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Immunovia reiterates its road to reimbursement for the IMMray PanCan-d test

Immunovia reiterates its road to reimbursement for the IMMray PanCan-d test LUND, Sweden, April 22, 2021 /PRNewswire/ Immunovia is launching its IMMray PanCan-d test in the US as a Laboratory Developed Test (LDT) in Q2 2021. The company will explore a positive Medicare coverage determination for the IMMray PanCan-d test through the Local Coverage Determination (LCD) process. The IMMray PanCan-d test will be performed at Immunovia Dx Laboratories in Marlborough, Massachusetts, and will be available to all patients in the US. In accordance with Medicare regulations, all Medicare billing will be conducted by Immunovia Dx Laboratories through the Medicare Administrative Contractor (MAC) that administers benefits in Massachusetts (National Government Services or NGS). Therefore, obtaining coverage from NGS would be sufficient for coverage of all Medicare-participating patients nationwide.

Immunovia reiterates its road to reimbursement for the IMMray™ PanCan-d test

Share this article LUND, Sweden, April 22, 2021 /PRNewswire/   Immunovia is launching its IMMray™ PanCan-d test in the US as a Laboratory Developed Test (LDT) in Q2 2021. The company will explore a positive Medicare coverage determination for the IMMray™ PanCan-d test through the Local Coverage Determination (LCD) process. The IMMray™ PanCan-d test will be performed at Immunovia Dx Laboratories in Marlborough, Massachusetts, and will be available to all patients in the US. In accordance with Medicare regulations, all Medicare billing will be conducted by Immunovia Dx Laboratories through the Medicare Administrative Contractor (MAC) that administers benefits in Massachusetts (National Government Services or NGS). Therefore, obtaining coverage from NGS would be sufficient for coverage of all Medicare-participating patients nationwide.

New Rules May Reduce Healthcare False Claims Liability

Advertisement New Rules Prohibiting the Government s Use of Certain ‘Guidance Documents May Reduce False Claims Liability for Health Care Providers Wednesday, February 17, 2021 Health care providers and others in the health sector have long complained at the unfairness of facing enforcement actions – and the fines and penalties that accompany them – for failure to follow a poorly publicized or otherwise obscure agency guidance such as a local coverage determination (LCD). In 2019, the United States Supreme Court provided significant relief when it held in  Azar v. Allina Health Services, 139 S. Ct. 1804 (2019), that an agency guidance that established or changed a “substantive legal standard” had to undergo a notice-and-comment process before adoption and enforcement. On Dec. 3, 2020, the Office of General Counsel for the Department of Health and Human Services (HHS-OGC) issued an Advisory Opinion and two final rules that provide a roadmap as to how the ag

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