Best practices in contract communications to be unveiled
at Streamlining Healthcare Conference
The Health Industry Distributors Association (HIDA) will release a new white
paper, Improving Pricing Accuracy: Best Practices in Contract
Communications, during a special session at its Streamlining Healthcare
Conference in Chicago, IL, on October 2. The paper offers detailed
procedures for automation of contract management processes, including price
authorization acknowledgements, chargeback reconciliations, and manufacturer
â€śMore than 45 companies came together to develop these guidelines for
manufacturers and distributors,â€ť said Elizabeth Hilla, Senior Vice
President, HIDA. â€śThis is a huge initiative that we will continue in 2015
and beyond, and is the first of many steps aimed at making our supply chain
leaner and less costly.â€ť
The recommendations resulted from a two-year effort to streamline healthcare
contracting processes among distributors, manufacturers, group purchasing
organizations, and providers. HIDA expects support for this initiative to
continue to grow as participating companies and trading partners put the
guidelines into action.
HIDA is the trade association representing medical products distribution
with members primarily serving the nationâ€™s hospital, long term care, and
physician/alternative care markets. For more information, visit
www.HIDA.org. For more information on HIDAâ€™s Streamlining Healthcare
initiative, visit www.streamlininghealthcare.org.
Life-saving drugs and deadly delays
The Food and Drug Administration just granted permission for â€śexpanded
accessâ€ť to an experimental medicine for Ebola. Itâ€™s OK as far as it goes,
but itâ€™s an exception to the FDAâ€™s reluctance to approve the use of
Safety and efficacy testing of the drug, designated TKM-Ebola, has barely
begun, and quantities are extremely limited. It will be given to patients
with confirmed or suspected Ebola infections, but not as part of a clinical
To put it less charitably, FDA routinely drags its feet on the approval of
products critical for the prevention or treatment of fatal diseases that are
far more common in this country than Ebola.
Consider the saga of Bexsero, a vaccine for meningitis B. Since the first
vaccine for bacterial meningitis was approved in 1974, immunization has
significantly reduced the threat â€” but a vaccine for MenB took much longer
to develop. Bexsero was approved last year by the European Union, Australia
and Canada â€” but it still hasnâ€™t gotten an FDA OK, though outbreaks continue
to occur on US campuses. (The most recent one killed a Georgetown University
student this month.)
And the mother of a woman who died in Michigan has organized bus trips for
dozens of people, mostly college-age kids, to Windsor, Ontario, where she
arranged for the group to be seen by a doctor and vaccinated.
Another example: pirfenidone, a drug meant to treat a pulmonary disorder
called idiopathic pulmonary fibrosis, or IPF, which kills tens of thousands
of Americans each year. The diseaseâ€™s cause is unknown, and there are no
FDA-approved therapies. But pirfenidone is marketed in Europe (since 2011),
Japan (2008), Canada (2012) and China. The drug won EU approval on the basis
of three randomized, double-blind, placebo-controlled studies â€” one done in
Japan and the other two in Europe and the United States.
Why is the FDA waiting? In 2010, an advisory committee of outside experts
recommended approval, but agency officials demanded another major clinical
study. The results, published last May, were impressive. Pirfenidone
markedly improved several laboratory and clinical measures of lung function
and, most importantly, reduced the probability of death from IPF. The FDA
will probably OK the drug by yearâ€™s end. But in four years of delay, IPF
will have killed more than 150,000 US patients.
Economist Diana Furchtgott-Roth has described similar delays in the approval
of drugs to treat Duchenne muscular dystrophy, multiple sclerosis and
The FDA bases priorities on factors other than data and the nationâ€™s medical
needs. Africaâ€™s Ebola outbreak is front-page news, so the FDA grants
expanded access for an Ebola drug. Similarly, the FDA last spring brokered
the creation of a clinical trial specifically to get an experimental
anti-viral drug to a young cancer patient suffering from an adenovirus
infection after a bone marrow transplant.
