[Federal Register Volume 88, Number 210 (Wednesday, November 1, 2023)]
[Proposed Rules]
[Pages 74947-74970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24068]


-----------------------------------------------------------------------

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: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: This proposed rule would implement 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. In 
particular, this rulemaking would establish for such health care 
providers a set of appropriate disincentives using authorities under 
applicable Federal law.

DATES: To be assured consideration, written or electronic comments must 
be received at one of the addresses provided below, no later than 5 
p.m. on January 2, 2024.

ADDRESSES: You may submit comments, identified by RIN 0955-AA05, by any 
of the following methods (please do not submit duplicate comments). 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
     Federal eRulemaking Portal: Follow the instructions for 
submitting comments. Attachments should be in Microsoft Word, Microsoft 
Excel, or Adobe PDF; however, we prefer Microsoft Word. https://www.regulations.gov.
     Regular, Express, or Overnight Mail: Department of Health 
and Human Services, Office of the National Coordinator for Health 
Information Technology, Attention: 21st Century Cures Act: 
Establishment of Disincentives for Health Care Providers That Have 
Committed Information Blocking Proposed Rule, Mary E. Switzer Building, 
Mail Stop: 7033A, 330 C Street SW, Washington, DC 20201. Please submit 
one original and two copies.
     Inspection of Public Comments: All comments received 
before the close of the comment period will be available for public 
inspection, including any personally identifiable or confidential 
business information that is included in a comment. Please do not 
include anything in your comment submission that you do not wish to 
share with the general public. For example, people typically do not 
wish to, and generally should not, share with the general public 
information such as: any person's social security number; date of 
birth; driver's license number; state identification number or foreign 
country equivalent; passport number; financial account number; credit 
or debit card number; individually identifiable health information; or 
any business information that could be considered proprietary. We will 
post all comments that are received before the close of the comment 
period at https://www.regulations.gov.
     Docket: For access to the docket to read background 
documents or comments received, go to https://www.regulations.gov.

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
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
III. Provisions of the Proposed Regulation
    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 No. 12866
    B. Regulatory Flexibility Act
    C. Unfunded Mandates Reform Act
    D. Executive Order 13132

I. Executive Summary

A. Purpose of Regulatory Action

    This proposed rule would implement 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'' (42 U.S.C. 300jj-52(b)(2)(B), 
Public Health Service Act (PHSA) section 3022(b)(2)(B), as added by 
section 4004 of the Cures Act (Pub. L. 114-255, Dec. 13, 2016)). The 
proposals in this rule would establish disincentives for certain health 
care providers (as defined in 45 CFR 171.102) that are also Medicare-
enrolled providers or suppliers.

[[Page 74948]]

B. Summary of Major Provisions

    This proposed rule would establish 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 are also Medicare-enrolled providers or suppliers. The 
proposed 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, the rule proposes to establish a process by 
which information would be shared with the public about health care 
providers that OIG determines have committed information blocking.
    Although the proposals in this rule would not establish 
disincentives for all of the health care providers included in the 45 
CFR 171.102 definition, the health care providers to whom these 
disincentives would apply furnish a broad array of services to a 
significant number of both Medicare beneficiaries and other patients. 
Thus, this set of disincentives would directly advance 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.
---------------------------------------------------------------------------

    \1\ Except if or as necessitated by the specific terminology of 
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.
---------------------------------------------------------------------------

    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 (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 of the health care providers within 
the definition of health care provider at 45 CFR 171.102. In section 
IV. of this proposed rule, we request information on how we can build 
on the proposals in this rule to establish disincentives for other 
health care providers, particularly those health care providers not 
participating in the CMS programs identified in this rule.
    Consistent with PHSA section 3022(b)(2)(B), the proposals in this 
rule to establish disincentives use 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 proposes that an 
eligible hospital or CAH would not be 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 would not be able to earn the three quarters of the annual 
market basket increase associated with qualifying as a meaningful EHR 
user, while a CAH subject to this disincentive would 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 proposes 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) would not be 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 
proposes that the determination by OIG that a MIPS eligible clinician 
committed information blocking would 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 proposes to codify this proposal under the 
definition of meaningful EHR user for MIPS at 42 CFR 414.1305 and add 
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 proposes 
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, would be barred from participating in the 
Shared Savings Program for at least 1 year. This may 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 
would prevent the ACO's participation in the Shared Savings Program.

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 proposed rule is 
not a significant regulatory action, as the potential costs associated 
with this proposed 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.

