21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking, 74947-74970 [2023-24068]
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Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules
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[FR Doc. 2023–24086 Filed 10–31–23; 8:45 am]
BILLING CODE 4164–01–P
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
Centers for Medicare &
Medicaid Services (CMS) and Office of
the National Coordinator for Health
Information Technology (ONC),
Department of Health and Human
Services (HHS).
ACTION: Proposed rule.
AGENCY:
This proposed rule would
implement the provision of the 21st
Century Cures Act specifying that a
health care provider determined by the
HHS Inspector General to have
committed information blocking shall
be referred to the appropriate agency to
be subject to appropriate disincentives
set forth through notice and comment
rulemaking. In particular, this
rulemaking would establish for such
health care providers a set of
appropriate disincentives using
authorities under applicable Federal
law.
DATES: To be assured consideration,
written or electronic comments must be
received at one of the addresses
provided below, no later than 5 p.m. on
January 2, 2024.
ADDRESSES: You may submit comments,
identified by RIN 0955–AA05, by any of
the following methods (please do not
submit duplicate comments). Because of
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SUMMARY:
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staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
• Federal eRulemaking Portal: Follow
the instructions for submitting
comments. Attachments should be in
Microsoft Word, Microsoft Excel, or
Adobe PDF; however, we prefer
Microsoft Word. https://
www.regulations.gov.
• Regular, Express, or Overnight Mail:
Department of Health and Human
Services, Office of the National
Coordinator for Health Information
Technology, Attention: 21st Century
Cures Act: Establishment of
Disincentives for Health Care Providers
That Have Committed Information
Blocking Proposed Rule, Mary E.
Switzer Building, Mail Stop: 7033A, 330
C Street SW, Washington, DC 20201.
Please submit one original and two
copies.
• Inspection of Public Comments: All
comments received before the close of
the comment period will be available for
public inspection, including any
personally identifiable or confidential
business information that is included in
a comment. Please do not include
anything in your comment submission
that you do not wish to share with the
general public. For example, people
typically do not wish to, and generally
should not, share with the general
public information such as: any person’s
social security number; date of birth;
driver’s license number; state
identification number or foreign country
equivalent; passport number; financial
account number; credit or debit card
number; individually identifiable health
information; or any business
information that could be considered
proprietary. We will post all comments
that are received before the close of the
comment period at https://
www.regulations.gov.
• Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Alexander Baker, Office of Policy,
Office of the National Coordinator for
Health Information Technology (ONC),
(202) 690–7151, for general issues.
Elizabeth Holland, Centers for
Medicare & Medicaid Services (CMS),
(443) 934–2532, for issues related to the
Promoting Interoperability Program and
the Promoting Interoperability
performance category of the Merit-Based
Incentive Payment System.
Aryanna Abouzari, Centers for
Medicare & Medicaid Services (CMS),
(415) 744–3668 or
SharedSavingsProgram@cms.hhs.gov,
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for issues related to the Medicare
Shared Savings Program.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of Regulatory Action
B. Summary of Major Provisions
C. Costs and Benefits
II. Background
A. Statutory Basis
B. Regulatory History
1. ONC Cures Act Final Rule
2. Office of Inspector General (OIG) Civil
Money Penalties (CMP) Final Rule
III. Provisions of the Proposed Regulation
A. Relevant Statutory Terms and
Provisions
1. Appropriate Agency
2. Authorities Under Applicable Federal
Law
3. Appropriate Disincentives
B. Approach To Determination of
Information Blocking and Application of
Disincentives
1. OIG Investigation and Referral
2. General Provisions for Application of
Disincentives
3. Transparency for Information Blocking
Determinations, Disincentives, and
Penalties
C. Appropriate Disincentives for Health
Care Providers
1. Background
2. Medicare Promoting Interoperability
Program for Eligible Hospitals and
Critical Access Hospitals (CAHs)
3. Promoting Interoperability Performance
Category of the Medicare Merit-Based
Incentive Payment System (MIPS)
4. Medicare Shared Savings Program
IV. Request for Information
V. Collection of Information Requirements
VI. Regulatory Impact Statement
A. Executive Order No. 12866
B. Regulatory Flexibility Act
C. Unfunded Mandates Reform Act
D. Executive Order 13132
I. Executive Summary
A. Purpose of Regulatory Action
This proposed rule would implement
the 21st Century Cures Act (Cures Act)
provision for referral of a health care
provider (individual or entity)
determined by the HHS Office of
Inspector General (OIG) to have
committed information blocking ‘‘to the
appropriate agency to be subject to
appropriate disincentives using
authorities under applicable Federal
law, as the Secretary sets forth through
notice and comment rulemaking’’ (42
U.S.C. 300jj–52(b)(2)(B), Public Health
Service Act (PHSA) section
3022(b)(2)(B), as added by section 4004
of the Cures Act (Pub. L. 114–255, Dec.
13, 2016)). The proposals in this rule
would establish disincentives for certain
health care providers (as defined in 45
CFR 171.102) that are also Medicareenrolled providers or suppliers.
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B. Summary of Major Provisions
This proposed rule would establish
disincentives applicable to certain
health care providers (as defined in 45
CFR 171.102) determined by OIG to
have committed information blocking
(as defined in 45 CFR 171.103) that are
also Medicare-enrolled providers or
suppliers. The proposed rule also
provides information related to OIG’s
investigation of claims of information
blocking and referral of a health care
provider to an appropriate agency to be
subject to appropriate disincentives.
Finally, the rule proposes to establish a
process by which information would be
shared with the public about health care
providers that OIG determines have
committed information blocking.
Although the proposals in this rule
would not establish disincentives for all
of the health care providers included in
the 45 CFR 171.102 definition, the
health care providers to whom these
disincentives would apply furnish a
broad array of services to a significant
number of both Medicare beneficiaries
and other patients. Thus, this set of
disincentives would directly advance
HHS priorities for deterring information
blocking, while also advancing
appropriate sharing of electronic health
information (EHI) by health care
providers 1 to support safer, more
coordinated care for all patients.
We believe it is important to establish
appropriate disincentives that account
for all health care providers that fall
within the definition of health care
provider (45 CFR 171.102). While
effective deterrence of information
blocking can benefit patients by
reducing the degree to which health
care providers engage in this practice,
fewer patients will benefit from these
deterrent effects if disincentives have
not been established for all of the health
care providers within the definition of
health care provider at 45 CFR 171.102.
In section IV. of this proposed rule, we
request information on how we can
build on the proposals in this rule to
establish disincentives for other health
care providers, particularly those health
care providers not participating in the
CMS programs identified in this rule.
Consistent with PHSA section
3022(b)(2)(B), the proposals in this rule
to establish disincentives use authorities
1 Except if or as necessitated by the specific
terminology of a particular statutory authority or
CFR section, we use in this rule ‘‘health care
provider,’’ ‘‘provider,’’ and ‘‘provider type’’ as
inclusive of individuals and entities that may be
characterized for purposes of Medicare enrollment
or particular reimbursement policies as providers or
suppliers—or both across different contexts such as
specific services furnished in particular settings.
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under applicable Federal law, as
follows:
• Under the authority for the
Medicare Promoting Interoperability
Program in the Social Security Act
(SSA), at sections 1886(b)(3)(B)(ix) and
1886(n) for eligible hospitals, and at
section 1814(l)(4) for critical access
hospitals (CAHs), CMS proposes that an
eligible hospital or CAH would not be
a meaningful electronic health record
(EHR) user in an EHR reporting period
if OIG refers, during the calendar year
of the reporting period, a determination
that the eligible hospital or CAH
committed information blocking as
defined at 45 CFR 171.103. As a result,
an eligible hospital subject to this
disincentive would not be able to earn
the three quarters of the annual market
basket increase associated with
qualifying as a meaningful EHR user,
while a CAH subject to this disincentive
would have its payment reduced to 100
percent of reasonable costs, from the
101 percent of reasonable costs it might
have otherwise earned, in an applicable
year.
• Under the authority in SSA sections
1848(o)(2)(A) and (D) and
1848(q)(2)(A)(iv) and (B)(iv), for the
Promoting Interoperability performance
category of the Merit-based Incentive
Payment System (MIPS), CMS proposes
that a health care provider defined in 45
CFR 171.102 that is a MIPS eligible
clinician (as defined in 42 CFR 414.1305
and including groups) would not be a
meaningful EHR user in a performance
period if OIG refers, during the calendar
year of the reporting period, a
determination that the MIPS eligible
clinician committed information
blocking as defined at 45 CFR 171.103.
CMS also proposes that the
determination by OIG that a MIPS
eligible clinician committed information
blocking would result in the MIPS
eligible clinician, if required to report
on the Promoting Interoperability
performance category of MIPS, not
earning a score in the performance
category (a zero score), which is
typically a quarter of the total final
composite performance score (a ‘‘final
score’’ as defined at 42 CFR 414.1305).
CMS proposes to codify this proposal
under the definition of meaningful EHR
user for MIPS at 42 CFR 414.1305 and
add it to the requirements for earning a
score for the MIPS Promoting
Interoperability performance category at
42 CFR 414.1375(b).
• Under the authority in SSA section
1899(b)(2)(G) for the Medicare Shared
Savings Program (Shared Savings
Program), CMS proposes that a health
care provider as defined in 45 CFR
171.102 that is an accountable care
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organization (ACO), ACO participant, or
ACO provider/supplier, if determined
by OIG to have committed information
blocking as defined at 45 CFR 171.103,
would be barred from participating in
the Shared Savings Program for at least
1 year. This may result in a health care
provider being removed from an ACO or
prevented from joining an ACO; and in
the instance where a health care
provider is an ACO, this would prevent
the ACO’s participation in the Shared
Savings Program.
C. Costs and Benefits
Executive Order 12866 on Regulatory
Planning and Review and Executive
Order 13563 on Improving Regulation
and Regulatory Review direct agencies
to assess all costs and benefits of
available regulatory alternatives and, if
regulation is necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health
and safety effects, distributive impacts,
and equity). Section 3(f) of Executive
Order 12866, as amended by Executive
Order 14094, defines a ‘‘significant
regulatory action’’ as an action that is
likely to result in a rule that may: (1)
have an annual effect on the economy
of $200 million or more (adjusted every
3 years by the Administrator of the
Office of Information and Regulatory
Affairs (OIRA) for changes in gross
domestic product), or adversely affect in
a material way the economy, a sector of
the economy, productivity, competition,
jobs, the environment, public health or
safety, or State, local, territorial, or tribal
governments or communities; (2) create
a serious inconsistency or otherwise
interfere with an action taken or
planned by another agency; (3)
materially alter the budgetary impact of
entitlements, grants, user fees, or loan
programs or the rights and obligations of
recipients thereof; or (4) raise legal or
policy issues for which centralized
review would meaningfully further the
President’s priorities or the principles
set forth in the Executive Order, as
specifically authorized in a timely
manner by the Administrator of OIRA in
each case. The Office of Management
and Budget (OMB) has determined that
this proposed rule is not a significant
regulatory action, as the potential costs
associated with this proposed rule
would not be greater than $200 million
per year and it does not meet any of the
other requirements to be a significant
regulatory action.
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II. Background
A. Statutory Basis
The Cures Act was enacted on
December 13, 2016, ‘‘[t]o accelerate the
discovery, development, and delivery of
21st century cures, and for other
purposes.’’ Section 4004 of the Cures
Act added section 3022 to the PHSA.
Section 3022(a)(1) of the PHSA defines
information blocking as practice that,
except as required by law or specified
by the Secretary pursuant to
rulemaking, is likely to interfere with,
prevent, or materially discourage access,
exchange, or use of electronic health
information. If the practice is conducted
by a health information technology
developer, exchange, or network, such
developer, exchange, or network knows,
or should know, that such practice is
likely to interfere with, prevent, or
materially discourage the access,
exchange, or use of electronic health
information. If the practice is conducted
by a health care provider, such provider
knows that such practice is
unreasonable and is likely to interfere
with, prevent, or materially discourage
access, exchange, or use of electronic
health information. Section 3022(a)(3) of
the PHSA further provides that the
Secretary shall, through rulemaking,
identify reasonable and necessary
activities that do not constitute
information blocking. Section 3022(a)(4)
of the PHSA states that the term
‘‘information blocking’’ does not
include any practice or conduct
occurring prior to the date that is 30
days after December 13, 2016 (the date
of the enactment of the Cures Act).2
Section 3022(a)(2) of the PHSA
describes certain practices that may
constitute information blocking.
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
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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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.
PHSA section 3022 also authorizes
ONC, the HHS Office for Civil Rights
(OCR), and OIG to consult, refer, and
coordinate to resolve claims of
information blocking. PHSA section
3022(b)(3)(A) authorizes OIG to refer
claims of information blocking to OCR
if OIG determines a consultation
regarding the health privacy and
security rules promulgated under
section 264(c) of the Health Insurance
Portability and Accountability Act of
1996 (HIPAA) (42 U.S.C. 1320d–2 note)
will resolve such claims. PHSA section
3022(d)(1) specifies that the National
Coordinator may serve as a technical
consultant to OIG and the Federal Trade
Commission (FTC) for purposes of
carrying out section 3022 and may share
information related to claims or
investigations of information blocking
with the FTC for purposes of such
investigations, in addition to requiring
the National Coordinator to share
information with OIG, as required by
law.
PHSA section 3022(d)(4) requires the
Secretary, in carrying out section 3022
and to the extent possible, to ensure that
information blocking penalties do not
duplicate penalty structures that would
otherwise apply with respect to
information blocking and the type of
individual or entity involved as of the
day before the date of enactment of the
Cures Act. Section 3022(a)(7) of the
PHSA states that, in carrying out section
3022, the Secretary shall ensure that
health care providers are not penalized
for the failure of developers of health
information technology or other entities
offering health information technology
to such providers to ensure that such
technology meets the requirements to be
certified under Title XXX of the PHSA.
We address the statutory basis for
each proposed disincentive in greater
detail in section III.C. of this proposed
rule.
3 ONC uses the term ‘‘civil money penalty’’ here,
rather than ‘‘civil monetary penalty’’ as used in
PHSA section 3022(b)(2)(A) for consistency with
OIG’s usage in the OIG CMP Final Rule (88 FR
42820).
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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
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
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purposes of the information blocking
regulations in 45 CFR part 171. ONC
noted that the definitions listed in
section 3000 of the PHSA apply ‘‘[i]n
this title,’’ which refers to Title XXX of
the PHSA (85 FR 25795). Section 3022
of the PHSA is included in Title XXX.
Since adopting a definition of health
care provider in the ONC Cures Act
Final Rule, the Secretary has not
proposed to modify the definition for
purposes of the information blocking
regulations.
The ONC Cures Act Final Rule also
established in 45 CFR 171.102
regulatory definitions for ‘‘health
information network or health
information exchange’’ and ‘‘health IT
developer of certified health IT,’’ 5
among other terms.6 The preamble text
of the ONC Cures Act Final Rule makes
clear that an individual or entity could
meet both the definition of a health care
provider and the definition of a health
IT developer of certified health IT (85
FR 25798 through 25799) or could meet
both the definition of a health care
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.
5 In the ONC Cures Act Final Rule, ONC defined
the term ‘‘health IT developer of certified health IT’’
in 45 CFR 171.102, instead of using the term that
appears in PHSA 3022(a)(1): ‘‘health IT developer.’’
ONC explained that, because title XXX of the PHSA
does not define ‘‘health information technology
developer,’’ ONC interpreted section 3022(a)(1)(B)
in light of the specific authority provided to OIG in
section 3022(b)(1)(A) and (b)(2). ONC noted that
section 3022(b)(2) discusses developers, networks,
and exchanges by referencing any individual or
entity described in section 3022(b)(1)(A) or (C).
Section 3022(b)(1)(A) states, in relevant part, that
OIG may investigate any claim that a health
information technology developer of certified health
information technology or other entity offering
certified health information technology engaged in
information blocking (85 FR 25795, emphasis
added).
6 In 2023, ONC has proposed to establish a
definition of what it means to ‘‘offer’’ certified
health IT, and to make a corresponding update to
the health IT developer of certified health IT
definition. These proposals are part of a proposed
rule titled ‘‘Health Data, Technology, and
Interoperability: Certification Program Updates,
Algorithm Transparency, and Information Sharing’’
(88 FR 23746) (HTI–1 Proposed Rule). The
comment period on the HTI–1 Proposed Rule ended
June 20, 2023. Public Comments are posted as part
of docket HHS–ONC–2023–0007, see https://
www.regulations.gov/docket/HHS-ONC-2023-0007/
comments.
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provider and a health information
exchange or network (85 FR 25801). We
mention these potential scenarios so
that health care providers are aware that
they would not necessarily only be
subject to the disincentives proposed in
this rule (should they be finalized), but
depending on the specific facts and
circumstances, they could meet the
definition of a health information
network or exchange, and therefore be
subject to civil money penalties, if
found by OIG to have committed
information blocking.
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.
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
7 For more information about the USCDI, see
https://www.healthit.gov/isa/united-states-coredata-interoperability-uscdi.
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related procedures at PHSA sections
3022(b)(2)(A) and (C) (88 FR 42825).
Specific to information blocking, OIG
also provided information on—but did
not propose regulations for—expected
enforcement priorities, the investigation
process, and OIG’s experience with
investigating conduct that includes an
intent element (88 FR 42822).
OIG subsequently addressed these
proposals in a final rule, ‘‘Grants,
Contracts, and Other Agreements: Fraud
and Abuse; Information Blocking; Office
of Inspector General’s Civil Money
Penalty Rules,’’ which appeared in the
Federal Register on July 3, 2023 (OIG
CMP Final Rule) (88 FR 42820). This
rulemaking addressed imposition of
CMPs for information blocking by
health IT developers or other entities
offering certified health IT, health
information exchanges, and health
information networks. The OIG CMP
Final Rule did not establish appropriate
disincentives for health care providers
that OIG has determined have
committed information blocking.
As mentioned above, a health care
provider that also meets the definition
of health IT developer of certified health
IT, or health information network or
health information exchange, or both,
under 45 CFR 171.102, may be subject
to information blocking CMPs (88 FR
42828). OIG has stated that as part of its
assessment of whether a health care
provider is a health information
network or exchange that could be
subject to civil money penalties for
information blocking, OIG anticipates
engaging with the health care provider
to better understand its functions and to
offer the provider an opportunity to
explain why it is not a health
information network or exchange (88 FR
42828).
III. Provisions of the Proposed
Regulation
A. Relevant Statutory Terms and
Provisions
In this section, we discuss certain
statutory terms and provisions in PHSA
sections 3022(a) and (b) related to the
establishment of appropriate
disincentives for health care providers
as defined in 45 CFR 171.102. For
brevity, we refer to PHSA section
3022(b)(2)(B), which states that health
care providers that OIG has determined
to have committed information blocking
‘‘shall be referred to the appropriate
agency to be subject to appropriate
disincentives using authorities under
applicable Federal law, as the Secretary
sets forth through notice and comment
rulemaking,’’ as the ‘‘disincentives
provision’’ throughout this section.
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1. Appropriate Agency
The disincentives provision states
that an individual or entity that is a
health care provider determined by OIG
to have committed information blocking
shall be referred to the ‘‘appropriate
agency’’ to be subject to appropriate
disincentives. Accordingly, we propose
to define ‘‘appropriate agency’’ in 45
CFR 171.102 to mean a government
agency that has established
disincentives for health care providers
that OIG determines have committed
information blocking. We note that,
under the disincentives provision, an
‘‘agency’’ may be any component of
HHS that has established a disincentive
or disincentives on behalf of the
Secretary of HHS, including any of the
Staff or Operating Divisions of HHS. For
example, the disincentives proposed in
section III.C. of this proposed rule are
proposed under authorities held by
CMS, which is an Operating Division of
HHS. Under our proposals, CMS would
be the ‘‘appropriate agency’’ to which
OIG would refer a health care provider
to be subject to disincentives.
We invite public comments on our
proposed definition of ‘‘appropriate
agency.’’
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2. Authorities Under Applicable Federal
Law
We propose to interpret the phrase
‘‘authorities under applicable Federal
law’’ in the disincentives provision to
mean that an appropriate agency may
only subject a health care provider to a
disincentive established using
authorities that could apply to
information blocking by a health care
provider subject to the authority, such
as health care providers participating in
a program supported by the authority. In
section III.C. of this proposed rule, CMS
identifies the authority under which
each disincentive is proposed.
3. Appropriate Disincentives
The Cures Act does not specify or
provide illustrations for the types of
disincentives that should be established.
As such, we propose to define the term
‘‘disincentive’’ in 45 CFR 171.102 to
mean a condition that may be imposed
by an appropriate agency on a health
care provider that OIG determines has
committed information blocking and is
specifically identified in 45 CFR
171.1001(a). In section III.B.2 of this
proposed rule, we propose to identify in
45 CFR 171.1001(a) those disincentives
that have been established pursuant to
the statute for the express purpose of
deterring information blocking
practices.
The term ‘‘appropriate’’ for
disincentives is likewise not defined in
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PHSA section 3022, nor are illustrations
provided. Under this proposal, a
disincentive for a health care provider
that OIG has determined to have
committed information blocking may be
any condition, established through
notice and comment rulemaking, that
would, in our estimation, deter
information blocking practices among
health care providers subject to the
information blocking regulations. In
section III.C. of this proposed rule, we
describe the potential impact that each
proposed disincentive would have on a
health care provider.
We note that the disincentives
provision does not limit the number of
disincentives that an appropriate agency
can impose on a health care provider.
Accordingly, we propose that a health
care provider would be subject to each
appropriate disincentive that an agency
has established through notice and
comment rulemaking and is applicable
to the health care provider. Imposing
cumulative disincentives, where
applicable, would further deter health
care providers from engaging in
information blocking.
We invite public comments on our
proposals to establish disincentives in
section III.C. of this proposed rule.
B. Approach To Determination of
Information Blocking and Application
of Disincentives
In this section we provide additional
detail about the process by which a
health care provider that has committed
information blocking would be subject
to appropriate disincentives for
information blocking. We begin with a
discussion of an OIG investigation of a
claim of information blocking, which
may result in OIG determining that the
health care provider committed
information blocking. We then discuss
how OIG would refer the health care
provider to an appropriate agency. Next,
we address certain general issues related
to the application of a disincentive by
an appropriate agency. Finally, we
propose an approach to make
information available to the public
about health care providers that have
been subject to an appropriate
disincentive for information blocking,
and about health information networks/
health information exchanges and
health IT developers of certified health
IT that have been determined by OIG to
have committed information blocking.
1. OIG Investigation and Referral
The following information regarding
OIG’s anticipated approach to
information blocking investigations of
health care providers is not a regulatory
proposal and is provided for
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information purposes only. This
preamble discussion of investigation
priorities for health care provider
information blocking claims is not
binding on OIG and HHS. It does not
impose any legal restrictions related to
OIG’s discretion to choose which health
care provider information blocking
complaints to investigate.
a. Anticipated Priorities
As with other conduct that OIG has
authority to investigate, OIG has
discretion to choose which information
blocking complaints to investigate. To
maximize efficient use of resources, OIG
generally focuses on selecting cases for
investigation that are consistent with its
enforcement priorities and intends to
apply that rationale to its approach for
selecting information blocking
complaints for investigation. In the OIG
CMP Final Rule, OIG described its
enforcement priorities for health IT
developers of certified health IT or other
entities offering certified health IT,
health information exchanges, and
health information networks that have
committed information blocking and are
subject to CMPs. OIG stated that its
information blocking CMP enforcement
priorities will include practices that: (i)
resulted in, are causing, or have the
potential to cause patient harm; (ii)
significantly impacted a provider’s
ability to care for patients; (iii) were of
long duration; (iv) caused financial loss
to Federal healthcare programs, or other
government or private entities; or (v)
were performed with actual knowledge.
OIG stated that it expected these
priorities will evolve as it gains more
experience investigating information
blocking (88 FR 42822).
For investigations of health care
providers, OIG expects to use four of
these priorities: (i) resulted in, are
causing, or have the potential to cause
patient harm; (ii) significantly impacted
a provider’s ability to care for patients;
(iii) were of long duration; and (iv)
caused financial loss to Federal health
care programs, or other government or
private entities. Again, although not a
regulatory proposal, OIG welcomes
comments on these priorities, including
comments on whether other issues
specific to information blocking by
health care providers should warrant
changing these priorities or adding
others.
OIG emphasizes that information
blocking, as defined in PHSA section
3022(a)(1) and in 45 CFR 171.103,
includes an element of intent. The
standard of intent for health care
providers was established by the Cures
Act in PHSA section 3022(a)(1)(B)(ii):
‘‘if conducted by a health care provider,
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such provider knows that such practice
is unreasonable and is likely to interfere
with, prevent, or materially discourage
access, exchange, or use of electronic
health information.’’ This is different
from the standard of intent in PHSA
section 3022(a)(1)(B)(i): ‘‘if conducted
by a health information technology
developer, exchange, or network, such
developer, exchange, or network knows,
or should know, that such practice is
likely to interfere with, prevent, or
materially discourage the access,
exchange, or use of electronic health
information.’’ The different intent
standard for information blocking by a
health care provider is why OIG does
not expect to use ‘‘actual knowledge’’ as
an enforcement priority. OIG has
significant experience and expertise
investigating and determining whether
to take an enforcement action based on
other laws that are intent-based (for
example, the Federal anti-kickback
statute, and Civil Monetary Penalties
Law, 42 U.S.C. 1320a–7b(b) and 1320a–
7a). This history will inform the use of
OIG’s discretion to investigate health
care providers that OIG believes may
have the requisite intent.
As noted in the OIG CMP Final Rule
(88 FR 42822), explanation of OIG’s
priorities can provide the public with a
better understanding of how OIG
anticipates allocating its resources for
information blocking enforcement.
Applicable to this proposed rule,
explanation of OIG’s priorities can
provide the public with a better
understanding of how OIG anticipates
allocating its resources to investigate
claims that health care providers
engaged in information blocking.
Prioritization ensures OIG can
effectively allocate its resources to target
information blocking claims that have
more negative effects on patients,
providers, and healthcare programs.
OIG’s enforcement priorities will inform
its decisions about which information
blocking allegations to pursue, but these
priorities are not dispositive. Each
allegation will present unique facts and
circumstances that must be assessed
individually. Each allegation will be
assessed to determine whether it
implicates one or more of the
enforcement priorities, or otherwise
merits further investigation and
potential enforcement action. Although
OIG’s anticipated priorities are framed
around individual allegations, OIG may
evaluate allegations and prioritize
investigations based in part on the
volume of claims relating to the same
(or similar) practices by the same entity
or individual (for example, a health care
provider or health information
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network). There is no specific formula
OIG can apply to every allegation that
allows it to effectively evaluate and
prioritize which claims merit
investigation.
b. Coordination With Other Agencies
In this section we summarize the
discussion in the OIG CMP Final Rule
of the ways ONC, OCR, and OIG will
consult, refer, and coordinate on
information blocking claims as
permitted by the Cures Act (88 FR
42823).
PHSA section 3022(d)(1) states that
the National Coordinator may serve as a
technical consultant to the Inspector
General. OIG will accordingly consult
with ONC throughout the investigative
process. Additionally, PHSA section
3022(b)(3)(A) provides the option for
OIG to refer claims of information
blocking to OCR when a consultation
regarding the health privacy and
security rules promulgated under
section 264(c) of HIPAA will resolve
such claims. Depending on the facts and
circumstances of the claim, OIG will
exercise this statutory discretion as
appropriate to refer information
blocking claims to OCR for resolution.
There is no set of facts or circumstances
that will always be referred to OCR. OIG
will work with OCR to determine which
claims should be referred to OCR under
the authority provided in PHSA section
3022(b)(3)(A). In addition to section
3022(b)(3)(A), OIG may request
technical assistance from OCR during an
information blocking investigation. It is
important to note that while section
3022(b)(3)(A) of the PHSA specifically
provides OIG with the authority to refer
information blocking claims to OCR,
OIG’s statutory authority to refer to OCR
allegations of violations of the HIPAA
Privacy, Security, or Breach Notification
Rules 8 is not solely based on PHSA
section 3022(b)(3)(A). Thus, OIG’s
authority to refer to OCR such
allegations against health care providers
is not limited to claims of information
blocking.
Finally, OIG stated that it anticipates
coordinating with other HHS agencies to
avoid duplicate penalties as identified
in section 3022(d)(4) of the PHSA.
Depending on the facts and
circumstances, OIG stated that it might
also consult or coordinate with a range
of other government agencies, including
CMS, FTC, or others (88 FR 42824).
c. Anticipated Approach to Referral
During an investigation of information
blocking by a health care provider, but
8 45
CFR parts 160 and 164, subparts A, C, D, and
E.
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prior to making a referral, OIG will
coordinate with the appropriate agency
to which OIG plans to refer its
determination of information blocking.
This coordination will ensure that the
appropriate agency is aware of a
potential referral and that OIG provides
the information the agency needs to take
appropriate action. OIG’s referral to the
appropriate agency will explain its
determination that a health care
provider committed information
blocking, including meeting the
requirements of the intent element of
PHSA section 3022(a)(1)(B)(ii).
We note that PHSA section 3022
authorizes OIG to investigate claims of
information blocking and requires OIG
to refer health care providers to an
appropriate agency when it determines
a health care provider has committed
information blocking, to be subject to
appropriate disincentives. Once OIG has
concluded its investigation and is
prepared to make a referral, it will send
information to the appropriate agency
indicating that the referral is made
pursuant to the statutory requirement in
PHSA section 3022(b)(2)(B). As part of
the referral, OIG will provide
information to explain its
determination, which may include: the
dates when OIG has determined the
information blocking violation(s)
occurred; analysis to explain how the
evidence demonstrates the health care
provider committed information
blocking (for instance, that the health
care provider’s ‘‘practice’’ 9 meets each
element of the information blocking
definition); copies of evidence collected
during the investigation (regardless of
whether it was collected by subpoena or
voluntarily provided to OIG); copies of
transcripts and video recordings (if
applicable) of any witness and affected
party testimony; and copies of
documents OIG relied upon to make its
determination that information blocking
occurred. OIG may provide additional
information as part of its referral based
on consultation with the appropriate
agency, to the extent permitted by
applicable law.
2. General Provisions for Application of
Disincentives
Following an investigation through
which OIG determines a health care
provider has committed information
blocking, and OIG’s referral of this
determination to an appropriate agency,
the health care provider would be
subject to disincentives that have been
9 Practice, as defined in 45 CFR 171.102, means
an act or omission by an actor (health care provider,
health IT developer of certified health IT, health
information network or health information
exchange).
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established under applicable Federal
law through notice and comment
rulemaking. In this section, we include
general proposals and information
related to the application of
disincentives. For information on the
specific disincentives proposed in this
rule and further discussion about how
each disincentive would be applied, we
refer readers to section III.C.
We propose to add a new subpart J to
45 CFR part 171, entitled ‘‘Disincentives
for Information Blocking by Health Care
Providers.’’ As proposed in 45 CFR
171.1000, this subpart would set forth
disincentives that an appropriate agency
would impose on a health care provider
based on a determination of information
blocking referred to that agency by OIG,
and certain procedures related to those
disincentives. We propose in 45 CFR
171.1001(a) that health care providers
that commit information blocking
would be subject to the following
disincentives from an appropriate
agency based on a determination of
information blocking referred by OIG,
where applicable. The disincentives
proposed for inclusion in 45 CFR
171.1001(a)(1) through (3) correspond to
the appropriate disincentives proposed
in section III.C. of this proposed rule,
which include:
• An eligible hospital or CAH as
defined in 42 CFR 495.4 is not a
meaningful EHR user as also defined in
that section;
• A MIPS eligible clinician as defined
in 42 CFR 414.1305, who is also a health
care provider as defined in 45 CFR
171.102, is not a meaningful EHR user
for MIPS as also defined in 42 CFR
414.1305; and
• ACOs who are health care providers
as defined in 45 CFR 171.102, ACO
participants, and ACO providers/
supplies will be removed from, or
denied approval to participate, in the
Medicare Shared Savings Program as
defined in 42 CFR part 425 for at least
1 year.
In the future, if we propose to
establish additional disincentives, we
intend to add such disincentives to the
disincentives listed in 45 CFR
171.1001(a).
We propose in 45 CFR 171.1002(a)
through (d) that an appropriate agency
that imposes a disincentive or
disincentives in § 171.1001(a) would
send a notice (using usual methods of
communication for the program or
payment system) to the health care
provider subject to the disincentive or
disincentives. This notice would
include:
• A description of the practice or
practices that formed the basis for the
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determination of information blocking
referred by OIG;
• The basis for the application of the
disincentive or disincentives being
imposed;
• The effect of each disincentive; and
• Any other information necessary for
a health care provider to understand
how each disincentive will be
implemented.
The information in this notice would
be based upon the authority used to
establish the disincentive and policy
finalized by the agency establishing the
disincentive. For instance, the notice
may contain specific information
regarding when a disincentive would be
imposed, which may be contingent on
both the authority used to establish the
disincentive and the specific policy
under which the disincentive is
established. We note that, where a
health care provider that has been
determined to have committed
information blocking is subject to
multiple disincentives established by an
appropriate agency, nothing in this
proposal would prevent the appropriate
agency from combining these notices
into a single communication.
Following the application of a
disincentive, a health care provider, as
defined in 45 CFR 171.102, may have
the right to appeal administratively a
disincentive if the authority used to
establish the disincentive provides for
such an appeal. We note that PHSA
section 3022(b)(2)(C) requires that the
imposition of CMPs that apply to health
IT developers of certified health IT, and
health information networks or health
information exchanges, that have
committed information blocking, follow
the procedures of SSA section 1128A,
which includes procedures for appeals.
