Billing News Jun 2019



CMS Outlines Comprehensive Strategy to Foster Innovation for Transformative Medical Technologies

  • June 5, 2019

The Administrator highlighted two specific actions: First, for issuing Healthcare Common Procedure Coding System (HCPCS) codes, CMS is changing the current process of allowing only one opportunity per year to apply for new Level II codes. The agency is moving to a process with quarterly opportunities to apply for drugs, and semi-annual...

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Test for Circulating Tumor DNA Wins FDA Breakthrough Designation

  • June 5, 2019

FDA has granted breakthrough device designation for Natera's test to detect and quantify circulating tumor DNA (ctDNA) after surgery in the blood of patients already diagnosed with some types of cancer and combined with certain drugs, Natera said Monday.  Natera said the FDA breakthrough designation will help support the company's...

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HHS Publishes Fact Sheet on Direct Liability of Business Associates Under HIPAA

  • June 5, 2019

On May 24, 2019, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a new fact sheet providing a compilation of all provisions through which a business associate may be held directly liable with the HIPAA Privacy, Security, Breach Notification, and Enforcement regulations. Under the Final Rule...

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Annual Report to the Nation: Overall Cancer Mortality Continues to Decline

  • June 5, 2019

The latest Annual Report to the Nation on the Status of Cancer finds that, for all cancer sites combined, cancer death rates continued to decline in men, women, and children in the United States from 1999 to 2016. Overall cancer incidence rates, or rates of new cancers, decreased in men from 2008 to 2015, after increasing from 1999 to 2008 and...

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MolDX Local Coverage Determination (LCD) Updates and LCD Article Updates: Part A and Part B - L37709

  • June 5, 2019

The Foodborne Gastrointestinal Panels Identified by Multiplex Nucleic Acid Amplification (NAATs) L37709 A/B MAC LCD was revised. The Billing and Coding: Foodborne Gastrointestinal Panels Identified by Multiplex Nucleic Acid Amplification (NAATs) A56593 A/B MAC Article was revised. Covered ICD-10 Codes Group 1: Codes added ICD-10 codes R19.7...

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Horizon, Invitae Partner to Provide Free Genetic Testing for Urea Cycle Disorder

  • June 5, 2019

Horizon Therapeutics has partnered with Invitae for its urea cycle disorder genetic (UCD) testing program, through which individuals who may have the rare genetic condition and their family members will receive testing at no charge. Within the program, Invitae will provide its Hyperammonemia Panel which assesses 58 genes involved with the enzymes...

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Agendia, Imegen Ink Distribution Deal for Breast Cancer Tests in Spain, Portugal

  • June 5, 2019

Agendia has signed an agreement with Valencia, Spain-based Imegen for the exclusive distribution of Agendia's MammaPrint and BluePrint breast cancer genomic tests in Spain and Portugal. MammaPrint measures the expression of 70 genes and classifies patients as either high risk or low risk of recurrence over a 10-year period. BluePrint is an 80-...

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Studies Outline Outcomes Associated with Cervical Cancer Screening, Triage Strategies

  • June 5, 2019

The researchers analyzed various screening strategies in 451 English- or Spanish-speaking women between the ages of 21 and 65 years old who were enrolled at San Francisco health clinics tested, taking into account the women's screening preferences, direct medical costs and the cost-effectiveness of each approach, the estimated quality of life...

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