[[Page 74949]]

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.'' Section 4004 of the Cures Act added section 3022 to 
the PHSA. Section 3022(a)(1) of the PHSA defines information blocking 
as 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. 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. If the practice is conducted 
by a health care provider, such 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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \3\ ONC uses 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).
---------------------------------------------------------------------------

    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) (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 proposed disincentive in 
greater detail in section III.C. of this proposed 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

[[Page 74950]]

purposes of the information blocking regulations in 45 CFR part 171. 
ONC noted that 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. Since 
adopting a definition of health care provider in the ONC Cures Act 
Final Rule, the Secretary has not proposed to modify the definition for 
purposes of the information blocking regulations.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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 through 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 proposed in 
this rule (should they be finalized), but depending on the specific 
facts and circumstances, they could meet the definition of a health 
information network or exchange, and therefore be subject to civil 
money penalties, if found by OIG to have committed information 
blocking.
---------------------------------------------------------------------------

    \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 2023, ONC has proposed to establish a definition of what 
it means to ``offer'' certified health IT, and to make a 
corresponding update to the health IT developer of certified health 
IT definition. These proposals are part of a proposed rule titled 
``Health Data, Technology, and Interoperability: Certification 
Program Updates, Algorithm Transparency, and Information Sharing'' 
(88 FR 23746) (HTI-1 Proposed Rule). The comment period on the HTI-1 
Proposed Rule ended June 20, 2023. Public Comments are posted as 
part of docket HHS-ONC-2023-0007, see https://www.regulations.gov/docket/HHS-ONC-2023-0007/comments.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \7\ For more information about the USCDI, see https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi.
---------------------------------------------------------------------------

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 at PHSA 
sections 3022(b)(2)(A) and (C) (88 FR 42825). 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 (88 FR 42822).
    OIG subsequently addressed these proposals in a final rule, 
``Grants, Contracts, and Other Agreements: Fraud and Abuse; Information 
Blocking; Office of Inspector General's Civil Money Penalty Rules,'' 
which 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, health information exchanges, and health 
information networks. The OIG CMP Final Rule did not establish 
appropriate disincentives for health care providers that OIG has 
determined have committed information blocking.
    As mentioned above, a health care provider that also meets the 
definition of health IT developer of certified health IT, or health 
information network or health information exchange, or both, under 45 
CFR 171.102, may be subject to information blocking CMPs (88 FR 42828). 
OIG has stated that as part of its assessment of whether a health care 
provider is a health information network or exchange that could be 
subject to civil money penalties for information blocking, OIG 
anticipates engaging with the health care provider to better understand 
its functions and to offer the provider an opportunity to explain why 
it is not a health information network or exchange (88 FR 42828).

III. Provisions of the Proposed Regulation

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.

[[Page 74951]]

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. Accordingly, we propose 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. We note that, 
under the disincentives provision, 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 proposed in section 
III.C. of this proposed rule are proposed under authorities held by 
CMS, which is an Operating Division of HHS. Under our proposals, CMS 
would be the ``appropriate agency'' to which OIG would refer a health 
care provider to be subject to disincentives.
    We invite public comments on our proposed definition of 
``appropriate agency.''
2. Authorities Under Applicable Federal Law
    We propose 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. In section III.C. of this proposed rule, 
CMS identifies the authority under which each disincentive is proposed.
3. Appropriate Disincentives
    The Cures Act does not specify or provide illustrations for the 
types of disincentives that should be established. As such, we propose 
to define the term ``disincentive'' in 45 CFR 171.102 to mean a 
condition that may be imposed by an appropriate agency on a health care 
provider that OIG determines has committed information blocking and is 
specifically identified in 45 CFR 171.1001(a). In section III.B.2 of 
this proposed rule, we propose 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.
    The term ``appropriate'' for disincentives is likewise not defined 
in PHSA section 3022, nor are illustrations provided. Under this 
proposal, 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. In section 
III.C. of this proposed rule, we describe the potential impact that 
each proposed disincentive would have on a health care provider.
    We note that the disincentives provision does not limit the number 
of disincentives that an appropriate agency can impose on a health care 
provider. Accordingly, we propose 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. Imposing cumulative disincentives, where applicable, 
would further deter health care providers from engaging in information 
blocking.
    We invite public comments on our proposals to establish 
disincentives in section III.C. of this proposed rule.

