Guest Blog
by Lauren Feldman

Lauren Feldman

The continued explosive growth in the diagnostics market is changing the health care paradigm. Rapidly evolving technologies are producing a plethora of new clinical laboratory tests, which address critical unmet needs in health care. Specifically, advances in molecular diagnostics present tremendous opportunities to significantly enhance patient care and accelerate personalized medicine. Innovation, particularly in the diagnostics space, is a driving force behind the push for greater coding accuracy and specificity.

The Protecting Access to Medicare Act of 2014 (PAMA) mandates the creation of specific Healthcare Common Procedure Coding System (HCPCS) codes for Advanced Diagnostic Laboratory Tests (ADLTs) and Clinical Diagnostic Laboratory Tests (CDLTs) that are cleared or approved by FDA. The existing HCPCS system is comprised of Level I codes — Current Procedural Terminology (CPT^®) — maintained by the American Medical Association (AMA) and Level II codes maintained by the Centers for Medicare & Medicaid Services (CMS).

Related to CMS’ rule-making under PAMA, the CPT Editorial Panel authorized the creation of a new clinical laboratory test section in the CPT code set. The new section provides a coding infrastructure whereby a clinical laboratory or manufacturer may request a code to specifically identify its test. Through its established, transparent processes, the CPT Editorial Panel is committed to ensuring the CPT code set remains uniform, predictable, and meets the needs of a broad cross-section of stakeholders.

To that end, the CPT Editorial Panel in conjunction with AMA CPT staff are hosting open, public meetings to solicit stakeholder input on the development of processes and structures to facilitate management of this new section of codes. The first meeting is scheduled for Tuesday, December 15, 2015, from 7:00 – 9:00 p.m. CST via conference call. A subsequent meeting is scheduled for Thursday, January 14, 2016 in Washington, D.C. To drive maximum consensus, the AMA encourages all interested stakeholders to engage in the discussions to help achieve a sustainable coding infrastructure that will ensure consistent national coding across Medicare and other public and private payers.

The aforementioned meetings will help guide the CPT Editorial Panel and CPT staff in generating a formal code change proposal to be considered at the February CPT Editorial Panel meeting (Feb. 4 – 6 at the Hyatt Regency, Miami, FL). In accordance with all CPT Editorial Panel meetings, the February meeting is open to the public, and the AMA invites you to participate in the deliberation.

For the full promise of personalized medicine to be realized at the clinical level, consistent and accurate coding is essential. As we continue to navigate this complex landscape, the goal is to create a comprehensive coding solution for reporting clinical laboratory tests, thereby enabling improved patient outcomes and access to care.

For more information on CPT Editorial Panel meetings and processes, please visit http://ama-assn.org/go/cpt.

—
Lauren Feldman
Senior Terminology and Strategy Consultant
American Medical Association

by Amy M. Miller, Ph.D.

Amy M. Miller, Ph.D.

The thought first crossed my mind in January, but it was validated on November 17. Unmistakably, 2015 is the year of personalized medicine.

November 17 started with two hearings on both sides of the Capitol. On the Senate side, Robert Califf, M.D., answered questions during his nomination hearing for the FDA commissioner position. The number of Senators referencing personalized medicine was remarkable, and a few members demonstrated deep knowledge of the field by mentioning laboratory-developed test (LDT) regulation specifically. But the activities on the other side were even more extraordinary.

While the Senate was questioning Califf, the House of Representatives Energy and Commerce Health Subcommittee held an entire hearing on LDT regulation. At focus was purportedly draft regulation circulated by the health subcommittee. The content of the hearing, however, reflected a much deeper analysis.

During the hearing, Patrick Conway, M.D., and Jeffrey Shuren, M.D., J.D., outlined the very different roles that the Centers for Medicare and Medicaid Services (CMS) and FDA play in the diagnostics space. Conway described how the Clinical Laboratory Improvement Amendments (CLIA) program focuses on laboratory operations, while test regulation is under the purview of FDA. When asked, repeatedly, if CLIA could be strengthened to accommodate the new science of personalized medicine, Conway consistently answered, without equivocation, “no.” For his part, Shuren stated FDA’s intention to finalize LDT guidance in early 2016.

Throughout both proceedings the newfound support personalized medicine now enjoys in Congress and in the executive branch was on display. We were watching progress. And the day wasn’t over.

Later on that day many stakeholders breathed a sigh of relief as CMS revoked its proposal to reduce the reimbursement rate for CareDx’s impactful personalized medicine test, AlloMap®, by 77 percent, restoring the recommended payment rate for the test to its original $2,821. Many similar determinations also conformed to community requests, and were well received as big wins for the personalized medicine community.

So, when I ended November 17 by attending the Coalition’s networking reception in Boston, I had occasion to celebrate. But even as 2015 winds down on these positive notes, the personalized medicine field still faces policy challenges.

