Author: Shelby Taylor

Where Do the Vaccines Go From Here? Issues With Vaccine Quality and Supply During COVID.

As the US begins to turn a new page since the Pandemic first devastated our country in 2020, many Americans plan to be vaccinated in efforts to return to life as they once imagined. The Biden Administration has placed tremendous support and funding behind vaccines produced by Pfizer, Moderna, and the Johnson & Johnson (J&J). While public health experts, including the CDC, deem all three vaccines safe with varying efficacy levels there is concern about the implications about the recent pause to the production of the Johnson & Johnson vaccine.

According to the CDC, the “pause” was recommended after some people developed “a rare and severe type of blood clot” two weeks after being vaccinated. Although alarm is expected, the occurrence of these type of blood clots is small (approx. 6 cases) compared to the 6.8 million doses issued. Health experts recommend for those originally signed up to receive the J&J vaccine simply attempt to reschedule to receive either the Pfizer or Moderna vaccine. Although the J&J vaccine which has passed vigorous testing and oversight from the CDC and FDA, the Janessen (Johnson & Johnson) company is expected to meet with regulators this month to ensure that vaccines continue to be safe for distribution. That meeting is open to the public. The meeting will be held by the CDC’s Advisory Committee on Immunization Practices the whose job it is to determine how the J&J vaccine will be used and changes in vaccine supply.

In terms of new production, the producers of the J&J vaccine are dealing with potential quality issues. The FDA further requested that J&J vaccines undergo additional testing and identify any potential sources of contamination. After an inspection of one production facility in Baltimore, the FDA noted several issues that would have to be addressed in order to continue to a supplier of vaccine products during COVID. In a statement released by J & J the roll out of the vaccine has been delayed in both the US and Europe. The statement also included information for those who are concerned about recognition and treatment of the related to that type of rare blood clot.

So where do we go from here? According to a report from CNN, the impact of the J &J pause should be minimal. Nonetheless, for Americans that are already skeptical about being vaccinated under emergency procedures this adds to the list of reasons not to be vaccinated. Health experts continue to stress the importance of putting this incident into context. Specifically, the CNN report points to the fact that the other vaccines by Pfizer and Moderna are designed differently from Johnson and Johnson and are completely safe. As Americans continue to decide whether to vaccinated, health experts hope that vaccine safety concerns won’t thwart the efforts of health experts, the Administration, and the public to move toward a coronavirus-free nation.

Can we disclose? School Privacy Issues During COVID-19

As COVID-19 continues to spread in the US, teachers, students, and their respective communities face tough privacy issues. Typically, the Health Insurance Portability and Accountability Act (HIPAA) delineates patients’ privacy rights regarding the disclosure of protected health information. However, this is not the case for student health information. The Family Educational Rights and Privacy Act (FERPA), enacted by the US Department of Education, provides guidance to schools handling privacy issues related to COVID-19. The difference between the two health information privacy acts is that FERPA specifically protects health information contained in school records. Similar to HIPAA, FERPA requires consent to disclose protected health information. However, the pandemic has created a “safety emergency exception” to the consent requirement.  

As children across the US slowly return to their classrooms, there are concerns about how and when information about COVID-19 cases will be released to teachers, school staff, students, and their families. USA Today reported inconsistencies in how school districts and health departments coordinate and release information. One reason for the inconsistencies is the lack of clarity at the state level regarding how to approach ongoing risk of COVID-19 in schools. The confusion because of the discrepancy in the application of FERPA compared to HIPAA. Specifically, HIPAA prevents the disclosure of health information, yet while FERPA allows the disclosure of such health information as long as it  as long as it does not include information that could identify the student.

The specific language in FERPA regarding student privacy prohibits the disclosure of the student’s name, ID, or any other information that could indirectly or directly be traced to the affected student.  Moreover, the language in FERPA mandates that the disclosure of health information is examined on a case-by-case basis. This provision ensures that only necessary information is disclosed in consideration of other students’ health during the Pandemic. Additionally, there is a recordkeeping section that requires schools to maintain a record of emergency disclosures that the affected student and parents can examine at any time.

