Jul 21, 2020

HFPP/Genetic Testing White Paper Blog

Alec Alexander
Deputy Administrator and Director of the Center for Program Integrity, CMS.

Genetic testing has revolutionized health care, opening new windows on prevention and new doors to the treatment of disease. Approximately ten new genetic tests enter the market every day, including those for prenatal screening, detecting hereditary traits linked to cancer, and selecting appropriate medications.

But as the use and cost of genetic testing continues to rise, the federal government, including the Centers for Medicare & Medicaid Services (CMS), must be proactive in our efforts to combat the increasing fraud, waste, and abuse in clinical genetic testing services across the country.  For example, last year multiple law enforcement and federal agencies launched “Operation Double Helix,” which resulted in charges against 35 people implicated in an alleged scheme involving illegal kickbacks and bribes by genetic testing laboratories in exchange for expensive, and medically unnecessary, cancer genetic tests. Such practices result in confusing and wasteful information for patients, compromise the integrity of programs such as Medicare and Medicaid, and ultimately take money out of the pockets of American taxpayers.

In response to this emerging problem, the Healthcare Fraud Prevention Partnership (HFPP) released its newest White Paper, “Genetic Testing: Fraud, Waste, and Abuse”. The HFPP is a voluntary public-private partnership whose members, including CMS work to identify and prevent fraud, waste, and abuse across the health care sector. HFPP Partners include federal government, state agencies, law enforcement, private health insurance plans, and health care anti-fraud associations. These HFPP Partners represent approximately 73% of covered lives in the U.S. The ultimate goal of the HFPP is to stop waste, fraud, and abuse before they even start—and before our health care dollars are lost or stolen.

This new HFPP paper first explains the clinical genetic testing field, establishing a common understanding for the audience. It then provides an overview of current guidance on the appropriate use of genetic testing services, and it discusses fraud, waste, and abuse schemes related to genetic testing that HFPP Partners have identified. The White Paper also describes the challenges that HFPP Partners believe make genetic testing services particularly vulnerable to potential fraud, waste, and abuse, including:

  • The need for stronger or updated controls and standards for genetic testing.
  • The complexity and continuing evolution of genetic testing.
  • The escalating marketing of tests.
  • And the growing patient demand for genetic testing.

Additionally, the paper outlines possible actions that payers can take to address these systematic challenges, including:

  • Assessing existing pre- and post- payment review processes and identifying risks in their payment/claims systems.
  • Developing public education communications for providers to share with patients to increase awareness about fraud schemes and the appropriate use of genetic testing.
  • And implementing a regular review cycle of newly approved genetic testing methods.

Overall, this newly released paper is intended to enhance the understanding of HFPP Partners and other stakeholders about genetic testing, and it can be used as a foundation for each organization to build their own efforts to reduce systemic vulnerabilities to potential fraud, waste, and abuse associated with genetic testing.  We want to ensure that the right payments are made at the right time to the right provider for covered, reasonable, and medically necessary services. The work of the HFPP—and its latest White Paper on Genetic Testing—is helping to do just that.

Additional information on the paper can be found in:

Established in 2012, the HFPP aims to provide insights to Partners on the universe of health care payments; works with health care fraud experts to identify emerging threats and to design new methods to combat them; and releases studies that outline ways that Partners can take substantive actions to stop fraudulent and improper payments from going out the door. Its overarching goal is to help Partners move from a reactive approach to a proactive one. The HFPP has grown to 170 Partners and, given its broad membership, it is uniquely positioned to examine emerging trends with fraud, waste, and abuse and to develop key recommendations and strategies to address them.

Learn more about the Partnership by viewing the fact sheet (PDF), and if you’re interested in joining it, investigate the benefits of the HFPP and how to become a partner.

The work of the HFPP is critical to CMS’ efforts, through our Center for Program Integrity, to prevent, detect, and combat fraud, waste, and abuse in the Medicare and Medicaid programs and the Exchanges—and to further our “Protecting Taxpayer Dollar Initiative,” one of CMS’ 16 strategic initiatives designed to deliver better value and results for patients through competition and innovation, and so help transform our health care system.

A top priority of the Trump Administration, the Protecting Taxpayer Dollar Initiative is enhancing and modernizing program integrity functions for Medicare, Medicaid, and the Exchanges to help us hold the healthcare system accountable, protect beneficiaries from harm, and safeguard taxpayer dollars while minimizing unnecessary provider burden. We’re doing this through innovative efforts such as artificial intelligence and appropriate private sector best practice methods.

Among the accomplishments of this initiative, CMS has already prevented between $5 and $23 billion in fraud through the Medicare Card Address Validation Project; saw a $5.32 billion decrease in estimated improper payments for home health and a $1.29 billion decrease in estimated improper payments for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) from 2016 to 2019; and witnessed a $1.82 billion drop in improper payments in Medicare Part B from 2018 to 2019.