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 
would be subject to appropriate disincentives for information blocking. 
We begin with a discussion of an OIG investigation of a claim of 
information blocking, which may result in OIG determining that the 
health care provider committed information blocking. We then discuss 
how OIG would refer the health care provider to an appropriate agency. 
Next, we address certain general issues related to the application of a 
disincentive by an appropriate agency. Finally, we propose an approach 
to make information available to the public about health care providers 
that have been subject to an appropriate disincentive for information 
blocking, and about health information networks/health information 
exchanges and health IT developers of certified health IT that have 
been determined by OIG to have committed information blocking.
1. OIG Investigation and Referral
    The following information regarding OIG's anticipated approach to 
information blocking investigations of health care providers is not a 
regulatory proposal and is provided for information purposes only. This 
preamble discussion of investigation priorities for health care 
provider information blocking claims 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.
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. In the OIG CMP Final Rule, OIG described its enforcement 
priorities for health IT developers of certified health IT or other 
entities offering certified health IT, health information exchanges, 
and health information networks that have committed information 
blocking and are subject to CMPs. OIG stated that its information 
blocking CMP enforcement priorities will include practices that: (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; (iv) caused financial loss to Federal 
healthcare programs, or other government or private entities; or (v) 
were performed with actual knowledge. OIG stated that it expected these 
priorities will evolve as it gains more experience investigating 
information blocking (88 FR 42822).
    For investigations of health care providers, OIG expects to use 
four of these 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. Again, although not a regulatory 
proposal, OIG welcomes comments on these priorities, including comments 
on whether other issues specific to information blocking by health care 
providers should warrant changing these priorities or adding others.
    OIG emphasizes that information blocking, as defined in PHSA 
section 3022(a)(1) and in 45 CFR 171.103, includes an element of 
intent. The standard of intent for health care providers was 
established by the Cures Act in PHSA section 3022(a)(1)(B)(ii): ``if 
conducted by a health care provider,

[[Page 74952]]

such 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.'' This is different from the 
standard of intent in PHSA section 3022(a)(1)(B)(i): ``if 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.'' The 
different intent standard for information blocking by a health care 
provider is why OIG does not expect to use ``actual knowledge'' as an 
enforcement priority. OIG has significant experience and expertise 
investigating and determining whether to take an enforcement action 
based on other laws that are intent-based (for example, the Federal 
anti-kickback statute, and Civil Monetary Penalties Law, 42 U.S.C. 
1320a-7b(b) and 1320a-7a). This history will inform the use of OIG's 
discretion to investigate health care providers that OIG believes may 
have the requisite intent.
    As noted in the OIG CMP Final Rule (88 FR 42822), explanation of 
OIG's priorities can provide the public with a better understanding of 
how OIG anticipates allocating its resources for information blocking 
enforcement. Applicable to this proposed rule, explanation of OIG's 
priorities can provide the public with a better understanding of how 
OIG anticipates allocating its resources to investigate claims that 
health care providers engaged in information blocking. Prioritization 
ensures OIG can effectively allocate its resources to target 
information blocking claims that have more negative effects on 
patients, providers, and healthcare programs. OIG's enforcement 
priorities will inform its decisions about which information blocking 
allegations to pursue, but these priorities are not dispositive. Each 
allegation will present unique facts and circumstances that must be 
assessed individually. 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. 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 (for 
example, a health care provider or health information network). There 
is no specific formula OIG can apply to every allegation that allows it 
to effectively evaluate and prioritize which claims merit 
investigation.
b. Coordination With Other Agencies
    In this section we summarize 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). In addition to section 3022(b)(3)(A), OIG may 
request technical assistance from OCR during an information blocking 
investigation. 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 \8\ 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.
---------------------------------------------------------------------------

    \8\ 45 CFR parts 160 and 164, subparts A, C, D, and E.
---------------------------------------------------------------------------

    Finally, OIG stated that it 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 
stated that it might also consult or coordinate with a range of other 
government agencies, including CMS, FTC, or others (88 FR 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'' \9\ meets 
each 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.
---------------------------------------------------------------------------

    \9\ 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).
---------------------------------------------------------------------------

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 
would be subject to disincentives that have been

