Free Flu Shots Cost More than Expected

Typically, individuals and families with health insurance have the advantage of receiving free flu shots every season, but a recent report from the Kaiser Health Network paints a different picture of the true cost insurers pay to provide free vaccinations to its plan holders. While the cost of a yearly flu shot appears low, the millions of Americans who are vaccinated in the US do not realize that the costs of providing such services are recouped in the high insurance premiums consumers pay each month. Specifically, the true cost of this “free” service can be found in the explanation of benefits provided by insurers. Moreover,  Kaiser Health Network reported significant variations in the cost of flu shots among health care payers and insurers.

Cigna reported paying different prices for the vaccine in DC versus MD where distances between some clinics were 10 miles or less. For instance, in 2017, the Peterson Kaiser Family Foundation Health System Tracker reported flu vaccine costs ranging from $28 to $80, with a misleading median cost of $45.” Insurance payers such as Cigna indicate that geographic variations are major price factors, even in the DC/MD region.

Market dominance has also been attributed to the varied cost of flu shots. Sutter Health, a nonprofit medical network giant, tentatively settled a lawsuit with expected damages of $2.7 billion after being accused of violating antitrust laws. Self-insured employers initiated the lawsuit and were later enjoined by California’s Attorney General’s Office. The lawsuit accused the conglomerate of taking advantage of its market dominance by charging insurers higher rates to provide flu shots at affiliated health care facilities. The state alleged that Sutter Health, a major health care system in Northern California, used its market dominance to drive up the cost of services and apply an all-or-nothing approach when contracting with insurance companies.

US antitrust law prohibits the use of unfair tactics to control a market or form a monopoly. When determining whether a company engaged in antitrust behavior, the court considers the company’s effect on the market as well as if the business activity intended to remove competition. Federal and state authorities can bring charges against those who violate these laws, and both civil and criminal remedies are available to companies affected by unlawful business activity.

The Sutter Health settlement may have nationwide implications on price negotiation tactics between large hospital systems and insurance companies. The lawsuit revealed that Sutter Health uses tactics to unnecessarily increase insurance prices. For example, Sutter Health uses factors such as location, competition, and plan provider when determining the cost to administer the vaccine. But the Kaiser Foundation reported that, even in consideration of those factors, Medicaid pays significantly less for the flu vaccine, and the price appears to be comparable across locations within states. This public revelation may send a signal to other large health systems who might be involved in similar practices.

Nonetheless, it seems disadvantageous for consumers to pay the high cost of the flu vaccine when there is no guarantee of its effectiveness. The rising cost of the flu vaccine is indicative of a larger problem in the US health delivery system. While the flu vaccine has proven beneficial to most Americans, its administration across the country lacks efficiency due to unfair business practices. Lawmakers should use the Sutter Health antitrust lawsuit as an opportunity to examine this aspect of the healthcare market and develop meaningful policies to prevent unfair and predatory practices.

Leave a Comment

Filed under Uncategorized

HIV Criminalization in the United States

Since the onset of the AIDS epidemic in the early 80s, public health officials and lawmakers have proposed legislative approaches to prevent HIV transmission at both the national and state level. lawmakers have tried to address this issue using punitive measures by enacting laws that criminalize high-risk behaviors linked to negligent HIV exposure. Twenty-five states criminalize behaviors that increases the risk for HIV exposure; and some states include low-risk behaviors like oral sex. Most of these laws were enacted before the emergence of antiretroviral therapy, and the laws do not account for other preventative measures such as condom use and pre-exposure prophylaxis (PreP).

States also criminalize intentional STD exposure, but typically result in short sentences (rarely exceed thirty-four months). Similarly, all states have assault and battery laws and other criminal statutes that can be used to prosecute high-risk behaviors that can lead to negligent HIV exposure. Despite its intention, state laws further sanction and stigmatize those with HIV. In addition to criminalizing certain behaviors, state law also determines the maximum sentences for violating HIV-specific statutes. The CDC reports that eight states issue sentences for HIV-specific violations between eleven and twenty years in prison; while two states impose longer sentences (greater than twenty years), and two may impose up to life in prison.

LGBTQ advocates outline how many of these laws were rooted in homophobia but gained traction by claiming to promote public health. Not only do they have a disproportionate effect on LGBTQ individuals, but these laws have a disparate impact on women and people of color. Aware of this discriminatory effect, the California legislature introduced Senate Bill 239 in February 2017. This bill reduces HIV transmission from felony to misdemeanor and repeals mandated criminal penalties for donating blood, organ, and breast milk while being HIV-positive. Unfortunately, not many states have followed suit.

Experts in AIDS research have long resisted these laws, claiming that they are ineffective and unwarranted. Linda-Fail Bekker, a professor of medicine at the Desmond Tutu HIV Foundation says, “in many cases, these misconceived laws exacerbate the spread of HIV by driving people living with, and at risk of, infection away from treatment services.” The science of dispelling HIV stigma is insufficient to end HIV criminalization. Lawmakers must consider the overarching human rights principles and advance public health efforts and education to adequately address the criminalization of HIV in the US.

