[Federal Register Volume 89, Number 126 (Monday, July 1, 2024)]
[Rules and Regulations]
[Pages 54662-54718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13793]
[[Page 54661]]
Vol. 89
Monday,
No. 126
July 1, 2024
Part II
Department of Health and Human Services
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Centers for Medicare and Medicaid Services
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42 CFR Part 414, et al.
45 CFR Part 171
21st Century Cures Act: Establishment of Disincentives for Health Care
Providers That Have Committed Information Blocking; Final Rule
Federal Register / Vol. 89 , No. 126 / Monday, July 1, 2024 / Rules
and Regulations
[[Page 54662]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 414, 425, and 495
Office of the Secretary
45 CFR Part 171
RIN 0955-AA05
21st Century Cures Act: Establishment of Disincentives for Health
Care Providers That Have Committed Information Blocking
AGENCY: Centers for Medicare & Medicaid Services (CMS) and Office of
the National Coordinator for Health Information Technology (ONC),
Department of Health and Human Services (HHS).
ACTION: Final rule.
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SUMMARY: This final rule implements the provision of the 21st Century
Cures Act specifying that a health care provider determined by the HHS
Inspector General to have committed information blocking shall be
referred to the appropriate agency to be subject to appropriate
disincentives set forth through notice and comment rulemaking. This
rulemaking establishes, for certain health care providers, a set of
appropriate disincentives using authorities under applicable Federal
law.
DATES: This rule is effective as of July 31, 2024.
FOR FURTHER INFORMATION CONTACT:
Alexander Baker, Office of Policy, Office of the National
Coordinator for Health Information Technology (ONC), (202) 690-7151,
for general issues.
Elizabeth Holland, Centers for Medicare & Medicaid Services (CMS),
(443) 934-2532, for issues related to the Promoting Interoperability
Program and the Promoting Interoperability performance category of the
Merit-Based Incentive Payment System.
Aryanna Abouzari, Centers for Medicare & Medicaid Services (CMS),
(415) 744-3668 or [email protected], for issues related
to the Medicare Shared Savings Program.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of Regulatory Action
B. Summary of Major Provisions
C. Costs and Benefits
D. Severability
II. Background
A. Statutory Basis
B. Regulatory History
1. ONC Cures Act Final Rule
2. Office of Inspector General (OIG) Civil Money Penalties (CMP)
Final Rule
3. Establishment of Disincentives for Health Care Providers That
Have Committed Information Blocking Proposed Rule
C. General Comments on the Disincentives Proposed Rule
III. Provisions of the Regulation and Anticipated Approach to
Investigations and Referrals
A. Relevant Statutory Terms and Provisions
1. Appropriate Agency
2. Authorities Under Applicable Federal Law
3. Appropriate Disincentives
B. Approach to Determination of Information Blocking and
Application of Disincentives
1. OIG Investigation and Referral
2. General Provisions for Application of Disincentives
3. Transparency for Information Blocking Determinations,
Disincentives, and Penalties
C. Appropriate Disincentives for Health Care Providers
1. Background
2. Medicare Promoting Interoperability Program for Eligible
Hospitals and Critical Access Hospitals (CAHs)
3. Promoting Interoperability Performance Category of the
Medicare Merit-Based Incentive Payment System (MIPS)
4. Medicare Shared Savings Program
IV. Request for Information
V. Collection of Information Requirements
VI. Regulatory Impact Statement
A. Executive Order 12866
B. Regulatory Flexibility Act
C. Unfunded Mandates Reform Act
D. Executive Order 13132
I. Executive Summary
A. Purpose of Regulatory Action
This final rule implements the 21st Century Cures Act (Cures Act)
provision for referral of a health care provider (individual or
entity), determined by the HHS Office of Inspector General (OIG) to
have committed information blocking, ``to the appropriate agency to be
subject to appropriate disincentives using authorities under applicable
Federal law, as the Secretary sets forth through notice and comment
rulemaking'' (section 3022(b)(2)(B) of the Public Health Service Act
(PHSA) (42 U.S.C. 300jj-52(b)(2)(B)), as added by section 4004 of the
Cures Act (Pub. L. 114-255, Dec. 13, 2016)). This final rule
establishes disincentives for certain health care providers (as defined
in 45 CFR 171.102) that are also Medicare-enrolled providers or
suppliers.
B. Summary of Major Provisions
This final rule establishes disincentives applicable to certain
health care providers (as defined in 45 CFR 171.102), determined by OIG
to have committed information blocking (as defined in 45 CFR 171.103),
that also are Medicare-enrolled providers or suppliers. This final rule
also provides information related to OIG's investigation of claims of
information blocking and referral of a health care provider to an
appropriate agency to be subject to appropriate disincentives. Finally,
this final rule establishes a process by which information will be
shared with the public about health care providers and other actors
(health IT developers or other entities offering certified health IT,
health information exchanges, and health information networks) that OIG
determines have committed information blocking.
Although this final rule does not establish disincentives for all
of the health care providers included in the 45 CFR 171.102 definition,
the health care providers to whom the disincentives finalized in this
rule apply furnish a broad array of services to a significant number of
both Medicare beneficiaries and other patients. Thus, this set of
disincentives directly advances HHS priorities for deterring
information blocking, while also advancing appropriate sharing of
electronic health information (EHI) by health care providers \1\ to
support safer, more coordinated care for all patients.
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\1\ Except if noted in reference a particular statutory
authority or CFR section, we use in this rule ``health care
provider,'' ``provider,'' and ``provider type'' as inclusive of
individuals and entities that may be characterized for purposes of
Medicare enrollment or particular reimbursement policies as
providers or suppliers--or both across different contexts such as
specific services furnished in particular settings.
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We believe it is important to establish appropriate disincentives
that account for all health care providers that fall within the
definition of health care provider at 45 CFR 171.102. While effective
deterrence of information blocking can benefit patients by reducing the
degree to which health care providers engage in this practice, fewer
patients will benefit from these deterrent effects if disincentives
have not been established for all health care providers within the
definition of health care provider at 45 CFR 171.102. In section IV of
the 21st Century Cures Act: Establishment of Disincentives for Health
Care Providers That Have Committed Information Blocking proposed rule
(Disincentives Proposed Rule), we requested information on how we could
establish disincentives for other health care providers, particularly
those health care providers not implicated under the CMS authorities
[[Page 54663]]
we proposed to use to establish disincentives in the proposed rule (88
FR 74966 and 74967).
Consistent with PHSA section 3022(b)(2)(B), in section III.C. of
this final rule, CMS has finalized the following disincentives using
authorities under applicable Federal law, as follows:
Under the authority for the Medicare Promoting
Interoperability Program in the Social Security Act (SSA), at sections
1886(b)(3)(B)(ix) and 1886(n) for eligible hospitals, and at section
1814(l)(4) for critical access hospitals (CAHs), CMS has finalized that
an eligible hospital or CAH is not a meaningful electronic health
record (EHR) user in an EHR reporting period if OIG refers, during the
calendar year of the reporting period, a determination that the
eligible hospital or CAH committed information blocking as defined at
45 CFR 171.103. As a result, an eligible hospital subject to this
disincentive will not be able to earn the three quarters of the annual
market basket increase associated with qualifying as a meaningful EHR
user, and a CAH subject to this disincentive will have its payment
reduced to 100 percent of reasonable costs, from the 101 percent of
reasonable costs it might have otherwise earned, in an applicable year.
Under the authority in SSA sections 1848(o)(2)(A) and (D)
and 1848(q)(2)(A)(iv) and (B)(iv), for the Promoting Interoperability
performance category of the Merit-based Incentive Payment System
(MIPS), CMS has finalized that a health care provider defined in 45 CFR
171.102 that is a MIPS eligible clinician (as defined in 42 CFR
414.1305 and including groups) is not a meaningful EHR user in a
performance period if OIG refers, during the calendar year of the
reporting period, a determination that the MIPS eligible clinician
committed information blocking as defined at 45 CFR 171.103. CMS also
has finalized that the determination by OIG that a MIPS eligible
clinician committed information blocking will result in the MIPS
eligible clinician, if required to report on the Promoting
Interoperability performance category of MIPS, not earning a score in
the performance category (a zero score), which is typically a quarter
of the total final composite performance score (a ``final score'' as
defined at 42 CFR 414.1305). CMS has codified this proposal under the
definition of meaningful EHR user for MIPS at 42 CFR 414.1305 and added
it to the requirements for earning a score for the MIPS Promoting
Interoperability performance category at 42 CFR 414.1375(b).
Under the authority in SSA section 1899(b)(2)(G) for the
Medicare Shared Savings Program (Shared Savings Program), CMS has
finalized that a health care provider as defined in 45 CFR 171.102 that
is an accountable care organization (ACO), ACO participant, or ACO
provider/supplier, if determined by OIG to have committed information
blocking as defined at 45 CFR 171.103, may be barred from participating
in the Shared Savings Program for at least 1 year (88 FR 74964 and
74965). In this final rule, in consideration of the comments received,
CMS has finalized incorporation of an alternative policy discussed in
the proposed rule, under which CMS will consider an OIG information
blocking determination in light of relevant facts and circumstances
before applying a disincentive under the Shared Savings Program, such
as denying the addition of an ACO participant to an ACO participant
list (or an ACO provider/supplier to the ACO provider/supplier list),
informing an ACO that remedial action should be taken against the ACO
participant (or ACO provider/supplier), denying an ACO's application to
participate in the Shared Savings Program if the remedial action is not
taken, or terminating an ACO's participation agreement with CMS. This
will result in a health care provider being removed from an ACO or
prevented from joining an ACO; and in the instance where a health care
provider is an ACO, this will prevent the ACO's participation in the
Shared Savings Program. The relevant facts and circumstances include
the nature of the health care provider's information blocking, the
health care provider's diligence in identifying and correcting the
problem, the time since the information blocking occurred, whether the
provider was previously subject to a disincentive in another program,
and other factors.
C. Costs and Benefits
Executive Order 12866 on Regulatory Planning and Review and
Executive Order 13563 on Improving Regulation and Regulatory Review
direct agencies to assess all costs and benefits of available
regulatory alternatives and, if regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety effects, distributive
impacts, and equity). Section 3(f) of Executive Order 12866, as amended
by Executive Order 14094, defines a ``significant regulatory action''
as an action that is likely to result in a rule that may: (1) have an
annual effect on the economy of $200 million or more (adjusted every 3
years by the Administrator of the Office of Information and Regulatory
Affairs (OIRA) for changes in gross domestic product), or adversely
affect in a material way the economy, a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local, territorial, or tribal governments or
communities; (2) create a serious inconsistency or otherwise interfere
with an action taken or planned by another agency; (3) materially alter
the budgetary impact of entitlements, grants, user fees, or loan
programs or the rights and obligations of recipients thereof; or (4)
raise legal or policy issues for which centralized review would
meaningfully further the President's priorities or the principles set
forth in the Executive Order, as specifically authorized in a timely
manner by the Administrator of OIRA in each case. The Office of
Management and Budget (OMB) has determined that this final rule is not
a significant regulatory action, as the potential costs associated with
this final rule would not be greater than $200 million per year, and it
does not meet any of the other requirements to be a significant
regulatory action.
D. Severability
We are clarifying and emphasizing our intent that if any provision
of this final rule is held to be invalid or unenforceable by its terms,
or as applied to any person or circumstance, or stayed pending further
action, it shall be severable from this final rule, and from rules and
regulations currently in effect, and not affect the remainder thereof
or the application of the provision to other persons not similarly
situated or to other, dissimilar circumstances. If any provision is
held to be invalid or unenforceable, the remaining provisions which
could function independently, should take effect and be given the
maximum effect permitted by law.
Through this rule, we adopt provisions that are intended to and
will operate independently of each other, even if each serves the same
general purpose or policy goal. Where a provision is necessarily
dependent on another, the context generally makes that clear (such as
by cross-reference to a particular standard, requirement, condition, or
pre-requisite). Where a provision that is dependent on one that is
stayed or held invalid or unenforceable, as described in the preceding
paragraph, is included in a subparagraph, paragraph, or section within
part 171 of 45 CFR or part 414, 425, or 495 of 42 CFR, we intend that
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other provisions of such subparagraph(s), paragraph(s), or section(s)
that operate independently of the provision stayed or held invalid or
unenforceable would remain in effect.
II. Background
A. Statutory Basis
The Cures Act was enacted on December 13, 2016, ``[t]o accelerate
the discovery, development, and delivery of 21st century cures, and for
other purposes'' (Pub. L. 114-255, December 16, 2016). Section 4004 of
the Cures Act added section 3022 to the PHSA. Section 3022(a)(1) of the
PHSA defines information blocking as a practice that, except as
required by law or specified by the Secretary pursuant to rulemaking,
is likely to interfere with, prevent, or materially discourage access,
exchange, or use of electronic health information, and: (1) if the
practice is conducted by a health information technology developer,
exchange, or network, such developer, exchange, or network knows, or
should know, that such practice is likely to interfere with, prevent,
or materially discourage the access, exchange, or use of electronic
health information; or (2) if the practice is conducted by a health
care provider, such health care provider knows that such practice is
unreasonable and is likely to interfere with, prevent, or materially
discourage access, exchange, or use of electronic health information.
Section 3022(a)(3) of the PHSA further provides that the Secretary
shall, through rulemaking, identify reasonable and necessary activities
that do not constitute information blocking. Section 3022(a)(4) of the
PHSA states that the term ``information blocking'' does not include any
practice or conduct occurring prior to the date that is 30 days after
December 13, 2016 (the date of the enactment of the Cures Act).\2\
Section 3022(a)(2) of the PHSA describes certain practices that may
constitute information blocking.
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\2\ As January 12, 2017, was the thirtieth day after December
13, 2016, conduct occurring on or after January 13, 2017, that
otherwise meets the PHSA section 3022(a) definition of ``information
blocking,'' would be included in that definition.
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Section 3022(b)(1) of the PHSA authorizes OIG to investigate
information blocking claims. Section 3022(b)(1)(B) of the PHSA
authorizes OIG to investigate claims that ``a health care provider
engaged in information blocking.'' Section 3022(b)(2)(B) of the PHSA
provides that any health care provider OIG determines to have committed
information blocking shall be referred to the appropriate agency to be
subject to appropriate disincentives using authorities under applicable
Federal law, as the Secretary sets forth through notice and comment
rulemaking. Sections 3022(b)(1)(A) and (C) of the PHSA authorize OIG to
investigate health information technology (IT) developers of certified
health IT or other entities offering certified health IT, health
information exchanges, and health information networks. Section
3022(b)(2)(A) of the PHSA authorizes the imposition of civil money
penalties (CMPs) \3\ not to exceed $1 million per violation on those
individuals and entities set forth in sections 3022(b)(1)(A) and (C) of
the PHSA.
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\3\ We use the term ``civil money penalty'' here, rather than
``civil monetary penalty'' as used in PHSA section 3022(b)(2)(A) for
consistency with OIG's usage in the OIG CMP Final Rule (88 FR
42820).
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PHSA section 3022 also authorizes ONC, the HHS Office for Civil
Rights (OCR), and OIG to consult, refer, and coordinate to resolve
claims of information blocking. PHSA section 3022(b)(3)(A) authorizes
OIG to refer claims of information blocking to OCR if OIG determines a
consultation regarding the health privacy and security rules
promulgated under section 264(c) of the Health Insurance Portability
and Accountability Act of 1996 (HIPAA) (Pub. L. 104-191, Aug. 21, 1996)
(42 U.S.C. 1320d-2 note) will resolve such claims. PHSA section
3022(d)(1) specifies that the National Coordinator may serve as a
technical consultant to OIG and the Federal Trade Commission (FTC) for
purposes of carrying out section 3022 and may share information related
to claims or investigations of information blocking with the FTC for
purposes of such investigations, in addition to requiring the National
Coordinator to share information with OIG, as required by law.
PHSA section 3022(d)(4) requires the Secretary, in carrying out
section 3022 and to the extent possible, to ensure that information
blocking penalties do not duplicate penalty structures that would
otherwise apply with respect to information blocking and the type of
individual or entity involved as of the day before the date of
enactment of the Cures Act. Section 3022(a)(7) of the PHSA states that,
in carrying out section 3022, the Secretary shall ensure that health
care providers are not penalized for the failure of developers of
health information technology or other entities offering health
information technology to such providers to ensure that such technology
meets the requirements to be certified under Title XXX of the PHSA.
We address the statutory basis for each disincentive in greater
detail in section III.C. of this final rule.
B. Regulatory History
1. ONC Cures Act Final Rule
On March 4, 2019, a proposed rule titled 21st Century Cures Act:
Interoperability, Information Blocking, and the ONC Health IT
Certification Program (ONC Cures Act Proposed Rule) appeared in the
Federal Register (84 FR 7424). The rule proposed to implement certain
provisions of the Cures Act to advance interoperability and support the
access, exchange, and use of electronic health information. The ONC
Cures Act Proposed Rule included a request for information regarding
potential disincentives for health care providers that have committed
information blocking and asked whether modifying disincentives already
available under existing Department programs and regulations would
provide for more effective deterrence (84 FR 7553).
On May 1, 2020, a final rule titled 21st Century Cures Act:
Interoperability, Information Blocking, and the ONC Health IT
Certification Program (ONC Cures Act Final Rule) appeared in the
Federal Register (85 FR 25642). The final rule identified eight
reasonable and necessary activities that do not constitute information
blocking, consistent with the requirement in PHSA section 3022(a)(3).
Such reasonable and necessary activities are often referred to as
``exceptions'' to the definition of information blocking, or
``information blocking exceptions,'' as specified in 45 CFR part 171.
The ONC Cures Act Final Rule finalized definitions that are
necessary to implement the statutory information blocking provision in
PHSA section 3022, including definitions related to the four classes of
individuals and entities covered by the statutory information blocking
provision: health care providers, health IT developers, health IT
networks, and health IT exchanges.
As the term ``health care provider'' is not explicitly defined in
section 3022 of the PHSA, as added by section 4004 of the Cures Act,
the ONC Cures Act Final Rule adopted in 45 CFR 171.102 the definition
of health care provider in section 3000(3) of the PHSA \4\ for
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purposes of the information blocking regulations in 45 CFR part 171.
The definitions listed in section 3000 of the PHSA apply ``[i]n this
title,'' which refers to Title XXX of the PHSA (85 FR 25795). Section
3022 of the PHSA is included in Title XXX.
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\4\ As defined in 42 U.S.C. 300-jj, the term ``health care
provider'' includes a hospital, skilled nursing facility, nursing
facility, home health entity or other long term care facility,
health care clinic, community mental health center (as defined in
section 300x-2(b)(1) of this title), renal dialysis facility, blood
center, ambulatory surgical center described in section 1395l(i) of
this title, emergency medical services provider, Federally qualified
health center, group practice, a pharmacist, a pharmacy, a
laboratory, a physician (as defined in section 1395x(r) of the
title), a practitioner (as described in section 1395u(b)(18)(C) of
the title), a provider operated by, or under contract with, the
Indian Health Service or by an Indian tribe (as defined in the
Indian Self-Determination and Education Assistance Act [25 U.S.C.
5301 et seq.]), tribal organization, or urban Indian organization
(as defined in section 1603 of title 5), a rural health clinic, a
covered entity under section 256b of this title, an ambulatory
surgical center described in section 1395l(i) of this title, a
therapist (as defined in section 1395w-4(k)(3)(B)(iii) of the
title), and any other category of health care facility, entity,
practitioner, or clinician determined appropriate by the Secretary.
See also this guidance document: https://www.healthit.gov/sites/default/files/page2/2020-08/Health_Care_Provider_Definitions_v3.pdf.
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The ONC Cures Act Final Rule also established in 45 CFR 171.102
regulatory definitions for ``health information network or health
information exchange'' and ``health IT developer of certified health
IT,'' \5\ among other terms.\6\ The preamble text of the ONC Cures Act
Final Rule makes clear that an individual or entity could meet both the
definition of a health care provider and the definition of a health IT
developer of certified health IT (85 FR 25798 and 25799), or could meet
both the definition of a health care provider and a health information
exchange or network (85 FR 25801). We mention these potential scenarios
so that health care providers are aware that they would not necessarily
only be subject to the disincentives finalized in this rule, but
depending on the specific facts and circumstances, they could meet the
definition of a health information network, health information
exchange, or health IT developer of certified health IT--and therefore
be subject to civil money penalties, if found by OIG to have committed
information blocking.
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\5\ In the ONC Cures Act Final Rule, ONC defined the term
``health IT developer of certified health IT'' in 45 CFR 171.102,
instead of using the term that appears in PHSA 3022(a)(1): ``health
IT developer.'' ONC explained that, because title XXX of the PHSA
does not define ``health information technology developer,'' ONC
interpreted section 3022(a)(1)(B) in light of the specific authority
provided to OIG in section 3022(b)(1)(A) and (b)(2). ONC noted that
section 3022(b)(2) discusses developers, networks, and exchanges by
referencing any individual or entity described in section
3022(b)(1)(A) or (C). Section 3022(b)(1)(A) states, in relevant
part, that OIG may investigate any claim that a health information
technology developer of certified health information technology or
other entity offering certified health information technology
engaged in information blocking (85 FR 25795, emphasis added).
\6\ In January 2024, ONC finalized a definition of what it means
to ``offer health IT,'' and finalized a corresponding update to the
``health IT developer of certified health IT'' definition. These
policies are part of a final rule titled Health Data, Technology,
and Interoperability: Certification Program Updates, Algorithm
Transparency, and Information Sharing (89 FR 1354 through 1358)
(HTI-1 Final Rule).
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On November 4, 2020, an interim final rule with comment period
titled Information Blocking and the ONC Health IT Certification
Program: Extension of Compliance Dates and Timeframes in Response to
the COVID-19 Public Health Emergency (ONC Cures Act Interim Final Rule)
appeared in the Federal Register (85 FR 70064). The ONC Cures Act
Interim Final Rule extended certain compliance dates and timeframes
adopted in the ONC Cures Act Final Rule to offer the healthcare system
additional flexibilities in furnishing services to combat the COVID-19
pandemic, including extending the applicability date for the
information blocking provisions to April 5, 2021 (85 FR 70068). The ONC
Cures Act Interim Final Rule also extended from May 2, 2022, to October
6, 2022, the date on which electronic health information as defined in
45 CFR 171.102 for purposes of the information blocking definition in
45 CFR 171.103 would no longer be limited to the subset of EHI that is
identified by data elements represented in the United States Core Data
for Interoperability (USCDI) standard adopted in 45 CFR 170.213 (85 FR
70069).\7\ On and after October 6, 2022, practices likely to interfere
with access, exchange, or use of any information falling within the
definition of EHI in 45 CFR 171.102 may constitute information blocking
as defined in 45 CFR 171.103.
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\7\ For more information about the USCDI, see: https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi.
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2. Office of Inspector General (OIG) Civil Money Penalties (CMP) Final
Rule
On April 24, 2020, a proposed rule titled Grants, Contracts, and
Other Agreements: Fraud and Abuse; Information Blocking; Revisions to
the Office of Inspector General's Civil Money Penalty Rules (OIG CMP
Proposed Rule) appeared in the Federal Register (85 FR 22979). The OIG
CMP Proposed Rule set forth proposed regulations to incorporate new CMP
authority for information blocking and related procedures in PHSA
section 3022 (85 FR 22982). Specific to information blocking, OIG also
provided information on--but did not propose regulations for--expected
enforcement priorities, the investigation process, and OIG's experience
with investigating conduct that includes an intent element (85 FR
22984).
A final rule titled Grants, Contracts, and Other Agreements: Fraud
and Abuse; Information Blocking; Office of Inspector General's Civil
Money Penalty Rules appeared in the Federal Register on July 3, 2023
(OIG CMP Final Rule) (88 FR 42820). This rulemaking addressed
imposition of CMPs for information blocking by health IT developers or
other entities offering certified health IT, and health information
exchanges and health information networks (HIEs/HINs). The OIG CMP
Final Rule did not establish appropriate disincentives for health care
providers that OIG has determined to have committed information
blocking.
In the OIG CMP Final Rule, OIG stated that a health care provider
that also meets the definition of a health IT developer of certified
health IT, or HIE/HIN, or both, under 45 CFR 171.102, may be subject to
information blocking CMPs (88 FR 42829). OIG further stated that as
part of its assessment of whether a health care provider is a HIN/HIE
that could be subject to CMPs for information blocking, OIG anticipates
engaging with the health care provider to better understand its
functions and to offer the health care provider an opportunity to
explain why it is not a HIN/HIE (88 FR 42828).
3. Establishment of Disincentives for Health Care Providers That Have
Committed Information Blocking Proposed Rule
On November 1, 2023, a proposed rule titled 21st Century Cures Act:
Establishment of Disincentives for Health Care Providers That Have
Committed Information Blocking appeared in the Federal Register (88 FR
74947) (Disincentives Proposed Rule). The Disincentives Proposed Rule
proposed to establish a set of appropriate disincentives for
information blocking by health care providers using authorities under
applicable Federal law, consistent with PHSA section 3022(b)(2)(B). The
Disincentives Proposed Rule also proposed to define certain statutory
terms and proposed to establish elements of a process for the
imposition of appropriate disincentives by an appropriate agency. The
Disincentives Proposed Rule further proposed to publicly post
information on ONC's website about health care providers that have been
determined by OIG to have committed information blocking and
subsequently referred by OIG to an appropriate agency to be subject to
appropriate disincentives, as well about health IT developers of
certified health
[[Page 54666]]
IT and HIEs/HINs and that have been determined by OIG to have committed
information blocking. Finally, the Disincentives Proposed Rule
requested public comment on establishing disincentives for other health
care providers included in the definition of health care provider in 45
CFR 171.102 that are subject to the information blocking regulations,
but were not implicated by the disincentives proposed in the
Disincentives Proposed Rule.
C. General Comments on the Disincentives Proposed Rule
We received a number of general comments on the Disincentives
Proposed Rule. A discussion of those comments and responses can be
found below.
Comments. Several commenters expressed general support for the
proposed disincentives for health care providers who have been found to
have committed information blocking. A few commenters stated that the
disincentives will lead to better patient outcomes, improved
information sharing, increased transparency, a reduction in systemic
inefficiency and waste, and improved accountability and compliance. A
few commenters expressed general support for the establishment of the
disincentives proposed because the disincentives are necessary and
appropriate and would discourage information blocking by health care
providers. Commenters also asserted that the proposed disincentives
would encourage data exchange and enhance interoperability.
Response. We thank the commenters for their support.
Comments. Many commenters recommended that HHS delay implementation
or enforcement of information blocking disincentives against health
care providers. Commenters recommended this delay in order for HHS to
provide education regarding issues such as: what constitutes
information blocking; the investigation process; the application of
disincentives; and information about exceptions. Commenters stated that
a delay was warranted because the information blocking regulations,
including the disincentives discussed in this final rule, are new and
complicated, requirements change frequently, and health care providers
need time to implement information sharing processes and identify best
practices. Commenter recommendations for how long to delay enforcement
following the publication of the final rule ranged from 1 to 2 years.
Response. We disagree with commenters that further delay in
establishing disincentives for health care providers that commit
information blocking is necessary. We note that the information
blocking regulations in the ONC Cures Act Final Rule went into effect
April 5, 2021 (85 FR 70068), and several years will have already passed
between the date when these regulations went into effect for health
care providers and the effective date of this final rule. In addition,
the disincentives CMS has finalized in this final rule are established
under authorities for existing programs with which health care
providers are already familiar. Thus, we do not believe it is necessary
to further delay establishment of disincentives. We refer readers to
section III.C. of this final rule, in which CMS describes how each of
the disincentives it has finalized will be effective upon the effective
date of this final rule.
We also note that section III.B.1. of this final rule states that
OIG will not begin investigating possible information blocking
committed by health care providers until after the effective date of
this rule, and that OIG will exercise its enforcement discretion not to
make any determinations regarding conduct occurring prior to the
effective date of this rule for information blocking disincentives. As
OIG will not make a determination on conduct occurring prior to the
effective date, OIG will not refer any health care providers based on a
determination of conduct occurring prior to the effective date of this
rule for information blocking disincentives. This means that no
disincentives finalized in this final rule will be applied to conduct
occurring before the effective date of this final rule.
We appreciate the recommendations regarding offering educational
opportunities that would be helpful to health care providers and will
consider these recommendations.
Comments. A few commenters requested that HHS set a maximum period
from the date the alleged information blocking complaint was referred,
after which HHS would not impose any disincentives, such as a 6-year
period to align with the time period for imposing CMPs for other
actors. Some commenters expressed concern that the proposed process for
investigating claims of information blocking and referring findings to
appropriate agencies for disincentives could cause a long delay between
the information blocking complaint being filed and the application of a
disincentive.
Response. For the disincentives finalized in section III.C. of this
final rule, CMS did not propose and has not finalized a maximum period
from the date the alleged information blocking complaint was referred,
after which CMS would not impose the disincentives it has finalized.
Because the authorities used to establish disincentives may include
requirements related to timing around the imposition of disincentives,
we believe it is more appropriate to allow appropriate agencies to
establish any such limits instead of setting a uniform limit for any
disincentive established to deter information blocking by health care
providers. We note that for the disincentive policy finalized under the
Shared Savings Program in section III.C.4., CMS will consider relevant
facts and circumstances before imposing a disincentive under the Shared
Savings Program, and CMS has stated that one of the relevant factors
CMS will consider is the time elapsed since a referral of information
blocking has taken place. For the disincentives finalized for the
Medicare Promoting Interoperability Program and the MIPS Promoting
Interoperability performance category in sections III.C.2. and
III.C.3., respectively, CMS has stated that it will impose the
applicable disincentive in the EHR reporting period or performance
period of the calendar year that a referral of a determination of
information blocking is received from OIG. We further recognize that
there may be a delay between the initial submission of an information
blocking claim and the eventual application of a disincentive if OIG
determines that the practices identified in the claim were information
blocking and refers the determination to an appropriate agency.
However, we are unable to estimate the time necessary to complete
investigations of these practices.
As commenters mentioned, section 3022(b)(2)(C) of the PHSA, which
applies to actors subject to the information blocking regulations that
are not health care providers (health IT developers or other entities
offering certified health IT, and HINs/HIEs), requires the imposition
of CMPs to follow the procedures set forth in section 1128A of the
Social Security Act (SSA). Section 1128A(c)(1) requires that an action
for CMPs must be initiated within 6 years from the date of the
occurrence. In the OIG CMP Final Rule, OIG stated that this would be 6
years from the date of the violation (88 FR 42826).
Comments. A few commenters recommended the creation of a
centralized HHS coordinating entity to
[[Page 54667]]
implement and oversee information blocking disincentives, provide a
main point of contact for health care providers to learn about the
process and resolve discrepancies, ensure coordination among agencies,
and minimize confusion and potential errors that could cause burden for
providers. One commenter stated that supplemental rulemaking would be
needed to create this centralized HHS coordinating entity and that HHS
should engage in this supplemental rulemaking before finalizing the
Disincentives Proposed Rule. A few commenters specifically suggested
the creation of a clearinghouse process to ensure disincentives applied
are not duplicative, arbitrary, and unduly punitive.
Response. We appreciate this recommendation. While we did not
propose to create an entity as recommended by the commenters, we may
consider this recommendation in future rulemaking. However, we do not
believe that establishing such an entity is necessary to finalize the
policies in this final rule, as many of these issues are addressed
through existing policies. For instance, regarding coordination between
agencies, we refer readers to the discussion in section III.B.1.b. of
this final rule where we discuss the ways ONC, OCR, and OIG will
consult, refer, and coordinate on information blocking claims as
permitted by the Cures Act (see also, 88 FR 42823 and 42824). We also
refer readers to the information provided about OIG's investigation
process in section III.B.1. of this final rule, which includes a
discussion of how OIG may engage with health care providers as part of
its investigation, as necessary, to understand specific facts and
circumstances related to an information blocking claim. The commenters
did not provide further information about how such an entity would
address issues related to ensuring disincentives are not duplicative,
arbitrary, and unduly punitive.
Comments. A few commenters recommended that ONC allow for
`complaint clearinghouses,' where health care providers or payers can
send their complaints alleging information blocking violations to an
independent, private sector third party who would aggregate those
complaints over time and submit them as a group to HHS to ensure
complaints are unattributed to specific complainants. Commenters
suggested this approach could mitigate concerns over retaliation,
retribution, or harm to business relationships associated with alleging
information blocking violations. A few commenters also recommended ONC,
OIG, and CMS be more transparent in providing specifics to the public
on how complaints will be handled to ensure interested parties have
transparency in knowing the status of their complaints, and when a
final decision can be expected.
Response. We thank commenters for their suggestions. As authorized
under PHSA section 3022(d)(3)(A), ONC has already established a ``a
standardized process for the public to submit reports on claims''
related to information blocking. We refer readers to the discussion of
the complaint process in the ONC Cures Act Final Rule (85 FR 25899 and
25900), as well as the Information Blocking Portal on ONC's website for
more information.\8\ Regarding commenters' concerns around harm
resulting from attribution of complaints to specific organizations, we
note that PHSA section 3022(d)(2) prohibits the National Coordinator
from disclosing ``[a]ny information that is received by the National
Coordinator in connection with a claim or suggestion of possible
information blocking and that could reasonably be expected to
facilitate identification of the source of the information'' except as
may be necessary to carry out the purpose of PHSA section 3022 (PHSA
section 3022(d)(2)(A)). As stated in the ONC Cures Act Final Rule, we
believe the publishing of complaints could lead to the identification
of the source of the information or reasonably facilitate
identification of the source; therefore, we do not intend to make
complaints publicly available (85 FR 25900). While the complaint
process is not required by statute to be established through
rulemaking, we will take commenters' input into consideration as we
continue to receive complaints related to information blocking.
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\8\ For more information, see: https://inquiry.healthit.gov/support/plugins/servlet/desk/portal/6.
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Comments. Commenters stated that health care providers are still
unclear about what practices are prohibited under the information
blocking regulations. Commenters also recommended that supplemental
rulemaking or sub-regulatory guidance be provided on certain topics
prior to implementation or enforcement of health care provider
information blocking disincentives, including: further describing
investigative processes and the application of disincentives; the
establishment of an appeals process; and describing how the
disincentives implemented under this final rule interact with existing
quality reporting program rules.
Response. We appreciate commenters' concerns and recognize that
many health care providers are still gaining awareness and
understanding of the information blocking regulations. We encourage
health care providers to review the resources available on ONC's
website to learn more about practices that may be information
blocking.\9\
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\9\ For more information, see: https://www.healthit.gov/faqs.
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We appreciate commenters' recommendations for topics HHS should
consider addressing through notice and comment rulemaking. However, we
note this final rule addresses many of these issues, including: the OIG
investigative process (section III.B.1.), application of disincentives
(section III.B.2.), and appeals processes (section III.B.2.). The
discussion of the disincentives finalized in sections III.C.2. through
III.C.4. does not identify any interactions with quality reporting
program rules. Quality reporting programs are entirely separate
authorities from those under which we proposed appropriate
disincentives (which we have finalized in section III.C. of this rule);
therefore, we are unclear what commenters' concerns are with respect to
information blocking disincentives and quality reporting programs.
The discussion of these issues provides additional information
regarding the policies we have finalized in this rule and further
notice and comment rulemaking on these topics is not necessary before
finalizing these policies, due to the completeness of the policies
described in this final rule.
Comments. A few commenters recommended that before implementing
health care provider information blocking disincentives the agencies
should work to advance EHR adoption and interoperability. Commenters
recommended that HHS further define and clarify interoperability
standards, and recognize that not all health care providers utilize
EHRs.
Response. We do not agree that the need for further advances with
respect to EHR adoption and interoperability should delay establishing
the disincentives for health care providers that have been found to
commit information blocking that we finalize in this rule. While we
recognize that additional progress can be made to improve
interoperability and advance adoption of EHRs, many health care
providers are using electronic health information today and could
engage in practices that are considered information blocking under PHSA
section 3022. Therefore, it is important
[[Page 54668]]
that appropriate disincentives exist to deter information blocking by
those health care providers that are currently using electronic health
information. We note that HHS has pursued activities to advance
interoperability in EHRs and other health IT systems through a variety
of initiatives, including the ONC Health IT Certification Program. For
more information about initiatives to advance interoperability, we
refer readers to resources on ONC's website.\10\
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\10\ For more information, see: https://www.healthit.gov/topic/interoperability.
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Comments. Several commenters provided recommendations about
specific scenarios that should not be considered information blocking,
including: a delay in the release of sensitive and distressing health
information and test results, such as for severe or complex diagnoses,
to allow for provider review; a delay in the release of information in
the interest of patient safety; a delay in the release of information
if a patient states that they will harm themselves if they receive a
diagnosis from their provider; or instances where a provider attempts
in good faith to comply with an exception or not engage in information
blocking.
Response. We thank commenters for their recommendations regarding
information blocking exceptions, however, we did not propose any
exceptions to information blocking in the Disincentives Proposed Rule
and these issues are out of scope for this final rule. In the ONC Cures
Act Final Rule (85 FR 25820), ONC established exceptions to information
blocking consistent with PHSA section 3022(a)(3), and subsequently made
revisions to these exceptions in the HTI-1 Final Rule (89 FR 1373). We
invite readers to review the information blocking exceptions to better
understand how various scenarios may be addressed by these
exceptions.\11\ We may also consider this input for future rulemaking
related to exceptions to information blocking.
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\11\ For more information on exceptions to information blocking,
see ONC's website: https://www.healthit.gov/topic/information-blocking.
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Comments. A few commenters recommended delaying the implementation
or enforcement of provider information blocking disincentives until
issues related to reproductive health data and privacy are resolved. A
few commenters expressed concern that the proposals described in
section III.C. of the Disincentives Proposed Rule could negatively
impact patient-provider relationships, risk patient and provider
criminalization, and lead to patients delaying seeking healthcare due
to reproductive health data and privacy issues. A few commenters
recommended considering the context of the healthcare landscape
following the overturning of the Federal constitutional right to an
abortion and subsequent legislation in certain states to criminalize
people who seek reproductive health care before finalizing the
proposals in section III.C. of the Disincentives Proposed Rule.
Commenters expressed concern that because of the financial impact the
proposed appropriate disincentives may carry, health care providers may
disclose sensitive health information, including reproductive health
information, to the detriment of people seeking reproductive care.
Commenters similarly expressed concern that the Disincentives Proposed
Rule could result in the disclosure of other forms of sensitive health
information, including information related to contraceptive access, in
vitro fertilization (IVF), gender-affirming healthcare, sexually
transmitted infections (STIs), intimate partner violence, and sexual
assault. A few commenters recommended providers be exempt from
information blocking requirements if they do not disclose patient
information to protect patient privacy related to sexual and
reproductive health and to protect the patient or themselves from
criminalization or harassment. The commenter also recommended that a
new ``good faith'' exception to information blocking should be
established under which providers acting in ``good faith'' to withhold
sensitive health information are presumed to be acting reasonably and
in the best interest of their patients. One commenter recommended that
implementation of disincentives should not occur until EHRs can ensure
sensitive health data can be protected, clear concise exceptions are
created, and consent management software is widely available.
Commenters stated that EHR vendors cannot currently meet data
segmentation standards for sensitive health information, such as
reproductive healthcare data. One commenter recommended delaying
implementation for 2 years to allow providers to comply with the
anticipated ``HIPAA Privacy Rule to Support Reproductive Health Care
Privacy'' final rule \12\ and ONC's ``Health Data, Technology, and
Interoperability: Certification Program Updates, Algorithm
Transparency, and Information Sharing'' proposed rule (88 FR
23746).\13\
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\12\ Subsequent to receiving this comment, the HIPAA Privacy
Rule To Support Reproductive Health Care Privacy final rule (89 FR
32976) appeared in the Federal Register on April 26, 2024.
\13\ The Health Data, Technology, and Interoperability:
Certification Program Updates, Algorithm Transparency, and
Information Sharing final rule (89 FR 1192) appeared in the Federal
Register on January 9, 2024.
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Response. We acknowledge the concerns commenters may have regarding
the sensitivity of health data relating to reproductive health care and
will take these comments under consideration. We further acknowledge
commenters' concerns that disincentives could lead to health care
providers disclosing sensitive health information, including
reproductive health information, and welcome commenters'
recommendations regarding an exception to information blocking when a
health care provider withholds sensitive information to protect the
patient or themselves from criminalization or harassment. However, we
did not propose exceptions to information blocking in the Disincentives
Proposed Rule and believe that such policies are out of scope for this
final rule. Instead, we will take these comments under consideration
for other rulemaking activities in which we focus on revising and
expanding the exceptions to information blocking.