[[Page 74953]]

established under applicable Federal law through notice and comment 
rulemaking. In this section, we include general proposals and 
information related to the application of disincentives. For 
information on the specific disincentives proposed in this rule and 
further discussion about how each disincentive would be applied, we 
refer readers to section III.C.
    We propose to add a new subpart J to 45 CFR part 171, entitled 
``Disincentives for Information Blocking by Health Care Providers.'' As 
proposed in 45 CFR 171.1000, this subpart would set forth disincentives 
that an appropriate agency would 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 propose 
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) correspond to the 
appropriate disincentives proposed in section III.C. of this proposed 
rule, which include:
     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 future, if we propose to establish additional disincentives, 
we intend to add such disincentives to the disincentives listed in 45 
CFR 171.1001(a).
    We propose 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. This notice would include:
     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.
    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. 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 note 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.
    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. We note that PHSA section 
3022(b)(2)(C) requires that the imposition of CMPs that apply to health 
IT developers of certified health IT, and health information networks 
or health information exchanges, 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 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.
3. Transparency for Information Blocking Determinations, Disincentives, 
and Penalties
    We believe that it is important to promote transparency about how 
and where information blocking is impacting the nationwide health 
information technology infrastructure. 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) 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. We propose to add a new subpart 
K to 45 CFR part 171, entitled ``Transparency for Information Blocking 
Determinations, Disincentives, and Penalties.'' 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 propose 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. For 
health care providers that are subject to a disincentive, we propose 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 propose 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 also recognize that under 
the authorities for the disincentives proposed in section III.C. of 
this proposed rule, an appropriate agency may have other obligations 
related to release of information about a participant that is a health 
care provider (as defined in 45 CFR 171.102) in programs under that 
authority. 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

[[Page 74954]]

on the Compare Tool in accordance with 42 CFR 414.1395. Therefore, we 
propose 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 propose 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 information networks (HINs)/health 
information exchanges (HIEs) and health IT developers of certified 
health IT that have been determined by OIG to have committed 
information blocking and have either resolved their civil money penalty 
(CMP) liability with OIG or had a CMP imposed by OIG for information 
blocking under subpart N of 42 CFR part 1003. To ensure accurate 
identification of actors, we propose in 45 CFR 171.1101(b)(1) to post 
the type of actor (e.g., HIN/HIE 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 propose to post on our public website, for 
all actors, would be the two types of information mentioned above 
regarding health care providers. First, in 45 CFR 171.1101(a)(1)(iii) 
and (b)(1)(iii), we propose 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 propose 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.
    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. Between April 5, 2021, and 
September 30, 2023, we received over 800 claims of information blocking 
through the Report Information Blocking Portal.\10\ We have publicly 
posted 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.\11\ 
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 settlements of liability, civil money penalties, and 
disincentives. 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 
and the public can confirm or dispel perceptions of information 
blocking within that infrastructure. Additionally, the combined 
transparency of the processes Congress authorized and instructed HHS to 
implement (i.e., ONC implementing a claims reporting process, as well 
as civil money penalties and 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 invite public comments on 
these proposals, including comments on whether we should publicly post 
additional information (and why) about health care providers, health IT 
developers, or health information networks/health information exchanges 
that have been determined by OIG to have committed information 
blocking.
---------------------------------------------------------------------------

    \10\ See ``Information Blocking Claims: By the Numbers,'' 
https://www.healthit.gov/data/quickstats/information-blocking-claims-numbers.
    \11\ https://www.healthit.gov/data/quickstats/information-blocking-claims-numbers.
---------------------------------------------------------------------------

C. Appropriate Disincentives for Health Care Providers

    In this section (III.C.), we propose to establish a set of 
disincentives for health care providers that have committed information 
blocking. These disincentives would be imposed following a referral of 
a determination of information blocking by OIG. Each of the proposed 
disincentives is being established using authorities under applicable 
Federal law, consistent with PHSA section 3022(b)(2)(B).
1. Background
a. Impacted Health Care Providers
    The disincentives proposed in this section would apply to a subset 
of the individuals and entities meeting the information blocking 
regulations'

[[Page 74955]]

