The leading causes of death in women are heart disease (22.3%), cancer (21.6%), chronic lower respiratory diseases (6.0%), and stroke (6.0%), according to the latest data, based on the year 2014, from the CDC. Despite these staggering statistics, however, new treatments continue to be developed-many of which will help lives and money. Here’s a closer look at the most common conditions within each cause of death category, measures being taken to prevent deaths associated with them, and the latest treatment advances.

Cardiovascular disease, which refers to conditions that involve narrowed or blocked blood vessels that can lead to a heart attack or stroke-such as atherosclerosis and coronary artery disease-is the number one cause of heart disease and death in women. In 2013, nearly 300,000 women died of heart disease-which accounts for about one in every four female deaths, the CDC reports.

Having high blood pressure is a major controllable risk factor for heart disease in women, and is the leading risk factor for heart failure and other heart-related conditions such as heart attack, stroke, and atrial fibrillation, says Carl J. Pepine

MD, cochair of the Cardiovascular Disease in Women Council, American College of Cardiology, and professor and emeritus chief, Division of Cardiovascular Medicine, Shands Hospital at the University of Florida

an academic health center in Gainesville, FL. Other major modifiable risk factors for heart attack include smoking, being overweight or obese, having high blood sugar or diabetes, lack of physical activity, and high cholesterol.

In addition to hypertension, heart disease and high cholesterol are risk factors for stroke, and women have more risk factors for stroke than men, says Tamer Abdelhak, MD, division chief, Inpatient Neurology, Vascular Neurology, and NeuroCritical Care

Spectrum Health, a not-for-profit integrated health system in Grand Rapids, MI. These risks include:

Natural bodily changes occurring as a result of pregnancy such as increased blood pressure and stress on the heart;

 Using hormone replacement therapy to relieve menopausal symptoms; and

Suffering from migraine headaches with aura.

Women in hypercoagulable states, such as having more than one miscarriage or deep venous thrombosis, are also at risk for stroke, Pepine says. Smoking, inactivity, and being overweight or obese are risk factors as well.

Although approximately 100 medications for high blood pressure exist, better management is needed to help prevent heart disease and stroke, says Pepine. For example, almost half of women in the United States have blood pressure in the hypertensive range, according to new guidelines from the American College of Cardiology and American Heart Association. Many women who should be taking medication for high blood pressure are not.

To reduce death due to heart attack, protocols are now in place to ensure that when paramedics reach a patient suspected of having a heart attack, they can assess the patient right away. If the person is indeed having a heart attack, paramedics will alert the emergency department so they are ready to get the patient to the catheterization lab where they can restore blood flow and aspirate the clot when they arrive. This minimizes the time it takes for the patient to have blood flow returned to heart muscle tissue-reducing the heart attack’s severity, says Thomas F. Boyden, MD, program director, Preventive Cardiology, and medical director, Preventive Cardiology and Cardiac Rehabilitation, Spectrum Health, Cardiovascular Services. Medical breakthroughs have shown that certain medications, such as beta blockers, reduce the chance of having another heart attack or having to return to the hospital due to complications of a heart attack.

Women who need hormonal therapy to aid in contraception or with menopausal symptoms may be able to decrease the risk of blood clots by using hormone medications available in lower doses that are more synthetic-which may cause less blood clotting, Pepine says. However, even low-estrogen birth control pills, in the presence of other risk factors, are associated with increased risk for stroke.

Some breakthroughs have occurred in reducing the incidence of heart attack and stroke in patients at risk of cardiovascular events. A new class of drugs introduced in 2015, PCSK9 inhibitors, uses monoclonal antibodies designed to protect LDL-cholesterol receptors and help reduce LDL-cholesterol, Boyden says. These medications have resulted in a reduced incidence of heart attack even if someone is also taking a statin medication such as Lipitor (atorvastatin) and Crestor (rosuvastatin)-the gold standard therapy for reducing cholesterol and risk of heart attack and stroke.

Like heart attack, timing is critical for getting to the hospital when stroke is suspected. Almost nine out of 10 strokes are due to blood clots, which can be dissolved with special medication and/or removed by special catheter devices. Another newer management approach for stroke within the last two years includes equipping ambulances with computed tomography scan machines, so medical personnel can obtain a brain scan and transmit images to a radiologist, confirm a diagnosis, and start treatment as soon as a patient reaches the emergency room or perhaps even while the patient is still in the ambulance, Pepine says.

Based on recent clinical trials, the window for performing a thrombectomy (removing blood clots) is now (as of January 2018) up to 24 hours. That means that stroke may be a reversible, curable disease if urgent treatments are employed early on, Abdelhak says. A limited number of hospitals in the United States, including Spectrum Health, offer catheter-based stroke care.

Most medications that are approved to treat high blood pressure are offered in generic forms, Pepine says. Many can be taken for just pennies a day. But many women who should be taking medication are not prescribed them, and many who have prescriptions are not taking them-which increases healthcare costs.

PCSK9 inhibitor medications can cost as much as $14,000 annually per patient. With the high cost of these agents and the modest added risk reduction provided by background statin therapy, many healthcare industry analysts have suggested that the cost benefit does not warrant its widespread use, Boyden says. However, if used for the right patients-those at the highest risk of recurrent heart attack, stroke, or death due to cardiovascular disease-others say the annual cost is justified by the reduced risk. These medication costs typically decline over time as manufacturers reassess the market and renegotiate contracts with insurers, so the cost/benefit ratio should improve.

The two most common types of cancer in women are breast and lung cancer with an estimated 252,170 and 105,510 new cases diagnosed in 2017, respectively, according to the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program. Despite breast cancer accounting for significantly more new diagnoses, lung cancer remains the leading cause of cancer death in women.