Section 4004 of the Cures Act, which added section 3022 to the
PHSA, does not amend existing laws governing the confidentiality,
privacy, and security of health information, such as HIPAA, its
implementing regulations at 45 CFR parts 160, and 164, or other
applicable Federal or state laws or regulations. Health care providers
are responsible for ensuring their compliance with applicable laws and
regulations governing confidentiality, privacy, and security of their
patients' health information.
Regarding commenters' statement that implementation of
disincentives should not occur until improvements to technical
approaches to data segmentation are achieved, we agree that this is an
important area for advancement. However, we believe that this work can
continue in parallel with the finalization of this rule and
establishment of information blocking disincentives for health care
providers.
Finally, we acknowledge that health care providers are also focused
on meeting other regulatory provisions. However, we reiterate that the
information blocking regulations in 45 CFR part 171 have been effective
since April 5, 2021, and that this final rule is focused on
establishing disincentives for practices that are inconsistent with
[[Page 54669]]
the existing regulations defining information blocking. It does not
create new affirmative obligations for health care providers.
Comments. One commenter expressed concerns that the changes to the
information blocking regulations have occurred too frequently, thereby
creating burden and confusion for health care providers. One commenter
expressed concern about the impact this new proposed disincentive
structure will have on health care providers, given that they are also
navigating other requirements related to EHI, such as surprise billing,
electronic prescription, and electronic clinical quality measures. The
commenter recommended that CMS remain cognizant of the many regulations
that govern the flow of EHI and the differences in health IT use
between provider types and sites of service.
Response. We appreciate commenters' concerns. We understand that
health care providers are continuing to gain experience and
understanding of the information blocking regulations, and that health
care providers have numerous compliance obligations with respect to
Federal laws and regulations. We will continue to collaborate closely
within the Department to consider other requirements that impact health
care providers and seek to reduce burden.
Comments. One commenter requested we provide lessons learned from
cases of information blocking on the website to help educate actors on
what does and does not qualify as information blocking. One commenter
recommended a nation-wide marketing campaign to educate patients about
information blocking practices and promote awareness of the information
blocking website.
Response. We appreciate the commenters' recommendations and will
take them into consideration as we develop educational materials in the
future. We note that there are resources available on ONC's website
\14\ about information blocking, which can help health care providers
learn about what practices constitute information blocking and how
health care providers can avoid these practices.
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\14\ For more information, see: https://www.healthit.gov/topic/information-blocking.
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III. Provisions of the Regulation and Anticipated Approach to
Investigations and Referrals
A. Relevant Statutory Terms and Provisions
In this section, we discuss certain statutory terms and provisions
in PHSA sections 3022(a) and (b) related to the establishment of
appropriate disincentives for health care providers as defined in 45
CFR 171.102. For brevity, we refer to PHSA section 3022(b)(2)(B), which
states that health care providers that OIG has determined to have
committed information blocking ``shall be referred to the appropriate
agency to be subject to appropriate disincentives using authorities
under applicable Federal law, as the Secretary sets forth through
notice and comment rulemaking,'' as the ``disincentives provision''
throughout this section.
1. Appropriate Agency
The disincentives provision states that an individual or entity
that is a health care provider determined by OIG to have committed
information blocking shall be referred to the ``appropriate agency'' to
be subject to appropriate disincentives. In the Disincentives Proposed
Rule, we proposed to define ``appropriate agency'' in 45 CFR 171.102 to
mean a government agency that has established disincentives for health
care providers that OIG determines have committed information blocking
(88 FR 74951). An ``agency'' may be any component of HHS that has
established a disincentive or disincentives on behalf of the Secretary
of HHS, including any of the Staff or Operating Divisions of HHS. For
example, the disincentives finalized in section III.C. of this final
rule are established using authorities held by CMS, which is an
Operating Division of HHS. Under the disincentives finalized in this
final rule, CMS is the ``appropriate agency'' to which OIG will refer a
health care provider to be subject to disincentives.
We invited public comments on our proposed definition of
``appropriate agency.'' The following is a summary of the comments we
received and our responses.
Comments. One commenter agreed that CMS would be the appropriate
agency for OIG referrals for enforcement because of the large
percentage of health care providers participating in the programs
discussed in section III.C. of the Disincentives Proposed Rule and the
fact that CMS administers those programs.
Response. We thank the commenter for their support. We wish to
clarify that an appropriate agency could include any of the Staff or
Operating Divisions of HHS. However, all of the disincentives finalized
in this rule were established using authorities for programs
administered by CMS.
Comments. One commenter contended that the proposed definition of
``appropriate agency'' is very broad and requested that the specific
agencies that may receive a referral and assess provider disincentives
be clarified and listed in the rule.
Response. We appreciate the comment but decline to change the
definition of ``appropriate agency'' to list all of the specific
agencies that may receive a referral and impose disincentives. We note
that, as of the effective date of this final rule, the only agency that
has established disincentives for health care providers is CMS. While
other disincentives could be established under other agencies through
future notice and comment rulemaking, we cannot preemptively identify
the agencies that may establish disincentives at this time. Therefore,
we believe maintaining the broad definition of appropriate agency is
appropriate as it allows for the potential addition of disincentives
established under other agencies in the future.
After consideration of the public comments, we have finalized our
definition of ``appropriate agency'' in 45 CFR 171.102 as proposed to
mean a government agency that has established disincentives for health
care providers that OIG determines have committed information blocking.
2. Authorities Under Applicable Federal Law
In the Disincentives Proposed Rule we proposed to interpret the
phrase ``authorities under applicable Federal law'' in the
disincentives provision to mean that an appropriate agency may only
subject a health care provider to a disincentive established using
authorities that could apply to information blocking by a health care
provider subject to the authority, such as health care providers
participating in a program supported by the authority (88 FR 74951). In
section III.C. of this final rule, CMS identifies the authority under
which each disincentive has been finalized.
The following is a summary of the comments we received and our
responses.
Comments. One commenter expressed concern that the proposed
interpretation of ``authorities under applicable Federal law'' limits
the agency's ability to put in place an effective and fair enforcement
structure for information blocking by limiting the applicable authority
only to those with already existing penalty structures that exist to
serve other policy goals. The commenter recommended that HHS revisit
its interpretation of ``authorities under applicable Federal law'' to
allow appropriate agencies to promulgate specific disincentives for
information blocking conduct that: permit
[[Page 54670]]
consideration of mitigation and aggravating factors; allow for a
broader range of disincentives (including technical assistance and
corrective action plans); and preserve a health care provider's due
process rights.
Response. We appreciate the commenter's recommendations. However,
we note that PHSA section 3022(b)(2)(B) specifies that disincentives
must be established ``using authorities under applicable Federal law.''
As a result, disincentives established by an appropriate agency must be
consistent with the authority under which the appropriate agency
establishes the disincentive through notice and comment rulemaking.
Furthermore, under the definition of ``disincentive'' that we have
finalized in 45 CFR 171.102, a disincentive is imposed for the purposes
of deterring information blocking. By finalizing this definition, we
intend to limit disincentives to only include the conditions
established by an appropriate agency that are intended to have a
deterrent effect on information blocking practices. The disincentives
provision in PHSA section 3022(b)(2)(B) and the definition of
disincentive that we have finalized in 45 CFR 171.102 do not limit an
appropriate agency from proposing, via notice and comment rulemaking,
to establish other programmatic elements mentioned by the commenters,
if such elements are within the scope of the appropriate agency's
authority.
Comments. One commenter stated that the interpretation of
``authorities under applicable Federal law'' described in the
Disincentives Proposed Rule limits HHS to promulgating disincentives
that are duplicative of existing penalty structures that might
otherwise apply to information blocking conduct committed by certain
health care providers. The commenter stated that this may conflict with
the statutory requirement in PHSA section 3022(d)(4). The commenter
stated that Congress' intent with the provision in PHSA section
3022(d)(4) was that HHS, in establishing disincentives, should take all
measures possible to not use existing authorities that could apply to
information blocking by a health care provider. The commenter further
stated that existing authorities under which we proposed to establish
disincentives in the Disincentives Proposed Rule, such as the Medicare
Promoting Interoperability Program as well as the Medicare Shared
Savings Program, exist to serve other policy goals and regulatory
requirements, and disincentives established under these authorities
should not qualify as an appropriate enforcement structure to target
information blocking specifically.
Response. We disagree that the disincentives CMS has finalized in
this final rule conflict with the statutory provision in PHSA section
3022(d)(4). Section 3022(d)(4) of the PHSA requires the Secretary, in
carrying out section 3022 and to the extent possible, to ensure that
information blocking penalties do not duplicate penalty structures that
would otherwise apply with respect to information blocking and the type
of individual or entity involved as of the day before the date of
enactment of the Cures Act. However, the disincentives that CMS has
finalized in section III.C. of this final rule create new policies to
deter information blocking that are based on a referral of a
determination by OIG that a health care provider has committed
information blocking as defined in PHSA section 3022(a).
After consideration of the public comments, we continue to view the
disincentives provision in PHSA section 3022(b)(2)(B) to require that
an appropriate agency may only subject a health care provider to a
disincentive established using authorities that could apply to
information blocking by a health care provider subject to the
authority, such as health care providers participating in a program
supported by the authority.
3. Appropriate Disincentives
We stated in the Disincentives Proposed Rule that the Cures Act
does not specify or provide illustrations for the types of
disincentives that should be established (88 FR 74951). As such, we
proposed to define the term ``disincentive'' in 45 CFR 171.102 to mean
a condition specified in 45 CFR 171.1001(a) that may be imposed by an
appropriate agency on a health care provider that OIG determines has
committed information blocking for the purpose of deterring information
blocking practices. In section III.B.2. of the Disincentives Proposed
Rule, we proposed to identify in 45 CFR 171.1001(a) those disincentives
that have been established pursuant to the statute for the express
purpose of deterring information blocking practices (88 FR 74952 and
74953).
We also noted that the term ``appropriate'' for disincentives is
likewise not defined in PHSA section 3022, nor are illustrations
provided. In the Disincentives Proposed Rule, we stated that a
disincentive for a health care provider that OIG has determined to have
committed information blocking may be any condition, established
through notice and comment rulemaking, that would, in our estimation,
deter information blocking practices among health care providers
subject to the information blocking regulations (88 FR 74951). In
section III.C. of the Disincentives Proposed Rule, CMS described the
potential impact that each proposed disincentive would have on a health
care provider (88 FR 74954 through 74966).
Finally, in the Disincentives Proposed Rule we noted that the
disincentives provision does not limit the number of disincentives that
an appropriate agency can impose on a health care provider (88 FR
74951). Accordingly, we proposed that a health care provider would be
subject to each appropriate disincentive that an agency has established
through notice and comment rulemaking and is applicable to the health
care provider. We stated that imposing cumulative disincentives, where
applicable, would further deter health care providers from engaging in
information blocking.
We invited public comments on our proposals to establish
disincentives in section III.C. of the Disincentives Proposed Rule (88
FR 74954 through 74966). The following is a summary of the comments we
received and our responses on the definition of the term
``disincentive'' and related proposals.
Comments. One commenter agreed that a health care provider should
be subject to appropriate and applicable disincentives established
through notice and comment rulemaking. Some commenters agreed that
subjecting health care providers to cumulative disincentives, where
applicable, may deter providers from engaging in information blocking.
Response. We thank the commenters for their support.
Comments. A few commenters expressed concern that the proposed
definition of ``appropriate disincentives'' is too broad and unclear.
The commenters requested that ONC narrow its definition of
``appropriate disincentives'' so that it is reflective of the
underlying statute's requirement that disincentives be appropriate.
Another commenter expressed concern that the definition does not impose
limits on what may be deemed ``appropriate,'' therefore any
disincentive proposed by an appropriate agency could theoretically meet
this broad standard. Commenters expressed that a disincentive structure
that does not consider the severity of the underlying misconduct cannot
be considered ``appropriate.''
Response. We thank the commenters for their input. We note that we
did not propose to define the term ``appropriate
[[Page 54671]]
disincentives.'' Instead, we proposed to define the term
``disincentive,'' to mean a condition specified in Sec. 171.1001(a)
that may be imposed by an appropriate agency on a health care provider
that OIG determines has committed information blocking for the purpose
of deterring information blocking practices (88 FR 74951). We have
finalized this proposed definition at 45 CFR 171.102 with a
modification to replace the phrase ``may be imposed'' with ``is
imposed'' to clarify that a disincentive is the completed action by an
appropriate agency to impose a condition on a health care provider that
OIG determines has committed information blocking.
Regarding commenter concerns that we did not propose to impose
limits on what may be deemed ``appropriate,'' and that a disincentive
which does not consider the severity of the underlying misconduct
should not be deemed ``appropriate,'' we reiterate that the term
``appropriate'' is not defined in PHSA section 3022, nor are
illustrations provided. We believe that term ``appropriate'' is
capacious and is best read to give the Secretary significant discretion
to craft disincentives using existing authorities. As we noted in the
Disincentives Proposed Rule, the key feature of appropriate
disincentives is that the agency believes that they will deter
information blocking (88 FR 74951). We have carefully considered each
disincentive we have finalized for appropriateness, as it relates to
deterring information blocking; in section III.C.2.-III.C.4., CMS
describes the potential impact of each proposed disincentive on a
health care provider which would result in deterring information
blocking practices.
However, we believe the disincentives finalized in section III.C.
also align with the use of the term ``appropriate'' in PHSA section
3022 by including certain limits on the impact of each disincentive.
For instance, under the Medicare Promoting Interoperability Program and
the MIPS Promoting Interoperability performance category, CMS has
finalized disincentives that affect otherwise applicable payment
adjustments based on a health care provider failing to meet the
requirements of each program by committing information blocking. In
sections III.C.2.c. and III.C.3.c., CMS has finalized that the
disincentive under each program would only be applied for the EHR
reporting period or performance period of the calendar year in which
OIG refers a determination of information blocking to CMS. Barring a
subsequent referral of a determination of information blocking, the
health care provider would be eligible to successfully meet the
program's requirements in the following calendar year's EHR reporting
period or performance period. As discussed in section III.C.4., the
disincentive finalized under the Medicare Shared Savings Program to
deter information blocking through potential denial of approval to
participate in or removal from the Shared Savings Program, limits the
duration of the disincentive to a year to ensure that health care
providers who have committed information blocking and corrected their
actions are not permanently barred from participating in the Shared
Savings Program. By balancing deterrent impact with these limits, CMS
has finalized disincentives consistent with the general direction in
PHSA section 3022 to establish disincentives that are ``appropriate.''
We disagree with the commenter that a disincentive that cannot be
adjusted to reflect the severity of the underlying misconduct cannot be
considered ``appropriate.'' To be sure, the agency imposing an
appropriate disincentive on a health care provider may not have the
flexibility to determine the value of the disincentive for each
individual or entity based on their conduct, as authorized for
developers, networks, and exchanges that engage in information blocking
under PHSA section 3022(b)(2)(A) (through CMPs). But lingering
inflexibility is a function of the statute's authorization only to use
``existing authorities'' to subject health care providers to
disincentives rather than CMPs.
Finally, we did not propose to define disincentive in the manner
commenters have suggested in order to preserve flexibility for agencies
to establish disincentives for information blocking. Since
disincentives must be established using authorities under applicable
Federal law (in accordance with PHSA section 3022(b)(2)(B)), there may
be a limited set of statutory provisions that could be used to
establish disincentives. Thus, we proposed and have finalized a
definition of disincentive that would not unduly limit our ability to
use available authorities to establish disincentives and have not
proposed to further limit disincentives through proposing a definition
for the term ``appropriate.''
Comments. One commenter recommended that ONC revise its proposed
definition of ``appropriate disincentives'' to explicitly incorporate
technical assistance or a corrective action plan. The commenter further
contended that this adjustment would be more consistent with HHS'
enforcement of other regulations, such as the HIPAA Privacy and
Security Rules.
Response. We appreciate the commenter's recommendation. We note
that we did not propose to define the term ``appropriate
disincentives.'' Instead, we proposed to define the term
``disincentive'' to mean a condition specified in Sec. 171.1001(a)
that may be imposed by an appropriate agency on a health care provider
that OIG determines has committed information blocking, for the purpose
of deterring information blocking practices. Activities such as the
provision of technical assistance or the provision of a corrective
action plan may not adequately deter information blocking practices,
and we decline to include such activities in the definition of a
disincentive at this time. We further refer readers to resources on
ONC's website \15\ about information blocking, which can help health
care providers learn about what practices constitute information
blocking and how health care providers can avoid these practices.
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\15\ For more information, see: https://www.healthit.gov/topic/information-blocking.
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Comments. Many commenters did not support our proposal for a health
care provider to be subject to each appropriate disincentive
established by an appropriate agency applicable to such health care
provider, without limit to the number of disincentives, and disagreed
that this policy would deter providers from engaging in information
blocking. One commenter contended that unlimited cumulative
disincentives should not be considered appropriate.
Several commenters expressed that subjecting health care providers
to multiple disincentives for the same misconduct, simply based on
their participation in multiple programs rather than the severity of
the conduct, is duplicative, overly punitive, and heightens the risk
for providers who participate in multiple CMS programs. A few
commenters recommended that HHS establish a clear process to reconcile
multiple disincentives and ensure fair and non-duplicative or punitive
enforcement for providers participating in multiple programs. A few
commenters suggested limiting the number of disincentives that could be
applied or clarifying under which program the disincentive would be
applied. A few commenters expressed concern that the allowance of
cumulative disincentives will create confusion and complexity.
Response. We thank commenters for their input. We disagree with
commenters that multiple disincentives will not deter information
blocking, as
[[Page 54672]]
the increased impact on a health care provider of receiving cumulative
disincentives is likely to be a stronger deterrent due to potentially
imposing greater adverse consequences on the health care provider that
commits information blocking. Moreover, health care providers who
participate in multiple programs may be larger than health care
providers who do not participate in multiple programs, or may have a
greater ability to influence health information exchange than other
health care providers, and so may need greater disincentive exposure to
deter information blocking practices.
Finally, we believe that the possibility of receiving cumulative
disincentives will have a greater deterrent effect on health care
providers that are determined to have committed information blocking,
since individual disincentives are likely to have variable impacts
depending on the circumstances of a given health care provider, as
further discussed in section III.C.1. of this final rule. If a health
care provider expects to only be subject to one disincentive, and the
health care provider expects the disincentive to have a small impact,
for instance, through minimal exposure under a certain program, the
value of that disincentive to deter information blocking practices for
that health care provider will be minimized. The availability of
disincentives under more than one authority can mitigate this issue, as
under our policy a health care provider may expect that they could be
subject to cumulative disincentives established under different
authorities, increasing the likelihood that there is an available
disincentive that will have a meaningful deterrent effect for that
specific health care provider.
We also disagree with the commenter that the term ``appropriate''
should be interpreted to prohibit applying multiple disincentives on a
health care provider that has committed information blocking. PHSA
section 3022(b)(2)(B) specifically contemplates that a health care
provider may be subject to ``appropriate disincentives''--plural. The
plain language of the statute therefore suggests that multiple
``disincentives'' would be ``appropriate.''
We further disagree that subjecting a health care provider to
multiple disincentives is unfair and overly punitive. The disincentives
that CMS has finalized in this final rule are established under
authorities which provide for specific requirements for programs
authorized under those authorities. CMS describes in section III.C. how
information blocking committed by a health care provider would conflict
with the requirements under each of the programs through which a
disincentive has been established. Accordingly, we believe it is
reasonable that a health care provider that has acted in a manner
inconsistent with these programs by committing information blocking
could be subject to a disincentive under that authority, regardless of
whether the health care provider has also been subject to a
disincentive established under another authority.
However, we believe it is necessary to provide further
clarification around our proposed policy with respect to cumulative
disincentives. Specifically, we believe that our proposed policy may
not have accounted for scenarios under which an appropriate agency may
choose to exercise discretion when imposing a disincentive. For
example, in section III.C.4. of this final rule, CMS has finalized a
policy under the authority for the Shared Savings Program, which CMS
originally discussed as an alternative policy in the Disincentives
Proposed Rule (88 FR 74966). This finalized policy will permit CMS, as
the appropriate agency, to consider relevant facts and circumstances
when deciding whether to apply a disincentive to an ACO, ACO
participant, or ACO provider/supplier in the Shared Savings Program.
We note that CMS has finalized this alternative policy for the
Medicare Shared Savings Program only, as this policy is consistent with
existing practices under the Shared Savings Program for addressing
program integrity issues among ACOs, ACO participants, or ACO
providers/suppliers. In addition, this policy addresses scenarios
specific to imposing a disincentive under the Shared Savings Program,
for instance, where removal of one entity from participation in an ACO
could result in the ACO not meeting program requirements such as
falling below the 5,000 assigned beneficiary threshold required by 42
CFR 425.110(a)(1), thereby interrupting care coordination benefits of
beneficiaries receiving care from ACO participants and ACO providers/
suppliers that did not commit information blocking. Under the finalized
alternative policy, CMS will consider relevant facts and circumstances
before imposing a disincentive under the Shared Savings Program. The
relevant facts and circumstances include the nature of the health care
provider's information blocking, the health care provider's diligence
in identifying and correcting the problem, the time since the
information blocking occurred, whether the provider was previously
subject to a disincentive in another program, and other factors. We
refer readers to section III.C.4. for a complete discussion of the
alternative policy finalized under the Shared Savings Program. As
discussed in sections III.C.2. and III.C.3. of this final rule, the
Medicare Promoting Interoperability Program and the MIPS Promoting
Interoperability performance category will impose a disincentive on an
applicable health care provider following a referral of an information
blocking determination by OIG.
Thus, we are revising our proposed policy for consistency with the
policies finalized in this rule. Where we stated in the proposed rule
(88 FR 74951) that a health care provider ``would'' be subject to each
appropriate disincentive that an agency has established through notice
and comment rulemaking and is applicable to the health care provider,
in this final rule we clarify that, under the disincentives provision,
a health care provider ``may'' be subject to each appropriate
disincentive that an agency has established through notice and comment
rulemaking and is applicable to the health care provider. Under this
revised policy, we acknowledge that an appropriate agency could
establish a policy that allows for discretion in imposing a
disincentive, consistent with the agency's authority and implementing
regulations.
Finally, we disagree with the commenters that a cumulative
disincentives approach will introduce more confusion and complexity. We
believe this final rule provides clarity about the disincentives
established under each of the relevant programs to ensure health care
providers understand the consequences they may face for committing
information blocking with respect to the requirements of each program.
Comments. A few commenters expressed concern about the negative and
disproportionate impact of potentially imposing cumulative
disincentives on small and less resourced practices. One commenter
recommended considering the relative impact of cumulative disincentives
on the health care provider, such as the size and resources of the
provider.
Response. We appreciate the commenters' concerns about the impact
of cumulative disincentives on small and less resourced practices.
However, we disagree with commenters that we should revise our policy
with respect to cumulative disincentives to be based on the size and
resources of the health care provider subject to the disincentive, as
we believe this policy should be consistent across health care
providers,
[[Page 54673]]
regardless of their size, and that any considerations with respect to
how an appropriate disincentive should impact health care providers
should be addressed by the appropriate agency establishing the
disincentive.
An appropriate agency, in establishing a disincentive and related
policies, could retain or implement policies based on the type of
health care provider subject to the disincentive, including small
practices, consistent with the agency's authority. For instance, CMS
automatically reweights the MIPS Promoting Interoperability performance
category to zero percent of a MIPS eligible clinician's final score if
the MIPS eligible clinician is in a small practice as defined in 42 CFR
414.1305 and does not submit data for the MIPS Promoting
Interoperability performance category for the applicable performance
period (42 CFR 414.1380(c)(2)(i)(C)(9)). In other words, if the MIPS
eligible clinician meets this criterion for automatic reweighting at 42
CFR 414.1380(c)(2)(i)(C)(9), the MIPS eligible clinician is not
required to complete the requirements for earning a score for the
Promoting Interoperability performance category as set forth in 42 CFR
414.1375. In such event, CMS does not assign a score for the MIPS
eligible clinician for the Promoting Interoperability performance
category and redistributes the weight of the performance category
(typically 25 percent of the final score) to the remaining performance
categories on which the MIPS eligible clinician is scored in accordance
with 42 CFR 414.1380(c)(2)(ii). In section III.C. of the proposed rule
and section III.C. of this final rule, CMS has neither proposed nor
finalized any policy that would amend this automatic reweighting policy
at 42 CFR 414.1380(c)(2)(i)(C)(9) for MIPS eligible clinicians in a
small practice if such practice were subject to the disincentive being
finalized as discussed section III.C.3. of this final rule.
After consideration of the public comments, we have finalized our
definition of the term ``disincentive'' in 45 CFR 171.102 as proposed
to mean a condition specified in 45 CFR 171.1001(a) that is imposed by
an appropriate agency on a health care provider that OIG determines has
committed information blocking for the purpose of deterring information
blocking practices. We have also finalized our policy, with
modification, that a health care provider may be subject to each
appropriate disincentive that an agency has established through notice
and comment rulemaking and is applicable to the health care provider.
B. Approach to Determination of Information Blocking and Application of
Disincentives
In this section we provide additional detail about the process by
which a health care provider that has committed information blocking
may be subject to appropriate disincentives for information blocking.
This section begins with a discussion, provided for informational
purposes and not including any final policies, of an OIG investigation
of a claim of information blocking and how OIG intends to refer a
health care provider it determines has committed information blocking
to an appropriate agency. Next, we discuss finalized proposals related
to the application of a disincentive by an appropriate agency. Finally,
we discuss our finalized approach to provide transparency into the
nationwide health IT infrastructure by making information available to
the public about health care providers that have been determined by OIG
to have committed information blocking and have been subject to an
appropriate disincentive for information blocking, and about health IT
developers of certified health IT and HIEs/HINs and that have been
determined by OIG to have committed information blocking.
1. OIG Investigation and Referral
In the Disincentives Proposed Rule, we provided information
regarding OIG's anticipated approach to information blocking
investigations of health care providers (88 FR 74951 and 74952). We
noted that this information was not a regulatory proposal and was
provided for information purposes only. Preamble discussion of
investigation priorities for health care provider information blocking
claims included in the Disincentives Proposed Rule, and restated below,
is not binding on OIG and HHS. It does not impose any legal
restrictions related to OIG's discretion to choose which health care
provider information blocking complaints to investigate. As the
discussion in the Disincentives Proposed Rule was not a regulatory
proposal, we have not included direct responses to comments provided on
this section (III.B.1.). However, to improve public understanding of
how OIG anticipates it will approach information blocking
investigations of health care providers, this section (III.B.1.) of the
preamble provides an informational statement to supplement the
discussion set forth in the Disincentives Proposed Rule.
We clarify here that OIG's investigation will depend on the
specific facts and circumstances presented in the allegation. OIG will
evaluate each allegation based on the facts and circumstances presented
in the allegation. As OIG investigates the allegations, though, the
scope of the investigation may change, and OIG may change the
individual(s) or entity(ies) under investigation depending on the
specific facts and circumstances it has found. Indeed, through
conducting an investigation, OIG will collect evidence which it will
use to evaluate the individual(s) or entity(ies) with potential
information blocking liability and potential information blocking
conduct. The vast bulk of material and relevant evidence (that is,
evidence relating to whether the actor committed information blocking)
will come from the actor whose conduct is at issue.
As part of OIG's investigation, OIG will need to evaluate whether
an individual or entity meets the definition of an actor under ONC's
regulations. OIG has previously stated that it will look to ONC's
regulations and any related guidance in evaluating whether an
individual or entity meets a specific actor definition, and OIG will
continue to do so for health care provider investigations (88 FR
42828). OIG will look to the regulations in effect at the time the
conduct occurred. Based on the definitions ONC has finalized for health
IT developer of certified health IT and HIN/HIE, a health care
provider, as set forth in 45 CFR 171.102, may meet the definition of a
health care provider and one of those definitions as well (88 FR
42829). OIG anticipates being in contact with health care providers as
part of its investigation, as necessary, to understand the specific
facts and circumstances. For example, OIG may need to engage with the
health care provider to understand whether the health care provider is
a HIN/HIE or a health IT developer of certified health IT. And as
mentioned above, much of the evidence gathered by OIG will likely come
from the individual(s) or entity(ties) under investigation.
As part of an investigation, OIG will evaluate whether information
blocking has occurred. OIG has previously stated that it will look to
ONC's regulations and any related guidance in evaluating whether
conduct constitutes information blocking, and OIG will continue to do
so with respect to health care providers (88 FR 42827). OIG will look
to ONC's information blocking regulations in 45 CFR part 171 in effect
at the time the conduct occurred. Through conducting an investigation,
OIG will collect evidence, which it will use to evaluate whether
conduct constitutes information blocking and whether an actor had the
requisite
[[Page 54674]]
intent. As mentioned above, OIG anticipates engaging with health care
providers during this process as it learns the facts and circumstances
of the allegation under investigation.
Regarding the timing of investigations, OIG will not begin
investigating health care providers until after the effective date of
this rule, and will exercise its enforcement discretion not to make any
determinations regarding conduct occurring prior to the effective date
of this rule for information blocking disincentives. As OIG will not
make a determination on conduct occurring prior to the effective date,
OIG will not refer any health care providers based on a determination
of conduct occurring prior to the effective date of this rule for
information blocking disincentives. This means that no disincentives
finalized in this final rule will be applied to conduct occurring
before the effective date of this final rule.
a. Anticipated Priorities
As with other conduct that OIG has authority to investigate, OIG
has discretion to choose which information blocking complaints to
investigate. To maximize efficient use of resources, OIG generally
focuses on selecting cases for investigation that are consistent with
its enforcement priorities and intends to apply that rationale to its
approach for selecting information blocking complaints for
investigation.
For investigations of health care providers, the Disincentives
Proposed Rule stated that OIG expects to use four priorities: (i)
resulted in, are causing, or have the potential to cause patient harm;
(ii) significantly impacted a provider's ability to care for patients;
(iii) were of long duration; and (iv) caused financial loss to Federal
health care programs, or other government or private entities (88 FR
74951). As mentioned in the above section concerning OIG
investigations, OIG's expected priorities are informational only and
are not binding on OIG decision making.
OIG's priorities for health care provider investigations differ
from the priorities set out in the OIG CMP Final Rule, due to the
differences in intent. In the OIG CMP Final Rule, OIG stated that it
would prioritize actors who had actual knowledge, as actual knowledge
is more egregious, when a lower intent is required (that is, when the
standard is ``knows, or should know'') (88 FR 42823). However, under
PHSA section 3022(a), the intent requirement for health care providers
is that the health care provider ``knows'' that a practice is
unreasonable and is likely to interfere with, prevent, or materially
discourage access, exchange, or use of electronic health information.
Because the Cures Act only provides a single intent standard
(``knows''), OIG will not consider actual knowledge as part of its
priorities for health care provider actors.
Consistent with the OIG CMP Final Rule (88 FR 42822), OIG's
enforcement priorities are a tool OIG uses to triage allegations and
allocate resources. OIG provides information about its enforcement
priorities so the public and stakeholders have a better understanding
of how OIG anticipates allocating resources for enforcement. OIG's
enforcement priorities will inform decisions about which information
blocking allegations to pursue, but these priorities are not
dispositive. Each allegation will be assessed to determine whether it
implicates one or more of the enforcement priorities, or otherwise
merits further investigation and potential enforcement action. There is
no specific formula OIG can apply to every allegation that allows OIG
to effectively evaluate and prioritize which claims merit
investigation.
Although OIG's anticipated priorities are framed around individual
allegations, OIG may evaluate allegations and prioritize investigations
based in part on the volume of claims relating to the same (or similar)
practices by the same entity or individual.
b. Coordination With Other Agencies
This section summarizes the discussion in the OIG CMP Final Rule of
the ways ONC, OCR, and OIG will consult, refer, and coordinate on
information blocking claims as permitted by the Cures Act (88 FR
42823).
PHSA section 3022(d)(1) states that the National Coordinator may
serve as a technical consultant to the Inspector General. OIG will
accordingly consult with ONC throughout the investigative process.
Additionally, PHSA section 3022(b)(3)(A) provides the option for OIG to
refer claims of information blocking to OCR when a consultation
regarding the health privacy and security rules promulgated under
section 264(c) of HIPAA will resolve such claims. Depending on the
facts and circumstances of the claim, OIG will exercise this statutory
discretion as appropriate to refer information blocking claims to OCR
for resolution. There is no set of facts or circumstances that will
always be referred to OCR. OIG will work with OCR to determine which
claims should be referred to OCR under the authority provided in PHSA
section 3022(b)(3)(A). It is important to note that while section
3022(b)(3)(A) of the PHSA specifically provides OIG with the authority
to refer information blocking claims to OCR, OIG's statutory authority
to refer to OCR allegations of violations of the HIPAA Privacy,
Security, or Breach Notification Rules \16\ is not solely based on PHSA
section 3022(b)(3)(A). Thus, OIG's authority to refer to OCR such
allegations against health care providers is not limited to claims of
information blocking.
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\16\ 45 CFR parts 160 and 164, subparts A, C, D, and E.
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Finally, OIG anticipates coordinating with other HHS agencies to
avoid duplicate penalties as identified in section 3022(d)(4) of the
PHSA. Depending on the facts and circumstances, OIG may also consult or
coordinate with a range of other government agencies, including CMS,
FTC, or others (88 FR 42823 and 42824).
c. Anticipated Approach to Referral
During an investigation of information blocking by a health care
provider, but prior to making a referral, OIG will coordinate with the
appropriate agency to which OIG plans to refer its determination of
information blocking. This coordination will ensure that the
appropriate agency is aware of a potential referral and that OIG
provides the information the agency needs to take appropriate action.
OIG's referral to the appropriate agency will explain its determination
that a health care provider committed information blocking, including
meeting the requirements of the intent element of PHSA section
3022(a)(1)(B)(ii).
We note that PHSA section 3022 authorizes OIG to investigate claims
of information blocking and requires OIG to refer health care providers
to an appropriate agency when it determines a health care provider has
committed information blocking, to be subject to appropriate
disincentives. Once OIG has concluded its investigation and is prepared
to make a referral, it will send information to the appropriate agency
indicating that the referral is made pursuant to the statutory
requirement in PHSA section 3022(b)(2)(B). As part of the referral, OIG
will provide information to explain its determination, which may
include: the dates when OIG has determined the information blocking
violation(s) occurred; analysis to explain how the evidence
demonstrates the health care provider committed information blocking
(for instance, that the health care provider's ``practice'' \17\ meets
each
[[Page 54675]]
element of the information blocking definition); copies of evidence
collected during the investigation (regardless of whether it was
collected by subpoena or voluntarily provided to OIG); copies of
transcripts and video recordings (if applicable) of any witness and
affected party testimony; and copies of documents OIG relied upon to
make its determination that information blocking occurred. OIG may
provide additional information as part of its referral based on
consultation with the appropriate agency, to the extent permitted by
applicable law.
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\17\ ``Practice,'' as defined in 45 CFR 171.102, means an act or
omission by an actor (health care provider, health IT developer of
certified health IT, health information network or health
information exchange).
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2. General Provisions for Application of Disincentives
Following an investigation through which OIG determines a health
care provider has committed information blocking, and OIG's referral of
this determination to an appropriate agency, the health care provider
may be subject to disincentives that have been established under
applicable Federal law through notice and comment rulemaking. In this
section, we include general provisions and information related to the
application of disincentives. For information on the specific
disincentives and further discussion about how each disincentive will
be applied, we refer readers to section III.C. of this final rule.
In the Disincentives Proposed Rule, we proposed to add a new
subpart J to 45 CFR part 171, entitled ``Disincentives for Information
Blocking by Health Care Providers'' (88 FR 74952 and 74953). We
proposed in 45 CFR 171.1000 that this subpart sets forth disincentives
that an appropriate agency may impose on a health care provider based
on a determination of information blocking referred to that agency by
OIG, and certain procedures related to those disincentives. We proposed
in 45 CFR 171.1001(a) that health care providers that commit
information blocking would be subject to the following disincentives
from an appropriate agency based on a determination of information
blocking referred by OIG, where applicable. The disincentives proposed
for inclusion in 45 CFR 171.1001(a)(1) through (3) corresponded to the
appropriate disincentives proposed in section III.C. of the
Disincentives Proposed Rule:
An eligible hospital or CAH as defined in 42 CFR 495.4 is
not a meaningful EHR user as also defined in that section;
A MIPS eligible clinician as defined in 42 CFR 414.1305,
who is also a health care provider as defined in 45 CFR 171.102, is not
a meaningful EHR user for MIPS as also defined in 42 CFR 414.1305; and
ACOs who are health care providers as defined in 45 CFR
171.102, ACO participants, and ACO providers/suppliers will be removed
from, or denied approval to participate, in the Medicare Shared Savings
Program as defined in 42 CFR part 425 for at least 1 year.
We noted that in the future, if we propose to establish additional
disincentives, we intend to add such disincentives to the disincentives
listed in 45 CFR 171.1001 (88 FR 74953).
We did not receive any comments on these proposals. However, we
have modified the regulation text in several ways to increase clarity.
First, we have made minor modifications to the language of the proposed
``scope'' section, in 45 CFR 171.1000, to better reflect language used
in this final rule. Second, we have replaced the proposed paragraph (a)
from 45 CFR 171.1001, which was redundant with the proposed ``scope''
section (45 CFR 171.1000), and reorganized the section to clearly
reflect that the disincentives finalized in this final rule, and that a
health care provider may be subject to, were established by CMS (45 CFR
171.1001(a) as finalized). If we finalize additional disincentives in
the future, we will add them to a paragraph under 45 CFR 171.1001
reflecting the appropriate agency that has established the
disincentive.
We have finalized, as proposed, the following disincentives in 45
CFR 171.1001(a)(1)-(3):
An eligible hospital or CAH as defined in 42 CFR 495.4 is
not a meaningful EHR user as also defined in that section;
A MIPS eligible clinician as defined in 42 CFR 414.1305,
who is also a health care provider as defined in 45 CFR 171.102, is not
a meaningful EHR user for MIPS as also defined in 42 CFR 414.1305; and
ACOs who are health care providers as defined in 45 CFR
171.102, ACO participants, and ACO providers/supplies will be removed
from, or denied approval to participate, in the Medicare Shared Savings
Program as defined in 42 CFR part 425 for at least 1 year.
In the Disincentives Proposed Rule, we proposed in 45 CFR
171.1002(a) through (d) that an appropriate agency that imposes a
disincentive or disincentives in Sec. 171.1001(a) would send a notice
(using usual methods of communication for the program or payment
system) to the health care provider subject to the disincentive or
disincentives (88 FR 74953). We proposed that this notice includes:
A description of the practice or practices that formed the
basis for the determination of information blocking referred by OIG;
The basis for the application of the disincentive or
disincentives being imposed;
The effect of each disincentive; and
Any other information necessary for a health care provider
to understand how each disincentive will be implemented.
In the Disincentives Proposed Rule we stated that the information
in this notice would be based upon the authority used to establish the
disincentive and policy finalized by the agency establishing the
disincentive (88 FR 74953). For instance, the notice may contain
specific information regarding when a disincentive would be imposed,
which may be contingent on both the authority used to establish the
disincentive and the specific policy under which the disincentive is
established. We noted that, where a health care provider that has been
determined to have committed information blocking is subject to
multiple disincentives established by an appropriate agency, nothing in
this proposal would prevent the appropriate agency from combining these
notices into a single communication.
Comments. One commenter requested clarification regarding whether
the proposal to send a notice to the health care provider subject to
the disincentive implies that all health care providers who have been
identified as alleged information blockers will receive a disincentive.
Response. A health care provider would only be subject to a
disincentive or disincentives and receive the notification described in
this section after a determination has been made by OIG that the health
care provider committed information blocking and OIG has referred that
determination to the appropriate agency, which is CMS for the purposes
of the disincentives finalized in this rule. A health care provider
that is merely alleged to have committed information blocking but has
not been investigated and determined by OIG to have committed
information blocking, would not receive a notification described in
this section.
Comments. One commenter expressed support for the proposed
notification policies and stated that these policies would improve
transparency.
[[Page 54676]]
Response. We thank the commenter for their support.
Comments. A few commenters recommended adding information or a
communications channel so that health care providers who have been
notified of a disincentive can respond to or communicate with OIG and
the agency issuing the disincentive regarding the finding, possible
mitigating circumstances, or establish a process to deter further cases
of information blocking. One commenter observed that this would
increase transparency, avoid patient confusion, and mitigate potential
unnecessary reputational damage. One commenter expressed concern that
the proposed notifications only inform health care providers of a
disincentive after they have been found to have committed information
blocking. This commenter expressed concern that a health care provider
found to have committed information blocking may have additional
practices being investigated or practices that could lead to another
finding of information blocking and that these practices would not be
included in the notification, for example, for them to fix potential
issues. This commenter recommended creating a form notification that
would inform health care providers of the information blocking issues
that have led to the disincentive so they could be fixed.
