A massive lawsuit filed in May by 44 states accuses 20 major drug makers of colluding for years to inflate prices on more than 100 generic drugs, including those to treat H.I.V., cancer and depression. If true, the alleged behavior is not just a violation of antitrust law, but also a betrayal of the government policies that created and defended the entire generic drug industry.
Most prescriptions in the U.S. today — 9 in 10 — are filled with generics, which are just as safe and effective as their brand-name equivalent. And yet generics account for only 22 percent of U.S. prescription drug spending. These prices are so low because of competition between makers of different versions of the same generic drug. The more competing generic alternatives, the lower the price, theoretically right down to the marginal cost of manufacturing the pill.
This success is the result of decades of careful federal and state policymaking, all geared towards introducing competition in prescription drug markets. The entire generic industry has its origins in the Hatch-Waxman Act of 1984. Prior to Hatch-Waxman, a company that wanted to sell a competing version of a drug whose patents had expired had to conduct lengthy and expensive clinical trials to get approval from the U.S. Food and Drug Administration. Hatch-Waxman established a quicker, less-expensive path to FDA approval that leans on the scientific research supporting the already approved brand-name drugs.
Hatch-Waxman also created incentives for generic drug makers to challenge drug patents that prevent competition. Successful challengers win a 180-day period of exclusivity during which their generic is the only one allowed to compete with the brand-name drug. The floodgates open and additional competition pushes prices down further after the 180-day period.
In this two-part series, we examine several common misconceptions
made by health tech start-up companies in working with Health Systems and
offers advice on how to recognize and address each. From approaching systems
with a solution-first mentality to not understanding the context in which
health systems work, we look to provide constructive criticisms meant to
support more effective partnerships between health systems and digital tech
and Reactions from the Industry
Understand the Current System Environment We Are Working In: In some cases,
technology solutions are barricading healthcare systems inside. In other
cases, they are allowing us to seamlessly interact with other systems. Typically, large healthcare systems have a
combination of both. For outside solutions to be effective,
start-ups need to be intimately familiar with the existing (and on-the-horizon)
systems that healthcare organizations are using or contemplating. Rarely
will a solution not have to interact with existing software solutions – and
this goes well beyond just the EMR.
Have an Integration Plan: A
stand-alone solution, which doesn’t tie to one or more of the healthcare
institutions key systems of record (SoR) or systems of engagement (SoE) is a
useless solution. Your solution should be able to stand alone in the first few
weeks, as users begin to use it and get familiar with its capabilities.
However, as soon as value is realized
(not necessarily achieved), it’s crucial that your solution support either SMART on FHIR, FHIR,
HL7v2.x, or all of the above. If you don’t have a believable integration story
fully worked out, you’re not ready to launch into the health system market. Go
back and do your homework.
Having a Clinician Is Nice, But Not Enough: The physician, nurse, or other clinician on your team helps credibility but we also understand the incentives associated with selling solutions, and this takes away from the altruism you think we will blindly swallow. And they are rarely businessmen or women who understand both the complexities of solving a problem that isn’t theirs and starting, let alone, running a company. Pair an MD with an MBA? Now we’re talking.
Start-ups are an increasingly important “node” within the
healthcare ecosystem. They are challenging status quo concepts that have
long been ingrained in the healthcare system, like questioning the value of
traditional EMR systems, or shifting the power of information to patients, or
breaking down cost and quality transparency barriers. They may be the future of
the industry, but startups have a long way to go to truly transform the
system. The reasons are many, from an incredibly convoluted and bureaucratic
review process and rigid risk-controlling regulations and policies, to the
large-scale organizational inertia most of our healthcare systems have.
And while all of these hurdles can and will be overcome if we work
together, there are still several lessons each “node” in the ecosystem can learn to more effectively work with each other.
This article is directed at the emerging digital solutions trying
resiliently to help transform this stubborn industry. It provides some critical
lessons in dealing with healthcare systems and is accompanied by reactions from
a digital solutions expert with serial digital health entrepreneurship
experience. We hope to provide perspective from two people living and
breathing, and surviving, from both sides of the
equation every day.
and Reactions from the Industry
Healthcare Startups Must Understand how Provider
Systems Operate: Most
health systems are increasingly becoming rightfully skeptical about new
solutions because they feel the solutions don’t understand the environment of
their system. To help overcome the challenges of introducing your innovation into a complex business and
clinical environment, startups must understand how health systems operate to
include how they make decisions, contract and evaluate solutions.