Treatment of non-small cell lung cancer has led the way into the era of personalized medicine. “While traditional treatments including surgery and radiation still play vital roles, numerous new therapies have become available,” says G. Paul Wright

Spectrum Health. “A patient’s tumor can be tested for molecular alterations that can predict how they will respond to certain medications and provide options for medications that target those specific alterations. This has provided greater precision in the treatments delivered, particularly for those with late-stage or recurrent cancer. Immunotherapies are also available for select patients. These provide effective treatment by sensitizing the cancer cells in a way that allows the patient’s own immune system to combat the disease.”

In breast cancer, recent trends have demonstrated benefits in changing the timing of chemotherapy delivery. “For patients in which chemotherapy is required, more often the chemotherapy is now given prior to surgery when possible,” Wright says. “This allows the treating physician to evaluate the treatment’s effectiveness by examining the specimen at the time of surgery.” Patients that don’t have any remaining tumor have a very good prognosis. Women who have residual tumor after chemotherapy are at high risk for recurrence. Several ongoing trials, such as the CREATE-X trial published in the 

, are investigating giving additional medications to women in the latter group to reduce recurrence and improve survival. This has already been shown to be an effective strategy. Immunotherapy has also provided some initial promise in women with certain types of breast cancer.

Angela J. Keleher, MD, director, Division of Breast Surgery, Allegheny Health Network, an academic medical center in Pittsburgh, says great strides are being made in tailoring breast cancer treatments to a woman’s specific tumor profile and developing liquid biopsies that can detect circulating tumor cells and guide physicians in treatment selection. New advances such as breast microseed, a one-time post-lumpectomy treatment, and Gamma Pod, which promises to eradicate breast tumors with just a week of radiation treatments, are shortening treatments for early-stage cancers, contributing to increased quality of life for cancer survivors.

Testing for molecular alterations has steeply decreased in cost over the past decade, however, many new medical treatments are expensive. One year of treatment with a newer immunotherapy drug can exceed $250,000. “While competition in this market is increasing, this has yet to drive down the cost of these therapies,” Wright says. “High costs are likely to limit the sustainability of these approaches and may increase the disparities in access to these treatments.”

To save money, Keleher says managed care organizations should emphasize prevention strategies-such as don’t smoke, maintain a proper body weight, exercise regularly, eat a balanced diet with lots of fruits and vegetables, and don’t drink alcohol excessively.

“Healthcare providers should discuss prevention with their patients at high risk for breast cancer,” Keleher says. Preventive measures include changing daily lifestyle behaviors, taking risk reduction medication, or having risk reducing surgery. For gene mutation carriers with a high risk of breast cancer, a prophylactic double mastectomy could save lives and healthcare costs in the long run.

Chronic obstructive pulmonary disease (COPD) is the top killer of women in the category of chronic lower respiratory diseases, with more than 7 million U.S. women having the diagnosis, according to the American Lung Association. This incurable, progressive lung condition that slowly destroys lung function is primarily caused by smoking, says Kiran Nair, DO, pulmonologist, Medical Chest Associates, a practice affiliated with Memorial Hermann Memorial City Medical Center in Houston, Texas. The number of deaths from COPD in women increased four-fold during the 1980s and 1990s.

Traditional treatments for COPD include inhaled medications that help keep airways open, such as inhaled bronchodilators and inhaled bronchodilator/corticosteroid combination therapies, says MeiLan Han, MD, associate professor of pulmonary medicine, University of Michigan, Ann Arbor, and spokesperson for the American Lung Association.

Over the past decade, new research has shed light on the underlying complex genetic underpinnings of the disease, and inflammation that drives it, Nair says. Based on this research, new medications in the pipeline target specific cells and components of the inflammation that drives the disease, and genetic markers are being identified that would increase a person’s susceptibility to the disease.

The annual cost of COPD is more than $30 billion, according to CDC estimates. “Any medication that will significantly reduce the frequency of hospitalizations will have a positive impact on the healthcare costs associated with COPD,” Nair says. “Most current medications that are prescribed have been shown to reduce the frequency and severity of hospitalizations, and newly developed medications are being investigated with these goals in mind.” 

But affording medications is problematic for many patients, due to multiple factors. Not only have no generic options been available in the United States until this year, Han says, many COPD patients have other conditions for which they must also pay for medications. In general, patients with COPD also tend to have lower socioeconomic status than those without COPD, which means that even modest copays may not be affordable for many.

Karen Appold is a medical writer in Lehigh Valley, Pennsylvania. 

Articles

The conditions that are the biggest drivers of female mortality, some preventive measures, and the latest treatment advances.

Top Four Causes of Female Mortality and Treatment Advances

In the past year, Indiana University (IU) Health, a large system in Indianapolis, has hired several new executives to tackle new initiatives, says Ryan Kitchell, executive vice president and chief administrative officer. “Investing in the new positions will directly enhance patient care by improving performance in such critical areas as population health programs, clinical effectiveness, and medical records management.”  The new positions include:

A senior vice president of population health 

tasked with improving the delivery and development of programs in care management, disease management, utilization management, and pharmacy benefit management.

tasked with leading the design and implementation of systemwide, patient-focused clinical teams delivering high-value interdisciplinary care. Major initiatives this individual oversees include reducing unwarranted practice variation, delivering evidence-based care with high reliability, leveraging the EHR, and effective use of pharmaceuticals and supplies.

A senior vice president and chief health information officer 

tasked with overseeing systemwide EHR clinical governance and design, with responsibility for long-term strategic planning and execution.

