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Recent Industry News

Department of HHS OIG

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The Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently testified before the United States Senate Committee on Health, Education, Labor, and Pensions on its role in implementing the 21st Century Cures Act (the “Cures Act”) health information technology (health IT) provisions.  In December 2016, Congress passed the Cures Act, which addresses many issues from adjusting drug development rules for pharmaceutical companies to strengthening evidence-based treatment programs for mental health illnesses.  The Cures Act also gives the OIG new investigative and enforcement authorities to address the negative impacts of information blocking in the health care industry.  Information blocking is a practice that inappropriately impedes the use or flow of information, where and when it is required within the health care system.  The OIG’s testimony primarily focused on these new OIG enforcement authorities and how they will ultimately enhance the Federal Government’s ability to stop information blocking.

During the OIG’s testimony, it explained that information blocking can pose a threat to patient safety.  Moreover, information blocking can undermine efforts by providers, payers, and others to make our health care system more efficient and effective.  For example, when significant information is unavailable in a patient’s medical record, a physician may unintentionally prescribe contraindicated medication, causing the patient to become sick.  Additionally, if providers do not readily share patient information, patients may be given duplicate tests that result in increased medical expenses.  Information blocking can also undermine the significant investment taxpayers have made in encouraging the adoption and use of effective technologies like EHRs.

The OIG understands the importance of addressing the negative impacts of information blocking as part of its mission to protect HHS program integrity and the health and welfare of program beneficiaries.  Previously, however, the OIG did not have the authority to investigate or take enforcement action on information blocking acts alone.  Instead, the OIG first encountered the concept of information blocking while applying the federal Anti-Kickback Statute (AKS) to donation arrangements.  Donation arrangements are arrangements where one party provides an EHR system to another party.  In 2006, the OIG issued a final rule that established an AKS safe harbor to protect certain EHR donation arrangements.  One of the safeguards prohibited donors and certain other parties from taking actions to limit or restrict the use, or interoperability, of donated EHR systems.  In creating the safe harbor, the OIG’s goal was to balance the reduction of potential fraud and abuse risks with the promotion of EHR technology that benefits patient care.

The EHR safe harbor conditions include concepts that parallel the Cures Act prohibition on information blocking, although the OIG did not previously use the term “information blocking”.  Over time, the OIG, along with Congress, HHS, and other stakeholders, became concerned that information blocking would be used to steer referrals.  In response, the OIG issued a reminder policy stating their position that EHR donation arrangements involving information blocking would be suspect under the AKS.

As a result of congressional passage of the Cures Act, the OIG has new authorities that enable it to address information blocking directly.  The Cures Act added two sections to the Public Health Services Act (PHSA) to codify these new authorities and enable direct OIG enforcement action.  Section 3022(b)(1) of the PHSA grants the OIG authority to investigate claims of certain parties, such as health IT developers or health care providers, engaging in information blocking.  Section 3022(b)(2) of the PHSA creates civil penalties of up to $1 million per violation, for those parties engaging in information blocking.  Further, to effectively implement these new authorities, the OIG must ensure that its enforcement actions target the specific practices identified as information blocking in the definition provided in Section 3022(a) of the PHSA.  That section addresses the Office of the National Coordinator for Health Information Technology’s (ONC) responsibility for identifying “reasonable and necessary” activities that do not constitute information blocking for purposes of the Cures Act.  This clarification will provide the legal basis upon which the OIG will conduct investigations and implement enforcement actions.

The OIG testified that it is prepared to use its new authorities to implement an enforcement approach that prevents information blocking, holds wrongdoers accountable, and helps protect patients and the health care system.  To be effective in this effort, the OIG believes that it needs a combination of clear compliance rules and targeted enforcement for noncompliance.  The Cures Act has been designed to cover a broad spectrum of conduct and arrangements involving information blocking by various parties, ranging from large electronic health IT developers to individual physicians.  The wide range of conduct and arrangements presents highly technical and complex issues.  Accordingly, the OIG engaged with various industry and private stakeholders to better understand the scope and complexity of information blocking.  The OIG also sought support from federal partners, such as the ONC, the Centers for Medicare and Medicaid Services, the HHS Office of Civil Rights, and the Federal Trade Commission.  With the knowledge gained from these parties, the OIG is better able to move forward in implementing an effective, efficient, and fair enforcement approach to stop information blocking.  The OIG also testified that it will continue to formalize processes for sharing complaints, referrals, and other information relevant to its information blocking enforcement efforts.

The OIG report is available at:

https://oig.hhs.gov/testimony/docs/2017/cannatti103117.pdf.

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