Again, fine on the merits - except that this effort was expended for a
single patient and only after the agency was subjected to â€śintense
pressureâ€ť from the public on Facebook and Twitter
Visit the New York Post for the opinion.
Citizen hackers tinker with medical devices
Jason Adams, a business-development executive by day and a molecular
biologist by training, had never considered himself a hacker. That changed
when he discovered an off-label way to monitor his 8-year-old daughter's
blood-sugar levels from afar.
His daughter Ella has Type 1 diabetes and wears a glucose monitor made by
DexcomInc. The device measures her blood sugar every five minutes and
displays it on a nearby receiver the size of a pager, a huge advantage in
helping monitor her blood sugar for spikes and potentially fatal drops. But
it can't transmit the data to the Internet, which meant Mr. Adams never sent
Ella to sleepovers for fear she could slip into a coma during the night.
Then Adams found NightScout, a system cobbled together by a constellation of
software engineers, many with diabetic children, who were frustrated by the
limitations of current technology. The open-source system they developed
essentially hacks the Dexcom device and uploads its data to the Internet,
which lets Adams see his daughterâ€™s blood-sugar levels on his Pebble
smartwatch wherever she is. It isn't perfect. It drains cell phone
batteries, can cut out at times and hasn't been approved by the FDA. But for
many, it has filled a gap.
The home-built setup is part of a shift in the way Americans relate to the
medical industry and their own healthcare. Technologically savvy patients
are starting to tinker under the hoods of medical contraptions, seeking more
influence over devices like blood-sugar monitors, insulin pumps and
defibrillators that record and control bodily functions. Their goal is
greater access to data and faster invention than is possible under the
formal regulatory process.
Patients have been tweaking hearing aids so they play music, using 3-D
printers to make their own prosthetics and fiddling with a device used to
measure acidity levels in the esophagus. The Massachusetts Institute of
Technology has been hosting "hackathons" where engineers and students try to
improve medical products and work out new solutions to common diseases. The
latest one, held last weekend, was aimed at improving breast pumps.
The tinkering is raising concern at the FDA, medical-device companies and
among some academics and clinicians that modifications are being used before
they are fully tested and safe for a broad audience. Continuous glucose
monitors such as the one Adams daughter uses are Class III medical devices,
meaning they get the highest level of regulatory scrutiny, and even new
support software must clear a battery of approvals.
The rigorous approval process is there for a reason. A diabetes patient can
come to rely on an alarm that prompts him or her to address dangerously high
or low blood sugar, so devices need to work predictably and be
comprehensible to patients who aren't schooled in technology.
Dexcom, the maker of the glucose monitor, is aware of NightScout, as is the
FDA, and neither is taking issue with it for now. While not completely
comfortable with the software, the FDA takes a risk-based approach to
enforcement and is concerned about its distribution and how it affects
Representatives of the FDA have encouraged NightScout's backers to consult
formally with the agency. The NightScout team said it filed an application
in August, and a formal meeting has been scheduled for next month.
Other do-it-yourself developments in diabetes controlâ€”in particular efforts
to come up with software to govern dosages of insulin, where errors could be
fatalâ€”have prompted more serious concerns. Such efforts are spreading
anyway. A nonprofit group started by a former Amazon.com Inc. engineer,
called Tidepool, is teaming up with makers of diabetes devices to create
better data displays for patients and their doctors.
The homegrown efforts are springing up, in part, because approvals through
formal channels can take a long time. A new Medtronic pump that communicates
with a glucose monitor and suspends insulin delivery when blood sugars are
low wasn't approved in the U.S. until 2013, after being used in Europe since
2009. Johnson & Johnson submitted a new version of its Animas insulin pump
that uses the Dexcom monitor in April 2013 and is still waiting for
approval. The device was approved in Europe in 2011.
The FDA acknowledges the frustration and doesn't want to be seen as standing
in the way of innovation. The FDA notes there are different requirements in
Europe for device approvals and that approvals depend on when manufacturers
submit their applications to U.S. regulators.
