Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 74947 

(1) To resolve a hold, if an article of 

food is held under paragraph (b) of this 

section because it is from a foreign 

facility that is not registered, the facility 

must be registered, and a valid 

registration number must be obtained 

and submitted to the FDA Division of 

Food Defense Targeting within 30 

calendar days from the date the notice 

of hold was issued. 

* * * * * 

Dated: October 26, 2023. 

Robert M. Califf, 

Commissioner of Food and Drugs. 

[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 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS) and Office of 

the National Coordinator for Health 

Information Technology (ONC), 

Department of Health and Human 

Services (HHS). 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

implement the provision of the 21st 

Century Cures Act specifying that a 

health care provider determined by the 

HHS Inspector General to have 

committed information blocking shall 

be referred to the appropriate agency to 

be subject to appropriate disincentives 

set forth through notice and comment 

rulemaking. In particular, this 

rulemaking would establish for such 

health care providers a set of 

appropriate disincentives using 

authorities under applicable Federal 

law. 

DATES: To be assured consideration, 

written or electronic comments must be 

received at one of the addresses 

provided below, no later than 5 p.m. on 

January 2, 2024. 

ADDRESSES: You may submit comments, 

identified by RIN 0955–AA05, by any of 

the following methods (please do not 

submit duplicate comments). Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

• Federal eRulemaking Portal: Follow 

the instructions for submitting 

comments. Attachments should be in 

Microsoft Word, Microsoft Excel, or 

Adobe PDF; however, we prefer 

Microsoft Word. https://

www.regulations.gov. 

• Regular, Express, or Overnight Mail: 

Department of Health and Human 

Services, Office of the National 

Coordinator for Health Information 

Technology, Attention: 21st Century 

Cures Act: Establishment of 

Disincentives for Health Care Providers 

That Have Committed Information 

Blocking Proposed Rule, Mary E. 

Switzer Building, Mail Stop: 7033A, 330 

C Street SW, Washington, DC 20201. 

Please submit one original and two 

copies. 

• Inspection of Public Comments: All 

comments received before the close of 

the comment period will be available for 

public inspection, including any 

personally identifiable or confidential 

business information that is included in 

a comment. Please do not include 

anything in your comment submission 

that you do not wish to share with the 

general public. For example, people 

typically do not wish to, and generally 

should not, share with the general 

public information such as: any person’s 

social security number; date of birth; 

driver’s license number; state 

identification number or foreign country 

equivalent; passport number; financial 

account number; credit or debit card 

number; individually identifiable health 

information; or any business 

information that could be considered 

proprietary. We will post all comments 

that are received before the close of the 

comment period at https://

www.regulations.gov. 

• Docket: For access to the docket to 

read background documents or 

comments received, go to https://

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Alexander Baker, Office of Policy, 

Office of the National Coordinator for 

Health Information Technology (ONC), 

(202) 690–7151, for general issues. 

Elizabeth Holland, Centers for 

Medicare & Medicaid Services (CMS), 

(443) 934–2532, for issues related to the 

Promoting Interoperability Program and 

the Promoting Interoperability 

performance category of the Merit-Based 

Incentive Payment System. 

Aryanna Abouzari, Centers for 

Medicare & Medicaid Services (CMS), 

(415) 744–3668 or 

SharedSavingsProgram@cms.hhs.gov, 

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. 


ddrumheller on DSK120RN23PROD with PROPOSALS1
74948 Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 

1Except 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. 

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 

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. 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 74949 

2As 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. 

3ONC 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). 

4As 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 

Continued 

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 

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. 

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 


ddrumheller on DSK120RN23PROD with PROPOSALS1
74950 Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 

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. 

7For more information about the USCDI, see 

https://www.healthit.gov/isa/united-states-coredata-interoperability-uscdi. 

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 

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 

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. 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 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, 


ddrumheller on DSK120RN23PROD with PROPOSALS1
74952 Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 

8 45 CFR parts 160 and 164, subparts A, C, D, and 

E. 

