CEHRT in a meaningful 
manner; (2) demonstrate to the satisfaction of the Secretary that their 
CEHRT is connected in a manner that provides for electronic exchange of 
health information to improve the quality of care; and (3) use CEHRT to 
submit information concerning quality measures and other measures as 
specified.
    More specifically, for the first requirement under SSA section 
1848(o)(2)(A)(i), a MIPS eligible clinician must demonstrate, to the 
satisfaction of the Secretary, that during the relevant performance 
period, the MIPS eligible clinician is ``using certified EHR technology 
in a meaningful manner.'' For the second requirement under SSA section 
1848(o)(2)(A)(ii), a MIPS eligible clinician must demonstrate, to the 
satisfaction of the Secretary, that during the relevant period CEHRT is 
``connected in a manner that provides, in accordance with law and 
standards applicable to the exchange of information, for the electronic 
exchange of health information to improve the quality of health \31\ 
care, such as promoting care coordination'' and the MIPS eligible 
clinician demonstrates, through ``a process specified by the Secretary, 
such as the use of an attestation'' that the MIPS eligible clinician 
``has not knowingly and willfully taken action (such as to disable 
functionality) to limit or restrict the compatibility or 
interoperability of the certified EHR technology.'' For the third 
requirement under SSA section 1848(o)(2)(A)(iii), a MIPS eligible 
clinician currently must submit information via their CEHRT on ``such 
clinical quality measures and such other measures as selected by the 
Secretary'' in ``a form and manner specified by the Secretary,'' 
including measures focused on providing patients with electronic access 
to their electronic health information, sending electronic health 
information to other health care providers, and receiving and 
incorporating electronic health information from other health care 
providers.
---------------------------------------------------------------------------

    \31\ In the Disincentives Proposed Rule (88 FR 74958), this word 
was inadvertently omitted from the quote of the statutory provision.
---------------------------------------------------------------------------

    As discussed further in section III.C.3.b. of the Disincentives 
Proposed Rule (88 FR 74959 and 74960) and this final rule, these three 
requirements for a MIPS eligible clinician to be

[[Page 54693]]

determined to be a meaningful user of CEHRT, particularly the first two 
requirements under SSA section 1848(o)(2)(A)(i) and (ii), would be 
substantially undermined and frustrated if the MIPS eligible clinician 
commits information blocking, such that application of an appropriate 
disincentive is warranted.
b. The MIPS Promoting Interoperability Performance Category 
Requirements as an Appropriate Disincentive for Information Blocking 
Under the PHSA
    In the Disincentives Proposed Rule, CMS stated it believes that the 
requirements set forth in SSA sections 1848(q)(2)(B)(iv) and 
1848(o)(2)(A) for the MIPS Promoting Interoperability performance 
category are an applicable Federal law for the purposes of establishing 
a disincentive for a health care provider that participates in MIPS and 
has been determined by OIG to have committed information blocking (88 
FR 74959). First, the definitions of MIPS eligible clinician and health 
care provider under 45 CFR 171.102 and the PHSA generally are aligned. 
Second, committing information blocking not only violates the law and 
principles set forth in the Cures Act, but also undermines the goals 
and purpose of the MIPS Promoting Interoperability performance 
category. On such basis, CMS proposed an appropriate disincentive for 
MIPS eligible clinicians that OIG determines have committed information 
blocking and for whom OIG refers its determination of information 
blocking to CMS, as discussed further in section III.C.3.c. of the 
Disincentives Proposed Rule (88 FR 74959 through 74962).
(1) Alignment of Definitions of MIPS Eligible Clinician and Health Care 
Provider Under the PHSA
    In the Disincentives Proposed Rule, CMS noted that it believes that 
the definitions of MIPS eligible clinician under the SSA and 42 CFR 
414.1305 and health care provider under PHSA section 3000(3) and 45 CFR 
171.102 generally are aligned (88 FR 74959). CMS believes this 
alignment will permit application of appropriate disincentives, as 
required by PHSA section 3022(b)(2)(B), to MIPS eligible clinicians, 
except for qualified audiologists. CMS proposed to codify this 
exception in the definition of Meaningful EHR User for MIPS at 42 CFR 
414.1305 (88 FR 74959).
    Beginning with the 2024 MIPS payment year, a MIPS eligible 
clinician is defined in 42 CFR 414.1305 as including: (1) a physician 
(as defined in SSA section 1861(r)); (2) a physician assistant, nurse 
practitioner, and clinical nurse specialist (as defined in SSA 
1861(aa)(5)); (3) a certified registered nurse anesthetist (defined in 
SSA section 1861(bb)(2)); (4) a physical therapist or occupational 
therapist; (5) a qualified speech-language pathologist; (6) a qualified 
audiologist (as defined in SSA section 1861(ll)(4)(B)); (7) a clinical 
psychologist (as defined by the Secretary for purposes of SSA section 
1861(ii)); (8) a registered dietician or nutrition professional; (9) a 
clinical social worker (as defined in SSA section 1861(hh)(1)); (10) a 
certified nurse midwife (as defined in SSA section 1861(gg)(2)); and 
(11) a group, identified by a unique single taxpayer identification 
number (TIN), with two or more eligible clinicians, one of which must 
be a MIPS eligible clinician, identified by their individual national 
provider identifier (NPI) and who have reassigned their billing rights 
to the single group TIN. However, for a given performance period/MIPS 
payment year, a MIPS eligible clinician does not include an eligible 
clinician who meets one of the exclusions set forth in 42 CFR 
414.1310(b), including being a Qualifying APM participant, Partial 
Qualifying APM Participant that does not elect to participate in MIPS, 
or does not exceed the low volume threshold (as these terms are defined 
in 42 CFR 414.1305).
    Meanwhile, the definition of ``health care provider'' under PHSA 
section 3000(3) as implemented in 45 CFR 171.102, includes the 
following which are also considered MIPS eligible clinicians: (1) a 
``group practice'' (which is not defined in the PHSA); (2) a physician 
(as defined in SSA section 1861(r)); (3) practitioners, as defined in 
SSA section 1842(b)(18)(C) to include: (a) a physician assistant, nurse 
practitioner, and clinical nurse specialist (as defined in SSA 
1861(aa)(5)); (b) a certified registered nurse anesthetist (defined in 
SSA section 1861(bb)(2)); (c) a certified nurse-midwife (as defined in 
SSA section 1861(gg)(2)); (d) a clinical social worker (as defined in 
SSA section 1861(hh)(1)); (e) a clinical psychologist (as defined by 
the Secretary for purposes of SSA section 1861(ii)); and (f) a 
registered dietician or nutrition professional; (4) therapists, as 
defined in SSA section 1848(k)(3)(B)(iii) to include: (a) a physical 
therapist; (b) an occupational therapist; and (c) a qualified speech-
language pathologist; and (5) ``any other category of health care 
facility, entity, practitioner, or clinician determined appropriate by 
the Secretary'' (88 FR 74959).
    At this time, only a qualified audiologist, included in the 
definition of MIPS eligible clinician in 42 CFR 414.1305 since the CY 
2019 performance period/2021 MIPS payment year, is not identified as a 
health care provider under 45 CFR 171.102 and PHSA section 3000(3). 
Because qualified audiologists are not included in the PHSA definition 
of health care provider, CMS proposed that MIPS eligible clinicians who 
are qualified audiologists would not be subject to the disincentive 
proposed for the MIPS Promoting Interoperability performance category 
(88 FR 74959).
    As discussed previously, groups, and multispecialty groups (as 
defined in 42 CFR 414.1305) also are included in the definition of MIPS 
eligible clinician and therefore are subject to payment adjustments 
under MIPS based on the performance of MIPS eligible clinicians that 
are included in these groups, under different sets of regulations in 42 
CFR part 414, subpart O. Meanwhile, as discussed previously, the 
definition of health care provider in PHSA section 3000(3) includes 
``group practice,'' but does not define what this term means. 
Accordingly, in the Disincentives Proposed Rule, CMS stated that it 
also believes that a group may be subject to the disincentive proposed 
for the MIPS Promoting Interoperability performance category if the 
group has been determined by OIG to have committed information 
blocking, or if MIPS eligible clinicians included in the group have 
committed information blocking (88 FR 74959).
(2) Information Blocking Conduct Undermines the Goals and Purpose of 
the MIPS Promoting Interoperability Performance Category
    As discussed in the Disincentives Proposed Rule, health care 
providers that engage in information blocking undermine and frustrate 
the purpose for requiring MIPS eligible clinicians to use CEHRT in a 
meaningful manner (88 FR 74960). Specifically, requiring MIPS eligible 
clinicians to use CEHRT is not limited to MIPS eligible clinicians 
adopting and implementing CEHRT for documenting clinical care in lieu 
of paper-based medical records. For use of CEHRT to be meaningful, SSA 
section 1848(o)(2)(A) requires that MIPS eligible clinicians use CEHRT 
to communicate with other treating health care providers, pharmacies, 
and oversight authorities regarding the patient's health information, 
including the MIPS eligible clinician's review and treatment of the 
patient's health. SSA sections 1848(o)(2)(A)(i) and (ii) require that 
MIPS eligible clinicians demonstrate

[[Page 54694]]

that they are meaningfully using CEHRT's key functionalities, such as 
electronically prescribing, and ensuring that CEHRT is ``connected in a 
manner that provides, in accordance with law and standards applicable 
to the exchange of information, for the electronic exchange of health 
information to improve the quality of health care,'' such as 
``promoting care coordination.'' SSA section 1848(o)(2)(A)(ii) further 
requires that the MIPS eligible clinician demonstrate that they have 
not ``knowingly and willfully taken action (such as to disable 
functionality) to limit or restrict the compatibility or 
interoperability'' of CEHRT, which is similar to the directive to 
investigate and discourage information blocking under PHSA section 
3022. In the Disincentives Proposed Rule, CMS noted that establishing 
an appropriate disincentive for information blocking under the MIPS 
Promoting Interoperability performance category would not only deter 
information blocking but would strengthen an existing merit-based 
incentive payment system that already encourages health care providers 
to support the access, exchange, and use of electronic health 
information (88 FR 74960).
    Furthermore, the requirements to be treated as a meaningful EHR 
user in SSA sections 1848(o)(2)(A)(i) and (ii) specify that a MIPS 
eligible clinician must demonstrate that they meet these requirements 
to the satisfaction of the Secretary. In the Disincentives Proposed 
Rule, CMS stated it believes these provisions authorize the Secretary 
to interpret these requirements through rulemaking as necessary to 
ensure that a MIPS eligible clinician satisfies the requirements to be 
a meaningful user of CEHRT as defined by the Secretary (88 FR 74960). 
Specifically, CMS noted that it believes it is appropriate for the 
Secretary to interpret these requirements through rulemaking to 
determine that a MIPS eligible clinician that has committed information 
blocking is not a meaningful EHR user (88 FR 74960). In the 
Disincentives Proposed Rule (88 FR 74960), CMS noted that the proposal 
was consistent with the goals of the MIPS Promoting Interoperability 
performance category, which include promoting health care efficiency 
and encouraging widespread health information exchange (81 FR 77200 
through 77202). CMS stated that information blocking by MIPS eligible 
clinicians frustrates both these goals (88 FR 74960).
    As noted in the Disincentives Proposed Rule, CMS believes a 
disincentive for information blocking associated with the MIPS 
Promoting Interoperability performance category would be an appropriate 
disincentive that would deter information blocking by other MIPS 
eligible clinicians, consistent with the discussion in section III.A.3. 
of the Disincentives Proposed Rule (88 FR 74960). While the exact 
monetary impact of the disincentive may vary for each MIPS eligible 
clinician based on the various factors CMS considers when determining 
the MIPS payment adjustment factor, CMS believes the proposed 
disincentive would deter information blocking by other MIPS eligible 
clinicians. In the Disincentives Proposed Rule, CMS noted that a MIPS 
eligible clinician who receives a score of zero in the MIPS Promoting 
Interoperability performance category under the proposed disincentive 
may not be able to earn a positive or neutral MIPS payment adjustment 
factor that they otherwise could have earned for their performance in 
MIPS (88 FR 74960).
    In the Disincentives Proposed Rule, to illustrate the degree to 
which this disincentive could deter information blocking, HHS analyzed 
the range of potential disincentive amounts MIPS eligible clinicians 
could be subject to if the proposed disincentive was imposed, using 
payment and MIPS data from 2021, the most recent year of publicly 
available data. For more information about this analysis, we refer 
readers to the Disincentives Proposed Rule (88 FR 74960).
c. Provisions
    Under the authority in SSA sections 1848(o)(2)(A) and (D), and 
1848(q)(2)(A)(iv) and (B)(iv), for the MIPS Promoting Interoperability 
performance category, CMS proposed that a MIPS eligible clinician would 
not be a meaningful EHR user in a performance period if OIG refers a 
determination that the MIPS eligible clinician committed information 
blocking (as defined at 45 CFR 171.103) at any time during the calendar 
year of the performance period (88 FR 74960 and 74961).\32\ CMS also 
proposed that the determination by OIG that the MIPS eligible clinician 
committed information blocking would result in a MIPS eligible 
clinician that is required to report on the MIPS Promoting 
Interoperability performance category not earning a score in the 
performance category (a zero score), which is typically a quarter of 
the total final score. CMS proposed to codify this proposal under the 
definition of meaningful EHR user for MIPS at 42 CFR 414.1305 and amend 
the requirements for earning a score for the MIPS Promoting 
Interoperability performance category at 42 CFR 414.1375(b) (88 FR 
74960 and 74961).
---------------------------------------------------------------------------

    \32\ As provided in 42 CFR 414.1320(h), for purposes of the 2024 
MIPS payment year and each subsequent MIPS payment year, the 
performance period for the MIPS Promoting Interoperability 
performance category is a minimum of a continuous 90-day period 
within the calendar year that occurs 2 years prior to the applicable 
MIPS payment year, up to and including the full calendar year. In 42 
CFR 414.1305, CMS has defined the ``MIPS payment year'' as the 
calendar year in which the MIPS payment adjustment factor is applied 
to Medicare Part B payments. In the CY 2024 Physician Fee Schedule 
proposed rule, CMS proposed that, beginning with the 2026 MIPS 
payment year, the performance period for the MIPS Promoting 
Interoperability performance category would be a minimum of a 
continuous 180-day period within the calendar year that occurs 2 
years prior to the applicable MIPS payment year, up to and including 
the full calendar year (88 FR 52578 through 52579). Since the 
Disincentives Proposed Rule appeared in the Federal Register, CMS 
finalized this proposal for amending the performance period for the 
MIPS Promoting Interoperability performance category, to a minimum 
of a continuous 180-day period, in the CY 2024 Physician Fee 
Schedule final rule and codified this amendment as proposed at 42 
CFR 414.1320(i) (88 FR 79351 through 79353).
---------------------------------------------------------------------------

    CMS considered applying the proposed disincentive based on the date 
that the MIPS eligible clinician committed the information blocking as 
determined by OIG, instead of the date OIG refers its determination to 
CMS (88 FR 74961). However, a significant period could pass between the 
date when the MIPS eligible clinician is determined to have committed 
information blocking, and the date when OIG makes a referral to CMS, 
due to the time required for OIG to fully investigate a claim of 
information blocking. Such delay between the date the information 
blocking allegedly occurred and OIG's referral could complicate our 
application of the disincentive and would likely necessitate 
reprocessing of a significant number of claims. Therefore, CMS decided 
to use the date of the OIG referral instead of the date of the 
information blocking occurrence to apply this proposed disincentive. 
Accordingly, CMS proposed to apply the proposed disincentive to the 
MIPS payment year associated with the calendar year in which OIG 
referred its determination to CMS (88 FR 74961).
    As provided in 42 CFR 414.1320, the applicable MIPS payment year is 
2 calendar years after the performance period. The time period between 
the performance period and the MIPS payment year permits CMS to review 
each MIPS eligible clinician's performance to determine their final 
score and MIPS payment adjustment factor. We noted that, under the

[[Page 54695]]

proposal, if OIG referred its determination that a MIPS eligible 
clinician committed information blocking in calendar year 2025, then 
CMS would apply the disincentive proposed herein for the 2027 MIPS 
payment year (88 FR 74961).
    In the Disincentives Proposed Rule, first, CMS proposed to amend 
the definition of ``meaningful EHR user for MIPS'' at 42 CFR 414.1305 
(88 FR 74961). The current definition states that a ``meaningful EHR 
user for MIPS means a MIPS eligible clinician who possesses CEHRT, uses 
the functionality of CEHRT, reports on applicable objectives and 
measures specified for the Promoting Interoperability performance 
category for a performance period in the form and manner specified by 
CMS, does not knowingly and willfully take action (such as to disable 
functionality) to limit or restrict the compatibility or 
interoperability of CEHRT, and engages in activities related to 
supporting providers with the performance of CEHRT.'' CMS proposed to 
add to this definition that a MIPS eligible clinician is not a 
meaningful EHR user in a performance period if OIG refers a 
determination that the clinician committed information blocking (as 
defined at 45 CFR 171.103) during the calendar year of the performance 
period (88 FR 74961). CMS also proposed other minor technical changes 
to the language of the definition. In the Disincentives Proposed Rule, 
CMS noted that, in tandem with other proposals for MIPS in this 
section, the proposed amendment to the definition in 42 CFR 414.1305 
would result in a MIPS eligible clinician not being able to earn points 
associated with the Promoting Interoperability performance category 
they may otherwise have earned, potentially resulting in a negative or 
neutral payment adjustment. As such, we stated that this potential 
outcome likely would deter health care providers from engaging in 
information blocking (88 FR 74961).
    Second, CMS proposed to amend the requirements for earning a score 
for the MIPS Promoting Interoperability performance category by adding 
a new requirement at 42 CFR 414.1375(b) (88 FR 74961). Currently, 42 
CFR 414.1375(b) provides that, to earn a score (other than zero) for 
the Promoting Interoperability performance category, the MIPS eligible 
clinician must meet certain requirements, including using CEHRT, 
reporting on the objectives and associated measures as specified by 
CMS, and attesting to certain statements and activities. CMS proposed 
to amend 42 CFR 414.1375(b) by adding that the MIPS eligible clinician 
must be a meaningful EHR user for MIPS as defined at 42 CFR 414.1305. 
In conjunction with the proposal to amend the definition of a 
meaningful EHR user for MIPS at 42 CFR 414.1305 discussed previously, 
CMS noted the proposal would establish a clear basis to apply a score 
of zero for the MIPS Promoting Interoperability performance category to 
a MIPS eligible clinician that fails to meet the definition of 
meaningful EHR user for MIPS during a performance period, specifically 
if OIG refers a determination of information blocking during the 
calendar year of the performance period (88 FR 74961).
    In the Disincentives Proposed Rule, CMS noted that, under these 
proposals, a MIPS eligible clinician that OIG determines has committed 
information blocking would not be a meaningful EHR user, and therefore 
would be unable to earn a score (instead, earning a score of zero) for 
the MIPS Promoting Interoperability performance category (88 FR 74961). 
Because a MIPS eligible clinician that has committed information 
blocking would not be a meaningful EHR user for a given performance 
period, they would earn a zero for the Promoting Interoperability 
performance category for the calendar year of the applicable 
performance period in which the determination of information blocking 
was referred by OIG. For example, if OIG refers a determination that a 
MIPS eligible clinician committed information blocking to CMS in CY 
2026, CMS would apply a score of zero for the Promoting 
Interoperability performance category for the 2028 MIPS payment year to 
the MIPS eligible clinician.
    In the Disincentives Proposed Rule, CMS explained that under this 
proposed disincentive for information blocking, a score of zero for the 
MIPS Promoting Interoperability performance category would negatively 
impact 25 percent of the MIPS eligible clinician's final score such 
that it would likely result in a negative MIPS payment adjustment for 
the applicable MIPS payment year (88 FR 74961). For example, applying 
the weights for the performance categories under 42 CFR 414.1380(c)(1), 
a score of zero for the Promoting Interoperability performance category 
would mean that the maximum final score a MIPS eligible clinician could 
achieve, if they performed perfectly in the remaining performance 
categories, would be 75 points.
    Then, as discussed previously, to determine the MIPS payment 
adjustment factor, CMS compares the MIPS eligible clinician's final 
score to the established performance threshold for that MIPS payment 
year. In 42 CFR 414.1405(b)(9)(ii), CMS established that the 
performance threshold for the 2025 MIPS payment year is 75 points. If, 
under this example, a MIPS eligible clinician still achieved 75 points 
for their final score for the 2025 MIPS payment year matching the 
established performance threshold of 75 points, then they would receive 
a neutral MIPS payment adjustment factor.
    In the CY 2024 Physician Fee Schedule proposed rule, CMS proposed 
that the performance threshold for the 2026 MIPS payment year would be 
82 points (88 FR 52596 through 52601). This proposal was not finalized 
in the CY 2024 Physician Fee Schedule Final Rule; instead, CMS 
finalized the performance threshold for the 2026 MIPS payment year as 
75 points at 42 CFR 414.1405(b)(9)(iii) (88 FR 79374 through 79376). 
However, if some other performance threshold higher than 75 points is 
finalized in a future MIPS payment year, then a MIPS eligible clinician 
(that OIG determined committed information blocking and received a 
score of zero in the Promoting Interoperability performance category 
and therefore, under our example, a final score of 75 points) would 
receive a negative MIPS payment adjustment factor. If CMS finalizes a 
performance threshold higher than 75 points in a future MIPS payment 
year, then the proposed disincentive would likely to result in a MIPS 
eligible clinician that commits information blocking, as determined by 
OIG, receiving a negative payment adjustment, up to negative nine 
percent for a final score of zero as set forth in 42 CFR 414.1405(b)(2) 
and (c).
    In the Disincentives Proposed Rule, CMS explained that, under these 
proposals, a MIPS eligible clinician, that otherwise fulfilled other 
requirements to demonstrate meaningful use of CEHRT for a performance 
period to earn a score for the Promoting Interoperability performance 
category, would nevertheless not be a meaningful EHR user for that 
performance period if OIG refers a determination of information 
blocking during the calendar year of the performance period (88 FR 
74962). This would result in the MIPS eligible clinician nevertheless 
earning a score of zero for the Promoting Interoperability performance 
category.\33\ Furthermore, if a MIPS eligible clinician earned a score 
of zero for the Promoting Interoperability performance category for a 
given year because CMS had