Response. We appreciate commenters' concerns and wish to clarify
that the notifications proposed in this section would be issued by an
appropriate agency following a referral of a determination of
information blocking by OIG that leads to the imposition of a
disincentive. For discussion of when communication between OIG and a
health care provider about alleged information blocking practices may
occur as part of an investigation (that is, prior to a determination of
information blocking), we refer readers to section III.B.1. of this
final rule.
After consideration of the public comments, we have finalized our
proposal with modification. In the Disincentives Proposed Rule, we
proposed in Sec. 171.1002 that an appropriate agency ``would send a
notice to the health care provider subject to the disincentive or
disincentives.'' However, we believe that the use of the affirmative
``shall,'' which we have finalized in the text of Sec. 171.1002, to
describe the action of an appropriate agency will provide greater
clarity to health care providers and better conveys the intent of the
policy, which is that an appropriate agency will send this notice in
all cases in which disincentives have been imposed on a health care
provider. For the finalized text of Sec. 171.1002, we also revise our
proposed reference to disincentives ``specified in Sec. 171.1001(a)''
to refer to disincentives ``specified in Sec. 171.1001'' instead,
since we have finalized that disincentives may be listed throughout
Sec. 171.1001 and not only under paragraph (a), which specifically
lists disincentives established by CMS. Therefore, we have finalized in
45 CFR 171.1002 that an appropriate agency that imposes a disincentive
or disincentives in Sec. 171.1001 shall send a notice (using usual
methods of communication for the program or payment system) to the
health care provider subject to the disincentive or disincentives. We
have finalized in 45 CFR 171.1002(a) through (d) the elements of the
notice as proposed.
In the Disincentives Proposed Rule, we noted that, following the
application of a disincentive, a health care provider, as defined in 45
CFR 171.102, may have the right to appeal administratively a
disincentive if the authority used to establish the disincentive
provides for such an appeal (88 FR 74953). We noted that PHSA section
3022(b)(2)(C) requires that the imposition of CMPs that apply to health
IT developers of certified health IT, and HINs/HIEs, that have
committed information blocking, follow the procedures of SSA section
1128A, which includes procedures for appeals. However, the Cures Act
did not provide similar instruction regarding administrative appeals of
disincentives for health care providers established under PHSA section
3022(b)(2)(B), and we did not propose a specific administrative appeals
process for health care provider appeals. Therefore, any right to
appeal administratively a disincentive, if available, would be provided
under the authorities used by the Secretary to establish the
disincentive through notice and comment rulemaking.
To provide additional information on these issues to the public, we
summarize and respond to comments on our statement regarding appeals.
Comments. Many commenters expressed concern that there is not a
clearly defined appeals process that would apply across all provider
types. Many of these commenters recommended that HHS adopt a single
appeals process through notice and comment rulemaking. Many commenters
expressed concern that relying on each program's appeals process
creates an unfair structure in which providers do not have equal appeal
rights. Some of these commenters further stated that this could require
some providers to appeal multiple times and that other providers may
not be able to appeal at all. Some commenters stated that the differing
appeals processes could create undue administrative burden, with some
requesting a single or streamlined process. A few commenters
recommended that HHS ensure that any future disincentives for other
provider types also allow for a clear and straightforward appeals
process.
Response. As noted in the Disincentives Proposed Rule, PHSA section
3022(b)(2)(C) requires that the imposition of CMPs that apply to health
IT developers of certified health IT, and HINs/HIEs, that have
committed information blocking, follow the procedures of SSA section
1128A, which includes procedures for administrative appeals (88 FR
74953). The Cures Act did not provide similar instruction regarding
administrative appeals of appropriate disincentives for health care
providers established under PHSA section 3022(b)(2)(B), and we did not
propose and have not finalized any regulations relating to
administrative appeals of the imposition of disincentives. Instead, we
reiterate that any right to appeal administratively a disincentive, if
available, would be provided under the authority used by the Secretary
to establish a disincentive.
Section 3022(b)(2)(B) of the PHSA requires that an OIG
determination be referred to the appropriate agency to ``be subject to
appropriate disincentives using authorities under applicable Federal
law.'' In establishing disincentives using authorities under applicable
Federal law, any administrative appeals processes required under those
existing authorities would also apply to the disincentives established
by an appropriate agency under that authority. We recognize that
reliance on any administrative appeals processes under the authority
used to establish a disincentive may result in variability in the
appeals processes available to health care providers, and that in some
cases, administrative appeals processes may be limited or unavailable.
However, we disagree that establishing a new single process for
administrative appeals would effectively address this variability, as
such a process may conflict with, or duplicate, administrative review
or appeals processes available under existing authorities. Accordingly,
we did not propose such a process in the Disincentives Proposed Rule.
If we establish additional disincentives in the future, we will
evaluate any administrative review or appeals process available under
the
[[Page 54677]]
authority used to establish the disincentive and how a disincentive
would be treated under such a process. However, we decline to limit
future disincentives to those which provide for administrative appeals
processes meeting certain standards, as we must balance these
considerations with our goal of identifying disincentives for all
health care providers subject to the information blocking regulations,
as defined in 45 CFR 171.102.
Comments. Many commenters provided recommendations for elements
that should be incorporated into an appeals process. Commenters
recommended that all health care providers should have the ability to
appeal an information blocking determination by OIG before referral or
application of a disincentive, as well as the ability to appeal the
application and calculation of the disincentive. Other commenters
recommended that HHS include evaluation criteria and definitions of
intent within the appeals process to ensure transparency. A few
commenters suggested that health care providers have the ability to
provide further information that may impact a determination. Some
commenters recommended entities that the commenters asserted would be
appropriate to handle the appeals; the specific entities that
commenters recommended were OIG, CMS, ONC, HHS, an Administrative Law
Judge, or an impartial agency not involved in the finding or
disincentive. Some commenters recommended that HHS ensure that the
entity reviewing appeals have sufficient technical expertise to review
the OIG finding.
Some commenters recommended potential models for the appeals
process, including the process described for ACOs in the Disincentives
Proposed Rule, the process established for health IT developers of
certified health IT, HINs/HIEs, Medicare programs, and the process for
appealing enforcement of the rules promulgated under the Administrative
Simplification provisions of HIPAA. Some commenters recommended that
HHS clearly define the timelines for the appeals process and build
these into the timeline for applying disincentives.
Response. We appreciate commenters' recommendations regarding
elements that should be included in an administrative appeals process,
as well as recommendations regarding existing appeals processes that
would be an appropriate model for review and appeal of disincentives.
However, we did not propose to establish a single process for the
administrative appeal of either a determination by OIG of information
blocking or a disincentive imposed by an appropriate agency based on a
referral of a determination of information blocking. Instead, the
ability of a health care provider subject to a disincentive to appeal
administratively the specific items identified by commenters, including
the information blocking determination by OIG, the determination that
information blocking conduct met the required intent standard, the
application of a disincentive, and the calculation of the disincentive,
would be based on the scope of any administrative appeal rights
provided under the authority used to establish an appropriate
disincentive. Likewise, any timelines for an administrative appeals
process may depend upon timelines already established related to
administrative appeal rights under the authority used to establish a
disincentive.
We appreciate the comment regarding technical expertise in review
of any administrative appeals of a disincentive. While the
responsibility for reviewing an appeal administratively would be
determined by the authority under which the disincentive has been
established and could vary across disincentives, we expect that other
agencies, such as ONC, could potentially provide technical assistance
to an appropriate agency as part of any administrative appeals process
that is available and exercised by a health care provider. We encourage
readers to review the information in section III.C. of this final rule
where CMS provides further discussion of relevant policies related to
administrative appeal, review, and reconsideration under authorities
used to establish disincentives.
Comments. One commenter requested clarification about the impact an
appeal would have on the application of a disincentive and the proposed
posting of information on the ONC website.
Response. Regarding the impact an appeal would have on the
application of a disincentive, we reiterate that any right to appeal
administratively a disincentive, if available, would be provided under
the authorities used by the Secretary to establish the disincentive.
Therefore, the impact of any appeal rights provided for by a specific
authority would depend on that authority. We encourage readers to
review the information in section III.C. of this final rule where CMS
provides further discussion of relevant policies related to appeal,
review, and reconsideration under authorities used to establish
disincentives.
As discussed further in section III.B.3. of this final rule
regarding our proposal for posting of information on ONC's website, we
have finalized our proposal regarding information that will be publicly
posted on ONC's website about actors that have been determined by OIG
to have committed information blocking (specifically, where the actor
is a health care provider, the health care provider's name, business
address (to ensure accurate provider identification), the practice
found to have been information blocking, including when the practice
occurred, the disincentive(s) applied, and where to find additional
information, where available, about the determination of information
blocking that is publicly available via HHS or another part of the U.S.
Government). Further, we have finalized at 45 CFR 171.1101(a)(2) that
the information specified in 45 CFR 171.1101(a)(1) will not be posted
prior to a disincentive being imposed and will not include information
about a disincentive that has not been applied. As noted in section
III.B.3., we have modified our finalized policy to provide further
clarification that posting of information about a disincentive will not
occur until after any available administrative appeals process has been
completed.
Comments. One commenter recommended not applying disincentives in
any program that does not have an appeals process that would allow
health care providers to appeal the finding and the disincentive.
Response. We appreciate the commenter's recommendation. However, we
decline to limit the establishment of disincentives to those
disincentives which can be established using authorities that provide
for administrative appeal rights meeting certain standards. Since we
must establish disincentives using authorities under applicable Federal
law as required under PHSA section 3022(b)(2)(B), we must balance our
interest in providing for administrative appeal rights with a limited
set of available authorities which can be used to establish appropriate
disincentives. We believe that focusing only on those authorities which
provide for a specific set of administrative appeal rights would limit
our ability to meet our goal of establishing appropriate disincentives
for the health care providers subject to the information blocking
regulations, as defined in 45 CFR 171.102.
We did not propose to establish a single administrative appeals
process for health care providers to appeal the application of
disincentives being finalized in this rule. We reiterate that any right
to appeal administratively a disincentive, if available, would be
provided under the authorities used by
[[Page 54678]]
the Secretary to establish the disincentive.
3. Transparency for Information Blocking Determinations, Disincentives,
and Penalties
In the Disincentives Proposed Rule, we stated that it is important
to promote transparency about how and where information blocking is
impacting the nationwide health information technology infrastructure
(88 FR 74953). We further stated that publicly releasing information,
including applicable public settlements, penalties, and disincentives,
about actors that have been determined by OIG to have committed
information blocking can inform the public about how and where
information blocking is occurring within the broader health information
technology infrastructure.
PHSA section 3001(c)(4) (42 U.S.C. 300jj-11(c)(4)) requires that
the National Coordinator maintain an internet website ``to ensure
transparency in promotion of a nationwide health information technology
infrastructure.'' We believe this provision provides the National
Coordinator with the authority to post information on ONC's website if
that information has an impact on issues relating to transparency in
the promotion of a nationwide health information technology
infrastructure. In the Disincentives Proposed Rule, we proposed to add
a new subpart K to 45 CFR part 171, entitled ``Transparency for
Information Blocking Determinations, Disincentives, and Penalties'' (88
FR 74953). As proposed in 45 CFR 171.1100, this subpart would set forth
the information that would be publicly posted on ONC's website about
actors that have been determined by OIG to have committed information
blocking.
We proposed in 45 CFR 171.1101 that, in order to provide insight
into how and where information blocking conduct is impacting the
broader nationwide health information technology infrastructure, ONC
would post on its public website information about actors that have
been determined by OIG to have committed information blocking (88 FR
74953). For health care providers that are subject to a disincentive,
we proposed in 45 CFR 171.1101(a)(1) that the following information
would be posted: health care provider's name, business address (to
ensure accurate provider identification), the practice found to have
been information blocking, the disincentive(s) applied, and where to
find additional information, where available, about the determination
of information blocking that is publicly available via HHS or another
part of the U.S. Government. We proposed in 45 CFR 171.1101(a)(2) that
the information specified in 45 CFR 171.1101(a)(1) would not be posted
prior to a disincentive being imposed and would not include information
about a disincentive that has not been applied.
We recognized that under the authorities used to establish the
disincentives proposed in section III.C. of the Disincentives Proposed
Rule, an appropriate agency may have other obligations related to the
release of information about a participant that is a health care
provider (as defined in 45 CFR 171.102) in programs under that
authority (88 FR 74953 and 74954). For instance, under SSA section
1848(q)(9)(C), MIPS eligible clinicians have a right to review
information about their performance in MIPS prior to having this
information publicly posted on the Compare Tool in accordance with 42
CFR 414.1395. Therefore, we proposed in 45 CFR 171.1101(a)(3) that
posting of the information about health care providers that have been
determined to have committed information blocking and have been subject
to a disincentive would be conducted in accordance with existing rights
to review information that may be associated with a disincentive
specified in 45 CFR 171.1001. For instance, where a health care
provider, as defined in 45 CFR 171.102, has a statutory right to review
performance information, this existing right would be exercised prior
to public posting of information regarding information blocking on the
website described above.
In order to provide insight into how and where information blocking
conduct is impacting the broader nationwide health information
technology infrastructure, we also proposed in 45 CFR 171.1101(b)(1) to
post on ONC's public website information specified in 45 CFR
171.1101(b)(1) about health IT developers of certified health IT and
HINs/HIEs that have been determined by OIG to have committed
information blocking and have either resolved their CMP liability with
OIG or had a CMP imposed by OIG for information blocking under subpart
N of 42 CFR part 1003 (88 FR 74954). To ensure accurate identification
of actors, we proposed in 45 CFR 171.1101(b)(1) to post the type of
actor (for example, HINs/HIEs or health IT developers of certified
health IT) and the actor's legal name, including any alternative or
additional trade name(s) under which the actor operates.
The last information we proposed to post on our public website, for
all actors, would be the two types of information mentioned above
regarding health care providers (88 FR 74954). First, in 45 CFR
171.1101(a)(1)(iii) and (b)(1)(iii), we proposed to post a description
of the practice, as the term is defined in 45 CFR 171.102 and
referenced in 45 CFR 171.103, found to have been information blocking.
In the case of a resolved CMP liability, we would post the practice
alleged to be information blocking. This information will help provide
transparency into how information blocking conduct is impacting the
nationwide health information technology infrastructure, and in
particular, specific practices that are impacting the infrastructure.
Second, in 45 CFR 171.1101(a)(1)(v) and (b)(1)(iv), we proposed to post
where to find additional information about the determination (or
resolution of CMP liability) of information blocking that is publicly
available via HHS or, where applicable, another part of the U.S.
Government. This information could include hyperlinks and other
information, to help interested persons find any additional information
about the determination, settlement, penalty, or disincentive that has
been made publicly available by the U.S. Government. Such publicly
available information would include any summaries or media releases
that may be posted by OIG, or another part of HHS, on their internet
website(s). It could also include additional information that may be
made publicly available about the determination by or other parts of
the U.S. Government. For example, if an actor who has exhausted
applicable administrative appeal procedures and brought action in a
Federal court for review of the decision that has become final, we
could post information on our website about the existence of the court
action and where or how to access information about the determination,
or resulting court action, that has been made publicly available by the
court. This information would provide additional context for how
information blocking conduct is impacting the nationwide health
information technology infrastructure.
In the Disincentives Proposed Rule, we stated that publicly posting
information about actors that have been determined by OIG to have
committed information blocking is important for providing transparency
into how and where information blocking conduct is occurring within and
impacting the broader nationwide health information technology
infrastructure (88 FR 74954). Between April 5, 2021, and September 30,
2023, we received over 800 claims of information blocking through the
[[Page 54679]]
Report Information Blocking Portal.\18\ We publicly post information
about these claims, which we update monthly. Beyond posting the number
of claims, the posted information includes claim counts by type of
claimant and claim counts by potential actor.\19\ While OIG has not
necessarily evaluated whether these claims qualify as information
blocking, this information provides transparency about how participants
in the nationwide health IT infrastructure perceive actions by actors
that are part of the same infrastructure, which is intended to support
the access, exchange, and use of EHI. A natural progression of the
posting of such information is the posting of information about actual
information blocking determinations by OIG, including any disincentives
applied to health care providers. This information can help the public
understand how the information blocking regulations, which seek to
prevent and address practices that unreasonably or unnecessarily
interfere with lawful access, exchange, or use of EHI through the
nationwide health IT infrastructure, are being enforced. It would also
provide clarity regarding how and where actors are engaging in
information blocking practices within the nationwide health IT
infrastructure. Based on this information, participants in the
nationwide health IT infrastructure, as well as members of the general
public, can confirm or dispel perceptions of information blocking
within that infrastructure. Additionally, the combined transparency
into the processes Congress authorized and instructed HHS to implement
(that is, ONC implementing a claims reporting process, disincentives
for applicable actors found to have committed information blocking by
OIG) would foster public confidence in the information blocking
enforcement framework and potentially encourage public participation in
that framework, whether by submitting a claim of information blocking
or participating in an OIG information blocking investigation. We
invited public comments on these proposals, including comments on
whether we should publicly post additional information (and why) about
health care providers, health IT developers of certified health IT, or
HINs/HIEs that have been determined by OIG to have committed
information blocking.
---------------------------------------------------------------------------
\18\ For more information, see: ``Information Blocking Claims:
By the Numbers,'' https://www.healthit.gov/data/quickstats/information-blocking-claims-numbers.
\19\ Ibid.
---------------------------------------------------------------------------
The following is a summary of the comments we received and our
responses.
Comments. Many commenters supported the proposal to publicly post
information about actors that have been determined to have committed
information blocking. Several commenters expressed that the proposal
would increase transparency by: providing a better understanding for
the healthcare community, including patients, about information
blocking practices and how they are assessed by HHS; providing greater
visibility to regulators and other health system stakeholders on the
gaps and barriers to information sharing; showing the degree to which
healthcare data is currently being blocked; supporting patients in
making informed decisions about future care; and providing health care
providers with information about health IT developers of certified
health IT and HINs/HIEs. Several commenters expressed that public
posting will further help prevent information blocking violations,
enhance accountability, and drive improvements.
Response. We thank commenters for the support of our proposal to
publicly post information about actors that have been determined to
have committed information blocking and, in the case of health care
providers, have been subject to a disincentive.
Comments. A few commenters supported the proposal, in 45 CFR
171.1101(a)(3), that posting of the information specified in 45 CFR
1101(a)(1) about health care providers that have been determined to
have committed information blocking and have been subject to a
disincentive would be conducted in accordance with existing rights to
review information that may be associated with the applied
disincentive. Other commenters expressed concern over not having the
ability to review what information is posted prior to the information
being publicly posted and recommended being able to review the
information for accuracy before posting. One commenter expressed
concern that health care provider information could be erroneously
posted and the burden to correct any inaccurate postings would fall
upon the provider after the fact.
Response. We thank commenters for their comments. We did not
propose a unique process by which health care providers would be
provided an opportunity to review information prior to posting on ONC's
website. The information that would be posted is basic information
about the health care provider and the information blocking
determination (for example, provider name and address, practice found
to be information blocking, disincentive(s) applied, and where to find
additional information about the determination of information blocking
that is publicly available via HHS or, where applicable, another part
of the U.S. Government) that would be derived and confirmed through the
OIG investigation and referral to CMS. HHS will work with healthcare
providers to correct any clerical errors in these information elements
to be posted prior to the information being posted on ONC's website or
to correct such information after posting.
Further, in the Disincentives Proposed Rule, we recognized that an
appropriate agency may have other program obligations related to
release of information about a participant that is a health care
provider (as defined in 45 CFR 171.102) in such programs (88 FR 74953
and 74954). On this basis, we proposed at 45 CFR 171.1101(a)(3) that
posting of the information about health care providers that have been
determined to have committed information blocking and have been subject
to a disincentive would be conducted in accordance with existing rights
to review information that may be associated with a disincentive
specified in 45 CFR 171.1001. For instance, where a health care
provider, as defined in 45 CFR 171.102, has a statutory right to review
performance information, this existing right would be exercised prior
to public posting of information regarding information blocking on the
website described above. We believe that establishing an additional
review process could potentially conflict with or duplicate these
existing statutory review rights, such as review rights provided under
MIPS at SSA section 1848(q)(9)(C).
Comments. Many comments recommended against public posting until
after a health care provider has completed an appeals process. Many
commenters also recommended not publicly posting information on the ONC
website if the actor(s) are conducting or have completed educational or
corrective steps, including providing a period of one or more years for
actors to complete corrective actions or come into compliance before
public posting.
Response. We did not propose a single administrative appeals
process for information blocking disincentives. Instead, as described
in section III.B.2. of this final rule, any right to appeal
administratively a disincentive, if available, would be provided under
the authorities used by the Secretary to establish a disincentive
through notice
[[Page 54680]]
and comment rulemaking. In proposing at 45 CFR 171.1101(a)(2) that
information will not be posted prior to a disincentive being imposed
and will not include information about a disincentive that has not been
applied, we intended to capture scenarios where a health care provider
may have a right to administratively appeal under the authority used to
establish the disincentive. Our intent was to be consistent with our
proposal for health IT developers of certified health IT and HIN/HIEs
in 45 CFR 171.1101(b)(2), which states that information will not be
posted on ONC's website until a CMP has become final consistent with
the procedures in subpart O of 42 CFR part 1003, which include
procedures for an appeal of a CMP. However, we believe that additional
clarity regarding the issue of appeals highlighted by the commenters is
necessary to ensure the language reflects our intended policy.
Therefore, we have finalized a modification to the provision in 45 CFR
171.1101(a)(2) to add that information will not be posted prior to the
completion of any administrative appeals process pursued by the health
care provider, for example, an appeals process provided for under the
authority used to establish the disincentive.
For health care providers, we note that we did not propose, and
have not finalized, corrective action options for those health care
providers that OIG has determined to have committed information
blocking, including remedial actions, to avoid public posting.
Regarding corrective action plans for health IT developers of certified
health IT or HINs/HIEs, we refer readers to the discussion in the OIG
CMP Final Rule, in which OIG states that it does not anticipate using
alternatives to CMPs such as corrective action plans at the time of the
final rule but may consider such approaches in the future (88 FR
42824).
Comments. One commenter stated that public posting should not be
implemented until all health care providers are equally disincentivized
for information blocking. Another commenter urged ONC to delay the
launch of this website until regulated health care providers and the
relevant Federal agencies have had experience with investigations and
referrals for disincentives and actors have received clearer guidance.
Response. We acknowledge commenters' concerns that this final rule
does not finalize disincentives that apply to all the types of health
care providers included in the health care provider definition at 45
CFR 171.102. However, it is important to begin providing transparency
about those health care providers to whom the disincentive(s) finalized
in this rule are applied in order to begin providing the public with
transparency about how and where information blocking is impacting the
nationwide health information technology infrastructure.
PHSA section 3001(c)(4) requires that the National Coordinator
maintain an internet website ``to ensure transparency in promotion of a
nationwide health information technology infrastructure.'' The website
where the information would appear is not a new website but rather the
current ONC website.\20\ We disagree that posting on the website should
be delayed until regulated health care providers and Federal agencies
have had experience with investigations and referrals for
disincentives. Federal agencies have experience with investigations and
referrals, and health care provider information already appears on
several websites throughout the Federal government. We also provide
data on the ONC website about claims or suggestions of possible
information blocking collected through the Report Information Blocking
Portal \21\ and education resources and guidance on the information
blocking regulations on the ONC website.\22\
---------------------------------------------------------------------------
\20\ For more information, see: https://www.healthit.gov/.
\21\ For more information, see: https://www.healthit.gov/data/quickstats/information-blocking-claims-numbers.
\22\ For more information, see: https://www.healthit.gov/topic/information-blocking.
---------------------------------------------------------------------------
Comments. Some commenters stated that posting health care provider
information is a second penalty on top of the monetary disincentive.
One commenter asked if public posting is considered a disincentive and
recommended it be classified as such. Several commenters expressed
concerns about the proposal to list the names of actors determined to
have engaged in information blocking on ONC's website, stating that
this provision will do little to advance transparency regarding the
impact of information blocking on the nationwide health information
technology infrastructure but will result in public shaming of actors
who have already been penalized for their conduct.
Response. We do not agree with commenters that publicly posting
health care provider names constitutes a disincentive. We also disagree
with commenters that the posting of health care provider names would be
sufficient to deter information blocking, consistent with our
discussion of appropriate disincentives in section III.A.3. of this
final rule. We note that the disincentives CMS proposed and has
finalized in this final rule would each potentially result in a
consequence for a health care provider that has been determined by OIG
to have committed information blocking, which CMS has stated would
deter information blocking practices. The posting of information about
health care providers that have committed blocking and been subject to
a disincentive does not reflect a consequence commensurate with an OIG
determination that the health care provider committed information
blocking or the disincentives CMS has finalized.
Last, we disagree that the posting of health care provider names
following the imposition of a disincentive as part of the information
publicly posted on ONC's website will not advance transparency about
information blocking practices. As we have stated, the purpose of
posting health care provider names is to ensure transparency in
promotion of a nationwide health information technology infrastructure,
as we explain elsewhere in this final rule.
Comments. A few commenters did not support public posting due to
the delay from when the information blocking practice may have occurred
and when the information would be publicly posted, stating that public
posting after an actor has completed corrective action would unfairly
label them information blockers and impose reputational harm after they
have already come into compliance. One commenter specifically expressed
concern with the delay in timing from when the information blocking act
may have occurred to when the information would be publicly posted,
because it may result in current health care providers operating under
an organizational TIN being punished for conduct committed by persons
who no longer operate under that TIN and that this could steer patients
away from these health care providers to the patient's detriment. A few
commenters expressed concern that a group of health care providers
could suffer reputational harm from public posting based on a single
actor, for instance, commenters expressed concerns about potential harm
from public posting information about health care providers who are not
involved in the information blocking or commit inadvertent acts.
Response. We appreciate commenters' concerns regarding the period
of time which may exist between the occurrence of the information
blocking conduct and the posting of information following the
imposition of a disincentive. We note that we did not
[[Page 54681]]
propose to establish a corrective action plan or other process to allow
any health care provider to demonstrate compliance with the information
blocking regulations following a determination by OIG that a practice
is information blocking. We also remind readers that the definition of
information blocking for health care providers requires that the health
care provider ``knows'' that a practice is unreasonable and is likely
to interfere with, prevent, or materially discourage access, exchange,
or use of electronic health information. This means there would not be
posting of unintentional, inadvertent acts of health care providers.
While a health care provider may subsequently pursue efforts to cease
the information blocking practice which resulted in the imposition of a
disincentive, it is still beneficial for the public to be able to
understand how and where information blocking is impacting the
nationwide health information technology infrastructure, including what
aspects of that infrastructure are being impacted by health care
providers.
Regarding health care providers operating under or employed by a
larger entity, we note that under the regulations we have finalized,
the information posted on ONC's website will be specific to the health
care provider that OIG has determined has committed information
blocking and that has been subject to a disincentive. If OIG determines
that a health care provider who is an individual has committed
information blocking and refers that individual to an appropriate
agency, and the individual is subject to a disincentive, ONC would post
only information regarding the individual, not any other entities with
which the individual is associated. If OIG determines that a health
care provider that is an entity, such as a group practice, has
committed information blocking, and the entity is subject to a
disincentive, ONC would post information about the entity.
Comments. Some commenters recommended ONC use certain criteria or
thresholds in order to decide whether to publicly post information
about a health care provider for information blocking. Commenters
recommended that ONC consider the following factors before determining
whether to publicly post information, including: whether there is
frequent, repeat, or significant information blocking, as opposed to
minor conduct undertaken in good faith; whether the public would
benefit from the information; whether the actor has corrected the
information blocking; and time since the information blocking occurred.
Other commenters recommended drawing greater attention to repeat
offenders and actors who continue to perform the same type of
information blocking for an extended period of time over actors who had
a single violation that they remediated quickly.
Response. We appreciate commenters' suggestions, but we did not
propose to utilize criteria to determine whether to publicly post
information about a health care provider and decline to adopt them in
this final rule. We believe it is important to provide transparency
with respect to any determination of information blocking that has
resulted in a health care provider being subject to a disincentive in
order to increase understanding about how and where information
blocking is impacting the nationwide health information technology
infrastructure, including the scope of information blocking practices
that have resulted in disincentives.
Regarding the suggested factor which referenced ``minor conduct
undertaken in good faith,'' we remind readers, as we did in a prior
response, that information blocking has an element of intent. For
health care providers, that intent is that the health care provider
knows that a practice is unreasonable and is likely to interfere with,
prevent, or materially discourage access, exchange, or use of
electronic health information.
We also remind readers that, as discussed in III.B.1.a. of this
final rule, OIG expects to use four priorities to inform decisions
about which information blocking allegations to pursue: (i) resulted
in, are causing, or have the potential to cause patient harm; (ii)
significantly impacted a provider's ability to care for patients; (iii)
were of long duration; and (iv) caused financial loss to Federal health
care programs, or other government or private entities. However, these
priorities are not dispositive. OIG will assess each allegation to
determine whether it implicates one or more of the enforcement
priorities, or otherwise merits further investigation and potential
enforcement action, and OIG may evaluate allegations and prioritize
investigations based in part on the volume of claims relating to the
same (or similar) practices by the same entity or individual.
Comments. A few commenters recommended that only deidentified actor
information be posted, at least initially. One commenter did not
support public posting of obstetrician-gynecologists' names, practice
information and information blocking determination, expressing concern
about criminalization and scrutiny of reproductive healthcare data. One
commenter recommended that rather than listing the details of
information blockers, ONC list all health care providers who are
successfully exchanging information.
Response. We disagree with the commenter that only deidentified
actor information should be publicly posted. The identification of
health care providers that have committed information blocking is
important for the public to be aware of the particular circumstances in
which information blocking is occurring and, therefore, to understand
which aspects of the nationwide health information technology
infrastructure are being impacted. We also disagree with the commenter
that we should not publicly post information regarding obstetrician-
gynecologists. If a health care provider has been determined by OIG to
have committed information blocking and is subject to a disincentive,
we will post information regardless of their specialty or practice. To
promote transparency, we believe it is important to release information
about actors that have been determined by OIG to have committed
information blocking to inform the public about how and where
information blocking is occurring within the broader health information
technology infrastructure. For more information about concerns
regarding withholding electronic health information related to
reproductive health care, we refer readers to a May 13, 2024, blog post
on ONC's website \23\ that explains how the ``HIPAA Privacy Rule to
Support Reproductive Health Care Privacy'' final rule (89 FR 32976),
which appeared in the Federal Register on April 26, 2024, and the
information blocking regulations work together to protect the privacy
of such health information.
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\23\ See: https://www.healthit.gov/buzz-blog/information-blocking/supporting-information-privacy-for-patients-now-and-always-four-reminders-of-how-hhs-information-blocking-regulations-recognize-privacy-rules.
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Regarding the recommendation to post information about those health
care providers that are successfully exchanging information, we note
that we did not propose to do so in the Disincentives Proposed Rule and
decline to finalize such a policy in this final rule. We also note that
some of this type of information may be made available through existing
mechanisms. For instance, the Medicare Promoting Interoperability
Program and MIPS Promoting Interoperability performance category
involve public reporting components about health care provider
performance in these programs, which
[[Page 54682]]
can reflect successful performance on measures of health information
exchange that contribute to performance under these programs.
Comments. A few commenters recommended posting the year or
timeframe in which the information blocking violation occurred. Several
commenters recommended establishing a time limit on posting the
information to the website by which to remove health care providers
from the information blocking list on the website.
Response. We thank commenters for the recommendation to include the
timeframe during which the information blocking occurred as part of the
information we are publicly posting. We stated in the Disincentive
Proposed Rule that we sought to help the public understand ``how'' and
``where'' information blocking is occurring within the broader health
information technology infrastructure (88 FR 74953). We agree that
information about when information blocking occurred is a critical
piece of information and that this concept is implicit in our interest
in providing transparency regarding ``how'' and ``where'' information
blocking occurred to support understanding of the scope of information
blocking practices over time that impact the nationwide health
information technology infrastructure. To this point, knowing when
information blocking occurred is part of knowing how it occurred.
Without this information, the public, including other health care
providers, would not know whether a particular practice determined to
be information blocking was a recent occurrence that may have
implications for their own recent or current interactions with the
health care provider that was found to have committed information
blocking; or whether the practice occurred at a time when such health
care providers had no interactions with the health care provider found
to have committed information blocking. Therefore, we agree with
commenters that it would be appropriate to explicitly identify the
timeframe as part of the ``description of the [information blocking]
practice'' that we proposed to include in the information for posting
in 45 CFR 171.1101(a)(1)(iii) for health care providers and 45 CFR
171.1101(b)(1)(iii) (88 FR 74954). Accordingly, we have modified the
language in 45 CFR 171.1101(a)(1)(iii) and 45 CFR 171.1101(b)(1)(iii)
to clarify that the description of the practice includes when the
practice occurred.
We did not propose to put a time limit on how long the information
would be posted on ONC's website, and we are not adopting the
commenter's recommendation. We may consider this recommendation in
future rulemaking.
Comments. One commenter expressed concern that HHS could further
use the posted information to apply additional disincentives or bar a
physician from participation in other programs and that additional
rulemaking would be needed for such uses.
Response. We appreciate the commenter's concern; however, we note
that the imposition of a disincentive would be based on a referral from
OIG of its determination that a health care provider committed
information blocking, rather than the public posting of information on
ONC's website. Moreover, we note that we have finalized that the
disincentives established for health care providers pursuant to PHSA
section 3022(b)(2)(B) are listed in 45 CFR 171.1001. Other actions not
listed in 45 CFR 171.1001 taken by Federal programs based on the
information publicly posted on ONC's website would not be a
disincentive and are outside the scope of this final rule.
Comments. One commenter stated that public posting of information
would lead to unintended consequences such as distrust or an
adversarial relationship between actors subject to the information
blocking regulations and HHS. Another commenter expressed concern that
public posting, combined with the potential for significant
disincentives, would deter information blocking complaints. The
commenter stated that the health data interoperability community is
dependent upon good working relationships between individuals and
organizations that operate in the space and that a complainant may
refrain from submitting information blocking claims in order to
maintain a good relationship with the individual or entity alleged to
have committed information blocking.
Response. We appreciate commenters' input but believe that the
value of publicly posting this information outweighs any concerns about
increasing distrust between health care providers and HHS or between
health care providers and other entities supporting health information
exchange. We note that information blocking negatively impacts health
care providers by limiting access to electronic health information that
may be necessary for effective care delivery and suggest that all
parties committed to increasing the exchange of electronic health
information should support the public availability of information about
how and where information blocking is impacting the nationwide health
information technology infrastructure.
After consideration of the public comments, we have finalized these
proposals with the modifications discussed above.
C. Appropriate Disincentives for Health Care Providers
In the Disincentives Proposed Rule, we proposed to establish a set
of disincentives for health care providers that have committed
information blocking (88 FR 74954 through 74966). We noted that each of
the proposed disincentives would be imposed by CMS following a referral
of a determination of information blocking by OIG. We stated that each
of the disincentives was being proposed using authorities under
applicable Federal law, consistent with PHSA section 3022(b)(2)(B).
1. Background
a. Impacted Health Care Providers
In the Disincentives Proposed Rule, we stated that the proposed
disincentives would apply to a subset of the individuals and entities
meeting the information blocking regulations' definition of health care
provider at 45 CFR 171.102 (88 FR 74954 and 74955). As discussed
hereafter, this rule establishes disincentives for health care
providers (as defined in 45 CFR 171.102) that are also eligible to
participate in certain Federal programs: the Medicare Promoting
Interoperability Program and the MIPS Promoting Interoperability
performance category (previously the EHR Incentive Programs); and the
Medicare Shared Savings Program.
In the Disincentives Proposed Rule, we recognized that the
disincentives proposed would only apply to certain health care
providers and that the information blocking regulations are also
applicable to health care providers that are not eligible to
participate in these programs (88 FR 74955). However, the policies we
have finalized in this rule are a first step that focuses on
authorities that pertain to certain health care providers that furnish
a broad array of healthcare services to large numbers of Medicare
beneficiaries and other patients. We believe optimal deterrence of
information blocking calls for imposing appropriate disincentives on
all health care providers (as defined at 45 CFR 171.102) determined by
OIG to have committed information blocking. In section IV. of this
final rule, we acknowledge public comments received in response to a
request for information on establishing disincentives, using applicable
Federal law, that could be
[[Page 54683]]
imposed on a broader range of health care providers.
b. Impact of Disincentives
In the Disincentives Proposed Rule, we stated that we believe the
proposed disincentives would deter information blocking by health care
providers. However, we recognized that the actual monetary impact
resulting from the application of the disincentives may vary across
health care providers subject to the disincentive (88 FR 74955). For
example, the disincentive proposed in section III.C.3. of the
Disincentives Proposed Rule, for the MIPS Promoting Interoperability
performance category, would result in an adjustment to payments under
Medicare Part B to MIPS eligible clinicians (as defined in 42 CFR
414.1305). This disincentive would reduce to zero the Promoting
Interoperability performance category score of any MIPS eligible
clinician that has been determined by OIG to have committed information
blocking (as defined at 45 CFR 171.103) during the calendar year (CY)
of the referral of a determination from OIG. However, the actual
financial impact experienced by a health care provider because of this
proposed disincentive being applied in MIPS would vary. For example,
Part B payments to the MIPS eligible clinician are subject to a MIPS
payment adjustment factor, which CMS determines based on the MIPS
eligible clinician's final score. We noted that, in determining each
MIPS eligible clinician's final score, CMS considers the assigned
weight of, and the MIPS eligible clinician's performance in, the four
MIPS performance categories, including the Promoting Interoperability
performance category. The MIPS eligible clinician's final score then
determines whether the eligible clinician earns a negative, neutral, or
positive payment adjustment factor that will be applied to the amounts
otherwise paid to the MIPS eligible clinician under Medicare Part B for
covered professional services during the applicable MIPS payment year
(88 FR 74955).
In the interest of addressing this variability, we discussed in the
Disincentives Proposed Rule that we had considered whether we could
propose an alternative approach under which we would tailor the
monetary impact of a disincentive imposed on a health care provider to
the severity of the conduct in which the health care provider engaged
(88 FR 74955). However, we stated that we did not believe it would be
feasible to develop such an approach for the disincentives proposed for
health care providers. We noted that, because disincentives must be
established using authorities under applicable Federal law, the statute
under which a disincentive is being established would need to
specifically authorize or provide sufficient discretion for an
appropriate agency to be able to adjust the monetary impact of the
disincentive to fit the gravity or severity of the information blocking
the health care provider has been determined to have committed. We
noted that, based on our review of potential authorities under which to
establish disincentives, we believed many authorities do not provide
discretion to adjust the monetary impact of a potential disincentive in
this fashion. For instance, in the Disincentives Proposed Rule, CMS
proposed to establish a disincentive through the Medicare Promoting
Interoperability Program utilizing authority in SSA section 1886 (88 FR
74955). Under this authority, CMS, as specified in section
1886(b)(3)(B)(ix)(I) of the SSA, adjusts payments for eligible
hospitals by a fixed proportion, based on whether or not an eligible
hospital (as defined in section 1886(n)(6)(B) of the SSA) is a
meaningful EHR user.
We did not make any proposals in this section of the Disincentives
Proposed Rule; however, we summarize and respond below to general
comments that we received on this discussion.
Comments. Some commenters expressed support for disincentives for
health care providers who have been found to have committed information
blocking. These commenters expressed that these disincentives will lead
to better patient outcomes, improved information sharing, increased
transparency, a reduction in systemic inefficiency and waste, and
improved accountability and compliance. Some commenters agreed that the
three programs described in the Disincentives Proposed Rule (that is,
the Medicare Promoting Interoperability Program for eligible hospitals
and CAHs, the Promoting Interoperability performance category of MIPS,
and the Medicare Shared Savings Program) are appropriate programs under
which to establish disincentives.
Response. We thank commenters for their support of the proposed
disincentives.
Comments. One commenter expressed that the proposed disincentives
impose substantial punishments on health care providers found to have
engaged in information blocking and thereby exceed the regulatory
authorities delegated to HHS agencies by Congress. The commenter stated
that the term ``disincentivize'' means the act of creating a
disincentive or withdrawing a previously existing incentive. However,
the commenter stated that the Disincentives Proposed Rule proposed
penalties that would impose significant punishments on health care
providers found to have engaged in information blocking. The commenter
cited West Virginia v. EPA,\24\ to suggest that the rule ``may'' have
the type of significant impact that requires Congress explicitly to
grant regulatory power to the agency.
