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The Meaning of Personalized Healthcare

July 10, 2020
10:47 am

Personalized medicine is one of the very popular buzzphrases in healthcare, but not everyone has a complete understanding of what personalized healthcare means for patients, the healthcare system and the future of medicine.  HLC member Genentech has provided an important service by describing this branch of medical science and its potential in recently-published sponsored content in Politico.

In the Politico piece, Dr. Mark Lee, Global Head of Personalized Health Care, Product Development for Roche and Genentech describes personalized medicine succinctly, “Scientific and technological advancements are allowing us to leverage the vast amounts of data that we can access to help patients receive the right treatment at the right time.  Not every patient responds the same way, and it is incredibly challenging to predict who’s going to benefit from which medicine and how.  But there is now more data per patient than ever before, allowing us to hone in on the subtle differences that make each of us unique to deliver more personalized treatments that can yield better outcomes.”

As Dr. Lee points out, in addition to improving care at the patient level, having this detailed information about patients of different ages, ethnicities, genetic backgrounds and health conditions will transform and strengthen clinical trials and drug development in years to come.

I highly recommend this content in Politico to gain a greater understanding of how personalized medicine will change care delivery in the foreseeable future.

Nonessential Care Is Essential

June 16, 2020
12:18 pm

An op-ed appeared in the New York Times entitled, “How Many More Will Die From Fear of the Coronavirus?”  Written by Cleveland Clinic chief executive and president Dr. Tomislav Mihaljevic and Mayo Clinic chief executive and president Dr. Gianrico Farrugia, the message is clear: the longer people avoid healthcare settings and ignore nonessential care, the more people will die preventable deaths.  These two well-respected leaders have made the case for people to return to their doctors with the reassurance that providers have transformed their work environments and are ready to treat people with Covid-19 precautions in place.  The “new normal” is here and may be around to stay for some time.  The full op-ed is available here.

 

Seriously ill people avoided hospitals and doctors’ offices. Patients need to return. It’s safe now.

By Tomislav Mihaljevic and Gianrico Farrugia

More than 100,000 Americans have died from Covid-19. Beyond those deaths are other casualties of the pandemic — Americans seriously ill with other ailments who avoided care because they feared contracting the coronavirus at hospitals and clinics.

The toll from their deaths may be close to the toll from Covid-19. The trends are clear and concerning. Government orders to shelter in place and health care leaders’ decisions to defer nonessential care successfully prevented the spread of the virus. But these policies — complicated by the loss of employer-provided health insurance as people lost their jobs — have had the unintended effect of delaying care for some of our sickest patients.

To prevent further harm, people with serious, complex and acute illnesses must now return to the doctor for care.

Across the country, we have seen sizable decreases in new cancer diagnoses (45 percent) and reports of heart attacks (38 percent) and strokes (30 percent). Visits to hospital emergency departments are down by as much as 40 percent, but measures of how sick emergency department patients are have risen by 20 percent, according to a Mayo Clinic study, suggesting how harmful the delay can be. Meanwhile, non-Covid-19 out-of-hospital deaths have increased, while in-hospital mortality has declined.

These statistics demonstrate that people with cancer are missing necessary screenings, and those with heart attack or stroke symptoms are staying home during the precious window of time when the damage is reversible. In fact, a recent poll by the American College of Emergency Physicians and Morning Consult found that 80 percent of Americans say they are concerned about contracting the coronavirus from visiting the emergency room.

Unfortunately, we’ve witnessed grievous outcomes as a result of these delays. Recently, a middle-aged patient with abdominal pain waited five days to come to a Mayo Clinic emergency department for help, before dying of a bowel obstruction. Similarly, a young woman delayed care for weeks out of a fear of Covid-19 before she was transferred to a Cleveland Clinic intensive care unit with undiagnosed leukemia. She died within weeks of her symptoms appearing. Both deaths were preventable.

The true cost of this epidemic will not be measured in dollars; it will be measured in human lives and human suffering. In the case of cancer alone, our calculations show we can expect a quarter of a million additional preventable deaths annually if normal care does not resume. Outcomes will be similar for those who forgo treatment for heart attacks and strokes.

Over the past 12 weeks, hospitals deferred nonessential care to prevent viral spread, conserve much-needed personal protective equipment and create capacity for an expected surge of Covid-19 patients. During that time, we also have adopted methods to care for all patients safely, including standard daily screenings for the staff and masking protocols for patients and the staff in the hospital and clinic. At this point, we are gradually returning to normal activities while also mitigating risk for both patients and staff members.

