JHC March 20

March 2020 • Vol.11 • No.2

Outbreak Response Preparedness is key for hospitals and health systems when responding to an infectious disease outbreak.

CONTENTS »» MARCH 2020

2 Cardinal announces surgical gown recall 4 Integrating Health Data 8 Outbreak Response

Preparedness is key for hospitals and health systems when responding to an infectious disease outbreak.

12 Identifying Gaps

ECRI Institute’s consulting helps providers respond to a multitude of issues related to infection control and prevention

14 Heart Disease: Talking Points Start a conversation with your physician customers by sharing news from the most recent American Heart Association’s Scientific Sessions Conferences

24 Industry News

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The Journal of Healthcare Contracting | March 2020

1

SUPPLY CHAIN

Cardinal announces surgical gown recall “To help address recall-related supply shortages, we have increased our own production of similar products and our employees have been working to identify alternative products,” Cardinal said. “In many cases, we have been working with industry partners who offer competing products. We are also offering AAMI Level 4 Gowns to help bridge the supply gap.”

Since the product hold was announced, Cardinal Health has terminated its relationship with the contract manufacturer. As of early January, the contract manufacturer is no longer registered with the FDA. “The top priority for hospitals and health systems is the safety and well-being of their patients,” said Tom Nickels, executive vice president, American Hospital In late January 2020, Cardinal Health informed customers of a voluntary recall

Association. “The AHA urges the FDA

for the surgical gowns produced by a contract manufacturer after “discovering that

and Cardinal Health to continue to provide

some gowns were produced in unapproved locations that did not maintain proper

more information and instructions for

environmental conditions as required by law, were not registered with the U.S. Food and

hospitals and health systems in order to ad-

Drug Administration (FDA) and were not qualified by Cardinal Health.”

dress their concerns about the impact this issue could have on their ability to provide care to patients. We have also encouraged

Upon learning of the issue, Cardinal

issue a hold for AAMI Level 3 surgical

member hospitals to notify the FDA about

Health said it initiated an investiga-

gowns produced by a contract manufac-

potential or actual supply issues.”

tion, quarantined the gowns, placed a

turer since September 2018,” the distribu-

hold on distribution of the gowns and

tor said in a release. “Those gowns are

priority is the safety of patients and

started communicating with customers

now subject to this voluntary recall.” Of

healthcare workers. “We apologize for

to ensure that the affected gowns were

the 9.1 million gowns included in this

the hardship caused by the recall and are

removed from use.

recall, 7.7 million units were distributed to

doing everything we can to help resolve

2,807 facilities, Cardinal said, and 1.4 mil-

this issue for our customers and the

lion were produced but not distributed.

patients they serve.”

“Based on the information we had, we determined it was necessary to proactively

2

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March 2020 | The Journal of Healthcare Contracting

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TRENDS

Integrating Health Data Physicians are preparing to integrate health data – and the technologies that

In fact, doctors and medical

harness it – into the clinical setting, writes Lloyd B. Minor, MD, dean of the Stanford

students are pursuing supplemental

University School of Medicine, in the 2020 Stanford Medicine Health Trends Report,

education in such things as advanced

“The Rise of the Data-Driven Physician.”

statistics, coding and population health, and they are open to using tools such as health apps and wearables as part of routine care, he adds.

In addition to conducting a secondary review of news articles, white papers and peer-review research for the 2020 Health Trends Report, Stanford Medicine worked with Brunswick Insight to conduct a survey of 523 U.S. physicians and 210 medical students and residents.

Algorithms and AI Approval of medical algorithms by the U.S. Food and Drug Administration has seen rapid growth over the past several

Which of the following innovations do you think have the most potential to transform the healthcare sector in the next five years?

years, according to the researchers. The

Personalized medicine Telemedicine Artificial intelligence Wearable consumer health monitoring devices Genetic screening for health risks Electronic health records Robotic surgery Virtual reality

of those algorithms are imaging-related,

Medical Futurist Institute reported in June 2019 that the FDA had approved a total of 46 algorithms since 2014. Many

Students and residents Physicians 64% 61% 58% 52% 40% 42% 41% 33% 32% 16% 15%

40% 43% 23% 19% 12%

Source: The Rise of the Data-Driven Physician, Stanford Medicine 2020 Health Trends Report

but some are being explored as tools to improve clinical workflows.

“There are still many outstanding questions about the technology, including what role AI should have in the patient-doctor relationship, ethical considerations, and, more practically, how it can best alleviate clinical practice burdens,” according to the Stanford researchers. “Having a basic fluency in AI will be important for clinicians to engage in these critical discussions going forward.”

4

March 2020 | The Journal of Healthcare Contracting

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POST-ACUTE CARE

Advanced education Nearly three-quarters of all medical students and nearly half of physicians are planning to pursue additional education in data science, according to the Stanford report.

ʯ ʯ ʯ ʯ

34% artificial intelligence.

Physicians and medical students

31% population health management.

also attribute clinical value to this data

27% clinical genomics.

when it comes to their patients as well.

23% advanced statistics and

Eighty percent of physicians and 78%

data science.

of students and residents said that

ʯ 22% coding and programming.

self-reported data from a health app is

Among medical students planning to take

“very” or “somewhat” valuable in terms

additional classes:

of clinical value, and 83% of physicians

ʯ 44% said they will pursue advanced

Wearables

and 79% of students and residents

statistics and data science.

Tomorrow’s physician will most likely

answered the same about data from a

36% population health management.

take wearables seriously. Already, 47% of

wearable device.

30% genetic counseling.

medical students, 50% of residents and

25% clinical genomics.

44% of physicians reported using a wear-

Physician is an unprecedented op-

23% coding and programming.

able health monitoring device, according

portunity to transform medicine and

13% artificial intelligence.

to the Stanford researchers. Furthermore,

improve patient outcomes,” conclude

when asked if they use the results of data

the researchers in the Stanford report.

Among physicians planning to take ad-

from their own wearable device to help

“And we are encouraged to see current

ditional classes:

inform their personal healthcare deci-

and future physicians taking steps to

sions, 67% of students, 56% of residents

actively prepare for this new era of data

and 71% of physicians said “yes.”

and digital health.”

ʯ ʯ ʯ ʯ ʯ

ʯ 38% said they will pursue genetic counseling.