A senior vice president of behavioral health services 

tasked with leading efforts to build enhanced capabilities to respond to growing demands to treat behavioral health patients, including opioid and mental health cases.

“As the system grows over the next five years, the new talent, investments, and focus in these positions will combine to enhance IU Health’s efforts to care for patients, including doing so proactively through population health,” Kitchell says. “The investments in new executive positions should also position IU Health to better face coming challenges in the healthcare industry that include a growing opioid abuse crisis, the need to become more engaged in population health, and pressures on providers to become more efficient.”

As more health systems and health plans across the country take similar steps to IU Health, we found four healthcare executives who have recently taken on new roles. Here’s what they entail. 

Angela McClure, Chief Experience Officer (CXO) 

McClure is CXO at Fresenius Medical Care North America, a large network of dialysis facilities, outpatient cardiac and vascular labs, and urgent care centers. McClure started at FMCNA three years ago as senior vice president of human resources for the company’s dialysis services and vascular access divisions, where she led teams that monitored consumer assessments, performance, and quality metrics. In October 2017, she became the CXO, bringing her expertise in human resources and customer experience across all 13 lines of business at FMCNA.

“The customer is at the center of all of our experiences. But who that customer is changes across business lines,” McClure says. “We want to make sure that customer experience is the same for all of our customers, whether it is our employees, our patients, physician partners, or vendors.”

McClure uses quality measures and incentives to better understand the patient experience and identify ways to improve it. “Our CEO has the shared vision around the culture of employees truly activating the patient experience,” she says. “Everything is data driven. As we develop the voices of the customers, employees, patients, and physicians, we look at ways that we are measured by the industry through MEPS (medical expenditure panel survey) data, but we also want to lean on what our employees recommend.”

Moretz became the CXO and assistant vice president of patient and family-centered care for Augusta University Health System, an academic health center that manages the clinical operations associated with Augusta University in Georgia, in May 2017. She provides strategic oversight, including developing patient and family advisors and integrating their voices in all aspects of the business. Within the department, she leads 25 team members, including patient experience coordinators, interpreters, and greeters.

“Beyond the typical duties, I also work with academic leaders in a number of ways to educate the next generation of healthcare professionals about patient- and family-centered care,” says Moretz. “Our role in this center is to continue to strengthen interprofessional collaborative practice, work with our population health team, build on our electronic health record usage with patient/family input, develop a transparency model as a way to improve services, and build an infrastructure within our medical college and other colleges to support patient- and family-centered practice.”

She says the next goals of the experience department include finding ways to educate patients about reducing their healthcare footprint. “This means exploring population health more closely and reaching out to those who may need our services in a different way,” Moretz says. “My favorite quote is, ‘When a flower doesn’t bloom, you fix the environment in which it grows, not the flower.’ Often we try to fix the patient and mold them around our systems. In reality, we need to partner and engage with patients to provide them an exceptional experience that goes beyond meeting basic expectations.”

Helen Macfie, PharmD, Chief Transformation Officer

As chief transformation officer of MemorialCare Health System, a nonprofit system with six hospitals, two medical groups, a health plan, and outpatient centers in California, Macfie works on strategic planning, performance health, and population health. She began working at the health system in 2005, and says her position evolved over time, starting with a focus on performance improvement and strategic planning, and adding population health in 2012.

“With the evolving complexity in healthcare, the drive toward population health and The Triple Aim, and the overall need for strategic planning rigor, this newer role is one that a number of leading organizations have incorporated to help knit together all the performance initiatives,” Macfie says.

Her role, which focuses on system transformation, performance improvement, clinical quality, patient safety, patient-family experience, and strategic planning, helps streamline the growing complexity of healthcare services, she says. “The role serves on our executive team, partnering with the executives across the system to drive transformation, not for the hospital only.”

The transformation department includes employees who work solely on performance, including best practices, lean management, and risk and clinical integration specialists. Macfie also manages ACO specialists that work with the organization’s medical foundation, and other employees deployed across the health system.

Recognizing that the customer base for health plans is expanding, Health Care Service Corporation (HCSC) promoted Farran from senior vice president of strategy and corporate relations to chief brand officer in January 2018. HCSC operates Blue Cross and Blue Shield plans in Illinois, Montana, New Mexico, Oklahoma and Texas.

“We are not an insurance carrier just about transactions, and to add value we realize that we need to provide data, information, and insight to all of our customers,” Farran says, adding that these  customers include consumers, employers, and government agencies.

The branding department is new to HCSC, but includes traditional functions such as marketing, public affairs, communications, and advertising. Farran says he is bringing together functional communications used in each department to create a unified, proactive voice for the organization. “We recognize that there are a lot of other areas that we need to be connected to, including the customer journey,” Farran says.

The branding department is also working to improve customer perception, he says. “The reforming healthcare market, advancement of technology, and the growth of consumerism forced us to think more broadly about how all of our stakeholders view us,” Farran says. “With so many touchpoints today, and even more in the future, every time we touch one of our customers we need to make sure we can give them the information and services they need.”

Donna Marbury is a writer in Columbus, Ohio.

Many healthcare organizations are expanding leadership roles to help meet business and patient-centered goals.

Four Healthcare Executives Take On New Managed Care Roles  

Industry dynamics have forced healthcare organizations to move beyond “business as usual” in some significant ways. While all must embrace the “Triple Aim” of clinical quality, patient experience, and operational efficiency, how they structure their business strategy must be tailored to their individual situations. Some must focus more on quality; others on growth.

This issue’s cover story explores how developing an executive compensation plan that maps to the strategy can play a large role in a successful transformation. I couldn’t agree more.

We recently helped a $500 million public trust healthcare system located in a suburb that’s home to a large state university revise its executive compensation plan. The school’s faculty and staff comprise a major part of the local population. They have commercial health insurance and represent a healthier population in general than other areas.