definition of health care provider at 45 CFR 171.102. Specifically, the 
proposals in this rule would provide 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.
    We recognize that the disincentives proposed in this rule 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. However, this 
proposed rule is a first step that focuses on authorities which pertain 
to certain health care providers that furnish a broad array of health 
care 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 proposed rule, we request 
public comment on establishing disincentives, using applicable Federal 
law, that could be imposed on a broader range of health care providers.
b. Impact of Disincentives
    We believe the disincentives proposed in this rule would deter 
information blocking by health care providers. However, we recognize 
that the actual monetary impact resulting from the application of the 
disincentives proposed in this section may vary across health care 
providers subject to the disincentive.
    For example, the disincentive proposed in section III.C.3. of this 
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 as a result 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. In determining each MIPS eligible clinician's 
final score, CMS takes into account 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.
    In the interest of addressing this variability, 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. However, we do not believe it would be feasible to 
develop such an approach for the disincentives we propose for health 
care providers. 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. Based on our review of potential 
authorities under which to establish disincentives, we believe many 
authorities do not provide discretion to adjust the monetary impact of 
a potential disincentive in this fashion. For instance, in section 
III.C.2. of this proposed rule, CMS proposes to establish a 
disincentive through the Medicare Promoting Interoperability Program 
utilizing authority in SSA section 1886. 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, on the basis of whether 
or not an eligible hospital (as defined in section 1886(n)(6)(B) of the 
SSA) is a meaningful EHR user.
2. Medicare Promoting Interoperability Program for Eligible Hospitals 
and Critical Access Hospitals (CAHs)
a. Background
    We intend 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) where OIG refers a determination that the eligible 
hospital or CAH committed information blocking. Under section 
1886(n)(3)(A) of the SSA, an eligible hospital or CAH \12\ 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, and 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. As discussed further in section 
III.C.2.b. of this proposed rule, these 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.
---------------------------------------------------------------------------

    \12\ 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.
    HHS has authority to apply disincentives to both eligible hospitals 
and CAHs. 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 this 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. The

[[Page 74956]]

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 through 
44317) as ``a hospital that is a subsection (d) hospital or a 
subsection (d) Puerto Rico hospital.'' Eligible hospitals are located 
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 can 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 previously, 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. 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).
    By establishing a disincentive for information blocking under the 
Medicare Promoting Interoperability Program, we are using an authority 
under applicable Federal law as required in section 3022(b)(2)(B) of 
the PHSA. Health care providers OIG determines 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 already 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.'' 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. 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.
    CMS also believes the proposed disincentive under the Medicare 
Promoting Interoperability Program would be an appropriate disincentive 
that would similarly deter information blocking by other eligible 
hospitals and CAHs, consistent with the discussion in section III.A.3. 
of this proposed rule. 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.
    HHS analyzed the range of potential disincentive amounts an 
eligible hospital could be subject to if the proposed disincentive was 
imposed, in order to illustrate the degree to which this disincentive 
could deter eligible hospitals from engaging in information blocking. 
We used payment data for IPPS eligible hospitals from the CMS Medicare 
Inpatient Hospitals dataset for 2021, the latest year of publicly 
available data.\13\ We considered the Medicare total payment amounts 
for each hospital, which consist of several variables, including Base, 
Medicare Severity Diagnosis Related Groups (MS-DRG), and adjustments 
such as Indirect Medical Education (IME)/Graduate Medical Education 
(GME), disproportionate share hospital (DSH), and outlier payments. We 
attempted to estimate the portion of hospitals' total payments subject 
to the market basket increase by excluding adjustments not subject to 
the increase, using data from CMS Hospital Cost Reports to subtract out 
DSH and IME/GME payments, which account for a large portion of

[[Page 74957]]

these adjustments.\14\ Since we did not account for other adjustments 
such as outlier payments, the remaining payment amount may overestimate 
the payment subject to the market basket increase.
---------------------------------------------------------------------------

    \13\ Available at https://data.cms.gov/provider-summary-by-type-of-service/medicare-inpatient-hospitals/medicare-inpatient-hospitals-by-provider.
    \14\ Available at https://www.cms.gov/research-statistics-data-and-systems/downloadable-public-use-files/cost-reports.
---------------------------------------------------------------------------

    We then conducted a simulation that applied the proposed 
disincentive amount to a market basket adjustment factor. We simulated 
a hypothetical scenario of a 3.2 percent market basket increase and a 
reduction of three quarters of that percentage increase if the proposed 
information blocking disincentive were applied.\15\ Under this 
scenario, a hospital that lost three quarters of the market basket 
increase due to the proposed information blocking disincentive would be 
left with a 0.8 percent market basket increase. Based on this 
calculation, we estimated a median disincentive amount of $394,353, and 
a 95 percent range of $30,406 to $2,430,766 across eligible hospitals. 
The value of the reduction in the market basket increase would be 
larger in dollar terms for hospitals with greater base IPPS payments.
---------------------------------------------------------------------------

    \15\ The hypothetical 3.2 percent market basket increase used in 
this simulation was based on the 2023 Medicare Trustees Report, 
which assumes a 3.2 percent annual market basket increase.
---------------------------------------------------------------------------

c. Proposals
    CMS is proposing 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. 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.
    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 OIG refers a determination of information blocking to CMS during the 
calendar year in which the EHR reporting period falls. 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 period 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 proposes 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.
    CMS further notes 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. Finally, CMS clarifies 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 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. 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.
    CMS invites 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).
d. Notification and Application of the Disincentive
    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 this 
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 invites public comment on these proposals.
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,\16\ in a meaningful 
manner, in

