JHC Nov 18

November 2018 • Vol.9 No.6

MVPs: Most Vulnerable Patients

Home visits are key to DaVita Health Solutions’ patient-centered approach to chronic care management

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CONTENTS »» NOVEMBER 2018

4 Fall Prevention

As the population ages, the risk for falls rises

12 MVPs: Most Vulnerable Patients Home visits are key to DaVita Health Solutions’ patient-centered approach to chronic care management

22 Health news and notes 28 Industry News

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The Journal of Healthcare Contracting | November 2018

3

POST-ACUTE CARE

Advanced age is an independent risk factor for falls. But so are related factors such as reduced activity; chronic conditions, including arthritis, neurologic disease, and incontinence; increased use of prescription medications, which might act synergistically on the central nervous system; and age-related changes in gait and balance.

Approximately one in four U.S. residents aged 65 years or older report falling each year, and fall-related emergency department visits are estimated at approximately 3 million per year, according to the CDC. In 2016, a total of 29,668 U.S. residents aged 65 and over

Fall Prevention As the population ages, the risk for falls rises

died as the result of a fall (age-adjusted rate of 61.6 per 100,000), compared with 18,334 deaths (47 per 100,000) in 2007.

The rate of deaths from falls among persons aged ≼65 years increased 31 percent from 2007 to 2016, increasing

Falls are the leading cause of injury-related deaths

in 30 states and the District of Columbia,

among persons aged 65 and over, and the age-adjusted rate of

and among men and women. Among

deaths from falls is increasing. The Centers for Disease Control

states in 2016, rates ranged from

and Prevention released its most recent statistics this spring.

24.4 per 100,000 (Alabama) to 142.7

Source: Centers for Disease Control and Prevention, May 2018 4

November 2018 | The Journal of Healthcare Contracting

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POST-ACUTE CARE

Deaths from falls among persons aged ≥65 years — United States, 2007–2016 2007

2016

2007–2016

Characteristic

No. of deaths Deaths per 100,000

No. of deaths

Annual Deaths per 100,000 percentage change

Total

18,334

47

29,668

61.6

3.0

Men

8,408

57.9 (56.7–59.2)

13,721

72.3 (71.1–73.5)

2.4

Women

9,926

40.2 (39.4–41.0)

15,947

54.0 (53.1–54.8)

3.8

65–74

2,594

13.2 (12.7–13.7)

4,479

15.6 (15.2–16.1)

1.8

75–85

6,552

50.1 (48.9–51.3)

8,735

61.4 (60.1–62.7)

2.3

≥85

9,188

182.3 (178.6–186.0)

16,454

257.9 (253.9–261.8)

3.9

Sex

Age group (yrs)

Source: Centers for Disease Control and Prevention, May 2018

(Wisconsin).

The

fastest-

growing rate was among persons aged ≥85 years (3.9 percent per year).

In 2016, there was a higher rate of fatal falls among older men, in contrast to the rate of nonfatal falls, which is higher among older women. This might have resulted from differences in the circumstance of a fall (e.g., from a ladder or while drinking), leading to more serious injuries, including head trauma, or higher rates of postfall complications in men.

The rate of deaths from falls might be increasing because of longer survival after the onset of common diseases such as heart disease, cancer, and stroke.

Adults aged ≥85 years are the fastestgrowing age group among U.S. residents and will reach approximately 8.9 million in 2030. Although the rate of deaths from falls is increasing among all persons aged ≥65 years, it is increasing fastest among those aged 85 and over (3.9 percent per year). Nationally, the rate of deaths from falls might be increasing because of longer survival after the onset of common diseases such as heart disease, cancer and stroke.

If the current rate remains stable, an estimated 43,000 U.S. residents aged ≥65 years will die because of a fall in 2030, and if the rate continues to increase, 59,000 fall-related deaths could result.

For more information https://www.cdc.gov/mmwr/volumes/67/wr/mm6718a1.htm?s_cid=mm6718a1 6

November 2018 | The Journal of Healthcare Contracting

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POST-ACUTE CARE

Exercise can help prevent falls Exercise can have a moderate impact on preventing falls in older adults at increased risk for falls, according to the United States Preventive Services Task Force in its final recommendations issued this spring. In many respects, its findings echo those that USPSTF – which is independent of the U.S. government – made in 2012.

USPSTF bases its recommendations on the evidence of both the benefits and harms of specific preventive care services. It does not consider the costs of providing a service in this assessment.