Three larger healthcare systems located in the adjacent city have all made acquisition overtures at one time or another in the last five years.

The organization had an annual incentive program for executives in place for several years that measured various generic areas of performance. As the board began to identify market share growth and financial performance as critical to future success, it became clear that the existing compensation program needed an update.

The management team worked to better understand the new business strategy. The specific long-range goals were to:

Grow the number of patients seeking ambulatory care in ambulatory settings versus the ER; and

Increase the overall number served across emergency, urgent, and outpatient care.

The nature of the relatively close-knit community is such that word-of-mouth referrals have great utility in increasing patient volume. The management team and the board estimated that establishing and staffing the required number of ambulatory care locations would take five to seven years. Similarly, the changes that would be required to routinely provide levels of quality and care sufficient to engender highly positive referrals in the community and then absorb the resulting increase in number served would also take at least five to seven years.

Based on the sustained levels of collaboration and effort required to succeed against these goals, the board determined that the organization’s executive compensation philosophy would be modified to incorporate a multi-year pay-for-performance strategy-an approach often used in public and other for-profit companies. However, based on its responsibilities as a public trust, the board agreed that earned incentives coupled with base salaries should never position executive total direct compensation at unreasonably high levels as compared to an annual review of similarly-situated organizations.

The result is a performance share plan for executives with annual share grants and three-year overlapping performance periods. The shares will grow in value as the organization increases its patients’ “willing-to-recommend” ratings, and achieves growth in ambulatory care.

In addition, executives have an annual incentive plan driven by performance in clinical, service, team, and operational excellence. Metrics are selected so that strong annual performance predicts success in the long-term plan.

While the organization is only a year into the plan, there is noticeable performance uptick on several of the short-term “excellence” metrics, and the leadership team now includes a discussion regarding their long-term incentive plan performance in their regular weekly meetings.

The strategy behind the overall compensation program is that as the team improves performance against the annual metrics, those positive outcomes achieved will contribute to the longer-range growth goals.

Steven Sullivan, a managing director with 

’s Houston office, has more than 20 years of consulting and industry experience assisting clients in executing their strategic human resources and compensation initiatives. His focus has been in the areas of executive compensation program benchmarking, design, and oversight in the healthcare industry and for tax-exempt businesses.

How one public trust healthcare system overhauled its overall compensation program and successfully transformed its financial operations.

How Healthcare Organizations are Rethinking Executive Compensation

The secretary of HHS, earlier this year, proposed a regulation to increase the maximum coverage term under short-term limited duration (STLD) insurance plans. The hope is to create more options for consumers to purchase less expensive health plans that provide varying levels of coverage, says Denise Stefan, president, Engage Insurance, a subsidiary of Engage Professional Employer Organization, a national human resources outsourcing firm.

Rules issued during the Obama Administration limit these plans to no more than three months in duration. The proposed regulation would allow short-term coverage to be offered for up to one year (364 days), or possibly longer.

Some states are taking action to guard against, what some fear, will be an influx of skimpy coverage that could leave consumers with large financial liabilities and destabilize their insurance markets. “While STLD plans can provide cheaper coverage for those who can pass an insurer’s health screening, consumers in less-than-perfect health will not have access to those plans and will have to remain in the ACA-compliant market,” says Sabrina Corlette, JD, research professor and project director at Georgetown University’s Center on Health Insurance Reforms, where she studies private health insurance policy. “Consequently, when insurers face a market with a smaller and sicker pool of enrollees, they will either exit or raise their prices to protect themselves, leaving people with pre-existing conditions and those who want comprehensive coverage with higher costs and fewer plan choices.”

California is considering banning STLD plans, stating that limited coverage does not appropriately protect consumers and disqualifies people who are sick from buying coverage, which is discriminatory. Other states including Connecticut, Maryland, New Jersey, Hawaii, Minnesota, Rhode Island, Vermont, Washington, and the District of Columbia are rallying around the need to restore individual mandate penalties, Stefan says. In Alaska, Minnesota, and Oregon, lawmakers are considering policies that reintroduce the concept of reinsurance funds to help protect health insurers from high-cost enrollees and help lower costs for everyone else.

Some states support the Administration’s efforts to introduce new healthcare coverage alternatives. “States are looking for different avenues that will allow consumers to access coverage, and some think that expanding STLD plans, despite their lack of consumer protections, will provide a lower premium option,” Corlette says.

Missouri, for example, has passed a bill that would codify the Trump Administration’s proposal to extend the duration of STLD plans to 364 days. Minnesota’s legislature is considering a similar proposal. Other states, such as Iowa and Idaho, are hoping to expand other alternative coverage arrangements that can skirt the ACA’s market rules and consumer protections, Corlette says. These states are passing legislation and issuing guidance allowing insurers to offer plans that provide less comprehensive coverage and discriminate against sick people, resulting in a much lower sticker price.



Short-term plans could cause large differences in health insurance costs and options state-to-state, says Saeed Aminzadeh, CEO, Decision Point Healthcare Solutions, a predictive analytics management company. “Essentially, these plans play in a relatively unregulated field, with varying (if any) minimum benefits and varying rules governing who can be covered and what can be underwritten,” he says. “With this comes massive differences in costs and products, without a baseline on how these plans can be compared.”


