[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]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 414, 425, and 495
Office of the Secretary
45 CFR Part 171
RIN 0955-AA05
21st Century Cures Act: Establishment of Disincentives for Health
Care Providers That Have Committed Information Blocking
AGENCY: Centers for Medicare & Medicaid Services (CMS) and Office of
the National Coordinator for Health Information Technology (ONC),
Department of Health and Human Services (HHS).
ACTION: Proposed rule.
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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.
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\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.
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We believe it is important to establish appropriate disincentives
that account for all health care providers that fall within the
definition of health care provider (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.
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\2\ As January 12, 2017, was the thirtieth day after December
13, 2016, conduct occurring on or after January 13, 2017, that
otherwise meets the PHSA section 3022(a) definition of ``information
blocking,'' would be included in that definition.
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Section 3022(b)(1) of the PHSA authorizes OIG to investigate
information blocking claims. Section 3022(b)(1)(B) of the PHSA
authorizes OIG to investigate claims that ``a health care provider
engaged in information blocking.'' Section 3022(b)(2)(B) of the PHSA
provides that any health care provider OIG determines to have committed
information blocking shall be referred to the appropriate agency to be
subject to appropriate disincentives using authorities under applicable
Federal law, as the Secretary sets forth through notice and comment
rulemaking. Sections 3022(b)(1)(A) and (C) of the PHSA authorize OIG to
investigate health information technology (IT) developers of certified
health IT or other entities offering certified health IT, health
information exchanges, and health information networks. Section
3022(b)(2)(A) of the PHSA authorizes the imposition of civil money
penalties (CMPs) \3\ not to exceed $1 million per violation on those
individuals and entities set forth in sections 3022(b)(1)(A) and (C) of
the PHSA.
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\3\ 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).
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PHSA section 3022 also authorizes ONC, the HHS Office for Civil
Rights (OCR), and OIG to consult, refer, and coordinate to resolve
claims of information blocking. PHSA section 3022(b)(3)(A) authorizes
OIG to refer claims of information blocking to OCR if OIG determines a
consultation regarding the health privacy and security rules
promulgated under section 264(c) of the Health Insurance Portability
and Accountability Act of 1996 (HIPAA) (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.
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\4\ As defined in 42 U.S.C 300-jj, the term ``health care
provider'' includes a hospital, skilled nursing facility, nursing
facility, home health entity or other long term care facility,
health care clinic, community mental health center (as defined in
section 300x-2(b)(1) of this title), renal dialysis facility, blood
center, ambulatory surgical center described in section 1395l(i) of
this title, emergency medical services provider, Federally qualified
health center, group practice, a pharmacist, a pharmacy, a
laboratory, a physician (as defined in section 1395x(r) of the
title), a practitioner (as described in section 1395u(b)(18)(C) of
the title), a provider operated by, or under contract with, the
Indian Health Service or by an Indian tribe (as defined in the
Indian Self-Determination and Education Assistance Act [25 U.S.C.
5301 et seq.]), tribal organization, or urban Indian organization
(as defined in section 1603 of title 5), a rural health clinic, a
covered entity under section 256b of this title, an ambulatory
surgical center described in section 1395l(i) of this title, a
therapist (as defined in section 1395w-4(k)(3)(B)(iii) of the
title), and any other category of health care facility, entity,
practitioner, or clinician determined appropriate by the Secretary.
See also this guidance document: https://www.healthit.gov/sites/default/files/page2/2020-08/Health_Care_Provider_Definitions_v3.pdf.
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The ONC Cures Act Final Rule also established in 45 CFR 171.102
regulatory definitions for ``health information network or health
information exchange'' and ``health IT developer of certified health
IT,'' \5\ among other terms.\6\ The preamble text of the ONC Cures Act
Final Rule makes clear that an individual or entity could meet both the
definition of a health care provider and the definition of a health IT
developer of certified health IT (85 FR 25798 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.
