[Federal Register Volume 88, Number 126 (Monday, July 3, 2023)]
[Rules and Regulations]
[Pages 42820-42841]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13851]



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Vol. 88

Monday,

No. 126

July 3, 2023

Part II





 Department of Health and Human Services





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Office of Inspector General





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42 CFR Parts 1003 and 1005





Grants, Contracts, and Other Agreements: Fraud and Abuse; Information 
Blocking; Office of Inspector General's Civil Money Penalty Rules; 
Final Rule

  Federal Register / Vol. 88, No. 126 / Monday, July 3, 2023 / Rules 
and Regulations  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of Inspector General

42 CFR Parts 1003 and 1005

RIN 0936-AA09


Grants, Contracts, and Other Agreements: Fraud and Abuse; 
Information Blocking; Office of Inspector General's Civil Money Penalty 
Rules

AGENCY: Office of Inspector General (OIG), Department of Health and 
Human Services (HHS).

ACTION: Final rule.

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SUMMARY: This final rule amends the civil money penalty (CMP) 
regulations of the Department of Health and Human Services (HHS) Office 
of Inspector General (OIG) to: incorporate new CMP authority for 
information blocking; incorporate new authorities for CMPs, 
assessments, and exclusions related to HHS grants, contracts, other 
agreements; and increase the maximum penalties for certain CMP 
violations.

DATES: This final rule is effective August 2, 2023, except for the 
additions of Sec. Sec.  1003.1400, 1003.1410, and 1003.1420 (amendatory 
instruction 10), which are effective on September 1, 2023.

FOR FURTHER INFORMATION CONTACT: Robert Penezic, (202) 539-4021, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Purpose and Need for Regulatory Action

    This final rule implements three statutory provisions: (1) the 
amendment of the Public Health Service Act (PHSA), 42 U.S.C. 300jj-52, 
by the 21st Century Cures Act (Cures Act) authorizing OIG to 
investigate claims of information blocking and providing the Secretary 
of HHS (Secretary) authority to impose CMPs for information blocking; 
(2) the amendment of the Civil Monetary Penalties Law (CMPL), 42 U.S.C. 
1320a-7a, by the Cures Act, Public Law 114-255, section 5003, 
authorizing HHS to impose CMPs, assessments, and exclusions upon 
individuals and entities that engage in fraud and other misconduct 
related to HHS grants, contracts, and other agreements (42 U.S.C. 
1320a-7a(o)-(s)); and (3) the increase in penalty amounts in the CMPL 
effected by the Bipartisan Budget Act of 2018 (BBA 2018), Public Law 
115-123. Each of these statutory amendments is discussed further below.
    First, section 4004 of the Cures Act added section 3022 to the 
PHSA, 42 U.S.C. 300jj-52 which, among other provisions, provides OIG 
the authority to investigate claims of information blocking and 
authorizes the Secretary to impose CMPs against a defined set of 
individuals and entities that OIG determines committed information 
blocking. Investigating and taking enforcement action against 
individuals and entities that engage in information blocking are 
consistent with OIG's history of investigating serious misconduct that 
impacts HHS programs and beneficiaries. Information blocking poses a 
threat to patient safety and undermines efforts by providers, payers, 
and others to make the health system more efficient and effective. 
Information blocking may also constitute an element of a fraud scheme, 
such as by forcing unnecessary tests or conditioning information 
exchange on referrals. Addressing the negative effects of information 
blocking is consistent with OIG's mission to protect the integrity of 
HHS programs, as well as the health and welfare of program 
beneficiaries.
    In this final rule, we implement section 3022(b)(2)(C) of the PHSA, 
which requires that the CMP for information blocking follow the 
procedures of section 1128A of the Social Security Act (SSA). 
Specifically, the final rule adds the information blocking CMP 
authority to the existing regulatory framework for the imposition and 
appeal of CMPs, assessments, and exclusions (42 CFR parts 1003 and 
1005) pursuant to section 3022(b)(2)(C) of the PHSA (42 U.S.C. 300jj-
52(b)(2)(C)). The amendments give individuals and entities subject to 
CMPs for information blocking the same procedural rights that currently 
exist under 42 CFR parts 1003 and 1005. Through this final rule, we 
codify this new information blocking authority at 42 CFR 1003.1400, 
1003.1410, and 1003.1420.
    The final rule also explains OIG's approach to enforcement, which 
will focus on information blocking allegations that pose greater risk 
to patients, providers, and health care programs, as well as OIG's 
anticipated consultation and coordination with the Office of the 
National Coordinator for Health Information Technology (ONC) and other 
agencies, as appropriate, in reviewing and investigating allegations of 
information blocking.
    On May 1, 2020, ONC published a final rule, 21st Century Cures Act: 
Interoperability, Information Blocking, and the ONC Health IT 
Certification Program (ONC Final Rule), in the Federal Register. 85 FR 
25642, May 1, 2020. Among other things, ONC through the ONC Final Rule 
promulgated the information blocking regulations defining information 
blocking and establishing exceptions to that definition. OIG's final 
rule incorporates the relevant information blocking regulations at 45 
part 171 as the basis for imposing CMPs for information blocking.
    Second, this final rule modifies 42 CFR parts 1003 and 1005 to add 
the new authority related to fraud and other misconduct involving 
grants, contracts, and other agreements into the existing regulatory 
framework for the imposition and appeal of CMPs, assessments, and 
exclusions. The additions: (1) expressly enumerate in the regulation 
the grant, contract, and other agreement fraud and misconduct CMPL 
authority; and (2) give individuals and entities sanctioned for fraud 
and other misconduct related to HHS grants, contracts, and other 
agreements the same procedural and appeal rights that currently exist 
under 42 CFR parts 1003 and 1005 for those sanctioned under the CMPL 
and other statutes for fraud and other misconduct related to, among 
other things, the Federal health care programs. In this final rule, we 
codify these new authorities and their corresponding sanctions in the 
regulations at 42 CFR 1003.110, 1003.130, 1003.140, 1003.700, 1003.710, 
1003.720, 1003.1550, 1003.1580, and 1005.1.
    On February 9, 2018, the President signed into law the BBA 2018. 
Section 50412 of the BBA 2018 amended the CMPL to increase the amounts 
of certain CMPs. 42 U.S.C. 1320a-7a(a), (b). This final rule codifies 
the increased CMPs at 42 CFR part 1003. Specifically, for conformity 
with the CMPL as amended by the BBA 2018, we revise the CMPs contained 
at 42 CFR 1003.210, 1003.310, and 1003.1010.

B. Legal Authority

    The legal authority for this regulatory action is found in the SSA 
and the PHSA, as amended by the Cures Act and the BBA 2018. The legal 
authority for the changes is listed by the parts of title 42 of the 
Code of Federal Regulations (CFR) that we propose to modify:

1003: 42 U.S.C. 1320a-7a(a)-(b), (o)-(s); 42 U.S.C. 300jj-52
1005: 42 U.S.C. 1320a-7a(o)-(s); 42 U.S.C. 300jj-52

C. Proposed Rule

    On April 24, 2020, OIG published a proposed rule (proposed pule) in 
the Federal Register setting forth certain proposed amendments to the 
CMP rules of HHS OIG. 85 FR 22979, April 24, 2020. The proposed rule 
set forth

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proposed regulations that would: (1) incorporate the new CMP authority 
for information blocking; (2) incorporate new authorities for CMPs, 
assessments, and exclusions related to HHS grants, contracts, other 
agreements; and (3) increase the maximum penalties for certain CMP 
violations. We solicited comments on those three proposed regulatory 
additions and changes to obtain public input. Specific to information 
blocking, we also provided information on--but did not propose 
regulations for--our expected enforcement priorities, the investigation 
process, and our experience with investigating conduct that includes an 
intent element. We received 49 timely comments, 48 of which were 
unique, from a broad range of stakeholders.

D. Final Rule

    This final rule incorporates into OIG's CMP regulations at 42 CFR 
parts 1003 and 1005 two new CMP authorities established by the Cures 
Act related to: (1) information blocking; and (2) fraud and other 
misconduct involving HHS grants, contracts, and other agreements. The 
final rule also incorporates into 42 CFR part 1003 new maximum CMP 
amounts for certain offenses, as set by the BBA 2018.
    In the context of information blocking, the Cures Act authorizes 
CMPs for any practice that is likely to interfere with, prevent, or 
materially discourage access, exchange, or use of electronic health 
information (EHI) if the practice is conducted by an entity that is: a 
developer of certified health information technology (IT); offering 
certified health IT; a health information exchange (HIE); or a health 
information network (HIN) and the entity knows or should know that the 
practice is likely to interfere with, prevent, or materially discourage 
the access, exchange, or use of EHI.
    The ONC Final Rule implements certain Cures Act information 
blocking provisions, including defining terms and establishing 
reasonable and necessary activities that do not constitute information 
blocking or ``exceptions'' to the definition of information blocking. 
OIG and ONC have coordinated extensively on the ONC Final Rule and this 
final rule to align both sets of regulations. As proposed, we 
incorporate the regulatory definitions and exceptions in ONC's 
regulations at 45 CFR part 171 related to information blocking as the 
basis for imposing CMPs and determining the amount of penalty imposed.
    In the context of HHS grants, contracts, and other agreements, the 
Cures Act authorizes CMPs, assessments, and exclusions for:
     knowingly presenting or causing to be presented a 
specified claim under a grant, contract, or other agreement that a 
person knows or should know is false or fraudulent;
     knowingly making, using, or causing to be made or used any 
false statement, omission, or misrepresentation of a material fact in 
any application, proposal, bid, progress report, or other document that 
is required to be submitted in order to directly or indirectly receive 
or retain funds provided in whole or in part by HHS pursuant to a 
grant, contract, or other agreement;
     knowingly making, using, or causing to be made or used, a 
false record or statement material to a false or fraudulent specified 
claim under a grant, contract, or other agreement;
     knowingly making, using, or causing to be made or used, a 
false record or statement material to an obligation to pay or transmit 
funds or property to HHS with respect to a grant, contract, or other 
agreement;
     knowingly concealing or knowingly and improperly avoiding 
or decreasing an obligation to pay or transmit funds or property to HHS 
with respect to a grant, contract, or other agreement; and
     failing to grant timely access, upon reasonable request, 
to OIG for the purposes of audits, investigations, evaluations, or 
other statutory functions of OIG in matters involving grants, 
contracts, or other agreements.
    We further codify changes to the CMP regulations at 42 CFR part 
1003 to conform with the CMP amounts contained in the SSA, as amended 
by the BBA 2018.

II. Background

    For more than 35 years, OIG has exercised authority to impose CMPs, 
assessments, and exclusions in furtherance of its mission to protect 
Federal health care and other Federal programs from fraud, waste, and 
abuse. The Cures Act established new CMP authorities related both to 
information blocking and to fraud and other prohibited conduct 
involving HHS grants, contracts, and other agreements. OIG also 
received authority through the BBA 2018 to impose larger CMPs for 
certain offenses committed after February 9, 2018.

A. Overview of OIG Civil Money Penalty Authorities

    The CMPL (section 1128A of the SSA, 42 U.S.C. 1320a-7a) was enacted 
in 1981 to provide HHS with the statutory authority to impose CMPs, 
assessments, and exclusions upon persons who commit fraud and other 
misconduct related to Federal health care programs, including Medicare 
and Medicaid. The Secretary delegated the CMPL's authorities to OIG. 53 
FR 12993, April 20, 1988. HHS has promulgated regulations at 42 CFR 
parts 1003 and 1005 that: (1) enumerate specific bases for the 
imposition of CMPs, assessments, and exclusion under the CMPL and other 
CMP statutes; (2) set forth the appeal rights of persons subject to 
those sanctions; and (3) outline the procedures under which a 
sanctioned party may appeal the sanction. Since 1981, Congress has 
created various other CMP authorities related to fraud and abuse that 
were delegated by the Secretary to OIG and added to part 1003.

B. The Cures Act and the ONC Final Rule

    The Cures Act added section 3022 of the PHSA, which defines conduct 
that constitutes information blocking by health IT developers of 
certified health IT, entities offering certified health IT, HIEs, HINs, 
and health care providers. Section 3022(a) of the PHSA defines 
information blocking as a practice that--(A) except as required by law 
or specified by the Secretary pursuant to rulemaking under section 
3022(a)(3), is likely to interfere with, prevent, or materially 
discourage access, exchange, or use of electronic health information; 
and (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; or (ii) if 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 
provides that the Secretary shall, through rulemaking, identify 
reasonable and necessary activities that do not constitute information 
blocking, and section 3022(a)(4) of the PHSA states that the term 
``information blocking'' does not include any conduct that occurred 
before January 13, 2017. The ONC Final Rule implements these sections 
of the PHSA at 45 CFR part 171.
    Section 3022(b)(1) of the PHSA authorizes OIG to investigate claims 
of information blocking described in section 3022(a) of the PHSA, and 
to investigate claims that health IT developers of certified health IT 
or other

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entities offering certified health IT have submitted false attestations 
under section 3001(c)(5)(D) of the PHSA as part of ONC's program for 
the voluntary certification of health IT (ONC Health IT Certification 
Program). Section 3022(b)(2)(A) authorizes the Secretary to impose CMPs 
not to exceed $1 million per violation on health IT developers of 
certified health IT or other entities offering certified health IT, 
HIEs, and HINs that OIG determines, following an investigation, 
committed information blocking. Section 3022(b)(2)(A) also provides 
that a determination of the CMP amounts shall consider factors such as 
the nature and extent of the information blocking and harm resulting 
from such information blocking including, where applicable, the number 
of patients affected, the number of providers affected, and the number 
of days the information blocking persisted. Section 3022(b)(2)(C) of 
the PHSA applies the procedures of section 1128A of the SSA to CMPs 
imposed under section 3022(b)(2) of the PHSA in the same manner as such 
provisions apply to a CMP or proceeding under section 1128A(a) of the 
SSA. This final rule implements section 3022(b)(2)(A) and (C) of the 
PHSA.
    Furthermore, section 3022(b)(2)(B) of the PHSA provides that any 
health care provider determined by OIG 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 of HHS sets forth through notice and comment 
rulemaking. This final rule does not implement section 3022(b)(2)(B) of 
the PHSA. However, a health IT developer of certified health IT, HIE, 
or HIN as defined in 45 CFR 171.102 determined by OIG to have committed 
information blocking could be subject to CMPs under this final rule 
even if that entity also met the definition of a health care provider 
at 45 CFR 171.102. For additional discussion related to health care 
providers that meet a definition of an actor subject to CMPs, see 
section IV.A.3. of this preamble.
    The Cures Act also identifies ways for ONC, the Office for Civil 
Rights (OCR), and OIG to consult, refer, and coordinate. For example, 
section 3022(b)(3) of the PHSA states that OIG may refer instances of 
information blocking to OCR when 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) 
will resolve such information blocking claims. Additionally, section 
3022(d)(1) of the PHSA requires ONC to share information with OIG as 
required by law. For additional discussion related to coordination, see 
section III.A.5 of the proposed rule preamble and section III.B. of 
this preamble.
    ONC's information blocking regulations at 45 CFR part 171 and the 
OIG CMP regulation at 42 CFR part 1003, subpart N, are designed to work 
in tandem. As a result, we encourage parties to read this final rule 
together with the ONC Final Rule. The ONC Final Rule defined 
``information blocking''--and specific terms related to information 
blocking--as well as implemented exceptions to the definition of 
information blocking. This final rule describes the parameters and 
procedures applicable to the CMP for information blocking.
    The Cures Act amended the CMPL to give HHS the authority to impose 
CMPs, assessments, and exclusions upon persons that commit fraud and 
other misconduct related to HHS grants, contracts, and other 
agreements. 42 U.S.C. 1320a-7a(o)-(s). This authority allows for the 
imposition of sanctions for a wide variety of fraudulent and improper 
conduct involving HHS grants, contracts, and other agreements 
including, among other things, the making of false or fraudulent 
specified claims to HHS, the submission of false or fraudulent 
documents to HHS, and the creation of false records related to HHS 
grants, contracts, or other agreements. The authority applies to a 
broad array of situations in which HHS provides funding, directly or 
indirectly, in whole or in part, pursuant to a grant, contract, or 
other agreement. The Cures Act also created a new set of definitions 
related to grant, contract, and other agreement fraud and misconduct, 
outlined the sanctions for violation of the statute, and referenced the 
procedures to be used when imposing sanctions under the statute.

C. The Bipartisan Budget Act of 2018

    The BBA 2018 amended the CMPL to increase certain CMP amounts 
contained in 42 U.S.C. 1320a-7a(a) and (b). The BBA 2018 increased the 
maximum CMP amounts in section 1128A(a) of the SSA (42 U.S.C. 1320a-7a) 
from $10,000 to $20,000; from $15,000 to $30,000; and from $50,000 to 
$100,000. The BBA 2018 increased the maximum CMP amounts in section 
1128A(b) of the SSA from $2,000 to $5,000 in paragraph (1), from $2,000 
to $5,000 in paragraph (2), and from $5,000 to $10,000 in paragraph 
(3)(A)(i). This statutory increase in CMP amounts is effective for acts 
committed after the date of enactment, February 9, 2018. This final 
rule updates our regulations to reflect the increased CMP amounts 
authorized by the 2018 BBA amendments.

