Industry leaders speculate about the financial impact of the
The medical device tax embedded in the
Patient Protection and Affordable Care Act (PPACA) that was
signed into law in March imposes a 2.3% excise tax on the sale and import of
Class I, II and III medical devices, beginning in 2013. The vast majority of
O&P products, as well as durable medical equipment, are considered Class I
devices. Medical device manufacturers and O&P industry leaders will be
tracking the development and implementation of this tax closely through the
legislative or regulatory processess before its 2013 implementation, according
to the National Association for the Advancement of Orthotics and Prosthetics
Last minute changes
medical device tax was limited to Class II and III medical
devices. These devices include implanted devices, such as hip replacements,
stents and pacemakers. Congress instituted a 2.9% tax on the sale and import of
those medical devices, raising $40 billion in 10 years. But industry pressure
later convinced Congress to reduce the impact of the tax to $20 billion over
Once we saw the first draft of the legislation, our members and
stakeholders in the medical device community reached out to elected officials
to tell them the impact that it would have on one of the only industries that
reduces the costs of health care and that still creates good jobs in this
economy, Mark Leahey, president and chief executive officer of Medical
Device Manufacturers Association (MDMA) said. While we appreciated the
$20 billion reduction and the efforts of congress who advocated for this, more
According to NAAOP, the original Senate bill was repealed and replaced
with a different tax of smaller magnitude during the reconciliation process,
known as the Health Care and Education Reconciliation Act (HCERA). The HCERA
compromise slashed the tax from 2.9% to 2.3%, in order to reduce the impact on
medical device manufacturers, but in order to continue to raise $20 billion in
revenue, the tax was expanded to include Class I medical devices. Although the
tax rate was cut, it now touches nearly all medical devices.
I think the original intent was to tax the large companies that
manufacture MRI machines, imaging equipment and other medical devices used in
hospitals and health offices across the country, Peter Thomas, JD general
counsel for the NAAOP, explained. But when they extended the tax to Class
I, they really opened the door. When they included Class I, they covered most
Legislators left a small window for medical device manufacturers and the
O&P industry. According to the HCERA, exclusions from the tax include:
eyeglasses, contact lenses, hearing aids and any other medical device
determined by the [Department of Health and Human Services] Secretary to be of
a type that is generally purchased by the general public at retail for
Every part of that last definition is important, Thomas
explained. Clearly, all of O&P is for individual use, arguably it is
at retail, depending on the definition of retail. The other issue is whether
O&P services and devices are generally available to the public.
O&P tends to be available to a subset of the general public that requires
use of these devices. We will be closely monitoring and trying to impact how
that definition ultimately impacts O&P.
Brian Gustin, CP, president of Forensic Prosthetics and Orthotics,
explained that because of the billions of dollars the health care bill intends
to cut, the O&P industry will no longer be excluded from similar tax
Unfortunately, I do not think there will be any legislative
process to exempt O&P because the government will not play favorites and
leave certain industries out, Gustin said. Quite frankly, O&P
is too small of a market for a legislator to fall on a sword for.
Providers pay heavy price
Although the health care debate that raged for more than a year has
simmered, questions regarding the 2,700 page bill remain. New and raised taxes
usually spell trouble for the consumer. The manufacturer sells a product to a
company at a higher price and the company charges the public more. The consumer
loses in the end.
Regarding the medical device tax, due to fee schedules, the end
users price is already set and can not be raised. Therefore, who will be
impacted from this tax?
Who this tax should really make nervous are the individual
providers who are going to be purchasing those devices, Gustin said.
Ultimately, the tax gets passed down to the consumer, but in this case,
the provider is the consumer, not necessarily the patient.
According to Gustin and Thomas, it is unlikely that medical device
manufacturers will simply absorb the tax. They wholeheartedly expect
manufacturers to pass that tax downstream to the provider by raising their
prices. Health care providers and O&P practitioners may be the ones forced
to absorb the tax.
The legislative route is a risky move for the O&P industry.
According to Thomas, the O&P community could band together with various
other groups and argue that they should be exempt or that any company with less
than a certain amount of revenue should be excluded. If they succeed and are
exempt, Thomas explained, the O&P industry could open itself up to
alternative tax provisions.
The question becomes if we are exempt from this tax, might there
be a risk of then being taxed as a regular retail sale, which has never applied
to O&P? Thomas asked.
How providers can prepare
According to Gustin, providers should reduce their costs in order to
offset the potential rise in price for medical devices. Providers should look
at their processes closely during everyday operations and ask themselves a
simple question why do we do this?
Does this process add value to the company? Gustin asked.
If it does not, my advice is to change it or eliminate it because it is
going to be tougher and tougher to remain viable when all of health care is
being asked to cut billions of dollars every year for 10 years.
Gustin dismissed the notion that the health care bill will provide more
customers for the O&P and thus offset any loss from raised taxes.
O&P insiders seem to believe the fallacy of volume,
Gustin explained. The fact of the matter is if you are selling something
at a loss, selling more of it does not make up for that loss, you actually get
a bigger loss.
Concerns for manufacturers
David Nexon, senior vice president of Advanced Medical Technology
Association (AdvaMed), said there is concern within the industry about the
impact of the medical device tax.
We will be looking at ways we can mitigate the impact of the
tax, Nexon explained. We will be working with the treasury
department and we will be keeping an eye on what is happening legislatively.
Any prudent sense tells you to start planning now, even though this tax will
not be applied until 2013.
However, a legislative appeal would require Congress to offset the cost
of the provision, thereby raising $20 billion in revenue in some other way.
This tax could mean layoffs, reduction in pay, pay freezes, or
reductions in cost structure, which would likely include the research and
development department, Nexon said.
The tax may force medical device companies to cut their budgets in the
short term in order to remain viable, according to Leahey.
Every poll and study that we have seen shows that companies will
cut back research and development, eliminate jobs and in extreme situations, go
out of business, Leahey said. Unfortunately, the tax is on gross
sales, regardless of whether or not your company is profitable. As a result,
this tax could prove to be a fatal blow to small and mid-sized companies that
are just beginning to grow.
Nexon agrees with Leaheys assessment.
If you are a new medical device company with less than 100
employees, you are just ramping up with little to no profits anyway,
Nexon explained. Trying to come up with additional 2.3% of revenue is a
Proponents of the tax argue that the bill would create approximately 30
million potential customers, therefore offsetting any potential budget
concerns. However, for many medical device manufacturers, this is not the case.
Most of our companys products are used in the acute care
setting, which all Americans, whether insured or not, have access to,
Leahey said. We do not anticipate any increase in sales once this bill is
The bottom line is that a tax on medical devices is not going to go
away. Even if this particular medical device tax is repealed, it will be
replaced with a new provision.
This thing is not over by any means, but at some point, something
has to give, Thomas said. They have to fund the expansion of health
care coverage somehow, unless Congress and the President essentially reverse
course on health care reform. by Anthony Calabro
The medical device tax is yet another bullet for the O&P community.
The provider, not the patient, will be asked to take the hit on this one. If
you add this to a long list of other hits, one begins to ask the question,
How much more can I take?
When this happens, usually the provider, patient and industry begin to
crumble due to lack of quality in service. You get what you pay for and if you
are not getting paid, the service will ultimately reflect that.
However, I still have hope that in the end our value to health care will
prevail. But in order for this to happen, we must educate our legislators and
work together as a team to address these various challenges. If suppliers,
providers and authorizing parties do not work together, this just might be the
Chief executive officer,
Snell Prosthetic and Orthotic Lab