“The repeal of the medical device tax is our number one priority for 2015. We are really hoping this is the year we see it repealed.”

So said Gail Rodriguez, executive director of the Medical Imaging & Technology Alliance, in a conversation with imagingBiz spurred by MITA’s hiring of a new policy director—Peter Weems, formerly with the healthcare financial consultancy van der Walde & Co. Our questions are in bold, her responses in plain text.

Aside from working for the repeal of the much-discussed tax, which we’ll get to, what else is high-priority for you heading into the new year?

If we were to describe our priorities for 2015, we could probably sum it up as making sure patients have access to technologies. Patient access has always been a concern. This year we’re getting at that both through Medicare coverage decisions and Medicare payment policies. So our priorities from the patient access perspective are fostering and providing the right evidence, making sure that CMS is publishing coverage decisions that improve access for beneficiaries.

At this point, there are three disease states that are undergoing coverage review. One of them is low-dose CT scanning for patients at high risk for lung cancer. We just received a conditional but positive coverage decision toward the end of 2014. Obviously, the devil now is in the details and we need to get clear on how the decision will be implemented, but it was a positive coverage decision. What it means for folks who are at risk for lung cancer, smokers and former smokers, is that up to 20,000 lives could be saved every year if they get this annual low-dose CT (LDCT) screening. That was a critically important decision, not only in terms of saving lives but also in terms of cost-effectiveness. Not only has this screening been shown to save lives, it’s also been shown to save money.

Is it your sense that the LDCT decision could be a signpost of positive things to come from CMS on pending coverage decisions?

No, I would never go that far. It’s really hard to get positive coverage decisions from Medicare. The evidentiary requirements are robust, and sometimes they seem to shift a little bit within CMS. So that’s another big priority for us here—trying to get clarity and trying to get CMS to identify a more standardized set of evidentiary requirements for coverage decisions.

One of the big bottlenecks for patient access is the changing goalposts on coverage decisions. So at the same time we’re applauding CMS for a positive but conditioned coverage decision for lung cancer screening, we also recognize that the target could move for different modalities.

For example, PET imaging for Alzheimer’s disease has received a decision for coverage with evidence development, and yet it’s not at all clear what those evidentiary requirements are going to be. They sometimes start to sound an awful lot like a randomized clinical trial, which, obviously, is not a coverage decision at all. And so that’s a much more constrained coverage decision that we’re trying to work through now.

Then there’s colon cancer, where CT colonography is just as sensitive as colonoscopy. That has really important ramifications for public health because it’s cheaper. If it’s just as effective, it should be more cost-effective for CMS, and it should increase screening rates as well, which is also a priority—to make sure that more patients are getting the screening they’re supposed to get.

What strikes you as a most challenging item on your to do list? Asked another way, what do you expect to have to fight hardest for?

The evidentiary requirements, and consistency among them, that’s a big deal. The device tax is a 3-year-old issue. We don’t expect it to be easy. We do expect that, with a Republican Congress, we do have a good shot at it this year. And it needs to happen. This is one of those issues that’s costing jobs and hurting innovation, so it needs to happen this year.

Also, MITA is a standards developing organization. We are an ANSI-accredited SDO, and in 2015 we’ll see an additional emphasis on writing safety standards and quality standards to protect patients, particularly in the radiation dose area—particularly driving the utilization of dose reduction, dose management and dose reporting technologies. What we’ve learned is that we can put those technologies out there, but we’re not always seeing them used among healthcare providers. So that’s a big priority for us this year as well, writing these standards and then pressing for their adoption.

Getting back to the device tax, a few days ago a USA Today editorial cited a Congressional Research Service study that found the tax would have minimal effect on sales and jobs. I’m guessing you have a counter opinion to that.

The category of medical devices comprises a lot of different things. Hips and knees are different from diagnostic imaging equipment. So I would counter that sales in advanced diagnostic imaging have been flat for several years now. To put a tax in place that is basically an excise tax on an industry that is already hurting can’t help but result in job loss. All of the big companies have admitted that there are costs to this, and 2.3% off the revenue line is a big number. It’s an especially big number for some of the smaller to medium size enterprises. The money has to come from somewhere, and in an economy that’s still recovering from the recession, that has already had cuts in reimbursements for 13 procedures in the last six years—it’s just kind of a series of dampening affects. And dampening is probably an understatement.

This is an industry we need to grow. Patients need access, and we’re bringing a lot more patients into the system. And for lifesaving technologies [such as those used in] screening studies, as we discussed earlier—lung cancer, Alzheimer’s, colon cancer, the big killers—to inflict this sort of damage through a tax on a really important industry can’t help but result in job losses. I don’t have a number per company what that might be, but I can tell you that all the [medical device] companies are feeling it and most are on record as saying there will be job cuts. Also, I don’t know whom was interviewed for the CRS study; I would need to know a little bit more about it before I could speak to the quality of their evidence.

Is there anything else on the horizon for MITA, in 2015 or beyond, that you’d like to speak to?

We hit most of the big high points—access to these technologies, a repeal of the medical device tax, and then a strong emphasis on the use of standards for safety and quality purposes. And also the use of standards in regulatory schemes as well. I believe we’ll see in coming years a much stronger emphasis among regulators on the importance of standards.

And you feel your outlook for reaching your goals is a little better with, frankly, the political party that tends to be particularly supportive of tax cuts now in control of both chambers of Congress. Yes?

Sure, but we’ve had really good bipartisan support. In the FY 2014 budget resolution, there was an amendment for repeal of the device tax. That passed 79 to 20, and gave evidence that this is not just a Republican issue anymore—we had 33 Democrats. The House bill to repeal the tax had 46 Democrats. So it’s become a really bipartisan issue, and we hope that number is going to grow.

Editor’s note: The final response was jointly answered by Rodriguez and Andy Dhokai, MITA’s director of government relations.