[[Page 54696]]

already determined the MIPS eligible clinician had otherwise not been a 
meaningful EHR user in that performance period due to its performance 
in the Promoting Interoperability performance category, imposition of 
the proposed disincentive would result in no additional impact on the 
MIPS eligible clinician during that MIPS payment year (88 FR 74962).
---------------------------------------------------------------------------

    \33\ Although this statement was not part of this explanation in 
the Disincentives Proposed Rule (88 FR 74962), we have added it for 
clarity. We believe this statement is logically inferred from the 
original proposal.
---------------------------------------------------------------------------

    CMS clarified in the Disincentives Proposed Rule that, even if 
multiple information blocking violations were identified as part of 
OIG's determination (including over multiple years) and referred to 
CMS, each referral of an information blocking determination by OIG 
would only affect a MIPS eligible clinician's status as a meaningful 
EHR user in a single performance period during the calendar year when 
the determination of information blocking was referred by OIG (88 FR 
74962). Barring an additional referral of an information blocking 
determination by OIG in the subsequent calendar year, a MIPS eligible 
clinician could be deemed a meaningful EHR user and earn a score for 
the Promoting Interoperability performance category in the following 
calendar year.
    CMS invited public comment on these proposals. CMS particularly 
requested comment on its approach to the application of a disincentive 
for OIG determinations that found that information blocking occurred in 
multiple years and whether there should be multiple disincentives for 
such instances (for example, disincentives in multiple calendar years/
performance periods compared to only one disincentive in the calendar 
year in which a referral from OIG is made).
    The following is a summary of the comments received and our 
responses.
    Comments. A few commenters supported the proposed application of 
disincentives in MIPS generally. One commenter noted that the 
disincentives will incentivize health IT use. Another commenter 
expressed that the Promoting Interoperability performance category is 
an appropriate avenue through which to apply the disincentives. A few 
commenters expressed general support for CMS' goals and purposes in 
applying disincentives to the MIPS Promoting Interoperability 
performance category, noting that the proposal is consistent with the 
Cures Act and that information blocking undermines the meaningful use 
of certified EHR technology.
    Response. We appreciate the support of these commenters. We believe 
that information blocking disrupts the meaningful use of CEHRT and 
exchange of electronic health information, as required by SSA section 
1848(o)(2)(A)(i) and (ii), and should be deterred. We believe the 
disincentive will serve as a deterrent to information blocking 
practices and reduce the incidence of information blocking.
    Comments. One commenter supported the proposal that health care 
providers determined by OIG to have engaged in information blocking 
should not be considered a meaningful EHR user within MIPS.
    Response. We appreciate the support of this commenter. We agree 
that information blocking is not consistent with the goals of the MIPS 
Promoting Interoperability performance category to support meaningful 
use of CEHRT and exchange of electronic health information, as required 
by SSA section 1848(o)(2)(A)(i) and (ii).
    Comments. A few commenters requested clarification on whether the 
reductions to the MIPS incentive payment will be deemed Recovered 
Penalty Funds pursuant to the Cures Act.
    Response. We note that ``reductions to the MIPS incentive payment'' 
does not accurately reflect how MIPS may affect MIPS eligible 
clinician's payments for covered professional services under Medicare 
Part B. We refer readers to our description of MIPS, including how CMS 
assesses a MIPS eligible clinician's performance and calculates and 
applies MIPS payment adjustment factors in section III.C.3.a. of the 
Disincentives Proposed Rule (88 FR 74957 through 74959) and this final 
rule.
    We reiterate that CMS proposed that OIG's referral of its 
determination that the MIPS eligible clinician committed information 
blocking would result in CMS specifying that the MIPS eligible 
clinician is not a meaningful EHR user and assigning the MIPS eligible 
clinician a score of zero for the Promoting Interoperability 
performance category. As we described in the Disincentive Proposed 
Rule, this may result in CMS calculating a MIPS payment adjustment 
factor that is neutral or negative (88 FR 74961 and 74962). When 
applied, a MIPS payment adjustment factor potentially adjusts Medicare 
Part B payments upwards or downwards and are not considered recovered 
penalty funds pursuant to Section 4004 of the Cures Act.
    Comments. Commenters sought clarity on whether, if an eligible 
hospital or CAH was found to have committed information blocking for 
which CMS imposed a disincentive under the Medicare Promoting 
Interoperability Program, a MIPS eligible clinician that practices in, 
or is affiliated with that eligible hospital or CAH (for example, an 
outpatient clinic) would also receive a disincentive under MIPS. 
Additionally, commenters sought clarity on whether a MIPS-eligible 
clinician that commits information blocking in a hospital setting would 
be assigned disincentives under both MIPS and the Medicare Promoting 
Interoperability Program based on the same finding.
    Response. If OIG refers a determination of information blocking for 
a health care provider, CMS will apply disincentives established 
through notice and comment rulemaking that are applicable to that 
health care provider. Accordingly, if OIG found that an eligible 
hospital or CAH committed information blocking and referred the 
determination to CMS, we would only impose the disincentive under the 
Medicare Promoting Interoperability Program, which is applicable to 
eligible hospitals and CAHs, to the hospital that has committed 
information blocking. We would not impose a separate disincentive on 
individual MIPS eligible clinicians that are affiliated with the 
hospital, provided that OIG did not similarly find that the individual 
MIPS eligible clinician(s) also committed information blocking and 
referred that determination to CMS.
    Comments. Several commenters expressed concern about the impact the 
proposed MIPS disincentive will have on patient access to care. A few 
commenters expressed that MIPS eligible clinicians may take on fewer 
Medicare beneficiaries as patients as a result of the potential impact 
of disincentives, while others may choose not to participate in the 
Medicare program at all, which may ultimately impact beneficiary access 
to care. One commenter contended that, because psychiatrists may be 
impacted, Medicare beneficiaries seeking mental health services could 
be negatively impacted by the proposed disincentives.
    Response. While we understand these concerns, MIPS eligible 
clinicians already are required to demonstrate they are not knowingly 
or willfully taking actions to limit or restrict the compatibility or 
interoperability of the CEHRT they use as set forth in SSA section 
1848(o)(2)(A)(ii). One of the current requirements of the MIPS 
Promoting Interoperability performance category is to attest ``yes'' to 
the self-reported attestation statement that they did not knowingly or 
willfully take action to limit or restrict compatibility or 
interoperability of CEHRT, which may include actions that are 
information blocking (42 CFR 414.1375(b)(3)(iii)).

[[Page 54697]]

    In addition, we believe that the practice of information blocking 
could cause potential harm to patients. Information blocking does not 
promote healthcare efficiency and does not encourage widespread health 
information exchange. We refer readers to our discussion of how 
information blocking conduct undermines the goals and purpose of the 
MIPS Promoting Interoperability performance category in section 
III.C.3.b.(2). of the Disincentives Proposed Rule (88 FR 74960) and 
this final rule.
    Comments. Several commenters expressed concern about the impact the 
proposed MIPS disincentive may have to increase burden and financial 
distress on health care providers. One commenter did not support the 
proposed impact of disincentive estimates for MIPS, noting that the 
penalties are economically significant and may be catastrophic for some 
practices. One commenter stated that this increasing burden is due to 
the changing nature of the underlying programs, requiring health care 
providers to continually monitor changes.
    Response. Finalizing the proposed disincentive provisions related 
to MIPS eligible clinicians should not increase burden on clinicians as 
it does not require the clinician to do anything additional. The 
proposed disincentive only applies if the MIPS eligible clinician 
engages in information blocking contrary to statute, including SSA 
section 1848(o)(2)(A). As for financial distress, MIPS eligible 
clinicians can avoid receipt of a disincentive for information blocking 
by not interfering with, preventing, or materially discouraging the 
access, exchange, or use of electronic health information.
    Comments. Several commenters shared recommendations on how CMS 
should apply disincentives in MIPS. A few commenters recommended that 
CMS establish more than one disincentive for MIPS eligible clinicians 
who are referred by OIG to allow the agency flexibility in determining 
the disincentive appropriate for each case. One commenter recommended 
that CMS provide clinicians who are successfully sharing information 
additional points for their MIPS score.
    Response. We thank commenters for their feedback. While we 
initially considered different approaches, we proposed to amend the 
definition of meaningful EHR user. We proposed that a MIPS eligible 
clinician who is referred to CMS by OIG for information blocking would 
not be considered a meaningful EHR user, thereby resulting in earning a 
zero for the Promoting Interoperability performance category.
    While we acknowledge information blocking conduct may vary in 
levels of severity, frequency, and potential patient harm, we believe 
our proposed disincentive for MIPS is most closely aligned with the 
directive at PHSA section 3022(b)(2)(B) (to apply an appropriate 
disincentive using authorities under applicable Federal law) and the 
statutory criteria for being treated as a meaningful EHR user in SSA 
section 1848(o)(2)(A) for the MIPS Promoting Interoperability 
performance category under SSA section 1848(q)(2)(B)(iv), as discussed 
previously. Information blocking inhibits the meaningful use of CEHRT 
and the electronic exchange of health information as required by SSA 
section 1848(o)(2)(A). Failure to meet all three criteria to be treated 
as a meaningful EHR user at SSA section 1848(o)(2)(A) means the MIPS 
eligible clinician has failed to meet the requirements for the MIPS 
Promoting Interoperability performance category, which we believe 
warrants a score of zero. We believe this disincentive is most 
consistent with these statutory requirements for a MIPS eligible 
clinician to demonstrate they are a meaningful user of CEHRT because, 
as discussed previously, information blocking undermines the goals and 
purposes of these requirements.
    Comments. A few commenters supported the proposal to use the date 
of the OIG referral instead of the date of the information blocking 
occurrence to apply the disincentive within MIPS, stating that this 
approach would avoid reprocessing of claims, allow health care 
providers to plan for a disincentive, and prevent additional 
administrative burden in the process.
    Response. We agree that using the date of the referral is the 
preferred approach as it allows us to apply the disincentive to the 
applicable MIPS payment year.
    Comments. One commenter recommended that CMS apply the disincentive 
to the performance period following the year in which OIG makes a 
determination on information blocking. A commenter expressed concern 
that the two-year period between when the referral occurs and when the 
disincentive is applied is too long and may not serve to correct health 
care provider behavior as a result. Another commenter recommended CMS 
not apply the disincentive in two MIPS payment years unless the 
information blocking conduct spanned more than 1 year, and that CMS 
apply the disincentives according to the length of time over which the 
conduct occurred.
    Response. We considered applying the disincentive to the year 
following the OIG referral but determined that it was not 
administratively feasible under CMS's existing MIPS policies and 
processes. We proposed that the disincentive be applied to the MIPS 
payment year 2 years after the year of the OIG referral. This aligns 
with current MIPS policy and processes, as the MIPS payment adjustment 
is applied to the MIPS payment year 2 years after the performance 
period.
    We did not propose to apply the disincentive to multiple years. 
Even if a referral from OIG identified information blocking conduct 
that occurred over multiple years, we would only apply a payment 
adjustment to the year the OIG referral was made.
    Comments. One commenter did not support the proposed amendments to 
the definition of a ``meaningful EHR user for MIPS,'' noting that the 
proposed policy does not consider the severity of the information 
blocking determination and is inconsistent with OIG's existing policies 
of considering multiple factors prior to determining the severity of a 
penalty for HIEs/HINs.
    Response. We thank the commenter for their feedback; however, we 
disagree. We believe that any instance of information blocking should 
not occur. OIG completes their investigation and then refers the 
determination to CMS. OIG does not impose the disincentive. We 
recognize that PHSA section 3022(b)(2)(A) states that, for health IT 
developers of certified health IT and HINs/HIEs who have committed 
information blocking that are subject to CMPs, the amount of the CMP 
shall consider factors such as the nature and extent of the information 
blocking. However, as discussed previously in this rule, this provision 
does not apply to health care providers that OIG refers to an 
appropriate agency to be subject to appropriate disincentives using 
authorities under applicable Federal law, as stated in PHSA section 
3022(b)(2)(B). The proposal we have finalized in this final rule is 
established under the authority for the MIPS Promoting Interoperability 
performance category in SSA section 1848(q). This authority is 
discussed previously in detail and in the Disincentives Proposed Rule 
(88 FR 74958 and 74959). As we discuss in a previous response to a 
comment, this authority does not provide us with the ability to adjust 
payments under MIPS according to a set of factors related to the 
severity of information blocking practices.

[[Page 54698]]

    Comments. Many commenters did not support the proposal to assign a 
zero score for the MIPS Promoting Interoperability performance category 
if a health care provider has committed information blocking. Many 
commenters expressed that the proposed disincentive is too severe, with 
some expressing concern that it would prevent eligible clinicians from 
earning a positive payment adjustment under MIPS and would likely 
result in a negative payment adjustment, especially if the performance 
threshold is increased in future years. Based on this, one commenter 
disagreed that the rule is not economically significant.
    Response. We thank commenters for their feedback. We believe that 
committing information blocking is not only inconsistent with PHSA 
section 3022 but also undermines the goals and purpose of the MIPS 
Promoting Interoperability performance category. We refer readers to 
our discussion in section III.C.3.b.(2). of the Disincentives Proposed 
Rule (88 FR 74960) and this final rule.
    As we discuss in a previous response to a comment, information 
blocking inhibits the meaningful use of CEHRT and the electronic 
exchange of health information as required by SSA section 
1848(o)(2)(A). Failure to meet all three criteria to be treated as a 
meaningful EHR user at SSA section 1848(o)(2)(A) means the MIPS 
eligible clinician has also failed to meet the requirements for the 
MIPS Promoting Interoperability performance category, which warrants a 
score of zero. This disincentive is consistent with the statutory 
requirements for a MIPS eligible clinician to demonstrate they are a 
meaningful user of CEHRT because, as discussed previously, information 
blocking undermines the goals and purposes of these requirements.
    We disagree that the disincentive is severe. It is closely aligned 
with the directive at PHSA section 3022(b)(2)(B) (to apply an 
appropriate disincentive using authorities under applicable Federal 
law) and the statutory requirements for MIPS. As discussed in section 
III.C.3.a.(1). of the Disincentives Proposed Rule (88 FR 74957 and 
74958) and this final rule, a MIPS eligible clinician receiving a final 
score of zero for all applicable performance categories would result in 
a negative MIPS adjustment factor of negative 9 percent (sections 
1848(q)(6)(A) and (B)(iv); 42 CFR 414.1405(c)). The MIPS statute at SSA 
sections 1848(q)(6)(A) and (B) establishes the framework by which CMS 
calculates MIPS payment adjustment factors based on CMS' assessment of 
MIPS eligible clinicians' performance in the four performance 
categories. Nothing in the MIPS disincentive we proposed and have 
finalized in this rule alters that framework. Instead, this 
disincentive explicitly relies on that framework, providing that an OIG 
referral of its determination that a MIPS eligible clinician committed 
information blocking means the MIPS eligible clinician does not meet 
the requirements for the Promoting Interoperability performance 
category, and therefore warrants receiving a zero score for that 
category.
    Further, we note that, after application of the linear scaling 
factor and budget neutrality, a final score above zero, but below the 
applicable performance threshold, may result in calculation of a MIPS 
payment adjustment factor between negative 9 percent and zero 
percent.\34\ Depending on how the MIPS eligible clinician performs in 
the other performance categories and the weight assigned to the 
applicable performance categories for the final score, the potential 
effect of application of this disincentive (a zero score for the 
Promoting Interoperability performance category) on calculation of the 
MIPS payment adjustment factor may be limited.
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    \34\ We refer readers to Table 60 in the CY 2024 Physician Fee 
Schedule final rule (88 FR 79379) for an illustration of the 
potential range of MIPS payment adjustment factors that may be 
calculated and applied based on comparison of a MIPS eligible 
clinician's final score to the applicable performance threshold. For 
instance, a final score of 0 to 18.75 points for the CY 2024 
performance period/2026 MIPS payment year may result in negative 9 
percent MIPS payment adjustment factor; a final score of 18.76 to 
74.99 may result in a MIPS payment adjustment factor between 
negative 9 percent and zero percent.
---------------------------------------------------------------------------