III. OIG's Anticipated Approach to Information Blocking CMP Enforcement

    The preamble to the proposed rule provided a nonbinding, 
informational overview of our anticipated information blocking 
enforcement priorities and the investigative process. We provided this 
information in the preamble to the proposed rule for informational 
purposes only and did not propose regulations on these topics. We 
received several comments on these topics, which are publicly available 
at https://www.regulations.gov/docket/HHSIG-2020-0001/comments. To 
improve public understanding of how we anticipate we will approach 
information blocking CMP enforcement, we further provide in section III 
of this preamble an informational statement to supplement the 
discussion set forth in the proposed rule. We note that this discussion 
of anticipated approach is limited to our investigation of those 
entities subject to CMPs and does not apply to the investigation of 
health care providers that may be referred for disincentives under 
section 3022(b)(2)(B) of the PHSA.

A. Anticipated Priorities

    The preamble to the proposed rule set forth our anticipated 
information blocking enforcement priorities as conduct that: (1) 
resulted in, is causing, or had the potential to cause patient harm; 
(2) significantly impacted a provider's ability to care for patients; 
(3) was of long duration; (4) caused financial loss to Federal health 
care programs, or other government or private entities; or (5) was 
performed with actual knowledge. We explained that we will select cases 
for investigation based on these priorities and expect that the 
enforcement priorities will evolve as OIG gains more experience 
investigating information blocking. We also emphasized that the 
definition of information blocking--as defined in section 3022(a) of 
the PHSA and 45 CFR 171.103(a)--includes an element of intent and that 
OIG lacked the authority to seek CMPs for information blocking against 
actors who did not have the requisite intent. We continue to anticipate 
the same enforcement priorities as set out in the preamble of the 
proposed rule and supplement that discussion below. We provide this 
explanation so that the public and stakeholders have a better 
understanding of how we anticipate allocating our resources to enforce 
the

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CMP for information blocking. Prioritization ensures OIG can 
effectively allocate its resources to target information blocking 
allegations that have more negative effects on patients, providers, and 
health care programs. Our enforcement priorities will inform our 
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. There is no specific 
formula we can apply to every allegation that allows OIG to effectively 
evaluate and prioritize which claims merit investigation.
    As addressed in section III.B of this preamble, we anticipate 
coordinating closely with ONC and other agencies as appropriate in 
reviewing allegations. Although our statement of anticipated priorities 
is 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) conduct by the same actor. That 
evaluation would include assessment of all information blocking claims 
received by ONC through the standardized process to receive claims from 
the public.
    We clarify here that OIG's anticipated priority relating to patient 
harm is not specific to individual harm, but rather may broadly 
encompass harm to a patient population, community, or the public. 
Additionally, with respect to our anticipated priority relating to 
actual knowledge, we note that health IT developers of certified health 
IT and health information exchanges and networks do not have to have 
actual knowledge in order to commit information blocking. But the 
conduct of someone who has actual knowledge is generally more egregious 
than the conduct of someone who only should know that their practice is 
likely to interfere with, prevent, or materially discourage access, 
exchange, or use of EHI. As a general matter, we would likely 
prioritize cases in which an actor has actual knowledge over cases in 
which the actor only should have known that the practice was likely to 
interfere with, prevent, or materially discourage the access, exchange, 
or use of EHI.
    Finally, we are stating that our current anticipated enforcement 
priorities may lead to investigations of anti-competitive conduct or 
unreasonable business practices. The ONC Final Rule provides, as 
examples, conduct that may implicate the information blocking 
provision, anti-competitive or unreasonable conduct, such as 
unconscionable or one-sided business terms for the access, exchange, or 
use of EHI, or the licensing of an interoperability element. For 
example, a contract containing unconscionable terms related to sharing 
of patient data could be anti-competitive conduct that impedes a 
provider's ability to care for patients. 85 FR 25812, May 1, 2020. A 
claim of such conduct would implicate OIG's enforcement priority 
related to a provider's ability to care for patients. Anti-competitive 
conduct resulting in information blocking could implicate other 
enforcement priorities as well, depending on the facts.
    OIG's enforcement priorities are a tool we use to triage 
allegations and allocate resources. We can and do expect to investigate 
allegations of other information blocking conduct not covered by the 
priorities. If conduct or patterns of conduct raise concerns, OIG may 
choose to investigate those allegations. And as we gain more experience 
with investigating information blocking, we will reassess our 
priorities accordingly. For example, as patients continue to adopt and 
use technology to access their EHI, the number of patients that will 
request their EHI directly from a health IT developer of certified 
health IT or HIE may increase. That may generate more allegations 
related to patient access to their EHI. Trends or changes in the types 
of allegations we receive may affect enforcement priorities in the 
future.

B. Coordination With Other Agencies

    The Cures Act identified ways for ONC, OCR, and OIG to consult, 
refer, and coordinate on information blocking claims. We elaborate on 
those processes here for informational purposes only.
    Section 3022(d)(1) of the PHSA states that ONC may serve as a 
technical consultant to OIG. Because ONC promulgated the information 
blocking regulations and exceptions, OIG will closely consult with ONC 
throughout the investigative process. ONC's subject matter expertise is 
vital to our evaluation of information blocking allegations. OIG will 
continue working closely with ONC as ONC develops information blocking 
guidance.
    Section 3022(d)(3) of the PHSA requires ONC to implement a 
standardized process for the public to submit reports on claims of 
information blocking, and section 3022(d)(1) requires ONC to share 
information with OIG as required by law. ONC has a standardized process 
for the public to submit reports on claims of information blocking 
through this website: https://inquiry.healthit.gov/support/plugins/servlet/desk/portal/6. In addition to the process required by the PHSA, 
OIG has its own hotline process through which individuals may submit 
claims of information blocking online at https://tips.oig.hhs.gov/ or 
by calling 1-800-447-8477. Regardless of whether a claim is made to ONC 
or OIG, ONC and OIG will coordinate in evaluating claims of information 
blocking and share information as permitted by law.
    Whether OIG's or ONC's authority is appropriate to address a claim 
of information blocking will depend on the facts and circumstances of 
the allegation and the results of an investigation. For example, ONC 
and OIG may initially agree that a claim is most appropriately 
evaluated through an OIG investigation. ONC has authority to take 
action against an individual or entity that is a developer 
participating in the ONC Health IT Certification Program. 45 CFR 
170.580. OIG has authority to impose CMPs against a health IT developer 
of certified health IT, which includes developers participating in the 
ONC Health IT Certification Program. Thus, an individual or entity that 
meets the definition of health IT developer of certified health IT 
could be subject to CMPs, termination of certification or other action 
under the ONC Health IT Certification Program review process, or both. 
85 FR 25789, May 1, 2020.
    In addition to coordination with ONC, section 3022(b)(3) of the 
PHSA provides the option for OIG to refer instances 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 information blocking claims. Depending on the facts and 
circumstances of an information blocking claim, OIG will exercise this 
statutory discretion as appropriate to refer persons to consult with 
OCR to resolve information blocking claims. 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 new 
authorities found in section 3022(b)(3) of the PHSA. In addition to 
section 3022(b)(3), OIG may request technical assistance from OCR 
during an information blocking investigation. OIG may also refer to OCR 
claims of information blocking that would be better resolved under 
OCR's HIPAA authorities.
    Specific to anti-competitive conduct, we note that section 3022(d) 
of the PHSA includes specific options for ONC

[[Page 42824]]

and OIG to coordinate with the Federal Trade Commission (FTC) related 
to an information blocking claim. Under section 3022(d)(1) of the PHSA, 
ONC may share information related to claims of information blocking or 
investigations by OIG with the FTC for purposes of such investigation. 
We will coordinate closely with ONC to identify claims and 
investigations or patterns of claims and investigations that may 
warrant referral to the FTC.
    We further note that following our investigation and the imposition 
of CMPs, our coordination with ONC, OCR, or other agencies as relevant 
may continue as part of an appeal of the imposition of CMPs by OIG. 
Upon the issuance of a notice of proposed determination for a CMP in 
accordance with 42 CFR 1003.1500, the actor may appeal the proposed 
determination for a CMP in accordance with the appeal procedures set 
forth in 42 CFR part 1005. As noted in 42 CFR 1005.2(a), a party 
sanctioned under any criteria in 42 CFR part 1003 may request a hearing 
before an administrative law judge (ALJ). 42 CFR 1005.2. The facts of 
the matter under appeal will determine the specific agencies with which 
we may coordinate.
    We also anticipate coordinating with other HHS agencies to avoid 
duplicate penalties. Section 3022(d)(4) of the PHSA requires that the 
Secretary, to the extent possible, ensure that penalties do not 
duplicate penalty structures that would otherwise apply to information 
blocking and the type of individual or entity involved as of the day 
before the enactment of the Cures Act, December 13, 2016. Depending on 
the facts and circumstances, OIG might also consult or coordinate with 
a range of other agencies that might have relevant information or be 
able to provide technical assistance, including the Centers for 
Medicare and Medicare Services (CMS), other HHS agencies, FTC, or 
others. We discuss what enforcement coordination may look like in 
section III.D of the preamble.

C. Anticipated Enforcement Approach

    Some commenters expressed interest in understanding OIG's 
enforcement approach, including: (1) whether OIG would include 
alternative actions, in lieu of the imposition of CMPs, such as 
providing actors subject to CMPs with additional education or 
corrective action plans; (2) whether OIG's approach to information 
blocking investigations would include investigating potential non-
compliance with the requirements of CMS's Promoting Interoperability 
Program for eligible hospitals and critical access hospitals (CAHs) and 
Merit-based Incentive Payment System (MIPS) promoting interoperability 
performance category for clinicians; (3) whether actors may be subject 
to False Claims Act (FCA) liability for engaging in conduct that 
constitutes information blocking; and (4) whether OIG plans to create a 
self-disclosure protocol (SDP).
    At this point, we do not anticipate using alternatives to CMPs as 
described by the commenters. OIG will have an SDP to resolve CMP 
liability and allow for lower penalties. As we gain more experience 
investigating and imposing CMPs for information blocking, we may 
further consider alternative enforcement approaches. HHS or OIG may 
also consider issuance of compliance guidance or other educational 
materials on the topic of information blocking.
    OIG's historical position in its administrative enforcement under 
the CMPL is that the Federal health care programs are best protected 
when persons who engage in fraudulent or other improper conduct are 
assessed a financial sanction. This remedial purpose is at the core of 
OIG's administrative enforcement authorities.
    The PHSA and existing regulatory structures provide options for ONC 
and OCR to conduct individualized education and corrective action plans 
when an actor has committed information blocking, and OIG may refer 
matters to ONC or OCR for such actions. For example, OIG may refer an 
allegation to OCR for consultation regarding the health privacy and 
security rules or for OCR to address under its HIPAA authorities. 
Similarly, OIG may refer an allegation to ONC to address under its 
direct review authority, under which ONC could impose a corrective 
action plan. ONC also stated in the ONC Final Rule that ONC's and OIG's 
respective authorities are independent and that either office may 
exercise its authority at any time. 85 FR 25789, May 1, 2020. Thus, 
OIG's enforcement action will only include a CMP, while ONC could purse 
a separate enforcement action within its authority, which could include 
a corrective action plan.
    As noted above, this rulemaking does not address OIG investigations 
of potential information blocking by healthcare providers. HHS is 
developing a separate notice of proposed rulemaking to establish 
appropriate disincentives for healthcare providers as described in the 
Unified Agenda at https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202210&RIN=0955-AA05. However, in response to 
commenters' inquiry we clarify that OIG does not intend to use its 
authority to investigate information blocking under section 3022(b)(1) 
of the PHSA to investigate potential non-compliance with CMS 
programmatic requirements, including those under the Promoting 
Interoperability Program for eligible hospitals and CAHs and MIPS 
promoting interoperability performance category for clinicians, that 
are distinct from the information blocking provisions of the PHSA. If 
investigations into alleged information blocking suggest a health care 
provider may be out of compliance with CMS programmatic requirements, 
OIG may refer such matters to CMS.
    Similarly, conduct that constitutes information blocking could 
create false claims liability for an actor. For example, by engaging in 
conduct that constitutes information blocking, a health IT developer of 
certified health IT may have falsified attestations made to ONC as part 
of the ONC Health IT Certification Program. By falsifying its 
attestation, the health IT developer of certified health IT may cause 
health care providers to file false attestations under MIPS. Such a 
fact-specific determination would be assessed in coordination with 
OIG's law enforcement partners, including the Department of Justice.
    Information blocking is newly regulated conduct, and OIG has not 
created an SDP specifically for information blocking; however, after 
the publication of this rule, OIG will add an information blocking SDP, 
including an online submission form, and other processes, to OIG's 
existing SDP located at https://oig.hhs.gov/compliance/self-disclosure-info/.
    We understand many stakeholders may not be familiar with OIG's 
current SDP and provide the following information regarding the 
forthcoming information blocking SDP and self-disclosure process. The 
information blocking SDP will provide actors with a framework and 
mechanism for evaluating, disclosing, coordinating, and resolving CMP 
liability for conduct that constitutes information blocking. When 
posted on our website, OIG's SDP will explain: (1) eligibility 
criteria, (2) manner and format, (3) required contents of a submission, 
and (4) expected resolution of the matter. The information blocking SDP 
will be available only to those actors seeking to resolve potential CMP 
liability.
    We recognize that whether to disclose potential information 
blocking violations to OIG is a significant decision; however, the 
significant benefits to disclosing potential information blocking 
violations to OIG should make that decision easier. First,

[[Page 42825]]

actors accepted by OIG into the SDP who cooperate with OIG during the 
self-disclosure process will pay lower damages than would normally be 
required in resolving a government-initiated investigation. Second, 
through our experience with OIG's existing SDP, we know that self-
disclosure provides the opportunity for an actor to avoid costs and 
disruptions associated with government-directed investigations and 
civil or administrative litigation. Finally, OIG created the original 
SDP to provide a consistent, specific, and detailed process that can be 
relied upon by all participants, and we are similarly committed to 
working with actors that use the SDP in good faith to disclose 
information blocking conduct and cooperate with OIG's review and 
resolution process.
    We reiterate that self-disclosing conduct is for an actor to 
resolve its own potential liability under the CMP for information 
blocking. It would not resolve any liability an actor may have under 
other applicable law, such as under HIPAA or under the ONC 
Certification Program. Actors should not self-disclose to seek opinions 
from OIG as to whether an individual or entity meets the definitions of 
a ``health IT developer of certified health IT'' or ``health 
information network or health information exchange'' in 45 CFR 171.102 
or whether conduct constitutes information blocking under section 
3022(a) of the PHSA and corresponding implementing regulations. Actors 
seeking to inform OIG about another individual's conduct should use the 
ONC portal or the OIG hotline.
    As mentioned above, OIG will provide additional information on our 
website regarding the SDP for information blocking after publication of 
this final rule. However, before such information is posted, OIG will 
accept self-disclosure of information blocking conduct. We refer actors 
to section IV.A.5 of the preamble that describes how we will evaluate 
disclosure of violations and cooperation with investigations.
    Specifically, it is a mitigating circumstance under the factors at 
42 CFR 1003.140(a)(2) for an actor to take appropriate and timely 
corrective action in response to a violation. Timely corrective action 
includes disclosing information blocking violations to OIG and fully 
cooperating with OIG's review and resolution of such disclosure.

D. Advisory Opinions

    Some commenters requested that OIG develop an advisory opinion 
process for individuals and entities to obtain advisory opinions on 
whether specified conduct constitutes information blocking for which 
OIG may impose a CMP. Pursuant to section 1128D(b) of the SSA, HHS, 
through OIG, publishes advisory opinions regarding the application of 
the Federal anti-kickback statute and the associated safe harbor 
provisions, as well as specified administrative sanction authorities, 
to proposed or existing arrangements. Section 1128D(b) specifies the 
matters subject to advisory opinions under that authority. The CMP for 
information blocking is not one of the administrative sanction 
authorities specified by section 1128D(b) of the SSA.
    Furthermore, the Cures Act did not establish an advisory opinion 
process with regard to the application of OIG's information blocking-
related administrative enforcement authorities. At present, OIG has no 
plans to develop and establish an advisory opinion process regarding 
the application of the CMP for information blocking. The Justification 
of Estimates to the Appropriations Committee for the President's fiscal 
year (FY) 2024 budget included a legislative proposal to provide HHS 
the authority to issue advisory opinions on information blocking 
practices.