If more Americans use STLD plans, Margaret Murray, 

 editorial advisor and CEO, Association for Community Affiliated Plans (ACAP), which represents plans that provide health insurance through publicly-supported programs, expects an unregulated market to arise that will ultimately attract the healthy, and turn ACA-compliant plans into ones that mainly attract high-risk individuals. ACAP recently contracted with Wakely Consulting Group to study how these plans would affect the ACA-compliant market over time. Over time, Wakely estimates that the proposed STLD plan changes and repeal of the individual mandate would lead to a 12.8% increase in premiums, and as many as 3.9 million people dropping ACA-compliant coverage.

Aminzadeh says short-term insurance plans will not be effective in lowering costs and improving quality. “Any initiative to reduce costs and avoidable utilization and improve quality works best when a member is continually engaged-they’re visiting their doctor, taking their medications, getting preventive screenings, and so forth,” he says. “Short-term plans, by design, will not promote these types of practices. In fact, these programs promote episodic care, which in turn can be a catalyst for increased overall costs.”

States that choose to allow the proliferation of alternative coverage, such as STLD plans, will find that their market becomes segmented, Corlette says. “Healthy people will flock to cheaper and less comprehensive plans; sick people and those who need comprehensive coverage, such as a couple wanting to start a family, will be forced to stay in the ACA-compliant market. That market will wither without healthy risk, and premiums will rise, driving even more people to cheaper alternatives. This is often referred to as the insurance death spiral, and it’s all too common when one set of insurers is allowed to play by a different set of rules.”

The bottom line, Aminzadeh says, is that there will be confusion, inconsistency, and incomparability.

Karen Appold is a medical writer in Lehigh Valley, Pennsylvania.

State policy variations related to these plans could have significant impacts on the overall insurance market. Here’s what you need to know.

State Policy Variations in Short Term Plans Could Affect the Industry

The number of Americans who believe vaccinations for diseases like measles and polio are crucial to public health has fallen 10% in the last 10 years (from 80% to 70%), according to a new survey from Research America.

The findings should be concerning for healthcare executives, not only due to the impact non-vaccinations can have on patients, but also due to the high cost.

The economic burden of diseases associated with 10 vaccines recommended by the CDC for adults was $8.95 billion, and unvaccinated people were responsible for almost 80% of that burden ($7.1 billion), according to a 

“Immunizations protect the public from serious diseases and assist in preventing illnesses, disabilities, and even deaths,” says Jennifer Seagle, PharmD, area clinical manager for CompleteRx. “Vaccines, when utilized, have the power to greatly reduce the financial burden on the healthcare global economy.”

Here are three vaccine developments that have far reaching implications.

Shingrix (GlaxoSmithKline), a recombinant zoster vaccine approved by the FDA in October 2017, has replaced Zostavax as the CDC’s preferred vaccine for the prevention of shingles in healthy adults 50 years and older. Shingrix is given as a two-dose series separated by two to six months and costs about $280 per two dose-series compared to $213 for a single Zostavax vaccine. In clinical trials, the efficacy of Shingrix topped 96.6% for adults 50 to 69 years old for prevention of shingles, but that fell to 92.3% in those older than 70.

The World Health Organization (WHO) along with other international health agencies including the Global Alliance for Rabies Control, developed the ‘Zero by 30’ initiative in 2015 with the goal to provide a common strategy to achieve zero human rabies deaths by 2030. The initiative focuses on improving access to vaccinations for bite victims, providing education on bite prevention and expanding dog vaccination coverage to reduce human exposure.

The Advisory Committee on Immunization Practice recommends annual influenza vaccination for all persons aged 6 months and older who do not have contraindications. According to the CDC, vaccine composition is reviewed annually through year-round surveillance in more than 100 national influenza centers around the world, after which the WHO makes recommendations on the composition of the influenza vaccine for each year. Overall vaccine effectiveness against influenza A-the predominant strain of influenza this season-was estimated at 25% as of February 15, 2018. The WHO made its recommendations in February for the strains to target for the 2018 to 2019 vaccine.

There are currently 214 vaccines in the pipeline worldwide, says Seagle. “Of those, 40 agents solely prevent influenza. Many vaccines are important during different stages of life and health insurers need to take this into account as they design plans.”

Two vaccines in development could greatly benefit public health. The first is a vaccine in phase 2 clinical trials for the prevention of 

 infections in patients who are undergoing pre-surgical prophylaxis for elected orthopedic surgery. The second is a vaccine in development for HIV that could be made available as early as 2020.

Erin Bastick, PharmD, RPh, is staff pharmacist at Southwest General Health Center, Middleburg Heights, Ohio.

Vaccines are an important part of creating “herd immunity” to keep infectious diseases in check. Here are three vaccine developments that have far reaching implications for public health.

Three Vaccine Developments Healthcare Execs Should Watch

One of the most formidable barriers to improving post-acute care is lack of trust between patients and their care teams, says Jamie Philyaw, MSW, vice president of care management at Raleigh-based Community Care of North Carolina (CCNC), a nonprofit organization that has a contract with the state to manage Medicaid patients.

She remembers a 50-something-year-old patient met by one of CCNC’s care managers at the patient’s hospital bedside a few years ago. The care manager didn’t know it at first, but this patient was living in a tent-and lacked access to medications for his heart disease or to a cardiologist. The care manager spent many months building trust with this patient, who was repeatedly readmitted, and who was also struggling with substance abuse and behavioral health issues.

CCNC learned about this particular patient through a daily report on hospital admissions the nonprofit receives from facilities throughout the state. The patient’s repeated hospital visits led to CCNC’s team classifying him as a priority patient, which meant he needed immediate support. Because of the trust the care manager built with him, the patient agreed to a referral to a cardiologist and accepted the offer of secure housing through a local faith-based organization.

The care manager even facilitated delivery of the patient’s medications to his tent before he accepted housing. That was “the carrot,” Philyaw says. It demonstrated to the patient that his care manager was invested in him as a person and helping to improving his health.

