IUD funding tests positive for more coverage

The Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) is breaking down financial barriers to birth control, at least when it comes to making long-acting reversible methods such as intrauterine devices (IUDs) accessible and affordable. A new study by the Guttmacher Institute, published in the journal “Contraception,” found that, of the 39 million women at risk for unintended pregnancies, 90 percent of them use contraception, and the number of them who now have access to affordable contraception has substantially increased since the passage of the ACA. Although coverage has expanded significantly, the study also found that cost factors still stand in the way of getting the patients the most appropriate form of birth control for them.

ACA requirements

A provision of the ACA requires that patients have the ability to obtain contraception coverage without out-of-pocket expenses. This requirement started being phased in during August 2012, and took effect for many health insurance plans in January 2013. Not all entities have to provide this coverage, as some grandfathered insurance plans remain, as well as religious-based organizations that do not have to provide coverage for their employees.

Study parameters

Researchers reviewed administrative data for 417,221 women whose physicians queried their insurance plans between January 2012 and March 2014 to determine whether they had coverage for a hormonal IUD and the extent of that coverage. The researchers found that in January 2012, 58 percent of women would have incurred out-of-pocket costs for an IUD, compared to only 13 percent of women in March 2014. The study found that differentials by age and region dissolved over the time period of the study, which, they believe, suggests that the ACA successfully reduced inequality among insured women.

Study findings

The study found that 87 percent of insured women would not have had to pay out of pocket for a hormonal IUD by the spring of 2014, a substantial increase from the 42 percent of women who would not have had to pay out of pocket before the implementation of the ACA provision in 2012. This increase occurred across all age groups and regions of the country.

IUD expenses are not totally covered, the study noted, as many of the associated expenses are not covered, such as visits for insertion and removal.

“This study adds to the growing body of evidence on the ACA’s impact on women’s contraceptive access,” said Megan Kavanaugh, a Senior Research Scientist at the Guttmacher Institute and one of the authors of the article. “Women seeking a hormonal IUD—one of the most effective forms of contraception available—may be dissuaded from obtaining one because of high out-of-pocket costs. As this study documents, the ACA is making these more expensive methods a realistic option for many women. More women can now choose a birth control method based on what works best for them as opposed to what they can afford.”


Researchers also noted that, because they analyzed private insurance queries, as opposed to the number of patients actually requesting the IUD or individuals for whom the IUD would be the best form of coverage, the study had some limitations. The actual number of all IUD inquiries could not be tabulated. This is because doctors would have known the public coverage parameters without having to inquire, and the inquiries were the basis of the study. Additionally, the study also indicated that13 percent of the women studied in March 2014 continued to face out-of-pocket costs to obtain a hormonal IUD, at least among privately insured individuals. Even so, the data suggest that the ACA has made tremendous advances in making this type of contraception more affordable.

A device for devices: Developing a national medical device surveillance system

A nationwide medical device surveillance system would be most effective if developed from existing health information systems, data registries, and health records, according to the recommendations of the Medical Device Registries Task Force (MDRTF), in a August 24, 2015 report. The MDRTF was tasked with identifying objectives, operations and architecture for such a national medical device surveillance system. The MDRTF report, which contains the task force’s recommendations for that national system, acknowledged that the task force did not recommend a de novo system, but instead, one that takes advantage of extant data systems to develop a nationwide network. The MDRTF report explained the importance using alongside existing systems and infrastructure to reach a public domain with an important data store of medical device information.


An article published in the Journal of the American Medical Association (JAMA), addressed the MDRTF’s recommendations and outlined the specific goals of the hypothetical network:

  • provide continuously updated benefit/risk and safety data on priority medical devices;
  • provide customized analyses supporting both regulatory and other key stakeholder decisions;
  • integrate broad electronic patient access infrastructure with implementation of standardized data elements and dictionaries, moving currently heterogeneous data into more structured domains reflecting the multidimensional aspects of device use, procedures, patients, and outcomes in clinical practice;
  • actively engage stakeholders to transform the medical device landscape from one of fragmentation, redundancy, and distrust to one of goodwill, inclusiveness, efficiency, continuity, and partnering;
  • pursue stepwise system development, sharing of lessons learned, and solutions use/reuse across device areas;
  • pursue sustainability through a progressive demonstration of value across stakeholders;
  • leverage international efforts; and
  • promote a portfolio of pilot programs capable of creating momentum toward this vision.