“The Rise of the Data-Driven

Editor’s note: Stanford Medicine 2020 Health Trends Report, “The Rise of the Data-Driven Physician” can be found at http://med.stanford.edu/ content/dam/sm/school/documents/Health-Trends-Report/Stanford%20Medicine%20Health%20Trends%20Report%202020.pdf.

Next month: National Public Health Week Helping your provider customers deliver high-quality medical care is your daily concern. But today, the line between medicine and public health is disappearing, as providers examine the impact of things like poverty, malnutrition and inadequate housing on people’s health.

During National Public Health Week – April 6-12 – The Journal of Healthcare Contracting readers will have a chance to talk about some of these big-picture issues with customers. The American Public Health Association has posted these daily themes for NPHW 2020: ʯ Monday, April 6: Mental health (Advocate for and promote emotional well-being.) ʯ Tuesday, April 7: Maternal and child health. (Ensure the health of mothers and babies throughout the lifespan.) ʯ Wednesday, April 8: Violence prevention. (Reduce personal and community violence to improve health.) ʯ Thursday, April 9: Environmental health. (Help protect and maintain a healthy planet.) ʯ Friday, April 10: Education. (Advocate for quality education and tools.) ʯ Saturday, April 11: Healthy housing. (Ensure access to affordable and safe housing.) ʯ Sunday, April 12: Economics. (Advocate for economic empowerment as the key to a healthy life.)

For more information on National Public Health Week, go to http://www.nphw.org/nphw-2020

6

March 2020 | The Journal of Healthcare Contracting

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8

March 2020 | The Journal of Healthcare Contracting

Outbreak Response Preparedness is key for hospitals and health systems when responding to an infectious disease outbreak.

The novel coronavirus (COVID-19) is not the first, nor will it be the last, infec-

making. SHEA members – healthcare

tious disease outbreak to make global headlines. “There have been a number of

epidemiologists and other experts in in-

outbreaks that have taught us that routine healthcare infection prevention is not enough

fection prevention and infectious diseases

when dealing with a novel infectious disease or an infection that has potential for caus-

working in collaboration with public

ing a lot of morbidity and mortality,” said Jennifer Anne Hanrahan, DO, an infection

health – are experienced in outbreak

disease specialist from the University of Toledo.

management, having overseen preparedness and management of COVID-19,

SARS, MERS-CoV, and Ebola have been transmitted in healthcare facilities, and preventing the spread of infection in hospitals is critical to containing these infections worldwide.

“These outbreaks have shown that emerging pathogen outbreaks can occur with little forewarning and cause disruption to hospitals and their ability to care for patients and keep healthcare workers safe,” Dr. Hanrahan said.

Being prepared The Society for Healthcare Epidemiology of America (SHEA) emphasizes the importance of supporting novel Coronavirus (COVID-19) preparedness efforts with rigorous commitment to infection prevention and science-based decision

Being prepared takes time, Hanrahan said.

“It can feel overwhelming when starting from scratch, and these tools help make preparation manageable.”

The Journal of Healthcare Contracting | March 2020

SARS, MERS-CoV, H1N1, influenza, and other infectious diseases, and are working diligently to ensure safety.

SHEA works closely with the Centers for Disease Control and Prevention (CDC), and over the past several years has given particular focus and investment to strengthen the infection prevention and control infrastructure for preparedness and response to emerging pathogens. The SHEA/CDC Outbreak Response Training Program (ORTP), created from 2016 to 2018, is a comprehensive program for hospital epidemiologists to be maximally effective to protect their patients, colleagues, and community from facility-level outbreaks to emerging pathogens, such as COVID-19. The ORTP provides expert-authored and selected resources in incident management, with tools and trainings

9

CORONAVIRUS

for development and implementation of

ponents of preparedness and response,

“Every outbreak has taught us a little

policies and identification of resources.

including successful implementation of

bit more and it is important to incorpo-

“The ORTP was developed to make sure

policies, and provides quick, direct access

rate these lessons into future planning,”

that those working in infection prevention,

to resources and tools selected by experts

said Hanrahan.

specifically healthcare epidemiologists and

as the most important and useful. The

infection preventionists, are knowledgeable

ORTP was created so the experts tasked

SHEA/CDC Outbreak Response

in incident management and the structures,

with preparedness and response can apply

Training Program (ORTP), visit

frameworks, and resources that help limit

their expertise to stopping the outbreak,

https://learningce.shea-online.org/

facility disruption, supplement resources, and

rather than spending precious time track-

content/sheacdc-outbreak-response-

prevent the spread of the pathogen,” said

ing down resources and navigating new or

training-program-ortp#group-tabs-

Hanrahan. “These outbreaks showed that

unpracticed roles.

node-course-default4.

For more information on the

education in incident management and preparation to work within an emergency response framework is essential stopping an emerging pathogen crisis.”

Being prepared takes time, Hanrahan said. “It can feel overwhelming when starting from scratch, and these tools help make preparation manageable.”

There are several different things that hospitals and healthcare workers have to think about in terms of their process for taking care of patients. For example, these outbreaks have demonstrated that training in proper donning and doffing techniques for personal protective equipment

Identifying gaps Both Ebola and SARS demonstrated that routine personal protective equipment was not sufficient to prevent infection in healthcare workers, said Jennifer Anne Hanrahan, DO, from the University of Toledo. “Learning how to don and doff the personal protective equipment properly takes time and practice and is specific to the type of equipment being used. Training is critical to properly donning and doffing PPE.” A number of other issues have also been identified and these are outlined in the SHEA Expert Guidance: Outbreak Response and Incident Management: SHEA Guidance and Resources for Healthcare Epidemiologists in United States Acute-Care Hospitals https://doi.org/10.1017/ice.2017.212.

(PPE) is critical in order to decrease risk of infection to healthcare workers and

Tool kits: https://ortp.guidelinecentral.com

other patients, Hanrahan said. The ORTP guides healthcare workers in the com-

10

March 2020 | The Journal of Healthcare Contracting

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INFECTION PREVENTION

Identifying Gaps ECRI Institute’s consulting helps providers respond to a multitude of issues related to infection control and prevention

On any given day in the United States, about 1 in 25 hospital patients has at least one healthcare-associated infection (HAI), according to estimates.