Dexcom plans to seek FDA approval for a software system similar to
NightScout by early next year with hopes of getting it on the market by
Chronic diseases such as diabetes, asthma and heart conditionsâ€”where cross
referencing data can help improve healthâ€”have been an early focus of
"This grass-roots initiative and drive is very important in accelerating the
development of these technologies," said Howard Wolpert, who runs a
technology institute at the Harvard-affiliated Joslin Diabetes Center. "It
is also important that the processes for approval can be accelerated so that
this can be done in a way that there is an element of regulatory oversight."
The institute has received funding from Dexcom.
Medical do-it-yourselfersâ€”including some of the people behind NightScoutâ€”are
now pushing to develop systems that combine the blood-sugar data from
glucose monitors with insulin dosing to even out spikes and troughs in blood
Some do-it-yourselfers are taking steps to commercialize their inventions.
Former Wall Street trader Bryan Mazlish has launched a startupâ€”Smartloop
LLCâ€”that has filed patents on computer-assisted technology to help manage
blood-sugar levels. Mr. Mazlish, whose son and wife have Type 1 diabetes,
has built a smartphone app that runs an algorithm to optimize blood-glucose
levels by advising on insulin dosing using data from glucose monitors.
Mr. Mazlish said he thinks the current system for developing new medical
devices could be improved upon, but figures he can have the most impact
going the commercial route.
Visit the Wall Street Journal for the story
The magic number that could end the Ebola epidemic
There are a lot of scary numbers floating around about Ebola. Take 1.4
million: the U.S. Centers for Disease Control and Preventionâ€™s (CDCâ€™s)
worst-case scenario for Ebola cases in Western Africa by the end of January.
Or two: the approximate number of healthy people infected by each new Ebola
But perhaps the most important Ebola number right now is 70 percent. Thatâ€™s
the proportion of patients who need to be isolated, in treatment centers or
at least in their homes, in order to put a quick end to the Ebola outbreak,
according to the CDC.
â€śOnce 70 percent of patients are effectively isolated, the outbreak
decreases at a rate nearly equal to the initial rate of increase,â€ť
researchers wrote in the CDCâ€™s Morbidity and Mortality Weekly Report. If 70
percent of the current outbreak was achieved by late December, the epidemic
â€śwould be almost ended by January 20.â€ť
Seventy percent is a number full of hope and dread. Hope, because itâ€™s a
goal that feels attainable; a developed country would be able to handle 70
percent isolation on its own soil in short order. Dread, because in
Ebola-swept regions like Liberia and Sierra Leone, we are nowhere near
achieving it. Right now, only about 18 percent of Ebola patients in Liberia
are being isolated.
Each day the epidemic persists makes 70 percent more difficult to reach.
More doctors, hospital beds and treatment centers will be needed, and more
people must be educated about the disease. For every 30-day delay, the peak
number of new daily cases triples, according to a model of the disease
created by the CDC.
Despite its reputation as a killer, Ebola isnâ€™t very good at reproducing
itself. The virus is spread through body fluids, not air, and it often kills
patients before they have a chance to spread the disease widely. When 70
percent of patients are isolated, the disease no longer spreads fast enough
to replace dying or recovering patients. It burns itself out.
All it takes to break the epidemic is to reach that magic number. What makes
the current outbreak so difficult is that itâ€™s happening in war-impoverished
countries that have no prior experience with Ebola and very few doctors and
hospitals to start with. The size of the outbreak also puts it in uncharted
The 1.4 million worst-case projection by the CDC, the agency's own
estimation, is â€śvery unlikely.â€ť It doesnâ€™t account for major health
interventions, which are already underway. For example, U.S. soldiers have
started arriving in Liberia after President Barack Obama pledged to help
build as many as 20 treatment centers, train 500 healthcare providers and
send 3,000 troops to assist. The Pentagon may spend as much as $1 billion
fighting the disease. Thatâ€™s a lot of numbers. Letâ€™s hope they add up to 70.
