Dear Mr. Zajic:
The Sequoia Project is pleased to submit these comments on the Proposed Rule on Grants, Contracts, and Other Agreements: Fraud and Abuse; Information Blocking; Office of Inspector General’s (OIG) Civil Money Penalty Rules. Our comments focus on the amendment by the 21st Century Cures Act (Cures Act) of the Public Health Service Act (PHSA), 42 U.S.C. 300jj-5, authorizing the OIG to investigate claims of information blocking and providing the Secretary (Secretary) of Health and Human Services (HHS) authority to impose Civil Monetary Penalties (CMPs) for information blocking.
The Sequoia Project is a non-profit, 501(c)(3) public-private collaborative that advances the interoperability of electronic health information for the public good. The Sequoia Project previously served as a corporate home for several independently governed health IT interoperability initiatives, including the eHealth Exchange health information network and the Carequality interoperability framework. The eHealth Exchange and Carequality now operate under their own non-profit organizations. The Sequoia Project currently supports the RSNA Image Share Validation Program, the Patient Unified Lookup System for Emergencies (PULSE), and the Interoperability Matters Cooperative. Lastly, we are honored to have been selected by the Office of the National Coordinator for Health IT (ONC) to be the Recognized Coordinating Entity (RCE) for the Trusted Exchange Framework and Common Agreement (TEFCA).
These comments reflect our experience supporting large-scale, nationwide health information sharing, including active work with several federal government agencies. Through these efforts, we serve as an experienced, transparent and neutral convener of public and private sector stakeholders to address and resolve practical challenges to interoperability. Our deep experience implementing national-level health IT interoperability, including our track record of supporting and operationalizing federal government and private sector interoperability initiatives, provide a unique perspective on the proposed rule.
More directly, these comments reflect the expert input of the Information Blocking Workgroup of the Sequoia Project’s Interoperability Matters Cooperative. This multi-stakeholder workgroup has been in place for over a year and has developed detailed comments and analysis of the ONC information blocking proposed and final rules.
We appreciate the efforts of OIG to codify its responsibilities for information blocking enforcement and the conciseness of its proposed regulatory text. We share an overall aim to improve the health and health care of patients and our nation through more seamless patient and provider access to patients’ health information. As OIG looks to finalize this proposed rule, we urge you to consider the attached perspectives of the Information Blocking Workgroup, especially on areas in guidance or regulatory language that would be benefit from further clarification.
These perspectives focus on:
- OIG investigative criteria;
- Approaches for the effective date of OIG’s information blocking CMP regulations;
- Incorporation of information blocking regulations into 42 CFR part 1003 and application of current CMP procedures and appeal process to information blocking CMPs;
- Regulatory language to codify the maximum OIG penalty per information blocking violation;
- Examples of single and multiple violations and the definition of “violation”; and
- Additional factors to consider in determining the amount of information blocking CMPs, including examples of conduct that should be subject to higher or lower penalty amounts
OIG acknowledges that health care providers are not subject to the imposition of Civil Money Penalties under the Cures Act and, therefore, the proposed rule is not applicable to health care providers. However, OIG also states that, per the Cures Act, it will determine whether a health care provider has committed information blocking and refer such cases to “the appropriate agency for appropriate disincentives”. Lastly, OIG further states that once a process is established through a forthcoming notice and comment rulemaking as required by the Cures Act, “OIG will coordinate with, and send referrals to, the agency or agencies identified in future rulemaking by the Secretary that will apply the appropriate disincentive for health care providers that engage in information blocking”.
It is our experience that there is significant uncertainty in the provider community, and other communities, about how OIG will handle complaints it receives about potential information blocking by providers, especially before completion of the referenced follow-on rulemaking. We urge OIG, as it finalizes this current proposed rule, to be explicit on how it will handle complaints of provider information blocking, including whether these will be referred to other agencies. This clarification should also address the role of OIG, if any, in enforcement related to CMS provider attestations that relate to behavior that could be considered information blocking.
We appreciate the opportunity to provide you our comments on the information blocking provisions of OIG’s proposed rule regarding its plans to investigate claims of information blocking and to apply Civil Monetary Penalties for information blocking. The Sequoia Project stands ready to assist you in any way that we can.
CEO, The Sequoia Project