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September 8, 2016
Cigna can’t sign up new Medicare customers due to U.S. probe
Health insurer Cigna Corp. won’t be able to sign up new customers for its private Medicare plans during the fall enrollment season this year because
of an investigation by U.S. regulators.
The Centers for Medicare and Medicaid Services said in January that it found “widespread and systemic failures” in Cigna’s private Medicare
business. On Tuesday, the Bloomfield, CT-based insurer said in a regulatory filing that it probably can’t fix the problems in time for the enrollment
season for private health insurance and drug coverage plans, which starts next month.
As of June 30, Cigna had about 533,000 customers in its Medicare plans, known as Medicare Advantage, and 1.04 million in its drug plans, known
as Medicare Part D, the company said on its website. The privately run insurance plans are sold as alternatives to the government-run version of the
health program for the elderly and disabled, and the drug benefit was created in 2003 to supplement health coverage.
Cigna was banned from marketing policies to new clients, and customers affected by the issues were given the option of switching to new coverage.
Existing Cigna customers will still be able to renew their plans for next year.
While Cigna has an agreement to be acquired by rival Anthem Inc. for $48 billion, a merger that would substantially consolidate the insurance
industry, the U.S. has sued to block the deal on antitrust grounds. The case is scheduled to go to trial in late November, though the Justice
Department has indicated it could be open to a settlement.
Visit Bloomberg for the story.
HHS accelerates development of mRNA-based Zika vaccine
The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) announced an $8.2
million contract award to Moderna Therapeutics of Cambridge, Massachusetts, to help speed the development of a novel vaccine to prevent the
spread of the Zika virus.
ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will provide technical assistance, oversight, and funding to advance
the Zika vaccine’s clinical development.
Under the initial 4-year agreement, BARDA will support a Phase 1 clinical trial, toxicology studies, vaccine formulation, and manufacturing. If
additional funding is identified the agreement could be extended up to a total of five years and a total of $125.5 million to support Phase 2 and 3
clinical trials, as well as large scale manufacturing.
Moderna’s vaccine uses messenger RNA, or mRNA, vaccine technology. Messenger RNA is a molecule that carries specific genetic codes to parts
of the cell. This type of vaccine uses messenger RNA containing the genetic sequence of the Zika virus to generate an immune response in people.
This new mRNA Zika vaccine development project is part of ASPR/BARDA’s comprehensive integrated portfolio approach for advanced research
and development, innovation, acquisition, and manufacturing of vaccines, drugs, diagnostic tools, and non-pharmaceutical products for public health
emergency threats. In addition to emerging infectious diseases, these threats include pandemic influenza, chemical, biological, radiological, and
nuclear agents, and antimicrobial resistant pathogens.
With the award, BARDA has obligated all of the $85 million in funds reprogrammed for Zika work that it received in April. These funds are being used
to develop Zika vaccine through one of BARDA’s Centers for Innovation in Advanced Development and Manufacturing (CIADM), as well as
Moderna’s mRNA vaccine and Takeda’s vaccine, four diagnostics, blood screening tests, and pathogen reduction technologies through private
sector partners. In addition, ASPR is providing Zika-positive blood samples to developers to validate the accuracy of new diagnostic tests. These
expenditures include:
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$49 million for vaccines
$20.7 million to develop diagnostics with ChemBio, InBios, OraSure, and DiaSorin
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$10.7 million to develop pathogen reduction technologies with Cerus
$4.1 million to develop technology to screen donated blood for the Zika virus
$500,000 for blood sample collection and distribution to developers
Visit HHS for the report.
Doctors wasting over two-thirds of their time doing paperwork
If medical school curricula were based on what a recent study says many doctors actually do with their time, more than half of medical school would
be on how to do paperwork. Medical school admissions essays would be on “why I really want do paperwork when I grow up.”
Indeed, a recently published study in the Annals of Internal Medicine found that for every hour physicians were seeing patients, they were spending
nearly two additional hours on paperwork. Is this really the best use of doctors’ training and ability?
The study confirmed what many physicians have already, the amount of paperwork that doctors have to do is out of control. Led by Christine Sinsky,
MD, at the American Medical Association, the study followed 57 U.S. physicians in family medicine, internal medicine, cardiology and orthopedics for
a total of 430 hours. In addition, 21 physicians completed after-hours diaries.
