Specialty medical companies can benefit from regulatory progress

Whenever health-centric regulations like the 21st Century Remedies Act appear on the horizon, they frequently raise challenges and questions, as well as breakthroughs. For example, while this legislation and other recent developments make it easier for patient registries to collect and share patient data, many are still struggling to figure out how best to use that data appropriately.

To learn more about how recent regulations can benefit drug research and development players, Outsourcing-Pharma recently spoke with Angela Kennedy, Director of Strategic Operations for Specialty Medical Companies at IQVIA.

OSP: What is a medical specialty society?

AK: A medical specialty society, also called a provider association, is a membership organization representing a specific group of medical professionals, for example, the American College of Surgeons. Medical specialty societies perform many important functions and services for their members, including education, advocacy, and health policy.

Medical Specialty Societies help improve and facilitate quality, effective and accessible patient care, leveraging member experience to research, develop and implement the highest standards and practices. They also help set standards of excellence in their profession through clinical practice guidelines, quality measures, and quality improvement programs, most through the use of directed clinical data registries. by clinicians.

OSP: How can the 21st Century Act help collect, share and use patient data?

Angela Kennedy, Director of Strategic Operations for Specialty Medical Companies, IQVIA

AK: The 21st Cures Act in the United States was signed into law by President Barack Obama on December 13, 2016. The bipartisan legislation aims to increase choice and access for patients and providers. Among many parts of its parts, The Cures Act aims to alleviate the regulatory burdens associated with the use of electronic health record (EHR) systems and health information (IT) technology.

After the Cures Act was enacted, it was forwarded to the Office of the National Health Information Technology Coordinator (ONC) and the Centers for Medicare & Medicaid Services (CMS) for review. ONC and CMS produced two sets of rules based on the interoperability, patient access and information blocking provisions of the Cures Act. These rules guide industry members, such as providers, payers, and technology vendors, when designing their health information systems. The ONC and CMS rules adhere to the interoperability and information blocking provisions of the Cures Act and are designed for increased patient access to their own information and ensure a standard of interoperability between the systems.

The Cures Act brought about new regulations that fundamentally change how patient data is accessed and reused. It contains provisions focused on promoting interoperability and requiring developers not to block information – or prevent or interfere with access, sharing or use of electronic health information (EHI). The ONC defines EHI in its final rule as “electronic protected health information (ePHI) in a designated records set (as defined in the Health Insurance Portability and Accountability Act (HIPAA) regulations), whether the records are used or maintained by or for a Covered Entitythere. »

For purposes of information blocking, EHI is limited to data elements represented in the United States Core Data for Interoperability (USCDI). In a major breakthrough, USCDI aims to improve the interoperability of various medical data systems and enable the exchange of data between stakeholders such as physicians, insurers, laboratories, clinical data registries and patients themselves. The final rule also contains an array of requirements for standards-based application programming interfaces (APIs) to support a patient’s access to and control over their electronic health information.

The ONC released its final information blocking rule in May 2020. The rule defines information blocking as any practice that interferes with the access, exchange, or use of EHI. The information blocking rule reinforces the rights of patients in terms of obtaining their electronic health data in the modern health IT environment. It also holds EHR providers accountable for ensuring that health information is accessible.

The rule came into full effect on April 5, 2021, requiring providers, vendors, and any healthcare “actor” who participates in health information exchanges to comply with it. At the root of the information blocking rule is a desire to make electronic health data more accessible to patients or other entities, as permitted by HIPAA. The final rule calls on industry to support the adoption of standards using secure Application Programming Interface (API) functionality, the leading standard for health information exchange is Fast Healthcare Interoperability Resources (FHIR), and the Cures Act propose the use of FHIR as a standard format.

Although the rule went into effect in April, healthcare organizations are not required to migrate to the Fast Healthcare Interoperability Resources (FHIR) v4 APIs until December 31, 2022. As the API deadline approaches FHIR v4, health informatics vendors and vendors will have to make decisions. on how to operate from a clinical perspective while respecting the information blocking rule.

CMS finalized the Interoperability and Patient Access Final Rule in March 2020, guiding the next phase of the Cures Act. CMS calls the new rules — which hold public and private entities accountable for enabling easy electronic access to health information — the most extensive health data sharing policies ever implemented by the federal government.

The rule requires CMS-regulated payers to implement patient access APIs and provider directories, as well as increase data sharing with other payers. Together, these rules attempt to make it easier for patients to access and control their health data. These final rules represent significant changes to how healthcare providers, health IT developers, and health plans use health IT.

OSP: Are there ways in which the 21st Century Care Act and other legislation/agency might lack support and guidance?

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(Irina_Strelnikova/iStock via Getty Images Plus)

AK: Even though the interoperability and information blocking requirements of the Cures Act and subsequent regulations are designed to move the healthcare industry toward greater access to data, the long phased implementation of these provisions is comes with challenges. The requirement is to move towards a more transparent system, but a significant number of specific details about compliance and enforcement of the guidelines are not yet established.

More than a year after the release of the final rule, confusion over information blocking remains widespread. CMS has not yet clarified the potential penalties that could be imposed on vendors for non-compliance, and the Office of Inspector General (OIG) has not finalized its proposed penalties for certified EHR vendors. and the exchange of health information. The finalization of some of these application aspects and a lot more clarity are absolutely essential.

OSP: Why does capturing a more complete picture of a patient’s health history help innovation in drug development? Moreover, how can it help to improve the efficiency of various aspects of drug development?

AK: In November 2021, Congress introduced the Cures Act 2.0. In Section 309 of the Cures 2.0 Act, which aims to increase the use of real-world evidence and support the use of data from clinical care data repositories and patient registries to meet study requirements post-approval for products regulated by the Food and Drug Administration. This legislation is designed to modernize the health care delivery system and make better use of real-world data and evidence across federal agencies.

Cures 2.0 also addresses the acceptance of decentralized trials. Clinical trials are needed to bring safe and effective drugs and devices to market. However, many drugs and devices are developed in small populations in controlled laboratory environments that may not reflect the actual experience of disease. Decentralized clinical trials, on the other hand, are conducted in a study participant’s home using digital tools. These may include more sensitive objective measures with greater information density and may include many more study participants.

Although fully decentralized assays are not suitable for all research, in many cases decentralized assays can profoundly enrich a study and the FDA should support the use of such assays.

Digital tools should not be validated by the FDA alone, but in collaboration with an appropriate medical specialty society, clinical expert, or physician informatics to build physician confidence in the tool. The use and validation of digital health tools are two of the most critical areas for physicians to successfully realize the potential of these technologies.

OSP: So how can capturing more complete patient health histories improve patient engagement and care?

AK: The Cures 2.0 Act builds on provisions of the 21st Century Cures Act that highlight how clinician-led clinical data registries are uniquely positioned to drive quality improvement initiatives. Cures 2.0 incorporates the 21st Century Cures Act definition of “clinician-led clinical data registry” as a clinical data repository established or operated by a clinician-led or controlled specialty medical society or other similar organization; designed to collect detailed, standardized data on an ongoing basis for medical procedures, services, or therapies for particular diseases, conditions, or exposures; provides feedback to participating data sources; and meets certain quality standards.

Section 411 of the Cures 2.0 Act, which would ensure clinician-led clinical data registries have meaningful access to real-world data (RWD) to better track patient outcomes over time, expand their ability to assess the safety and effectiveness of medical treatments, and provide them with the information needed to assess the cost-effectiveness of therapies. This legislation would allow clinician-led clinical data registries to link their outcome data to claims data in a way that would help determine the value of new medical technologies and therapies and assist in the development of effective alternative payment models. (“APM”).

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