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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.

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.

Importing Prescription Drugs Will Create More Problems than it Solves

September 11, 2019
12:03 pm

Several years ago, there was a significant push in Congress to allow wholesale importation of prescription drugs from other countries into the United States.  The Healthcare Leadership Council found itself in an opportune position to examine this idea, given that our membership includes not only pharmaceutical manufacturers and healthcare payers, but also the companies that would facilitate the distribution of these imported products.

We found that the promised cost savings from importation were an illusion.  When shipping, relabeling, storage, liability coverage and other costs were factored into the mix, the cost differential between medicines in this country and those from countries that employ government price controls was largely erased.  It has never been surprising that HHS Secretaries and FDA Commissioners from both Republican and Democratic presidential administrations over the years have attested that the risks connected with drug importation far exceeded any possible rewards.

But now the issue is back in a big way.  States – including Vermont, Colorado, and Florida – have passed legislation to set up their own drug importation programs, pending federal government approval, and the current administration has indicated a willingness to work with them in making this happen.  Also, Congress is once again considering importation legislation. This is troubling.

The only difference between the drug importation issue today and when we first examined it is that the dangers have exacerbated while the benefits have not.  There are certain facts that policymakers should keep in mind when contemplating the prospects of opening our borders to drugs from outside the U.S.

  • We already have a drug crisis in this country, much of it fueled by the proliferation of lethal fentanyl that is originating in other countries and finding its way here through our ports and via the international mail service.
  • The world is facing an enormous health challenge driven by the increase in counterfeit drugs. The World Health Organization has estimated that one in every 10 pharmaceutical products in low- and middle-income countries is falsified or substandard.  Opening our borders increases our exposure to this danger.
  • Since we first examined this issue, there has been an explosion in the number of online pharmacies.  According to the National Association of Boards of Pharmacy, there are over 35,000 online drug sellers and 96 percent of them are in violation of applicable laws.  Many of these operations are based in Canada, the nation often cited as the safe place from which to import drugs.
  • And just to dispense with the notion that importing drugs from Canada will drastically lower prices, the numbers simply don’t work.  Canada’s population is barely more than one-tenth that of the United States and our neighbors to the north have already been enduring problems with drug shortages.  The idea that Canada can provide a sufficient supply of prescription medications to meet American demands is ludicrous.

By all means, we should be having a national conversation on healthcare affordability and accessibility in the United States, seeking solutions that will ensure patients have access to the treatments they need while also maintaining an environment that incentivizes lifesaving medical innovation.  A serious discussion requires credible ideas, though, and drug importation doesn’t fit that bill.

Congress Poised to Step Up for Medical Innovation

April 12, 2019
1:30 pm

In a city as divided along partisan lines as Washington, D.C. is these days, you don’t often come across a legislative idea that wins broad support from both sides of the aisle.  The fact that a majority of the U.S. House of Representatives is sponsoring legislation to repeal the medical device excise tax is a strong indicator that it’s time to act to take this counterproductive tax off the books.

This week, a House bill to repeal the medical device tax was introduced by a quartet of lawmakers, Representatives Ron Kind (D-WI), Jackie Walorski (R-IN), Scott Peters (D-CA) and Richard Hudson (R-NC).  This legislation has 227 original cosponsors and follows the introduction of a companion bill in the U.S. Senate by Senators Pat Toomey (R-PA) and Amy Klobuchar (D-MN).

Congress has previously acknowledged the inherent flaws in this tax by suspending its implementation.  The next logical step is full repeal.  A 2.3 percent excise tax on medical device company revenues – not profits – is extraordinarily punitive and disproportionately harmful to innovators still trying to establish themselves in the marketplace.  The tax has had a negative effect on investment and job creation and undermines medical innovation at a time in which we need to be incentivizing it.

Chronic disease continues to be the greatest driver of healthcare cost escalation.  By continuing to develop more effective treatments and technology, we can enable patients and their healthcare providers to better manage these conditions and reduce the frequency of emergency room visits and acute care episodes.  An excise tax on the tools needed to improve quality of life and achieve greater health system sustainability makes no sense.  A bipartisan majority of Congress wants to do away with this tax.  They should move expeditiously to do so.