“ECRI’s engineering team has performed comparative evaluations in our testing laboratory of automated handhygiene devices and equipment to help

Indeed, there are quite a few areas that

12

For example, lapses in sterilization and

hospitals know which products are best

create vulnerabilities for infections at hos-

high-level disinfection are especially con-

for reducing infection risks,” said Davis.

pitals and health systems, said James Davis,

cerning, he said. There are environmental

“Other areas of vulnerability involve in-

MSN, RN, CCRN-K, HEM, CIC, FAPIC,

and construction-related factors. Hand

fection prevention program management,

Senior Infection Prevention & Patient

hygiene is a well-known concern for the

medical device issues broadly, as well as

Safety Analyst/Consultant, ECRI Institute.

spread of infections.

infection prevention considerations in the

March 2020 | The Journal of Healthcare Contracting

expert), we fly them out to get the job The following are best practices ECRI helps hospitals and health systems develop for better infection prevention: ʯ Situational awareness processes, policies, procedures, supply procurement and facility risk assessment – (Ebola, SARS, Influenza, COVID-19) ʯ Health IT: For example, modification of the electronic health record (EHR) to capture process and outcome measures for infection-related issues. The Partnership for Health IT Patient Safety, a multi-stakeholder collaborative convened and operated by ECRI Institute looks at these types of issues and our infection preventionists add to the content where/ when appropriate. ʯ Regulatory and certification preparedness and response to regulators/inspectors.

done right the first time.”

Davis said the ECRI Infection Preventionists look at a variety of inputs to develop the gap analysis and action plans from (but not limited to): 1. Systems (physical and electronic) 2. Devices (medical and standard) 3. Mechanicals/plant engineering 4. Staffing 5. Workflow 6. Infection prevention program effectiveness 7. Data validation 8. Surveillance techniques

“ Behind each consultant stands the power of ECRI’s full knowledge base of multidisciplinary experts, making ECRI unique in these consultations.”

– James Davis

(manual and electronic) 9. Epidemiologic data and analysis 10. Human factors/ergonomics 11. Cleaning and disinfection 12. Sterilization/high level disinfection 13. Environmental factors/ industrial hygiene 14. Infection control risk assessment for construction (consultation, planning, program evaluation,

selection and procurement of equipment

while ECRI staff of medical device

and devices.”

engineers, epidemiologists, architects,

15. Policy and procedure review

accident and forensics specialists, and

16. Implementation science

clinicians review findings and provide

17. Infection forensics

Consultation ECRI receives a broad range of requests

onsite and online training)

additional recommendations.

“For example, if we are onsite for

“ECRI is basically a one-stop shop for

from hospitals and healthcare systems for

an outbreak and the consultant sus-

infection prevention and control consulta-

infection prevention and control (IPC)

pects that that the potential reservoir

tion and resources.”

consultation. To meet those requests,

is medical-device related, we immedi-

ECRI has developed an IPC consultation

ately call in the expertise of the clinical

that is led by certified infection control-

engineering staff in our Health Devices

prepared experts with advanced degrees.

group,” said Davis. “That instant ex-

“Behind each consultant stands the

pertise advises us, in real time, about

power of ECRI’s full knowledge base of

the nature of the device and potential

multi-disciplinary experts, making ECRI

mechanisms that would put the device

unique in these consultations,” said Davis.

at risk for being a causative factor.

ECRI Institute’s certified infection

If we need an engineer or a medical

preventionists conduct onsite consultations,

forensics expert onsite (or any other

The Journal of Healthcare Contracting | March 2020

ECRI has been updating its Coronavirus Outbreak Preparedness Center on a regular basis.

The resources include very specific information on emergency preparedness supplies.

13

HEALTH FOCUS

Heart Disease: Talking Points Start a conversation with your physician customers by sharing news from the most recent American Heart Association’s Scientific Sessions Conferences

E-cigarettes match traditional smoking in some heart risks

even more than traditional cigarettes. The preliminary findings were presented at

blood flow in 19 smokers, ages 24 to 32,

E-cigarettes may be perceived as safer

the American Heart Association's most

immediately before and after using either

than traditional cigarettes, but two studies

recent Scientific Sessions meeting, held in

e-cigarettes or traditional cigarettes. Blood

say they are just as dangerous, or even

November 2019 in Philadelphia.

flow was measured while participants

worse, for your heart. One study found

14

In the first study, which included 476

The second study analyzed heart

were at rest and again as they performed a

vaping can worsen several heart disease

healthy adults, e-cigarette users had higher

risk factors – cholesterol, triglycerides and

“bad” LDL cholesterol and lower overall

glucose levels – at levels equal to tradi-

cholesterol compared to nonsmokers.

director of public health research at

tional cigarettes. A second study found e-

In people who both vaped and smoked,

Cedars-Sinai Medical Center, said the

cigarettes decrease blood flow in the heart

“good” HDL cholesterol was lower.

finding that heart blood flow was reduced

handgrip exercise.

Study co-author Dr. Susan Cheng,

March 2020 | The Journal of Healthcare Contracting

in e-cigarette users while at rest was a

People who follow DASH eat foods

have worse outcomes than people who

surprise. “Providers counseling patients

low in salt and that contain high levels

on the use of nicotine products will want

of nutrients to help lower blood pres-

to consider the possibility that e-cigs may

sure, such as potassium, magnesium and

data on 5,747 HIV-positive and 33,497

confer as much and potentially even more

calcium. These foods include fresh fruit

HIV-negative veterans with heart failure

harm to users and especially patients at

and vegetables, beans and lentils, and

being cared for from 2000 to 2018 in the

risk for vascular disease,” she said.

whole grains.

Veterans Affairs Health Care System.

don't have HIV.” Erqou and his colleagues analyzed

The study found 30.7% of HIV-positive veterans with heart failure died from any

High blood pressure, unhealthy diets in women of childbearing age

HIV could increase risk of death from heart failure

cause, compared with 20.3% of HIV-neg-

After a heart failure diagnosis, people who

admission rates for any cause were 50.2%

One in five women of childbearing age

are HIV-positive are more likely to be hos-

for those with HIV compared with 38.5%

has high blood pressure, and a new study

pitalized or die of any cause than those not

for those without.

shows that few of them are on a diet that

infected with HIV, new research shows.

could help them – and their babies – re-

The study is the largest to date to look at

duce their risk for health problems.

how HIV status affects people diagnosed

ative veterans with heart failure. Hospital

with heart failure, a chronic condition in

Obesity, other factors may speed up brain aging

any cause are associated with hyperten-

which the heart is unable to pump enough

The brains of middle-age adults may be

sion. Women who go into a pregnancy

blood and oxygen that cells need.

aging prematurely if they have obesity

Nearly 40% of maternal deaths from

with high blood pressure are at risk of having a baby who has a low birth weight or is born premature. Dr. Lara Kovell, an assistant professor of cardiology at the University of Massachusetts Medical School in Worcester, presented preliminary findings of the study at the American Heart Association's Scientific Sessions in Philadelphia.