However, the Cures Act did not provide
similar instruction regarding appeals of
disincentives for health care providers
established under PHSA section
3022(b)(2)(B). Therefore, any right to
appeal administratively a disincentive,
if available, would be provided under
the authorities used by the Secretary to
establish the disincentive through
notice and comment rulemaking.
3. Transparency for Information
Blocking Determinations, Disincentives,
and Penalties
We believe that it is important to
promote transparency about how and
where information blocking is
impacting the nationwide health
information technology infrastructure.
Publicly releasing information,
including applicable public settlements,
penalties, and disincentives, about
actors that have been determined by
OIG to have committed information
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blocking can inform the public about
how and where information blocking is
occurring within the broader health
information technology infrastructure.
PHSA section 3001(c)(4) requires that
the National Coordinator maintain an
internet website ‘‘to ensure transparency
in promotion of a nationwide health
information technology infrastructure.’’
We believe this provision provides the
National Coordinator with the authority
to post information on ONC’s website if
that information has an impact on issues
relating to transparency in the
promotion of a nationwide health
information technology infrastructure.
We propose to add a new subpart K to
45 CFR part 171, entitled ‘‘Transparency
for Information Blocking
Determinations, Disincentives, and
Penalties.’’ As proposed in 45 CFR
171.1100, this subpart would set forth
the information that would be publicly
posted on ONC’s website about actors
that have been determined by OIG to
have committed information blocking.
We propose in 45 CFR 171.1101 that,
in order to provide insight into how and
where information blocking conduct is
impacting the broader nationwide
health information technology
infrastructure, ONC would post on its
public website information about actors
that have been determined by OIG to
have committed information blocking.
For health care providers that are
subject to a disincentive, we propose in
45 CFR 171.1101(a)(1) that the following
information would be posted: health
care provider’s name, business address
(to ensure accurate provider
identification), the practice found to
have been information blocking, the
disincentive(s) applied, and where to
find additional information, where
available, about the determination of
information blocking that is publicly
available via HHS or another part of the
U.S. Government. We propose in 45
CFR 171.1101(a)(2) that the information
specified in 45 CFR 171.1101(a)(1)
would not be posted prior to a
disincentive being imposed and would
not include information about a
disincentive that has not been applied.
We also recognize that under the
authorities for the disincentives
proposed in section III.C. of this
proposed rule, an appropriate agency
may have other obligations related to
release of information about a
participant that is a health care provider
(as defined in 45 CFR 171.102) in
programs under that authority. For
instance, under SSA section
1848(q)(9)(C), MIPS eligible clinicians
have a right to review information about
their performance in MIPS prior to
having this information publicly posted
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on the Compare Tool in accordance
with 42 CFR 414.1395. Therefore, we
propose in 45 CFR 171.1101(a)(3) that
posting of the information about health
care providers that have been
determined to have committed
information blocking and have been
subject to a disincentive would be
conducted in accordance with existing
rights to review information that may be
associated with a disincentive specified
in 45 CFR 171.1001. For instance, where
a health care provider, as defined in 45
CFR 171.102, has a statutory right to
review performance information, this
existing right would be exercised prior
to public posting of information
regarding information blocking on the
website described above.
In order to provide insight into how
and where information blocking
conduct is impacting the broader
nationwide health information
technology infrastructure, we also
propose in 45 CFR 171.1101(b)(1) to
post on ONC’s public website
information specified in 45 CFR
171.1101(b)(1) about health information
networks (HINs)/health information
exchanges (HIEs) and health IT
developers of certified health IT that
have been determined by OIG to have
committed information blocking and
have either resolved their civil money
penalty (CMP) liability with OIG or had
a CMP imposed by OIG for information
blocking under subpart N of 42 CFR part
1003. To ensure accurate identification
of actors, we propose in 45 CFR
171.1101(b)(1) to post the type of actor
(e.g., HIN/HIE or health IT developers of
certified health IT) and the actor’s legal
name, including any alternative or
additional trade name(s) under which
the actor operates.
The last information we propose to
post on our public website, for all
actors, would be the two types of
information mentioned above regarding
health care providers. First, in 45 CFR
171.1101(a)(1)(iii) and (b)(1)(iii), we
propose to post, a description of the
practice, as the term is defined in 45
CFR 171.102 and referenced in 45 CFR
171.103, found to have been information
blocking. In the case of a resolved CMP
liability, we would post the practice
alleged to be information blocking. This
information will help provide
transparency into how information
blocking conduct is impacting the
nationwide health information
technology infrastructure, and in
particular, specific practices that are
impacting the infrastructure. Second, in
45 CFR 171.1101(a)(1)(v) and (b)(1)(iv),
we propose to post where to find
additional information about the
determination (or resolution of CMP
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liability) of information blocking that is
publicly available via HHS or, where
applicable, another part of the U.S.
Government. This information could
include hyperlinks and other
information, to help interested persons
find any additional information about
the determination, settlement, penalty,
or disincentive that has been made
publicly available by the U.S.
Government. Such publicly available
information would include any
summaries or media releases that may
be posted by OIG, or another part of
HHS, on their internet website(s). It
could also include additional
information that may be made publicly
available about the determination by or
other parts of the U.S. Government. For
example, if an actor who has exhausted
applicable administrative appeal
procedures and brought action in a
Federal court for review of the decision
that has become final, we could post
information on our website about the
existence of the court action and where
or how to access information about the
determination, or resulting court action,
that has been made publicly available
by the court. This information would
provide additional context for how
information blocking conduct is
impacting the nationwide health
information technology infrastructure.
Publicly posting information about
actors that have been determined by
OIG to have committed information
blocking is important for providing
transparency into how and where
information blocking conduct is
occurring within and impacting the
broader nationwide health information
technology infrastructure. Between
April 5, 2021, and September 30, 2023,
we received over 800 claims of
information blocking through the Report
Information Blocking Portal.10 We have
publicly posted information about these
claims, which we update monthly.
Beyond posting the number of claims,
the posted information includes claim
counts by type of claimant and claim
counts by potential actor.11 While OIG
has not necessarily evaluated whether
these claims qualify as information
blocking, this information provides
transparency about how participants in
the nationwide health IT infrastructure
perceive actions by actors that are part
of the same infrastructure, which is
intended to support the access,
exchange, and use of EHI. A natural
progression of the posting of such
10 See
‘‘Information Blocking Claims: By the
Numbers,’’ https://www.healthit.gov/data/
quickstats/information-blocking-claims-numbers.
11 https://www.healthit.gov/data/quickstats/
information-blocking-claims-numbers.
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information is the posting of
information about actual information
blocking determinations by OIG,
including any settlements of liability,
civil money penalties, and
disincentives. This information can help
the public understand how the
information blocking regulations, which
seek to prevent and address practices
that unreasonably or unnecessarily
interfere with lawful access, exchange,
or use of EHI through the nationwide
health IT infrastructure, are being
enforced. It would also provide clarity
regarding how and where actors are
engaging in information blocking
practices within the nationwide health
IT infrastructure. Based on this
information, participants in the
nationwide health IT infrastructure and
the public can confirm or dispel
perceptions of information blocking
within that infrastructure. Additionally,
the combined transparency of the
processes Congress authorized and
instructed HHS to implement (i.e., ONC
implementing a claims reporting
process, as well as civil money penalties
and disincentives for applicable actors
found to have committed information
blocking by OIG) would foster public
confidence in the information blocking
enforcement framework and potentially
encourage public participation in that
framework, whether by submitting a
claim of information blocking or
participating in an OIG information
blocking investigation. We invite public
comments on these proposals, including
comments on whether we should
publicly post additional information
(and why) about health care providers,
health IT developers, or health
information networks/health
information exchanges that have been
determined by OIG to have committed
information blocking.
C. Appropriate Disincentives for Health
Care Providers
In this section (III.C.), we propose to
establish a set of disincentives for health
care providers that have committed
information blocking. These
disincentives would be imposed
following a referral of a determination of
information blocking by OIG. Each of
the proposed disincentives is being
established using authorities under
applicable Federal law, consistent with
PHSA section 3022(b)(2)(B).
1. Background
a. Impacted Health Care Providers
The disincentives proposed in this
section would apply to a subset of the
individuals and entities meeting the
information blocking regulations’
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definition of health care provider at 45
CFR 171.102. Specifically, the proposals
in this rule would provide disincentives
for health care providers (as defined in
45 CFR 171.102) that are also eligible to
participate in certain Federal programs:
the Medicare Promoting Interoperability
Program and the MIPS Promoting
Interoperability performance category
(previously the EHR Incentive
Programs); and the Medicare Shared
Savings Program.
We recognize that the disincentives
proposed in this rule would only apply
to certain health care providers and that
the information blocking regulations are
also applicable to health care providers
that are not eligible to participate in
these programs. However, this proposed
rule is a first step that focuses on
authorities which pertain to certain
health care providers that furnish a
broad array of health care services to
large numbers of Medicare beneficiaries
and other patients. We believe optimal
deterrence of information blocking calls
for imposing appropriate disincentives
on all health care providers (as defined
at 45 CFR 171.102) determined by OIG
to have committed information
blocking. In section IV. of this proposed
rule, we request public comment on
establishing disincentives, using
applicable Federal law, that could be
imposed on a broader range of health
care providers.
b. Impact of Disincentives
We believe the disincentives
proposed in this rule would deter
information blocking by health care
providers. However, we recognize that
the actual monetary impact resulting
from the application of the disincentives
proposed in this section may vary across
health care providers subject to the
disincentive.
For example, the disincentive
proposed in section III.C.3. of this
proposed rule for the MIPS Promoting
Interoperability performance category
would result in an adjustment to
payments under Medicare Part B to
MIPS eligible clinicians (as defined in
42 CFR 414.1305). This disincentive
would reduce to zero the Promoting
Interoperability performance category
score of any MIPS eligible clinician that
has been determined by OIG to have
committed information blocking (as
defined at 45 CFR 171.103) during the
calendar year (CY) of the referral of a
determination from OIG. However, the
actual financial impact experienced by
a health care provider as a result of this
proposed disincentive being applied in
MIPS would vary. For example, Part B
payments to the MIPS eligible clinician
are subject to a MIPS payment
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adjustment factor, which CMS
determines based on the MIPS eligible
clinician’s final score. In determining
each MIPS eligible clinician’s final
score, CMS takes into account the
assigned weight of, and the MIPS
eligible clinician’s performance in, the
four MIPS performance categories,
including the Promoting Interoperability
performance category. The MIPS eligible
clinician’s final score then determines
whether the eligible clinician earns a
negative, neutral, or positive payment
adjustment factor that will be applied to
the amounts otherwise paid to the MIPS
eligible clinician under Medicare Part B
for covered professional services during
the applicable MIPS payment year.
In the interest of addressing this
variability, we considered whether we
could propose an alternative approach
under which we would tailor the
monetary impact of a disincentive
imposed on a health care provider to the
severity of the conduct in which the
health care provider engaged. However,
we do not believe it would be feasible
to develop such an approach for the
disincentives we propose for health care
providers. Because disincentives must
be established using authorities under
applicable Federal law, the statute
under which a disincentive is being
established would need to specifically
authorize or provide sufficient
discretion for an appropriate agency to
be able to adjust the monetary impact of
the disincentive to fit the gravity or
severity of the information blocking the
health care provider has been
determined to have committed. Based
on our review of potential authorities
under which to establish disincentives,
we believe many authorities do not
provide discretion to adjust the
monetary impact of a potential
disincentive in this fashion. For
instance, in section III.C.2. of this
proposed rule, CMS proposes to
establish a disincentive through the
Medicare Promoting Interoperability
Program utilizing authority in SSA
section 1886. Under this authority,
CMS, as specified in section
1886(b)(3)(B)(ix)(I) of the SSA, adjusts
payments for eligible hospitals by a
fixed proportion, on the basis of
whether or not an eligible hospital (as
defined in section 1886(n)(6)(B) of the
SSA) is a meaningful EHR user.
2. Medicare Promoting Interoperability
Program for Eligible Hospitals and
Critical Access Hospitals (CAHs)
a. Background
We intend to use existing Medicare
Promoting Interoperability Program
authority concerning the meaningful use
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of certified EHR technology (CEHRT) to
impose disincentives on eligible
hospitals and CAHs that OIG determines
have committed information blocking
(defined in 45 CFR 171.103) where OIG
refers a determination that the eligible
hospital or CAH committed information
blocking. Under section 1886(n)(3)(A) of
the SSA, an eligible hospital or CAH 12
is treated as a meaningful EHR user for
the EHR reporting period for a payment
year if it demonstrates to the satisfaction
of the Secretary, and among other
requirements, that during the EHR
reporting period: (1) the eligible hospital
used CEHRT in a meaningful manner;
and (2) the CEHRT is connected in a
manner that provides, in accordance
with law and standards applicable to
the exchange of information, for the
electronic exchange of health
information. As discussed further in
section III.C.2.b. of this proposed rule,
these requirements for an eligible
hospital or CAH to be a meaningful EHR
user would be substantially undermined
and frustrated if the eligible hospital or
CAH commits information blocking,
such that application of an appropriate
disincentive is warranted.
Under section 1886(b)(3)(B)(ix) of the
SSA, if an eligible hospital does not
demonstrate that it has met the
requirements to be a meaningful EHR
user under section 1886(n)(3)(A), CMS
will reduce the eligible hospital’s
payment by three quarters of the
applicable percentage increase in the
market basket update or rate-of-increase
for hospitals. Under section 1814(l)(4) of
the SSA, if the Secretary determines that
a CAH has not been a meaningful EHR
user for a given EHR reporting period,
CMS will pay that CAH 100 percent of
its reasonable costs, instead of 101
percent of reasonable costs, which is the
amount that the CAH would have
received as a meaningful EHR user
under the Medicare Promoting
Interoperability Program.
HHS has authority to apply
disincentives to both eligible hospitals
and CAHs. PHSA section 3022(b)(2)(B)
authorizes HHS to apply disincentives
to health care providers OIG determines
have committed information blocking.
As discussed in section II.B.1 of this
proposed rule, HHS has adopted, for
purposes of the information blocking
regulations in 45 CFR part 171, the
definition of health care provider in
section 3000(3) of the PHSA, which
includes health care providers that are
eligible for participation in the Medicare
Promoting Interoperability Program. The
12 Section 1814(l)(3) of the SSA applies to critical
access hospitals the standard for determining a
meaningful EHR user in section 1886(n)(3).
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definition of ‘‘health care provider’’ in
section 3000(3) of the PHSA includes
‘‘hospital’’ as a health care provider.
Section 1886(n)(6)(B) of the SSA defines
the term ‘‘eligible hospital’’ for the
purposes of the Medicare Promoting
Interoperability Program (75 FR 44316
through 44317) as ‘‘a hospital that is a
subsection (d) hospital or a subsection
(d) Puerto Rico hospital.’’ Eligible
hospitals are located in one of the fifty
States or the District of Columbia (75 FR
44448). Hospitals in Puerto Rico became
eligible hospitals for the Medicare
Promoting Interoperability Program
with the passage of the Consolidated
Appropriations Act of 2016 (Pub. L.
114–113, Dec. 18, 2015). A CAH is
defined in section 1861(mm) of the SSA
as ‘‘a facility that has been certified as
a critical access hospital under section
1820(e).’’ ‘‘Hospital’’ is not further
defined under the PHSA definition in
section 3000(3). Therefore, CMS
interprets the term ‘‘hospital’’ in section
3000(3) of the PHSA to include both
eligible hospitals and CAHs that can
participate in the Medicare Promoting
Interoperability Program.
b. The Medicare Promoting
Interoperability Program as an
Appropriate Disincentive for
Information Blocking Under the PHSA
As discussed previously, the
requirements under SSA section
1886(n)(3)(A) that an eligible hospital or
CAH must meet to a be meaningful EHR
user, particularly the first two
requirements under SSA section
1886(n)(3)(A)(i) and (ii), would be
substantially undermined and frustrated
if the eligible hospital or CAH commits
information blocking, such that
application of an appropriate
disincentive is warranted. To be
considered a meaningful EHR user
under section 1886(n)(3)(A) of the SSA,
an eligible hospital or CAH must, in
brief: (1) demonstrate to the satisfaction
of the Secretary the use of CEHRT in a
meaningful manner, (2) demonstrate to
the satisfaction of the Secretary that
their CEHRT is connected in a manner
that provides for electronic exchange of
health information to improve the
quality of health care, and (3) use
CEHRT to submit information
concerning quality measures and other
measures as specified. With respect to
the electronic exchange of health
information requirement in SSA section
1886(n)(3)(A)(ii), an eligible hospital or
CAH must demonstrate to the
satisfaction of the Secretary that its
CEHRT is ‘‘connected in a manner that
provides, in accordance with law and
standards applicable to the exchange of
information, for the electronic exchange
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of health information to improve the
quality of health care, such as
promoting care coordination, and . . .
demonstrates . . . that the hospital has
not knowingly and willfully taken
action (such as to disable functionality)
to limit or restrict the compatibility or
interoperability of the certified EHR
technology.’’ Two examples of the CMS
requirements for health information
exchange include the requirement for
eligible hospitals and CAHs to report on
the Health Information Exchange
Objective and the Provider to Patient
Exchange Objective, both of which are
part of the requirements for
demonstrating the meaningful use of
CEHRT, in accordance with SSA section
1886(n)(3).
By establishing a disincentive for
information blocking under the
Medicare Promoting Interoperability
Program, we are using an authority
under applicable Federal law as
required in section 3022(b)(2)(B) of the
PHSA. Health care providers OIG
determines have committed information
blocking, and for which OIG refers its
determination to CMS, would be subject
to a disincentive under applicable law
as they are participating in the Medicare
Promoting Interoperability Program
authorized by that applicable law. In
addition, the Medicare Promoting
Interoperability Program already
requires eligible hospitals and CAHs to
engage in practices that encourage the
access, exchange, and use of electronic
health information to avoid a downward
payment adjustment. The requirements
an eligible hospital or CAH must meet
to be treated as a meaningful EHR user
in section 1886(n)(3)(A)(i) and (ii) of the
SSA specify that an eligible hospital or
CAH must demonstrate that it meets
these requirements ‘‘to the satisfaction
of the Secretary.’’ CMS believes these
provisions authorize the Secretary to
interpret these requirements through
rulemaking as necessary to ensure that
an eligible hospital or CAH satisfies the
requirements to be a meaningful EHR
user as defined by the Secretary.
Specifically, CMS believes it is
appropriate for the Secretary to interpret
these requirements through rulemaking
to determine that an eligible hospital or
CAH that has committed information
blocking, and for which OIG refers its
determination of information blocking
to CMS, has not met the definition of a
meaningful EHR user. This proposal is
consistent with the goals of the
Medicare Promoting Interoperability
Program, which include the
advancement of CEHRT utilization,
focusing on interoperability and data
sharing (81 FR 79837). Information
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blocking by eligible hospitals and CAHs
would frustrate both these goals.
CMS also believes the proposed
disincentive under the Medicare
Promoting Interoperability Program
would be an appropriate disincentive
that would similarly deter information
blocking by other eligible hospitals and
CAHs, consistent with the discussion in
section III.A.3. of this proposed rule.
While the exact monetary impact of the
disincentive would vary based on the
specific eligible hospital, CMS believes
a reduction of three quarters of the
annual market basket update would
deter eligible hospitals from engaging in
information blocking because it would
reduce the inpatient prospective
payment system (IPPS) payment that an
eligible hospital could have earned had
it met other requirements under the
Medicare Promoting Interoperability
Program. Similarly, though the exact
dollar amount would vary based on the
specific CAH, CMS believes that
receiving 100 percent of reasonable
costs instead of the 101 percent of
reasonable costs that a CAH may have
earned for successful participation in
the Medicare Promoting Interoperability
Program would deter information
blocking by CAHs because it would
reduce the reimbursement a CAH could
have received had it met other
requirements under the Medicare
Promoting Interoperability Program.
HHS analyzed the range of potential
disincentive amounts an eligible
hospital could be subject to if the
proposed disincentive was imposed, in
order to illustrate the degree to which
this disincentive could deter eligible
hospitals from engaging in information
blocking. We used payment data for
IPPS eligible hospitals from the CMS
Medicare Inpatient Hospitals dataset for
2021, the latest year of publicly
available data.13 We considered the
Medicare total payment amounts for
each hospital, which consist of several
variables, including Base, Medicare
Severity Diagnosis Related Groups (MS–
DRG), and adjustments such as Indirect
Medical Education (IME)/Graduate
Medical Education (GME),
disproportionate share hospital (DSH),
and outlier payments. We attempted to
estimate the portion of hospitals’ total
payments subject to the market basket
increase by excluding adjustments not
subject to the increase, using data from
CMS Hospital Cost Reports to subtract
out DSH and IME/GME payments,
which account for a large portion of
13 Available at https://data.cms.gov/providersummary-by-type-of-service/medicare-inpatienthospitals/medicare-inpatient-hospitals-by-provider.
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these adjustments.14 Since we did not
account for other adjustments such as
outlier payments, the remaining
payment amount may overestimate the
payment subject to the market basket
increase.
We then conducted a simulation that
applied the proposed disincentive
amount to a market basket adjustment
factor. We simulated a hypothetical
scenario of a 3.2 percent market basket
increase and a reduction of three
quarters of that percentage increase if
the proposed information blocking
disincentive were applied.15 Under this
scenario, a hospital that lost three
quarters of the market basket increase
due to the proposed information
blocking disincentive would be left with
a 0.8 percent market basket increase.
Based on this calculation, we estimated
a median disincentive amount of
$394,353, and a 95 percent range of
$30,406 to $2,430,766 across eligible
hospitals. The value of the reduction in
the market basket increase would be
larger in dollar terms for hospitals with
greater base IPPS payments.
c. Proposals
CMS is proposing to revise the
definition of ‘‘Meaningful EHR User’’ in
42 CFR 495.4 to state that an eligible
hospital or CAH is not a meaningful
EHR user in a calendar year if OIG refers
a determination that the eligible
hospital or CAH committed information
blocking, as defined at 45 CFR 171.103,
during the calendar year of the EHR
reporting period. As a result of the
proposal, CMS would apply a
downward payment adjustment under
the Medicare Promoting Interoperability
Program to any such eligible hospital or
CAH because the eligible hospital or
CAH would not be a meaningful EHR
user, as required under SSA sections
1886(b)(3)(B)(ix) and 1814(l)(4). For
eligible hospitals, CMS would apply the
downward adjustment to the payment
adjustment year that occurs 2 years after
the calendar year when the OIG referral
occurs. For CAHs, CMS would apply the
downward adjustment to the payment
adjustment year that is the same as the
calendar year when the OIG referral
occurs.
As a result of these proposals, an
eligible hospital or CAH that otherwise
fulfilled the required objectives and
measures to demonstrate that it is a
meaningful EHR user for an EHR
14 Available
at https://www.cms.gov/researchstatistics-data-and-systems/downloadable-publicuse-files/cost-reports.
15 The hypothetical 3.2 percent market basket
increase used in this simulation was based on the
2023 Medicare Trustees Report, which assumes a
3.2 percent annual market basket increase.
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reporting period would nevertheless not
be a meaningful EHR user for that EHR
reporting period if OIG refers a
determination of information blocking
to CMS during the calendar year in
which the EHR reporting period falls.
CMS considered applying this proposed
disincentive based on the date that the
eligible hospital or CAH committed the
information blocking as determined by
OIG, instead of the date OIG refers its
determination to CMS. However, a
significant period of time could pass
between the date when the eligible
hospital or CAH is determined to have
committed information blocking, and
the date when OIG makes a referral to
CMS, due to the time required for OIG
to fully investigate a claim of
information blocking. Such delay
between the date the information
blocking occurred and OIG’s referral
could complicate the application of the
disincentive and would likely
necessitate reprocessing of a significant
number of claims. Therefore, CMS
proposes to use the date of the OIG
referral instead of the date of the
information blocking occurrence to
apply the proposed disincentive.
Accordingly, CMS would apply the
proposed disincentive to the payment
adjustment year associated with the
calendar year in which the OIG referred
its determination to CMS.
CMS further notes that if an eligible
hospital or CAH received the applicable
downward payment adjustment because
CMS had already determined the
eligible hospital or CAH had otherwise
not been a meaningful EHR user during
the applicable EHR reporting period due
to its performance in the Medicare
Promoting Interoperability Program,
imposition of the proposed disincentive
would result in no additional impact on
the eligible hospital or CAH during that
payment adjustment year. Finally, CMS
clarifies that, even if multiple
information blocking violations were
identified as part of OIG’s determination
(including over multiple years) and
referred to CMS, each referral of an
information blocking determination by
OIG would only affect an eligible
hospital’s or CAH’s status as a
meaningful EHR user in a single EHR
reporting period during the calendar
year when the determination of
information blocking was referred by
OIG. Unless OIG makes an additional
referral of an information blocking
determination in the subsequent
calendar year, an eligible hospital or
CAH would again be able to qualify as
a meaningful EHR user starting in the
subsequent EHR reporting period.
CMS invites public comment on these
proposals, particularly on its approach
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74957
to the application of a disincentive for
OIG determinations that found that
information blocking occurred in
multiple years and whether there
should be multiple disincentives for
such instances (for example,
disincentives in multiple calendar
years/reporting periods compared to
only the calendar year/reporting period
in which OIG made the referral).
d. Notification and Application of the
Disincentive
After OIG has determined that a
health care provider has committed
information blocking and referred that
health care provider to CMS, CMS
would notify the eligible hospital or
CAH that OIG determined that the
eligible hospital or CAH committed
information blocking as defined under
45 CFR 171.103, and thus the eligible
hospital or CAH was not a meaningful
EHR user for the EHR reporting period
in the calendar year when OIG referred
its information blocking determination
to CMS. This notice would be issued in
accordance with the notice
requirements proposed at 45 CFR
171.1002, as discussed in section III.B.2
of this proposed rule.
As a result of our proposal to modify
the definition of meaningful EHR user
in 42 CFR 495.4, the application of the
disincentive would result in a
downward payment adjustment for
eligible hospitals 2 years after the OIG
referral of a determination of
information blocking to CMS. Based
upon the existing regulation at 42 CFR
495.4, the downward payment
adjustment would apply 2 years after
the year of the referral and the EHR
reporting period in which the eligible
hospital was not a meaningful EHR user.
For CAHs, the downward payment
adjustment would apply to the payment
adjustment year in which the OIG
referral was made.
CMS invites public comment on these
proposals.
3. Promoting Interoperability
Performance Category of the Medicare
Merit-Based Incentive Payment System
(MIPS)
a. Background
MIPS requires that MIPS eligible
clinicians use CEHRT, as defined at SSA
section 1848(o)(4) and 42 CFR
414.1305,16 in a meaningful manner, in
16 For MIPS, SSA section 1848(o)(4) defines
CEHRT as a qualified electronic health record (as
defined in PHSA section 3000(13)) that is certified
by ONC pursuant to PHSA section 3001(c)(5) as
meeting standards adopted under PHSA section
3004 that are applicable to the type of record
involved, as determined by the Secretary. CMS has
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accordance with SSA sections
1848(q)(2)(A)(iv) and (B)(iv) and
1848(o)(2) and 42 CFR 414.1375, to earn
a score for the MIPS Promoting
Interoperability performance category.
We intend to use this existing authority,
requiring the meaningful use of CEHRT,
to impose disincentives on MIPS
eligible clinicians that OIG determines
to have committed information blocking
as defined at 45 CFR 171.103.
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(1) MIPS Overview—Scoring and
Payment Calculations
Authorized by the Medicare Access
and CHIP Reauthorization Act of 2015
(MACRA) (Pub. L. 114–10, April 16,
2015), the Quality Payment Program is
a payment incentive program, by which
the Medicare program rewards MIPS
eligible clinicians who provide highvalue, high-quality services in a costefficient manner. The Quality Payment
Program includes two participation
tracks for clinicians providing services
under the Medicare program: MIPS and
Advanced Alternative Payment Models
(APMs). The statutory requirements for
MIPS are set forth in SSA sections
1848(q) and (r).
For the MIPS participation track,
MIPS eligible clinicians are subject to a
MIPS payment adjustment (positive,
negative, or neutral) based on their
performance in four performance
categories (cost, quality, improvement
activities, and Promoting
Interoperability) compared to the
established performance threshold for
that performance period/MIPS payment
year. CMS assesses each MIPS eligible
clinician’s total performance according
to established performance standards
with respect to the applicable measures
and activities specified in each of these
four performance categories during a
performance period to compute a final
composite performance score (a ‘‘final
score’’ as defined at 42 CFR 414.1305)
in accordance with our policies set forth
in 42 CFR 414.1380.
In calculating the final score, CMS
must apply different weights for the four
performance categories, subject to
certain exceptions, as set forth in SSA
section 1848(q)(5) and at 42 CFR
414.1380. Unless CMS assigns a
different scoring weight pursuant to
these exceptions, for the CY 2024
performance period/2026 MIPS
payment year, the scoring weights are as
follows: 30 percent for the quality
performance category; 30 percent for the
cost performance category; 15 percent
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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for the improvement activities
performance category; and 25 percent
for the Promoting Interoperability
performance category (SSA section
1848(q)(5)(E); 42 CFR 414.1380(c)(1)).
To calculate the payment adjustment
factor that will be applied to the
amounts otherwise paid to MIPS eligible
clinicians under Medicare Part B for
covered professional services during the
applicable MIPS payment year, CMS
then compares the final score to the
performance threshold CMS has
established for that performance period/
MIPS payment year at 42 CFR
414.1405(b). The MIPS payment
adjustment factors specified for a year
must result in differential payments
such that MIPS eligible clinicians with
final scores above the performance
threshold receive a positive MIPS
payment adjustment factor, those with
final scores at the performance
threshold receive a neutral MIPS
payment adjustment factor, and those
with final scores below the performance
threshold receive a negative MIPS
payment adjustment factor. As further
specified in SSA section 1848(q)(6)(F)
and 42 CFR 414.1405, CMS also applies
a scaling factor to determine the MIPS
payment adjustment factor for each
MIPS eligible clinician, and CMS must
ensure that the estimated aggregate
increases and decreases in payments to
all MIPS eligible clinicians as a result of
MIPS payment adjustment factors are
budget neutral for that MIPS payment
year. As provided in SSA sections
1848(q)(6)(A) and (B)(iv) and 42 CFR
414.1405(c), the positive MIPS payment
adjustment factor may be up to 9
percent for a final score of 100 and the
negative MIPS payment adjustment
factor may be up to negative 9 percent
for a final score of zero.
(2) MIPS Promoting Interoperability
Performance Category
For MIPS eligible clinicians, SSA
section 1848(q)(2)(A)(iv) includes the
meaningful use of CEHRT as one of the
four performance categories by which a
MIPS eligible clinician is assessed to
determine a MIPS payment adjustment
factor, as discussed previously. CMS
refers to this performance category as
the Promoting Interoperability
performance category. SSA section
1848(q)(2)(B)(iv) provides that the
requirements set forth in SSA section
1848(o)(2) for determining whether a
MIPS eligible clinician is a meaningful
user of CEHRT also apply to our
assessment of MIPS eligible clinicians’
performance on measures and activities
with respect to the MIPS Promoting
Interoperability performance category.
Also, SSA section 1848(o)(2)(D)
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generally provides that the requirements
for being a meaningful EHR user under
section 1848(o)(2) continue to apply for
purposes of MIPS.
A MIPS eligible clinician that is not
a meaningful user of CEHRT in
accordance with SSA section
1848(o)(2)(A) cannot satisfy the
requirements of the MIPS Promoting
Interoperability performance category
and, therefore, would earn a score of
zero for this performance category.
Applying the weights for the
performance categories under 42 CFR
414.1380(c)(1), a score of zero for the
Promoting Interoperability performance
category would mean that the maximum
final score a MIPS eligible clinician
could achieve, if they performed
perfectly in the three remaining
performance categories, would be 75
points.
To be a meaningful EHR user under
SSA section 1848(o)(2)(A) (and therefore
meet the requirements of the MIPS
Promoting Interoperability performance
category under SSA section
1848(q)(2)(B)(iv)), a MIPS eligible
clinician must meet three requirements
related to the meaningful use of CEHRT
during a performance period for a MIPS
payment year. In brief, the MIPS eligible
clinician must (1) demonstrate to the
satisfaction of the Secretary the use of
CEHRT in a meaningful manner; (2)
demonstrate to the satisfaction of the
Secretary that their CEHRT is connected
in a manner that provides for electronic
exchange of health information to
improve the quality of care; and (3) use
CEHRT to submit information
concerning quality measures and other
measures as specified.
More specifically, for the first
requirement under SSA section
1848(o)(2)(A)(i), a MIPS eligible
clinician must demonstrate, to the
satisfaction of the Secretary, that during
the relevant performance period, the
MIPS eligible clinician is ‘‘using
certified EHR technology in a
meaningful manner.’’ For the second
requirement under SSA section
1848(o)(2)(A)(ii), a MIPS eligible
clinician must demonstrate, to the
satisfaction of the Secretary, that during
the relevant period CEHRT is
‘‘connected in a manner that provides,
in accordance with law and standards
applicable to the exchange of
information, for the electronic exchange
of health information to improve the
quality of care, such as promoting care
coordination’’ and the MIPS eligible
clinician demonstrates, through ‘‘a
process specified by the Secretary, such
as the use of an attestation’’ that the
MIPS eligible clinician ‘‘has not
knowingly and willfully taken action
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(such as to disable functionality) to limit
or restrict the compatibility or
interoperability of the certified EHR
technology.’’ For the third requirement
under SSA section 1848(o)(2)(A)(iii), a
MIPS eligible clinician currently must
submit information via their CEHRT on
‘‘such clinical quality measures and
such other measures as selected by the
Secretary’’ in ‘‘a form and manner
specified by the Secretary,’’ including
measures focused on providing patients
with electronic access to their electronic
health information, sending electronic
health information to other health care
providers, and receiving and
incorporating electronic health
information from other health care
providers.
