Testimony Before the United States Senate Committee on  
Health, Education, Labor, and Pensions 
 
 
 
 
Implementation of the 21st Century Cures Act:  
Achieving the Promise of Health Information Technology  
 
Testimony of: 
 
James A. Cannatti III 
Senior Counselor for Health Information Technology 
Office of Inspector General  
U.S. Department of Health and Human Services 
 
 
 
 
October 31, 2017 
2:30 p.m. 
430 Dirksen Senate Office Building 
  Testimony of: 
James A. Cannatti III 
Senior Counselor for Health Information Technology 
   Office of Inspector General, U.S. Department of Health and Human Services 
 
Good afternoon, Chairman Alexander, Ranking Member Murray, and other distinguished 
Members of the Committee.  I am James Cannatti, Senior Counselor for Health Information 
Technology for the Office of Inspector General (OIG), U.S. Department of Health and Human 
Services (HHS or Department).  Thank you for the opportunity to appear before you to discuss 
OIGs role in the implementation of the health information technology (health IT) provisions of 
the 21st Century Cures Act (the Cures Act).  My testimony today will focus on our new 
information blocking investigative and enforcement authorities provided under Section 4004 of 
the Cures Act. 
 
Information Blocking Harms Patient Care and Our Health Care System 
 
In general terms, information blocking is a practice that inappropriately impedes the flow or use 
of information.1  The availability of information when and where it is needed is a critical element 
of a high-functioning health care system.   
 
OIG has long acknowledged the importance of the appropriate flow of information, subject, of 
course, to privacy and security protections.  In fact, OIG has highlighted the issue for the past 
several years in our annual list of Top Management and Performance Challenges facing the 
Department.2  Addressing the negative impacts of information blocking is consistent with OIGs 
mission to protect the integrity of HHS programs, as well as the health and welfare of program 
beneficiaries.   
 
Information blocking can pose a threat to patient safety and undermine efforts by providers, 
payors, and others to make our health care system more efficient and effective.  For example, 
when pertinent information is not available in a patients record, a physician may inadvertently 
prescribe a contraindicated drug causing the patient to become ill.  Further, when results are not 
shared between providers, patients may be subjected to duplicate tests.  Beyond unnecessarily 
exposing patients to risks associated with the tests,3 payors and patients incur unnecessary costs 
for the duplicative services.  Information blocking also threatens the significant investment 
taxpayers have made in encouraging the adoption and use of technologies like electronic health 
records (EHRs).     
 
                                                           
1 Section 4004 of the Cures Act added a specific definition of information blocking for purposes of the statute.  That 
definition is codified at Section 3022(a) of the Public Health Services Act, 42 U.S.C.  300jj-52(a). 
2 For 2016, OIG identified 10 top management and performance challenges, including one entitled Health 
Information Technology and the Meaningful and Secure Exchange and Use of Electronic Information.  OIGs 2016 
Top Management and Performance Challenges Facing HHS is available at https://oig.hhs.gov/reports-and-
publications/top-challenges/2016/. 
3 Some tests pose greater risks than others; for example, some tests may be more invasive or expose the patient to 
higher levels of radiation than other tests.    
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  OIGs Approach to Information Blocking Before the Cures Act 
 
Historically, OIG had no authority to investigate or take enforcement action based solely on acts 
of information blocking.  Rather, the concept arose for us in the context of the application of the 
Federal anti-kickback statute (the Anti-Kickback Statute)4 to arrangements in which one party, 
such as a hospital, provides an EHR system to another party, such as a physician group practice.  
These donation arrangements were designed to facilitate and promote broad adoption of EHRs.  
Questions arose about the need for safe harbor protection for some of these donation 
arrangements.  In 2006, OIG issued a final rule establishing a safe harbor that protected certain 
EHR donation arrangements and required, among other conditions, that donated EHR software 
be interoperable (the EHR safe harbor).5  Our goal was to promot[e] the adoption of 
interoperable [EHR] technology that benefits patient care while reducing the likelihood that the 
safe harbor [would] be misused by donors to secure referrals from those receiving the 
technology.6  As with all safe harbors, we attempted to strike a balanceendeavoring to include 
safeguards that minimize potential fraud and abuse risks, without impacting the positive benefits 
of the underlying arrangements.  In the case of the EHR safe harbor, one of the key safeguards 
prohibited donors and certain other parties from taking actions to limit or restrict the use, 
compatibility, or interoperability of donated EHR systems.   
 