Visit Bloomberg for the story.
Ebola: 'Magic Bullets' or Current Tools?
European health authorities want to compile an overview of all the available
data on experimental medications for Ebola. The World Health Organization
(WHO) is planning to issue guidance on the potential therapeutic use of
serum from Ebola survivors.
But the emphasis on "magic bullets" misses the point that basic care already
available in West Africa could markedly cut the fatality rate, according to
an international group of physicians experienced in treating Ebola patients
in the current epidemic.
"Intravenous catheters, fluids, and electrolyte replacement are readily
available but thus far are being used much too sparingly," according to
FranĂ§ois Lamontagne, MD, of the Centre Hospitalier Universitaire de
Sherbrooke in Sherbrooke, Quebec, and colleagues. Such "simple
interventions" can prevent deaths from hypovolemia and metabolic
abnormalities, they argued online in the New England Journal of Medicine.
The epidemic has now led to 6,553 infections and 3,083 deaths, numbers that
the WHO says are almost certainly a vast underestimate.
But many of the deaths are preventable and "reflect the natural history of
the illness, not an inability to alter its course," Lamontagne and
colleagues argued. Many patients, no longer able to drink, are left without
adequate intravenous fluid resuscitation, they reported, and when
biochemistry measurements have been available "we have commonly found
extreme serum sodium and potassium abnormalities."
One barrier to correcting such abnormalities is the lack of trained
clinicians, Lamontagne and colleagues said, but specialist care isn't
needed, just "fundamental acute care skills" and supplies that are already
available in the region. "We are convinced that it's possible to save many
more patients," the clinicians argued.
The commentary comes as the European Medicines Agency begins to review
what's known about various Ebola treatments currently under development. The
goal, the agency said in a statement, is to create an overview of the
various experimental medicines to "support decision-making" by health
In Guinea, WHO said, the situation "appears to have stabilized" with between
75 and 100 new confirmed cases in each of the past 5 weeks. Transmission in
the capital, Conakry, is relatively moderate. The cumulative total of
confirmed, probable, and suspected cases in Guinea stands at 1,074, with 648
deaths, according to a situation report issued Friday.
Liberia, on the other hand, has seen an anomalous decline in new confirmed
cases, the agency said, mainly because no confirmed cases were reported from
the capital, Monrovia, from Sept. 14 to 21. But that is probably because of
delays in reporting, the WHO said, since responders in the country -- and
especially in Monrovia -- continue to report deterioration in the situation.
Liberia has been especially hard-hit, with a cumulative total of 3,458
confirmed, probable, and suspected cases and 1,830 deaths.
And in Sierra Leone, the WHO situation report said, the number of new
confirmed cases reported has increased in each of the past five weeks,
driven primarily by newly reported cases in the capital, Freetown. The
country has a cumulative total of 2,021 confirmed, probable, and suspected
cases and 605 deaths.
The Friday report suggests that the disease continues to spread, with cases
seen in the Guinean province of Kindia and the district of Grand Kru in
The WHO continues to warn that the case totals are moving targets and very
likely underestimate the total disease burden.
Source reference: Lamontagne F, et al "Doing today's work superbly well -
treating Ebola with current tools" N Engl J Med 2014; DOI:
Visit MedPage Today for the study
NIH and FDA win top award for intellectual property
licensing of meningitis vaccine
The National Institutes of Health and the U.S. Food and Drug Administration
will receive a top national award for the yearâ€™s most outstanding
intellectual property licensing deal, for technology transfer of a
pioneering, low-cost meningitis vaccine launched in sub-Saharan Africa. The
2014 Deals of Distinction Award will be presented to the two federal
agencies and their collaborators by the Licensing Executives Society
External Web Site Policy at the societyâ€™s 50th annual meeting, Oct. 5-8 in
NIH and the FDA teamed with PATH External Web Site Policy, a Seattle-based
non-profit leader in global health innovation, and the Serum Institute of
India (SII) to develop MenAfriVac. The vaccine has a low production cost and
does not require constant refrigeration, making it ideal for use in remote
locations. A critical part of the manufacturing process for the vaccine is
based upon a patent license granted from the NIH Office of Technology
Transfer (NIH OTT) to PATH.
