May 06, 2021
3:42 pm
Biopharmaceutical companies are receiving justified praise for the rapid speed with which they produced effective vaccines against COVID-19, offering hope for a return to normalcy from a pandemic that has cost lives and damaged economies. The success of vaccine production underscores the critical importance of investments in research and development and the value those investments can bring in the future. Pfizer scientists, for example, are already exploring how the mRNA technology used to create a COVID-19 vaccine can be utilized to develop advanced treatments for cancer, HIV, and other diseases.
Thus, it’s mystifying that there is a push to discourage this kind of investment by shredding the intellectual property protections held by the vaccine makers.
The Biden Administration has done a superb job in COVID-19 vaccine distribution and administration, but it has taken a misstep on the intellectual property issue. Yesterday, the U.S. Trade Representative said that the United States would now support a move in the World Trade Organization to waive patent protections for vaccine products. India and South Africa had initiated this action, ostensibly to open the door for poorer countries to create their own generic version of vaccines.
Seeking this waiver is a move based on a false premise that vaccines are not making their way around the world. In fact, vaccine manufacturers have pledged to supply over 12 billion doses by the end of this year and working with the World Health Organization to supply doses to 90 developing countries at a discounted price. Eliminating patent protections will do less for global vaccine production and dissemination than what is already occurring. Any country seeking to make its own version would have to acquire vaccine components and the knowledge on how to manufacture the products and then generate large-scale manufacturing capabilities. This would take significant time.
The long-term harm here is to future research and development. Intellectual property protections are vital to the development of new treatments, cures and vaccines. Without those protections, there is no incentive to invest in the research cycle that can require years and billions of dollars just to get one new product through the development pipeline. The WTO move achieves limited short-term gain while risking damage that could leave the world more vulnerable to the next public health crisis.
September 16, 2020
3:09 pm
With progress continuing on development of a vaccine for COVID-19, conversations are taking place over the best strategies for distributing a vaccine, once approved, to millions of Americans. In the post below, two executives from Pfizer – one of the companies involved in coronavirus vaccine development – point out that local pharmacies are a logical vaccination site, but that will also require harmonization of state laws that affect the roles of pharmacists in providing care.
Enhance and Expand Access to Vaccines
By:
Robert Popovian, Pharm.D., MS, Vice-President US Government Relations, Pfizer Inc.
Dave Hering, Regional President, North America, for Pfizer Vaccines.
It was not so long ago, and certainly within the memory of many older Americans, when the fear and uncertainty we are experiencing today with coronavirus were much more common. Before the advent of vaccines for a vast number of diseases, it was not uncommon for people to know friends and family members who had contracted measles, mumps, rubella or polio. Families routinely had to deal with the impact of these diseases on everyday life and, more significantly, manage life-long disabilities like loss of vision, hearing or mobility.
There are scores of studies on the positive impact that vaccination has had on public health. In addition, vaccines are one of the most cost-beneficial interventions in health care. It is estimated that caring for unvaccinated adults costs the U.S. health care system approximately $7 billion per year.
Vaccination rates in the United States for most serious ailments are in the 90th percentile for children, while for adults, the immunization rates are abysmal. For example, less than 50 percent of adults age 19 and older get a flu shot every year. What’s even more alarming is that for adult patients between the ages of 18 and 65 with risk factors (e.g., patients with asthma or chronic bronchitis or smoking history), the rate of pneumococcal vaccination is only 23 percent. Both measures are well below the Healthy 2020 targets set by the U.S. Office of Disease Prevention and Health Promotion.
One approach to encourage adult vaccination is to further expand the ability of community-based pharmacists to administer vaccines. Patients and health systems have benefited most when pharmacists are allowed to immunize patients.
Roughly 9 out of 10 Americans live within 5 miles of a pharmacy that provides vaccination services to patients without an appointment. Community pharmacies offer extended hours of service compared to other sites-of-care, which is especially important for younger, healthier adults for whom immunization rates are exceptionally low.
Also, the evidence is clear that allowing pharmacists to administer vaccines is the lowest-cost alternative for providing this essential public health service. For the most vulnerable adults, our seniors, there may be additional access issues because a majority of family physicians either aren’t stocking or are unable to bill for all available vaccines, especially those reimbursed under Medicare Part D.
Unfortunately, there are significant variations in state laws governing pharmacists’ ability to immunize patients. States that have more restrictions on pharmacists’ ability to provide vaccinations may negatively affect public health and increase health care costs. Therefore, it is of utmost importance for states to expand and harmonize state laws governing pharmacist authority to immunize and allow pharmacists to administer all Food and Drug Administration-approved and Advisory Committee on Immunization Practices (ACIP) recommended adult vaccines.
The recent guidance from Health and Human Services (HHS) allows pharmacists to administer any COVID-19 vaccine, which is FDA-authorized or FDA-licensed, is a step in the right direction. However, the HHS direction under the Public Readiness and Emergency Preparedness Act (PREP Act) is time-limited and mandates that it be based on ACIP recommendation.
Reducing vaccine-preventable disease prevalence and overall health care costs is critical for all Americans. The best way to achieve both goals is through increased vaccination of adults in the United States, particularly at the pharmacy. Policymakers must take the important step of implementing state laws to expand pharmacists’ immunization authority for adults, so we are better prepared if and when the next public health crisis occurs.
August 13, 2020
4:49 pm
It actually seems elementary when you think about it. To deliver the best possible and most cost-efficient care to patients, particularly those with complex chronic conditions, it is essential for all aspects of the healthcare system – primary care physicians, specialists, hospitals, pharmaceutical and medical device manufacturers, pharmacies, and others – to work together to coordinate patient care and deliver comprehensive treatment.
Currently, however, our federal laws and regulations prevent that type of patient-centered collaboration. Measures known as the Stark Law and the Anti-Kickback Statute were created in the era of fee-for-service medicine to prevent bad actors from acting in ways adverse to a patient’s interests in order to gain some sort of financial benefit. In our current transition to holistic value-based care, though, these fraud and abuse safeguards are serving as daunting legal barriers to the kind of working relationships that deliver optimal health outcomes.
We are hopeful this is on the verge of changing. The Department of Health and Human Services has developed, with extensive public input, new rules to modernize these outdated laws and regulations and create opportunities for healthcare professionals and organizations to collaborate without fear of legal reprisal. There will still be more than adequate protections against fraud and abuse, but the obstacles to patient-centered, value-based care will be significantly alleviated.
These new rules were submitted by HHS to the Office of Management and Budget for final review and approval last month. The Healthcare Leadership Council is one of more than 120 healthcare companies, associations, and patient advocacy groups that has asked President Trump to intervene and bring this critical work across the regulatory finish line.
As the letter to the president puts it, with the finalization of these rules “victory can be claimed in the name of helping get better coordinated care and reducing overall healthcare costs.” We don’t see any reason to wait to begin reaping these benefits.
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.
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.
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