[[Page 74958]]

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. 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.
---------------------------------------------------------------------------

    \16\ 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
    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 payment incentive program, 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).
    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 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, 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)).
    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 our 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 three 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 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

[[Page 74959]]

(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.
    As discussed further in section III.C.3.b. of this proposed rule, 
these three requirements for a MIPS eligible clinician to be 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
    As discussed previously, we believe 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. 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 is 
proposing 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 this proposed rule.
(1) Alignment of Definitions of MIPS Eligible Clinician and Health Care 
Provider Under the PHSA
    CMS 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. 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 proposes to codify this 
exception in the definition of Meaningful EHR User for MIPS at 42 CFR 
414.1305.
    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.''
    CMS notes that, 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 proposes that MIPS 
eligible clinicians who are qualified audiologists would not be subject 
to the disincentive proposed for the MIPS Promoting Interoperability 
performance category in this proposed rule.
    As discussed previously in this section (III.C.3.b.(1)), 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, CMS also believes that a group may be 
subject to the disincentive proposed for the MIPS Promoting 
Interoperability performance category in this proposed rule 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.

[[Page 74960]]

(2) Information Blocking Conduct Undermines the Goals and Purpose of 
the MIPS Promoting Interoperability Performance Category
    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. 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 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 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. 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.
    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. CMS 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. Specifically, CMS 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. This proposal is 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). 
Information blocking by MIPS eligible clinicians frustrates both these 
goals.
    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 this proposed rule. 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. A MIPS eligible 
clinician who receives a score of zero in the MIPS Promoting 
Interoperability performance category under this proposed disincentive 
may not be able to earn a positive or neutral MIPS payment adjustment 
factor that they otherwise would have earned for their performance in 
MIPS.
    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 actual payment and MIPS data from 2021, 
the most recent year of publicly available data. The three data sets 
used were the Medicare Fee-For-Service Provider Utilization & Payment 
Data--Physician and Other Practitioners Dataset; the Clinician Public 
Reporting: Overall MIPS Performance Dataset and the Quality Payment 
Program Experience Dataset.17 18 19 The Medicare Fee-For-
Service Provider Utilization file contains actual payments to 
clinicians under Medicare Part B. We simulated disincentive amounts for 
all eligible clinicians on an individual basis by applying zero points 
for the Promoting Interoperability performance category portion of the 
MIPS score and using the MIPS scoring policies from the CY 2021 
performance year. We estimated potential disincentive amounts for 
groups by multiplying estimated per-clinical disincentive amounts by 
the number of eligible clinicians in estimated group sizes.
---------------------------------------------------------------------------

    \17\ Provider Utilization and Payment Data available at https://catalog.data.gov/dataset/medicare-physician-other-practitioners-by-provider-b297e.
    \18\ Overall MIPS Performance Dataset available at https://data.cms.gov/provider-data/dataset/a174-a962.
    \19\ Quality Payment Program Experience Dataset available at 
https://data.cms.gov/quality-of-care/quality-payment-program-experience/data.
---------------------------------------------------------------------------

    We first assessed the overall payment to eligible clinicians as 
well as the portion of the payment that was based on a positive or 
negative adjustment based on their MIPS score. We then varied the MIPS 
score based on lower scores on the Promoting Interoperability 
performance category portion, determined the change in positive or 
negative adjustment amount, and recalculated the payment under Medicare 
Part B. The difference between the actual 2021 payment and the 
simulated payment under the lower score represents the disincentive 
amount calculated in the simulation for individual eligible clinicians. 
We estimated a median individual disincentive amount of $686 and a 95 
percent range (the 2.5th to 97.5th percentile of estimated disincentive 
amounts) of $38 to $7,184 across all eligible clinicians (including 
those who may have been in a group). Based on the median estimated 
disincentive amount of $686 and estimated median group size of six 
clinicians, we estimated a group disincentive of $4,116 and a range of 
$1,372 to $165,326 for group sizes ranging from two to 241 clinicians 
(the estimated 2.5th to 97.5th percentile of group sizes). In 
consideration of MIPS eligible clinicians that may be subject to 
higher-than-median disincentives, we also simulated estimates for a 
median-sized group of six clinicians and an estimated 75th percentile 
per-clinician disincentive amount of $1,798. Based on this, we 
estimated a disincentive of $10,788. We noted that the ranges of 
potential group disincentive amounts vary based on individual clinician 
payments and group sizes.
c. Proposals
    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 proposes 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)