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\24\ 597 U.S. 697 (2022).
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Response. We disagree that the disincentives that CMS has finalized
in section III.C. of this final rule exceed the regulatory authority
Congress granted to the Secretary in the Cures Act. Section 4004 of the
Cures Act amended the PHSA to create section 3022(b)(2)(B), which
states that a health care provider ``shall be referred to the
appropriate agency to be subject to appropriate disincentives using
authorities under applicable Federal law, as the Secretary sets forth
through notice and comment rulemaking.'' The commenter does not dispute
that each of the disincentives CMS proposed and has finalized in this
section (III.C.) use authorities under applicable Federal law, and we
are adopting each disincentive through this notice-and-comment
rulemaking. The agency is applying existing authorities to individuals
and entities that are already subject to them, to disincentivize one
set of prohibited behaviors. This is not one of the ``extraordinary
cases'' in which the ``history and the breadth of the authority that
the agency has asserted, and the economic and political significance of
that assertion'' merits increased scrutiny.\25\ Even if it did, the
statute has specifically delegated responsibility for establishing
appropriate disincentives to the Secretary of HHS, through notice and
comment rulemaking, and so provides all express authorization that
might be needed.
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\25\ West Virginia v. EPA, 597 U.S. 697, 721 (2022).
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The commenter reads the term ``disincentive'' to exclude penalties
or punishment. We agree that we should account for statute's use of the
term ``disincentives.'' We do so by adopting a definition of
``disincentive'' in 45 CFR 171.102 that includes conditions imposed by
an appropriate agency on a health care provider that OIG determines has
committed information blocking, for the purpose of deterring
information blocking. A disincentive could be any condition that would
have a deterrent effect on information blocking, as explained in
section III.A.3. of this final rule. But we reject the commenter's
effort to draw a strict line between deterrence and punishment.
[[Page 54684]]
Those two concepts are often interrelated.\26\
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\26\ See Exxon Shipping Co. v. Baker, 554 U.S. 471, 493 (2008),
(noting one ``aim'' of ``punishment'' is ``deterrence''); Hudson v.
United States, 522 U.S. 93, 102 (1997), (``[A]ll civil penalties
have some deterrent effect.'').
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Finally, CMS has finalized disincentives that are designed to deter
information blocking; they are not impermissibly punitive. As discussed
in section III.C.2. of this final rule, a reduction of three quarters
of the annual market basket update deters eligible hospitals from
engaging in information blocking because it would reduce the inpatient
prospective payment system (IPPS) payment that an eligible hospital
could have earned had it met other requirements under the Medicare
Promoting Interoperability Program. For CAHs, receiving 100 percent of
reasonable costs instead of the 101 percent of reasonable costs that a
CAH may have earned for successful participation in the Medicare
Promoting Interoperability Program deters information blocking by CAHs
because it reduces the reimbursement a CAH could have received had it
met other requirements under the Medicare Promoting Interoperability
Program. For MIPS eligible clinicians, the disincentive under the MIPS
Promoting Interoperability performance category deters information
blocking by other MIPS eligible clinicians because a MIPS eligible
clinician who receives a score of zero in the MIPS Promoting
Interoperability performance category under the disincentive cannot
earn a positive MIPS payment adjustment factor that they otherwise
could have earned for their performance in MIPS (88 FR 74960). Finally,
the disincentive CMS has finalized under the Shared Savings Program
deters information blocking by potentially withholding revenue which an
ACO or participant in an ACO might otherwise have earned through
participation in the Shared Savings Program.
Comments. Many commenters expressed concern that the proposed
disincentives will have a differential impact, are variable and
confusing, and are not equitable across programs, circumstances of
individual health care providers, and years. A few commenters expressed
concern that there would be a much greater burden for clinicians in the
Shared Savings Program compared to clinicians who are only subject to
disincentives under the MIPS Promoting Interoperability performance
category, because the monetary disincentive would be much greater for
Shared Savings Program clinicians and would potentially interrupt care
coordination and harm Medicare beneficiaries' care. Others stated that
hospitals could be disproportionately impacted, citing concerns about
the high variability of disincentive amounts that could be imposed on
hospitals based on the market basket increase in a given year and the
proportion of Medicare patients served. Commenters also noted that
hospitals face unique financial and operational challenges, such as
narrow operating margins and minimal reserves. Several commenters
expressed concern that disincentives would lead to a larger burden and
impact for health care providers with a larger proportion of Medicare
claims, patients, and reimbursement. Several commenters expressed
concern that disincentives would vary from year to year based on the
value of the market basket adjustment and certain performance
incentives in a given year. A few commenters specifically expressed
concern that variation in disincentives between referral years could be
based on how quickly OIG processes the case and refers it to CMS for
action.
Response. We understand commenters' concerns about the potential
for the disincentives CMS has finalized in this rule to vary based on
factors related to the circumstances of the health care provider, such
as the amount of Medicare reimbursement received. However, under PHSA
section 3022(b)(2)(B), we must establish disincentives ``using
authorities under applicable Federal law.'' As discussed in section
III.A.2. of this final rule, we may therefore only establish, through
notice and comment rulemaking, a disincentive for health care providers
using an authority Congress has previously granted to an appropriate
agency. Where these authorities result in differential treatment of a
health care provider based on the health care provider's circumstances
or based on changes to the regulations promulgated under that authority
over time, these elements will ultimately impact the value of the
disincentive established under that authority. We acknowledged this
variability, providing a specific example with respect to the MIPS
Promoting Interoperability performance category, in the Disincentives
Proposed Rule (88 FR 74955).
However, we disagree that this variability is a compelling reason
to not establish a certain disincentive. Such variability already
exists as part of these programs. For instance, the monetary impact on
an eligible hospital that is not a meaningful EHR user because it fails
to meet the objectives and measures associated with the Medicare
Promoting Interoperability Program will be higher for an eligible
hospital that receives a greater volume of Medicare payment than an
eligible hospital that receives a lower volume of Medicare payment.
Under section 1886(b)(3)(B)(ix) of the SSA, if an eligible hospital
does not demonstrate that it has met the requirements to be a
meaningful EHR user under section 1886(n)(3)(A), CMS reduces the
eligible hospital's payment by three quarters of the applicable
percentage increase in the market basket update or rate-of-increase for
hospitals. Under SSA 1886(b)(3)(B), the market basket update is a
percentage applied to a hospital's base operating cost, meaning that
the monetary value of the market basket update depends on the
hospitals' base operating cost. This variability is integrated into the
authority Congress established for the program, and Congress has
required the Secretary to establish appropriate disincentives using
authorities under Federal law.
We further disagree with the commenters that ensuring equitable
treatment across programs is necessary to finalize the disincentives we
are establishing in this final rule. The authorities under which we
have finalized disincentives require health care providers to satisfy
certain requirements in order to participate in a program that may
provide incentives or other benefits. In the case of the MIPS Promoting
Interoperability performance category and the Medicare Promoting
Interoperability Program, eligible clinicians, and eligible hospitals
and CAHs, have the opportunity earn positive Medicare payment
adjustments as specified under each authority. Under the Shared Savings
Program, ACOs, ACO providers/suppliers, and participants have the
opportunity to earn additional revenue through participation in an ACO
if the ACO meets the requirements to earn shared savings payments.
As discussed in section III.C., by committing information blocking,
a health care provider is engaging in behavior that conflicts with core
requirements of each of these programs. Health care providers that
participate in CMS programs offering opportunities to receive positive
payment adjustments or additional revenue take on increased
responsibilities associated with these programs. To deter information
blocking, we believe that where a health care provider commits
information blocking, it should not receive these benefits, consistent
with the increased responsibilities that these programs impose. Thus,
as discussed by CMS under each part of this section (III.C.) in which
it has finalized a disincentive,
[[Page 54685]]
each of these disincentives is warranted under the authorities that CMS
has used to establish the disincentive.
Comments. Many commenters expressed concern that the proposed
disincentives could be extreme or harsh for health care providers. A
few commenters expressed concern that the burden of health care
provider information blocking disincentives would be greater for
smaller, safety net, and less resourced health care providers. One
commenter expressed concern that the disincentives would create extra
burden for health care providers or sites of service that lack
experience with electronic health records.
Response. We appreciate commenters' concerns regarding the
potential impact of the proposed disincentives, especially on smaller
health care providers. However, we remind readers that, as noted in
section III.A.3. of this final rule, we believe that disincentives
should have the effect of deterring information blocking practices. We
also remind readers that, in order for a practice by a health care
provider to be considered information blocking under PHSA section
3022(a), the health care provider must know that ``such practice is
unreasonable and is likely to interfere with, prevent, or materially
discourage access, exchange, or use of electronic health information.''
Therefore, we believe that health care providers can avoid the burden
of the finalized disincentives by not engaging in information blocking,
including conduct that the health care provider knows is unreasonable.
Finally, we note that certain authorities used by CMS to finalize
disincentives in this final rule include policies which already reflect
the size of the health care provider, such as payment adjustments which
reflect the volume of payments received by a health care provider under
Medicare.
Regarding the comment that disincentives will create additional
burden for health care providers that lack experience with electronic
health records, we understand that commenters are concerned that a
health care provider could be determined to have committed information
blocking due to a lack of knowledge or expertise about technology tools
used to exchange of electronic health information. However, we wish to
emphasize that for a practice committed by a health care provider to
meet the definition of information blocking, the health care provider
must know that such practice is unreasonable, as discussed above.
Comments. Many commenters expressed concern that the proposed
disincentive structure does not provide flexibility for HHS to apply
disincentives that are reasonable, appropriate, and proportional for
the specific instance of information blocking. Many commenters
recommended that disincentives should be tailored to the severity or
frequency of conduct, or the degree to which the conduct resulted in
patient harm. Other commenters suggested tailoring disincentives based
on other factors such as: whether the health care provider participates
in an HIE; whether a health care provider made a good faith attempt to
not engage in information blocking or comply with an exception; whether
the health care provider made proactive efforts to promote access to
information; state-specific circumstances affecting the health care
provider; and whether the health care provider is engaged in
complicated medical areas, such as reproductive and gender-affirming
care. Commenters expressed that tailoring disincentives in this way
would increase the proposed policy's effectiveness and reduce
disproportionate impact. Some commenters recommended including a
maximum disincentive amount to ensure health care providers are not
unduly penalized. Commenters stated that although the Cures Act
requires the disincentives to be made ``using authorities under
applicable Federal law,'' such language could permit different
disincentive thresholds, scaling, or other ways to establish and
appropriately calibrate financial penalties. A few commenters
recommended that the alternative policy discussed in the Disincentives
Proposed Rule for the Shared Savings Program, in which CMS would review
other facts and circumstances of the case should be applied for all
health care provider information blocking disincentives to allow for
consideration of frequency, severity, and intent and to allow for
remediation.
Response. We acknowledge commenters' recommendations to link the
impact of disincentives to different factors, such as the severity or
scale of the conduct. As discussed in the Disincentives Proposed Rule,
we considered whether we could propose an alternative approach under
which we would tailor the monetary impact of a disincentive imposed on
a health care provider to the severity of the conduct in which the
health care provider engaged (88 FR 74955). However, we stated that,
because disincentives must be established using authorities under
applicable Federal law, the statute under which a disincentive is being
established would need to specifically authorize or provide sufficient
discretion for an appropriate agency to be able to adjust the monetary
impact of the disincentive to fit the gravity or severity of the
information blocking the health care provider has been determined to
have committed. We further noted that, based on our review of potential
authorities under which to establish disincentives, many authorities do
not provide discretion to adjust the monetary impact of a potential
disincentive in this fashion (88 FR 74955). For instance, as discussed
in the Disincentives Proposed Rule, the authority we used in section
1886(b)(3)(B)(ix)(I) of the SSA to establish a disincentive under the
Medicare Promoting Interoperability Program does not allow for such
discretion (88 FR 74955).
In the case of the Shared Savings Program, CMS has finalized a
policy based on an alternative proposal discussed in the Disincentives
Proposed Rule. This policy will allow the Shared Savings Program to
exercise discretion about whether or not to impose a disincentive based
on certain factors, consistent with existing discretion exercised by
the Shared Savings Program when addressing program integrity issues and
issues specific to the effects of imposing a disincentive under the
Shared Savings Program on other individuals and entities that may
participate in an ACO. CMS states in section III.C.4. that these
factors include the time since the information blocking conduct
occurred and whether the ACO or provider/supplier has taken steps to
mitigate this conduct. However, it is important to note that CMS has
finalized this as a policy specific to the Shared Savings Program.
For disincentives established under the Medicare Promoting
Interoperability Program and the MIPS Promoting Interoperability
performance category, which have been established under different
authorities in the SSA, CMS did not propose and has not finalized to
take such factors into consideration before imposing a disincentive.
Comments. Many commenters recommended that steps such as initial
notices or warnings of non-compliance, education, corrective action,
and technical assistance be utilized before applying a disincentive for
a health care provider found to have committed information blocking.
Several commenters recommended that education and technical assistance
should be provided before applying a disincentive for specific health
care providers, including health care providers that disproportionately
serve low-income, minority, underserved, or
[[Page 54686]]
immigrant populations; solo and small practitioners; and other less
resourced health care providers. Some commenters recommended these
steps should be used until health care providers gain experience with
the information blocking requirements or for first time offenders.
Commenters recommended these steps for a number of reasons, including:
the information blocking requirements are new and complex and many
health care providers do not yet fully understand the requirements;
most information blocking is inadvertent and should not be subject to
significant penalties as an initial step; such steps could avoid
potential negative impacts on patient access and Medicare
participation; and corrective steps before a disincentive would better
promote information sharing and prevent future information blocking
violations.
Many commenters expressed that such approaches would be consistent
with other HHS and CMS programs and policies that allow for education
and corrective steps. A few commenters expressed that the terminology
used in PHSA section 3022(b)(2)(B), ``appropriate disincentives,''
allows HHS to establish disincentives other than financial
disincentives. One commenter stated that the programs HHS is proposing
to establish disincentives for already have the authority to provide
health care providers with opportunities for corrective action,
education, and learning periods before imposing disincentives.
Response. We appreciate the commenters' recommendations to provide
for corrective action plans, technical assistance, or other activities
for health care providers that have been determined by OIG to have
committed information blocking. We note that we did not propose, and
have not finalized, that elements such as individualized or corrective
action would be generally available to any health care provider that
OIG has determined to have committed information blocking. Nor did we
propose that activities such as corrective action plans or technical
assistance would be generally available to certain types of health care
providers, such as less-resourced providers or first-time offenders.
Commenters did not identify a separate authority under which to
establish the general availability of a corrective action plan process
for any health care provider that has been determined by OIG to have
committed information blocking. We note that in section III.C.4. of
this final rule, CMS has finalized that, prior to imposing a
disincentive under the Shared Savings Program, it will take into
consideration any evidence that indicated whether conduct that resulted
in a determination of information blocking had been corrected and
appropriate safeguards had been put in place to prevent its
reoccurrence.
Regarding commenters' suggestions to provide education and
technical assistance before applying a disincentive for health care
providers that are smaller, less resourced, or care for specific
populations, we note that any considerations with respect to how an
appropriate disincentive should impact health care providers with
certain attributes would be addressed by the appropriate agency
establishing the disincentive. In section III.A.1, an appropriate
agency, in establishing a disincentive, could retain or implement
policies based on the type of health care provider subject to the
disincentive, including small practices, consistent with the agency's
authority. For instance, in section III.A.3. of this final rule we
discuss existing regulations under the MIPS Promoting Interoperability
performance category which pertain to small practices.
Regarding commenters' suggestion to not impose disincentives on
``first-time offenders'' and instead utilize a corrective action plan,
we note that such a policy ignores both the intent standard for a
finding of information blocking by a health care provider and how any
disincentive may impact a provider's behavior. To engage in information
blocking, a health provider must know that the practice was
unreasonable and that the practice was likely to interfere with,
prevent, or materially discourage the access, exchange, or use of EHI.
This intent standard supports establishing disincentives that would
appropriately address and deter such culpable actions by health care
providers. Further, creating a blanket policy that would give each
health care provider a ``free offense'' could incentivize providers not
to refrain from committing information blocking until they are caught.
We do not believe that is the type of ``disincentive'' required by the
statute.
Comments. A few commenters recommended considering whether a health
care provider has self-disclosed a violation before applying a
disincentive. Several commenters recommended offering a self-disclosure
protocol (SDP).
Response. We appreciate the commenters' recommendations. The Cures
Act did not require, and we did not propose, to establish a self-
disclosure protocol for health care providers who have committed
information blocking. We note that OIG stated in the OIG CMP Final Rule
that it would make a self-disclosure protocol available to those actors
seeking to resolve their information blocking CMP liability (88 FR
42824 and 42825). However, we do not believe a self-disclosure protocol
would be feasible with respect to the finalized disincentives for
health care providers. An appropriate agency's ability to adjust a
disincentive to reflect the severity of the underlying information
blocking conduct is dependent on whether the authority under applicable
Federal law used to establish the disincentives allows for such an
adjustment, consistent with section 3022(b)(2)(B) of the PHSA. For
instance, as discussed previously, we are unable to adjust the amount
of the reduction in the market basket increase, which is the basis for
the disincentive finalized under the Medicare Promoting
Interoperability Program in section III.C.2. of this final rule. With
respect to this finalized disincentive, a self-disclosure protocol
would have limited utility as we would be unable to adjust a health
care provider's ``liability''.
Comments. One commenter requested clarification of whether the
proposed disincentive structure allows CMS to determine whether to
apply a disincentive once it receives a referral from OIG, and if so,
if CMS can determine to which program or programs a disincentive may
apply (for example if a physician works in a hospital).
Response. Under PHSA section 3022(b)(2)(B), as discussed in section
III.A.2. of this final rule, disincentives must be established using
authorities under applicable Federal law, as the Secretary sets forth
through notice and comment rulemaking. As we have finalized in section
III.A., a health care provider who has committed information blocking
and is referred by OIG to an appropriate agency could be subject to
each disincentive established by the appropriate agency that is
applicable to the health care provider. CMS has finalized in the Shared
Savings Program a policy in this final rule under which it will
consider certain factors prior to taking action against an ACO, ACO
participant, or ACO provider/supplier, consistent with existing
processes in the Shared Savings Program. CMS did not propose and has
not finalized a policy to consider additional factors prior to imposing
the disincentives being finalized under the Medicare Promoting
Interoperability Program and the MIPS Promoting Interoperability
performance category.
Comments. Some commenters expressed concern about the unintended
consequences of the proposed
[[Page 54687]]
disincentives. Commenters suggested that the proposed disincentives may
discourage health care providers from participating in the Medicare
programs, including quality and value-based programs. Additionally,
commenters expressed that health care providers who receive a greater
proportion of their payments from Medicare would be exposed to greater
financial risk under the proposed disincentives and would therefore be
disincentivized to treat Medicare beneficiaries. Commenters also stated
that the financial impacts of the proposed disincentives could: cause
hospitals and health systems to disinvest from health IT; reduce the
ability to report existing interoperability measures; increase
financial risk for already precarious health care providers; impact
access to care; increase documentation burden for health care providers
to demonstrate they are not information blocking; reduce physician
morale; and increase burnout. A few commenters recommended that HHS
design disincentives through collaboration with interested parties.
Others recommended that if HHS implements the rule as proposed that it
monitor for potential unintended consequences and impacts of the
disincentives on deterring information blocking.
Response. We appreciate the commenters' concerns, but we disagree
that establishing disincentives will discourage participation in these
programs. Each of the programs for which CMS has finalized
disincentives already requires health care providers to meet certain
requirements, which they have been willing to meet in order to
potentially earn the incentives or benefits associated with these
programs. To avoid the disincentives finalized by CMS in this rule,
health care providers do not need to complete any additional program
requirements beyond refraining from conduct that meets the definition
of information blocking in the information blocking regulations, which
have been effective since April 5, 2021 (85 FR 70066). Due to the lack
of significant administrative burden associated with disincentives, we
do not believe finalizing these policies will lead to significant
numbers of health care providers forgoing the opportunity to earn the
incentives or benefits available from the programs under which we have
finalized disincentives.
Comments. Several commenters recommended other authorities under
which to propose disincentives, or programs that should serve as models
for disincentives. These included: the Administrative Simplification
provisions of HIPAA; CMS Conditions of Coverage and Conditions of
Participation; electronic prescribing of controlled substances (EPCS)
disincentives for certain health care provider types; and CMS' Improper
Payment Measurements Program's Payment Error Rate Measurement's (PERM).
Commenters identified aspects of these programs that they asserted
would be desirable as part of the implementation of disincentives, such
as: education and corrective action plans to allow actors to resolve
liability; non-punitive methods of resolution; a warning and grace
period prior to penalties similar to warnings provided for price
transparency requirements; and a tiered approach depending on the
severity of the violation, which they stated would result in
appropriate disincentives and a more just determination.
Response. We thank commenters for their recommendations and may
consider them for future rulemaking.
We did not make any proposals and have not finalized any policies
in this section.
2. Medicare Promoting Interoperability Program for Eligible Hospitals
and Critical Access Hospitals (CAHs)
a. Background
In the Disincentives Proposed Rule, CMS stated that we intended to
use existing Medicare Promoting Interoperability Program authority
concerning the meaningful use of certified EHR technology (CEHRT) to
impose disincentives on eligible hospitals and CAHs that OIG determines
have committed information blocking (defined in 45 CFR 171.103) and for
which OIG refers a determination to CMS (88 FR 74955). Under section
1886(n)(3)(A) of the SSA, an eligible hospital or CAH \27\ is treated
as a meaningful EHR user for the EHR reporting period for a payment
year if it demonstrates to the satisfaction of the Secretary, among
other requirements, that during the EHR reporting period: (1) the
eligible hospital used CEHRT in a meaningful manner; and (2) the CEHRT
is connected in a manner that provides, in accordance with law and
standards applicable to the exchange of information, for the electronic
exchange of health information. In the Disincentives Proposed Rule, CMS
stated that the requirements for an eligible hospital or CAH to be a
meaningful EHR user would be substantially undermined and frustrated if
the eligible hospital or CAH commits information blocking, such that
application of an appropriate disincentive is warranted (88 FR 74955).
---------------------------------------------------------------------------
\27\ Section 1814(l)(3) of the SSA applies to critical access
hospitals the standard for determining a meaningful EHR user in
section 1886(n)(3).
---------------------------------------------------------------------------
Under section 1886(b)(3)(B)(ix) of the SSA, if an eligible hospital
does not demonstrate that it has met the requirements to be a
meaningful EHR user under section 1886(n)(3)(A), CMS will reduce the
eligible hospital's payment by three quarters of the applicable
percentage increase in the market basket update, or rate-of-increase
for hospitals. Under section 1814(l)(4) of the SSA, if the Secretary
determines that a CAH has not been a meaningful EHR user for a given
EHR reporting period, CMS will pay that CAH 100 percent of its
reasonable costs, instead of 101 percent of reasonable costs, which is
the amount that the CAH would have received as a meaningful EHR user
under the Medicare Promoting Interoperability Program.
As discussed in the Disincentives Proposed Rule, HHS has authority
to apply disincentives to both eligible hospitals and CAHs (88 FR
74955). PHSA section 3022(b)(2)(B) authorizes HHS to apply
disincentives to health care providers OIG determines have committed
information blocking. As discussed in section II.B.1 of the
Disincentives Proposed Rule, HHS has adopted, for purposes of the
information blocking regulations in 45 CFR part 171, the definition of
health care provider in section 3000(3) of the PHSA, which includes
health care providers that are eligible for participation in the
Medicare Promoting Interoperability Program (88 FR 74949 and 74950).
The definition of ``health care provider'' in section 3000(3) of the
PHSA includes ``hospital'' as a health care provider. Section
1886(n)(6)(B) of the SSA defines the term ``eligible hospital'' for the
purposes of the Medicare Promoting Interoperability Program (75 FR
44316 and 44317) as ``a hospital that is a subsection (d) hospital or a
subsection (d) Puerto Rico hospital.'' Eligible hospitals are in one of
the fifty States or the District of Columbia (75 FR 44448). Hospitals
in Puerto Rico became eligible hospitals for the Medicare Promoting
Interoperability Program with the passage of the Consolidated
Appropriations Act of 2016 (Pub. L. 114-113, Dec. 18, 2015). A CAH is
defined in section 1861(mm) of the SSA as ``a facility that has been
certified as a critical access hospital under section 1820(e).''
``Hospital'' is not further defined under the PHSA definition in
section 3000(3). Therefore, CMS interprets the term ``hospital'' in
section 3000(3) of the PHSA to include both eligible hospitals and CAHs
that are
[[Page 54688]]
eligible to participate in the Medicare Promoting Interoperability
Program.
b. The Medicare Promoting Interoperability Program as an Appropriate
Disincentive for Information Blocking Under the PHSA
As discussed in the Disincentives Proposed Rule, the requirements
under SSA section 1886(n)(3)(A) that an eligible hospital or CAH must
meet to a be meaningful EHR user, particularly the first two
requirements under SSA section 1886(n)(3)(A)(i) and (ii), would be
substantially undermined and frustrated if the eligible hospital or CAH
commits information blocking, such that application of an appropriate
disincentive is warranted (88 FR 74956). To be considered a meaningful
EHR user under section 1886(n)(3)(A) of the SSA, an eligible hospital
or CAH must, in brief: (1) demonstrate to the satisfaction of the
Secretary the use of CEHRT in a meaningful manner, (2) demonstrate to
the satisfaction of the Secretary that their CEHRT is connected in a
manner that provides for electronic exchange of health information to
improve the quality of health care, and (3) use CEHRT to submit
information concerning quality measures and other measures as
specified. With respect to the electronic exchange of health
information requirement in SSA section 1886(n)(3)(A)(ii), an eligible
hospital or CAH must demonstrate to the satisfaction of the Secretary
that its CEHRT is ``connected in a manner that provides, in accordance
with law and standards applicable to the exchange of information, for
the electronic exchange of health information to improve the quality of
health care, such as promoting care coordination, and . . .
demonstrates . . . that the hospital has not knowingly and willfully
taken action (such as to disable functionality) to limit or restrict
the compatibility or interoperability of the certified EHR
technology.'' Two examples of the CMS requirements for health
information exchange include the requirement for eligible hospitals and
CAHs to report on the Health Information Exchange Objective and the
Provider to Patient Exchange Objective, both of which are part of the
requirements for demonstrating the meaningful use of CEHRT, in
accordance with SSA section 1886(n)(3).
As discussed in the Disincentives Proposed Rule, by establishing a
disincentive for information blocking under the Medicare Promoting
Interoperability Program, CMS is using an authority under applicable
Federal law as required in section 3022(b)(2)(B) of the PHSA (88 FR
74956). Eligible hospitals and CAHs that OIG determines to have
committed information blocking, and for which OIG refers its
determination to CMS, would be subject to a disincentive under
applicable law, as they are participating in the Medicare Promoting
Interoperability Program authorized by that applicable law. In
addition, the Medicare Promoting Interoperability Program requires
eligible hospitals and CAHs to engage in practices that encourage the
access, exchange, and use of electronic health information to avoid a
downward payment adjustment. The requirements an eligible hospital or
CAH must meet to be treated as a meaningful EHR user in section
1886(n)(3)(A)(i) and (ii) of the SSA specify that an eligible hospital
or CAH must demonstrate that it meets these requirements ``to the
satisfaction of the Secretary.'' As discussed in the Disincentives
Proposed Rule, CMS believes these provisions authorize the Secretary to
interpret these requirements through rulemaking as necessary to ensure
that an eligible hospital or CAH satisfies the requirements to be a
meaningful EHR user as defined by the Secretary (88 FR 74956).
Specifically, CMS believes it is appropriate for the Secretary to
interpret these requirements through rulemaking to determine that an
eligible hospital or CAH that has committed information blocking, and
for which OIG refers its determination of information blocking to CMS,
has not met the definition of a meaningful EHR user. This proposal is
consistent with the goals of the Medicare Promoting Interoperability
Program, which include the advancement of CEHRT utilization, focusing
on interoperability and data sharing (81 FR 79837); information
blocking by eligible hospitals and CAHs would frustrate both these
goals (88 FR 74956).
In the Disincentives Proposed Rule, CMS also stated that it
believes the proposed disincentive under the Medicare Promoting
Interoperability Program would be an appropriate disincentive that
would deter information blocking by eligible hospitals and CAHs,
consistent with the discussion in section III.A.3. of the Disincentives
Proposed Rule (88 FR 74956). While the exact monetary impact of the
disincentive would vary based on the specific eligible hospital, CMS
believes a reduction of three quarters of the annual market basket
update would deter eligible hospitals from engaging in information
blocking because it would reduce the inpatient prospective payment
system (IPPS) payment that an eligible hospital could have earned had
it met other requirements under the Medicare Promoting Interoperability
Program. Similarly, though the exact dollar amount would vary based on
the specific CAH, CMS believes that receiving 100 percent of reasonable
costs instead of the 101 percent of reasonable costs that a CAH may
have earned for successful participation in the Medicare Promoting
Interoperability Program would deter information blocking by CAHs
because it would reduce the reimbursement a CAH could have received had
it met other requirements under the Medicare Promoting Interoperability
Program (88 FR 74956).
In the Disincentives Proposed Rule, HHS analyzed the range of
potential disincentive amounts an eligible hospital could be subject to
if the proposed disincentive was imposed, to illustrate the degree to
which this disincentive could deter eligible hospitals from engaging in
information blocking. For more information about this analysis, we
refer readers to the Disincentive Proposed Rule (88 FR 74956 and
74957).
c. Provisions
In the Disincentives Proposed Rule, CMS proposed to revise the
definition of ``Meaningful EHR User'' in 42 CFR 495.4 to state that an
eligible hospital or CAH is not a meaningful EHR user in a calendar
year if OIG refers a determination that the eligible hospital or CAH
committed information blocking, as defined at 45 CFR 171.103, during
the calendar year of the EHR reporting period (88 FR 74957). As a
result of the proposal, CMS would apply a downward payment adjustment
under the Medicare Promoting Interoperability Program to any such
eligible hospital or CAH because the eligible hospital or CAH would not
be a meaningful EHR user, as required under SSA sections
1886(b)(3)(B)(ix) and 1814(l)(4). For eligible hospitals, CMS would
apply the downward adjustment to the payment adjustment year that
occurs 2 years after the calendar year when the OIG referral occurs.
For CAHs, CMS would apply the downward adjustment to the payment
adjustment year that is the same as the calendar year when the OIG
referral occurs.
In the Disincentives Proposed Rule, CMS noted that as a result of
these proposals, an eligible hospital or CAH that otherwise fulfilled
the required objectives and measures to demonstrate that it is a
meaningful EHR user for an EHR reporting period would nevertheless not
be a meaningful EHR user for that EHR reporting period if
[[Page 54689]]
OIG refers a determination of information blocking to CMS during the
calendar year in which the EHR reporting period falls (88 FR 74957).
CMS considered applying this proposed disincentive based on the date
that the eligible hospital or CAH committed the information blocking as
determined by OIG, instead of the date OIG refers its determination to
CMS. However, a significant amount of time could pass between the date
when the eligible hospital or CAH is determined to have committed
information blocking, and the date when OIG makes a referral to CMS,
due to the time required for OIG to fully investigate a claim of
information blocking. Such delay between the date the information
blocking occurred, and OIG's referral could complicate the application
of the disincentive and would likely necessitate reprocessing of a
significant number of claims. Therefore, CMS proposed to use the date
of the OIG referral instead of the date of the information blocking
occurrence to apply the proposed disincentive. Accordingly, CMS would
apply the proposed disincentive to the payment adjustment year
associated with the calendar year in which the OIG referred its
determination to CMS (88 FR 74957).
CMS further noted in the Disincentives Proposed Rule that if an
eligible hospital or CAH received the applicable downward payment
adjustment because CMS had already determined the eligible hospital or
CAH had otherwise not been a meaningful EHR user during the applicable
EHR reporting period due to its performance in the Medicare Promoting
Interoperability Program, imposition of the proposed disincentive would
result in no additional impact on the eligible hospital or CAH during
that payment adjustment year (88 FR 74957). Finally, even if multiple
information blocking violations were identified as part of OIG's
determination (including over multiple years) and referred to CMS, each
referral of an information blocking determination by OIG would only
affect an eligible hospital's or CAH's status as a meaningful EHR user
in a single EHR reporting period during the calendar year when the
determination of information blocking was referred to CMS by OIG.
Unless OIG makes an additional referral of an information blocking
determination in the subsequent calendar year, an eligible hospital or
CAH would again be able to qualify as a meaningful EHR user starting in
the subsequent EHR reporting period (88 FR 74957).
CMS invited public comment on these proposals, particularly on its
approach to the application of a disincentive for OIG determinations
that found that information blocking occurred in multiple years and
whether there should be multiple disincentives for such instances (for
example, disincentives in multiple calendar years/reporting periods
compared to only the calendar year/reporting period in which OIG made
the referral). The following is a summary of the comments we received
and our responses.
Comments. One commenter supported our proposal to apply
disincentives to eligible hospitals and CAHs, referred by OIG to CMS,
for information blocking. The commenter stated that the approach would
not involve additional services or requirements for patients, and that
this structure incentivizes the use of health IT and exchange of
electronic health information.
Response. We thank this commenter for their support and agree that
using an existing program and its existing structure to establish a
disincentive, without including additional requirements for eligible
hospitals and CAHs, does incentivize the meaningful use of CEHRT. We
also agree that this approach continues to promote the interoperable
exchange of health information for patients, eligible hospitals, and
CAHs.
Comments. One commenter supported the underlying goal of
encouraging information exchange but strongly opposed the proposed
disincentive. They stated that these disincentives could damage
essential eligible hospitals and CAHs and undermine HHS goals by
decreasing resources available to otherwise make appropriate
investments in their IT infrastructure. Several commenters opposed the
disincentive stating that it is excessive, potentially harmful to
already fragile eligible hospitals and CAHs, and has the potential to
eliminate annual payment updates for offenders. Several commenters
stated that this disincentive is unsustainable financially.
Response. We thank commenters for sharing this feedback and
expressing their concerns. We disagree that this disincentive is
unsustainable, excessive, and potentially harmful. This disincentive
utilizes the existing payment adjustments that are currently applied
under the Medicare Promoting Interoperability Program (previously the
Medicare EHR Incentive Program) and were authorized as part of the
American Recovery and Reinvestment Act of 2009, and we have chosen to
use that authority for these payment adjustments to establish a
disincentive for information blocking determinations by OIG. As
described, we consider eligible hospitals and CAHs that commit
information blocking as not demonstrating the meaningful use of CEHRT.
We are aligning the disincentive we are finalizing with the existing
process for those who do not meet the minimum requirements for
demonstrating the meaningful use of CEHRT.
In addition, there are eligible hospitals and CAHs that receive the
same payment adjustment as would apply under this disincentive due to
their failure to participate, or through unsuccessfully demonstrating
meaningful use by not meeting the minimum program requirements in the
EHR reporting period for a payment adjustment year. These hospitals
would not experience an additional impact if OIG refers a determination
that they committed information blocking, if such eligible hospitals or
CAHs also fail to participate or unsuccessfully demonstrate meaningful
use by not meeting the minimum program requirements in a given EHR
reporting period. Foundationally, being considered a meaningful user of
CEHRT in the Medicare Promoting Interoperability Program reflects that
an eligible hospital or CAH is meaningfully using health IT and sharing
health information. If an eligible hospital or CAH is not meaningfully
using CEHRT, including by engaging in information blocking conduct,
they would be subject to the same payment adjustment as would an
eligible hospital or CAH that fails to meet our other program
requirements.
Comments. Many commenters supported our proposed disincentive
policy but have asked for an extension in various forms. Some
commenters asked that disincentives start 2 years after the effective
date of this final rule, to give eligible hospitals and CAHs two
additional years of support and education to understand what is
considered information blocking, and to ensure adequate training for
their staff. Several commenters asked for an undefined grace period to
educate staff and utilize support services from OIG, ONC, and CMS, to
fully understand these policies before the disincentives are
implemented. A few commenters suggested that we delay the disincentives
policy, and instead start with a non-enforcement period before punitive
penalties begin. Lastly, some commenters asked that we delay the
disincentives policy, and instead start with a corrective action plan,
followed by punitive penalties in the future.
[[Page 54690]]
Response. We thank commenters for their feedback. We appreciate the
suggestions asking for additional support and education and may
consider this feedback. However, we do not agree that the disincentive
policy should be delayed for a minimum of 2 years after the release of
this final rule. As discussed above, the payment adjustment structure
for not meeting the definition of being a meaningful user of CEHRT
under the Medicare Promoting Interoperability Program is not new or
unique to information blocking. Eligible hospitals and CAHs are already
subject to payment adjustments under the Medicare Promoting
Interoperability Program if they fail to meet the requirements of being
a meaningful user of CEHRT based on not meeting minimum program
requirements (sections 1886(b)(3)(B) and 1814(l) of the Act). We have
finalized our proposal to update the definition of meaningful EHR user
in 42 CFR 495.4 to exclude from that definition eligible hospitals and
CAHs that OIG refers to CMS based on a determination of information
blocking. Therefore, the only additional requirement for eligible
hospitals and CAHs is that OIG did not refer a determination that the
eligible hospital or CAH committed information blocking as defined at
45 CFR 171.103 during the calendar year of the EHR reporting period. We
further note that the information blocking regulations in the ONC Cures
Act Final Rule went into effect April 5, 2021 (85 FR 70068), and
several years will have already passed between the date when these
regulations went into effect for health care providers and the
effective date of this final rule.
We refer readers to section III.B.1. of this final rule which
states that OIG will not begin investigating health care providers
until after the effective date of this rule, and that OIG will exercise
its enforcement discretion not to make any determinations regarding
conduct occurring prior to the effective date of this rule for
information blocking disincentives. As OIG will not make a
determination on conduct occurring prior to the effective date, OIG
will not refer any health care providers based on a determination of
conduct occurring prior to the effective date of this rule for
information blocking disincentives (see also, 88 FR 42823 and 42824).
This means that no disincentives finalized in this final rule will be
applied to conduct occurring before the effective date of this final
rule, which is 30 days after the final rule appears in the Federal
Register.
We appreciate the recommendations regarding offering educational
opportunities that would be helpful to health care providers and will
consider these recommendations.
Comments. Many commenters asked that CMS reconsider the
disincentives policy to reflect a tiered approach, proportional to
severity and frequency, suggesting that as proposed, a singular
disincentive conflates egregious claims with minor claims, and one-time
offenders with repeat offenders. Several commenters suggested that CMS
consider applying a disincentive only to egregious claims rather than
all claims.
Response. We thank commenters for this feedback. As discussed
previously, the definition of meaningful EHR user is central to the
Medicare Promoting Interoperability Program and this policy. While we
acknowledge there may be varying levels of severity, frequency, and
potential patient harm encompassed in different OIG determinations of
information blocking, we will receive all determinations of information
blocking that are referred to CMS by OIG. As we have finalized our
proposal to revise the definition of ``Meaningful EHR User,'' the
disincentive associated with not being a meaningful EHR user would be
applying the existing downward adjustment under the Medicare Promoting
Interoperability Program. This downward adjustment was established in
the American Recovery and Reinvestment Act of 2009, and CMS does not
have the flexibility to adjust the level of the downward adjustment
utilizing a tiered approach. For instance, as discussed in the
Disincentives Proposed Rule (88 FR 74955), under section
1886(b)(3)(B)(ix)(I) of the SSA, CMS adjusts payments for eligible
hospitals by a fixed proportion, based on whether an eligible hospital
(as defined in section 1886(n)(6)(B) of the SSA) is a meaningful EHR
user.
We note that while our proposed policy states that each referral of
an information blocking determination by OIG would only affect an
eligible hospital's or CAH's status as a meaningful EHR user in a
single EHR reporting period during the calendar year when the
determination of information blocking was referred by OIG, it is
possible that repeated subsequent determinations could be referred by
OIG in future years. We will address all determinations referred by OIG
applicable to eligible hospitals and CAHs within the existing payment
adjustment under the Medicare Promoting Interoperability Program, as
finalized in this final rule.