In addition to daily reports on hospital visits across the state, CCNC also receives patient referrals from practicing clinicians and through embedded care managers at hospitals and practices throughout the state.

While some hospitals and physician practices receive a high volume of Medicaid patients and, thus, merit having a full-time CCNC care manager embedded at the facility, other facilities may have a care manager on-site a few hours a week. CCNC “meets patients where they are,” whether that’s at the bedside or in a physicians practice, or in their home (or tent, in the situation with the 50-something-year-old patient mentioned earlier), says Philyaw.

The organization provides services to all 100 counties in the state, which means it has “a lot of boots on the ground,” she says.

Physicians rely on the care managers to help determine patients’ complex needs and how to facilitate appropriate post-acute care, says Paul Mahoney, vice president for communications, CCNC. In fact, one care manager has relationships with physicians that span more than nine years, he says.

A critical aspect of what helps the program work is ensuring care managers are viewed as an asset by physicians. For example, CCNC’s care managers add value rather than cause disruption to a busy emergency room, says Philyaw. They often have office space and a regular schedule at the healthcare facility, which means patients have access to care management services when they need it. Care managers also provide detailed care management reports, attend follow-up visits along with patients, and, in some cases, document care in the EHR.

Care managers often meet patients before they’ve been discharged from the hospital-literally, while they’re still in a hospital bed. It’s at this point that a care manager can get involved in discharge planning-and schedule in-home assessments to determine any socioeconomic factors that may impact their approach.

An in-home assessment by CCNC was a lifesaver for an 8-year-old girl who was visiting the ER monthly due to severe distress from asthma, says Mahoney. The nonprofit got a referral from a physician who was alarmed about the number of times the patient had been to the emergency room, he adds. During the home visit, the care manager witnessed that the child’s home was infested with cockroaches and severe mold.

Because the child was living with her family in public housing, CCNC contacted the municipality to have the necessary repairs made to the home and had the cockroaches removed. As a result, the child was put on the appropriate medications and can now attend school regularly, Mahoney says. Because CCNC could determine the root cause of the patient’s asthma-related distress, the state was able to save money that would have been spent treating her in a medical facility.

Danika Mills, MSW, director of care management, notes that, for every dollar invested in CCNC, the state receives $3 in value.

In terms of care quality, inpatient admissions for CCNC clients are 28% below expected admissions, and emergency room visits are 8.4% below expected, according to CCNC’s 2017 annual quality report. The nonprofit’s management of chronic diseases including diabetes and hypertension exceed five of six HEDIS benchmarks for all reporting years.
Information sharing considerations

Kristen Barlow, senior consultant at The Advisory Board, says post-acute care providers are largely “pen and paper endeavors,” meaning most don’t have access to the EHRs used by physician practices and hospitals.

That’s a “nut that hasn’t been cracked” by a lot of post-acute care providers, she says. One challenge is the financial barrier-in that EHR vendors charge for their software based on a per-user license basis and post-acute care providers can’t pay for access to all of their healthcare partners’ EHR platforms.

This is another reason CCNC’s approach of embedding care managers in hospitals and physician practices works. They have access to those providers’ EHRs, which gives the nonprofit greater insight into the patients it’s treating, says Philyaw. “It’s a win-win and, to my knowledge, we have not had a provider push back regarding payment for [EHR] access,” she says. Because CCNC works with Medicaid patients, the organization also has access to patients’ utilization history and claims data.

Soon the nonprofit will implement a platform from population health and care management software firm VirtualHealth, which will allow providers to make referrals to CCNC electronically. In addition, the platform will provide data feeds related to admissions, discharges, and transfers, medical and pharmacy claims, EHR and lab results, and risk scoring, in addition to other information types, says Adam Sabloff, founder and CEO.

Having this data in one place will increase collaboration and facilitate risk stratification, he says. While Sabloff credits health information exchanges with capturing data from some healthcare entities, these data entities don’t analyze information about patients’ hospitalizations or alert care providers that a patient needs a new medication, which he says the new platform will do.

A nonprofit organization is helping turn the tide on readmissions in North Carolina. The small steps it’s taking are resulting in big differences.

How Embedded Care Managers Reduce Readmissions

Generic drugs are not immune to price increases, and the problem is worsening.

Prices for these drugs fell 59% from the first quarter of 2010 through the second quarter of 2015, but prices for more than 20% of generic drugs increased more than 100% in the same time period, according to the Government Accountability Office (GAO).

The GAO considers lack of competition to be the primary driver of generic drug price increases. And in fact, the FDA reports that more than half of its approved generics are not being sold and another 14% are of “unknown marketing status.”

But experts say rising prices also can be attributed to pricing abuses, such as extending patents and exclusivity by branded drug manufacturers, and insufficient action by the FDA and government to ensure generic drugs are reviewed and approved for entry into the market.

The problem boils down to market dynamics, says Ken Majkowski, PharmD, chief pharmacy officer of FamilyWize, a community-based organization that offers a free prescriptions savings program. “Prices go up because pharmaceutical companies feel they can charge more and thus make more. They go down if there is increasing competition or threat of government intervention,” he says.

That is only the short list of challenges. Adding to the fray, are:

Patent extensions by slightly tweaking products.

Expenses associated with entering the marketplace.

 Backlogs of Abbreviated New Drug Applications (ANDAs).

More brand drug manufacturers paying generic companies not to launch drugs, a tactic which the Federal Trade Commission estimates costs U.S. consumers and taxpayers $3.5 billion in higher drug costs annually.

Circumstances in which the same product is sold under a generic name by the manufacturer of the branded product, enabling 180 days of exclusivity awarded to the first producer of a generic.