The technology was invented by FDA scientists and subsequently sublicensed
by PATH to SII under the Meningitis Vaccine Project, a partnership of PATH
and the World Health Organization (WHO). The vaccine targets the most common
form of bacterial meningitis, known as serogroup A, found in sub-Saharan
Africa. According to WHO, 80 to 85 percent of all meningitis infections in
the region are from group A.
Meningococcal meningitis, a deadly bacterial infection of the brain, can be
prevented with vaccination, but the production technology is complex and
generally beyond the capacity of infrastructures in most developing
countries. The patent license agreement involving the FDA-developed
technology and the expertise of the NIH technology transfer officers was
critical to developing and transferring the technology needed to manufacture
MenAfriVac at an affordable cost for the 26 African countries where
serogroup A meningitis is most common.
Through a partnership organized by PATH, NIH OTT licensed the technology
needed to make the new vaccine, which was developed by Dr. Che-Hung Robert
Lee and Dr. Carl Frasch of the FDAâ€™s Center for Biologics Evaluation and
Research. PATH worked with SII, which agreed to scale up the technology in
exchange for technical know-how and produce the vaccine at a cost that
African countries could afford, thus providing stable and sustainable access
MenAfriVac was launched in a vaccination campaign in Burkina Faso in
December 2010. To date, more than 150 million people in 12 African countries
have been vaccinated with no reported cases of serogroup A meningitis in
Visit NIH for the story.
Roche breast cancer drug 'unprecedented' in extending
A new breast cancer drug from Roche has shown "unprecedented" benefits in
extending lives in a clinical trial and experts urged its widespread use for
women with an aggressive form of the disease.
Patients with a type of breast cancer known as HER2 positive, which makes up
about a quarter of all breast cancers, who were given Perjeta on top of
older medicine Herceptin and chemotherapy lived 15.7 months longer than
those on Herceptin and chemotherapy alone.
That is the longest extension to survival ever seen for a drug studied in
metastatic breast cancer and also an unusually good result for any type of
metastatic cancer, where disease has spread to other parts of the body.
Both Herceptin and Perjeta are antibodies designed to block the function of
HER2, a protein produced by a cancer-linked gene. Perjeta, also known as
pertuzumab, binds to a different part of the same protein, which makes
combining the two drugs extra effective.
Perjeta, which was approved by regulators two years ago, was tested in the
Roche-backed study involving more than 800 women.
Researchers had previously reported the Perjeta drug regimen significantly
extended progression-free survival, or the period of time patients live
without their disease worsening, but the final overall survival data has
taken longer to collect.
The median overall survival time was 56.5 months for those given Perjeta
against the already impressive 40.8 months for patients taking only the
older drugs. Looking at the study results a different way, the risk of dying
was reduced by 32 percent for women who received the Perjeta regimen
compared to those who got Herceptin and chemotherapy.
While both Perjeta and Herceptin have side effects, including rash, diarrhea
and a potentially adverse impact on heart function, using the two drugs
together did not make these issues any worse.
Swain and Javier Cortes, another researcher on the study from the Vall
Dâ€™Hebron Institute of Oncology in Barcelona, said the results suggested
using Perjeta should now be the standard of care for HER2 positive breast
A favorable reaction from oncologists will underpin expectations of strong
sales for Perjeta, which analysts currently expect to sell $3.1 billion a
year by 2018, according to consensus forecasts compiled by Thomson Reuters
Cortellis. But it poses a challenge for healthcare providers, since Perjeta
and Herceptin are costly injectable drugs and the multiple-drug regimen
promises to strain budgets.