Kovell and her colleagues analyzed data

People who follow DASH eat foods low in salt and that contain high levels of nutrients to help lower blood pressure, such as potassium, magnesium and calcium. These foods include fresh fruit and vegetables, beans and lentils, and whole grains.

collected on 8,740 women ages 20 to 50 taking part in a national health and nutrition study from 2001 to 2016. They found that 22.4% had high blood pressure.

“We found that people with heart failure who are HIV-positive are more

or other factors linked to cardiovascular disease, new research has found.

Researchers scored how healthy

likely than those who are HIV-negative to

Almost one-quarter of adults have

the women ate and how much salt they

be smokers, have heart and liver disease,

metabolic syndrome, a set of factors that

consumed compared to guidelines set

and have depression or abuse drugs,” said

in combination amplify a person's risk of

out in the Dietary Approaches to Stop

lead study author Dr. Sebhat Erqou, an

heart disease, diabetes, stroke and other

Hypertension – or DASH – diet. It is

assistant professor of medicine at Brown

illnesses. In the research, participants were

recommended for all adults with high

University in Providence, Rhode Island.

considered metabolically unhealthy if they

blood pressure. They found that 7% of

He also is a cardiologist at the Providence

had two or more such factors: high blood

the women who had high blood pressure

VA Medical Center and Lifespan Cardio-

pressure; high blood sugar; high blood

were adhering to a DASH-like diet, while

vascular Institute. “But even after taking

triglyceride levels; or low levels of HDL,

10% with normal blood pressure were.

this into account, people with HIV still

the "good" cholesterol – or if they took

The Journal of Healthcare Contracting | March 2020

15

HEALTH FOCUS

medicine for diabetes, high blood pressure or cholesterol.

Participants were part of the Fram-

to the loss of neurons and supporting

ingham Heart Study, a decades-long

cells, said lead researcher Dr. Rebecca

investigation of cardiovascular disease

Angoff, clinical fellow in medicine at Har-

imaging and tests of thinking skills to

risk. None had diabetes or neurological

vard Medical School's Beth Israel Dea-

evaluate more than 2,100 women and

conditions such as stroke or dementia.

coness Medical Center in Boston. "Aging,

men ages 37 to 55. Compared with the

Among people who were metabolically

decreased blood flow and diseases like

healthiest participants, those who were

unhealthy, MRIs revealed lower total cere-

Alzheimer's can lead to a smaller brain."

metabolically unhealthy, obese or both

bral brain volume – in essence, a smaller

showed evidence of brain decline. The

brain – than was measured in metaboli-

cally unhealthy and obese showed the

preliminary study was presented in No-

cally healthy people.

most signs of subtle injury to the brain's

Researchers used magnetic resonance

vember at the American Heart Associa-

Lower cerebral brain volume is a sign

tion's Scientific Sessions in Philadelphia.

of injury throughout the brain that leads

Participants who were both metaboli-

white matter – tissue that provides crucial connections throughout the brain. These injuries, which have been linked to early

Research has begun to reveal a link between calcium buildup in the breast and coronary artery calcification, an established measure that helps predict cardiovascular disease risk.

Alzheimer's disease, result from blood vessel abnormalities and may be due to risk factors such as high blood pressure and diabetes, Angoff said.

On the cognitive tests, obesity was linked to poorer scores. Specifically, those who were obese but metabolically healthy performed worse on a combination of six tests of thinking skills, and on individual tests that measured verbal memory and abstract reasoning. Participants who were obese and metabolically unhealthy scored lower for abstract reasoning and on a test measuring visual details and spatial memory.

Could mammograms screen for heart disease?

By screening for breast cancer, mammography has helped save hundreds of thousands of lives. Using the test to also screen for heart disease might someday help save many more.

Besides revealing masses that may be tumors, digital mammography – a technique in which low-dose X-ray images are captured and enhanced using computer technology – can reveal buildup of calcium in the arteries in the breast. About 13% of women are estimated to have this buildup, called breast arterial calcification,

16

March 2020 | The Journal of Healthcare Contracting

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HEALTH FOCUS

or BAC, including about 10% of women

colleagues presented preliminary research

in their 40s and around half of women in

examining the utility of BAC in predicting

their 80s.

existing or future heart failure, a condi-

Meth use producing younger, harder-to-treat heart failure patients

tion in which the heart is weakened and

Widespread methamphetamine use is

doesn't pump properly.

creating a unique form of severe heart

Early studies so far have found BAC’s presence appears to signal an elevated risk for heart attack, stroke and other car-

failure, according to research that shows

diovascular consequences. Research has

2006-2016 for 278 middle-aged and older

these patients tend to be younger and

begun to reveal a link between calcium

women who had both a mammogram and

have poor outcomes, according to the

buildup in the breast and coronary artery

coronary calcium test within a one-year

American Heart Association. “This is a

calcification, an established measure that

window. Almost one-third of the women

strikingly different type of patient,” said

helps predict cardiovascular disease risk.

had BAC, and 7% had heart failure. Even

Dr. Isac Thomas, an assistant professor

after accounting for age, diabetes and

at the University of California, San Diego

Scientific Sessions conference in Novem-

high blood pressure, all heart failure risk

School of Medicine, and lead author of a

ber 2019, Dr. Quan Minh Bui, general

factors, women with calcium buildup in

study released at the American Heart As-

cardiology fellow at the University of

the breast arteries had 2.2 times the odds

sociation’s Scientific Sessions conference

California, San Diego, and his UCSD

of having or developing heart failure.

in Chicago in November 2018.

At the American Heart Association's

18

The study looked at records from

March 2020 | The Journal of Healthcare Contracting

The non-acute continuum is complicated.

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Did you know 34% of health system leaders say that aligning their non-acute supply chain is their biggest challenge?*

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HEALTH FOCUS

In the study, Thomas and his colleagues reviewed electronic health records for patients treated at UC San Diego Health between 2005 and 2016. They identified 4,470 patients with methamphetamine abuse; 20,576 patients with heart failure; and 896 patients with both meth abuse and heart failure.

