Category: Blog

On January 17, 2020,
the U.S. Supreme Court
granted the writ of certiorari to hear two cases involving employers’
obligation to provide health insurance coverage for contraceptives. Employers
are currently
required to provide employees with health insurance including women’s
preventive care under the Affordable Care Act (“ACA”). In 2011, the U.S.
Department of Health and Human Services (“DHHS’) announced a rule to allow employers to use religious
beliefs as an exception to providing female employees with insurance that
includes women’s preventive care.  Later,
in 2017, DHHS announced an interim rule which expanded
upon its original exemption to include employers who had not only religious
conflicts but also moral or ethical objections. 

The Supreme Court
consolidated two cases relating to the DHHS’ rule.  The first case began before the new rule went
into effect, when the Attorney General of Pennsylvania filed for a
preliminary injunction to stop the rules enforcement. The District Court for
the Eastern District of Pennsylvania entered a nationwide injunction against
the rule’s enforcement;  the Third Circuit Court upheld
the District Court’s decision. The second
case involves a right of intervener filed by the Little Sisters of the
Poor, a mission based organization led by catholic nuns 
who intervened to object to the national
injunction on the DHS’ rule.

 In support of the DHHS rule, religious
organization and employers contend that under the Religious Freedom Restoration Act (“RFRA”) they are entitled to exercise their religious
belief.  Since the use of contraception is
not supported by those religious beliefs, religious organizations claim an
exemption from the ACA requirement.  However,
Pennsylvania
argued that the DHHS did not follow the rule making requirements under the
Administrative Procedures Act, and the rule goes beyond the legislative intent
of the ACA.  Further, RFRA does not
create an exception for the ACA requirement because the ACA’s requirement does
not put a substantial burden on religious exercise.  Finally, Pennsylvania argues that the interim
rule would create irreparable harm to state citizens by limiting access to
affordable health care.

This is not the first
time the Supreme Court has listened to an argument regarding the religious
exception to the ACA. In 2014, the court decided in Burwell v. Hobby Lobby Stores by a 5-4 decision
that under RFRA, DHS could expand religious exceptions to for-profit companies
since those rights were already extended to non-profit companies. In her dissent,
Justice Ginsburg, disagreed with the majority’s view because for-profit
companies are not allowed to declare a religion.  Additionally, judicial
precedent states that a religious belief cannot “impinge on the rights of
third parties”.

In the writ for certiorari
in Little Sisters of the Poor Home for the Aged v. Burwell, the petitioners
asked
the Court to answer whether the federal government lawfully exempted
religious objectors from the regulatory requirement to provide health plans
that include contraceptive coverage.  Meanwhile,
in Trump v. Pennsylvania, the State of Pennsylvania proposed the following
questions to the Court: First, whether the
agencies had statutory authority under the ACA and the RFRA, to expand the
conscience exemption to the contraceptive-coverage mandate; and second, whether
the agencies’ decision to forgo notice and opportunity for public comment
before issuing the interim final rules rendered the final rules—which were
issued after notice and comment—invalid under the Administrative Procedure Act,
5 U.S.C. 551 et seq., 701 et seq; and third, whether the court of appeals erred
in affirming a nationwide preliminary injunction barring implementation of the
final rules.

The Supreme Court is
poised to deliver its opinion on this high-profile issue before the end of the
current session. The court’s decision might finally clarify the obligations
employers have to provide women’s preventative healthcare to female employees
and if there are exceptions to that obligation under RFRA, the ACA or the U.S.
Constitution. 

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.

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.

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.

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.

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.