As discussed further in section
III.C.3.b. of this proposed rule, these
three requirements for a MIPS eligible
clinician to be determined to be a
meaningful user of CEHRT, particularly
the first two requirements under SSA
section 1848(o)(2)(A)(i) and (ii), would
be substantially undermined and
frustrated if the MIPS eligible clinician
commits information blocking, such that
application of an appropriate
disincentive is warranted.
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b. The MIPS Promoting Interoperability
Performance Category Requirements as
an Appropriate Disincentive for
Information Blocking Under the PHSA
As discussed previously, we believe
that the requirements set forth in SSA
sections 1848(q)(2)(B)(iv) and
1848(o)(2)(A) for the MIPS Promoting
Interoperability performance category
are an applicable Federal law for the
purposes of establishing a disincentive
for a health care provider that
participates in MIPS and has been
determined by OIG to have committed
information blocking. First, the
definitions of MIPS eligible clinician
and health care provider under 45 CFR
171.102 and the PHSA generally are
aligned. Second, committing
information blocking not only violates
the law and principles set forth in the
Cures Act, but also undermines the
goals and purpose of the MIPS
Promoting Interoperability performance
category. On such basis, CMS is
proposing an appropriate disincentive
for MIPS eligible clinicians that OIG
determines have committed information
blocking and for whom OIG refers its
determination of information blocking
to CMS, as discussed further in section
III.C.3.c. of this proposed rule.
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(1) Alignment of Definitions of MIPS
Eligible Clinician and Health Care
Provider Under the PHSA
CMS believes that the definitions of
MIPS eligible clinician under the SSA
and 42 CFR 414.1305 and health care
provider under PHSA section 3000(3)
and 45 CFR 171.102 generally are
aligned. CMS believes this alignment
will permit application of appropriate
disincentives, as required by PHSA
section 3022(b)(2)(B), to MIPS eligible
clinicians, except for qualified
audiologists. CMS proposes to codify
this exception in the definition of
Meaningful EHR User for MIPS at 42
CFR 414.1305.
Beginning with the 2024 MIPS
payment year, a MIPS eligible clinician
is defined in 42 CFR 414.1305 as
including: (1) a physician (as defined in
SSA section 1861(r)); (2) a physician
assistant, nurse practitioner, and
clinical nurse specialist (as defined in
SSA 1861(aa)(5)); (3) a certified
registered nurse anesthetist (defined in
SSA section 1861(bb)(2)); (4) a physical
therapist or occupational therapist; (5) a
qualified speech-language pathologist;
(6) a qualified audiologist (as defined in
SSA section 1861(ll)(4)(B)); (7) a clinical
psychologist (as defined by the
Secretary for purposes of SSA section
1861(ii)); (8) a registered dietician or
nutrition professional; (9) a clinical
social worker (as defined in SSA section
1861(hh)(1)); (10) a certified nurse
midwife (as defined in SSA section
1861(gg)(2)); and (11) a group, identified
by a unique single taxpayer
identification number (TIN), with two or
more eligible clinicians, one of which
must be a MIPS eligible clinician,
identified by their individual national
provider identifier (NPI) and who have
reassigned their billing rights to the
single group TIN. However, for a given
performance period/MIPS payment
year, a MIPS eligible clinician does not
include an eligible clinician who meets
one of the exclusions set forth in 42 CFR
414.1310(b), including being a
Qualifying APM participant, Partial
Qualifying APM Participant that does
not elect to participate in MIPS, or does
not exceed the low volume threshold (as
these terms are defined in 42 CFR
414.1305).
Meanwhile, the definition of ‘‘health
care provider’’ under PHSA section
3000(3) as implemented in 45 CFR
171.102, includes the following which
are also considered MIPS eligible
clinicians: (1) a ‘‘group practice’’ (which
is not defined in the PHSA); (2) a
physician (as defined in SSA section
1861(r)); (3) practitioners, as defined in
SSA section 1842(b)(18)(C) to include:
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(a) a physician assistant, nurse
practitioner, and clinical nurse
specialist (as defined in SSA
1861(aa)(5)); (b) a certified registered
nurse anesthetist (defined in SSA
section 1861(bb)(2)); (c) a certified
nurse-midwife (as defined in SSA
section 1861(gg)(2)); (d) a clinical social
worker (as defined in SSA section
1861(hh)(1)); (e) a clinical psychologist
(as defined by the Secretary for
purposes of SSA section 1861(ii)); and
(f) a registered dietician or nutrition
professional; (4) therapists, as defined in
SSA section 1848(k)(3)(B)(iii) to
include: (a) a physical therapist; (b) an
occupational therapist; and (c) a
qualified speech-language pathologist;
and (5) ‘‘any other category of health
care facility, entity, practitioner, or
clinician determined appropriate by the
Secretary.’’
CMS notes that, at this time, only a
qualified audiologist, included in the
definition of MIPS eligible clinician in
42 CFR 414.1305 since the CY 2019
performance period/2021 MIPS
payment year, is not identified as a
health care provider under 45 CFR
171.102 and PHSA section 3000(3).
Because qualified audiologists are not
included in the PHSA definition of
health care provider, CMS proposes that
MIPS eligible clinicians who are
qualified audiologists would not be
subject to the disincentive proposed for
the MIPS Promoting Interoperability
performance category in this proposed
rule.
As discussed previously in this
section (III.C.3.b.(1)), groups and
multispecialty groups (as defined in 42
CFR 414.1305) also are included in the
definition of MIPS eligible clinician and
therefore are subject to payment
adjustments under MIPS based on the
performance of MIPS eligible clinicians
that are included in these groups, under
different sets of regulations in 42 CFR
part 414, subpart O. Meanwhile, as
discussed previously, the definition of
health care provider in PHSA section
3000(3) includes ‘‘group practice,’’ but
does not define what this term means.
Accordingly, CMS also believes that a
group may be subject to the disincentive
proposed for the MIPS Promoting
Interoperability performance category in
this proposed rule if the group has been
determined by OIG to have committed
information blocking, or if MIPS eligible
clinicians included in the group have
committed information blocking.
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(2) Information Blocking Conduct
Undermines the Goals and Purpose of
the MIPS Promoting Interoperability
Performance Category
Health care providers that engage in
information blocking undermine and
frustrate the purpose for requiring MIPS
eligible clinicians to use CEHRT in a
meaningful manner. Specifically,
requiring MIPS eligible clinicians to use
CEHRT is not limited to MIPS eligible
clinicians adopting and implementing
CEHRT for documenting clinical care in
lieu of paper-based medical records. For
use of CEHRT to be meaningful, SSA
section 1848(o)(2)(A) requires that MIPS
eligible clinicians use CEHRT to
communicate with other treating
providers, pharmacies, and oversight
authorities regarding the patient’s health
information, including the MIPS eligible
clinician’s review and treatment of the
patient’s health. SSA sections
1848(o)(2)(A)(i) and (ii) require that
MIPS eligible clinicians demonstrate
that they are meaningfully using
CEHRT’s key functionalities, such as
electronically prescribing, and ensuring
that CEHRT is ‘‘connected in a manner
that provides, in accordance with law
and standards applicable to the
exchange of information, for the
electronic exchange of health
information to improve the quality of
health care,’’ such as ‘‘promoting care
coordination.’’ SSA section
1848(o)(2)(A)(ii) further requires that the
MIPS eligible clinician demonstrate that
they have not ‘‘knowingly and willfully
taken action (such as to disable
functionality) to limit or restrict the
compatibility or interoperability’’ of
CEHRT, which is similar to the directive
to investigate and discourage
information blocking under PHSA
section 3022. Establishing an
appropriate disincentive for information
blocking under the MIPS Promoting
Interoperability performance category
would not only deter information
blocking, but would strengthen an
existing merit-based incentive payment
system that already encourages health
care providers to support the access,
exchange, and use of electronic health
information.
Furthermore, the requirements to be
treated as a meaningful EHR user in
SSA sections 1848(o)(2)(A)(i) and (ii)
specify that a MIPS eligible clinician
must demonstrate that they meet these
requirements to the satisfaction of the
Secretary. CMS believes these
provisions authorize the Secretary to
interpret these requirements through
rulemaking as necessary to ensure that
a MIPS eligible clinician satisfies the
requirements to be a meaningful user of
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CEHRT as defined by the Secretary.
Specifically, CMS believes it is
appropriate for the Secretary to interpret
these requirements through rulemaking
to determine that a MIPS eligible
clinician that has committed
information blocking is not a
meaningful EHR user. This proposal is
consistent with the goals of the MIPS
Promoting Interoperability performance
category, which include promoting
health care efficiency and encouraging
widespread health information
exchange (81 FR 77200 through 77202).
Information blocking by MIPS eligible
clinicians frustrates both these goals.
CMS believes a disincentive for
information blocking associated with
the MIPS Promoting Interoperability
performance category would be an
appropriate disincentive that would
deter information blocking by other
MIPS eligible clinicians, consistent with
the discussion in section III.A.3. of this
proposed rule. While the exact
monetary impact of the disincentive
may vary for each MIPS eligible
clinician based on the various factors
CMS considers when determining the
MIPS payment adjustment factor, CMS
believes the proposed disincentive
would deter information blocking by
other MIPS eligible clinicians. A MIPS
eligible clinician who receives a score of
zero in the MIPS Promoting
Interoperability performance category
under this proposed disincentive may
not be able to earn a positive or neutral
MIPS payment adjustment factor that
they otherwise would have earned for
their performance in MIPS.
To illustrate the degree to which this
disincentive could deter information
blocking, HHS analyzed the range of
potential disincentive amounts MIPS
eligible clinicians could be subject to if
the proposed disincentive was imposed,
using actual payment and MIPS data
from 2021, the most recent year of
publicly available data. The three data
sets used were the Medicare Fee-ForService Provider Utilization & Payment
Data—Physician and Other Practitioners
Dataset; the Clinician Public Reporting:
Overall MIPS Performance Dataset and
the Quality Payment Program
Experience Dataset.17 18 19 The Medicare
Fee-For-Service Provider Utilization file
contains actual payments to clinicians
17 Provider Utilization and Payment Data
available at https://catalog.data.gov/dataset/
medicare-physician-other-practitioners-by-providerb297e.
18 Overall MIPS Performance Dataset available at
https://data.cms.gov/provider-data/dataset/a174a962.
19 Quality Payment Program Experience Dataset
available at https://data.cms.gov/quality-of-care/
quality-payment-program-experience/data.
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under Medicare Part B. We simulated
disincentive amounts for all eligible
clinicians on an individual basis by
applying zero points for the Promoting
Interoperability performance category
portion of the MIPS score and using the
MIPS scoring policies from the CY 2021
performance year. We estimated
potential disincentive amounts for
groups by multiplying estimated perclinical disincentive amounts by the
number of eligible clinicians in
estimated group sizes.
We first assessed the overall payment
to eligible clinicians as well as the
portion of the payment that was based
on a positive or negative adjustment
based on their MIPS score. We then
varied the MIPS score based on lower
scores on the Promoting Interoperability
performance category portion,
determined the change in positive or
negative adjustment amount, and
recalculated the payment under
Medicare Part B. The difference between
the actual 2021 payment and the
simulated payment under the lower
score represents the disincentive
amount calculated in the simulation for
individual eligible clinicians. We
estimated a median individual
disincentive amount of $686 and a 95
percent range (the 2.5th to 97.5th
percentile of estimated disincentive
amounts) of $38 to $7,184 across all
eligible clinicians (including those who
may have been in a group). Based on the
median estimated disincentive amount
of $686 and estimated median group
size of six clinicians, we estimated a
group disincentive of $4,116 and a range
of $1,372 to $165,326 for group sizes
ranging from two to 241 clinicians (the
estimated 2.5th to 97.5th percentile of
group sizes). In consideration of MIPS
eligible clinicians that may be subject to
higher-than-median disincentives, we
also simulated estimates for a mediansized group of six clinicians and an
estimated 75th percentile per-clinician
disincentive amount of $1,798. Based on
this, we estimated a disincentive of
$10,788. We noted that the ranges of
potential group disincentive amounts
vary based on individual clinician
payments and group sizes.
c. Proposals
Under the authority in SSA sections
1848(o)(2)(A) and (D), and
1848(q)(2)(A)(iv) and (B)(iv), for the
MIPS Promoting Interoperability
performance category, CMS proposes
that a MIPS eligible clinician would not
be a meaningful EHR user in a
performance period if OIG refers a
determination that the MIPS eligible
clinician committed information
blocking (as defined at 45 CFR 171.103)
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at any time during the calendar year of
the performance period.20 CMS also
proposes that the determination by OIG
that the MIPS eligible clinician
committed information blocking would
result in a MIPS eligible clinician that
is required to report on the MIPS
Promoting Interoperability performance
category not earning a score in the
performance category (a zero score),
which is typically a quarter of the total
final score. CMS proposes to codify this
proposal under the definition of
meaningful EHR user for MIPS at 42
CFR 414.1305 and amend the
requirements for earning a score for the
MIPS Promoting Interoperability
performance category at 42 CFR
414.1375(b).
CMS considered applying this
proposed disincentive based on the date
that the MIPS eligible clinician
committed the information blocking as
determined by OIG, instead of the date
OIG refers its determination to CMS.
However, a significant period of time
could pass between the date when the
MIPS eligible clinician is determined to
have committed information blocking,
and the date when OIG makes a referral
to CMS, due to the time required for
OIG to fully investigate a claim of
information blocking. Such delay
between the date the information
blocking allegedly occurred and OIG’s
referral could complicate our
application of the disincentive and
would likely necessitate reprocessing of
a significant number of claims.
Therefore, CMS decided to use the date
of the OIG referral instead of the date of
the information blocking occurrence to
apply this proposed disincentive.
Accordingly, CMS would apply the
proposed disincentive to the MIPS
payment year associated with the
calendar year in which OIG referred its
determination to CMS.
As provided in 42 CFR 414.1320, the
applicable MIPS payment year is 2
calendar years after the performance
period. This time period between the
20 As provided in 42 CFR 414.1320(h), for
purposes of the 2024 MIPS payment year and each
subsequent MIPS payment year, the performance
period for the MIPS Promoting Interoperability
performance category is a minimum of a continuous
90-day period within the calendar year that occurs
2 years prior to the applicable MIPS payment year,
up to and including the full calendar year. In 42
CFR 414.1305, CMS has defined the ‘‘MIPS
payment year’’ as the calendar year in which the
MIPS payment adjustment factor is applied to
Medicare Part B payments. In the CY 2024
Physician Fee Schedule proposed rule, CMS
proposed that, beginning with the 2026 MIPS
payment year, the performance period for the MIPS
Promoting Interoperability performance category is
a minimum of a continuous 180-day period within
the calendar year that occurs 2 years prior to the
applicable MIPS payment year, up to and including
the full calendar year (88 FR 52578 through 52579).
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performance period and the MIPS
payment year permits CMS to review
each MIPS eligible clinician’s
performance to determine their final
score and MIPS payment adjustment
factor. Under our proposal, if OIG
referred its determination that a MIPS
eligible clinician committed information
blocking in calendar year 2025, then
CMS would apply the disincentive
proposed herein for the 2027 MIPS
payment year.
First, CMS proposes to amend the
definition of ‘‘meaningful EHR user for
MIPS’’ at 42 CFR 414.1305. The current
definition of meaningful EHR user for
MIPS definition states that a
‘‘meaningful EHR user for MIPS means
a MIPS eligible clinician who possesses
CEHRT, uses the functionality of
CEHRT, reports on applicable objectives
and measures specified for the
Promoting Interoperability performance
category for a performance period in the
form and manner specified by CMS,
does not knowingly and willfully take
action (such as to disable functionality)
to limit or restrict the compatibility or
interoperability of CEHRT, and engages
in activities related to supporting
providers with the performance of
CEHRT.’’ CMS proposes to add to this
definition that a MIPS eligible clinician
is not a meaningful EHR user in a
performance period if OIG refers a
determination that the clinician
committed information blocking (as
defined at 45 CFR 171.103) during the
calendar year of the performance period.
CMS also proposes other minor
technical changes to the language of the
definition. In tandem with other
proposals in this section, this proposed
amendment to the definition in 42 CFR
414.1305 would result in a MIPS
eligible clinician not being able to earn
points associated with the Promoting
Interoperability performance category
they may otherwise have earned,
potentially resulting in a negative or
neutral payment adjustment. As such,
this potential outcome likely would
deter health care providers from
engaging in information blocking.
Second, CMS proposes to amend our
requirements for earning a score for the
MIPS Promoting Interoperability
performance category by adding a new
requirement at 42 CFR 414.1375(b).
Currently, 42 CFR 414.1375(b) provides
that, to earn a score (other than zero) for
the Promoting Interoperability
performance category, the MIPS eligible
clinician must meet certain
requirements, including using CEHRT,
reporting on the objectives and
associated measures as specified by
CMS, and attesting to certain statements
and activities. CMS proposes to amend
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42 CFR 414.1375(b) by adding that the
MIPS eligible clinician must be a
meaningful EHR user for MIPS as
defined at 42 CFR 414.1305. In
conjunction with our proposal to amend
the definition of a meaningful EHR user
for MIPS at 42 CFR 414.1305 discussed
previously, CMS believes this proposal
would establish a clear basis to apply a
score of zero for the MIPS Promoting
Interoperability performance category to
a MIPS eligible clinician that fails to
meet the definition of meaningful EHR
user for MIPS during a performance
period, specifically if OIG refers a
determination of information blocking
during the calendar year of the
performance period.
Under these proposals, a MIPS
eligible clinician that OIG determines
has committed information blocking
would not be a meaningful EHR user,
and therefore would be unable to earn
a score (instead, earning a score of zero)
for the MIPS Promoting Interoperability
performance category. Because a MIPS
eligible clinician that has committed
information blocking would not be a
meaningful EHR user for a given
performance period, they would earn a
zero for the Promoting Interoperability
performance category for the calendar
year of the applicable performance
period in which the determination of
information blocking was referred by
OIG. For example, if OIG refers a
determination that a MIPS eligible
clinician committed information
blocking to CMS in CY 2026, CMS
would apply a score of zero for the
Promoting Interoperability performance
category for the CY 2028 MIPS payment
year to the MIPS eligible clinician.
Under this proposed disincentive for
information blocking, a score of zero for
the MIPS Promoting Interoperability
performance category would negatively
impact 25 percent of the MIPS eligible
clinician’s final score such that it would
likely result in a negative MIPS payment
adjustment for the applicable MIPS
payment year. For example, applying
the weights for the performance
categories under 42 CFR 414.1380(c)(1),
a score of zero for the Promoting
Interoperability performance category
would mean that the maximum final
score a MIPS eligible clinician could
achieve, if they performed perfectly in
the three remaining performance
categories, would be 75 points.
Then, as discussed previously, to
determine the MIPS payment
adjustment factor, CMS compares the
MIPS eligible clinician’s final score to
the established performance threshold
for that MIPS payment year. In 42 CFR
414.1405(b)(9)(ii), CMS established that
the performance threshold for the 2025
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MIPS payment year is 75 points. If,
under this example, a MIPS eligible
clinician still achieved 75 points for
their final score for the 2025 MIPS
payment year matching the established
performance threshold of 75 points,
then they would receive a neutral MIPS
payment adjustment factor.
However, in the CY 2024 Physician
Fee Schedule proposed rule, CMS
proposed that the performance
threshold for the 2026 MIPS payment
year would be 82 points (88 FR 52596
through 52601). If this performance
threshold of 82 points is finalized for
the 2026 MIPS payment year, or some
other performance threshold higher than
75 points is finalized in a future MIPS
payment year, then, under our example,
a MIPS eligible clinician (that OIG
determined committed information
blocking and received a score of zero in
the Promoting Interoperability
performance category and therefore a
final score of 75 points) would receive
a negative MIPS payment adjustment
factor. If CMS finalizes a performance
threshold higher than 75 points in a
future MIPS payment year, this
proposed disincentive would likely to
result in a MIPS eligible clinician that
commits information blocking, as
determined by OIG, receiving a negative
payment adjustment, up to negative
nine percent for a final score of zero as
set forth in 42 CFR 414.1405(b)(2) and
(c).
Under this proposal, a MIPS eligible
clinician that otherwise fulfilled other
requirements to demonstrate meaningful
use for a performance period, and
earned a score for the Promoting
Interoperability performance category,
would nevertheless not be a meaningful
EHR user for that performance period if
OIG refers a determination of
information blocking during the
calendar year of the performance period.
CMS further notes that if a MIPS eligible
clinician earned a score of zero for the
Promoting Interoperability performance
category for a given year because CMS
had already determined the MIPS
eligible clinician had otherwise not
been a meaningful EHR user in that
performance period due to its
performance in the Promoting
Interoperability performance category,
imposition of the proposed disincentive
would result in no additional impact on
the MIPS eligible clinician during that
MIPS payment year.
CMS clarifies that, even if multiple
information blocking violations were
identified as part of OIG’s determination
(including over multiple years) and
referred to CMS, each referral of an
information blocking determination by
OIG would only affect a MIPS eligible
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clinician’s status as a meaningful EHR
user in a single performance period
during the calendar year when the
determination of information blocking
was referred by OIG. Barring an
additional referral of an information
blocking determination by OIG in the
subsequent calendar year, a MIPS
eligible clinician could be deemed a
meaningful EHR user and earn a score
for the Promoting Interoperability
performance category in the following
calendar year.
CMS invites public comment on these
proposals. CMS particularly requests
comment on its approach to the
application of a disincentive for OIG
determinations that found that
information blocking occurred in
multiple years and whether there
should be multiple disincentives for
such instances (for example,
disincentives in multiple calendar
years/performance periods compared to
only one disincentive in the calendar
year in which a referral from OIG is
made).
(1) Groups and Virtual Groups
CMS also proposes that if data for the
MIPS Promoting Interoperability
performance category is submitted as a
group or virtual group then the
application of the disincentive would be
made at that level. CMS refers readers
to our prior rulemaking governing
groups and virtual groups (81 FR 77073
through 77077) and our regulations at
42 CFR 414.1305 (defining MIPS eligible
clinicians as including groups as well as
separately defining groups and virtual
groups) and 414.1315 (governing virtual
groups). MIPS eligible clinicians who
submit data as a part of a group or
virtual group and individually will be
evaluated as an individual and as a
group for all performance categories.
Beginning with the CY 2021
performance period/2023 MIPS
payment year, if a TIN/NPI has a virtual
group final score associated with it, we
will use the virtual group final score to
determine the MIPS payment
adjustment; if a TIN/NPI does not have
a virtual group final score associated
with it, we will use the highest available
final score associated with the TIN/NPI
to determine the MIPS payment
adjustment (85 FR 84917 through
84919). CMS would apply the MIPS
payment adjustment factor to the
Medicare Part B claims during the MIPS
payment year for the MIPS eligible
clinicians in the group or virtual group.
Thus, if CMS is calculating a final score
and MIPS payment adjustment factor for
a group or virtual group and OIG refers
a finding of information blocking to
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CMS, CMS would apply the proposed
disincentive to the whole group.
(2) Reweighting Policies
CMS has established policies that
result in the reweighting of the
Promoting Interoperability performance
category for certain MIPS eligible
clinicians at 42 CFR 414.1380(c)(2).
These include but are not limited to
hospital-based clinicians (81 FR 77238
through 77420, 82 FR 53684, and 82 FR
53686 through 53687) and Ambulatory
Surgical Center-based clinicians (82 FR
53684). CMS is not proposing changes
to its existing reweighting policies for
MIPS eligible clinicians.
Starting with the CY 2022
performance period/2024 MIPS
payment year performance period CMS
automatically reweights small practices
for the Promoting Interoperability
performance category (86 FR 65485
through 65487; 42 CFR
414.1380(c)(2)(i)(C)(9)). CMS is not
proposing changes to our existing policy
for MIPS eligible clinicians in small
practices.
CMS notes that if these MIPS eligible
clinicians choose to submit data for the
Promoting Interoperability performance
category, their reweighting is canceled,
and they could be subject to a
disincentive if OIG refers a
determination of information blocking
to CMS.
d. Notification of the Disincentive
After OIG has determined that a
health care provider has committed
information blocking and referred that
health care provider to CMS, CMS
would notify the MIPS eligible clinician
that OIG determined that the eligible
clinician committed information
blocking as defined under 45 CFR
171.103, and thus the MIPS eligible
clinician was not a meaningful EHR
user for the performance period in the
calendar year when OIG referred its
information blocking determination to
CMS. CMS would apply the proposed
disincentive to the MIPS payment year
associated with the calendar year in
which the OIG referred its
determination to CMS. This notice
would be issued in accordance with the
notice requirements for disincentives
proposed in 45 CFR 171.1002 (see also
section III.B.2. of this proposed rule).
CMS invites public comment on this
proposal.
4. Medicare Shared Savings Program
a. Background
(1) Statutory Authority for Disincentive
Section 3022 of the Patient Protection
and Affordable Care Act (PPACA) (Pub.
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L. 111–148, Mar. 23, 2010) added
section 1899 to the Social Security Act
(SSA) (42 U.S.C. 1395jjj), which
established the Medicare Shared
Savings Program (Shared Savings
Program). In accordance with the
statute, groups of providers of services
and suppliers (referred to herein as
‘‘ACO participants’’) and their
associated health care providers
(referred to herein as ‘‘ACO providers/
suppliers’’) meeting criteria specified by
the Secretary may work together to
manage and coordinate care for
Medicare fee-for-service beneficiaries
through an ACO. ACOs that meet
quality performance standards
established by the Secretary are eligible
to receive payments for shared savings
the ACO generates for Medicare and to
avoid sharing losses at the maximum
level. One condition of participation
required by the statute is for the ACO
to define certain processes, including a
mandate to ‘‘define processes to
promote evidence-based medicine and
patient engagement, report on quality
and cost measures, and coordinate care,
such as through the use of telehealth,
remote patient monitoring, and other
such enabling technologies’’ (Social
Security Act section 1899(b)(2)(G)).
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(2) Shared Savings Program Regulations
The Shared Savings Program
regulations at 42 CFR part 425 set forth,
among other things, requirements for
ACO eligibility, quality reporting, and
other program requirements and
beneficiary protections.21 The
regulations at 42 CFR 425.116 require
that an ACO, as a condition of
participation in the Shared Savings
Program, must effectuate an agreement
with its ACO participants and ACO
providers/suppliers (as defined at 42
CFR 425.20). This agreement must
expressly require the ACO participant to
agree, and to ensure that each ACO
provider/supplier billing through the
TIN of the ACO participant agrees, to
participate in the Shared Savings
Program and to comply with the
requirements of the Shared Savings
Program and all other applicable
Federal laws and regulations including,
but not limited to: (1) Federal criminal
law; (2) The False Claims Act (31 U.S.C.
3729 et seq.); (3) The anti-kickback
statute (42 U.S.C. 1320a–7b(b)); (4) The
civil monetary penalties law (42 U.S.C.
21 Shared Savings Program regulations generally
specify standards for an ACO, which is bound by
its participation agreement to the standards. CMS
generally specifies standards applicable to an ACO
participant and ACO provider/supplier that is
participating in the ACO through its regulation of
the ACO.
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1320a–7a); and (5) The physician selfreferral law (42 U.S.C. 1395nn).
CMS has interpreted the requirement
at section 1899(b)(1)(G) of the SSA that
an ACO coordinates care for assigned
beneficiaries using enabling
technologies to require an ACO (and, by
agreement, an ACO participant and
ACO provider/supplier) to, among other
things, define its methods and processes
established to coordinate care across
and among health care providers both
inside and outside the ACO and have a
written plan to ‘‘encourage and promote
use of enabling technologies for
improving care coordination for
beneficiaries’’ (42 CFR 425.112(b)(4)(i)
and (b)(4)(ii)(C)). Enabling technologies
may include one or more of the
following: electronic health records and
other health IT tools; telehealth services,
including remote patient monitoring;
electronic exchange of health
information; and other electronic tools
to engage beneficiaries in their care. The
ACO must ensure that ACO participants
and ACO providers/suppliers comply
with and implement the defined care
coordination process, including the
encouragement and promotion of
enabling technologies, and the remedial
processes and penalties (including the
potential for expulsion) applicable to
ACO participants and ACO providers/
suppliers for failure to comply with and
implement the required process (see 42
CFR 425.112(a)(3)). Sharing health
information using enabling technologies
across all health care providers engaged
in a beneficiary’s care (both inside and
outside the ACO) for purposes of care
coordination and quality improvement
is an essential aspect of the ACO’s
activities. Moreover, this type of
information sharing among health care
providers (both inside and outside the
ACO) supports quality measurement
and quality reporting activities, which
are necessary in order for the ACO to be
eligible to share in savings and are also
used in determining the amount of
shared losses.
Before the start of an agreement
period, before each performance year
thereafter, and at such other times as
specified by CMS, the ACO must submit
to CMS an ACO participant list and an
ACO provider/supplier list (see 42 CFR
425.118(a)). The ACO must certify the
submitted lists annually. All Medicareenrolled 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
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submits the ACO participant list and the
ACO provider/supplier list.
CMS may deny an ACO, ACO
participant, and/or an ACO provider/
supplier participation in the Shared
Savings Program if the entity or
individual has a history of program
integrity issues (see 42 CFR
425.305(a)(2)). CMS screens ACOs, ACO
participants, and ACO providers/
suppliers during the Shared Savings
Program application process and
periodically thereafter (for example,
during the annual certification of the
ACO participant and ACO provider/
supplier lists) with regard to their
program integrity history (including any
history of Medicare program exclusions
or other sanctions and affiliations with
individuals or entities that have a
history of program integrity issues) (see
42 CFR 425.305(a)(1)). In the Medicare
Shared Savings Program Final Rule (76
FR 67802), CMS stated that the results
of the screening would need to be
considered in light of the relevant facts
and circumstances. CMS did not draw a
bright line regarding when an entity’s
history of program integrity issues
justifies denial of a Shared Savings
Program participation agreement. CMS
stated instead that we would likely
consider the nature of the applicant’s
program integrity issues (including the
program integrity history of affiliated
individuals and entities), the available
evidence, the entity’s diligence in
identifying and correcting the problem,
and other factors. CMS stated that we
intended to ensure that ACOs, ACO
participants, and ACO providers/
suppliers would not pose a risk of fraud
or abuse within the Shared Savings
Program while recognizing that some
program integrity allegations may not
have been fully adjudicated.
CMS may terminate the participation
agreement with an ACO when the ACO,
its ACO participants, or its ACO
providers/suppliers or other individuals
or entities performing functions or
services related to ACO activities fail to
comply with any of the requirements of
the Shared Savings Program under 42
CFR part 425 (§ 425.218(a) and (b)). This
includes, but is not limited to,
violations of the physician self-referral
prohibition, CMP law, Federal antikickback 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
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imposition of a corrective action plan,
denial of incentive payments, and
termination of the ACO participant
agreement, to address noncompliance
with the requirements of the Shared
Savings Program and other program
integrity issues, including program
integrity issues identified by CMS (42
CFR 425.116(a)(7)). Taken together,
these regulations ensure that CMS may
take appropriate enforcement actions
when CMS’ screening process or
oversight of ACOs reveals a history of
program integrity issues or when an
ACO, an ACO participant or ACO
provider/suppliers and other
individuals or entities performing
functions or services related to ACO
activities fail to comply with the
requirements of the Shared Savings
Program, including failure to comply
with other Federal laws that are relevant
to the ACO’s operations, such as the
Cures Act’s information blocking
provision (PHSA section 3022).
b. Proposals
CMS proposes to revise the Shared
Savings Program regulations to establish
disincentives for health care providers,
including ACOs, ACO participants, or
ACO providers/suppliers, that engage in
information blocking. Under this
proposal, a health care provider that
OIG determines has committed
information blocking may not
participate in the Shared Savings
Program for a period of at least 1 year.
Information blocking runs contrary to
the care coordination goals of the
Shared Savings Program. ACO
participants and their ACO providers/
suppliers participating in an ACO in the
Shared Savings Program use enabling
technologies (such as electronic health
records) to improve care coordination
for beneficiaries. The ability of ACO
providers/suppliers to exchange
information between health care
providers (both inside and outside the
ACO) is essential for the operations of
the ACO, including for effective
coordination of care and quality
improvement activities and services for
assigned beneficiaries.
First, CMS proposes to amend 42 CFR
425.208(b) to include a specific
reference to the Cures Act information
blocking provision codified in the
PHSA. The provision would be one of
many laws with which ACOs (and by
agreement, their ACO participants and
ACO providers/suppliers) must
comply.22 In this case, compliance is
22 CMS notes that the list of laws included at 42
CFR 425.208(b) with which an ACO must comply
is not an exclusive list. ACOs, ACO participants,
and ACO providers/suppliers must continue to
comply with all applicable Federal laws.
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required because a Medicare enrolled
‘‘health care provider,’’ to which an
information blocking disincentive may
apply, includes ACO providers/
suppliers (See 42 CFR 400.202 and
425.20 and 45 CFR 171.102). The effect
of adding a specific reference to the
information blocking provision would
be to require that, as a condition of
participation in the Shared Savings
Program, an ACO must specifically
agree (and must require its ACO
participants, ACO providers/suppliers,
and other individuals or entities
performing functions or services related
to the ACO’s activities to agree) to not
commit information blocking as defined
in PHSA section 3022(a).