Compared to the average 67-year-old heart failure patient in the study, people with heart failure who use meth were 17 years younger and predominantly male.

Compared to the average 67-year-old heart failure patient in the study, people with heart failure who use meth were 17

The CAC takes cross-sectional images

American Heart Association's Scientific

years younger and predominantly male.

of the vessels that supply blood to the

Sessions meeting.

They also were more likely to have other

heart muscle, to check for the buildup of

substance abuse or psychiatric problems,

calcified plaque. The measurement can

rates in the U.S. have declined in recent

such as mood and anxiety disorders. Even

help a doctor identify who is at risk for

decades among 35- to 74-year-olds.

though meth-using patients were younger,

heart disease before a person has signs or

But in a more recent study, research-

they had a higher five-year hospital read-

symptoms. The test isn’t recommended

ers wanted to look specifically at how

mission rate for heart failure.

for everyone, but according to the guide-

many younger people were having heart

lines, some groups where CAC testing

attacks. They included data from a multi-

may be useful are:

state study of more than 28,000 people

The good news is, other studies suggest that if meth users with heart failure go through a treatment program and

ʯ People reluctant to begin statin

hospitalized for heart attacks from 1995

stop using the drug, depending on the

therapy and who want to understand

to 2014. The results showed 30% of

amount of inflammation and scarring,

their risk and potential benefit

those patients were young, age 35 to 54.

there is the potential to reverse some of the heart damage. The challenge, says Thomas, is for doctors to identify these patients, who can mistrust healthcare providers and don't always disclose drug use.

Coronary calcium test could help clarify heart disease risk – and control cholesterol

more precisely.

More important, they found the

ʯ People concerned about restarting

people having heart attacks were

statin therapy after stopping

increasingly young, from 27% at the

treatment because of side effects.

start of the study to 32% at the end.

ʯ Men ages 55 to 80 or women 60

Among women having heart attacks,

to 80 with few risk factors who

the increase in young patients went

question whether they would benefit

from 21% to 31%, a bigger jump

from statin therapy.

than in young men. Researchers also

ʯ People ages 40 to 55 with an

found that young women had a lower

estimated 10-year risk for developing

probability than men of getting lipid-

heart disease between 5% and 7.5%,

lowering therapy, including antiplatelet

When doctors are sorting out what to

and risk factors that increase their

drugs, beta blockers, coronary angiog-

do about a patient's cholesterol, a key

chances of heart disease.

raphy and coronary revascularization.

calculation is the patient's future risk for

“Traditionally, coronary artery disease

developing heart disease. But what if that

is seen as a man's disease, so women who come to the emergency department with

coronary artery calcium test (CAC) can

Heart attacks are becoming more common in younger people, especially women

help identify patients between 40 and 75

Heart attacks are increasingly occurring

author and a cardiology fellow at the Uni-

years who will benefit from statins when

in younger people, especially women,

versity of North Carolina School of Medi-

risk status is uncertain.

according to a study presented at the 2018

cine. “Also, the presentation of heart attack

risk is uncertain? Cholesterol guidelines released in November 2018 suggest a

20

Past research has shown heart attack

chest pain might not be seen as high-risk,” said Dr. Sameer Arora, the study's lead

March 2020 | The Journal of Healthcare Contracting

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HEALTH FOCUS

is different in men and women. Women

people with diabetes who are age 40 to

be diagnosed as Type 2 diabetes. Over

are more likely to present with atypical

75. The guidelines also give other recom-

the past 20 years, the number of adults

symptoms compared to men, and their

mendations for people with diabetes

diagnosed with diabetes has more than

heart attack is more likely to be missed.”

based on age and other risk factors.

tripled as the population has aged and

The reality has been scientifically clear for a while, but many people are not aware

become more overweight or obese.

There are well-established risk factors

People with diabetes need to monitor cholesterol

of the connection: Middle-age adults with

for heart disease, such as smoking, high

diabetes are usually considered at moderate

blood pressure and high blood sugar.

For people with diabetes, blood sugar

to high risk for cardiovascular disease.

There also are what the new cholesterol

isn’t the only important measurement.

More than 30 million people in the

guidelines call “risk-enhancing factors”

The most recent cholesterol guidelines,

United States have diabetes, although

such as family history, chronic kidney dis-

issued in November 2018, suggest the

one in four doesn't know it, accord-

ease and metabolic syndrome. Metabolic

more than 110 million U.S. adults with

ing to Centers for Disease Control and

syndrome is a cluster of at least three

diabetes or prediabetes also should

Prevention (CDC). Another 80 million

diagnosed conditions, including high

manage their cholesterol. The guidelines

have prediabetes, a serious health condi-

blood pressure, high blood sugar, excess

suggest doctors consider prescribing

tion where blood sugar levels are higher

body fat around the waist and abnormal

cholesterol-lowering drugs (statins) to

than normal, but not high enough yet to

cholesterol levels.

Medicare adds coronary angioplasty to ASC coverage The Centers for Medicare & Medicaid Services (CMS) added six coronary intervention procedures to its list of ambulatorysurgery-center-covered surgical procedures. Effective Jan. 1, the following three coronary intervention procedures, and three associated add-on procedures, were to be covered by Medicare:

ʯ CPT code 92920 (Percutaneous transluminal coronary ʯ ʯ ʯ

angioplasty; single major coronary artery or branch).

CPT code 92921 (Percutaneous transluminal coronary angioplasty; each additional branch of a major coronary artery (list separately in addition to code for primary procedure).

CPT code 92928 (Percutaneous transcatheter placement of intracoronary stent(s), with coronary angioplasty when performed; single major coronary artery or branch).

CPT code 92929 (Percutaneous transcatheter placement of intracoronary stent(s), with coronary angioplasty when performed; each additional branch of a major

ʯ

ʯ

coronary artery (list separately in addition to code for primary procedure).

CPT code C9600 (Percutaneous transcatheter placement of drug eluting intracoronary stent(s), with coronary angioplasty when performed; single major coronary artery or branch).

CPT code C9601 (Percutaneous transcatheter placement of drug-eluting intracoronary stent(s), with coronary angioplasty when performed; each additional branch of a major coronary artery (list separately in addition to code for primary procedure) to the ASC CPL.