    As we state in section VI. of this final rule, the Office of 
Management and Budget has determined that the proposed rule is not a 
significant regulatory action as the potential costs associated with 
the proposed rule would not be greater than $200 million per year nor 
would this action meet the other conditions necessary to be deemed 
significant.
    Comments. Some expressed concern that disincentives may have a 
significant negative financial impact on practices. A few commenters 
contended that the proposed disincentive was too severe for first time 
offenders. Other commenters expressed concern about the impact this 
proposal would have on smaller practices, with some expressing concern 
that it may cause disproportionate financial distress to smaller 
practices.
    Response. We appreciate the feedback, but health care providers, 
including MIPS eligible clinicians, should not engage in information 
blocking practices. The impact associated with the disincentive meets 
our goal of deterring information blocking, which includes ``first-
time'' conduct by health care providers. We also reiterate that 
information blocking practices by health care providers include an 
element of intent, in which the health care provider must know that a 
practice is unreasonable and likely to interfere with the exchange, 
access or use of electronic health information. We remind readers that 
we did not propose to modify our reweighting policies and small 
practices will continue to be automatically reweighted for the 
Promoting Interoperability performance category as provided in 42 CFR 
414.1380(c)(2)(i)(C)(9).
    Comments. One commenter expressed concern that, upon receipt of 
notice from CMS regarding OIG's finding that the MIPS eligible 
clinician committed information blocking and application of the 
disincentive, individual MIPS eligible clinicians or groups will have 
less incentive to report additional measures under the MIPS Promoting 
Interoperability performance category. They recommended deducting 10 
points from the category score in a calendar year of the performance 
period if the OIG refers a determination of information blocking. 
Several commenters recommended that CMS instead implement a scalable 
system that would impose different disincentives depending on the 
severity or mitigating factors of the information blocking violation. A 
few commenters recommended a percentage or point deduction rather than 
failing the entire Promoting Interoperability performance category and 
scaling it to severity.
    Response. We thank commenters for their input. While we did 
initially consider some of these alternatives, we ultimately decided 
not to propose them. As we discuss in a previous response to a comment, 
the disincentive we proposed and have finalized closely aligns with the 
directive at PHSA section 3022(b)(2)(B) (to apply an appropriate 
disincentive using authorities under applicable Federal law) and the 
statutory requirements MIPS. Information blocking inhibits the 
meaningful use of CEHRT and the electronic exchange of health 
information as required by SSA section 1848(o)(2)(A). Failure to meet 
all three criteria to be treated as a meaningful EHR user at SSA 
section 1848(o)(2)(A) means the MIPS eligible clinician has also failed 
to meet the requirements for the MIPS Promoting Interoperability 
performance category, which warrants a

[[Page 54699]]

score of zero. We believe any other disincentive option would be 
contrary to these statutory requirements for a MIPS eligible clinician 
to demonstrate they are a meaningful user of CEHRT because, as 
discussed previously, information blocking undermines the goals and 
purposes of these requirements.
    The policies that we proposed and have finalized, including 
modification to the definition of meaningful EHR user for MIPS (42 CFR 
414.1305), will result in a MIPS eligible clinician not being able to 
earn points associated with the Promoting Interoperability performance 
category if they were found to have committed information blocking. 
Regarding the recommendation to tie the disincentive to a reduction of 
10 points in the performance category, and the recommendation to tie a 
point reduction to the severity of the information blocking conduct 
referred by OIG, we note that we did not propose these alternatives for 
the reasons stated above.
    Comments. One commenter recommended CMS consider additional 
incentives within the Promoting Interoperability performance category 
to promote the flow of electronic health information and to deter 
information blocking.
    Response. We appreciate this input and may consider it in future 
rulemaking. In recent years, we have added measures to the Promoting 
Interoperability performance category such as the Enabling Exchange 
under the Trusted Exchange Framework and Common Agreement (TEFCA) 
measure, to encourage the bi-directional exchange of patient 
information (87 FR 70067).
    Comments. Another commenter requested CMS clarify how cases in 
which MIPS eligible clinicians transition from reporting traditional 
MIPS to MIPS Value Pathways (MVPs) during the OIG investigation would 
be addressed and whether penalties would be imposed given the different 
participation options within the MVP framework, expressing concern 
about confusion and implementation challenges.
    Response. The MIPS Promoting Interoperability performance category 
is a foundational component of every MVP. As such, if a finding of 
information blocking is referred to CMS by OIG, we would apply the 
disincentive to the MIPS eligible clinician participating in an MVP.
    After consideration of the public comments, CMS has finalized our 
proposal to revise the definition of ``meaningful EHR user'' for MIPS 
at 42 CFR 414.1305 to state that a MIPS eligible clinician is not a 
meaningful EHR user in a performance period if OIG refers a 
determination that the clinician committed information blocking, as 
defined at 45 CFR 171.103, during the calendar year of the performance 
period. CMS has also finalized minor technical modifications to this 
definition as proposed (88 FR 74961). Consistent with our discussion in 
section III.C.3.b.(1), CMS has finalized this definition to also 
exclude a qualified audiologist from application of this disincentive. 
We originally noted this exclusion in the regulation text we proposed 
in the Disincentive Proposed Rule (88 FR 74968). Therefore, CMS has 
finalized the amendment to the regulatory definition of meaningful EHR 
user for MIPS at 42 CFR 414.1305 generally as proposed, with a 
modification to address group reporting as discussed in section 
III.C.3.c.(1) of this rule.
    CMS has finalized our proposal that if OIG refers a determination 
to CMS that the MIPS eligible clinician is found to have committed 
information blocking, the MIPS eligible clinician will not earn a score 
in the Promoting Interoperability performance category (a zero score), 
which is typically a quarter of the total MIPS score. Further, CMS has 
finalized the proposal that we will apply the disincentive to the MIPS 
payment year associated with the calendar year in which OIG referred 
its determination to CMS. To codify this policy, CMS also has finalized 
its proposal to amend the requirements for earning a score for the MIPS 
Promoting Interoperability performance category at 42 CFR 414.1375(b) 
as proposed.
    Lastly, CMS has finalized its proposal that, if multiple 
information blocking violations are identified as part of OIG's 
determination (including over multiple years) and referred to CMS, each 
referral of an information blocking determination by OIG would only 
affect a MIPS eligible clinician's status as a meaningful EHR user in a 
single performance period during the calendar year when the 
determination of information blocking was referred to CMS by OIG.
    The final policies in this rule will become effective 30 days after 
the final rule appears in the Federal Register. As noted in section 
III.B.1. of this final rule, OIG will not begin investigating health 
care providers until after the effective date of this rule, and will 
exercise its enforcement discretion not to make any determinations 
regarding conduct occurring prior to the effective date of this rule 
for information blocking disincentives. As OIG will not make a 
determination on conduct occurring prior to the effective date, OIG 
will not refer any health care providers based on a determination of 
conduct occurring prior to the effective date of this rule for 
information blocking disincentives. This means that CMS will not impose 
the disincentive finalized under the MIPS Promoting Interoperability 
performance category on information blocking conduct occurring before 
the effective date of this final rule.
(1) Groups and Virtual Groups
    In the Disincentives Proposed Rule, CMS proposed that, if data for 
the MIPS Promoting Interoperability performance category is submitted 
as a group or virtual group, then the application of the disincentive 
would be made at that level (88 FR 74962). CMS referred readers to our 
prior rulemaking governing groups and virtual groups (81 FR 77073 
through 77077) and our regulations at 42 CFR 414.1305 (defining MIPS 
eligible clinicians as including groups as well as separately defining 
groups and virtual groups) and 414.1315 (governing virtual groups). 
Additionally, we refer readers to SSA section 1848(q)(1)(D), which 
provides the Secretary with authority to establish and apply a process 
to assess the performance of MIPS eligible clinicians in a group 
practice as a whole group under MIPS, including the group's performance 
in the Promoting Interoperability performance category.
    In the Disincentives Proposed Rule, CMS explained that MIPS 
eligible clinicians who submit data as a part of a group, virtual 
group, or individually will be evaluated as an individual or as a group 
for all performance categories (88 FR 74962). We clarify in this final 
rule that if a MIPS eligible clinician reports data for MIPS as a group 
and an individual, the payment adjustment will be based on the highest 
final score.\35\ Beginning with the CY 2021 performance period/2023 
MIPS payment year, if a TIN/NPI has a virtual group final score 
associated with it, CMS will use the virtual group final score to 
determine the MIPS payment adjustment; if a TIN/NPI does not have a 
virtual group final score associated with it, we will use the highest 
available final score associated with the TIN/NPI to determine the MIPS 
payment adjustment (85 FR 84917 through 84919). CMS noted that it would 
apply the MIPS payment adjustment factor to the Medicare Part B claims 
during the

[[Page 54700]]

MIPS payment year for the MIPS eligible clinicians in the group or 
virtual group. Thus, CMS proposed that, if CMS is calculating a final 
score and MIPS payment adjustment factor for a group or virtual group 
and OIG refers a finding of information blocking to CMS, CMS would 
apply the proposed disincentive to the whole group.
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    \35\ Although CMS did not include this clarification in the 
Disincentives Proposed Rule, this statement is consistent with 
existing MIPS policies governing individual and group reporting. See 
the CY 2017 Quality Payment Program final rule (81 FR 77330 through 
77332).
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    The following is a summary of the comments we received and our 
responses.
    Comments. A few commenters requested clarification on the proposal 
to apply the disincentive at the group level. Others requested 
clarification on how OIG would address a group practice that committed 
information blocking, but that does not participate in MIPS at the 
group level. Another commenter requested additional information on how 
CMS would address instances in which a MIPS eligible clinician that is 
found to have committed information blocking reports both as a group 
and as an individual, how this policy will be applied to subgroups when 
a subgroup is identified, and whether the appropriate disincentive will 
be applied to an entire group, regardless of whether the information 
blocking practice was limited to a particular subgroup.
    Response. In situations where OIG refers a determination of 
information blocking for multiple NPIs we would apply the disincentive 
to each NPI. If OIG determines a group consisting of one or more MIPS 
eligible clinicians has committed information blocking and the MIPS 
eligible clinicians submit data as a group, the disincentive would be 
applied at the group level. However, as discussed in more detail below, 
consistent with PHSA section 3022(a)(6), if OIG determines a single 
MIPS eligible clinician within a group has committed information 
blocking (and not the group itself), then we would seek to apply the 
disincentive to the individual MIPS eligible clinician.
    Comments. Several commenters expressed concern that this proposal 
would discourage group, virtual group, and subgroup reporting, which 
commenters stated would undermine CMS' goals of reducing the overall 
reporting burden and increasing participation in value-based payment 
models. Commenters expressed that the proposal could dissuade health 
care providers from reporting at the group level, due to concerns about 
being unfairly penalized for the actions of one bad actor in a group 
and may impact participation in virtual groups even more because 
clinicians may practice in different locations and may use different 
EHR systems.
    Response. We disagree with the commenters that finalizing this 
disincentive policy will discourage group submissions, as we believe 
the benefits of group reporting outweigh the potential risk of being 
subject to a disincentive, as MIPS eligible clinicians that comply with 
the information blocking regulations will not be subject to a 
disincentive. We have finalized that, if OIG determines the group has 
committed information blocking, then we will apply the disincentive to 
the group. However, as discussed in more detail below, consistent with 
PHSA section 3022(a)(6), if OIG determines a single MIPS eligible 
clinician within a group has committed information blocking (and not 
the group itself), then we would seek to apply the disincentive to the 
individual MIPS eligible clinician.
    Comments. Many commenters did not support the proposal to apply the 
disincentive at the group level, noting that the proposal is overly 
punitive. Some commenters noted that in large groups hundreds or 
thousands of MIPS eligible clinicians could be penalized for the action 
of one within the group. Some commenters noted that a TIN serves many 
purposes and cannot be easily undone to avoid a disincentive for a 
group.
    Response. We thank commenters for their feedback but decline to 
modify our proposal in response to these comments. MIPS eligible 
clinicians do not have to report data as a group; it is a choice that 
they make. However, as discussed in more detail below, consistent with 
PHSA section 3022(a)(6), if OIG determines a single MIPS eligible 
clinician within a group has committed information blocking (and not 
the group itself), then we would seek to apply the disincentive to the 
individual MIPS eligible clinician.
    Comments. Another commenter requested clarification on how a case 
would be handled in which a health care provider commits information 
blocking during a specific MIPS performance period, and then moves to a 
new practice before the application of the MIPS payment adjustment.
    Response. We will apply the disincentive to the MIPS payment year 2 
years after CMS receives the information blocking referral from OIG. 
The application of the disincentive will follow the MIPS eligible 
clinician.\36\ As discussed in more detail below, consistent with PHSA 
section 3022(a)(6), if OIG determines a single MIPS eligible clinician 
within a group has committed information blocking (and not the group 
itself), then we would seek to apply the disincentive to the individual 
MIPS eligible clinician.
---------------------------------------------------------------------------

    \36\ For more information, see: the CY 2017 Quality Payment 
Program Final Rule (81 FR 77330 through 77332).
---------------------------------------------------------------------------

    Comments. Several commenters recommended that CMS apply the 
disincentive only to the health care provider(s) that were found to 
have committed information blocking rather than the entire group or 
virtual group. Some noted that an entire group or individuals not 
practicing in the same location or have a direct relationship should 
not be punished for the actions of another individual that may be 
beyond their control. A few commenters recommended individual 
physicians found to be information blockers could be excluded from the 
group data or be required to report and be assessed separately. One 
commenter contended that punishing the entire group for the behavior of 
one individual appears to be contrary to the definitions at PHSA 
3022(a)(6). One commenter requested that CMS look at the details of the 
case, determine the extent of and institutional role of the information 
blocking, and provide appropriate corrective action recommendations and 
education. One commenter recommended disincentives be applied to 
individual health care providers unless the subgroup or group has 
adopted enterprise-wide policies or taken actions as an enterprise that 
constitute information blocking. Some commenters requested that CMS 
work to determine a more equitable way to apply a disincentive in these 
situations, including a later application of the disincentive.
    Response. We acknowledge commenters' concerns with the policy we 
proposed for group reporting. PHSA section 3022(a)(6) relates to 
limiting what conduct can be determined to constitute information 
blocking. We will comply with PHSA section 3022(a)(6) in applying the 
disincentive we have finalized for the MIPS Promoting Interoperability 
performance category. If OIG determines that a group \37\ has committed 
information blocking and the group reports at the group level, then we 
would apply the disincentive to the group. If OIG determines that 
multiple individual MIPS eligible clinicians within a group have 
committed information blocking and they report at the individual level, 
then we would apply the disincentive to each MIPS eligible clinician 
individually. However, if OIG determines an individual MIPS

[[Page 54701]]

eligible clinician within a group has committed information blocking 
(and not the group itself), then we would seek to apply the 
disincentive to the individual MIPS eligible clinician.
---------------------------------------------------------------------------

    \37\ We define this term in our regulation at 42 CFR 414.1305 as 
a single TIN of two or more eligible clinicians (including at least 
one MIPS eligible clinician), as identified by their individual NPI, 
who have reassigned their billing rights to the TIN.
---------------------------------------------------------------------------

    To clarify this intent, we are finalizing our proposed amendment to 
the definition of meaningful EHR user for MIPS at Sec.  414.1305 with 
modification. Specifically, we are adding language reflecting the 
requirement at PHSA section 3022(a)(6), providing that the term 
``information blocking,'' with respect to an individual MIPS eligible 
clinician or group, shall not include an act or practice other than an 
act or practice committed by such individual MIPS eligible clinician or 
group. We will seek to address in future rulemaking how we will 
effectuate this requirement, including how we may disaggregate an 
individual MIPS eligible clinician's data from a group's data if OIG 
determines that only the individual MIPS eligible clinician (and not 
the group) committed information blocking.
    Comments. A few commenters specifically expressed concern that the 
existing MIPS review process would not address the underlying 
information blocking determination or cause of the zero score for the 
MIPS Promoting Interoperability performance category because it would 
not address the information blocking finding itself. One commenter 
expressed concern that there would be no mechanism for physicians to 
appeal the appropriateness of the specific disincentives chosen by CMS 
once it has received an information blocking determination referral 
from OIG. One commenter requested additional clarification on how the 
targeted review process within MIPS would apply to information blocking 
disincentives.
    Response. As discussed in section III.B.2. of this final rule, the 
Cures Act did not provide instruction regarding appeals of 
disincentives for health care providers established under PHSA section 
3022(b)(2)(B). Therefore, any right to appeal administratively a 
disincentive, if available, would be provided under the authorities 
used by the Secretary to establish the disincentive through notice and 
comment rulemaking. We refer readers to the targeted review process we 
established at 42 CFR 414.1385(a) in accordance with SSA section 
1848(q)(13)(A).
    After consideration of the public comments, we have finalized our 
proposed amendment to the definition of meaningful EHR user for MIPS at 
Sec.  414.1305 with modification. Specifically, we have added language 
reflecting the requirement at PHSA section 3022(a)(6), providing that 
the term ``information blocking,'' with respect to an individual MIPS 
eligible clinician or group, shall not include an act or practice other 
than an act or practice committed by such individual MIPS eligible 
clinician or group. We will seek to address in future rulemaking how we 
will effectuate this requirement, including how we may disaggregate an 
individual MIPS eligible clinician's data from a group's data if OIG 
determines that only the individual MIPS eligible clinician (and not 
the group) committed information blocking.
(2) Reweighting Policies
    In the Disincentives Proposed Rule we noted that CMS has 
established policies that result in the reweighting of the Promoting 
Interoperability performance category for certain MIPS eligible 
clinicians at 42 CFR 414.1380(c)(2) (88 FR 74962). These include but 
are not limited to hospital-based clinicians (81 FR 77238 through 
77420, 82 FR 53684, and 82 FR 53686 through 53687) and Ambulatory 
Surgical Center-based clinicians (82 FR 53684). CMS did not propose 
changes to its existing reweighting policies for MIPS eligible 
clinicians in the Disincentives Proposed Rule.
    Starting with the CY 2022 performance period/2024 MIPS payment year 
performance period CMS automatically reweights small practices for the 
Promoting Interoperability performance category (86 FR 65485 through 
65487; 42 CFR 414.1380(c)(2)(i)(C)(9)). CMS did not propose changes to 
our existing policy for MIPS eligible clinicians in small practices in 
the Disincentives Proposed Rule.
    CMS noted in the Disincentives Proposed Rule that if these MIPS 
eligible clinicians choose to submit data for the Promoting 
Interoperability performance category, their reweighting is canceled, 
and they could be subject to a disincentive if OIG refers a 
determination of information blocking to CMS (88 FR 74962).
    Comments. A few commenters supported CMS' decision to not propose 
any changes to the existing MIPS reweighting policies.
    Response. We thank commenters for their support.
    Comments. Several commenters requested that CMS clarify how the 
existing significant hardship exemptions for the MIPS Promoting 
Interoperability performance category will interact with the proposed 
MIPS disincentives.
    Response. CMS did not propose any changes to the existing 
reweighting policies for significant hardship or other types of 
exceptions for the MIPS Promoting Interoperability performance category 
set forth at 42 CFR 414.1380(c)(2)(i)(C). These reweighting policies 
provide bases by which CMS may reweight the 25 percent weight assigned 
to the MIPS Promoting Interoperability performance category and 
redistribute that weight to other categories on which the MIPS eligible 
clinician may be scored in accordance with 42 CFR 414.1380(c)(2)(ii). 
If CMS reweights the Promoting Interoperability performance category to 
zero percent in accordance with these reweighting policies, then the 
Promoting Interoperability performance category is not assigned any 
score (zero or otherwise) and is not included in CMS's calculation of 
the MIPS eligible clinician's final score.
    To clarify, if the Promoting Interoperability performance category 
is reweighted to zero percent for a given performance period/MIPS 
payment year in accordance with these policies, then CMS does not 
assess whether the MIPS eligible clinician is a meaningful EHR user 
and, therefore, does not include any score for the performance category 
in the MIPS eligible clinician's final score. In this circumstance, 
this disincentive would not affect the MIPS eligible clinician's final 
score.
    Comments. One commenter requested guidance on how CMS would decide 
which disincentive to apply to a case in which a hospitalist is found 
to have engaged in information blocking. One commenter also supported 
CMS' proposal to not impact the status or MIPS scoring of ``non-patient 
facing'' and ``hospital-based'' MIPS eligible clinicians, or other MIPS 
eligible clinicians automatically reweighted from the Promoting 
Interoperability performance category.
    Response. A hospitalist likely may be a licensed physician meeting 
the definition of MIPS eligible clinician set forth at 42 CFR 414.1305. 
We refer readers to our discussion in section III.C.3.b.(1) of the 
Disincentives Proposed rule (88 FR 74959) and this final rule regarding 
the alignment of definitions of MIPS eligible clinician and health care 
provider under the PHSA.
    Whether an individual or group is subject to MIPS and its 
requirements will be determined in accordance with the applicable 
statute at SSA section 1848(q) and our regulations at 42 CFR part 414, 
subpart O. We note that, in the Disincentives Proposed Rule, CMS did 
not propose any changes to the MIPS reweighting policies at 42 CFR 
414.1380(c)(2) (88 FR 74962). Therefore,