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\5\ In the ONC Cures Act Final Rule, ONC defined the term
``health IT developer of certified health IT'' in 45 CFR 171.102,
instead of using the term that appears in PHSA 3022(a)(1): ``health
IT developer.'' ONC explained that, because title XXX of the PHSA
does not define ``health information technology developer,'' ONC
interpreted section 3022(a)(1)(B) in light of the specific authority
provided to OIG in section 3022(b)(1)(A) and (b)(2). ONC noted that
section 3022(b)(2) discusses developers, networks, and exchanges by
referencing any individual or entity described in section
3022(b)(1)(A) or (C). Section 3022(b)(1)(A) states, in relevant
part, that OIG may investigate any claim that a health information
technology developer of certified health information technology or
other entity offering certified health information technology
engaged in information blocking (85 FR 25795, emphasis added).
\6\ In 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.
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On November 4, 2020, an interim final rule with comment period
titled ``Information Blocking and the ONC Health IT Certification
Program: Extension of Compliance Dates and Timeframes in Response to
the COVID-19 Public Health Emergency'' (ONC Cures Act Interim Final
Rule) appeared in the Federal Register (85 FR 70064). The ONC Cures Act
Interim Final Rule extended certain compliance dates and timeframes
adopted in the ONC Cures Act Final Rule to offer the healthcare system
additional flexibilities in furnishing services to combat the COVID-19
pandemic, including extending the applicability date for the
information blocking provisions to April 5, 2021 (85 FR 70068). The ONC
Cures Act Interim Final Rule also extended from May 2, 2022, to October
6, 2022, the date on which electronic health information as defined in
45 CFR 171.102 for purposes of the information blocking definition in
45 CFR 171.103 would no longer be limited to the subset of EHI that is
identified by data elements represented in the United States Core Data
for Interoperability (USCDI) standard adopted in 45 CFR 170.213 (85 FR
70069).\7\ On and after October 6, 2022, practices likely to interfere
with access, exchange, or use of any information falling within the
definition of EHI in 45 CFR 171.102 may constitute information blocking
as defined in 45 CFR 171.103.
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\7\ For more information about the USCDI, see https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi.
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2. Office of Inspector General (OIG) Civil Money Penalties (CMP) Final
Rule
On April 24, 2020, a proposed rule titled ``Grants, Contracts, and
Other Agreements: Fraud and Abuse; Information Blocking; Revisions to
the Office of Inspector General's Civil Money Penalty Rules'' (OIG CMP
Proposed Rule) appeared in the Federal Register (85 FR 22979). The OIG
CMP Proposed Rule set forth proposed regulations to incorporate new CMP
authority for information blocking and related procedures 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.
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\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.
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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.
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\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).
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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.
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\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.
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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.
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\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.
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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.
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\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.
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(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.
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\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.
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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).
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\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).
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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).
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\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.
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CMS has interpreted the requirement at section 1899(b)(1)(G) of the
SSA that an ACO coordinates care for assigned beneficiaries using
enabling technologies to require an ACO (and, by agreement, an ACO
participant and ACO provider/supplier) to, among other things, define
its methods and processes established to coordinate care across and
among health care providers both inside and outside the ACO and have a
written plan to ``encourage and promote use of enabling technologies
for improving care coordination for beneficiaries'' (42 CFR
425.112(b)(4)(i) and (b)(4)(ii)(C)). Enabling technologies may include
one or more of the following: electronic health records and other
health IT tools; telehealth services, including remote patient
monitoring; electronic exchange of health information; and other
electronic tools to engage beneficiaries in their care. The ACO must
ensure that ACO participants and ACO providers/suppliers comply with
and implement the defined care coordination process, including the
encouragement and promotion of enabling technologies, and the remedial
processes and penalties (including the potential for expulsion)
applicable to ACO participants and ACO providers/suppliers for failure
to comply with and implement the required process (see 42 CFR
425.112(a)(3)). Sharing health information using enabling technologies
across all health care providers engaged in a beneficiary's care (both
inside and 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).
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\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.
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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