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The Health Information Trust Alliance (HITRUST) is a not-for-profit organization that was established to improve the security and confidentiality of health related information. Working with healthcare, technology, and information security leaders, HITRUST established the HITRUST Common Security Framework (CSF), a certifiable framework that all healthcare organizations can implement. It is intended for any organizations that create, access, store, or exchange health information. By implementing the CSF, organizations can also better manage risks and compliance issues associated with health information.

 

The foundation of all HITRUST programs and services is the HITRUST Common Security Framework (CSF), a certifiable controls framework that provides organizations with the needed structure, detail and clarity relating to information security tailored to the healthcare industry. The HITRUST CSF Assurance Program provides compliance assessment and reporting for HIPAA, HITECH, and other healthcare regulatory compliance requirements by leveraging the CSF. The program includes the risk management oversight and assessment methodology governed by HITRUST and is designed for the unique regulatory and business needs of the healthcare industry.

 

CSF Assessors are those organizations that have been approved by HITRUST for performing assessment and services associated with the CSF Assurance Program and the Common Security Framework (CSF). CSF Assessors are critical to HITRUST's efforts to provide trained resources to healthcare organizations of varying size and complexity to assess compliance with security control requirements and document corrective action plans that align with the CSF.

 

As of August 2012, UHY LLP is one of only 15 nationally recognized CSF Assessors qualified to provide assessment and other services associated with the CSF Assurance Program.  UHY is the ONLY firm that can provide HITRUST in conjunction with SOC (formerly SAS 70) attestation and PCI-DSS (payment card) assessments.   Our team of experts are fully qualified to assist with other types of HIPAA initiatives, including security and privacy strategy, HIPAA risk assessments, and HIPAA compliance attestation.

 

For more information on this topic please contact a member of our health care team  in Farmington Hills (248) 355-1040 or Sterling Heights (586) 254-1040 or visit us on the Web at uhy-us.com.

 

A "taxable medical device" is any device defined in Section 201(h) of the Federal Food, Drug & Cosmetic Act (FFDCA) that is intended for humans. The FFDCA generally defines the term "device" as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, that is recognized in the official National Formulary or the United States Pharmacopeia, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease; or intended to affect the structure or any function of the body and does not achieve its primary intended purpose by being metabolized or by chemical action within or on the body. This excludes eyeglasses, contact lenses, hearing aids, or any other medical device determined to be generally purchased by the general public at retail for individual use. Export sales and sales for further manufacture are also exempt.

 

Although this may sound straight-forward, many complications remain with the hope that IRS regulations will soon clarify. These areas include devices that have medical and non-medical uses, veterinary devices which are also used on humans, devices for retail sale and sold within the healthcare industry, research use devices, limited use investigational devices, devices sold in part to other manufacturers as well as individually, and medical devices used as demonstration products.

 

The taxable event occurs when title to the taxable article passes from the manufacturer to a purchaser. The taxable sale price of a taxable device also includes any charge for coverings or containers and any charge to placing the article in a condition to be packed and ready for shipment. Items such as transportation, installation and insurance are exempt.

 

Opponents of the medical device excise tax feel this onerous tax will hurt innovation, harm patient care and weaken the position of the United States as the global leader in medical device innovation.

 

Filing and Payment

 

Filing requirements are fulfilled by completing and filing Form 720 Quarterly Federal Excise Tax Return. The due dates are as follows:

 

 

Generally, semi-monthly deposits are required for the first 15 days of the month and for the 16^th through the last day of the month, deposits should routinely be made through the Electronic Federal Tax Payment System (EFTPS). Under the regular method, deposits are due roughly 14 days after the semi-monthly deposit dates.

 

While the pressure for legislative relief continues to circulate, it would be prudent to assume the tax will apply at the start of the new year. If a company mistakenly pays excise tax on devices not subject to the tax, a procedure exists to claim a refund.

For more information on this topic please contact a member of our health care team  in Farmington Hills (248) 355-1040 or Sterling Heights (586) 254-1040 or visit us on the Web at uhy-us.com.