“While we acknowledge that a majority of Medicare beneficiaries may not be suitable candidates to receive these procedures in an ASC setting due to factors such as age and comorbidities, we believe it is important to make these procedures payable in the ASC setting, in order to ensure access to these coronary intervention procedures for those beneficiaries who are appropriate candidates to receive them in an ASC setting,” wrote CMS in its Final Rule. (https://www.federalregister.gov/documents/2019/11/12/2019-24138/medicare-program-changes-to-hospitaloutpatient-prospective-payment-and-ambulatory-surgical-center)

22

March 2020 | The Journal of Healthcare Contracting

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PATIENT CARE

INTERVENTIONAL CARE

ENVIRONMENT OF CARE

NEWS

CORONAVIRUS NEWS • WEEK OF FEB. 17-21 China reports sharp drop in new cases, but doubts re-emerge over data

situation, [and] the Australians, Canadians.

U.S. lawmakers to boost U.S. production

I’m speaking mostly generic medicines,

of medical masks. Bowen wrote President

which are 90% of the medicines we take.”

Barack Obama in 2010 and President

The Hubei province at the center of the

Read more of Gibson’s opinions here.

Donald Trump in 2017, warning of the

novel coronavirus outbreak reported

million masks a day if it runs its machines

infections raised concerns about the reliability of the data. The China death toll

Drugmakers in India, which produce 20%

Texas facility, scarred by the boom-bust

tops 2,000 and cases top 75,000. Initially,

of the world’s drug supply by volume, are

cycle that occurred after the swine flu

Chinese authorities were using nucleic

bracing for potential disruption from the

pandemic in 2009. Read more here.

acid tests to confirm virus presence, but

coronavirus. The outbreak threatens to

those tests require days of processing and

disrupt the supply of raw materials from

led to nucleic acid shortages. The Hubei

China. Enough supplies are currently on

U.S. hospitals prep for spread of coronavirus in the states

province introduced a faster diagnostic

hand to continue production, but opera-

Hospitals are bracing for the potential

method last week through CT scans to

tions could be threatened if the outbreak

spread of coronavirus in the U.S. The

reveal lung infections and confirm the

continues to cause disruption in China.

strict quarantine and screening measures

virus, leading to a sharp increase in cases.

Approximately 70% of the raw materi-

enacted by the CDC have given hospi-

However, on Wednesday, authorities said

als India uses in drug manufacturing are

tals time to review their pandemic plans

they were removing that category of clini-

imported from China, and the Hubei

and stockpile needed equipment. “We’re

cally diagnosed cases from their criteria

province is a major production hub. India

buying some time now that it hasn’t really

of confirmed cases, resulting in 279 cases

is the world’s largest exporter of generic

spread so much in the United States,” Dr.

being removed from the Hubei count.

drugs, sending large volumes to the U.S.

Mark Jarrett, the chief quality officer for

Read more here.

It’s estimated that companies that make

Northwell Health (New York, NY), told

anti-infective and hormone therapies

MedicineNet. “That’s giving us a chance

are most at risk from material shortages.

to gear up factories and address supply

Read more here.

chain issues.” The coronavirus epidemic

another change in how China diagnoses

Expert warns of mass U.S. medicine shortages by mid-March if COVID-19 continues to ravage China

24

shortage. Prestige Ameritech can make 1

Drugmakers in India particularly vulnerable to shortages due to coronavirus

a steep drop in new cases. However,

around the clock. However, Bowen is hesitant to ramp up production at his

has hampered supply chains out of China and is highlighting the problems with U.S.

Rosemary Gibson wrote the book, “China

Texas manufacturer caught in coronavirus supply chain panic

Rx: Exposing the Risks of America’s

Prestige Ameritech (Fort Worth, TX), a

supply orders. That, on top of a tough

Dependence on China for Medicine,” and

full-line domestic surgical mask manufac-

U.S. flu season, is straining the capacity of

she predicts the U.S. will see shortages of

turer, was producing 600,000 masks each

many hospitals. Read more here.

medicines by mid-March if conditions

day but struggling to meet demand as the

do not vastly improve in China due to

number of coronavirus cases in China

coronavirus. “We should never have been

skyrocketed in the past week. CEO Mike

Outbreak helps U.S. lawmakers push case on drug shortage bills

in this situation,” Gibson told WCNC

Bowen was receiving cold calls on his cell

With no end in sight for the coronavirus

(Charlotte, NC). “All roads lead to China

phone from people saying they represent-

outbreak, it is prompting fears of drug

in the core ingredients, the chemicals, the

ed foreign governments and wanted to

shortages in the U.S. due to the pharma-

molecules – the real starting material to

make bulk purchases. Bowen said this was

ceutical supply chain’s reliance on China.

make our medicines. China’s dominance

the exact scenario he predicted 15 years

The epidemic is helping U.S. lawmakers

is global. The Europeans are in the same

ago when he asked federal agencies and

who were already working on bills to

hospitals’ dependence on “just-in-time”

March 2020 | The Journal of Healthcare Contracting

NEWS

address drug shortages prove their point.

and other drugs if supply problems from

global supply chain for many prod-

Rep. Anna Eshoo (D-CA) chairs the

China’s coronavirus outbreak cannot be

ucts. Some drugmakers in China have

Energy and Commerce Health Subcom-

resolved soon. EU Chamber of Com-

restarted production after an extended

mittee and has been looking at this issue

merce President Joerg Wuttke added that

break for the Chinese New Year, but

since last fall when her panel held a hear-

Beijing was making supply chain problems

worldwide governments are trying to

ing on the drug supply chain. Read more

worse with a mandatory quarantine of

determine whether drug shortages will

about her thoughts here and what she

arrivals from abroad. The capital city in

result from the continued coronavirus

told Roll Call, a newspaper and website

China is requiring a 14-day quarantine for

outbreak. Concerns were raised by health

in Washington, D.C., in a podcast.

all arrivals, which Wuttke said would make

ministers from France and Finland at an

it difficult to fly in technical experts to help

emergency meeting Brussels (Belgium)

SARS-like damage seen in dead coronavirus patient

if facilities are down. Wuttke called the

about shortages. The FDA has stated

measures against WHO guidelines. He also

that it is vigilant about added resources

A lung biopsy of a Chinese patient who

said the disruption from the epidemic had

and is monitoring the situation closely.

died of the coronavirus COVID-19

driven home diversifying away from China.

