Industry officials, including leadership at the Advanced Medical Technology Association, are calling on FDA and CMS to improve coordination to prevent mixed messaging as part of the competitive bidding process, with FDA recently acknowledging divergent focuses from the two agencies, according to informed industry sources. The disconnect — with CMS and health reformers focusing on lowest prices of products, and FDA stressing more support services — leads to planning confusion for manufacturers of sophisticated therapy products for the home, sources said.

Manufacturers don’t know whether to develop lowest cost products to win CMS competitions or to strive to meet FDA standards for product support.

CMS’ competitive bidding process, started two years ago, is seen by some in the industry as squarely looking at the price of products, while FDA is focused on the safety and effectiveness of those devices, thus requiring a higher level of service than the bids permit, sources said.

FDA is about to publish guidelines on the safe and effective use of complex products to be used in the home as part of its medical device Home Use Initiative, under which the agency is zeroing in on developing safe-use education and oversight over complex home devices like negative pressure wound therapy devices, ventilators and dialysis machines (see FDA Week, April 23). But the guidelines’ effectiveness is contingent on how well the two agencies communicate, sources said.

The competitive bid process “is focused on products, and FDA is focused on the support of those products,” a source said. “That’s where the disconnect is. … These things are both evolving and at some point, CMS and FDA will need to come together to close these disconnects. They’re just developing products that aren’t aligned right now.”

The migration of sophisticated products into the home is broadly seen as appropriate because it gets patients out of the hospital quicker, improves patients’ quality of life and lowers the cost of care with a decreased reliance on higher-priced hospital settings. FDA, however, has four concerns about the technologies originally designed for the institutional setting being moved into the home.

The first concern is FDA’s responsibility over clearance of the products in the home. When it comes to clearing a product from this group of complex therapeutic devices, FDA sees it as important to clear products that have been designed specifically for the home. A product designed for the hospital setting may be designed with more complexity than could be easily adapted to the home, and FDA worries that the products must be designed simpler for patients and families to deal with them.

“That’s the main concern, that products being used in the home are being designed for the home, to meet the simpler needs for non-professional caregivers,” the source said. “That’s clearly an FDA manufacturer responsibility.”

Secondly, FDA is focused on labeling, given that products like negative pressure wound therapy pumps can be used for many wound types. The labels therefore must be simple enough where patients and families can understand them, which is another FDA responsibility.

But the third concern, training of clinical caregivers or patients’ families for the home-use products, is not a responsibility of FDA, and frequently not even a responsibility of the manufacturers. The suppliers who provide the products to the home are largely given this training role, and thus it drifts from FDA’s oversight and more toward CMS’ supervision.

And the fourth area, the 24/7 customer support — including tracking and monitoring to make sure products are working as intended — is more of a shared responsibility. Usually, a serious problem is reported to FDA, but the service of providing customer support is usually a supplier responsibility and thus more of a CMS responsibility, sources said.

“If you have a simple product like a walker or a cane, three or four are not as important, but in sophisticated categories that training and education support are incredibly important,” an industry source said. “What we’re hoping for, and what FDA is hoping will happen, is that CMS will acknowledge you can’t competitively bid a walker the same way you competitively bid a complex piece of therapeutic equipment.”

Industry leaders and FDA are hoping that the agency’s home-use guidelines will force CMS to require supplier quality standards to make sure training and patient support is provided as part of competitive bids for sophisticated equipment.

“We are hoping that [the guidelines] will lead to a collaborative discussion with CMS about what kinds of requirements need to be imposed on the suppliers of those complex pieces of equipment if those products are competitively bid,” the source said. “Industry is now trying to connect the dots between FDA’s conclusions based on their experiences and what’s happening with CMS, where competitive bidding is taking place.”

The most effective way to fix the problem would be for FDA to convince CMS to subdivide the products that are being competitively bid, and to put an extra layer of supplier requirements for those complex pieces of equipment in the bid process, sources agreed.

There needs to be far more inter-agency communication to prevent the fissure from continuing, said Cathy Burzik, president of Kinetic Concepts Inc., and a member of AdvaMed’s board of directors.

“CMS is driving the lowest price, to where lowest price bidders wins, and FDA is saying, ‘no, wait a minute, it needs to be high quality,” Burzik told FDA Week. “I think there needs to be way more interaction and collaboration here so that the situation gets corrected for manufacturers and patients.”

First-time bidders for these complex home-use categories should be required to present a business plan that includes training and patient support, sources said. That would create service standards for that category of products, which would itself be a step forward given that standards for negative pressure wound therapy products do not exist.

FDA is being “very consistent” with this request, but industry is “encouraging them to work collaboratively” with manufacturer, supplier and the clinical communities to figure out how to address its four home-use requirements, a source said.

Leadership is also required from HHS at this point to help guide CMS to write standards to have suppliers bidding in these categories to commit to training and support, the source said.

“It would be easy for the secretary to tell CMS that the post-market folks at FDA have raised some concerns about these complex products used in home, and since you are setting up the bid program for these products, we think the two agencies need to talk to make sure all those concerns are addressed,” the source said.

Industry is upbeat on CMS filling this void thanks in large part to FDA’s home-use initiative work. In the past, CMS has said they understand the problem, and yet they did not produce the standards, said an industry source who met with CMS.

“But now my level of optimism has gone up, now that FDA has identified these as significant issues,” the source said. “We’re going to circle back again with CMS, now that FDA is raising the same concerns. It’s another validation that we need a new way to evaluate bids.” — Seth Freedland (sfreedland@iwpnews.com