Although we did not use the term information blocking at the time, the EHR safe harbor 
conditions included concepts that align closely with the Cures Act prohibition on information 
blocking.  We were concerned that information blocking would serve as a method of locking in 
or steering referrals, conduct prohibited by the Anti-Kickback Statute.  Over time, our concerns 
about this risk grew.  Moreover, Congress, HHS, and other stakeholders began raising additional 
concerns about information blocking.  Accordingly, we issued a policy reminder in 2015 to again 
warn the industry about the impact of information blocking on potential safe harbor protection, 
and we went so far as to restate our position that EHR donation arrangements involving 
information blocking would be suspect under the Anti-Kickback Statute.7 
 
The Cures Act Empowers OIG to Directly Address Information Blocking 
 
With the passage of the Cures Act in December 2016, Congress gave OIG new authorities that 
will allow us to address the issue of information blocking more directlybeyond those limited 
circumstances in which the conduct is a part of a larger kickback scheme.  The Cures Act added 
section 3022(b)(1) of the Public Health Services Act,8 which granted OIG specific authority to 
investigate claims that certain parties (health information technology developers, health care 
providers, and others) engaged in information blocking as defined in section 3022(a).  Further, 
subsection (b)(2) established penalties for those engaged in information blocking.  For 
developers and certain other parties, the penalties take the form of civil monetary penalties not to 
                                                           
4 42 U.S.C.  1320a-7b(b). 
5 71 Fed. Reg. 45110 (Aug. 8, 2006); 42 C.F.R.  1001.952(y).  We most recently modified the EHR safe harbor at 
the end of 2013.  78 Fed. Reg. 79208 (Dec. 27, 2013).     
6 78 Fed. Reg. 79208 (Dec. 27, 2013). 
7 OIG Alert, OIG Policy Reminder: Information Blocking and the Federal Anti-Kickback Statute (Oct. 6, 2015), 
available at https://oig.hhs.gov/compliance/alerts/guidance/policy-reminder-100615.pdf.  
8 42 U.S.C.  300jj-52. 
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  exceed $1 million per violation.9  For health care providers, the Cures Act directs OIG to refer 
such parties to the appropriate agency to be subject to appropriate disincentives. . . .10   
 
OIGs information blocking authorities under the statute are directly tied to the definition of 
information blocking in Section 3022(a).  That definition contemplates rulemaking to identify 
reasonable and necessary activities that would not constitute information blocking for purposes 
of the Cures Act.  Within the Department, our colleagues at the Office of the National 
Coordinator for Health Information Technology (ONC) have been tasked with that rulemaking, 
which will address the definition of information blocking within the meaning of Section 3022 
and will provide the legal basis that OIG will use to assess conduct during our investigations and 
enforcement actions. 
 
OIG Is Preparing for Effective, Efficient, and Fair Enforcement 
 
OIG has been readying for effective, efficient, and fair enforcement.  Our goal is to protect 
patients and the health care system by stopping information blocking.  We aim to leverage our 
new authorities to change behaviors in the industry.  We believe this can best be accomplished 
through a combination of clear rules of the road for those who want to comply with the law and 
targeted enforcement against those who choose to break it.   
 
The Cures Act information blocking prohibition covers a broad spectrum of conduct and 
arrangements.  It covers everyone from large electronic health IT developers to individual 
physicians.  And the information blocking landscape is complex.  It combines highly technical 
issues and a breadth of business arrangements and scenarios.  Stakeholder engagement is critical 
to developing a deep understanding of this complex landscape.  That is why we began engaging 
with industry and other private stakeholders that expressed an interest in sharing their unique 
perspectives on information blocking.  To date, we have held more than a dozen stakeholder 
meetings with representatives from a wide cross-section of the health care and technology 
communities.  We have included our colleagues from ONC in these meetings to further 
coordination on this topic within HHS.  The insights gained from stakeholders will help us as we 
implement an effective, efficient, and fair enforcement approach to the issue of information 
blocking. 
 
We have also engaged with our Federal partners, including ONC, the Centers for Medicare & 
Medicaid Services, the HHS Office for Civil Rights, and the Federal Trade Commission.  For 
example, we have provided technical assistance to ONC on enforcement-related issues in order 
to inform its policy formulation efforts.  Additionally, we are working to formalize processes for 
sharing complaints, referrals, and other information relevant to information blocking 
enforcement efforts within HHS that build on existing efforts, where possible.  These efforts are 
intended to ensure that we are prepared to leverage the new tools to curb information blocking. 
 
                                                           
9 Section 3022(b)(2)(A) of the Public Health Services Act, 42 U.S.C.  300jj-52(b)(2)(A). 
10 Section 3022(b)(2)(B) of the Public Health Services Act, 42 U.S.C.  300jj-52(b)(2)(B). 
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  Conclusion 
 
Stopping information blocking is important for patients and the broader health care system.  The 
Cures Act provides important new authorities that enhance the Governments ability to address 
this problem.  OIG is working diligently, alongside our HHS partners and with substantial input 
from private stakeholders, to implement an enforcement approach that deters information 
blocking, holds wrongdoers accountable, promotes the integrity of HHS programs, helps protect 
the health and welfare of program beneficiaries, and benefits the American public. 
 
Thank you for the opportunity to testify on this important issue.  I look forward to answering 
questions. 
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October 31, 2017