Conflicts of interest within FDA advisory committee
April 14, 2024
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April 14, 2024
Conflicts of interest can pose thorny policy dilemmas. KFF Health News highlighted a recent situation in which ten members of a fourteen member committee had received funding from a manufacturer whose product was being considered for patient use. One member received almost $200,000 in funding. While none of the payments were directly related to the medical device in question, outside observers can easily ask whether the advisors can be impartial judges, especially those receiving substantial amounts of funding.
Apparently, FDA considers it a conflict of interest when the committee member has financial interests that "may be impacted" by his or her work on the committee. It also seems that part of the guideline is that if the relationship is more than a year in the past, it does not pose a problem. Those guidelines seem far less strict than what might exist for other industries. At the same time, it does seem difficult to craft guidelines, especially if there are only a few experts in a specific area and if there are only a few large companies and most advisor candidates have received some funding from them. Nevertheless, it seems that at the very least, such appearances of conflict of interest should be clearly disclosed publicly.
Interestingly, the committee member who received the most funding from the manufacturer ended up voting most negatively against the product (relative to other committee members). However, the policy for conflicts of interest should not be crafted based on a single example.
April 07, 2024
The federal health insurance exchange for the Affordable Care Act wants to make it easy for patients to sign up for and switch health insurance plans. However, is it too easy? KFF Health News reports on the increasing fraud among health insurance agents vying for monthly commissions. Apparently, with "only a person's name, date of birth, and state," an agent can switch a patient from one plan to another. Patient consent is assumed, but there seems to be inadequate measures to verify such consent.
Beyond being an inconvenience, such switches can have severe financial consequences, such as patients owing thousands of dollars for higher premiums that they did not sign up for. Patients might also delay medications and surgeries if they find out that their new plans do not cover what they need.
At least some state exchanges have implemented measures to thwart such fraud: "In Colorado, for example, customers create accounts on the state's online market and can choose which brokers have access. Pennsylvania has a similar setup. California sends a one-time password to the consumer, who then gives it to the agent before any changes can be made."
Where there is sufficient financial incentive, it seems that it would only be a matter of time before a naive system built on trust is abused. While the Centers for Medicare and Medicaid Services has announced plans to curb such abuse, it is concerning that they did not anticipate these problems earlier.
March 31, 2024
KFF Family News reported on recent legislation in California that allows teenagers on Medi-Cal insurance (in California) to gain access to mental health counseling without needing authorization from parents. Some lawmakers voted against the legislation, with the sentiment that "If my child is dealing with a mental health crisis, I want to know about it." However, teenagers on private health insurance plans already have access to mental health counseling without requiring parental authorization.
Both sides likely have a reasonable basis for their arguments: on one hand, parents should be involved with and consent to mental health treatment of their children, but on the other hand, there might be some situations (especially in abusive or neglectful households) where such requirements prove harmful. The particular example of the teenager who championed the legislation does not seem compelling based on what is presented in the article, although her accomplishment in seeing her advocacy result in a new law is noteworthy. Either way, there does seem to be an issue of consistency, where the requirement to have parental consent should not depend on whether the health insurance is private or public.
March 24, 2024
Mental health continues to grow as an issue, and not everyone has access to a mental health therapist. KFF Health News reported on California's creative effort to help alleviate the shortage of mental health professionals by paying for peer support leaders to conduct group therapy sessions. Being able to share one's difficulties and to connect with others seem to be helpful with regards to people's mental health, and those activities do not require mental health professionals. While not a complete solution, this approach seems to benefit those who cannot afford to see mental health professionals, and likely also benefits the peer leaders themselves.
The article listed some reasons that local governments encounter when trying to hire enough mental health therapists, including offering salaries that are lower than industry and not offering perks like remote work. A fuller solution likely involves increasing salaries, and perhaps for the longer term, increasing the supply of mental health professionals (for example, by offering tuition subsidies in return for agreement to work for the government).
March 17, 2024
KFF Health news reported on the increasing prevalence and impact of contract disputes between healthcare providers and payers ("21 insurer-provider standoffs in the third quarter of 2023, a 91% increase over the same period the year before"). When providers and payers cannot come to an agreement, patients suffer the hassle of finding new doctors who are in-network. Even when providers and payers do come to an agreement, it is often at the end of a game of brinkmanship in which patients are warned to prepare for the possibility of needing to find new doctors.
The article does point out the asymmetry where patients can only select a health insurance plan once a year (absent certain life events), but providers can leave an insurance network at any point in a year. The article comments "That is particularly galling for patients because, whether obtaining insurance through an employer or buying it on the marketplace, they generally choose a policy based on whether it covers their desired doctors and hospital or an expensive drug they need." It seems reasonable to require that in-network status for provider institutions (e.g. clinics or hospitals) must be made known at least one month before open enrollment, and by contract, should remain in effect for the entire year following that open enrollment period.
One law professor speculates that the rise in contract disputes is because of hospital price transparency regulations that went into effect in 2021. Since providers can now see how much payers are paying their competitors, they can use that information to negotiate for better compensation -- if so, this is most likely an unintended consequence of the pricing transparency regulation.