Quest Diagnostics is excited to present this article excerpt, reprinted with permission from Mary Ann Chaffee, Vice President of Policy and Federal Affairs for Surescripts^®.

As Congress reconvenes in Washington, here are 6 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 healthcare information, and discourage practices that unreasonably prevent the access, exchange or use of such information.

More 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.

2. The Trusted Exchange Framework and Common Agreement (TEFCA)

The gist: TEFCA is intended to establish the infrastructure model and the governing approach for users in different networks to securely share basic clinical information with each other—all under commonly agreed-to expectations and rules. In August 2019, the Office of the National Coordinator for Health Information Technology (ONC) awarded a cooperative agreement to The Sequoia Project to serve as the Recognized Coordinating Entity (RCE) to administer a new nationwide network based on the Common Agreement. 

Status: The RCE recently finalized the common agreement, which include standard operating procedures as well as the Qualified Health Information Network (QHIN) technical framework. ONC expects to begin reviewing QHIN applications and onboarding QHINs to the network by the second half of 2022.

3. HIPAA Notice of Proposed Rule Making and Care Management

The gist: The current HIPAA regulation limits the ability to access protected health information (PHI) for purposes of care coordination and case management with entities that are not healthcare providers. HHS is looking to change that. The HIPAA Notice of Proposed Rule Making modifies the current regulation in order to support individuals’ engagement in their healthcare, remove barriers to coordinated care, and decrease regulatory burdens on healthcare providers and health plans.

More background: These modifications address impediments to the transition to value-based healthcare by limiting or discouraging care coordination and care management communications among individuals and covered entities (including hospitals, physicians, and other healthcare providers, payers, and insurers) or posing other unnecessary burdens. The NPRM includes proposals to address these burdens while continuing to protect the privacy and security of individuals’ PHI.

Status: This is a proposed rule, pending the publication of a final rule by the HHS Office of Civil Rights.

4. Real-Time Prescription Benefit Tools

The gist: The Consolidated Appropriations Act of 2020 included three provisions aimed at accelerating adoption and use of a real-time benefit tool (RTBT) for prescription drugs by 1) requiring that all Part D insurers provide for a RTBT that enables electronic transmission of eligibility, formulary and benefit information to each enrollee’s prescribing clinician; (2) adding use of a RTBT to the Merit-Based Incentive Payment System (MIPS) measures, and (3) requiring qualified EHRs under the ONC Health IT Certification Program to include a RTBT that conveys patient-specific cost and coverage information.

Status: The requirement on Part D plans was implemented on January 1, 2021. The second provision regarding MIPS took effect January 1, 2022. However, HHS’ implementation of the third provision, which requires qualified EHRs to include RTBT functionality that conveys patient-specific cost and coverage information, has been delayed. The delay is due to the requirement that rulemaking be conducted by CMS and ONC prior to implementation.

5. Electronic Prior Authorization Requirement

The gist: On Dec 31, 2020, CMS issued a final rule that, for the first time, requires Part D prescription drug plans and prescribers to support a new electronic prior authorization (ePA) transaction standard for their Part D e-prescribing programs. The rule, which has an effective date of January 1, 2022, but allowed plans to begin adopting it on January 1, 2021, also requires Part D plans to adopt NCPDP SCRIPT standard v2017071.

Status: This rule took effect on January 1, 2022, and adoption is underway.

6. EPCS Federal Mandate

The gist: On December 1, 2020, CMS announced in a final rule its decision to require that Part D providers use e-prescribing of controlled substances (EPCS) effective January 1, 2021. The rule implements a provision of the SUPPORT for Patients and Communities Act, which became law in 2018.

Status: While the rule is in effect, CMS has delayed the start date for compliance actions by one year to January 1, 2023. The start date for compliance actions for Part D prescriptions written for beneficiaries in long-term care facilities has also been delayed to January 1, 2025. CMS will initially enforce compliance by sending compliance letters to prescribers violating the EPCS mandate.  In addition to the federal mandate, e-prescribing requirements, which include EPCS, have taken effect in 32 states as of January 1, 2022, covering 71% of the U.S. population. 

Quanum Practice Solutions from Quest Diagnostics offers a full range of products and services to support the needs of physicians and patients. Quanum Electronic Health Record (EHR) is fully certified to meet CMS regulatory requirements and includes electronic prescribing functionality. Quanum ePrescribing, which includes Electronic Prescribing for Controlled Substances (EPCS) and electronic prior authorization (ePA) within the prescriber workflow, can be added for a low monthly fee. The DEA-compliant EPCS solution has the potential to reduce medication errors, prescription theft, and forgery. ePA helps you streamline your ePrescribing workflow with the most efficient prior authorization process to help improve your practice’s efficiency and avoid post-visit disruptions. Our real-time prescription benefit gives users the power of price transparency while helping improve specialty medication prescribing and medication adherence.

Contact us via email to learn more.

Disclaimer: The views expressed in this blog post do not necessarily reflect the views of Quest Diagnostics®, or any of its employees.