Falls are the leading cause of injury-related morbidity and mortality among older adults in the United States, says USPSTF. In 2014, 28.7 percent of community-dwelling adults 65 years or older reported falling, resulting in 29 million falls (37.5 percent of which needed medical treatment or restricted activity for a day or longer) and an estimated 33,000 deaths in 2015.

Unfortunately, no instrument has been clearly identified as accurate and feasible for identifying older adults at increased risk for falls. According to USPSTF, a patient’s history of falls is the most commonly used factor that consistently identifies persons at high risk for falls.

Exercise interventions Effective exercise interventions include supervised individual and group classes and physical therapy. The most common exercise component in programs reviewed by USPSTF was gait, balance, and functional training (17 trials), followed by resistance training (13 trials), flexibility (eight trials), and endurance training (five trials). Three studies included tai chi, and five studies included general physical activity. The most common frequency and duration for exercise interventions was three sessions per week for 12 months, although duration of exercise interventions ranged from two to 42 months.

The 2008 U.S. Department of Health and Human Services guidelines recommended that older adults get at least 150 minutes per week of moderate-intensity or 75 minutes per week of vigorousintensity aerobic physical activity, as well as muscle-strengthening activities twice per week. It also recommended performing balance training on three or more days per week for older adults at risk for falls because of a recent fall or difficulty walking.

In its findings, the USPSTF notes that the National Institute on Aging outlines four interventions for the prevention of falls:

exercise for strength and balance, monitoring for environmental hazards, regular medical care to ensure optimized hearing and vision, and medication management.

According to the AGS, detecting a history of falls is fundamental to a falls reduction program, and it recommends that all older adults be asked about falls once a year.

The AGS further recommends that older persons who have experienced a fall should have their gait and balance assessed using one of the available evaluations; those who cannot perform or perform poorly should be given a falls risk assessment that includes a focused medical history, physical examination, functional assessment, and an environmental assessment. The AGS also recommends the following interventions for falls prevention: • Adaptation or modification of home environment (e.g., elimination of clutter and throw rugs, adequate lighting, etc.).

• Withdrawal or minimization of psychoactive or other medications.

• Management of postural hypotension (low blood pressure occurring when standing up from a sitting or lyingdown position).

• Management of foot problems and footwear.

• Exercise (particularly balance), strength, and gait training.

• Vitamin D supplementation of at least 800 IU per day for persons with vitamin D deficiency or who are at increased risk for falls.

Source: U.S. Preventive Services Task Force, https://www.uspreventiveservicestaskforce.org/Page/Document/ RecommendationStatementFinal/falls-prevention-in-older-adults-interventions1

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November 2018 | The Journal of Healthcare Contracting

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POST-ACUTE CARE

Home care and safety: A difficult match Institute for Healthcare Improvement report lists risks, solutions

The safety of care provided in the home has not yet received nearly as much attention as patient safety in hospitals and other clinical settings, despite the fact that the home has become the site of care The safety of care for many people, says provided in the the Institute for Healthcare Improvement (IHI) home has not yet in its report, “No Place received nearly as Like Home: Advancing much attention the Safety of Care in as patient safety the Home.”

In 2016, more than 2 in hospitals million personal care atand other tendants provided care clinical settings. in the home, according to the U.S. Department of Labor. Across the country, workers from home health agencies provide home health care services to more than 3 million Medicare beneficiaries. The

10

Department of Labor predicts that by 2026, the number of personal care attendants will rise by 40 percent.

IHI convened an expert panel in November 2017 to consider the challenges to safety in the home setting and to offer recommendations for improvement. Its report identifies nine risks and their potential harms: • Adverse events related to medication and other forms of treatment.

• Injuries due to physical hazards in the home (e.g., falls).

• Injuries related to equipment and technology.

• Pressure injuries.

• Infections.

• Conditions related to poor nutrition.

• Adverse effects on family caregivers.

• Adverse effects on home care workers.

• Potential neglect and abuse of care recipients.

To read more, visit ihi.org/no-place-like-home.

November 2018 | The Journal of Healthcare Contracting

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PATIENT CARE

INTERVENTIONAL CARE

ENVIRONMENT OF CARE

MVPs: Most Vulnerable Patients

Home visits are key to DaVita Health Solutions’ patient-centered approach to chronic care management

Editor’s note: Chronic diseases and conditions – such as heart disease, stroke, cancer, type 2 diabetes, chronic obstructive pulmonary disease, obesity and arthritis – are among the most common, costly, and preventable of all health problems. As of 2012, about half of all adults – 117 million people – had one or more chronic health conditions. One in four adults had two or more chronic health conditions. Seven of the top 10 causes of death in 2014 were chronic diseases.