IV. Summary of Final Rule Provisions, Public Comments, and OIG Response

A. The CMP for Information Blocking

    As a general matter, commenters were supportive of OIG's proposed 
information blocking rules but sought more information and guidance 
from both ONC and OIG. Commenters suggested that the effective date for 
the CMP for information blocking rules be delayed as a result of the 
ongoing public health emergency (PHE) due to SARS-CoV-2, which causes 
COVID-19, and the requests for additional guidance from ONC and OIG. 
Many commenters sought clarification on the ONC Final Rule, such as 
whether an individual or entity falls within the category of actors 
that OIG would subject to CMPs for information blocking. Many 
commenters requested that OIG, either in this final rule or through 
guidance, further elaborate on and provide examples of how OIG will 
determine violations and CMP amounts. We have considered these comments 
carefully in developing the final rule, as described in more detail in 
responses to comments.
1. Information Blocking CMP Regulatory Authority & CMP Process
    We proposed to add the CMP for information blocking to our existing 
CMP regulations at 42 CFR part 1003 and to apply the existing 
procedural and appeal rights at 42 CFR parts 1003 and 1005 to the CMP 
for information blocking. We solicited comment on the proposed 
application of the existing CMP procedures and appeal process in parts 
1003 and 1005 to the CMP for information blocking. Commenters were 
generally in favor of incorporating the CMP for information blocking 
into these sections and applying the existing appeal processes set 
forth at 42 CFR part 1005. In this rule, we finalize the addition of 
the CMP for information blocking to 42 CFR part 1003 and the 
application of parts 1003 and 1005 to the CMP for information blocking 
as proposed without modification.
    We also proposed to add the authority for OIG's imposition of CMPs 
for information blocking (section 3022 of the PHSA, 42 U.S.C. 300jj-52) 
to the list of statutory CMP provisions that appears in 42 CFR 
1003.100. We received no comment on this proposed change and finalize 
the rule as proposed without modification.
    Comment: One commenter believed that the application of 42 CFR 
1005.7 to the CMP for information blocking was unworkable in its 
current form. The commenter believed that the discovery process under 
42 CFR 1005.7 as currently written was inconsistent with the Cures 
Act's intent for ONC, OCR, and OIG to consult, refer, and coordinate in 
the investigation and enforcement of investigation blocking. The 
commenter further stated that, consistent with the prior OIG final 
rule, Amendments to the OIG Exclusion and CMP Authorities Resulting 
From Public Law 100-93, 57 FR 3325, January 29, 1992, OIG would only be 
required to produce documents in its possession and not documents in 
the possession of other branches or divisions of HHS. The commenter 
further believed 42 CFR 1005.7 as written would prohibit individuals 
and entities that appeal the imposition of CMPs for information 
blocking from obtaining relevant documentary evidence maintained in 
ONC's possession. The commenter also believed that OIG could abuse the 
discovery process by refusing to take ``possession'' of documents in 
ONC's care, custody, or control in an effort to avoid producing them. 
The commenter further believed that, as ONC would not be covered by the 
discovery rule at 42 CFR 1005.7, ONC would not be subject to any 
document preservation requirement that would increase the potential for 
the spoliation or destruction of evidence.
    Response: We did not propose revising--and this final rule does not 
make revisions to--42 CFR 1005.7. The

[[Page 42826]]

CMP for information blocking appeals will be subject to discovery rules 
in 42 CFR 1005.7 because the Cures Act requires OIG to follow existing 
CMP procedures. Section 3022(b)(2)(C) of the PHSA requires the CMP for 
information blocking to follow procedures of section 1128A of the SSA, 
and 42 CFR part 1005 implements those procedures. Therefore, applying 
the procedures at 42 CFR part 1005 to CMP for information blocking 
appeals is consistent with the Cures Act.
    We appreciate that the CMP appeals process and the discovery 
provided therein may be new for many actors subject to CMPs for 
information blocking, and we further elaborate below.
    Whenever we propose to impose CMPs for information blocking, the 
actor will have the opportunity to appeal the CMPs. That appeal will be 
heard by an administrative law judge (ALJ) and governed by the 
procedures set forth in 42 CFR part 1005. The regulation at 42 CFR 
1005.7 addresses discovery and allows each party to request that the 
other party produce nonprivileged documents that are relevant and 
material to the issues before the ALJ for inspection and copying. If 
the other party objects to producing the requested documents, the party 
requesting the documents can ask the ALJ to compel discovery.
    The discovery regulations that will apply to appeals of CMPs for 
information blocking are the same regulations that have applied to 
existing CMPL administrative litigation. These regulations and this 
process have been approved by administrative tribunals and Federal 
courts. We provide limited discovery in our CMP cases even though it is 
not required in administrative proceedings at all. 57 FR 3298, January 
29, 1992. The regulation at 42 CFR 1005.7 limits discovery to the 
exchange of material and relevant documents to avoid the time-consuming 
discovery fights that can affect civil litigation. Additionally, the 
vast bulk of material and relevant evidence (i.e., evidence relating to 
whether the actor committed information blocking) will come from the 
actor whose conduct is at issue and not the government.
    In addition to the specific discovery rules in 42 CFR 1005.7, there 
are other provisions in 42 CFR part 1005 that ensure transparency and 
fairness in an appeal. For example, 42 CFR 1005.8 calls for the parties 
to exchange witness lists, copies of prior written statements of 
proposed witnesses, and copies of proposed hearing exhibits. If OIG 
proposed to use documents or testimony from ONC or other government 
agencies as evidence in support of the imposition of CMPs, those 
exhibits and statements would be made available under 42 CFR 1005.8.
    Regarding the commenter's specific concern that 42 CFR 1005.7 is 
not consistent with the coordination with ONC and OCR suggested by the 
Cures Act, we do not agree. The Cures Act provides OIG the 
discretionary authority to coordinate or consult with ONC and OCR, as 
necessary. For example, under section 3022(b)(3)(A) of the PHSA, OIG 
``may refer'' instances of information blocking to OCR if we determine 
that consulting with OCR may resolve an information blocking claim. 
While not required, we expect that nearly all information blocking 
investigations will be done in coordination with ONC. This close 
coordination with another HHS agency is not unique to information 
blocking or the Cures Act. Many of our CMP cases involve similarly 
close coordination with CMS, for example. There is nothing unique to 
the Cures Act that would necessitate a change from our current 
discovery procedures.
    We do not agree with the commenter's concerns about spoliation or 
destruction of documents in ONC's possession. ONC would not be a party 
to discovery in a CMP for information blocking matter, so the concept 
of spoliation--at least as the term is used in civil litigation--would 
be inapplicable. Regardless, as a part of the Federal Government ONC is 
subject to regulations and policies governing document maintenance and 
retention, including those promulgated by the National Archives and 
Records Administration.
    Comment: Some commenters expressed interest in more information 
about documentation and record retention requirements. They wanted to 
understand how to demonstrate compliance with an information blocking 
exception.
    Response: We did not propose and are not finalizing a record 
retention requirement specific to the CMP for information blocking. 
Furthermore, this final rule does not provide additional guidance 
regarding which documents are required to demonstrate compliance with 
an ONC exception for information blocking because that is outside the 
scope of this rule and OIG's authority. OIG will consider any 
documentation provided by an actor during an investigation to evaluate 
whether a practice constitutes information blocking.
    OIG has 6 years from the date an actor committed a practice that 
constitutes information blocking to impose a CMP. Section 3022(b)(2)(C) 
of the PHSA requires that the CMP for information blocking follow the 
procedures under section 1128A of the SSA, and section 1128A(c)(1) 
requires that an action for CMPs must be initiated within 6 years from 
the date the violation occurred.
    Even though pursuant to section 1128A of the SSA OIG may commence 
an action to impose CMPs up to 6 years after the date of a violation, 
an actor may want to maintain information for additional time beyond 6 
years. Actors in a CMP enforcement action bear the burden of proof for 
affirmative defenses and mitigating circumstances by a preponderance of 
the evidence. 42 CFR 1005.15(b)(1).
    How an actor meets that burden may depend, in part, on records or 
documentation they maintain. For example, a party may choose to 
maintain documents demonstrating they meet a specific exception in the 
information blocking regulations in 45 CFR part 171.
    Furthermore, the ONC Final Rule did not establish record retention 
requirements for actors to maintain documents relating to an exception 
for a specified period of time. Although ONC did not set record 
retention duration requirements, ONC explained that many exceptions 
with documentation conditions are related to other existing regulatory 
requirements that have document retention standards. For example, the 
Security Exception at 45 CFR 171.203 is closely aligned to the HIPAA 
Security Rule, which has a six-year documentation retention requirement 
in 45 CFR 164.316. 85 FR 25819, May 1, 2020.
    We also note that the ONC Final Rule established records and 
information retention requirements for health IT developers of 
certified health IT as part of the ONC Health IT Certification Program. 
The Maintenance of Certification requirement at 45 CFR 170.402(b) 
generally requires a health IT developer participating in the ONC 
Health IT Certification Program to retain all records and information 
necessary to demonstrate initial and ongoing compliance with the 
requirements of the ONC Health IT Certification Program for a period of 
10 years beginning from the date of certification.
2. Effective Date
    We proposed two alternative effective dates for the CMP for 
information blocking. The first proposal proposed an effective date of 
60 days from the date of the publication of the final rule. OIG 
recognized that information blocking is newly regulated conduct and 
that individuals and entities would require time to take steps to 
achieve compliance with the ONC Final Rule. The second

[[Page 42827]]

proposal proposed that we would set a specific date when OIG's CMP 
regulations would become effective. OIG specifically proposed an 
effective date of October 1, 2020, but also noted that we were 
considering effective dates sooner or later than October 1, 2020. Most 
of the comments submitted in response to the proposed rule expressed a 
preference for one of the two proposed approaches. Commenters preferred 
having a date certain, but no specific effective date was the clear 
preferred approach by a majority of those who preferred a date certain. 
Commenters also made several recommendations for alternative 
approaches.
    We are finalizing an effective date for the CMP for information 
blocking of September 1, 2023.
    Comment: Most commenters suggested that OIG adopt a date certain 
and specifically align the effective date of its CMP for information 
blocking with the effective dates for the ONC Final Rule and the CMS 
Interoperability and Patient Access Final Rule (CMS Final Rule) (85 FR 
25510, May 1, 2020). Some commenters stated that having a single 
effective date/enforcement date for all three rules would be beneficial 
for preparing for compliance with these rules. Some proposed specific, 
alternative effective dates to allow individuals and entities time to 
come into compliance. Others did not propose specific effective dates, 
but proposed an extended period of time between the publication of the 
final rule and the start of enforcement to permit additional time for 
ONC to issue additional guidance, for ONC to provide education and 
outreach, and for OIG to take into consideration the PHE. Some believed 
that enforcement should begin 3 months after publication of OIG's final 
rule while several commenters believed the appropriate amount of time 
was 6 months after publication of this rule. A few commenters suggested 
that the appropriate amount of time was 1 year or 2 years after 
publication of this rule. Some commenters supported the proposal for an 
effective date of the CMP for information blocking to be 60 days after 
publication of the final rule. The commenters who supported this 
proposal believed that 60 days after publication provided sufficient 
time for actors to review and respond to any items that OIG was to 
outline in its final rule and provide sufficient flexibility and 
assistance to actors seeking to comply.
    Response: Having considered the comments, we are finalizing our 
proposal for an effective date for the CMP for information blocking at 
42 CFR 1003.1400, 1003.1410, and 1003.420 as September 1, 2023. We 
believe this effective date responds to requests for such a delay. It 
also addresses commenters' concerns about having time to obtain 
additional guidance and come into compliance, particularly given the 
amount of time between the publication of the proposed rule and this 
final rule. In addition, the selection of this effective date aligns 
with the goals stated in the proposed rule of providing individuals and 
entities sufficient time to finalize their ongoing efforts to comply 
with the ONC information blocking regulations and putting the industry 
on notice of when penalties will apply to information blocking conduct. 
This effective date is consistent with the requests of commenters who 
supported a date certain because those commenters largely sought a 
specific date to have additional time for compliance efforts. This 
effective date achieves that goal based on the time between the 
proposed rule and this rule, which is longer than most specific dates 
proposed by commenters.
    As commenters shared with us in responses to the proposed rule, the 
PHE has significantly affected the United States, patients, health care 
providers, and the many individuals and entities that support health 
care operations. Actors that could be subject to the CMP for 
information blocking have been responding to COVID-19 on many fronts 
including addressing information technology-related requirements 
related to COVID-19, such as reporting data to multiple government 
agencies. All of this has increased demands on health IT developers of 
certified health IT, HIEs, and HINs. Recognizing these unprecedented 
circumstances, the effective date for the CMP for information blocking 
is reasonable and aligns with the goals stated in the proposed rule. 
Furthermore, OIG will not impose a CMP on information blocking conduct 
occurring before the effective date of this final rule.
    We reiterate that the effective date of the CMP for information 
blocking only applies to those actors defined at 45 CFR 171.102 as 
health IT developers of certified health IT, HINs, and HIEs. We note 
that the CMP for information blocking does not apply to health care 
providers except to the extent such health care providers meet the 
definition of a health IT developer of certified health IT or an HIN/
HIE. We discuss in section IV.A.3 of the preamble of this final rule 
how we evaluate whether health care providers may meet the health IT 
developer of certified health IT or an HIN/HIE.
3. Basis for Civil Money Penalties for Information Blocking
    OIG proposed a basis for the CMP for information blocking at 42 CFR 
1003.1400. In setting forth the basis for the CMP in the proposed rule, 
we proposed that we may impose a CMP against any individual or entity 
as defined in 45 CFR 171.103(b) that commits information blocking, as 
defined in 45 CFR part 171. We also proposed that OIG's enforcement 
would rely on the regulatory definitions set forth by ONC in the ONC 
Final Rule. Commenters agreed with OIG's proposed approach but 
requested clarification as to how OIG would interpret the definitions 
set forth in 45 CFR 171.103(a)(2).
    We note that since the publication of the proposed rule, ONC has 
published the ONC interim final rule (IFR) (85 FR 70064, November 4, 
2020) that clarified that 45 CFR 171.103(a)(2) refers to health IT 
developers of certified health IT rather than health information 
technology developers.
    In this final rule, we finalize 42 CFR 1003.1400 as proposed with a 
technical correction that incorporates 45 CFR 171.103(a)(2) instead of 
45 CFR 171.103(b) and a slight language change to reflect our intent.
    Comment: One commenter noted that the regulatory text of our 
proposed Sec.  1003.1400 should have cited 45 CFR 171.103(a)(2) instead 
of Sec.  171.103(b) when referring to those individuals or entities 
subject to civil money penalties.
    Response: We agree with the commenter that the correct citation is 
45 CFR 171.103(a)(2) and are making this technical correction at 42 CFR 
1003.1400. Our intent, as expressed in the proposed rule, was to 
incorporate ONC's definition of ``information blocking,'' which matches 
the statutory language in section 3022(a)(1) of the PHSA. This final 
rule corrects the technical citation error in the proposed rule and is 
not a substantive change.
    We further note that we have changed the language ``as defined in'' 
to ``as set forth in'' consistent with our intent to incorporate ONC's 
information blocking regulations in 45 CFR part 171. The regulation at 
45 CFR part 171 includes general provisions, including definitions, 
relevant to the information blocking regulations, as well as the 
``exceptions'' to the definition of information blocking. We believe 
this language change from ``as defined in'' to ``as set forth in'' 
better reflects our intent to incorporate all of ONC's information 
blocking regulations into the OIG CMP regulations.