[[Page 54702]]

if a hospitalist meets the definition of a hospital-based MIPS eligible 
clinician at 42 CFR 414.1305, CMS may continue to reweight the 
Promoting Interoperability performance category to zero percent for the 
hospitalist in accordance with 42 CFR 414.1380(c)(2)(i)(C)(6), subject 
to any other applicable requirements.
    We did not make any proposals in this section. We note that, if a 
MIPS eligible clinician submits data for the Promoting Interoperability 
performance category, their reweighting may be cancelled in accordance 
with 42 CFR 414.1380(c)(2)(i)(C), and they could be subject to a 
disincentive if OIG refers a determination of information blocking to 
CMS.
d. Notification of the Disincentive
    In the Disincentives Proposed Rule we noted that after OIG has 
determined that a health care provider has committed information 
blocking and referred that health care provider to CMS, CMS would 
notify the MIPS eligible clinician that OIG determined that the 
eligible clinician committed information blocking as defined under 45 
CFR 171.103, and thus the MIPS eligible clinician was not a meaningful 
EHR user for the performance period in the calendar year when OIG 
referred its information blocking determination to CMS (88 FR 74962). 
We stated that we would apply the proposed disincentive to the MIPS 
payment year associated with the calendar year in which the OIG 
referred its determination to CMS. We noted that this notice would be 
issued in accordance with the notice requirements for disincentives 
proposed in 45 CFR 171.1002 (see also section III.B.2. of the 
Disincentives Proposed Rule and this final rule).
    CMS invited public comment on this proposal.
    The following is a summary of the comments we received and our 
responses.
    Comments. One commenter expressed concern that applying 
disincentives within MIPS without providing the physician an 
opportunity to correct the issue would cause financial harm to 
practices, reduce the resources practices have available to develop 
robust information sharing capabilities, and disincentivize quality 
reporting and improvement efforts.
    Response: We did not propose a mechanism by which MIPS eligible 
clinicians could engage in a corrective action plan or other activity 
to demonstrate compliance and avoid a disincentive. We remind readers 
that the definition of information blocking in PHSA section 3022(a) 
requires that a health care provider ``knows'' that a practice is 
unreasonable and is likely to interfere with, prevent, or materially 
discourage access, exchange, or use of electronic health information.
    After consideration of the public comments, CMS has finalized its 
proposal to notify a MIPS eligible clinician that OIG determined that 
the MIPS eligible clinician committed information blocking as defined 
under 45 CFR 171.103, and, in accordance with the definition of 
``meaningful EHR user,'' that the MIPS eligible clinician was not a 
meaningful EHR user for the performance period in the calendar year 
when OIG referred its information blocking determination to CMS.
4. Medicare Shared Savings Program
a. Background
(1) Statutory Authority for Disincentive
    In the Disincentives Proposed Rule, we explained that Section 3022 
of the Patient Protection and Affordable Care Act (PPACA) (Pub. L. 111-
148, Mar. 23, 2010) added section 1899 to the Social Security Act (SSA) 
(42 U.S.C. 1395jjj), which established the Medicare Shared Savings 
Program (Shared Savings Program) (88 FR 74963). In accordance with the 
statute, groups of providers of services and suppliers (referred to 
herein as ``ACO participants'') and their associated health care 
providers (referred to herein as ``ACO providers/suppliers'') meeting 
criteria specified by the Secretary may work together to manage and 
coordinate care for Medicare fee-for-service beneficiaries through an 
ACO. ACOs that meet quality performance standards established by the 
Secretary are eligible to receive payments for shared savings the ACO 
generates for Medicare and to avoid sharing losses at the maximum 
level. One condition of participation required by the statute is for 
the ACO to define certain processes, including a mandate to ``define 
processes to promote evidence-based medicine and patient engagement, 
report on quality and cost measures, and coordinate care, such as 
through the use of telehealth, remote patient monitoring, and other 
such enabling technologies'' (Social Security Act section 
1899(b)(2)(G)).
(2) Shared Savings Program Regulations
    In the Disincentives Proposed Rule, we explained that the Shared 
Savings Program regulations at 42 CFR part 425 set forth, among other 
things, requirements for ACO eligibility, quality reporting, and other 
program requirements and beneficiary protections (88 FR 74963).\38\ The 
regulations at 42 CFR 425.116 require that an ACO, as a condition of 
participation in the Shared Savings Program, must effectuate an 
agreement with its ACO participants and ACO providers/suppliers (as 
defined at 42 CFR 425.20). This agreement must expressly require the 
ACO participant to agree, and to ensure that each ACO provider/supplier 
billing through the TIN of the ACO participant agrees, to participate 
in the Shared Savings Program and to comply with the requirements of 
the Shared Savings Program and all other applicable Federal laws and 
regulations including, but not limited to: (1) Federal criminal law; 
(2) The False Claims Act (31 U.S.C. 3729 et seq.); (3) The anti-
kickback statute (42 U.S.C. 1320a-7b(b)); (4) The civil monetary 
penalties law (42 U.S.C. 1320a-7a); and (5) The physician self-referral 
law (42 U.S.C. 1395nn).
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    \38\ Shared Savings Program regulations generally specify 
standards for an ACO, which is bound by its participation agreement 
to the standards. CMS generally specifies standards applicable to an 
ACO participant and ACO provider/supplier that is participating in 
the ACO through its regulation of the ACO.
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    CMS has interpreted the requirement at section 1899(b)(1)(G) of the 
SSA that an ACO coordinates care for assigned beneficiaries using 
enabling technologies to require an ACO (and, by agreement, an ACO 
participant and ACO provider/supplier) to, among other things, define 
its methods and processes established to coordinate care across and 
among health care providers both inside and outside the ACO and have a 
written plan to ``encourage and promote use of enabling technologies 
for improving care coordination for beneficiaries'' (42 CFR 
425.112(b)(4)(i) and (b)(4)(ii)(C)). Enabling technologies may include 
one or more of the following: electronic health records and other 
health IT tools; telehealth services, including remote patient 
monitoring; electronic exchange of health information; and other 
electronic tools to engage beneficiaries in their care. The ACO must 
ensure that ACO participants and ACO providers/suppliers comply with 
and implement the defined care coordination process, including the 
encouragement and promotion of enabling technologies, and the remedial 
processes and penalties (including the potential for expulsion) 
applicable to ACO participants and ACO providers/suppliers for failure 
to comply with and implement the required process (see 42 CFR 
425.112(a)(3)). Sharing health information using enabling technologies 
across all health care providers engaged in a beneficiary's care (both 
inside and

[[Page 54703]]

outside the ACO) for purposes of care coordination and quality 
improvement is an essential aspect of the ACO's activities. Moreover, 
this type of information sharing among health care providers (both 
inside and outside the ACO) supports quality measurement and quality 
reporting activities, which are necessary for the ACO to be eligible to 
share in savings and are also used in determining the amount of shared 
losses.
    Before the start of an agreement period, before each performance 
year thereafter, and at such other times as specified by CMS, the ACO 
must submit to CMS an ACO participant list and an ACO provider/supplier 
list (see 42 CFR 425.118(a); citing 42 CFR 425.302(a)(2)). The ACO must 
certify the accuracy, completeness, and truthfulness of the data and 
information contained in the submitted lists annually. All Medicare-
enrolled individuals and entities that have reassigned their right to 
receive Medicare payment to the TIN of the ACO participant must be 
included on the ACO provider/supplier list and must agree to 
participate in the ACO and comply with the requirements of the Shared 
Savings Program before the ACO submits the ACO participant list and the 
ACO provider/supplier list.
    CMS may deny an ACO, ACO participant, and/or an ACO provider/
supplier participation in the Shared Savings Program if the entity or 
individual has a history of program integrity issues (see 42 CFR 
425.305(a)(2)). CMS screens ACOs, ACO participants, and ACO providers/
suppliers during the Shared Savings Program application process and 
periodically thereafter (for example, during the annual certification 
of the ACO participant and ACO provider/supplier lists) with regard to 
their program integrity history (including any history of Medicare 
program exclusions or other sanctions and affiliations with individuals 
or entities that have a history of program integrity issues) (see 42 
CFR 425.305(a)(1)). In the Medicare Shared Savings Program Final Rule 
(76 FR 67802), CMS stated that the results of the screening would be 
considered in light of the relevant facts and circumstances. CMS did 
not draw a bright line regarding when an entity's history of program 
integrity issues would justify denial of a Shared Savings Program 
participation agreement. CMS stated instead that we would likely 
consider the nature of the applicant's program integrity issues 
(including the program integrity history of affiliated individuals and 
entities), the available evidence, the entity's diligence in 
identifying and correcting the problem, and other factors. CMS stated 
that we intended to ensure that ACOs, ACO participants, and ACO 
providers/suppliers would not pose a risk of fraud or abuse within the 
Shared Savings Program while recognizing that some program integrity 
allegations may not have been fully adjudicated.
    CMS may terminate an ACO's Shared Savings Program participation 
agreement if the ACO, its ACO participants, or its ACO providers/
suppliers or other individuals or entities performing functions or 
services related to ACO activities fail to comply with any of the 
requirements of the Shared Savings Program under 42 CFR part 425 (Sec.  
425.218(a) and (b)). This includes, but is not limited to, violations 
of the physician self-referral prohibition, CMP law, Federal anti-
kickback statute, antitrust laws, or any other applicable Medicare 
laws, rules, or regulations that are relevant to ACO operations. 
Similarly, CMS requires that the agreement the ACO effectuates with its 
ACO participants must permit the ACO to take remedial action against 
the ACO participant, and must require the ACO participant, in turn, to 
take remedial action against its ACO providers/suppliers, including 
imposition of a corrective action plan, denial of incentive payments, 
and termination of the ACO participant agreement, to address 
noncompliance with the requirements of the Shared Savings Program and 
other program integrity issues, including program integrity issues 
identified by CMS (42 CFR 425.116(a)(7)). Taken together, these 
regulations ensure that CMS may take appropriate enforcement actions 
when CMS' screening process or oversight of an ACO reveals a history of 
program integrity issues and when an ACO, an ACO participant or an ACO 
provider/supplier and other individuals or entities performing 
functions or services related to ACO activities fail to comply with the 
requirements of the Shared Savings Program, including failure to comply 
with other Federal laws that are relevant to the ACO's operations, such 
as the Cures Act's information blocking provision (PHSA section 3022).
b. Provisions
    In the Disincentives Proposed Rule, CMS proposed to revise the 
Shared Savings Program regulations to establish disincentives for 
health care providers, including ACOs, ACO participants, or ACO 
providers/suppliers, that engage in information blocking (88 FR 74964). 
CMS proposed that a health care provider that OIG determines has 
committed information blocking may not participate in the Shared 
Savings Program for a period of at least 1 year.
    In the Disincentives Proposed Rule, we discussed that information 
blocking runs contrary to the care coordination goals of the Shared 
Savings Program (88 FR 74964). ACO participants and their ACO 
providers/suppliers participating in an ACO in the Shared Savings 
Program use enabling technologies (such as electronic health records) 
to improve care coordination for beneficiaries. The ability of ACO 
providers/suppliers to exchange information between health care 
providers (both inside and outside the ACO) is essential for the 
operations of the ACO, including for effective coordination of care and 
quality improvement activities and services for assigned beneficiaries.
    In the Disincentives Proposed Rule, first, CMS proposed to amend 42 
CFR 425.208(b) to include a specific reference to the Cures Act 
information blocking provision codified in the PHSA (88 FR 74964). We 
noted that the provision would be one of many laws with which ACOs (and 
by agreement, their ACO participants and ACO providers/suppliers) must 
comply.\39\ We noted that in this case, compliance is required because 
a Medicare enrolled ``health care provider,'' to which an information 
blocking disincentive may apply, includes ACO providers/suppliers (See 
42 CFR 400.202 and 425.20 and 45 CFR 171.102). We explained that the 
effect of adding a specific reference to the information blocking 
provision would be to require that, as a condition of participation in 
the Shared Savings Program, an ACO must specifically agree (and must 
require its ACO participants, ACO providers/suppliers, and other 
individuals or entities performing functions or services related to the 
ACO's activities to agree) to not commit information blocking as 
defined in PHSA section 3022(a).
---------------------------------------------------------------------------

    \39\ CMS notes that the list of laws included at 42 CFR 
425.208(b) with which an ACO must comply is not an exclusive list. 
ACOs, ACO participants, and ACO providers/suppliers must continue to 
comply with all applicable Federal laws.
---------------------------------------------------------------------------

    Second, CMS proposed to revise 42 CFR 425.305(a)(1) to specify that 
the program integrity history on which ACOs, ACO participants, and ACO 
providers/suppliers are reviewed during the Shared Savings Program 
application process and periodically thereafter includes, but is not 
limited to, a history of Medicare program exclusions or other 
sanctions, noncompliance with the requirements of the Shared Savings 
Program, or violations of laws specified at 42 CFR 425.208(b) (88 FR 
74964). We

[[Page 54704]]

explained that this revision would provide the basis for CMS to deny 
participation in the Shared Savings Program to a health care provider 
that is an ACO, an ACO participant, or an ACO provider/supplier when 
the health care provider has engaged in information blocking, as 
determined by OIG.
    Third, CMS proposed to make a conforming modification to the 
provision related to the grounds for CMS to terminate an ACO at 42 CFR 
425.218(b)(3) based on ``[v]iolations of the physician self-referral 
prohibition, civil monetary penalties (CMP) law, Federal anti-kickback 
statute, antitrust laws, or any other applicable Medicare laws, rules, 
or regulations that are relevant to ACO operations.'' CMS proposed to 
replace this language with ``[v]iolations of any applicable laws, 
rules, or regulations that are relevant to ACO operations, including, 
but not limited to, the laws specified at Sec.  425.208(b)'' (88 FR 
74964).
    Pursuant to CMS' authority under 42 CFR 425.206(a)(1) to deny an 
ACO's participation in the Shared Savings Program, CMS' authority under 
42 CFR 425.118(b)(1)(iii) to deny the addition of a health care 
provider to an ACO's participation list, and CMS' authority under 42 
CFR 425.305(a) to screen for program integrity issues, CMS proposed to 
screen ACOs, ACO participants, and ACO providers/suppliers for an OIG 
determination of information blocking and deny the addition of such a 
health care provider to an ACO's participation list for the period of 
at least 1 year (88 FR 74964). In the case of an ACO that is a health 
care provider, CMS proposed to deny the ACO's application to 
participate in the Shared Savings Program for the period of at least 1 
year. We noted that if the ACO were to re-apply to participate in the 
Shared Savings Program in a subsequent year, then CMS would review 
whether OIG had made any subsequent determinations of information 
blocking with respect to the ACO as a health care provider as well as 
any evidence that indicated whether the issue had been corrected and 
appropriate safeguards had been put in place to prevent its 
reoccurrence, as part of the ACO's application process. CMS therefore 
proposed in the Disincentives Proposed Rule that, in cases where the 
result of the program integrity screening identifies that an ACO 
(acting as a health care provider), ACO participant, or ACO provider/
supplier, has committed information blocking, as determined by OIG, CMS 
would take the following actions, as applicable:
     Pursuant to 42 CFR 425.118(b)(1)(iii), CMS would deny the 
request of the ACO to add an ACO participant to its ACO participant 
list on the basis of the results of the program integrity screening 
under 42 CFR 425.305(a).
     Pursuant to 42 CFR 425.116(a)(7) and (b)(7), CMS would 
notify an ACO currently participating in the Shared Savings Program if 
one of its ACO participants or ACO providers/suppliers is determined by 
OIG to have committed information blocking so that the ACO can take 
remedial action--removing the ACO participant from the ACO participant 
list or the ACO provider/supplier from the ACO provider/supplier list--
as required by the ACO participant agreement.
     Pursuant to 42 CFR 425.305(a)(2), CMS would deny an ACO's 
Shared Savings Program application if the results of a program 
integrity screening under 42 CFR 425.305(a)(1) reveal a history of 
program integrity issues or other sanctions and affiliations with 
individuals or entities that have a history of program integrity 
issues.
     Pursuant to 42 CFR 425.218(a) and (b)(3), CMS would 
terminate an ACO participation agreement in the case of a failure to 
comply with requirements of the Shared Savings Program, including 
violations of any applicable laws, rules, or regulations that are 
relevant to ACO operations, including, but not limited to, the laws 
specified at 42 CFR 425.208(b) (88 FR 74964 and 74965).
    In the Disincentives Proposed Rule, CMS noted that each of these 
actions would deter information blocking consistent with the discussion 
of an appropriate disincentive in section III.A.3. of the Disincentives 
Proposed Rule (88 FR 74965). We noted that restricting the ability for 
these entities to participate in the Shared Savings Program for at 
least 1 year would result in these health care providers potentially 
not receiving revenue that they might otherwise have earned if they had 
participated in the Shared Savings Program.
    In the Disincentives Proposed Rule, CMS stated that the period of 
time of the disincentive would be at least 1 performance year (88 FR 
74965). We explained that we would determine if it would be appropriate 
for the period to exceed 1 year if OIG has made any subsequent 
determinations of information blocking (for example, CMS would be 
unlikely to impose a disincentive greater than 1 year if the 
information blocking occurred in the past and there was evidence that 
the information blocking had stopped) and whether safeguards have been 
put in place to prevent the information blocking that was the subject 
of OIG's determination. We noted that prior to imposing any 
disincentive arising from an OIG determination of information blocking, 
CMS would provide a notice in accordance with the notice requirements 
proposed in 45 CFR 171.1002 (88 FR 74953) that would specify the 
disincentive would be imposed for at least 1 performance year.
    In the Disincentives Proposed Rule, CMS proposed to apply the 
disincentive no sooner than the first performance year after we receive 
a referral of an information blocking determination from OIG and in 
which the health care provider is to participate in the Shared Savings 
Program (88 FR 74965). We explained in the Disincentives Proposed Rule 
that CMS performs a program integrity screening of ACOs, ACO 
participants, and ACO providers/suppliers as part of the annual 
application/change request process for new and existing ACOs, which 
typically occurs between May and October during the performance year. 
In the case of the new addition of an ACO participant (TIN) to an ACO's 
participant list, CMS stated that we would prevent the TIN from joining 
the ACO as an ACO participant if the program integrity screening 
reveals that the TIN has engaged in information blocking, as determined 
by OIG. In the case of an existing ACO participant, CMS stated that we 
would notify the ACO that an ACO participant or an ACO provider/
supplier had committed information blocking, as determined by OIG, so 
the ACO can remove the ACO participant or ACO provider/supplier from 
its ACO participant list or ACO provider/supplier list, as applicable. 
If the TIN were to remain on the ACO participant list or ACO provider/
supplier list when the ACO certifies its ACO participant list for the 
next performance year, we stated that then CMS would issue a compliance 
action to the ACO. We noted that continued noncompliance (for example, 
failure to remove the TIN) would result in termination of the ACO's 
participant agreement with CMS, as the ACO would have failed to enforce 
the terms of its ACO participant agreement.
    In the Disincentives Proposed Rule, CMS stated that applying the 
disincentive prospectively is the most appropriate timing for the 
disincentive (88 FR 74965). We noted that it would be impractical and 
inequitable for CMS to apply the disincentive retrospectively or in the 
same year in which CMS received a referral from OIG. Applying the 
disincentive to a historical performance year or a performance year