DaVita has a term for patients with multiple chronic conditions who are heavy utilizers of our healthcare system – MVPs, or most vulnerable patients.

12

November 2018 | The Journal of Healthcare Contracting

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CHRONIC CARE MANAGEMENT

Known for its renal care services, the Denver-based company has a

he says. One out of every four

long history of partnering with payers and risk-bearing entities to man-

patients has at least one hospital

age the total cost of care for patients with kidney disease. Since 2016,

stay per year; and one out of every

with the creation of its DaVita Health Solutions division, the company

five Medicare patients is readmit-

has broadened its approach by working with payers to provide care

ted within 30 days. On average,

for high-risk patients with multiple chronic conditions, such as heart

MVPs visit 20 doctors and take 51

failure, COPD, diabetes, etc. To do so, it is leveraging its long history

medications per year. “They need

of running house call programs (since 2007) and post-acute care pro-

a high-touch, highly personalized

grams (since 2001) in several markets through its medical group, DaVita

care model that can complement

Medical Group.

their current care/providers and

(In December 2017, DaVita

meet them when and where they

Inc. announced that its DaVita

need care most – within the home

Medical Group subsidiary will

or skilled nursing facility – while

combine with health services

providing 24x7 care coordination

company Optum.)

and a support network.

MVPs are the highest-risk (and

“That is exactly what DHS does,

often, the highest-cost) patients

and we believe it is the future of

in the healthcare system today,

healthcare for this highly vulner-

says DHS President Hank Schliss-

able and costly population,” says

berg. Forty-one percent of U.S.

Schlissberg. “It will require health

healthcare spending is driven by 12 percent of the population with five or more chronic conditions, he points out. This is also one of the fastest-growing segments of the U.S. patient population, expected to grow by more than 20 percent over the next decade.

“If we can’t figure out how to better treat our nation’s MVP population, we will continue to fail them as care providers, and our healthcare costs will continue to spiral,” says Schlissberg.

One out of every three of the most vulnerable patients visits the ER at least one time per year, 14

Hank Schlissberg

“These patients often cannot easily manage the 51 medications (on average) they take per year or visit the 20 doctors (on average) they see per year.”

plans working together with providers to implement new care models and innovative programs (such as house calls) that can improve the quality and cost of care for these members.”

DHS recently completed its first partnership with a large regional health plan, says Schlissberg.

The company built a physicianled, home-centered care model for the plan’s most vulnerable members, and then smoothly transitioned those capabilities after successfully demonstrating positive health trends and operational efficiencies.

November 2018 | The Journal of Healthcare Contracting

CHRONIC CARE MANAGEMENT

How it works DaVita Health Solutions leadership includes executives from DaVita Medical Group who were responsible for launching and running its house calls and post-acute care programs. “We took best practices from those programs, combined with our integrated kidney care program expertise, and formed DHS,” says Schlissberg.

“The traditional care model for those with multiple chronic conditions does not work. These patients often cannot easily manage the 51 medications (on average) they take per year or visit the 20 doctors (on average) they see per year. And they often cannot properly coordinate their care across their specialists and primary care physician.”

Each of these patients’ chronic conditions requires complex management, he points out. “A onesize-fits-all care model that relies on traditional office visits that ofOver nearly two years, DHS served approximately 7,000 patients in the

ten last 15 minutes will never work

partnership with over 600 local primary care physicians, specialists and

for this population. Their needs re-

extended care teams, including family members, caregivers, hospitals,

quire comprehensive care teams

SNFs and home care agencies. Among the results:

working together to ensure coor-

• 10-15 percent fewer emergency room visits.

• 35-40 percent fewer hospitalizations.

16

dinated and convenient care.”

When DHS partners with a

• 15-20 percent lower cost of care.

health plan, the company builds

• 46 percent lower SNF length of stay.

out a care team and works within

• 64 percent lower SNF-to-acute 30-day readmission rate.

the community to partner with

• 91 percent patient satisfaction rating.

the plan’s primary care physicians.

November 2018 | The Journal of Healthcare Contracting

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CHRONIC CARE MANAGEMENT

Community-based care teams include MDs, NPs, RNs, behavioral

critical for establishing a care plan,

health specialists, palliative care specialists, social workers, pharma-

which we then coordinate with

cists and dietitians.

existing doctors,” says Schlissberg.