So, what are the legal and public health implications for unconsented disclosure during COVID-19? Containing the spread of the virus, for the time being, has to be the number one priority. There is a real threat to public health and safety when students and parents are unaware of COVID-19 cases that occur within their respective schools. It is understandable that tension may arise when disclosing student health information without clear guidance from state and federal leadership on how to protect those privacy interests. The rationale for withholding such important information during a global pandemic makes no sense. The solution to widespread confusion and inconsistencies is transparency across the board in terms of tracking the spread of the virus. Such transparency in school systems ensures that school districts across the US are doing their jobs and taking the proper precautions to protect the health of our nation’s children.

Please contact Managing Editor for sources.

The ACA meets COVID-19: Now What?

Before the
Affordable Healthcare Act (ACA), 44 million Americans were uninsured. While the
Affordable Care Act (ACA), passed in 2010, improved the provision and delivery
of healthcare to over 16 million Americans, there are still gaps in coverage. Since its rollout, the ACA has faced several legal
challenges including a lawsuit filed in 2016 against Sylvia Burwell, the HHS
Secretary during the Obama Administration. This initial challenge sparked a
nationwide injunction against certain ACA provisions. In what has been known as
the landmark ACA case, U.S. v. Texas, 20 states sought to strike down the entire Act after
challenging the individual mandate to maintain health coverage each tax year
that was enacted following the passage of the Tax Cuts and Jobs Act of 2018 ( under the Trump Administration). The Supreme
Court is expected to make its final ruling later this year as to whether ACA,
in its entirety, will be upheld.

COVID-19 crisis further complicates the ACA issues. A vaccine is likely not going
to be available for the next year or so, meaning it will be available only after
the Supreme Court will make its decision. Experts suspect that overturning the ACA will cost many Americans their insurance
benefits, which limits their access to vaccines (when available), leaving
Americans vulnerable to the continued spread of the virus. High-ranking elected
officials view the continued pursuit of some courts to strike down the ACA as  “unconscionable” during a public health emergency such as

Lawmakers are split on their
views of the ACA in the wake of the 2020 Pandemic. Democratic lawmakers have
expressed concerns over the problems that gaps in coverage will have on the spread
of COVID-19, while Republican lawmakers have upheld their contention that
Americans’ previously demonstrated intent to seek alternatives to ACA health
plans, negates arguments that ACA should re-open enrollment. A House Republican
further noted that coronavirus testing is free and the Administration reports
that many states continue to expand Medicare to cover those experiencing loss
of jobs and health coverage. 

In contrast to what Republican lawmakers presented in
the ACA debate, nine states (Colorado,
Connecticut, Maryland, Massachusetts, Nevada, New York, Rhode Island, and
Washington) have made it possible for its citizens to obtain some form of
medical coverage during the COVID-19 crisis. Typical of most insurance plans,
individuals and families can only elect coverage during open enrollment once a
year without a qualifying status change. Nonetheless, these nine states have
created a special enrollment for citizens or extending the current open
enrollment period. Insurers are supportive of these states and are looking for
ways to mitigate any risks associated with new enrollees during the Pandemic.

Kaiser Family Foundation describes the use of ACA
health plans as a safety net during the Pandemic that can be used by Americans
who have lost wages due to reduced hours or business closings. Subsequent
limits on health coverage may cause some to delay care which harms the health
of the community. KFF further reports substantial out-of-pocket expenses for
those hospitalized. The report insists that
gaps in coverage will cause some people to delay treatment which could have
serious consequences as the country tries to reduce the number of new or
undiagnosed COVID-19 infections. As the ACA moves closer to its final day
in court and the COVID-19 continues as a pandemic lawmakers are now asked to
consider whether the health of the nation should suffer as a result of
political turmoil.