Second, CMS proposes to revise 42
CFR 425.305(a)(1) to specify that the
program integrity history on which
ACOs, ACO participants, and ACO
providers/suppliers are reviewed during
the Shared Savings Program application
process and periodically thereafter
includes, but is not limited to, a history
of Medicare program exclusions or other
sanctions, noncompliance with the
requirements of the Shared Savings
Program, or violations of laws specified
at 42 CFR 425.208(b). This revision
would provide the basis for CMS to
deny participation in the Shared
Savings Program to a health care
provider that is an ACO, an ACO
participant, or an ACO provider/
supplier when the health care provider
has engaged in information blocking, as
determined by OIG.
Third, CMS proposes to make a
conforming modification to the
provision related to the grounds for
CMS to terminate an ACO at 42 CFR
425.218(b)(3) based on ‘‘[v]iolations of
the physician self-referral prohibition,
civil monetary penalties (CMP) law,
Federal anti-kickback statute, antitrust
laws, or any other applicable Medicare
laws, rules, or regulations that are
relevant to ACO operations.’’ CMS
proposes to replace this language with
‘‘[v]iolations of any applicable laws,
rules, or regulations that are relevant to
ACO operations, including, but not
limited to, the laws specified at
§ 425.208(b).’’
Pursuant to CMS’ authority under 42
CFR 425.206(a)(1)(iii) to deny an ACO’s
participation in the Shared Savings
Program, CMS’ authority under 42 CFR
425.118(b)(1)(iii) to deny the addition of
a health care provider to an ACO’s
participation list, and CMS’ authority
under 42 CFR 425.305(a) to screen for
program integrity issues, CMS proposes
to screen ACOs, ACO participants, and
ACO providers/suppliers for an OIG
determination of information blocking
and deny the addition of such a health
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care provider to an ACO’s participation
list for the period of at least 1 year. In
the case of an ACO that is a health care
provider, CMS proposes to deny the
ACO’s application to participate in the
Shared Savings Program for the period
of at least 1 year. If the ACO were to reapply to participate in the Shared
Savings Program in a subsequent year,
then CMS would review whether OIG
had made any subsequent
determinations of information blocking
with respect to the ACO as a health care
provider as well as any evidence that
indicated whether the issue had been
corrected and appropriate safeguards
had been put in place to prevent its
reoccurrence, as part of the ACO’s
application process. CMS therefore
proposes that, in cases where the result
of the program integrity screening
identifies that an ACO (acting as a
health care provider), ACO participant,
or ACO provider/supplier, has
committed information blocking, as
determined by OIG, CMS would take the
following actions, as applicable:
• Pursuant to 42 CFR
425.118(b)(1)(iii), CMS would deny the
request of the ACO to add an ACO
participant to its ACO participant list on
the basis of the results of the program
integrity screening under 42 CFR
425.305(a).
• Pursuant to 42 CFR 425.116(a)(7)
and (b)(7), CMS would notify an ACO
currently participating in the Shared
Savings Program if one of its ACO
participants or ACO providers/suppliers
is determined by OIG to have committed
information blocking so that the ACO
can take remedial action—removing the
ACO participant from the ACO
participant list or the ACO provider/
supplier from the ACO provider/
supplier list—as required by the ACO
participant agreement.
• Pursuant to 42 CFR 425.305(a)(2),
CMS would deny an ACO’s Shared
Savings Program application if the
results of a program integrity screening
under 42 CFR 425.305(a)(1) reveal a
history of program integrity issues or
other sanctions and affiliations with
individuals or entities that have a
history of program integrity issues.
• Pursuant to 42 CFR 425.218(a) and
(b)(3), CMS would terminate an ACO
participation agreement in the case of a
failure to comply with requirements of
the Shared Savings Program, including
violations of any applicable laws, rules,
or regulations that are relevant to ACO
operations, including, but not limited
to, the laws specified at 42 CFR
425.208(b).
Each of these actions would deter
information blocking consistent with
the discussion of an appropriate
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disincentive in section III.A.3. of this
proposed rule. Restricting the ability for
these entities to participate in the
Shared Savings Program for at least 1
year would result in these health care
providers potentially not receiving
revenue that they might otherwise have
earned if they had participated in the
Shared Savings Program.
The period of time of the disincentive
would be at least 1 performance year.
CMS would determine if it would be
appropriate for the period to exceed 1
year if OIG has made any subsequent
determinations of information blocking
(for example, CMS would be unlikely
impose a disincentive greater than 1
year if the information blocking
occurred in the past and there was
evidence that the information blocking
had stopped) and whether safeguards
have been put in place to prevent the
information blocking that was the
subject of OIG’s determination. Prior to
imposing any disincentive arising from
an OIG determination of information
blocking, CMS would provide a notice
in accordance with the notice
requirements proposed in 45 CFR
171.1002 (see section III.B.2 of this
proposed rule) that would specify the
disincentive would be imposed for at
least 1 performance year.
CMS proposes to apply the
disincentive no sooner than the first
performance year after we receive a
referral of an information blocking
determination from OIG and in which
the health care provider is to participate
in the Shared Savings Program. CMS
performs a program integrity screening
of ACOs, ACO participants, and ACO
providers/suppliers as part of the
annual application/change request
process for new and existing ACOs,
which typically occurs between May
and October during the performance
year. In the case of the new addition of
an ACO participant (TIN) to an ACO’s
participant list, CMS would prevent the
TIN from joining the ACO as an ACO
participant if the program integrity
screening reveals that the TIN has
engaged in information blocking, as
determined by OIG. In the case of an
existing ACO participant, CMS would
notify the ACO that an ACO participant
or an ACO provider/supplier had
committed information blocking, as
determined by OIG, so the ACO can
remove the ACO participant or ACO
provider/supplier from its ACO
participant list or ACO provider/
supplier list, as applicable. If the TIN
were to remain on the ACO participant
list or ACO provider/supplier list when
the ACO certifies its ACO participant
list for the next performance year, then
CMS would issue a compliance action
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to the ACO. Continued noncompliance
(for example, failure to remove the TIN)
would result in termination of the
ACO’s participant agreement with CMS,
as the ACO would have failed to enforce
the terms of its ACO participant
agreement.
Applying the disincentive
prospectively is the most appropriate
timing for the disincentive. It would be
impractical and inequitable for CMS to
apply the disincentive retrospectively or
in the same year in which CMS received
a referral from OIG. Applying the
disincentive to a historical performance
year or a performance year
contemporaneous to the OIG’s
determination would unfairly affect
other ACO participants that did not
commit the information blocking and
likely were not aware of the information
blocking. CMS recognizes, however, that
the prospective application of the
disincentive means that it may be
applied to a health care provider
substantially after the information
blocking occurred, during the provider’s
first attempt to participate in the Shared
Savings Program, and after the provider
was previously subject to a disincentive
in another program, such as MIPS. As
discussed in more detail below, CMS is
contemplating an approach under
which a health care provider could
participate in the Shared Savings
Program if a significant amount of time
(for example, 3 to 5 years) had passed
between the occurrence of the
information blocking and OIG’s
determination, and the provider had
given assurances in the form and
manner specified by CMS that the issue
had been corrected and appropriate
safeguards had been put in place to
prevent its reoccurrence.
After the completion of the last
performance year in which the
disincentive was applied, an ACO may
submit a change request to add the TIN
or include the NPI on its ACO
participant list or ACO provider/
supplier list, as applicable, for a
subsequent performance year, and CMS
would approve the addition, assuming
that all other Shared Savings Program
requirements for adding a TIN or NPI
are met, so long as (1) OIG has not made
any additional determinations of
information blocking, and (2) the ACO
provides assurances (in the form and
manner required by CMS) that the
information blocking is no longer
ongoing and that the ACO has put
safeguards in place to prevent the
information blocking that was the
subject of the referral. If, however, OIG
made and referred an additional
information blocking determination
(that is either related or unrelated to the
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previous OIG referral) in a subsequent
year or the ACO cannot provide
assurance that the information blocking
has ceased, then CMS would continue
to deny participation.
In addition, CMS would notify ACOs
about an ACO participant or ACO
provider/supplier that had committed
information blocking, as determined by
OIG, so that the ACO could take
remedial action—removing the ACO
participant from the ACO participant
list or the ACO provider/supplier from
the ACO provider/supplier list—as
required by the ACO participant
agreement. ACOs are well-positioned to
take remedial action against ACO
participants and ACO providers/
suppliers that have been found by OIG
to have committed information blocking
as a result of their ACO participant
agreements, which provide for the ACO
to take remedial action against the ACO
participant, and require the ACO
participant to take remedial action
against its ACO providers/suppliers,
including imposition of a corrective
action plan, denial of incentive
payments, and termination of the ACO
participant agreement, to address
noncompliance with the requirements
of the Shared Savings Program and
other program integrity issues.
By way of example, consider if in
January 2025 OIG determined that an
ACO participant has committed
information blocking as recently as 2024
and referred this determination to CMS.
Under CMS’ proposal, the ACO
participant would be able to remain on
the ACO’s certified participant list for
the duration of the 2025 performance
year. However, CMS would notify the
ACO that an ACO participant had been
determined to have committed
information blocking by OIG and that
CMS expected the ACO to take remedial
action by removing the ACO participant
from its ACO participant list for a
specified period of time. To determine
if removal was warranted for a period in
addition to performance year 2026, CMS
would consider whether there was any
evidence to suggest that that
information blocking was still occurring
(for example, whether OIG had made a
subsequent determination of
information blocking) and whether
safeguards had been put in place to
prevent the information blocking that
was the subject of the referral. Upon a
review of these criteria, CMS may
require the affected ACO to remove the
ACO participant prior to recertification
of the ACO participant list for
additional performance years. If the
ACO participant were to remain when
the ACO certifies its ACO participant
list for performance year 2026, CMS
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would inform the ACO that it was
obligated to take remedial action against
the ACO participant by removing it from
the ACO participant list for performance
year 2026; if it failed to do so, CMS
would remove the ACO participant from
the ACO’s participant list and take
compliance action against the ACO up
to terminating the ACO pursuant to 42
CFR 425.218(b)(1) and (3). In the case of
a disincentive that was applied only for
performance year 2026, if the ACO were
to submit a change request to add the
ACO participant for performance year
2027 or a subsequent year, then CMS
would review whether OIG had made
any subsequent determinations of
information blocking with respect to the
ACO participant as well as any evidence
that indicated whether the issue had
been corrected and appropriate
safeguards had been put in place to
prevent its reoccurrence, prior to
approving the ACO participant to
participate in the ACO for performance
year 2027 or the subsequent year.
If an ACO applicant or a renewal ACO
applicant that is itself a health care
provider (for example, a large multispecialty practice that forms a single
participant ACO using its existing legal
entity and governing body under 42 CFR
425.104) is the subject of an OIG
information blocking determination,
CMS would deny the ACO’s application
for participation in the Shared Savings
Program for the upcoming performance
year for which it was applying to
participate. Should OIG make a
determination of information blocking
with respect to an ACO that is already
participating in the Shared Savings
Program and refer the determination to
us for the application of a disincentive,
CMS may terminate the ACO’s
participation agreement for the
upcoming performance year. CMS
would assess a subsequent application
from an ACO to which the disincentive
had been applied under the same
criteria described for assessing the
return of an ACO participant or ACO
provider/supplier. The ACO may
participate in the Shared Savings
Program after the duration of the
disincentive so long as OIG had not
made a subsequent determination of
information blocking applicable to the
health care provider and whether there
was evidence that the issue had been
corrected and appropriate safeguards
had been put in place to prevent its
reoccurrence, prior to approving the
ACO’s application to participate in the
Shared Savings Program in a subsequent
performance year.
The Shared Savings Program is
considering an alternative policy in
which CMS would not apply a
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disincentive in certain circumstances
despite an OIG information blocking
determination. Under this alternative
policy, the Shared Savings Program
would consider OIG’s referral of an
information blocking determination in
light of the relevant facts and
circumstances before denying the
addition of an ACO participant to an
ACO participant list (or an ACO
provider/supplier to the ACO provider/
supplier list), informing an ACO that
remedial action should be taken against
the ACO participant (or ACO provider/
supplier), or denying an ACO’s
application to participate in the Shared
Savings Program. The relevant facts and
circumstances could include the nature
of the health care provider’s information
blocking, the health care provider’s
diligence in identifying and correcting
the problem, the time since the
information blocking occurred, the time
since the OIG’s determination of
information blocking, and other factors.
This alternative policy would offer some
flexibility in certain circumstances,
where prohibiting an ACO, ACO
participant, or ACO provider/supplier
from participating in the Shared Savings
Program would distort participation
incentives and therefore be less
appropriate. We are particularly
concerned about situations in which
many years have passed since an ACO
participant or ACO provider/supplier
was found to be an information blocker
and such an issue had long been
remediated. In such a case, the ACO
participant or ACO provider/supplier
might be incentivized to apply to the
Shared Savings Program for a year in
which it did not actually intend to
participate merely to avoid being barred
from doing so at a future date when it
did intend to participate, wasting the
resources of the ACO and CMS. Such an
alternative policy could allow a health
care provider to participate in the
Shared Savings Program if a significant
amount of time had passed between the
occurrence of the information blocking
and the OIG’s determination, and the
provider had given assurances in the
form and manner specified by CMS that
the issue had been corrected and
appropriate safeguards had been put in
place to prevent its reoccurrence.
An ACO may be able to appeal the
application of an information blocking
disincentive in the Shared Savings
Program. An ACO may appeal an initial
determination that is not prohibited
from administrative or judicial review
under 42 CFR 425.800 by requesting a
reconsideration review by a CMS
reconsideration official (42 CFR
425.802(a)). To the extent it is not
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barred by 42 CFR 425.800, an ACO may
appeal the removal or denial of a health
care provider from an ACO participant
list as a result of the referral by OIG of
an ACO participant that OIG had
determined to be an information
blocker. Subject to the same limitation,
an ACO applicant or ACO may appeal
the denial of the ACO applicant’s
application or termination of the ACO’s
participation agreement as a result of
the referral by OIG of the ACO applicant
or ACO that the OIG had determined to
be an information blocker. The
underlying information blocking
determination made by OIG, however
would not be subject to the Shared
Savings Program’s reconsideration
process. The OIG determination is not
an initial determination made by CMS,
but a determination made by another
agency. The Shared Savings Program
reconsideration process may not negate,
diminish, or otherwise alter the
applicability of determinations made by
other government agencies (see 42 CFR
425.808(b)).
We remind all health care providers
and ACOs that it is possible that a
health care provider or any entity, such
as an ACO, may meet the definition of
a health information network or health
information exchange, which is a
functional definition, or the definition
of a health IT developer of certified
health IT, codified in 45 CFR 171.102.
If it is found by OIG that such health
care provider or entity meets either
definition and, while under the same set
of facts and circumstances, is also found
by OIG to have committed information
blocking, then the health care provider
or entity would be subject to a different
intent standard and civil money
penalties administered by OIG (see
generally 88 FR 42820; see 88 FR 42828
through 42829).
We invite public comment on these
proposals and on whether additional
actions should be taken.
IV. Request for Information
As discussed in section III.C.1. of this
proposed rule, we recognize that the
disincentives we propose would only
apply to a subset of health care
providers as defined in 45 CFR 171.102.
However, we believe it is important for
HHS to establish appropriate
disincentives that would apply to all
health care providers, as such providers
are defined in 45 CFR 171.102. This
would ensure that any health care
provider, as defined in 45 CFR 171.102,
that has engaged in information
blocking would be subject to
appropriate disincentives by an
appropriate agency, consistent with the
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disincentives provision at PHSA section
3022(b)(2)(B).
We request information from the
public on additional appropriate
disincentives that we should consider in
future rulemaking, particularly
disincentives that would apply to health
care providers, as defined in 45 CFR
171.102, that are not implicated by the
disincentives proposed in this rule. We
encourage commenters to identify
specific health care providers (for
example, laboratories, pharmacies, postacute care providers, etc.) and
associated potential disincentives using
authorities under applicable Federal
law. We also request information about
the health care providers that HHS
should prioritize when establishing
additional disincentives.
V. Collection of Information
Requirements
This document does not impose any
new information collection
requirements, that is, reporting,
recordkeeping or third-party disclosure
requirements. Consequently, there is no
need for review by the Office of
Management and Budget under the
authority of the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.).
ddrumheller on DSK120RN23PROD with PROPOSALS1
VI. Regulatory Impact Statement
We have examined the impacts of this
proposed rule as required by Executive
Order 12866 on Regulatory Planning
and Review (September 30, 1993),
Executive Order 13563 on Improving
Regulation and Regulatory Review
(January 18, 2011), Executive Order
14094 entitled ‘‘Modernizing Regulatory
Review’’ (April 6, 2023), the Regulatory
Flexibility Act (RFA) (Pub. L. 96–354,
September 19, 1980), section 1102(b) of
the Social Security Act, section 202 of
the Unfunded Mandates Reform Act of
1995 (March 22, 1995; Pub. L. 104–4),
and Executive Order 13132 on
Federalism (August 4, 1999).
A. Executive Order 12866
Executive Order 12866, as amended
by Executive Order 14094 published on
April 6, 2023, directs agencies to assess
all costs and benefits of available
regulatory alternatives and, if
regulations are necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, and public
health and safety effects; distributive
impacts; and equity). A regulatory
impact analysis must be prepared for
major rules with significant effects (for
example, $200 million or more in any
given year). This is not a major rule as
defined at 5 U.S.C. 804(2); it is not
significant under section 3(f)(1) because
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it does not reach that economic
threshold, nor does it meet the other
criteria outlined in the Executive order.
This proposed rule would implement
provisions of the Cures Act through
changes to 45 CFR part 171 and 42 CFR
parts 414, 425, and 495. We believe that
the likely aggregate economic effect of
these regulations would be significantly
less than $200 million.
The expected benefits of this
proposed rule would be to deter
information blocking that interferes
with effective health information
exchange and negatively impacts many
important aspects of healthcare. We
refer readers to the impact analysis of
the benefits of prohibiting and deterring
information blocking in the ONC Cures
Act Final Rule, which encompasses all
anticipated benefits without
differentiation among actors (85 FR
25936).
We anticipate that OIG would incur
some costs associated with investigation
as authorized by the Cures Act. The
Consolidated Appropriations Act, 2022
appropriates to OIG funding necessary
for carrying out information blocking
activities (Pub. L. 117–103, March 15,
2022). Additionally, investigated parties
may incur some costs in response to an
OIG investigation or in response to the
application of a disincentive by an
agency with the authority to impose a
disincentive. Absent information about
the frequency of prohibited practices,
including the number of OIG
determinations of information blocking
in a given year that could be referred to
an appropriate agency, we are unable to
determine the potential costs of this
regulation.
The monetary value of the
disincentives proposed in this rule, if
imposed on a health care provider by an
appropriate agency, would be
considered transfers. We are unable to
reliably estimate the aggregate value of
potential disincentive amounts because
the value of the disincentive may vary
based on other provisions specific to the
authority under which the disincentive
has been established, as discussed in
section III.C.1. of this proposed rule. For
instance, the value of a disincentive
imposed on an eligible hospital under
the disincentive proposed in section
III.C.2. of this proposed rule would
depend on the amount of IPPS payment
received by the eligible hospital.
We invite public comment on
potential impacts of the rulemaking.
B. Regulatory Flexibility Act
The RFA and the Small Business
Regulatory Enforcement and Fairness
Act of 1996, which amended the RFA,
require agencies to analyze options for
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74967
regulatory relief of small businesses. For
purposes of the RFA, small entities
include small businesses, nonprofit
organizations, and Government
agencies.
The Department considers a rule to
have a significant impact on a
substantial number of small entities if it
has an impact of more than 3 percent of
revenue for more than 5 percent of
affected small entities. This proposed
rule would not have a significant impact
on the operations of a substantial
number of small entities, as these
changes would not impose any new
requirement on any party. We have
concluded that this proposed rule likely
would not have a significant impact on
a substantial number of small entities
and that a regulatory flexibility analysis
is not required for this rulemaking.
Additionally, the Secretary proposes to
certify that this proposed rule would not
have a significant impact on a
substantial number of small entities.
In addition, section 1102(b) the SSA
(42 U.S.C. 1302) requires us to prepare
a regulatory impact analysis if a rule
under Titles XVIII or XIX or section B
of Title XI of the SSA may have a
significant impact the operations of a
substantial number of small rural
hospitals. We have concluded that this
proposed rule would not have a
significant impact on the operations of
a substantial number of small rural
hospitals because these changes would
not impose any requirement on any
party. Therefore, a regulatory impact
analysis under section 1102(b) of the
SSA is not required for this rulemaking.
Therefore, the Secretary has certified
that this proposed rule will not have a
significant impact on the operations of
a substantial number of small rural
hospitals.
C. Unfunded Mandates Reform Act
Section 202 of the Unfunded
Mandates Reform Act of 1995, Public
Law 104–4, requires that agencies assess
anticipated costs and benefits before
issuing any rule that may result in
expenditures in any 1 year by State,
local, or Tribal governments, in the
aggregate, or by the private sector, of
$100 million, adjusted annually for
inflation. There are no significant costs
associated with these proposals that
would impose mandates on State, local,
or Tribal governments or the private
sector resulting in an expenditure of
$177 million in 2023 (after adjustment
for inflation) or more in any given year.
A full analysis under the Unfunded
Mandates Reform Act is not necessary.
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D. Executive Order 13132
42 CFR Chapter IV
§ 425.208 Provisions of participation
agreement.
Executive Order 13132, Federalism,
establishes certain requirements that an
agency must meet when it promulgates
a rule that imposes substantial direct
requirements or costs on State and local
governments, preempts State law, or
otherwise has federalism implications.
In reviewing this rule under the
threshold criteria of Executive Order
13132, we have determined that this
proposed rule would not significantly
affect the rights, roles, and
responsibilities of State or local
governments. Nothing in this proposed
rule imposes substantial direct
requirements or costs on State and local
governments, preempts State law, or
otherwise has federalism implications.
We are not aware of any State laws or
regulations that are contradicted or
impeded by any of the provisions in this
proposed rule.
PART 414—PAYMENT FOR PART B
MEDICAL AND OTHER HEALTH
SERVICES
*
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.
ddrumheller on DSK120RN23PROD with PROPOSALS1
45 CFR Part 171
Computer technology, Electronic
health record, Electronic information
system, Electronic transactions, Health,
Healthcare, Health care provider, Health
information exchange, Health
information technology, Health
information network, Health insurance,
Health records, Hospitals, Privacy,
Reporting and recordkeeping
requirements, Public health, Security.
For the reasons set forth in the
preamble, HHS proposes to amend 42
CFR chapter IV and 45 CFR part 171 as
follows:
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1. The authority citation for part 414
continues to read as follows:
■
Authority: 42 U.S.C. 1302, 1395hh, and
1395rr(b)(l).
2. Amend § 414.1305 by revising the
definition of ‘‘Meaningful EHR user for
MIPS’’ to read as follows:
■
§ 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.
*
*
*
*
*
■ 3. Amend § 414.1375 by revising
paragraph (b) introductory text to read
as follows:
*
*
*
*
(b) * * *
(6) The information blocking
provision of the 21st Century Cures Act
(42 U.S.C. 300jj–52).
*
*
*
*
*
■ 6. Amend § 425.218 by revising
paragraph (b)(3) to read as follows:
§ 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
§ 425.208(b).
*
*
*
*
*
■ 7. Amend § 425.305 by revising
paragraph (a)(1) to read as follows:
§ 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
§ 425.208(b).
*
*
*
*
*
§ 414.1375 Promoting Interoperability (PI)
performance category.
PART 495—STANDARDS FOR THE
ELECTRONIC HEALTH RECORD
TECHNOLOGY INCENTIVE PROGRAM
*
■
*
*
*
*
(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
4. The authority citation for part 425
continues to read as follows:
■
Authority: 42 U.S.C. 1302, 1306, 1395hh,
and 1395jjj.
5. Amend § 425.208 by adding
paragraph (b)(6) to read as follows:
■
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8. The authority citation for part 495
continues to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
9. Amend § 495.4 in the definition of
‘‘Meaningful EHR user’’ by revising
paragraph (1) introductory text and
adding paragraph (4) to read as follows:
■
§ 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
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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
10. The authority citation for part 171
continues to read as follows:
■
Authority: 42 U.S.C. 300jj–52; 5 U.S.C.
552.
11. Amend § 171.102 by adding, in
alphabetical order, the definition of
‘‘Appropriate agency’’ and
‘‘Disincentive’’ to read as follows:
■
§ 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 § 171.1001(a) that may be
imposed by an appropriate agency on a
health care provider that OIG
determines has committed information
blocking for the purpose of deterring
information blocking practices.
*
*
*
*
*
Subparts D through I [Added and
Reserved]
■
12. Add reserved subparts D through
I.
■
13. Add subpart J to read as follows:
Subpart J—Disincentives for
Information Blocking by Health Care
Providers
Sec.
171.1000
171.1001
171.1002
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Scope.
This subpart sets forth disincentives
that an appropriate agency may impose
on a health care provider based on a
determination of information blocking
referred to that agency by OIG, and
certain procedures related to those
disincentives.
§ 171.1001
Disincentives.
(a) Health care providers that commit
information blocking are subject to the
following disincentives from an
appropriate agency based on a
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§ 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 § 171.1001(a) would send a notice to
the health care provider subject to the
disincentive or disincentives, via usual
methods of communication for the
program or payment system under
which the disincentive is applied, that
includes:
(a) A description of the practice or
practices that formed the basis for the
determination of information blocking
referred by OIG;
(b) The basis for the application of the
disincentive or disincentives being
imposed;
(c) The effect of each disincentive;
and
(d) Any other information necessary
for a health care provider to understand
how each disincentive will be
implemented.
■ 14. Add subpart K to read as follows:
Subpart K—Transparency for
Information Blocking Determinations,
Disincentives, and Penalties
Scope.
Disincentives.
Notice of disincentive.
§ 171.1000
determination of information blocking
referred by OIG:
(1) An eligible hospital or critical
access hospital (CAH) as defined in 42
CFR 495.4 is not a meaningful electronic
health record (EHR) user as also defined
in 42 CFR 495.4.
(2) A Merit-based Incentive Payment
System (MIPS) eligible clinician as
defined in 42 CFR 414.1305, who is also
a health care provider as defined in
§ 171.102, is not a meaningful EHR user
for MIPS as defined in 42 CFR 414.1305.
(3) Accountable care organizations
(ACOs) who are health care providers as
defined in § 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.
171.1100 Scope.
171.1101 Posting of information for actors
found to have committed information
blocking.
§ 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.
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§ 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 § 171.1001(a) for
information blocking:
(i) Health care provider name;
(ii) Business address;
(iii) The practice, as the term is
defined in § 171.102 and referenced in
§ 171.103, found to have been
information blocking;
(iv) Disincentive(s) applied; and
(iv) Where to find any additional
information about the determination of
information blocking that is publicly
available via HHS or, where applicable,
another part of the U.S. Government.
(2) The information specified in
paragraph (a)(1) of this section will not
be posted prior to a disincentive being
imposed and will not include
information about a disincentive that
has not been applied.
(3) Posting of the information
specified in paragraph (a)(1) of this
section will be conducted in accordance
with existing rights to review
information that may be associated with
a disincentive specified in § 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 § 171.102 and referenced in
§ 171.103, found to have been
information blocking or alleged to be
information blocking in the situation
specified in paragraph (b)(2)(i) of this
section; and
(iv) Where to find any additional
information about the determination (or
resolution of information blocking as
specified in paragraph (b)(2)(i) of this
section) of information blocking that is
publicly available via HHS or, where
applicable, another part of the U.S.
Government.
(2) The information specified in
paragraph (b)(1) of this section will not
be posted until one of the following
occurs:
(i) OIG enters into a resolution of civil
money penalty (CMP) liability; or
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[FAR Case 2021–019; Docket No. FAR–
2021–0019; Sequence No. 1]
company name (if any), and ‘‘FAR Case
2021–019’’ on your attached document.
If your comment cannot be submitted
using https://www.regulations.gov, call
or email the points of contact in the FOR
FURTHER INFORMATION CONTACT section of
this document for alternate instructions.
Instructions: Please submit comments
only and cite ‘‘FAR Case 2021–019’’ in
all correspondence related to this case.
Comments received generally will be
posted without change to https://
www.regulations.gov, including any
personal and/or business confidential
information provided. Public comments
may be submitted as an individual, as
an organization, or anonymously (see
frequently asked questions at https://
www.regulations.gov/faq). To confirm
receipt of your comment(s), please
check https://www.regulations.gov,
approximately two to three days after
submission to verify posting.
RIN 9000–AO35
FOR FURTHER INFORMATION CONTACT:
(ii) A CMP imposed under subpart N
of 42 CFR part 1003 has become final
consistent with the procedures in
subpart O of 42 CFR part 1003.
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2023–24068 Filed 10–30–23; 11:15 am]
BILLING CODE 4150–45–P
DEPARTMENT OF DEFENSE
GENERAL SERVICES
ADMINISTRATION
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
48 CFR Parts 1, 2, 4, 7, 10, 11, 12, 37,
39, and 52
Federal Acquisition Regulation:
Standardizing Cybersecurity
Requirements for Unclassified Federal
Information Systems; Extension of
Comment Period
Department of Defense (DoD),
General Services Administration (GSA),
and National Aeronautics and Space
Administration (NASA).
ACTION: Proposed rule; extension of
comment period.
AGENCY:
DoD, GSA, and NASA issued
a proposed rule on October 3, 2023,
proposing to amend the Federal
Acquisition Regulation (FAR) to
partially implement an Executive Order
to standardize cybersecurity contractual
requirements across Federal agencies for
unclassified Federal information
systems, and a statute on improving the
Nation’s cybersecurity. The deadline for
submitting comments is being extended
from December 4, 2023, to February 2,
2024, to provide additional time for
interested parties to provide comments
on the proposed rule.
DATES: For the proposed rule published
on October 3, 2023 (88 FR 68402), the
deadline to submit comments is
extended. Submit comments by
February 2, 2024.
ADDRESSES: Submit comments in
response to FAR Case 2021–019 to the
Federal eRulemaking portal at https://
www.regulations.gov by searching for
‘‘FAR Case 2021–019’’. Select the link
‘‘Comment Now’’ that corresponds with
‘‘FAR Case 2021–019’’. Follow the
instructions provided on the ‘‘Comment
Now’’ screen. Please include your name,
ddrumheller on DSK120RN23PROD with PROPOSALS1
SUMMARY:
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For
clarification of content, Ms. Carrie
Moore, Procurement Analyst, at 571–
300–5917 or by email at carrie.moore@
gsa.gov. For information pertaining to
status, publication schedules, or
alternate instructions for submitting
comments if https://
www.regulations.gov cannot be used,
contact the Regulatory Secretariat
Division at 202–501–4755 or
GSARegSec@gsa.gov. Please cite FAR
Case 2021–019.
SUPPLEMENTARY INFORMATION:
I. Background
DoD, GSA, and NASA published a
proposed rule in the Federal Register at
88 FR 68402 on October 3, 2023. The
comment period is extended to February
2, 2024, to allow additional time for
interested parties to develop comments
on the rule.
List of Subjects in 48 CFR Parts 1, 2, 4,
7, 10, 11, 12, 37, 39, and 52
Government procurement.
William F. Clark,
Director, Office of Government-wide
Acquisition Policy, Office of Acquisition
Policy, Office of Government-wide Policy.
[FR Doc. 2023–24026 Filed 10–31–23; 8:45 am]
BILLING CODE 6820–EP–P
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DEPARTMENT OF DEFENSE
GENERAL SERVICES
ADMINISTRATION
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
48 CFR Parts 1, 2, 4, 7, 10, 11, 12, 39,
and 52
[FAR Case 2021–017; Docket No. FAR–
2021–0017; Sequence No. 1]
RIN 9000–AO34
Federal Acquisition Regulation: Cyber
Threat and Incident Reporting and
Information Sharing; Extension of
Comment Period
Department of Defense (DoD),
General Services Administration (GSA),
and National Aeronautics and Space
Administration (NASA).
ACTION: Proposed rule; extension of
comment period.
AGENCY:
DoD, GSA, and NASA issued
a proposed rule on October 3, 2023,
proposing to amend the Federal
Acquisition Regulation (FAR) to
implement an Executive order on cyber
threats and incident reporting and
information sharing for Federal
contractors and to implement related
cybersecurity policies. The deadline for
submitting comments is being extended
from December 4, 2023, to February 2,
2024, to provide additional time for
interested parties to provide comments
on the proposed rule.
DATES: For the proposed rule published
on October 3, 2023 (88 FR 68055), the
comment period is extended. Submit
comments by February 2, 2024.
ADDRESSES: Submit comments in
response to FAR Case 2021–017 to the
Federal eRulemaking portal at https://
www.regulations.gov by searching for
‘‘FAR Case 2021–017’’. Select the link
‘‘Comment Now’’ that corresponds with
‘‘FAR Case 2021–017’’. Follow the
instructions provided on the ‘‘Comment
Now’’ screen. Please include your name,
company name (if any), and ‘‘FAR Case
2021–017’’ on your attached document.
If your comment cannot be submitted
using https://www.regulations.gov, call
or email the points of contact in the FOR
FURTHER INFORMATION CONTACT section of
this document for alternate instructions.
Instructions: Please submit comments
only and cite ‘‘FAR Case 2021–017’’ in
all correspondence related to this case.