[[Page 42828]]

    Comment: Commenters requested clarification as to whether they meet 
the definition of HIN/HIE. Some commenters requested clarification on 
whether they would meet the definition of HIN/HIE under specific facts, 
such as by using ONC-certified application programming interface (API) 
technology as a health care provider, or by engaging in specific 
processes as a health plan. Some commenters requested clarification as 
to whether certain types of entities met the definition of HIN/HIE, 
specifically asking whether a public health institution combating 
COVID-19, clinical data registries, public health agencies, or a health 
plan would ever be considered an HIN/HIE. Other commenters requested 
clarification and examples of when a health care provider would meet 
the definition of HIN/HIE and be subject to CMPs rather than 
disincentives. Some commenters suggested that a health care provider or 
payer should never be considered an HIN/HIE for purposes of the final 
rule.
    Response: OIG will use the definitions in ONC regulations at 45 CFR 
171.102 and any guidance issued by ONC when evaluating whether an 
individual or entity meets the definition of HIN/HIE. Such 
determinations are individualized and highly dependent on the facts and 
circumstances presented. Because the ONC definition of HIE/HIN is a 
functional definition that does not specifically include or exclude any 
particular individuals or entities, OIG cannot establish in this final 
rule whether specific individuals or entities or categories of 
individuals or entities would meet the definition of HIN/HIE as some 
commenters requested. OIG investigations of information blocking will 
include gathering facts necessary to assess whether a specific 
individual or entity meets a definition of health IT developer of 
certified health IT or HIE/HIN. Furthermore, we proposed following the 
definitions promulgated in the ONC Final Rule, which are now found at 
45 CFR 171.102, and which do not exempt specific types of individuals 
or entities from the definition of an HIN/HIE that could commit 
information blocking. Accordingly, we decline to exempt specific types 
of individuals or entities, including providers or payers, in this 
final rule.
    The ONC regulations define an HIN/HIE as an individual or entity 
that determines, controls, or has the discretion to administer any 
requirement, policy, or agreement that permits, enables, or requires 
the use of any technology or services for access, exchange, or use of 
EHI: (1) among more than two unaffiliated individuals or entities 
(other than the individual or entity to which this definition might 
apply) that are enabled to exchange with each other; and (2) that is 
for a treatment, payment, or health care operations purpose, as such 
terms are defined in 45 CFR 164.501 regardless of whether such 
individuals or entities are subject to the requirements of 45 CFR parts 
160 and 164. 45 CFR 171.102. When determining whether an individual or 
entity meets the definition of an HIN/HIE, we may consult with ONC.
    In making a fact-specific assessment of whether an individual or 
entity meets the definition of an HIN/HIE in 45 CFR 171.102, we would 
assess whether the individual or entity determines, controls, or has 
the discretion to administer any requirement, policy, or agreement that 
permits, enables, or requires the use of any technology or services for 
access, exchange, or use of EHI among two or more unaffiliated entities 
(other than the individual or entity that is the subject of the 
allegation) that are enabled to exchange with each other for a 
treatment, payment, or health care operations purpose as such terms are 
defined in 45 CFR 164.501. As stated in the ONC Final Rule, the 
definition of HIN/HIE in 45 CFR 171.102 does not cover bilateral 
exchanges in which an intermediary is simply performing a service on 
behalf of one entity in providing EHI to another entity or multiple 
entities and no actual exchange is taking place among all entities. 85 
FR 25802, May 1, 2020. The ONC Final Rule also states that for the two 
unaffiliated individuals or entities besides the HIE/HIN to be enabled, 
the parties must have the ability and the discretion to exchange with 
each other under the policies, agreements, technology, and/or services. 
85 FR 25802, May 1, 2020. Based on the ONC Final Rule and depending on 
the specific facts and circumstances, public health institutions, 
clinical data registries, public health agencies, health plans, and 
health care providers could meet the definition of an HIN/HIE. As part 
of our assessment of whether a health care provider or other entity is 
an HIN/HIE that could be subject to CMPs for information blocking, OIG 
anticipates engaging with the health care provider or other entity to 
better understand its functions and to offer the provider an 
opportunity to explain why it is not an HIN/HIE. We note further that 
should the definitions in 45 CFR part 171 change in the future, we 
would continue to look to applicable definitions in 45 CFR part 171 
when determining whether an individual or entity was an HIN/HIE at the 
time of the conduct.
    Comment: One commenter noted that the definition of HIN/HIE could 
apply to individuals serving on HIN governance and advisory committees 
and requested clarification about whether OIG would direct enforcement 
against an individual serving on an advisory board for an entity that 
qualifies as an HIN. The commenter noted that HIEs and HINs rely upon 
their governance and advisory committees and that individuals subject 
to enforcement may not want to provide their perspectives or 
participate on these committees.
    Response: While we believe it is unlikely that an individual 
serving on an HIN/HIE governance and advisory committee would be 
subject to information blocking enforcement, such individuals could be 
subject to enforcement if, based on the specific facts, they meet the 
definition of HIN/HIE and have engaged in information blocking with the 
requisite intent. To provide transparency on how OIG would assess an 
allegation involving an individual described by the commenter, we 
provide the following explanation.
    Consistent with section 3022(b)(2)(A) of the PHSA, individuals or 
entities subject to the CMP for information blocking must fall within a 
definition in 45 CFR 171.102 that describes one of the categories of 
actors that are subject to the CMP under section 3022(b)(2)(A) (i.e., 
developers, networks and exchanges). First, we emphasize that to 
determine whether an individual on an advisory board met the definition 
of an HIN/HIE, we would assess the specific facts and circumstances in 
the case. In assessing whether an individual met the definition of HIN/
HIE, OIG would consider the advisory board's purpose and authority to 
determine, control, or have discretion to administer any requirement 
policy, or agreement. OIG would also consider the individual's role, 
the individual's authority, and whether the individual determines, 
controls, or has the discretion to administer any requirement, policy, 
or agreement as a member of the advisory board. An individual or entity 
that does not determine, administer, or have discretion to administer a 
policy, requirement, or agreement would not meet the definition of an 
HIN/HIE. For example, the mere act of serving on an advisory board 
would not mean an individual is an HIN/HIE.
    Second, to impose CMPs against an individual, OIG would have to 
demonstrate that the individual committed an act of information 
blocking, which includes a requisite intent. Assuming the individual on 
the

[[Page 42829]]

advisory board met the definition of an HIN/HIE, OIG would examine 
whether the individual engaged in a practice that constituted 
information blocking. We would analyze the specific practice engaged in 
by the individual to determine CMP liability. This is consistent with 
section 3022(a)(6) of the PHSA, which states that information blocking 
with respect to an individual or entity shall not include an act or 
practice other than an act or practice committed by such individual or 
entity. Also consistent with the statute and the implementing 
regulations in 45 CFR 171.103(a)(2), we would determine whether the 
individual knew or should have known that the practice in which the 
individual engaged was likely to interfere with the access, exchange, 
or use of EHI.
    OIG maintains discretion in evaluating what claims to investigate 
and when to impose CMPs. OIG is not required to--and does not expect to 
be able to--investigate every allegation it receives. Similarly, OIG 
may decide it is appropriate to impose CMPs on an entity but not on 
both an entity and an individual for the same conduct.
    Comment: One commenter requested guidance on whether a health care 
provider would ever be viewed as a health IT developer of certified 
health IT. The commenter specifically asked whether a health care 
provider that sublicensed certified health IT to an unaffiliated 
provider could be subject to CMPs.
    Response: A health care provider may meet the definition of a 
health IT developer of certified health IT in Sec.  171.102, depending 
on the specific facts and circumstances. This regulatory definition 
excludes from its scope a health care provider that self-develops 
health IT for its own use. If any other individual or entity, including 
a health care provider, develops or offers one or more health IT 
modules certified under the ONC Health IT Certification Program, then 
they may meet the definition of health IT developer of certified health 
IT. If an individual or entity meets the definition of health IT 
developer of certified health IT and engages in conduct constituting 
information blocking, then that individual or entity could be subject 
to CMPs.
    Regarding the commenter's specific question, section 3022(b)(1)(A) 
of the PHSA authorizes OIG to investigate claims of information 
blocking against any ``other entity offering certified health 
information technology,'' and the definition of a health IT developer 
of certified health IT at 45 CFR 171.102 includes an individual or 
entity that ``offers health information technology.'' ONC further 
clarified in the ONC Final Rule its policy goal to hold all entities 
that could, as a developer or offeror, engage in information blocking 
accountable for their practices that are within the definition of 
information blocking in 45 CFR 171.103. ONC expressly considered 
comments to exclude from the definition those entities that only offer 
technology, rather than modify, configure, or develop it, and declined 
to do so. 85 FR 25798-99, May 1, 2020. OIG would assess whether a 
provider that sublicenses technology to an unaffiliated entity meets 
the definition of a health IT developer of certified health IT at 45 
CFR 171.102 based on the specific facts and circumstances.
    ONC specifically exempted health care providers that self-develop 
health IT for their own use from the definition of ``health IT 
developer of certified health IT.'' The ONC Final Rule clarifies that 
health care providers that self-develop health IT for their own use 
refers to health care providers that are the primary users of the 
health IT and are responsible for its certification status. 85 FR 
25799, May 1, 2020. The ONC Final Rule states that ONC interprets ``a 
health care provider that self-develops health IT for its own use'' to 
mean that a health care provider does not offer the self-developed 
health IT to other entities on a commercial basis or otherwise. 85 FR 
25799, May 1, 2020. The ONC Final Rule clarifies that a self-developer 
is not an offeror if it issues login credentials to a licensed health 
care professional in an independent practice that allow the use of a 
hospital's electronic health records (EHRs) to furnish and document 
care to patients in the hospital. 85 FR 25799, May 1, 2020. Whether an 
individual or entity ``offers health information technology'' requires 
a fact-specific inquiry, and we expect to consult with ONC in 
determining whether an individual or entity meets this definition.
    As part of any investigation, OIG will need to evaluate whether an 
individual or entity meets the definition of health IT developer of 
certified health IT or health information exchange or network. If OIG 
determines this definition is met and conduct meets the definition of 
information blocking, OIG may impose CMPs.
    Comment: One commenter asked whether a parent company could be 
subject to CMPs for information blocking based on the conduct of a 
subsidiary.
    Response: Whether information blocking on the part of a subsidiary 
is attributable to the parent entity depends on the specific facts and 
circumstances.
    Specifically, if a subsidiary acts as the agent of the parent, the 
parent may be subject to CMPs for the act of the subsidiary if the 
subsidiary commits information blocking within the scope of agency. 
Section 3022(b)(2)(C) of the PHSA states that the provisions of section 
1128A of the SSA shall apply to a CMP for information blocking. Section 
1128A(l) of the SSA states that a principal is liable for penalties, 
assessments, and exclusion for the acts of the principal's agent acting 
within the scope of agency.
    There may be other instances when information blocking by a 
subsidiary may create CMP liability for the parent. We note that 
nothing in the statute or ONC Final Rule precludes such liability, and 
the ONC Final Rule provides that a health IT developer of certified 
health IT includes not only the entity that is legally responsible for 
the certification status of the health IT but could also include any 
subsidiaries or successors, depending on the specific facts and 
circumstances of a particular case. 85 FR 25800, May 1, 2020. At this 
time, we do not have sufficient experience or evidence to delineate 
specific circumstances where a parent might be liable for information 
blocking by its subsidiary. We would make any determinations based on 
the specific facts and circumstances presented.
    Comment: One commenter believed that EHR vendors may limit the 
access of third-party vendors to data, data stores, databases, and 
endpoints that store data that are not part of the United States Core 
Data for Interoperability (USCDI).\1\ Specifically, the commenter was 
concerned that an EHR vendor may grant a health care provider access to 
a database and then deny a third-party vendor the same access. The 
commenter suggested OIG monitor and penalize EHR vendors that restrict 
access to data not represented in the USCDI.
---------------------------------------------------------------------------

    \1\ USCDI is a standardized set of health data classes and 
constituent data elements for nationwide, interoperable health 
information exchange.
---------------------------------------------------------------------------

    Response: Whether a practice constitutes information blocking 
depends on the specific facts and circumstances. First, the practice 
must involve EHI as defined in ONC's information blocking regulations. 
On and after October 6, 2022, EHI for purposes of the information 
blocking definition in 45 CFR 171.103(a) is not limited to the 
information identified by data elements represented in the USCDI 
standard adopted in 45 CFR 170.213, and practices that interfere with 
access,

[[Page 42830]]

exchange, or use of any information falling within the definition of 
EHI in 45 CFR 171.102 may constitute information blocking.
    However, even after October 6, 2022, the definition of EHI still 
excludes certain types of data that an actor may have. For example, EHI 
does not include psychotherapy notes as defined in 45 CFR 164.501. 
Therefore, the specific facts and circumstances will determine whether 
the data that is the subject of a claim of information blocking 
constitutes EHI.
    Second, the practice must constitute information blocking and the 
individual or entity must have had the requisite intent. We will assess 
whether the practice is likely to interfere with the access, exchange, 
or use of EHI, and whether the practice was required by law or met one 
of the information blocking exceptions. For example, in assessing an 
allegation similar to the commenter's fact pattern, we may assess 
whether the health IT developer of certified health IT provided the EHI 
to the health care provider and the third-party vendor using an 
alternative manner specified by the third-party vendor consistent with 
the Content & Manner Exception in 45 CFR 171.301.
    Comment: One commenter encouraged OIG to impose CMPs for 
information blocking on health IT developers of certified health IT 
with transfer of liability provisions in their contracts. The commenter 
noted that small and mid-size organizational health care providers are 
often presented with service contracts that have undesirable terms on a 
``take it or leave it'' basis because they may have only one health IT 
developer available or lack the market share (i.e., leverage) necessary 
to negotiate out of the undesirable terms.
    Response: OIG's information blocking regulations establish the 
basis for imposing CMPs for information blocking, which is whether the 
conduct constitutes information blocking as defined in 45 CFR 171.103. 
The ONC Final Rule established that a variety of contractual provisions 
could interfere with the access, exchange, and use of EHI and thus 
implicate the information blocking provision. For example, ONC 
explained that a contract may implicate the information blocking 
provision if it includes unconscionable terms for the access, exchange, 
or use of EHI, or licensing of an interoperability element that could 
include, but is not limited to, agreeing to indemnify the actor for 
acts beyond standard practice, such as gross negligence on the part of 
the actor. ONC explained further that such terms may be problematic 
with regard to information blocking in situations involving unequal 
bargaining power relating to accessing, exchanging, and using EHI. 85 
FR 25812, May 1, 2020. We will consult with ONC as necessary to inform 
our determinations as to whether specific service contracts, 
provisions, and related practices that transfer liability implicate the 
information blocking provision.
    Comment: One commenter stated that the CMS Final Rule requires 
State Medicaid agencies to make claims with a service date on or after 
January 1, 2016, available to a beneficiary or a beneficiary's personal 
representative. But the rule did not specify how long these claims had 
to be made available. The commenter asked whether the purging of those 
claims would subject State Medicaid agencies to information blocking 
penalties.
    Response: OIG does not intend to use its authority to investigate 
information blocking under section 3022(b)(1) of the PHSA to 
investigate compliance under CMS program requirements. If an 
investigation uncovers conduct that suggests non-compliance with CMS 
program requirements, OIG may refer such matters to CMS.
4. Definition of Violation
    OIG proposed that a violation be defined as a practice, as defined 
at 45 CFR 171.102, that constitutes information blocking, as defined at 
45 CFR part 171. We have finalized the definition of violation as 
proposed with a slight modification at 42 CFR 1003.1410(a).
    Comment: Many commenters expressed support for our proposed 
definition of ``violation'' and the incorporation of ONC's definition 
of ``practice.'' Commenters requested that we provide additional 
clarity and guidance as to the distinction between a single violation 
and multiple violations. Other commenters stated that we should provide 
more specific criteria for identifying a single violation as opposed to 
multiple violations. Some commenters requested additional clarity as to 
whether a practice involving multiple patient records would constitute 
multiple violations.
    Response: As finalized in this rule, a violation is a practice, as 
defined in 45 CFR 171.102, that constitutes information blocking, as 
set forth in 45 CFR part 171. We note that we have changed the language 
from ``as defined in'' to ``as set forth in,'' consistent with our 
intent to incorporate all of ONC's regulations. Whether a practice 
constitutes a violation depends on the specific facts and 
circumstances. We did not propose, and therefore this rule does not 
finalize, specific criteria that we would use to identify single or 
multiple violations because we do not have enough information or 
experience with information blocking enforcement to allow us to 
establish a set of criteria that could apply uniformly to all 
information blocking allegations. As we gain more experience in 
assessing allegations, conducting information blocking investigations, 
and imposing CMPs, we may identify patterns or data that allow us to 
develop guidance with more specific criteria.
    In response to commenters' requests, we are providing below 
hypothetical examples illustrating how we would determine whether 
information blocking practices constitute single or multiple 
violations. The examples set out in the proposed rule at 85 FR 22986-87 
remain applicable. But, we clarify that the examples provided in the 
proposed rule should be understood as involving health IT developers of 
certified health IT, since health IT developers that do not meet the 
regulatory definition of health IT developers of certified health IT 
would not be subject to CMPs. We emphasize that the examples in this 
preamble and in the preamble to the proposed rule are illustrative, 
fact-dependent, and not exhaustive. We further note that while our 
examples discuss the use of health information technology certified 
under the ONC Certification Program, an individual or entity that meets 
the definition of a health IT developer of certified health IT or HIE/
HIN may engage in conduct that constitutes information blocking 
relating to health IT certified under the ONC Certification Program, 
health IT not certified under the ONC Certification Program, or a 
combination of both.
    The following hypothetical examples of conduct assume that the 
facts meet all the elements of the information blocking definition--
including the requisite level of statutory intent.
     A health IT developer (D1) connects to an API supplied by 
health IT developer of certified health IT (D2). D2's API has been 
certified to 45 CFR 170.315(g)(10) (standardized API for patient and 
population services) of the ONC Certification Program and is subject to 
the ONC Condition of Certification requirements at 45 CFR 170.404 
(certified API technology). A health care provider using D1's health IT 
makes a single request to receive EHI for a single patient via D2's 
certified API technology. D2 denies this request. OIG would consider 
this a single violation by D2 affecting a single patient. The violation 
would consist of D2's denial of

