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Previously, the applicant had to send the entire source code of the software; now, the BPTO requires only a hash digital summary of its most relevant and important parts in order to identify the computer program.

The new electronic process basically consists of the issuance of an Official Tax Receipt (“GRU” – the Guia de Recolhimento da União, is a document that was established by the Brazilian Treasury Department and used in order to make payments to organizations, funds, governmental bodies, foundations and other entities) that will generate a Declaration of Veracity.

This LCD addresses only the medical necessity of ESAs for conditions other than those included in CMS policies.. 100-04, Chapter 8, Section 60, for specifics related to use for patients on dialysis.

The services subject to this policy are those billed with an “-EC” modifier.

Maintenance of secrecy is solely the responsibility of the applicant.

Previously, such secrecy needed to be updated every 10 years.

Therefore, a technical expert can prove there was no modification in the document, since it was turned from source code into hash.At the time of registration, the applicant may also request before the BPTO that the software be filed under secrecy.In such a case, the documentation filed at the Office cannot be disclosed, except if requested either by a court or by the registrant itself.Physical Abuse, Sexual Abuse, Emotional Abuse and Neglect are all categories of Significant Harm.Harm is defined as the ill treatment or impairment of health and development.

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