As for commenters' concerns that a single disincentive conflates
egregious claims with minor claims, we remind readers that prior to the
application of the disincentive OIG will investigate an allegation and
determine if information blocking has occurred. As discussed in
III.B.1. of this final rule, OIG's enforcement priorities inform
decisions about which information blocking allegations to pursue, but
they are not dispositive. Indeed, OIG will assess each allegation to
determine whether it implicates one or more of the enforcement
priorities, or otherwise merits further investigation and potential
enforcement action, and OIG may evaluate allegations and prioritize
investigations based in part on the volume of claims relating to the
same (or similar) practices by the same entity or individual.
Additionally, we take this opportunity to remind readers that CMS's
application of a disincentive will be based on the referral of OIG's
determination that information blocking has occurred. Information
blocking includes an element of intent, which for health care providers
is that the health care provider knows that a practice is unreasonable
and is likely to interfere with, prevent, or materially discourage
access, exchange, or use of EHI.
Comments. A few commenters raised concerns regarding the timing
between OIG receiving a referral, the claim being referred to CMS, and
the timing of the disincentive. Commenters asked that disincentives be
the same for all cases of information blocking, rather than based on
hospital size, annual market basket updates, or reasonable costs. Under
the proposal, if a large eligible hospital and a CAH are each referred
to OIG with a claim of information blocking, the penalties vary based
on EHR reporting period, size, and hospital type.
Response. We thank commenters for sharing this feedback. We
understand that some commenters believe that the disincentive should be
based on the date that the information blocking occurred, but doing so
would be administratively difficult, and therefore impractical, to
implement because it would likely involve reprocessing past claims.
Since we expect the time it takes OIG to fully investigate an
information blocking claim and refer a determination to CMS will vary,
we decided not to use the date that OIG determines information blocking
conduct occurred to determine the application of the payment
adjustment. Instead, CMS will use the date of the OIG referral to CMS
and specify that the eligible hospital or CAH is not a meaningful user
of CEHRT for the EHR reporting period in that calendar year. The
payment adjustment will apply to the payment adjustment year 2 years
[[Page 54691]]
later. We agree that with the existing payment adjustment under the
Medicare Promoting Interoperability Program, there is variation in the
annual market basket updates for eligible hospitals and in reasonable
costs for CAHs. As a result of that variability, there would be
variability in the amount of any disincentives imposed under the
Medicare Promoting Interoperability Program as a result of an OIG
referral of a determination of information blocking. While CMS did
consider alternative approaches (88 FR 74957), we have finalized our
proposal to revise the definition of meaningful EHR user in 42 CFR
495.4, and therefore the requirements to be considered a meaningful EHR
user. While we are mindful there is variation in the monetary impact of
payment adjustments under the Medicare Promoting Interoperability
Program based on size, hospital type, and timing of receiving the
referral of an OIG determination of information blocking, we
respectfully disagree with commenters that the monetary impact of the
disincentive should be the same for all eligible hospitals or CAHs, as
this could disproportionately impact hospitals with lower Medicare
claims volumes.
After consideration of the public comments, CMS has finalized our
proposal to revise the definition of ``Meaningful EHR User'' in 42 CFR
495.4 to state that an eligible hospital or CAH is not a meaningful EHR
user in a calendar year if OIG refers a determination that the eligible
hospital or CAH committed information blocking, as defined at 45 CFR
171.103, during the calendar year of the EHR reporting period.
For eligible hospitals, CMS will apply a downward payment
adjustment to the payment year that occurs 2 years after the calendar
year when an OIG referral occurs. This is a reduction of three quarters
of the annual market basket update that an eligible hospital could have
earned.
For CAHs, CMS will apply a downward payment adjustment to the
payment year that is the same as the calendar year when the OIG
referral occurs. This reduction results in a payment of 100 percent of
reasonable costs instead of the 101 percent of reasonable costs that a
CAH could have earned.
Lastly, CMS has finalized our proposal that if multiple information
blocking violations are identified as part of OIG's determination
(including over multiple years) and referred to CMS, each referral of
an information blocking determination by OIG will only affect an
eligible hospital's or CAH's status as a meaningful EHR user in a
single EHR reporting period during the calendar year when the
determination of information blocking was referred to CMS by OIG.
d. Notification and Application of the Disincentive
In the Disincentives Proposed Rule, CMS stated that after OIG has
determined that a health care provider has committed information
blocking and referred that health care provider to CMS, CMS would
notify the eligible hospital or CAH that OIG determined that the
eligible hospital or CAH committed information blocking as defined
under 45 CFR 171.103, and thus the eligible hospital or CAH was not a
meaningful EHR user for the EHR reporting period in the calendar year
when OIG referred its information blocking determination to CMS. This
notice would be issued in accordance with the notice requirements
proposed at 45 CFR 171.1002, as discussed in section III.B.2. of the
proposed rule.
As a result of our proposal to modify the definition of meaningful
EHR user in 42 CFR 495.4, the application of the disincentive would
result in a downward payment adjustment for eligible hospitals 2 years
after the OIG referral of a determination of information blocking to
CMS. Based upon the existing regulation at 42 CFR 495.4, the downward
payment adjustment would apply 2 years after the year of the referral
and the EHR reporting period in which the eligible hospital was not a
meaningful EHR user. For CAHs, the downward payment adjustment would
apply to the payment adjustment year in which the OIG referral was
made.
CMS invited public comment on these proposals. The following is a
summary of the comments we received and our responses.
Comments. Commenters asked for ample notification from CMS that a
determination has been referred from OIG to CMS regarding information
blocking.
Response. We thank commenters for their support on this proposal
and agree that ample notification and communication is necessary.
After consideration of the public comments, CMS has finalized our
proposal that we will notify an eligible hospital or CAH that OIG has
determined that the eligible hospital or CAH committed information
blocking as defined under 45 CFR 171.103, and, as a result, that the
eligible hospital or CAH was not a meaningful EHR user for EHR
reporting period in the calendar year when OIG referred its information
blocking determination to CMS.
3. Promoting Interoperability Performance Category of the Medicare
Merit-Based Incentive Payment System (MIPS)
a. Background
MIPS requires that MIPS eligible clinicians use CEHRT, as defined
at SSA section 1848(o)(4) and 42 CFR 414.1305,\28\ in a meaningful
manner, in accordance with SSA sections 1848(q)(2)(A)(iv) and (B)(iv)
and 1848(o)(2) and 42 CFR 414.1375, to earn a score for the MIPS
Promoting Interoperability performance category. In the Disincentives
Proposed Rule, CMS stated that we intend to use this existing
authority, requiring the meaningful use of CEHRT, to impose
disincentives on MIPS eligible clinicians that OIG determines to have
committed information blocking as defined at 45 CFR 171.103 (88 FR
74957 and 74958).
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\28\ For MIPS, SSA section 1848(o)(4) defines CEHRT as a
qualified electronic health record (as defined in PHSA section
3000(13)) that is certified by ONC pursuant to PHSA section
3001(c)(5) as meeting standards adopted under PHSA section 3004 that
are applicable to the type of record involved, as determined by the
Secretary. CMS has codified the definition of CEHRT, including
additional criteria it must be certified as meeting, that MIPS
eligible clinicians must use at 42 CFR 414.1305.
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(1) MIPS Overview--Scoring and Payment Calculations
As authorized by the Medicare Access and CHIP Reauthorization Act
of 2015 (MACRA) (Pub. L. 114-10, April 16, 2015), the Quality Payment
Program is a value-based payment program,\29\ by which the Medicare
program rewards MIPS eligible clinicians who provide high-value, high-
quality services in a cost-efficient manner. The Quality Payment
Program includes two participation tracks for clinicians providing
services under the Medicare program: MIPS and Advanced Alternative
Payment Models (APMs). The statutory requirements for MIPS are set
forth in SSA sections 1848(q) and (r).
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\29\ In the Disincentives Proposed Rule, we referred to the
Quality Payment Program as a payment incentive program (88 FR
74958). Within the Quality Payment Program, MIPS is more
appropriately described as a value-based payment system, and we have
revised this statement for clarity and precision.
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For the MIPS participation track, MIPS eligible clinicians are
subject to a MIPS payment adjustment (positive, negative, or neutral)
based on their performance in four performance categories (cost,
quality, improvement activities, and Promoting Interoperability)
compared to the
[[Page 54692]]
established performance threshold for that performance period/MIPS
payment year. CMS assesses each MIPS eligible clinician's total
performance according to established performance standards with respect
to the applicable measures and activities specified in each of these
four performance categories during a performance period to compute a
final composite performance score (a ``final score'' as defined at 42
CFR 414.1305) in accordance with our policies set forth in 42 CFR
414.1380.
In calculating the final score, CMS must apply different weights
for the four performance categories, subject to certain exceptions, as
set forth in SSA section 1848(q)(5) and at 42 CFR 414.1380. Unless CMS
assigns a different scoring weight pursuant to these exceptions, for
the CY 2024 performance period/2026 MIPS payment year and subsequent
performance periods/MIPS payment years,\30\ the scoring weights are as
follows: 30 percent for the quality performance category; 30 percent
for the cost performance category; 15 percent for the improvement
activities performance category; and 25 percent for the Promoting
Interoperability performance category (SSA section 1848(q)(5)(E); 42
CFR 414.1380(c)(1)).
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\30\ In the Disincentives Proposed Rule, we only noted that
these scoring weights apply to the CY 2024 performance period/2026
MIPS payment year (88 FR 74958). However, as set forth in SSA
section 1848(q)(5)(E), these scoring weights applied beginning 6
years after MIPS began applying to Medicare Part B payments (CY 2017
performance period/2019 MIPS payment year) and continue to apply for
each subsequent year thereafter. Accordingly, we amended this
description in this final rule for clarity and accuracy to note that
these scoring weights continue to apply, provided CMS does not
assign a different scoring weight pursuant to applicable exceptions.
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To calculate the payment adjustment factor that will be applied to
the amounts otherwise paid to MIPS eligible clinicians under Medicare
Part B for covered professional services during the applicable MIPS
payment year, CMS then compares the final score to the performance
threshold CMS has established for that performance period/MIPS payment
year at 42 CFR 414.1405(b). The MIPS payment adjustment factors
specified for a year must result in differential payments such that
MIPS eligible clinicians with final scores above the performance
threshold receive a positive MIPS payment adjustment factor, those with
final scores at the performance threshold receive a neutral MIPS
payment adjustment factor, and those with final scores below the
performance threshold receive a negative MIPS payment adjustment
factor. As further specified in SSA section 1848(q)(6)(F) and 42 CFR
414.1405, CMS also applies a scaling factor to determine the MIPS
payment adjustment factor for each MIPS eligible clinician, and CMS
must ensure that the estimated aggregate increases and decreases in
payments to all MIPS eligible clinicians as a result of MIPS payment
adjustment factors are budget neutral for that MIPS payment year. As
provided in SSA sections 1848(q)(6)(A) and (B)(iv) and 42 CFR
414.1405(c), the positive MIPS payment adjustment factor may be up to 9
percent for a final score of 100 and the negative MIPS payment
adjustment factor may be up to negative 9 percent for a final score of
zero.
(2) MIPS Promoting Interoperability Performance Category
For MIPS eligible clinicians, SSA section 1848(q)(2)(A)(iv)
includes the meaningful use of CEHRT as one of the four performance
categories by which a MIPS eligible clinician is assessed to determine
a MIPS payment adjustment factor, as discussed previously. CMS refers
to this performance category as the Promoting Interoperability
performance category. SSA section 1848(q)(2)(B)(iv) provides that the
requirements set forth in SSA section 1848(o)(2) for determining
whether a MIPS eligible clinician is a meaningful user of CEHRT also
apply to CMS's assessment of MIPS eligible clinicians' performance on
measures and activities with respect to the MIPS Promoting
Interoperability performance category. Also, SSA section 1848(o)(2)(D)
generally provides that the requirements for being a meaningful EHR
user under section 1848(o)(2) continue to apply for purposes of MIPS.
A MIPS eligible clinician that is not a meaningful user of CEHRT in
accordance with SSA section 1848(o)(2)(A) cannot satisfy the
requirements of the MIPS Promoting Interoperability performance
category and, therefore, would earn a score of zero for this
performance category. Applying the weights for the performance
categories under 42 CFR 414.1380(c)(1), a score of zero for the
Promoting Interoperability performance category would mean that the
maximum final score a MIPS eligible clinician could achieve, if they
performed perfectly in the remaining performance categories, would be
75 points.
To be a meaningful EHR user under SSA section 1848(o)(2)(A) (and
therefore meet the requirements of the MIPS Promoting Interoperability
performance category under SSA section 1848(q)(2)(B)(iv)), a MIPS
eligible clinician must meet three requirements related to the
meaningful use of CEHRT during a performance period for a MIPS payment
year. In brief, the MIPS eligible clinician must: (1) demonstrate to
the satisfaction of the Secretary the use of CEHRT in a meaningful
manner; (2) demonstrate to the satisfaction of the Secretary that their
CEHRT is connected in a manner that provides for electronic exchange of
health information to improve the quality of care; and (3) use CEHRT to
submit information concerning quality measures and other measures as
specified.
More specifically, for the first requirement under SSA section
1848(o)(2)(A)(i), a MIPS eligible clinician must demonstrate, to the
satisfaction of the Secretary, that during the relevant performance
period, the MIPS eligible clinician is ``using certified EHR technology
in a meaningful manner.'' For the second requirement under SSA section
1848(o)(2)(A)(ii), a MIPS eligible clinician must demonstrate, to the
satisfaction of the Secretary, that during the relevant period CEHRT is
``connected in a manner that provides, in accordance with law and
standards applicable to the exchange of information, for the electronic
exchange of health information to improve the quality of health \31\
care, such as promoting care coordination'' and the MIPS eligible
clinician demonstrates, through ``a process specified by the Secretary,
such as the use of an attestation'' that the MIPS eligible clinician
``has not knowingly and willfully taken action (such as to disable
functionality) to limit or restrict the compatibility or
interoperability of the certified EHR technology.'' For the third
requirement under SSA section 1848(o)(2)(A)(iii), a MIPS eligible
clinician currently must submit information via their CEHRT on ``such
clinical quality measures and such other measures as selected by the
Secretary'' in ``a form and manner specified by the Secretary,''
including measures focused on providing patients with electronic access
to their electronic health information, sending electronic health
information to other health care providers, and receiving and
incorporating electronic health information from other health care
providers.
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\31\ In the Disincentives Proposed Rule (88 FR 74958), this word
was inadvertently omitted from the quote of the statutory provision.
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As discussed further in section III.C.3.b. of the Disincentives
Proposed Rule (88 FR 74959 and 74960) and this final rule, these three
requirements for a MIPS eligible clinician to be
[[Page 54693]]
determined to be a meaningful user of CEHRT, particularly the first two
requirements under SSA section 1848(o)(2)(A)(i) and (ii), would be
substantially undermined and frustrated if the MIPS eligible clinician
commits information blocking, such that application of an appropriate
disincentive is warranted.
b. The MIPS Promoting Interoperability Performance Category
Requirements as an Appropriate Disincentive for Information Blocking
Under the PHSA
In the Disincentives Proposed Rule, CMS stated it believes that the
requirements set forth in SSA sections 1848(q)(2)(B)(iv) and
1848(o)(2)(A) for the MIPS Promoting Interoperability performance
category are an applicable Federal law for the purposes of establishing
a disincentive for a health care provider that participates in MIPS and
has been determined by OIG to have committed information blocking (88
FR 74959). First, the definitions of MIPS eligible clinician and health
care provider under 45 CFR 171.102 and the PHSA generally are aligned.
Second, committing information blocking not only violates the law and
principles set forth in the Cures Act, but also undermines the goals
and purpose of the MIPS Promoting Interoperability performance
category. On such basis, CMS proposed an appropriate disincentive for
MIPS eligible clinicians that OIG determines have committed information
blocking and for whom OIG refers its determination of information
blocking to CMS, as discussed further in section III.C.3.c. of the
Disincentives Proposed Rule (88 FR 74959 through 74962).
(1) Alignment of Definitions of MIPS Eligible Clinician and Health Care
Provider Under the PHSA
In the Disincentives Proposed Rule, CMS noted that it believes that
the definitions of MIPS eligible clinician under the SSA and 42 CFR
414.1305 and health care provider under PHSA section 3000(3) and 45 CFR
171.102 generally are aligned (88 FR 74959). CMS believes this
alignment will permit application of appropriate disincentives, as
required by PHSA section 3022(b)(2)(B), to MIPS eligible clinicians,
except for qualified audiologists. CMS proposed to codify this
exception in the definition of Meaningful EHR User for MIPS at 42 CFR
414.1305 (88 FR 74959).
Beginning with the 2024 MIPS payment year, a MIPS eligible
clinician is defined in 42 CFR 414.1305 as including: (1) a physician
(as defined in SSA section 1861(r)); (2) a physician assistant, nurse
practitioner, and clinical nurse specialist (as defined in SSA
1861(aa)(5)); (3) a certified registered nurse anesthetist (defined in
SSA section 1861(bb)(2)); (4) a physical therapist or occupational
therapist; (5) a qualified speech-language pathologist; (6) a qualified
audiologist (as defined in SSA section 1861(ll)(4)(B)); (7) a clinical
psychologist (as defined by the Secretary for purposes of SSA section
1861(ii)); (8) a registered dietician or nutrition professional; (9) a
clinical social worker (as defined in SSA section 1861(hh)(1)); (10) a
certified nurse midwife (as defined in SSA section 1861(gg)(2)); and
(11) a group, identified by a unique single taxpayer identification
number (TIN), with two or more eligible clinicians, one of which must
be a MIPS eligible clinician, identified by their individual national
provider identifier (NPI) and who have reassigned their billing rights
to the single group TIN. However, for a given performance period/MIPS
payment year, a MIPS eligible clinician does not include an eligible
clinician who meets one of the exclusions set forth in 42 CFR
414.1310(b), including being a Qualifying APM participant, Partial
Qualifying APM Participant that does not elect to participate in MIPS,
or does not exceed the low volume threshold (as these terms are defined
in 42 CFR 414.1305).
Meanwhile, the definition of ``health care provider'' under PHSA
section 3000(3) as implemented in 45 CFR 171.102, includes the
following which are also considered MIPS eligible clinicians: (1) a
``group practice'' (which is not defined in the PHSA); (2) a physician
(as defined in SSA section 1861(r)); (3) practitioners, as defined in
SSA section 1842(b)(18)(C) to include: (a) a physician assistant, nurse
practitioner, and clinical nurse specialist (as defined in SSA
1861(aa)(5)); (b) a certified registered nurse anesthetist (defined in
SSA section 1861(bb)(2)); (c) a certified nurse-midwife (as defined in
SSA section 1861(gg)(2)); (d) a clinical social worker (as defined in
SSA section 1861(hh)(1)); (e) a clinical psychologist (as defined by
the Secretary for purposes of SSA section 1861(ii)); and (f) a
registered dietician or nutrition professional; (4) therapists, as
defined in SSA section 1848(k)(3)(B)(iii) to include: (a) a physical
therapist; (b) an occupational therapist; and (c) a qualified speech-
language pathologist; and (5) ``any other category of health care
facility, entity, practitioner, or clinician determined appropriate by
the Secretary'' (88 FR 74959).
At this time, only a qualified audiologist, included in the
definition of MIPS eligible clinician in 42 CFR 414.1305 since the CY
2019 performance period/2021 MIPS payment year, is not identified as a
health care provider under 45 CFR 171.102 and PHSA section 3000(3).
Because qualified audiologists are not included in the PHSA definition
of health care provider, CMS proposed that MIPS eligible clinicians who
are qualified audiologists would not be subject to the disincentive
proposed for the MIPS Promoting Interoperability performance category
(88 FR 74959).
As discussed previously, groups, and multispecialty groups (as
defined in 42 CFR 414.1305) also are included in the definition of MIPS
eligible clinician and therefore are subject to payment adjustments
under MIPS based on the performance of MIPS eligible clinicians that
are included in these groups, under different sets of regulations in 42
CFR part 414, subpart O. Meanwhile, as discussed previously, the
definition of health care provider in PHSA section 3000(3) includes
``group practice,'' but does not define what this term means.
Accordingly, in the Disincentives Proposed Rule, CMS stated that it
also believes that a group may be subject to the disincentive proposed
for the MIPS Promoting Interoperability performance category if the
group has been determined by OIG to have committed information
blocking, or if MIPS eligible clinicians included in the group have
committed information blocking (88 FR 74959).
(2) Information Blocking Conduct Undermines the Goals and Purpose of
the MIPS Promoting Interoperability Performance Category
As discussed in the Disincentives Proposed Rule, health care
providers that engage in information blocking undermine and frustrate
the purpose for requiring MIPS eligible clinicians to use CEHRT in a
meaningful manner (88 FR 74960). Specifically, requiring MIPS eligible
clinicians to use CEHRT is not limited to MIPS eligible clinicians
adopting and implementing CEHRT for documenting clinical care in lieu
of paper-based medical records. For use of CEHRT to be meaningful, SSA
section 1848(o)(2)(A) requires that MIPS eligible clinicians use CEHRT
to communicate with other treating health care providers, pharmacies,
and oversight authorities regarding the patient's health information,
including the MIPS eligible clinician's review and treatment of the
patient's health. SSA sections 1848(o)(2)(A)(i) and (ii) require that
MIPS eligible clinicians demonstrate
[[Page 54694]]
that they are meaningfully using CEHRT's key functionalities, such as
electronically prescribing, and ensuring that CEHRT is ``connected in a
manner that provides, in accordance with law and standards applicable
to the exchange of information, for the electronic exchange of health
information to improve the quality of health care,'' such as
``promoting care coordination.'' SSA section 1848(o)(2)(A)(ii) further
requires that the MIPS eligible clinician demonstrate that they have
not ``knowingly and willfully taken action (such as to disable
functionality) to limit or restrict the compatibility or
interoperability'' of CEHRT, which is similar to the directive to
investigate and discourage information blocking under PHSA section
3022. In the Disincentives Proposed Rule, CMS noted that establishing
an appropriate disincentive for information blocking under the MIPS
Promoting Interoperability performance category would not only deter
information blocking but would strengthen an existing merit-based
incentive payment system that already encourages health care providers
to support the access, exchange, and use of electronic health
information (88 FR 74960).
Furthermore, the requirements to be treated as a meaningful EHR
user in SSA sections 1848(o)(2)(A)(i) and (ii) specify that a MIPS
eligible clinician must demonstrate that they meet these requirements
to the satisfaction of the Secretary. In the Disincentives Proposed
Rule, CMS stated it believes these provisions authorize the Secretary
to interpret these requirements through rulemaking as necessary to
ensure that a MIPS eligible clinician satisfies the requirements to be
a meaningful user of CEHRT as defined by the Secretary (88 FR 74960).
Specifically, CMS noted that it believes it is appropriate for the
Secretary to interpret these requirements through rulemaking to
determine that a MIPS eligible clinician that has committed information
blocking is not a meaningful EHR user (88 FR 74960). In the
Disincentives Proposed Rule (88 FR 74960), CMS noted that the proposal
was consistent with the goals of the MIPS Promoting Interoperability
performance category, which include promoting health care efficiency
and encouraging widespread health information exchange (81 FR 77200
through 77202). CMS stated that information blocking by MIPS eligible
clinicians frustrates both these goals (88 FR 74960).
As noted in the Disincentives Proposed Rule, CMS believes a
disincentive for information blocking associated with the MIPS
Promoting Interoperability performance category would be an appropriate
disincentive that would deter information blocking by other MIPS
eligible clinicians, consistent with the discussion in section III.A.3.
of the Disincentives Proposed Rule (88 FR 74960). While the exact
monetary impact of the disincentive may vary for each MIPS eligible
clinician based on the various factors CMS considers when determining
the MIPS payment adjustment factor, CMS believes the proposed
disincentive would deter information blocking by other MIPS eligible
clinicians. In the Disincentives Proposed Rule, CMS noted that a MIPS
eligible clinician who receives a score of zero in the MIPS Promoting
Interoperability performance category under the proposed disincentive
may not be able to earn a positive or neutral MIPS payment adjustment
factor that they otherwise could have earned for their performance in
MIPS (88 FR 74960).
In the Disincentives Proposed Rule, to illustrate the degree to
which this disincentive could deter information blocking, HHS analyzed
the range of potential disincentive amounts MIPS eligible clinicians
could be subject to if the proposed disincentive was imposed, using
payment and MIPS data from 2021, the most recent year of publicly
available data. For more information about this analysis, we refer
readers to the Disincentives Proposed Rule (88 FR 74960).
c. Provisions
Under the authority in SSA sections 1848(o)(2)(A) and (D), and
1848(q)(2)(A)(iv) and (B)(iv), for the MIPS Promoting Interoperability
performance category, CMS proposed that a MIPS eligible clinician would
not be a meaningful EHR user in a performance period if OIG refers a
determination that the MIPS eligible clinician committed information
blocking (as defined at 45 CFR 171.103) at any time during the calendar
year of the performance period (88 FR 74960 and 74961).\32\ CMS also
proposed that the determination by OIG that the MIPS eligible clinician
committed information blocking would result in a MIPS eligible
clinician that is required to report on the MIPS Promoting
Interoperability performance category not earning a score in the
performance category (a zero score), which is typically a quarter of
the total final score. CMS proposed to codify this proposal under the
definition of meaningful EHR user for MIPS at 42 CFR 414.1305 and amend
the requirements for earning a score for the MIPS Promoting
Interoperability performance category at 42 CFR 414.1375(b) (88 FR
74960 and 74961).
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\32\ As provided in 42 CFR 414.1320(h), for purposes of the 2024
MIPS payment year and each subsequent MIPS payment year, the
performance period for the MIPS Promoting Interoperability
performance category is a minimum of a continuous 90-day period
within the calendar year that occurs 2 years prior to the applicable
MIPS payment year, up to and including the full calendar year. In 42
CFR 414.1305, CMS has defined the ``MIPS payment year'' as the
calendar year in which the MIPS payment adjustment factor is applied
to Medicare Part B payments. In the CY 2024 Physician Fee Schedule
proposed rule, CMS proposed that, beginning with the 2026 MIPS
payment year, the performance period for the MIPS Promoting
Interoperability performance category would be a minimum of a
continuous 180-day period within the calendar year that occurs 2
years prior to the applicable MIPS payment year, up to and including
the full calendar year (88 FR 52578 through 52579). Since the
Disincentives Proposed Rule appeared in the Federal Register, CMS
finalized this proposal for amending the performance period for the
MIPS Promoting Interoperability performance category, to a minimum
of a continuous 180-day period, in the CY 2024 Physician Fee
Schedule final rule and codified this amendment as proposed at 42
CFR 414.1320(i) (88 FR 79351 through 79353).
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CMS considered applying the proposed disincentive based on the date
that the MIPS eligible clinician committed the information blocking as
determined by OIG, instead of the date OIG refers its determination to
CMS (88 FR 74961). However, a significant period could pass between the
date when the MIPS eligible clinician is determined to have committed
information blocking, and the date when OIG makes a referral to CMS,
due to the time required for OIG to fully investigate a claim of
information blocking. Such delay between the date the information
blocking allegedly occurred and OIG's referral could complicate our
application of the disincentive and would likely necessitate
reprocessing of a significant number of claims. Therefore, CMS decided
to use the date of the OIG referral instead of the date of the
information blocking occurrence to apply this proposed disincentive.
Accordingly, CMS proposed to apply the proposed disincentive to the
MIPS payment year associated with the calendar year in which OIG
referred its determination to CMS (88 FR 74961).
As provided in 42 CFR 414.1320, the applicable MIPS payment year is
2 calendar years after the performance period. The time period between
the performance period and the MIPS payment year permits CMS to review
each MIPS eligible clinician's performance to determine their final
score and MIPS payment adjustment factor. We noted that, under the
[[Page 54695]]
proposal, if OIG referred its determination that a MIPS eligible
clinician committed information blocking in calendar year 2025, then
CMS would apply the disincentive proposed herein for the 2027 MIPS
payment year (88 FR 74961).
In the Disincentives Proposed Rule, first, CMS proposed to amend
the definition of ``meaningful EHR user for MIPS'' at 42 CFR 414.1305
(88 FR 74961). The current definition states that a ``meaningful EHR
user for MIPS means a MIPS eligible clinician who possesses CEHRT, uses
the functionality of CEHRT, reports on applicable objectives and
measures specified for the Promoting Interoperability performance
category for a performance period in the form and manner specified by
CMS, does not knowingly and willfully take action (such as to disable
functionality) to limit or restrict the compatibility or
interoperability of CEHRT, and engages in activities related to
supporting providers with the performance of CEHRT.'' CMS proposed to
add to this definition that a MIPS eligible clinician is not a
meaningful EHR user in a performance period if OIG refers a
determination that the clinician committed information blocking (as
defined at 45 CFR 171.103) during the calendar year of the performance
period (88 FR 74961). CMS also proposed other minor technical changes
to the language of the definition. In the Disincentives Proposed Rule,
CMS noted that, in tandem with other proposals for MIPS in this
section, the proposed amendment to the definition in 42 CFR 414.1305
would result in a MIPS eligible clinician not being able to earn points
associated with the Promoting Interoperability performance category
they may otherwise have earned, potentially resulting in a negative or
neutral payment adjustment. As such, we stated that this potential
outcome likely would deter health care providers from engaging in
information blocking (88 FR 74961).
Second, CMS proposed to amend the requirements for earning a score
for the MIPS Promoting Interoperability performance category by adding
a new requirement at 42 CFR 414.1375(b) (88 FR 74961). Currently, 42
CFR 414.1375(b) provides that, to earn a score (other than zero) for
the Promoting Interoperability performance category, the MIPS eligible
clinician must meet certain requirements, including using CEHRT,
reporting on the objectives and associated measures as specified by
CMS, and attesting to certain statements and activities. CMS proposed
to amend 42 CFR 414.1375(b) by adding that the MIPS eligible clinician
must be a meaningful EHR user for MIPS as defined at 42 CFR 414.1305.
In conjunction with the proposal to amend the definition of a
meaningful EHR user for MIPS at 42 CFR 414.1305 discussed previously,
CMS noted the proposal would establish a clear basis to apply a score
of zero for the MIPS Promoting Interoperability performance category to
a MIPS eligible clinician that fails to meet the definition of
meaningful EHR user for MIPS during a performance period, specifically
if OIG refers a determination of information blocking during the
calendar year of the performance period (88 FR 74961).
In the Disincentives Proposed Rule, CMS noted that, under these
proposals, a MIPS eligible clinician that OIG determines has committed
information blocking would not be a meaningful EHR user, and therefore
would be unable to earn a score (instead, earning a score of zero) for
the MIPS Promoting Interoperability performance category (88 FR 74961).
Because a MIPS eligible clinician that has committed information
blocking would not be a meaningful EHR user for a given performance
period, they would earn a zero for the Promoting Interoperability
performance category for the calendar year of the applicable
performance period in which the determination of information blocking
was referred by OIG. For example, if OIG refers a determination that a
MIPS eligible clinician committed information blocking to CMS in CY
2026, CMS would apply a score of zero for the Promoting
Interoperability performance category for the 2028 MIPS payment year to
the MIPS eligible clinician.
In the Disincentives Proposed Rule, CMS explained that under this
proposed disincentive for information blocking, a score of zero for the
MIPS Promoting Interoperability performance category would negatively
impact 25 percent of the MIPS eligible clinician's final score such
that it would likely result in a negative MIPS payment adjustment for
the applicable MIPS payment year (88 FR 74961). For example, applying
the weights for the performance categories under 42 CFR 414.1380(c)(1),
a score of zero for the Promoting Interoperability performance category
would mean that the maximum final score a MIPS eligible clinician could
achieve, if they performed perfectly in the remaining performance
categories, would be 75 points.
Then, as discussed previously, to determine the MIPS payment
adjustment factor, CMS compares the MIPS eligible clinician's final
score to the established performance threshold for that MIPS payment
year. In 42 CFR 414.1405(b)(9)(ii), CMS established that the
performance threshold for the 2025 MIPS payment year is 75 points. If,
under this example, a MIPS eligible clinician still achieved 75 points
for their final score for the 2025 MIPS payment year matching the
established performance threshold of 75 points, then they would receive
a neutral MIPS payment adjustment factor.
In the CY 2024 Physician Fee Schedule proposed rule, CMS proposed
that the performance threshold for the 2026 MIPS payment year would be
82 points (88 FR 52596 through 52601). This proposal was not finalized
in the CY 2024 Physician Fee Schedule Final Rule; instead, CMS
finalized the performance threshold for the 2026 MIPS payment year as
75 points at 42 CFR 414.1405(b)(9)(iii) (88 FR 79374 through 79376).
However, if some other performance threshold higher than 75 points is
finalized in a future MIPS payment year, then a MIPS eligible clinician
(that OIG determined committed information blocking and received a
score of zero in the Promoting Interoperability performance category
and therefore, under our example, a final score of 75 points) would
receive a negative MIPS payment adjustment factor. If CMS finalizes a
performance threshold higher than 75 points in a future MIPS payment
year, then the proposed disincentive would likely to result in a MIPS
eligible clinician that commits information blocking, as determined by
OIG, receiving a negative payment adjustment, up to negative nine
percent for a final score of zero as set forth in 42 CFR 414.1405(b)(2)
and (c).
In the Disincentives Proposed Rule, CMS explained that, under these
proposals, a MIPS eligible clinician, that otherwise fulfilled other
requirements to demonstrate meaningful use of CEHRT for a performance
period to earn a score for the Promoting Interoperability performance
category, would nevertheless not be a meaningful EHR user for that
performance period if OIG refers a determination of information
blocking during the calendar year of the performance period (88 FR
74962). This would result in the MIPS eligible clinician nevertheless
earning a score of zero for the Promoting Interoperability performance
category.\33\ Furthermore, if a MIPS eligible clinician earned a score
of zero for the Promoting Interoperability performance category for a
given year because CMS had
[[Page 54696]]
already determined the MIPS eligible clinician had otherwise not been a
meaningful EHR user in that performance period due to its performance
in the Promoting Interoperability performance category, imposition of
the proposed disincentive would result in no additional impact on the
MIPS eligible clinician during that MIPS payment year (88 FR 74962).
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\33\ Although this statement was not part of this explanation in
the Disincentives Proposed Rule (88 FR 74962), we have added it for
clarity. We believe this statement is logically inferred from the
original proposal.
---------------------------------------------------------------------------
CMS clarified in the Disincentives Proposed Rule that, even if
multiple information blocking violations were identified as part of
OIG's determination (including over multiple years) and referred to
CMS, each referral of an information blocking determination by OIG
would only affect a MIPS eligible clinician's status as a meaningful
EHR user in a single performance period during the calendar year when
the determination of information blocking was referred by OIG (88 FR
74962). Barring an additional referral of an information blocking
determination by OIG in the subsequent calendar year, a MIPS eligible
clinician could be deemed a meaningful EHR user and earn a score for
the Promoting Interoperability performance category in the following
calendar year.
CMS invited public comment on these proposals. CMS particularly
requested comment on its approach to the application of a disincentive
for OIG determinations that found that information blocking occurred in
multiple years and whether there should be multiple disincentives for
such instances (for example, disincentives in multiple calendar years/
performance periods compared to only one disincentive in the calendar
year in which a referral from OIG is made).
The following is a summary of the comments received and our
responses.
Comments. A few commenters supported the proposed application of
disincentives in MIPS generally. One commenter noted that the
disincentives will incentivize health IT use. Another commenter
expressed that the Promoting Interoperability performance category is
an appropriate avenue through which to apply the disincentives. A few
commenters expressed general support for CMS' goals and purposes in
applying disincentives to the MIPS Promoting Interoperability
performance category, noting that the proposal is consistent with the
Cures Act and that information blocking undermines the meaningful use
of certified EHR technology.
Response. We appreciate the support of these commenters. We believe
that information blocking disrupts the meaningful use of CEHRT and
exchange of electronic health information, as required by SSA section
1848(o)(2)(A)(i) and (ii), and should be deterred. We believe the
disincentive will serve as a deterrent to information blocking
practices and reduce the incidence of information blocking.
Comments. One commenter supported the proposal that health care
providers determined by OIG to have engaged in information blocking
should not be considered a meaningful EHR user within MIPS.
Response. We appreciate the support of this commenter. We agree
that information blocking is not consistent with the goals of the MIPS
Promoting Interoperability performance category to support meaningful
use of CEHRT and exchange of electronic health information, as required
by SSA section 1848(o)(2)(A)(i) and (ii).
Comments. A few commenters requested clarification on whether the
reductions to the MIPS incentive payment will be deemed Recovered
Penalty Funds pursuant to the Cures Act.
Response. We note that ``reductions to the MIPS incentive payment''
does not accurately reflect how MIPS may affect MIPS eligible
clinician's payments for covered professional services under Medicare
Part B. We refer readers to our description of MIPS, including how CMS
assesses a MIPS eligible clinician's performance and calculates and
applies MIPS payment adjustment factors in section III.C.3.a. of the
Disincentives Proposed Rule (88 FR 74957 through 74959) and this final
rule.
We reiterate that CMS proposed that OIG's referral of its
determination that the MIPS eligible clinician committed information
blocking would result in CMS specifying that the MIPS eligible
clinician is not a meaningful EHR user and assigning the MIPS eligible
clinician a score of zero for the Promoting Interoperability
performance category. As we described in the Disincentive Proposed
Rule, this may result in CMS calculating a MIPS payment adjustment
factor that is neutral or negative (88 FR 74961 and 74962). When
applied, a MIPS payment adjustment factor potentially adjusts Medicare
Part B payments upwards or downwards and are not considered recovered
penalty funds pursuant to Section 4004 of the Cures Act.
Comments. Commenters sought clarity on whether, if an eligible
hospital or CAH was found to have committed information blocking for
which CMS imposed a disincentive under the Medicare Promoting
Interoperability Program, a MIPS eligible clinician that practices in,
or is affiliated with that eligible hospital or CAH (for example, an
outpatient clinic) would also receive a disincentive under MIPS.
Additionally, commenters sought clarity on whether a MIPS-eligible
clinician that commits information blocking in a hospital setting would
be assigned disincentives under both MIPS and the Medicare Promoting
Interoperability Program based on the same finding.
Response. If OIG refers a determination of information blocking for
a health care provider, CMS will apply disincentives established
through notice and comment rulemaking that are applicable to that
health care provider. Accordingly, if OIG found that an eligible
hospital or CAH committed information blocking and referred the
determination to CMS, we would only impose the disincentive under the
Medicare Promoting Interoperability Program, which is applicable to
eligible hospitals and CAHs, to the hospital that has committed
information blocking. We would not impose a separate disincentive on
individual MIPS eligible clinicians that are affiliated with the
hospital, provided that OIG did not similarly find that the individual
MIPS eligible clinician(s) also committed information blocking and
referred that determination to CMS.
Comments. Several commenters expressed concern about the impact the
proposed MIPS disincentive will have on patient access to care. A few
commenters expressed that MIPS eligible clinicians may take on fewer
Medicare beneficiaries as patients as a result of the potential impact
of disincentives, while others may choose not to participate in the
Medicare program at all, which may ultimately impact beneficiary access
to care. One commenter contended that, because psychiatrists may be
impacted, Medicare beneficiaries seeking mental health services could
be negatively impacted by the proposed disincentives.
Response. While we understand these concerns, MIPS eligible
clinicians already are required to demonstrate they are not knowingly
or willfully taking actions to limit or restrict the compatibility or
interoperability of the CEHRT they use as set forth in SSA section
1848(o)(2)(A)(ii). One of the current requirements of the MIPS
Promoting Interoperability performance category is to attest ``yes'' to
the self-reported attestation statement that they did not knowingly or
willfully take action to limit or restrict compatibility or
interoperability of CEHRT, which may include actions that are
information blocking (42 CFR 414.1375(b)(3)(iii)).
[[Page 54697]]
In addition, we believe that the practice of information blocking
could cause potential harm to patients. Information blocking does not
promote healthcare efficiency and does not encourage widespread health
information exchange. We refer readers to our discussion of how
information blocking conduct undermines the goals and purpose of the
MIPS Promoting Interoperability performance category in section
III.C.3.b.(2). of the Disincentives Proposed Rule (88 FR 74960) and
this final rule.
Comments. Several commenters expressed concern about the impact the
proposed MIPS disincentive may have to increase burden and financial
distress on health care providers. One commenter did not support the
proposed impact of disincentive estimates for MIPS, noting that the
penalties are economically significant and may be catastrophic for some
practices. One commenter stated that this increasing burden is due to
the changing nature of the underlying programs, requiring health care
providers to continually monitor changes.
