Practicing with Precision:

Sep 20, 2018 at 02:07 pm by admin


Barriers, Resources to Integrating Precision Medicine

Precision Medicine.

The very name neatly sums up providers' universal hope to dispense medicine in the most efficient, effective, precise manner possible to the benefit of a patient based on that person's individual profile. Yet, integrating the discipline into practice is often anything but an exact science.

A number of barriers - from a barrage of new discoveries to difficulties with authorization and reimbursement - have hindered physicians as they seek to offer patients the best option to treat a range of conditions and illnesses. The American Medical Association (AMA) has taken a leadership role in working with stakeholders, from researchers and colleagues to payers and policymakers, to address a number of key issues cited by physicians on the frontlines of care.

Already critical to the delivery of patient-centered care in a variety of specialty areas including oncology and rare disease, the discipline is only anticipated to grow as new discoveries come online daily. To enable that growth, the AMA has recognized physicians need readily available resources to learn about the rapidly changing field and its impact on patient care.

The national organization has developed a number of educational resources, including the "Precision Medicine for Your Practice" series, which includes online modules to enhance awareness of physicians and healthcare providers of the different ways genetic testing can be incorporated to improve health outcomes for patients. According to the national organization, "The modules - developed by the AMA in partnership with Scripps Translational Science Institute and The Jackson Laboratory - cover specific topics in genomics and precision medicine, including expanded carrier screening, prenatal cell-free DNA screening, somatic cancer panel testing, cardiogenomics, neurogenomics and pharmacogenomics. The modules offer CME free of charge and can be found on the AMA's website."

Currently, those modules are available online at education.ama-assn.org/precision-medicine.html. However, the AMA is updating its Education Hub so the address will likely change as that transition occurs but should be searchable in the association's new education section.

The AMA is also supporting continued research as a formal partner in the National Institutes of Health "All of Us" research program, which is building a large research cohort for precision medicine. The goal of the initiative is to better understand genomic influences and how they interact with lifestyle and the environment. More information on the large-scale project is available at allofus.nih.gov.

While precision medicine holds great promise for the future, current payment systems have proven to be a significant barrier to clinical integration. Additionally, more work is needed on the clinical decision-support front to assist providers in identifying and deploying appropriate testing. On a related note, the AMA said there is a widespread shortage of medical geneticists and other clinicians with specialized knowledge to help drive broad clinical integration.

"The AMA is working on several fronts to address these barriers. For example, the AMA has advanced several priorities to expand coverage and payment and access, as well as educational initiatives and support for research and clinical validation," the organization responded to the Medical News in a statement. While efforts to ensure coverage and payment for clinically validated precision medicine continue, the AMA noted, "An ongoing challenge has been the rapidly evolving coverage and payment policies of government and commercial health insurers that have not necessarily kept pace with innovation and clinical validation in genetics and genomics. There are some commercial insurers that are imposing either prior authorization requirements or other utilization management policies due to their fixed capacity to keep pace with the change, which impacts and challenges patient access and clinical integration."

At the beginning of 2017, the AMA joined with 16 other organizations representing the continuum of care to release the Prior Authorization and Utilization Management Reform Principles, calling for an array of improvements in utilization management including addressing the key issues of clinical validity, transparency, fairness, timely access, continuity of care, alternatives and exemptions. "The release of these principles spurred important conversations between provider and health plan organizations on the need for prior authorization reform. An important initial outcome of those discussions was the January 2018 release of the Consensus Statement on Improving the Prior Authorization Process," stated the AMA.

The consensus statement from six national organizations representing physicians, hospitals, pharmacists, practice managers and payers reflected an agreement between providers and payers to meaningful address the process impacting the delivery of cutting-edge care.

With the shortage of medical geneticists and specialized clinicians deploying precision medicine ... and with those who do possess that specialized knowledge and skill set often clustered at major academic centers . . . the AMA has focused on increasing access to genetic and genomic consultations through the utilization of telehealth and e-consults. Strong supporters of using technology to expand access and knowledge, the organization hailed a proposal to allow the Medicare program to cover inter-professional e-consults beginning Jan. 1, 2019. "This is very important news for physicians and patients who will be able to obtain patient-specific medical genetic consultations more rapidly and without constraints of geography, while ensuring care coordination and care delivery by the primary care provider," the AMA stated.

"With all of this optimism and promise, consistent coverage policies that reflect the evidence base remain a critical factor in the successful implementation of precision medicine, as well as the infrastructure to support widespread clinical decision-support for the right patient, right test at the right time," noted the AMA. Although excited about forward movement in terms of expanding access through e-consults and the work to address prior authorization impediments, the national physician group said additional challenges remain, including concerns over affordability and accessibility. A growing concern is the potential impact of efforts that could limit the number of clinical laboratories offering testing due to payment cuts. "The AMA is committed to addressing these challenges though advocacy efforts, investing in a number of educational initiatives, as well as promoting continued discovery and innovation through the All of Us campaign."

RELATED LINKS:

AMA Overview of Precision Medicine Topics

Precision Medicine for Your Practice Series

Consensus Statement on Improving the Prior Authorization Process

NIH All of Us Research Initiative

NIH Genetic Testing Resource

CDC Evaluating Genomic Tests

Sections: Clinical