Little incentive from PBMs to encourage drug manufacturers to lower prices because profits increase as drug prices do.

Erin Fox, senior director of drug information, University of Utah Health, also points to excessive price hikes, as was the case with Daraprim (pyrimethamine), when Turing CEO Martin Shkreli hiked up the price overnight from $13.50 to $750 a tablet-a 4,000% increase for a drug first approved in 1953.

She also is concerned about the unintended consequences of the FDA’s 2006 Unapproved Drugs Initiative, which removed unapproved drugs from the market. For example, intravenous vasopressin for hypotension received FDA approval in November 2014 under the name of Vasostrict (vasopressin Injection). After being marketed for nearly a century without FDA approval, no other manufacturers were allowed to produce the drug. Its price soared to $138.40 per vial from it original cost of $4.27, a 3,141% increase, says Fox.

In the early 1980s, the Federal Food, Drug, and Cosmetic Act enabled generic companies to receive regulatory approval for drugs by filing ANDAs, but few manufacturers took advantage.

As a result, the Drug Price Competition and Patent Term Restoration Act of 1984, better known as the Hatch-Waxman Act, was born, encouraging innovation in pharmaceutical research and development through incentives and helping generic drugs reach the market more quickly. At the same time, it allows drug patent owners to regain the time lost on a patent term while awaiting FDA approval.

To close the circle started by Hatch-Waxman, the industry awaits the enactment of the Creates Act (which is pending in Congress) and the implementation of many promises made by President Trump and FDA Commissioner Scott Gottlieb, MD.

The Creates Act would promote drug price competition by making it easier for medicines with patents that have expired to be sold as less expensive generic versions.

The Act would also override misuse of the Risk Evaluation and Mitigation Strategy (REMS) by brand drug manufacturers. Manufacturers have used limited distribution as an excuse to prevent access to samples by generic companies for bioequivalence testing. The Act makes it possible for generic manufacturers to sue in federal court to obtain samples.

In June 2017, the FDA published a list of off-patent, off-exclusivity branded drugs without approved generics and implemented a new policy to speed up the review of generic drug applications when competition is limited until there are three approved generics for a given branded drug.

This past January, the agency moved closer to reducing gaming by branded companies that could delay generic drug entry; resolving scientific and regulatory obstacles to approval of generic versions of certain complex drugs; and reducing the time it takes to get a new generic drug approved, primarily by facilitating fewer review cycles.

While 90% of non-generic drug applications receive approval in the first cycle of review, only 30% of generics make it through on the first try, according to the FDA. However, 2017 was a record year for generic drug approvals: 763 new generic versions of drugs-112 more than in 2016 and almost twice as many as in 2014.

The FDA is creating incentives for developing biosimilars and an easier process for their approval, and plans to issue new guidance on how to more efficiently handle citizen petitions to prevent delay of generic drug review. Developed by the FDA, these petitions allow individuals and community organizations to request changes to health policy. Branded drug manufacturers submit more than 92% of these petitions, according to the FDA.

On May 11, President Trump discussed drug pricing during a press conference. He reemphasized the need for competition and a need to prevent foreign countries from providing the same drugs at lower costs. He also stated his support for eliminating drug middlemen and speeding up the approval of generics.

Academy of Managed Care Pharmacy CEO Susan A. Cantrell, RPh, says there are several opportunities for addressing the rising cost of pharmaceuticals that were not included in the president’s blueprint, such as reducing barriers to the adoption of value-based contracting and encouraging real-world evidence to demonstrate the value and quality of prescription medications in improving patient outcomes.

Prices of more than 20% of generic drugs increased more than 100% between 2010 and 2015.

How New Initiatives Could Affect Generic Drug Costs

One day, patients will be able to walk into telephone booth-like structures that analyze changes to their moles. The information derived from the booth will then help dermatologists identify possible signs of melanoma. At least, that’s what Joseph Kvedar, MD, vice president of Partners Connected Health, which leverages information technology to deliver patient care outside traditional medical settings, hopes will happen in the near future.

“Computers do much better than humans do at detecting those changes,” says Kvedar, who is also a dermatologist at Boston’s Partners HealthCare.

To help support that point, he cites an article 

, which revealed that computer algorithms can diagnose melanoma better or as well as dermatologists. Kvedar says that when computers can take on this task (a capability known as artificial intelligence), it will enable him to focus more on clinical decision-making and treatment plan discussions with patients.

In terms of the promise of artificial intelligence for clinical purposes, Kvedar casts the net much wider than dermatology. For example, specialties such as pulmonology, where lung changes need to be detected, and cardiology, where echocardiogram changes should be monitored, could benefit from the technology.

Here are five other technology developments to watch.

1. Digital health devices that help predict patient needs

One area that’s ripe for innovation is diabetes care, which costs $327 billion each year in the United States, 

the American Diabetes Association. Managing this chronic condition better would lead to a reduction in deaths, amputations, and other complications such as cardiovascular disease and damage to the nerves, kidneys, and eyes.

David Klonoff, MD, medical director at the Diabetes Research Institute at San Mateo, California’s Mills-Peninsula Medical Center, says that new wearable and implanted sensors that provide a “window into human physiology” are improving data collection among diabetic patients and patients with other chronic conditions.

“This torrent of data can be analyzed and stored in the cloud and then converted into actionable information, which can then be sent back to the patient,” he says.

Decision-support software can then instruct patients to take certain actions, such as taking more insulin, if no contraindications are present. For example, diabetes patients now have access to continuous glucose monitors which measure the glucose level every five minutes.

Klonoff adds that providers can use software to present patterns of glucose levels for future reference, advise what actions to take based on current levels and directional trends in glucose levels-and the software can also connect with insulin pumps to deliver appropriate doses of insulin.

