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9009 - Imposition of Annual Fee on Medical Device Manufacturers and Importers

 
Implementation Status 
Statutory Text 

Summary

Repealed and replaced by section 1405 of HCERA, summarized here. Imposes an excise tax of 2.3 percent on sales price of medical devices by manufacturers, producers or importers. Applies to devices defined in section 201(h) of the Federal Food, Drug and Cosmetic Act intended for humans; exempts eyeglasses, contact lenses, hearing aids and other devices determined by HHS to be generally purchased by the general public at retail for individual use. Stipulates that selected manufacturers’ excise tax exemptions specified at Internal Revenue Code section 4221(a) and section 6416(b)(2) shall not apply while leaving others – e.g., for tax-free sales for further manufacture or export under 4221(a) – intact. Applicable to sales after December 31, 2012.

#Durable Medical Equipment, #Medical Devices, #Tax

Implementation Status

 
Summary 
Statutory Text 

On December 7, 2012, the IRS published a final rule implementing the medical device tax for CY 2013. The IRS also released Notice 2012-77 providing interim guidance on several related issues not addressed in the final regulations, including the determination of sales price, the tax treatment of medical software licenses, the taxability of donated medical devices and the taxability of medical convenience kits.  The IRS also has FAQs regarding the tax and a homepage with general information on this provision.

On August 19, the Treasury’s Inspector General for Tax Administration released a report, “The ACA: An Improved Strategy Is Needed to Ensure Accurate Reporting and Payment of the Medical Device Excise Tax” (available here). The report finds that medical device tax collections are below original IRS estimates and provides recommendations to strengthen IRS administration of the tax.

On Jan. 6, Rep. Paulsen (R-MN) reintroduced legislation to repeal the ACA medical device tax. On Jan. 13, 2015, Sens. Hatch (R-UT) and Klobuchar (D-MN) reintroduced device tax repeal legislation. Also that day, the Congressional Research Service issued a report on the tax’s impact on research and jobs suggesting a “modest effect” (e.g., reported here).

On Apr. 23, the Senate Finance Subcommittee on Health convened a hearing to discuss the impact of the medical device tax on the industry, U.S. healthcare system and patient outcomes.

On June 2, the House Ways and Means Committee marked up and advanced H.R. 160 to repeal the ACA’s medical device tax. On June 5, CBO estimated that H.R. 160 would cost $24.4 billion over the next 10 years. On June 15, the White House threatened a veto of the House legislation (H.R. 160). On June 18, the House passed H.R. 160 (280-140).

On July 30, GAO released an analysis of 102 companies finding that average net sales and profits increased by 4% annually between 2005 and 2014, capturing a period before and after broader ACA and device tax implementation. GAO says the “analysis does not infer a causal relationship between these provisions and changes in companies’ net sales or profits, because any changes could be due to other factors, such as mergers and acquisitions, the introduction of new products, and product recalls.

On Dec. 18, President Obama signed the Consolidated Appropriations Act, 2016, which includes a two-year delay of the ACA Cadillac tax, as well as a two-year suspension of the ACA medical device tax and one-year suspension of the health insurer tax. Also see these updates reflected on the IRS’ ACA tax page.

2017

On Jan. 23, 2017, President Trump signed an executive order on minimizing the burdens of the ACA that alluded to using regulatory authority to “waive, defer, grant exemptions from, or delay the implementation of any provision or requirement of the Act that would impose a fiscal burden on any State or a cost, fee, tax, penalty, or regulatory burden on individuals, families, healthcare providers, health insurers, patients, recipients of healthcare services, purchasers of health insurance, or makers of medical devices, products, or medications.”

2018

On Jan. 22, a continuing resolution funding the government through Feb. 8 further suspended the Affordable Care Act device tax in 2018 and 2019, the insurer tax in 2019, and Cadillac tax through 2021.

2019

On December 20, 2019, President Trump signed the Consolidated Appropriations Act, 2020 (available here), which permanently repeals the ACA health insurer tax, medical device tax, and Cadillac tax.

Statutory Text

 
Implementation Status 
Summary 

SEC. 9009. IMPOSITION OF ANNUAL FEE ON MEDICAL DEVICE MANUFACTURERS
AND IMPORTERS REPEALED AND REPLACED.
øRepealed by section 1405(d) of HCERA, without redesignation
of succeeding sections; previously amended by section 10904(a) of
PPACA. Note section 1405(a)-(c) of HCERA amended the IRC to
provide an excise tax on medical device manufacturers, as follows:¿
(a) ƒSec. 1405(a) of HCERA≈ In General.— Chapter 32 of the
Internal Revenue Code of 1986 is amended—
(1) by inserting after subchapter D the following new subchapter:
‘‘Subchapter E—Medical Devices
‘‘Sec. 4191. Medical devices.
‘‘SEC. 4191. MEDICAL DEVICES.
‘‘(a) IN GENERAL.—There is hereby imposed on the sale of any
taxable medical device by the manufacturer, producer, or importer
a tax equal to 2.3 percent of the price for which so sold.
‘‘(b) TAXABLE MEDICAL DEVICE.—For purposes of this section—
‘‘(1) IN GENERAL.—The term ‘taxable medical device’ means
any device (as defined in section 201(h) of the Federal Food,
Drug, and Cosmetic Act) intended for humans.
‘‘(2) EXEMPTIONS.—Such term shall not include—
‘‘(A) eyeglasses,
‘‘(B) contact lenses,
‘‘(C) hearing aids, and
‘‘(D) any other medical device determined by the Secretary
to be of a type which is generally purchased by the
general public at retail for individual use.’’, and
(2) by inserting after the item relating to subchapter D in
the table of subchapters for such chapter the following new
item:
‘‘SUBCHAPTER E. MEDICAL DEVICES’’.
(1) Section 4221(a) of the Internal Revenue Code of 1986 is
amended by adding at the end the following new sentence: ‘‘In
the case of the tax imposed by section 4191, paragraphs (3), (4),
(5), and (6) shall not apply.’’.
(2) Section 6416(b)(2) of such Code is amended by adding
at the end the following: ‘‘In the case of the tax imposed by section
4191, subparagraphs (B), (C), (D), and (E) shall not
apply.’’.
(c) ƒSec. 1405(c) of HCERA:≈ Effective Date.—The amendments
made by this section shall apply to sales after December 31, 2012.
(b) ƒSec. 1405(b) of HCERA:≈ Certain Exemptions Not to
Apply.—
VerDate

Browse ACA Titles

  • I-Quality, Affordable Health Care for all Americans
  • II-Role of Public Programs
  • III-Improving the Quality and Efficiency of Health Care
  • IV-Prevention of Chronic Disease and Improving Public Health
  • V-Health Care Workforce
  • VI-Transparency and Program Integrity
  • VII-Improving Access to Innovative Medical Therapies
  • VIII-Community Living Assistance Services and Supports (CLASS ACT)
  • IX-Revenue Provisions

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