Comments received generally will be
posted without change to https://
www.regulations.gov, including any
personal and/or business confidential
information provided. Public comments
SUMMARY:
E:\FR\FM\01NOP1.SGM
01NOP1
]]>Agencies
[Federal Register Volume 88, Number 210 (Wednesday, November 1, 2023)]
[Proposed Rules]
[Pages 74947-74970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24068]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 414, 425, and 495
Office of the Secretary
45 CFR Part 171
RIN 0955-AA05
21st Century Cures Act: Establishment of Disincentives for Health
Care Providers That Have Committed Information Blocking
AGENCY: Centers for Medicare & Medicaid Services (CMS) and Office of
the National Coordinator for Health Information Technology (ONC),
Department of Health and Human Services (HHS).
ACTION: Proposed rule.
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SUMMARY: This proposed rule would implement the provision of the 21st
Century Cures Act specifying that a health care provider determined by
the HHS Inspector General to have committed information blocking shall
be referred to the appropriate agency to be subject to appropriate
disincentives set forth through notice and comment rulemaking. In
particular, this rulemaking would establish for such health care
providers a set of appropriate disincentives using authorities under
applicable Federal law.
DATES: To be assured consideration, written or electronic comments must
be received at one of the addresses provided below, no later than 5
p.m. on January 2, 2024.
ADDRESSES: You may submit comments, identified by RIN 0955-AA05, by any
of the following methods (please do not submit duplicate comments).
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
Federal eRulemaking Portal: Follow the instructions for
submitting comments. Attachments should be in Microsoft Word, Microsoft
Excel, or Adobe PDF; however, we prefer Microsoft Word. https://www.regulations.gov.
Regular, Express, or Overnight Mail: Department of Health
and Human Services, Office of the National Coordinator for Health
Information Technology, Attention: 21st Century Cures Act:
Establishment of Disincentives for Health Care Providers That Have
Committed Information Blocking Proposed Rule, Mary E. Switzer Building,
Mail Stop: 7033A, 330 C Street SW, Washington, DC 20201. Please submit
one original and two copies.
Inspection of Public Comments: All comments received
before the close of the comment period will be available for public
inspection, including any personally identifiable or confidential
business information that is included in a comment. Please do not
include anything in your comment submission that you do not wish to
share with the general public. For example, people typically do not
wish to, and generally should not, share with the general public
information such as: any person's social security number; date of
birth; driver's license number; state identification number or foreign
country equivalent; passport number; financial account number; credit
or debit card number; individually identifiable health information; or
any business information that could be considered proprietary. We will
post all comments that are received before the close of the comment
period at https://www.regulations.gov.
Docket: For access to the docket to read background
documents or comments received, go to https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Alexander Baker, Office of Policy, Office of the National
Coordinator for Health Information Technology (ONC), (202) 690-7151,
for general issues.
Elizabeth Holland, Centers for Medicare & Medicaid Services (CMS),
(443) 934-2532, for issues related to the Promoting Interoperability
Program and the Promoting Interoperability performance category of the
Merit-Based Incentive Payment System.
Aryanna Abouzari, Centers for Medicare & Medicaid Services (CMS),
(415) 744-3668 or [email protected], for issues related
to the Medicare Shared Savings Program.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of Regulatory Action
B. Summary of Major Provisions
C. Costs and Benefits
II. Background
A. Statutory Basis
B. Regulatory History
1. ONC Cures Act Final Rule
2. Office of Inspector General (OIG) Civil Money Penalties (CMP)
Final Rule
III. Provisions of the Proposed Regulation
A. Relevant Statutory Terms and Provisions
1. Appropriate Agency
2. Authorities Under Applicable Federal Law
3. Appropriate Disincentives
B. Approach To Determination of Information Blocking and
Application of Disincentives
1. OIG Investigation and Referral
2. General Provisions for Application of Disincentives
3. Transparency for Information Blocking Determinations,
Disincentives, and Penalties
C. Appropriate Disincentives for Health Care Providers
1. Background
2. Medicare Promoting Interoperability Program for Eligible
Hospitals and Critical Access Hospitals (CAHs)
3. Promoting Interoperability Performance Category of the
Medicare Merit-Based Incentive Payment System (MIPS)
4. Medicare Shared Savings Program
IV. Request for Information
V. Collection of Information Requirements
VI. Regulatory Impact Statement
A. Executive Order No. 12866
B. Regulatory Flexibility Act
C. Unfunded Mandates Reform Act
D. Executive Order 13132
I. Executive Summary
A. Purpose of Regulatory Action
This proposed rule would implement the 21st Century Cures Act
(Cures Act) provision for referral of a health care provider
(individual or entity) determined by the HHS Office of Inspector
General (OIG) to have committed information blocking ``to the
appropriate agency to be subject to appropriate disincentives using
authorities under applicable Federal law, as the Secretary sets forth
through notice and comment rulemaking'' (42 U.S.C. 300jj-52(b)(2)(B),
Public Health Service Act (PHSA) section 3022(b)(2)(B), as added by
section 4004 of the Cures Act (Pub. L. 114-255, Dec. 13, 2016)). The
proposals in this rule would establish disincentives for certain health
care providers (as defined in 45 CFR 171.102) that are also Medicare-
enrolled providers or suppliers.
[[Page 74948]]
B. Summary of Major Provisions
This proposed rule would establish disincentives applicable to
certain health care providers (as defined in 45 CFR 171.102) determined
by OIG to have committed information blocking (as defined in 45 CFR
171.103) that are also Medicare-enrolled providers or suppliers. The
proposed rule also provides information related to OIG's investigation
of claims of information blocking and referral of a health care
provider to an appropriate agency to be subject to appropriate
disincentives. Finally, the rule proposes to establish a process by
which information would be shared with the public about health care
providers that OIG determines have committed information blocking.
Although the proposals in this rule would not establish
disincentives for all of the health care providers included in the 45
CFR 171.102 definition, the health care providers to whom these
disincentives would apply furnish a broad array of services to a
significant number of both Medicare beneficiaries and other patients.
Thus, this set of disincentives would directly advance HHS priorities
for deterring information blocking, while also advancing appropriate
sharing of electronic health information (EHI) by health care providers
\1\ to support safer, more coordinated care for all patients.
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\1\ Except if or as necessitated by the specific terminology of
a particular statutory authority or CFR section, we use in this rule
``health care provider,'' ``provider,'' and ``provider type'' as
inclusive of individuals and entities that may be characterized for
purposes of Medicare enrollment or particular reimbursement policies
as providers or suppliers--or both across different contexts such as
specific services furnished in particular settings.
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We believe it is important to establish appropriate disincentives
that account for all health care providers that fall within the
definition of health care provider (45 CFR 171.102). While effective
deterrence of information blocking can benefit patients by reducing the
degree to which health care providers engage in this practice, fewer
patients will benefit from these deterrent effects if disincentives
have not been established for all of the health care providers within
the definition of health care provider at 45 CFR 171.102. In section
IV. of this proposed rule, we request information on how we can build
on the proposals in this rule to establish disincentives for other
health care providers, particularly those health care providers not
participating in the CMS programs identified in this rule.
Consistent with PHSA section 3022(b)(2)(B), the proposals in this
rule to establish disincentives use authorities under applicable
Federal law, as follows:
Under the authority for the Medicare Promoting
Interoperability Program in the Social Security Act (SSA), at sections
1886(b)(3)(B)(ix) and 1886(n) for eligible hospitals, and at section
1814(l)(4) for critical access hospitals (CAHs), CMS proposes that an
eligible hospital or CAH would not be a meaningful electronic health
record (EHR) user in an EHR reporting period if OIG refers, during the
calendar year of the reporting period, a determination that the
eligible hospital or CAH committed information blocking as defined at
45 CFR 171.103. As a result, an eligible hospital subject to this
disincentive would not be able to earn the three quarters of the annual
market basket increase associated with qualifying as a meaningful EHR
user, while a CAH subject to this disincentive would have its payment
reduced to 100 percent of reasonable costs, from the 101 percent of
reasonable costs it might have otherwise earned, in an applicable year.
Under the authority in SSA sections 1848(o)(2)(A) and (D)
and 1848(q)(2)(A)(iv) and (B)(iv), for the Promoting Interoperability
performance category of the Merit-based Incentive Payment System
(MIPS), CMS proposes that a health care provider defined in 45 CFR
171.102 that is a MIPS eligible clinician (as defined in 42 CFR
414.1305 and including groups) would not be a meaningful EHR user in a
performance period if OIG refers, during the calendar year of the
reporting period, a determination that the MIPS eligible clinician
committed information blocking as defined at 45 CFR 171.103. CMS also
proposes that the determination by OIG that a MIPS eligible clinician
committed information blocking would result in the MIPS eligible
clinician, if required to report on the Promoting Interoperability
performance category of MIPS, not earning a score in the performance
category (a zero score), which is typically a quarter of the total
final composite performance score (a ``final score'' as defined at 42
CFR 414.1305). CMS proposes to codify this proposal under the
definition of meaningful EHR user for MIPS at 42 CFR 414.1305 and add
it to the requirements for earning a score for the MIPS Promoting
Interoperability performance category at 42 CFR 414.1375(b).
Under the authority in SSA section 1899(b)(2)(G) for the
Medicare Shared Savings Program (Shared Savings Program), CMS proposes
that a health care provider as defined in 45 CFR 171.102 that is an
accountable care organization (ACO), ACO participant, or ACO provider/
supplier, if determined by OIG to have committed information blocking
as defined at 45 CFR 171.103, would be barred from participating in the
Shared Savings Program for at least 1 year. This may result in a health
care provider being removed from an ACO or prevented from joining an
ACO; and in the instance where a health care provider is an ACO, this
would prevent the ACO's participation in the Shared Savings Program.
C. Costs and Benefits
Executive Order 12866 on Regulatory Planning and Review and
Executive Order 13563 on Improving Regulation and Regulatory Review
direct agencies to assess all costs and benefits of available
regulatory alternatives and, if regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety effects, distributive
impacts, and equity). Section 3(f) of Executive Order 12866, as amended
by Executive Order 14094, defines a ``significant regulatory action''
as an action that is likely to result in a rule that may: (1) have an
annual effect on the economy of $200 million or more (adjusted every 3
years by the Administrator of the Office of Information and Regulatory
Affairs (OIRA) for changes in gross domestic product), or adversely
affect in a material way the economy, a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local, territorial, or tribal governments or
communities; (2) create a serious inconsistency or otherwise interfere
with an action taken or planned by another agency; (3) materially alter
the budgetary impact of entitlements, grants, user fees, or loan
programs or the rights and obligations of recipients thereof; or (4)
raise legal or policy issues for which centralized review would
meaningfully further the President's priorities or the principles set
forth in the Executive Order, as specifically authorized in a timely
manner by the Administrator of OIRA in each case. The Office of
Management and Budget (OMB) has determined that this proposed rule is
not a significant regulatory action, as the potential costs associated
with this proposed rule would not be greater than $200 million per year
and it does not meet any of the other requirements to be a significant
regulatory action.
[[Page 74949]]
II. Background
A. Statutory Basis
The Cures Act was enacted on December 13, 2016, ``[t]o accelerate
the discovery, development, and delivery of 21st century cures, and for
other purposes.'' Section 4004 of the Cures Act added section 3022 to
the PHSA. Section 3022(a)(1) of the PHSA defines information blocking
as practice that, except as required by law or specified by the
Secretary pursuant to rulemaking, is likely to interfere with, prevent,
or materially discourage access, exchange, or use of electronic health
information. If the practice is conducted by a health information
technology developer, exchange, or network, such developer, exchange,
or network knows, or should know, that such practice is likely to
interfere with, prevent, or materially discourage the access, exchange,
or use of electronic health information. If the practice is conducted
by a health care provider, such provider knows that such practice is
unreasonable and is likely to interfere with, prevent, or materially
discourage access, exchange, or use of electronic health information.
Section 3022(a)(3) of the PHSA further provides that the Secretary
shall, through rulemaking, identify reasonable and necessary activities
that do not constitute information blocking. Section 3022(a)(4) of the
PHSA states that the term ``information blocking'' does not include any
practice or conduct occurring prior to the date that is 30 days after
December 13, 2016 (the date of the enactment of the Cures Act).\2\
Section 3022(a)(2) of the PHSA describes certain practices that may
constitute information blocking.
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\2\ As January 12, 2017, was the thirtieth day after December
13, 2016, conduct occurring on or after January 13, 2017, that
otherwise meets the PHSA section 3022(a) definition of ``information
blocking,'' would be included in that definition.
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Section 3022(b)(1) of the PHSA authorizes OIG to investigate
information blocking claims. Section 3022(b)(1)(B) of the PHSA
authorizes OIG to investigate claims that ``a health care provider
engaged in information blocking.'' Section 3022(b)(2)(B) of the PHSA
provides that any health care provider OIG determines to have committed
information blocking shall be referred to the appropriate agency to be
subject to appropriate disincentives using authorities under applicable
Federal law, as the Secretary sets forth through notice and comment
rulemaking. Sections 3022(b)(1)(A) and (C) of the PHSA authorize OIG to
investigate health information technology (IT) developers of certified
health IT or other entities offering certified health IT, health
information exchanges, and health information networks. Section
3022(b)(2)(A) of the PHSA authorizes the imposition of civil money
penalties (CMPs) \3\ not to exceed $1 million per violation on those
individuals and entities set forth in sections 3022(b)(1)(A) and (C) of
the PHSA.
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\3\ ONC uses the term ``civil money penalty'' here, rather than
``civil monetary penalty'' as used in PHSA section 3022(b)(2)(A) for
consistency with OIG's usage in the OIG CMP Final Rule (88 FR
42820).
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PHSA section 3022 also authorizes ONC, the HHS Office for Civil
Rights (OCR), and OIG to consult, refer, and coordinate to resolve
claims of information blocking. PHSA section 3022(b)(3)(A) authorizes
OIG to refer claims of information blocking to OCR if OIG determines a
consultation regarding the health privacy and security rules
promulgated under section 264(c) of the Health Insurance Portability
and Accountability Act of 1996 (HIPAA) (42 U.S.C. 1320d-2 note) will
resolve such claims. PHSA section 3022(d)(1) specifies that the
National Coordinator may serve as a technical consultant to OIG and the
Federal Trade Commission (FTC) for purposes of carrying out section
3022 and may share information related to claims or investigations of
information blocking with the FTC for purposes of such investigations,
in addition to requiring the National Coordinator to share information
with OIG, as required by law.
PHSA section 3022(d)(4) requires the Secretary, in carrying out
section 3022 and to the extent possible, to ensure that information
blocking penalties do not duplicate penalty structures that would
otherwise apply with respect to information blocking and the type of
individual or entity involved as of the day before the date of
enactment of the Cures Act. Section 3022(a)(7) of the PHSA states that,
in carrying out section 3022, the Secretary shall ensure that health
care providers are not penalized for the failure of developers of
health information technology or other entities offering health
information technology to such providers to ensure that such technology
meets the requirements to be certified under Title XXX of the PHSA.
We address the statutory basis for each proposed disincentive in
greater detail in section III.C. of this proposed rule.
B. Regulatory History
1. ONC Cures Act Final Rule
On March 4, 2019, a proposed rule titled ``21st Century Cures Act:
Interoperability, Information Blocking, and the ONC Health IT
Certification Program'' (ONC Cures Act Proposed Rule) appeared in the
Federal Register (84 FR 7424). The rule proposed to implement certain
provisions of the Cures Act to advance interoperability and support the
access, exchange, and use of electronic health information. The ONC
Cures Act Proposed Rule included a request for information regarding
potential disincentives for health care providers that have committed
information blocking and asked whether modifying disincentives already
available under existing Department programs and regulations would
provide for more effective deterrence (84 FR 7553).
On May 1, 2020, a final rule titled ``21st Century Cures Act:
Interoperability, Information Blocking, and the ONC Health IT
Certification Program'' (ONC Cures Act Final Rule) appeared in the
Federal Register (85 FR 25642). The final rule identified eight
reasonable and necessary activities that do not constitute information
blocking, consistent with the requirement in PHSA section 3022(a)(3).
Such reasonable and necessary activities are often referred to as
``exceptions'' to the definition of information blocking, or
``information blocking exceptions,'' as specified in 45 CFR part 171.
The ONC Cures Act Final Rule finalized definitions that are
necessary to implement the statutory information blocking provision in
PHSA section 3022, including definitions related to the four classes of
individuals and entities covered by the statutory information blocking
provision: health care providers, health IT developers, health IT
networks, and health IT exchanges.
As the term ``health care provider'' is not explicitly defined in
section 3022 of the PHSA as added by section 4004 of the Cures Act, the
ONC Cures Act Final Rule adopted in 45 CFR 171.102 the definition of
health care provider in section 3000(3) of the PHSA \4\ for
[[Page 74950]]
purposes of the information blocking regulations in 45 CFR part 171.
ONC noted that the definitions listed in section 3000 of the PHSA apply
``[i]n this title,'' which refers to Title XXX of the PHSA (85 FR
25795). Section 3022 of the PHSA is included in Title XXX. Since
adopting a definition of health care provider in the ONC Cures Act
Final Rule, the Secretary has not proposed to modify the definition for
purposes of the information blocking regulations.
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\4\ As defined in 42 U.S.C 300-jj, the term ``health care
provider'' includes a hospital, skilled nursing facility, nursing
facility, home health entity or other long term care facility,
health care clinic, community mental health center (as defined in
section 300x-2(b)(1) of this title), renal dialysis facility, blood
center, ambulatory surgical center described in section 1395l(i) of
this title, emergency medical services provider, Federally qualified
health center, group practice, a pharmacist, a pharmacy, a
laboratory, a physician (as defined in section 1395x(r) of the
title), a practitioner (as described in section 1395u(b)(18)(C) of
the title), a provider operated by, or under contract with, the
Indian Health Service or by an Indian tribe (as defined in the
Indian Self-Determination and Education Assistance Act [25 U.S.C.
5301 et seq.]), tribal organization, or urban Indian organization
(as defined in section 1603 of title 5), a rural health clinic, a
covered entity under section 256b of this title, an ambulatory
surgical center described in section 1395l(i) of this title, a
therapist (as defined in section 1395w-4(k)(3)(B)(iii) of the
title), and any other category of health care facility, entity,
practitioner, or clinician determined appropriate by the Secretary.
See also this guidance document: https://www.healthit.gov/sites/default/files/page2/2020-08/Health_Care_Provider_Definitions_v3.pdf.
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The ONC Cures Act Final Rule also established in 45 CFR 171.102
regulatory definitions for ``health information network or health
information exchange'' and ``health IT developer of certified health
IT,'' \5\ among other terms.\6\ The preamble text of the ONC Cures Act
Final Rule makes clear that an individual or entity could meet both the
definition of a health care provider and the definition of a health IT
developer of certified health IT (85 FR 25798 through 25799) or could
meet both the definition of a health care provider and a health
information exchange or network (85 FR 25801). We mention these
potential scenarios so that health care providers are aware that they
would not necessarily only be subject to the disincentives proposed in
this rule (should they be finalized), but depending on the specific
facts and circumstances, they could meet the definition of a health
information network or exchange, and therefore be subject to civil
money penalties, if found by OIG to have committed information
blocking.
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\5\ In the ONC Cures Act Final Rule, ONC defined the term
``health IT developer of certified health IT'' in 45 CFR 171.102,
instead of using the term that appears in PHSA 3022(a)(1): ``health
IT developer.'' ONC explained that, because title XXX of the PHSA
does not define ``health information technology developer,'' ONC
interpreted section 3022(a)(1)(B) in light of the specific authority
provided to OIG in section 3022(b)(1)(A) and (b)(2). ONC noted that
section 3022(b)(2) discusses developers, networks, and exchanges by
referencing any individual or entity described in section
3022(b)(1)(A) or (C). Section 3022(b)(1)(A) states, in relevant
part, that OIG may investigate any claim that a health information
technology developer of certified health information technology or
other entity offering certified health information technology
engaged in information blocking (85 FR 25795, emphasis added).
\6\ In 2023, ONC has proposed to establish a definition of what
it means to ``offer'' certified health IT, and to make a
corresponding update to the health IT developer of certified health
IT definition. These proposals are part of a proposed rule titled
``Health Data, Technology, and Interoperability: Certification
Program Updates, Algorithm Transparency, and Information Sharing''
(88 FR 23746) (HTI-1 Proposed Rule). The comment period on the HTI-1
Proposed Rule ended June 20, 2023. Public Comments are posted as
part of docket HHS-ONC-2023-0007, see https://www.regulations.gov/docket/HHS-ONC-2023-0007/comments.
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On November 4, 2020, an interim final rule with comment period
titled ``Information Blocking and the ONC Health IT Certification
Program: Extension of Compliance Dates and Timeframes in Response to
the COVID-19 Public Health Emergency'' (ONC Cures Act Interim Final
Rule) appeared in the Federal Register (85 FR 70064). The ONC Cures Act
Interim Final Rule extended certain compliance dates and timeframes
adopted in the ONC Cures Act Final Rule to offer the healthcare system
additional flexibilities in furnishing services to combat the COVID-19
pandemic, including extending the applicability date for the
information blocking provisions to April 5, 2021 (85 FR 70068). The ONC
Cures Act Interim Final Rule also extended from May 2, 2022, to October
6, 2022, the date on which electronic health information as defined in
45 CFR 171.102 for purposes of the information blocking definition in
45 CFR 171.103 would no longer be limited to the subset of EHI that is
identified by data elements represented in the United States Core Data
for Interoperability (USCDI) standard adopted in 45 CFR 170.213 (85 FR
70069).\7\ On and after October 6, 2022, practices likely to interfere
with access, exchange, or use of any information falling within the
definition of EHI in 45 CFR 171.102 may constitute information blocking
as defined in 45 CFR 171.103.
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\7\ For more information about the USCDI, see https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi.
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2. Office of Inspector General (OIG) Civil Money Penalties (CMP) Final
Rule
On April 24, 2020, a proposed rule titled ``Grants, Contracts, and
Other Agreements: Fraud and Abuse; Information Blocking; Revisions to
the Office of Inspector General's Civil Money Penalty Rules'' (OIG CMP
Proposed Rule) appeared in the Federal Register (85 FR 22979). The OIG
CMP Proposed Rule set forth proposed regulations to incorporate new CMP
authority for information blocking and related procedures at PHSA
sections 3022(b)(2)(A) and (C) (88 FR 42825). Specific to information
blocking, OIG also provided information on--but did not propose
regulations for--expected enforcement priorities, the investigation
process, and OIG's experience with investigating conduct that includes
an intent element (88 FR 42822).
OIG subsequently addressed these proposals in a final rule,
``Grants, Contracts, and Other Agreements: Fraud and Abuse; Information
Blocking; Office of Inspector General's Civil Money Penalty Rules,''
which appeared in the Federal Register on July 3, 2023 (OIG CMP Final
Rule) (88 FR 42820). This rulemaking addressed imposition of CMPs for
information blocking by health IT developers or other entities offering
certified health IT, health information exchanges, and health
information networks. The OIG CMP Final Rule did not establish
appropriate disincentives for health care providers that OIG has
determined have committed information blocking.
As mentioned above, a health care provider that also meets the
definition of health IT developer of certified health IT, or health
information network or health information exchange, or both, under 45
CFR 171.102, may be subject to information blocking CMPs (88 FR 42828).
OIG has stated that as part of its assessment of whether a health care
provider is a health information network or exchange that could be
subject to civil money penalties for information blocking, OIG
anticipates engaging with the health care provider to better understand
its functions and to offer the provider an opportunity to explain why
it is not a health information network or exchange (88 FR 42828).
III. Provisions of the Proposed Regulation
A. Relevant Statutory Terms and Provisions
In this section, we discuss certain statutory terms and provisions
in PHSA sections 3022(a) and (b) related to the establishment of
appropriate disincentives for health care providers as defined in 45
CFR 171.102. For brevity, we refer to PHSA section 3022(b)(2)(B), which
states that health care providers that OIG has determined to have
committed information blocking ``shall be referred to the appropriate
agency to be subject to appropriate disincentives using authorities
under applicable Federal law, as the Secretary sets forth through
notice and comment rulemaking,'' as the ``disincentives provision''
throughout this section.
[[Page 74951]]
1. Appropriate Agency
The disincentives provision states that an individual or entity
that is a health care provider determined by OIG to have committed
information blocking shall be referred to the ``appropriate agency'' to
be subject to appropriate disincentives. Accordingly, we propose to
define ``appropriate agency'' in 45 CFR 171.102 to mean a government
agency that has established disincentives for health care providers
that OIG determines have committed information blocking. We note that,
under the disincentives provision, an ``agency'' may be any component
of HHS that has established a disincentive or disincentives on behalf
of the Secretary of HHS, including any of the Staff or Operating
Divisions of HHS. For example, the disincentives proposed in section
III.C. of this proposed rule are proposed under authorities held by
CMS, which is an Operating Division of HHS. Under our proposals, CMS
would be the ``appropriate agency'' to which OIG would refer a health
care provider to be subject to disincentives.
We invite public comments on our proposed definition of
``appropriate agency.''
2. Authorities Under Applicable Federal Law
We propose to interpret the phrase ``authorities under applicable
Federal law'' in the disincentives provision to mean that an
appropriate agency may only subject a health care provider to a
disincentive established using authorities that could apply to
information blocking by a health care provider subject to the
authority, such as health care providers participating in a program
supported by the authority. In section III.C. of this proposed rule,
CMS identifies the authority under which each disincentive is proposed.
3. Appropriate Disincentives
The Cures Act does not specify or provide illustrations for the
types of disincentives that should be established. As such, we propose
to define the term ``disincentive'' in 45 CFR 171.102 to mean a
condition that may be imposed by an appropriate agency on a health care
provider that OIG determines has committed information blocking and is
specifically identified in 45 CFR 171.1001(a). In section III.B.2 of
this proposed rule, we propose to identify in 45 CFR 171.1001(a) those
disincentives that have been established pursuant to the statute for
the express purpose of deterring information blocking practices.
The term ``appropriate'' for disincentives is likewise not defined
in PHSA section 3022, nor are illustrations provided. Under this
proposal, a disincentive for a health care provider that OIG has
determined to have committed information blocking may be any condition,
established through notice and comment rulemaking, that would, in our
estimation, deter information blocking practices among health care
providers subject to the information blocking regulations. In section
III.C. of this proposed rule, we describe the potential impact that
each proposed disincentive would have on a health care provider.
We note that the disincentives provision does not limit the number
of disincentives that an appropriate agency can impose on a health care
provider. Accordingly, we propose that a health care provider would be
subject to each appropriate disincentive that an agency has established
through notice and comment rulemaking and is applicable to the health
care provider. Imposing cumulative disincentives, where applicable,
would further deter health care providers from engaging in information
blocking.
We invite public comments on our proposals to establish
disincentives in section III.C. of this proposed rule.
B. Approach To Determination of Information Blocking and Application of
Disincentives
In this section we provide additional detail about the process by
which a health care provider that has committed information blocking
would be subject to appropriate disincentives for information blocking.
We begin with a discussion of an OIG investigation of a claim of
information blocking, which may result in OIG determining that the
health care provider committed information blocking. We then discuss
how OIG would refer the health care provider to an appropriate agency.
Next, we address certain general issues related to the application of a
disincentive by an appropriate agency. Finally, we propose an approach
to make information available to the public about health care providers
that have been subject to an appropriate disincentive for information
blocking, and about health information networks/health information
exchanges and health IT developers of certified health IT that have
been determined by OIG to have committed information blocking.
1. OIG Investigation and Referral
The following information regarding OIG's anticipated approach to
information blocking investigations of health care providers is not a
regulatory proposal and is provided for information purposes only. This
preamble discussion of investigation priorities for health care
provider information blocking claims is not binding on OIG and HHS. It
does not impose any legal restrictions related to OIG's discretion to
choose which health care provider information blocking complaints to
investigate.
a. Anticipated Priorities
As with other conduct that OIG has authority to investigate, OIG
has discretion to choose which information blocking complaints to
investigate. To maximize efficient use of resources, OIG generally
focuses on selecting cases for investigation that are consistent with
its enforcement priorities and intends to apply that rationale to its
approach for selecting information blocking complaints for
investigation. In the OIG CMP Final Rule, OIG described its enforcement
priorities for health IT developers of certified health IT or other
entities offering certified health IT, health information exchanges,
and health information networks that have committed information
blocking and are subject to CMPs. OIG stated that its information
blocking CMP enforcement priorities will include practices that: (i)
resulted in, are causing, or have the potential to cause patient harm;
(ii) significantly impacted a provider's ability to care for patients;
(iii) were of long duration; (iv) caused financial loss to Federal
healthcare programs, or other government or private entities; or (v)
were performed with actual knowledge. OIG stated that it expected these
priorities will evolve as it gains more experience investigating
information blocking (88 FR 42822).
For investigations of health care providers, OIG expects to use
four of these priorities: (i) resulted in, are causing, or have the
potential to cause patient harm; (ii) significantly impacted a
provider's ability to care for patients; (iii) were of long duration;
and (iv) caused financial loss to Federal health care programs, or
other government or private entities. Again, although not a regulatory
proposal, OIG welcomes comments on these priorities, including comments
on whether other issues specific to information blocking by health care
providers should warrant changing these priorities or adding others.
OIG emphasizes that information blocking, as defined in PHSA
section 3022(a)(1) and in 45 CFR 171.103, includes an element of
intent. The standard of intent for health care providers was
established by the Cures Act in PHSA section 3022(a)(1)(B)(ii): ``if
conducted by a health care provider,
[[Page 74952]]
such provider knows that such practice is unreasonable and is likely to
interfere with, prevent, or materially discourage access, exchange, or
use of electronic health information.'' This is different from the
standard of intent in PHSA section 3022(a)(1)(B)(i): ``if conducted by
a health information technology developer, exchange, or network, such
developer, exchange, or network knows, or should know, that such
practice is likely to interfere with, prevent, or materially discourage
the access, exchange, or use of electronic health information.'' The
different intent standard for information blocking by a health care
provider is why OIG does not expect to use ``actual knowledge'' as an
enforcement priority. OIG has significant experience and expertise
investigating and determining whether to take an enforcement action
based on other laws that are intent-based (for example, the Federal
anti-kickback statute, and Civil Monetary Penalties Law, 42 U.S.C.
1320a-7b(b) and 1320a-7a). This history will inform the use of OIG's
discretion to investigate health care providers that OIG believes may
have the requisite intent.
As noted in the OIG CMP Final Rule (88 FR 42822), explanation of
OIG's priorities can provide the public with a better understanding of
how OIG anticipates allocating its resources for information blocking
enforcement. Applicable to this proposed rule, explanation of OIG's
priorities can provide the public with a better understanding of how
OIG anticipates allocating its resources to investigate claims that
health care providers engaged in information blocking. Prioritization
ensures OIG can effectively allocate its resources to target
information blocking claims that have more negative effects on
patients, providers, and healthcare programs. OIG's enforcement
priorities will inform its decisions about which information blocking
allegations to pursue, but these priorities are not dispositive. Each
allegation will present unique facts and circumstances that must be
assessed individually. Each allegation will be assessed to determine
whether it implicates one or more of the enforcement priorities, or
otherwise merits further investigation and potential enforcement
action. Although OIG's anticipated priorities are framed around
individual allegations, OIG may evaluate allegations and prioritize
investigations based in part on the volume of claims relating to the
same (or similar) practices by the same entity or individual (for
example, a health care provider or health information network). There
is no specific formula OIG can apply to every allegation that allows it
to effectively evaluate and prioritize which claims merit
investigation.
b. Coordination With Other Agencies
In this section we summarize the discussion in the OIG CMP Final
Rule of the ways ONC, OCR, and OIG will consult, refer, and coordinate
on information blocking claims as permitted by the Cures Act (88 FR
42823).
PHSA section 3022(d)(1) states that the National Coordinator may
serve as a technical consultant to the Inspector General. OIG will
accordingly consult with ONC throughout the investigative process.
Additionally, PHSA section 3022(b)(3)(A) provides the option for OIG to
refer claims of information blocking to OCR when a consultation
regarding the health privacy and security rules promulgated under
section 264(c) of HIPAA will resolve such claims. Depending on the
facts and circumstances of the claim, OIG will exercise this statutory
discretion as appropriate to refer information blocking claims to OCR
for resolution. There is no set of facts or circumstances that will
always be referred to OCR. OIG will work with OCR to determine which
claims should be referred to OCR under the authority provided in PHSA
section 3022(b)(3)(A). In addition to section 3022(b)(3)(A), OIG may
request technical assistance from OCR during an information blocking
investigation. It is important to note that while section 3022(b)(3)(A)
of the PHSA specifically provides OIG with the authority to refer
information blocking claims to OCR, OIG's statutory authority to refer
to OCR allegations of violations of the HIPAA Privacy, Security, or
Breach Notification Rules \8\ is not solely based on PHSA section
3022(b)(3)(A). Thus, OIG's authority to refer to OCR such allegations
against health care providers is not limited to claims of information
blocking.
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\8\ 45 CFR parts 160 and 164, subparts A, C, D, and E.
---------------------------------------------------------------------------
Finally, OIG stated that it anticipates coordinating with other HHS
agencies to avoid duplicate penalties as identified in section
3022(d)(4) of the PHSA. Depending on the facts and circumstances, OIG
stated that it might also consult or coordinate with a range of other
government agencies, including CMS, FTC, or others (88 FR 42824).
c. Anticipated Approach to Referral
During an investigation of information blocking by a health care
provider, but prior to making a referral, OIG will coordinate with the
appropriate agency to which OIG plans to refer its determination of
information blocking. This coordination will ensure that the
appropriate agency is aware of a potential referral and that OIG
provides the information the agency needs to take appropriate action.
OIG's referral to the appropriate agency will explain its determination
that a health care provider committed information blocking, including
meeting the requirements of the intent element of PHSA section
3022(a)(1)(B)(ii).