[[Page 42831]]

the request to exchange EHI to the provider through D2's certified API.
     A health care provider using technology from a health IT 
developer (D1) makes a single request to receive EHI for 10 patients 
through the certified API technology of a health IT developer of health 
IT (D2). D2 takes a single action to prevent the provider from 
receiving any patients' information via the API. OIG would consider 
this as a single violation affecting multiple patients. This is a 
single violation as D2 took a single action to deny all requests from 
the provider. The number of patients affected by the violation would be 
considered when determining the amount of the CMP.
     A health care provider using health IT supplied by a 
health IT developer (D1) makes multiple, separate requests to receive 
EHI for several patients via certified API technology supplied by a 
health IT developer of certified health IT (D2). Each request is for 
EHI for one or more patients. D2 denies each individual request but 
does not set up the system to deny all requests made by the health care 
provider through D2's certified API technology. Thus, D2 is taking 
separate actions to block individual requests. OIG would consider this 
conduct to consist of multiple violations affecting multiple patient 
records. Each denial would be considered a separate violation. The 
number of patients affected by each violation would be considered in 
determining the amount of the penalty per violation. We note that for 
purposes of this example, each denial by D2 constitutes a separate act 
and thus a separate violation. Thus, if the health care provider using 
D1's health IT made one request for one patient's EHI, a second request 
for three patients' EHI, and a third request for five patients' EHI, 
there would be three separate violations but the penalties may vary due 
to the number of patients affected by each violation. The action or 
actions taken by D2 in response to the health care provider's requests 
provide the basis for assessing whether a practice constitutes a single 
or multiple violations.
     A health care provider using health IT supplied by a 
health IT developer (D1) makes multiple requests to receive EHI for a 
single patient via certified API technology supplied by a health IT 
developer of certified health IT (D2). But D2 has updated its system to 
deny all requests made by anyone using D1's technology. Thus, none of 
the requests by the provider using D1's health IT result in the 
provider receiving any EHI and D2 always denies requests based on the 
system change. OIG would consider this practice a single violation. The 
violation in this case is the singular action to update the system to 
always deny EHI to anyone requesting to receive the EHI via D1 or D1's 
health IT. The result of this violation is that all of the requests are 
denied; however, each individual denial does not constitute a 
violation. The number of patients affected by D2's denial may 
constitute an aggravating circumstance resulting in an increased 
penalty.
     A health IT developer of certified health IT enters into a 
software license agreement with a health care provider that requires 
that the health care provider pay a fee for the express purpose of 
permitting the health care provider to export patients' EHI via the 
capability certified according to 45 CFR 170.315(b)(10) for switching 
health IT systems. When the health care provider requests the 
electronic export, the health IT developer of certified health IT 
charges the health care provider the fee. We note that the Fees 
Exception in 45 CFR 171.302 excludes fees charged for an export using 
functionality certified according to 45 CFR 170.315(b)(10) for purposes 
of switching health IT. OIG would consider this conduct to include two 
violations. The first violation would be inclusion of the contract 
provision (fee) that is likely to interfere with, prevent, or 
materially discourage access, exchange, or use of EHI. The second 
violation would be charging the health care provider the fee. Charging 
the fee in this case constitutes a separate action, and therefore a 
separate violation from the inclusion of the fee in the software 
license agreement.
    We emphasize that information blocking only requires engaging in a 
practice that is likely to interfere with, prohibit, or materially 
discourage the access, exchange, or use of EHI. Information blocking 
does not require that the practice actually interferes with, prohibits, 
or materially discourages the access, exchange, or use of EHI.
    Comment: One commenter expressed concern that the example in the 
proposed rule concerning the health IT developer vetting a third-party 
application might cause health IT developers to forgo necessary 
security and privacy vetting of applications due to fear of potentially 
committing an information blocking violation.
    Response: In the preamble to the proposed rule, we provided an 
example where a health IT developer requires vetting of third-party 
applications before the applications can access the health IT 
developer's product, but the health IT developer denies applications 
based on the functionality of the application and not for a privacy or 
security concern. 85 FR 22987. We note that the ONC Final Rule 
contained a discussion of vetting, and we agree with the commenter that 
our example in the preamble to the proposed rule at 85 FR 22987 could 
benefit from additional explanation.
    Before clarifying our example, we provide some of the discussion of 
``vetting'' from the ONC Final Rule. First, we note that ``vetting'' in 
this context is intended to mean a determination regarding whether the 
application posed a security risk to the health IT developer of 
certified health IT's software. Second, pursuant to the ONC Final Rule, 
a vetting process applied in a discriminatory or unreasonable manner 
could implicate the information blocking provision. 85 FR 25814-17, May 
1, 2020. Third, the ONC Final Rule states that for certified API 
technology (e.g., a Health IT Module certified to Sec.  170.315(g)(10), 
which includes the use of OAuth2 among other security requirements 
(see, e.g., 85 FR 25741) in addition to its focus on ``read-only''/
responses to requests for EHI to be transmitted, there should be few, 
if any, security concerns about the risks posed by patient-facing apps 
to the disclosing actor's health IT systems (because the apps would 
only be permitted to receive EHI at the patient's decision). Thus, for 
third-party applications chosen by individuals to facilitate their 
access to their EHI held by actors, there would generally not be a need 
for ``vetting'' on security grounds and such vetting actions would be 
an interference. 85 FR 25815, May 1, 2020. Fourth, actors, such as 
health care providers, have the ability to conduct whatever ``vetting'' 
they deem necessary of entities (e.g., app developers) that would be 
their business associates under HIPAA before granting access and use of 
EHI to the entities. In this regard, covered entities must conduct 
necessary vetting in order to comply with the HIPAA Security Rule. 85 
FR 25815, May 1, 2020.
    With this in mind, we clarify the example as follows. A health IT 
developer of certified health IT requires vetting of third-party 
applications to determine whether the applications pose a security risk 
before the applications are permitted to interface or integrate with 
the health IT developer of certified health IT's product, which 
contains EHI. The health IT developer of certified health IT does not 
apply this vetting process to third party applications selected and 
authorized by a patient or provider to receive EHI from ``certified API 
technology,'' as defined as 45 CFR 170.404(c). The health IT developer 
of certified health IT does not

[[Page 42832]]

apply this vetting to patients or API Information Sources, as defined 
at 45 CFR 170.404(c), which are only receiving EHI through a 
standardized API. And, the health IT developer of certified health IT 
does not engage the third-party applications as a business associate or 
business associate subcontractor. The health IT developer of certified 
health IT uses vetting to deny EHI access to third-party applications 
that compete with one of the developer's applications. The health IT 
developer of certified health IT then denies third-party applications 
solely on the basis that they compete with one of the developer's 
applications. Each denial based on the competitive nature of the third-
party application is considered a separate violation, as it is a 
separate act or omission.
    If an actor, such as a health IT developer of certified health IT, 
identifies specific security risks posed by a third-party application, 
the actor may address those risks consistent with the Security 
Exception at 45 CFR 171.203 to ensure its practices are not considered 
information blocking.
    Comment: One commenter requested that OIG consider compliance with 
privacy and security standards as an important factor when evaluating 
what constitutes a violation.
    Response: Both section 3022(a)(1)(A) of PHSA and 45 CFR 
171.103(a)(1) exempt from the definition of information blocking 
practices required by law. Therefore, if a practice is required by 
privacy or security laws, it does not constitute information blocking. 
85 FR 25846, May 1, 2020. However, privacy and security standards that 
are not required by law (such as trade best practices or voluntary 
industry standards) would not be exempt from the definition of 
information blocking, unless an exception applies. When investigating 
an allegation, we may coordinate with other agencies to understand 
whether the practice was required under applicable privacy and security 
laws.
    Additionally, ONC established separate Privacy and Security 
Exceptions at 45 CFR 171.202 and 171.203. If a practice meets all 
conditions of an exception at all relevant times, then the practice 
would not be considered information blocking. When investigating an 
allegation, OIG will assess whether a practice meets an exception.
    Comment: Several commenters requested that OIG clarify its view on 
when the enactment of a policy constitutes information blocking. 
Commenters requested clarity on whether OIG would view the enactment of 
a policy that constitutes information blocking as a single violation or 
multiple violations. Some commenters suggested that consistent and 
repetitive implementation of a policy should be considered a single 
violation, regardless of the number of times the policy was applied. 
Another commenter suggested that we should approach violations and 
penalties as OCR did in its HIPAA Administrative Simplification 
Enforcement Final Rule, 71 FR 8390, February 16, 2006, specifically 
that we should consider a pattern or practice of information blocking 
to be more violations than a single instance emanating from the same 
conduct or type of conduct.
    Response: We will treat the enactment of a policy that is likely to 
interfere with, prevent, or materially discourage as one violation. But 
each enforcement of the policy will constitute another, separate 
violation. If the creation or existence of the policy alone is what 
determined the number of violations, and not the number of times the 
policy was enforced, large organizations with many customers or 
significant market share would be able to enact policies--regardless of 
whether they have been written or formalized--and engage in nationwide 
conduct constituting information blocking against multiple individuals 
or entities knowing that the maximum penalty would be the statutory 
maximum of $1 million. A practice is defined as an act or omission by 
an actor. 45 CFR 171.102. Given that our definition of violation 
incorporates the word ``practice'' and expressly refers to ONC's 
definition of practice, the number of violations is connected to the 
number of discrete acts engaged in by the actor and will depend on the 
specific facts and circumstances.
5. Determinations Regarding the Penalty Amounts
    We proposed to add new 42 CFR 1003.1420 that would codify the 
statutory factors that OIG must consider when imposing CMPs for 
committing information blocking. Section 3022(b)(2)(A) of the PHSA 
mandates that in determining the amount of a CMP for information 
blocking, OIG must consider factors such as the nature and extent of 
the information blocking and the harm resulting from such information 
blocking including, where applicable, the number of patients affected, 
the number of providers affected, and the number of days the 
information blocking persisted. The proposed regulatory text included 
these statutory factors. Given the novel nature of information blocking 
investigations and enforcement, we recognized in the preamble to the 
proposed rule that we have limited experience to inform the proposal of 
additional aggravating and mitigating circumstances to adjust the CMP 
penalties. Thus, we proposed only to implement the statutory factors 
described above. We also solicited comment on any additional factors 
that we should consider for the final rule. We received several 
comments on proposed factors and a number of recommendations to 
implement other factors.
    We are finalizing 42 CFR 1003.1420 as proposed with a modification 
to the regulatory text at 42 CFR 1003.1420(a), which is the factor for 
``nature and extent of the information blocking.'' For this factor, we 
have added to the regulatory text the specific facts that section 
3022(b)(2)(A) of the PHSA directs us to take into account where 
applicable: the number of patients affected (42 CFR 1003.1420(a)(1)), 
number of providers affected (42 CFR 1003.1420(a)(2)), and the number 
of days the information blocking persisted (42 CFR 1003.1420(a)(3)). In 
the preamble of the proposed rule, we explained our intent was to 
specifically implement the exact statutory factors in section 
3022(b)(2)(A). 85 FR 22987, April 24, 2020.
    Comment: Some commenters requested that OIG consider additional 
aggravating and mitigating factors when determining the penalty amount 
it will impose. Commenters suggested considering characteristics of the 
actor, including an actor's size, market share, whether the actor faced 
systemic barriers to interoperability, whether the actor took 
corrective action prior to imposition of a penalty, and the actor's 
compliance, specifically the actor's history of compliance with the 
information blocking rules, the robustness of an actor's compliance 
program, and whether the actor made good faith efforts to seek ONC/OIG 
guidance. Some commenters suggested considering the consequences of the 
conduct, such as whether the information blocking resulted in patient 
harm and the severity of that harm, and whether the information 
blocking impacted another actor's ability to access information (i.e., 
interfered with a provider's ability to deliver patient care). Some 
commenters suggested looking at the specific conduct at issue, 
specifically whether the information blocking involved a single 
violation or multiple violations, whether an actor had specific intent 
to engage in information blocking, whether the actor had control and 
the extent of that control over the EHI, and whether there were 
contributory practices by others.

[[Page 42833]]

Some commenters suggested that OIG consider mitigating factors beyond 
an actor's control, such as the effects of natural disasters and public 
health emergencies (such as the PHE caused by the COVID-19 pandemic) on 
health care delivery and data exchange. Furthermore, commenters also 
suggested that practices that exacerbate the negative impact of natural 
disasters and public health emergencies be considered an aggravating 
factor. Some commenters suggested that OIG should consider adopting 
factors based on factors used by OCR in assessing HIPAA CMPs. Some 
commenters recommended that OIG consider instances of an actor self-
disclosing information blocking conduct as a mitigating factor.
    Response: We thank commenters for the recommendations of additional 
aggravating and mitigating factors that OIG should consider. We may 
consider implementing additional, specific factors in the future via 
notice and comment rulemaking as we gain more experience in enforcing 
the CMP for information blocking. At this time, however, we are 
finalizing the statutory factors listed in section 3022(b)(2)(A) of the 
PHSA as we proposed, with the modification to the proposed factor for 
``nature and extent of the information blocking'' described above.
    While we are not adopting additional aggravating and mitigating 
factors specific to information blocking, we observe that the existing, 
general factors we must consider under the CMPL will apply to the CMP 
for information blocking and may address many of the commenters' 
concerns. The PHSA requires that the provisions of section 1128A of the 
SSA (other than subsection (a) and (b) of such section) apply to a CMP 
for information blocking in the same manner as such provisions apply to 
a CMP or proceeding under section 1128A(a) of the Act. Section 1128A(d) 
of the SSA requires that OIG, when determining the amount or scope of 
any assessment, penalty or exclusion imposed under subsection (a), take 
into account ``(1) the nature of claims and the circumstances under 
which they were presented, (2) the degree of culpability, history of 
prior offenses, and financial condition of the person presenting the 
claims, and (3) such other matters as justice may require.'' 42 U.S.C. 
1320a-7a(d). These broad general factors apply to the CMP for 
information blocking set forth in the PHSA as they do under section 
1128A(a) of the SSA. They encompass some of the mitigating or 
aggravating factors recommended by commenters.
    The existing regulatory framework for OIG's CMPs requires that we 
apply the aggravating and mitigating factors in 42 CFR 1003.140 to the 
CMP for information blocking determinations in a manner consistent with 
section 1128A.
    As we set forth in the OIG Medicare and State Health Care Programs: 
Fraud and Abuse Revisions to the Office of Inspector General's Civil 
Monetary Penalty Rules Final Rule (Revisions Rule), we consider the 
financial condition of an actor after we evaluate the facts and 
circumstances of conduct and weigh aggravating and mitigating factors 
to determine an appropriate penalty and assessment amount. 81 FR 88334, 
December 7, 2016. Once OIG proposes a penalty amount, the individual or 
entity may request that OIG consider its ability to pay the proposed 
amount under procedures discussed in the Revisions Rule at 81 FR 88338.
    In addition to the general factors in section 1128A, section 
3022(b)(2)(A) of the PHSA specifies a non-exhaustive list of factors 
that we must consider when imposing CMPs for information blocking. In 
the proposed rule, we proposed incorporating the PHSA's specific 
information blocking factors into our existing regulations at new Sec.  
1003.1420 of title 42. This new section complements the existing 
section at 42 CFR 1003.140.
    We recognize that the statutory factors enumerated in the PHSA may 
overlap with the general statutory and regulatory factors for all CMPs 
in section 1128A of the SSA and in 42 CFR 1003.140. For example, we 
recognize that ``the nature and circumstances of the violation,'' 42 
CFR 1003.140(a)(1), is a similar factor to the ``nature and extent of 
the information blocking'' and that, consequently, there may be a fact 
pattern that implicates both factors. We would not apply both or 
``double count'' these factors when determining the penalty. We would 
make a holistic consideration of all aggravating factors when 
determining the amount of any penalty; this approach would take into 
account the similarity of the factors.
    Many of the commenters' suggested factors, such as whether the 
information blocking resulted in patient harm and the severity of that 
harm, whether the actor had specific intent to engage in information 
blocking, and whether there was one violation or multiple violations, 
are already encapsulated by the general factors in 42 CFR 1003.140 or 
the specific information blocking factors in 42 CFR 1003.1410 finalized 
by this rule. We provide the following examples to illustrate how the 
issues raised by commenters may be considered when we assess penalty 
amounts using the two sets of factors at 42 CFR 1003.140 or 1003.1420.
    For example, to assess the ``nature and circumstances'' in 42 CFR 
1003.140 and ``nature and extent'' of the information blocking in 42 
CFR 1003.1420, we will consider the factual nature, circumstances, and 
extent of the information blocking conduct. Depending on the specific 
facts and circumstances, these factors may include whether the practice 
actually interfered with the access, exchange, or use of EHI; the 
number of violations; whether an actor took corrective action; whether 
an actor faced systemic barriers to interoperability; to what extent 
the actor had control over the EHI; the actor's size; and the market 
share.
    Similarly, the general factor in 42 CFR 1003.140 relating to degree 
of culpability would allow us to consider the commenters' suggested 
factors relating to whether an actor had actual knowledge or whether an 
actor had specific intent to engage in information blocking.
    Additionally, to assess the ``harm'' factor in 42 CFR 1003.1420, we 
will consider whether any harm--including physical or financial harm--
occurred and evaluate the severity and extent of the harm. In 
accordance with the statutory language, we will consider the number of 
patients affected, number of providers affected, and the duration of 
the information blocking conduct. We recognize that the primary factors 
set forth at Sec.  1003.140 may also contemplate harm. (For example, in 
the Revisions Rule, we stated that our consideration of the ``nature 
and circumstances'' would include ''whether patients were or could have 
been harmed.'' 81 FR 88337, December 7, 2016.)
    With respect to consideration of self-disclosure of information 
blocking conduct, it is a mitigating circumstance under the general 
factors at 42 CFR 1003.140(a)(2) for an actor to take appropriate and 
timely corrective action in response to a violation. Relevant 
corrective action must include disclosing the violation to OIG through 
the SDP and fully cooperating with OIG's review and resolution of such 
disclosure. As discussed in section III.C of the preamble, OIG does not 
currently have an SDP for information blocking and plans on creating a 
specific SDP for information blocking after publication of this rule.
    We are also not adding factors related to the circumstances 
surrounding the commission of the act, such as a factor that evaluates 
whether there were contributory practices by others or an intervening 
natural disaster. In some