[[Page 74961]]

at any time during the calendar year of the performance period.\20\ CMS 
also proposes 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 proposes 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).
---------------------------------------------------------------------------

    \20\ 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 is 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).
---------------------------------------------------------------------------

    CMS considered applying this 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. However, a significant period of time 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 would apply the proposed disincentive to the MIPS 
payment year associated with the calendar year in which OIG referred 
its determination to CMS.
    As provided in 42 CFR 414.1320, the applicable MIPS payment year is 
2 calendar years after the performance period. This 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. Under our 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.
    First, CMS proposes to amend the definition of ``meaningful EHR 
user for MIPS'' at 42 CFR 414.1305. The current definition of 
meaningful EHR user for MIPS 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 proposes 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. CMS also proposes other minor technical changes to the language 
of the definition. In tandem with other proposals in this section, this 
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, this potential outcome likely would deter health 
care providers from engaging in information blocking.
    Second, CMS proposes to amend our requirements for earning a score 
for the MIPS Promoting Interoperability performance category by adding 
a new requirement at 42 CFR 414.1375(b). 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 proposes 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 our proposal to amend the definition of a meaningful 
EHR user for MIPS at 42 CFR 414.1305 discussed previously, CMS believes 
this 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.
    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. 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 CY 2028 MIPS 
payment year to the MIPS eligible clinician.
    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. 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 three 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

[[Page 74962]]

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.
    However, 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). If this performance 
threshold of 82 points is finalized for the 2026 MIPS payment year, or 
some other performance threshold higher than 75 points is finalized in 
a future MIPS payment year, then, under our example, a MIPS eligible 
clinician (that OIG determined committed information blocking and 
received a score of zero in the Promoting Interoperability performance 
category and therefore 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, this 
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).
    Under this proposal, a MIPS eligible clinician that otherwise 
fulfilled other requirements to demonstrate meaningful use for a 
performance period, and earned 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. CMS further notes that if a MIPS eligible clinician 
earned a score of zero for the Promoting Interoperability performance 
category for a given year because CMS had 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.
    CMS clarifies 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. 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 invites public comment on these proposals. CMS particularly 
requests 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).
(1) Groups and Virtual Groups
    CMS also proposes 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. CMS refers 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). MIPS eligible clinicians who submit data as 
a part of a group or virtual group and individually will be evaluated 
as an individual and as a group for all performance categories. 
Beginning with the CY 2021 performance period/2023 MIPS payment year, 
if a TIN/NPI has a virtual group final score associated with it, we 
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 would apply the MIPS payment 
adjustment factor to the Medicare Part B claims during the MIPS payment 
year for the MIPS eligible clinicians in the group or virtual group. 
Thus, 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.
(2) Reweighting Policies
    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). 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 is not proposing changes to its 
existing reweighting policies for MIPS eligible clinicians.
    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 is not proposing changes to 
our existing policy for MIPS eligible clinicians in small practices.
    CMS notes 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.
d. Notification of the Disincentive
    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. CMS would apply 
the proposed disincentive to the MIPS payment year associated with the 
calendar year in which the OIG referred its determination to CMS. 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 
this proposed rule).
    CMS invites public comment on this proposal.
4. Medicare Shared Savings Program
a. Background
(1) Statutory Authority for Disincentive
    Section 3022 of the Patient Protection and Affordable Care Act 
(PPACA) (Pub.

[[Page 74963]]

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). 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
    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.\21\ 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).
---------------------------------------------------------------------------

    \21\ 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.
---------------------------------------------------------------------------

    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 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 in order 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)). The ACO must certify 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 need 
to 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 justifies 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 the participation agreement with an ACO when 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

[[Page 74964]]

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 ACOs reveals a history of 
program integrity issues or when an ACO, an ACO participant or ACO 
provider/suppliers 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. Proposals
    CMS proposes 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. Under this proposal, 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.
    Information blocking runs contrary to the care coordination goals 
of the Shared Savings Program. 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.
    First, CMS proposes to amend 42 CFR 425.208(b) to include a 
specific reference to the Cures Act information blocking provision 
codified in the PHSA. The provision would be one of many laws with 
which ACOs (and by agreement, their ACO participants and ACO providers/
suppliers) must comply.\22\ 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). 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).
---------------------------------------------------------------------------