Recognize that Decisions are Consensus-driven and Permissions-based: Unlike
other industries, where “shadow IT” is rampant and there can be one or two “key
decision makers,” in health systems you’re not likely to get very far without
figuring out how to build consensus among an array of influencers and then
figuring out how to get permissions from a group of key decision makers. You
should seek a “Sherpa” that understands enough about your solution to champion
the idea of change – which is really what you’re seeking when you’re
selling a new solution (the solution is just the means to accomplish the change,
it’s the change that’s hard). The first thing to focus on is to identify the
group of decision makers and how you convince them that the status quo should
be abandoned in favor of any change –
then, once you know how to convince them of some
change you’ll work with the group to get the right permissions to work on the
change management process – which will then influence a purchase of your
Introduction Every day and in every corner of the country, innovative health care leaders are conceiving of strategies and programs to manage their patients’ health, as an alternative to treating their sickness (see Figure 1).
The value-based contracts that have proliferated in this
country over the past decade and which now account for about half of the money
spent on healthcare allow these wellness investments to make good financial
sense in addition to benefiting patient health.
However, a phenomenon in health coverage in the US is
increasing costs, destabilizing care continuity and holding back the potential
of value-based care. It prevents us from making the long-term investments we
Churn refers to gaining, losing, or moving between sources of coverage. Every year, approximately a quarter of the US population switches out of their health plan. Reasons can be voluntary or involuntary from the perspective of the beneficiary (see Table 1) and vary from changes in job status, eligibility, insurance offerings, and preference, to non-payment of premiums, to unawareness of pending coverage termination.
The Office of the National Coordinator (ONC) and the Centers for Medicare and Medicaid (CMS) have proposed final rules on interoperability, data blocking, and other activities as part of implementing the 21st Century Cures Act. In this series, we will explore the ideas behind the rules, why they are necessary and the expected impact. Given that these are complex and controversial topics open to interpretation, we invite readers to respond with their own ideas, corrections, and opinions. In part five of this series, we look at how competition unlocks innovation, and how the proposed rules may disrupt the balance between innovation, intellectual property (IP), and supporting business models.
The recent publication of proposed rules by ONC and CMS set off a flurry of activity. In anticipation of their implementation, the health care industry is wrestling with many questions around business models. What practices inhibit competition and innovation? How do we balance the need for competition while protecting legitimate intellectual property rights? How can vendors ensure profit growth when pricing is heavily regulated? In this article, we will examine how competition unlocks innovation and the possible disruptions the proposed rules may bring for innovation, intellectual property (IP) and supporting business models.
In most markets, innovation is driven forward by competition. Businesses compete on equal footing, and their investment in R&D drives innovation forward. Innovation in health care has been dramatically outpaced by other markets, leading to an urgent need for both disruptive and evolutionary innovation.
What is inhibiting health care innovation? The rules identify a combination of tactics employed in health care that restrict the free flow of clinical data, such as:
These tactics slow innovation by contributing to an
environment where stakeholders resist pushing the boundaries — often because
they are contractually obligated not
to. The legislation and proposed rules are designed to address the ongoing
failure of the market to resolve these conflicts.
As the rules are finalized, we will continue to monitor whether
the ONC defines these practices as innovation stifling and how they will
implement regulations — both carrot and stick — to move the industry forward.
In the 20th century, hospitals completed their
transformation from the hospice-like institutions of the Middle Ages, into
large, gleaming centers of advanced medical expertise and technology that save
and improve lives every day. But an unintended consequence of hospitals’
dazzling capabilities is a staggering cost burden that’s proving toxic to the
Today, hospital care accounts for approximately 33% of the US’ $3.5 trillion annual health care expenditures, according to CMS. The drivers of hospital costs are complex and hard to tackle, including (but not limited to) market consolidation that enables price hikes, heavy administrative burdens, expensive technology and patient usage patterns.
In The Innovator’s Prescription, Clayton Christensen et al. explained another important driver of high hospital care costs: conflation under one roof of business models designed to address very different needs—such as the need for diagnosis of unique, complex conditions and experimental treatments, versus that for highly standardized services (for instance, some surgical procedures). This common phenomenon makes optimization of either business model very difficult, and thus drives up overhead costs.
One solution to this seemingly intractable
problem is to make home and community the default locations for care, where in
many circumstances it can be provided less expensively, more conveniently, and
more effectively than in a hospital. Fortunately, business model innovation
toward this end is gaining traction.
The 2016 21st Century CURES Act is the law. It is built around two phrases: “information blocking” and “without special effort” that give the administration tremendous power to regulate anti-competitive behavior in the health information sector. The resulting draft regulation, February’s Notice of Proposed Rulemaking (NPRM) is a breakthrough attempt to bend the healthcare cost curve through patient empowerment and competition. It could be the last best chance to avoid a $6 Trillion, 20% of GDP future without introducing strict price controls.