“We work with the health plan to announce the program to its highest-risk members as a complimentary benefit program to which they

It is also important from a coding and documentation standpoint.

have the gift to receive,” says Schlissberg. The initial communication

“Our biggest challenge is get-

usually comes from the plan to its members and is supported by com-

ting in the door, as some patients

munication from primary care physicians. “We also work with local SNFs

are reluctant to have a doctor or

to ensure health plan members are seen by our skilled nursing facility

nurse visit them at home,” he says.

specialists (SNFists), so their care can be coordinated.”

“But once we gain their trust and establish a relationship so they

“ We identify care needs that can only be found within the home – like tripping risks and other health hazards, medication management issues, social care needs, dietary needs, transportation needs, etc.”

are comfortable setting up an initial house calls visit, we have found the first visit – which is usually one and a half to two hours – highly valuable. The patients are comfortable in their home setting and reveal more about their care needs than when they are in an office setting.

“In that initial visit, we are able

Partnering with local primary care physicians and specialists is an

to build out a comprehensive care

important part of DHS’s clinical and business strategy, says Schlissberg.

plan that includes both their per-

Although DHS provides primary-care-type services, it is not the prima-

sonal and health goals. We also

ry care physician of record, he says. “We provide an incremental layer of

identify care needs that can only

service; and we intentionally partner with local physicians.”

be found within the home – like

Local caregivers typically welcome the assistance they receive from

tripping risks and other health

DHS, he adds. “They want to do the right thing by their patients, and

hazards, medication management

they know that they can’t possibly address the needs of most MVPs in

issues, social care needs, dietary

a 15-minute office visit. You can’t learn everything you need to know

needs, transportation needs, etc.

unless you are in the home, meeting caregivers, looking at the home

We can then incorporate those

environment and all the determinants of health.”

broader care needs with action-

That’s the role the DHS team plays.

Care plan

18

able next steps into each member’s comprehensive plan.

“People welcome this. We hear

Every engagement begins with a comprehensive health assessment of

things like, ‘I just didn’t know

the patient in his or her home or the skilled nursing facility. “This is most

healthcare could be like this.’”

November 2018 | The Journal of Healthcare Contracting

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CHRONIC CARE MANAGEMENT

Palliative care can also be an important part of the plan.

have significant social and behav-

“There is little more powerful than having a patient tell clinicians,

ioral health challenges, and require

‘my daughter is getting married in November and I want to be able

more attention than a traditional

to walk her down the aisle,’” says Schlissberg. “The ability to help them

office setting can typically offer.

achieve that goal is among the most beautiful things we do.”

“A different care model is re-

DHS also operates post-acute care programs that involve em-

quired, and incumbent payers

ployed SNFists who work in concert with the house calls care team.

and providers are just not posi-

These SNFists round within the skilled nursing facility when a DHS/

tioned to solve it. Payers are too

health plan member is admitted. “They work to ensure expedited

far from the point of care and are

dismissals and smooth transitions, and also coordinate care with the

trying their best to do telephonic

house calls care team and member primary care physicians. And we

care management on massive

staff a 24x7 member support center to provide after-hours care and

scale. Providers, who are inher-

regular coordination.”

ently local, don’t have the scale to build capabilities and interven-

“ You can’t learn everything you need to know unless you are in the home, meeting caregivers, looking at the home environment and all the determinants of health.”

tions for the 5 percent of patients –the MVPs – when they have to focus on the 95 percent.

“We believe at the core of this new care model are good old fashioned house calls, like the old Marcus Welby TV show. Doctors with black bags coming to you, like our parents and grandparents remember. Except now the housecalls ‘doctor’ is an entire care team with social workers, nurse practitioners, behavioral health special-

The payoff

“We feel a moral imperative to

Schlissberg admits that the DHS program is labor-intensive and re-

make a difference for these pa-

quires comprehensive care teams supported by care coordinators, call

tients, the ones who are most in

centers and operations teams. It also requires the right population of

need of a different care model,” he

members within a market to justify the program costs. But DHS leads

says. “Caring for these members

to fewer ER visits, fewer hospitalizations and lower healthcare costs, so

is a critical next step in creating a

the investment pays off.

sustainable ecosystem for patients,

“Today’s healthcare system is just not built for MVPs, who are frequent utilizers of the ER and hospital, heavy users of prescription drugs, who 20

ists, care coordinators, etc.

payers and employers, and in their evolution to value-based care.”