Unfortunately, unpredictable and arbitrary policy decisions, like the proposal to reduce the reimbursement rates for AlloMap® and other personalized medicine tests, are common at CMS. These decisions are unnecessarily disruptive to the field, and it is my hope that in the coming year CMS will adhere to recommendations that seek to protect the interests of personalized medicine, like those PMC provided in its letter on the proposed rule for implementing the Protecting Access to Medicare Act (PAMA) passed in 2014.

Adhering to these kinds of recommendations is of paramount importance, because in the year of personalized medicine, extraordinary days like November 17 are becoming all too common.

—
Amy M. Miller, Ph.D.
Executive Vice President
Personalized Medicine Coalition

Guest Blog
by Ralph Snyderman, M.D.

Ralph Snyderman, M.D.

At a White House briefing on June 26, 2000 announcing the initial sequencing of the human genome, President Clinton said:

“Genome science will have a real impact on all our lives — and even more, on the lives of our children. It will revolutionize the diagnosis, prevention, and treatment of most, if not all, human diseases.”

President Clinton likened the importance of this accomplishment to Galileo’s discoveries leading to the understanding of the motions of the universe, and he anticipated that cancer would be thought of as a constellation of stars rather than a disease.

Just last month, I had the privilege of delivering the opening address at the 11th Annual Personalized Medicine Conference at Harvard University.  I was asked to reflect on the progress made in personalized medicine over the last 15 years.  The title, “Personalized Medicine:  Then, Now, and Coming Soon,” reflected my analysis.

By the late 1990s, it was clear to me that the confluence of rapidly emerging technologies including genomics, proteomics, metabolomics, bioinformatics, and digital technologies had the capability to profoundly impact the understanding of disease, but also, more importantly, enable the prediction of each individual’s disease susceptibilities, disease progression, and likelihood of disease events, thereby enabling a new form of health care. Rather than reacting to established disease, care could be personalized, predictive, preventive, and proactive. By 2002, my colleagues and I proposed a paradigm shift from disease care to personalized health care.

Since its inception, the field, often called personalized or precision medicine, has advanced in ways that could not have been anticipated at the onset. Most impressive has been the progress in genomic and related technologies. Next-generation sequencing, beginning in 2007, increased the speed and lowered the cost of gene sequencing at a rate far greater than Moore’s law. The capability to perform full genome or exome sequencing on millions of people as well as the coupling of each individual’s genomic data, environmental exposures, and clinical outcomes will profoundly impact our understanding of the drivers of health and disease. Progress in allied fields of “-omics” along with single-cell genomic and metabolic pathway analyses combined with the ability to store and analyze vast amounts of data are already providing far greater definition of the mechanistic basis of disease.

The greatest benefits of personalized medicine have been in the treatment of cancer, where the identification of the drivers of an individual’s disease has enabled therapies targeted to the specific pathology.  Targeted therapies and companion diagnostics have already had a profound impact on cancer treatment. Advances in immunotherapy used in synergy with targeted therapies are recognized as the wave of the future.

In contrast to advances in technology and in diagnosing, defining, and specifically treating disease, progress in applying genomics to enhancing health and preventing disease has been disappointing. This is due in part to the difficulty of understanding the complexity of the roles of genetics and environmental factors in the development of chronic diseases. Even more important has been the refractoriness of the health care delivery system to embrace proactive and personalized approaches. This resistance is due in part to the system’s focus on treating established disease and a reimbursement system that rewards disease interventions rather than prevention.

In grading the progress of personalized medicine during its first 15 years, my assessment is as follows: Technological advances: A; Disease treatment: B (A for cancer, but thus far limited beyond this); Disease prevention: D-; and, Health enhancement: F.

Ralph Snyderman’s Personalized Medicine Report Card

Looking forward to the next decade, I am optimistic that great progress will be made in fulfilling the original dream for personalized medicine to prevent as well as cure disease. Technology is likely to continue to outperform expectations. Precision medicine initiatives with “big data” analysis will identify the genetic and environmental factors impacting health and disease, providing better tools for predicting and preventing chronic diseases. More and better targeted therapies, immunotherapies, and gene therapies will soon personalize the care of many diseases. Digital technologies will spur mobile health capabilities and enhance the involvement of patients in their care, a necessary component of disease prevention.

New models for delivering personalized health care are being developed and are beginning to demonstrate their effectiveness especially when coupled with strategies for enhancing patient engagement. Indeed, the Veterans Health Administration has identified personalized, proactive, and patient-driven health care as a strategic priority. I also have made the development of working models of personalized health care my primary focus.

I have been informed that I will receive the “Pioneer Award” at the upcoming Personalized Medicine World Conference in January 2016. For this, I am truly grateful. It has been a privilege and a joy to have participated in the transformation of medicine to personalized health care.

—
Ralph Snyderman, M.D.
James B. Duke Professor of Medicine
Chancellor Emeritus
Duke University