[[Page 54705]]

contemporaneous to the OIG's determination would unfairly affect other 
ACO participants that did not commit the information blocking and 
likely were not aware of the information blocking. CMS recognized, 
however, that the prospective application of the disincentive means 
that it may be applied to a health care provider substantially after 
the information blocking occurred, during the provider's first attempt 
to participate in the Shared Savings Program, and after the provider 
was previously subject to a disincentive in another program, such as 
MIPS. As discussed in the Disincentives Proposed Rule (88 FR 74966) and 
below, CMS contemplated an approach under which a health care provider 
could participate in the Shared Savings Program if a significant amount 
of time (for example, 3 to 5 years) had passed between the occurrence 
of the information blocking and OIG's determination, and the provider 
had given assurances in the form and manner specified by CMS that the 
issue had been corrected and appropriate safeguards had been put in 
place to prevent its reoccurrence.
    In the Disincentives Proposed Rule, CMS explained that after the 
completion of the last performance year in which the disincentive was 
applied, an ACO may submit a change request to add the TIN or include 
the NPI on its ACO participant list or ACO provider/supplier list, as 
applicable, for a subsequent performance year, and CMS would approve 
the addition, assuming that all other Shared Savings Program 
requirements for adding a TIN or NPI are met, so long as (1) OIG has 
not made any additional determinations of information blocking, and (2) 
the ACO provides assurances (in the form and manner required by CMS) 
that the information blocking is no longer ongoing and that the ACO has 
put safeguards in place to prevent the information blocking that was 
the subject of the referral (88 FR 74965). If, however, OIG made and 
referred an additional information blocking determination (that is 
either related or unrelated to the previous OIG referral) in a 
subsequent year or the ACO cannot provide assurance that the 
information blocking has ceased, we discussed that CMS would continue 
to deny participation.
    In addition, in the Disincentives Proposed Rule, we stated that CMS 
would notify ACOs about an ACO participant or ACO provider/supplier 
that had committed information blocking, as determined by OIG, so that 
the ACO could take remedial action--removing the ACO participant from 
the ACO participant list or the ACO provider/supplier from the ACO 
provider/supplier list--as required by the ACO participant agreement 
(88 FR 74965). We noted that ACOs are well-positioned to take remedial 
action against ACO participants and ACO providers/suppliers that have 
been found by OIG to have committed information blocking as a result of 
their ACO participant agreements, which provide for the ACO to take 
remedial action against the ACO participant, and require the ACO 
participant to take remedial action against its ACO providers/
suppliers, including imposition of a corrective action plan, denial of 
incentive payments, and termination of the ACO participant agreement, 
to address noncompliance with the requirements of the Shared Savings 
Program and other program integrity issues.
    By way of example, consider if in January 2025, OIG determined that 
an ACO participant has committed information blocking as recently as 
2024 and referred this determination to CMS. In the Disincentives 
Proposed Rule, CMS explained that under the proposal, the ACO 
participant would be able to remain on the ACO's certified participant 
list for the duration of the 2025 performance year (88 FR 74965). 
However, we explained that CMS would notify the ACO that an ACO 
participant had been determined to have committed information blocking 
by OIG and that CMS expected the ACO to take remedial action by 
removing the ACO participant from its ACO participant list for a 
specified period of time. To determine if removal was warranted for a 
period in addition to performance year 2026, CMS stated that it would 
consider whether there was any evidence to suggest that that 
information blocking was still occurring (for example, whether OIG had 
made a subsequent determination of information blocking) and whether 
safeguards had been put in place to prevent the information blocking 
that was the subject of the referral. In the Disincentives Proposed 
Rule, we noted that upon a review of these criteria, CMS may require 
the affected ACO to remove the ACO participant prior to recertification 
of the ACO participant list for additional performance years. If the 
ACO participant were to remain when the ACO certifies its ACO 
participant list for performance year 2026, we explained that CMS would 
inform the ACO that it was obligated to take remedial action against 
the ACO participant by removing it from the ACO participant list for 
performance year 2026; if it failed to do so, CMS would remove the ACO 
participant from the ACO's participant list and take compliance action 
against the ACO up to terminating the ACO pursuant to 42 CFR 
425.218(b)(1) and (3). In the case of a disincentive that was applied 
only for performance year 2026, we explained that if the ACO were to 
submit a change request to add the ACO participant for performance year 
2027 or a subsequent year, then CMS would review whether OIG had made 
any subsequent determinations of information blocking with respect to 
the ACO participant as well as any evidence that indicated whether the 
issue had been corrected and appropriate safeguards had been put in 
place to prevent its reoccurrence, prior to approving the ACO 
participant to participate in the ACO for performance year 2027 or the 
subsequent year.
    In the Disincentives Proposed Rule, we explained that if an ACO 
applicant or a renewal ACO applicant that is itself a health care 
provider (for example, a large multi-specialty practice that forms a 
single participant ACO using its existing legal entity and governing 
body under 42 CFR 425.104) is the subject of an OIG information 
blocking determination, CMS would deny the ACO's application for 
participation in the Shared Savings Program for the upcoming 
performance year for which it was applying to participate (88 FR 
74966). CMS noted that should OIG make a determination of information 
blocking with respect to an ACO that is already participating in the 
Shared Savings Program and refer the determination to us for the 
application of a disincentive, CMS may terminate the ACO's 
participation agreement for the upcoming performance year. We stated 
that CMS would assess a subsequent application from an ACO to which the 
disincentive had been applied under the same criteria described for 
assessing the return of an ACO participant or ACO provider/supplier. We 
noted that the ACO may participate in the Shared Savings Program after 
the duration of the disincentive so long as OIG had not made a 
subsequent determination of information blocking applicable to the 
health care provider and whether there was evidence that the issue had 
been corrected and appropriate safeguards had been put in place to 
prevent its reoccurrence, prior to approving the ACO's application to 
participate in the Shared Savings Program in a subsequent performance 
year.
    In the Disincentives Proposed Rule, CMS also considered an 
alternative policy in which CMS would not apply a disincentive in 
certain circumstances despite an OIG information blocking

[[Page 54706]]

determination. CMS explained that under this alternative policy, the 
Shared Savings Program would consider OIG's referral of an information 
blocking determination in light of the relevant facts and circumstances 
before denying the addition of an ACO participant to an ACO participant 
list (or an ACO provider/supplier to the ACO provider/supplier list), 
informing an ACO that remedial action should be taken against the ACO 
participant (or ACO provider/supplier), or denying an ACO's application 
to participate in the Shared Savings Program (88 FR 74966). We 
explained that the relevant facts and circumstances could include the 
nature of the health care provider's information blocking, the health 
care provider's diligence in identifying and correcting the problem, 
the time since the information blocking occurred, the time since the 
OIG's determination of information blocking, and other factors. We 
noted that this alternative policy would offer some flexibility in 
certain circumstances, where prohibiting an ACO, ACO participant, or 
ACO provider/supplier from participating in the Shared Savings Program 
would distort participation incentives and therefore be less 
appropriate. We noted that we were particularly concerned about 
situations in which many years have passed since an ACO participant or 
ACO provider/supplier was found to be an information blocker and such 
an issue had long been remediated. We noted that in such a case, the 
ACO participant or ACO provider/supplier might be incentivized to apply 
to the Shared Savings Program for a year in which it did not actually 
intend to participate merely to avoid being barred from doing so at a 
future date when it did intend to participate, wasting the resources of 
the ACO and CMS. We explained that, under such an alternative policy, a 
health care provider could participate in the Shared Savings Program if 
a significant amount of time had passed between the occurrence of the 
information blocking and the OIG's determination, and the provider had 
given assurances in the form and manner specified by CMS that the issue 
had been corrected and appropriate safeguards had been put in place to 
prevent its reoccurrence.
    In the Disincentives Proposed Rule, we noted that an ACO may be 
able to appeal the application of an information blocking disincentive 
in the Shared Savings Program (88 FR 74966). An ACO may appeal an 
initial determination that is not prohibited from administrative or 
judicial review under 42 CFR 425.800 by requesting a reconsideration 
review by a CMS reconsideration official (42 CFR 425.802(a)). To the 
extent it is not barred by 42 CFR 425.800, an ACO may appeal the 
removal or denial of a health care provider from an ACO participant 
list as a result of the referral by OIG of an ACO participant that OIG 
had determined to be an information blocker. Subject to the same 
limitation, an ACO applicant or ACO may appeal the denial of the ACO 
applicant's application or termination of the ACO's participation 
agreement as a result of the referral by OIG of the ACO applicant or 
ACO that the OIG had determined to be an information blocker. We 
explained that the underlying information blocking determination made 
by OIG, however, would not be subject to the Shared Savings Program's 
reconsideration process. We noted that the OIG determination is not an 
initial determination made by CMS, but a determination made by another 
agency. The Shared Savings Program reconsideration process may not 
negate, diminish, or otherwise alter the applicability of 
determinations made by other government agencies (see 42 CFR 
425.808(b)).
    In the Disincentives Proposed Rule, we reminded all health care 
providers and ACOs that it is possible that a health care provider or 
any entity, such as an ACO, may meet the definition of a HIN/HIE, which 
is a functional definition, or the definition of a health IT developer 
of certified health IT, codified in 45 CFR 171.102 (88 FR 74966). We 
noted that if it is found by OIG that such health care provider or 
entity meets either definition and, while under the same set of facts 
and circumstances, is also found by OIG to have committed information 
blocking, then the health care provider or entity would be subject to a 
different intent standard and civil money penalties administered by OIG 
(see generally 88 FR 42820; see 88 FR 42828 and 42829).
    CMS invited public comment on these proposals and on whether 
additional actions should be taken.
    The following is a summary of the comments we received and our 
responses.
    Comments. Several commenters supported CMS' proposed disincentive 
for the Shared Savings Program. These commenters explained that the 
proposed disincentive is consistent with the intent of the Cures Act 
and that it will help promote widespread electronic exchange of health 
information across the healthcare spectrum. Commenters also explained 
that the proposal is consistent with an ACO's goal to utilize 
technologies like EHRs to facilitate care coordination, quality 
improvement activities, and patient-centered care. One commenter 
supported the proposed disincentive for the Shared Savings Program 
because it would impact a wider set of health care providers and thus 
have a greater deterrent effect among health care providers compared to 
the proposed disincentives for the Medicare Promoting Interoperability 
Program and MIPS. Another commenter specifically supported the proposal 
to apply the disincentive for at least 1 year and explained that the 
proposed approach is appropriate and consistent with the other 
disincentives proposed in this rulemaking.
    Response. We agree that sharing health information using enabling 
technologies across all health care providers engaged in a 
beneficiary's care (both inside and outside the ACO) for purposes of 
care coordination and quality improvement is an essential activity for 
health care providers participating in an ACO in the Shared Savings 
Program. This type of information sharing among health care providers 
(both inside and outside the ACO) supports care coordination, quality 
measurement, and quality reporting activities, which are necessary in 
order for the ACO to participate in the Shared Savings Program. We 
appreciate commenters' support for the proposal to revise the Shared 
Savings Program regulations to establish disincentives for health care 
providers, including ACOs, ACO participants, or ACO providers/
suppliers, that engage in information blocking. We agree that the 
proposal meets the objectives of the Cures Act by establishing 
appropriate disincentives for health care providers, as defined in 45 
CFR 171.102, that have been determined by OIG to have committed 
information blocking.
    Comments. Many commenters opposed the proposal to deny ACOs, ACO 
participants, and ACO providers/suppliers from participating in the 
Shared Savings Program if they are determined by OIG to have committed 
information blocking. Commenters stated that the proposal would reduce 
the number of health care providers and ACOs participating in the 
Shared Savings Program, which would effectively impede progress towards 
delivering care based on outcomes, rather than volume, while also 
disrupting improvements in patient care and diminishing resources that 
ACOs use to improve patient care. Other commenters stated that 
prohibiting participation in the Shared Savings Program would disrupt 
patient care and worsen healthcare quality and

[[Page 54707]]

outcomes, explaining that CMS' proposal would deny Medicare patients 
access to enhanced services that ACOs offer, such as care coordination 
and case management services. These commenters further explained that 
if a health care provider is excluded from the Shared Savings Program, 
it would be impossible to deliver many of those services because 
providers would no longer receive claims data for their patients from 
the Shared Savings Program. Several commenters expressed concern that 
if a health care provider was removed from an ACO, patients assigned to 
an ACO would no longer have access to that provider or the patient 
would be forced to find an alternative provider, which could cause 
treatment delays and disrupt care continuity. Additionally, many 
commenters explained that the proposal would undermine CMS' goal of 
having all Medicare beneficiaries in an accountable care relationship 
by 2030 and would prevent CMS from effectively addressing healthcare 
costs and quality. Several commenters expressed concern that the 
proposed disincentive would disproportionately affect health care 
provider participation in ACOs serving patients in rural areas, dual-
eligible beneficiaries, and patients with disabilities. These 
commenters also raised concerns about the impact on Medicare 
beneficiaries in rural areas, stating that specialist health care 
providers participating in ACOs are often the only specialists 
available to serve these communities.
    Response. While we appreciate the commenters' concerns about the 
potential negative consequences resulting from application of the 
disincentive, such as reduced participation in value-based care and a 
reduction of care coordination services, the purpose of the proposal is 
to implement the Cures Act by creating a disincentive that deters 
health care providers from committing information blocking. We disagree 
with commenters' concerns as we do not expect that the proposal would 
reduce the number of health care providers and ACOs participating in 
the Shared Savings Program by a significant amount. Removal from, or 
denial of approval to participate in, the Shared Savings Program would 
be limited to those health care providers that have committed 
information blocking, as determined by OIG. Removal is an appropriate 
disincentive because it protects beneficiaries and denies health care 
providers the opportunity to benefit financially and reputationally 
from participation in the Shared Savings Program.
    We disagree with commenters' concerns that application of the 
disincentive could disrupt patient care and compromise beneficiary 
outcomes. Beneficiary care would already be negatively affected by 
information blocking; this disincentive thus is intended to prevent 
negative outcomes from occurring. Information blocking runs counter to 
the goals of value-based care, such as care coordination and quality 
improvement, and health care providers that engage in information 
blocking may harm beneficiaries by denying them the benefits of value-
based care. Furthermore, beneficiaries receiving care from ACO 
providers/suppliers that regularly engage in information blocking might 
not receive the full benefits of value-based care because the 
information blocking may prevent the sharing of information critical to 
care coordination and quality improvement among the beneficiary's 
health care providers. With respect to commenters' concerns about how 
to reconcile the disincentive with CMS' goal of having 100 percent of 
people with Original Medicare in a care relationship with 
accountability for quality and total cost of care by 2030,\40\ the 
proposal aims to deter health care providers from information blocking 
and hold accountable those health care providers that engage in such 
practices. In doing so, the proposal supports CMS' broader goal of 
incentivizing health care providers to coordinate care effectively 
across care settings so that they can improve patient outcomes and 
lower costs.
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    \40\ A description of the Innovation Center's strategy to 
support primary care can be found here: https://www.cms.gov/blog/cms-innovation-centers-strategy-support-high-quality-primary-care.
---------------------------------------------------------------------------

    Regarding commenters' concerns that the removal of a health care 
provider from an ACO due to information blocking would result in ACO 
beneficiaries no longer having access to their provider, we clarify 
that this is not the case. The denial of approval to participate in or 
removal of a health care provider from the Shared Savings Program 
through the application of this disincentive does not exclude the 
provider from Medicare. A Medicare beneficiary aligned to an ACO may 
see the Medicare enrolled health care provider of his or her choice, 
regardless of whether the provider is a participant or provider/
supplier in an ACO. Similarly, we clarify that Medicare beneficiaries 
in rural areas, dual-eligible beneficiaries, and patients with 
disabilities, could continue to see a Medicare enrolled health care 
provider of their choice, irrespective of whether that health care 
provider is an ACO participant or ACO provider/supplier.
    Based on the comments we received, however, we recognize that 
denial of approval to participate in or removal from the Shared Savings 
Program is not warranted in every instance. For this reason and for the 
additional reasons discussed below, we have finalized the proposal with 
modifications to incorporate the alternative discussed in the 
Disincentives Proposed Rule. This will enable us to consider an OIG 
information blocking determination in light of the relevant facts and 
circumstances of the information blocking determination and subsequent 
remediation before applying the disincentive. This approach is 
consistent with the Cures Act's command to implement ``appropriate 
disincentives'' and balances CMS' efforts to improve the quality and 
efficiency of items and services provided to beneficiaries through 
value-based care.
    Comments. Many commenters supported CMS' alternative policy for the 
Shared Savings Program in which CMS would consider an OIG information 
blocking determination in light of the relevant facts and circumstances 
before denying the addition of an ACO participant to an ACO participant 
list (or an ACO provider/supplier to the ACO provider/supplier list), 
informing an ACO that remedial action should be taken against the ACO 
participant (or ACO provider/supplier), or denying an ACO's application 
to participate in the Shared Savings Program if the remedial action is 
not taken. Commenters explained that this alternative policy would 
provide CMS with flexibility to consider an information blocking 
determination in light of the relevant facts and circumstances, such as 
whether the health care provider subject to the information blocking 
determination had taken corrective action and established safeguards to 
prevent future instances of information blocking or if significant time 
had passed since the information blocking occurred. One commenter 
recommended that CMS always consider information blocking 
determinations in light of the relevant facts and circumstances, 
including during the initial screening process when CMS reviews ACOs' 
program integrity history for OIG determinations of information 
blocking. Another commenter supported the alternative policy, noting 
that education and remediation would be more appropriate than applying 
the disincentive. One