Leave a Comment

Filed under Uncategorized

FDA Regulation of Underage ENDS Use and the Incidence of Fatal Lung Disease.

The Food and Drug Administration (FDA) has tightened its regulation of e-cigarettes and other electronic nicotine delivery systems (ENDS) since it promulgated a rule extending existing tobacco regulations to ENDS in August of 2016. Many of these regulatory developments occurred under former FDA Commissioner Scott Gottlieb with the objective of curbing widespread underage use of ENDS and continue even after Gottlieb has resigned his post as commissioner.

In September 2019, the Trump administration asked the FDA to ban flavored e-liquids amid a surge in underage use of ENDS, and as hundreds of cases of life-threatening or sometimes fatal ENDS-related lung illnesses occurred. Studies have indicated a strong likelihood that flavored e-liquids draw teenagers to ENDS use, so this ban could be an important step in lowering underage ENDS use in those who already use the devices, and in deterring other minors from experimenting with nicotine use in the first place.

However, the FDA’s previous attempts to restrict the availability of a wide array of e-liquid flavor options were unsuccessful. Underage use of ENDS has been a problem for several years, but support for this regulatory measure has only grown substantially in the months leading up to September 2019. The difference in support appears to be related to the numerous instances of illnesses and deaths caused by ENDS-related lung disease in recent months which is a separate problem from the ongoing issue of ENDS use by teenagers.

Where instances of teen use of ENDS are often linked to lax online sales policies and the appeal of flavored e-liquid, investigations by the CDC and FDA have linked many of the recent instances of lung illness to the use of illegally tampered with vaping products. Because of the differences in the causes of these problems, they might not both be solved by a ban on most of the currently available e-liquid flavoring options. Many of the products associated with serious lung injury and death have been bought illegally online and have been adulterated by third parties. The adulterated ENDS components frequently contain compounds, such as cannabidiol and tetrahydrocannabinol, found in marijuana. Therefore, the new flavor regulations promulgated by the FDA do not directly address the increase in ENDS-related lung illnesses.

Banning many flavors in e-liquids and other ENDS components, can have a positive impact by addressing problems with underage use of these products. However, many supporters of the new rules expect a decline in the instance of life-threatening ENDS-related lung illness to occur as a result of the restrictions of e-liquid flavors. Such a decline might not occur until the devices causing lung illness are removed from the stream of commerce. Therefore, more restrictions on the availability of illegal ENDS products online could help to address this issue going forward.

Leave a Comment

Filed under Uncategorized

Google, Fitbit, and the Sale of Our Private Health Data

On November 1, 2019, Google’s Senior Vice President of Devices and Services Rick Osterloh announced in a blog post that Google had entered into an agreement to acquire Fitbit, Inc. This move signaled Google’s efforts to become a leading company in the $25 billion wearables market after failing to make a splash with its own line of Wear OS products. However, many current Fitbit customers and privacy watchdogs are concerned over the implications the sale will have on the privacy of the health data that Fitbit collects. The current lack of legal protection over health data collected by wearable technology and the inherent value of consumer data to Google’s business model presents a problematic combination that could see an erosion of consumer privacy.

The primary legal structure governing the use of personal health information (“PHI”) is the Health Insurance Portability & Accountability Act of 1996, commonly referred to as HIPAA. The purpose of HIPPA is to mandate industry-wide standards for health care information and require the protection and confidential handling of PHI. Over the past two decades, the framework HIPAA established has become central to the protection of PHI and has held healthcare providers accountable in instances where PHI has been exposed.

Yet the rise in wearable technology and its functionality in recent years has exposed a gap in HIPAA protection. As the law is written, HIPAA does not apply to health data collected by wearable health technology. This is because HIPAA only governs organizations considered to be “covered entities,” which the law states as either a health plan, a health care clearinghouse, a health care provider, or health care. Fitbit, as an organization that only collects health data for its customers’ own use (e.g. tracking step count for the user to view) and not to provide health care services, does not qualify as a covered entity. As a non-covered entity, Fitbit is not required to abide by the HIPAA-mandated regulations for the protection of PHI even though the nature of the information it collects (e.g. name, address, phone identification number, height, weight, heart rate, etc.) qualifies as PHI as defined by HIPAA. Thus, users are left to rely upon Fitbit’s self-published privacy policy and the notion that the company will not breach or change that policy for the protection of their sensitive information.

