On Tuesday, June 23, HIMSS and the Personal Connected Health Alliance (PCHAlliance) provided written comments to the Grants, Contracts, and Other Agreements: Fraud and Abuse; Information Blocking; Office of Inspector General's (OIG's) Civil Money Penalty (CMP) Rules Proposed Regulation, which is focused on facilitating broader data exchange across the entire healthcare ecosystem and enforcement around occurrences of information blocking as well as CMPs.
HIMSS and PCHAlliance expressed support for the efforts occurring across the Department of Health and Human Services (HHS) to provide patients with secure access to actionable information that assists them in directing their own healthcare as well as inhibits the blocking of information that contributes to more seamless care delivery.
Our comments to HHS OIG also highlight the need to enhance coordination efforts among HHS agencies, particularly with the Office of the National Coordinator for Health IT (ONC), on how the CMP Regulation will align with ONC’s Interoperability and Information Blocking Regulation, as well as how to ensure the community is better informed about all of the compliance and enforcement dates where the regulations intersect and overlap.
As OIG is planning to incorporate ONC’s regulations, OIG enforcement will rely on the regulatory definition of information blocking and the related exceptions. Our letter underscores the significant uncertainty across stakeholders about which entities should be considered health information networks/health information exchanges, healthcare providers or meet the definition of both regulated actors. More clarification and examples from OIG and ONC would be helpful to the community as they implement the interoperability regulations. As the attention of many health systems is focused on managing growing demands for COVID-19 care, OIG and ONC should also consider these factors when finalizing timelines for information blocking compliance and enforcement.
In addition, our letter asks that OIG exercise its enforcement discretion and delay imposing CMPs for six months after publication of the Final Regulation. Healthcare stakeholders will encounter a steep learning curve about how best to interpret and implement these new regulations, so more time will be beneficial to community-wide implementation efforts. For the period between the effective date and six months after Final Regulation publication, OIG should focus on providing regulated actors with informal guidance about how the agency is interpreting specific actions that actors have undertaken that could be considered information blocking. We also ask that OIG be explicit that its information blocking investigations and enforcement not be retroactive to any period prior to the effective date of the Final Regulation.
HIMSS and PCHAlliance’s letter asks that OIG prioritize the development of sub-regulatory guidance to keep the community updated on OIG’s current thought processes on information blocking and how it is approaching various instances of potential violations during investigations. As OIG’s priorities evolve and new situations arise, using sub-regulatory guidance as a tool to guide stakeholders would be extremely helpful. We recognize it may be challenging for OIG to regularly publish guidance documents, but in lieu of any formal advisory opinions that OIG is able to release, these documents will be indispensable.
Our Comment Letter also emphasizes how OIG cannot successfully fulfill its duties without adequate resources to develop sub-regulatory guidance and advisory opinions that inform the community’s actions. OIG should be investing in hiring additional personnel and developing new training programs and educational resources on information blocking. We characterize any additional OIG funding as an opportunity to build up the robust directory of informal guidance documents that the community needs in order to understand the importance of broadly sharing information.
Moreover, our comment letter asks HHS OIG align the factors that it will consider for investigations with similar work undertaken across HHS. For example, we suggest OIG look to align the work it is undertaking on information blocking with the factors that the HHS Office of Civil Rights (OCR) uses to investigate Health Insurance Portability and Accountability Act of 1996 (HIPAA) Violations.
Many stakeholders are already familiar with how OCR is evaluating potential HIPAA investigations, so OIG alignment with OCR factors would provide the community with a higher degree of certainty around expectations. HHS OIG should also prepare healthcare providers for the upcoming rulemaking around implementing information blocking “provider disincentives,” as the agency’s focus in this Proposed Regulation is on the regulated actors other than healthcare providers. OIG should work to describe how information blocking enforcement will be applied to healthcare providers, including the other agencies to refer providers, and the appropriate disincentives to be applied thereafter.
HIMSS Government Relations
The HIMSS policy team works closely with the U.S. Congress, federal decision makers, state legislatures and governments, and other organizations to recommend policy, and legislative and regulatory solutions to improve health through information and technology.
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