[[Page 42834]]

instances, these factors are subsumed in existing general factors. 
Moreover, section 3022(a)(6) of the PHSA states that ``information 
blocking, with respect to an individual or entity, shall not include an 
act or practice other than an act or practice committed by such 
individual or entity.'' Information blocking, as to health IT 
developers of certified health IT, HIEs, and HINs, is a practice that 
an actor ``knows'' or ``should know'' is likely to interfere with, 
prevent, or materially discourage the access, exchange, or use of EHI. 
For example, in the circumstance of an intervening natural disaster 
that prevents an actor from responding to requests for data, the actor 
may not have the requisite level of intent. In such a situation, it is 
unlikely that there would be a sufficient basis to pursue CMPs for 
information blocking against the actor, and consideration of the 
factors relating to determination of the amount of any penalty would 
not be necessary.
    Finally, we note that the modification to 42 CFR 1003.1420(a) 
finalized in this final rule adds three specific facts OIG must 
consider where applicable (number of patients affected, number of 
providers, and number of days the information blocking persisted). This 
modification aligns the factors at Sec.  1003.1420(a) more precisely 
with the language of the PHSA. As we stated in the proposed rule, 
section 3022(b)(2)(A) of the PHSA mandates the consideration of the 
nature and extent of the information blocking and harm resulting from 
such information blocking including, where applicable, the number of 
patients affected, the number of providers affected, and the number of 
days the information blocking persisted. We intended the language of 
our proposed rule to reflect these statutory factors. 85 FR 22987, 
April 24, 2020. These factors may also address several of the 
commenters' concerns related to consideration of impact on patients and 
providers.
    Comment: Some commenters suggested an additional mitigating factor 
of whether an actor was acting in accordance with another Federal law, 
State law, or court order limiting or prescribing certain behaviors.
    Response: Section 3022(a)(1)(A) of the PHSA and 45 CFR 
171.103(a)(1) explicitly exclude conduct that is required by law from 
the definition of information blocking. Therefore, if an actor's 
conduct is required by law, it would not meet the definition of 
information blocking, and OIG would not have the authority to impose 
CMPs. In the ONC Final Rule, ONC explained that court orders and 
binding administrative decisions are considered ``required by law.'' 85 
FR 25794, May 1, 2020.
    Comment: Some commenters sought clarification about how OIG will 
consider the proposed factors and whether they will be weighted. Some 
commenters requested additional detail on the range of potential 
penalty amounts that OIG may issue and the circumstances or thresholds 
that trigger such penalty amounts. For example, one commenter requested 
a chart to show how different facts and circumstances would result in 
different penalty amounts. This commenter also proposed that OIG set a 
baseline penalty amount to provide guidance on how OIG would set 
penalties for specific conduct. Some commenters requested clarification 
on the circumstances and thresholds leading up to the maximum penalty 
of $1 million. One commenter asked whether penalties assessed would be 
per organization impacted by the information blocking or per patient 
impacted by the information blocking.
    Response: Our goal in setting penalty amounts is for a penalty to 
be fair, reasonable, and commensurate with the conduct so that 
wrongdoers are held accountable and future information blocking conduct 
is deterred. Accordingly, setting penalty amounts necessitates 
consideration of the particular facts of each case and does not lend 
itself to one-size-fits-all formulas or thresholds. The amount of each 
penalty will be determined per violation and will be based on the 
aggravating and mitigating factors.
    Section 3022(b)(2)(A) of the PHSA requires the consideration of the 
number of providers affected and the number of patients affected when 
evaluating the nature and extent of the information blocking and the 
harm resulting from such information blocking. We consider the number 
of providers affected and number of patients affected under 42 CFR 
1003.1420. In evaluating the nature and extent of the violation, we may 
also consider the number of organizations impacted by the information 
blocking, in addition to the number of patients and providers 
affected.\2\
---------------------------------------------------------------------------

    \2\ We could consider the number of organizations under the 
``nature and circumstances of the violation'' factor at 42 CFR 
1003.140 or the ``nature and extent of information blocking'' at 42 
CFR 1003.1420. As we discuss elsewhere in this section IV.A.5 of the 
preamble, the factors set forth at 42 CFR 1003.140 may overlap at 42 
CFR 1003.1420, but we would not double count them.
---------------------------------------------------------------------------

    The penalty amount will be based on a case-specific application of 
each identified aggravating and mitigating factor. Because penalty 
amounts require case-by-case evaluation, we decline to set a baseline 
penalty amount, set thresholds, or create a chart as commenters 
requested. Similarly, in assessing a penalty amount, OIG may weigh the 
aggravating and mitigating factors at 42 CFR 1003.140 and 1003.1420, 
but this weighting will not follow a formula. Application of the 
aggravating and mitigating factors will result in the penalty assessed 
being fair and reasonable. We would expect that the maximum penalty of 
$1 million per violation would apply to particularly egregious conduct.
    Comment: Some commenters had concerns that when considering the 
number of patients and number of providers affected, OIG would impose 
lower penalty amounts for information blocking against smaller 
entities, thereby incentivizing information blocking against smaller 
entities. Other commenters raised concerns that the inclusion and 
implementation of the ``number of days'' factor in determining CMP 
amounts would result in an improperly low penalty amount for conduct 
that had serious effects but did not last long.
    Response: Section 3022(b)(2)(A) of the PHSA requires OIG to 
consider, among other factors, the number of patients affected, the 
number of providers affected, and the number of days the information 
blocking persisted. As noted above, OIG's determination of a penalty 
amount will not rely on a rigid formula for weighing those factors but 
rather on a case-specific analysis of each identified aggravating and 
mitigating factor. Nothing in these factors would require OIG to impose 
a lower CMP amount for information blocking against small entities, 
even when such entities have fewer patients and providers than larger 
entities. OIG is mindful that information blocking against small 
entities can have significant adverse impacts for the entities and 
their patients and providers. For example, application of the factors 
at 42 CFR 1003.1420(a) and (b) to the specific facts and circumstances 
could result in a higher penalty because the information blocking had 
significant, negative impacts even for short periods of time on an 
individual or small entities. Moreover, if conduct results in 
significant harm, including lasting harm to patients, OIG would 
consider such harm as a potential aggravating factor when determining 
the appropriate penalty amount.
    Comment: Some commenters requested clarification about what OIG 
considers to be ``harm resulting from'' information blocking. Some 
commenters suggested OIG should interpret ``harm'' to mean physical 
harm to a patient's

[[Page 42835]]

health and well-being and suggested that OIG also consider financial 
harm that patients, providers, or third-party actors suffer as a result 
of information blocking. Other commenters raised concerns that 
intentional information blockers will be allowed to get away with 
``near misses'' if OIG does not consider both the potential and actual 
harm resulting from information blocking as aggravating factors.
    Response: In the proposed rule, we stated that section 
3022(b)(2)(A) of the PHSA mandates that OIG must take into 
consideration factors such as the nature and extent of the information 
blocking and the harm resulting from such information blocking 
including, where applicable, the number of patients affected, the 
number of providers affected, and the number of days the information 
blocking persisted in determining the amount of a CMP. 85 FR 22987, 
April 24, 2020. We proposed incorporating these factors at 42 CFR 
1003.1420, and noted that these factors were like factors found in 
other sections of part 1003. We did not propose a definition of 
``harm'' in the proposed rule. We solicited comment on this factor and 
other potential factors we should consider.
    In response to commenters' suggestions regarding the types of harm 
covered by Sec.  1003.1420(b), we agree that ``harm'' should cover both 
physical and financial harm. Nothing in section 3022(b)(2)(B) of the 
PHSA indicates that harm should be limited to only one type or a 
specific type of harm. We are not finalizing a definition of the word 
harm. We intend to interpret harm in accordance with its plain meaning, 
ensuring that we can consider a range of harms that may result from 
information blocking conduct. As we gain more experience investigating 
and imposing CMPs for information blocking, we may add additional 
factors related to specific types of harm through rulemaking.
    We appreciate the concern regarding intentional information 
blockers that might get away with ``near misses.'' We do not believe 
this would be the case. The definition of information blocking applies 
to conduct that is ``likely'' to interfere with the access, exchange, 
or use of EHI, thus capturing conduct with a potential to cause harm. 
With respect to determination of a penalty amount after information 
blocking is established, as noted above OIG will consider a range of 
aggravating factors and would not consider ``resulting in harm'' in 
isolation.
6. Additional Comments
    Comment: One commenter noted that the proposed rule stated 
investigated parties may incur some costs in response to an OIG 
investigation or enforcement action and encouraged OIG not to impose 
CMPs unless OIG determined the party committed information blocking. 
The commenter also asked how investigative fees are calculated in the 
instance that investigated parties incur costs in response to an OIG 
investigation or enforcement action.
    Response: OIG will impose CMPs where appropriate and does not 
separately charge costs to investigated parties as the comment 
contemplates. OIG also does not reimburse investigated parties for 
costs. We included estimated costs for investigated parties or subjects 
in the proposed rule as part of our Regulatory Impact Analysis (RIA). 
The costs described in the RIA only estimate the potential economic 
impact of the proposed rule, which includes costs that a subject being 
investigated may incur. For example, a party may incur costs in 
preparing documents in response to a subpoena or hiring an attorney to 
represent them during an investigation.

B. CMPs, Assessments, and Exclusions for Fraud or False Claims or 
Similar Conduct Related to Grants, Contracts, and Other Agreements

    The Cures Act amendments to the CMPL authorize the Secretary to 
impose penalties, assessments, and exclusions for a variety of 
fraudulent and other improper conduct related to HHS grants, contracts, 
and other agreements. 42 U.S.C. 1320a-7a(o)-(s). In the proposed rule, 
we proposed to incorporate this authority into 42 CFR parts 1003 and 
1005, which is the existing regulatory framework for the imposition and 
appeal of OIG penalties, assessments, and exclusions. We received 
comments related to this authority on only three topics: (1) the 
proposed definition of ``other agreement'' in 42 CFR 1003.110; (2) the 
proposed aggravating and mitigating factors in 42 CFR 1003.720 that 
will be used by OIG to determine the severity of the penalties, 
assessments, and exclusions it imposes; and (3) OIG enforcement 
priorities. We received no comments on the definitions we proposed to 
add to 42 CFR 1003.110 except ``other agreement'' as noted above, and 
are finalizing those definitions accordingly. We received no comments 
on 42 CFR 1003.710, which identifies the maximum penalties and 
assessments OIG may impose for fraud and other improper conduct 
involving HHS grants, contracts, and other agreements. We also received 
no comments on changes to 42 CFR 1003.130, 1003.1550, and 1003.1580, 
which relate to the calculation and collection of assessments imposed 
under this part and the use of statistical sampling. We finalize 42 CFR 
1003.130, 1003.710, 1003.1550, and 1003.1580 as proposed without 
modification accordingly. We received no comments on 42 CFR 1003.700, 
which sets forth the bases for OIG's imposition of sanctions for fraud 
and other improper conduct related to grants, contracts, and other 
agreements, but are modifying 42 CFR 1003.700(a)(5) for clarity by 
adding a citation to the existing regulatory definition of ``failure to 
grant timely access'' at 42 CFR 1003.200(b)(10). We proposed, and are 
finalizing, that the changes to 42 CFR 1003.110, 1003.130, 1003.700, 
1003.710, 1003.720, 1003.1550, and 1003.1580 will be effective 30 days 
from the publication date of the final rule.
1. Definition of ``Other Agreement''
    In the proposed rule, we proposed adopting at 42 CFR 1003.110 the 
statutory definition of ``other agreement'' that would apply to CMPs 
brought under 42 CFR 1003.700. This definition includes but is not 
limited to a cooperative agreement, scholarship, fellowship, loan, 
subsidy, payment for a specified use, donation agreement, award, or 
subaward (regardless of whether one or more of the persons entering 
into the agreement is a contractor or subcontractor). 42 U.S.C. 1320a-
7a(q)(3). We noted in the proposed rule that this definition is broad 
and identifies a nonexclusive list of arrangements that could 
constitute ``other agreements'' under the statute. We stated that when 
OIG investigates potential misconduct and decides whether to impose 
sanctions, it will evaluate matters on a case-by-case basis to 
determine whether the funding arrangement at issue constitutes an 
``other agreement'' under the statute and whether the conduct at issue 
violates the statute. We are finalizing the definition of ``other 
agreement'' as proposed in 42 CFR 1003.110, without modification.
    Comment: Several commenters requested that OIG provide more detail 
on which arrangements could constitute ``other agreements'' under the 
regulation. For example, one commenter asked OIG to provide additional 
clarity on how OIG will determine which ``other agreements'' fall 
within the meaning of the statute. Another commenter asked OIG to 
provide specific examples of scenarios involving ``other agreements'' 
where it would apply its CMPL authority.
    Response: The statutory definition of ``other agreement,'' which 
has been

[[Page 42836]]