Fitbit currently collects data from its 28 million active users, and even showed off the power of its data last year by showcasing trends it gleaned from 150 billion hours of heart data, the largest set of heart-rate data ever collected. This type of large-scale data collection and use falls perfectly in line with Google’s own business practices in recent years. According to a 2018 report, Google is one of the largest collectors of personal data—even collecting more than Facebook. Google uses its hardware, websites, and applications to actively and passively collect as much data on its users as possible. The Associated Press found that even when users disabled the “location history” feature in several Google websites and applications, Google was still collecting and storing users’ locations.

This data has become one of Google’s most valuable assets. Data is the driving force behind Google’s ability to effectively deliver ads, which accounted for 83.75% of its 2019 Q3 revenue. Google’s ad revenue has also increased year-over-year from $21 billion in 2008 to $116 billion in 2018. A company whose primary source of revenue is the use of data for targeted ads will gain unfettered access to one of the largest health data sets in the world. This is why, although Fitbit and Google both stated that Fitbit data would not be used in Google ads, many critics are skeptical of Google’s intentions.

Google is poised to control vast amounts of our personal data and can use it from targeted ads (e.g. ads for running shorts based upon increased running activity) to conducting beneficial or agenda-driven medical research. However the data is used, Google is gaining increased access to our most sensitive and personal information, not protected by HIPAA, while remaining a company whose main goal is not public health. This lack of legal protection over PHI data collected by wearable technology—and the immense value of data to Google’s business model—present clear privacy concerns for consumers that will only continue until action is taken to expand HIPAA in order to effectively protect all PHI.

Leave a Comment

Filed under Uncategorized

We the Pat[i]ents: HHS v Gilead

On November 6, 2019, the US Department of Health and Human Services (HHS) filed suit against pharmaceutical manufacturer Gilead Sciences, Inc., seeking damages against the company for infringing on HHS patents for pre-exposure prophylaxis (known as “PrEP”) for HIV prevention.  Gilead manufactures and sells two pills—Descovy and Truvada—for use in a PrEP regimen.  In an online statement released the same day, HHS claims that Gilead received approval from the US Food and Drug Administration (FDA) to produce Descovy and Truvada for post-infection HIV treatment, and following taxpayer-funded research by the US Centers for Disease Control and Prevention (CDC), Gilead obtained FDA approval to use the drugs as preventative treatment—despite not obtaining licenses to use the patents.

Two decades after the AIDS epidemic began, CDC researchers developed medications to prevent HIV infection after exposure.  According to the CDC, the government’s patented regimens are 99 percent effective at preventing HIV contraction after exposure to the virus.  According to HHS, the US Patent and Trademark Office granted four patents allowing HHS to license (and receive royalties for) CDC’s PrEP regimens.  HHS alleges Gilead refused to reach a licensure agreement with the government on multiple occasions.

AIDS activist organizations, such as PrEP4All, have urged HHS to collect royalties from Gilead, arguing the manufacturer used the government’s (and taxpayer-funded) intellectual property to raise prices for Truvada.  Accusations of Gilead’s “price-gouging” practices led to a House Committee on Oversight and Government Reform hearing in May.  During the hearing, lawmakers asked Gilead’s CEO about Truvada’s prices overseas—in Australia, the drug only costs $8 per person per month.

Gilead has argued that rising costs support research.  In 2004, when Truvada was first approved as HIV treatment, its monthly wholesale cost was $650.  When the drug was approved for a PrEP regimen in 2012, its cost rose to $1,159, according to research from Truven Health Analytics.  The pill is now over $1,750 per month, or $21,100 per year, though health insurance can offset out-of-pocket costs.  The drug brought Gilead $3 billion in sales last year.

To help patients obtain the drug, the company offers the Gilead Advancing Access program to help eligible patients pay for their medication—and even patients with commercial health insurance might not have a copay.  In the spring of 2019, Gilead donated enough medication to cover up to 200,000 patients over the next 11 years.  However, only 10 percent of those who need the drug receive it.

This past summer, Gilead challenged the government’s patents.  A Gilead executive corroborated HHS’ claim that the manufacturer and the agency could not reach a license agreement during several years of discussions.  In a November 7 statement published in STAT, a Gilead spokesperson claimed the patents granted to HHS for PrEP and PEP (post-exposure prophylaxis) are not valid, and that HHS filed for patents without alerting the manufacturer, which it was obligated to do.  The company argues that HHS’ patents are not valid because other entities developed antiretroviral therapies for PrEP and PEP before HHS claimed invention in 2006.  The company also claims that it invented Truvada, funded the clinical trials that led to FDA’s 2004 approval, spent $1.1 billion in research and development for the drug—including for subsequent studies on PrEP regimens—and similarly bore costs for Descovy.

According to the activists, HHS could use royalties to fund HIV prevention efforts and treatments.  On the same day that HHS filed suit, the Journal of Acquired Immune Deficiency Syndromes published a study from Abbott Laboratories and the University of Missouri, Kansas City, announcing that scientists discovered a new strain of the HIV virus—the first in 19 years.

SOURCES: Available upon request.

Leave a Comment

Filed under Uncategorized