In the United States, the monthly price of Perjeta is approximately $5,900,
while Herceptin costs around $5,300, a Roche spokeswoman said. Prices in
Europe are lower.
For Roche, Perjeta is an important new product that should help defend its
position in breast cancer, following the success of Herceptin, which was
first approved in 1998.
The company said the latest data would be submitted to regulatory
authorities around the world for inclusion in the prescribing information
The Swiss drugmaker also has another related drug called Kadcyla, which is
also being tested in combination with Perjeta. Some analysts believe
Kadcyla's prospects could be curbed if results from that combination are not
better than the impressive findings reported this weekend.
Visit Reuters for the study.
Enterovirus: CDC investigates Colorado Children for link
between ED-68 and paralysis
Health researchers are investigating whether the enterovirus-68 respiratory
disease thatâ€™s been seen in especially high rates this year is related to a
neurological condition that causes limb weakness and paralysis. In a
Friday statement, the CDC said it planned to work with the state health
department to â€śinvestigate these cases among children in Colorado who had
respiratory illness and later developed neurologic illness.â€ť
Of the eight children tested, four were found to have cases of
enterovirus-68, ABC News reported Saturday.
â€śIt is a spectrum of arm or leg weakness that can be as mild as weakness or
as severe as paralysis,â€ť Dr. Larry Wolk, chief medical officer for
the Colorado Department of Public Health and Environment, told ABC News.
â€śWhat ties them all together though are findings of spots or lesions in the
grey matter of the spinal cord on MRI scans.â€ť He also said the children were
between the ages of 1 and 18.
Enteroviruses are relatively common usually cause between 10 million and 15
million cases a year. Symptoms usually present like a bad cold, with cough
and body aches. But this year, children have been experiencing wheezing and
other breathing problems. The CDC said enterovirus-68 â€śappears to be the
predominant type of enterovirus this year, and may be contributing to the
increases in severe respiratory illnesses.â€ť
Some 277 confirmed cases have been reported in 40 states from mid-August to
Sept. 26. But the CDC said a spike during these months is normal. â€śWeâ€™re
currently in the middle of the enterovirus season,â€ť it said in the public
statement, adding itâ€™s likely
the incidents will decline in the fall.
Visit the IB Times for the article.
Donâ€™t miss the annual UDI Conference!
As an educational authority on UDI, the 6th industry stakeholders, together
with the FDA UDI Team, will meet to ensure accurate UDI implementation and
continued adoption momentum. The annual UDI conference will take place
October 28-29, 2014, in Baltimore, MD.
HPN is proud to sponsor the UDI Conference, an important industry gathering
for medical device manufacturers, distributors, and hospitals to learn about
the UDI Regulation and the Global UDI Database (GUDID). Teams encouraged to
attend this significant conference include those from medical device
manufacturers, healthcare distributors, group purchasing organizations,
hospitals and healthcare providers and healthcare industry professionals.
What to expect if you attend the UDI conference:
Learn technical details about the UDI
Regulation from the FDA Team
See how to best utilize the Global UDI
Database (GUDID) to harness the data
Understand the requirements for your
automatic identification systems
Create a plan for implementation
Gain the knowledge and establish resources
needed to guide your organization
** NEW this year â€“ A special â€śProvider Trackâ€ť will be offered as part
of the Conference Program, which is hosted by the Association for Healthcare
Resource & Materials Management (AHRMM).
The UDI Regulation requires new/improved systems and processes to
efficiently mark/tag equipment, scan device information at various points in
its life cycle, and transmit that data to the GUDID and other software
systems. The UDI Conference allows attendees to interact directly with the
FDA UDI team, investigate UDI technology in the exhibit hall, plan a
migration path, and network with peers in the healthcare industry in one
place, at one time.
To secure a seat at the best price, when registering, enter "HPN" in the
promotional code field and automatically save $100. Team registrations are
encouraged. If 2 or more from the same company are planning to attend,
firstname.lastname@example.org to receive a discount code. Register today at
For additional conference details and the most up-to-date information,