We note that PHSA section 3022 authorizes OIG to investigate claims
of information blocking and requires OIG to refer health care providers
to an appropriate agency when it determines a health care provider has
committed information blocking, to be subject to appropriate
disincentives. Once OIG has concluded its investigation and is prepared
to make a referral, it will send information to the appropriate agency
indicating that the referral is made pursuant to the statutory
requirement in PHSA section 3022(b)(2)(B). As part of the referral, OIG
will provide information to explain its determination, which may
include: the dates when OIG has determined the information blocking
violation(s) occurred; analysis to explain how the evidence
demonstrates the health care provider committed information blocking
(for instance, that the health care provider's ``practice'' \9\ meets
each element of the information blocking definition); copies of
evidence collected during the investigation (regardless of whether it
was collected by subpoena or voluntarily provided to OIG); copies of
transcripts and video recordings (if applicable) of any witness and
affected party testimony; and copies of documents OIG relied upon to
make its determination that information blocking occurred. OIG may
provide additional information as part of its referral based on
consultation with the appropriate agency, to the extent permitted by
applicable law.
---------------------------------------------------------------------------
\9\ Practice, as defined in 45 CFR 171.102, means an act or
omission by an actor (health care provider, health IT developer of
certified health IT, health information network or health
information exchange).
---------------------------------------------------------------------------
2. General Provisions for Application of Disincentives
Following an investigation through which OIG determines a health
care provider has committed information blocking, and OIG's referral of
this determination to an appropriate agency, the health care provider
would be subject to disincentives that have been
[[Page 74953]]
established under applicable Federal law through notice and comment
rulemaking. In this section, we include general proposals and
information related to the application of disincentives. For
information on the specific disincentives proposed in this rule and
further discussion about how each disincentive would be applied, we
refer readers to section III.C.
We propose to add a new subpart J to 45 CFR part 171, entitled
``Disincentives for Information Blocking by Health Care Providers.'' As
proposed in 45 CFR 171.1000, this subpart would set forth disincentives
that an appropriate agency would impose on a health care provider based
on a determination of information blocking referred to that agency by
OIG, and certain procedures related to those disincentives. We propose
in 45 CFR 171.1001(a) that health care providers that commit
information blocking would be subject to the following disincentives
from an appropriate agency based on a determination of information
blocking referred by OIG, where applicable. The disincentives proposed
for inclusion in 45 CFR 171.1001(a)(1) through (3) correspond to the
appropriate disincentives proposed in section III.C. of this proposed
rule, which include:
An eligible hospital or CAH as defined in 42 CFR 495.4 is
not a meaningful EHR user as also defined in that section;
A MIPS eligible clinician as defined in 42 CFR 414.1305,
who is also a health care provider as defined in 45 CFR 171.102, is not
a meaningful EHR user for MIPS as also defined in 42 CFR 414.1305; and
ACOs who are health care providers as defined in 45 CFR
171.102, ACO participants, and ACO providers/supplies will be removed
from, or denied approval to participate, in the Medicare Shared Savings
Program as defined in 42 CFR part 425 for at least 1 year.
In the future, if we propose to establish additional disincentives,
we intend to add such disincentives to the disincentives listed in 45
CFR 171.1001(a).
We propose in 45 CFR 171.1002(a) through (d) that an appropriate
agency that imposes a disincentive or disincentives in Sec.
171.1001(a) would send a notice (using usual methods of communication
for the program or payment system) to the health care provider subject
to the disincentive or disincentives. This notice would include:
A description of the practice or practices that formed the
basis for the determination of information blocking referred by OIG;
The basis for the application of the disincentive or
disincentives being imposed;
The effect of each disincentive; and
Any other information necessary for a health care provider
to understand how each disincentive will be implemented.
The information in this notice would be based upon the authority
used to establish the disincentive and policy finalized by the agency
establishing the disincentive. For instance, the notice may contain
specific information regarding when a disincentive would be imposed,
which may be contingent on both the authority used to establish the
disincentive and the specific policy under which the disincentive is
established. We note that, where a health care provider that has been
determined to have committed information blocking is subject to
multiple disincentives established by an appropriate agency, nothing in
this proposal would prevent the appropriate agency from combining these
notices into a single communication.
Following the application of a disincentive, a health care
provider, as defined in 45 CFR 171.102, may have the right to appeal
administratively a disincentive if the authority used to establish the
disincentive provides for such an appeal. We note that PHSA section
3022(b)(2)(C) requires that the imposition of CMPs that apply to health
IT developers of certified health IT, and health information networks
or health information exchanges, that have committed information
blocking, follow the procedures of SSA section 1128A, which includes
procedures for appeals. However, the Cures Act did not provide similar
instruction regarding appeals of disincentives for health care
providers established under PHSA section 3022(b)(2)(B). Therefore, any
right to appeal administratively a disincentive, if available, would be
provided under the authorities used by the Secretary to establish the
disincentive through notice and comment rulemaking.
3. Transparency for Information Blocking Determinations, Disincentives,
and Penalties
We believe that it is important to promote transparency about how
and where information blocking is impacting the nationwide health
information technology infrastructure. Publicly releasing information,
including applicable public settlements, penalties, and disincentives,
about actors that have been determined by OIG to have committed
information blocking can inform the public about how and where
information blocking is occurring within the broader health information
technology infrastructure.
PHSA section 3001(c)(4) requires that the National Coordinator
maintain an internet website ``to ensure transparency in promotion of a
nationwide health information technology infrastructure.'' We believe
this provision provides the National Coordinator with the authority to
post information on ONC's website if that information has an impact on
issues relating to transparency in the promotion of a nationwide health
information technology infrastructure. We propose to add a new subpart
K to 45 CFR part 171, entitled ``Transparency for Information Blocking
Determinations, Disincentives, and Penalties.'' As proposed in 45 CFR
171.1100, this subpart would set forth the information that would be
publicly posted on ONC's website about actors that have been determined
by OIG to have committed information blocking.
We propose in 45 CFR 171.1101 that, in order to provide insight
into how and where information blocking conduct is impacting the
broader nationwide health information technology infrastructure, ONC
would post on its public website information about actors that have
been determined by OIG to have committed information blocking. For
health care providers that are subject to a disincentive, we propose in
45 CFR 171.1101(a)(1) that the following information would be posted:
health care provider's name, business address (to ensure accurate
provider identification), the practice found to have been information
blocking, the disincentive(s) applied, and where to find additional
information, where available, about the determination of information
blocking that is publicly available via HHS or another part of the U.S.
Government. We propose in 45 CFR 171.1101(a)(2) that the information
specified in 45 CFR 171.1101(a)(1) would not be posted prior to a
disincentive being imposed and would not include information about a
disincentive that has not been applied. We also recognize that under
the authorities for the disincentives proposed in section III.C. of
this proposed rule, an appropriate agency may have other obligations
related to release of information about a participant that is a health
care provider (as defined in 45 CFR 171.102) in programs under that
authority. For instance, under SSA section 1848(q)(9)(C), MIPS eligible
clinicians have a right to review information about their performance
in MIPS prior to having this information publicly posted
[[Page 74954]]
on the Compare Tool in accordance with 42 CFR 414.1395. Therefore, we
propose in 45 CFR 171.1101(a)(3) that posting of the information about
health care providers that have been determined to have committed
information blocking and have been subject to a disincentive would be
conducted in accordance with existing rights to review information that
may be associated with a disincentive specified in 45 CFR 171.1001. For
instance, where a health care provider, as defined in 45 CFR 171.102,
has a statutory right to review performance information, this existing
right would be exercised prior to public posting of information
regarding information blocking on the website described above.
In order to provide insight into how and where information blocking
conduct is impacting the broader nationwide health information
technology infrastructure, we also propose in 45 CFR 171.1101(b)(1) to
post on ONC's public website information specified in 45 CFR
171.1101(b)(1) about health information networks (HINs)/health
information exchanges (HIEs) and health IT developers of certified
health IT that have been determined by OIG to have committed
information blocking and have either resolved their civil money penalty
(CMP) liability with OIG or had a CMP imposed by OIG for information
blocking under subpart N of 42 CFR part 1003. To ensure accurate
identification of actors, we propose in 45 CFR 171.1101(b)(1) to post
the type of actor (e.g., HIN/HIE or health IT developers of certified
health IT) and the actor's legal name, including any alternative or
additional trade name(s) under which the actor operates.
The last information we propose to post on our public website, for
all actors, would be the two types of information mentioned above
regarding health care providers. First, in 45 CFR 171.1101(a)(1)(iii)
and (b)(1)(iii), we propose to post, a description of the practice, as
the term is defined in 45 CFR 171.102 and referenced in 45 CFR 171.103,
found to have been information blocking. In the case of a resolved CMP
liability, we would post the practice alleged to be information
blocking. This information will help provide transparency into how
information blocking conduct is impacting the nationwide health
information technology infrastructure, and in particular, specific
practices that are impacting the infrastructure. Second, in 45 CFR
171.1101(a)(1)(v) and (b)(1)(iv), we propose to post where to find
additional information about the determination (or resolution of CMP
liability) of information blocking that is publicly available via HHS
or, where applicable, another part of the U.S. Government. This
information could include hyperlinks and other information, to help
interested persons find any additional information about the
determination, settlement, penalty, or disincentive that has been made
publicly available by the U.S. Government. Such publicly available
information would include any summaries or media releases that may be
posted by OIG, or another part of HHS, on their internet website(s). It
could also include additional information that may be made publicly
available about the determination by or other parts of the U.S.
Government. For example, if an actor who has exhausted applicable
administrative appeal procedures and brought action in a Federal court
for review of the decision that has become final, we could post
information on our website about the existence of the court action and
where or how to access information about the determination, or
resulting court action, that has been made publicly available by the
court. This information would provide additional context for how
information blocking conduct is impacting the nationwide health
information technology infrastructure.
Publicly posting information about actors that have been determined
by OIG to have committed information blocking is important for
providing transparency into how and where information blocking conduct
is occurring within and impacting the broader nationwide health
information technology infrastructure. Between April 5, 2021, and
September 30, 2023, we received over 800 claims of information blocking
through the Report Information Blocking Portal.\10\ We have publicly
posted information about these claims, which we update monthly. Beyond
posting the number of claims, the posted information includes claim
counts by type of claimant and claim counts by potential actor.\11\
While OIG has not necessarily evaluated whether these claims qualify as
information blocking, this information provides transparency about how
participants in the nationwide health IT infrastructure perceive
actions by actors that are part of the same infrastructure, which is
intended to support the access, exchange, and use of EHI. A natural
progression of the posting of such information is the posting of
information about actual information blocking determinations by OIG,
including any settlements of liability, civil money penalties, and
disincentives. This information can help the public understand how the
information blocking regulations, which seek to prevent and address
practices that unreasonably or unnecessarily interfere with lawful
access, exchange, or use of EHI through the nationwide health IT
infrastructure, are being enforced. It would also provide clarity
regarding how and where actors are engaging in information blocking
practices within the nationwide health IT infrastructure. Based on this
information, participants in the nationwide health IT infrastructure
and the public can confirm or dispel perceptions of information
blocking within that infrastructure. Additionally, the combined
transparency of the processes Congress authorized and instructed HHS to
implement (i.e., ONC implementing a claims reporting process, as well
as civil money penalties and disincentives for applicable actors found
to have committed information blocking by OIG) would foster public
confidence in the information blocking enforcement framework and
potentially encourage public participation in that framework, whether
by submitting a claim of information blocking or participating in an
OIG information blocking investigation. We invite public comments on
these proposals, including comments on whether we should publicly post
additional information (and why) about health care providers, health IT
developers, or health information networks/health information exchanges
that have been determined by OIG to have committed information
blocking.
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\10\ See ``Information Blocking Claims: By the Numbers,''
https://www.healthit.gov/data/quickstats/information-blocking-claims-numbers.
\11\ https://www.healthit.gov/data/quickstats/information-blocking-claims-numbers.
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C. Appropriate Disincentives for Health Care Providers
In this section (III.C.), we propose to establish a set of
disincentives for health care providers that have committed information
blocking. These disincentives would be imposed following a referral of
a determination of information blocking by OIG. Each of the proposed
disincentives is being established using authorities under applicable
Federal law, consistent with PHSA section 3022(b)(2)(B).
1. Background
a. Impacted Health Care Providers
The disincentives proposed in this section would apply to a subset
of the individuals and entities meeting the information blocking
regulations'
[[Page 74955]]
definition of health care provider at 45 CFR 171.102. Specifically, the
proposals in this rule would provide disincentives for health care
providers (as defined in 45 CFR 171.102) that are also eligible to
participate in certain Federal programs: the Medicare Promoting
Interoperability Program and the MIPS Promoting Interoperability
performance category (previously the EHR Incentive Programs); and the
Medicare Shared Savings Program.
We recognize that the disincentives proposed in this rule would
only apply to certain health care providers and that the information
blocking regulations are also applicable to health care providers that
are not eligible to participate in these programs. However, this
proposed rule is a first step that focuses on authorities which pertain
to certain health care providers that furnish a broad array of health
care services to large numbers of Medicare beneficiaries and other
patients. We believe optimal deterrence of information blocking calls
for imposing appropriate disincentives on all health care providers (as
defined at 45 CFR 171.102) determined by OIG to have committed
information blocking. In section IV. of this proposed rule, we request
public comment on establishing disincentives, using applicable Federal
law, that could be imposed on a broader range of health care providers.
b. Impact of Disincentives
We believe the disincentives proposed in this rule would deter
information blocking by health care providers. However, we recognize
that the actual monetary impact resulting from the application of the
disincentives proposed in this section may vary across health care
providers subject to the disincentive.
For example, the disincentive proposed in section III.C.3. of this
proposed rule for the MIPS Promoting Interoperability performance
category would result in an adjustment to payments under Medicare Part
B to MIPS eligible clinicians (as defined in 42 CFR 414.1305). This
disincentive would reduce to zero the Promoting Interoperability
performance category score of any MIPS eligible clinician that has been
determined by OIG to have committed information blocking (as defined at
45 CFR 171.103) during the calendar year (CY) of the referral of a
determination from OIG. However, the actual financial impact
experienced by a health care provider as a result of this proposed
disincentive being applied in MIPS would vary. For example, Part B
payments to the MIPS eligible clinician are subject to a MIPS payment
adjustment factor, which CMS determines based on the MIPS eligible
clinician's final score. In determining each MIPS eligible clinician's
final score, CMS takes into account the assigned weight of, and the
MIPS eligible clinician's performance in, the four MIPS performance
categories, including the Promoting Interoperability performance
category. The MIPS eligible clinician's final score then determines
whether the eligible clinician earns a negative, neutral, or positive
payment adjustment factor that will be applied to the amounts otherwise
paid to the MIPS eligible clinician under Medicare Part B for covered
professional services during the applicable MIPS payment year.
In the interest of addressing this variability, we considered
whether we could propose an alternative approach under which we would
tailor the monetary impact of a disincentive imposed on a health care
provider to the severity of the conduct in which the health care
provider engaged. However, we do not believe it would be feasible to
develop such an approach for the disincentives we propose for health
care providers. Because disincentives must be established using
authorities under applicable Federal law, the statute under which a
disincentive is being established would need to specifically authorize
or provide sufficient discretion for an appropriate agency to be able
to adjust the monetary impact of the disincentive to fit the gravity or
severity of the information blocking the health care provider has been
determined to have committed. Based on our review of potential
authorities under which to establish disincentives, we believe many
authorities do not provide discretion to adjust the monetary impact of
a potential disincentive in this fashion. For instance, in section
III.C.2. of this proposed rule, CMS proposes to establish a
disincentive through the Medicare Promoting Interoperability Program
utilizing authority in SSA section 1886. Under this authority, CMS, as
specified in section 1886(b)(3)(B)(ix)(I) of the SSA, adjusts payments
for eligible hospitals by a fixed proportion, on the basis of whether
or not an eligible hospital (as defined in section 1886(n)(6)(B) of the
SSA) is a meaningful EHR user.
2. Medicare Promoting Interoperability Program for Eligible Hospitals
and Critical Access Hospitals (CAHs)
a. Background
We intend to use existing Medicare Promoting Interoperability
Program authority concerning the meaningful use of certified EHR
technology (CEHRT) to impose disincentives on eligible hospitals and
CAHs that OIG determines have committed information blocking (defined
in 45 CFR 171.103) where OIG refers a determination that the eligible
hospital or CAH committed information blocking. Under section
1886(n)(3)(A) of the SSA, an eligible hospital or CAH \12\ is treated
as a meaningful EHR user for the EHR reporting period for a payment
year if it demonstrates to the satisfaction of the Secretary, and among
other requirements, that during the EHR reporting period: (1) the
eligible hospital used CEHRT in a meaningful manner; and (2) the CEHRT
is connected in a manner that provides, in accordance with law and
standards applicable to the exchange of information, for the electronic
exchange of health information. As discussed further in section
III.C.2.b. of this proposed rule, these requirements for an eligible
hospital or CAH to be a meaningful EHR user would be substantially
undermined and frustrated if the eligible hospital or CAH commits
information blocking, such that application of an appropriate
disincentive is warranted.
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\12\ Section 1814(l)(3) of the SSA applies to critical access
hospitals the standard for determining a meaningful EHR user in
section 1886(n)(3).
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Under section 1886(b)(3)(B)(ix) of the SSA, if an eligible hospital
does not demonstrate that it has met the requirements to be a
meaningful EHR user under section 1886(n)(3)(A), CMS will reduce the
eligible hospital's payment by three quarters of the applicable
percentage increase in the market basket update or rate-of-increase for
hospitals. Under section 1814(l)(4) of the SSA, if the Secretary
determines that a CAH has not been a meaningful EHR user for a given
EHR reporting period, CMS will pay that CAH 100 percent of its
reasonable costs, instead of 101 percent of reasonable costs, which is
the amount that the CAH would have received as a meaningful EHR user
under the Medicare Promoting Interoperability Program.
HHS has authority to apply disincentives to both eligible hospitals
and CAHs. PHSA section 3022(b)(2)(B) authorizes HHS to apply
disincentives to health care providers OIG determines have committed
information blocking. As discussed in section II.B.1 of this proposed
rule, HHS has adopted, for purposes of the information blocking
regulations in 45 CFR part 171, the definition of health care provider
in section 3000(3) of the PHSA, which includes health care providers
that are eligible for participation in the Medicare Promoting
Interoperability Program. The
[[Page 74956]]
definition of ``health care provider'' in section 3000(3) of the PHSA
includes ``hospital'' as a health care provider. Section 1886(n)(6)(B)
of the SSA defines the term ``eligible hospital'' for the purposes of
the Medicare Promoting Interoperability Program (75 FR 44316 through
44317) as ``a hospital that is a subsection (d) hospital or a
subsection (d) Puerto Rico hospital.'' Eligible hospitals are located
in one of the fifty States or the District of Columbia (75 FR 44448).
Hospitals in Puerto Rico became eligible hospitals for the Medicare
Promoting Interoperability Program with the passage of the Consolidated
Appropriations Act of 2016 (Pub. L. 114-113, Dec. 18, 2015). A CAH is
defined in section 1861(mm) of the SSA as ``a facility that has been
certified as a critical access hospital under section 1820(e).''
``Hospital'' is not further defined under the PHSA definition in
section 3000(3). Therefore, CMS interprets the term ``hospital'' in
section 3000(3) of the PHSA to include both eligible hospitals and CAHs
that can participate in the Medicare Promoting Interoperability
Program.
b. The Medicare Promoting Interoperability Program as an Appropriate
Disincentive for Information Blocking Under the PHSA
As discussed previously, the requirements under SSA section
1886(n)(3)(A) that an eligible hospital or CAH must meet to a be
meaningful EHR user, particularly the first two requirements under SSA
section 1886(n)(3)(A)(i) and (ii), would be substantially undermined
and frustrated if the eligible hospital or CAH commits information
blocking, such that application of an appropriate disincentive is
warranted. To be considered a meaningful EHR user under section
1886(n)(3)(A) of the SSA, an eligible hospital or CAH must, in brief:
(1) demonstrate to the satisfaction of the Secretary the use of CEHRT
in a meaningful manner, (2) demonstrate to the satisfaction of the
Secretary that their CEHRT is connected in a manner that provides for
electronic exchange of health information to improve the quality of
health care, and (3) use CEHRT to submit information concerning quality
measures and other measures as specified. With respect to the
electronic exchange of health information requirement in SSA section
1886(n)(3)(A)(ii), an eligible hospital or CAH must demonstrate to the
satisfaction of the Secretary that its CEHRT is ``connected in a manner
that provides, in accordance with law and standards applicable to the
exchange of information, for the electronic exchange of health
information to improve the quality of health care, such as promoting
care coordination, and . . . demonstrates . . . that the hospital has
not knowingly and willfully taken action (such as to disable
functionality) to limit or restrict the compatibility or
interoperability of the certified EHR technology.'' Two examples of the
CMS requirements for health information exchange include the
requirement for eligible hospitals and CAHs to report on the Health
Information Exchange Objective and the Provider to Patient Exchange
Objective, both of which are part of the requirements for demonstrating
the meaningful use of CEHRT, in accordance with SSA section 1886(n)(3).
By establishing a disincentive for information blocking under the
Medicare Promoting Interoperability Program, we are using an authority
under applicable Federal law as required in section 3022(b)(2)(B) of
the PHSA. Health care providers OIG determines have committed
information blocking, and for which OIG refers its determination to
CMS, would be subject to a disincentive under applicable law as they
are participating in the Medicare Promoting Interoperability Program
authorized by that applicable law. In addition, the Medicare Promoting
Interoperability Program already requires eligible hospitals and CAHs
to engage in practices that encourage the access, exchange, and use of
electronic health information to avoid a downward payment adjustment.
The requirements an eligible hospital or CAH must meet to be treated as
a meaningful EHR user in section 1886(n)(3)(A)(i) and (ii) of the SSA
specify that an eligible hospital or CAH must demonstrate that it meets
these requirements ``to the satisfaction of the Secretary.'' CMS
believes these provisions authorize the Secretary to interpret these
requirements through rulemaking as necessary to ensure that an eligible
hospital or CAH satisfies the requirements to be a meaningful EHR user
as defined by the Secretary. Specifically, CMS believes it is
appropriate for the Secretary to interpret these requirements through
rulemaking to determine that an eligible hospital or CAH that has
committed information blocking, and for which OIG refers its
determination of information blocking to CMS, has not met the
definition of a meaningful EHR user. This proposal is consistent with
the goals of the Medicare Promoting Interoperability Program, which
include the advancement of CEHRT utilization, focusing on
interoperability and data sharing (81 FR 79837). Information blocking
by eligible hospitals and CAHs would frustrate both these goals.
CMS also believes the proposed disincentive under the Medicare
Promoting Interoperability Program would be an appropriate disincentive
that would similarly deter information blocking by other eligible
hospitals and CAHs, consistent with the discussion in section III.A.3.
of this proposed rule. While the exact monetary impact of the
disincentive would vary based on the specific eligible hospital, CMS
believes a reduction of three quarters of the annual market basket
update would deter eligible hospitals from engaging in information
blocking because it would reduce the inpatient prospective payment
system (IPPS) payment that an eligible hospital could have earned had
it met other requirements under the Medicare Promoting Interoperability
Program. Similarly, though the exact dollar amount would vary based on
the specific CAH, CMS believes that receiving 100 percent of reasonable
costs instead of the 101 percent of reasonable costs that a CAH may
have earned for successful participation in the Medicare Promoting
Interoperability Program would deter information blocking by CAHs
because it would reduce the reimbursement a CAH could have received had
it met other requirements under the Medicare Promoting Interoperability
Program.
HHS analyzed the range of potential disincentive amounts an
eligible hospital could be subject to if the proposed disincentive was
imposed, in order to illustrate the degree to which this disincentive
could deter eligible hospitals from engaging in information blocking.
We used payment data for IPPS eligible hospitals from the CMS Medicare
Inpatient Hospitals dataset for 2021, the latest year of publicly
available data.\13\ We considered the Medicare total payment amounts
for each hospital, which consist of several variables, including Base,
Medicare Severity Diagnosis Related Groups (MS-DRG), and adjustments
such as Indirect Medical Education (IME)/Graduate Medical Education
(GME), disproportionate share hospital (DSH), and outlier payments. We
attempted to estimate the portion of hospitals' total payments subject
to the market basket increase by excluding adjustments not subject to
the increase, using data from CMS Hospital Cost Reports to subtract out
DSH and IME/GME payments, which account for a large portion of
[[Page 74957]]
these adjustments.\14\ Since we did not account for other adjustments
such as outlier payments, the remaining payment amount may overestimate
the payment subject to the market basket increase.
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\13\ Available at https://data.cms.gov/provider-summary-by-type-of-service/medicare-inpatient-hospitals/medicare-inpatient-hospitals-by-provider.
\14\ Available at https://www.cms.gov/research-statistics-data-and-systems/downloadable-public-use-files/cost-reports.
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We then conducted a simulation that applied the proposed
disincentive amount to a market basket adjustment factor. We simulated
a hypothetical scenario of a 3.2 percent market basket increase and a
reduction of three quarters of that percentage increase if the proposed
information blocking disincentive were applied.\15\ Under this
scenario, a hospital that lost three quarters of the market basket
increase due to the proposed information blocking disincentive would be
left with a 0.8 percent market basket increase. Based on this
calculation, we estimated a median disincentive amount of $394,353, and
a 95 percent range of $30,406 to $2,430,766 across eligible hospitals.
The value of the reduction in the market basket increase would be
larger in dollar terms for hospitals with greater base IPPS payments.
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\15\ The hypothetical 3.2 percent market basket increase used in
this simulation was based on the 2023 Medicare Trustees Report,
which assumes a 3.2 percent annual market basket increase.
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c. Proposals
CMS is proposing to revise the definition of ``Meaningful EHR
User'' in 42 CFR 495.4 to state that an eligible hospital or CAH is not
a meaningful EHR user in a calendar year if OIG refers a determination
that the eligible hospital or CAH committed information blocking, as
defined at 45 CFR 171.103, during the calendar year of the EHR
reporting period. As a result of the proposal, CMS would apply a
downward payment adjustment under the Medicare Promoting
Interoperability Program to any such eligible hospital or CAH because
the eligible hospital or CAH would not be a meaningful EHR user, as
required under SSA sections 1886(b)(3)(B)(ix) and 1814(l)(4). For
eligible hospitals, CMS would apply the downward adjustment to the
payment adjustment year that occurs 2 years after the calendar year
when the OIG referral occurs. For CAHs, CMS would apply the downward
adjustment to the payment adjustment year that is the same as the
calendar year when the OIG referral occurs.
As a result of these proposals, an eligible hospital or CAH that
otherwise fulfilled the required objectives and measures to demonstrate
that it is a meaningful EHR user for an EHR reporting period would
nevertheless not be a meaningful EHR user for that EHR reporting period
if OIG refers a determination of information blocking to CMS during the
calendar year in which the EHR reporting period falls. CMS considered
applying this proposed disincentive based on the date that the eligible
hospital or CAH committed the information blocking as determined by
OIG, instead of the date OIG refers its determination to CMS. However,
a significant period of time could pass between the date when the
eligible hospital or CAH is determined to have committed information
blocking, and the date when OIG makes a referral to CMS, due to the
time required for OIG to fully investigate a claim of information
blocking. Such delay between the date the information blocking occurred
and OIG's referral could complicate the application of the disincentive
and would likely necessitate reprocessing of a significant number of
claims. Therefore, CMS proposes to use the date of the OIG referral
instead of the date of the information blocking occurrence to apply the
proposed disincentive. Accordingly, CMS would apply the proposed
disincentive to the payment adjustment year associated with the
calendar year in which the OIG referred its determination to CMS.
CMS further notes that if an eligible hospital or CAH received the
applicable downward payment adjustment because CMS had already
determined the eligible hospital or CAH had otherwise not been a
meaningful EHR user during the applicable EHR reporting period due to
its performance in the Medicare Promoting Interoperability Program,
imposition of the proposed disincentive would result in no additional
impact on the eligible hospital or CAH during that payment adjustment
year. Finally, CMS clarifies that, even if multiple information
blocking violations were identified as part of OIG's determination
(including over multiple years) and referred to CMS, each referral of
an information blocking determination by OIG would only affect an
eligible hospital's or CAH's status as a meaningful EHR user in a
single EHR reporting period during the calendar year when the
determination of information blocking was referred by OIG. Unless OIG
makes an additional referral of an information blocking determination
in the subsequent calendar year, an eligible hospital or CAH would
again be able to qualify as a meaningful EHR user starting in the
subsequent EHR reporting period.
CMS invites public comment on these proposals, particularly on its
approach to the application of a disincentive for OIG determinations
that found that information blocking occurred in multiple years and
whether there should be multiple disincentives for such instances (for
example, disincentives in multiple calendar years/reporting periods
compared to only the calendar year/reporting period in which OIG made
the referral).
d. Notification and Application of the Disincentive
After OIG has determined that a health care provider has committed
information blocking and referred that health care provider to CMS, CMS
would notify the eligible hospital or CAH that OIG determined that the
eligible hospital or CAH committed information blocking as defined
under 45 CFR 171.103, and thus the eligible hospital or CAH was not a
meaningful EHR user for the EHR reporting period in the calendar year
when OIG referred its information blocking determination to CMS. This
notice would be issued in accordance with the notice requirements
proposed at 45 CFR 171.1002, as discussed in section III.B.2 of this
proposed rule.
As a result of our proposal to modify the definition of meaningful
EHR user in 42 CFR 495.4, the application of the disincentive would
result in a downward payment adjustment for eligible hospitals 2 years
after the OIG referral of a determination of information blocking to
CMS. Based upon the existing regulation at 42 CFR 495.4, the downward
payment adjustment would apply 2 years after the year of the referral
and the EHR reporting period in which the eligible hospital was not a
meaningful EHR user. For CAHs, the downward payment adjustment would
apply to the payment adjustment year in which the OIG referral was
made.
CMS invites public comment on these proposals.
3. Promoting Interoperability Performance Category of the Medicare
Merit-Based Incentive Payment System (MIPS)
a. Background
MIPS requires that MIPS eligible clinicians use CEHRT, as defined
at SSA section 1848(o)(4) and 42 CFR 414.1305,\16\ in a meaningful
manner, in
[[Page 74958]]
accordance with SSA sections 1848(q)(2)(A)(iv) and (B)(iv) and
1848(o)(2) and 42 CFR 414.1375, to earn a score for the MIPS Promoting
Interoperability performance category. We intend to use this existing
authority, requiring the meaningful use of CEHRT, to impose
disincentives on MIPS eligible clinicians that OIG determines to have
committed information blocking as defined at 45 CFR 171.103.
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\16\ For MIPS, SSA section 1848(o)(4) defines CEHRT as a
qualified electronic health record (as defined in PHSA section
3000(13)) that is certified by ONC pursuant to PHSA section
3001(c)(5) as meeting standards adopted under PHSA section 3004 that
are applicable to the type of record involved, as determined by the
Secretary. CMS has codified the definition of CEHRT, including
additional criteria it must be certified as meeting, that MIPS
eligible clinicians must use at 42 CFR 414.1305.
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(1) MIPS Overview--Scoring and Payment Calculations
Authorized by the Medicare Access and CHIP Reauthorization Act of
2015 (MACRA) (Pub. L. 114-10, April 16, 2015), the Quality Payment
Program is a payment incentive program, by which the Medicare program
rewards MIPS eligible clinicians who provide high-value, high-quality
services in a cost-efficient manner. The Quality Payment Program
includes two participation tracks for clinicians providing services
under the Medicare program: MIPS and Advanced Alternative Payment
Models (APMs). The statutory requirements for MIPS are set forth in SSA
sections 1848(q) and (r).
For the MIPS participation track, MIPS eligible clinicians are
subject to a MIPS payment adjustment (positive, negative, or neutral)
based on their performance in four performance categories (cost,
quality, improvement activities, and Promoting Interoperability)
compared to the established performance threshold for that performance
period/MIPS payment year. CMS assesses each MIPS eligible clinician's
total performance according to established performance standards with
respect to the applicable measures and activities specified in each of
these four performance categories during a performance period to
compute a final composite performance score (a ``final score'' as
defined at 42 CFR 414.1305) in accordance with our policies set forth
in 42 CFR 414.1380.
In calculating the final score, CMS must apply different weights
for the four performance categories, subject to certain exceptions, as
set forth in SSA section 1848(q)(5) and at 42 CFR 414.1380. Unless CMS
assigns a different scoring weight pursuant to these exceptions, for
the CY 2024 performance period/2026 MIPS payment year, the scoring
weights are as follows: 30 percent for the quality performance
category; 30 percent for the cost performance category; 15 percent for
the improvement activities performance category; and 25 percent for the
Promoting Interoperability performance category (SSA section
1848(q)(5)(E); 42 CFR 414.1380(c)(1)).
To calculate the payment adjustment factor that will be applied to
the amounts otherwise paid to MIPS eligible clinicians under Medicare
Part B for covered professional services during the applicable MIPS
payment year, CMS then compares the final score to the performance
threshold CMS has established for that performance period/MIPS payment
year at 42 CFR 414.1405(b). The MIPS payment adjustment factors
specified for a year must result in differential payments such that
MIPS eligible clinicians with final scores above the performance
threshold receive a positive MIPS payment adjustment factor, those with
final scores at the performance threshold receive a neutral MIPS
payment adjustment factor, and those with final scores below the
performance threshold receive a negative MIPS payment adjustment
factor. As further specified in SSA section 1848(q)(6)(F) and 42 CFR
414.1405, CMS also applies a scaling factor to determine the MIPS
payment adjustment factor for each MIPS eligible clinician, and CMS
must ensure that the estimated aggregate increases and decreases in
payments to all MIPS eligible clinicians as a result of MIPS payment
adjustment factors are budget neutral for that MIPS payment year. As
provided in SSA sections 1848(q)(6)(A) and (B)(iv) and 42 CFR
414.1405(c), the positive MIPS payment adjustment factor may be up to 9
percent for a final score of 100 and the negative MIPS payment
adjustment factor may be up to negative 9 percent for a final score of
zero.