The Covid-19 crisis has changed the practice of medicine in fundamental ways in just a matter of months. Telemedicine, for instance, allowed us to pivot quickly from in-person care to virtual care. We have continued to provide necessary care to our patients while promoting social distancing, reducing the risk of viral spread and recognizing patients’ fears.

Both Cleveland Clinic and Mayo Clinic have gone from providing thousands of virtual visits per month before the pandemic to hundreds of thousands now across a broad range of demographics and conditions. At Cleveland Clinic, 94 percent of diabetes patients were cared for virtually in April.

While virtual visits are here to stay, there are obvious limitations. There is no substitute for in-person care for those who are severely ill or require early interventions for life-threatening conditions. Those are the ones who — even in the midst of this pandemic — must seek the care they need.

Patients who need care at a clinic or hospital or doctor’s office should know they have reduced the risk of Covid-19 through proven infection-control precautions under guidelines from the Centers for Disease Control and Prevention. We’re taking unprecedented actions, such as restricting visiting hours, screening patient and caregiver temperatures at entrances, encouraging employees to work from home whenever possible, providing spaces that allow for social distancing, and requiring proper hand hygiene, cough etiquette and masking.

All of these strategies are intended to significantly reduce risk while allowing for vital, high-quality care for our patients.

The novel coronavirus will not go away soon, but its systemic side effects of fear and deferred care must.

We will continue to give vigilant attention to Covid-19 while urgently addressing the other deadly diseases that haven’t taken a pause during the pandemic. For patients with medical conditions that require in-person care, please allow us to safely care for you — do not delay. Lives depend on it.

The Systemic Flaw that is Health Inequity

April 15, 2020
5:51 pm

During times of crisis, a point of structural weakness becomes glaringly visible and vulnerable.  The COVID-19 pandemic has placed a spotlight on the inequities that exist in this country when it comes to health and well-being.  The importance of the social determinants of health is more apparent than ever.

As concerns grew about the virus spreading, the predominant proportion of white collar workers could storm the grocery stores and then settle in for the long haul in front of their laptops.  Meanwhile, blue collar workers began losing jobs and health protection, or were forced to work in hazardous conditions, constantly at risk of exposure to the virus.  Available data is making clear the socioeconomic divide that COVID-19 has laid bare.  In New York City, the bottom income quadrant accounts for 36 percent of all coronavirus cases in the city while the top quadrant accounts for just 10 percent.

Those who have no choice but to risk exposure in order to receive a paycheck, or conduct daily life activities like visit a laundromat or make frequent trips to the grocery store because they don’t have the money to stock up the pantry, are the ones who have the least access to quality healthcare to protect their lives.  People in low-income jobs, or who have lost their job during the pandemic, face hospitalizations with high out-of-pocket costs if they become sick.  They also frequently don’t have the support systems to help them in the event of serious illness.

As this virus has a greater impact on those who are less able to achieve social distancing, it’s creating a greater awareness of the work that needs to be done on social determinants.  The World Health Organization has provided examples of the factors that, besides clinical care, play a role in population health.  Safe and affordable housing, access to education, public safety, availability of healthy foods, local health services, toxic-free environments – all have a tremendous effect on our health and longevity and too many Americans are lacking some or all of these determinants.

The good news is that the healthcare industry is devoting considerable resources and attention to addressing health disparities and the social determinants of health.  The Healthcare Leadership Council has held a national summit on the issue and issued a report with specific recommendations.  And, on the ground, we’re seeing multiple initiatives that are demonstrating how community health programs, telehealth services, and expanding the definition of health benefits to include commodities like housing and transportation are making a difference in the lives of vulnerable populations.

The COVID-19 crisis is making it clear that we need to accelerate these efforts.

Addressing the Bacterial Infection Threat That Can Complicate Covid-19 Cases

March 31, 2020
9:52 am

Dr. Julie Gerberding, former head of the Centers for Disease Control and Prevention and today an executive vice president for Merck for strategic communications, global public policy, and population health wrote an op-ed for STAT News on the high mortality rate associated with COVID-19 patients who develop a secondary bacterial infection.  She said this underscores the need for research and development into new antibiotics.  The op-ed is found below and here.

