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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.

Leading Hospital CEO Addresses Data Interoperability

February 25, 2020
11:51 am

Massive amounts of healthcare data are collected across the nation, and as technology advances the question of how to use it has continued to be a discussion.  There have been hearings on Capitol Hill about interoperability and data privacy and security, and the Healthcare Leadership Council (HLC) recently hosted a congressional briefing on the subject of health data.  The resources of the private sector have been focused on utilizing data for innovation in the treatment of patients.  There has been open dialogue between healthcare organizations and government agencies regarding the best way to approach regulations surrounding the use of health data.  Joseph Impicciche, the president and CEO of Ascension, in his Morning Consult op-ed supports proposed rules by the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid Services (CMS) on advancing nationwide interoperability and encourages additional work be done to ensure continuous improvement in patient outcomes.

HHS Policies to Promote Secure Exchange of Data Will Lead to Better Health Care

By Joseph Impicciche February 10, 2020

Health care is undergoing dramatic transformation, and the entities accountable for delivering compassionate care to patients are being challenged to meet these new and evolving needs. The dimensions of this transformation are deep and wide, and the complexities of providing care extend far beyond those traditionally involved in managing patients’ health and wellness.

Health care providers are focused on the same goal: improving health and health care for patients and consumers. This requires coordination across an expanding number of constituencies who must have access to greater clinical insight, leveraged to accelerate the delivery of novel care models and therapies. Essential to these requirements is access to robust clinical datasets and tools that facilitate real-time clinical workflow integration so that comprehensive care coordination is available to and benefits all those we serve, while maintaining patient data privacy and security.

With the future of health care dependent on the ability to make data-driven decisions, we applaud the Department of Health and Human Services’ continuous efforts and leadership through the Office of the National Coordinator for Health Information Technology and the Centers for Medicare and Medicaid Services on advancing nationwide interoperability. The proposed new policies have the potential to take an important next step in granting consumers seamless and secure access to data and increase the vehicles for the exchange of electronic health information across providers and systems. They should be used as the starting point for further discussions and potentially thoughtful modification, led by the spectrum of stakeholders involved in the delivery and receipt of care.

Every day, providers, patients and consumers find themselves trying to piece together the health information they need from siloed systems across the care delivery continuum. Within each of these systems, information is entombed in proprietary data models that effectively create dependency on a single electronic health record vendor’s platform.

Exchanging health information from disparate platforms has proven cumbersome. It can be difficult to positively confirm a patient’s identity, as no unique national identifier exists. And even when records can be accurately matched, the scope of data exchanged is often limited and not fully supportive of integrated care delivery across the continuum.

It recently has been suggested that these gaps are not significant impediments to the delivery of coordinated, whole-person care. Some argue that closing these gaps will create unsupportable fiscal and administrative burdens for health systems and providers, as well as untenable privacy and security risks for patients and consumers.

New policies must acknowledge and seek to ease the cost and administrative burden on providers; appropriate timelines should be afforded, and privacy and security risks should be mitigated. However, a properly considered rule should ultimately be finalized because of the overall benefit it will provide to patients and providers alike. We believe the cost of doing nothing is too high; the persistence of current approaches will not be economically sustainable and will not support the more sophisticated approaches to privacy and security that will be required to adequately serve patients, consumers and providers across the continuum.

Today, after incredible focus and expenditure by federal agencies and tireless work at technology adoption by numerous stakeholder groups, we’re still very far from realizing our shared goal: a robust, standards-based, cloud-enabled health care information architecture that will support broad health care data interoperability and benefit patients across the continuum of care.

The failure is multidimensional and includes the lack of common data model implementation at scale, the lack of a national health care information identifier at the individual level, and the absence of a meaningful scope of application program interfaces across health care technology platforms — both legacy and newly emerging platforms outside the traditional health care ecosystem.

The solution lies in applying new technologies — some developed in other industries — to accelerate the democratization of commoditized health care data housed in modern cloud-based architectures. Accordingly, we applaud the work of HHS, ONC and CMS in tackling what is admittedly a complex issue. They are seeking to develop a forward-looking policy that drives common health care data model development, supports accelerated development of APIs and promotes the development of software applications that support provider, patient and consumer choice in health care technology to enable true multiparty health care process integration.

Without a doubt, the pursuit of democratized health care information must be approached carefully and in parallel to the evolution of more sophisticated privacy and security frameworks. Multi-stakeholder input will be required to ensure that next-generation privacy and security policies account for the technological capabilities, increasing cybersecurity threats and greatly expanded scope of health care constituencies that now exist.

Recognition of the importance of these capabilities is not new. Foundational support for their achievement rests with a sweeping series of federal legislation enacted over the last 20 years, including the Health Insurance Portability and Accountability Act, the Health Information Technology for Economics and Clinical Health Act, the Affordable Care Act and others. The broad goal underpinning each of these policies was to create the framework necessary for the efficient and effective creation, distribution and utilization of digital health care information to benefit patients.

