In 2019, 18.6% of the US population was covered by Medicare¹. In the next 10 years, the population of Medicare beneficiaries is projected to increase by ~26 million people¹. The number of Medicare members requiring genetic testing will increase dramatically, particularly as molecular techniques become more commonplace in the diagnosis and treatment of later-onset diseases like cancer. Unfortunately, determining which tests are covered for Medicare patients can be exceptionally complex for members, providers, and payers alike. In this article, we explain some of the important complexities of interpreting genetic testing policies for Medicare beneficiaries.

Policy Complexities

• Medicare coverage policies are divided by jurisdiction. There are eight different Medicare jurisdictions throughout the USA. Each jurisdiction is administered by entities known as Medicare Administrative Contractors or MACs. Five of these jurisdictions currently use policies authored by the Molecular Diagnostic Program (MolDx), administered by the Palmetto GBA MAC . The other three jurisdictions use policies authored by other MACs. This can lead to jurisdictional differences which result in certain tests being covered by one MAC but not another.
• Compared to Commercial carriers, the Center for Medicare/Medicaid Services (CMS) and MACs have significantly more molecular testing policies (800+ in total). To add further complexity, there is a hierarchy in how these policies are enforced, beginning with pertinent National Coverage Determinations (NCDs), followed by Local Coverage Determinations (LCDs) and Local Coverage Articles (LCAs).²
• Virtually all Medicare molecular testing policies require a patient to be symptomatic for the condition being tested. Defining and enforcing “symptomatic” can be nuanced in some cases and requires specific genetics expertise.
• While policies are often similar or duplicated across jurisdictions, there is no standard process for policy creation or updates. Policies are created in draft format and may stay in that format for a few days, months, or even years. Some policies never move past draft format and are eventually deleted without becoming active. A policy may become active in one jurisdiction while remaining in draft format in another jurisdiction. Similarly, a policy may be updated in one jurisdiction and updated much later in other jurisdictions.
• When policies are updated, there is no provider notification of those updates or public announcement.
• There is no way to consistently search the Medicare policies to determine which policy best fits each clinical scenario as the policies are searchable by title but the policy title does not always fully describe the policy content or intent. Within the policies themselves, the criteria for coverage are not consistently formatted or even under consistent headings and so can be difficult to find and interpret.

Genetic Counselors: Integral to Healthcare Provider Teams

To add to the complex challenges associated with genetic testing for Medicare beneficiaries, in many policies, CMS supports or requires the incorporation of expert genetic counseling when an individual is being considered for genetic testing. However, the primary provisioners of genetic counseling, certified and licensed genetic counselors, are not currently recognized as health care providers by CMS. This omission forces primary care and other healthcare providers without training in genetics to add understanding the above complexities to their already long list of tasks to accomplish for their patients.

Legislation to support inclusion of genetic counselors to the CMS recognized healthcare team is being presented to Congress as legislation H.R.3235 Access to Genetic Counselor Services Act. Please consider sending this easy to submit letter to your member of congress to show your support.

Summary

As you can see, the genetic testing landscape for Medicare beneficiaries is convoluted and dynamic. This landscape is expected to continue to change as new genetic testing technologies are developed and recommended by experts in genetics and genomics.  With the predicted increases in the number of Medicare beneficiaries expected to use these services³,  health plans need to be proactive in identifying solutions  to address utilization management for Medicare lines of business in the genetic testing space.

We support numerous regional and national health plan clients in managing genetic testing within the Medicare and Medicaid populations. InformedDNA’s utilization management solutions have created streamlined processes to manage CMS policy surveillance, allowing us to remain current on all policy changes or additions. And, our depth of genetics expertise and broad experience with management of genetic testing for Medicare and Medicaid beneficiaries ensures accurate interpretation and adjudication of complex and frequently changing policies.

InformedDNA leverages the expertise of the largest, most experienced, full-time staff of lab-independent, board-certified genetics specialists in the U.S. to help ensure that health plans, health systems, hospitals, pharmaceutical companies, clinicians and patients all have access to the highest quality genetics services.

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Sources:

1. Report to the Congress: Medicare and the Health Care Delivery System, Medpac, June 2015
2. The Sentinel, Genetic Tests and Medicare: Coverage and Oversight, Mike Klug, May 2019
3. https://www.census.gov/popclock/  U.S. Census Bureau, U.S. and World Population Clock, January 1, 2020 (329,135,084)