November 2018 | The Journal of Healthcare Contracting

Rx Only ©2016 B. Braun Medical Inc. Bethlehem, PA. All rights reserved. 16-5430_JHC_5/16_RTS3

HEALTH NEWS

Health news and notes Screening for urinary incontinence

expertise in women’s health across the

Women of all ages may benefit from annual screening for uri-

lifespan to develop, review, and update

nary incontinence, according to a new guideline adopted by

recommendations for women’s preven-

the Women’s Preventive Services Initiative (WPSI). The guideline

tive healthcare services

recommends doctors screen women beginning in adolescence

22

to find whether they experience urinary incontinence and how

You’ve got the meats!

it affects their activities and quality of life, says an August article

If you’ve abandoned red meat in an at-

published in the Annals of Internal Medicine.

tempt to stay healthy, you may be able to

Urinary incontinence affects an estimated 51 percent of wom-

enjoy it again. A June study in The Ameri-

en and increases in prevalence with age, ranging from 13 percent

can Journal of Clinical Nutrition shows a

in young women who have never been pregnant, to 47 percent

Mediterranean-style diet that includes

in middle-age women, to 75 percent in older women, according

some lean unprocessed red meat could

to the article. These rates are twice those reported in men.

help adults manage their weight.

The WPSI maintains that screening has the potential to de-

The Mediterranean Pattern diet – which

tect urinary incontinence in many women who fail to report it

includes components such as eating plant-

due to factors like embarrassment or stigma. Screenings, which

based foods, substituting olive oil for but-

can be clinician- or self-administered, should include questions

ter, and using herbs and spices rather

about whether a woman has symptoms of urinary incontinence;

than salt for flavor – has been in style

the type and degree of incontinence; and how symptoms affect

for some time. But researchers at Purdue

her health, function and quality of life, the article says.

University and the University of Texas no-

The American College of Obstetricians and Gynecologists

ticed that even though health agencies

(ACOG) launched the WPSI in 2016. Through a five-year coop-

encourage Americans to lower their red

erative agreement with the U.S. Department of Health and Hu-

meat intake, past studies indicated that

man Services, Health Resources and Services Administration

the Mediterranean diet might still lead to

(HRSA), ACOG is engaging a coalition of national health profes-

benefits – like decreased risk for type 2 dia-

sional organizations and consumer and patient advocates with

betes – even in people who eat red meats.

November 2018 | The Journal of Healthcare Contracting

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HEALTH NEWS

trial with 41 people, the researchers found that participants, who

Gestational diabetes and blood tests

were overweight or obese, lost weight when they ate a Mediter-

Other NIH-supported research shows

ranean Pattern diet with lean unprocessed red meats.

that early-pregnancy blood tests may

So they decided to test those findings. Through a randomized

“No one’s arguing for fat-marbled meats, processed meats

help identify women at risk for gesta-

or meats chargrilled to a crisp in the barbecue,” Amby Burfoot

tional diabetes. The condition occurs

writes in a Washington Post article on the study. “But modest

during pregnancy when blood sugar

amounts of lean, unprocessed red meat don’t appear to have

levels rise too high, and it increases the

major health risks. At least not if consumed within a Mediter-

mother’s chances of developing other

ranean diet framework that includes lots of fruit, vegetables,

health issues down the line, like high

whole grains, fish and olive oil.”

blood pressure disorders of pregnancy and type 2 diabetes later in life.

Some hope for MS

Researchers used the HbA1c (or A1C)

Certain drugs could help repair nerve damage caused by

blood test, which is used to diagnose

multiple sclerosis.

type 2 diabetes, for the study. They analyzed test records, taken from

“ Our results suggest that the HbA1c test potentially could help identify women at risk for gestational diabetes early in pregnancy, when lifestyle changes may be more effective in reducing their risk.”

the National Institute of Child Health and Human Development Fetal Growth Study, of 107 women who later developed gestational diabetes and 214 women who didn’t.

– Cuilin Zhang

Women who went on to develop gestational diabetes

24

Researchers at Case Western Reserve University, the New

had higher HbA1c levels (an average of

York Stem Cell Foundation Research Institute and George Wash-

5.3 percent), compared to those with-

ington University collaborated on a study to find how the anti-

out gestational diabetes (an average

fungal drug miconazole activates stem cells to repair damage

HbA1c level of 5.1 percent). Each .1

to myelin, the lining that insulates nerves in the brain and spinal

percent increase in HbA1c above 5.1

cord. Myelin damage causes interruptions to nerve cell commu-

percent in early pregnancy was associ-

nication, leading to muscle weakness, vision and coordination

ated with a 22 percent higher risk for

problems, and other MS symptoms.

gestational diabetes.