Response. Finalizing the proposed disincentive provisions related
to MIPS eligible clinicians should not increase burden on clinicians as
it does not require the clinician to do anything additional. The
proposed disincentive only applies if the MIPS eligible clinician
engages in information blocking contrary to statute, including SSA
section 1848(o)(2)(A). As for financial distress, MIPS eligible
clinicians can avoid receipt of a disincentive for information blocking
by not interfering with, preventing, or materially discouraging the
access, exchange, or use of electronic health information.
Comments. Several commenters shared recommendations on how CMS
should apply disincentives in MIPS. A few commenters recommended that
CMS establish more than one disincentive for MIPS eligible clinicians
who are referred by OIG to allow the agency flexibility in determining
the disincentive appropriate for each case. One commenter recommended
that CMS provide clinicians who are successfully sharing information
additional points for their MIPS score.
Response. We thank commenters for their feedback. While we
initially considered different approaches, we proposed to amend the
definition of meaningful EHR user. We proposed that a MIPS eligible
clinician who is referred to CMS by OIG for information blocking would
not be considered a meaningful EHR user, thereby resulting in earning a
zero for the Promoting Interoperability performance category.
While we acknowledge information blocking conduct may vary in
levels of severity, frequency, and potential patient harm, we believe
our proposed disincentive for MIPS is most closely aligned with the
directive at PHSA section 3022(b)(2)(B) (to apply an appropriate
disincentive using authorities under applicable Federal law) and the
statutory criteria for being treated as a meaningful EHR user in SSA
section 1848(o)(2)(A) for the MIPS Promoting Interoperability
performance category under SSA section 1848(q)(2)(B)(iv), as discussed
previously. Information blocking inhibits the meaningful use of CEHRT
and the electronic exchange of health information as required by SSA
section 1848(o)(2)(A). Failure to meet all three criteria to be treated
as a meaningful EHR user at SSA section 1848(o)(2)(A) means the MIPS
eligible clinician has failed to meet the requirements for the MIPS
Promoting Interoperability performance category, which we believe
warrants a score of zero. We believe this disincentive is most
consistent with these statutory requirements for a MIPS eligible
clinician to demonstrate they are a meaningful user of CEHRT because,
as discussed previously, information blocking undermines the goals and
purposes of these requirements.
Comments. A few commenters supported the proposal to use the date
of the OIG referral instead of the date of the information blocking
occurrence to apply the disincentive within MIPS, stating that this
approach would avoid reprocessing of claims, allow health care
providers to plan for a disincentive, and prevent additional
administrative burden in the process.
Response. We agree that using the date of the referral is the
preferred approach as it allows us to apply the disincentive to the
applicable MIPS payment year.
Comments. One commenter recommended that CMS apply the disincentive
to the performance period following the year in which OIG makes a
determination on information blocking. A commenter expressed concern
that the two-year period between when the referral occurs and when the
disincentive is applied is too long and may not serve to correct health
care provider behavior as a result. Another commenter recommended CMS
not apply the disincentive in two MIPS payment years unless the
information blocking conduct spanned more than 1 year, and that CMS
apply the disincentives according to the length of time over which the
conduct occurred.
Response. We considered applying the disincentive to the year
following the OIG referral but determined that it was not
administratively feasible under CMS's existing MIPS policies and
processes. We proposed that the disincentive be applied to the MIPS
payment year 2 years after the year of the OIG referral. This aligns
with current MIPS policy and processes, as the MIPS payment adjustment
is applied to the MIPS payment year 2 years after the performance
period.
We did not propose to apply the disincentive to multiple years.
Even if a referral from OIG identified information blocking conduct
that occurred over multiple years, we would only apply a payment
adjustment to the year the OIG referral was made.
Comments. One commenter did not support the proposed amendments to
the definition of a ``meaningful EHR user for MIPS,'' noting that the
proposed policy does not consider the severity of the information
blocking determination and is inconsistent with OIG's existing policies
of considering multiple factors prior to determining the severity of a
penalty for HIEs/HINs.
Response. We thank the commenter for their feedback; however, we
disagree. We believe that any instance of information blocking should
not occur. OIG completes their investigation and then refers the
determination to CMS. OIG does not impose the disincentive. We
recognize that PHSA section 3022(b)(2)(A) states that, for health IT
developers of certified health IT and HINs/HIEs who have committed
information blocking that are subject to CMPs, the amount of the CMP
shall consider factors such as the nature and extent of the information
blocking. However, as discussed previously in this rule, this provision
does not apply to health care providers that OIG refers to an
appropriate agency to be subject to appropriate disincentives using
authorities under applicable Federal law, as stated in PHSA section
3022(b)(2)(B). The proposal we have finalized in this final rule is
established under the authority for the MIPS Promoting Interoperability
performance category in SSA section 1848(q). This authority is
discussed previously in detail and in the Disincentives Proposed Rule
(88 FR 74958 and 74959). As we discuss in a previous response to a
comment, this authority does not provide us with the ability to adjust
payments under MIPS according to a set of factors related to the
severity of information blocking practices.
[[Page 54698]]
Comments. Many commenters did not support the proposal to assign a
zero score for the MIPS Promoting Interoperability performance category
if a health care provider has committed information blocking. Many
commenters expressed that the proposed disincentive is too severe, with
some expressing concern that it would prevent eligible clinicians from
earning a positive payment adjustment under MIPS and would likely
result in a negative payment adjustment, especially if the performance
threshold is increased in future years. Based on this, one commenter
disagreed that the rule is not economically significant.
Response. We thank commenters for their feedback. We believe that
committing information blocking is not only inconsistent with PHSA
section 3022 but also undermines the goals and purpose of the MIPS
Promoting Interoperability performance category. We refer readers to
our discussion in section III.C.3.b.(2). of the Disincentives Proposed
Rule (88 FR 74960) and this final rule.
As we discuss in a previous response to a comment, information
blocking inhibits the meaningful use of CEHRT and the electronic
exchange of health information as required by SSA section
1848(o)(2)(A). Failure to meet all three criteria to be treated as a
meaningful EHR user at SSA section 1848(o)(2)(A) means the MIPS
eligible clinician has also failed to meet the requirements for the
MIPS Promoting Interoperability performance category, which warrants a
score of zero. This disincentive is consistent with the statutory
requirements for a MIPS eligible clinician to demonstrate they are a
meaningful user of CEHRT because, as discussed previously, information
blocking undermines the goals and purposes of these requirements.
We disagree that the disincentive is severe. It is closely aligned
with the directive at PHSA section 3022(b)(2)(B) (to apply an
appropriate disincentive using authorities under applicable Federal
law) and the statutory requirements for MIPS. As discussed in section
III.C.3.a.(1). of the Disincentives Proposed Rule (88 FR 74957 and
74958) and this final rule, a MIPS eligible clinician receiving a final
score of zero for all applicable performance categories would result in
a negative MIPS adjustment factor of negative 9 percent (sections
1848(q)(6)(A) and (B)(iv); 42 CFR 414.1405(c)). The MIPS statute at SSA
sections 1848(q)(6)(A) and (B) establishes the framework by which CMS
calculates MIPS payment adjustment factors based on CMS' assessment of
MIPS eligible clinicians' performance in the four performance
categories. Nothing in the MIPS disincentive we proposed and have
finalized in this rule alters that framework. Instead, this
disincentive explicitly relies on that framework, providing that an OIG
referral of its determination that a MIPS eligible clinician committed
information blocking means the MIPS eligible clinician does not meet
the requirements for the Promoting Interoperability performance
category, and therefore warrants receiving a zero score for that
category.
Further, we note that, after application of the linear scaling
factor and budget neutrality, a final score above zero, but below the
applicable performance threshold, may result in calculation of a MIPS
payment adjustment factor between negative 9 percent and zero
percent.\34\ Depending on how the MIPS eligible clinician performs in
the other performance categories and the weight assigned to the
applicable performance categories for the final score, the potential
effect of application of this disincentive (a zero score for the
Promoting Interoperability performance category) on calculation of the
MIPS payment adjustment factor may be limited.
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\34\ We refer readers to Table 60 in the CY 2024 Physician Fee
Schedule final rule (88 FR 79379) for an illustration of the
potential range of MIPS payment adjustment factors that may be
calculated and applied based on comparison of a MIPS eligible
clinician's final score to the applicable performance threshold. For
instance, a final score of 0 to 18.75 points for the CY 2024
performance period/2026 MIPS payment year may result in negative 9
percent MIPS payment adjustment factor; a final score of 18.76 to
74.99 may result in a MIPS payment adjustment factor between
negative 9 percent and zero percent.
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As we state in section VI. of this final rule, the Office of
Management and Budget has determined that the proposed rule is not a
significant regulatory action as the potential costs associated with
the proposed rule would not be greater than $200 million per year nor
would this action meet the other conditions necessary to be deemed
significant.
Comments. Some expressed concern that disincentives may have a
significant negative financial impact on practices. A few commenters
contended that the proposed disincentive was too severe for first time
offenders. Other commenters expressed concern about the impact this
proposal would have on smaller practices, with some expressing concern
that it may cause disproportionate financial distress to smaller
practices.
Response. We appreciate the feedback, but health care providers,
including MIPS eligible clinicians, should not engage in information
blocking practices. The impact associated with the disincentive meets
our goal of deterring information blocking, which includes ``first-
time'' conduct by health care providers. We also reiterate that
information blocking practices by health care providers include an
element of intent, in which the health care provider must know that a
practice is unreasonable and likely to interfere with the exchange,
access or use of electronic health information. We remind readers that
we did not propose to modify our reweighting policies and small
practices will continue to be automatically reweighted for the
Promoting Interoperability performance category as provided in 42 CFR
414.1380(c)(2)(i)(C)(9).
Comments. One commenter expressed concern that, upon receipt of
notice from CMS regarding OIG's finding that the MIPS eligible
clinician committed information blocking and application of the
disincentive, individual MIPS eligible clinicians or groups will have
less incentive to report additional measures under the MIPS Promoting
Interoperability performance category. They recommended deducting 10
points from the category score in a calendar year of the performance
period if the OIG refers a determination of information blocking.
Several commenters recommended that CMS instead implement a scalable
system that would impose different disincentives depending on the
severity or mitigating factors of the information blocking violation. A
few commenters recommended a percentage or point deduction rather than
failing the entire Promoting Interoperability performance category and
scaling it to severity.
Response. We thank commenters for their input. While we did
initially consider some of these alternatives, we ultimately decided
not to propose them. As we discuss in a previous response to a comment,
the disincentive we proposed and have finalized closely aligns with the
directive at PHSA section 3022(b)(2)(B) (to apply an appropriate
disincentive using authorities under applicable Federal law) and the
statutory requirements MIPS. Information blocking inhibits the
meaningful use of CEHRT and the electronic exchange of health
information as required by SSA section 1848(o)(2)(A). Failure to meet
all three criteria to be treated as a meaningful EHR user at SSA
section 1848(o)(2)(A) means the MIPS eligible clinician has also failed
to meet the requirements for the MIPS Promoting Interoperability
performance category, which warrants a
[[Page 54699]]
score of zero. We believe any other disincentive option would be
contrary to these statutory requirements for a MIPS eligible clinician
to demonstrate they are a meaningful user of CEHRT because, as
discussed previously, information blocking undermines the goals and
purposes of these requirements.
The policies that we proposed and have finalized, including
modification to the definition of meaningful EHR user for MIPS (42 CFR
414.1305), will result in a MIPS eligible clinician not being able to
earn points associated with the Promoting Interoperability performance
category if they were found to have committed information blocking.
Regarding the recommendation to tie the disincentive to a reduction of
10 points in the performance category, and the recommendation to tie a
point reduction to the severity of the information blocking conduct
referred by OIG, we note that we did not propose these alternatives for
the reasons stated above.
Comments. One commenter recommended CMS consider additional
incentives within the Promoting Interoperability performance category
to promote the flow of electronic health information and to deter
information blocking.
Response. We appreciate this input and may consider it in future
rulemaking. In recent years, we have added measures to the Promoting
Interoperability performance category such as the Enabling Exchange
under the Trusted Exchange Framework and Common Agreement (TEFCA)
measure, to encourage the bi-directional exchange of patient
information (87 FR 70067).
Comments. Another commenter requested CMS clarify how cases in
which MIPS eligible clinicians transition from reporting traditional
MIPS to MIPS Value Pathways (MVPs) during the OIG investigation would
be addressed and whether penalties would be imposed given the different
participation options within the MVP framework, expressing concern
about confusion and implementation challenges.
Response. The MIPS Promoting Interoperability performance category
is a foundational component of every MVP. As such, if a finding of
information blocking is referred to CMS by OIG, we would apply the
disincentive to the MIPS eligible clinician participating in an MVP.
After consideration of the public comments, CMS has finalized our
proposal to revise the definition of ``meaningful EHR user'' for MIPS
at 42 CFR 414.1305 to state that a MIPS eligible clinician is not a
meaningful EHR user in a performance period if OIG refers a
determination that the clinician committed information blocking, as
defined at 45 CFR 171.103, during the calendar year of the performance
period. CMS has also finalized minor technical modifications to this
definition as proposed (88 FR 74961). Consistent with our discussion in
section III.C.3.b.(1), CMS has finalized this definition to also
exclude a qualified audiologist from application of this disincentive.
We originally noted this exclusion in the regulation text we proposed
in the Disincentive Proposed Rule (88 FR 74968). Therefore, CMS has
finalized the amendment to the regulatory definition of meaningful EHR
user for MIPS at 42 CFR 414.1305 generally as proposed, with a
modification to address group reporting as discussed in section
III.C.3.c.(1) of this rule.
CMS has finalized our proposal that if OIG refers a determination
to CMS that the MIPS eligible clinician is found to have committed
information blocking, the MIPS eligible clinician will not earn a score
in the Promoting Interoperability performance category (a zero score),
which is typically a quarter of the total MIPS score. Further, CMS has
finalized the proposal that we will apply the disincentive to the MIPS
payment year associated with the calendar year in which OIG referred
its determination to CMS. To codify this policy, CMS also has finalized
its proposal to amend the requirements for earning a score for the MIPS
Promoting Interoperability performance category at 42 CFR 414.1375(b)
as proposed.
Lastly, CMS has finalized its proposal that, if multiple
information blocking violations are identified as part of OIG's
determination (including over multiple years) and referred to CMS, each
referral of an information blocking determination by OIG would only
affect a MIPS eligible clinician's status as a meaningful EHR user in a
single performance period during the calendar year when the
determination of information blocking was referred to CMS by OIG.
The final policies in this rule will become effective 30 days after
the final rule appears in the Federal Register. As noted in section
III.B.1. of this final rule, OIG will not begin investigating health
care providers until after the effective date of this rule, and will
exercise its enforcement discretion not to make any determinations
regarding conduct occurring prior to the effective date of this rule
for information blocking disincentives. As OIG will not make a
determination on conduct occurring prior to the effective date, OIG
will not refer any health care providers based on a determination of
conduct occurring prior to the effective date of this rule for
information blocking disincentives. This means that CMS will not impose
the disincentive finalized under the MIPS Promoting Interoperability
performance category on information blocking conduct occurring before
the effective date of this final rule.
(1) Groups and Virtual Groups
In the Disincentives Proposed Rule, CMS proposed that, if data for
the MIPS Promoting Interoperability performance category is submitted
as a group or virtual group, then the application of the disincentive
would be made at that level (88 FR 74962). CMS referred readers to our
prior rulemaking governing groups and virtual groups (81 FR 77073
through 77077) and our regulations at 42 CFR 414.1305 (defining MIPS
eligible clinicians as including groups as well as separately defining
groups and virtual groups) and 414.1315 (governing virtual groups).
Additionally, we refer readers to SSA section 1848(q)(1)(D), which
provides the Secretary with authority to establish and apply a process
to assess the performance of MIPS eligible clinicians in a group
practice as a whole group under MIPS, including the group's performance
in the Promoting Interoperability performance category.
In the Disincentives Proposed Rule, CMS explained that MIPS
eligible clinicians who submit data as a part of a group, virtual
group, or individually will be evaluated as an individual or as a group
for all performance categories (88 FR 74962). We clarify in this final
rule that if a MIPS eligible clinician reports data for MIPS as a group
and an individual, the payment adjustment will be based on the highest
final score.\35\ Beginning with the CY 2021 performance period/2023
MIPS payment year, if a TIN/NPI has a virtual group final score
associated with it, CMS will use the virtual group final score to
determine the MIPS payment adjustment; if a TIN/NPI does not have a
virtual group final score associated with it, we will use the highest
available final score associated with the TIN/NPI to determine the MIPS
payment adjustment (85 FR 84917 through 84919). CMS noted that it would
apply the MIPS payment adjustment factor to the Medicare Part B claims
during the
[[Page 54700]]
MIPS payment year for the MIPS eligible clinicians in the group or
virtual group. Thus, CMS proposed that, if CMS is calculating a final
score and MIPS payment adjustment factor for a group or virtual group
and OIG refers a finding of information blocking to CMS, CMS would
apply the proposed disincentive to the whole group.
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\35\ Although CMS did not include this clarification in the
Disincentives Proposed Rule, this statement is consistent with
existing MIPS policies governing individual and group reporting. See
the CY 2017 Quality Payment Program final rule (81 FR 77330 through
77332).
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The following is a summary of the comments we received and our
responses.
Comments. A few commenters requested clarification on the proposal
to apply the disincentive at the group level. Others requested
clarification on how OIG would address a group practice that committed
information blocking, but that does not participate in MIPS at the
group level. Another commenter requested additional information on how
CMS would address instances in which a MIPS eligible clinician that is
found to have committed information blocking reports both as a group
and as an individual, how this policy will be applied to subgroups when
a subgroup is identified, and whether the appropriate disincentive will
be applied to an entire group, regardless of whether the information
blocking practice was limited to a particular subgroup.
Response. In situations where OIG refers a determination of
information blocking for multiple NPIs we would apply the disincentive
to each NPI. If OIG determines a group consisting of one or more MIPS
eligible clinicians has committed information blocking and the MIPS
eligible clinicians submit data as a group, the disincentive would be
applied at the group level. However, as discussed in more detail below,
consistent with PHSA section 3022(a)(6), if OIG determines a single
MIPS eligible clinician within a group has committed information
blocking (and not the group itself), then we would seek to apply the
disincentive to the individual MIPS eligible clinician.
Comments. Several commenters expressed concern that this proposal
would discourage group, virtual group, and subgroup reporting, which
commenters stated would undermine CMS' goals of reducing the overall
reporting burden and increasing participation in value-based payment
models. Commenters expressed that the proposal could dissuade health
care providers from reporting at the group level, due to concerns about
being unfairly penalized for the actions of one bad actor in a group
and may impact participation in virtual groups even more because
clinicians may practice in different locations and may use different
EHR systems.
Response. We disagree with the commenters that finalizing this
disincentive policy will discourage group submissions, as we believe
the benefits of group reporting outweigh the potential risk of being
subject to a disincentive, as MIPS eligible clinicians that comply with
the information blocking regulations will not be subject to a
disincentive. We have finalized that, if OIG determines the group has
committed information blocking, then we will apply the disincentive to
the group. However, as discussed in more detail below, consistent with
PHSA section 3022(a)(6), if OIG determines a single MIPS eligible
clinician within a group has committed information blocking (and not
the group itself), then we would seek to apply the disincentive to the
individual MIPS eligible clinician.
Comments. Many commenters did not support the proposal to apply the
disincentive at the group level, noting that the proposal is overly
punitive. Some commenters noted that in large groups hundreds or
thousands of MIPS eligible clinicians could be penalized for the action
of one within the group. Some commenters noted that a TIN serves many
purposes and cannot be easily undone to avoid a disincentive for a
group.
Response. We thank commenters for their feedback but decline to
modify our proposal in response to these comments. MIPS eligible
clinicians do not have to report data as a group; it is a choice that
they make. However, as discussed in more detail below, consistent with
PHSA section 3022(a)(6), if OIG determines a single MIPS eligible
clinician within a group has committed information blocking (and not
the group itself), then we would seek to apply the disincentive to the
individual MIPS eligible clinician.
Comments. Another commenter requested clarification on how a case
would be handled in which a health care provider commits information
blocking during a specific MIPS performance period, and then moves to a
new practice before the application of the MIPS payment adjustment.
Response. We will apply the disincentive to the MIPS payment year 2
years after CMS receives the information blocking referral from OIG.
The application of the disincentive will follow the MIPS eligible
clinician.\36\ As discussed in more detail below, consistent with PHSA
section 3022(a)(6), if OIG determines a single MIPS eligible clinician
within a group has committed information blocking (and not the group
itself), then we would seek to apply the disincentive to the individual
MIPS eligible clinician.
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\36\ For more information, see: the CY 2017 Quality Payment
Program Final Rule (81 FR 77330 through 77332).
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Comments. Several commenters recommended that CMS apply the
disincentive only to the health care provider(s) that were found to
have committed information blocking rather than the entire group or
virtual group. Some noted that an entire group or individuals not
practicing in the same location or have a direct relationship should
not be punished for the actions of another individual that may be
beyond their control. A few commenters recommended individual
physicians found to be information blockers could be excluded from the
group data or be required to report and be assessed separately. One
commenter contended that punishing the entire group for the behavior of
one individual appears to be contrary to the definitions at PHSA
3022(a)(6). One commenter requested that CMS look at the details of the
case, determine the extent of and institutional role of the information
blocking, and provide appropriate corrective action recommendations and
education. One commenter recommended disincentives be applied to
individual health care providers unless the subgroup or group has
adopted enterprise-wide policies or taken actions as an enterprise that
constitute information blocking. Some commenters requested that CMS
work to determine a more equitable way to apply a disincentive in these
situations, including a later application of the disincentive.
Response. We acknowledge commenters' concerns with the policy we
proposed for group reporting. PHSA section 3022(a)(6) relates to
limiting what conduct can be determined to constitute information
blocking. We will comply with PHSA section 3022(a)(6) in applying the
disincentive we have finalized for the MIPS Promoting Interoperability
performance category. If OIG determines that a group \37\ has committed
information blocking and the group reports at the group level, then we
would apply the disincentive to the group. If OIG determines that
multiple individual MIPS eligible clinicians within a group have
committed information blocking and they report at the individual level,
then we would apply the disincentive to each MIPS eligible clinician
individually. However, if OIG determines an individual MIPS
[[Page 54701]]
eligible clinician within a group has committed information blocking
(and not the group itself), then we would seek to apply the
disincentive to the individual MIPS eligible clinician.
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\37\ We define this term in our regulation at 42 CFR 414.1305 as
a single TIN of two or more eligible clinicians (including at least
one MIPS eligible clinician), as identified by their individual NPI,
who have reassigned their billing rights to the TIN.
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To clarify this intent, we are finalizing our proposed amendment to
the definition of meaningful EHR user for MIPS at Sec. 414.1305 with
modification. Specifically, we are adding language reflecting the
requirement at PHSA section 3022(a)(6), providing that the term
``information blocking,'' with respect to an individual MIPS eligible
clinician or group, shall not include an act or practice other than an
act or practice committed by such individual MIPS eligible clinician or
group. We will seek to address in future rulemaking how we will
effectuate this requirement, including how we may disaggregate an
individual MIPS eligible clinician's data from a group's data if OIG
determines that only the individual MIPS eligible clinician (and not
the group) committed information blocking.
Comments. A few commenters specifically expressed concern that the
existing MIPS review process would not address the underlying
information blocking determination or cause of the zero score for the
MIPS Promoting Interoperability performance category because it would
not address the information blocking finding itself. One commenter
expressed concern that there would be no mechanism for physicians to
appeal the appropriateness of the specific disincentives chosen by CMS
once it has received an information blocking determination referral
from OIG. One commenter requested additional clarification on how the
targeted review process within MIPS would apply to information blocking
disincentives.
Response. As discussed in section III.B.2. of this final rule, the
Cures Act did not provide instruction regarding appeals of
disincentives for health care providers established under PHSA section
3022(b)(2)(B). Therefore, any right to appeal administratively a
disincentive, if available, would be provided under the authorities
used by the Secretary to establish the disincentive through notice and
comment rulemaking. We refer readers to the targeted review process we
established at 42 CFR 414.1385(a) in accordance with SSA section
1848(q)(13)(A).
After consideration of the public comments, we have finalized our
proposed amendment to the definition of meaningful EHR user for MIPS at
Sec. 414.1305 with modification. Specifically, we have added language
reflecting the requirement at PHSA section 3022(a)(6), providing that
the term ``information blocking,'' with respect to an individual MIPS
eligible clinician or group, shall not include an act or practice other
than an act or practice committed by such individual MIPS eligible
clinician or group. We will seek to address in future rulemaking how we
will effectuate this requirement, including how we may disaggregate an
individual MIPS eligible clinician's data from a group's data if OIG
determines that only the individual MIPS eligible clinician (and not
the group) committed information blocking.
(2) Reweighting Policies
In the Disincentives Proposed Rule we noted that CMS has
established policies that result in the reweighting of the Promoting
Interoperability performance category for certain MIPS eligible
clinicians at 42 CFR 414.1380(c)(2) (88 FR 74962). These include but
are not limited to hospital-based clinicians (81 FR 77238 through
77420, 82 FR 53684, and 82 FR 53686 through 53687) and Ambulatory
Surgical Center-based clinicians (82 FR 53684). CMS did not propose
changes to its existing reweighting policies for MIPS eligible
clinicians in the Disincentives Proposed Rule.
Starting with the CY 2022 performance period/2024 MIPS payment year
performance period CMS automatically reweights small practices for the
Promoting Interoperability performance category (86 FR 65485 through
65487; 42 CFR 414.1380(c)(2)(i)(C)(9)). CMS did not propose changes to
our existing policy for MIPS eligible clinicians in small practices in
the Disincentives Proposed Rule.
CMS noted in the Disincentives Proposed Rule that if these MIPS
eligible clinicians choose to submit data for the Promoting
Interoperability performance category, their reweighting is canceled,
and they could be subject to a disincentive if OIG refers a
determination of information blocking to CMS (88 FR 74962).
Comments. A few commenters supported CMS' decision to not propose
any changes to the existing MIPS reweighting policies.
Response. We thank commenters for their support.
Comments. Several commenters requested that CMS clarify how the
existing significant hardship exemptions for the MIPS Promoting
Interoperability performance category will interact with the proposed
MIPS disincentives.
Response. CMS did not propose any changes to the existing
reweighting policies for significant hardship or other types of
exceptions for the MIPS Promoting Interoperability performance category
set forth at 42 CFR 414.1380(c)(2)(i)(C). These reweighting policies
provide bases by which CMS may reweight the 25 percent weight assigned
to the MIPS Promoting Interoperability performance category and
redistribute that weight to other categories on which the MIPS eligible
clinician may be scored in accordance with 42 CFR 414.1380(c)(2)(ii).
If CMS reweights the Promoting Interoperability performance category to
zero percent in accordance with these reweighting policies, then the
Promoting Interoperability performance category is not assigned any
score (zero or otherwise) and is not included in CMS's calculation of
the MIPS eligible clinician's final score.
To clarify, if the Promoting Interoperability performance category
is reweighted to zero percent for a given performance period/MIPS
payment year in accordance with these policies, then CMS does not
assess whether the MIPS eligible clinician is a meaningful EHR user
and, therefore, does not include any score for the performance category
in the MIPS eligible clinician's final score. In this circumstance,
this disincentive would not affect the MIPS eligible clinician's final
score.
Comments. One commenter requested guidance on how CMS would decide
which disincentive to apply to a case in which a hospitalist is found
to have engaged in information blocking. One commenter also supported
CMS' proposal to not impact the status or MIPS scoring of ``non-patient
facing'' and ``hospital-based'' MIPS eligible clinicians, or other MIPS
eligible clinicians automatically reweighted from the Promoting
Interoperability performance category.
Response. A hospitalist likely may be a licensed physician meeting
the definition of MIPS eligible clinician set forth at 42 CFR 414.1305.
We refer readers to our discussion in section III.C.3.b.(1) of the
Disincentives Proposed rule (88 FR 74959) and this final rule regarding
the alignment of definitions of MIPS eligible clinician and health care
provider under the PHSA.
Whether an individual or group is subject to MIPS and its
requirements will be determined in accordance with the applicable
statute at SSA section 1848(q) and our regulations at 42 CFR part 414,
subpart O. We note that, in the Disincentives Proposed Rule, CMS did
not propose any changes to the MIPS reweighting policies at 42 CFR
414.1380(c)(2) (88 FR 74962). Therefore,
[[Page 54702]]
if a hospitalist meets the definition of a hospital-based MIPS eligible
clinician at 42 CFR 414.1305, CMS may continue to reweight the
Promoting Interoperability performance category to zero percent for the
hospitalist in accordance with 42 CFR 414.1380(c)(2)(i)(C)(6), subject
to any other applicable requirements.
We did not make any proposals in this section. We note that, if a
MIPS eligible clinician submits data for the Promoting Interoperability
performance category, their reweighting may be cancelled in accordance
with 42 CFR 414.1380(c)(2)(i)(C), and they could be subject to a
disincentive if OIG refers a determination of information blocking to
CMS.
d. Notification of the Disincentive
In the Disincentives Proposed Rule we noted that after OIG has
determined that a health care provider has committed information
blocking and referred that health care provider to CMS, CMS would
notify the MIPS eligible clinician that OIG determined that the
eligible clinician committed information blocking as defined under 45
CFR 171.103, and thus the MIPS eligible clinician was not a meaningful
EHR user for the performance period in the calendar year when OIG
referred its information blocking determination to CMS (88 FR 74962).
We stated that we would apply the proposed disincentive to the MIPS
payment year associated with the calendar year in which the OIG
referred its determination to CMS. We noted that this notice would be
issued in accordance with the notice requirements for disincentives
proposed in 45 CFR 171.1002 (see also section III.B.2. of the
Disincentives Proposed Rule and this final rule).
CMS invited public comment on this proposal.
The following is a summary of the comments we received and our
responses.
Comments. One commenter expressed concern that applying
disincentives within MIPS without providing the physician an
opportunity to correct the issue would cause financial harm to
practices, reduce the resources practices have available to develop
robust information sharing capabilities, and disincentivize quality
reporting and improvement efforts.
Response: We did not propose a mechanism by which MIPS eligible
clinicians could engage in a corrective action plan or other activity
to demonstrate compliance and avoid a disincentive. We remind readers
that the definition of information blocking in PHSA section 3022(a)
requires that a health care provider ``knows'' that a practice is
unreasonable and is likely to interfere with, prevent, or materially
discourage access, exchange, or use of electronic health information.
After consideration of the public comments, CMS has finalized its
proposal to notify a MIPS eligible clinician that OIG determined that
the MIPS eligible clinician committed information blocking as defined
under 45 CFR 171.103, and, in accordance with the definition of
``meaningful EHR user,'' that the MIPS eligible clinician was not a
meaningful EHR user for the performance period in the calendar year
when OIG referred its information blocking determination to CMS.
4. Medicare Shared Savings Program
a. Background
(1) Statutory Authority for Disincentive
In the Disincentives Proposed Rule, we explained that Section 3022
of the Patient Protection and Affordable Care Act (PPACA) (Pub. L. 111-
148, Mar. 23, 2010) added section 1899 to the Social Security Act (SSA)
(42 U.S.C. 1395jjj), which established the Medicare Shared Savings
Program (Shared Savings Program) (88 FR 74963). In accordance with the
statute, groups of providers of services and suppliers (referred to
herein as ``ACO participants'') and their associated health care
providers (referred to herein as ``ACO providers/suppliers'') meeting
criteria specified by the Secretary may work together to manage and
coordinate care for Medicare fee-for-service beneficiaries through an
ACO. ACOs that meet quality performance standards established by the
Secretary are eligible to receive payments for shared savings the ACO
generates for Medicare and to avoid sharing losses at the maximum
level. One condition of participation required by the statute is for
the ACO to define certain processes, including a mandate to ``define
processes to promote evidence-based medicine and patient engagement,
report on quality and cost measures, and coordinate care, such as
through the use of telehealth, remote patient monitoring, and other
such enabling technologies'' (Social Security Act section
1899(b)(2)(G)).
(2) Shared Savings Program Regulations
In the Disincentives Proposed Rule, we explained that the Shared
Savings Program regulations at 42 CFR part 425 set forth, among other
things, requirements for ACO eligibility, quality reporting, and other
program requirements and beneficiary protections (88 FR 74963).\38\ The
regulations at 42 CFR 425.116 require that an ACO, as a condition of
participation in the Shared Savings Program, must effectuate an
agreement with its ACO participants and ACO providers/suppliers (as
defined at 42 CFR 425.20). This agreement must expressly require the
ACO participant to agree, and to ensure that each ACO provider/supplier
billing through the TIN of the ACO participant agrees, to participate
in the Shared Savings Program and to comply with the requirements of
the Shared Savings Program and all other applicable Federal laws and
regulations including, but not limited to: (1) Federal criminal law;
(2) The False Claims Act (31 U.S.C. 3729 et seq.); (3) The anti-
kickback statute (42 U.S.C. 1320a-7b(b)); (4) The civil monetary
penalties law (42 U.S.C. 1320a-7a); and (5) The physician self-referral
law (42 U.S.C. 1395nn).
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\38\ Shared Savings Program regulations generally specify
standards for an ACO, which is bound by its participation agreement
to the standards. CMS generally specifies standards applicable to an
ACO participant and ACO provider/supplier that is participating in
the ACO through its regulation of the ACO.
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CMS has interpreted the requirement at section 1899(b)(1)(G) of the
SSA that an ACO coordinates care for assigned beneficiaries using
enabling technologies to require an ACO (and, by agreement, an ACO
participant and ACO provider/supplier) to, among other things, define
its methods and processes established to coordinate care across and
among health care providers both inside and outside the ACO and have a
written plan to ``encourage and promote use of enabling technologies
for improving care coordination for beneficiaries'' (42 CFR
425.112(b)(4)(i) and (b)(4)(ii)(C)). Enabling technologies may include
one or more of the following: electronic health records and other
health IT tools; telehealth services, including remote patient
monitoring; electronic exchange of health information; and other
electronic tools to engage beneficiaries in their care. The ACO must
ensure that ACO participants and ACO providers/suppliers comply with
and implement the defined care coordination process, including the
encouragement and promotion of enabling technologies, and the remedial
processes and penalties (including the potential for expulsion)
applicable to ACO participants and ACO providers/suppliers for failure
to comply with and implement the required process (see 42 CFR
425.112(a)(3)). Sharing health information using enabling technologies
across all health care providers engaged in a beneficiary's care (both
inside and
[[Page 54703]]
outside the ACO) for purposes of care coordination and quality
improvement is an essential aspect of the ACO's activities. Moreover,
this type of information sharing among health care providers (both
inside and outside the ACO) supports quality measurement and quality
reporting activities, which are necessary for the ACO to be eligible to
share in savings and are also used in determining the amount of shared
losses.
Before the start of an agreement period, before each performance
year thereafter, and at such other times as specified by CMS, the ACO
must submit to CMS an ACO participant list and an ACO provider/supplier
list (see 42 CFR 425.118(a); citing 42 CFR 425.302(a)(2)). The ACO must
certify the accuracy, completeness, and truthfulness of the data and
information contained in the submitted lists annually. All Medicare-
enrolled individuals and entities that have reassigned their right to
receive Medicare payment to the TIN of the ACO participant must be
included on the ACO provider/supplier list and must agree to
participate in the ACO and comply with the requirements of the Shared
Savings Program before the ACO submits the ACO participant list and the
ACO provider/supplier list.
CMS may deny an ACO, ACO participant, and/or an ACO provider/
supplier participation in the Shared Savings Program if the entity or
individual has a history of program integrity issues (see 42 CFR
425.305(a)(2)). CMS screens ACOs, ACO participants, and ACO providers/
suppliers during the Shared Savings Program application process and
periodically thereafter (for example, during the annual certification
of the ACO participant and ACO provider/supplier lists) with regard to
their program integrity history (including any history of Medicare
program exclusions or other sanctions and affiliations with individuals
or entities that have a history of program integrity issues) (see 42
CFR 425.305(a)(1)). In the Medicare Shared Savings Program Final Rule
(76 FR 67802), CMS stated that the results of the screening would be
considered in light of the relevant facts and circumstances. CMS did
not draw a bright line regarding when an entity's history of program
integrity issues would justify denial of a Shared Savings Program
participation agreement. CMS stated instead that we would likely
consider the nature of the applicant's program integrity issues
(including the program integrity history of affiliated individuals and
entities), the available evidence, the entity's diligence in
identifying and correcting the problem, and other factors. CMS stated
that we intended to ensure that ACOs, ACO participants, and ACO
providers/suppliers would not pose a risk of fraud or abuse within the
Shared Savings Program while recognizing that some program integrity
allegations may not have been fully adjudicated.
CMS may terminate an ACO's Shared Savings Program participation
agreement if the ACO, its ACO participants, or its ACO providers/
suppliers or other individuals or entities performing functions or
services related to ACO activities fail to comply with any of the
requirements of the Shared Savings Program under 42 CFR part 425 (Sec.
425.218(a) and (b)). This includes, but is not limited to, violations
of the physician self-referral prohibition, CMP law, Federal anti-
kickback statute, antitrust laws, or any other applicable Medicare
laws, rules, or regulations that are relevant to ACO operations.
Similarly, CMS requires that the agreement the ACO effectuates with its
ACO participants must permit the ACO to take remedial action against
the ACO participant, and must require the ACO participant, in turn, to
take remedial action against its ACO providers/suppliers, including
imposition of a corrective action plan, denial of incentive payments,
and termination of the ACO participant agreement, to address
noncompliance with the requirements of the Shared Savings Program and
other program integrity issues, including program integrity issues
identified by CMS (42 CFR 425.116(a)(7)). Taken together, these
regulations ensure that CMS may take appropriate enforcement actions
when CMS' screening process or oversight of an ACO reveals a history of
program integrity issues and when an ACO, an ACO participant or an ACO
provider/supplier and other individuals or entities performing
functions or services related to ACO activities fail to comply with the
requirements of the Shared Savings Program, including failure to comply
with other Federal laws that are relevant to the ACO's operations, such
as the Cures Act's information blocking provision (PHSA section 3022).
b. Provisions
In the Disincentives Proposed Rule, CMS proposed to revise the
Shared Savings Program regulations to establish disincentives for
health care providers, including ACOs, ACO participants, or ACO
providers/suppliers, that engage in information blocking (88 FR 74964).
CMS proposed that a health care provider that OIG determines has
committed information blocking may not participate in the Shared
Savings Program for a period of at least 1 year.
In the Disincentives Proposed Rule, we discussed that information
blocking runs contrary to the care coordination goals of the Shared
Savings Program (88 FR 74964). ACO participants and their ACO
providers/suppliers participating in an ACO in the Shared Savings
Program use enabling technologies (such as electronic health records)
to improve care coordination for beneficiaries. The ability of ACO
providers/suppliers to exchange information between health care
providers (both inside and outside the ACO) is essential for the
operations of the ACO, including for effective coordination of care and
quality improvement activities and services for assigned beneficiaries.
In the Disincentives Proposed Rule, first, CMS proposed to amend 42
CFR 425.208(b) to include a specific reference to the Cures Act
information blocking provision codified in the PHSA (88 FR 74964). We
noted that the provision would be one of many laws with which ACOs (and
by agreement, their ACO participants and ACO providers/suppliers) must
comply.\39\ We noted that in this case, compliance is required because
a Medicare enrolled ``health care provider,'' to which an information
blocking disincentive may apply, includes ACO providers/suppliers (See
42 CFR 400.202 and 425.20 and 45 CFR 171.102). We explained that the
effect of adding a specific reference to the information blocking
provision would be to require that, as a condition of participation in
the Shared Savings Program, an ACO must specifically agree (and must
require its ACO participants, ACO providers/suppliers, and other
individuals or entities performing functions or services related to the
ACO's activities to agree) to not commit information blocking as
defined in PHSA section 3022(a).
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\39\ CMS notes that the list of laws included at 42 CFR
425.208(b) with which an ACO must comply is not an exclusive list.
ACOs, ACO participants, and ACO providers/suppliers must continue to
comply with all applicable Federal laws.
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Second, CMS proposed to revise 42 CFR 425.305(a)(1) to specify that
the program integrity history on which ACOs, ACO participants, and ACO
providers/suppliers are reviewed during the Shared Savings Program
application process and periodically thereafter includes, but is not
limited to, a history of Medicare program exclusions or other
sanctions, noncompliance with the requirements of the Shared Savings
Program, or violations of laws specified at 42 CFR 425.208(b) (88 FR
74964). We
[[Page 54704]]
explained that this revision would provide the basis for CMS to deny
participation in the Shared Savings Program to a health care provider
that is an ACO, an ACO participant, or an ACO provider/supplier when
the health care provider has engaged in information blocking, as
determined by OIG.