Antibiotic resistance: the hidden threat lurking behind Covid-19

By Julie L. Gerberding

March 23, 2020

The ongoing Covid-19 pandemic highlights the critical need for rapid development of vaccines and antiviral treatments to reduce the number of hospitalizations and deaths caused by this dangerous new coronavirus, SARS-CoV-2. The biopharmaceutical industry has quickly responded and at least 80 candidates are already in development. With good luck, we will eventually have some of the tools we need to fight this new global threat.

But there is an even larger threat lurking behind the current outbreak, one that is already killing hundreds of thousands of people around the world and that will complicate the care of many Covid-19 patients. It is the hidden threat from antibiotic resistance — bacteria that are not killed by standard antibiotics. Unfortunately, the pipeline of drugs to manage these deadly infections is nearly dry.

Although antibiotic resistance hasn’t gotten our attention in the same way that SARS-CoV-2 has, antibiotic-resistant bacteria present a growing global menace. In the U.S. alone, we see 2.8 million antibiotic-resistant infections each year and more than 35,000 deaths, though experts fear that the real number is much higher. The so-called superbugs that cause these infections thrive in hospitals and medical facilities, putting all patients — whether they’re getting care for a minor illness or major surgery — at risk.

The patients at greatest risk from superbugs are the ones who are already more vulnerable to illness from viral lung infections like influenza, severe acute respiratory syndrome (SARS), and Covid-19. The 2009 H1N1 influenza pandemic, for example, claimed nearly 300,000 lives around the world. Many of those deaths — between 29% and 55% — were actually caused by secondary bacterial pneumonia, according to the Centers for Disease Control and Prevention. It’s a one-two punch: A virus can weaken the body, making it easier for complex, hard-to-treat bacteria to take hold.

The new coronavirus is no exception. Already, some studies have found that 1 in 7 patients hospitalized with Covid-19 has acquired a dangerous secondary bacterial infection, and 50% of patients who have died had such infections. The challenge of antibiotic resistance could become an enormous force of additional sickness and death across our health system as the toll of coronavirus pneumonia stretches critical care units beyond their capacity.

Seventeen years ago, when I was leading the CDC, we worried about antibiotic resistance complicating the care of SARS patients. We knew then that America’s arsenal of antibiotics was not sufficient to guarantee we could manage a large outbreak of drug-resistant bacteria. Since then, these bacteria have only become more widespread, more deadly, and far more difficult to treat, yet our stable of antibiotics to manage them has barely increased. In fact, the gap between the superbug threats we face and the antibiotics we have to combat them is rapidly growing wider.

We can’t predict when or where the next pandemic-triggering virus will emerge, but we can predict that secondary bacterial infections will follow. To fight these superbugs, we desperately need new antibiotics. An important question policymakers should be asking themselves is this: Why don’t we have powerful antibiotics on hand when we need them the most?

In a perfect world, we would always have new antibiotics to fight emerging antibiotic-resistant infections, ready to use when a crisis like the Covid-19 pandemic strikes. But developing new antibiotics takes time and can cost more than $1 billion and that investment cannot be recovered by wide use of new antibiotics because they must be used as sparingly as possible to preserve their effectiveness for as long as possible.

Current hospital reimbursement systems generally discourage use of new antibiotics, even when patients clearly need them, because they are more expensive than older antibiotics. Understandably, hospitals that are already challenged to cover the rising costs of care find it hard to justify the inclusion of more expensive drugs on their formularies.

As a result of this unique market dynamic — low reimbursement and low-volume use — many of our country’s most promising antibiotic developers have gone out of business or suffered severe financial losses, including three biotechnology companies within the last year.

This market failure must be corrected as if lives depend on it because they do — as we may soon see as cases of Covid-19 increase. Reimbursement reform will both improve appropriate access to novel antibiotics and encourage private investment in the pipeline. While other proposals have been discussed, including stockpiling and further grant funding for research, these measures do not address the underlying issues.

Recognizing this need is critical, Sens. Bob Casey (D-Pa.) and Bill Cassidy (R-La.) and Reps. Danny Davis (D-Ill.) and Kenny Marchant (R-Texas) have introduced the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act, a bipartisan bill that would reform Medicare reimbursement to make it easier for hospitals to use the antibiotic that is most appropriate for a patient. Right now, there’s a strict cap on how much hospitals are reimbursed by Medicare for inpatient services, which deters use of new targeted antibiotics that might be the best course of therapy for patients with superbug infections.

Passing the DISARM Act is a first step we can take to help ensure that hospitals are not financially penalized when providing patients the lifesaving antibiotics they need. This is good for patients and will, in turn, sustain the confidence investors need to support companies developing new antibiotics. Policymakers must also create incentives, like market entry rewards and other “pull” mechanisms, that clearly signal to biopharmaceutical companies that the antibiotic pipeline merits ongoing research and development investment.

