In addition for the factors that would allow a device

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In addition for the factors that would allow a device to fall under the category of “regularly available,” the IRS factors for determining whether a device is designed primarily for use in a medical institution or office or by a medical professional include: 1. Whether the device generally must be implanted, inserted, operated, or otherwise administered by a medical professional;
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2. Whether the cost to acquire, maintain, and/or use the device requires a large initial investment and/or ongoing expenditure that is not affordable for the average individual consumer; 4. Whether the device is a Class III device under the FDA system of classification; 5. Whether the device is classified by the FDA under certain regulations (see p. 45) 6. Whether the device qualifies as durable medical equipment, prosthetics, orthotics, and supplies for which payment is available exclusively on a rental basis under the Medicare Part B payment rules, and is an “item requiring frequent and substantial servicing” as defined in 42 CFR 414.222. Those companies that will be subject to the medical device excise tax will be required to fill out Form 720, Quarterly Federal Excise Tax Return, and pay the IRS. Form 720 is filed with the IRS quarterly, and the first return to report the medical device excise tax will be due by April 30, 2013, for the quarterly period including January, February, and March 2013. Manufacturers and importers must, however, make semi-monthly deposits where the tax liability exceeds US $2,500 for the quarter (www.irs.gov). Opponents of this provision are specifically unhappy at what they say would be a devastating effect to innovation, patient care, and job creation. Forbes predicts that with more money going towards the tax, companies will have less money to invest in research and development. Also, because of the tax, medical device manufacturer companies may be forced to raise the prices of their product resulting in less demand for their products and eventually cause the companies to let some employees go in order to keep up with rising costs and loss of sales (www.forbes.com). Roth Capital has released a report after a study conducted to see what effect the device tax would have on the medical device industry and also the United States economy.
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What Roth did was ask companies how they plan to manage through the new tax. The report determined that over 80% would either cut jobs or forego new hires. The report also said that more than 75% would either cut or forego new R&D projects as a result of the tax. The report also found that 85% of companies would be expanding overseas taking jobs away from Americans (www.policymed.com). Starting in the year 2014, a provision of the Affordable Care Act that will take effect is the Health Insurance Premium Tax Credit. This tax credit is aimed at helping families and individuals afford insurance coverage purchased through an Affordable Insurance Exchange (www.irs.gov). The Congressional Budget Office estimates that once the provisions of the
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