Historically, the FDA and drugmakers

found that he had lung damage reminis-

Read more here.

have turned to alternate suppliers to help

cent of two prior coronavirus-related

make up shortfalls. Read more here.

died on Jan. 27 after falling ill two weeks

Wuhan hospital director dies as death toll nears 2,000

earlier. He was treated with various medi-

Liu Zhiming, the director of Wuhan’s

cations, including anti-infection treatment

Wuchang Hospital, died Tuesday at the

FDA response to active supply chain surveillance amid outbreak

alfa-2b, HIV medications lopinavir and

age of 51. Wuhan Municipal Health

The FDA states that it is aware of the

ritonavir and the antibiotic moxifloxacin

Commission confirmed the death in a

likely impact on the medical product sup-

to prevent secondary bacterial infection.

statement saying, “Since the outbreak,

ply chain, including potential disruptions

His fever decreased as a result of the

Comrade Liu Zhiming, regardless of his

to supply or shortages of critical medical

treatment, but his breathing worsened,

personal safety, led the medical staff of

products in the U.S., due to the coronavi-

and his blood-oxygen levels fell dramati-

Wuchang Hospital to fight the epidemic,

rus outbreak. The FDA states that it is not

cally. According to a new report in The

and made important contributions to the

waiting for drug and device manufactur-

Lancet, “The pathological features of

prevention and control of new-type coro-

ers to report shortages, but is proactively

COVID-19 greatly resemble those seen in

navirus pneumonia in our city.” Thou-

reaching out to manufacturers as part

SARS and MERS coronavirus infection.

sands of medical workers from across

of its approach to identifying potential

In addition, the liver biopsy specimens

China have been sent to Wuhan in recent

disruptions or shortages. It has dedicated

of the patient with COVID-19 showed

weeks to help the overwhelmed local

additional resources to review and coor-

moderate microvascular steatosis and mild

authorities. Liu is the ninth known fatality

dinate data to better identify any potential

lobular and portal activity, indicating the

among medical personnel battling the

vulnerabilities to the U.S. medical product

injury could have been caused by either

epidemic in China. The current death toll

sector. Finally, it confirms that it has been

SARS-CoV-2 infection or drug-induced

is 1,868 dead with 72,436 confirmed cases

in contact with hundreds of manufacturers

liver injury.” Read more here.

in mainland China. Read more here.

of human and animal drugs and medical

outbreaks, SARS and MERS. The patient

devices, as well as syncing up with global

26

Pharmacies may face shortage of antibiotics, other drugs if supply problems cannot be resolved

Worldwide concern for drug shortages grows as outbreak continues

regulators, like the European Medicines

The head of a European business group

China is the largest producer of active

manufacturing discontinuances

in China warned Tuesday that the world’s

pharmaceutical ingredients (APIs) in

or interruptions due to the outbreak.

pharmacies may face a shortage of antibiotics

the world and is the starting point in the

Read more from the FDA here.

Agency, to assess and monitor for indications and early warning signs of potential

March 2020 | The Journal of Healthcare Contracting

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NEWS

WEEK OF FEB. 10-14 Coronavirus more contagious than flu, less deadly The new strain of coronavirus, now

Coronavirus exposes U.S. pharma’s supply chain vulnerability, writes Tennessee senator

Coronavirus test kits shipped to U.S. states are not working as expected

formally named COVID-19, is “a lot

It has been more than 50 years since

Some of the coronavirus test kits

more contagious” than the flu, ac-

the last federal quarantine was issued, to

shipped to labs across the U.S. are not

cording to AstraZeneca CEO Pascal

control a deadly smallpox outbreak. Dr.

working as they, according to the CDC.

Soriot. “What we have all learned is

Janet Woodcock, the director of the FDA’s

As a result, the CDC is remaking parts

that the virus leads to a lower mortal-

Center for Drug Evaluation and Research,

of the test kits after some produced

ity than the flu virus, but it’s a lot

testified before Congress this past October

inconclusive test results. The kits were

more contagious, the virus is very

that the U.S. “has become a world leader in

sent to states to speed up the testing

contagious,” Soriot told CNBC. At

drug discovery and development, but is no

process, but the states discovered the

least 19 million people across the

longer in the forefront of drug manufac-

flaw during the verification process.

U.S. have been infected with the flu

turing.” Sen. Marsha Blackburn (R-TN)

However, not all states have been af-

virus this flu season, according to the

writes on the U.S. pharma supply chain

fected. For example, the Illinois Depart-

CDC, and it has resulted in 10,000

and its reliance on China here.

ment of Public Health said it has not had any issues with the kits and it is

deaths and 180,000 hospitalizations.

continuing with its testing for the coro-

is optimistic that Chinese authorities

Coronavirus cases spike in China; death toll over 1,300, caseload over 60,000

would be able to contain the virus.

Doctors in China have adopted a new

with the latest one reported among U.S.

Read more here.

way of diagnosing the novel coronavirus,

evacuees at a military base in San Diego

leading to a spike of 23% in confirmed

County, CA. Read more here.

Soriot said, despite the high contagion rate of the COVID-19 virus he

28

navirus. There have been 14 confirmed coronavirus cases reported in the U.S.

CDC director says coronavirus could stay in U.S. through the year and beyond

cases and a jump in the number of deaths

Dr. Robert Redfield, the director of

when a person tested positively for the

the CDC, says that the coronavirus will

virus, but the government is no longer

Moody’s indicates healthcare companies to see mixed results from expanded coronavirus outbreak

likely stay for “beyond this season, or

requiring a positive test. New cases are

U.S. healthcare companies would see

beyond this year,” in the U.S. “Right

now being confirmed if a person is simply

mixed effects of a more significant

now, we’re in aggressive containment

diagnosed by a doctor. Officials in Hubei

coronavirus outbreak within and

mode,” said Redfield. “I think even-

province, the heart of the outbreak,

outside of China, according to a new

tually the virus will find a foothold

reported 254 new deaths and 15,152 new

stress report from Moody’s Inves-

and we will get community-based

cases of coronavirus. The increase brought

tors Service. If the outbreak spreads

transmission.” Redfield said it would

the death toll to at least 1,369 and the

significantly in China, it would dampen

become a disease like the seasonal flu

number of confirmed cases to more than

demand for U.S. healthcare companies

and questioned whether China has the

60,000. “We’re now getting a better indica-

that sell products there. Moody’s said

situation under control, suggesting that

tion of what’s actually happening in the

it is already seeing evidence of that

the country allow the CDC to conduct

community,” John Nicholls, a professor of

on medical device companies’ earn-

on-the-ground work. Only the World

pathology at the University of Hong Kong

ings calls. Companies that use Chinese

Health Organization (WHO) has been

and a prominent researcher during the

components, including pharmaceutical

helping China assess the outbreak so

SARS outbreak in 2003, told CBS News.

ingredients, to make their products could

far. Read more here.