This post highlights patient-directed access as the essential pro-competition aspect of the NPRM which allows the patient’s data to follow the patient to any service, any physician, any caregiver, anywhere in the country or in the world.
According the 2019 Bloomberg Healthiest Country Index, the U.S. ranks 35th out of 169 countries. Even though we are the 11th wealthiest country in the world, we are behind pretty much all developed economies in terms of health. In the Americas, not just Canada (16th) but also Cuba (30th), Chile and Costa Rica (tied for 33rd) rank ahead of us in this Bloomberg study.
To answer this layered question, we need to look at the top ranked countries in the Bloomberg Index: From first to 12th, they are Spain; Italy; Iceland; Japan; Switzerland; Sweden; Australia; Singapore; Norway; Israel; Luxembourg; and France. What are they doing right that the U.S. isn’t? In a nutshell, they embrace half a dozen critical economic and societal traits that are absent in the U.S.:
· Universal health care
· Better diet: fresh ingredients and less packaged and processed food
When it comes to access to health care, the 34 countries that are ahead of the U.S. in the Bloomberg health rankings all offer universal health care to their people. This means that preventive, primary and acute care is available to 100% of the population. In contrast, 25 – 30 million Americans do not have health care insurance, and an equal number are under insured. For 15 – 18% of our population, financial concerns about how to pay for a visit to the doctor, how to meet high insurance deductibles, or cash payments after insurance take precedence over taking care of their health. Lack of preventive care leads to visits to the emergency rooms for ailments that could have been prevented through regular primary care follow-up, at a very high cost to our health system. Note: We spent $10,700 per capita in health care in 2017, more than three as much as Spain ($3,200) and Italy ($3,400). Many Americans postpone important medical operations for years, until they reach 65 years of age, when they finally qualify for universal health care or Medicare. Lack of prevention and primary care, health interventions postponed, and the constant worry that medical costs might bankrupt one’s family: none of this is conducive to healthy lives.
As news of Tom Brokaw’s cancer diagnosis spreads, so does his revelation that his cancer treatments cost nearly $10,000 per day. In spite of this devastating diagnosis, Mr. Brokaw is not taking his financial privilege for granted. He is using his voice to bring attention to the millions of Americans who are unable to afford their cancer treatments.
My patient Phil is among them. At a recent appointment, Phil
mentioned that his wife has asked for divorce. When I inquired, he revealed a
situation so common in oncology, we have a name for it: Financial
Toxicity. This occurs when the burden of medical costs becomes so high,
it worsens health and increases distress.
Phil, at the age of 53, suffers with the same type of bone
cancer as Mr. Brokaw. Phil had to stop working because of treatments and
increasing pain. His wife’s full time job was barely enough to support
them. Even with health insurance, the medical bills were mounting. Many
plans require co-pays of 20 percent or more of total costs, leading to insurmountable
patient debt. Phil’s wife began to panic about their future and her debt
inheritance. In spite of loving her husband, divorce has felt like the only
solution to avoiding financial devastation.
Health systems and employers are bypassing insurers to deliver higher-quality, more affordable care
By MICHAEL J. ALKIRE
Employee health plan premiums are rising along with the total healthcare spending tab, spurring employers to rethink their benefits design strategy. Footing the tab, employers are becoming a more active and forceful driver in managing wellness, seeking healthcare partners that can keep their workforce healthy through affordable, convenient care.
health systems assume accountability for the health of their communities, a
market has been born that is ripe for new partnerships between local health
systems and national employers in their community to resourcefully and
effectively manage wellness and overall healthcare costs. Together, they are bypassing traditional
third-party payers to pursue a new type of healthcare financing and delivery
While just 3 percent of self-insured employers are contracting directly with health systems today, dodging third parties to redesign employee benefit and care plans is becoming increasingly popular. AdventHealth in Florida announced a partnership with Disney in 2018 to provide health benefits to Disney employees at a lower cost in exchange for taking on some risk, and Henry Ford Health System has a multi-year, risk-based contract with General Motors.
The notion of bypassing payers is attractive for employers, especially on the back of consecutive cost increases they and their employees have swallowed over the last several years. Payers have traditionally offered employers rigid, fee-for-service plans that not only provide little room for customization, but often exacerbate issues with care coordination and lead to suboptimal health outcomes for both employees and their families. Adding to this frustration for employers is the need to manage complex benefits packages and their corresponding administrative burdens.