Misadventures in health reporting: Coronavirus 2020

Since the beginning of 2020, the Centers for Disease Control
Prevention (CDC)
has been mounting a response to a respiratory disease, that, at present, has
been declared a public health emergency in 80 countries, including the US. The
SAR-CoV-2 virus, also known as the Coronavirus (COVID-19), has elicited the
concern and attention of public health authorities, the healthcare community,
and the public-at-large. As the Coronavirus continues to grow globally and
begins to emerge through cases in parts of the US, the greatest dilemma is who
and what to believe. Social media has exploded over the recent conflicts in
reporting between leaders in government and public health officials.

Americans should be concerned about the credibility and
timeliness of reporting as this emergency continues to trend in the news. Here
are some tips for those of you want to know if Coronavirus is happening the way
it’s being reported.

  • Consider the source. There are many internet and
    social media outlets reporting on every facet of news, so it is easy to be
    compelled by a flashy headline or a credible name reference. An agency like the
    CDC and organizations such as the World Health Organization (WHO) are tasked
    with protecting the health of the public nationally and globally, and in many ways
    are responsible for the preparedness of their respective officials and
    effectiveness of subsequent responses at every level. Specifically, the CDC, in
    collaboration with the WHO, confirmed COVID-19 emerged as a virus spread
    by person-to-person contact—and was first detected in travelers from the Wuhan
    Province of China.

  • Remember news changes rapidly. Try not to get
    hung up on the evening news or trending social media updates about the virus,
    because these are likely to change within hours (sometimes minutes). Since
    January 21, the WHO released 42 “situation
    on the Coronavirus, providing
    the most up-to-date and accurate developments concerning the virus. The purpose
    of these reports is to monitor the number of 
    confirmed cases and deaths globally, and to provide the public with
    routine updates on the WHO’s efforts to deliver supplies to support the global
    response to the Coronavirus. Similarly, the CDC continues to provide health
    notices to debunk the fear and stigma around the origin of the virus and the
    severity of the risk of its spread. Ultimately, you should expect to see
    changes in travel patterns, stories about the increased use of protective gear,
    and local and state officials making regular statements to the public.

  • At a White House Press Conference last month,
    Vice President Mike Pence made a statement on the impact
    of Coronavirus in America. Pence reported the risk to Americans as “low” while
    the incidence of Coronavirus grows in different regions of the country. Pence
    also assured Americans that the administration rolled out a new Coronavirus
    to streamline information to the public and coordinate efforts
    with partnering countries to track the progress of the global response. Nonetheless,
    CNN reports that the CDC urges Americans to prepare themselves for the worst. The
    report goes on to suggest how daily life will change in the face of a
    Coronavirus epidemic. CNN reports an uncertain future based on conflicting
    remarks during the White House Press Conference.

  • Observe standard precautions. While the risk
    remains low, Americans are planning for the worst. California
    has declared a state of emergency after a recent Coronavirus-related death.
    Moreover, NBC
    reports that President Trump signed an $8 billion spending package for
    CA to use in wake of the virus outbreak. To date, states affected by the virus
    have begun rolling out guidelines for treatment and possible quarantine of
    patients as new cases emerge. For instance, local health authorities in New
    York have implemented screening procedures for citizens returning to the US
    from countries affected by Coronavirus. Other states continue to publish
    statements of their efforts to prevent the transmission and spread of the
    Coronavirus through universities and schools in various communities.

What should be taken from the CDC and other state and local
health authorities is that you should observe standard precautions, which can
reduce the transmission of the virus.
posted a simple statement about preventing human-to-human spread of the virus by
suggesting washing hands, covering mouths, and staying home if you’re sick. In
the wake of uncertainty of the trajectory of the virus, Americans can be
certain that our coverage of and reporting on the Coronavirus will be driven by
how the administration, health authorities, and media want to frame the
national and global response.

Free Flu Shots Cost More than Expected

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.

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.

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
, 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.

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.