(2) MIPS Promoting Interoperability Performance Category
For MIPS eligible clinicians, SSA section 1848(q)(2)(A)(iv)
includes the meaningful use of CEHRT as one of the four performance
categories by which a MIPS eligible clinician is assessed to determine
a MIPS payment adjustment factor, as discussed previously. CMS refers
to this performance category as the Promoting Interoperability
performance category. SSA section 1848(q)(2)(B)(iv) provides that the
requirements set forth in SSA section 1848(o)(2) for determining
whether a MIPS eligible clinician is a meaningful user of CEHRT also
apply to our assessment of MIPS eligible clinicians' performance on
measures and activities with respect to the MIPS Promoting
Interoperability performance category. Also, SSA section 1848(o)(2)(D)
generally provides that the requirements for being a meaningful EHR
user under section 1848(o)(2) continue to apply for purposes of MIPS.
A MIPS eligible clinician that is not a meaningful user of CEHRT in
accordance with SSA section 1848(o)(2)(A) cannot satisfy the
requirements of the MIPS Promoting Interoperability performance
category and, therefore, would earn a score of zero for this
performance category. Applying the weights for the performance
categories under 42 CFR 414.1380(c)(1), a score of zero for the
Promoting Interoperability performance category would mean that the
maximum final score a MIPS eligible clinician could achieve, if they
performed perfectly in the three remaining performance categories,
would be 75 points.
To be a meaningful EHR user under SSA section 1848(o)(2)(A) (and
therefore meet the requirements of the MIPS Promoting Interoperability
performance category under SSA section 1848(q)(2)(B)(iv)), a MIPS
eligible clinician must meet three requirements related to the
meaningful use of CEHRT during a performance period for a MIPS payment
year. In brief, the MIPS eligible clinician must (1) demonstrate to the
satisfaction of the Secretary the use of CEHRT in a meaningful manner;
(2) demonstrate to the satisfaction of the Secretary that their CEHRT
is connected in a manner that provides for electronic exchange of
health information to improve the quality of care; and (3) use CEHRT to
submit information concerning quality measures and other measures as
specified.
More specifically, for the first requirement under SSA section
1848(o)(2)(A)(i), a MIPS eligible clinician must demonstrate, to the
satisfaction of the Secretary, that during the relevant performance
period, the MIPS eligible clinician is ``using certified EHR technology
in a meaningful manner.'' For the second requirement under SSA section
1848(o)(2)(A)(ii), a MIPS eligible clinician must demonstrate, to the
satisfaction of the Secretary, that during the relevant period CEHRT is
``connected in a manner that provides, in accordance with law and
standards applicable to the exchange of information, for the electronic
exchange of health information to improve the quality of care, such as
promoting care coordination'' and the MIPS eligible clinician
demonstrates, through ``a process specified by the Secretary, such as
the use of an attestation'' that the MIPS eligible clinician ``has not
knowingly and willfully taken action
[[Page 74959]]
(such as to disable functionality) to limit or restrict the
compatibility or interoperability of the certified EHR technology.''
For the third requirement under SSA section 1848(o)(2)(A)(iii), a MIPS
eligible clinician currently must submit information via their CEHRT on
``such clinical quality measures and such other measures as selected by
the Secretary'' in ``a form and manner specified by the Secretary,''
including measures focused on providing patients with electronic access
to their electronic health information, sending electronic health
information to other health care providers, and receiving and
incorporating electronic health information from other health care
providers.
As discussed further in section III.C.3.b. of this proposed rule,
these three requirements for a MIPS eligible clinician to be determined
to be a meaningful user of CEHRT, particularly the first two
requirements under SSA section 1848(o)(2)(A)(i) and (ii), would be
substantially undermined and frustrated if the MIPS eligible clinician
commits information blocking, such that application of an appropriate
disincentive is warranted.
b. The MIPS Promoting Interoperability Performance Category
Requirements as an Appropriate Disincentive for Information Blocking
Under the PHSA
As discussed previously, we believe that the requirements set forth
in SSA sections 1848(q)(2)(B)(iv) and 1848(o)(2)(A) for the MIPS
Promoting Interoperability performance category are an applicable
Federal law for the purposes of establishing a disincentive for a
health care provider that participates in MIPS and has been determined
by OIG to have committed information blocking. First, the definitions
of MIPS eligible clinician and health care provider under 45 CFR
171.102 and the PHSA generally are aligned. Second, committing
information blocking not only violates the law and principles set forth
in the Cures Act, but also undermines the goals and purpose of the MIPS
Promoting Interoperability performance category. On such basis, CMS is
proposing an appropriate disincentive for MIPS eligible clinicians that
OIG determines have committed information blocking and for whom OIG
refers its determination of information blocking to CMS, as discussed
further in section III.C.3.c. of this proposed rule.
(1) Alignment of Definitions of MIPS Eligible Clinician and Health Care
Provider Under the PHSA
CMS believes that the definitions of MIPS eligible clinician under
the SSA and 42 CFR 414.1305 and health care provider under PHSA section
3000(3) and 45 CFR 171.102 generally are aligned. CMS believes this
alignment will permit application of appropriate disincentives, as
required by PHSA section 3022(b)(2)(B), to MIPS eligible clinicians,
except for qualified audiologists. CMS proposes to codify this
exception in the definition of Meaningful EHR User for MIPS at 42 CFR
414.1305.
Beginning with the 2024 MIPS payment year, a MIPS eligible
clinician is defined in 42 CFR 414.1305 as including: (1) a physician
(as defined in SSA section 1861(r)); (2) a physician assistant, nurse
practitioner, and clinical nurse specialist (as defined in SSA
1861(aa)(5)); (3) a certified registered nurse anesthetist (defined in
SSA section 1861(bb)(2)); (4) a physical therapist or occupational
therapist; (5) a qualified speech-language pathologist; (6) a qualified
audiologist (as defined in SSA section 1861(ll)(4)(B)); (7) a clinical
psychologist (as defined by the Secretary for purposes of SSA section
1861(ii)); (8) a registered dietician or nutrition professional; (9) a
clinical social worker (as defined in SSA section 1861(hh)(1)); (10) a
certified nurse midwife (as defined in SSA section 1861(gg)(2)); and
(11) a group, identified by a unique single taxpayer identification
number (TIN), with two or more eligible clinicians, one of which must
be a MIPS eligible clinician, identified by their individual national
provider identifier (NPI) and who have reassigned their billing rights
to the single group TIN. However, for a given performance period/MIPS
payment year, a MIPS eligible clinician does not include an eligible
clinician who meets one of the exclusions set forth in 42 CFR
414.1310(b), including being a Qualifying APM participant, Partial
Qualifying APM Participant that does not elect to participate in MIPS,
or does not exceed the low volume threshold (as these terms are defined
in 42 CFR 414.1305).
Meanwhile, the definition of ``health care provider'' under PHSA
section 3000(3) as implemented in 45 CFR 171.102, includes the
following which are also considered MIPS eligible clinicians: (1) a
``group practice'' (which is not defined in the PHSA); (2) a physician
(as defined in SSA section 1861(r)); (3) practitioners, as defined in
SSA section 1842(b)(18)(C) to include: (a) a physician assistant, nurse
practitioner, and clinical nurse specialist (as defined in SSA
1861(aa)(5)); (b) a certified registered nurse anesthetist (defined in
SSA section 1861(bb)(2)); (c) a certified nurse-midwife (as defined in
SSA section 1861(gg)(2)); (d) a clinical social worker (as defined in
SSA section 1861(hh)(1)); (e) a clinical psychologist (as defined by
the Secretary for purposes of SSA section 1861(ii)); and (f) a
registered dietician or nutrition professional; (4) therapists, as
defined in SSA section 1848(k)(3)(B)(iii) to include: (a) a physical
therapist; (b) an occupational therapist; and (c) a qualified speech-
language pathologist; and (5) ``any other category of health care
facility, entity, practitioner, or clinician determined appropriate by
the Secretary.''
CMS notes that, at this time, only a qualified audiologist,
included in the definition of MIPS eligible clinician in 42 CFR
414.1305 since the CY 2019 performance period/2021 MIPS payment year,
is not identified as a health care provider under 45 CFR 171.102 and
PHSA section 3000(3). Because qualified audiologists are not included
in the PHSA definition of health care provider, CMS proposes that MIPS
eligible clinicians who are qualified audiologists would not be subject
to the disincentive proposed for the MIPS Promoting Interoperability
performance category in this proposed rule.
As discussed previously in this section (III.C.3.b.(1)), groups and
multispecialty groups (as defined in 42 CFR 414.1305) also are included
in the definition of MIPS eligible clinician and therefore are subject
to payment adjustments under MIPS based on the performance of MIPS
eligible clinicians that are included in these groups, under different
sets of regulations in 42 CFR part 414, subpart O. Meanwhile, as
discussed previously, the definition of health care provider in PHSA
section 3000(3) includes ``group practice,'' but does not define what
this term means. Accordingly, CMS also believes that a group may be
subject to the disincentive proposed for the MIPS Promoting
Interoperability performance category in this proposed rule if the
group has been determined by OIG to have committed information
blocking, or if MIPS eligible clinicians included in the group have
committed information blocking.
[[Page 74960]]
(2) Information Blocking Conduct Undermines the Goals and Purpose of
the MIPS Promoting Interoperability Performance Category
Health care providers that engage in information blocking undermine
and frustrate the purpose for requiring MIPS eligible clinicians to use
CEHRT in a meaningful manner. Specifically, requiring MIPS eligible
clinicians to use CEHRT is not limited to MIPS eligible clinicians
adopting and implementing CEHRT for documenting clinical care in lieu
of paper-based medical records. For use of CEHRT to be meaningful, SSA
section 1848(o)(2)(A) requires that MIPS eligible clinicians use CEHRT
to communicate with other treating providers, pharmacies, and oversight
authorities regarding the patient's health information, including the
MIPS eligible clinician's review and treatment of the patient's health.
SSA sections 1848(o)(2)(A)(i) and (ii) require that MIPS eligible
clinicians demonstrate that they are meaningfully using CEHRT's key
functionalities, such as electronically prescribing, and ensuring that
CEHRT is ``connected in a manner that provides, in accordance with law
and standards applicable to the exchange of information, for the
electronic exchange of health information to improve the quality of
health care,'' such as ``promoting care coordination.'' SSA section
1848(o)(2)(A)(ii) further requires that the MIPS eligible clinician
demonstrate that they have not ``knowingly and willfully taken action
(such as to disable functionality) to limit or restrict the
compatibility or interoperability'' of CEHRT, which is similar to the
directive to investigate and discourage information blocking under PHSA
section 3022. Establishing an appropriate disincentive for information
blocking under the MIPS Promoting Interoperability performance category
would not only deter information blocking, but would strengthen an
existing merit-based incentive payment system that already encourages
health care providers to support the access, exchange, and use of
electronic health information.
Furthermore, the requirements to be treated as a meaningful EHR
user in SSA sections 1848(o)(2)(A)(i) and (ii) specify that a MIPS
eligible clinician must demonstrate that they meet these requirements
to the satisfaction of the Secretary. CMS believes these provisions
authorize the Secretary to interpret these requirements through
rulemaking as necessary to ensure that a MIPS eligible clinician
satisfies the requirements to be a meaningful user of CEHRT as defined
by the Secretary. Specifically, CMS believes it is appropriate for the
Secretary to interpret these requirements through rulemaking to
determine that a MIPS eligible clinician that has committed information
blocking is not a meaningful EHR user. This proposal is consistent with
the goals of the MIPS Promoting Interoperability performance category,
which include promoting health care efficiency and encouraging
widespread health information exchange (81 FR 77200 through 77202).
Information blocking by MIPS eligible clinicians frustrates both these
goals.
CMS believes a disincentive for information blocking associated
with the MIPS Promoting Interoperability performance category would be
an appropriate disincentive that would deter information blocking by
other MIPS eligible clinicians, consistent with the discussion in
section III.A.3. of this proposed rule. While the exact monetary impact
of the disincentive may vary for each MIPS eligible clinician based on
the various factors CMS considers when determining the MIPS payment
adjustment factor, CMS believes the proposed disincentive would deter
information blocking by other MIPS eligible clinicians. A MIPS eligible
clinician who receives a score of zero in the MIPS Promoting
Interoperability performance category under this proposed disincentive
may not be able to earn a positive or neutral MIPS payment adjustment
factor that they otherwise would have earned for their performance in
MIPS.
To illustrate the degree to which this disincentive could deter
information blocking, HHS analyzed the range of potential disincentive
amounts MIPS eligible clinicians could be subject to if the proposed
disincentive was imposed, using actual payment and MIPS data from 2021,
the most recent year of publicly available data. The three data sets
used were the Medicare Fee-For-Service Provider Utilization & Payment
Data--Physician and Other Practitioners Dataset; the Clinician Public
Reporting: Overall MIPS Performance Dataset and the Quality Payment
Program Experience Dataset.17 18 19 The Medicare Fee-For-
Service Provider Utilization file contains actual payments to
clinicians under Medicare Part B. We simulated disincentive amounts for
all eligible clinicians on an individual basis by applying zero points
for the Promoting Interoperability performance category portion of the
MIPS score and using the MIPS scoring policies from the CY 2021
performance year. We estimated potential disincentive amounts for
groups by multiplying estimated per-clinical disincentive amounts by
the number of eligible clinicians in estimated group sizes.
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\17\ Provider Utilization and Payment Data available at https://catalog.data.gov/dataset/medicare-physician-other-practitioners-by-provider-b297e.
\18\ Overall MIPS Performance Dataset available at https://data.cms.gov/provider-data/dataset/a174-a962.
\19\ Quality Payment Program Experience Dataset available at
https://data.cms.gov/quality-of-care/quality-payment-program-experience/data.
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We first assessed the overall payment to eligible clinicians as
well as the portion of the payment that was based on a positive or
negative adjustment based on their MIPS score. We then varied the MIPS
score based on lower scores on the Promoting Interoperability
performance category portion, determined the change in positive or
negative adjustment amount, and recalculated the payment under Medicare
Part B. The difference between the actual 2021 payment and the
simulated payment under the lower score represents the disincentive
amount calculated in the simulation for individual eligible clinicians.
We estimated a median individual disincentive amount of $686 and a 95
percent range (the 2.5th to 97.5th percentile of estimated disincentive
amounts) of $38 to $7,184 across all eligible clinicians (including
those who may have been in a group). Based on the median estimated
disincentive amount of $686 and estimated median group size of six
clinicians, we estimated a group disincentive of $4,116 and a range of
$1,372 to $165,326 for group sizes ranging from two to 241 clinicians
(the estimated 2.5th to 97.5th percentile of group sizes). In
consideration of MIPS eligible clinicians that may be subject to
higher-than-median disincentives, we also simulated estimates for a
median-sized group of six clinicians and an estimated 75th percentile
per-clinician disincentive amount of $1,798. Based on this, we
estimated a disincentive of $10,788. We noted that the ranges of
potential group disincentive amounts vary based on individual clinician
payments and group sizes.
c. Proposals
Under the authority in SSA sections 1848(o)(2)(A) and (D), and
1848(q)(2)(A)(iv) and (B)(iv), for the MIPS Promoting Interoperability
performance category, CMS proposes that a MIPS eligible clinician would
not be a meaningful EHR user in a performance period if OIG refers a
determination that the MIPS eligible clinician committed information
blocking (as defined at 45 CFR 171.103)
[[Page 74961]]
at any time during the calendar year of the performance period.\20\ CMS
also proposes that the determination by OIG that the MIPS eligible
clinician committed information blocking would result in a MIPS
eligible clinician that is required to report on the MIPS Promoting
Interoperability performance category not earning a score in the
performance category (a zero score), which is typically a quarter of
the total final score. CMS proposes to codify this proposal under the
definition of meaningful EHR user for MIPS at 42 CFR 414.1305 and amend
the requirements for earning a score for the MIPS Promoting
Interoperability performance category at 42 CFR 414.1375(b).
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\20\ As provided in 42 CFR 414.1320(h), for purposes of the 2024
MIPS payment year and each subsequent MIPS payment year, the
performance period for the MIPS Promoting Interoperability
performance category is a minimum of a continuous 90-day period
within the calendar year that occurs 2 years prior to the applicable
MIPS payment year, up to and including the full calendar year. In 42
CFR 414.1305, CMS has defined the ``MIPS payment year'' as the
calendar year in which the MIPS payment adjustment factor is applied
to Medicare Part B payments. In the CY 2024 Physician Fee Schedule
proposed rule, CMS proposed that, beginning with the 2026 MIPS
payment year, the performance period for the MIPS Promoting
Interoperability performance category is a minimum of a continuous
180-day period within the calendar year that occurs 2 years prior to
the applicable MIPS payment year, up to and including the full
calendar year (88 FR 52578 through 52579).
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CMS considered applying this proposed disincentive based on the
date that the MIPS eligible clinician committed the information
blocking as determined by OIG, instead of the date OIG refers its
determination to CMS. However, a significant period of time could pass
between the date when the MIPS eligible clinician is determined to have
committed information blocking, and the date when OIG makes a referral
to CMS, due to the time required for OIG to fully investigate a claim
of information blocking. Such delay between the date the information
blocking allegedly occurred and OIG's referral could complicate our
application of the disincentive and would likely necessitate
reprocessing of a significant number of claims. Therefore, CMS decided
to use the date of the OIG referral instead of the date of the
information blocking occurrence to apply this proposed disincentive.
Accordingly, CMS would apply the proposed disincentive to the MIPS
payment year associated with the calendar year in which OIG referred
its determination to CMS.
As provided in 42 CFR 414.1320, the applicable MIPS payment year is
2 calendar years after the performance period. This time period between
the performance period and the MIPS payment year permits CMS to review
each MIPS eligible clinician's performance to determine their final
score and MIPS payment adjustment factor. Under our proposal, if OIG
referred its determination that a MIPS eligible clinician committed
information blocking in calendar year 2025, then CMS would apply the
disincentive proposed herein for the 2027 MIPS payment year.
First, CMS proposes to amend the definition of ``meaningful EHR
user for MIPS'' at 42 CFR 414.1305. The current definition of
meaningful EHR user for MIPS definition states that a ``meaningful EHR
user for MIPS means a MIPS eligible clinician who possesses CEHRT, uses
the functionality of CEHRT, reports on applicable objectives and
measures specified for the Promoting Interoperability performance
category for a performance period in the form and manner specified by
CMS, does not knowingly and willfully take action (such as to disable
functionality) to limit or restrict the compatibility or
interoperability of CEHRT, and engages in activities related to
supporting providers with the performance of CEHRT.'' CMS proposes to
add to this definition that a MIPS eligible clinician is not a
meaningful EHR user in a performance period if OIG refers a
determination that the clinician committed information blocking (as
defined at 45 CFR 171.103) during the calendar year of the performance
period. CMS also proposes other minor technical changes to the language
of the definition. In tandem with other proposals in this section, this
proposed amendment to the definition in 42 CFR 414.1305 would result in
a MIPS eligible clinician not being able to earn points associated with
the Promoting Interoperability performance category they may otherwise
have earned, potentially resulting in a negative or neutral payment
adjustment. As such, this potential outcome likely would deter health
care providers from engaging in information blocking.
Second, CMS proposes to amend our requirements for earning a score
for the MIPS Promoting Interoperability performance category by adding
a new requirement at 42 CFR 414.1375(b). Currently, 42 CFR 414.1375(b)
provides that, to earn a score (other than zero) for the Promoting
Interoperability performance category, the MIPS eligible clinician must
meet certain requirements, including using CEHRT, reporting on the
objectives and associated measures as specified by CMS, and attesting
to certain statements and activities. CMS proposes to amend 42 CFR
414.1375(b) by adding that the MIPS eligible clinician must be a
meaningful EHR user for MIPS as defined at 42 CFR 414.1305. In
conjunction with our proposal to amend the definition of a meaningful
EHR user for MIPS at 42 CFR 414.1305 discussed previously, CMS believes
this proposal would establish a clear basis to apply a score of zero
for the MIPS Promoting Interoperability performance category to a MIPS
eligible clinician that fails to meet the definition of meaningful EHR
user for MIPS during a performance period, specifically if OIG refers a
determination of information blocking during the calendar year of the
performance period.
Under these proposals, a MIPS eligible clinician that OIG
determines has committed information blocking would not be a meaningful
EHR user, and therefore would be unable to earn a score (instead,
earning a score of zero) for the MIPS Promoting Interoperability
performance category. Because a MIPS eligible clinician that has
committed information blocking would not be a meaningful EHR user for a
given performance period, they would earn a zero for the Promoting
Interoperability performance category for the calendar year of the
applicable performance period in which the determination of information
blocking was referred by OIG. For example, if OIG refers a
determination that a MIPS eligible clinician committed information
blocking to CMS in CY 2026, CMS would apply a score of zero for the
Promoting Interoperability performance category for the CY 2028 MIPS
payment year to the MIPS eligible clinician.
Under this proposed disincentive for information blocking, a score
of zero for the MIPS Promoting Interoperability performance category
would negatively impact 25 percent of the MIPS eligible clinician's
final score such that it would likely result in a negative MIPS payment
adjustment for the applicable MIPS payment year. For example, applying
the weights for the performance categories under 42 CFR 414.1380(c)(1),
a score of zero for the Promoting Interoperability performance category
would mean that the maximum final score a MIPS eligible clinician could
achieve, if they performed perfectly in the three remaining performance
categories, would be 75 points.
Then, as discussed previously, to determine the MIPS payment
adjustment factor, CMS compares the MIPS eligible clinician's final
score to the established performance threshold for that MIPS payment
year. In 42 CFR 414.1405(b)(9)(ii), CMS established that the
performance threshold for the 2025
[[Page 74962]]
MIPS payment year is 75 points. If, under this example, a MIPS eligible
clinician still achieved 75 points for their final score for the 2025
MIPS payment year matching the established performance threshold of 75
points, then they would receive a neutral MIPS payment adjustment
factor.
However, in the CY 2024 Physician Fee Schedule proposed rule, CMS
proposed that the performance threshold for the 2026 MIPS payment year
would be 82 points (88 FR 52596 through 52601). If this performance
threshold of 82 points is finalized for the 2026 MIPS payment year, or
some other performance threshold higher than 75 points is finalized in
a future MIPS payment year, then, under our example, a MIPS eligible
clinician (that OIG determined committed information blocking and
received a score of zero in the Promoting Interoperability performance
category and therefore a final score of 75 points) would receive a
negative MIPS payment adjustment factor. If CMS finalizes a performance
threshold higher than 75 points in a future MIPS payment year, this
proposed disincentive would likely to result in a MIPS eligible
clinician that commits information blocking, as determined by OIG,
receiving a negative payment adjustment, up to negative nine percent
for a final score of zero as set forth in 42 CFR 414.1405(b)(2) and
(c).
Under this proposal, a MIPS eligible clinician that otherwise
fulfilled other requirements to demonstrate meaningful use for a
performance period, and earned a score for the Promoting
Interoperability performance category, would nevertheless not be a
meaningful EHR user for that performance period if OIG refers a
determination of information blocking during the calendar year of the
performance period. CMS further notes that if a MIPS eligible clinician
earned a score of zero for the Promoting Interoperability performance
category for a given year because CMS had already determined the MIPS
eligible clinician had otherwise not been a meaningful EHR user in that
performance period due to its performance in the Promoting
Interoperability performance category, imposition of the proposed
disincentive would result in no additional impact on the MIPS eligible
clinician during that MIPS payment year.
CMS clarifies that, even if multiple information blocking
violations were identified as part of OIG's determination (including
over multiple years) and referred to CMS, each referral of an
information blocking determination by OIG would only affect a MIPS
eligible clinician's status as a meaningful EHR user in a single
performance period during the calendar year when the determination of
information blocking was referred by OIG. Barring an additional
referral of an information blocking determination by OIG in the
subsequent calendar year, a MIPS eligible clinician could be deemed a
meaningful EHR user and earn a score for the Promoting Interoperability
performance category in the following calendar year.
CMS invites public comment on these proposals. CMS particularly
requests comment on its approach to the application of a disincentive
for OIG determinations that found that information blocking occurred in
multiple years and whether there should be multiple disincentives for
such instances (for example, disincentives in multiple calendar years/
performance periods compared to only one disincentive in the calendar
year in which a referral from OIG is made).
(1) Groups and Virtual Groups
CMS also proposes that if data for the MIPS Promoting
Interoperability performance category is submitted as a group or
virtual group then the application of the disincentive would be made at
that level. CMS refers readers to our prior rulemaking governing groups
and virtual groups (81 FR 77073 through 77077) and our regulations at
42 CFR 414.1305 (defining MIPS eligible clinicians as including groups
as well as separately defining groups and virtual groups) and 414.1315
(governing virtual groups). MIPS eligible clinicians who submit data as
a part of a group or virtual group and individually will be evaluated
as an individual and as a group for all performance categories.
Beginning with the CY 2021 performance period/2023 MIPS payment year,
if a TIN/NPI has a virtual group final score associated with it, we
will use the virtual group final score to determine the MIPS payment
adjustment; if a TIN/NPI does not have a virtual group final score
associated with it, we will use the highest available final score
associated with the TIN/NPI to determine the MIPS payment adjustment
(85 FR 84917 through 84919). CMS would apply the MIPS payment
adjustment factor to the Medicare Part B claims during the MIPS payment
year for the MIPS eligible clinicians in the group or virtual group.
Thus, if CMS is calculating a final score and MIPS payment adjustment
factor for a group or virtual group and OIG refers a finding of
information blocking to CMS, CMS would apply the proposed disincentive
to the whole group.
(2) Reweighting Policies
CMS has established policies that result in the reweighting of the
Promoting Interoperability performance category for certain MIPS
eligible clinicians at 42 CFR 414.1380(c)(2). These include but are not
limited to hospital-based clinicians (81 FR 77238 through 77420, 82 FR
53684, and 82 FR 53686 through 53687) and Ambulatory Surgical Center-
based clinicians (82 FR 53684). CMS is not proposing changes to its
existing reweighting policies for MIPS eligible clinicians.
Starting with the CY 2022 performance period/2024 MIPS payment year
performance period CMS automatically reweights small practices for the
Promoting Interoperability performance category (86 FR 65485 through
65487; 42 CFR 414.1380(c)(2)(i)(C)(9)). CMS is not proposing changes to
our existing policy for MIPS eligible clinicians in small practices.
CMS notes that if these MIPS eligible clinicians choose to submit
data for the Promoting Interoperability performance category, their
reweighting is canceled, and they could be subject to a disincentive if
OIG refers a determination of information blocking to CMS.
d. Notification of the Disincentive
After OIG has determined that a health care provider has committed
information blocking and referred that health care provider to CMS, CMS
would notify the MIPS eligible clinician that OIG determined that the
eligible clinician committed information blocking as defined under 45
CFR 171.103, and thus the MIPS eligible clinician was not a meaningful
EHR user for the performance period in the calendar year when OIG
referred its information blocking determination to CMS. CMS would apply
the proposed disincentive to the MIPS payment year associated with the
calendar year in which the OIG referred its determination to CMS. This
notice would be issued in accordance with the notice requirements for
disincentives proposed in 45 CFR 171.1002 (see also section III.B.2. of
this proposed rule).
CMS invites public comment on this proposal.
4. Medicare Shared Savings Program
a. Background
(1) Statutory Authority for Disincentive
Section 3022 of the Patient Protection and Affordable Care Act
(PPACA) (Pub.
[[Page 74963]]
L. 111-148, Mar. 23, 2010) added section 1899 to the Social Security
Act (SSA) (42 U.S.C. 1395jjj), which established the Medicare Shared
Savings Program (Shared Savings Program). In accordance with the
statute, groups of providers of services and suppliers (referred to
herein as ``ACO participants'') and their associated health care
providers (referred to herein as ``ACO providers/suppliers'') meeting
criteria specified by the Secretary may work together to manage and
coordinate care for Medicare fee-for-service beneficiaries through an
ACO. ACOs that meet quality performance standards established by the
Secretary are eligible to receive payments for shared savings the ACO
generates for Medicare and to avoid sharing losses at the maximum
level. One condition of participation required by the statute is for
the ACO to define certain processes, including a mandate to ``define
processes to promote evidence-based medicine and patient engagement,
report on quality and cost measures, and coordinate care, such as
through the use of telehealth, remote patient monitoring, and other
such enabling technologies'' (Social Security Act section
1899(b)(2)(G)).
(2) Shared Savings Program Regulations
The Shared Savings Program regulations at 42 CFR part 425 set
forth, among other things, requirements for ACO eligibility, quality
reporting, and other program requirements and beneficiary
protections.\21\ The regulations at 42 CFR 425.116 require that an ACO,
as a condition of participation in the Shared Savings Program, must
effectuate an agreement with its ACO participants and ACO providers/
suppliers (as defined at 42 CFR 425.20). This agreement must expressly
require the ACO participant to agree, and to ensure that each ACO
provider/supplier billing through the TIN of the ACO participant
agrees, to participate in the Shared Savings Program and to comply with
the requirements of the Shared Savings Program and all other applicable
Federal laws and regulations including, but not limited to: (1) Federal
criminal law; (2) The False Claims Act (31 U.S.C. 3729 et seq.); (3)
The anti-kickback statute (42 U.S.C. 1320a-7b(b)); (4) The civil
monetary penalties law (42 U.S.C. 1320a-7a); and (5) The physician
self-referral law (42 U.S.C. 1395nn).
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\21\ Shared Savings Program regulations generally specify
standards for an ACO, which is bound by its participation agreement
to the standards. CMS generally specifies standards applicable to an
ACO participant and ACO provider/supplier that is participating in
the ACO through its regulation of the ACO.
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CMS has interpreted the requirement at section 1899(b)(1)(G) of the
SSA that an ACO coordinates care for assigned beneficiaries using
enabling technologies to require an ACO (and, by agreement, an ACO
participant and ACO provider/supplier) to, among other things, define
its methods and processes established to coordinate care across and
among health care providers both inside and outside the ACO and have a
written plan to ``encourage and promote use of enabling technologies
for improving care coordination for beneficiaries'' (42 CFR
425.112(b)(4)(i) and (b)(4)(ii)(C)). Enabling technologies may include
one or more of the following: electronic health records and other
health IT tools; telehealth services, including remote patient
monitoring; electronic exchange of health information; and other
electronic tools to engage beneficiaries in their care. The ACO must
ensure that ACO participants and ACO providers/suppliers comply with
and implement the defined care coordination process, including the
encouragement and promotion of enabling technologies, and the remedial
processes and penalties (including the potential for expulsion)
applicable to ACO participants and ACO providers/suppliers for failure
to comply with and implement the required process (see 42 CFR
425.112(a)(3)). Sharing health information using enabling technologies
across all health care providers engaged in a beneficiary's care (both
inside and outside the ACO) for purposes of care coordination and
quality improvement is an essential aspect of the ACO's activities.
Moreover, this type of information sharing among health care providers
(both inside and outside the ACO) supports quality measurement and
quality reporting activities, which are necessary in order for the ACO
to be eligible to share in savings and are also used in determining the
amount of shared losses.
Before the start of an agreement period, before each performance
year thereafter, and at such other times as specified by CMS, the ACO
must submit to CMS an ACO participant list and an ACO provider/supplier
list (see 42 CFR 425.118(a)). The ACO must certify the submitted lists
annually. All Medicare-enrolled individuals and entities that have
reassigned their right to receive Medicare payment to the TIN of the
ACO participant must be included on the ACO provider/supplier list and
must agree to participate in the ACO and comply with the requirements
of the Shared Savings Program before the ACO submits the ACO
participant list and the ACO provider/supplier list.
CMS may deny an ACO, ACO participant, and/or an ACO provider/
supplier participation in the Shared Savings Program if the entity or
individual has a history of program integrity issues (see 42 CFR
425.305(a)(2)). CMS screens ACOs, ACO participants, and ACO providers/
suppliers during the Shared Savings Program application process and
periodically thereafter (for example, during the annual certification
of the ACO participant and ACO provider/supplier lists) with regard to
their program integrity history (including any history of Medicare
program exclusions or other sanctions and affiliations with individuals
or entities that have a history of program integrity issues) (see 42
CFR 425.305(a)(1)). In the Medicare Shared Savings Program Final Rule
(76 FR 67802), CMS stated that the results of the screening would need
to be considered in light of the relevant facts and circumstances. CMS
did not draw a bright line regarding when an entity's history of
program integrity issues justifies denial of a Shared Savings Program
participation agreement. CMS stated instead that we would likely
consider the nature of the applicant's program integrity issues
(including the program integrity history of affiliated individuals and
entities), the available evidence, the entity's diligence in
identifying and correcting the problem, and other factors. CMS stated
that we intended to ensure that ACOs, ACO participants, and ACO
providers/suppliers would not pose a risk of fraud or abuse within the
Shared Savings Program while recognizing that some program integrity
allegations may not have been fully adjudicated.