[[Page 54708]]

commenter agreed with CMS that the disincentive as proposed may distort 
participation incentives and that the alternative proposal may help 
ameliorate these concerns. Another commenter stated that the 
alternative policy would help CMS balance the need to prevent 
information blocking while ensuring the financial stability of ACOs and 
providers participating in the Shared Savings Program. A few commenters 
recommended that CMS also consider the size of the practice, number of 
eligible clinicians in the practice, and relationship between the ACO 
and the entity found to have committed information blocking when 
applying the disincentive.
    Response. We agree with commenters that the alternative policy will 
allow us to consider an OIG information blocking determination in light 
of the relevant facts and circumstances before applying a disincentive, 
such as denying the addition of an ACO participant to an ACO 
participant list (or an ACO provider/supplier to the ACO provider/
supplier list), informing an ACO that remedial action should be taken 
against the ACO participant (or ACO provider/supplier), or denying an 
ACO's application to participate in the Shared Savings Program if the 
remedial action is not taken. For an ACO that is already participating 
in the Shared Savings Program, the alternative policy will also allow 
us to consider an OIG information blocking determination in light of 
the relevant facts and circumstances prior to terminating the ACO's 
participation agreement with CMS for the upcoming performance year. The 
relevant facts and circumstances include the nature of the health care 
provider's information blocking, the health care provider's diligence 
in identifying and correcting the problem, the time since the 
information blocking occurred, whether the provider was previously 
subject to a disincentive in another program, and other factors. In the 
case of an ACO applicant, a renewal ACO applicant, or an ACO 
participant TIN that would be a new addition to an ACO's participant 
list, we would request information from the ACO that indicated whether 
the information blocking had been corrected and appropriate safeguards 
had been put in place to prevent its reoccurrence. For ACOs, ACO 
participants, or ACO providers/suppliers that are already participating 
in the Shared Savings Program, we would issue a compliance action, 
which would include a request for the same information.
    Additionally, we agree with commenters that if the risk of 
reoccurrence of information blocking has been mitigated, it would be 
beneficial to take that into consideration before imposing a 
disincentive that could interrupt the care coordination benefits of 
beneficiaries receiving care from ACO participants and ACO providers/
suppliers. For example, removal of a large ACO participant TIN that had 
corrected the information blocking that occurred 10 years prior to 
OIG's determination and had imposed safeguards to prevent its 
reoccurrence, could result in the multi-TIN ACO falling below the 5,000 
assigned beneficiary threshold required by 42 CFR 425.110(a)(1). Having 
the discretion to consider the facts and circumstances of the 
information blocking provider's remediation efforts and past 
disincentives prior to imposing a disincentive will allow the Shared 
Savings Program to best determine if removal from, or denial of 
approval to participate in the Shared Savings Program, is warranted 
while minimizing unintended consequences for ACOs, ACO participants, 
and ACO providers/suppliers that had no involvement in the information 
blocking activity that was the subject of OIG's determination. For 
these reasons, we have finalized the proposal with modifications to 
incorporate the alternative policy.
    Comments. Many commenters urged CMS to consider implementing less 
severe disincentives that would encourage compliance with the 
information blocking regulations without discouraging participation in 
value-based care models. These commenters recommended that CMS partner 
with ACOs to identify and remediate cases of information blocking 
instead of implementing disincentives that affect participation in the 
Shared Savings Program. The commenters explained that ACOs already have 
expertise in data sharing and reporting instances of information 
blocking, thus ACOs are well-positioned to assist HHS in advancing 
their interoperability goals. A few commenters stated that the proposed 
disincentive creates arbitrary penalties that neither address the 
underlying causes of information blocking nor allow health care 
providers to rectify the behaviors that led to information blocking. 
Several commenters explained that the proposed disincentive is 
excessive and disproportionate to the offense and that it may cause 
more harm than the underlying instance of information blocking.
    Response. While we appreciate the commenters' concerns about the 
perceived severity and appropriateness of the proposed disincentives, 
information blocking can result in serious and adverse effects on 
beneficiary care and outcomes. For this reason, the denial of approval 
to participate or removal of health care providers that have been 
determined by OIG to have committed information blocking is both 
appropriate and proportional to the underlying information blocking 
activity. We disagree that the proposed disincentive creates arbitrary 
penalties that fail to address the underlying causes of information 
blocking and do not permit health care providers to rectify the 
behaviors that led to information blocking. To the contrary, the 
proposal would impose a clear disincentive--denial of approval to 
participate in or removal from the Shared Savings Program for at least 
1 year--on the specific health care provider that committed information 
blocking, as determined by OIG.
    Further, the disincentive would not prohibit a health care provider 
that had committed information blocking, as determined by OIG, from 
correcting the information blocking activity and participating in the 
Shared Savings Program in the future. The intent of the proposal is to 
implement PHSA section 3022(b)(2)(B) by creating a disincentive that 
discourages health care providers from committing information blocking. 
It is not clear that merely requiring that a healthcare provider take 
corrective action would adequately discourage repeated information 
blocking when one considers that substantial time that may elapse 
between the information blocking and an OIG determination. With respect 
to the suggestions that CMS partner with ACOs to identify and remediate 
cases of information blocking, we encourage ACOs to report any 
instances of information blocking to ONC or OIG. Given that ACOs are 
engaged in care coordination and quality improvement activities, they 
may encounter instances of information blocking as they seek to achieve 
the goals of accountable care in the Shared Savings Program.
    We agree with commenters that depending upon the circumstances of 
the case, CMS may need more flexibility in applying a disincentive 
under the Shared Savings Program than was provided for under the 
proposal. We have therefore finalized the proposal with modifications 
to incorporate the alternative policy discussed in the Disincentives 
Proposed Rule (88 FR 74966). This will allow us to consider an OIG 
information blocking determination in light of the relevant facts and 
circumstances before applying a disincentive, such as denying the 
addition of an ACO participant to an ACO participant list (or an ACO 
provider/supplier to the ACO provider/

[[Page 54709]]

supplier list), informing an ACO that remedial action should be taken 
against the ACO participant (or ACO provider/supplier), denying an 
ACO's application to participate in the Shared Savings Program if the 
remedial action is not taken, or terminating an ACO's participation 
agreement with CMS. We reiterate that the relevant facts and 
circumstances include the nature of the health care provider's 
information blocking, the health care provider's diligence in 
identifying and correcting the problem, the time since the information 
blocking occurred, whether the provider was previously subject to a 
disincentive in another program, and other factors. As discussed above, 
this approach achieves the balance of disincentivizing information 
blocking in the Shared Savings Program while ensuring that CMS can 
consider whether a health care provider who has committed information 
blocking, received disincentives elsewhere for it, and corrected the 
conduct should be barred from participating in the Shared Savings 
Program prior to imposing a disincentive.
    Comments. Commenters expressed concern that the proposal would 
inadvertently discourage or deter participation in value-based care 
models, such as the Shared Savings Program, because ACOs and ACO 
participants face significant disruption and financial instability if 
they are removed from the Shared Savings Program. Many commenters were 
concerned that the proposed policy would have negative financial and 
operational consequences for ACOs. One commenter explained that if an 
ACO is suspended from the Shared Savings Program or if a large ACO 
participant or health care provider is removed from an ACO, the 
resulting financial impact could be the loss of millions of dollars in 
potential shared savings revenue, which could result in the ACO 
collapsing completely.
    Other commenters expressed concern that the proposed disincentive 
could upend ACO operations and greatly compound the financial 
instability of the ACO and participating physician participants. One 
commenter expressed concern that the proposed disincentive would be 
especially detrimental for ACOs operating in rural areas, where 
Medicare Advantage enrollment exceeds traditional Medicare enrollment. 
The commenter stated that removing even one participant TIN could force 
the entire ACO to collapse, severely disrupting patient care and 
punishing not only the TIN that committed information blocking, but 
also all ACO participants. A few commenters explained that the 
potential financial impacts of the proposed disincentive are not 
aligned with the severity of the underlying information blocking 
offense. Commenters suggested that the financial disincentives imposed 
on ACOs should more closely correspond to the severity of the 
information blocking violation.
    A few commenters stated that suspending ACOs from the Shared 
Savings Program would also cause the government to lose millions of 
dollars in shared savings. Several commenters also expressed concern 
that suspension of ACOs from the Shared Savings Program may also make 
ACOs ineligible for Advanced APM bonus payments. Commenters emphasized 
that ACOs depend on these bonus payments to cover investment and care 
coordination costs. Another commenter questioned how the proposal would 
impact physicians who participate in an ACO but do not meet the 
Advanced APM threshold for exemption from the MIPS Program. 
Specifically, the commenter inquired if these physicians who have been 
found by OIG to have committed information blocking would be removed as 
an ACO participant and subject to disincentives under the MIPS program. 
A few commenters expressed concerns that the proposed disincentive 
would hinder overall data exchange and information sharing that is 
essential to ACO operations and structure. Another commenter expressed 
concern that the disincentive would cause adverse financial impacts to 
the healthcare system and contribute to hospital closures. Finally, one 
commenter stated that the disincentive may hinder an ACO's ability to 
meet network adequacy requirements if health care providers who have 
committed information blocking are removed from the ACO.
    Response. We appreciate the commenters' concerns regarding the 
potential financial and operational impacts on ACOs of disincentives 
for information blocking. The proposed disincentive will serve as a 
deterrent to information blocking by health care providers 
participating in the Shared Savings Program. Commenters' concerns about 
the negative financial consequences for health care providers and ACOs 
of the disincentive, as well as how disruptive it may be, support this 
conclusion.
    A strong disincentive is likely to be most appropriate in deterring 
information blocking given the nature of the activity and its effect on 
essential aspects of Shared Savings Program. Information blocking is 
not an inadvertent practice. A health care provider has only committed 
information blocking if the provider engaged in a practice that the 
provider ``[knew] is unreasonable and likely to interfere with access, 
exchange, or use of electronic health information'' (45 CFR 171.103). 
As discussed above, information blocking runs contrary to the 
overarching goals of the Shared Savings Program, as the ability of ACO 
participants and ACO providers/suppliers to exchange information 
between health care providers (both inside and outside the ACO) is 
essential for the operations of the ACO, including for effective 
coordination of care, quality improvement activities, and related 
services for assigned beneficiaries. If health care providers 
participating in the Shared Savings Program are determined by OIG to 
have committed information blocking, it is reasonable to remove or 
prevent any such health care providers from participating in the Shared 
Savings Program for at least one performance year, given that the 
health care providers intentionally acted in a manner that may have 
impaired activities central to the Shared Savings Program: care 
coordination and improvement in the quality and efficiency of 
beneficiary care.
    We disagree with the commenters' statement that suspending ACOs 
from the Shared Savings Program would also cause the government to lose 
millions of dollars in shared savings. The participation of information 
blockers in the Shared Savings Program undermines the integrity of the 
program and may harm an ACO's efforts to coordinate and improve the 
quality and efficiency of beneficiary care. Moreover, if ACOs that have 
committed information blocking (as determined by OIG) are removed from 
the Shared Savings Program for at least one performance year, their 
removal may actually prevent losses by shifting government resources to 
ACOs that are focused on care coordination and quality improvement 
activities. With respect to the impact the proposed disincentive will 
have on cost savings in the Medicare program, as discussed in the 
Regulatory Impact Statement of the Disincentives Proposed Rule (88 FR 
74967), the expected benefits of this rule would be to deter 
information blocking that interferes with effective health information 
exchange and negatively impacts many important aspects of healthcare. 
We refer readers to the impact analysis of the benefits of prohibiting 
and deterring information blocking in the ONC Cures Act Final Rule (85 
FR 25936).
    Regarding whether clinicians who have been found by OIG to have 
committed information blocking would

[[Page 54710]]

be removed as an ACO participant and subject to disincentives under the 
MIPS program, we confirm that such clinicians could be removed as ACO 
participants and, if they are MIPS eligible clinicians, they could also 
be subject to the information blocking disincentive under MIPS. While 
we acknowledge the commenters' concerns that removing or denying an ACO 
participant from an ACO could result in downstream effects that have 
implications for eligibility of Advanced APM incentive payments and 
scoring under MIPS, we reiterate that the approach is to deter 
information blocking by health care providers participating in the 
Shared Savings Program through the imposition of appropriate 
disincentives consistent with the requirements of the Cures Act.
    It is important to clarify that there is no network adequacy 
requirement in the Shared Savings Program. Unlike other healthcare 
programs, such as managed care plans, the Shared Savings Program does 
not limit beneficiaries to receiving care from only the providers and 
suppliers that participate in the ACO. Thus, there is no need in the 
Shared Savings Program to impose network adequacy requirements on 
participating ACOs. Concerns about the effect of the disincentive as it 
relates to network adequacy are thus unwarranted.
    Comments. Many commenters did not support the proposed disincentive 
on the basis that it would be unfair and inappropriate to penalize the 
entire ACO for the actions of one individual ACO participant or ACO 
provider/supplier determined by OIG to have committed information 
blocking. Some commenters stated that if one ACO participant or ACO 
provider/supplier is determined to have committed information blocking, 
then the entire ACO entity would be prohibited from participating in 
the Shared Savings Program. Commenters expressed concern that excluding 
an entire ACO would harm patients who rely on those ACOs for their 
healthcare. The commenters explained that by denying participation to 
all health care providers in an ACO due to the actions of a few, 
patients' access and continuity of care would ultimately suffer. One 
commenter stated that ACO participants who did not engage in 
information blocking themselves would likely be unaware of and unable 
to control the actions of other participants who did commit information 
blocking and that it would be unfair to penalize the broader group for 
the actions of a few individuals. Another commenter expressed concern 
about an ACO being banned from the Shared Savings Program if a single 
health care provider within the ACO is found by OIG to have committed 
information blocking, especially if the information blocking activity 
is inconsistent with documented ACO policies and practices.
    Response. The concerns expressed by the commenters indicate that 
there might be a misunderstanding about the proposed disincentive. Our 
intention is not to penalize the entire ACO entity for the actions of a 
single ACO participant or ACO provider/supplier that is the subject of 
an OIG information blocking determination. Instead, the proposal would 
impose a disincentive on the specific health care provider that 
committed information blocking, as determined by OIG. In the 
Disincentives Proposed Rule (88 FR 74965), we explained that CMS would 
notify ACOs about an ACO participant or ACO provider/supplier that had 
committed information blocking, as determined by OIG, so that the ACO 
could take remedial action--removing the ACO participant from the ACO 
participant list or the ACO provider/supplier from the ACO provider/
supplier list--as required by the ACO participant agreement (88 FR 
74965). ACOs are expected to take remedial action against ACO 
participants and ACO providers/suppliers that have been found by OIG to 
have committed information blocking through their ACO participant 
agreements, which must permit the ACO to take remedial action against 
the ACO participant, and require the ACO participant to take remedial 
action against its ACO providers/suppliers, including imposition of a 
corrective action plan, denial of incentive payments, and termination 
of the ACO participant agreement, to address noncompliance with the 
requirements of the Shared Savings Program and other program integrity 
issues. Should the ACO fail to take the appropriate remedial action 
against the ACO participant or ACO provider/supplier, CMS may take 
action against the ACO consistent with its authority at 42 CFR 425.216 
and 425.218.
    While it is true that consequences may extend to ACO participants 
or ACO providers/suppliers if the ACO itself is found by OIG to have 
committed information blocking, our focus is on imposing disincentives 
for information blocking on the specific health care provider that has 
committed information blocking, not on imposing disincentives on entire 
groups of health care providers or ACO participants that had no 
involvement in the activity that resulted in an information blocking 
determination by OIG. We also understand the concerns raised about 
fairness and patient access, and we agree with commenters that there 
could be a negative impact to an ACO if an ACO participant with a large 
number of assigned beneficiaries is found by OIG to have committed 
information blocking, requiring removal of the ACO participant from the 
ACO participant list as a result of the proposed disincentive. However, 
it is important that ACOs make their own assessment of potential ACO 
participants--and the potential ACO participant's commitment to 
information sharing for the purposes of care coordination, quality 
measurement, and quality reporting activities--prior to contracting 
with them. We reiterate that the goal of the proposal is to ensure that 
appropriate disincentives are imposed on health care providers that 
have committed information blocking, as determined by OIG, while 
minimizing unintended consequences for ACOs and Medicare beneficiaries. 
We have finalized the proposal with modifications so that we will 
consider an OIG information blocking determination in light of the 
relevant facts and circumstances before applying a disincentive.
    Comments. Several commenters expressed concerns with CMS' proposal 
to remove ACO participants and ACO providers/suppliers at the TIN level 
rather than at the individual or NPI level. Commenters stated that 
implementing disincentives at the TIN level would negatively affect not 
only health care providers who engaged in information blocking, but 
also those who did not. One commenter expressed concern that this 
approach could undermine existing contractual agreements between CMS 
and ACOs while another commenter stated that applying the disincentive 
at the TIN-level would negatively impact patient attribution 
calculations and the beneficiaries receiving services from that TIN. A 
few commenters requested that CMS clarify how the proposed disincentive 
and the removal of ACO providers/suppliers would impact patient 
attribution and who would subsequently assume responsibility for those 
patients' care. Other commenters requested clarification on how ACO 
suspension would impact health care providers and suppliers in relation 
to Shared Savings Program rules allowing gradual progression from one-
sided to two-sided risk arrangements over certain time periods.
    Response. While we appreciate the concerns raised by commenters 
regarding the application of disincentives at the ACO participant

[[Page 54711]]

TIN level, it is important to clarify that the approach is designed to 
hold accountable the health care provider OIG determined to be 
responsible for information blocking, whether that is at the ACO 
participant TIN or NPI level. While we understand that not every 
individual within an ACO participant TIN may be directly involved in 
information blocking activities, holding the ACO participant TIN 
accountable (if the ACO participant TIN is the entity found by OIG to 
have committed information blocking) is required under PHSA section 
3022(b)(2)(B), which specifies that health care providers (individuals 
or entities) that have been determined by OIG to have committed 
information blocking shall be subject to appropriate disincentives. 
Please refer to the discussion of the definition of health care 
provider at 45 CFR 171.102 in section II.B.1. of this rule. Should OIG 
determine that information blocking has occurred at the NPI level (in 
other words, that an ACO provider/supplier has committed information 
blocking), we would notify the ACO so that it could take remedial 
action--removing the ACO provider/supplier from the ACO's provider/
supplier list--as required by the ACO participant agreement. We would 
not impose a disincentive at the ACO participant TIN level or the ACO 
level if only an ACO provider/suppler was determined by OIG to have 
committed information blocking.
    With respect to how the removal of an ACO participant or ACO 
providers/suppliers could affect an ACO's assigned beneficiary 
population, it is important to note that CMS assigns beneficiaries to 
an ACO as a whole; beneficiaries are not assigned to a particular ACO 
participant TIN or ACO provider/supplier. We acknowledge that removal 
or denial of an ACO participant or ACO provider/suppler as a result of 
an OIG information blocking determination could impact the number of 
beneficiaries assigned to an ACO, and we expect the risk of this 
occurring is a valuable deterrent against information blocking that may 
lead to the implementation of ACO operating procedures that proactively 
prevent information blocking. As discussed above, however, this would 
not affect beneficiary access to care. Medicare beneficiaries may 
continue to see the health care provider of his or her choice, 
regardless of whether the provider is a participant or provide/supplier 
in an ACO, or the beneficiary is assigned to a particular ACO.
    The termination of an ACO from the Shared Savings Program for at 
least one performance year as a result of an information blocking 
determination would interrupt the ACO's progression along the BASIC 
track's glide path from a one-sided to two-sided risk arrangement, and 
the ACO would need to meet eligibility determinations regarding what 
level of participation they would be eligible for when reentering their 
participation in the Shared Savings Program. We do not foresee, 
however, similar challenges to progress to two-sided risk for ACO 
participants or ACO providers/suppliers that are prevented from joining 
or that are removed from an ACO as a result of an information blocking 
determination.
    After the completion of the last performance year in which the 
disincentive was applied, an ACO may submit a change request to add the 
TIN or include the NPI on its ACO participant list or ACO provider/
supplier list, as applicable, for a subsequent performance year, and 
CMS would approve the addition, assuming that all other Shared Savings 
Program requirements for adding a TIN or NPI are met, so long as (1) 
OIG has not made any additional determinations of information blocking, 
and (2) the ACO provides assurances (in the form and manner required by 
CMS) that the information blocking is no longer ongoing and that the 
ACO has put safeguards in place to prevent the information blocking 
that was the subject of the referral.
    Comments. One commenter expressed concern about the impacts of the 
proposed disincentive on skilled nursing facilities (SNFs) 
specifically. The commenter explained that because SNFs have been 
excluded from Federal health IT incentive programs, SNFs may not have 
the requisite technology to be able to share information as required 
under the information blocking regulations. As a result, the commenter 
recommended that OIG and CMS consider each ACO health care provider's 
unique situation and not apply a one-size-fits-all standard approach to 
all providers participating in an ACO. The commenter further 
recommended that CMS provide certain health care providers with 
exemptions from the proposed disincentive for the Shared Savings 
Program. Specifically, the commenter requested that CMS exclude SNFs 
from the proposed disincentive if the SNF is the only health care 
provider in a rural or underserved location and all other ACO 
participation requirements are met. The commenter stated that this 
exception would ensure that Medicare beneficiaries are not denied 
access to nearby SNFs and post-acute care. The commenter also requested 
that CMS exclude SNFs or any ACO providers/suppliers if their ACO 
participant agreements are structured so that they do not receive the 
ACO's shared savings from the proposed disincentive. The commenter 
noted that ACOs are not required to share incentive payments and earned 
shared savings with ACO health care providers in their network, such as 
SNFs. Therefore, applying the disincentive without this exemption would 
further deter SNF participation in ACOs.
    Response. We appreciate the commenter's concerns regarding the 
potential impact of the proposed disincentive on SNFs participating in 
the Shared Savings Program. We recognize that these facilities were not 
eligible for participation in the Medicare and Medicaid EHR Incentive 
Programs. However, it is important to clarify that SNFs are explicitly 
included in the definition of health care provider defined in 45 CFR 
171.102 (which codifies the definition of health care provider in 
section 3000(3) of the PHSA) for which the Cures Act instructs the 
Secretary to establish appropriate disincentives for information 
blocking. While it is true that the initial implementation of 
appropriate disincentives in this rule, through the Shared Savings 
Program, MIPS, and the Medicare Promoting Interoperability Program, may 
not reach all types of health care providers defined at 45 CFR 171.102, 
to exempt a single type of health care provider participating in one of 
these programs from the disincentive would be particularly inequitable 
and thwart the purpose of the rule. For these reasons, we are unwilling 
and unable to grant any exemptions for SNFs that are ACO participants 
or SNF affiliates from the proposed disincentive, as requested by the 
commenter. We nonetheless recognize the vital role SNFs play in 
providing post-acute care, particularly in rural or underserved areas, 
and we recognize that it is important to clarify that Medicare 
beneficiaries may continue to utilize the SNF of his or her choice, 
regardless of whether the SNF, or the health care providers rendering 
serves at the SNF, is an ACO participant or ACO provider/supplier in an 
ACO.
    More broadly, we agree with the commenter that it is important to 
consider the unique circumstances of health care providers when 
implementing the proposed disincentive under the Shared Savings 
Program, and we agree that a one-size-fits-all approach may not be 
suitable for all health care providers, especially those facing 
technological limitations. For this reason, finalizing the proposal 
with modifications to incorporate the