Read more here.

also suffer supply chain disruptions. The

blamed on the virus. China previously only counted a coronavirus case as confirmed

March 2020 | The Journal of Healthcare Contracting

NEWS

turing and supply chain partners, as well

ences and Johnson & Johnson (J&J) are

Coronavirus may be over by April in China, but WHO warns of global threat

working to develop novel medications

Coronavirus infections in China may be

WHO, the Chinese Ministry of Health,

or use existing ones to treat or prevent

over by April, according to China’s senior

and the CDC, to address shortages as

conditions. Read more here.

medical advisor, but the WHO warns of

they occur. Given this situation and acute

outbreak also provides some opportunity. U.S. drug companies like Gilead Sci-

the Pandemic Supply Chain Network,

a “very grave” global threat. China’s fore-

market needs, we anticipate disruptions

CMS reminds providers to review infection control protocols amid outbreak

most medical advisor on the outbreak,

to orders for certain infection products

Zhong Nanshan, has said numbers of

in various markets. Please contact your

new cases were falling in some places and

local Henry Schein consultant for specific

CMS sent a memo to state survey

held out hope the epidemic may peak this

inventory inquiries.” A spokesperson

agency directors, encouraging all

month. Zhong won fame for his role in

for Henry Schein, speaking to Business

healthcare facilities to carefully review

combating the outbreak of SARS in 2003.

Insider, said, “It’s too soon to say what

their infection control information and

However, WHO chief Tedros Adhanom

the long-term effects will be on busi-

protocols amid the coronavirus out-

Ghebreyesus appealed for the sharing of

ness from the outbreak. Henry Schein

break. “Because coronavirus infections

virus samples and speeding up research

reports on our Q4 financial results later

can rapidly appear and spread, facilities

into drugs and vaccines. “With 99% of

this month, and we’ll have a better sense

must take steps to prepare, includ-

cases in China, this remains very mush an

by then of the impact of the outbreak.”

ing reviewing their infection control

emergency for that country, but one that

Read more about the concerns to

policies and practices to prevent the

holds a very grave threat for the rest of

medical practitioners here.

spread of infection,” CMS said in the

the world,” he says. Read more here.

It also states that healthcare staff and

Hospitals stockpile supplies amid coronavirus-related mask shortage; Schein makes statement

Boston Scientific puts dollar amount on possible losses to coronavirus, absorbs hits in supply chain

surveyors, including federal, state and

The coronavirus has fueled fears of

Boston Scientific (Marlborough, MA)

local contractors are expected to adhere

a shortage of key protective medical

has estimated the coronavirus outbreak

to standard infection control practices,

devices, namely the specialized N95 res-

will cost the company from $10 million

such as CDC recommendations on

pirator masks that are needed to protect

to $40 million in sales. Boston Scien-

standard hand hygiene practices.

health workers treating infectious patients.

tific expects $12 billion in sales this

Read the full memo here.

The CDC recommends that medical

year, but it’s a sign of how the effects

memo. The memo includes information and links to resources to combat the illness caused by the novel coronavirus.

30

as global health organizations including

employees working with coronavirus

of coronavirus are beginning to be felt

Coronavirus death toll surpasses 1,000 in mainland China

patients wear N95 masks, specifically. Any

across the global economy. The virus

disruption in the distribution of sup-

outbreak hit airline and oil stocks in

Monday saw the largest single-day death

plies like N95 masks could pose a risk to

late January, and the impact on much

tool yet in mainland China as 108 people

medical practitioners who rely on certain

of the rest of the corporate landscape

died, bringing the total to more than

pieces of protective equipment. Henry

is building slowly. Boston Scientific

1,000 deaths. More cases were identified,

Schein’s website now includes a notice for

says it expects to absorb revenue

bringing that total to 42,638 in mainland

consumers in the U.S. stating, “Due to the

hits from canceled surgeries in

China. Meanwhile, two senior health of-

coronavirus outbreak, we are experiencing

areas where the virus is prevalent, and

ficials in the Chinese province of Hubei,

higher than normal demand globally for

from disruptions in its supply chain.

the epicenter of the outbreak, have

infection control products such as masks,

Read more on Boston Scientific and

been fired. Read more about the latest

goggles and face shields, among other

other companies bracing for the im-

updates here.

items. We are working with our manufac-

pact of coronavirus here.

March 2020 | The Journal of Healthcare Contracting

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SONOCHECK™ When the ultrasonic cleaner is supplying sufficient energy and condi�ons are correct, SonoCheck™ will change color. Problems such as insufficient energy, overloading, water level, improper temperature and degassing will increase the �me needed for the color change. In the case of major problems the SonoCheck™ will not change color at all.

TOSI® Reveal the hidden areas of instruments with the TOSI® washer test, the easy to use blood soil device that directly correlates to the cleaning challenge of surgical instruments. TOSI® is the first device to provide a consistent, repeatable, and reliable method for evalua�ng the cleaning effec�veness of the automated instrument washer.

LUMCHECK™ The LumCheck™ is designed as an independent check on the cleaning performance of pulse-flow lumen washers. Embedded on the stainless steel plate is a specially formulated blood soil which includes the toughest components of blood to clean.

FLEXICHECK™ This kit simulates a flexible endoscope channel to challenge the cleaning efficiency of endoscope washers with channel irriga�on apparatus. A clear flexible tube is a�ached to a lumen device with a test coupon placed inside; the en�re device is hooked up to the irriga�on port of the endoscope washer.

HEMOCHECK™/PROCHEK-II™ Go beyond what you can see with all-in-one detec�on kits for blood or protein residue. HemoCheck™ is simple to interpret and indicates blood residue down to 0.1μg. The ProChek-II™ measures for residual protein on surfaces down to 0.1μg.

HEALTHMARK INDUSTRIES CO. | HMARK.COM | 800.521.6224 | HEALTHMARK@HMARK.COM

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