What’s lacking, and what Klonoff hopes will be developed soon, is a process for assembling a highly detailed set of phenotypic and genotypic data that can predict outcomes and select the appropriate therapies for patients.

In addition, says Klonoff, healthcare leaders need to figure out how to validate the security of the vast amount of data generated by these and other medical devices, in addition to EHRs and other clinical and administrative applications (such as billing systems).

2. AI that helps payers and providers save time and money

As much buzz as there has been about using artificial intelligence for clinical purposes, companies that are using artificial intelligence for administrative services are increasingly receiving investment and attention.

Case in point: Mountain View, California-based Qventus, which recently received $30 billion in venture capital funding. The company launched with its first customer in 2014 and gives healthcare facilities real-time insight into their operations, such as the number of patients in the emergency room at any given time and opportunities to reduce unnecessary lab tests.

Harsha Madannavar, managing director and partner with L.E.K. Consulting, recommends keeping an eye on AI platforms that will help handle claims processing with a second level of scrutiny. That’s what payers really care about, he adds.

Futurists who want to figure out ways to optimize these processes for payers should focus on points of failure in the way claims are currently processed and opportunities to reduce the rate at which claims are reviewed inaccurately, says Madannavar.

3. Clinical support tools that improve decision making

One of the first specialties to adopt clinical support tools is radiology. Many radiologists interpreting digital mammography exams rely on computer-aided detection tools, which use algorithms to achieve high sensitivity and low false-positive rates to detect breast calcifications in mammograms.

In addition to improving diagnosis and treatment decisions, clinical support tools help radiologists interpret more exams each day. This will be helpful to the industry, especially given the aging population, Madannavar says.

One of the strongest value propositions for clinical support tools is their ability to reduce error rates, he says. For example, 

approximately one in 25 times, a doctor will incorrectly diagnose the existence of breast cancer in a patient’s lymph nodes

Outside the world of radiology, clinicians are using decision support tools to improve outcomes for patients. At Stanford Children’s Hospital, a clinical support tool called Premie BiliRecs is helping pediatricians determine whether patients need to be treated for hyperbilirubinemia, a condition that occurs when there’s too much bilirubin. The result of the excess bilirubin is jaundice, which may appear at birth or at any time after birth.

Jonathan Palma, MD, a clinical associate professor in pediatrics/neonatal and development medicine at Stanford Children’s Hospital, helped develop this tool because the evidence consensus for lab values for jaundice is “a bit wishy washy,” he says. Without this tool, pediatricians must rely on relatively ill-defined parameters to assess the existence of excess bilirubin in their patients, he says.

Pediatricians-or other members of the care team in the pediatric intensive care unit-can enter the patient’s post-menstrual age and their total serum bilirubin into the tool to determine if phototherapy is appropriate. The tool is available online, and pediatricians at Stanford Children’s can launch the tool within the hospital’s EHR, which then captures the patient’s clinical information and populates the tool with that information.

While treatment of jaundice isn’t prohibitively expensive, Palma says payers should be interested in this tool because treatment can be resource intensive; that means a nurse has to uncover the baby, find the light, and put it on the baby. He also notes that the long-term side effects of phototherapy are unknown.

The tool was built in late 2015, made available for use in January 2016, and has been in use at Stanford Children’s since then. Premie BiliRecs has been accessed more than 44,000 times inside Stanford University and elsewhere, says Palma, who notes that, with the tool, adherence to clinical recommendations have gone up from 48% to 70% of median-and some months, it hits 90% adherence.

4. Technology that improves information sharing and care coordination

 as distributed systems that log transaction records on linked blocks and then store them on an encrypted ledger. The security behind blockchain depends on a network of replicated, synched databases. Time- and date-stamped updates made by users are done on a permissions-based basis.

While blockchain got its start in 2008, it wasn’t until 2014 or 2015 that the healthcare industry started to consider how it could solve some of its most pressing challenges, such as providing patients with access to their comprehensive health data, says Mike Jacobs, senior distinguished engineer at Optum.

Jacobs expects that the industry won’t truly embrace this technology for another two to five years, but he’s excited about Optum’s partnership with Humana, MultiPlan, and Quest Diagnostics on a pilot program that uses blockchain. This project will attempt to ensure that provider data is available in health plan provider directories. The current cost of researching and making available accurate provider data is $2.1 billion annually, according to an announcement about the partnership.

The goals of the pilot, which was announced in April, include providing consumers with accurate information when they need it and potentially reducing operating costs while improving data quality. Rather than each entity calling providers to update their information in provider directories, this information will be shared across the partner organizations using blockchain.

5. Decision-support tools for pre-authorization and prescription costs

Several payers are developing tools to help consumers and providers better understand the cost of prescriptions. UnitedHealthcare, for example, has developed a tool that doctors can use within their EHR to provide real-time drug prices to patients, says Tim Kaya, chief operating officer for UnitedHealthcare Networks. Called PreCheck MyScript, the tool is tied to the specific pharmacy where the patient picks up their prescriptions and can also process any necessary prior authorizations in real time.

The tool provides lower-cost drug alternatives and confirms the patient’s out-of-pocket cost based on their specific benefit plan, says Kaya, noting that between 20% to 30% of all new prescriptions result in a call back to the prescriber, typically because the patient wasn’t aware of their out-of-pocket cost or the prescription required a pre-authorization. With this tool there will be “no more surprises” when the patient walks into the pharmacy, says Kaya.

The tool has processed 2.3 million transactions since it launched in summer 2017.

These tools will reduce healthcare costs and improve care quality.

Vol 28 No 7