[[Page 54712]]

alternative policy will allow us to consider the unique circumstances 
of the health care provider when applying this disincentive, and we 
will consider an OIG information blocking determination in light of the 
relevant facts and circumstances before applying a disincentive, such 
as denying the addition of an ACO participant to an ACO participant 
list (or an ACO provider/supplier to the ACO provider/supplier list), 
informing an ACO that remedial action should be taken against the ACO 
participant (or ACO provider/supplier), denying an ACO's application to 
participate in the Shared Savings Program if the remedial action is not 
taken, or terminating an ACO's participation agreement with CMS.
    Comments. Several commenters stated that the proposed disincentive 
is excessive, redundant, and constitutes a double penalty because 
health care providers found by OIG to have committed information 
blocking will be subject to disincentives under MIPS and may also be 
subject to removal from the Shared Savings Program for at least 1 year. 
One commenter expressed concern that cumulative disincentives could be 
more pronounced for hospitals based on removal from the Shared Savings 
Program in the violation year and receiving a market basket decrease 
the following year under MIPS.
    Response. We understand commenters' concerns about the potential 
for cumulative disincentives for health care providers found by OIG to 
have committed information blocking. We have finalized the proposed 
policy with modifications to incorporate the alternative policy we 
outlined in the Disincentives Proposed Rule (88 FR 74966), under which 
we will consider OIG's referral of an information blocking 
determination in light of the relevant facts and circumstances, 
including the nature of the health care provider's information 
blocking, the health care provider's diligence in identifying and 
correcting the problem, the time since the information blocking 
occurred, whether a health care provider was previously subject to a 
disincentive in another program, before denying the addition of an ACO 
participant to an ACO participant list (or an ACO provider/supplier to 
the ACO provider/supplier list), informing an ACO that remedial action 
should be taken against the ACO participant (or ACO provider/supplier), 
denying an ACO's application to participate in the Shared Savings 
Program, or terminating an ACO's participation agreement with CMS. This 
approach furthers the Shared Savings Program's goal of imposing 
appropriate disincentives for information blocking consistent with the 
Cures Act, while ensuring relevant facts and circumstances are used to 
inform decisions made under the Shared Savings Program.
    Comments. A few commenters recommended that CMS adopt specific 
revisions to the proposal. One commenter expressed concern that 
requiring ACOs to remove ACO participants or ACO health care providers 
could impose undue administrative burdens on ACOs. The commenter 
recommended that CMS assume the responsibility of removing entities 
that have committed information blocking from the ACO and notify the 
affected ACO when it has taken such actions. One commenter suggested 
that, prior to imposing any disincentives on ACOs, we provide 
accommodations for hardship, have a well-defined investigative process, 
and establish a graduated disincentive structure that accounts for the 
impact ACOs have on the communities they serve. Another commenter 
recommended that CMS establish more than one disincentive option for 
ACOs, ACO participants, and ACO providers/suppliers to provide 
flexibility in determining the disincentive appropriate for each case.
    Response. While we understand that removing ACO participants or ACO 
providers/suppliers that have committed information blocking, as 
determined by OIG, could result in additional work for the ACO, CMS 
expects ACOs to be equipped to take remedial action against their ACO 
participants under their agreements with the ACO participants. We also 
expect ACO participants, in turn, to take remedial action against its 
ACO providers/suppliers, including imposition of a corrective action 
plan, denial of incentive payments, and termination of the ACO 
participant agreement, to address noncompliance with the requirements 
of the Shared Savings Program and other program integrity issues, 
including program integrity issues identified by CMS (42 CFR 
425.116(a)(7)). For these reasons, the remedial action CMS expects ACOs 
and ACO participants to take in the case of an OIG determination of 
information blocking is consistent with their existing obligations 
under the Shared Savings Program and should not represent an undue 
burden.
    Regarding the suggestion that CMS provide hardship accommodations 
prior to imposing any disincentives on ACOs and that CMS have a well-
defined investigative process and establish a graduated disincentive 
structure that accounts for the impact ACOs have on the communities 
they serve, we have finalized the proposed policy with modifications to 
incorporate the alternative policy so that we will consider OIG's 
referral of an information blocking determination in light of the 
relevant facts and circumstances. This approach will require that we 
carefully consider the unique circumstances of an ACO prior to imposing 
any disincentive, and it obviates the need for a hardship accommodation 
or a graduated disincentive structure. While we appreciate the 
suggestion to establish multiple disincentive options for ACOs, ACO 
participants, and ACO providers/suppliers, we decline to do so. As 
mentioned above, the alternative policy we are adopting provides CMS 
with the discretion to consider the relevant facts and circumstances 
before applying a disincentive, such as denying the addition of an ACO 
participant to an ACO participant list (or an ACO provider/supplier to 
the ACO provider/supplier list), informing an ACO that remedial action 
should be taken against the ACO participant (or ACO provider/supplier), 
denying an ACO's application to participate in the Shared Savings 
Program if the remedial action is not taken, or terminating an ACO's 
participation agreement with CMS. This approach provides adequate 
flexibility in the application of appropriate disincentives under the 
Shared Savings program.
    Comments. Several commenters opposed to the proposal urged us to 
consider alternative disincentives. Many commenters recommended that 
CMS allow ACOs, ACO participants, and ACO providers/suppliers to take 
remedial or corrective action rather than removal from the Shared 
Savings Program. Commenters explained that remedial actions could 
include a probation period, a reduction or withhold of shared savings 
or incentives, corrective action plans, or mandatory education for 
those who have engaged in information blocking. Commenters further 
explained that allowing ACOs, ACO participants, and ACO providers/
suppliers to take corrective action would allow CMS to impose 
disincentives on health care providers determined by OIG to have 
committed information blocking while still allowing those providers to 
participate in the Shared Savings Program. Several commenters also 
recommended that CMS and ONC provide education and technical assistance 
to ACOs, ACO participants, and ACO providers/suppliers on the proposed 
disincentive and its potential

[[Page 54713]]

impacts. They also suggested that CMS consider a tiered or scaled 
approach that accounts for the circumstances and frequency of 
misconduct when determining the appropriate disincentive to apply. A 
few commenters recommended that CMS delay implementing disincentives 
specific to ACOs or the Shared Savings Program and instead introduce 
disincentives in a separate rule once the risks to patient outcomes are 
better understood. Another commenter recommended that CMS consult 
closely with ACOs to ensure that CMS understands the potential impacts 
of any proposed disincentives. One commenter suggested that instead of 
limiting ACO participation in the Shared Savings Program, CMS should 
expand safe harbor protections to facilitate EHR information sharing 
between hospitals, health systems, and ACOs. The commenter explained 
that this would more effectively promote interoperability compared to 
the proposed disincentive. Another commenter recommended that ACOs 
should only be excluded from the Shared Savings Program if the 
determination of information blocking is related to activity that is 
integral to the function or operations of the ACO. In addition, a few 
commenters recommended that CMS consider disincentives that reduce the 
Advanced Alternative Payment Model (APM) incentive payment or 
conversion factor for health care providers. For example, these 
commenters recommended that health care providers in an Advanced APM 
found by OIG to have committed information blocking receive only 75 
percent of their eligible Advanced APM bonus payment. The commenters 
explained that this alternative would better align with the 
disincentive proposed for MIPS eligible clinicians and would not deny 
access to care for beneficiaries.
    Response. We appreciate commenters' suggestions for alternative 
disincentives but, for the reasons previously noted and for the 
additional reasons discussed below, we have finalized the proposal with 
modifications to incorporate the alternative policy discussed in the 
Disincentives Proposed Rule. In accordance with PHSA section 
3022(b)(2)(B), we are required to impose disincentives for health care 
providers that are found by OIG to have committed information blocking. 
While we understand the benefits of an approach that would impose 
remedial or corrective actions rather than denial of approval to 
participate in or removal from the Shared Savings Program, those 
approaches may not have any deterrent effect, which is a fundamental 
aspect of any disincentive. In addition, the relevance of remedial and 
corrective actions may be limited in light of the time that may elapse 
between the underlying information blocking conduct and OIG's 
investigation. The disincentive we are adopting strikes a careful 
balance between deterring information blocking through meaningful 
consequences and ensuring that health care providers who have committed 
information blocking and corrected their actions are not permanently 
barred from participating in the Shared Savings Program.
    We appreciate the recommendation to delay implementation of the 
proposed disincentive until patient outcomes are better understood. We 
are concerned, however, that delaying implementation of the 
disincentive could adversely affect patient care, as information 
blocking could impede effective care coordination and quality 
improvement activities within ACOs. Moreover, the proposed disincentive 
will serve as a deterrent to information blocking by health care 
providers participating in the Shared Savings Program. For these 
reasons, we decline to delay the implementation of disincentives for 
information blocking. In addition, the information blocking regulations 
in the ONC Cures Act Final Rule were released on May 1, 2020, and it is 
not necessary to further delay the establishment of disincentives for 
health care providers that have been found by OIG to have committed 
information blocking. While expanding safe harbor protections for EHR 
information sharing may facilitate data sharing and interoperability, 
we did not propose any such safe harbor expansion in the Disincentives 
Proposed Rule; therefore, this suggestion is beyond the scope of the 
disincentive proposed by the Shared Savings Program. Regarding the 
suggestion to exclude ACOs from the Shared Savings Program only if the 
determination of information blocking is related to integral ACO 
activities, we recognize the importance of considering the context of 
information blocking incidents, which is why we have finalized the 
proposed policy with modifications to incorporate the alternative 
policy, under which we will consider whether to impose a disincentive 
under the Shared Savings Program in light of the relevant facts and 
circumstances. Our use of a consistent standard in the Shared Savings 
Program for all instances of information blocking will ensure fairness 
in the application of disincentives for ACOs, ACO participants, and ACO 
providers/suppliers.
    While we appreciate the recommendation to reduce Advanced APM 
incentive payments for health care providers found to have committed 
information blocking, we have not identified authority that would 
permit us to alter APM incentive payments issued pursuant to section 
1833(z)(1) of the Social Security Act and 42 CFR 414.1450. Finalizing 
the proposed disincentive with modifications to incorporate the 
alternative policy is an effective way to impose disincentives for 
information blocking and to promote interoperability among ACOs, ACO 
participants, and ACO providers/suppliers.
    Comments. A few commenters requested clarification on which 
disincentives will apply in specific situations such as: whether a 
disincentive would apply to an ACO if a hospitalist is found to be 
information blocking and the hospital participates in an ACO; if a 
hospitalist is found to be information blocking would the health care 
provider and the hospital receive disincentives; and, if a physician, 
who is a MIPS eligible clinician and a participant in a Shared Savings 
Program ACO, is an information blocker could the physician potentially 
be penalized under MIPS and also removed from the ACO for a year.
    Response. As discussed above, the proposal imposes a disincentive 
on the specific health care provider that committed information 
blocking, as determined by OIG. Whether the hospitalist or the hospital 
has committed information blocking will be determined by OIG through 
its investigation. If a hospitalist is determined by OIG to have 
committed information blocking and CMS is applying the disincentive, 
CMS would notify the ACO so that the ACO and ACO participant could take 
remedial action--removing the hospitalist from either the ACO 
participant list or the ACO provider/supplier list, as applicable, 
pursuant to the ACO participant agreement.
    We understand commenters' concerns about the potential for 
cumulative disincentives for health care providers found by OIG to have 
committed information blocking, such as a MIPS eligible clinician 
participating in an ACO. As discussed above, we have finalized the 
proposed policy with modifications to incorporate the alternative 
policy we outlined in the Disincentives Proposed Rule, under which we 
will consider OIG's referral of an information blocking determination

[[Page 54714]]

in light of the relevant facts and circumstances, including the nature 
of the health care provider's information blocking, the health care 
provider's diligence in identifying and correcting the problem, the 
time since the information blocking occurred, whether a health care 
provider was previously subject to a disincentive in another program, 
before applying a disincentive, such as denying the addition of an ACO 
participant to an ACO participant list (or an ACO provider/supplier to 
the ACO provider/supplier list), informing an ACO that remedial action 
should be taken against the ACO participant (or ACO provider/supplier), 
denying an ACO's application to participate in the Shared Savings 
Program, or terminating an ACO's participation agreement with CMS (88 
FR 74966). This approach furthers the Shared Savings Program's goal of 
imposing disincentives for information blocking consistent with the 
Cures Act, while ensuring relevant facts and circumstances are used to 
inform decisions made under the Shared Savings Program.
    Comments. One commenter expressed concern with the timing of the 
disincentive. The commenter explained that because OIG investigations 
of information blocking can take years to complete, ACO participants 
that have committed information blocking may no longer be participating 
in the ACO or the Shared Savings Program by the time CMS receives the 
referral. The commenter recommended that CMS clarify that if OIG refers 
to CMS a finding that a former ACO participant committed information 
blocking, the disincentive should not apply to the ACO or its remaining 
ACO participants.
    Response. We appreciate the commenter's concern and request for 
additional information about the timing of a disincentive for 
information blocking. We want to clarify that if a former ACO 
participant is determined by OIG to have committed information 
blocking, we would not impose a disincentive on the ACO or the 
remaining ACO participants. As we explained in the Disincentives 
Proposed Rule, applying the disincentive prospectively is the most 
appropriate timing for the disincentive, as it would be impractical and 
inequitable for CMS to apply the disincentive retrospectively or in the 
same year in which CMS received a referral from OIG (88 FR 74965). 
Prospective application of the disincentive will also enable ACOs to 
remove any ACO participant TINs or ACO providers/suppliers during the 
annual application and change request cycle that have committed 
information blocking, as determined by OIG. Applying the disincentive 
to a historical performance year or a performance year contemporaneous 
to OIG's determination would unfairly affect other ACO participants 
that did not commit the information blocking and likely were not aware 
of the information blocking (88 FR 74965).
    Comments. A few commenters expressed concern that ACO participants 
would only be able to appeal the application of the disincentive but 
not the actual information blocking determination. One commenter 
expressed concern that an appeal process may not be available under 
existing rules for Shared Savings Program ACO participants. Another 
commenter noted that a finding of information blocking could have 
future program integrity implications. A few commenters specifically 
requested that HHS clarify the rights of both ACOs and clinicians 
within an ACO to appeal an information blocking finding and provide 
extenuating information, such as why they contend an exception applied.
    Response. As discussed in the Disincentives Proposed Rule (88 FR 
74966), an ACO may appeal an initial determination that is not 
prohibited from administrative or judicial review under 42 CFR 425.800 
by requesting a reconsideration review by a CMS reconsideration 
official (42 CFR 425.802(a)). Individual ACO participants do not have 
the right to request an appeal under the Shared Savings Program 
regulations. To the extent it is not barred by 42 CFR 425.800, an ACO 
may appeal (on behalf of an ACO participant) the removal or denial of a 
health care provider from an ACO participant list as a result of the 
referral by OIG of an ACO participant that OIG had determined to be an 
information blocker. Subject to the same limitation, an ACO applicant 
or ACO may appeal the denial of the ACO applicant's application or 
termination of the ACO's participation agreement as a result of the 
referral by OIG of the ACO applicant or ACO that the OIG had determined 
to be an information blocker. The underlying information blocking 
determination made by OIG, however, is not subject to the Shared 
Savings Program's reconsideration process. The OIG determination is not 
an initial determination made by CMS, but a determination made by 
another agency and the Shared Savings Program reconsideration process 
may not negate, diminish, or otherwise alter the applicability of 
determinations made by other government agencies (see 42 CFR 
425.808(b)). In the Disincentives Proposed Rule, we noted that we 
considered OIG to be a separate and distinct agency from CMS for the 
purposes of this provision (88 FR 74966). The Shared Savings Program's 
reconsideration process would thus not be the appropriate forum to seek 
reconsideration of OIG's determination.
    After consideration of the public comments, CMS has finalized the 
alternative policy that will consider an OIG information blocking 
determination in light of the relevant facts and circumstances before 
applying a disincentive, such as denying the addition of an ACO 
participant to an ACO participant list (or an ACO provider/supplier to 
the ACO provider/supplier list), informing an ACO that remedial action 
should be taken against the ACO participant (or ACO provider/supplier), 
denying an ACO's application to participate in the Shared Savings 
Program if the remedial action is not taken, or terminating an ACO's 
participation agreement with CMS. The relevant facts and circumstances 
include the nature of the health care provider's information blocking, 
the health care provider's diligence in identifying and correcting the 
problem, the time since the information blocking occurred, whether the 
provider was previously subject to a disincentive in another program, 
and other factors.
    CMS notes that the final policies in this rule will become 
effective 30 days after the official publication date. However, we note 
that section III.B.1. of this final rule states that OIG will not begin 
investigating health care providers until after the effective date of 
this rule, and that OIG will exercise its enforcement discretion not to 
make any determinations regarding conduct occurring prior to the 
effective date of this rule for information blocking disincentives. As 
OIG will not make a determination on conduct occurring prior to the 
effective date, OIG will not refer any health care providers based on a 
determination of conduct occurring prior to the effective date of this 
rule for information blocking disincentives. This means that CMS will 
not impose the disincentive in the Shared Savings Program for 
information blocking committed prior to the effective date of this 
final rule. We further clarify that any disincentives under the Shared 
Savings Program for information blocking determinations referred by OIG 
would be imposed after January 1, 2025.

IV. Request for Information

    As discussed in section III.C.1. of the Disincentives Proposed 
Rule, we recognize that the disincentives we proposed would only apply 
to a subset of health care providers as defined in 45

[[Page 54715]]

CFR 171.102 (88 FR 74954 and 74955). However, we believe it is 
important for HHS to establish appropriate disincentives that would 
apply to all health care providers, as such providers are defined in 45 
CFR 171.102. This would ensure that any health care provider, as 
defined in 45 CFR 171.102, that has engaged in information blocking 
would be subject to appropriate disincentives by an appropriate agency, 
consistent with the disincentives provision at PHSA section 
3022(b)(2)(B).
    We requested information from the public on additional appropriate 
disincentives that we should consider in future rulemaking, 
particularly disincentives that would apply to health care providers, 
as defined in 45 CFR 171.102, that are not implicated by the 
disincentives proposed in the Disincentives Proposed Rule (88 FR 74966 
and 74967). We encouraged commenters to identify specific health care 
providers (for example, laboratories, pharmacies, post-acute care 
providers, etc.) and associated potential disincentives using 
authorities under applicable Federal law. We also requested information 
about the health care providers that HHS should prioritize when 
establishing additional disincentives.
    We received 32 submissions on this RFI. We thank commenters for 
their comments. We have shared all the comments received with the 
appropriate agencies and offices for consideration in subsequent 
rulemaking to establish additional disincentives for specific health 
care providers.