incorporated verbatim into 42 CFR 1003.110, is broad and defines 
``other agreement'' to include (but not be limited to) a ``cooperative 
agreement, scholarship, fellowship, loan, subsidy, payment for a 
specified use, donation agreement, award, or subaward (regardless of 
whether one or more of the persons entering into the agreement is a 
contractor or subcontractor).'' It is not possible to identify with 
specificity all the various types of agreements that may fall under the 
definition of ``other agreement.'' The nine examples of ``other 
agreement'' identified in the statute along with the text of 42 U.S.C. 
1320a-7a(o)-(s) demonstrate that Congress intended ``other agreement'' 
to be read broadly to include, for example, not only those direct 
agreements between the Secretary and recipients of HHS funding but also 
agreements between recipients of HHS funding and subrecipients such as 
subcontractors and subawardees. The definition of ``specified claim,'' 
for example, includes those requests for payment submitted by a 
subawardee to an HHS awardee that is receiving funding directly from 
the Secretary. 42 U.S.C. 1320a-7a(r). In addition, 42 U.S.C. 1320a-
7a(o)(2) permits OIG to impose sanctions upon an entity that, among 
other things, creates false documents that are required to be submitted 
in order to indirectly receive funds from the Secretary. Any person 
that receives HHS funding directly or indirectly through an agreement 
is potentially subject to liability under the CMPL if they engage in 
any of the improper conduct identified in the regulation including but 
not limited to making misrepresentations in applications for the 
funding, presenting false or fraudulent specified claims related to the 
funding, and creating false records related to the funding.
2. Factors in Mitigation and Aggravation
    The regulation at 42 CFR 1003.720 of the proposed rule proposed 
factors for OIG to consider in mitigation and aggravation when 
determining the appropriate penalty, assessment, and period of 
exclusion to impose upon persons who engage in fraud and other improper 
conduct related to HHS grants, contracts, and other agreements. In 42 
CFR 1003.720(a), for example, we proposed that OIG would consider 
identifying as a mitigating factor a circumstance in which the amount 
of funds involved with the improper conduct was less than $5,000. Then, 
in 42 CFR 1003.720(b), we proposed considering as an aggravating factor 
a circumstance in which the amount of funds involved was more than 
$50,000. We are finalizing 42 CFR 1003.720 as proposed without 
modification.
    Comment: One commenter suggested that the proposed monetary 
thresholds created in 42 CFR 1003.720(a) and (b) of $5,000 and $50,000 
are too low and need to be adjusted upwards because they will lead to 
overly harsh determinations for CMPL violations related to grants, 
contracts, and other agreements that involve what the commenter 
characterized as small amounts of HHS funding. The commenter suggested 
that OIG consider it a mitigating factor in 42 CFR 1003.720(a) if the 
amount of funds involved with the improper conduct was less than 
$50,000 and consider it an aggravating factor in 42 CFR 1003.720(b) if 
the amount of funds involved with the improper conduct was more than 
$250,000.
    Response: We are not accepting the commenter's suggestion to 
upwardly adjust the monetary thresholds proposed in 42 CFR 1003.720(a) 
and (b). The thresholds proposed in 42 CFR 1003.720(a) and (b) are the 
same thresholds that exist under 42 CFR 1003.220 related to damages 
sustained by HHS for fraud and similar conduct related to the Federal 
health care programs. OIG believes it is important for 42 CFR 1003.720 
and 1003.220 to be consistent because both provide guidelines for OIG 
to evaluate the same factor and relate to damages sustained by HHS 
programs as a result of fraud or similar conduct.
    Comment: Two commenters requested that OIG consider as a mitigating 
circumstance in an action for failure to grant timely access to OIG 
under 42 CFR 1003.700(a)(5) whether a party acted in good faith in 
attempting to comply with OIG's request for timely access in matters 
involving HHS grants, contracts, or other agreements. The commenters 
both pointed to challenges surrounding the current COVID-19 pandemic as 
an example of a circumstance in which a party might act in good faith 
in attempting to comply with OIG's request for access but might be 
unable to comply with it.
    Response: We are not adopting this suggestion. Existing mitigating 
factors in 42 CFR 1003.140 that apply to all CMPs in 42 CFR part 1003 
address commenters' request to assess whether the party acted in good 
faith as a mitigating factor. As finalized, section 1003.720 identifies 
factors in mitigation that OIG should consider when imposing sanctions 
and states that those factors should be read in conjunction with the 
factors listed in 42 CFR 1003.140. Section 1003.140 requires OIG to 
consider in mitigation ``the degree of culpability'' of the person 
against whom a sanction is imposed (42 CFR 1003.140(a)(2)), ``the 
nature and circumstances of the violation'' (42 CFR 1003.140(a)(1)), 
and ``such other matters as justice may require'' (42 CFR 
1003.140(a)(5)). Under these existing mitigating factors, we would 
account for a party's good faith in attempting to comply with an OIG 
timely access request consistent with 42 CFR 1003.140(a)(1), (2), and 
(5). Therefore, it is unnecessary to explicitly add good faith as a 
mitigating factor to 42 CFR 1003.720.
3. OIG Enforcement Regarding Grants, Contracts, and Other Agreements
    The regulation at 42 CFR 1003.700 identifies the grounds for OIG's 
imposition of penalties, assessments, and exclusions for fraud and 
other improper conduct related to HHS grants, contracts, and other 
agreements, and sets forth the levels of intent required to violate 
each offense. One commenter asked that OIG only exercise its discretion 
to impose sanctions when it finds bad intent or other truly abusive, 
egregious, and intentional wrongdoing. We are not adopting this 
suggestion and are finalizing 42 CFR 1003.700 as proposed with 
modification only to 42 CFR 1003.700(a)(5) as discussed below.
    Comment: One commenter noted that many HHS grants, contracts, and 
other agreements are complex and require specific and detailed 
information from and actions by parties applying for the funds. The 
commenter also noted that regulatory requirements sometimes change, 
especially in times of a PHE such as the PHE for COVID-19, and that 
complying with shifting requirements can be difficult. The commenter 
asked that OIG take into consideration these complexities, ambiguities, 
and shifting requirements when exercising its discretion in enforcing 
the CMPs and that it do so only when the facts demonstrate bad intent 
or other truly abusive, egregious, and intentional wrongdoing by the 
parties applying for or receiving HHS funds.
    Response: The CMPL authorizes the imposition of penalties, 
assessments, and exclusions for a variety of fraudulent and other 
improper conduct related to HHS grants, contracts, and other 
agreements, and sets forth the levels of intent required to violate 
each of the offenses it creates. 42 U.S.C. 1320a-7a(o). In determining 
whether to impose sanctions and the severity of those sanctions, OIG 
will consider all of the relevant facts and circumstances surrounding 
an allegation of wrongdoing in light of the factors identified in the 
CMPL (42 U.S.C.

[[Page 42837]]

1320a-7a(d)) and the regulation. 42 CFR 1003.140 and 1003.720. 
Depending on the facts and circumstances of any particular case, it may 
be appropriate for OIG to consider the difficulties raised by the 
commenter, including those related to the PHE for COVID-19, in 
determining whether a person has violated the CMPL and, if so, the 
severity of the sanction OIG proposes to impose.
4. Modification to 42 CFR 1003.700(a)(5)
    The regulation at 42 CFR 1003.700(a)(5) incorporates into part 1003 
OIG's statutory authority under 42 U.S.C. 1320a-7a(o)(5) to impose 
CMPs, assessments, and exclusions for the failure to grant timely 
access to OIG for the purpose of audits, investigations, evaluations, 
or other statutory functions of OIG in matters involving grants, 
contracts, or other agreements. We stated in the proposed rule at 85 FR 
22982 that 42 U.S.C. 1320a-7a(o)(5) largely mirrors the statutory 
language that has for many years given OIG the authority to impose 
sanctions for the failure to grant timely access to OIG related to 
health care claims. Furthermore, we stated at 85 FR 22980 of the 
proposed rule that it was our intent to incorporate into OIG's existing 
CMP regulations the new CMP authorities related to fraud and other 
misconduct involving HHS grants, contracts, and other agreements. 
However, our proposed regulatory text at 42 CFR 1003.700(a)(5) omitted 
a citation to the existing regulatory definition of ``failure to grant 
timely access'' that is located at Sec.  1003.200(b)(10), in a section 
of part 1003 that relates to fraud involving Federal health care 
claims. Consistent with our intent to incorporate into part 1003 our 
authority to impose sanctions for failure to grant timely access 
related to grants, contracts, and other agreements, our view that this 
authority mirrors the authority OIG has had for many years related to 
health care claims and, for clarity, we are finalizing 42 CFR 
1003.700(a)(5) with a cross-reference to the existing definition of 
``failure to grant timely access'' to make clear that the definition of 
that term at 42 CFR 1003.200(b)(10) is applicable to actions under 42 
CFR 1003.700(a)(5).

C. The Bipartisan Budget Act of 2018

    The BBA of 2018 amended the CMPL to increase certain CMP amounts 
contained in 42 U.S.C. 1320a-7a(a) and (b). The BBA 2018 increased 
maximum civil money penalties in section 1128A(a) of the SSA (42 U.S.C. 
1320a-7a) from $10,000 to $20,000; from $15,000 to $30,000; and from 
$50,000 to $100,000. The BBA 2018 increased maximum civil money 
penalties in section 1128A(b) of the SSA from $2,000 to $5,000 in 
paragraph (1), from $2,000 to $5,000 in paragraph (2), and from $5,000 
to $10,000 in paragraph (3)(A)(i). This statutory increase in CMP 
amounts is effective for acts committed after the date of enactment, 
February 9, 2018. In the proposed rule, we proposed increasing the 
civil money penalties in accordance with the BBA 2018. Specifically, 
for conformity with the CMPL as amended by the BBA 2018, we proposed to 
revise the civil money penalties contained at 42 CFR 1003.210, 
1003.310, and 1003.1010.
    The BBA 2018 increased penalty maximums for conduct that occurred 
after February 9, 2018. Accordingly, for each of the provisions below, 
we proposed language increasing the maximum penalty for conduct that 
occurred after February 9, 2018, and maintaining the pre-BBA 2018 
penalty maximums for conduct that occurred on or before that date. The 
penalty amounts for conduct that occurred after February 9, 2018, in 
proposed 42 CFR 1003.210 were as follows: $20,000 for paragraphs 
(a)(1), (3), (4), and (8); $30,000 for paragraphs (a)(2) and (9); 
$100,000 for paragraphs (a)(6) and (7); and $10,000 for paragraph 
(a)(10)(i). Similarly, we proposed to increase the penalty maximum for 
conduct that occurred after February 9, 2018, at 42 CFR 1003.310(a)(3) 
to $100,000, and at 42 CFR 1003.1010(a) to $20,000. We received no 
comments on this proposal and we are finalizing the penalty amounts as 
proposed without modification, effective August 2, 2023 as required by 
the Administrative Procedure Act (APA).

E. Additional Changes to Part 1003

    We proposed to change the cross-reference in 42 1003.140(c)(3) to 
correct a scrivener's error from a prior rulemaking on December 7, 
2018. 81 FR 88354. We proposed to add a new paragraph (d)(5) to 42 CFR 
1003.140 stating that the penalty amounts in part 1003 are adjusted 
annually for inflation and eliminating the footnotes 1 through 12 in 
part 1003 to simplify those sections. We received no comments on these 
proposed changes, and we are finalizing them with a correction to a 
typographical error in the regulatory text in the citation to the 
Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101-
410) effective August 2, 2023.

F. Changes to 42 CFR Part 1005

    The procedures set forth in part 1005 govern the appeal of CMPs, 
assessments, and exclusions in all cases for which OIG has been 
delegated authority to impose those sanctions including cases involving 
grants, contracts, and other agreements, and information blocking. As 
such, we proposed deleting the phrase ``under Medicare or the State 
health care programs'' from the definitions of ``civil money penalty 
cases'' and ``exclusion cases'' at 42 CFR 1005.1 to correctly define 
those terms as applying to all cases for which OIG has been delegated 
authority to apply CMPs, assessments, and exclusions not only to those 
cases involving Medicare or the State health care programs. We received 
no comments regarding this change and are finalizing it as proposed, 
without modification, in 42 CFR 1005.1, effective August 2, 2023.

IV. Regulatory Impact Statement

    We have examined the impact of this final rule as required by 
Executive Order 12866, the Regulatory Flexibility Act (RFA) of 1980, 
the Unfunded Mandates Reform Act of 1995, and Executive Order 13132.

A. Executive Order No. 12866

    Executive Order 12866 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 per 
section 3(f)(1) of Executive Order 12866 (i.e., $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 per section 3(f)(1) because it does not 
reach that economic threshold. The vast majority of Federal health care 
programs would be minimally impacted from an economic perspective, if 
at all, by these proposals.
    This final rule would enact new statutory enforcement provisions, 
including new CMP authorities. The regulatory changes implement 
provisions of the Cures Act and BBA 2018 into 42 CFR parts 1003 and 
1005. We believe that the likely aggregate economic effect of these 
regulations would be significantly less than $100 million.
    The expected benefits of the regulation are deterring conduct that 
negatively affects the integrity of HHS grants, contracts, and other 
agreements and potentially enhanced statutory compliance by HHS 
grantees, contractors, and other parties. It also will deter 
information blocking conduct

[[Page 42838]]

that interferes with effective health information exchange and 
negatively impacts many important aspects of health and health care. We 
refer readers to the impact analysis of the benefits of prohibiting and 
deterring information blocking in section XII.C.2.a.(4.2) of the ONC 
Final Rule, 85 FR 25906, May 1, 2020.
    We anticipate that OIG will incur some costs associated with 
investigation and enforcement of the statutes underlying these penalty 
provisions. The Consolidated Appropriations Act, 2022 appropriates to 
OIG funding necessary for carrying out information blocking activities. 
Public Law 117-103, March 15, 2022. Additionally, investigated parties 
may incur some costs in response to an OIG investigation or enforcement 
action. Absent information about the frequency of prohibited conduct, 
we are unable to determine precisely the potential costs of this 
regulation.
    Civil money penalties and assessments, if any, would be considered 
transfers. However, we are unable to reliably estimate potential 
penalty and assessment amounts because enforcement action will depend 
on the facts and circumstances of individual cases, some conduct 
subject to enforcement will be newly regulated, and some cases may 
result in settlement. We did not receive any comments 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 final rule should 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. These changes largely enact 
existing regulatory authority. In addition, we expect that increases in 
the maximum penalty finalized here will only have an impact in a small 
number of cases. As a result, we have concluded that this final rule 
likely will not have a significant impact on a substantial number of 
small entities and that a regulatory flexibility analysis is not 
required for this rulemaking.
    In addition, section 1102(b) of 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 on the operations of a substantial number of small rural 
hospitals. We have concluded that this final rule should 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 and small rural hospitals are not subject to CMPs for 
information blocking under this final rule. Therefore, a regulatory 
impact analysis under section 1102(b) is not required for this 
rulemaking.

C. Unfunded Mandates Reform Act

    Section 202 of the Unfunded Mandates Reform Act of 1995, Public Law 
104-4, also requires that agencies assess anticipated costs and 
benefits before issuing any rule that may result in expenditures in any 
one year by State, local, or Tribal governments in the aggregate, or by 
the private sector, of $100 million, adjusted annually for inflation. 
We believe that there are no significant costs associated with these 
revisions that would impose any mandates on State, local, or Tribal 
governments or the private sector that would result in an expenditure 
of $158 million (after adjustment for inflation) or more in any given 
year and that a full analysis under the Unfunded Mandates Reform Act is 
not necessary.

D. Executive Order 13132

    Executive Order 13132, Federalism, establishes certain requirements 
that an agency must meet when it promulgates a rule that imposes 
substantial direct requirements or costs on State and local 
governments, preempts State law, or otherwise has federalism 
implications. In reviewing this rule under the threshold criteria of 
Executive Order 13132, we have determined that this final rule would 
not significantly affect the rights, roles, and responsibilities of 
State or local governments. Nothing in this final rule imposes 
substantial direct requirements or costs on State and local 
governments, preempts State law, or otherwise has federalism 
implications. We are not aware of any State laws or regulations that 
are contradicted or impeded by any of the provisions in this final 
rule.
    The Secretary is authorized by 42 U.S.C. 1320a-7a(o), which we 
enact in the regulation at 42 CFR 1003.700, to impose CMPs and 
assessments against individuals and entities that engage in fraud and 
other improper conduct against specified State agencies that administer 
or supervise the administration of grants, contracts, and other 
agreements funded in whole or in part by the Secretary. Additionally, 
42 U.S.C. 1320a-7a(f)(4) directs that these CMPs and assessments be 
deposited into the Treasury of the United States. Amounts collected 
under this authority could not be used to compensate a State for 
damages it incurs due to improper conduct related to grants, contracts, 
or other agreements funded by the Secretary that are administered or 
supervised by specified State agencies.
    However, neither 42 U.S.C. 1320a-7a nor this final rule preclude or 
impede any State's authority to pursue actions against entities and 
individuals that defraud or otherwise engage in improper conduct 
related to grants, contracts, or other agreements funded by the 
Secretary that are administered or supervised by specified State 
agencies. For this reason, the Secretary's authority related to 
specified State agencies will not have a substantial direct effect on 
the States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government.
    Based on OIG's prior approach to enforcement that involves State 
programs and agencies, we also anticipate coordinating closely with the 
relevant State authorities, which would provide States notice about the 
improper conduct and the opportunity to pursue action under the State 
authority.

V. Paperwork Reduction Act

    These changes to parts 1003 and 1005 impose no new reporting 
requirements or collections of information. Therefore, a Paperwork 
Reduction Act review is not required.

List of Subjects

42 CFR Part 1003

    Contracts, Fraud, Grant programs--health, Information blocking, 
Penalties.

42 CFR Part 1005

    Administrative practice and procedure.

    For the reasons stated in the preamble, the Office of Inspector 
General, Department of Health and Human Services, amends 42 CFR chapter 
V, subchapter B, as follows:

[[Page 42839]]

PART 1003--CIVIL MONEY PENALTIES, ASSESSMENTS AND EXCLUSIONS

0
1. Revise the authority citation for part 1003 to read as follows:

    Authority:  42 U.S.C. 262a, 300jj-52, 1302, 1320a-7, 1320a-7a, 
1320b-10, 1395u(j), 1395u(k), 1395cc(j), 1395w-141(i)(3), 
1395dd(d)(1), 1395mm, 1395nn(g), 1395ss(d), 1396b(m), 11131(c), and 
11137(b)(2).


0
2. Amend Sec.  1003.100 by:
0
a. Revising paragraph (a); and
0
b. In paragraph (b)(1), adding ``(CMPs)'' following ``civil money 
penalties'' and a semicolon following ``this part''.
    The revision reads as follows:


Sec.  1003.100  Basis and purpose.

    (a) Basis. This part implements sections 1128(c), 1128A, 1140, 
1819(b)(3)(B), 1819(g)(2)(A), 1857(g)(2)(A), 1860D-12(b)(3)(E), 1860D-
31(i)(3), 1862(b)(3)(C), 1867(d)(1), 1876(i)(6), 1877(g), 1882(d), 
1891(c)(1); 1903(m)(5), 1919(b)(3)(B), 1919(g)(2)(A), 1927(b)(3)(B), 
1927(b)(3)(C), and 1929(i)(3) of the Social Security Act; sections 
421(c) and 427(b)(2) of Public Law 99-660; section 201(i) of Public Law 
107-188 (42 U.S.C. 1320a-7(c), 1320a-7a, 1320b-10, 1395i-3(b)(3)(B), 
1395i-3(g)(2)(A), 1395w-27(g)(2)(A), 1395w-112(b)(3)(E), 1395w-
141(i)(3), 1395y(b)(3)(B), 1395dd(d)(1), 1395mm(i)(6), 1395nn(g), 
1395ss(d), 1395bbb(c)(1), 1396b(m)(5), 1396r(b)(3)(B), 1396r(g)(2)(A), 
1396r-8(b)(3)(B), 1396r-8(b)(3)(C), 1396t(i)(3), 11131(c), 11137(b)(2), 
and 262a(i)); and section 3022 of the Public Health Service Act (42 
U.S.C. 300jj-52).
* * * * *

0
3. Amend Sec.  1003.110 by:
0
a. Adding the definitions of ``Department,'' ``Obligation,'' ``Other 
agreement,'' and ``Program beneficiary'' in alphabetical order;
0
b. Revising the definition of ``Reasonable request;'' and
0
c. Adding the definitions of ``Recipient,'' ``Specified claim,'' and 
``Specified State agency'' in alphabetical order.
    The revision and additions read as follows:


Sec.  1003.110  Definitions.