Third, CMS proposed to make a conforming modification to the
provision related to the grounds for CMS to terminate an ACO at 42 CFR
425.218(b)(3) based on ``[v]iolations of the physician self-referral
prohibition, civil monetary penalties (CMP) law, Federal anti-kickback
statute, antitrust laws, or any other applicable Medicare laws, rules,
or regulations that are relevant to ACO operations.'' CMS proposed to
replace this language with ``[v]iolations of any applicable laws,
rules, or regulations that are relevant to ACO operations, including,
but not limited to, the laws specified at Sec. 425.208(b)'' (88 FR
74964).
Pursuant to CMS' authority under 42 CFR 425.206(a)(1) to deny an
ACO's participation in the Shared Savings Program, CMS' authority under
42 CFR 425.118(b)(1)(iii) to deny the addition of a health care
provider to an ACO's participation list, and CMS' authority under 42
CFR 425.305(a) to screen for program integrity issues, CMS proposed to
screen ACOs, ACO participants, and ACO providers/suppliers for an OIG
determination of information blocking and deny the addition of such a
health care provider to an ACO's participation list for the period of
at least 1 year (88 FR 74964). In the case of an ACO that is a health
care provider, CMS proposed to deny the ACO's application to
participate in the Shared Savings Program for the period of at least 1
year. We noted that if the ACO were to re-apply to participate in the
Shared Savings Program in a subsequent year, then CMS would review
whether OIG had made any subsequent determinations of information
blocking with respect to the ACO as a health care provider as well as
any evidence that indicated whether the issue had been corrected and
appropriate safeguards had been put in place to prevent its
reoccurrence, as part of the ACO's application process. CMS therefore
proposed in the Disincentives Proposed Rule that, in cases where the
result of the program integrity screening identifies that an ACO
(acting as a health care provider), ACO participant, or ACO provider/
supplier, has committed information blocking, as determined by OIG, CMS
would take the following actions, as applicable:
Pursuant to 42 CFR 425.118(b)(1)(iii), CMS would deny the
request of the ACO to add an ACO participant to its ACO participant
list on the basis of the results of the program integrity screening
under 42 CFR 425.305(a).
Pursuant to 42 CFR 425.116(a)(7) and (b)(7), CMS would
notify an ACO currently participating in the Shared Savings Program if
one of its ACO participants or ACO providers/suppliers is determined by
OIG to have committed information blocking so that the ACO can take
remedial action--removing the ACO participant from the ACO participant
list or the ACO provider/supplier from the ACO provider/supplier list--
as required by the ACO participant agreement.
Pursuant to 42 CFR 425.305(a)(2), CMS would deny an ACO's
Shared Savings Program application if the results of a program
integrity screening under 42 CFR 425.305(a)(1) reveal a history of
program integrity issues or other sanctions and affiliations with
individuals or entities that have a history of program integrity
issues.
Pursuant to 42 CFR 425.218(a) and (b)(3), CMS would
terminate an ACO participation agreement in the case of a failure to
comply with requirements of the Shared Savings Program, including
violations of any applicable laws, rules, or regulations that are
relevant to ACO operations, including, but not limited to, the laws
specified at 42 CFR 425.208(b) (88 FR 74964 and 74965).
In the Disincentives Proposed Rule, CMS noted that each of these
actions would deter information blocking consistent with the discussion
of an appropriate disincentive in section III.A.3. of the Disincentives
Proposed Rule (88 FR 74965). We noted that restricting the ability for
these entities to participate in the Shared Savings Program for at
least 1 year would result in these health care providers potentially
not receiving revenue that they might otherwise have earned if they had
participated in the Shared Savings Program.
In the Disincentives Proposed Rule, CMS stated that the period of
time of the disincentive would be at least 1 performance year (88 FR
74965). We explained that we would determine if it would be appropriate
for the period to exceed 1 year if OIG has made any subsequent
determinations of information blocking (for example, CMS would be
unlikely to impose a disincentive greater than 1 year if the
information blocking occurred in the past and there was evidence that
the information blocking had stopped) and whether safeguards have been
put in place to prevent the information blocking that was the subject
of OIG's determination. We noted that prior to imposing any
disincentive arising from an OIG determination of information blocking,
CMS would provide a notice in accordance with the notice requirements
proposed in 45 CFR 171.1002 (88 FR 74953) that would specify the
disincentive would be imposed for at least 1 performance year.
In the Disincentives Proposed Rule, CMS proposed to apply the
disincentive no sooner than the first performance year after we receive
a referral of an information blocking determination from OIG and in
which the health care provider is to participate in the Shared Savings
Program (88 FR 74965). We explained in the Disincentives Proposed Rule
that CMS performs a program integrity screening of ACOs, ACO
participants, and ACO providers/suppliers as part of the annual
application/change request process for new and existing ACOs, which
typically occurs between May and October during the performance year.
In the case of the new addition of an ACO participant (TIN) to an ACO's
participant list, CMS stated that we would prevent the TIN from joining
the ACO as an ACO participant if the program integrity screening
reveals that the TIN has engaged in information blocking, as determined
by OIG. In the case of an existing ACO participant, CMS stated that we
would notify the ACO that an ACO participant or an ACO provider/
supplier had committed information blocking, as determined by OIG, so
the ACO can remove the ACO participant or ACO provider/supplier from
its ACO participant list or ACO provider/supplier list, as applicable.
If the TIN were to remain on the ACO participant list or ACO provider/
supplier list when the ACO certifies its ACO participant list for the
next performance year, we stated that then CMS would issue a compliance
action to the ACO. We noted that continued noncompliance (for example,
failure to remove the TIN) would result in termination of the ACO's
participant agreement with CMS, as the ACO would have failed to enforce
the terms of its ACO participant agreement.
In the Disincentives Proposed Rule, CMS stated that applying the
disincentive prospectively is the most appropriate timing for the
disincentive (88 FR 74965). We noted that it would be impractical and
inequitable for CMS to apply the disincentive retrospectively or in the
same year in which CMS received a referral from OIG. Applying the
disincentive to a historical performance year or a performance year
[[Page 54705]]
contemporaneous to the OIG's determination would unfairly affect other
ACO participants that did not commit the information blocking and
likely were not aware of the information blocking. CMS recognized,
however, that the prospective application of the disincentive means
that it may be applied to a health care provider substantially after
the information blocking occurred, during the provider's first attempt
to participate in the Shared Savings Program, and after the provider
was previously subject to a disincentive in another program, such as
MIPS. As discussed in the Disincentives Proposed Rule (88 FR 74966) and
below, CMS contemplated an approach under which a health care provider
could participate in the Shared Savings Program if a significant amount
of time (for example, 3 to 5 years) had passed between the occurrence
of the information blocking and OIG's determination, and the provider
had given assurances in the form and manner specified by CMS that the
issue had been corrected and appropriate safeguards had been put in
place to prevent its reoccurrence.
In the Disincentives Proposed Rule, CMS explained that after the
completion of the last performance year in which the disincentive was
applied, an ACO may submit a change request to add the TIN or include
the NPI on its ACO participant list or ACO provider/supplier list, as
applicable, for a subsequent performance year, and CMS would approve
the addition, assuming that all other Shared Savings Program
requirements for adding a TIN or NPI are met, so long as (1) OIG has
not made any additional determinations of information blocking, and (2)
the ACO provides assurances (in the form and manner required by CMS)
that the information blocking is no longer ongoing and that the ACO has
put safeguards in place to prevent the information blocking that was
the subject of the referral (88 FR 74965). If, however, OIG made and
referred an additional information blocking determination (that is
either related or unrelated to the previous OIG referral) in a
subsequent year or the ACO cannot provide assurance that the
information blocking has ceased, we discussed that CMS would continue
to deny participation.
In addition, in the Disincentives Proposed Rule, we stated that CMS
would notify ACOs about an ACO participant or ACO provider/supplier
that had committed information blocking, as determined by OIG, so that
the ACO could take remedial action--removing the ACO participant from
the ACO participant list or the ACO provider/supplier from the ACO
provider/supplier list--as required by the ACO participant agreement
(88 FR 74965). We noted that ACOs are well-positioned to take remedial
action against ACO participants and ACO providers/suppliers that have
been found by OIG to have committed information blocking as a result of
their ACO participant agreements, which provide for the ACO to take
remedial action against the ACO participant, and require the ACO
participant to take remedial action against its ACO providers/
suppliers, including imposition of a corrective action plan, denial of
incentive payments, and termination of the ACO participant agreement,
to address noncompliance with the requirements of the Shared Savings
Program and other program integrity issues.
By way of example, consider if in January 2025, OIG determined that
an ACO participant has committed information blocking as recently as
2024 and referred this determination to CMS. In the Disincentives
Proposed Rule, CMS explained that under the proposal, the ACO
participant would be able to remain on the ACO's certified participant
list for the duration of the 2025 performance year (88 FR 74965).
However, we explained that CMS would notify the ACO that an ACO
participant had been determined to have committed information blocking
by OIG and that CMS expected the ACO to take remedial action by
removing the ACO participant from its ACO participant list for a
specified period of time. To determine if removal was warranted for a
period in addition to performance year 2026, CMS stated that it would
consider whether there was any evidence to suggest that that
information blocking was still occurring (for example, whether OIG had
made a subsequent determination of information blocking) and whether
safeguards had been put in place to prevent the information blocking
that was the subject of the referral. In the Disincentives Proposed
Rule, we noted that upon a review of these criteria, CMS may require
the affected ACO to remove the ACO participant prior to recertification
of the ACO participant list for additional performance years. If the
ACO participant were to remain when the ACO certifies its ACO
participant list for performance year 2026, we explained that CMS would
inform the ACO that it was obligated to take remedial action against
the ACO participant by removing it from the ACO participant list for
performance year 2026; if it failed to do so, CMS would remove the ACO
participant from the ACO's participant list and take compliance action
against the ACO up to terminating the ACO pursuant to 42 CFR
425.218(b)(1) and (3). In the case of a disincentive that was applied
only for performance year 2026, we explained that if the ACO were to
submit a change request to add the ACO participant for performance year
2027 or a subsequent year, then CMS would review whether OIG had made
any subsequent determinations of information blocking with respect to
the ACO participant as well as any evidence that indicated whether the
issue had been corrected and appropriate safeguards had been put in
place to prevent its reoccurrence, prior to approving the ACO
participant to participate in the ACO for performance year 2027 or the
subsequent year.
In the Disincentives Proposed Rule, we explained that if an ACO
applicant or a renewal ACO applicant that is itself a health care
provider (for example, a large multi-specialty practice that forms a
single participant ACO using its existing legal entity and governing
body under 42 CFR 425.104) is the subject of an OIG information
blocking determination, CMS would deny the ACO's application for
participation in the Shared Savings Program for the upcoming
performance year for which it was applying to participate (88 FR
74966). CMS noted that should OIG make a determination of information
blocking with respect to an ACO that is already participating in the
Shared Savings Program and refer the determination to us for the
application of a disincentive, CMS may terminate the ACO's
participation agreement for the upcoming performance year. We stated
that CMS would assess a subsequent application from an ACO to which the
disincentive had been applied under the same criteria described for
assessing the return of an ACO participant or ACO provider/supplier. We
noted that the ACO may participate in the Shared Savings Program after
the duration of the disincentive so long as OIG had not made a
subsequent determination of information blocking applicable to the
health care provider and whether there was evidence that the issue had
been corrected and appropriate safeguards had been put in place to
prevent its reoccurrence, prior to approving the ACO's application to
participate in the Shared Savings Program in a subsequent performance
year.
In the Disincentives Proposed Rule, CMS also considered an
alternative policy in which CMS would not apply a disincentive in
certain circumstances despite an OIG information blocking
[[Page 54706]]
determination. CMS explained that under this alternative policy, the
Shared Savings Program would consider OIG's referral of an information
blocking determination in light of the relevant facts and circumstances
before denying the addition of an ACO participant to an ACO participant
list (or an ACO provider/supplier to the ACO provider/supplier list),
informing an ACO that remedial action should be taken against the ACO
participant (or ACO provider/supplier), or denying an ACO's application
to participate in the Shared Savings Program (88 FR 74966). We
explained that the relevant facts and circumstances could include the
nature of the health care provider's information blocking, the health
care provider's diligence in identifying and correcting the problem,
the time since the information blocking occurred, the time since the
OIG's determination of information blocking, and other factors. We
noted that this alternative policy would offer some flexibility in
certain circumstances, where prohibiting an ACO, ACO participant, or
ACO provider/supplier from participating in the Shared Savings Program
would distort participation incentives and therefore be less
appropriate. We noted that we were particularly concerned about
situations in which many years have passed since an ACO participant or
ACO provider/supplier was found to be an information blocker and such
an issue had long been remediated. We noted that in such a case, the
ACO participant or ACO provider/supplier might be incentivized to apply
to the Shared Savings Program for a year in which it did not actually
intend to participate merely to avoid being barred from doing so at a
future date when it did intend to participate, wasting the resources of
the ACO and CMS. We explained that, under such an alternative policy, a
health care provider could participate in the Shared Savings Program if
a significant amount of time had passed between the occurrence of the
information blocking and the OIG's determination, and the provider had
given assurances in the form and manner specified by CMS that the issue
had been corrected and appropriate safeguards had been put in place to
prevent its reoccurrence.
In the Disincentives Proposed Rule, we noted that an ACO may be
able to appeal the application of an information blocking disincentive
in the Shared Savings Program (88 FR 74966). An ACO may appeal an
initial determination that is not prohibited from administrative or
judicial review under 42 CFR 425.800 by requesting a reconsideration
review by a CMS reconsideration official (42 CFR 425.802(a)). To the
extent it is not barred by 42 CFR 425.800, an ACO may appeal the
removal or denial of a health care provider from an ACO participant
list as a result of the referral by OIG of an ACO participant that OIG
had determined to be an information blocker. Subject to the same
limitation, an ACO applicant or ACO may appeal the denial of the ACO
applicant's application or termination of the ACO's participation
agreement as a result of the referral by OIG of the ACO applicant or
ACO that the OIG had determined to be an information blocker. We
explained that the underlying information blocking determination made
by OIG, however, would not be subject to the Shared Savings Program's
reconsideration process. We noted that the OIG determination is not an
initial determination made by CMS, but a determination made by another
agency. The Shared Savings Program reconsideration process may not
negate, diminish, or otherwise alter the applicability of
determinations made by other government agencies (see 42 CFR
425.808(b)).
In the Disincentives Proposed Rule, we reminded all health care
providers and ACOs that it is possible that a health care provider or
any entity, such as an ACO, may meet the definition of a HIN/HIE, which
is a functional definition, or the definition of a health IT developer
of certified health IT, codified in 45 CFR 171.102 (88 FR 74966). We
noted that if it is found by OIG that such health care provider or
entity meets either definition and, while under the same set of facts
and circumstances, is also found by OIG to have committed information
blocking, then the health care provider or entity would be subject to a
different intent standard and civil money penalties administered by OIG
(see generally 88 FR 42820; see 88 FR 42828 and 42829).
CMS invited public comment on these proposals and on whether
additional actions should be taken.
The following is a summary of the comments we received and our
responses.
Comments. Several commenters supported CMS' proposed disincentive
for the Shared Savings Program. These commenters explained that the
proposed disincentive is consistent with the intent of the Cures Act
and that it will help promote widespread electronic exchange of health
information across the healthcare spectrum. Commenters also explained
that the proposal is consistent with an ACO's goal to utilize
technologies like EHRs to facilitate care coordination, quality
improvement activities, and patient-centered care. One commenter
supported the proposed disincentive for the Shared Savings Program
because it would impact a wider set of health care providers and thus
have a greater deterrent effect among health care providers compared to
the proposed disincentives for the Medicare Promoting Interoperability
Program and MIPS. Another commenter specifically supported the proposal
to apply the disincentive for at least 1 year and explained that the
proposed approach is appropriate and consistent with the other
disincentives proposed in this rulemaking.
Response. We agree that sharing health information using enabling
technologies across all health care providers engaged in a
beneficiary's care (both inside and outside the ACO) for purposes of
care coordination and quality improvement is an essential activity for
health care providers participating in an ACO in the Shared Savings
Program. This type of information sharing among health care providers
(both inside and outside the ACO) supports care coordination, quality
measurement, and quality reporting activities, which are necessary in
order for the ACO to participate in the Shared Savings Program. We
appreciate commenters' support for the proposal to revise the Shared
Savings Program regulations to establish disincentives for health care
providers, including ACOs, ACO participants, or ACO providers/
suppliers, that engage in information blocking. We agree that the
proposal meets the objectives of the Cures Act by establishing
appropriate disincentives for health care providers, as defined in 45
CFR 171.102, that have been determined by OIG to have committed
information blocking.
Comments. Many commenters opposed the proposal to deny ACOs, ACO
participants, and ACO providers/suppliers from participating in the
Shared Savings Program if they are determined by OIG to have committed
information blocking. Commenters stated that the proposal would reduce
the number of health care providers and ACOs participating in the
Shared Savings Program, which would effectively impede progress towards
delivering care based on outcomes, rather than volume, while also
disrupting improvements in patient care and diminishing resources that
ACOs use to improve patient care. Other commenters stated that
prohibiting participation in the Shared Savings Program would disrupt
patient care and worsen healthcare quality and
[[Page 54707]]
outcomes, explaining that CMS' proposal would deny Medicare patients
access to enhanced services that ACOs offer, such as care coordination
and case management services. These commenters further explained that
if a health care provider is excluded from the Shared Savings Program,
it would be impossible to deliver many of those services because
providers would no longer receive claims data for their patients from
the Shared Savings Program. Several commenters expressed concern that
if a health care provider was removed from an ACO, patients assigned to
an ACO would no longer have access to that provider or the patient
would be forced to find an alternative provider, which could cause
treatment delays and disrupt care continuity. Additionally, many
commenters explained that the proposal would undermine CMS' goal of
having all Medicare beneficiaries in an accountable care relationship
by 2030 and would prevent CMS from effectively addressing healthcare
costs and quality. Several commenters expressed concern that the
proposed disincentive would disproportionately affect health care
provider participation in ACOs serving patients in rural areas, dual-
eligible beneficiaries, and patients with disabilities. These
commenters also raised concerns about the impact on Medicare
beneficiaries in rural areas, stating that specialist health care
providers participating in ACOs are often the only specialists
available to serve these communities.
Response. While we appreciate the commenters' concerns about the
potential negative consequences resulting from application of the
disincentive, such as reduced participation in value-based care and a
reduction of care coordination services, the purpose of the proposal is
to implement the Cures Act by creating a disincentive that deters
health care providers from committing information blocking. We disagree
with commenters' concerns as we do not expect that the proposal would
reduce the number of health care providers and ACOs participating in
the Shared Savings Program by a significant amount. Removal from, or
denial of approval to participate in, the Shared Savings Program would
be limited to those health care providers that have committed
information blocking, as determined by OIG. Removal is an appropriate
disincentive because it protects beneficiaries and denies health care
providers the opportunity to benefit financially and reputationally
from participation in the Shared Savings Program.
We disagree with commenters' concerns that application of the
disincentive could disrupt patient care and compromise beneficiary
outcomes. Beneficiary care would already be negatively affected by
information blocking; this disincentive thus is intended to prevent
negative outcomes from occurring. Information blocking runs counter to
the goals of value-based care, such as care coordination and quality
improvement, and health care providers that engage in information
blocking may harm beneficiaries by denying them the benefits of value-
based care. Furthermore, beneficiaries receiving care from ACO
providers/suppliers that regularly engage in information blocking might
not receive the full benefits of value-based care because the
information blocking may prevent the sharing of information critical to
care coordination and quality improvement among the beneficiary's
health care providers. With respect to commenters' concerns about how
to reconcile the disincentive with CMS' goal of having 100 percent of
people with Original Medicare in a care relationship with
accountability for quality and total cost of care by 2030,\40\ the
proposal aims to deter health care providers from information blocking
and hold accountable those health care providers that engage in such
practices. In doing so, the proposal supports CMS' broader goal of
incentivizing health care providers to coordinate care effectively
across care settings so that they can improve patient outcomes and
lower costs.
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\40\ A description of the Innovation Center's strategy to
support primary care can be found here: https://www.cms.gov/blog/cms-innovation-centers-strategy-support-high-quality-primary-care.
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Regarding commenters' concerns that the removal of a health care
provider from an ACO due to information blocking would result in ACO
beneficiaries no longer having access to their provider, we clarify
that this is not the case. The denial of approval to participate in or
removal of a health care provider from the Shared Savings Program
through the application of this disincentive does not exclude the
provider from Medicare. A Medicare beneficiary aligned to an ACO may
see the Medicare enrolled health care provider of his or her choice,
regardless of whether the provider is a participant or provider/
supplier in an ACO. Similarly, we clarify that Medicare beneficiaries
in rural areas, dual-eligible beneficiaries, and patients with
disabilities, could continue to see a Medicare enrolled health care
provider of their choice, irrespective of whether that health care
provider is an ACO participant or ACO provider/supplier.
Based on the comments we received, however, we recognize that
denial of approval to participate in or removal from the Shared Savings
Program is not warranted in every instance. For this reason and for the
additional reasons discussed below, we have finalized the proposal with
modifications to incorporate the alternative discussed in the
Disincentives Proposed Rule. This will enable us to consider an OIG
information blocking determination in light of the relevant facts and
circumstances of the information blocking determination and subsequent
remediation before applying the disincentive. This approach is
consistent with the Cures Act's command to implement ``appropriate
disincentives'' and balances CMS' efforts to improve the quality and
efficiency of items and services provided to beneficiaries through
value-based care.
Comments. Many commenters supported CMS' alternative policy for the
Shared Savings Program in which CMS would consider an OIG information
blocking determination in light of the relevant facts and circumstances
before denying the addition of an ACO participant to an ACO participant
list (or an ACO provider/supplier to the ACO provider/supplier list),
informing an ACO that remedial action should be taken against the ACO
participant (or ACO provider/supplier), or denying an ACO's application
to participate in the Shared Savings Program if the remedial action is
not taken. Commenters explained that this alternative policy would
provide CMS with flexibility to consider an information blocking
determination in light of the relevant facts and circumstances, such as
whether the health care provider subject to the information blocking
determination had taken corrective action and established safeguards to
prevent future instances of information blocking or if significant time
had passed since the information blocking occurred. One commenter
recommended that CMS always consider information blocking
determinations in light of the relevant facts and circumstances,
including during the initial screening process when CMS reviews ACOs'
program integrity history for OIG determinations of information
blocking. Another commenter supported the alternative policy, noting
that education and remediation would be more appropriate than applying
the disincentive. One
[[Page 54708]]
commenter agreed with CMS that the disincentive as proposed may distort
participation incentives and that the alternative proposal may help
ameliorate these concerns. Another commenter stated that the
alternative policy would help CMS balance the need to prevent
information blocking while ensuring the financial stability of ACOs and
providers participating in the Shared Savings Program. A few commenters
recommended that CMS also consider the size of the practice, number of
eligible clinicians in the practice, and relationship between the ACO
and the entity found to have committed information blocking when
applying the disincentive.
Response. We agree with commenters that the alternative policy will
allow us to consider an OIG information blocking determination in light
of the relevant facts and circumstances before applying a disincentive,
such as denying the addition of an ACO participant to an ACO
participant list (or an ACO provider/supplier to the ACO provider/
supplier list), informing an ACO that remedial action should be taken
against the ACO participant (or ACO provider/supplier), or denying an
ACO's application to participate in the Shared Savings Program if the
remedial action is not taken. For an ACO that is already participating
in the Shared Savings Program, the alternative policy will also allow
us to consider an OIG information blocking determination in light of
the relevant facts and circumstances prior to terminating the ACO's
participation agreement with CMS for the upcoming performance year. The
relevant facts and circumstances include the nature of the health care
provider's information blocking, the health care provider's diligence
in identifying and correcting the problem, the time since the
information blocking occurred, whether the provider was previously
subject to a disincentive in another program, and other factors. In the
case of an ACO applicant, a renewal ACO applicant, or an ACO
participant TIN that would be a new addition to an ACO's participant
list, we would request information from the ACO that indicated whether
the information blocking had been corrected and appropriate safeguards
had been put in place to prevent its reoccurrence. For ACOs, ACO
participants, or ACO providers/suppliers that are already participating
in the Shared Savings Program, we would issue a compliance action,
which would include a request for the same information.
Additionally, we agree with commenters that if the risk of
reoccurrence of information blocking has been mitigated, it would be
beneficial to take that into consideration before imposing a
disincentive that could interrupt the care coordination benefits of
beneficiaries receiving care from ACO participants and ACO providers/
suppliers. For example, removal of a large ACO participant TIN that had
corrected the information blocking that occurred 10 years prior to
OIG's determination and had imposed safeguards to prevent its
reoccurrence, could result in the multi-TIN ACO falling below the 5,000
assigned beneficiary threshold required by 42 CFR 425.110(a)(1). Having
the discretion to consider the facts and circumstances of the
information blocking provider's remediation efforts and past
disincentives prior to imposing a disincentive will allow the Shared
Savings Program to best determine if removal from, or denial of
approval to participate in the Shared Savings Program, is warranted
while minimizing unintended consequences for ACOs, ACO participants,
and ACO providers/suppliers that had no involvement in the information
blocking activity that was the subject of OIG's determination. For
these reasons, we have finalized the proposal with modifications to
incorporate the alternative policy.
Comments. Many commenters urged CMS to consider implementing less
severe disincentives that would encourage compliance with the
information blocking regulations without discouraging participation in
value-based care models. These commenters recommended that CMS partner
with ACOs to identify and remediate cases of information blocking
instead of implementing disincentives that affect participation in the
Shared Savings Program. The commenters explained that ACOs already have
expertise in data sharing and reporting instances of information
blocking, thus ACOs are well-positioned to assist HHS in advancing
their interoperability goals. A few commenters stated that the proposed
disincentive creates arbitrary penalties that neither address the
underlying causes of information blocking nor allow health care
providers to rectify the behaviors that led to information blocking.
Several commenters explained that the proposed disincentive is
excessive and disproportionate to the offense and that it may cause
more harm than the underlying instance of information blocking.
Response. While we appreciate the commenters' concerns about the
perceived severity and appropriateness of the proposed disincentives,
information blocking can result in serious and adverse effects on
beneficiary care and outcomes. For this reason, the denial of approval
to participate or removal of health care providers that have been
determined by OIG to have committed information blocking is both
appropriate and proportional to the underlying information blocking
activity. We disagree that the proposed disincentive creates arbitrary
penalties that fail to address the underlying causes of information
blocking and do not permit health care providers to rectify the
behaviors that led to information blocking. To the contrary, the
proposal would impose a clear disincentive--denial of approval to
participate in or removal from the Shared Savings Program for at least
1 year--on the specific health care provider that committed information
blocking, as determined by OIG.
Further, the disincentive would not prohibit a health care provider
that had committed information blocking, as determined by OIG, from
correcting the information blocking activity and participating in the
Shared Savings Program in the future. The intent of the proposal is to
implement PHSA section 3022(b)(2)(B) by creating a disincentive that
discourages health care providers from committing information blocking.
It is not clear that merely requiring that a healthcare provider take
corrective action would adequately discourage repeated information
blocking when one considers that substantial time that may elapse
between the information blocking and an OIG determination. With respect
to the suggestions that CMS partner with ACOs to identify and remediate
cases of information blocking, we encourage ACOs to report any
instances of information blocking to ONC or OIG. Given that ACOs are
engaged in care coordination and quality improvement activities, they
may encounter instances of information blocking as they seek to achieve
the goals of accountable care in the Shared Savings Program.
We agree with commenters that depending upon the circumstances of
the case, CMS may need more flexibility in applying a disincentive
under the Shared Savings Program than was provided for under the
proposal. We have therefore finalized the proposal with modifications
to incorporate the alternative policy discussed in the Disincentives
Proposed Rule (88 FR 74966). This will allow us to consider an OIG
information blocking determination in light of the relevant facts and
circumstances before applying a disincentive, such as denying the
addition of an ACO participant to an ACO participant list (or an ACO
provider/supplier to the ACO provider/
[[Page 54709]]
supplier list), informing an ACO that remedial action should be taken
against the ACO participant (or ACO provider/supplier), denying an
ACO's application to participate in the Shared Savings Program if the
remedial action is not taken, or terminating an ACO's participation
agreement with CMS. We reiterate that the relevant facts and
circumstances include the nature of the health care provider's
information blocking, the health care provider's diligence in
identifying and correcting the problem, the time since the information
blocking occurred, whether the provider was previously subject to a
disincentive in another program, and other factors. As discussed above,
this approach achieves the balance of disincentivizing information
blocking in the Shared Savings Program while ensuring that CMS can
consider whether a health care provider who has committed information
blocking, received disincentives elsewhere for it, and corrected the
conduct should be barred from participating in the Shared Savings
Program prior to imposing a disincentive.
Comments. Commenters expressed concern that the proposal would
inadvertently discourage or deter participation in value-based care
models, such as the Shared Savings Program, because ACOs and ACO
participants face significant disruption and financial instability if
they are removed from the Shared Savings Program. Many commenters were
concerned that the proposed policy would have negative financial and
operational consequences for ACOs. One commenter explained that if an
ACO is suspended from the Shared Savings Program or if a large ACO
participant or health care provider is removed from an ACO, the
resulting financial impact could be the loss of millions of dollars in
potential shared savings revenue, which could result in the ACO
collapsing completely.
Other commenters expressed concern that the proposed disincentive
could upend ACO operations and greatly compound the financial
instability of the ACO and participating physician participants. One
commenter expressed concern that the proposed disincentive would be
especially detrimental for ACOs operating in rural areas, where
Medicare Advantage enrollment exceeds traditional Medicare enrollment.
The commenter stated that removing even one participant TIN could force
the entire ACO to collapse, severely disrupting patient care and
punishing not only the TIN that committed information blocking, but
also all ACO participants. A few commenters explained that the
potential financial impacts of the proposed disincentive are not
aligned with the severity of the underlying information blocking
offense. Commenters suggested that the financial disincentives imposed
on ACOs should more closely correspond to the severity of the
information blocking violation.
A few commenters stated that suspending ACOs from the Shared
Savings Program would also cause the government to lose millions of
dollars in shared savings. Several commenters also expressed concern
that suspension of ACOs from the Shared Savings Program may also make
ACOs ineligible for Advanced APM bonus payments. Commenters emphasized
that ACOs depend on these bonus payments to cover investment and care
coordination costs. Another commenter questioned how the proposal would
impact physicians who participate in an ACO but do not meet the
Advanced APM threshold for exemption from the MIPS Program.
Specifically, the commenter inquired if these physicians who have been
found by OIG to have committed information blocking would be removed as
an ACO participant and subject to disincentives under the MIPS program.
A few commenters expressed concerns that the proposed disincentive
would hinder overall data exchange and information sharing that is
essential to ACO operations and structure. Another commenter expressed
concern that the disincentive would cause adverse financial impacts to
the healthcare system and contribute to hospital closures. Finally, one
commenter stated that the disincentive may hinder an ACO's ability to
meet network adequacy requirements if health care providers who have
committed information blocking are removed from the ACO.
Response. We appreciate the commenters' concerns regarding the
potential financial and operational impacts on ACOs of disincentives
for information blocking. The proposed disincentive will serve as a
deterrent to information blocking by health care providers
participating in the Shared Savings Program. Commenters' concerns about
the negative financial consequences for health care providers and ACOs
of the disincentive, as well as how disruptive it may be, support this
conclusion.
A strong disincentive is likely to be most appropriate in deterring
information blocking given the nature of the activity and its effect on
essential aspects of Shared Savings Program. Information blocking is
not an inadvertent practice. A health care provider has only committed
information blocking if the provider engaged in a practice that the
provider ``[knew] is unreasonable and likely to interfere with access,
exchange, or use of electronic health information'' (45 CFR 171.103).
As discussed above, information blocking runs contrary to the
overarching goals of the Shared Savings Program, as the ability of ACO
participants and ACO providers/suppliers to exchange information
between health care providers (both inside and outside the ACO) is
essential for the operations of the ACO, including for effective
coordination of care, quality improvement activities, and related
services for assigned beneficiaries. If health care providers
participating in the Shared Savings Program are determined by OIG to
have committed information blocking, it is reasonable to remove or
prevent any such health care providers from participating in the Shared
Savings Program for at least one performance year, given that the
health care providers intentionally acted in a manner that may have
impaired activities central to the Shared Savings Program: care
coordination and improvement in the quality and efficiency of
beneficiary care.
We disagree with the commenters' statement that suspending ACOs
from the Shared Savings Program would also cause the government to lose
millions of dollars in shared savings. The participation of information
blockers in the Shared Savings Program undermines the integrity of the
program and may harm an ACO's efforts to coordinate and improve the
quality and efficiency of beneficiary care. Moreover, if ACOs that have
committed information blocking (as determined by OIG) are removed from
the Shared Savings Program for at least one performance year, their
removal may actually prevent losses by shifting government resources to
ACOs that are focused on care coordination and quality improvement
activities. With respect to the impact the proposed disincentive will
have on cost savings in the Medicare program, as discussed in the
Regulatory Impact Statement of the Disincentives Proposed Rule (88 FR
74967), the expected benefits of this rule would be to deter
information blocking that interferes with effective health information
exchange and negatively impacts many important aspects of healthcare.
We refer readers to the impact analysis of the benefits of prohibiting
and deterring information blocking in the ONC Cures Act Final Rule (85
FR 25936).
Regarding whether clinicians who have been found by OIG to have
committed information blocking would
[[Page 54710]]
be removed as an ACO participant and subject to disincentives under the
MIPS program, we confirm that such clinicians could be removed as ACO
participants and, if they are MIPS eligible clinicians, they could also
be subject to the information blocking disincentive under MIPS. While
we acknowledge the commenters' concerns that removing or denying an ACO
participant from an ACO could result in downstream effects that have
implications for eligibility of Advanced APM incentive payments and
scoring under MIPS, we reiterate that the approach is to deter
information blocking by health care providers participating in the
Shared Savings Program through the imposition of appropriate
disincentives consistent with the requirements of the Cures Act.
It is important to clarify that there is no network adequacy
requirement in the Shared Savings Program. Unlike other healthcare
programs, such as managed care plans, the Shared Savings Program does
not limit beneficiaries to receiving care from only the providers and
suppliers that participate in the ACO. Thus, there is no need in the
Shared Savings Program to impose network adequacy requirements on
participating ACOs. Concerns about the effect of the disincentive as it
relates to network adequacy are thus unwarranted.
Comments. Many commenters did not support the proposed disincentive
on the basis that it would be unfair and inappropriate to penalize the
entire ACO for the actions of one individual ACO participant or ACO
provider/supplier determined by OIG to have committed information
blocking. Some commenters stated that if one ACO participant or ACO
provider/supplier is determined to have committed information blocking,
then the entire ACO entity would be prohibited from participating in
the Shared Savings Program. Commenters expressed concern that excluding
an entire ACO would harm patients who rely on those ACOs for their
healthcare. The commenters explained that by denying participation to
all health care providers in an ACO due to the actions of a few,
patients' access and continuity of care would ultimately suffer. One
commenter stated that ACO participants who did not engage in
information blocking themselves would likely be unaware of and unable
to control the actions of other participants who did commit information
blocking and that it would be unfair to penalize the broader group for
the actions of a few individuals. Another commenter expressed concern
about an ACO being banned from the Shared Savings Program if a single
health care provider within the ACO is found by OIG to have committed
information blocking, especially if the information blocking activity
is inconsistent with documented ACO policies and practices.
Response. The concerns expressed by the commenters indicate that
there might be a misunderstanding about the proposed disincentive. Our
intention is not to penalize the entire ACO entity for the actions of a
single ACO participant or ACO provider/supplier that is the subject of
an OIG information blocking determination. Instead, the proposal would
impose a disincentive on the specific health care provider that
committed information blocking, as determined by OIG. In the
Disincentives Proposed Rule (88 FR 74965), we explained that CMS would
notify ACOs about an ACO participant or ACO provider/supplier that had
committed information blocking, as determined by OIG, so that the ACO
could take remedial action--removing the ACO participant from the ACO
participant list or the ACO provider/supplier from the ACO provider/
supplier list--as required by the ACO participant agreement (88 FR
74965). ACOs are expected to take remedial action against ACO
participants and ACO providers/suppliers that have been found by OIG to
have committed information blocking through their ACO participant
agreements, which must permit the ACO to take remedial action against
the ACO participant, and require the ACO participant to take remedial
action against its ACO providers/suppliers, including imposition of a
corrective action plan, denial of incentive payments, and termination
of the ACO participant agreement, to address noncompliance with the
requirements of the Shared Savings Program and other program integrity
issues. Should the ACO fail to take the appropriate remedial action
against the ACO participant or ACO provider/supplier, CMS may take
action against the ACO consistent with its authority at 42 CFR 425.216
and 425.218.
While it is true that consequences may extend to ACO participants
or ACO providers/suppliers if the ACO itself is found by OIG to have
committed information blocking, our focus is on imposing disincentives
for information blocking on the specific health care provider that has
committed information blocking, not on imposing disincentives on entire
groups of health care providers or ACO participants that had no
involvement in the activity that resulted in an information blocking
determination by OIG. We also understand the concerns raised about
fairness and patient access, and we agree with commenters that there
could be a negative impact to an ACO if an ACO participant with a large
number of assigned beneficiaries is found by OIG to have committed
information blocking, requiring removal of the ACO participant from the
ACO participant list as a result of the proposed disincentive. However,
it is important that ACOs make their own assessment of potential ACO
participants--and the potential ACO participant's commitment to
information sharing for the purposes of care coordination, quality
measurement, and quality reporting activities--prior to contracting
with them. We reiterate that the goal of the proposal is to ensure that
appropriate disincentives are imposed on health care providers that
have committed information blocking, as determined by OIG, while
minimizing unintended consequences for ACOs and Medicare beneficiaries.
We have finalized the proposal with modifications so that we will
consider an OIG information blocking determination in light of the
relevant facts and circumstances before applying a disincentive.
Comments. Several commenters expressed concerns with CMS' proposal
to remove ACO participants and ACO providers/suppliers at the TIN level
rather than at the individual or NPI level. Commenters stated that
implementing disincentives at the TIN level would negatively affect not
only health care providers who engaged in information blocking, but
also those who did not. One commenter expressed concern that this
approach could undermine existing contractual agreements between CMS
and ACOs while another commenter stated that applying the disincentive
at the TIN-level would negatively impact patient attribution
calculations and the beneficiaries receiving services from that TIN. A
few commenters requested that CMS clarify how the proposed disincentive
and the removal of ACO providers/suppliers would impact patient
attribution and who would subsequently assume responsibility for those
patients' care. Other commenters requested clarification on how ACO
suspension would impact health care providers and suppliers in relation
to Shared Savings Program rules allowing gradual progression from one-
sided to two-sided risk arrangements over certain time periods.
Response. While we appreciate the concerns raised by commenters
regarding the application of disincentives at the ACO participant
[[Page 54711]]
TIN level, it is important to clarify that the approach is designed to
hold accountable the health care provider OIG determined to be
responsible for information blocking, whether that is at the ACO
participant TIN or NPI level. While we understand that not every
individual within an ACO participant TIN may be directly involved in
information blocking activities, holding the ACO participant TIN
accountable (if the ACO participant TIN is the entity found by OIG to
have committed information blocking) is required under PHSA section
3022(b)(2)(B), which specifies that health care providers (individuals
or entities) that have been determined by OIG to have committed
information blocking shall be subject to appropriate disincentives.
Please refer to the discussion of the definition of health care
provider at 45 CFR 171.102 in section II.B.1. of this rule. Should OIG
determine that information blocking has occurred at the NPI level (in
other words, that an ACO provider/supplier has committed information
blocking), we would notify the ACO so that it could take remedial
action--removing the ACO provider/supplier from the ACO's provider/
supplier list--as required by the ACO participant agreement. We would
not impose a disincentive at the ACO participant TIN level or the ACO
level if only an ACO provider/suppler was determined by OIG to have
committed information blocking.
