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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.

Hello – It’s Your Healthcare Provider With an Important Message About Your Health

May 29, 2020
1:19 pm

By Bill Lucia
(Mr. Lucia is chairman, president and CEO of HMS, a leading healthcare technology and analytics company and a Healthcare Leadership Council member)

Nobody wants to have their dinner interrupted by a telemarketer or to be hassled at work by a debt collector. But how many of you welcome a call or text message from your healthcare provider when it pertains to your care?

If you answered yes, then you’re with the more than 98% of people who opt to continue these messages via text and or phone calls spanning appointment and prescription drug reminders, prescription drug recall notices, chronic disease management information and post-operative instructions.  Right now, some patients may occasionally receive these communications from their physician, pharmacist or insurer, but more often than not these communications simply don’t occur.

So what’s the hang up you ask? A long-standing federal law, the Telecommunication Consumer Protection Act (TCPA) and its corresponding regulations.

Passed by Congress in 1991, the TCPA sought to limit unwanted telemarketing calls and solicitations. Since the enactment, the Federal Communications Commission (FCC) issued a 2015 Order that created an exemption for healthcare messages intended to facilitate rightful and legitimate communications with patients while preventing telemarketing and other unwanted solicitations. The Order has fallen far short of its promise, however, and continues, along with the many technical requirements it includes, to block valuable and wanted communication between healthcare entities and patients, including those participating in government administered programs.

The current coronavirus (COVID-19) pandemic has put a spotlight on the importance of healthcare-specific communications and outreach and the TCPA barriers that otherwise stand in the way. On March 20, 2020, the Federal Communications Commission (FCC) declared that COVID-19 was an “emergency” under the TCPA, thereby further enabling such healthcare outreach.  As a result, information regarding CDC guidelines and recommendations, how to access telehealth, behavioral and mental health services, extended prescription refill authorizations, and prescription mail order instructions have been sent to millions of patients – enabling continuity of care, encouraging social distancing, and ensuring capacity to treat those affected by COVID through alternative care pathways for non-COVID patients.

Pandemic aside – the benefits of such healthcare outreach are numerous, including patient empowerment and consumerism, better outcomes, improved quality and cost containment.  For example, vaccination rates can be improved by 30% – critically important as we anxiously await a COVID vaccine, but also to address the growing gap in other routine baby and well child vaccines for preventable diseases like the measles.  For the highest cost, most vulnerable populations such as individuals with diabetes, mental illness, or cardiovascular disease, medication adherence is critical. With outreach and engagement, adherence can be improved by 5% – 25%.

Make no mistake these communications are not robocalls, or even unwanted. Rather, only patients with a known relationship are contacted and on average, 86% of patients have said these calls and messages are valuable and approximately 90% continue the message when given the option. While the FCC and Congress seek to thwart robocall efforts, albeit through the TRACED Act and accompanying regulations or otherwise, it’s important that those efforts don’t directly or indirectly interfere with the authorized call reminding a diabetic patient to refill his or her life-sustaining insulin medication, the call informing a parent how to schedule a well-child visit and important immunizations for their child, or other appropriate (and often automated) calls and texts that healthcare providers and payers place to patients.

While the novel coronavirus has pressed the need and value of patient engagement, permanently expanding the TCPA healthcare exception beyond the emergency period is desperately needed. At the same time, efforts to thwart unwanted communications must be targeted verses broad so as not to block wanted healthcare outreach. Both will have a positive impact on patient health and public health at large.

 

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.