As we work with moms to try to navigate the insurance process to get a breast pump, one question comes up over and over. Why are some moms receiving a double electric pump from their insurance company while other insurance companies are only offering a manual pump? We asked our CEO, Decky Goodrich, to explain:
The problem has multiple layers. First, the Affordable Care Act language isn’t specific enough about what exactly insurance companies need to cover and how the breast pumps would be covered and fulfilled. That’s because the system of medical device approval isn’t all inclusive. If medical devices were treated like pharmaceuticals, the vague wording in the ACA would have been enough to assure a quality efficacious product.
Medical devices, such as breast pumps, are classified by the FDA as either 510(k) approved for marketing or 510(k) exempt. The process for 510(k) clearance is very technical and complicated, but it basically requires the manufacturer of the device to show that the device seeking approval is substantially equivalent in safety and effectiveness to another lawfully marketed device. In short, a breast pump that has the 510(k) approval has met minimum standards set by other predicate devices (but does not assure quality). 510(k) exempt devices are not reviewed by the FDA and have no performance or predicate device requirement.
Had the Affordable Care Act at least required a 510(k) device which supports double pumping, this would have closed the door to allowing insurance companies to offer a 510(k) exempt product like a hand pump, which has no effectiveness standard at all.
How did this contribute to the pump shortage?
The vague wording leaves the insurance companies to determine what they will provide to their members. Because each insurance company was free to decide what their interpretation of the standard was, the DME providers were not sure what was going to be covered by each company, so they couldn’t forecast what would be needed.
The ACA went into effect on August 1st, 2012, but only for plans that renewed after that date. Because so many plans renewed on January 1st, and no information was available on what those plans were going to cover before that date, DMEs couldn’t predict the market. So, when the DMEs couldn’t predict the market they couldn’t communicate any future needs to the manufacturers. DMEs cannot legally bill an insurance company until they deliver a product or service to the mom, so on January 1st, total chaos erupted.
Aside from the obvious shortage and difficulty placing orders, how does this affect moms?
When a mom needs a pump to initiate or maintain supply, and she can’t get one, she has few options. She can spend the money out of pocket, even though she’s entitled to a pump at no cost to her, or she can wait and risk losing her milk supply. You can imagine how stressful this is. Many moms knew a pump would be covered and trusted the system. When you have a baby, you don’t typically have a lot of extra money. Many moms are taking time off work at less than their normal wage and there are a lot of other expenses.
A good quality double electric breast pump is not a luxury item for most moms. Whether you are returning to work or have a baby in the NICU or have a medical condition that requires the use of a breast pump, you need to pump milk to give to your baby. What’s your other option? In addition to the shortage of breast pumps in the DME market, from our conversations with moms, we’ve seen that it’s become harder to almost impossible to get a pump from some insurance plans even when you are proving medical necessity.
If this continues, breastfeeding rates will decrease and moms who can’t afford to purchase a breast pump out of pocket will be forced to use formula. The saddest part of all this is that most of these moms are determined to breastfeed. Breast milk has been proven to be healthier for both the baby and the mom, so the preventative care side of what the Affordable Care Act was supposed to help is being totally derailed. We’ve worked so hard to promote breastfeeding that it’s heartbreaking to see this situation impact breastfeeding so negatively.
What do you think would fix this problem?
In the short term, insurance companies could allow moms to purchase pumps directly from the retailer of their choice and reimburse them while the supply issues at the DMEs get worked out. Moms with a medical necessity for a breast pump should be provided with a way to get a good quality double electric breast pump immediately.
In the long term, the system of determining what pumps are sufficient for a mom’s needs and how to provide those pumps efficiently will have to be overhauled.