The research team found that miconazole and similar drugs

“Our results suggest that the HbA1c

block the enzyme CYP51. Doing so encourages stem cells to

test potentially could help identify wom-

form new oligodendrocytes, cells that create myelin coatings.

en at risk for gestational diabetes early in

The findings were published in July in Nature Methods. Read

pregnancy, when lifestyle changes may be

about it in an article from the National Institutes of Health,

more effective in reducing their risk,” said

which funded the study.

Cuilin Zhang, the study’s senior author.

November 2018 | The Journal of Healthcare Contracting

INOMAX® (NITRIC OXIDE) GAS, FOR INHALATION

Because Every Moment Counts

INCLUD ALL ED * S ’ IT

IT’

INOmax Total Care®

C

A complete system with comprehensive care is included in your INOmax Total Care contract at no extra cost.

When critical moments arise, INOmax Total Care is there to help ensure your patients are getting uninterrupted delivery of inhaled nitric oxide.

• Over 18 years on market with over 700,000 patients treated1 • Continued innovation for delivery system enhancements • Emergency deliveries of all INOmax Total Care components within hours† • Live, around-the-clock medical and technical support and training • Ongoing INOMAX® (nitric oxide) gas, for inhalation reimbursement assessment and assistance included in your INOMAX contract (Note: You are ultimately responsible for determining the appropriate reimbursement strategies and billing codes)

Indication INOMAX is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

Important Safety Information • INOMAX is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood.

2017 EMERGENCY

DELIVERIES L INCL

1

UD ED

IT

CONTRACT

C

AL DRUG &’SDEVICE IT

2,700+ IN YOUR NO EXTRA COST

• In patients with pre-existing left ventricular dysfunction, INOMAX may increase pulmonary capillary wedge pressure leading to pulmonary edema.

• Monitor for PaO2, inspired NO2, and methemoglobin during INOMAX administration.

• INOMAX must be administered using a calibrated INOmax DSIR® Nitric Oxide Delivery System operated by trained personnel. Only validated ventilator systems should be used in conjunction with INOMAX.

• The most common adverse reaction is hypotension.

• Abrupt discontinuation of INOMAX may lead to increasing You are encouraged to report negative side effects pulmonary artery pressure and worsening oxygenation. of prescription drugs to the FDA. Visit MedWatch or • Methemoglobinemia and NO2 levels are dose dependent. call 1-800-FDA-1088.

Nitric oxide donor compounds may have an additive Please visit inomax.com/PI for Full Prescribing effect with INOMAX on the risk of developing Information. methemoglobinemia. Nitrogen dioxide may cause airway inflammation and damage to lung tissues.

Visit inomax.com/totalcare to find out more about what’s included in your contract. *INOmax Total Care is included at no extra cost to contracted INOMAX customers. †Emergency deliveries of various components are often made within 4 to 6 hours but may take up to 24 hours, depending on hospital location and/or circumstances.

Reference: 1. Data on file. Hampton, NJ: Mallinckrodt Pharmaceuticals.

Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. © 2018 Mallinckrodt US-1800073 August 2018

INOmax®(nitric oxide gas)

Brief Summary of Prescribing Information INDICATIONS AND USAGE Treatment of Hypoxic Respiratory Failure INOmax® is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilator support and other appropriate agents.

CONTRAINDICATIONS INOmax is contraindicated in neonates dependent on right-to-left shunting of blood.

WARNINGS AND PRECAUTIONS Rebound Pulmonary Hypertension Syndrome following Abrupt Discontinuation Wean from INOmax. Abrupt discontinuation of INOmax may lead to worsening oxygenation and increasing pulmonary artery pressure, i.e., Rebound Pulmonary Hypertension Syndrome. Signs and symptoms of Rebound Pulmonary Hypertension Syndrome include hypoxemia, systemic hypotension, bradycardia, and decreased cardiac output. If Rebound Pulmonary Hypertension occurs, reinstate INOmax therapy immediately.

Hypoxemia from Methemoglobinemia Nitric oxide combines with hemoglobin to form methemoglobin, which does not transport oxygen. Methemoglobin levels increase with the dose of INOmax; it can take 8 hours or more before steadystate methemoglobin levels are attained. Monitor methemoglobin and adjust the dose of INOmax to optimize oxygenation.

