Six Regulatory and Policy Issues to Watch in 2022

As Congress reconvenes in Washington this week, here are six healthcare regulatory and policy issues we’re keeping our eyes on. We hope this primer will help demystify the state of the health IT regulatory environment and give readers a deeper understanding of the impact and import of this activity.

1. The 21st Century Cures Act, Interoperability and Patient Access Rules

The gist: In 2020, the Department of Health and Human Services (HHS) issued two related rules to implement the 21st Century Cures Act to encourage interoperability among health information technology systems, improve patient access to their health care information, and discourage practices that unreasonably prevent the access, exchange or use of such information. These rules, among many other things:

— Prohibit “information blocking,” defined by HHS as a practice likely to interfere with access, exchange or use of electronic health information, unless the practice is required by law or covered by an applicable exception

— Require hospitals participating in programs regulated by the Centers for Medicare and Medicaid Services (CMS) to send electronic patient event notifications of a patient’s admission, discharge, or transfer (ADT). For more information, check out the CMS Interoperability and Patient Access Fact Sheet.

Background: The intent of these rules is to address concerns that healthcare organizations may make it unnecessarily difficult for patients and providers to obtain electronic health information, whether it's upon a patient's request, or for purposes already permitted under applicable law, such as the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

Status: These rules are in effect. We expect the HHS Office of Inspector General (OIG) to release its final rule regarding the enforcement of the information blocking provision early this year.

Context and commentary: Surescripts supports the goal of these rules, and our existing business practices align with the intent and requirements of the rules. As always, we support the secure exchange of health information to improve patient safety, lower costs and ensure quality care. We are active participants in the work happening across the industry and government to make healthcare information more accessible to support patient care. For example, we have contributed to discussions on the 21st Century Cures Act and the Trusted Exchange Framework and Common Agreement (TEFCA). We are also engaged with the Carin Alliance, NCPDP, the Da Vinci Project, the Argonaut Project, The Sequoia Project, Direct Trust, Carequality and many other initiatives associated with setting standards and developing approaches to sharing information.