    \22\ 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 proposes 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). 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 proposes 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 proposes 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).''
    Pursuant to CMS' authority under 42 CFR 425.206(a)(1)(iii) 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 proposes 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. In the case of an ACO that is a health care provider, 
CMS proposes to deny the ACO's application to participate in the Shared 
Savings Program for the period of at least 1 year. 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 proposes 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).
    Each of these actions would deter information blocking consistent 
with the discussion of an appropriate

[[Page 74965]]

disincentive in section III.A.3. of this proposed rule. 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.
    The period of time of the disincentive would be at least 1 
performance year. CMS 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 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. 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 
(see section III.B.2 of this proposed rule) that would specify the 
disincentive would be imposed for at least 1 performance year.
    CMS proposes 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. 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 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 
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, then CMS would issue a compliance action to the 
ACO. 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.
    Applying the disincentive prospectively is the most appropriate 
timing for the disincentive. 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 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 recognizes, 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 more detail below, CMS is contemplating 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.
    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. 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, then CMS would continue to deny 
participation.
    In addition, 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. 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. Under CMS' proposal, the 
ACO participant would be able to remain on the ACO's certified 
participant list for the duration of the 2025 performance year. 
However, 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 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. 
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, CMS

[[Page 74966]]

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, 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.
    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. 
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. 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. 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.
    The Shared Savings Program is considering an alternative policy in 
which CMS would not apply a disincentive in certain circumstances 
despite an OIG information blocking determination. 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. 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. 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 are 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. 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. Such 
an alternative policy could allow a health care provider to 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.
    An ACO may be able to appeal the application of an information 
blocking disincentive in the Shared Savings Program. 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. The 
underlying information blocking determination made by OIG, however 
would not be 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. 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)).
    We remind 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 health information network or health information 
exchange, which is a functional definition, or the definition of a 
health IT developer of certified health IT, codified in 45 CFR 171.102. 
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 through 42829).
    We invite public comment on these proposals and on whether 
additional actions should be taken.

IV. Request for Information

    As discussed in section III.C.1. of this proposed rule, we 
recognize that the disincentives we propose would only apply to a 
subset of health care providers as defined in 45 CFR 171.102. 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

[[Page 74967]]

disincentives provision at PHSA section 3022(b)(2)(B).
    We request 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 this rule. We encourage 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 
request information about the health care providers that HHS should 
prioritize when establishing additional disincentives.

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 proposed 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), and Executive Order 13132 on 
Federalism (August 4, 1999).

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) because it does not reach that economic threshold, nor does it 
meet the other criteria outlined in the Executive order.
    This proposed rule would implement provisions of the Cures Act 
through changes to 45 CFR part 171 and 42 CFR parts 414, 425, and 495. 
We believe that the likely aggregate economic effect of these 
regulations would be significantly less than $200 million.
    The expected benefits of this proposed 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, 
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 appropriates to OIG funding necessary for 
carrying out information blocking activities (Pub. L. 117-103, March 
15, 2022). 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 proposed 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 proposed rule. For instance, the 
value of a disincentive imposed on an eligible hospital under the 
disincentive proposed in section III.C.2. of this proposed rule would 
depend on the amount of IPPS payment received by the eligible hospital.
    We invite public comment on potential impacts of the rulemaking.

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 proposed 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 proposed 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 proposes to certify that this proposed 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 proposed 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 proposed 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 proposals that would 
impose mandates on State, local, or Tribal governments or the private 
sector resulting in an expenditure of $177 million in 2023 (after 
adjustment for inflation) or more in any given year. A full analysis 
under the Unfunded Mandates Reform Act is not necessary.

[[Page 74968]]

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 proposed rule would 
not significantly affect the rights, roles, and responsibilities of 
State or local governments. Nothing in this proposed 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 proposed 
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 proposes to amend 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:


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.
* * * * *
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

[[Page 74969]]

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 
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.
* * * * *

Subparts D through I [Added and Reserved]

0
12. Add reserved subparts D 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 based on a determination of 
information blocking referred to that agency by OIG, and certain 
procedures related to those disincentives.


Sec.  171.1001  Disincentives.

    (a) Health care providers that commit information blocking are 
subject to the following disincentives from an appropriate agency based 
on a determination of information blocking referred by OIG:
    (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.
    (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(a) would 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.


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;
    (iv) Disincentive(s) applied; and
    (iv) 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 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
    (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

[[Page 74970]]

    (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. 2023-24068 Filed 10-30-23; 11:15 am]
BILLING CODE 4150-45-P