If methemoglobin levels do not resolve with decrease in dose or discontinuation of INOmax, additional therapy may be warranted to treat methemoglobinemia.

Airway Injury from Nitrogen Dioxide Nitrogen dioxide (NO2) forms in gas mixtures containing NO and O2.

Nitrogen dioxide may cause airway inflammation and damage to lung tissues.

If there is an unexpected change in NO2 concentration, or if the NO2 concentration reaches 3 ppm when measured in the breathing circuit, then the delivery system should be assessed in accordance with the Nitric Oxide Delivery System O&M Manual troubleshooting section, and the NO2 analyzer should be recalibrated. The dose of INOmax and/or FiO2 should be adjusted as appropriate.

Worsening Heart Failure Patients with left ventricular dysfunction treated with INOmax may experience pulmonary edema, increased pulmonary capillary wedge pressure, worsening of left ventricular dysfunction, systemic hypotension, bradycardia and cardiac arrest. Discontinue INOmax while providing symptomatic care.

26

ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The adverse reaction information from the clinical studies does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Controlled studies have included 325 patients on INOmax doses of 5 to 80 ppm and 251 patients on placebo. Total mortality in the pooled trials was 11% on placebo and 9% on INOmax, a result adequate to exclude INOmax mortality being more than 40% worse than placebo.

In both the NINOS and CINRGI studies, the duration of hospitalization was similar in INOmax and placebo-treated groups.

From all controlled studies, at least 6 months of follow-up is available for 278 patients who received INOmax and 212 patients who received placebo. Among these patients, there was no evidence of an adverse effect of treatment on the need for rehospitalization, special medical services, pulmonary disease, or neurological sequelae.

In the NINOS study, treatment groups were similar with respect to the incidence and severity of intracranial hemorrhage, Grade IV hemorrhage, periventricular leukomalacia, cerebral infarction, seizures requiring anticonvulsant therapy, pulmonary hemorrhage, or gastrointestinal hemorrhage.

In CINRGI, the only adverse reaction (>2% higher incidence on INOmax than on placebo) was hypotension (14% vs. 11%).

Based upon post-marketing experience, accidental exposure to nitric oxide for inhalation in hospital staff has been associated with chest discomfort, dizziness, dry throat, dyspnea, and headache.

DRUG INTERACTIONS Nitric Oxide Donor Agents Nitric oxide donor agents such as prilocaine, sodium nitroprusside and nitroglycerine may increase the risk of developing methemoglobinemia.

OVERDOSAGE Overdosage with INOmax is manifest by elevations in methemoglobin and pulmonary toxicities associated with inspired NO2. Elevated NO2 may cause acute lung injury.

Elevations in methemoglobin reduce the oxygen delivery capacity of the circulation. In clinical studies, NO2 levels >3 ppm or methemoglobin levels >7% were treated by reducing the dose of, or discontinuing, INOmax.

Methemoglobinemia that does not resolve after reduction or discontinuation of therapy can be treated with intravenous vitamin C, intravenous methylene blue, or blood transfusion, based upon the clinical situation.

INOMAX® is a registered trademark of a Mallinckrodt Pharmaceuticals company. © 2018 Mallinckrodt. US-1800236 August 2018

November 2018 | The Journal of Healthcare Contracting

HEALTH NEWS

The findings were published in Nature

Gym class memories

Scientific Reports. Read about it in this

Finally, the way you felt about gym class as a kid could affect the

NIH article.

way you feel about exercise now.

Researchers at Iowa State University surveyed 1,028 adults

Nothing to hit but the heights

about their experiences with physical education during pri-

Virtual reality may help people over-

They found that survey participants who enjoyed gym class

come their fear of heights. The findings,

when they were younger were more likely to exercise now

published in July in The Lancet, mean

– and enjoy it – than participants who didn’t like gym class.

mary and secondary school and their exercise habits today.

that with further research, virtual reality

The reasons participants didn’t enjoy gym class most often

could be used as an affordable tool for

had to do with embarrassment, whether from being chosen last

mental health treatment.

for sports teams or from being made to feel incompetent by

The research team at the Univer-

PE teachers or classmates. On the flip side, the people who en-

sity of Oxford studied a sample of 100

joyed gym class often enjoyed the activities and the opportuni-

adults who scored more than 29 on the

ties to spend time with peers.