The results? Physicians spent 27% of their time in their offices seeing patients and 49.2% of their time doing paperwork, which including using the
electric health record (EHR) system. Even when the doctors were in the examination room with patients, they were spending only 52.9% of the time
talking to or examining the patients and 37.0% doing…you guessed it… paperwork. Moreover, the doctors who completed the after-hours diaries
indicated that they were spending one to two hours each night doing - drum roll please - paperwork (or EHR).
The reason for the overwhelming paperwork is four-fold.
First, there are now so many people involved in a doctor’s practice beyond the doctor herself.
Secondly, doctors are not designing much of the paperwork. Therefore, whoever is designing and requiring the paperwork has little clue on how to
make doctors’ lives easier.
The third problem is that many doctors are not getting any help to do the paperwork. Hospitals and clinics do not seem to be investing in clerical and
administrative support for doctors. Some current regulations may be preventing others from helping physicians, such as those that require a
physician to be the person entering orders into a computer.
Fourth of all, the system is not changing to accommodate doctors. How much investment is there in finding and implementing ways to improve clinic
operations and the workflow and lives of physicians? How much funding is going towards such research?
As a result of the growing mass of paperwork with no change in sight, many doctors do not have time to do things most useful to their patients,
society and frankly the clinics and hospitals at which they work.
Do physicians have time to counsel their patients on weight management, opioid use, mental health, surgical questions and complications and a host
of other things that patients want and need? Are physicians prescribing too many antibiotics, opioids and unnecessary medications because they
don’t have time to carefully examine the patients and consider other options? Is excessive paperwork leading to physician burnout and
dissatisfaction?
Indeed, a study in the Mayo Clinic Proceedings from two months ago in July had surveyed physicians from all specialties from across the U.S. and
found that many were dissatisfied with having to use EHR’s and this led to frustration and burnout.
Visit Forbes for the story.
U.N. advises 6 months of abstinence, safe sex when returning from Zika zones
Men and women returning from areas with Zika outbreaks should practice safe sex or abstinence for six months, the World Health Organization said
Tuesday. Earlier guidelines applied only to men and only for eight weeks after returning from areas dealing with Zika epidemics. The guideline now
applies to everyone, even if they aren’t showing symptoms.
There have been several cases of Zika transmission from asymptomatic men to woman and asymptomatic women to men reported, WHO said. Zika
is transmitted primarily through infected mosquitoes, but also through bodily fluids.
Nearly 70 countries have reported instances of Zika infections from mosquitoes and 11 countries have reported person-to-person Zika transmission,
WHO said.
Infection during pregnancy can cause serious birth defects. People infected with Zika can experience fevers, joint pains and rashes. About 2,700
cases of Zika have been reported in the U.S., according to the Centers for Disease Control and Prevention.
Zika remains a global health emergency, WHO said.
Visit PIX11 for the article.
FDA has extended UDI compliance date for labelers of certain Class II devices
The FDA has informed labelers that they have extended the compliance date for UDI label and GUDID submission requirements to September 24,
2018, for certain class II devices as explained below. In addition, the agency is clarifying that for device constituents of certain combination products
described below the compliance date for UDI label and GUDID submission requirements is September 24, 2018.
(See the original deadline dates)
The Compliance date is extended for UDI label and data submission requirements to September 24, 2018, for certain class II devices:
Collections of two or more different devices packaged together in which the devices in the package are not individually labeled. On January 4, 2016,
the FDA issued a draft guidance document entitled “Unique Device Identification: Convenience Kits: Draft Guidance for Industry and Food and Drug
Administration Staff in which the agency proposes an interpretation of the term “convenience kit” for purposes of applying the exception under 21
CFR 801.30(a)(11).
Repackaged single-use devices. 21 CFR 801.30(a)(3) provides that individual single-use devices, other than implants, all of a single version or
model, are not required to bear a UDI provided they are distributed together in a single device package, intended to be stored in that device package
until removed for use, and not intended for individual commercial distribution. The UDI label and GUDID submission requirements’ compliance dates
for repackagers of class II single-use devices that are not individually labeled with a UDI is extended to September 24, 2018. This extension does not
apply to implantable, life-supporting or life sustaining devices.
Visit the FDA for the updated letter.
FDA issues safety communication regarding use of ovarian cancer screening tests
The FDA is alerting women about the risks associated with the use of tests being marketed as ovarian cancer screening tests. The Agency is
especially concerned about delaying effective preventive treatments for women who show no symptoms, but who are still at increased risk for
developing ovarian cancer.