As we come together to fight today’s Covid-19 crisis, we must also look ahead to the next one. We cannot be short-sighted, and we cannot be complacent, especially about antibiotic resistance. We must put measures in place to ensure that we have the antibiotics we need — today and in the future. The time to act is now.

Julie L. Gerberding, M.D., is chief patient officer and executive vice president for strategic communications, global public policy, and population health at Merck. She was director of the CDC from 2002 to 2009.

Guest Post: The Underutilization of Prevention

March 12, 2020
11:50 am

Robert Popovian is Vice President of U.S. Government Relations at Pfizer

One of the most underutilized ways to reduce medical costs in the U.S. is health care prevention. Unfortunately, politicians choose instead to implement draconian policies such as price controls or utilization management, which focus solely on cost management without any consideration given to patient outcomes or the value of an intervention to society.

The reason policymakers promote these types of measures is twofold. One, these policies are simple to implement and two, they reach their intended results quickly by reducing budgets, whether it be hospital costs or drug expenditures. On the other hand, promotion of preventative measures are complicated and challenging to implement and are thus ignored, despite the fact that the data show that such measures lead to better patient outcomes, including improvements in quality of life and productivity.

The two examples of preventative interventions that have not only shown to reduce costs but also improve outcomes are improving immunization rates and medication adherence.

Vaccines are one of the most cost-beneficial interventions in health care. In the U.S., we have done a great job ensuring our children are protected from various communicable diseases. Vaccination rates for most serious ailments are in the 90th percentile for children. However, the same cannot be said when it comes to adults, as their vaccination rates are abysmal. For example, less than 50% of adults get a flu shot every year.  What’s even more alarming is that approximately 20% of high-risk patients (e.g., patients suffering from lung disease) receive a pneumococcal vaccine. Both measures are well below the Healthy 2020 targets set by the Office of Disease Prevention and Health Promotion (ODPHP).

One approach to encourage adult vaccination is to further expand community-based pharmacist immunization capabilities. The evidence is clear that allowing pharmacists to provide vaccinations is the lowest cost alternative for providing this essential public health service. So it is vital that we expand and harmonize state laws governing pharmacist authority to immunize and to allow pharmacists to administer all Food and Drug Administration (FDA) approved and Advisory Committee for Immunization Practices (ACIP) recommended vaccines.

The second example of a cost-saving preventative intervention is medication adherence. One of the most cost-effective ways to improve patient adherence is through pharmacist-led medication synchronization. Medication synchronization is a service that has been offered for the past several years by pharmacists to patients who take multiple chronic medications.

A pharmacist collaborating with a physician and in consultation with the patient ensures that all of the patient’s medications are refilled on the same day. Pharmacists operationalize the concept by making an appointment with a patient to pick up their prescriptions every month, or at 60 or 90 days — depending on the refill schedule — and to discuss other issues pertinent to their care, such as over-the-counter medicine usage, smoking cessation needs or vaccination requirements. Medication synchronization has not only reduced the number of trips a patient has to take to the pharmacy and lessened the administrative burden for pharmacists and physicians, but most importantly it has led to better patient medication adherence and cost savings overall.

In 2014, for example, the Centers for Medicaid and Medicare Services (CMS) decided that patients enrolled in Medicare Part D plans should have the opportunity to synchronize their medications if they choose to and if it is deemed appropriate by their pharmacist or physician, not only because it improved adherence but also because of the overall health care cost reductions. In their analysis, CMS stated, “while the estimated total 6-year cost of this rule to Part D sponsors is $0.5 million, the savings to Part D sponsors and beneficiaries is $1.8 billion.” More recently, a research article published in Health Affairs suggested that patients with cardiovascular disease whose medications were synchronized were three times more adherent with their medications leading to 9% lower hospitalization and emergency department visits.

Fortunately, most states except for California and a handful of smaller ones have taken the lead from CMS to allow all patients in need to benefit from medication synchronization. It is now up to the pharmacists to offer this service universally to their patients.

No one denies that saving health care costs is a noble cause, and everyone agrees that it is not an easy task. However, policymakers are only focusing on the side of the ledger marked “cost”.  Instead, they should be implementing policies that guide us towards the goal of disease prevention to achieve the ultimate endpoint of reducing health care costs while improving patient outcomes.