V. Collection of Information Requirements

    This document does not impose any new information collection 
requirements, that is, reporting, recordkeeping or third-party 
disclosure requirements. Consequently, there is no need for review by 
the Office of Management and Budget under the authority of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

VI. Regulatory Impact Statement

    We have examined the impacts of this final rule as required by 
Executive Order 12866 on Regulatory Planning and Review (September 30, 
1993), Executive Order 13563 on Improving Regulation and Regulatory 
Review (January 18, 2011), Executive Order 14094 entitled ``Modernizing 
Regulatory Review'' (April 6, 2023), the Regulatory Flexibility Act 
(RFA) (Pub. L. 96-354, September 19, 1980), section 1102(b) of the 
Social Security Act, section 202 of the Unfunded Mandates Reform Act of 
1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on 
Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 
804(2)).

A. Executive Order 12866

    Executive Order 12866, as amended by Executive Order 14094 
published on April 6, 2023, directs agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulations are 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, and public health and 
safety effects; distributive impacts; and equity). A regulatory impact 
analysis must be prepared for major rules with significant effects (for 
example, $200 million or more in any given year). This is not a major 
rule as defined at 5 U.S.C. 804(2); it is not significant under section 
3(f)(1) of Executive Order 12866 because it does not reach that 
economic threshold, nor does it meet the other criteria outlined in the 
Executive order.
    This final rule would implement provisions of the Cures Act through 
changes to 45 CFR part 171 and 42 CFR parts 414, 425, and 495. For the 
reasons set forth below, we believe that the likely aggregate economic 
effect of these regulations would be significantly less than $200 
million.
    The expected benefits of this final rule would be to deter 
information blocking that interferes with effective health information 
exchange and negatively impacts many important aspects of healthcare. 
We refer readers to the impact analysis of the benefits of deterring 
information blocking in the ONC Cures Act Final Rule, which encompasses 
all anticipated benefits without differentiation among actors (85 FR 
25936).
    We anticipate that OIG would incur some costs associated with 
investigation as authorized by the Cures Act. The Consolidated 
Appropriations Act, 2022, provides OIG the authority to use its 
existing funding to conduct information blocking activities (Pub. L. 
117-103, March 15, 2022). OIG has not received additional 
appropriations or increased funding levels specific to information 
blocking.
    Additionally, investigated parties may incur some costs in response 
to an OIG investigation or in response to the application of a 
disincentive by an agency with the authority to impose a disincentive. 
Absent information about the frequency of prohibited practices, 
including the number of OIG determinations of information blocking in a 
given year that could be referred to an appropriate agency, we are 
unable to determine the potential costs of this regulation.
    The monetary value of the disincentives finalized in this rule, if 
imposed on a health care provider by an appropriate agency, would be 
considered transfers. We are unable to reliably estimate the aggregate 
value of potential disincentive amounts because the value of the 
disincentive may vary based on other provisions specific to the 
authority under which the disincentive has been established, as 
discussed in section III.C.1. of this final rule. For instance, the 
value of a disincentive imposed on an eligible hospital under the 
disincentive finalized in section III.C.2. of this final rule would 
depend on the amount of IPPS payment received by the eligible hospital.
    We invited public comment on potential impacts of the rulemaking. 
The following is a summary of the comments we received and our 
responses.
    Comments. A few commenters expressed disagreement with ONC's 
assertion that the proposed rule will have economically insignificant 
effects. These commenters expressed that the Disincentives Proposed 
Rule underestimated the potential financial impact to entities 
operating under the authorities in section III.C. of the proposed rule. 
One commenter stated that health care providers with a larger share of 
Medicare patients could face financial costs approximately ten times 
greater than the estimated median impact. Additionally, this commenter 
expressed that the potential loss of savings to the Medicare Trust Fund 
as a result of barring participation in the Shared Savings Program 
would likely result in the rule having an annual economic effect 
exceeding $200 million, citing the significant amount of aggregate 
savings to the Medicare Trust Fund and average savings per ACO. One 
commenter recommended delaying the rule until HHS conducts an 
assessment of the rule's impact on clinicians and patient access, 
expressing concern that the proposed financial disincentives might 
negatively impact access to care.
    Response. We acknowledge commenters' concerns about the impact that 
applying disincentives may have on individual health care providers. In 
the Disincentives Proposed Rule, we provided illustrative estimates of 
the monetary value of the proposed disincentive for eligible hospitals 
under the Medicare Promoting Interoperability Program (88 FR 74956 and 
74957) and for eligible clinicians under the MIPS Promoting 
Interoperability performance category (88 FR 74960). While we presented 
median values, as well as 95

[[Page 54716]]

percent ranges of estimates, in both cases, we acknowledge that there 
may be outlier examples that result in monetary values that are 
significantly higher than the figures presented in the analysis. 
However, we disagree that these figures, or other information 
commenters may provide about potential impacts on individual health 
care providers, directly impact our analysis of whether this is a 
significant regulatory action. As noted above, we are unable to 
reliably estimate either the frequency of prohibited practices, 
including the number of OIG determinations of information blocking in a 
given year that could be referred to an appropriate agency as a subset 
of all prohibited practices that could be determined to be information 
blocking, or the aggregate value of potential disincentive amounts, 
because the value of the disincentive may vary based on other 
provisions specific to the authority under which the disincentive has 
been established. Regarding the potential loss of savings to the 
Medicare Trust Fund associated with the disincentive finalized under 
the Shared Savings Program, we disagree that this would indicate that 
the rule would have an annual economic effect exceeding $200 million. 
The figures cited by the commenter of aggregate savings of the Shared 
Savings Program and average savings per ACO do not provide information 
about the amount of savings that would be lost due to the imposition of 
disincentives under the Shared Savings Program, as disincentives would 
only be imposed on an ACO that is a health care provider, an ACO 
participant, or an ACO provider/supplier that has been determined by 
OIG to have committed information blocking, referred to CMS as the 
appropriate agency to be subject to disincentives. As CMS has finalized 
in section III.C.4., CMS will also determine whether to impose a 
disincentive under the Shared Savings Program based on relevant facts 
and circumstances. As stated above, we are unable to reliably estimate 
the frequency of prohibited practices or the aggregate value of 
potential disincentive amounts, and commenters provided no additional 
information or data for their assertion that the costs will be higher.

B. Regulatory Flexibility Act

    The RFA and the Small Business Regulatory Enforcement and Fairness 
Act of 1996, which amended the RFA, require agencies to analyze options 
for regulatory relief of small businesses. For purposes of the RFA, 
small entities include small businesses, nonprofit organizations, and 
Government agencies.
    The Department considers a rule to have a significant impact on a 
substantial number of small entities if it has an impact of more than 3 
percent of revenue for more than 5 percent of affected small entities. 
This final rule would not have a significant impact on the operations 
of a substantial number of small entities, as these changes would not 
impose any new requirement on any party. We have concluded that this 
final rule likely would not have a significant impact on a substantial 
number of small entities and that a regulatory flexibility analysis is 
not required for this rulemaking. Additionally, the Secretary certifies 
that this final rule would not have a significant impact on a 
substantial number of small entities.
    In addition, section 1102(b) the SSA (42 U.S.C. 1302) requires us 
to prepare a regulatory impact analysis if a rule under Titles XVIII or 
XIX or section B of Title XI of the SSA may have a significant impact 
the operations of a substantial number of small rural hospitals. We 
have concluded that this final rule would not have a significant impact 
on the operations of a substantial number of small rural hospitals 
because these changes would not impose any requirement on any party. 
Therefore, a regulatory impact analysis under section 1102(b) of the 
SSA is not required for this rulemaking. Therefore, the Secretary has 
certified that this final rule will not have a significant impact on 
the operations of a substantial number of small rural hospitals.

C. Unfunded Mandates Reform Act

    Section 202 of the Unfunded Mandates Reform Act of 1995, Public Law 
104-4, requires that agencies assess anticipated costs and benefits 
before issuing any rule that may result in expenditures in any 1 year 
by State, local, or Tribal governments, in the aggregate, or by the 
private sector, of $100 million, adjusted annually for inflation. There 
are no significant costs associated with these finalized proposals that 
would impose mandates on State, local, or Tribal governments or the 
private sector resulting in an expenditure of $183 million in 2024 
(after adjustment for inflation) or more in any given year. A full 
analysis under the Unfunded Mandates Reform Act is not necessary.

D. Executive Order 13132

    Executive Order 13132, Federalism, establishes certain requirements 
that an agency must meet when it promulgates a rule that imposes 
substantial direct requirements or costs on State and local 
governments, preempts State law, or otherwise has federalism 
implications. In reviewing this rule under the threshold criteria of 
Executive Order 13132, we have determined that this final rule would 
not significantly affect the rights, roles, and responsibilities of 
State or local governments. Nothing in this final rule imposes 
substantial direct requirements or costs on State and local 
governments, preempts State law, or otherwise has federalism 
implications. We are not aware of any State laws or regulations that 
are contradicted or impeded by any of the provisions in this final 
rule.

List of Subjects

42 CFR Part 414

    Administrative practice and procedure, Biologics, Diseases, Drugs, 
Health facilities, Health professions, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 425

    Administrative practice and procedure, Health facilities, Health 
professions, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 495

    Administrative practice and procedure, Health facilities, Health 
maintenance organizations (HMO), Health professions, Health records, 
Medicaid, Medicare, Penalties, Privacy, Reporting and recordkeeping 
requirements.

45 CFR Part 171

    Computer technology, Electronic health record, Electronic 
information system, Electronic transactions, Health, Healthcare, Health 
care provider, Health information exchange, Health information 
technology, Health information network, Health insurance, Health 
records, Hospitals, Privacy, Reporting and recordkeeping requirements, 
Public health, Security.

    For the reasons set forth in the preamble, HHS amends 42 CFR 
chapter IV and 45 CFR part 171 as follows:

42 CFR Chapter IV

PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES

0
1. The authority citation for part 414 continues to read as follows:

    Authority: 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l).


0
2. Amend Sec.  414.1305 by revising the definition of ``Meaningful EHR 
user for MIPS'' to read as follows:

[[Page 54717]]

Sec.  414.1305  Definitions.

* * * * *
    Meaningful EHR user for MIPS means a MIPS eligible clinician that 
possesses CEHRT, uses the functionality of CEHRT, reports on applicable 
objectives and measures specified for the Promoting Interoperability 
performance category for a performance period in the form and manner 
specified by CMS, does not knowingly and willfully take action (such as 
to disable functionality) to limit or restrict the compatibility or 
interoperability of CEHRT, and engages in activities related to 
supporting providers with the performance of CEHRT. In addition, a MIPS 
eligible clinician (other than a qualified audiologist) is not a 
meaningful EHR user for a performance period if the HHS Inspector 
General refers a determination that the MIPS eligible clinician 
committed information blocking as defined at 45 CFR 171.103 during the 
calendar year of the performance period. The term ``information 
blocking,'' with respect to an individual MIPS eligible clinician or 
group, shall not include an act or practice other than an act or 
practice committed by such individual MIPS eligible clinician or group.
* * * * *

0
3. Amend Sec.  414.1375 by revising paragraph (b) introductory text to 
read as follows:


Sec.  414.1375  Promoting Interoperability (PI) performance category.

* * * * *
    (b) Reporting for the Promoting Interoperability performance 
category. To earn a performance category score for the Promoting 
Interoperability performance category for inclusion in the final score, 
a MIPS eligible clinician must be a meaningful EHR user for MIPS and:
* * * * *

PART 425--MEDICARE SHARED SAVINGS PROGRAM

0
4. The authority citation for part 425 continues to read as follows:

    Authority: 42 U.S.C. 1302, 1306, 1395hh, and 1395jjj.


0
5. Amend Sec.  425.208 by adding paragraph (b)(6) to read as follows:


Sec.  425.208  Provisions of participation agreement.

* * * * *
    (b) * * *
    (6) The information blocking provision of the 21st Century Cures 
Act (42 U.S.C. 300jj-52).
* * * * *

0
6. Amend Sec.  425.218 by revising paragraph (b)(3) to read as follows:


Sec.  425.218  Termination of the participation agreement by CMS.

* * * * *
    (b) * * *
    (3) Violations of any applicable laws, rules, or regulations that 
are relevant to ACO operations, including, but not limited to, the laws 
specified at Sec.  425.208(b).
* * * * *

0
7. Amend Sec.  425.305 by revising paragraph (a)(1) to read as follows:


Sec.  425.305  Other program safeguards.

    (a) * * *
    (1) ACOs, ACO participants, and ACO providers/suppliers are 
reviewed during the Shared Savings Program application process and 
periodically thereafter with regard to their program integrity history, 
including any history of Medicare program exclusions or other sanctions 
and affiliations with individuals or entities that have a history of 
program integrity issues. Program integrity history issues include, but 
are not limited to, a history of Medicare program exclusions or other 
sanctions, noncompliance with the requirements of the Shared Savings 
Program, or violations of laws specified at Sec.  425.208(b).
* * * * *

PART 495--STANDARDS FOR THE ELECTRONIC HEALTH RECORD TECHNOLOGY 
INCENTIVE PROGRAM

0
8. The authority citation for part 495 continues to read as follows:

    Authority:  42 U.S.C. 1302 and 1395hh.


0
9. Amend Sec.  495.4 in the definition of ``Meaningful EHR user'' by 
revising paragraph (1) introductory text and adding paragraph (4) to 
read as follows:


Sec.  495.4  Definitions.

* * * * *
    Meaningful EHR user * * *
    (1) Subject to paragraphs (3) and (4) of this definition, an 
eligible professional, eligible hospital or CAH that, for an EHR 
reporting period for a payment year or payment adjustment year--
* * * * *
    (4) An eligible professional, eligible hospital or CAH is not a 
meaningful EHR user in a payment adjustment year if the HHS Inspector 
General refers a determination that the eligible hospital or CAH 
committed information blocking as defined at 45 CFR 171.103 during the 
calendar year of the EHR reporting period.
* * * * *

45 CFR Subtitle A

PART 171--INFORMATION BLOCKING

0
10. The authority citation for part 171 continues to read as follows:

    Authority:  42 U.S.C. 300jj-52; 5 U.S.C. 552.


0
11. Amend Sec.  171.102 by adding, in alphabetical order, the 
definition of ``Appropriate agency'' and ``Disincentive'' to read as 
follows:


Sec.  171.102   Definitions.

* * * * *
    Appropriate agency means a government agency that has established 
disincentives for health care providers that the Office of Inspector 
General (OIG) determines have committed information blocking.
* * * * *
    Disincentive means a condition specified in Sec.  171.1001(a) that 
is imposed by an appropriate agency on a health care provider that OIG 
determines has committed information blocking for the purpose of 
deterring information blocking practices.
* * * * *

Subparts E Through I [Added and Reserved]

0
12. Add and reserve subparts E through I.

0
13. Add subpart J to read as follows:

Subpart J--Disincentives for Information Blocking by Health Care 
Providers

Sec.
171.1000 Scope.
171.1001 Disincentives.
171.1002 Notice of disincentive.


Sec.  171.1000   Scope.

    This subpart sets forth disincentives that an appropriate agency 
may impose on a health care provider that OIG determines has committed 
information blocking, and certain procedures related to those 
disincentives.


Sec.  171.1001  Disincentives.

    (a) Centers for Medicare & Medicaid Services may apply the 
following disincentives:
    (1) An eligible hospital or critical access hospital (CAH) as 
defined in 42 CFR 495.4 is not a meaningful electronic health record 
(EHR) user as also defined in 42 CFR 495.4.
    (2) A Merit-based Incentive Payment System (MIPS) eligible 
clinician as defined in 42 CFR 414.1305, who is also a health care 
provider as defined in Sec.  171.102, is not a meaningful EHR user for 
MIPS as defined in 42 CFR 414.1305.

[[Page 54718]]

    (3) Accountable care organizations (ACOs) who are health care 
providers as defined in Sec.  171.102, ACO participants, and ACO 
providers/suppliers will be removed from, or denied approval to 
participate, in the Medicare Shared Savings Program as defined in 42 
CFR part 425 for at least 1 year.
    (b) [Reserved]


Sec.  171.1002   Notice of disincentive.

    Following referral of a determination of information blocking by 
OIG, an appropriate agency that imposes a disincentive or disincentives 
specified in Sec.  171.1001 shall send a notice to the health care 
provider subject to the disincentive or disincentives, via usual 
methods of communication for the program or payment system under which 
the disincentive is applied, that includes:
    (a) A description of the practice or practices that formed the 
basis for the determination of information blocking referred by OIG;
    (b) The basis for the application of the disincentive or 
disincentives being imposed;
    (c) The effect of each disincentive; and
    (d) Any other information necessary for a health care provider to 
understand how each disincentive will be implemented.

0
14. Add subpart K to read as follows:

Subpart K--Transparency for Information Blocking Determinations, 
Disincentives, and Penalties

Sec.
171.1100 Scope.
171.1101 Posting of information for actors found to have committed 
information blocking.

    Authority: 42 U.S.C. 300jj-11(c)(4).


Sec.  171.1100   Scope.

    This subpart sets forth the information that will be posted on the 
Office of the National Coordinator for Health Information Technology's 
(ONC) public website about actors that have been determined by the HHS 
Office of Inspector General to have committed information blocking.


Sec.  171.1101  Posting of information for actors found to have 
committed information blocking.

    (a) Health care providers. (1) ONC will post on its public website 
the following information about health care providers that have been 
subject to a disincentive in Sec.  171.1001(a) for information 
blocking:
    (i) Health care provider name;
    (ii) Business address;
    (iii) The practice, as the term is defined in Sec.  171.102 and 
referenced in Sec.  171.103, found to have been information blocking, 
including when the practice occurred;
    (iv) Disincentive(s) applied; and
    (v) Where to find any additional information about the 
determination of information blocking that is publicly available via 
HHS or, where applicable, another part of the U.S. Government.
    (2) The information specified in paragraph (a)(1) of this section 
will not be posted prior to a disincentive being imposed or the 
completion of any administrative appeals process pursued by the health 
care provider, and will not include information about a disincentive 
that has not been applied.
    (3) Posting of the information specified in paragraph (a)(1) of 
this section will be conducted in accordance with existing rights to 
review information that may be associated with a disincentive specified 
in Sec.  171.1001.
    (b) Health IT developers of certified health IT and health 
information networks or health information exchanges. (1) ONC will post 
on its public website the following information, to the extent 
applicable, about health information networks/health information 
exchanges and health IT developers of certified health IT (actors) that 
have been determined by the HHS Office of Inspector General to have 
committed information blocking:
    (i) Type of actor;
    (ii) Actor's legal name, including any alternative or additional 
trade name(s) under which the actor operates;
    (iii) The practice, as the term is defined in Sec.  171.102 and 
referenced in Sec.  171.103, found to have been information blocking or 
alleged to be information blocking in the situation specified in 
paragraph (b)(2)(i) of this section, and including when the practice 
occurred; and
    (iv) Where to find any additional information about the 
determination (or resolution of information blocking as specified in 
paragraph (b)(2)(i) of this section) of information blocking that is 
publicly available via HHS or, where applicable, another part of the 
U.S. Government.
    (2) The information specified in paragraph (b)(1) of this section 
will not be posted until one of the following occurs:
    (i) OIG enters into a resolution of civil money penalty (CMP) 
liability; or
    (ii) A CMP imposed under subpart N of 42 CFR part 1003 has become 
final consistent with the procedures in subpart O of 42 CFR part 1003.

Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2024-13793 Filed 6-26-24; 4:15 pm]
BILLING CODE 4150-45-P