9Practice, 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). 

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. 

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. 

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 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 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 § 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 


ddrumheller on DSK120RN23PROD with PROPOSALS1
74954 Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 

10See ‘‘Information Blocking Claims: By the 

Numbers,’’ https://www.healthit.gov/data/ 

quickstats/information-blocking-claims-numbers. 

11https://www.healthit.gov/data/quickstats/ 

information-blocking-claims-numbers. 

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. 

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’ 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 74955 

12Section 1814(l)(3) of the SSA applies to critical 

access hospitals the standard for determining a 

meaningful EHR user in section 1886(n)(3). 

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. 

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 


ddrumheller on DSK120RN23PROD with PROPOSALS1
74956 Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 

13Available at https://data.cms.gov/providersummary-by-type-of-service/medicare-inpatienthospitals/medicare-inpatient-hospitals-by-provider. 

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 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 74957 

14Available at https://www.cms.gov/researchstatistics-data-and-systems/downloadable-publicuse-files/cost-reports. 

15The 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. 

16For 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 

Continued 

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 

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 


ddrumheller on DSK120RN23PROD with PROPOSALS1
74958 Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 

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. 

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. 

(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 

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 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 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. 


ddrumheller on DSK120RN23PROD with PROPOSALS1
74960 Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 

17Provider Utilization and Payment Data 

available at https://catalog.data.gov/dataset/ 

medicare-physician-other-practitioners-by-providerb297e. 

18Overall MIPS Performance Dataset available at 

https://data.cms.gov/provider-data/dataset/a174- 

a962. 

19Quality Payment Program Experience Dataset 

available at https://data.cms.gov/quality-of-care/ 

quality-payment-program-experience/data. 

(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-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 

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) 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 74961 

20As 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). 

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 

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 


ddrumheller on DSK120RN23PROD with PROPOSALS1
74962 Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 

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. 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 74963 

21Shared 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. 

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 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 

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 


ddrumheller on DSK120RN23PROD with PROPOSALS1
74964 Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 

22CMS 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. 

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). 

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 

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 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 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 


ddrumheller on DSK120RN23PROD with PROPOSALS1
74966 Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 

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 

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 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 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, 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.). 

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. 


ddrumheller on DSK120RN23PROD with PROPOSALS1
74968 Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 

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 

■ 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: 

§ 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 

■ 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: 

§ 425.208 Provisions of participation 

agreement. 

* * * * * 

(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). 

* * * * * 

PART 495—STANDARDS FOR THE 

ELECTRONIC HEALTH RECORD 

TECHNOLOGY INCENTIVE PROGRAM 

■ 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 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 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 

■ 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 Scope. 

171.1001 Disincentives. 

171.1002 Notice of disincentive. 

§ 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. 

§ 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 

§ 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] 

§ 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 

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. 

§ 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 


ddrumheller on DSK120RN23PROD with PROPOSALS1
74970 Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Proposed Rules 

(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 

[FAR Case 2021–019; Docket No. FAR– 

2021–0019; Sequence No. 1] 

RIN 9000–AO35 

Federal Acquisition Regulation: 

Standardizing Cybersecurity 

Requirements for Unclassified Federal 

Information Systems; Extension of 

Comment Period 

AGENCY: Department of Defense (DoD), 

General Services Administration (GSA), 

and National Aeronautics and Space 

Administration (NASA). 

ACTION: Proposed rule; extension of 

comment period. 

SUMMARY: 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, 

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. 

FOR FURTHER INFORMATION CONTACT: 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 

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 

AGENCY: Department of Defense (DoD), 

General Services Administration (GSA), 

and National Aeronautics and Space 

Administration (NASA). 

ACTION: Proposed rule; extension of 

comment period. 

SUMMARY: 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 


ddrumheller on DSK120RN23PROD with PROPOSALS1