* * * * *
    Department means the Department of Health and Human Services.
* * * * *
    Obligation for the purposes of Sec.  1003.700 means an established 
duty, whether or not fixed, arising from an express or implied 
contractual, grantor-grantee, or licensor-licensee relationship for a 
fee-based or similar relationship, from statute or regulation, or from 
the retention of any overpayment.
    Other agreement for the purposes of Sec.  1003.700 includes a 
cooperative agreement, scholarship, fellowship, loan, subsidy, payment 
for a specified use, donation agreement, award, or subaward (regardless 
of whether one or more of the persons entering into the agreement is a 
contractor or subcontractor).
* * * * *
    Program beneficiary means--in the case of a grant, contract, or 
other agreement designed to accomplish the objective of awarding or 
otherwise furnishing benefits or assistance to individuals and for 
which the Secretary provides funding--an individual who applies for or 
who receives such benefits or assistance from such grant, contract, or 
other agreement. Such term does not include--with respect to such 
grant, contract, or other agreement--an officer, employee, or agent of 
a person or entity that receives such grant or that enters into such 
contract or other agreement.
    Reasonable request with respect to Sec. Sec.  1003.200(b)(10) and 
1003.700(a)(5) means a written request signed by a designated 
representative of the OIG and made by a properly identified agent of 
the OIG during reasonable business hours. The request will include:
    (1) A statement of the authority for the request;
    (2) The person's rights in responding to the request;
    (3) The definition of ``reasonable request'' and ``failure to grant 
timely access'' under this part;
    (4) The deadline by which the OIG requests access; and
    (5) The amount of the civil money penalty or assessment that could 
be imposed and the effective date, length, and scope and effect of the 
exclusion that would be imposed for failure to comply with the request, 
and the earliest date that a request for reinstatement would be 
considered.
    Recipient for the purposes of Sec.  1003.700 means any person 
(excluding a program beneficiary as defined in this section) directly 
or indirectly receiving money or property under a grant, contract, or 
other agreement funded in whole or in part by the Secretary, including 
a subrecipient or subcontractor.
* * * * *
    Specified claim means any application, request, or demand under a 
grant, contract, or other agreement for money or property, whether or 
not the United States or a specified State agency has title to the 
money or property, that is not a claim (as defined in this section) and 
that:
    (1) Is presented or caused to be presented to an officer, employee, 
or agent of the Department or agency thereof, or of any specified State 
agency; or
    (2) Is made to a contractor, grantee, or other recipient if the 
money or property is to be spent or used on the Department's behalf or 
to advance a Department program or interest, and if the Department:
    (i) Provides or has provided any portion of the money or property 
requested or demanded; or
    (ii) Will reimburse such contractor, grantee, or other recipient 
for any portion of the money or property which is requested or 
demanded.
    Specified State agency means an agency of a State government 
established or designated to administer or supervise the administration 
of a grant, contract, or other agreement funded in whole or in part by 
the Secretary.
* * * * *

0
4. Revise Sec.  1003.130 to read as follows:


Sec.  1003.130  Assessments.

    The assessment in this part is in lieu of damages sustained by the 
Department, a State agency, or a specified State agency because of the 
violation.

0
5. Amend Sec.  1003.140 by:
0
a. In paragraph (c)(3), removing the phrase ``(as defined by paragraph 
(e)(2) of this section)'' and adding the phrase ``(as defined by 
paragraph (d)(2) of this section)'' in its place.
0
b. Adding paragraph (d)(5).
    The addition reads as follows:


Sec.  1003.140  Determinations regarding the amount of penalties and 
assessments and the period of exclusion.

* * * * *
    (d) * * *
    (5) The penalty amounts in this part are updated annually, as 
adjusted in accordance with the Federal Civil Penalties Inflation 
Adjustment Act of 1990, as amended by the Federal Civil Penalties 
Inflation Adjustment Act Improvements Act of 2015 (section 701 of Pub. 
L. 114-74). Annually adjusted amounts are published at 45 CFR part 102.

0
6. Amend Sec.  1003.210 by revising paragraphs (a)(1) through (4) and 
(6) through (9), (a)(10) introductory text, and (a)(10)(i) to read as 
follows:


Sec.  1003.210  Amount of penalties and assessments.

    (a) * * *

[[Page 42840]]

    (1) Except as provided in this section, the OIG may impose a 
penalty of not more than $10,000 for conduct that occurred on or before 
February 9, 2018, and not more than $20,000 for conduct that occurred 
after February 9, 2018, for each individual violation that is subject 
to a determination under this subpart.
    (2) The OIG may impose a penalty of not more than $15,000 for 
conduct that occurred on or before February 9, 2018, and not more than 
$30,000 for conduct that occurred after February 9, 2018, for each 
person with respect to whom a determination was made that false or 
misleading information was given under Sec.  1003.200(b)(2).
    (3) The OIG may impose a penalty of not more than $10,000 for 
conduct that occurred on or before February 9, 2018, and not more than 
$20,000 for conduct that occurred after February 9, 2018, per day for 
each day that the prohibited relationship described in Sec.  
1003.200(b)(3) occurs.
    (4) For each individual violation of Sec.  1003.200(b)(4), the OIG 
may impose a penalty of not more than $10,000 for conduct that occurred 
on or before February 9, 2018, and not more than $20,000 for conduct 
that occurred after February 9, 2018, for each separately billable or 
non-separately-billable item or service provided, furnished, ordered, 
or prescribed by an excluded individual or entity.
* * * * *
    (6) The OIG may impose a penalty of not more than $50,000 for 
conduct that occurred on or before February 9, 2018, and not more than 
$100,000 for conduct that occurred after February 9, 2018, for each 
false statement, omission, or misrepresentation of a material fact in 
violation of Sec.  1003.200(b)(7).
    (7) The OIG may impose a penalty of not more than $50,000 for 
conduct that occurred on or before February 9, 2018, and not more than 
$100,000 for conduct that occurred after February 9, 2018, for each 
false record or statement in violation of Sec.  1003.200(b)(9).
    (8) The OIG may impose a penalty of not more than $10,000 for 
conduct that occurred on or before February 9, 2018, and not more than 
$20,000 for conduct that occurred after February 9, 2018, for each item 
or service related to an overpayment that is not reported and returned 
in accordance with section 1128J(d) of the Act in violation of Sec.  
1003.200(b)(8).
    (9) The OIG may impose a penalty of not more than $15,000 for 
conduct that occurred on or before February 9, 2018, and not more than 
$30,000 for conduct that occurred after February 9, 2018, for each day 
of failure to grant timely access in violation of Sec.  
1003.200(b)(10).
    (10) For each false certification in violation of Sec.  
1003.200(c), the OIG may impose a penalty of not more than the greater 
of:
    (i) $5,000 for conduct that occurred on or before February 9, 2018, 
and $10,000 for conduct that occurred after February 9, 2018; or
* * * * *

0
7. Amend Sec.  1003.310 by revising paragraph (a)(3) to read as 
follows:


Sec.  1003.310  Amount of penalties and assessments.

    (a) * * *
    (3) $50,000 for conduct that occurred on or before February 9, 
2018, and $100,000 for conduct that occurred after February 9, 2018, 
for each offer, payment, solicitation, or receipt of remuneration that 
is subject to a determination under Sec.  1003.300(d).
* * * * *

0
8. Add subpart G (consisting of Sec. Sec.  1003.700, 1003.710, and 
1003.720) to read as follows:

Subpart G--CMPs, Assessments, and Exclusions for Fraud or False 
Claims or Similar Conduct Related to Grants, Contracts, and Other 
Agreements

Sec.
1003.700 Basis for civil money penalties, assessments, and 
exclusions.
1003.710 Amount of penalties and assessments.
1003.720 Determinations regarding the amount of penalties and 
assessments and period of exclusion.


Sec.  1003.700  Basis for civil money penalties, assessments, and 
exclusions.

    The OIG may impose a penalty, assessment, and an exclusion against 
any person including an organization, agency, or other entity, but 
excluding a program beneficiary (as defined in Sec.  1003.110), that, 
with respect to a grant, contract, or other agreement for which the 
Secretary provides funding:
    (a) Knowingly presents or causes to be presented a specified claim 
(as defined in Sec.  1003.110) under such grant, contract, or other 
agreement that the person knows or should know is false or fraudulent;
    (b) Knowingly makes, uses, or causes to be made or used, any false 
statement, omission, or misrepresentation of a material fact in any 
application, proposal, bid, progress report, or other document that is 
required to be submitted in order to directly or indirectly receive or 
retain funds provided in whole or in part by such Secretary pursuant to 
such grant, contract, or other agreement;
    (c) Knowingly makes, uses, or causes to be made or used, a false 
record or statement material to a false or fraudulent specified claim 
under such grant, contract, or other agreement;
    (d) Knowingly makes, uses, or causes to be made or used, a false 
record or statement material to an obligation (as defined in Sec.  
1003.110) to pay or transmit funds or property to such Secretary with 
respect to such grant, contract, or other agreement, or knowingly 
conceals or knowingly and improperly avoids or decreases an obligation 
to pay or transmit funds or property to such Secretary with respect to 
such grant, contract, or other agreement; or
    (e) Fails to grant timely access (as defined in Sec.  
1003.200(b)(10)), upon reasonable request (as defined in Sec.  
1003.110), to the Inspector General of the Department, for the purpose 
of audits, investigations, evaluations, or other statutory functions of 
such Inspector General in matters involving such grants, contracts, or 
other agreements.


Sec.  1003.710  Amount of penalties and assessments.

    (a) Penalties. (1) In cases under Sec.  1003.700(a)(1), the OIG may 
impose a penalty of not more than $10,000 for each specified claim.
    (2) In cases under Sec.  1003.700(a)(2), the OIG may impose a 
penalty of not more than $50,000 for each false statement, omission, or 
misrepresentation of a material fact.
    (3) In cases under Sec.  1003.700(a)(3), the OIG may impose a 
penalty of not more than $50,000 for each false record or statement.
    (4) In cases under Sec.  1003.700(a)(4), the OIG may impose a 
penalty of not more than $50,000 for each false record or statement or 
not more than $10,000 for each day that the person knowingly conceals 
or knowingly and improperly avoids or decreases an obligation to pay.
    (5) In cases under Sec.  1003.700(a)(5), the OIG may impose a 
penalty of not more than $15,000 for each day of the failure described 
in Sec.  1003.700(a)(5).
    (b) Assessments. (1) In cases under Sec.  1003.700(a)(1) and (3), 
such a person shall be subject to an assessment of not more than three 
times the amount claimed in the specified claim described in Sec.  
1003.700(a)(1) and (3) in lieu of damages sustained by the United 
States or a specified State agency because of such specified claim.
    (2) In cases under Sec.  1003.700(a)(2) and (4), such a person 
shall be subject to an assessment of not more than three times the 
total amount of the funds described in Sec.  1003.700(a)(2) and (4), 
respectively (or, in the case of an obligation to transmit property to 
the Secretary described in Sec.  1003.700(a)(4), of the

[[Page 42841]]

value of the property described in Sec.  1003.700(a)(4)) in lieu of 
damages sustained by the United States or a specified State agency 
because of such case.


Sec.  1003.720  Determinations regarding the amount of penalties and 
assessments and period of exclusion.

    In considering the factors listed in Sec.  1003.140:
    (a) It should be considered a mitigating circumstance if all the 
violations included in the action brought under this part were of the 
same type and occurred within a short period of time, there were few 
such violations, and the total amount claimed or requested related to 
the violations was less than $5,000.
    (b) Aggravating circumstances include but are not limited to:
    (1) The violations were of several types or occurred over a lengthy 
period of time;
    (2) There were many such violations (or the nature and 
circumstances indicate a pattern of false or fraudulent specified 
claims, requests for payment, or a pattern of violations);
    (3) The amount requested or claimed or related to the violations 
was $50,000 or more; or
    (4) The violation resulted, or could have resulted, in physical 
harm to any individual.


Sec.  1003.1010  [Amended]

0
9. Amend Sec.  1003.1010 in paragraph (a) by removing the figure 
``$10,000'' and adding in its place the phrase ``$10,000 for conduct 
that occurred on or before February 9, 2018, and $20,000 for conduct 
that occurred after February 9, 2018,''.

0
10. Effective September 1, 2023, add subpart N (consisting of 
Sec. Sec.  1003.1400, 1003.1410, and 1003.1420) to read as follows:

Subpart N--CMPs for Information Blocking

Sec.
1003.1400 Basis for civil money penalties.
1003.1410 Amount of penalties.
1003.1420 Determinations regarding the amount of penalties.


Sec.  1003.1400  Basis for civil money penalties.

    The OIG may impose a civil money penalty against any individual or 
entity described in 45 CFR 171.103(a)(2) that commits information 
blocking, as set forth in 45 CFR part 171.


Sec.  1003.1410  Amount of penalties.

    The OIG may impose a penalty of not more than $1,000,000 per 
violation.
    (a) For this subpart, violation means a practice, as defined in 45 
CFR 171.102, that constitutes information blocking, as set forth in 45 
CFR part 171.
    (b) [Reserved]


Sec.  1003.1420  Determinations regarding the amount of penalties.

    In considering the factors listed in Sec.  1003.140, the OIG shall 
take into account:
    (a) The nature and extent of the information blocking including 
where applicable:
    (1) The number of patients affected;
    (2) The number of providers affected; and
    (3) The number of days the information blocking persisted; and
    (b) The harm resulting from such information blocking including 
where applicable:
    (1) The number of patients affected;
    (2) The number of providers affected; and
    (3) The number of days the information blocking persisted.


Sec.  1003.1550  [Amended]

0
11. Amend Sec.  1003.1550 in paragraph (b) by removing the phrase 
``where the claim'' and adding the phrase ``where the claim or 
specified claim'' in its place.

0
12. Amend Sec.  1003.1580 by revising paragraph (a) to read as follows:


Sec.  1003.1580  Statistical sampling.

    (a) In meeting the burden of proof in Sec.  1005.15 of this 
chapter, the OIG may introduce the results of a statistical sampling 
study as evidence of the number and amount of claims, specified claims, 
and/or requests for payment, as described in this part, that were 
presented, or caused to be presented, by the respondent. Such a 
statistical sampling study, if based upon an appropriate sampling and 
computed by valid statistical methods, shall constitute prima facie 
evidence of the number and amount of claims, specified claims, or 
requests for payment, as described in this part.
* * * * *


Sec.  Sec.  1003.210, 1003.310, 1003.410, 1003.510, 1003.610, 1003.810, 
1003.910, 1003.1010, 1003.110, 1003.1210, and 1003.1310  [Amended]

0
13. In addition to the amendments set forth above, in 42 CFR part 1003, 
amend each section referenced in the first column of the following 
table by removing the footnote referenced in the second column.

------------------------------------------------------------------------
                           Section                             Footnote
------------------------------------------------------------------------
1003.210(a) heading.........................................           1
1003.310(a) heading.........................................           2
1003.410(a) heading.........................................           3
1003.410(b)(2)..............................................           4
1003.510 introductory text..................................           5
1003.610(a) introductory text...............................           6
1003.810 introductory text..................................           7
1003.910....................................................           8
1003.1010 introductory text.................................           9
1003.1110 introductory text.................................          10
1003.1210 introductory text.................................          11
1003.1310...................................................          12
------------------------------------------------------------------------

PART 1005--APPEALS OF EXCLUSIONS, CIVIL MONEY PENALTIES AND 
ASSESSMENTS

0
14. The authority citation for part 1005 continues to read as follows:

    Authority:  42 U.S.C. 405(a), 405(b), 1302, 1320a-7, 1320a-7a 
and 1320c-5.


0
15. Amend Sec.  1005.1 by revising the definitions of ``Civil money 
penalty cases'' and ``Exclusion cases'' to read as follows:


Sec.  1005.1  Definitions.

    Civil money penalty cases refers to all proceedings arising under 
any of the statutory bases for which the OIG has been delegated 
authority to impose civil money penalties (CMPs).
* * * * *
    Exclusion cases refers to all proceedings arising under any of the 
statutory bases for which the OIG has been delegated authority to 
impose exclusions.
* * * * *

    Dated: June 26, 2023.
Xavier Becerra,
Secretary.
[FR Doc. 2023-13851 Filed 6-30-23; 8:45 am]
BILLING CODE 4152-01-P