According to the JAMA article, current systems, including electronic health records (EHRs) and data sources, are inadequate from a medical device registry standpoint because they “do not contain all the elements necessary for device evaluations, including device and procedural details, patient descriptors, or long-term outcomes.” The MDRTF recommended that the ideal network would get around such limitations through interoperability—linking several registries in order to achieve a more comprehensive data collection than one single source would allow. The MDRTF called this hypothetical interoperable network a “coordinated registries network” (CRN). A series of CRNs would then serve as “the foundational architectural construct for the national system.” The five priority principles for CRN functionality that the MDRTF recommended include: “(1) the ability to uniquely identify medical devices; (2) implementation of standardized clinical vocabularies and dictionaries; (3) reusable interoperability solutions linking diverse, strategically complementary data sources; (4) partnered, inclusive governance; and (5) value-based, incentivized sustainability.”

Benefits and Challenges

If a functional CRN or system of CRNs were developed, the benefits for patient safety and device development could be significant. Such a system could provide faster and more comprehensive post market information about device risks and benefits over the total product life cycle of medical devices. CRNs could facilitate better access to device information including information about the device itself, operator and user experience, procedure, and patient profiles. A national network could be used to profile medical devices based upon specific characteristics, in order to identify devices with higher risks. Some important device characteristics that could lead to such profiling include:

  • serious public health consequences of device failure;
  • new technology with safety and effectiveness concerns that are not well understood;
  • devices with significant design variations; and
  • devices with costs that are higher than current therapy costs.

However, the MDRTF acknowledged that an interoperable data system like a CRN also presents challenges in the form of privacy and ethical dilemmas. The MDRTF recommended that CRNs address privacy and ethics problems by engaging patients in a way that allows for patient control of personal health data.

Impact of CRNs

The report explained that CRNs “are well-positioned to inform premarket study designs and post market performance, and hence positively impact the total product lifecycle for related devices.” The proposed network would benefit from the wealth of information held in a variety of different data stores to allow for a more comprehensive and more helpful surveillance system. The JAMA article acknowledges that although the coordination effort necessary to make CRNs possible would be complex—due to the intricacy of data sharing and standardization—the article also suggests that “doing so could allow more effective, low-cost, real-time, rich safety and research opportunities.”

5 years of improvement for FDA’s medical device program

Medical device technology is advancing at a rapid pace. New devices improve on the technology of existing devices to make less invasive treatments possible, provide new options to patients whose conditions would have been considered untreatable in the past, and create technologies that will be keystones in precision medicine and other emerging fields. The FDA is responsible for facilitating device innovation and patient access to new medical technology and also must provide the oversight to minimize risks and ensure that devices provide clinical benefits. Since 2010, the agency has improved Americans’ access to safe and effective medical devices, approving new devices in less time than in the past. A report titled “FDA’s Role in Ensuring American Patients Have Access to Safe and Effective Medical Device Technology” shows marked improvement in all areas of device review, which the report attributes to a combination of programmatic improvements and innovative approaches to applying existing authorities.

Device oversight framework

The Medical Device Amendments of 1976 (MDA) (P.L. 94-295) established a flexible framework for the FDA’s oversight of medical devices. The legislation required the agency to tailor its oversight of devices to the degree of risk presented. Although medical devices inherently carry risk, the MDA did not require the FDA to eliminate all risks, but instead to establish a reasonable assurance of safety and effectiveness.

For premarket review of devices, which applies to about half of all devices, the FDA’s evidentiary standard is valid scientific evidence. This assures that the evidence is of sufficient quality that it can be relied on to determine whether or not a device should be approved or cleared.

The flexible approach created by the MDA provides the FDA with tools to assure safety and effectiveness of devices. It also allows the agency to adapt its oversight as medical technology advances.

