MACRA and the Evolving Landscape of Healthcare Regulations

Introduction

The Medicare Access and CHIP Reauthorization Act (MACRA) of 2015 marked a significant shift in healthcare regulations, particularly in how Medicare reimburses providers and promotes the use of health information technology. This article explores MACRA's impact, the transition from Meaningful Use to Promoting Interoperability, and the implementation of information blocking rules under the 21st Century Cures Act.

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Understanding MACRA

MACRA was signed into law on April 16, 2015, with the primary goals of:

1. Repealing the Sustainable Growth Rate (SGR) formula for determining Medicare payments
2. Changing the way that Medicare rewards clinicians for value over volume
3. Streamlining multiple quality programs under the new Merit-Based Incentive Payment System (MIPS)
4. Providing bonus payments for participation in eligible alternative payment models (APMs)

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The Shift from Meaningful Use to Promoting Interoperability

Meaningful Use Background

The Meaningful Use program, introduced in 2011 as part of the HITECH Act, incentivized the adoption and meaningful use of certified electronic health record technology (CEHRT).

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Transition under MACRA

1. Renaming: MACRA rebranded the Meaningful Use program as "Promoting Interoperability" (PI) for eligible clinicians.
2. Integration into MIPS: PI became one of four performance categories under MIPS, along with Quality, Improvement Activities, and Cost.
3. Focus Shift: While Meaningful Use primarily focused on EHR adoption, PI emphasizes:
   • Interoperability
   • Information exchange
   • Patient access to health information
4. Scoring Changes: The program moved from a pass/fail system to a performance-based scoring methodology.
5. Flexibility: MACRA introduced more flexibility in measure selection and reporting.

Key Changes in Promoting Interoperability

1. Emphasis on Outcomes: Greater focus on how technology is used to improve patient care rather than mere implementation.
2. Data Exchange: Increased requirements for bi-directional data exchange with other providers and public health agencies.
3. Patient Engagement: Enhanced measures for providing patients with access to their health information and the ability to view, download, and transmit their records.
4. Security: Continued emphasis on security risk analysis and protection of patient health information.

Information Blocking Rules under the 21st Century Cures Act

The 21st Century Cures Act, signed into law in December 2016, included provisions to advance interoperability and support the free exchange of health information. A key component of this is the prohibition on information blocking.

Definition of Information Blocking

Information blocking is defined as any practice likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information (EHI).

Key Aspects of Information Blocking Rules

1. Applicability: The rules apply to healthcare providers, health IT developers, health information exchanges, and health information networks.
2. Exceptions: The rules outline eight exceptions where actions that might otherwise constitute information blocking are permitted.
3. Enforcement: The Office of the Inspector General (OIG) is responsible for investigating and enforcing information blocking rules.
4. Penalties: Violators can face significant penalties, including civil monetary penalties and disincentives for healthcare providers.

Implementation Timeline

• April 5, 2021: Information Blocking rules went into effect.
• October 6, 2022: Expansion of EHI definition to include all electronic protected health information (ePHI) in a designated record set.

Impact on Healthcare Providers and Organizations

1. Technology Updates: Providers and organizations need to ensure their health IT systems support increased interoperability and patient access.
2. Policy Changes: Revision of organizational policies to comply with information blocking rules and promote data sharing.
3. Workflow Adjustments: Adapting clinical and administrative workflows to support enhanced interoperability and patient access.
4. Training: Educating staff on new requirements, particularly regarding information blocking and patient data access.
5. Patient Engagement: Developing strategies to support and encourage patient access and use of their health information.

Challenges and Opportunities

Challenges

1. Complexity: Understanding and implementing the nuanced requirements of MACRA and information blocking rules.
2. Technical Hurdles: Ensuring systems can support increased interoperability and data exchange.
3. Privacy Concerns: Balancing increased data sharing with privacy and security requirements.
4. Cost: Implementing necessary technological and operational changes can be expensive.

Opportunities

1. Improved Care Coordination: Enhanced data exchange can lead to better coordinated and more efficient care.
2. Patient Empowerment: Increased access to health information can empower patients to take a more active role in their healthcare.
3. Innovation: The push for interoperability and open APIs can drive innovation in healthcare technology.
4. Data-Driven Improvements: Greater data availability can support quality improvement initiatives and population health management.

Conclusion

MACRA, the transition to Promoting Interoperability, and the implementation of information blocking rules represent a significant evolution in healthcare regulations. These changes reflect a broader shift towards value-based care, patient empowerment, and data-driven healthcare.

As the healthcare industry continues to adapt to these changes, providers and organizations must stay informed about regulatory requirements, invest in compliant technology, and develop strategies to leverage these changes for improved patient care and outcomes.

The journey towards a more interoperable, patient-centered healthcare system is ongoing, and these regulatory changes are important steps in that direction. As technology continues to evolve and new challenges emerge, further regulatory adjustments are likely, requiring continued adaptability from all stakeholders in the healthcare ecosystem.