The work to build on these foundational policies must continue. HHS’ proposed rule warrants careful consideration and thoughtful modification to minimize burden, ensure data privacy and security and provide appropriate time for implementation. With such changes, HHS’ new rules will help advance the progression toward a framework that allows data to be optimally available to improve patient care while providing robust privacy protections and data security.

 

Joseph R. Impicciche, JD, MHA, is president and chief executive officer of Ascension.

The Necessary Next Step in the Battle Against Substance Addiction

January 28, 2020
3:42 pm

One area in which we have seen a great deal of bipartisanship in Washington is in the effort to prevent and treat substance use disorder.  In 2018, Congress passed groundbreaking legislation by overwhelming margins in both houses that gave states the resources they need to combat what was then commonly known as the opioid crisis.

But as U.S. Representative Diana DeGette (D-CO) pointed out at a recent congressional hearing, the battle is far from over.  As she said, this addiction crisis has come in waves – the first being prescription pain medicines, the second heroin, the third synthetic opioids like fentanyl, and now, “it looks like a ‘fourth wave’ of the crisis may have already arrived.  The opioid epidemic has fueled a huge increase in methamphetamine use.  In 2018, there were more than twice as many deaths involving meth as 2015, and meth is increasingly turning up in overdose deaths and drug busts across the country.”

Given this continued high level of addiction and overdose cases, it is imperative that we give healthcare providers the tools they need to effectively treat substance use disorder patients.  So, an essential next step in combating this drug crisis must involve addressing regulatory barriers that are standing between medical professionals and the information they need to provide effective diagnosis and treatment.

A law that is more than 40 years old, known as 42 CFR Part 2, places information sharing in substance use disorder cases on a different plane that that applied to all other patients under HIPAA laws.  42 CFR Part 2 places strict limitations on confidential data sharing among front-line caregivers and, in so doing, makes care coordination extraordinarily difficult.  This outdated law worsens the odds of substance use disorder patients surviving and recovering.

There are two bills that have been introduced in Congress to address this problem.  The Overdose Prevention and Patient Safety Act in the House and the Protecting Jessica Grubb’s Legacy Act in the Senate would remove these regulatory stumbling blocks and enable caregivers to have the information they need to do their jobs.

The necessity of these measures was underscored by an official with the North Carolina Department of Health and Human Services, who told Congress,  “We have invested a lot of resources through peer support and other tools to try to support that coordination, care management, etc. but there is still a huge limitation.  Even doctors within the same system can’t easily talk to each other to coordinate care around their patients.  North Carolina is fully supportive of modernizing 42 CFR in an attempt to maintain privacy but also move us to integrated care.”

National Obesity Care Week: Behind the Scenes of Obesity

September 19, 2019
4:19 pm

September 16-20 is National Obesity Care Week (NOCW).  NOCW is a source for science-based information on obesity.  More than 93 million Americans are affected by obesity, with an estimated cost of $480 billion to the healthcare system.  The Healthcare Leadership Council (HLC) has joined as a partner of NOCW, advancing our conviction that people who struggle with obesity deserve access to quality care and must be treated with dignity and respect.

Recently, HLC has been focused on how the healthcare system can utilize research on social determinants of health so that essential socioeconomic and environmental factors can be considered and addressed in addition to one’s clinical care.  At the beginning of this week, HLC hosted a Hill briefing that had an expert panel present on reducing disparities in health.  While this particular briefing looked at the whole patient from a pediatric and senior perspective rather than zeroing in on obesity, there is a strong relationship between obesity and low socioeconomic status that cannot be ignored.

Many HLC members have recognized the need to reach out and invest in the well-being of surrounding communities:

  • BlueCross BlueShield of Tennessee has taken many avenues to encourage healthy lifestyles of Tennesseans, such as revitalizing neighborhoods with parks, and repaving the roads with bike lanes.
  • The Bristol-Myers Squibb Foundation provided resources to establish one of New Jersey’s largest and most comprehensive children’s hospitals which includes a clinical center of excellence dedicated to the study and treat childhood obesity.
  • Fairview Health System launched a new 24-week Healthy Lifestyle Plan that combines evidence-based weight loss strategies with one-on-one lifestyle coaching.  This approach can address medical issues that make it hard for someone to lose weight on their own, such as hormone levels, the side effects of prescription drugs, or chronic conditions like sleep apnea.
  • Teladoc Health has invested in a personalized virtual care platform for physical and behavioral health, addressing the root of the problem for chronic disease with digital therapeutic interventions and sustainable behavioral change.

It is promising that across the healthcare spectrum there have been a variety of solutions offered to address obesity, but much progress must still be achieved to make a lasting impact on the health of millions of Americans.  Many people do not know that obesity is a disease, and education is the just the first step to achieving NOCW’s goal of access to comprehensive obesity care.  More voices are needed to enact change.  Additional information about ways to take action is available on ObesityCareWeek.org/ACTION.