FDA oversight adaptations

According to the report, the FDA has implemented new policies and programmatic changes in the past five years that respond to the needs of American patients. These adaptations ensure that Americans have timely access to high-quality, safe, and effective devices, and also respond to new challenges created by rapidly evolving fields of medical innovation. The initiatives include the following.

  • Streamlining clinical trials. The FDA established a Clinical Trials Program to coordinate its oversight of clinical studies of devices, provide interventions if an application review takes too much time, offer more opportunities for interactions with sponsors, expand training for review staff, and establish new or modified policies in this area.
  • Flexible decision making. The FDA implemented a series of new premarket policies that build on the MDA’s risk-based framework. Many of the policies affect important review decisions and impact public health by speeding access to new safe and effective devices.
  • Regulatory science programs. The FDA invested in several new regulatory science programs to reduce the time and cost, but not quality, of data development for devices. These programs promote the development and use of tools, analytical methods, and data sources in premarket applications to bring safe and effective devices to market faster and at less cost.
  • Adapting to new technology. The FDA device program has adapted to new technologies, focusing its oversight efforts on medical devices that present greater risks, with the goal of permitting access to a range of products while ensuring the safety and effectiveness of a subset of mobile medical apps that present greater risk to patients if they do not work as intended.


Thanks to the adaptations and changes implemented by the FDA in the past five years, the following improvements are quantified in the report:

  • significant decreases in time to decision for premarket submissions;
  • a higher percentage of cleared and approved submissions;
  • decreases in the number of pending submissions at the end of a year; and
  • improved customer satisfaction.

UV ‘disinfectant’ device marketers see the light, stop false advertising

Two marketers of ultraviolet (UV) light “disinfectant” devices agreed to stop making false and unsubstantiated claims about their products’ ability to kill highly contagious microorganisms such as foot fungus, MRSA, E. coli, and Salmonella through the use of UV lights. The FTC announced the settlement with the marketers of the devices, some of which were sold for as much as $159.99, and were marketed in various stores and online retailers, including Amazon.com, Target.com, and Walgreens.com.


The FTC filed separate lawsuits in district courts in Illinois and California against Angel Sales, Inc., which marketed the shUVee® device, and Zadro Health Solutions, Inc., which marketed the Nano-UV™ device. Both Angel and Zadro agreed to settle the false and unsubstantiated advertising claims, which resulted in a $656,423 judgment against Angel, and a $629,359 judgment against Zadro. Additionally, both are prohibited from making false and unsubstantiated claims about their devices’ disinfecting efficacy, and all future claims about their products health benefits or efficacy must be based on reliable scientific evidence.


The FTC alleged that Angel and its owners made false and unsubstantiated claims about their shUVee device, which was marketed through their own website and national retailer websites, including Amazon.com., Walgreens.com, and the SkyMall catalog. The shUVee advertising made claims that the device, which sold for $99.99 to $139.99 each, could keep shoes odor free and that it could kill “95 percent of germs, bacteria, even the fungus responsible for the highly contagious MRSA bacteria—in less than an hour.”


According to the FTC, Zadro made similar false and unsubstantiated claims about its device, the Nano-UV, including claims that it killed “99.99 percent of target bacteria—E. coli, Salmonella, and the H1N1 (swine flu) virus in 10 seconds,” and that it produced “sufficient energy to damage and alter DNA of all kinds of microorganisms.” Additionally, the Nano-UV packaging claimed that the wands were proven effective in killing 99 percent of germs on various surfaces, including nurseries, food preparation areas, public restrooms, and clinics. The devices were sold for $59.99 to $159.99, and were marketed through Zadro’s website and through other online sites, including Amazon.com, Drugstore.com, Target.com, Brookstone.com and through catalogs, including Hammacher Schlemmer, Frontgate, and SkyMall.

Jessica Rich, Director of the FTC’s Bureau of Consumer Protection stated, “The defendants said their devices’ UV rays would kill dangerous microorganisms, but they didn’t have scientific evidence to back that up.”