Precision Oncology Company Nabs Coverage for Advanced Cancer Test

Guardant Health Nabs Medicare Coverage for TissueNext Advanced Cancer Test

Medicare has given the coverage thumbs-up to Guardant Health’s Guardant 360 TissueNext test to identify advanced cancer patients who may benefit from biomarker-informed treatment. The basis for the decision is a local coverage determination (LCD) for next-generation sequencing-based tests from Medicare Administrative Contractor Palmetto GBA that was originally issued in February 2020. Under the LCD, Medicare will cover the TissueNext test as a standalone service for fee-for-service patients that:

• Have recurrent, relapsed, refractory, metastatic, or advanced cancer;
• Have not been previously tested by the same test for the same genetic content; and
• Are seeking further treatment.

In addition, the test must also include the minimum genes and genomic positions required to identify clinically relevant FDA-approved therapies with a companion diagnostic biomarker, as well as other biomarkers known to be necessary for clinical decision-making for its intended use that can reasonably be detected by the test.

OIG Calls Out Medicare Advantage Plans for Not Reimbursing Physicians for Medically Necessary Services

Medicare Advantage plans often refuse to provide patients and reimburse doctors for medically necessary care that meets Medicare coverage rules. That’s the conclusion of a new OIG report based on an analysis of a stratified random sample of 250 denials of prior authorization requests and 250 payment denials issued by 15 of the largest Medicare Advantage Organizations (MAOs) during June 1−7, 2019. Of the prior authorization request denials reviewed, 13 percent met Medicare coverage rules, as did 18 percent of the physician reimbursement requests denied. Advanced imaging services, such as MRIs, and stays in post-acute care facilities, were among the types of medical services wrongfully denied, according to the report. Reasons for the wrongful denials cited:

• Use of clinical criteria not contained in Medicare coverage rules;
• Requesting unnecessary documentation; and
• Genuine error.

“Although MAOs) approve the vast majority of requests for services and payment, they issue millions of denials each year and CMS's annual audits of MAOs have highlighted widespread and persistent problems related to inappropriate denials of services and payments,” the report states. What makes the problem so concerning—and the reason it’s on OIG’s audit radar—is that Medicare Advantage is a capitated payment model in which providers are paid a fixed amount per beneficiary, thereby creating a potential incentive for MAOs to deny access to services and payment in an attempt to increase profits.

US Eclipses Europe as Medtechs’ Market of Choice

Historically, heavy-handed FDA regulation has been a major turnoff for many medtech companies seeking to enter the US market, making Europe a more attractive alternative. However, those preferences may be changing. In a new Boston Consulting Group and UCLA Biodesign survey of 104 medtech senior executives, 89 percent said that they plan to prioritize FDA over European Union CE authorization going forward. The reason is simple: regulation—specifically, the EU’s new In Vitro Diagnostic Regulation (IVDR), which is scheduled to take effect on May 26. Simply stated, the new IVDR is a regulatory nightmare that has made securing CE marking for new products more “complex and unpredictable,” according to the survey. Coupled with recent attempts by the FDA to woo global medtechs, the EU has now seemingly fallen behind not just the US but also China and Japan on the list of priority markets. (For more about the IVDR, see Laboratory Industry Report, January 31, 2022.)