CMS may terminate the participation agreement with an ACO when the
ACO, its ACO participants, or its ACO providers/suppliers or other
individuals or entities performing functions or services related to ACO
activities fail to comply with any of the requirements of the Shared
Savings Program under 42 CFR part 425 (Sec. 425.218(a) and (b)). This
includes, but is not limited to, violations of the physician self-
referral prohibition, CMP law, Federal anti-kickback statute, antitrust
laws, or any other applicable Medicare laws, rules, or regulations that
are relevant to ACO operations. Similarly, CMS requires that the
agreement the ACO effectuates with its ACO participants must permit the
ACO to take remedial action against the ACO participant, and must
require the ACO participant, in turn, to take remedial action against
its ACO providers/suppliers, including
[[Page 74964]]
imposition of a corrective action plan, denial of incentive payments,
and termination of the ACO participant agreement, to address
noncompliance with the requirements of the Shared Savings Program and
other program integrity issues, including program integrity issues
identified by CMS (42 CFR 425.116(a)(7)). Taken together, these
regulations ensure that CMS may take appropriate enforcement actions
when CMS' screening process or oversight of ACOs reveals a history of
program integrity issues or when an ACO, an ACO participant or ACO
provider/suppliers and other individuals or entities performing
functions or services related to ACO activities fail to comply with the
requirements of the Shared Savings Program, including failure to comply
with other Federal laws that are relevant to the ACO's operations, such
as the Cures Act's information blocking provision (PHSA section 3022).
b. Proposals
CMS proposes to revise the Shared Savings Program regulations to
establish disincentives for health care providers, including ACOs, ACO
participants, or ACO providers/suppliers, that engage in information
blocking. Under this proposal, a health care provider that OIG
determines has committed information blocking may not participate in
the Shared Savings Program for a period of at least 1 year.
Information blocking runs contrary to the care coordination goals
of the Shared Savings Program. ACO participants and their ACO
providers/suppliers participating in an ACO in the Shared Savings
Program use enabling technologies (such as electronic health records)
to improve care coordination for beneficiaries. The ability of ACO
providers/suppliers to exchange information between health care
providers (both inside and outside the ACO) is essential for the
operations of the ACO, including for effective coordination of care and
quality improvement activities and services for assigned beneficiaries.
First, CMS proposes to amend 42 CFR 425.208(b) to include a
specific reference to the Cures Act information blocking provision
codified in the PHSA. The provision would be one of many laws with
which ACOs (and by agreement, their ACO participants and ACO providers/
suppliers) must comply.\22\ In this case, compliance is required
because a Medicare enrolled ``health care provider,'' to which an
information blocking disincentive may apply, includes ACO providers/
suppliers (See 42 CFR 400.202 and 425.20 and 45 CFR 171.102). The
effect of adding a specific reference to the information blocking
provision would be to require that, as a condition of participation in
the Shared Savings Program, an ACO must specifically agree (and must
require its ACO participants, ACO providers/suppliers, and other
individuals or entities performing functions or services related to the
ACO's activities to agree) to not commit information blocking as
defined in PHSA section 3022(a).
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\22\ CMS notes that the list of laws included at 42 CFR
425.208(b) with which an ACO must comply is not an exclusive list.
ACOs, ACO participants, and ACO providers/suppliers must continue to
comply with all applicable Federal laws.
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Second, CMS proposes to revise 42 CFR 425.305(a)(1) to specify that
the program integrity history on which ACOs, ACO participants, and ACO
providers/suppliers are reviewed during the Shared Savings Program
application process and periodically thereafter includes, but is not
limited to, a history of Medicare program exclusions or other
sanctions, noncompliance with the requirements of the Shared Savings
Program, or violations of laws specified at 42 CFR 425.208(b). This
revision would provide the basis for CMS to deny participation in the
Shared Savings Program to a health care provider that is an ACO, an ACO
participant, or an ACO provider/supplier when the health care provider
has engaged in information blocking, as determined by OIG.
Third, CMS proposes to make a conforming modification to the
provision related to the grounds for CMS to terminate an ACO at 42 CFR
425.218(b)(3) based on ``[v]iolations of the physician self-referral
prohibition, civil monetary penalties (CMP) law, Federal anti-kickback
statute, antitrust laws, or any other applicable Medicare laws, rules,
or regulations that are relevant to ACO operations.'' CMS proposes to
replace this language with ``[v]iolations of any applicable laws,
rules, or regulations that are relevant to ACO operations, including,
but not limited to, the laws specified at Sec. 425.208(b).''
Pursuant to CMS' authority under 42 CFR 425.206(a)(1)(iii) to deny
an ACO's participation in the Shared Savings Program, CMS' authority
under 42 CFR 425.118(b)(1)(iii) to deny the addition of a health care
provider to an ACO's participation list, and CMS' authority under 42
CFR 425.305(a) to screen for program integrity issues, CMS proposes to
screen ACOs, ACO participants, and ACO providers/suppliers for an OIG
determination of information blocking and deny the addition of such a
health care provider to an ACO's participation list for the period of
at least 1 year. In the case of an ACO that is a health care provider,
CMS proposes to deny the ACO's application to participate in the Shared
Savings Program for the period of at least 1 year. If the ACO were to
re-apply to participate in the Shared Savings Program in a subsequent
year, then CMS would review whether OIG had made any subsequent
determinations of information blocking with respect to the ACO as a
health care provider as well as any evidence that indicated whether the
issue had been corrected and appropriate safeguards had been put in
place to prevent its reoccurrence, as part of the ACO's application
process. CMS therefore proposes that, in cases where the result of the
program integrity screening identifies that an ACO (acting as a health
care provider), ACO participant, or ACO provider/supplier, has
committed information blocking, as determined by OIG, CMS would take
the following actions, as applicable:
Pursuant to 42 CFR 425.118(b)(1)(iii), CMS would deny the
request of the ACO to add an ACO participant to its ACO participant
list on the basis of the results of the program integrity screening
under 42 CFR 425.305(a).
Pursuant to 42 CFR 425.116(a)(7) and (b)(7), CMS would
notify an ACO currently participating in the Shared Savings Program if
one of its ACO participants or ACO providers/suppliers is determined by
OIG to have committed information blocking so that the ACO can take
remedial action--removing the ACO participant from the ACO participant
list or the ACO provider/supplier from the ACO provider/supplier list--
as required by the ACO participant agreement.
Pursuant to 42 CFR 425.305(a)(2), CMS would deny an ACO's
Shared Savings Program application if the results of a program
integrity screening under 42 CFR 425.305(a)(1) reveal a history of
program integrity issues or other sanctions and affiliations with
individuals or entities that have a history of program integrity
issues.
Pursuant to 42 CFR 425.218(a) and (b)(3), CMS would
terminate an ACO participation agreement in the case of a failure to
comply with requirements of the Shared Savings Program, including
violations of any applicable laws, rules, or regulations that are
relevant to ACO operations, including, but not limited to, the laws
specified at 42 CFR 425.208(b).
Each of these actions would deter information blocking consistent
with the discussion of an appropriate
[[Page 74965]]
disincentive in section III.A.3. of this proposed rule. Restricting the
ability for these entities to participate in the Shared Savings Program
for at least 1 year would result in these health care providers
potentially not receiving revenue that they might otherwise have earned
if they had participated in the Shared Savings Program.
The period of time of the disincentive would be at least 1
performance year. CMS would determine if it would be appropriate for
the period to exceed 1 year if OIG has made any subsequent
determinations of information blocking (for example, CMS would be
unlikely impose a disincentive greater than 1 year if the information
blocking occurred in the past and there was evidence that the
information blocking had stopped) and whether safeguards have been put
in place to prevent the information blocking that was the subject of
OIG's determination. Prior to imposing any disincentive arising from an
OIG determination of information blocking, CMS would provide a notice
in accordance with the notice requirements proposed in 45 CFR 171.1002
(see section III.B.2 of this proposed rule) that would specify the
disincentive would be imposed for at least 1 performance year.
CMS proposes to apply the disincentive no sooner than the first
performance year after we receive a referral of an information blocking
determination from OIG and in which the health care provider is to
participate in the Shared Savings Program. CMS performs a program
integrity screening of ACOs, ACO participants, and ACO providers/
suppliers as part of the annual application/change request process for
new and existing ACOs, which typically occurs between May and October
during the performance year. In the case of the new addition of an ACO
participant (TIN) to an ACO's participant list, CMS would prevent the
TIN from joining the ACO as an ACO participant if the program integrity
screening reveals that the TIN has engaged in information blocking, as
determined by OIG. In the case of an existing ACO participant, CMS
would notify the ACO that an ACO participant or an ACO provider/
supplier had committed information blocking, as determined by OIG, so
the ACO can remove the ACO participant or ACO provider/supplier from
its ACO participant list or ACO provider/supplier list, as applicable.
If the TIN were to remain on the ACO participant list or ACO provider/
supplier list when the ACO certifies its ACO participant list for the
next performance year, then CMS would issue a compliance action to the
ACO. Continued noncompliance (for example, failure to remove the TIN)
would result in termination of the ACO's participant agreement with
CMS, as the ACO would have failed to enforce the terms of its ACO
participant agreement.
Applying the disincentive prospectively is the most appropriate
timing for the disincentive. It would be impractical and inequitable
for CMS to apply the disincentive retrospectively or in the same year
in which CMS received a referral from OIG. Applying the disincentive to
a historical performance year or a performance year contemporaneous to
the OIG's determination would unfairly affect other ACO participants
that did not commit the information blocking and likely were not aware
of the information blocking. CMS recognizes, however, that the
prospective application of the disincentive means that it may be
applied to a health care provider substantially after the information
blocking occurred, during the provider's first attempt to participate
in the Shared Savings Program, and after the provider was previously
subject to a disincentive in another program, such as MIPS. As
discussed in more detail below, CMS is contemplating an approach under
which a health care provider could participate in the Shared Savings
Program if a significant amount of time (for example, 3 to 5 years) had
passed between the occurrence of the information blocking and OIG's
determination, and the provider had given assurances in the form and
manner specified by CMS that the issue had been corrected and
appropriate safeguards had been put in place to prevent its
reoccurrence.
After the completion of the last performance year in which the
disincentive was applied, an ACO may submit a change request to add the
TIN or include the NPI on its ACO participant list or ACO provider/
supplier list, as applicable, for a subsequent performance year, and
CMS would approve the addition, assuming that all other Shared Savings
Program requirements for adding a TIN or NPI are met, so long as (1)
OIG has not made any additional determinations of information blocking,
and (2) the ACO provides assurances (in the form and manner required by
CMS) that the information blocking is no longer ongoing and that the
ACO has put safeguards in place to prevent the information blocking
that was the subject of the referral. If, however, OIG made and
referred an additional information blocking determination (that is
either related or unrelated to the previous OIG referral) in a
subsequent year or the ACO cannot provide assurance that the
information blocking has ceased, then CMS would continue to deny
participation.
In addition, CMS would notify ACOs about an ACO participant or ACO
provider/supplier that had committed information blocking, as
determined by OIG, so that the ACO could take remedial action--removing
the ACO participant from the ACO participant list or the ACO provider/
supplier from the ACO provider/supplier list--as required by the ACO
participant agreement. ACOs are well-positioned to take remedial action
against ACO participants and ACO providers/suppliers that have been
found by OIG to have committed information blocking as a result of
their ACO participant agreements, which provide for the ACO to take
remedial action against the ACO participant, and require the ACO
participant to take remedial action against its ACO providers/
suppliers, including imposition of a corrective action plan, denial of
incentive payments, and termination of the ACO participant agreement,
to address noncompliance with the requirements of the Shared Savings
Program and other program integrity issues.
By way of example, consider if in January 2025 OIG determined that
an ACO participant has committed information blocking as recently as
2024 and referred this determination to CMS. Under CMS' proposal, the
ACO participant would be able to remain on the ACO's certified
participant list for the duration of the 2025 performance year.
However, CMS would notify the ACO that an ACO participant had been
determined to have committed information blocking by OIG and that CMS
expected the ACO to take remedial action by removing the ACO
participant from its ACO participant list for a specified period of
time. To determine if removal was warranted for a period in addition to
performance year 2026, CMS would consider whether there was any
evidence to suggest that that information blocking was still occurring
(for example, whether OIG had made a subsequent determination of
information blocking) and whether safeguards had been put in place to
prevent the information blocking that was the subject of the referral.
Upon a review of these criteria, CMS may require the affected ACO to
remove the ACO participant prior to recertification of the ACO
participant list for additional performance years. If the ACO
participant were to remain when the ACO certifies its ACO participant
list for performance year 2026, CMS
[[Page 74966]]
would inform the ACO that it was obligated to take remedial action
against the ACO participant by removing it from the ACO participant
list for performance year 2026; if it failed to do so, CMS would remove
the ACO participant from the ACO's participant list and take compliance
action against the ACO up to terminating the ACO pursuant to 42 CFR
425.218(b)(1) and (3). In the case of a disincentive that was applied
only for performance year 2026, if the ACO were to submit a change
request to add the ACO participant for performance year 2027 or a
subsequent year, then CMS would review whether OIG had made any
subsequent determinations of information blocking with respect to the
ACO participant as well as any evidence that indicated whether the
issue had been corrected and appropriate safeguards had been put in
place to prevent its reoccurrence, prior to approving the ACO
participant to participate in the ACO for performance year 2027 or the
subsequent year.
If an ACO applicant or a renewal ACO applicant that is itself a
health care provider (for example, a large multi-specialty practice
that forms a single participant ACO using its existing legal entity and
governing body under 42 CFR 425.104) is the subject of an OIG
information blocking determination, CMS would deny the ACO's
application for participation in the Shared Savings Program for the
upcoming performance year for which it was applying to participate.
Should OIG make a determination of information blocking with respect to
an ACO that is already participating in the Shared Savings Program and
refer the determination to us for the application of a disincentive,
CMS may terminate the ACO's participation agreement for the upcoming
performance year. CMS would assess a subsequent application from an ACO
to which the disincentive had been applied under the same criteria
described for assessing the return of an ACO participant or ACO
provider/supplier. The ACO may participate in the Shared Savings
Program after the duration of the disincentive so long as OIG had not
made a subsequent determination of information blocking applicable to
the health care provider and whether there was evidence that the issue
had been corrected and appropriate safeguards had been put in place to
prevent its reoccurrence, prior to approving the ACO's application to
participate in the Shared Savings Program in a subsequent performance
year.
The Shared Savings Program is considering an alternative policy in
which CMS would not apply a disincentive in certain circumstances
despite an OIG information blocking determination. Under this
alternative policy, the Shared Savings Program would consider OIG's
referral of an information blocking determination in light of the
relevant facts and circumstances before denying the addition of an ACO
participant to an ACO participant list (or an ACO provider/supplier to
the ACO provider/supplier list), informing an ACO that remedial action
should be taken against the ACO participant (or ACO provider/supplier),
or denying an ACO's application to participate in the Shared Savings
Program. The relevant facts and circumstances could include the nature
of the health care provider's information blocking, the health care
provider's diligence in identifying and correcting the problem, the
time since the information blocking occurred, the time since the OIG's
determination of information blocking, and other factors. This
alternative policy would offer some flexibility in certain
circumstances, where prohibiting an ACO, ACO participant, or ACO
provider/supplier from participating in the Shared Savings Program
would distort participation incentives and therefore be less
appropriate. We are particularly concerned about situations in which
many years have passed since an ACO participant or ACO provider/
supplier was found to be an information blocker and such an issue had
long been remediated. In such a case, the ACO participant or ACO
provider/supplier might be incentivized to apply to the Shared Savings
Program for a year in which it did not actually intend to participate
merely to avoid being barred from doing so at a future date when it did
intend to participate, wasting the resources of the ACO and CMS. Such
an alternative policy could allow a health care provider to participate
in the Shared Savings Program if a significant amount of time had
passed between the occurrence of the information blocking and the OIG's
determination, and the provider had given assurances in the form and
manner specified by CMS that the issue had been corrected and
appropriate safeguards had been put in place to prevent its
reoccurrence.
An ACO may be able to appeal the application of an information
blocking disincentive in the Shared Savings Program. An ACO may appeal
an initial determination that is not prohibited from administrative or
judicial review under 42 CFR 425.800 by requesting a reconsideration
review by a CMS reconsideration official (42 CFR 425.802(a)). To the
extent it is not barred by 42 CFR 425.800, an ACO may appeal the
removal or denial of a health care provider from an ACO participant
list as a result of the referral by OIG of an ACO participant that OIG
had determined to be an information blocker. Subject to the same
limitation, an ACO applicant or ACO may appeal the denial of the ACO
applicant's application or termination of the ACO's participation
agreement as a result of the referral by OIG of the ACO applicant or
ACO that the OIG had determined to be an information blocker. The
underlying information blocking determination made by OIG, however
would not be subject to the Shared Savings Program's reconsideration
process. The OIG determination is not an initial determination made by
CMS, but a determination made by another agency. The Shared Savings
Program reconsideration process may not negate, diminish, or otherwise
alter the applicability of determinations made by other government
agencies (see 42 CFR 425.808(b)).
We remind all health care providers and ACOs that it is possible
that a health care provider or any entity, such as an ACO, may meet the
definition of a health information network or health information
exchange, which is a functional definition, or the definition of a
health IT developer of certified health IT, codified in 45 CFR 171.102.
If it is found by OIG that such health care provider or entity meets
either definition and, while under the same set of facts and
circumstances, is also found by OIG to have committed information
blocking, then the health care provider or entity would be subject to a
different intent standard and civil money penalties administered by OIG
(see generally 88 FR 42820; see 88 FR 42828 through 42829).
We invite public comment on these proposals and on whether
additional actions should be taken.
IV. Request for Information
As discussed in section III.C.1. of this proposed rule, we
recognize that the disincentives we propose would only apply to a
subset of health care providers as defined in 45 CFR 171.102. However,
we believe it is important for HHS to establish appropriate
disincentives that would apply to all health care providers, as such
providers are defined in 45 CFR 171.102. This would ensure that any
health care provider, as defined in 45 CFR 171.102, that has engaged in
information blocking would be subject to appropriate disincentives by
an appropriate agency, consistent with the
[[Page 74967]]
disincentives provision at PHSA section 3022(b)(2)(B).
We request information from the public on additional appropriate
disincentives that we should consider in future rulemaking,
particularly disincentives that would apply to health care providers,
as defined in 45 CFR 171.102, that are not implicated by the
disincentives proposed in this rule. We encourage commenters to
identify specific health care providers (for example, laboratories,
pharmacies, post-acute care providers, etc.) and associated potential
disincentives using authorities under applicable Federal law. We also
request information about the health care providers that HHS should
prioritize when establishing additional disincentives.
V. Collection of Information Requirements
This document does not impose any new information collection
requirements, that is, reporting, recordkeeping or third-party
disclosure requirements. Consequently, there is no need for review by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
VI. Regulatory Impact Statement
We have examined the impacts of this proposed rule as required by
Executive Order 12866 on Regulatory Planning and Review (September 30,
1993), Executive Order 13563 on Improving Regulation and Regulatory
Review (January 18, 2011), Executive Order 14094 entitled ``Modernizing
Regulatory Review'' (April 6, 2023), the Regulatory Flexibility Act
(RFA) (Pub. L. 96-354, September 19, 1980), section 1102(b) of the
Social Security Act, section 202 of the Unfunded Mandates Reform Act of
1995 (March 22, 1995; Pub. L. 104-4), and Executive Order 13132 on
Federalism (August 4, 1999).
A. Executive Order 12866
Executive Order 12866, as amended by Executive Order 14094
published on April 6, 2023, directs agencies to assess all costs and
benefits of available regulatory alternatives and, if regulations are
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, and public health and
safety effects; distributive impacts; and equity). A regulatory impact
analysis must be prepared for major rules with significant effects (for
example, $200 million or more in any given year). This is not a major
rule as defined at 5 U.S.C. 804(2); it is not significant under section
3(f)(1) because it does not reach that economic threshold, nor does it
meet the other criteria outlined in the Executive order.
This proposed rule would implement provisions of the Cures Act
through changes to 45 CFR part 171 and 42 CFR parts 414, 425, and 495.
We believe that the likely aggregate economic effect of these
regulations would be significantly less than $200 million.
The expected benefits of this proposed rule would be to deter
information blocking that interferes with effective health information
exchange and negatively impacts many important aspects of healthcare.
We refer readers to the impact analysis of the benefits of prohibiting
and deterring information blocking in the ONC Cures Act Final Rule,
which encompasses all anticipated benefits without differentiation
among actors (85 FR 25936).
We anticipate that OIG would incur some costs associated with
investigation as authorized by the Cures Act. The Consolidated
Appropriations Act, 2022 appropriates to OIG funding necessary for
carrying out information blocking activities (Pub. L. 117-103, March
15, 2022). Additionally, investigated parties may incur some costs in
response to an OIG investigation or in response to the application of a
disincentive by an agency with the authority to impose a disincentive.
Absent information about the frequency of prohibited practices,
including the number of OIG determinations of information blocking in a
given year that could be referred to an appropriate agency, we are
unable to determine the potential costs of this regulation.
The monetary value of the disincentives proposed in this rule, if
imposed on a health care provider by an appropriate agency, would be
considered transfers. We are unable to reliably estimate the aggregate
value of potential disincentive amounts because the value of the
disincentive may vary based on other provisions specific to the
authority under which the disincentive has been established, as
discussed in section III.C.1. of this proposed rule. For instance, the
value of a disincentive imposed on an eligible hospital under the
disincentive proposed in section III.C.2. of this proposed rule would
depend on the amount of IPPS payment received by the eligible hospital.
We invite public comment on potential impacts of the rulemaking.
B. Regulatory Flexibility Act
The RFA and the Small Business Regulatory Enforcement and Fairness
Act of 1996, which amended the RFA, require agencies to analyze options
for regulatory relief of small businesses. For purposes of the RFA,
small entities include small businesses, nonprofit organizations, and
Government agencies.
The Department considers a rule to have a significant impact on a
substantial number of small entities if it has an impact of more than 3
percent of revenue for more than 5 percent of affected small entities.
This proposed rule would not have a significant impact on the
operations of a substantial number of small entities, as these changes
would not impose any new requirement on any party. We have concluded
that this proposed rule likely would not have a significant impact on a
substantial number of small entities and that a regulatory flexibility
analysis is not required for this rulemaking. Additionally, the
Secretary proposes to certify that this proposed rule would not have a
significant impact on a substantial number of small entities.
In addition, section 1102(b) the SSA (42 U.S.C. 1302) requires us
to prepare a regulatory impact analysis if a rule under Titles XVIII or
XIX or section B of Title XI of the SSA may have a significant impact
the operations of a substantial number of small rural hospitals. We
have concluded that this proposed rule would not have a significant
impact on the operations of a substantial number of small rural
hospitals because these changes would not impose any requirement on any
party. Therefore, a regulatory impact analysis under section 1102(b) of
the SSA is not required for this rulemaking. Therefore, the Secretary
has certified that this proposed rule will not have a significant
impact on the operations of a substantial number of small rural
hospitals.
C. Unfunded Mandates Reform Act
Section 202 of the Unfunded Mandates Reform Act of 1995, Public Law
104-4, requires that agencies assess anticipated costs and benefits
before issuing any rule that may result in expenditures in any 1 year
by State, local, or Tribal governments, in the aggregate, or by the
private sector, of $100 million, adjusted annually for inflation. There
are no significant costs associated with these proposals that would
impose mandates on State, local, or Tribal governments or the private
sector resulting in an expenditure of $177 million in 2023 (after
adjustment for inflation) or more in any given year. A full analysis
under the Unfunded Mandates Reform Act is not necessary.
[[Page 74968]]
D. Executive Order 13132
Executive Order 13132, Federalism, establishes certain requirements
that an agency must meet when it promulgates a rule that imposes
substantial direct requirements or costs on State and local
governments, preempts State law, or otherwise has federalism
implications. In reviewing this rule under the threshold criteria of
Executive Order 13132, we have determined that this proposed rule would
not significantly affect the rights, roles, and responsibilities of
State or local governments. Nothing in this proposed rule imposes
substantial direct requirements or costs on State and local
governments, preempts State law, or otherwise has federalism
implications. We are not aware of any State laws or regulations that
are contradicted or impeded by any of the provisions in this proposed
rule.
List of Subjects
42 CFR Part 414
Administrative practice and procedure, Biologics, Diseases, Drugs,
Health facilities, Health professions, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 425
Administrative practice and procedure, Health facilities, Health
professions, Medicare, Reporting and recordkeeping requirements.
42 CFR Part 495
Administrative practice and procedure, Health facilities, Health
maintenance organizations (HMO), Health professions, Health records,
Medicaid, Medicare, Penalties, Privacy, Reporting and recordkeeping
requirements.
45 CFR Part 171
Computer technology, Electronic health record, Electronic
information system, Electronic transactions, Health, Healthcare, Health
care provider, Health information exchange, Health information
technology, Health information network, Health insurance, Health
records, Hospitals, Privacy, Reporting and recordkeeping requirements,
Public health, Security.
For the reasons set forth in the preamble, HHS proposes to amend 42
CFR chapter IV and 45 CFR part 171 as follows:
42 CFR Chapter IV
PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES
0
1. The authority citation for part 414 continues to read as follows:
Authority: 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l).
0
2. Amend Sec. 414.1305 by revising the definition of ``Meaningful EHR
user for MIPS'' to read as follows:
Sec. 414.1305 Definitions.
* * * * *
Meaningful EHR user for MIPS means a MIPS eligible clinician that
possesses CEHRT, uses the functionality of CEHRT, reports on applicable
objectives and measures specified for the Promoting Interoperability
performance category for a performance period in the form and manner
specified by CMS, does not knowingly and willfully take action (such as
to disable functionality) to limit or restrict the compatibility or
interoperability of CEHRT, and engages in activities related to
supporting providers with the performance of CEHRT. In addition, a MIPS
eligible clinician (other than a qualified audiologist) is not a
meaningful EHR user for a performance period if the HHS Inspector
General refers a determination that the MIPS eligible clinician
committed information blocking as defined at 45 CFR 171.103 during the
calendar year of the performance period.
* * * * *
0
3. Amend Sec. 414.1375 by revising paragraph (b) introductory text to
read as follows:
Sec. 414.1375 Promoting Interoperability (PI) performance category.
* * * * *
(b) Reporting for the Promoting Interoperability performance
category. To earn a performance category score for the Promoting
Interoperability performance category for inclusion in the final score,
a MIPS eligible clinician must be a meaningful EHR user for MIPS and:
* * * * *
PART 425--MEDICARE SHARED SAVINGS PROGRAM
0
4. The authority citation for part 425 continues to read as follows:
Authority: 42 U.S.C. 1302, 1306, 1395hh, and 1395jjj.
0
5. Amend Sec. 425.208 by adding paragraph (b)(6) to read as follows:
Sec. 425.208 Provisions of participation agreement.
* * * * *
(b) * * *
(6) The information blocking provision of the 21st Century Cures
Act (42 U.S.C. 300jj-52).
* * * * *
0
6. Amend Sec. 425.218 by revising paragraph (b)(3) to read as follows:
Sec. 425.218 Termination of the participation agreement by CMS.
* * * * *
(b) * * *
(3) Violations of any applicable laws, rules, or regulations that
are relevant to ACO operations, including, but not limited to, the laws
specified at Sec. 425.208(b).
* * * * *
0
7. Amend Sec. 425.305 by revising paragraph (a)(1) to read as follows:
Sec. 425.305 Other program safeguards.
(a) * * *
(1) ACOs, ACO participants, and ACO providers/suppliers are
reviewed during the Shared Savings Program application process and
periodically thereafter with regard to their program integrity history,
including any history of Medicare program exclusions or other sanctions
and affiliations with individuals or entities that have a history of
program integrity issues. Program integrity history issues include, but
are not limited to, a history of Medicare program exclusions or other
sanctions, noncompliance with the requirements of the Shared Savings
Program, or violations of laws specified at Sec. 425.208(b).
* * * * *
PART 495--STANDARDS FOR THE ELECTRONIC HEALTH RECORD TECHNOLOGY
INCENTIVE PROGRAM
0
8. The authority citation for part 495 continues to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
0
9. Amend Sec. 495.4 in the definition of ``Meaningful EHR user'' by
revising paragraph (1) introductory text and adding paragraph (4) to
read as follows:
Sec. 495.4 Definitions.
* * * * *
Meaningful EHR user * * *
(1) Subject to paragraphs (3) and (4) of this definition, an
eligible professional, eligible hospital or CAH that, for an EHR
reporting period for a payment year or payment adjustment year--
* * * * *
(4) An eligible professional, eligible hospital or CAH is not a
meaningful
[[Page 74969]]
EHR user in a payment adjustment year if the HHS Inspector General
refers a determination that the eligible hospital or CAH committed
information blocking as defined at 45 CFR 171.103 during the calendar
year of the EHR reporting period.
* * * * *
45 CFR Subtitle A
PART 171--INFORMATION BLOCKING
0
10. The authority citation for part 171 continues to read as follows:
Authority: 42 U.S.C. 300jj-52; 5 U.S.C. 552.
0
11. Amend Sec. 171.102 by adding, in alphabetical order, the
definition of ``Appropriate agency'' and ``Disincentive'' to read as
follows:
Sec. 171.102 Definitions.
* * * * *
Appropriate agency means a government agency that has established
disincentives for health care providers that the Office of Inspector
General (OIG) determines have committed information blocking.
* * * * *
Disincentive means a condition specified in Sec. 171.1001(a) that
may be imposed by an appropriate agency on a health care provider that
OIG determines has committed information blocking for the purpose of
deterring information blocking practices.
* * * * *
Subparts D through I [Added and Reserved]
0
12. Add reserved subparts D through I.
0
13. Add subpart J to read as follows:
Subpart J--Disincentives for Information Blocking by Health Care
Providers
Sec.
171.1000 Scope.
171.1001 Disincentives.
171.1002 Notice of disincentive.
Sec. 171.1000 Scope.
This subpart sets forth disincentives that an appropriate agency
may impose on a health care provider based on a determination of
information blocking referred to that agency by OIG, and certain
procedures related to those disincentives.
Sec. 171.1001 Disincentives.
(a) Health care providers that commit information blocking are
subject to the following disincentives from an appropriate agency based
on a determination of information blocking referred by OIG:
(1) An eligible hospital or critical access hospital (CAH) as
defined in 42 CFR 495.4 is not a meaningful electronic health record
(EHR) user as also defined in 42 CFR 495.4.
(2) A Merit-based Incentive Payment System (MIPS) eligible
clinician as defined in 42 CFR 414.1305, who is also a health care
provider as defined in Sec. 171.102, is not a meaningful EHR user for
MIPS as defined in 42 CFR 414.1305.
(3) Accountable care organizations (ACOs) who are health care
providers as defined in Sec. 171.102, ACO participants, and ACO
providers/suppliers will be removed from, or denied approval to
participate, in the Medicare Shared Savings Program as defined in 42
CFR part 425 for at least 1 year.
(b) [Reserved]
Sec. 171.1002 Notice of disincentive.
Following referral of a determination of information blocking by
OIG, an appropriate agency that imposes a disincentive or disincentives
specified in Sec. 171.1001(a) would send a notice to the health care
provider subject to the disincentive or disincentives, via usual
methods of communication for the program or payment system under which
the disincentive is applied, that includes:
(a) A description of the practice or practices that formed the
basis for the determination of information blocking referred by OIG;
(b) The basis for the application of the disincentive or
disincentives being imposed;
(c) The effect of each disincentive; and
(d) Any other information necessary for a health care provider to
understand how each disincentive will be implemented.
0
14. Add subpart K to read as follows:
Subpart K--Transparency for Information Blocking Determinations,
Disincentives, and Penalties
Sec.
171.1100 Scope.
171.1101 Posting of information for actors found to have committed
information blocking.
Sec. 171.1100 Scope.
This subpart sets forth the information that will be posted on the
Office of the National Coordinator for Health Information Technology's
(ONC) public website about actors that have been determined by the HHS
Office of Inspector General to have committed information blocking.
Sec. 171.1101 Posting of information for actors found to have
committed information blocking.
(a) Health care providers. (1) ONC will post on its public website
the following information about health care providers that have been
subject to a disincentive in Sec. 171.1001(a) for information
blocking:
(i) Health care provider name;
(ii) Business address;
(iii) The practice, as the term is defined in Sec. 171.102 and
referenced in Sec. 171.103, found to have been information blocking;
(iv) Disincentive(s) applied; and
(iv) Where to find any additional information about the
determination of information blocking that is publicly available via
HHS or, where applicable, another part of the U.S. Government.
(2) The information specified in paragraph (a)(1) of this section
will not be posted prior to a disincentive being imposed and will not
include information about a disincentive that has not been applied.
(3) Posting of the information specified in paragraph (a)(1) of
this section will be conducted in accordance with existing rights to
review information that may be associated with a disincentive specified
in Sec. 171.1001.
(b) Health IT developers of certified health IT and health
information networks or health information exchanges. (1) ONC will post
on its public website the following information, to the extent
applicable, about health information networks/health information
exchanges and health IT developers of certified health IT (actors) that
have been determined by the HHS Office of Inspector General to have
committed information blocking:
(i) Type of actor;
(ii) Actor's legal name, including any alternative or additional
trade name(s) under which the actor operates;
(iii) The practice, as the term is defined in Sec. 171.102 and
referenced in Sec. 171.103, found to have been information blocking or
alleged to be information blocking in the situation specified in
paragraph (b)(2)(i) of this section; and
(iv) Where to find any additional information about the
determination (or resolution of information blocking as specified in
paragraph (b)(2)(i) of this section) of information blocking that is
publicly available via HHS or, where applicable, another part of the
U.S. Government.
(2) The information specified in paragraph (b)(1) of this section
will not be posted until one of the following occurs:
(i) OIG enters into a resolution of civil money penalty (CMP)
liability; or
[[Page 74970]]
(ii) A CMP imposed under subpart N of 42 CFR part 1003 has become
final consistent with the procedures in subpart O of 42 CFR part 1003.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2023-24068 Filed 10-30-23; 11:15 am]
BILLING CODE 4150-45-P