Despite extensive research and published studies, there are currently no screening tests for ovarian cancer that are sensitive enough to reliably
screen for ovarian cancer without a high number of inaccurate results. However, over the years, numerous companies have marketed tests that
claim to screen for and detect ovarian cancer.
FDA is concerned that women and their physicians may be misled by such claims and rely on inaccurate results to make treatment decisions. Based
on the FDA’s review of available clinical data from ovarian cancer screening trials and recommendations from healthcare professional societies and
the U.S. Preventive Services Task Force, available data do not demonstrate that currently available ovarian cancer screening tests are accurate and
reliable in screening asymptomatic women for early ovarian cancer.
Using unproven ovarian cancer screening tests also may be harmful for women with increased risk for developing ovarian cancer. The FDA believes
that women at high risk for developing ovarian cancer should not use any currently offered test that claims to screen for ovarian cancer.
The National Cancer Institute estimates that in 2016, more than 22,000 women will be diagnosed with ovarian cancer. Women who have reached
menopause, women who have a family history of ovarian cancer, and women with the BRCA1 or BRCA2 genetic mutations have the highest risk for
developing ovarian cancer.
Read the FDA MedWatch safety alert.
Big drop in chickenpox cases since 2-dose vaccine began
United States Health Officials reported chickenpox numbers have gone down in the U.S. since 2006, when doctors started recommending a second
dose of the vaccine.
According to CBS News, states reporting vaccination data noted an 85 percent drop in the disease between 2005-2006 and 2013-2014. These
numbers reported by the U.S. Centers for Disease Control and Prevention. The greatest decrease was among the 5 to 14 age group. This is the age
group most likely to have received a second dosage of the varicella vaccine.
Before vaccination, chickenpox was commonplace, with 4 million Americans on average getting the virus annually in the early 1990s. Of those, as
many as 13,500 were hospitalized, and 100 to 150 died in a given year, according to the CDC report.
The CDC has credited vaccination with preventing more than 3.5 million cases of chickenpox, 9,000 hospitalizations, and 100 deaths each year.
The vaccine doesn’t prevent chickenpox in everyone, but when cases do occur in people who’ve received the vaccine, the disease is usually milder
than it is in unvaccinated people.
Fewer cases means state health officials can better study the characteristics of new outbreaks -- such as symptom severity, the number of
hospitalizations and whether or not patients were vaccinated, the agency said.
The CDC recommends kids get the first dose at age 12-to-15 months and the second dose when they are 4 to 6 years old.
Visit Local8now for the story.
Study finds novel ionic silver treatment decreases up to 100% of Staph aureus contamination of hospital linens
A peer-reviewed study titled "Reduction in bacterial contamination of hospital textiles by a novel silver based laundry treatment" was published in the
September issue of the American Journal of Infection Control (AJIC). The study's authors looked across three different community hospitals at the
effectiveness of SilvaClean, a new ionic silver antimicrobial applied to linens after each washing.
Addressing environmental cleanliness through textiles is a critical issue for hospitals. Hospital acquired infections (HAIs) are potentially lethal for
patients and pose significant financial risks for hospitals. According to a Centers for Disease Control & Prevention (CDC) report, hospital acquired
HAIs kill nearly 200 people in the U.S. every day and affect 1 in 25 hospital patients. These numbers do not include infections acquired at skilled
nursing, long-term acute care and outpatient surgery facilities.
Published research shows that 60% of hospital staff uniforms were colonized with potentially pathogenic bacteria, including drug-resistant organisms
such as the superbugs MRSA and CRE, and a separate published research paper shows 55% of clean bed linens were contaminated before contact
with the patient. Contracting MRSA increases a patient's chance of acquiring a staph infection within the following 12 months.
The new peer-reviewed study in AJIC compares SilvaClean treated hospital sheets and patient gowns to untreated hospital sheets and patient
gowns both before and after patient use.
The authors found that treating sheets and gowns with SilvaClean resulted in decreases in microbial contamination before patient use of 88% and
89% respectively. SilvaClean was found to be persistent, reducing total bacterial counts by 30% on sheets and 45% on gowns after patients had
used them. SilvaClean treatment of the textiles resulted in 100% decreases of Staphylococcus aureus on sheets and gowns before patient use and
decreases after patient use of 74% on sheets and 89% gowns.
To learn more about SilvaClean, please visit www.appliedsilver.com.