Heights Interpretation Questionnaire. Forty-nine of those people then underwent the experimental treatment, a virtual reality program that had participants accompany a “virtual coach” (named Nic) through a 10-story office building where they completed a series of tasks. These

The way you felt about gym class as a kid could affect the way you feel about exercise now. Researchers at Iowa State University surveyed 1,028 adults about their experiences with physical education during primary and secondary school and their exercise habits today.

tasks, which included things like rescuing a cat from a tree and playing a

While the results show correlation, not causation – it

xylophone near the edge of the floor, be-

could be that nonathletic students didn’t enjoy gym class

came more difficult as users progressed

– the study authors believe PE teachers could learn from

through the program.

this. Random choosing of teams, for example, could help

All of the virtual reality participants

decrease embarrassment from being the last one picked.

reported a reduction in fear of heights

And noncompetitive physical activities, like dance or yoga,

following the treatment, and by the time

might help students learn to enjoy exercise more than team

researchers followed up, 34 of those par-

sports can.

ticipants (69 percent of the group) fell be-

“It would be great if P.E. classes could teach kids that mov-

low the entry criterion on the HIQ, com-

ing is fun,” lead study author Matthew Ladwig told The New

pared with none in the control group.

York Times in this article describing the findings, which

Read the full study here, and a University of Oxford article about it here.

The Journal of Healthcare Contracting | November 2018

were published in the Translational Journal of the American College of Sports Medicine.

27

NEWS

Flu season could cost employers $21B Influenza cost employers more than $21 billion in lost productivity during the 2017-18 flu season, according to an estimate from global outplacement and executive coaching firm Challenger, Gray & Christmas Inc. The company estimated the flu sickened 25 million workers last season. Based on this estimate, analysts calculated average wages lost due to missing four eight-hour shifts using data from the Bureau of Labor Statistics. They estimated flu caused $21.39 billion in losses for US employers. The company advised that employers, especially those with open offices and shared workspaces, should treat these spaces and other common areas as gyms treat exercise equipment. This includes daily cleanings of all surfaces with disinfectant. Employers should also keep soap and hand sanitizer in plentiful supply.

Best Buy to move into health space with $800M acquisition of GreatCall Inc Best Buy has agreed to acquire GreatCall Inc (San Francisco, CA) for $800 million. The deal will expand Best Buy’s reach in the health space. Founded in 2006, GreatCall makes Jitterbug mobile phones and Lively wearable devices that provide easy, onetouch access to U.S.-based agents who can connect the user to family caregivers, provide concierge services or dispatch emergency personnel Moving forward, GreatCall will continue to operate separately, with CEO David Inns staying on in his role. The company’s headquarters will remain in San Diego and its caring centers will remain at their current locations in Carlsbad, California, and Reno, Nevada. This is the largest acquisition in Best Buy’s history. Best Buy’s acquisition of GreatCall is subject to regulatory approvals and other customary closing conditions. It’s expected to close by the end of Best Buy’s fiscal 2019 third quarter.

28

New collaborative to tackle end-to-end supply chain challenges Executives from 12 healthcare organizations formed the Healthcare Supply Chain Collaborative to address and solve longstanding supply chain issues.

The new organization’s mission is to transform the healthcare supply chain through best practices for processes and data. To address these issues from an end-to-end supply chain perspective, the organization’s leadership includes manufacturers, distributors, providers, and group purchasing organizations.

The organization will initially focus on two primary areas: Supply chain visibility and contract administration and pricing. The Health Industry Distributors Association (HIDA) will provide staffing for the Collaborative. Members of its steering committee include senior executives from: BD (Becton, Dickson & Company), Cardinal Health, Henry Schein, Johnson & Johnson, The Mayo Clinic, McKesson MedicalSurgical, Medline, Medtronic, Owens & Minor, Premier Inc, Quidel, UAB Medicine, and Vizient Inc. The Healthcare Supply Chain Collaborative will host a conference April 17-18, 2019, with sessions focusing on contract administration, e-commerce, and supply chain visibility. Industry organizations are invited to attend and to participate with the Collaborative.

To join the Collaborative, or for more information, contact Jeff Girardi at Girardi@hida.org.

HCA makes $500,000 donation to hurricane relief HCA Healthcare (Nashville, TN) announced a donation of $500,000 to the American Red Cross to help people affected by Hurricane Florence. In South Carolina, HCA Healthcare has five hospital campuses, including Grand Strand Medical Center, the only Level 1 trauma center in the eastern part of the state, and 38 other sites of care.

November 2018 | The Journal of Healthcare Contracting

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