With respect to how the removal of an ACO participant or ACO
providers/suppliers could affect an ACO's assigned beneficiary
population, it is important to note that CMS assigns beneficiaries to
an ACO as a whole; beneficiaries are not assigned to a particular ACO
participant TIN or ACO provider/supplier. We acknowledge that removal
or denial of an ACO participant or ACO provider/suppler as a result of
an OIG information blocking determination could impact the number of
beneficiaries assigned to an ACO, and we expect the risk of this
occurring is a valuable deterrent against information blocking that may
lead to the implementation of ACO operating procedures that proactively
prevent information blocking. As discussed above, however, this would
not affect beneficiary access to care. Medicare beneficiaries may
continue to see the health care provider of his or her choice,
regardless of whether the provider is a participant or provide/supplier
in an ACO, or the beneficiary is assigned to a particular ACO.
The termination of an ACO from the Shared Savings Program for at
least one performance year as a result of an information blocking
determination would interrupt the ACO's progression along the BASIC
track's glide path from a one-sided to two-sided risk arrangement, and
the ACO would need to meet eligibility determinations regarding what
level of participation they would be eligible for when reentering their
participation in the Shared Savings Program. We do not foresee,
however, similar challenges to progress to two-sided risk for ACO
participants or ACO providers/suppliers that are prevented from joining
or that are removed from an ACO as a result of an information blocking
determination.
After the completion of the last performance year in which the
disincentive was applied, an ACO may submit a change request to add the
TIN or include the NPI on its ACO participant list or ACO provider/
supplier list, as applicable, for a subsequent performance year, and
CMS would approve the addition, assuming that all other Shared Savings
Program requirements for adding a TIN or NPI are met, so long as (1)
OIG has not made any additional determinations of information blocking,
and (2) the ACO provides assurances (in the form and manner required by
CMS) that the information blocking is no longer ongoing and that the
ACO has put safeguards in place to prevent the information blocking
that was the subject of the referral.
Comments. One commenter expressed concern about the impacts of the
proposed disincentive on skilled nursing facilities (SNFs)
specifically. The commenter explained that because SNFs have been
excluded from Federal health IT incentive programs, SNFs may not have
the requisite technology to be able to share information as required
under the information blocking regulations. As a result, the commenter
recommended that OIG and CMS consider each ACO health care provider's
unique situation and not apply a one-size-fits-all standard approach to
all providers participating in an ACO. The commenter further
recommended that CMS provide certain health care providers with
exemptions from the proposed disincentive for the Shared Savings
Program. Specifically, the commenter requested that CMS exclude SNFs
from the proposed disincentive if the SNF is the only health care
provider in a rural or underserved location and all other ACO
participation requirements are met. The commenter stated that this
exception would ensure that Medicare beneficiaries are not denied
access to nearby SNFs and post-acute care. The commenter also requested
that CMS exclude SNFs or any ACO providers/suppliers if their ACO
participant agreements are structured so that they do not receive the
ACO's shared savings from the proposed disincentive. The commenter
noted that ACOs are not required to share incentive payments and earned
shared savings with ACO health care providers in their network, such as
SNFs. Therefore, applying the disincentive without this exemption would
further deter SNF participation in ACOs.
Response. We appreciate the commenter's concerns regarding the
potential impact of the proposed disincentive on SNFs participating in
the Shared Savings Program. We recognize that these facilities were not
eligible for participation in the Medicare and Medicaid EHR Incentive
Programs. However, it is important to clarify that SNFs are explicitly
included in the definition of health care provider defined in 45 CFR
171.102 (which codifies the definition of health care provider in
section 3000(3) of the PHSA) for which the Cures Act instructs the
Secretary to establish appropriate disincentives for information
blocking. While it is true that the initial implementation of
appropriate disincentives in this rule, through the Shared Savings
Program, MIPS, and the Medicare Promoting Interoperability Program, may
not reach all types of health care providers defined at 45 CFR 171.102,
to exempt a single type of health care provider participating in one of
these programs from the disincentive would be particularly inequitable
and thwart the purpose of the rule. For these reasons, we are unwilling
and unable to grant any exemptions for SNFs that are ACO participants
or SNF affiliates from the proposed disincentive, as requested by the
commenter. We nonetheless recognize the vital role SNFs play in
providing post-acute care, particularly in rural or underserved areas,
and we recognize that it is important to clarify that Medicare
beneficiaries may continue to utilize the SNF of his or her choice,
regardless of whether the SNF, or the health care providers rendering
serves at the SNF, is an ACO participant or ACO provider/supplier in an
ACO.
More broadly, we agree with the commenter that it is important to
consider the unique circumstances of health care providers when
implementing the proposed disincentive under the Shared Savings
Program, and we agree that a one-size-fits-all approach may not be
suitable for all health care providers, especially those facing
technological limitations. For this reason, finalizing the proposal
with modifications to incorporate the
[[Page 54712]]
alternative policy will allow us to consider the unique circumstances
of the health care provider when applying this disincentive, and we
will consider an OIG information blocking determination in light of the
relevant facts and circumstances before applying a disincentive, such
as denying the addition of an ACO participant to an ACO participant
list (or an ACO provider/supplier to the ACO provider/supplier list),
informing an ACO that remedial action should be taken against the ACO
participant (or ACO provider/supplier), denying an ACO's application to
participate in the Shared Savings Program if the remedial action is not
taken, or terminating an ACO's participation agreement with CMS.
Comments. Several commenters stated that the proposed disincentive
is excessive, redundant, and constitutes a double penalty because
health care providers found by OIG to have committed information
blocking will be subject to disincentives under MIPS and may also be
subject to removal from the Shared Savings Program for at least 1 year.
One commenter expressed concern that cumulative disincentives could be
more pronounced for hospitals based on removal from the Shared Savings
Program in the violation year and receiving a market basket decrease
the following year under MIPS.
Response. We understand commenters' concerns about the potential
for cumulative disincentives for health care providers found by OIG to
have committed information blocking. We have finalized the proposed
policy with modifications to incorporate the alternative policy we
outlined in the Disincentives Proposed Rule (88 FR 74966), under which
we will consider OIG's referral of an information blocking
determination in light of the relevant facts and circumstances,
including the nature of the health care provider's information
blocking, the health care provider's diligence in identifying and
correcting the problem, the time since the information blocking
occurred, whether a health care provider was previously subject to a
disincentive in another program, before denying the addition of an ACO
participant to an ACO participant list (or an ACO provider/supplier to
the ACO provider/supplier list), informing an ACO that remedial action
should be taken against the ACO participant (or ACO provider/supplier),
denying an ACO's application to participate in the Shared Savings
Program, or terminating an ACO's participation agreement with CMS. This
approach furthers the Shared Savings Program's goal of imposing
appropriate disincentives for information blocking consistent with the
Cures Act, while ensuring relevant facts and circumstances are used to
inform decisions made under the Shared Savings Program.
Comments. A few commenters recommended that CMS adopt specific
revisions to the proposal. One commenter expressed concern that
requiring ACOs to remove ACO participants or ACO health care providers
could impose undue administrative burdens on ACOs. The commenter
recommended that CMS assume the responsibility of removing entities
that have committed information blocking from the ACO and notify the
affected ACO when it has taken such actions. One commenter suggested
that, prior to imposing any disincentives on ACOs, we provide
accommodations for hardship, have a well-defined investigative process,
and establish a graduated disincentive structure that accounts for the
impact ACOs have on the communities they serve. Another commenter
recommended that CMS establish more than one disincentive option for
ACOs, ACO participants, and ACO providers/suppliers to provide
flexibility in determining the disincentive appropriate for each case.
Response. While we understand that removing ACO participants or ACO
providers/suppliers that have committed information blocking, as
determined by OIG, could result in additional work for the ACO, CMS
expects ACOs to be equipped to take remedial action against their ACO
participants under their agreements with the ACO participants. We also
expect ACO participants, in turn, to take remedial action against its
ACO providers/suppliers, including imposition of a corrective action
plan, denial of incentive payments, and termination of the ACO
participant agreement, to address noncompliance with the requirements
of the Shared Savings Program and other program integrity issues,
including program integrity issues identified by CMS (42 CFR
425.116(a)(7)). For these reasons, the remedial action CMS expects ACOs
and ACO participants to take in the case of an OIG determination of
information blocking is consistent with their existing obligations
under the Shared Savings Program and should not represent an undue
burden.
Regarding the suggestion that CMS provide hardship accommodations
prior to imposing any disincentives on ACOs and that CMS have a well-
defined investigative process and establish a graduated disincentive
structure that accounts for the impact ACOs have on the communities
they serve, we have finalized the proposed policy with modifications to
incorporate the alternative policy so that we will consider OIG's
referral of an information blocking determination in light of the
relevant facts and circumstances. This approach will require that we
carefully consider the unique circumstances of an ACO prior to imposing
any disincentive, and it obviates the need for a hardship accommodation
or a graduated disincentive structure. While we appreciate the
suggestion to establish multiple disincentive options for ACOs, ACO
participants, and ACO providers/suppliers, we decline to do so. As
mentioned above, the alternative policy we are adopting provides CMS
with the discretion to consider the relevant facts and circumstances
before applying a disincentive, such as denying the addition of an ACO
participant to an ACO participant list (or an ACO provider/supplier to
the ACO provider/supplier list), informing an ACO that remedial action
should be taken against the ACO participant (or ACO provider/supplier),
denying an ACO's application to participate in the Shared Savings
Program if the remedial action is not taken, or terminating an ACO's
participation agreement with CMS. This approach provides adequate
flexibility in the application of appropriate disincentives under the
Shared Savings program.
Comments. Several commenters opposed to the proposal urged us to
consider alternative disincentives. Many commenters recommended that
CMS allow ACOs, ACO participants, and ACO providers/suppliers to take
remedial or corrective action rather than removal from the Shared
Savings Program. Commenters explained that remedial actions could
include a probation period, a reduction or withhold of shared savings
or incentives, corrective action plans, or mandatory education for
those who have engaged in information blocking. Commenters further
explained that allowing ACOs, ACO participants, and ACO providers/
suppliers to take corrective action would allow CMS to impose
disincentives on health care providers determined by OIG to have
committed information blocking while still allowing those providers to
participate in the Shared Savings Program. Several commenters also
recommended that CMS and ONC provide education and technical assistance
to ACOs, ACO participants, and ACO providers/suppliers on the proposed
disincentive and its potential
[[Page 54713]]
impacts. They also suggested that CMS consider a tiered or scaled
approach that accounts for the circumstances and frequency of
misconduct when determining the appropriate disincentive to apply. A
few commenters recommended that CMS delay implementing disincentives
specific to ACOs or the Shared Savings Program and instead introduce
disincentives in a separate rule once the risks to patient outcomes are
better understood. Another commenter recommended that CMS consult
closely with ACOs to ensure that CMS understands the potential impacts
of any proposed disincentives. One commenter suggested that instead of
limiting ACO participation in the Shared Savings Program, CMS should
expand safe harbor protections to facilitate EHR information sharing
between hospitals, health systems, and ACOs. The commenter explained
that this would more effectively promote interoperability compared to
the proposed disincentive. Another commenter recommended that ACOs
should only be excluded from the Shared Savings Program if the
determination of information blocking is related to activity that is
integral to the function or operations of the ACO. In addition, a few
commenters recommended that CMS consider disincentives that reduce the
Advanced Alternative Payment Model (APM) incentive payment or
conversion factor for health care providers. For example, these
commenters recommended that health care providers in an Advanced APM
found by OIG to have committed information blocking receive only 75
percent of their eligible Advanced APM bonus payment. The commenters
explained that this alternative would better align with the
disincentive proposed for MIPS eligible clinicians and would not deny
access to care for beneficiaries.
Response. We appreciate commenters' suggestions for alternative
disincentives but, for the reasons previously noted and for the
additional reasons discussed below, we have finalized the proposal with
modifications to incorporate the alternative policy discussed in the
Disincentives Proposed Rule. In accordance with PHSA section
3022(b)(2)(B), we are required to impose disincentives for health care
providers that are found by OIG to have committed information blocking.
While we understand the benefits of an approach that would impose
remedial or corrective actions rather than denial of approval to
participate in or removal from the Shared Savings Program, those
approaches may not have any deterrent effect, which is a fundamental
aspect of any disincentive. In addition, the relevance of remedial and
corrective actions may be limited in light of the time that may elapse
between the underlying information blocking conduct and OIG's
investigation. The disincentive we are adopting strikes a careful
balance between deterring information blocking through meaningful
consequences and ensuring that health care providers who have committed
information blocking and corrected their actions are not permanently
barred from participating in the Shared Savings Program.
We appreciate the recommendation to delay implementation of the
proposed disincentive until patient outcomes are better understood. We
are concerned, however, that delaying implementation of the
disincentive could adversely affect patient care, as information
blocking could impede effective care coordination and quality
improvement activities within ACOs. Moreover, the proposed disincentive
will serve as a deterrent to information blocking by health care
providers participating in the Shared Savings Program. For these
reasons, we decline to delay the implementation of disincentives for
information blocking. In addition, the information blocking regulations
in the ONC Cures Act Final Rule were released on May 1, 2020, and it is
not necessary to further delay the establishment of disincentives for
health care providers that have been found by OIG to have committed
information blocking. While expanding safe harbor protections for EHR
information sharing may facilitate data sharing and interoperability,
we did not propose any such safe harbor expansion in the Disincentives
Proposed Rule; therefore, this suggestion is beyond the scope of the
disincentive proposed by the Shared Savings Program. Regarding the
suggestion to exclude ACOs from the Shared Savings Program only if the
determination of information blocking is related to integral ACO
activities, we recognize the importance of considering the context of
information blocking incidents, which is why we have finalized the
proposed policy with modifications to incorporate the alternative
policy, under which we will consider whether to impose a disincentive
under the Shared Savings Program in light of the relevant facts and
circumstances. Our use of a consistent standard in the Shared Savings
Program for all instances of information blocking will ensure fairness
in the application of disincentives for ACOs, ACO participants, and ACO
providers/suppliers.
While we appreciate the recommendation to reduce Advanced APM
incentive payments for health care providers found to have committed
information blocking, we have not identified authority that would
permit us to alter APM incentive payments issued pursuant to section
1833(z)(1) of the Social Security Act and 42 CFR 414.1450. Finalizing
the proposed disincentive with modifications to incorporate the
alternative policy is an effective way to impose disincentives for
information blocking and to promote interoperability among ACOs, ACO
participants, and ACO providers/suppliers.
Comments. A few commenters requested clarification on which
disincentives will apply in specific situations such as: whether a
disincentive would apply to an ACO if a hospitalist is found to be
information blocking and the hospital participates in an ACO; if a
hospitalist is found to be information blocking would the health care
provider and the hospital receive disincentives; and, if a physician,
who is a MIPS eligible clinician and a participant in a Shared Savings
Program ACO, is an information blocker could the physician potentially
be penalized under MIPS and also removed from the ACO for a year.
Response. As discussed above, the proposal imposes a disincentive
on the specific health care provider that committed information
blocking, as determined by OIG. Whether the hospitalist or the hospital
has committed information blocking will be determined by OIG through
its investigation. If a hospitalist is determined by OIG to have
committed information blocking and CMS is applying the disincentive,
CMS would notify the ACO so that the ACO and ACO participant could take
remedial action--removing the hospitalist from either the ACO
participant list or the ACO provider/supplier list, as applicable,
pursuant to the ACO participant agreement.
We understand commenters' concerns about the potential for
cumulative disincentives for health care providers found by OIG to have
committed information blocking, such as a MIPS eligible clinician
participating in an ACO. As discussed above, we have finalized the
proposed policy with modifications to incorporate the alternative
policy we outlined in the Disincentives Proposed Rule, under which we
will consider OIG's referral of an information blocking determination
[[Page 54714]]
in light of the relevant facts and circumstances, including the nature
of the health care provider's information blocking, the health care
provider's diligence in identifying and correcting the problem, the
time since the information blocking occurred, whether a health care
provider was previously subject to a disincentive in another program,
before applying a disincentive, such as denying the addition of an ACO
participant to an ACO participant list (or an ACO provider/supplier to
the ACO provider/supplier list), informing an ACO that remedial action
should be taken against the ACO participant (or ACO provider/supplier),
denying an ACO's application to participate in the Shared Savings
Program, or terminating an ACO's participation agreement with CMS (88
FR 74966). This approach furthers the Shared Savings Program's goal of
imposing disincentives for information blocking consistent with the
Cures Act, while ensuring relevant facts and circumstances are used to
inform decisions made under the Shared Savings Program.
Comments. One commenter expressed concern with the timing of the
disincentive. The commenter explained that because OIG investigations
of information blocking can take years to complete, ACO participants
that have committed information blocking may no longer be participating
in the ACO or the Shared Savings Program by the time CMS receives the
referral. The commenter recommended that CMS clarify that if OIG refers
to CMS a finding that a former ACO participant committed information
blocking, the disincentive should not apply to the ACO or its remaining
ACO participants.
Response. We appreciate the commenter's concern and request for
additional information about the timing of a disincentive for
information blocking. We want to clarify that if a former ACO
participant is determined by OIG to have committed information
blocking, we would not impose a disincentive on the ACO or the
remaining ACO participants. As we explained in the Disincentives
Proposed Rule, applying the disincentive prospectively is the most
appropriate timing for the disincentive, as it would be impractical and
inequitable for CMS to apply the disincentive retrospectively or in the
same year in which CMS received a referral from OIG (88 FR 74965).
Prospective application of the disincentive will also enable ACOs to
remove any ACO participant TINs or ACO providers/suppliers during the
annual application and change request cycle that have committed
information blocking, as determined by OIG. Applying the disincentive
to a historical performance year or a performance year contemporaneous
to OIG's determination would unfairly affect other ACO participants
that did not commit the information blocking and likely were not aware
of the information blocking (88 FR 74965).
Comments. A few commenters expressed concern that ACO participants
would only be able to appeal the application of the disincentive but
not the actual information blocking determination. One commenter
expressed concern that an appeal process may not be available under
existing rules for Shared Savings Program ACO participants. Another
commenter noted that a finding of information blocking could have
future program integrity implications. A few commenters specifically
requested that HHS clarify the rights of both ACOs and clinicians
within an ACO to appeal an information blocking finding and provide
extenuating information, such as why they contend an exception applied.
Response. As discussed in the Disincentives Proposed Rule (88 FR
74966), an ACO may appeal an initial determination that is not
prohibited from administrative or judicial review under 42 CFR 425.800
by requesting a reconsideration review by a CMS reconsideration
official (42 CFR 425.802(a)). Individual ACO participants do not have
the right to request an appeal under the Shared Savings Program
regulations. To the extent it is not barred by 42 CFR 425.800, an ACO
may appeal (on behalf of an ACO participant) the removal or denial of a
health care provider from an ACO participant list as a result of the
referral by OIG of an ACO participant that OIG had determined to be an
information blocker. Subject to the same limitation, an ACO applicant
or ACO may appeal the denial of the ACO applicant's application or
termination of the ACO's participation agreement as a result of the
referral by OIG of the ACO applicant or ACO that the OIG had determined
to be an information blocker. The underlying information blocking
determination made by OIG, however, is not subject to the Shared
Savings Program's reconsideration process. The OIG determination is not
an initial determination made by CMS, but a determination made by
another agency and the Shared Savings Program reconsideration process
may not negate, diminish, or otherwise alter the applicability of
determinations made by other government agencies (see 42 CFR
425.808(b)). In the Disincentives Proposed Rule, we noted that we
considered OIG to be a separate and distinct agency from CMS for the
purposes of this provision (88 FR 74966). The Shared Savings Program's
reconsideration process would thus not be the appropriate forum to seek
reconsideration of OIG's determination.
After consideration of the public comments, CMS has finalized the
alternative policy that will consider an OIG information blocking
determination in light of the relevant facts and circumstances before
applying a disincentive, such as denying the addition of an ACO
participant to an ACO participant list (or an ACO provider/supplier to
the ACO provider/supplier list), informing an ACO that remedial action
should be taken against the ACO participant (or ACO provider/supplier),
denying an ACO's application to participate in the Shared Savings
Program if the remedial action is not taken, or terminating an ACO's
participation agreement with CMS. The relevant facts and circumstances
include the nature of the health care provider's information blocking,
the health care provider's diligence in identifying and correcting the
problem, the time since the information blocking occurred, whether the
provider was previously subject to a disincentive in another program,
and other factors.
CMS notes that the final policies in this rule will become
effective 30 days after the official publication date. However, we note
that section III.B.1. of this final rule states that OIG will not begin
investigating health care providers until after the effective date of
this rule, and that OIG will exercise its enforcement discretion not to
make any determinations regarding conduct occurring prior to the
effective date of this rule for information blocking disincentives. As
OIG will not make a determination on conduct occurring prior to the
effective date, OIG will not refer any health care providers based on a
determination of conduct occurring prior to the effective date of this
rule for information blocking disincentives. This means that CMS will
not impose the disincentive in the Shared Savings Program for
information blocking committed prior to the effective date of this
final rule. We further clarify that any disincentives under the Shared
Savings Program for information blocking determinations referred by OIG
would be imposed after January 1, 2025.
IV. Request for Information
As discussed in section III.C.1. of the Disincentives Proposed
Rule, we recognize that the disincentives we proposed would only apply
to a subset of health care providers as defined in 45
[[Page 54715]]
CFR 171.102 (88 FR 74954 and 74955). However, we believe it is
important for HHS to establish appropriate disincentives that would
apply to all health care providers, as such providers are defined in 45
CFR 171.102. This would ensure that any health care provider, as
defined in 45 CFR 171.102, that has engaged in information blocking
would be subject to appropriate disincentives by an appropriate agency,
consistent with the disincentives provision at PHSA section
3022(b)(2)(B).
We requested information from the public on additional appropriate
disincentives that we should consider in future rulemaking,
particularly disincentives that would apply to health care providers,
as defined in 45 CFR 171.102, that are not implicated by the
disincentives proposed in the Disincentives Proposed Rule (88 FR 74966
and 74967). We encouraged commenters to identify specific health care
providers (for example, laboratories, pharmacies, post-acute care
providers, etc.) and associated potential disincentives using
authorities under applicable Federal law. We also requested information
about the health care providers that HHS should prioritize when
establishing additional disincentives.
We received 32 submissions on this RFI. We thank commenters for
their comments. We have shared all the comments received with the
appropriate agencies and offices for consideration in subsequent
rulemaking to establish additional disincentives for specific health
care providers.
V. Collection of Information Requirements
This document does not impose any new information collection
requirements, that is, reporting, recordkeeping or third-party
disclosure requirements. Consequently, there is no need for review by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
VI. Regulatory Impact Statement
We have examined the impacts of this final rule as required by
Executive Order 12866 on Regulatory Planning and Review (September 30,
1993), Executive Order 13563 on Improving Regulation and Regulatory
Review (January 18, 2011), Executive Order 14094 entitled ``Modernizing
Regulatory Review'' (April 6, 2023), the Regulatory Flexibility Act
(RFA) (Pub. L. 96-354, September 19, 1980), section 1102(b) of the
Social Security Act, section 202 of the Unfunded Mandates Reform Act of
1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on
Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C.
804(2)).
A. Executive Order 12866
Executive Order 12866, as amended by Executive Order 14094
published on April 6, 2023, directs agencies to assess all costs and
benefits of available regulatory alternatives and, if regulations are
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, and public health and
safety effects; distributive impacts; and equity). A regulatory impact
analysis must be prepared for major rules with significant effects (for
example, $200 million or more in any given year). This is not a major
rule as defined at 5 U.S.C. 804(2); it is not significant under section
3(f)(1) of Executive Order 12866 because it does not reach that
economic threshold, nor does it meet the other criteria outlined in the
Executive order.
This final rule would implement provisions of the Cures Act through
changes to 45 CFR part 171 and 42 CFR parts 414, 425, and 495. For the
reasons set forth below, we believe that the likely aggregate economic
effect of these regulations would be significantly less than $200
million.
The expected benefits of this final rule would be to deter
information blocking that interferes with effective health information
exchange and negatively impacts many important aspects of healthcare.
We refer readers to the impact analysis of the benefits of deterring
information blocking in the ONC Cures Act Final Rule, which encompasses
all anticipated benefits without differentiation among actors (85 FR
25936).
We anticipate that OIG would incur some costs associated with
investigation as authorized by the Cures Act. The Consolidated
Appropriations Act, 2022, provides OIG the authority to use its
existing funding to conduct information blocking activities (Pub. L.
117-103, March 15, 2022). OIG has not received additional
appropriations or increased funding levels specific to information
blocking.
Additionally, investigated parties may incur some costs in response
to an OIG investigation or in response to the application of a
disincentive by an agency with the authority to impose a disincentive.
Absent information about the frequency of prohibited practices,
including the number of OIG determinations of information blocking in a
given year that could be referred to an appropriate agency, we are
unable to determine the potential costs of this regulation.
The monetary value of the disincentives finalized in this rule, if
imposed on a health care provider by an appropriate agency, would be
considered transfers. We are unable to reliably estimate the aggregate
value of potential disincentive amounts because the value of the
disincentive may vary based on other provisions specific to the
authority under which the disincentive has been established, as
discussed in section III.C.1. of this final rule. For instance, the
value of a disincentive imposed on an eligible hospital under the
disincentive finalized in section III.C.2. of this final rule would
depend on the amount of IPPS payment received by the eligible hospital.
We invited public comment on potential impacts of the rulemaking.
The following is a summary of the comments we received and our
responses.
Comments. A few commenters expressed disagreement with ONC's
assertion that the proposed rule will have economically insignificant
effects. These commenters expressed that the Disincentives Proposed
Rule underestimated the potential financial impact to entities
operating under the authorities in section III.C. of the proposed rule.
One commenter stated that health care providers with a larger share of
Medicare patients could face financial costs approximately ten times
greater than the estimated median impact. Additionally, this commenter
expressed that the potential loss of savings to the Medicare Trust Fund
as a result of barring participation in the Shared Savings Program
would likely result in the rule having an annual economic effect
exceeding $200 million, citing the significant amount of aggregate
savings to the Medicare Trust Fund and average savings per ACO. One
commenter recommended delaying the rule until HHS conducts an
assessment of the rule's impact on clinicians and patient access,
expressing concern that the proposed financial disincentives might
negatively impact access to care.
Response. We acknowledge commenters' concerns about the impact that
applying disincentives may have on individual health care providers. In
the Disincentives Proposed Rule, we provided illustrative estimates of
the monetary value of the proposed disincentive for eligible hospitals
under the Medicare Promoting Interoperability Program (88 FR 74956 and
74957) and for eligible clinicians under the MIPS Promoting
Interoperability performance category (88 FR 74960). While we presented
median values, as well as 95
[[Page 54716]]
percent ranges of estimates, in both cases, we acknowledge that there
may be outlier examples that result in monetary values that are
significantly higher than the figures presented in the analysis.
However, we disagree that these figures, or other information
commenters may provide about potential impacts on individual health
care providers, directly impact our analysis of whether this is a
significant regulatory action. As noted above, we are unable to
reliably estimate either the frequency of prohibited practices,
including the number of OIG determinations of information blocking in a
given year that could be referred to an appropriate agency as a subset
of all prohibited practices that could be determined to be information
blocking, or the aggregate value of potential disincentive amounts,
because the value of the disincentive may vary based on other
provisions specific to the authority under which the disincentive has
been established. Regarding the potential loss of savings to the
Medicare Trust Fund associated with the disincentive finalized under
the Shared Savings Program, we disagree that this would indicate that
the rule would have an annual economic effect exceeding $200 million.
The figures cited by the commenter of aggregate savings of the Shared
Savings Program and average savings per ACO do not provide information
about the amount of savings that would be lost due to the imposition of
disincentives under the Shared Savings Program, as disincentives would
only be imposed on an ACO that is a health care provider, an ACO
participant, or an ACO provider/supplier that has been determined by
OIG to have committed information blocking, referred to CMS as the
appropriate agency to be subject to disincentives. As CMS has finalized
in section III.C.4., CMS will also determine whether to impose a
disincentive under the Shared Savings Program based on relevant facts
and circumstances. As stated above, we are unable to reliably estimate
the frequency of prohibited practices or the aggregate value of
potential disincentive amounts, and commenters provided no additional
information or data for their assertion that the costs will be higher.
B. Regulatory Flexibility Act
The RFA and the Small Business Regulatory Enforcement and Fairness
Act of 1996, which amended the RFA, require agencies to analyze options
for regulatory relief of small businesses. For purposes of the RFA,
small entities include small businesses, nonprofit organizations, and
Government agencies.
The Department considers a rule to have a significant impact on a
substantial number of small entities if it has an impact of more than 3
percent of revenue for more than 5 percent of affected small entities.
This final rule would not have a significant impact on the operations
of a substantial number of small entities, as these changes would not
impose any new requirement on any party. We have concluded that this
final rule likely would not have a significant impact on a substantial
number of small entities and that a regulatory flexibility analysis is
not required for this rulemaking. Additionally, the Secretary certifies
that this final rule would not have a significant impact on a
substantial number of small entities.
In addition, section 1102(b) the SSA (42 U.S.C. 1302) requires us
to prepare a regulatory impact analysis if a rule under Titles XVIII or
XIX or section B of Title XI of the SSA may have a significant impact
the operations of a substantial number of small rural hospitals. We
have concluded that this final rule would not have a significant impact
on the operations of a substantial number of small rural hospitals
because these changes would not impose any requirement on any party.
Therefore, a regulatory impact analysis under section 1102(b) of the
SSA is not required for this rulemaking. Therefore, the Secretary has
certified that this final rule will not have a significant impact on
the operations of a substantial number of small rural hospitals.
C. Unfunded Mandates Reform Act
Section 202 of the Unfunded Mandates Reform Act of 1995, Public Law
104-4, requires that agencies assess anticipated costs and benefits
before issuing any rule that may result in expenditures in any 1 year
by State, local, or Tribal governments, in the aggregate, or by the
private sector, of $100 million, adjusted annually for inflation. There
are no significant costs associated with these finalized proposals that
would impose mandates on State, local, or Tribal governments or the
private sector resulting in an expenditure of $183 million in 2024
(after adjustment for inflation) or more in any given year. A full
analysis under the Unfunded Mandates Reform Act is not necessary.
D. Executive Order 13132
Executive Order 13132, Federalism, establishes certain requirements
that an agency must meet when it promulgates a rule that imposes
substantial direct requirements or costs on State and local
governments, preempts State law, or otherwise has federalism
implications. In reviewing this rule under the threshold criteria of
Executive Order 13132, we have determined that this final rule would
not significantly affect the rights, roles, and responsibilities of
State or local governments. Nothing in this final rule imposes
substantial direct requirements or costs on State and local
governments, preempts State law, or otherwise has federalism
implications. We are not aware of any State laws or regulations that
are contradicted or impeded by any of the provisions in this final
rule.
List of Subjects
42 CFR Part 414
Administrative practice and procedure, Biologics, Diseases, Drugs,
Health facilities, Health professions, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 425
Administrative practice and procedure, Health facilities, Health
professions, Medicare, Reporting and recordkeeping requirements.
42 CFR Part 495
Administrative practice and procedure, Health facilities, Health
maintenance organizations (HMO), Health professions, Health records,
Medicaid, Medicare, Penalties, Privacy, Reporting and recordkeeping
requirements.
45 CFR Part 171
Computer technology, Electronic health record, Electronic
information system, Electronic transactions, Health, Healthcare, Health
care provider, Health information exchange, Health information
technology, Health information network, Health insurance, Health
records, Hospitals, Privacy, Reporting and recordkeeping requirements,
Public health, Security.
For the reasons set forth in the preamble, HHS amends 42 CFR
chapter IV and 45 CFR part 171 as follows:
42 CFR Chapter IV
PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES
0
1. The authority citation for part 414 continues to read as follows:
Authority: 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l).
0
2. Amend Sec. 414.1305 by revising the definition of ``Meaningful EHR
user for MIPS'' to read as follows:
[[Page 54717]]
Sec. 414.1305 Definitions.
* * * * *
Meaningful EHR user for MIPS means a MIPS eligible clinician that
possesses CEHRT, uses the functionality of CEHRT, reports on applicable
objectives and measures specified for the Promoting Interoperability
performance category for a performance period in the form and manner
specified by CMS, does not knowingly and willfully take action (such as
to disable functionality) to limit or restrict the compatibility or
interoperability of CEHRT, and engages in activities related to
supporting providers with the performance of CEHRT. In addition, a MIPS
eligible clinician (other than a qualified audiologist) is not a
meaningful EHR user for a performance period if the HHS Inspector
General refers a determination that the MIPS eligible clinician
committed information blocking as defined at 45 CFR 171.103 during the
calendar year of the performance period. The term ``information
blocking,'' with respect to an individual MIPS eligible clinician or
group, shall not include an act or practice other than an act or
practice committed by such individual MIPS eligible clinician or group.
* * * * *
0
3. Amend Sec. 414.1375 by revising paragraph (b) introductory text to
read as follows:
Sec. 414.1375 Promoting Interoperability (PI) performance category.
* * * * *
(b) Reporting for the Promoting Interoperability performance
category. To earn a performance category score for the Promoting
Interoperability performance category for inclusion in the final score,
a MIPS eligible clinician must be a meaningful EHR user for MIPS and:
* * * * *
PART 425--MEDICARE SHARED SAVINGS PROGRAM
0
4. The authority citation for part 425 continues to read as follows:
Authority: 42 U.S.C. 1302, 1306, 1395hh, and 1395jjj.
0
5. Amend Sec. 425.208 by adding paragraph (b)(6) to read as follows:
Sec. 425.208 Provisions of participation agreement.
* * * * *
(b) * * *
(6) The information blocking provision of the 21st Century Cures
Act (42 U.S.C. 300jj-52).
* * * * *
0
6. Amend Sec. 425.218 by revising paragraph (b)(3) to read as follows:
Sec. 425.218 Termination of the participation agreement by CMS.
* * * * *
(b) * * *
(3) Violations of any applicable laws, rules, or regulations that
are relevant to ACO operations, including, but not limited to, the laws
specified at Sec. 425.208(b).
* * * * *
0
7. Amend Sec. 425.305 by revising paragraph (a)(1) to read as follows:
Sec. 425.305 Other program safeguards.
(a) * * *
(1) ACOs, ACO participants, and ACO providers/suppliers are
reviewed during the Shared Savings Program application process and
periodically thereafter with regard to their program integrity history,
including any history of Medicare program exclusions or other sanctions
and affiliations with individuals or entities that have a history of
program integrity issues. Program integrity history issues include, but
are not limited to, a history of Medicare program exclusions or other
sanctions, noncompliance with the requirements of the Shared Savings
Program, or violations of laws specified at Sec. 425.208(b).
* * * * *
PART 495--STANDARDS FOR THE ELECTRONIC HEALTH RECORD TECHNOLOGY
INCENTIVE PROGRAM
0
8. The authority citation for part 495 continues to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
0
9. Amend Sec. 495.4 in the definition of ``Meaningful EHR user'' by
revising paragraph (1) introductory text and adding paragraph (4) to
read as follows:
Sec. 495.4 Definitions.
* * * * *
Meaningful EHR user * * *
(1) Subject to paragraphs (3) and (4) of this definition, an
eligible professional, eligible hospital or CAH that, for an EHR
reporting period for a payment year or payment adjustment year--
* * * * *
(4) An eligible professional, eligible hospital or CAH is not a
meaningful EHR user in a payment adjustment year if the HHS Inspector
General refers a determination that the eligible hospital or CAH
committed information blocking as defined at 45 CFR 171.103 during the
calendar year of the EHR reporting period.
* * * * *
45 CFR Subtitle A
PART 171--INFORMATION BLOCKING
0
10. The authority citation for part 171 continues to read as follows:
Authority: 42 U.S.C. 300jj-52; 5 U.S.C. 552.
0
11. Amend Sec. 171.102 by adding, in alphabetical order, the
definition of ``Appropriate agency'' and ``Disincentive'' to read as
follows:
Sec. 171.102 Definitions.
* * * * *
Appropriate agency means a government agency that has established
disincentives for health care providers that the Office of Inspector
General (OIG) determines have committed information blocking.
* * * * *
Disincentive means a condition specified in Sec. 171.1001(a) that
is imposed by an appropriate agency on a health care provider that OIG
determines has committed information blocking for the purpose of
deterring information blocking practices.
* * * * *
Subparts E Through I [Added and Reserved]
0
12. Add and reserve subparts E through I.
0
13. Add subpart J to read as follows:
Subpart J--Disincentives for Information Blocking by Health Care
Providers
Sec.
171.1000 Scope.
171.1001 Disincentives.
171.1002 Notice of disincentive.
Sec. 171.1000 Scope.
This subpart sets forth disincentives that an appropriate agency
may impose on a health care provider that OIG determines has committed
information blocking, and certain procedures related to those
disincentives.
Sec. 171.1001 Disincentives.
(a) Centers for Medicare & Medicaid Services may apply the
following disincentives:
(1) An eligible hospital or critical access hospital (CAH) as
defined in 42 CFR 495.4 is not a meaningful electronic health record
(EHR) user as also defined in 42 CFR 495.4.
(2) A Merit-based Incentive Payment System (MIPS) eligible
clinician as defined in 42 CFR 414.1305, who is also a health care
provider as defined in Sec. 171.102, is not a meaningful EHR user for
MIPS as defined in 42 CFR 414.1305.
[[Page 54718]]
(3) Accountable care organizations (ACOs) who are health care
providers as defined in Sec. 171.102, ACO participants, and ACO
providers/suppliers will be removed from, or denied approval to
participate, in the Medicare Shared Savings Program as defined in 42
CFR part 425 for at least 1 year.
(b) [Reserved]
Sec. 171.1002 Notice of disincentive.
Following referral of a determination of information blocking by
OIG, an appropriate agency that imposes a disincentive or disincentives
specified in Sec. 171.1001 shall send a notice to the health care
provider subject to the disincentive or disincentives, via usual
methods of communication for the program or payment system under which
the disincentive is applied, that includes:
(a) A description of the practice or practices that formed the
basis for the determination of information blocking referred by OIG;
(b) The basis for the application of the disincentive or
disincentives being imposed;
(c) The effect of each disincentive; and
(d) Any other information necessary for a health care provider to
understand how each disincentive will be implemented.
0
14. Add subpart K to read as follows:
Subpart K--Transparency for Information Blocking Determinations,
Disincentives, and Penalties
Sec.
171.1100 Scope.
171.1101 Posting of information for actors found to have committed
information blocking.
Authority: 42 U.S.C. 300jj-11(c)(4).
Sec. 171.1100 Scope.
This subpart sets forth the information that will be posted on the
Office of the National Coordinator for Health Information Technology's
(ONC) public website about actors that have been determined by the HHS
Office of Inspector General to have committed information blocking.
Sec. 171.1101 Posting of information for actors found to have
committed information blocking.
(a) Health care providers. (1) ONC will post on its public website
the following information about health care providers that have been
subject to a disincentive in Sec. 171.1001(a) for information
blocking:
(i) Health care provider name;
(ii) Business address;
(iii) The practice, as the term is defined in Sec. 171.102 and
referenced in Sec. 171.103, found to have been information blocking,
including when the practice occurred;
(iv) Disincentive(s) applied; and
(v) Where to find any additional information about the
determination of information blocking that is publicly available via
HHS or, where applicable, another part of the U.S. Government.
(2) The information specified in paragraph (a)(1) of this section
will not be posted prior to a disincentive being imposed or the
completion of any administrative appeals process pursued by the health
care provider, and will not include information about a disincentive
that has not been applied.
(3) Posting of the information specified in paragraph (a)(1) of
this section will be conducted in accordance with existing rights to
review information that may be associated with a disincentive specified
in Sec. 171.1001.
(b) Health IT developers of certified health IT and health
information networks or health information exchanges. (1) ONC will post
on its public website the following information, to the extent
applicable, about health information networks/health information
exchanges and health IT developers of certified health IT (actors) that
have been determined by the HHS Office of Inspector General to have
committed information blocking:
(i) Type of actor;
(ii) Actor's legal name, including any alternative or additional
trade name(s) under which the actor operates;
(iii) The practice, as the term is defined in Sec. 171.102 and
referenced in Sec. 171.103, found to have been information blocking or
alleged to be information blocking in the situation specified in
paragraph (b)(2)(i) of this section, and including when the practice
occurred; and
(iv) Where to find any additional information about the
determination (or resolution of information blocking as specified in
paragraph (b)(2)(i) of this section) of information blocking that is
publicly available via HHS or, where applicable, another part of the
U.S. Government.
(2) The information specified in paragraph (b)(1) of this section
will not be posted until one of the following occurs:
(i) OIG enters into a resolution of civil money penalty (CMP)
liability; or
(ii) A CMP imposed under subpart N of 42 CFR part 1003 has become
final consistent with the procedures in subpart O of 42 CFR part 1003.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2024-13793 Filed 6-26-24; 4:15 pm]
BILLING CODE 4150-45-P